<?xml version="1.0" encoding="UTF-8"?>
<FEDREG xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:noNamespaceSchemaLocation="FRMergedXML.xsd">
    <VOL>89</VOL>
    <NO>237</NO>
    <DATE>Tuesday, December 10, 2024</DATE>
    <UNITNAME>Contents</UNITNAME>
    <CNTNTS>
        <AGCY>
            <EAR>
                Agency Health
                <PRTPAGE P="iii"/>
            </EAR>
            <HD>Agency for Healthcare Research and Quality</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Supplemental Evidence and Data Request:</SJ>
                <SJDENT>
                    <SJDOC>Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies, </SJDOC>
                    <PGS>99265-99267</PGS>
                    <FRDOCBP>2024-28933</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Agricultural Marketing</EAR>
            <HD>Agricultural Marketing Service</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Referendum Procedure:</SJ>
                <SJDENT>
                    <SJDOC>Natural Grass Sod Promotion, Research, and Information Order, </SJDOC>
                    <PGS>99059-99064</PGS>
                    <FRDOCBP>2024-28388</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Natural Grass Sod Promotion, Research, and Information Order, </DOC>
                    <PGS>99149-99169</PGS>
                    <FRDOCBP>2024-28389</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Agriculture</EAR>
            <HD>Agriculture Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Agricultural Marketing Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Commodity Credit Corporation</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Farm Service Agency</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Forest Service</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>99212</PGS>
                    <FRDOCBP>2024-28941</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>AIRFORCE</EAR>
            <HD>Air Force Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>99232-99233</PGS>
                    <FRDOCBP>2024-28967</FRDOCBP>
                </DOCENT>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Scientific Advisory Board, </SJDOC>
                    <PGS>99233</PGS>
                    <FRDOCBP>2024-28919</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Army</EAR>
            <HD>Army Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>99233-99234</PGS>
                    <FRDOCBP>2024-28968</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Consumer Financial Protection</EAR>
            <HD>Bureau of Consumer Financial Protection</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Defining Larger Participants of a Market for General-Use Digital Consumer Payment Applications, </DOC>
                    <PGS>99582-99654</PGS>
                    <FRDOCBP>2024-27836</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Centers Medicare</EAR>
            <HD>Centers for Medicare &amp; Medicaid Services</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Medicare and Medicaid Programs:</SJ>
                <SJDENT>
                    <SJDOC>Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly, </SJDOC>
                    <PGS>99340-99579</PGS>
                    <FRDOCBP>2024-27939</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Civil Rights</EAR>
            <HD>Civil Rights Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>U.S. Virgin Islands Advisory Committee, </SJDOC>
                    <PGS>99221</PGS>
                    <FRDOCBP>2024-28894</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Utah Advisory Committee, </SJDOC>
                    <PGS>99220-99221</PGS>
                    <FRDOCBP>2024-28893</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Commerce</EAR>
            <HD>Commerce Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>International Trade Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Oceanic and Atmospheric Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Patent and Trademark Office</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Commodity Credit</EAR>
            <HD>Commodity Credit Corporation</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Funds Availability:</SJ>
                <SJDENT>
                    <SJDOC>Marketing Assistance for Specialty Crops, </SJDOC>
                    <PGS>99212-99220</PGS>
                    <FRDOCBP>2024-29017</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Consumer Product</EAR>
            <HD>Consumer Product Safety Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Testing and Recordkeeping Requirements for Carpets and Rugs, </SJDOC>
                    <PGS>99231-99232</PGS>
                    <FRDOCBP>2024-28898</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Defense Department</EAR>
            <HD>Defense Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Air Force Department</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Army Department</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Navy Department</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>99234-99237</PGS>
                    <FRDOCBP>2024-28970</FRDOCBP>
                      
                    <FRDOCBP>2024-28971</FRDOCBP>
                      
                    <FRDOCBP>2024-28972</FRDOCBP>
                      
                    <FRDOCBP>2024-28973</FRDOCBP>
                      
                    <FRDOCBP>2024-28974</FRDOCBP>
                      
                    <FRDOCBP>2024-28975</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Education Department</EAR>
            <HD>Education Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>President's Board of Advisors on Historically Black Colleges and Universities, </SJDOC>
                    <PGS>99239-99240</PGS>
                    <FRDOCBP>2024-28944</FRDOCBP>
                </SJDENT>
                <SJ>Membership:</SJ>
                <SJDENT>
                    <SJDOC>National Advisory Committee on Institutional Quality and  Integrity, </SJDOC>
                    <PGS>99238-99239</PGS>
                    <FRDOCBP>2024-28979</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Employment and Training</EAR>
            <HD>Employment and Training Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Federal Unemployment Tax Act Credit Reductions Applicable for 2024, </DOC>
                    <PGS>99282-99283</PGS>
                    <FRDOCBP>2024-28880</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Energy Department</EAR>
            <HD>Energy Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Energy Regulatory Commission</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Environmental Protection</EAR>
            <HD>Environmental Protection Agency</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Federal Good Neighbor Plan for the 2015 Ozone National Ambient Air Quality Standards;</SJ>
                <SJDENT>
                    <SJDOC>Notice on Remand of the Record of the Good Neighbor Plan to Respond to Certain Comments, </SJDOC>
                    <PGS>99105-99129</PGS>
                    <FRDOCBP>2024-28739</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Air Quality State Implementation Plans; Approvals and Promulgations:</SJ>
                <SJDENT>
                    <SJDOC>South Carolina; Updates to the Cross-State Air Pollution Rule, </SJDOC>
                    <PGS>99180-99184</PGS>
                    <FRDOCBP>2024-28873</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Washington; Southwest Clean Air Agency; Revisions to Excess Emissions, Startup, Shutdown, and General Requirements, </SJDOC>
                    <PGS>99177-99180</PGS>
                    <FRDOCBP>2024-28804</FRDOCBP>
                </SJDENT>
                <SJ>Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Chlorpyrifos, </SJDOC>
                    <PGS>99184-99207</PGS>
                    <FRDOCBP>2024-28332</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>White House Environmental Justice Advisory Council, </SJDOC>
                    <PGS>99252-99253</PGS>
                    <FRDOCBP>2024-28953</FRDOCBP>
                </SJDENT>
                <SJ>Pesticide Registration Review:</SJ>
                <SJDENT>
                    <SJDOC>Proposed Decisions for Several Pesticides, </SJDOC>
                    <PGS>99253-99257</PGS>
                    <FRDOCBP>2024-28976</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>
                Export Import
                <PRTPAGE P="iv"/>
            </EAR>
            <HD>Export-Import Bank</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Co-Financing Certificate, </SJDOC>
                    <PGS>99259-99260</PGS>
                    <FRDOCBP>2024-28903</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Exporter's Certificate for Loan Guarantee and Medium-Term Insurance Programs, </SJDOC>
                    <PGS>99257-99258</PGS>
                    <FRDOCBP>2024-28915</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Itemized Statement of Payments Long-Term Guarantee and Direct Loan—Local Costs, </SJDOC>
                    <PGS>99257</PGS>
                    <FRDOCBP>2024-28904</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Itemized Statement of Payments—Local Costs for Export-Import Bank Credit Guarantee Facility, </SJDOC>
                    <PGS>99258</PGS>
                    <FRDOCBP>2024-28906</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Itemized Statement of Payments—Long-Term Guarantees and Direct Loans—U.S. Costs, </SJDOC>
                    <PGS>99258-99259</PGS>
                    <FRDOCBP>2024-28905</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Itemized Statement of Payments—U.S. Costs for Export-Import Bank Credit Guarantee Facility, </SJDOC>
                    <PGS>99260</PGS>
                    <FRDOCBP>2024-28907</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Multi-Buyer Select Risk Policy Exclusions Worksheet, </SJDOC>
                    <PGS>99259</PGS>
                    <FRDOCBP>2024-28902</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Farm Service</EAR>
            <HD>Farm Service Agency</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Funds Availability:</SJ>
                <SJDENT>
                    <SJDOC>Marketing Assistance for Specialty Crops, </SJDOC>
                    <PGS>99212-99220</PGS>
                    <FRDOCBP>2024-29017</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Aviation</EAR>
            <HD>Federal Aviation Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Airspace Designations and Reporting Points:</SJ>
                <SJDENT>
                    <SJDOC>Youngstown/Warren, OH, </SJDOC>
                    <PGS>99064-99065</PGS>
                    <FRDOCBP>2024-28922</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments, </DOC>
                    <PGS>99065-99069</PGS>
                    <FRDOCBP>2024-28936</FRDOCBP>
                      
                    <FRDOCBP>2024-28937</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Airspace Designations and Reporting Points:</SJ>
                <SJDENT>
                    <SJDOC>Cheyenne, WY, </SJDOC>
                    <PGS>99173-99175</PGS>
                    <FRDOCBP>2024-28872</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Stanford, MT, </SJDOC>
                    <PGS>99172-99173</PGS>
                    <FRDOCBP>2024-28869</FRDOCBP>
                </SJDENT>
                <SJ>Airworthiness Directives:</SJ>
                <SJDENT>
                    <SJDOC>Airbus Helicopters, </SJDOC>
                    <PGS>99169-99172</PGS>
                    <FRDOCBP>2024-28831</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Energy</EAR>
            <HD>Federal Energy Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Application:</SJ>
                <SJDENT>
                    <SJDOC>Lake Upchurch Dam Preservation Association, </SJDOC>
                    <PGS>99241-99242</PGS>
                    <FRDOCBP>2024-28956</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Midwest Hydro, LLC, </SJDOC>
                    <PGS>99242-99246</PGS>
                    <FRDOCBP>2024-28961</FRDOCBP>
                      
                    <FRDOCBP>2024-28963</FRDOCBP>
                      
                    <FRDOCBP>2024-28966</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>STS Hydropower, LLC, </SJDOC>
                    <PGS>99250-99252</PGS>
                    <FRDOCBP>2024-28958</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Combined Filings, </DOC>
                    <PGS>99240-99241, 99248-99249</PGS>
                    <FRDOCBP>2024-28955</FRDOCBP>
                      
                    <FRDOCBP>2024-28957</FRDOCBP>
                </DOCENT>
                <SJ>Effectiveness of Exempt Wholesale Generator and Foreign Utility Company Status:</SJ>
                <SJDENT>
                    <SJDOC>Westlands Transmission Project Owner, LLC, BRP Avila BESS LLC, et al., </SJDOC>
                    <PGS>99241</PGS>
                    <FRDOCBP>2024-28952</FRDOCBP>
                </SJDENT>
                <SJ>Environmental Assessments; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Texas Connector Pipeline, LLC, Texas Connector Amendment Project, </SJDOC>
                    <PGS>99247</PGS>
                    <FRDOCBP>2024-28964</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Federal and State Current Issues Collaborative, </DOC>
                    <PGS>99243-99244</PGS>
                    <FRDOCBP>2024-28965</FRDOCBP>
                </DOCENT>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>WorkshOPP on FERC's Role in Regulating the Construction and Restoration of Interstate Natural Gas Transmission Pipeline Projects, </SJDOC>
                    <PGS>99244</PGS>
                    <FRDOCBP>2024-28962</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Oil Pipeline Capacity Allocation Issues and Anomalous Conditions, </DOC>
                    <PGS>99249-99250</PGS>
                    <FRDOCBP>2024-28960</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Financial</EAR>
            <HD>Federal Financial Institutions Examination Council</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Appraisal Subcommittee, </SJDOC>
                    <PGS>99260-99261</PGS>
                    <FRDOCBP>2024-28908</FRDOCBP>
                      
                    <FRDOCBP>2024-28909</FRDOCBP>
                      
                    <FRDOCBP>2024-28912</FRDOCBP>
                      
                    <FRDOCBP>2024-28913</FRDOCBP>
                      
                    <FRDOCBP>2024-28916</FRDOCBP>
                      
                    <FRDOCBP>2024-28917</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Highway</EAR>
            <HD>Federal Highway Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>99323-99324</PGS>
                    <FRDOCBP>2024-28947</FRDOCBP>
                </DOCENT>
                <SJ>Final Federal Agency Action:</SJ>
                <SJDENT>
                    <SJDOC>I-15; 24th Street Interchange Project in Utah; Finding of No Significant Impact, </SJDOC>
                    <PGS>99324-99325</PGS>
                    <FRDOCBP>2024-28986</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Maritime</EAR>
            <HD>Federal Maritime Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Closure of Investigation into Conditions Affecting United States Carriers in Connection with Canadian Ballast Water Regulation in the United States/Canada Great Lakes Trade, </DOC>
                    <PGS>99261-99263</PGS>
                    <FRDOCBP>2024-28996</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Railroad</EAR>
            <HD>Federal Railroad Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>99325-99327</PGS>
                    <FRDOCBP>2024-28921</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Reserve</EAR>
            <HD>Federal Reserve System</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Change in Bank Control:</SJ>
                <SJDENT>
                    <SJDOC>Acquisitions of Shares of a Bank or Bank Holding Company, </SJDOC>
                    <PGS>99263</PGS>
                    <FRDOCBP>2024-28992</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Privacy Act; Systems of Records, </DOC>
                    <PGS>99263-99265</PGS>
                    <FRDOCBP>2024-28926</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Trade</EAR>
            <HD>Federal Trade Commission</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Telemarketing Sales Rule, </DOC>
                    <PGS>99069-99076</PGS>
                    <FRDOCBP>2024-28399</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Fish</EAR>
            <HD>Fish and Wildlife Service</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Endangered and Threatened Species:</SJ>
                <SJDENT>
                    <SJDOC>Endangered Species Status for the Penasco Least Chipmunk and Designation of Critical Habitat, </SJDOC>
                    <PGS>99656-99687</PGS>
                    <FRDOCBP>2024-28338</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Status for the Fluminense Swallowtail Butterfly, Harris' Mimic Swallowtail Butterfly, and Hahnel's Amazonian Swallowtail Butterfly, </SJDOC>
                    <PGS>99129-99138</PGS>
                    <FRDOCBP>2024-28430</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Endangered and Threatened Species:</SJ>
                <SJDENT>
                    <SJDOC>12-Month Not-Warranted Finding for the Rio Grande Cutthroat Trout, </SJDOC>
                    <PGS>99207-99211</PGS>
                    <FRDOCBP>2024-28749</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Forest</EAR>
            <HD>Forest Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Environmental Impact Statements; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Wallowa-Whitman National Forest, Oregon; Wallowa-Whitman National Forest Travel Management Plan; Withdrawal, </SJDOC>
                    <PGS>99220</PGS>
                    <FRDOCBP>2024-28920</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Health and Human</EAR>
            <HD>Health and Human Services Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Agency for Healthcare Research and Quality</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Centers for Medicare &amp; Medicaid Services</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Institutes of Health</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Interior</EAR>
            <HD>Interior Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Fish and Wildlife Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Land Management Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Park Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Office of Natural Resources Revenue</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Surface Mining Reclamation and Enforcement Office</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>
                International Trade Adm
                <PRTPAGE P="v"/>
            </EAR>
            <HD>International Trade Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Antidumping or Countervailing Duty Investigations, Orders, or Reviews:</SJ>
                <SJDENT>
                    <SJDOC>Certain Carbon and Alloy Steel Cut-to-Length Plate from the Republic of Korea, </SJDOC>
                    <PGS>99224-99225</PGS>
                    <FRDOCBP>2024-28990</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Forged Steel Fittings from the People's Republic of China, </SJDOC>
                    <PGS>99221-99223</PGS>
                    <FRDOCBP>2024-28928</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Organic Soybean Meal from India, </SJDOC>
                    <PGS>99223-99224</PGS>
                    <FRDOCBP>2024-28991</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Refillable Stainless Steel Kegs from the People's Republic of China, </SJDOC>
                    <PGS>99226-99227</PGS>
                    <FRDOCBP>2024-28946</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>International Trade Com</EAR>
            <HD>International Trade Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Investigations; Determinations, Modifications, and Rulings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Certain Networking Equipment Supporting NETCONF, </SJDOC>
                    <PGS>99277-99278</PGS>
                    <FRDOCBP>2024-28925</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Certain Power Converter Modules and Computing Systems Containing the Same, </SJDOC>
                    <PGS>99278-99280</PGS>
                    <FRDOCBP>2024-28935</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Paper File Folders from Cambodia and Sri Lanka, </SJDOC>
                    <PGS>99281</PGS>
                    <FRDOCBP>2024-28983</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Silicomanganese from India, Kazakhstan, and Venezuela, </SJDOC>
                    <PGS>99281</PGS>
                    <FRDOCBP>2024-28982</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Justice Department</EAR>
            <HD>Justice Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>United States Marshals Service</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Labor Department</EAR>
            <HD>Labor Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Employment and Training Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Mine Safety and Health Administration</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Diesel-Powered Equipment in Underground Coal Mines, </SJDOC>
                    <PGS>99283-99284</PGS>
                    <FRDOCBP>2024-28888</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Notification of Methane Detected in Underground Metal and Nonmetal Mine Atmospheres, </SJDOC>
                    <PGS>99283</PGS>
                    <FRDOCBP>2024-28878</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Land</EAR>
            <HD>Land Management Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Mineral Surveys, Mineral Patent Applications, Adverse Claims, Protests, and Contests, </SJDOC>
                    <PGS>99269-99270</PGS>
                    <FRDOCBP>2024-28948</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Onshore Oil and Gas Operations and Production, </SJDOC>
                    <PGS>99270-99271</PGS>
                    <FRDOCBP>2024-28950</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Surveys and Focus Groups to Support Outcomes-Focused Management (Recreation Survey and Focus Groups), </SJDOC>
                    <PGS>99268-99269</PGS>
                    <FRDOCBP>2024-28951</FRDOCBP>
                </SJDENT>
                <SJ>Application for Withdrawal:</SJ>
                <SJDENT>
                    <SJDOC>John R. Fox Range, Fort Huachuca, AZ; Opportunity for Public Meeting, </SJDOC>
                    <PGS>99271-99272</PGS>
                    <FRDOCBP>2024-28938</FRDOCBP>
                </SJDENT>
                <SJ>Oil and Gas Lease Sale:</SJ>
                <SJDENT>
                    <SJDOC>Detailed Statement for the Coastal Plain 2025 Sale, </SJDOC>
                    <PGS>99270</PGS>
                    <FRDOCBP>2024-28989</FRDOCBP>
                </SJDENT>
                <SJ>Public Land Order:</SJ>
                <SJDENT>
                    <SJDOC>No. 7953; Withdrawal Revocation, Restoration of Public Lands, Transfer into Trust, Nevada, </SJDOC>
                    <PGS>99272-99273</PGS>
                    <FRDOCBP>2024-28949</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Mine</EAR>
            <HD>Mine Safety and Health Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Testing, Evaluation, and Approval of Electric Motor-Driven Mine Equipment and Accessories, </DOC>
                    <PGS>99085-99105</PGS>
                    <FRDOCBP>2024-28315</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Petition:</SJ>
                <SJDENT>
                    <SJDOC>Modification of Application of Existing Mandatory Safety Standards, </SJDOC>
                    <PGS>99284-99314</PGS>
                    <FRDOCBP>2024-29031</FRDOCBP>
                      
                    <FRDOCBP>2024-29033</FRDOCBP>
                      
                    <FRDOCBP>2024-28879</FRDOCBP>
                      
                    <FRDOCBP>2024-28882</FRDOCBP>
                      
                    <FRDOCBP>2024-28883</FRDOCBP>
                      
                    <FRDOCBP>2024-28884</FRDOCBP>
                      
                    <FRDOCBP>2024-28885</FRDOCBP>
                      
                    <FRDOCBP>2024-28886</FRDOCBP>
                      
                    <FRDOCBP>2024-28887</FRDOCBP>
                      
                    <FRDOCBP>2024-28890</FRDOCBP>
                      
                    <FRDOCBP>2024-28891</FRDOCBP>
                      
                    <FRDOCBP>2024-29027</FRDOCBP>
                      
                    <FRDOCBP>2024-29030</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Institute</EAR>
            <HD>National Institutes of Health</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Government-Owned Materials, </DOC>
                    <PGS>99267-99268</PGS>
                    <FRDOCBP>2024-28924</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Labor</EAR>
            <HD>National Labor Relations Board</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Performance Review Board Members, </DOC>
                    <PGS>99314</PGS>
                    <FRDOCBP>2024-28877</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Oceanic</EAR>
            <HD>National Oceanic and Atmospheric Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Fisheries of the Atlantic:</SJ>
                <SJDENT>
                    <SJDOC>Atlantic Migratory Group Cobia; 2024 Commercial Closure for Atlantic Migratory Group Cobia, </SJDOC>
                    <PGS>99147-99148</PGS>
                    <FRDOCBP>2024-28943</FRDOCBP>
                </SJDENT>
                <SJ>Fisheries of the Northeastern United States:</SJ>
                <SJDENT>
                    <SJDOC>2025 Specifications for the Summer Flounder, Scup, Black Sea Bass, and Bluefish Fisheries, </SJDOC>
                    <PGS>99138-99147</PGS>
                    <FRDOCBP>2024-28845</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Summer Flounder Fishery; 2024 Commercial Quota Harvested for the State of Connecticut, </SJDOC>
                    <PGS>99138</PGS>
                    <FRDOCBP>2024-28889</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Taking or Importing of Marine Mammals:</SJ>
                <SJDENT>
                    <SJDOC>Marine Site Characterization Surveys off Rhode Island and Massachusetts, </SJDOC>
                    <PGS>99227-99230</PGS>
                    <FRDOCBP>2024-28994</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Park</EAR>
            <HD>National Park Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Draft Director's Order:</SJ>
                <SJDENT>
                    <SJDOC>Policies and Procedures Governing Accessibility of Facilities, Programs, Services, and Activities, </SJDOC>
                    <PGS>99273</PGS>
                    <FRDOCBP>2024-28942</FRDOCBP>
                </SJDENT>
                <SJ>National Register of Historic Places:</SJ>
                <SJDENT>
                    <SJDOC>Pending Nominations and Related Actions, </SJDOC>
                    <PGS>99273-99275</PGS>
                    <FRDOCBP>2024-28981</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Science</EAR>
            <HD>National Science Foundation</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Advisory Committee for Technology, Innovation and Partnerships; Cancellation, </SJDOC>
                    <PGS>99314</PGS>
                    <FRDOCBP>2024-28977</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Navy</EAR>
            <HD>Navy Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>99237-99238</PGS>
                    <FRDOCBP>2024-28969</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Nuclear Regulatory</EAR>
            <HD>Nuclear Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Environmental Assessments; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Louisiana Energy Services, LLC, dba Urenco USA, National Enrichment Facility, </SJDOC>
                    <PGS>99314-99316</PGS>
                    <FRDOCBP>2024-28929</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Natural Resources</EAR>
            <HD>Office of Natural Resources Revenue</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>States' Decisions on Participating in Accounting and Auditing Relief for Federal Oil and Gas Marginal Properties, </DOC>
                    <PGS>99275-99276</PGS>
                    <FRDOCBP>2024-28876</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Patent</EAR>
            <HD>Patent and Trademark Office</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Anti-Piracy Symposium, </SJDOC>
                    <PGS>99230-99231</PGS>
                    <FRDOCBP>2024-28133</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Personnel</EAR>
            <HD>Personnel Management Office</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>President's Commission on White House Fellowships Advisory Committee, </SJDOC>
                    <PGS>99316</PGS>
                    <FRDOCBP>2024-28940</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>
                Pipeline
                <PRTPAGE P="vi"/>
            </EAR>
            <HD>Pipeline and Hazardous Materials Safety Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>National Environmental Policy Act Implementing Procedures:</SJ>
                <SJDENT>
                    <SJDOC>Proposed Categorical Exclusions, </SJDOC>
                    <PGS>99327-99334</PGS>
                    <FRDOCBP>2024-28899</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Postal Regulatory</EAR>
            <HD>Postal Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>New Postal Products, </DOC>
                    <PGS>99316-99317</PGS>
                    <FRDOCBP>2024-28901</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Securities</EAR>
            <HD>Securities and Exchange Commission</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>List of Rules to be Reviewed Pursuant to the Regulatory Flexibility Act, </DOC>
                    <PGS>99175-99176</PGS>
                    <FRDOCBP>2024-28353</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>99319-99320</PGS>
                    <FRDOCBP>2024-28875</FRDOCBP>
                </DOCENT>
                <SJ>Self-Regulatory Organizations; Proposed Rule Changes:</SJ>
                <SJDENT>
                    <SJDOC>New York Stock Exchange, LLC, </SJDOC>
                    <PGS>99320-99322</PGS>
                    <FRDOCBP>2024-28897</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>NYSE Arca, Inc., </SJDOC>
                    <PGS>99318-99319</PGS>
                    <FRDOCBP>2024-28896</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Small Business</EAR>
            <HD>Small Business Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Disaster Declaration:</SJ>
                <SJDENT>
                    <SJDOC>Havasupai Tribe; Public Assistance Only, </SJDOC>
                    <PGS>99322</PGS>
                    <FRDOCBP>2024-28923</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>State Department</EAR>
            <HD>State Department</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>International Traffic in Arms:</SJ>
                <SJDENT>
                    <SJDOC>Registration Fees, </SJDOC>
                    <PGS>99081-99085</PGS>
                    <FRDOCBP>2024-29032</FRDOCBP>
                </SJDENT>
                <SJ>Visas:</SJ>
                <SJDENT>
                    <SJDOC>Special Immigrant Visas—U.S. Government Employee Special Immigrant Visas for Service Abroad, </SJDOC>
                    <PGS>99076-99081</PGS>
                    <FRDOCBP>2024-28846</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Culturally Significant Objects Imported for Exhibition:</SJ>
                <SJDENT>
                    <SJDOC>Jack Whitten: The Messenger, </SJDOC>
                    <PGS>99322-99323</PGS>
                    <FRDOCBP>2024-28918</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Myth and Marble: Ancient Roman Sculpture from the Torlonia Collection, </SJDOC>
                    <PGS>99323</PGS>
                    <FRDOCBP>2024-28911</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Surface Mining</EAR>
            <HD>Surface Mining Reclamation and Enforcement Office</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Exemption for Coal Extraction Incidental to the Extraction of Other Minerals, </SJDOC>
                    <PGS>99276-99277</PGS>
                    <FRDOCBP>2024-28997</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Transportation Department</EAR>
            <HD>Transportation Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Aviation Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Highway Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Railroad Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Pipeline and Hazardous Materials Safety Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>U.S. Marshals</EAR>
            <HD>United States Marshals Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Preliminary Background Check Form, </SJDOC>
                    <PGS>99281-99282</PGS>
                    <FRDOCBP>2024-28954</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Veteran Affairs</EAR>
            <HD>Veterans Affairs Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Change in Student Status, </SJDOC>
                    <PGS>99335</PGS>
                    <FRDOCBP>2024-28895</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Privacy Act; Systems of Records, </DOC>
                    <PGS>99335-99338</PGS>
                    <FRDOCBP>2024-28959</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <PTS>
            <HD SOURCE="HED">Separate Parts In This Issue</HD>
            <HD>Part II</HD>
            <DOCENT>
                <DOC>Health and Human Services Department, Centers for Medicare &amp; Medicaid Services, </DOC>
                <PGS>99340-99579</PGS>
                <FRDOCBP>2024-27939</FRDOCBP>
            </DOCENT>
            <HD>Part III</HD>
            <DOCENT>
                <DOC>Bureau of Consumer Financial Protection, </DOC>
                <PGS>99582-99654</PGS>
                <FRDOCBP>2024-27836</FRDOCBP>
            </DOCENT>
            <HD>Part IV</HD>
            <DOCENT>
                <DOC>Interior Department, Fish and Wildlife Service, </DOC>
                <PGS>99656-99687</PGS>
                <FRDOCBP>2024-28338</FRDOCBP>
            </DOCENT>
        </PTS>
        <AIDS>
            <HD SOURCE="HED">Reader Aids</HD>
            <P>Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.</P>
            <P>To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.</P>
        </AIDS>
    </CNTNTS>
    <VOL>89</VOL>
    <NO>237</NO>
    <DATE>Tuesday, December 10, 2024</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <RULES>
        <RULE>
            <PREAMB>
                <PRTPAGE P="99059"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Agricultural Marketing Service</SUBAGY>
                <CFR>7 CFR Part 1240</CFR>
                <DEPDOC>[Doc. No. AMS-LP-21-0028]</DEPDOC>
                <RIN>RIN 0581-AE07</RIN>
                <SUBJECT>Natural Grass Sod Promotion, Research, and Information Order; Referendum Procedures</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Agricultural Marketing Service, USDA.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This rule establishes procedures for conducting a referendum to determine whether issuance of the proposed Natural Grass Sod Promotion, Research, and Information Order (Order) is favored by natural grass sod producers. The procedures will also be used for any subsequent referenda under the Order. The proposed Order is published separately in this issue of the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective December 10, 2024.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Maribel Reyna, Director, Research and Promotion Division, Telephone: (202) 302-1139; or Email: 
                        <E T="03">Maribel.Reyna@usda.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This final rule is issued pursuant to the Commodity Promotion, Research, and Information Act of 1996 (1996 Act) (7 U.S.C. 7411-7425).</P>
                <P>
                    As part of this rulemaking process, two proposed rulemakings were published in the 
                    <E T="04">Federal Register</E>
                     on October 16, 2023. The first rulemaking described the industry's proposed Order (88 FR 71306), and the second rulemaking proposed referendum procedures for the Order (88 FR 71302). Both proposed rulemakings provided a 60-day comment period that ended December 15, 2023. A total of 72 comments were received for the proposed referendum procedures and 174 comments were received for the proposed Order. The comments for the proposed Order are addressed in a separate proposed rulemaking published in this issue of the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD1">Executive Orders 12866, 13563, and 14094</HD>
                <P>Executive Orders (E.O.) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. E.O. 14094 updates and modernizes E.O. 12866 and directs agencies to conduct proactive outreach to engage interested and affected parties through a variety of means, such as through field offices, and alternative platforms and media. This final rule does not meet the definition of a significant regulatory action contained in section 3(f) of E.O. 12866, as amended by E.O. 14094, and, therefore, the Office of Management and Budget (OMB) has waived review of this action.</P>
                <HD SOURCE="HD1">Executive Order 12988</HD>
                <P>This final rule has been reviewed under E.O. 12988, Civil Justice Reform. It is not intended to have retroactive effect. Section 524 of the 1996 Act provides that it shall not affect or preempt any other Federal or State law authorizing promotion or research relating to an agricultural commodity.</P>
                <P>Under section 519 of the 1996 Act, a person subject to an order may file a written petition with the Secretary of Agriculture (Secretary) stating that the order, any provision of the order, or any obligation imposed in connection with the order, is not established in accordance with the law, and requesting a modification of the order or an exemption from the order. Any petition filed challenging an order, any provision of an order, or any obligation imposed in connection with an order, shall be filed within two years after the effective date of the order, provision, or obligation subject to challenge in the petition. The petitioner will have the opportunity for a hearing on the petition. Thereafter, the Secretary will issue a ruling on the petition. The 1996 Act provides that the district court of the United States for any district in which the petitioner resides or conducts business shall have jurisdiction to review a final ruling on the petition, if the petitioner files a complaint for that purpose not later than 20 days after the date of the entry of Secretary's final ruling.</P>
                <HD SOURCE="HD1">Executive Order 13175</HD>
                <P>This final rule has been reviewed under E.O. 13175, Consultation and Coordination with Indian Tribal Governments. E.O. 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on: (1) policies that have tribal implications, including regulations, legislative comments, or proposed legislation; and (2) other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.</P>
                <P>AMS has assessed the impact of this final rule on Indian tribes and determined that this final rule will not have tribal implications that require consultation under E.O. 13175. AMS hosts a quarterly teleconference with tribal leaders where matters of mutual interest regarding the marketing of agricultural products are discussed. Information about the regulation will be shared during an upcoming quarterly call, and tribal leaders will be informed about the proposed Order and the opportunity to vote. AMS will work with the U.S. Department of Agriculture (USDA) Office of Tribal Relations to ensure meaningful consultation is provided as needed with regards to the regulations.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    AMS will conduct the referendum. AMS will also conduct extensive outreach to natural grass sod producers to inform them of the referendum voting process and the deadlines for voting. As an up-front referendum, producers will vote on whether they favor issuance of the proposed Order, which was revised based on comments received from the public. The program will be implemented if it is favored by a simple majority of natural grass sod producers voting in the referendum that have been 
                    <PRTPAGE P="99060"/>
                    engaged in the production and sale of natural grass sod products in the United States during a representative period determined by the Secretary. The revised proposed Order, including comment analysis, is published separately in this issue of the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>Should the referendum result in support for the creation of the program, AMS will publish a final rule for the Order that will include the date when assessments will begin. The referendum procedures in this final rule will also be used for any subsequent referenda conducted under the Order.</P>
                <HD SOURCE="HD1">Authority in the 1996 Act</HD>
                <P>The 1996 Act (7 U.S.C. 7411-7425) authorizes USDA to establish agricultural commodity research and promotion orders that may include a combination of promotion, research, industry information, and consumer information activities funded by mandatory assessments. These programs are designed to maintain and expand markets and uses for agricultural commodities as defined under section 513(1) of the 1996 Act (7 U.S.C. 7412(1)). The 1996 Act provides for alternatives within the terms of a variety of provisions. Paragraph (e) of section 518 of the 1996 Act (7 U.S.C. 7417(e)) provides three options for determining industry approval of a new research and promotion program: (1) by a majority of those persons voting; (2) by persons voting for approval who represent a majority of the volume of the agricultural commodity; or (3) by a majority of those persons voting for approval who also represent a majority of the volume of the agricultural commodity. In addition, paragraphs (a) and (b) of section 518 of the 1996 Act (7 U.S.C. 7417(a) and (b)) provide for referenda to ascertain approval of an order to be conducted either prior to its going into effect or within three years after assessments first begin under the order.</P>
                <HD SOURCE="HD1">Program Overview</HD>
                <P>AMS received a proposal for a national research and promotion program for natural grass sod from Turfgrass Producers International (TPI). TPI is an industry organization made up of members from across the natural grass seed and sod industry worldwide. If favored, the program would be financed by an assessment on natural grass sod products and administered by a board of industry members selected by the Secretary. Initially, producers would pay one-tenth (1/10th) of one penny ($0.01) per square foot, or the equivalent thereof, of natural grass sod products sold in the United States. No natural grass sod producer would be exempt from paying the assessment unless producing a certified organic product under the National Organic Program.</P>
                <P>If favored, the purpose of the program would be to strengthen the position of natural grass in the marketplace, maintain and expand markets for natural grass, and develop new uses for natural grass. TPI proposed that a referendum be held among eligible natural grass sod producers to determine whether they favor implementation of the program prior to the Order going into effect. TPI recommended that the program be implemented if it is favored by a simple majority of the natural grass sod producers voting in the referendum.</P>
                <HD SOURCE="HD1">Summary of Regulatory Text</HD>
                <P>This section highlights key provisions of the referendum procedures for the proposed Order. The referendum procedures will be located in the U.S. Code of Federal Regulations at 7 CFR part 1240, subpart B—Referendum Procedures.</P>
                <HD SOURCE="HD1">Definitions</HD>
                <P>
                    Section 1240.81 of the Referendum Procedures defines certain terms that will be used throughout. All terms have the same meaning as set forth in the proposed rulemaking published in the 
                    <E T="04">Federal Register</E>
                     on October 16, 2023 (88 FR 71306) in § 1240.20 of subpart A.
                </P>
                <P>Section 1240.83 discusses eligibility and manner of persons voting. An eligible natural grass sod producer; an officer or employee of an eligible natural grass sod producer; or an administrator, executor, or trustee of an eligible natural grass sod producer may cast a ballot. Any individual voting in a referendum shall certify that such individual has the authority to take such action. Upon request of the referendum agent, the individual must submit adequate evidence of such authority.</P>
                <P>Section 1240.84 discusses the referendum agent, appointed by the Administrator, who will provide instructions for voting and conduct the referendum. The referendum agent will determine the time period during which ballots may be cast and give reasonable public notice of the referendum, not less than thirty (30) days before the referendum is conducted. No person who claims to be an eligible natural grass sod producer will be refused a ballot. At the end of the voting period the agent will tabulate the results, prepare a report on the referendum, and announce the results to the public.</P>
                <HD SOURCE="HD1">Final Regulatory Flexibility Analysis</HD>
                <P>In accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612), AMS is required to examine the impact of this final rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.</P>
                <P>The purpose of the Regulatory Flexibility Act is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened. At the time this analysis was prepared, the Small Business Administration defined small agricultural producers (NAICS Code 111421) as those having annual receipts of no more than $3,250,000 (13 CFR 121.201). This represents an increase from the size standard ($750,000) that was applied when AMS prepared the initial regulatory flexibility analysis. AMS applied the updated threshold for purposes of analysis in this final rule. The changes do not impact AMS's ultimate determination regarding the impact of the rule on small entities.</P>
                <P>According to the 2022 USDA Census of Agriculture data, there are 1,447 farms in the U.S. producing natural grass; of those, approximately 80 percent (or 1,150 farms) are small agricultural producers based on value of sales per farm.</P>
                <P>USDA will conduct the referendum to determine if eligible natural grass sod producers favor issuance of the proposed Order. As previously mentioned, paragraph (e) of section 518 of the 1996 Act (7 U.S.C. 7417) provides three options for determining industry approval of a new research and promotion program: (1) by a majority of those persons voting; (2) by persons voting for approval who represent a majority of the volume of the agricultural commodity; or (3) by a majority of those persons voting for approval who also represent a majority of the volume of the agricultural commodity.</P>
                <P>
                    This program is an industry-led effort to drive consumer demand for natural grass sod products through the development and implementation of programs, plans, and projects of research, information, and promotion, with funding for such efforts provided by the industry through assessments paid by natural grass sod producers involved in the production of monostands or blends or mixtures of Bentgrass, Bermudagrass, Buffalograss, Centipedegrass, Fine fescue, Kentucky bluegrass, Ryegrass, Seashore Paspalum, Saint Augustinegrass, Tall fescue, Zoysiagrass, Bahiagrass, and other native or adapted grasses harvested and 
                    <PRTPAGE P="99061"/>
                    sold as sod, and products containing natural grass with artificial elements that are sold as sod (“natural grass sod products”). In order to ensure that natural grass sod producers decide whether this program should be implemented and, subsequently, whether it should continue or not, this program will be implemented only if it is favored by a majority of natural grass sod producers voting in a referendum. This procedure will also be used for any subsequent referendum under the Order. Eligible natural grass sod producers will have the opportunity to participate in the referendum. Voting in the referendum is optional and this rule outlines the requirements for doing so.
                </P>
                <P>Regarding alternatives, USDA will consider a variety of options to hold the referendum vote including email, mail, electronic voting through a smartphone application or website, sending ballots to one central location by mail ballot or through electronic mail, or by other means selected by the Administrator. AMS has previously conducted referenda through USDA Farm Service Agency County Offices for some larger checkoff programs. For more recently created programs, AMS has utilized an online voting application. AMS will provide easy access to information for potential voters through an email, telephone number, and internet-based resources.</P>
                <P>This action will impose an additional reporting burden on natural grass sod producers. Natural grass sod producers will have the opportunity to complete and submit a ballot to USDA indicating whether they favor implementation of the proposed Order or, for subsequent referenda of an approved program, a continuance of the program. The specific burden for the ballot is detailed later in this document in the section titled Paperwork Reduction Act. As with all Federal promotion programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. Finally, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.</P>
                <P>AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.</P>
                <P>Regarding outreach efforts, AMS will keep natural grass sod producers informed throughout the program implementation and referendum process to ensure that they are aware of and are able to participate in the program implementation process. AMS will also publicize information regarding the referendum process so that trade associations and related industry media are informed and can amplify the information to eligible producers.</P>
                <HD SOURCE="HD1">Paperwork Reduction Act</HD>
                <P>In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the referendum ballot, which represents the information collection and recordkeeping requirements that is imposed by this rule, has been submitted to OMB for approval.</P>
                <P>
                    <E T="03">Title:</E>
                     Natural Grass Sod Promotion, Research, and Information Order; Referendum Procedures.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     0581-0348.
                </P>
                <P>
                    <E T="03">Expiration Date of Approval:</E>
                     3 years from OMB date of approval.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     New information collection for research and promotion programs.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The information collection requirements in the request are essential to carry out the intent of the 1996 Act. The information collection concerns a proposal received by USDA for a national research and promotion program for natural grass sod. The program would be financed by an assessment on natural grass sod and would be administered by a board of industry members selected by the Secretary.
                </P>
                <P>A referendum will be held among natural grass sod producers to determine whether they favor issuance of the proposed Order before it goes into effect. The purpose of the program would be to help build the market for natural grass sod.</P>
                <P>The information collection requirements in this final rule concern the initial referendum that will be held to determine whether the program is favored by industry and any subsequent referenda conducted under the proposed Order, if it is approved. The ballot will be completed by natural grass sod producers who want to indicate whether they support implementation or continuation of the program.</P>
                <P>
                    For the purpose of estimating the cost of reporting and recordkeeping, this final rule uses $56.18 per hour. To arrive at this amount, AMS used the mean hourly earnings of farmers, ranchers, and other agricultural managers from the U.S. Department of Labor, Bureau of Labor Statistics, May 2023 National Occupational Employment and Wages Estimates,
                    <SU>1</SU>
                    <FTREF/>
                     that is, $43.35 and added an additional 29.6 percent to account for benefits and compensation.
                    <SU>2</SU>
                    <FTREF/>
                     This calculation results in a total hourly wage of $56.18. Costs of benefits and compensation guidance was obtained from the Bureau of Labor Statistics News Release issued September 10, 2024.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Occupational Employment and Wages, May 2023; 11-9013 Farmers, Ranchers, and Other Agricultural Managers 
                        <E T="03">https://www.bls.gov/oes/current/oes_nat.htm.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         News Release for Employer Costs for Employee Compensation—June 2024, 
                        <E T="03">https://www.bls.gov/news.release/pdf/ecec.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Economic News Release: Employer Costs for Employee Compensation Summary for September 10, 2024 
                        <E T="03">https://www.bls.gov/news.release/ecec.nr0.htm.</E>
                    </P>
                </FTNT>
                <P>Information collection requirement that is included in this final rule is:</P>
                <P>
                    <E T="03">LP-8 Referendum Ballot and LP-8-1 Envelope (OMB Form No. 0581-0348).</E>
                </P>
                <P>
                    <E T="03">Estimate of Burden:</E>
                     Public recordkeeping burden for this collection of information is estimated to average 0.25 hours per referendum ballot.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Natural grass sod producers.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     1,447.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses per Respondent:</E>
                     1 for initial referenda (Once implemented, subsequent referenda every 7 years thereafter 0.14 per year.)
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden on Respondents:</E>
                     362 hours for initial referenda (20 hours for subsequent referendum.)
                </P>
                <P>
                    <E T="03">Total Cost:</E>
                     (362 hours × $56.18) $20,337.16.
                </P>
                <P>The ballot will be added to the other information collections approved under OMB No. 0581-0348.</P>
                <P>An estimated 1,447 respondents would provide information to AMS. The estimated cost of providing the information to AMS by respondents is $20,337.16. This total has been estimated by multiplying 362 total hours required for reporting and recordkeeping by $56.18 per hour, representing the average hourly earnings plus benefits by various occupations involved in keeping this information. Data for computation of this hourly rate was obtained from the U.S. Department of Labor Statistics.</P>
                <HD SOURCE="HD1">Comment Analysis</HD>
                <P>
                    A proposed rule describing the referendum procedures was published in the 
                    <E T="04">Federal Register</E>
                     on October 16, 2023 (88 FR 71302). A notice to trade was announced by AMS and the proposed rulemaking provided a 60-day comment period ending December 15, 2023. Seventy-two total comments were received. Of the 72 comments, 62 supported the proposed Order and the referendum procedures as written. Three comments were in favor of the 
                    <PRTPAGE P="99062"/>
                    referendum procedures but suggested various edits to the proposed rulemaking. Two comments did not support the referendum and provided further recommendations to change the proposed rulemaking. Four comments were not in favor of establishing a sod program.
                    <SU>4</SU>
                    <FTREF/>
                     One comment neither supported nor opposed the proposed referendum procedures.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Comments opposed to the proposed Order are discussed in the proposed rulemaking titled Natural Grass Sod Promotion, Research, and Information Order, which is published separately in this edition of the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Voting Process</HD>
                <P>Of the 62 commentors who supported the referendum procedures as written, 36 commentors expressed specific support for the voting provision in § 1240.83(a), which states that “[e]ach eligible natural grass sod producer . . . shall be entitled to cast only one ballot in any referenda.” These commentors agreed that each producer should be allowed one vote regardless of the size of their farm(s) or production volume. These commentors stated that this was the most equitable and fair method for voting.</P>
                <P>Only six commentors said they disagreed with the one-producer one-vote procedure in proposed § 1240.83(a). Four of the six commentors would rather apply option 2 of section 518(e) of the 1996 Act (7 U.S.C. 7417(e)), under which industry approval of a new research and promotion program is determined by persons voting for approval who represent a majority of the volume of the agricultural commodity. In their opinion, because large producers would pay more in assessments than smaller producers, acreage or production should be considered. One commentor supported a voting process that would combine options 2 and 3 of the 1996 Act; however, the commentor did not provide any further details. Another commentor stated that the proposed Order should be approved only if it is favored by a majority (50 percent + one vote) of all industry producers in the United States who are eligible to vote, or by those voting who represent a majority of all production acreage in the United States.</P>
                <P>Section 518(e) of the 1996 Act (7 U.S.C. 7417(e)) provides three options for determining industry approval of a new research and promotion program: (1) by a majority of those persons voting; (2) by persons voting for approval who represent a majority of the volume of the agricultural commodity; or (3) by a majority of those persons voting for approval who also represent a majority of the volume of the agricultural commodity. Allowing a majority of persons voting in a referendum to determine whether an order should be approved (and allocating one vote to each eligible natural grass sod producer, as provided in proposed § 1240.83(a)), is an acceptable option to count votes and determine industry approval of a new research and promotion program. Considering this is acceptable under the 1996 Act and the majority of the commentors supported the referendum procedures as written, § 1240.83(a) remains unchanged.</P>
                <P>Twenty comments encouraged AMS to conduct a referendum using electronic voting as this method could yield higher voter participation, decrease referendum costs, and would be the safest and most efficient method. One comment stated that paper ballots should be optional. Section 1240.83(c) of the referenda procedures allows ballots to be cast “by mail, electronic mail, electronic voting . . . or by any other means set forth by the Department.” Since this section allows for multiple methods of casting ballots, this section will remain as written.</P>
                <HD SOURCE="HD2">Comments Opposed With Additional Recommendations</HD>
                <P>
                    Two commentors were opposed to the proposed referendum procedures, suggested the referendum is being conducted prematurely, and provided several recommendations.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         These commentors also objected to elements of the proposed Order, and those portions of their comments are addressed in the proposed rulemaking titled Natural Grass Sod Promotion, Research, and Information Order, which is published separately in this edition of the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </FTNT>
                <P>First, they recommended “modify[ing]” the “eligible natural grass sod producer” definition to require AMS to identify all natural grass sod producers in the United States and ensure that each producer is informed about the proposed program prior to any referendum. AMS will use several methods to identify as many eligible natural grass sod producers as possible, to include self-identification from producers and industry input.</P>
                <P>Second, they stated that AMS should conduct a remedial round of public outreach to re-assess industry support for the program following an approximately 3-year period, during which they claim the proposed Order was not visible or part of regular industry discussions. However, TPI conducted extensive industry engagement regarding the proposed program, including educational outreach to local organizations and individual producers, solicited input on industry's interest in a national checkoff program, and determined that there was substantial interest in moving forward with a national program.</P>
                <P>As the commentors noted, industry hosted a webinar to get feedback from natural grass sod producers regarding their interest in developing a national grass sod checkoff program. On May 19, 2020, U.S. sod producers participated in a 2-hour online seminar to learn more about USDA research and promotion programs. After this webinar, attendees were polled to determine their interest in developing a national checkoff program for the natural grass sod industry and 64 percent stated they were very interested, 20 percent stated they were interested, 13 percent stated they were interested in learning more, and only 3 percent stated they were not interested. Since the industry formally submitted its proposed Order on June 18, 2021, USDA has been conducting various required steps to offer a new research and promotion program for industry consideration. This work included the preparation and review of numerous documents, shepherding the proposed program through OMB's regulatory review process, and the drafting and ultimate publication of the proposed program and referendum rules on October 16, 2023.</P>
                <P>Additionally, TPI submitted industry letters of support that confirmed the industry's desire to pursue a research and promotion program to fund research and communicate the benefits of natural grass to the public. Further, if in the future the industry determines that the Order is no longer in their best interests, the Order may be amended through the regulatory process or terminated.</P>
                <P>Third, an additional recommendation encouraged USDA to establish a clear schedule and procedures for the referendum. This commentor provided a sample schedule that included a 120-day enrollment period to identify all eligible sod producers and a 120-day period to conduct industry education and outreach. AMS, through public notice on its website, post cards, letters, and through its external networks, will make a referendum schedule, instructions, and any other relevant information available for all eligible producers so that trade associations and related industry media can amplify the information.</P>
                <P>
                    The fourth and final recommendation encouraged USDA to complete an improved analysis to consider various factors such as the cost to collect, report, and remit assessments, particularly for operations with multiple farms, in multiple States. AMS recognizes that 
                    <PRTPAGE P="99063"/>
                    each industry is diverse in various ways such as size, method of production and distribution, business practices, marketing strategies, staff size, and region. The updated regulatory analysis in this rule and subpart A did not factor every unique method of collecting assessments but rather focused on the number of farms reported and square foot of sod sold nationwide according to the 2022 U.S. Census. Furthermore, the commentors did not include any information or data to show that USDA's analysis of the impact of assessments on sod producers under the proposed program is inaccurate. The initial referendum will provide eligible sod producers an opportunity to vote to determine whether they favor establishment of the checkoff program.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 7 CFR Part 1240</HD>
                    <P>Administrative practice and procedure, Advertising, Consumer information, Marketing agreements, Natural grass sod, Promotion, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <REGTEXT TITLE="7" PART="1240">
                    <AMDPAR>For the reason set forth in the preamble, title 7, chapter XI of the Code of Federal Regulations, is amended by adding part 1240 to read as follows:</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 1240—NATURAL GRASS SOD PROMOTION, RESEARCH, AND INFORMATION ORDER</HD>
                        <CONTENTS>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart A—[Reserved]</HD>
                            </SUBPART>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart B—Referendum Procedures</HD>
                                <SECHD>Sec.</SECHD>
                                <SECTNO>1240.80</SECTNO>
                                <SUBJECT>General.</SUBJECT>
                                <SECTNO>1240.81</SECTNO>
                                <SUBJECT>Definitions.</SUBJECT>
                                <SECTNO>1240.83</SECTNO>
                                <SUBJECT>Voting.</SUBJECT>
                                <SECTNO>1240.84</SECTNO>
                                <SUBJECT>Instructions.</SUBJECT>
                                <SECTNO>1240.85</SECTNO>
                                <SUBJECT>Subagents.</SUBJECT>
                                <SECTNO>1240.86</SECTNO>
                                <SUBJECT>Ballots.</SUBJECT>
                                <SECTNO>1240.87</SECTNO>
                                <SUBJECT>Referendum Report.</SUBJECT>
                                <SECTNO>1240.88</SECTNO>
                                <SUBJECT>Confidential Information.</SUBJECT>
                                <SECTNO>1240.89</SECTNO>
                                <SUBJECT>OMB Control Number.</SUBJECT>
                            </SUBPART>
                        </CONTENTS>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>7 U.S.C. 7401, 7411-7425.</P>
                        </AUTH>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart A—[Reserved]</HD>
                        </SUBPART>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart B—Referendum Procedures</HD>
                            <SECTION>
                                <SECTNO>§ 1240.80</SECTNO>
                                <SUBJECT>General.</SUBJECT>
                                <P>Referenda to determine whether eligible natural grass sod producers favor the issuance, continuance, amendment, suspension, or termination of the Natural Grass Sod Promotion, Research and Information Order shall be conducted in accordance with this subpart.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 1240.81</SECTNO>
                                <SUBJECT>Definitions.</SUBJECT>
                                <P>For purposes of this subpart, the following terms shall have the meanings set forth in this section:</P>
                                <P>
                                    <E T="03">Administrator</E>
                                     means the Administrator of the Agricultural Marketing Service, or any officer or employee of USDA to whom there has been delegated or may be delegated the authority to act in the Administrator's stead.
                                </P>
                                <P>
                                    <E T="03">Referenda</E>
                                     refers, collectively, to the initial referendum and any subsequent referenda.
                                </P>
                                <P>
                                    <E T="03">Referendum</E>
                                     refers, individually, to the initial referendum or a subsequent referendum.
                                </P>
                                <P>
                                    <E T="03">Referendum agent or agent</E>
                                     means the individual or individuals designated by the Secretary to conduct the referendum.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 1240.83</SECTNO>
                                <SUBJECT>Voting.</SUBJECT>
                                <P>(a) Each eligible natural grass sod producer that has sold natural grass sod products in the United States during the representative period is eligible to vote in the initial referendum or subsequent referenda and shall be entitled to cast only one ballot in any referenda.</P>
                                <P>(b) Proxy voting is not authorized, but an officer or employee of an eligible natural grass sod producer, or an administrator, executor, or trustee of an eligible natural grass sod producer may cast a ballot on behalf of such entity. Any individual so voting in a referendum shall certify that such individual is an officer or employee of the eligible natural grass sod producer, or an administrator, executive, or trustee of the eligible natural grass sod producer and that such individual has the authority to take such action. Upon request of the referendum agent, the individual shall submit adequate evidence of such authority.</P>
                                <P>(c) All ballots are to be cast by mail, electronic mail, electronic voting through a smartphone application or website, sending ballots to a central location by mail ballot or through electronic mail, or by any other means set forth by the Department.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 1240.84</SECTNO>
                                <SUBJECT>Instructions.</SUBJECT>
                                <P>The referendum agent shall conduct the referendum, in the manner provided in this subpart, under the supervision of the Administrator. The Administrator may prescribe additional instructions, consistent with the provisions of this subpart, to govern the procedure to be followed by the referendum agent. Such agent shall:</P>
                                <P>(a) Determine the time period during which ballots may be cast;</P>
                                <P>(b) Provide ballots and related material to be used in the referendum. The ballot shall provide for recording essential information, including that needed for ascertaining whether the person voting, or on whose behalf the vote is cast, is an eligible natural grass sod producer;</P>
                                <P>(c) Give reasonable public notice of the referendum, not less than 30 days before the referendum is to be conducted:</P>
                                <P>(1) By using available media or public information sources, without incurring advertising expense, to publicize the dates, places, method of voting, eligibility requirements, and other pertinent information. Such sources of publicity may include, but are not limited to, print, radio, email communications, and social media; and</P>
                                <P>(2) By such other means as the agent may deem advisable.</P>
                                <P>(d) Distribute to eligible natural grass sod producers whose names and contact information are known to the referendum agent, the instructions on voting, a ballot, and a summary of the terms and conditions of the proposed Natural Grass Sod Promotion, Research, and Information Order or the continuance of the Natural Grass Sod Promotion, Research, and Information Order, as the case may be. No person who claims to be an eligible natural grass sod producer shall be refused a ballot;</P>
                                <P>(e) At the end of the voting period, collect, open, number, and review the ballots and tabulate the results in the presence of an agent of a third party authorized to monitor the referendum process;</P>
                                <P>(f) Prepare a report on the referendum; and</P>
                                <P>(g) Announce the results to the public.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 1240.85</SECTNO>
                                <SUBJECT>Subagents.</SUBJECT>
                                <P>The referendum agent may appoint any individual or individuals necessary or desirable to assist the agent in performing such agent's functions under this subpart. Each individual so appointed may be authorized by the agent to perform any or all of the functions which, in the absence of such appointment, shall be performed by the agent.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 1240.86</SECTNO>
                                <SUBJECT>Ballots.</SUBJECT>
                                <P>The referendum agent and subagents shall accept all ballots cast. However, if an agent or subagent deems that a ballot should be challenged for any reason, the agent or subagent shall endorse above their signature, on the ballot, a statement to the effect that such ballot was challenged, by whom challenged, the reasons therefore, the results of any investigations made with respect thereto, and the disposition thereof. Ballots deemed invalid under this subpart shall not be counted.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 1240.87</SECTNO>
                                <SUBJECT>Referendum report.</SUBJECT>
                                <P>
                                    Except as otherwise directed, the referendum agent shall prepare and 
                                    <PRTPAGE P="99064"/>
                                    submit to the Administrator a report on the results of the referendum, the manner in which it was conducted, the extent and kind of public notice given, and other information pertinent to the analysis of the referendum and its results.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 1240.88</SECTNO>
                                <SUBJECT>Confidential information.</SUBJECT>
                                <P>The ballots and other information or reports that reveal, or tend to reveal, the vote of any natural grass sod producer and the voter list shall be strictly confidential and shall not be disclosed.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 1240.89</SECTNO>
                                <SUBJECT>OMB control number.</SUBJECT>
                                <P>The control number assigned to the information collection requirement in this subpart by the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35, is OMB control number 0581-.0348.</P>
                            </SECTION>
                        </SUBPART>
                    </PART>
                </REGTEXT>
                <SIG>
                    <NAME>Melissa Bailey,</NAME>
                    <TITLE>Associate Administrator, Agricultural Marketing Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28388 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 71</CFR>
                <DEPDOC>[Docket No. FAA-2024-2294; Airspace Docket No. 24-AGL-21]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Amendment of Class D and Class E Airspace and Revocation of Class E Airspace; Youngstown/Warren, OH</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action amends the Class D and Class E airspace and revokes Class E airspace at Youngstown/Warren, OH. This action is the result of an airspace review conducted due to the decommissioning of the Youngstown very high frequency omnidirectional range (VOR) as part of the VOR Minimum Operational Network (MON) Program. The name and geographic coordinates of the airport are also being updated to coincide with the FAA's aeronautical database. This action brings the airspace into compliance with FAA orders and supports instrument flight rule (IFR) procedures and operations.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective 0901 UTC, February 20, 2025. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11 and publication of conforming amendments.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        A copy of the Notice of Proposed Rulemaking (NPRM), all comments received, this final rule, and all background material may be viewed online at 
                        <E T="03">www.regulations.gov</E>
                         using the FAA Docket number. Electronic retrieval help and guidelines are available on the website. It is available 24 hours each day, 365 days each year.
                    </P>
                    <P>
                        FAA Order JO 7400.11J, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at 
                        <E T="03">www.faa.gov/air_traffic/publications/.</E>
                         You may also contact the Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class D airspace and the Class E airspace extending upward from 700 feet above the surface at Youngstown/Warren Regional Airport, Youngstown/Warren, OH, to support IFR operations at this airport, and revokes the Class E airspace extending upward from 700 feet above the surface at Lansdowne Airport, Youngstown, OH.</P>
                <HD SOURCE="HD1">History</HD>
                <P>
                    The FAA published an NPRM for Docket No. FAA-2024-2294 in the 
                    <E T="04">Federal Register</E>
                     (89 FR 80433; October 3, 2024) proposing to amend the Class D and Class E airspace and revoke Class E airspace at Youngstown/Warren, OH. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.
                </P>
                <HD SOURCE="HD1">Incorporation by Reference</HD>
                <P>
                    Class D and E airspace designations are published in paragraphs 5000 and 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11J, dated July 31, 2024, and effective September 15, 2024. FAA Order JO 7400.11J is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.
                </P>
                <P>FAA Order JO 7400.11J lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.</P>
                <HD SOURCE="HD1">The Rule</HD>
                <P>This amendment to 14 CFR part 71:</P>
                <P>Modifies the Class D airspace to within a 4.5-mile (increased from a 4.4-mile) radius of Youngstown/Warren Regional Airport, Youngstown/Warren, OH; updates the name (previously Youngstown-Warren Regional Airport) and the geographic coordinates of the airport to coincide with the FAA's aeronautical database;</P>
                <P>And modifies the Class E airspace extending upward from 700 feet above the surface at Youngstown/Warren Regional Airport by removing the Youngstown VORTAC and associated extension from the airspace legal description; removes the Lansdowne Airport, Youngstown, OH, and the associated airspace from the airspace legal description as the instrument procedures have been cancelled and the airspace is no longer required; updates the header of the airspace legal description from “Youngstown-Warren Regional Airport, OH” to “Youngstown/Warren, OH” to coincide with the FAA's aeronautical database and comply with changes to FAA Order JO 7400.2P, Procedures for Handling Airspace Matters; and updates the name (previously Youngstown-Warren Regional Airport) and the geographic coordinates of the airport to coincide with the FAA's aeronautical database.</P>
                <HD SOURCE="HD1">Regulatory Notices and Analyses</HD>
                <P>
                    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT 
                    <PRTPAGE P="99065"/>
                    Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
                </P>
                <HD SOURCE="HD1">Environmental Review</HD>
                <P>The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.</P>
                <LSTSUB>
                    <HD SOURCE="HED">Lists of Subjects in 14 CFR 71</HD>
                    <P>Airspace, Incorporation by reference, Navigation (air). </P>
                </LSTSUB>
                <HD SOURCE="HD1">The Amendment</HD>
                <P>In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <REGTEXT TITLE="14" PART="71">
                    <AMDPAR>1. The authority citation for 14 CFR part 71 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>49 U.S.C. 106(f); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                    </AUTH>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 71.1</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="14" PART="71">
                    <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11J, Airspace Designations and Reporting Points, dated July 31, 2024, and effective September 15, 2024, is amended as follows:</AMDPAR>
                    <EXTRACT>
                        <HD SOURCE="HD2">Paragraph 5000 Class D Airspace.</HD>
                        <STARS/>
                        <HD SOURCE="HD1">AGL OH D Youngstown/Warren, OH [Amended]</HD>
                        <FP SOURCE="FP-2">Youngstown/Warren Regional Airport, OH</FP>
                        <FP SOURCE="FP1-2">(Lat. 41°15′42″ N, long. 80°40′49″ W)</FP>
                        <P>That airspace extending upward from the surface to and including 3,700 feet MSL within a 4.5-mile radius of the Youngstown/Warren Regional Airport.</P>
                        <STARS/>
                        <HD SOURCE="HD2">Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth.</HD>
                        <STARS/>
                        <HD SOURCE="HD1">AGL OH E5 Youngstown/Warren, OH [Amended]</HD>
                        <FP SOURCE="FP-2">Youngstown/Warren Regional Airport, OH</FP>
                        <FP SOURCE="FP1-2">(Lat. 41°15′42″ N, long. 80°40′49″ W)</FP>
                        <P>That airspace extending upward from 700 feet above the surface within a 7-mile radius of the Youngstown/Warren Regional Airport.</P>
                        <STARS/>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued in Fort Worth, Texas, on December 4, 2024.</DATED>
                    <NAME>Martin A. Skinner,</NAME>
                    <TITLE>Acting Manager, Operations Support Group, ATO Central Service Center.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28922 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 97</CFR>
                <DEPDOC>[Docket No. 31577; Amdt. No. 4141]</DEPDOC>
                <SUBJECT>Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums and Obstacle Departure procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective December 10, 2024. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.</P>
                    <P>The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of December 10, 2024.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Availability of matters incorporated by reference in the amendment is as follows:</P>
                </ADD>
                <HD SOURCE="HD1">For Examination</HD>
                <P>1. U.S. Department of Transportation, Docket Ops-M30. 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.</P>
                <P>2. The FAA Air Traffic Organization Service Area in which the affected airport is located;</P>
                <P>3. The office of Aeronautical Information Services, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,</P>
                <P>
                    4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit 
                    <E T="03">www.archives.gov/federal-register/cfr/ibr-locations</E>
                     or email 
                    <E T="03">fr.inspection@nara.gov.</E>
                </P>
                <HD SOURCE="HD1">Availability</HD>
                <P>
                    All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at 
                    <E T="03">nfdc.faa.gov</E>
                     to register. Additionally, individual SIAP and Takeoff Minimums and ODP copies may be obtained from the FAA Air Traffic Organization Service Area in which the affected airport is located.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Thomas J. Nichols, Standards Section Manager, Flight Procedures and Airspace Group, Flight Technologies and Procedures Division, Office of Safety Standards, Flight Standards Service, Aviation Safety, Federal Aviation Administration. Mailing Address: FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace Group, 6500 South MacArthur Blvd., STB Annex, Bldg. 26, Room 217, Oklahoma City, OK 73099. Telephone (405) 954-1139.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION: </HD>
                <P>This rule amends 14 CFR part 97 by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The applicable FAA Forms are 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B, when required by an entry on 8260-15A, and 8260-15C.</P>
                <P>
                    The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the 
                    <E T="04">Federal Register</E>
                     expensive and impractical. 
                    <PRTPAGE P="99066"/>
                    Further, pilots do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPS, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Material Incorporated by Reference</HD>
                <P>
                    The material incorporated by reference is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <P>The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.</P>
                <HD SOURCE="HD1">The Rule</HD>
                <P>This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Air Missions (NOTAM) as an emergency action of immediate flights safety relating directly to published aeronautical charts.</P>
                <P>The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.</P>
                <P>Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.</P>
                <P>The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore-(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <LSTSUB>
                    <HD SOURCE="HED">Lists of Subjects in 14 CFR Part 97</HD>
                    <P>Air Traffic Control, Airports, Incorporation by reference, Navigation (Air).</P>
                </LSTSUB>
                <SIG>
                    <DATED>Issued in Washington, DC, on November 22, 2024.</DATED>
                    <NAME>Thomas J. Nichols,</NAME>
                    <TITLE>Standards Section Manager, Flight Procedures and Airspace Group, Flight Technologies and Procedures Division, Office of Safety Standards, Flight Standards Service, Aviation Safety, Federal Aviation Administration.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Adoption of the Amendment</HD>
                <P>Accordingly, pursuant to the authority delegated to me, 14 CFR part 97 is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES</HD>
                </PART>
                <REGTEXT TITLE="14" PART="97">
                    <AMDPAR>1. The authority citation for part 97 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="14" PART="97">
                    <AMDPAR>2. Part 97 is amended to read as follows:</AMDPAR>
                    <EXTRACT>
                        <HD SOURCE="HD2">Effective 26 December 2024</HD>
                        <FP SOURCE="FP-1">Kingman, AZ, IGM, RNAV (GPS) Z RWY 21, Orig-D</FP>
                        <FP SOURCE="FP-1">Long Beach, CA, LGB, RNAV (RNP) RWY 26R, Amdt 2</FP>
                        <FP SOURCE="FP-1">San Diego, CA, SAN, RNAV (RNP) Z RWY 27, Amdt 1</FP>
                        <FP SOURCE="FP-1">Santa Ana, CA, SNA, ILS OR LOC RWY 20R, ILS RWY 20R (SA CAT I), Amdt 14B</FP>
                        <FP SOURCE="FP-1">Santa Ana, CA, SNA, LOC BC RWY 2L, Amdt 14</FP>
                        <FP SOURCE="FP-1">Santa Ana, CA, SNA, RNAV (GPS) Y RWY 2L, Amdt 3</FP>
                        <FP SOURCE="FP-1">Santa Ana, CA, SNA, RNAV (GPS) Y RWY 20R, Amdt 4</FP>
                        <FP SOURCE="FP-1">Creston, IA, CSQ, RNAV (GPS) RWY 34, Amdt 2</FP>
                        <FP SOURCE="FP-1">Bowling Green, KY, BWG, ILS Y OR LOC Y RWY 3, Amdt 3</FP>
                        <FP SOURCE="FP-1">Bowling Green, KY, BWG, ILS Z OR LOC Z RWY 3, Amdt 1</FP>
                        <FP SOURCE="FP-1">Nantucket, MA, ACK, ILS OR LOC RWY 24, ILS RWY 24 (SA CAT I), Amdt 17</FP>
                        <FP SOURCE="FP-1">Alpena, MI, APN, RNAV (GPS) RWY 1, Orig-E</FP>
                        <FP SOURCE="FP-1">Alpena, MI, APN, RNAV (GPS) RWY 7, Orig</FP>
                        <FP SOURCE="FP-1">Alpena, MI, APN, RNAV (GPS) RWY 25, Orig</FP>
                        <FP SOURCE="FP-1">Alpena, MI, KAPN, Takeoff Minimums and Obstacle DP, Orig-A</FP>
                        <FP SOURCE="FP-1">Grayling, MI, GOV, RNAV (GPS) RWY 14, Amdt 1</FP>
                        <FP SOURCE="FP-1">Grayling, MI, GOV, VOR RWY 14, Amdt 3</FP>
                        <FP SOURCE="FP-1">Pellston, MI, PLN, RNAV (GPS) RWY 5, Amdt 1</FP>
                        <FP SOURCE="FP-1">Brainerd, MN, BRD, RNAV (GPS) RWY 34, Amdt 1</FP>
                        <FP SOURCE="FP-1">Columbus, OH, CMH, RNAV (RNP) Z RWY 10L, Amdt 3</FP>
                        <FP SOURCE="FP-1">Columbus, OH, CMH, RNAV (RNP) Z RWY 10R, Amdt 3</FP>
                        <FP SOURCE="FP-1">Lebanon, OH, I68, RNAV (GPS) RWY 1, Amdt 3B</FP>
                        <FP SOURCE="FP-1">Painesville, OH, 2G1, RNAV (GPS)-A, Orig</FP>
                        <FP SOURCE="FP-1">Painesville, OH, 2G1, VOR OR GPS-A, Orig-D, CANCELED</FP>
                        <FP SOURCE="FP-1">Enid, OK, WDG, ILS OR LOC RWY 35, Amdt 8</FP>
                        <FP SOURCE="FP-1">Enid, OK, WDG, RNAV (GPS) RWY 35, Amdt 3</FP>
                        <FP SOURCE="FP-1">Providence, RI, PVD, RNAV (GPS) Y RWY 23, Amdt 2C</FP>
                        <FP SOURCE="FP-1">Dallas, TX, DAL, RNAV (GPS) Y RWY 13L, Amdt 1D</FP>
                        <FP SOURCE="FP-1">Waco, TX, ACT, RNAV (GPS) RWY 1, Amdt 2</FP>
                        <FP SOURCE="FP-1">Provo, UT, PVU, ILS OR LOC RWY 13, Amdt 6</FP>
                        <FP SOURCE="FP-1">Provo, UT, PVU, RNAV (GPS) RWY 13, Amdt 4</FP>
                        <FP SOURCE="FP-1">Beckley, WV, BKW, ILS OR LOC RWY 19, Amdt 8</FP>
                        <FP SOURCE="FP-1">Summersville, WV, SXL, RNAV (GPS)-A, Amdt 1</FP>
                        <P>
                            <E T="03">Rescinded:</E>
                             On October 30, 2024 (89 FR 86237), the FAA published an Amendment in Docket No. 31571, Amdt No. 4135, to part 97 of the Federal Aviation Regulations under §§ 97.25, 97.29, and 97.33. The following entry for Melbourne, FL, effective December 26, 2024, is hereby rescinded in its entirety:
                        </P>
                        <FP SOURCE="FP-1">Melbourne, FL, MLB, ILS OR LOC RWY 9R, Amdt 13</FP>
                        <FP SOURCE="FP-1">Melbourne, FL, MLB, LOC BC RWY 27L, Amdt 11</FP>
                        <FP SOURCE="FP-1">Melbourne, FL, MLB, RNAV (GPS) RWY 9L, Amdt 2</FP>
                        <FP SOURCE="FP-1">Melbourne, FL, MLB, RNAV (GPS) RWY 9R, Amdt 2</FP>
                        <FP SOURCE="FP-1">Melbourne, FL, MLB, RNAV (GPS) RWY 27L, Amdt 2</FP>
                        <FP SOURCE="FP-1">Melbourne, FL, MLB, RNAV (GPS) RWY 27R, Amdt 2</FP>
                    </EXTRACT>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28936 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <PRTPAGE P="99067"/>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 97</CFR>
                <DEPDOC>[Docket No. 31578; Amdt. No. 4142]</DEPDOC>
                <SUBJECT>Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective December 10, 2024. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.</P>
                    <P>The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of December 10, 2024.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Availability of matter incorporated by reference in the amendment is as follows:</P>
                </ADD>
                <HD SOURCE="HD1">For Examination</HD>
                <P>1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;</P>
                <P>2. The FAA Air Traffic Organization Service Area in which the affected airport is located;</P>
                <P>3. The office of Aeronautical Information Services, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,</P>
                <P>4. The National Archives and Records Administration (NARA).</P>
                <P>
                    For information on the availability of this material at NARA, visit 
                    <E T="03">www.archives.gov/federal-register/cfr/ibr-locations</E>
                     or email 
                    <E T="03">fr.inspection@nara.gov.</E>
                </P>
                <HD SOURCE="HD1">Availability</HD>
                <P>
                    All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at 
                    <E T="03">nfdc.faa.gov</E>
                     to register. Additionally, individual SIAP and Takeoff Minimums and ODP copies may be obtained from the FAA Air Traffic Organization Service Area in which the affected airport is located.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Thomas J. Nichols, Standards Section Manager, Flight Procedures and Airspace Group, Flight Technologies and Procedures Division, Office of Safety Standards, Flight Standards Service, Aviation Safety, Federal Aviation Administration. Mailing Address: FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace Group, 6500 South MacArthur Blvd., STB Annex, Bldg 26, Room 217, Oklahoma City, OK 73099. Telephone: (405) 954-1139.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This rule amends 14 CFR part 97 by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Air Missions (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the 
                    <E T="04">Federal Register</E>
                     expensive and impractical. Further, pilots do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary. This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Material Incorporated by Reference</HD>
                <P>
                    The material incorporated by reference is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <P>The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.</P>
                <HD SOURCE="HD1">The Rule</HD>
                <P>This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.</P>
                <P>The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.</P>
                <P>The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.</P>
                <P>Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.</P>
                <P>The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 97</HD>
                    <P>Air Traffic Control, Airports, Incorporation by reference, Navigation (Air).</P>
                </LSTSUB>
                <SIG>
                    <PRTPAGE P="99068"/>
                    <DATED>Issued in Washington, DC on November 22, 2024.</DATED>
                    <NAME>Thomas J. Nichols,</NAME>
                    <TITLE>Standards Section Manager, Flight Procedures and Airspace Group, Flight Technologies and Procedures Division, Office of Safety Standards, Flight Standards Service, Aviation Safety, Federal Aviation Administration.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Adoption of the Amendment</HD>
                <P>Accordingly, pursuant to the authority delegated to me, 14 CFR part 97 is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES</HD>
                </PART>
                <REGTEXT TITLE="14" PART="97">
                    <AMDPAR>1. The authority citation for part 97 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="14" PART="97">
                    <AMDPAR>2. Part 97 is amended to read as follows:</AMDPAR>
                    <P>By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:</P>
                    <HD SOURCE="HD2">* * * Effective Upon Publication</HD>
                    <GPOTABLE COLS="7" OPTS="L2,tp0,i1" CDEF="xs48,xls24,r50,r75,10,10,xs120">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">AIRAC date</CHED>
                            <CHED H="1">State</CHED>
                            <CHED H="1">City</CHED>
                            <CHED H="1">Airport</CHED>
                            <CHED H="1">FDC No.</CHED>
                            <CHED H="1">FDC date</CHED>
                            <CHED H="1">Procedure name</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>NY</ENT>
                            <ENT>Farmingdale</ENT>
                            <ENT>Republic</ENT>
                            <ENT>4/1519</ENT>
                            <ENT>10/21/24</ENT>
                            <ENT>This NOTAM, published in Docket No. 31576, Amdt No. 4140, TL 25-01, (89 FR 92030, November 21, 2024) is hereby rescinded in its entirety.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>TX</ENT>
                            <ENT>Houston</ENT>
                            <ENT>Houston Exec</ENT>
                            <ENT>4/4714</ENT>
                            <ENT>8/7/2024</ENT>
                            <ENT>This NOTAM, published in Docket No. 31576, Amdt No. 4140, TL 25-01, (89 FR 92030, November 21, 2024) is hereby rescinded in its entirety.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>AK</ENT>
                            <ENT>Savoonga</ENT>
                            <ENT>Savoonga</ENT>
                            <ENT>4/7038</ENT>
                            <ENT>10/10/2024</ENT>
                            <ENT>This NOTAM, published in Docket No. 31576, Amdt No. 4140, TL 25-01, (89 FR 92030, November 21, 2024) is hereby rescinded in its entirety.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>AK</ENT>
                            <ENT>Coldfoot</ENT>
                            <ENT>Coldfoot</ENT>
                            <ENT>4/0003</ENT>
                            <ENT>11/7/24</ENT>
                            <ENT>RNAV (GPS)-A, Amdt 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>AK</ENT>
                            <ENT>Coldfoot</ENT>
                            <ENT>Coldfoot</ENT>
                            <ENT>4/0005</ENT>
                            <ENT>11/7/24</ENT>
                            <ENT>RNAV (GPS) RWY 2, Amdt 2.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>CA</ENT>
                            <ENT>Santa Ana</ENT>
                            <ENT>John Wayne/Orange County</ENT>
                            <ENT>4/0009</ENT>
                            <ENT>11/7/24</ENT>
                            <ENT>LDA RWY 20R, Amdt 2A.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>WI</ENT>
                            <ENT>Antigo</ENT>
                            <ENT>Langlade County</ENT>
                            <ENT>4/1138</ENT>
                            <ENT>11/8/24</ENT>
                            <ENT>RNAV (GPS) RWY 35, Amdt 2B</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>WI</ENT>
                            <ENT>Antigo</ENT>
                            <ENT>Langlade County</ENT>
                            <ENT>4/1140</ENT>
                            <ENT>11/8/24</ENT>
                            <ENT>RNAV (GPS) RWY 17, Amdt 2A.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>ME</ENT>
                            <ENT>Presque Isle</ENT>
                            <ENT>Presque Isle Intl</ENT>
                            <ENT>4/1146</ENT>
                            <ENT>11/8/24</ENT>
                            <ENT>ILS OR LOC RWY 1, Amdt 7A.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>ME</ENT>
                            <ENT>Presque Isle</ENT>
                            <ENT>Presque Isle Intl</ENT>
                            <ENT>4/1148</ENT>
                            <ENT>11/8/24</ENT>
                            <ENT>RNAV (GPS) RWY 1, Amdt 2.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>ME</ENT>
                            <ENT>Presque Isle</ENT>
                            <ENT>Presque Isle Intl</ENT>
                            <ENT>4/1150</ENT>
                            <ENT>11/8/24</ENT>
                            <ENT>RNAV (GPS) RWY 19, Amdt 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>ME</ENT>
                            <ENT>Presque Isle</ENT>
                            <ENT>Presque Isle Intl</ENT>
                            <ENT>4/1152</ENT>
                            <ENT>11/8/24</ENT>
                            <ENT>RNAV (GPS) RWY 28, Amdt 2.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>ME</ENT>
                            <ENT>Presque Isle</ENT>
                            <ENT>Presque Isle Intl</ENT>
                            <ENT>4/1153</ENT>
                            <ENT>11/8/24</ENT>
                            <ENT>VOR RWY 19, Amdt 10C.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>SC</ENT>
                            <ENT>Walterboro</ENT>
                            <ENT>Lowcountry Rgnl</ENT>
                            <ENT>4/1160</ENT>
                            <ENT>11/8/24</ENT>
                            <ENT>ILS Z OR LOC Z RWY 23, Orig.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>TX</ENT>
                            <ENT>Houston</ENT>
                            <ENT>Houston Exec</ENT>
                            <ENT>4/1235</ENT>
                            <ENT>11/8/24</ENT>
                            <ENT>RNAV (GPS) RWY 18, Orig-B.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>DC</ENT>
                            <ENT>Washington</ENT>
                            <ENT>Washington Dulles Intl</ENT>
                            <ENT>4/1269</ENT>
                            <ENT>11/12/24</ENT>
                            <ENT>ILS OR LOC RWY 1C, ILS RWY 1C (SA CAT II), AMDT 3.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>MI</ENT>
                            <ENT>Alpena</ENT>
                            <ENT>Alpena County Rgnl</ENT>
                            <ENT>4/4915</ENT>
                            <ENT>11/15/24</ENT>
                            <ENT>ILS OR LOC RWY 1, Amdt 9C.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>NY</ENT>
                            <ENT>Farmingdale</ENT>
                            <ENT>Republic</ENT>
                            <ENT>4/5373</ENT>
                            <ENT>11/18/24</ENT>
                            <ENT>RNAV (GPS) Y RWY 14, Amdt 2E.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>WI</ENT>
                            <ENT>West Bend</ENT>
                            <ENT>West Bend Muni</ENT>
                            <ENT>4/6044</ENT>
                            <ENT>10/30/24</ENT>
                            <ENT>RNAV (GPS) RWY 31, Orig-B.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>ND</ENT>
                            <ENT>Grand Forks</ENT>
                            <ENT>Grand Forks Intl</ENT>
                            <ENT>4/6780</ENT>
                            <ENT>10/31/24</ENT>
                            <ENT>LOC BC RWY 17R, Amdt 13A.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>ND</ENT>
                            <ENT>Grand Forks</ENT>
                            <ENT>Grand Forks Intl</ENT>
                            <ENT>4/6795</ENT>
                            <ENT>10/31/24</ENT>
                            <ENT>RNAV (GPS) RWY 17R, Amdt 1A.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>ND</ENT>
                            <ENT>Grand Forks</ENT>
                            <ENT>Grand Forks Intl</ENT>
                            <ENT>4/6801</ENT>
                            <ENT>10/31/24</ENT>
                            <ENT>RNAV (GPS) RWY 35L, Orig-C.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>ND</ENT>
                            <ENT>Grand Forks</ENT>
                            <ENT>Grand Forks Intl</ENT>
                            <ENT>4/6802</ENT>
                            <ENT>10/31/24</ENT>
                            <ENT>VOR RWY 35L, Amdt 7B.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>ND</ENT>
                            <ENT>Grand Forks</ENT>
                            <ENT>Grand Forks Intl</ENT>
                            <ENT>4/6803</ENT>
                            <ENT>10/31/24</ENT>
                            <ENT>ILS OR LOC RWY 35L, Amdt 12C.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>ND</ENT>
                            <ENT>Grand Forks</ENT>
                            <ENT>Grand Forks Intl</ENT>
                            <ENT>4/6804</ENT>
                            <ENT>10/31/24</ENT>
                            <ENT>VOR RWY 17R, Amdt 6B.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>CA</ENT>
                            <ENT>Turlock</ENT>
                            <ENT>Turlock Muni</ENT>
                            <ENT>4/6870</ENT>
                            <ENT>11/4/24</ENT>
                            <ENT>RNAV (GPS)-A, Orig.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>FL</ENT>
                            <ENT>Fort Myers</ENT>
                            <ENT>Page Fld</ENT>
                            <ENT>4/7041</ENT>
                            <ENT>11/1/24</ENT>
                            <ENT>RNAV (GPS) RWY 23, Amdt 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>OR</ENT>
                            <ENT>Klamath Falls</ENT>
                            <ENT>Crater Lake/Klamath Rgnl</ENT>
                            <ENT>4/7058</ENT>
                            <ENT>11/4/24</ENT>
                            <ENT>VOR/DME OR TACAN RWY 14, Amdt 5C.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>OK</ENT>
                            <ENT>El Reno</ENT>
                            <ENT>El Reno Rgnl</ENT>
                            <ENT>4/7065</ENT>
                            <ENT>11/4/24</ENT>
                            <ENT>RNAV (GPS) RWY 35, Amdt 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>OK</ENT>
                            <ENT>El Reno</ENT>
                            <ENT>El Reno Rgnl</ENT>
                            <ENT>4/7070</ENT>
                            <ENT>11/4/24</ENT>
                            <ENT>RNAV (GPS) RWY 17, Amdt 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>WY</ENT>
                            <ENT>Cody</ENT>
                            <ENT>Yellowstone Rgnl</ENT>
                            <ENT>4/8016</ENT>
                            <ENT>11/4/24</ENT>
                            <ENT>RNAV (GPS)-B, Amdt 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>WY</ENT>
                            <ENT>Cody</ENT>
                            <ENT>Yellowstone Rgnl</ENT>
                            <ENT>4/8018</ENT>
                            <ENT>11/4/24</ENT>
                            <ENT>VOR-A, Amdt 9.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>ND</ENT>
                            <ENT>Bottineau</ENT>
                            <ENT>Bottineau Muni</ENT>
                            <ENT>4/8737</ENT>
                            <ENT>11/5/24</ENT>
                            <ENT>RNAV (GPS) RWY 31, Amdt 1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>PW</ENT>
                            <ENT>Babelthuap Island</ENT>
                            <ENT>Palau Intl</ENT>
                            <ENT>4/9523</ENT>
                            <ENT>11/6/24</ENT>
                            <ENT>RNAV (GPS) RWY 9, Orig-C.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>HI</ENT>
                            <ENT>Kamuela</ENT>
                            <ENT>Waimea-Kohala</ENT>
                            <ENT>4/9831</ENT>
                            <ENT>10/16/2024</ENT>
                            <ENT>VOR/DME RWY 4, Amdt 1C.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>HI</ENT>
                            <ENT>Kamuela</ENT>
                            <ENT>Waimea-Kohala</ENT>
                            <ENT>4/9832</ENT>
                            <ENT>10/16/2024</ENT>
                            <ENT>RNAV (GPS) RWY 4, Amdt 1B.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>HI</ENT>
                            <ENT>Kamuela</ENT>
                            <ENT>Waimea-Kohala</ENT>
                            <ENT>4/9833</ENT>
                            <ENT>10/16/2024</ENT>
                            <ENT>RNAV (GPS) RWY 22, Orig-D.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>AK</ENT>
                            <ENT>Soldotna</ENT>
                            <ENT>Soldotna</ENT>
                            <ENT>4/9971</ENT>
                            <ENT>9/5/2024</ENT>
                            <ENT>RNAV (GPS) RWY 25, Amdt 2.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-Dec-24</ENT>
                            <ENT>AK</ENT>
                            <ENT>Soldotna</ENT>
                            <ENT>Soldotna</ENT>
                            <ENT>4/9973</ENT>
                            <ENT>9/5/2024</ENT>
                            <ENT>RNAV (GPS) RWY 7, Amdt 1A.</ENT>
                        </ROW>
                    </GPOTABLE>
                </REGTEXT>
                <PRTPAGE P="99069"/>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28937 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL TRADE COMMISSION</AGENCY>
                <CFR>16 CFR Part 310</CFR>
                <RIN>RIN 3084-AB19</RIN>
                <SUBJECT>Telemarketing Sales Rule</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Trade Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Trade Commission (“FTC” or “Commission”) adopts amendments to the Telemarketing Sales Rule (“TSR” or “Rule”) that extend the Rule's applicability to inbound telemarketing calls in response to an advertisement through any medium or direct mail solicitation in which technical support products or services are offered for sale.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The amendments are effective January 9, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Relevant portions of the record of this proceeding, including this document, are available at 
                        <E T="03">https://www.ftc.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Benjamin R. Davidson, (202) 326-3055, 
                        <E T="03">bdavidson@ftc.gov,</E>
                         or Patricia Hsue, (202) 326-3132, 
                        <E T="03">phsue@ftc.gov,</E>
                         Division of Marketing Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Mail Stop CC-6316, Washington, DC 20580.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This document states the basis and purpose for the Commission's decision to adopt amendments to the TSR that were proposed and published for public comment in the 
                    <E T="04">Federal Register</E>
                     on April 16, 2024, in a notice of proposed rulemaking (“2024 NPRM”).
                    <SU>1</SU>
                    <FTREF/>
                     The Commission has carefully reviewed and considered the entire record on the issues presented in this rulemaking proceeding. The record includes 25 public comments submitted by a variety of interested parties, none of which opposed the issuance of a final rule amending the TSR to cover technical support calls made by consumers in response to solicitations. The Commission has decided to adopt, with one modification, the proposed amendments to the TSR that are intended to address consumer injury from deceptive technical support scams.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         89 FR 26798 (Apr. 16, 2024). This document also concludes the ongoing Regulatory Review.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    Congress enacted the Telemarketing and Consumer Fraud and Abuse Prevention Act (“Telemarketing Act” or “Act”) in 1994 to curb abusive telemarketing practices and provide key anti-fraud and privacy protections to consumers.
                    <SU>2</SU>
                    <FTREF/>
                     The Act directed the Commission to adopt a rule prohibiting deceptive or abusive telemarketing practices.
                    <SU>3</SU>
                    <FTREF/>
                     Pursuant to the Act, the Commission promulgated the TSR on August 23, 1995.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Public Law 103-297, 108 Stat. 1545 (1997) (codified as amended at 15 U.S.C. 6101-6108).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         15 U.S.C. 6102(a)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Statement of Basis and Purpose and Final Rule (“Original TSR”), 60 FR 43842 (Aug. 23, 1995).
                    </P>
                </FTNT>
                <P>
                    The Rule prohibits deceptive or abusive telemarketing practices, such as misrepresenting several categories of material information or making false or misleading statements to induce a person to pay for a good or service.
                    <SU>5</SU>
                    <FTREF/>
                     The Rule also requires sellers and telemarketers to make specific disclosures and keep certain records of their telemarketing activities.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See, e.g.,</E>
                         16 CFR 310.3(a); 
                        <E T="03">see also</E>
                         Original TSR, 60 FR 43848-51.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See, e.g.,</E>
                         16 CFR 310.3(a)(1), 310.5; 
                        <E T="03">see also</E>
                         Original TSR, 60 FR 43846-48, 43851, 43857.
                    </P>
                </FTNT>
                <P>
                    Since 1995, the Commission has amended the Rule on five occasions: (1) in 2003 to create the National Do Not Call (“DNC”) Registry and extend the Rule to telemarketing calls soliciting charitable contributions (“charity calls”); 
                    <SU>7</SU>
                    <FTREF/>
                     (2) in 2008 to prohibit prerecorded messages (“robocalls”) in sales calls and charity calls; 
                    <SU>8</SU>
                    <FTREF/>
                     (3) in 2010 to ban the telemarketing of debt relief services requiring an advance fee; 
                    <SU>9</SU>
                    <FTREF/>
                     (4) in 2015 to bar the use in telemarketing of certain payment mechanisms widely used in fraudulent transactions; 
                    <SU>10</SU>
                    <FTREF/>
                     and (5) in 2024 to modify the Rule's recordkeeping requirements and prohibit deception in calls between businesses.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         Statement of Basis and Purpose and Final Amended Rule (“2003 TSR Amendments”), 68 FR 4580 (Jan. 29, 2003) (adding Do Not Call Registry, charitable solicitations, and other provisions). The Telemarketing Act was amended in 2001 to extend its coverage to telemarketing calls seeking charitable contributions. 
                        <E T="03">See</E>
                         Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act (“USA PATRIOT Act”), Public Law 107-56, 115 Stat. 272 (Oct. 26, 2001) (adding charitable contribution to the definition of telemarketing and amending the Act to require certain disclosures in calls seeking charitable contributions).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         Statement of Basis and Purpose and Final Rule Amendments (“2008 TSR Amendments”), 73 FR 51164 (Aug. 29, 2008) (addressing the use of robocalls).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         Statement of Basis and Purpose and Final Rule Amendments (“2010 TSR Amendments”), 75 FR 48458 (Aug. 10, 2010) (adding debt relief provisions, including a prohibition on misrepresenting material aspects of debt relief services in § 310.3(a)(2)(x)). The Commission subsequently published technical corrections to § 310.4 of the TSR. 76 FR 58716 (Sept. 22, 2011).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         Statement of Basis and Purpose and Final Rule Amendments (“2015 TSR Amendments”), 80 FR 77520 (Dec. 14, 2015) (prohibiting the use of remotely created checks and payment orders, cash-to-cash money transfers, and cash reload mechanisms).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         Statement of Basis and Purpose and Final Rule Amendments (“2024 Amendments”), 89 FR 26760 (Apr. 16, 2024).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Overview of the Proposed Amendments to the TSR</HD>
                <P>
                    The Rule exempts from its coverage certain calls that consumers make to telemarketers, known as inbound calls.
                    <SU>12</SU>
                    <FTREF/>
                     The Rule generally exempts inbound calls that are: (1) not the result of any solicitation, (2) in response to certain advertisements, and (3) in response to a direct mail solicitation that contains certain information.
                    <SU>13</SU>
                    <FTREF/>
                     However, the exemptions for inbound calls contain exclusions for certain types of calls that are often deceptive, such as inbound calls relating to investment opportunities, debt relief services, and prize promotions.
                    <SU>14</SU>
                    <FTREF/>
                     In the 2024 NPRM, the Commission proposed covering inbound telemarketing of technical support services (or tech support) in the Rule (
                    <E T="03">i.e.,</E>
                     adding it to the exclusions identified in § 310.6(b)(5) and (6)) because of the harm associated with telemarketing these products and services.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See</E>
                         16 CFR 310.6(b)(4) through (6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         2024 NPRM, 89 FR 26798.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">A. Tech Support</HD>
                <P>
                    Tech support scams consistently generate large numbers of consumer complaints.
                    <SU>16</SU>
                    <FTREF/>
                     The scams can begin in a variety of ways. Sometimes the scammer places an outbound call to consumers warning them that their computers have been infected.
                    <SU>17</SU>
                    <FTREF/>
                     Other scammers use deceptive computer pop-up messages that claim the consumer's computer has a problem and direct the consumer to call a phone number to fix the errors.
                    <SU>18</SU>
                    <FTREF/>
                     Still other scammers place advertisements with search engines that appear when consumers search for their computer company's tech support telephone number.
                    <SU>19</SU>
                    <FTREF/>
                     And sometimes, 
                    <PRTPAGE P="99070"/>
                    scammers pay computer security software companies so that when consumers call to activate their service, they reach the scammer and are pitched additional and unnecessary products and services.
                    <SU>20</SU>
                    <FTREF/>
                     Once consumers connect with the scammer, whether through outbound telemarketing or inbound telemarketing, the scammers deceive consumers about a variety of problems with their computers and persuade consumers to purchase subscription tech support services or software that they do not need.
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See</E>
                         FTC Consumer Sentinel Network Databook 2023 at 87, 
                        <E T="03">available at https://www.ftc.gov/system/files/ftc_gov/pdf/CSN-Annual-Data-Book-2023.pdf</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See, e.g.,</E>
                         Prepared Statement of the Federal Trade Commission Before the United States Senate Special Committee on Aging on Combatting Technical Support Scams (“Tech Support Testimony”), at 3-5 (Oct. 21, 2015), 
                        <E T="03">available at https://www.ftc.gov/system/files/documents/public_statements/826561/151021techsupporttestimony.pdf</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">Id; see also</E>
                         Complaint, 
                        <E T="03">FTC</E>
                         v. 
                        <E T="03">Click4Support, LLC,</E>
                         No. 15-cv-05777-SD, at 9-10 (E.D. Pa. Oct. 26, 2015), 
                        <E T="03">
                            available at https://www.ftc.gov/system/
                            <PRTPAGE/>
                            files/documents/cases/151113click4supportcmpt.pdf
                        </E>
                         (last visited Sept. 5, 2024) (“Click4Support”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See</E>
                         Complaint, 
                        <E T="03">FTC</E>
                         v. 
                        <E T="03">Inbound Call Experts,</E>
                         No. 9:14-cv-81935 (S.D. Fla. Nov. 19, 2014), 
                        <E T="03">available at https://www.ftc.gov/system/files/documents/cases/141119icecmpt.pdf</E>
                         (last visited Sept. 5, 2024) (“Inbound Call Experts”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         Tech Support Testimony at 3.
                    </P>
                </FTNT>
                <P>
                    Although tech support scams have typically targeted consumers looking for help with computers, tech support scams also target consumers looking for help with other electronic devices, such as cellular phones and smart home devices. News stories report on consumers encountering tech support scams when they search for help with their iPhones,
                    <SU>22</SU>
                    <FTREF/>
                     receive pop-up messages on their iPads,
                    <SU>23</SU>
                    <FTREF/>
                     or look for support for their Kindle tablets.
                    <SU>24</SU>
                    <FTREF/>
                     In August 2022, Amazon filed a lawsuit alleging that a deceptive tech support operation targeted consumers who were seeking help with their smart home doorbells and streaming video services.
                    <SU>25</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         “Woman loses $1,500 to fake Apple Customer Service Scam,” WCPO ABC 9, Cincinnati, (May 20, 2022), 
                        <E T="03">available at https://www.wcpo.com/money/consumer/dont-waste-your-money/woman-loses-1-500-to-fake-apple-customer-service-scam</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         “Computer scam costs 2 older Pittsburgh women thousands of dollars, police warn,” CBS News, Pittsburgh (Feb. 20, 2024) 
                        <E T="03">available at https://www.cbsnews.com/pittsburgh/news/pittsburgh-scam-tech-support-bitcoin-older-residents-targeted</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         “Don't get Scammed by Fake Amazon Kindle and Fire Tablet Support Sites” (Feb. 22, 2016), 
                        <E T="03">available at https://blog.the-ebook-reader.com/2016/02/22/dont-get-scammed-by-fake-amazon-kindle-and-fire-tablet-support-sites/</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         
                        <E T="03">Amazon.com, Inc.</E>
                         v. 
                        <E T="03">Pionera, Inc.,</E>
                         No. 2:22-cv-1491 (E.D. Cal. Aug. 23, 2022).
                    </P>
                </FTNT>
                <P>
                    Consumer complaints about tech support scams have increased dramatically over the last few years, ranging from approximately 40,000 complaints in 2017 to more than 90,000 complaints in 2023.
                    <SU>26</SU>
                    <FTREF/>
                     In 2023, consumers reported losing approximately $242 million to these scams, with a median loss of $1,400.
                    <SU>27</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         FTC Consumer Sentinel Network Databook 2023 at 87.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">See https://public.tableau.com/app/profile/federal.trade.commission/viz/shared/GW63DJFGP</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <P>
                    Moreover, tech support scams disproportionately harm older consumers. In 2023, consumers 60 years of age and older were six times more likely to report a financial loss to tech support scams compared to younger consumers.
                    <SU>28</SU>
                    <FTREF/>
                     Analysis of consumer fraud reports confirm that a disproportionate number of older consumers have reported losing money to tech support scams. From 2015 to 2018, older consumers filed more reports on tech support scams than on any other fraud category.
                    <SU>29</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         
                        <E T="03">See</E>
                         2023 Protecting Older Consumers Report at 29, 
                        <E T="03">available at https://www.ftc.gov/system/files/ftc_gov/pdf/p144400olderadultsreportoct2023.pdf</E>
                         (last visited Sept. 5, 2024). In 2022, older consumers were five times as likely to report a financial loss to tech support scams. 
                        <E T="03">See</E>
                         2022 Protecting Oder Consumers Report at 31, 
                        <E T="03">available at https://www.ftc.gov/reports/protecting-older-consumers-2021-2022-report-federal-trade-commission</E>
                         (last visited Sept. 5, 2024). In 2020, older consumers were six times as likely to report a financial loss to tech support scams as compared to younger consumers.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Data Spotlight, Older adults hit hardest by tech support scams (March 7, 2019), 
                        <E T="03">available at https://www.ftc.gov/news-events/data-visualizations/data-spotlight/2019/03/older-adults-hardest-hit-tech-support-scams</E>
                         (last visited Oct. 17, 2024); 
                        <E T="03">see also</E>
                         FTC Report to Congress, Protecting Older Consumers, 2018-2019 (“2019 Protecting Older Consumers Report”) at 5 (Oct. 18, 2019), 
                        <E T="03">available at https://www.ftc.gov/reports/protecting-older-consumers-2018-2019-report-federal-trade-commission</E>
                         (last visited Sept. 5, 2024). In 2021, reports of online shopping frauds and business imposter frauds were the top fraud complaint for older consumers, with tech support scams dropping to third. 2022 Protecting Older Consumers Report, at 31. Older consumers, however, are disproportionately more likely to lose money to tech support scams. 
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    The Commission has responded to tech support scams through consumer education and law enforcement actions. For consumer education, the Commission has issued guidance to consumers including “New tech support scammers want your life savings,” 
                    <SU>30</SU>
                    <FTREF/>
                     “How to Spot, Avoid, and Report Tech Support Scams,” 
                    <SU>31</SU>
                    <FTREF/>
                     and “Keep tech support strangers out of your computer.” 
                    <SU>32</SU>
                    <FTREF/>
                     The Commission has also responded to particular tech support campaigns with consumer education such as “Fake Calls from Apple and Amazon Support: What you need to know,” 
                    <SU>33</SU>
                    <FTREF/>
                     “No gift cards for tech support scammers,” 
                    <SU>34</SU>
                    <FTREF/>
                     and “FTC asking for access to your computer? It's a scam.” 
                    <SU>35</SU>
                    <FTREF/>
                     Other government agencies and consumer organizations have also issued guidance on tech support scams.
                    <SU>36</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         “New tech support scammers want your life savings” (Mar. 7, 2024), 
                        <E T="03">available at https://consumer.ftc.gov/consumer-alerts/2024/03/new-tech-support-scammers-want-your-life-savings</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         “How to Spot, Avoid, and Report Tech Support Scams” (Sept. 6, 2022), 
                        <E T="03">available at https://consumer.ftc.gov/articles/how-spot-avoid-and-report-tech-support-scams</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         “Keep tech support strangers out of your computer” (Mar. 7, 2019), 
                        <E T="03">available at https://consumer.ftc.gov/consumer-alerts/2019/03/keep-tech-support-strangers-out-your-computer</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         “Fake Calls from Apple and Amazon Support: What you need to know” (Dec. 3, 2020), 
                        <E T="03">available at https://consumer.ftc.gov/consumer-alerts/2020/12/fake-calls-apple-and-amazon-support-what-you-need-know</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         “No gift cards for tech support scammers” (June 6, 2018), 
                        <E T="03">available at https://consumer.ftc.gov/consumer-alerts/2018/06/no-gift-cards-tech-support-scammers</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         “FTC asking for access to your computer? It's a scam” (Apr. 6, 2018), 
                        <E T="03">available at https://consumer.ftc.gov/consumer-alerts/2018/04/ftc-asking-access-your-computer-its-scam</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         
                        <E T="03">See, e.g.,</E>
                         AARP, “How to Get Good Tech Support” (Jan. 3, 2022), 
                        <E T="03">available at https://www.aarp.org/home-family/personal-technology/info-2021/tips-for-getting-tech-support.html</E>
                         (last visited June 23, 2023); Consumer Financial Protection Bureau, “What you should do about tech support scams” (Jan. 21, 2021), 
                        <E T="03">available at https://www.consumerfinance.gov/about-us/blog/what-you-should-know-about-tech-support-scams/</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <P>
                    In addition to consumer education, the Commission and other State and Federal law enforcement partners have brought a multitude of actions against tech support scammers. For example, on May 12, 2017, the Commission announced “Operation Tech Trap” which consisted of 29 law enforcement actions brought by the Commission and other law enforcement agencies against tech support schemes.
                    <SU>37</SU>
                    <FTREF/>
                     On March 7, 2019, the Department of Justice announced the largest-ever elder fraud sweep, which focused on tech-support scams and involved actions against “more than 260 defendants from around the globe who victimized more than two million Americans.” 
                    <SU>38</SU>
                    <FTREF/>
                     In addition, the Commission has filed numerous tech support cases outside the scope of such coordinated law enforcement sweeps.
                    <SU>39</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Press Release, FTC and Federal, State and International Partners Announce Major Crackdown on Tech Support Scams (May 12, 2017), 
                        <E T="03">available at https://www.ftc.gov/news-events/press-releases/2017/05/ftc-federal-state-international-partners-announce-major-crackdown</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         Press Release, Justice Department Coordinates Largest-Ever Nationwide Elder Fraud Sweep (Mar. 7, 2019), 
                        <E T="03">available at https://www.justice.gov/opa/pr/justice-department-coordinates-largest-ever-nationwide-elder-fraud-sweep-0</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         
                        <E T="03">See, e.g., FTC</E>
                         v. 
                        <E T="03">Restoro Cyprus Ltd.,</E>
                         No. 1:24-cv-754 (D.D.C. Mar. 14, 2024) (complaint alleging that tech support scammers took tens of millions of dollars from consumers through pop-ups and internet ads), 
                        <E T="03">available at https://www.ftc.gov/system/files/ftc_gov/pdf/1-ComplaintagainstRestoro.pdf</E>
                         (last visited Sept. 5, 2024); 
                        <E T="03">United States</E>
                         v. 
                        <E T="03">Nexway SASU,</E>
                         No. 1:23-cv-900 (D.D.C. 
                        <PRTPAGE/>
                        Apr. 3, 2023) (complaint alleging that Nexway provided payment processing services for several deceptive tech support operations), 
                        <E T="03">available at https://www.ftc.gov/system/files/ftc_gov/pdf/nexway-complaint.pdf</E>
                         (last visited Sept. 5, 2024); 
                        <E T="03">FTC</E>
                         v. 
                        <E T="03">RevenueWire, Inc.,</E>
                         No. 1:20-cv-1032 (D.D.C. April 21, 2020) (complaint alleging that companies to which RevenueWire provided payment processing services used pop-up dialog boxes that claimed to have detected computer infections and directed consumers to call a 1-800 number), 
                        <E T="03">available at https://www.ftc.gov/system/files/documents/cases/revcomp3.pdf</E>
                         (last visited Sept. 5, 2024); 
                        <E T="03">FTC</E>
                         v. 
                        <E T="03">Boost Software, Inc.,</E>
                         No. 14-cv-81397 (S.D. Fla. Nov. 10, 2014), 
                        <E T="03">available at https://www.ftc.gov/system/files/documents/cases/141119vastboostcmpt.pdf</E>
                         (last visited Sept. 5, 2024); Click4Support; Inbound Call Experts.
                    </P>
                </FTNT>
                <PRTPAGE P="99071"/>
                <P>
                    While the Commission has sued tech support scams for engaging in deceptive practices under the TSR where applicable, the Commission has also brought cases under the FTC Act alone if the telemarketer's practices could arguably fall within an exemption to the TSR. In 
                    <E T="03">FTC</E>
                     v. 
                    <E T="03">PCCare247,</E>
                     for example, the Commission used the FTC Act to seek monetary relief from a tech support operation that placed deceptive online advertisements to induce consumers to place inbound calls.
                    <SU>40</SU>
                    <FTREF/>
                     The calls at issue in 
                    <E T="03">PCCare 247</E>
                     may have fallen outside of the Rule to the extent they were telephone calls initiated by a consumer in response to an advertisement.
                    <SU>41</SU>
                    <FTREF/>
                     Similarly, in 
                    <E T="03">FTC</E>
                     v. 
                    <E T="03">Vylah Tec LLC,</E>
                     the Commission used the FTC Act to seek monetary relief from a tech support operation that lured consumers by placing deceptive pop-up messages warning consumers that their computers had been infected with viruses.
                    <SU>42</SU>
                    <FTREF/>
                     The calls at issue in 
                    <E T="03">Vylah Tec</E>
                     may have fallen outside the Rule if a court were to have determined that pop-up messages are a form of advertisement or a direct mail solicitation under the Rule.
                    <SU>43</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         Complaint, 
                        <E T="03">FTC</E>
                         v. 
                        <E T="03">PCCare247, Inc.,</E>
                         No. 12-cv-7189 (S.D.N.Y. Oct. 3, 2012) (“PCCare247”), 
                        <E T="03">available at https://www.ftc.gov/sites/default/files/documents/cases/2012/10/121003pccarecmpt.pdf</E>
                         (last visited Sept. 5, 2024) (“PCCare247”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         
                        <E T="03">See</E>
                         16 CFR 310.6(b)(5). Even if the consumer's call was in response to an advertisement, the Rule would apply to instances of upselling included in the call. 
                        <E T="03">Id.</E>
                         at § 310.6(b)(5)(iii). If, for example, the consumer initiated a call for technical support with their computer and the consumer was pitched additional software products or computer services, that transaction would likely be an upsell under the Rule.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         Complaint, 
                        <E T="03">FTC</E>
                         v. 
                        <E T="03">Vylah Tec LLC,</E>
                         No. 17-cv-228-FtM-99MRM (M.D. Fla. May 17, 2017) (“Vylah Tec”), 
                        <E T="03">available at https://www.ftc.gov/system/files/documents/cases/162_3253_vylah_tec_llc_complant.pdf</E>
                         (last visited Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         In an abundance of caution, the Commission pursued its claim regarding the pop-ups under section 5 of the FTC Act, 15 U.S.C. 45. The Commission, however, does not believe such pop-up messages are exempt under the Rule. The exemption in § 310.6(b)(5) “applies to calls in response to television commercials, infomercials, home shopping programs, magazine and newspaper advertisements, and other forms of mass media advertising solicitation. . . . In the Commission's experience, calls responding to general media advertising do not typically involve the forms of deception and abuse the Act seeks to stem.” 60 FR 43860. The Commission also generally has not observed pop-up messages that contained the disclosures necessary to fall within the exemption for direct mail solicitations.
                    </P>
                </FTNT>
                <P>
                    Prior to April 2021, the Commission routinely relied upon section 13(b) of the FTC Act, 15 U.S.C. 53(b), to obtain monetary relief for consumers injured by conduct that fell outside the scope of the Rule, such as the conduct described in the preceding paragraph. The Supreme Court's decision in 
                    <E T="03">AMG Capital Management, LLC</E>
                     v. 
                    <E T="03">FTC,</E>
                     held the Commission could not obtain monetary relief under section 13(b).
                    <SU>44</SU>
                    <FTREF/>
                     As a result, the Commission is now constrained in its ability to redress consumers harmed by tech support scams whose deceptive business practices arguably fall beyond the reach of the Rule. Amending the Rule, by adding tech support services to the list of exclusions from the inbound call exemption, will clarify that all tech support scams are potentially subject to the Rule, and allow the Commission to redress consumer injuries under section 19(a)(1) of the FTC Act, 15 U.S.C. 57b(a)(1).
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         
                        <E T="03">See AMG Cap. Mgmt., LLC</E>
                         v. 
                        <E T="03">FTC,</E>
                         141 S. Ct. 1341, 1352 (2021).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Overview of Public Comments</HD>
                <P>
                    The Commission has carefully reviewed and analyzed the record developed in this proceeding. The Commission received 25 comments, 24 of which were either from individual consumers or anonymous commenters. Of the individual and anonymous comments, one comment from a former tech support employee supported the proposal and noted that it does not burden employees.
                    <SU>45</SU>
                    <FTREF/>
                     The rest of the 24 individual and anonymous comments did not respond to the questions in the 2024 NPRM. The comments ranged from requesting a complete ban of telemarketing, to consumers expressing frustration at the volume of unwanted telemarketing calls they receive.
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         We cite public comments by the name of the commenting organization or individual. 
                        <E T="03">See</E>
                         Kilmer 2024-27.
                    </P>
                </FTNT>
                <P>
                    The Electronic Privacy and Information Center and the National Consumer Law Center (on behalf of its low-income clients) (“EPIC and NCLC”) submitted a comment that recommended several additional amendments to the Rule and requested several clarifications.
                    <SU>46</SU>
                    <FTREF/>
                     First, EPIC and NCLC recommended that the definition of tech support be modified to explicitly include repair to software programs or applications in addition to electronic devices.
                    <SU>47</SU>
                    <FTREF/>
                     The Commission's definition of tech support, which applies to “any device on which code can be downloaded, installed, run, or otherwise used,” is intended to include problems with software or applications on those devices. The definition is not limited to the physical device itself, or the hardware components of the device, and the Commission's law enforcement experience shows that tech support scammers often tell consumers that problems exist with the programs on their electronic devices. For example, some tech support scams tell consumers that particular software programs are malfunctioning.
                    <SU>48</SU>
                    <FTREF/>
                     Other tech support scams warn consumers that they have inadvertently installed malicious programs on their computers.
                    <SU>49</SU>
                    <FTREF/>
                     Still other scams begin with an offer to help consumers with software applications, such as help resetting email passwords.
                    <SU>50</SU>
                    <FTREF/>
                     To avoid any potential confusion, the Commission will modify the definition to explicitly include software, as discussed below.
                </P>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         
                        <E T="03">See</E>
                         EPIC and NCLC 2024-25 (“EPIC and NCLC”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         EPIC and NCLC at 4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         
                        <E T="03">See Click4Support</E>
                         at 4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         
                        <E T="03">See Inbound Call Experts</E>
                         at 11.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         
                        <E T="03">See</E>
                         Complaint, 
                        <E T="03">FTC</E>
                         v. 
                        <E T="03">Elite IT Partners, Inc.,</E>
                         No. 2:19-cv-125 (D. Utah Feb. 25, 2019), 
                        <E T="03">available at https://www.ftc.gov/system/files/documents/cases/elite_dkt_1_complaint_3-7-19.pdf</E>
                         (last visited Sept. 5, 2024) (“Elite IT”).
                    </P>
                </FTNT>
                <P>
                    Second, EPIC and NCLC suggested that the definition of tech support be modified to note that the term device “specifically include[s] the performance or security of both hardware components and firmware used in conjunction with the device, even if the telemarketer does not reference the device through which those components may be used.” 
                    <SU>51</SU>
                    <FTREF/>
                     The Commission does not believe that EPIC and NCLC's proposed change is necessary because the unmodified term “device” includes all parts of the device such as hardware or firmware regardless of whether those components are specifically referenced.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         EPIC and NCLC at 4.
                    </P>
                </FTNT>
                <P>
                    Third, EPIC and NCLC suggested that the definition of tech support be modified to include “offers for insurance, extended warranty, or similar plans for device software.” 
                    <SU>52</SU>
                    <FTREF/>
                     Many tech support scams sell consumers long-term and continuity programs that will purportedly repair devices in the future if other problems arise.
                    <SU>53</SU>
                    <FTREF/>
                     The definition 
                    <PRTPAGE P="99072"/>
                    of tech support encompasses such products because it includes a “plan” or “program” to “repair, maintain, or improve the performance or security of any device.” To the extent EPIC and NCLC suggest that the Commission explicitly extend the definition to cover insurance or warranty plans that replace the device rather than repair, maintain or improve the device, the Commission declines to do so. The Commission has not encountered tech support scams that sell only insurance or warranties to replace a device rather than repair a device. As such, the Commission does not believe the record supports such an extension or that one is necessary. The Commission notes, however, that the current definition does reach warranties or similar plans that are offered to repair, maintain, or improve the performance of devices.
                    <SU>54</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         EPIC and NCLC at 4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Complaint, 
                        <E T="03">FTC</E>
                         v. 
                        <E T="03">Pecon Software Ltd.,</E>
                         No 12-cv-7186 (S.D.N.Y. Sep 24, 2012), 
                        <E T="03">available at https://www.ftc.gov/sites/default/files/documents/cases/2012/10/121003peconcmpt.pdf</E>
                         (last visited Sept. 5, 2024); Elite IT at 13.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         EPIC and NCLC also requested that the Commission make additional clarifications to the FTC's Business Guidance, “Complying with the Telemarketing Sales Rule” 
                        <E T="03">available at https://www.ftc.gov/business-guidance/resources/complying-telemarketing-sales-rule</E>
                         (last visited Sept. 5, 2024). The Commission will not respond to these suggestions because the content of the business guidance is not related to the ongoing rulemaking.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Final Amended Rule</HD>
                <HD SOURCE="HD2">A. Definition of Technical Support Service</HD>
                <P>The final rule defines technical support service as any plan, program, software, or service that is marketed to repair, maintain, or improve the performance or security of any device on which code can be downloaded, installed, run, or otherwise used, such as a computer, smartphone, tablet, or smart home product, including any software or application run on such device. This definition has one modification from the definition proposed in the 2024 NPRM. It adds the phrase “any software or application run on such device” to avoid any potential confusion as to whether tech support services or products that are related only to software or applications are covered by the Rule.</P>
                <P>This definition is drafted broadly because, in the Commission's experience, tech support scams have evolved with changes in consumer behavior and technology, and will continue to evolve. While drafted to be flexible to evolving schemes, the definition's focus on a type of plan or service marketed in a particular manner provides specificity regarding its coverage.</P>
                <P>
                    The definition of tech support also excludes “any plan, program, software, or service in which the person providing the repair, maintenance, or improvement obtains physical possession of the device being repaired.” In the Commission's experience, tech support scams typically do not involve situations where the repair includes physical interaction with the device, such as replacing a computer hard drive or repairing a broken phone screen.
                    <SU>55</SU>
                    <FTREF/>
                     Whether this interaction involves face-to-face contact between the consumer and the person providing the repair, or the consumer shipping the device to the repair person and waiting for a return shipment, the Commission believes that tech support scams rarely involve physical repair of electronic devices.
                    <SU>56</SU>
                    <FTREF/>
                     The Rule currently exempts calls in which payment is not required until “after a face-to-face sales or donation presentation by the seller.” 
                    <SU>57</SU>
                    <FTREF/>
                     In creating that exemption, the Commission explained that the “occurrence of a face-to-face meeting limits the incidence of telemarketing deception and abuse” because the “paradigm of telemarketing fraud involves an interstate telephone call in which the customer has no other direct contact with the caller.” 
                    <SU>58</SU>
                    <FTREF/>
                     Here too, the “paradigm” of tech support scams involves consumers speaking with third parties with whom they have limited contact and often at a time when they have been misled to believe that they have a problem with their electronic device. Physical in-person repair does not involve the same pressures as remote tech support, and it is less conducive to scams.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         Tech support scammers sometimes obtain remote access to a computer or electronic device. “Physical possession” does not include such remote access.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         The Commission's lawsuit against Office Depot is an exception to this pattern. 
                        <E T="03">See FTC</E>
                         v. 
                        <E T="03">Office Depot Inc.,</E>
                         9:19-cv-80431 (S.D. Fla. Mar. 29, 2019) (alleging that Office Depot and Support.com deceived consumers who brought their computers into Office Depot stores for support services).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         16 CFR 310.6(b)(3).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         Original TSR, 60 FR 43860.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Requirements for Technical Support Telemarketing Calls</HD>
                <P>
                    The final rule adds “technical support services” to the categories of calls excluded from the TSR's exemptions for inbound calls “in response to an advertisement through any medium” and inbound calls in response to “a direct mail solicitation,” including email.
                    <SU>59</SU>
                    <FTREF/>
                     The Commission created these exemptions in the Rule based on its consideration of four factors: whether Congress intended certain types of sales activity to be exempt under the Rule; whether the conduct or business in question “already is regulated extensively by Federal or State law”; whether the conduct “lends itself easily to the forms of deception or abuse that the Act is intended to address”; and whether requiring business to comply the Rule would be “unduly burdensome weighed against the likelihood that sellers or telemarketers engaged in fraud would use an exemption to circumvent Rule coverage.” 
                    <SU>60</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>59</SU>
                         16 CFR 310.6(b)(5) and (6). For “direct mail solicitations” to qualify for the exemption, the solicitations must “clearly, conspicuously, and truthfully disclose[ ] all material information listed in § 310.3(a)(1)” and contain “no material misrepresentation regarding any item contained in § 310.3(d).”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>60</SU>
                         Original TSR, 60 FR 43859.
                    </P>
                </FTNT>
                <P>
                    The Commission decided to create exemptions from the Rule for calls in response to advertisements and direct mail solicitation because, in the Commission's experience, calls in response to these solicitations “do not typically involve the forms of deception and abuse the Act seeks to stem.” 
                    <SU>61</SU>
                    <FTREF/>
                     At the same time, the Commission recognized that “some deceptive sellers or telemarketers use mass media or general advertising to entice their victims to call, particularly in relation to the sale of investment opportunities, specific credit-related programs” and other areas.
                    <SU>62</SU>
                    <FTREF/>
                     The Commission decided to exclude certain categories of calls from the exemptions given its “experience with the marketing of these deceptive telemarketing schemes.” 
                    <SU>63</SU>
                    <FTREF/>
                     The Commission's experience with tech support schemes also supports excluding tech support calls from the exemptions for inbound calls in response to advertisements and direct mail solicitations.
                    <SU>64</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>61</SU>
                         
                        <E T="03">Id.</E>
                         43860.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>62</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>63</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>64</SU>
                         
                        <E T="03">See</E>
                         supra, notes 37-39.
                    </P>
                </FTNT>
                <P>
                    The final rule minimizes the burden on tech support businesses that do not engage in deceptive practices. First, tech support calls “that are not the result of any solicitation by a seller, charitable organization, or telemarketer” are still exempt under § 310.6(b)(5). Under this exemption, as long as the call is not solicited, a telephone call initiated by a consumer to the consumer's computer manufacturer for technical support or a home security company about a disruption to their service due to a device malfunction would not be subject to the Rule unless, as part of that transaction, the company also engaged in an upsell.
                    <SU>65</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>65</SU>
                         16 CFR 310.6(b)(4).
                    </P>
                </FTNT>
                <P>
                    Second, excluding tech support where the person providing the service takes physical possession of the device will also limit the breadth of the Rule. For 
                    <PRTPAGE P="99073"/>
                    example, consumer calls to a local repair shop or to the manufacturer of their device seeking physical repairs will not be subject to the Rule.
                </P>
                <HD SOURCE="HD1">IV. Paperwork Reduction Act</HD>
                <P>
                    The Rule contains various provisions that constitute information collection requirements as defined by 5 CFR 1320.3(c), the definitional provision within the Office of Management and Budget (“OMB”) regulations implementing the Paperwork Reduction Act (“PRA”). 44 U.S.C. chapter 35. OMB has approved the Rule's existing information collection requirements through April 30, 2027 (OMB Control No. 3084-0097). The amendment newly requires certain inbound tech support calls to comply with the Rule's recordkeeping and disclosure requirements. This will increase the PRA burden for sellers or telemarketers as detailed below. Accordingly, FTC staff is simultaneously submitting this final rule and associated Supporting Statement to OMB for review under the PRA.
                    <SU>66</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>66</SU>
                         This PRA analysis focuses specifically on the information collection requirements created by or otherwise affected by the amendment.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">A. Estimated Annual Hours Burden</HD>
                <P>The Commission estimates the PRA burden of the proposed amendments based on its knowledge of the telemarketing industry and data compiled from the Do Not Call Registry. The annual hours of burden for sellers or telemarketers will consist of two components: the time required to make disclosures and the costs of complying with the Rule's recordkeeping requirements.</P>
                <P>
                    First the Commission estimates that the disclosure burden will take 18,318 hours. The Commission uses the same methodology it has used in the past to calculate the disclosure burden for categories of calls that are excluded from the TSR's exemptions for inbound calls.
                    <SU>67</SU>
                    <FTREF/>
                     The Commission estimates that there are 63,900,000 inbound tech support calls per year. To arrive at this figure, the Commission estimates that there are 1.8 billion inbound telemarketing calls annually that result in sales.
                    <SU>68</SU>
                    <FTREF/>
                     To estimate how many of those calls are for tech support, the Commission uses the ratio of tech support complaints to the total number of telemarketing complaints it receives, based on the assumption that the percentage of total complaints also reflects the percentage of total calls. In 2023, there were 91,196 complaints about tech support and 2,566,261 fraud complaints.
                    <SU>69</SU>
                    <FTREF/>
                     Thus the Commission estimates 3.55% of the inbound calls were related to tech support, 
                    <E T="03">i.e.,</E>
                     91,196 ÷ 2,566,261. That translates to 63,900,000 inbound tech support calls, 
                    <E T="03">i.e.,</E>
                     3.55% of 1.8 billion.
                </P>
                <FTNT>
                    <P>
                        <SU>67</SU>
                         
                        <E T="03">See, e.g.,</E>
                         Agency Information Collection Activities; Proposed Collection; Comment Request; Extension. 87 FR 23179 (Apr. 19, 2022).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>68</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>69</SU>
                         
                        <E T="03">See</E>
                         FTC, Consumer Sentinel Network Data Book 2023 at 9, 88.
                    </P>
                </FTNT>
                <P>
                    Staff assumes that there will be no disclosure burden for non-fraudulent calls because those calls likely already disclose the information required by the Rule. Thus, the Rule would create a new disclosure burden only on fraudulent calls. Staff estimates that 12.90% of telemarketing calls are fraudulent. This estimate is based on dividing a Congressional estimate of annual consumer injury from telemarketing fraud ($40 billion) 
                    <SU>70</SU>
                    <FTREF/>
                     by available data on total consumer and business-to-business telemarketing sales ($310.0 billion projected for 2016).
                    <SU>71</SU>
                    <FTREF/>
                     Thus, staff estimates that 12.90% of the 63,900,000 tech support calls are fraudulent, which amounts to 8,243,100 calls. Staff further assumes that the disclosures take 8 seconds per call. Thus, the total burden is the number of fraudulent calls multiplied by the disclosure burden per call and converted to hours (8,243,100 calls × 8 seconds per call ÷ 3,600 to convert to hours), or 18,318 hours.
                </P>
                <FTNT>
                    <P>
                        <SU>70</SU>
                         
                        <E T="03">House Committee on Government Operations, The Scourge of Telemarketing Fraud: What Can Be Done Against It,</E>
                         H.R. Rep. 421, 102nd Cong., 1st Sess. at 7 (Dec. 18, 1991). The Federal Bureau of Investigation (FBI) believes that this estimate overstates telemarketing fraud losses as a result of its investigations and closings of once massive telemarketing boiler room operations. 
                        <E T="03">See</E>
                         FBI, 
                        <E T="03">A Byte Out of History: Turning the Tables on Telemarketing Fraud</E>
                         (Dec. 8, 2010), 
                        <E T="03">available at https://www.fbi.gov/news/stories/2010/december/telemarketing_120810/telemarketing_120810.</E>
                          
                        <E T="03">See also</E>
                         internet Crime Complaint Center, 2020 Annual Report on internet Crime (citing $4.1 billion of losses claimed in consumer complaints for 2020), available at 
                        <E T="03">https://www.ic3.gov/Media/PDF/AnnualReport/2020_IC3Report.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>71</SU>
                         Direct Marketing Association (DMA) 2013 Statistical Fact Book (Jan. 2013) at 5 (providing projections up through 2016).
                    </P>
                </FTNT>
                <P>
                    Second, the estimated recordkeeping burden is 92,250 hours. Estimating this burden requires estimating how many new telemarketing entities will be subject to the TSR when the amendment goes into effect. Staff first estimates the number of existing telemarketing entities that engage in tech support sales. In calendar year 2023, 10,350 telemarketing entities accessed the Do Not Call Registry; however, 566 were “exempt” entities obtaining access to data.
                    <SU>72</SU>
                    <FTREF/>
                     Of the non-exempt entities, 6,318 obtained data for a single State. Staff assumes that these 6,318 entities are operating solely intrastate, and thus would not be subject to the TSR. Therefore, staff estimates that approximately 3,466 telemarketing entities (10,350 − 566 exempt − 6,318 intrastate) are currently subject to the TSR. To estimate the percentage of those entities that sell tech support products and services, staff again divides the number of telemarketing fraud complaints for tech support by the total number of telemarketing fraud complaints, 
                    <E T="03">i.e.,</E>
                     91,196 ÷ 2,566,261 = 3.55%. Staff then multiplies that percentage by the number of telemarketing entities (3,466) to produce the estimate that 123 telemarketing entities sell tech support products and services.
                </P>
                <FTNT>
                    <P>
                        <SU>72</SU>
                         
                        <E T="03">See</E>
                         National Do Not Call Registry Data Book for Fiscal Year 2023 (“Data Book”), 
                        <E T="03">available at https://www.ftc.gov/system/files/ftc_gov/pdf/Do-Not-Call-Data-Book-2023.pdf</E>
                         (last visited Sept. 5, 2024). An exempt entity is one that, although not subject to the TSR, voluntarily chooses to scrub its calling lists against the data in the Registry.
                    </P>
                </FTNT>
                <P>
                    When the amendment goes into effect, additional businesses will likely be covered by the TSR. For example, tech support companies that advertise their products through general advertisements and do not engage in upselling may be subject to the Rule for the first time.
                    <SU>73</SU>
                    <FTREF/>
                     On the other hand, companies that market through a combination of advertisements and outbound telemarketing are already subject to the Rule. Companies that receive inbound calls from consumers with questions about their products and that engage in upsells of technical support services are also already subject to the Rule. The Commission estimates that the amendment will increase the number of telemarketing entities that receive inbound tech support calls by a factor of 5, which would mean that an additional 615 entities (123 × 5) will be covered by the Rule.
                </P>
                <FTNT>
                    <P>
                        <SU>73</SU>
                         16 CFR 310.6(b)(5).
                    </P>
                </FTNT>
                <P>The Commission estimates that complying with the TSR's current recordkeeping requirements requires 150 hours for new entrants to develop recordkeeping systems that comply with the TSR, for a total annual recordkeeping burden of 92,250 hours (150 × 615).</P>
                <HD SOURCE="HD2">B. Estimated Annual Labor Costs</HD>
                <P>
                    The Commission estimates annual labor costs by applying appropriate hourly wage rates to the burden hours described above. The Commission estimates that the annual labor cost for disclosures will be $323,130. This total is the product of applying an assumed hourly wage of $17.64 for 18,318 hours 
                    <PRTPAGE P="99074"/>
                    of disclosures.
                    <SU>74</SU>
                    <FTREF/>
                     The Commission estimates that the annual labor cost for recordkeeping will be $2,947,388. This is calculated by applying a skilled labor rate of $31.95/hour 
                    <SU>75</SU>
                    <FTREF/>
                     to the estimated 150 burden hours for the estimated 615 entities that will now be covered by the Rule ($31.95 × 150 × 615).
                </P>
                <FTNT>
                    <P>
                        <SU>74</SU>
                         This figure is derived from the mean hourly wage shown for Telemarketers. 
                        <E T="03">See</E>
                         “Occupational Employment and Wages—May 2023,” U.S. Department of Labor, (Apr. 3, 2024) Table 1 (“National employment and wage data from the Occupational Employment Statistics survey by occupation, May 2023”), 
                        <E T="03">available at https://www.bls.gov/oes/current/oes_nat.htm</E>
                         (last visited  Sept. 5, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>75</SU>
                         This figure is derived from the mean hourly wage shown for Computer Support Specialists from the U.S. Department of Labor source set out in the prior footnote.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Estimated Annual Non-Labor Costs</HD>
                <P>The Commission estimates that the annual non-labor costs per entity for recordkeeping are $55 a year, which is derived from $5 for electronically storing audio files, and $50 for storing the required records. The Commission thus estimates that the annual non-labor costs will be $33,855 (615 entries × $55).</P>
                <HD SOURCE="HD1">V. Regulatory Flexibility Act</HD>
                <P>
                    The Regulatory Flexibility Act (“RFA”), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, requires that the Commission conduct an analysis of the anticipated economic impact of the amendment on small entities.
                    <SU>76</SU>
                    <FTREF/>
                     The RFA requires that the Commission provide a Final Regulatory Flexibility Analysis (“FRFA”) with a final rule unless the Commission certifies that the rule will not have a significant economic impact on a substantial number of small entities.
                    <SU>77</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>76</SU>
                         5 U.S.C. 601 through 612.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>77</SU>
                         5 U.S.C. 605.
                    </P>
                </FTNT>
                <P>The Commission believes that the final rule will not have a significant economic impact upon small entities, nor will it affect a substantial number of small businesses. In the Commission's view, the final rule should not significantly increase the costs of small entities that are sellers or telemarketers. Therefore, based on available information, the Commission certifies that the final rule will not have a significant economic impact on a substantial number of small entities, and hereby provides notice of that certification to the Small Business Administration (“SBA”). Nevertheless, because the Commission included an IFRA in the NPRM, the Commission has also performed an FRFA below.</P>
                <HD SOURCE="HD2">A. Statement of the Need for, and Objective of, the Rule</HD>
                <P>
                    The legal basis for the amendment is the Telemarketing Act, which authorizes the Commission to issue rules to prohibit deceptive or abusive telemarketing practices.
                    <SU>78</SU>
                    <FTREF/>
                     The Commission is issuing the final rule to expressly exclude tech support calls from the exemptions for inbound calls by consumers in response to advertisements and direct mail solicitations from tech support services. As described in section II of this final rule, the amendment is intended to address the widespread harm caused by deceptive tech support services, which disproportionately impact older consumers compared to younger ones.
                </P>
                <FTNT>
                    <P>
                        <SU>78</SU>
                         15 U.S.C. 6102(a)(1).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Statement of the Significant Issues Raised by the Public Comments in Response to the Initial Regulatory Flexibility Analysis, a Statement of the Assessment of the Agency of Such Issues, and a Statement of Any Changes Made in the Proposed Rule as a Result of Such Comments</HD>
                <P>The agency did not receive public comments that responded to the initial regulatory flexibility analysis.</P>
                <HD SOURCE="HD2">C. The Response of the Agency to Any Comments Filed by the Chief Counsel for Advocacy of the Small Business Administration in Response to the Proposed Rule, and a Detailed Statement of Any Change Made to the Proposed Rule in the Final Rule as a Result of the Comments</HD>
                <P>The Small Business Administration did not file comments in response to the proposed rule.</P>
                <HD SOURCE="HD2">D. Description and Estimated Number of Small Entities to Which the Rule Will Apply</HD>
                <P>
                    The amendment to the Rule affects sellers and telemarketers that sell technical support services through inbound telemarketing calls that are made in response to advertisements and direct mail solicitations. As noted in section IV of this final rule (Paperwork Reduction Act), staff estimates that there are 615 such entities that would be covered by the Rule. For telemarketers, a small business is defined by the SBA as one whose average annual receipts do not exceed $25.5 million.
                    <SU>79</SU>
                    <FTREF/>
                     Commission staff are unable to determine a precise estimate of how many sellers or telemarketers constitute small entities as defined by SBA. The Commission sought comment on this issue but did not receive any information from commenters.
                </P>
                <FTNT>
                    <P>
                        <SU>79</SU>
                         Telemarketers are typically classified as “Telemarketing Bureaus and Other contact Centers,” (NAICS Code 561422). 
                        <E T="03">See</E>
                         Table of Small Business Size Standards Matched to North American Industry Classification System Codes, 
                        <E T="03">available at https://www.sba.gov/sites/sbagov/files/2023-06/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023%20%282%29.pdf</E>
                         (last visited, Sept. 5, 2024).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">E. Projected Reporting, Recordkeeping, and Other Compliance Requirements, Including Classes of Small Entities and Professional Skills Needed To Comply</HD>
                <P>The amendment will require sellers and telemarketers that sell technical support services through inbound telemarketing calls made in response to advertisements and direct mail solicitations to comply with the TSR's disclosure and recordkeeping requirements. The small entities potentially covered by the amendment will include all such entities subject to the Rule. The Commission has described the skills necessary to comply with these recordkeeping requirements in section IV of this final rule (Paperwork Reduction Act).</P>
                <HD SOURCE="HD2">F. Significant Alternatives to the Amendment</HD>
                <P>The Commission believes that there are no significant alternatives to the amendment. The Commission has over many years pursued alternatives to the amendment in the form of law enforcement and consumer outreach. The continued injury caused by these scams shows that the amendment to the Rule is necessary. See section II.A of this final rule for more details.</P>
                <P>Additionally, the final rule modified the scope of the definition of technical support services by adding the phrase “any software or application run on such device,” in order to avoid any potential confusion as to whether tech support services or products that are related only to software or applications are covered by the Rule. This definition is still otherwise drafted broadly because, in the Commission's experience, tech support scams have evolved with changes in consumer behavior and technology and will continue to evolve. But while drafted to be flexible to evolving schemes, the definition of technical support services focuses on a type of plan or service marketed in a particular manner provides specificity regarding its coverage. See section III.A of this final rule for more details.</P>
                <P>
                    Lastly, the final rule minimizes the burden on tech support businesses that do not engage in deceptive practices. First, tech support calls “that are not the result of any solicitation by a seller, charitable organization, or telemarketer” are still exempt under § 310.6(b)(5). 
                    <PRTPAGE P="99075"/>
                    Second, excluding tech support where the person providing the service takes physical possession of the device will also limit the breadth of the Rule. See section III.B of this final rule for more details.
                </P>
                <HD SOURCE="HD1">VI. Congressional Review Act</HD>
                <P>
                    Pursuant to the Congressional Review Act, 5 U.S.C. 801 
                    <E T="03">et seq.,</E>
                     the Office of
                </P>
                <P>Information and Regulatory Affairs designated these rule amendments as not a “major rule,” as defined by 5 U.S.C. 804(2).</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 16 CFR Part 310</HD>
                    <P>Advertising, Consumer protection, Telephone, Trade practices.</P>
                </LSTSUB>
                <P>For the reasons stated above, the Federal Trade Commission amends part 310 of title 16 of the Code of Federal Regulations as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 310—TELEMARKETING SALES RULE</HD>
                </PART>
                <REGTEXT TITLE="16" PART="310">
                    <AMDPAR>1. The authority for part 310 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 15 U.S.C. 6101-6108.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="16" PART="310">
                    <AMDPAR>2. Amend § 310.2 by:</AMDPAR>
                    <AMDPAR>a. Redesignating paragraphs (gg) through (ii) as paragraphs (hh) through (jj); and</AMDPAR>
                    <AMDPAR>b. Adding new paragraph (gg).</AMDPAR>
                    <P>The addition reads as follows:</P>
                    <SECTION>
                        <SECTNO>§ 310.2</SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">(gg) Technical support service</E>
                             means any plan, program, software, or service that is marketed to repair, maintain, or improve the performance or security of any device on which code can be downloaded, installed, run, or otherwise used, such as a computer, smartphone, tablet, or smart home product, including any software or application run on such device. Technical support service does not include any plan, program, software, or service in which the person providing the repair, maintenance, or improvement obtains physical possession of the device being repaired.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="16" PART="310">
                    <AMDPAR>3. Amend § 310.6 by revising paragraphs (b)(5)(i) and (b)(6)(i) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 310.6</SECTNO>
                        <SUBJECT>Exemptions.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(5) * * *</P>
                        <P>(i) Calls initiated by a customer or donor in response to an advertisement relating to investment opportunities, debt relief services, technical support services, business opportunities other than business arrangements covered by the Franchise Rule or Business Opportunity Rule, or advertisements involving offers for goods or services described in § 310.3(a)(1)(vi) or § 310.4(a)(2) through (4);</P>
                        <STARS/>
                        <P>(6) * * *</P>
                        <P>(i) Calls initiated by a customer in response to a direct mail solicitation relating to prize promotions, investment opportunities, debt relief services, technical support services, business opportunities other than business arrangements covered by the Franchise Rule or Business Opportunity Rule, or goods or services described in § 310.3(a)(1)(vi) or § 310.4(a)(2) through (4);</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <P>By direction of the Commission, Commissioner Ferguson dissenting.</P>
                <SIG>
                    <NAME>April J. Tabor,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P> The following appendix will not appear in the Code of Federal Regulations.</P>
                </NOTE>
                <APPENDIX>
                    <HD SOURCE="HED">Appendix A—Concurring Statement of Commissioner Melissa Holyoak</HD>
                    <P>
                        Older American adults are squarely in the crosshairs of fraudsters that use technical support scams.
                        <SU>1</SU>
                        <FTREF/>
                         So are our veterans.
                        <SU>2</SU>
                        <FTREF/>
                         Unfortunately, these “older adults [are] disproportionately impacted by [technical support] scams and are five times more likely than younger adults to report losing money to them.” 
                        <SU>3</SU>
                        <FTREF/>
                         And financial losses due to such scams have been increasing in recent years.
                        <SU>4</SU>
                        <FTREF/>
                         I believe the Commission is at its best when it works to address such fraud—the central focus of our consumer protection mission, which will continue to be one of my key priorities while I serve at the Commission. And the Telemarketing Sales Rule (TSR), as amended today, is an extension of the Commission's focus on fraud and will ensure that we can protect some of America's most vulnerable consumers through more robust enforcement. Because today's amendment is sound and will help protect some of America's most vulnerable consumers, I concur.
                        <SU>5</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             
                            <E T="03">See</E>
                             Report, Fed. Trade Comm'n, Protecting Older Consumers 2023-2024, at 12-13, 15, 21 (2024), 
                            <E T="03">https://www.ftc.gov/system/files/ftc_gov/pdf/federal-trade-commission-protecting-older-adults-report_102024.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             
                            <E T="03">See id.</E>
                             at 15; 
                            <E T="03">see also</E>
                             Oral Remarks of Commissioner Melissa Holyoak, Open Commission Meeting, at 1 (Nov. 14, 2024), 
                            <E T="03">https://www.ftc.gov/system/files/ftc_gov/pdf/holyoak-ocm111424remarks.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             Report, 
                            <E T="03">supra</E>
                             note 1, at 12.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             I thank the Commission's Division of Marketing Practices for their efforts.
                        </P>
                    </FTNT>
                    <P>
                        Elections have consequences. But it is hardly novel policy to lawfully amend the long-standing, bipartisan TSR—which Congress, not the current Chair, decided the Commission should promulgate and enforce—to cover an ongoing and increasing threat to some of the most vulnerable in America. And even if this amendment were somehow novel policy, it is entirely consistent with President-elect Trump's past aggressive anti-fraud policies, along with his “relentless commitment to keep America's seniors safe.” 
                        <SU>6</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             
                            <E T="03">Cf., e.g., Remarks by President Trump in Roundtable Discussion on Fighting for America's Seniors,</E>
                             The White House (June 15, 2020) (describing then-President Trump's “ironclad commitment to protecting and caring for America's seniors” and work to protect them from fraud), 
                            <E T="03">https://trumpwhitehouse.archives.gov/briefings-statements/remarks-president-trump-roundtable-discussion-fighting-americas-seniors/.</E>
                             To my knowledge, no other Commissioner believes this amendment is poor policy or inconsistent with our legal authorities, or would do anything but help older Americans—including those that played a pivotal role in President-elect Trump's recent victory. 
                            <E T="03">See, e.g.,</E>
                             Susan Milligan, 
                            <E T="03">How Older Voters Powered Trump's Election Engine,</E>
                             AARP (Nov. 7, 2024), 
                            <E T="03">https://www.aarp.org/politics-society/government-elections/info-2024/election-analysis-older-voters.html.</E>
                        </P>
                    </FTNT>
                    <P>
                        Since joining the Commission, I have not hesitated to dissent when the Majority has gone beyond what Congress has authorized or otherwise acted wrongly,
                        <SU>7</SU>
                        <FTREF/>
                         including when I have stood alone in articulating such concerns.
                        <SU>8</SU>
                        <FTREF/>
                         While it is true that the current Majority has prioritized controversial and unlawful rulemakings over the last four years, as we turn the page I believe the Commission should redirect its efforts and resources toward enforcement against fraud and, only where appropriate, rulemakings that ensure the Commission can robustly prosecute fraud and provide consumers redress. Today's amendment is consistent with this new direction I believe the Commission should chart. And it is sound policy that fits squarely within the Commission's storied past and its mission to protect the American people from fraudsters and scammers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Dissenting Statement of Commissioner Melissa Holyoak, Joined by Commissioner Andrew N. Ferguson, 
                            <E T="03">In re the Non-Compete Clause Rule,</E>
                             Matter No. P201200 (June 28, 2024), 
                            <E T="03">https://www.ftc.gov/system/files/ftc_gov/pdf/2024-6-28-commissioner-holyoak-nc.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Dissenting Statement of Commissioner Melissa Holyoak, 
                            <E T="03">Negative Option Rule,</E>
                             FTC Matter No. P064202 (Oct. 16, 2024), 
                            <E T="03">https://www.ftc.gov/system/files/ftc_gov/pdf/holyoak-dissenting-statement-re-negative-option-rule.pdf;</E>
                             Dissenting Statement of Commissioner Melissa Holyoak, 
                            <E T="03">In re Pharmacy Benefit Managers Report,</E>
                             Matter No. P221200 (July 9, 2024), 
                            <E T="03">https://www.ftc.gov/system/files/ftc_gov/pdf/Holyoak-Statement-Pharmacy-Benefit-Managers-Report.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">Dissenting Statement of Commissioner Andrew N. Ferguson</HD>
                    <P>
                        I dissent from this rulemaking not because it is bad policy, but because the time for rulemaking by the Biden-Harris FTC is over. The American people have roundly rejected its regulatory assault on American business. They delivered a resounding victory for President Trump and a decisive mandate for his vision for the most pro-innovation, pro-competition, pro-worker, and pro-consumer administration in the history of our country. The proper role of this lame-duck Commission is not to announce new policies, 
                        <PRTPAGE P="99076"/>
                        but to hold down the fort, conduct routine law enforcement, and provide for an orderly transition to the Trump Administration. I will vote against all new rules not required by statute, and any enforcement action that advances an unprecedented theory of liability until that transition is complete.
                    </P>
                </APPENDIX>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28399 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6750-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF STATE</AGENCY>
                <CFR>22 CFR Part 42</CFR>
                <DEPDOC>[Public Notice: 12446]</DEPDOC>
                <RIN>RIN 1400-AF82</RIN>
                <SUBJECT>Visas: Special Immigrant Visas—U.S. Government Employee Special Immigrant Visas for Service Abroad</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of State.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This final rule makes updates to reflect a statutory change to the class of individuals who may qualify for Special Immigrant Visas (SIVs).</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective December 10, 2024.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jami Thompson, Senior Regulatory Coordinator, U.S. Department of State, Bureau of Consular Affairs, Visa Services, 600 19th Street NW, Washington, DC 20522, (202) 485-7586, 
                        <E T="03">VisaRegs@state.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Special Immigrant Visas for Certain Employees or Former Employees of the United States Abroad, and for the Surviving Spouses or Children of Certain Deceased Employees of the U.S. Government Abroad</HD>
                <HD SOURCE="HD2">A. Legal Authority</HD>
                <P>Section 203(b)(4) of the Immigration and Nationality Act (INA), as amended 8 U.S.C. 1153(b)(4), generally provides that visas may be issued to qualified special immigrants described in INA section 101(a)(27). Among the individuals considered “special immigrants” as defined in this provision, INA section 101(a)(27)(D), 8 U.S.C. 1101(a)(27)(D), defines “special immigrant” to include employees, or honorably retired former employees, of the U.S. Government abroad, or of the American Institute in Taiwan, who have performed faithful service for a total of fifteen years or more, in addition to their accompanying spouse and children, and who have been recommended and approved for such status in accordance with enumerated criteria.</P>
                <P>
                    Section 403(a) of the Emergency Security Supplemental Appropriations Act, 2021 (“ESSAA”), Public Law 117-31, 135 Stat. 309, 318, amended the definition of a special immigrant at INA section 101(a)(27)(D) to include a new subclause (ii). The new subclause includes in the definition of “special immigrant” the surviving spouse or child of an employee of the United States Government abroad: 
                    <E T="03">Provided,</E>
                     [t]hat the employee performed faithful service for a total of not less than 15 years or was killed in the line of duty.” Under this provision, the qualifying surviving spouse or child of a U.S. Government employee is a principal applicant for special immigrant status, and consequently, their current spouse and minor child(ren) are entitled to SIVs as derivatives under INA section 203(d), 8 U.S.C. 1153(d), if accompanying or following to join the qualifying surviving spouse or parent. Pursuant to section 403(d) of the ESSAA, these changes are effective June 30, 2021, and have retroactive effect.
                </P>
                <P>In addition to the qualifications for this group of “special immigrants,” INA section 204(a)(1)(G)(ii) governs the process through which an individual claiming status as a special immigrant under INA section 101(a)(27)(D) must file a petition with the Department of State, requiring that they first be recommended and approved for such status.</P>
                <HD SOURCE="HD2">B. Processing for Special Immigrants Under INA Section 101(a)(27)(D)</HD>
                <P>Under INA sections 204(a)(1)(G)(ii) and 101(a)(27)(D)(i), acquisition of special immigrant status under INA section 101(a)(27)(D) requires multiple sequential steps. First, the principal officer of the U.S. embassy or consulate with jurisdiction over where the individual was employed must have recommended the granting of special immigrant status in exceptional circumstances, and the Secretary of State or appropriate designee must have approved the recommendation and found that it is in the national interest to grant such status. Second, under INA section 204(a)(1)(G)(ii), only after the approval of the recommendation, the applicant may submit a Form DS-1884, Petition to Classify Special Immigrant Under INA 203(b)(4) as an Employee or Former Employee of the U.S. Government Abroad, or the Surviving Spouse or Child of an Employee of the U.S. Government Abroad, to a consular officer at a foreign service post. Under Department regulations at 22 CFR 42.34(b)(2), the date the applicant's properly completed DS-1884 is accepted becomes the applicant's priority date. Those same regulations at 22 CFR 42.34(b)(4) provide that a petition from a qualifying individual is valid for six months from the date of approval or the date an immigrant visa number becomes available, whichever is later.</P>
                <HD SOURCE="HD2">C. What is the impact of the ESSAA?</HD>
                <P>Prior to passage of the ESSAA, if the employee were to die before entering the United States using their immigrant visa, the surviving spouse or child would be ineligible for immigrant status. With the passage of the ESSAA, a surviving spouse and surviving child(ren), as a principal applicant, are eligible to seek qualification as a special immigrant. Additionally, in situations where the employee did not pursue special immigrant status prior to the employee's death, their surviving spouse and/or child may now qualify to be approved for status. These changes apply retroactively, meaning that the surviving spouse or child of an employee who died prior to the effective date of the ESSAA may also seek to qualify. To be a surviving spouse, the spousal relationship must have existed at the time of the deceased employee's death. To be a surviving child, the adult son or daughter of the deceased employee must have met the definition of “child” under INA section 101(b)(1) on the date of the employee's death.</P>
                <HD SOURCE="HD1">II. Changes the Department Is Making</HD>
                <HD SOURCE="HD2">A. 22 CFR 42.11</HD>
                <P>This rule makes updates to the Department's regulations at 22 CFR 42.11 that list the symbols of the current immigrant visa classifications to conform with the new classifications added by the ESSAA. Specifically, under the “Employment 4th Preference (Certain Special Immigrants)” header, the Department is adding: The “SS1” symbol that will be used for issuance of SIVs to the surviving spouse or child of a U.S. Government employee; the “SS2” symbol that will be used for issuance of an SIV to the current spouse of an SS1 who qualifies as a derivative under INA 203(d); and the “SS3” symbol that will be used for issuance of an SIV to the minor child(ren) of an SS1 who meet(s) the definition of “child” under INA 101(b)(1) and 203(h), and qualify(ies) as a derivative under INA 203(d).</P>
                <HD SOURCE="HD2">B. 22 CFR 42.34</HD>
                <P>
                    This rule makes changes to Department regulations at 22 CFR 42.34 to conform with the expanded definition of “special immigrant” under the ESSAA. For the reasons explained below, the Department believes these (or 
                    <PRTPAGE P="99077"/>
                    equivalent) changes are necessary to implement the best reading of the ESSAA. The changes include the explanation of the classification of a surviving spouse or child of an employee of the United States Government abroad who was killed in the line of duty, or who performed faithful service for at least fifteen years before their death.
                </P>
                <P>As summarized above, the ESSAA added a new subsection (ii) to INA 101(a)(27)(D) and amended INA 101(a)(27)(D) to specify that a “special immigrant” includes an individual described in clause (D)(i) “or” clause (D)(ii). The ESSAA did not amend INA 204(a)(1)(G)(ii), which governs the process through which an individual petitions for status “as a special immigrant under INA 101(a)(27)(D).” Consequently, as this provision was not amended to distinguish the petition process for special immigrants described in INA 101(a)(27)(D)(i) or INA 101(a)(27)(D)(ii), INA 204(a)(1)(G)(ii) continues to govern the petition process for both subcategories of “special immigrants” described in section 101(a)(27)(D), providing that applicants seeking status under either subcategory “may file a petition . . . only after notification by the Secretary of State that such status has been recommended and approved pursuant to such section.” Although INA 101(a)(27)(D)(ii) as amended does not expressly reference a framework for recommendation and approval, INA 101(a)(27)(D)(i) establishes the standards for a recommendation and approval process, including that the recommendation of an individual for special immigrant status be made in “exceptional circumstances” and the approval be “in the national interest,” as well as identifies officers vested with authority for those respective functions. Incorporating into INA 101(a)(27)(D)(ii) the standards and process for recommendation and approval expressly provided by Congress in INA 101(a)(27)(D)(i) reflects the best reading of the statutory framework as amended by ensuring consistency with the companion provision in INA 204(a)(1)(G)(ii) requiring recommendation and approval of such cases and ensuring the consistent application of the longstanding framework for the granting of special immigrant visas to U.S. Government employees.</P>
                <P>To address potential inconsistencies in how this change would be implemented using the existing definition of “exceptional circumstances” at 22 CFR 42.34(c)(7), this rule explains the circumstances in which a surviving spouse or child would be recommended for special immigrant status, based on the criteria described in INA section 101(a)(27)(D)(ii). In addition to qualifying employees' deaths that occurred in the line of duty, these include when the deceased employee performed at least 15 years of faithful service for the U.S. Government and either would have qualified for special immigrant status before dying or was employed by the U.S. Government as of the date of their death or in the immediately preceding five-year period. These parameters will encompass those family members of deceased employees who, but for their death following at least 15 years of faithful service, were likely to have soon qualified for special immigrant status by accumulating 20 years of faithful service (where 20 years is a strong indicator of exceptional circumstances under 22 CFR 42.34(c)(7)(ii)(E)). This standard encompasses those who were employed by the U.S. Government in the period immediately preceding their death, as the Department anticipates that in some cases, an employee may have ceased employment by the U.S. Government with the intention of returning, but for circumstances out of their control. For example, an employee who dies following a serious illness may have ceased or temporarily left their employment for a period to combat their illness. Consequently, to provide clarity to the public and support consistent application, the rule establishes a rebuttable presumption that a death occurring more than five years after cessation of employment is not related to the cessation of their employment for purposes of their surviving spouse or child qualifying for special immigrant status.</P>
                <P>The Department believes this five-year presumption will account for the gravity and severity of the circumstances surrounding cessation of employment, and the likelihood that a previously employed individual would have returned to work to complete 20 years of service, if they were able to do so. This presumption is rebuttable and will require case-specific consideration of those individuals whose circumstances fall outside the five-year presumption and who wish to provide evidence to establish their qualifications. Surviving spouses and children of employees who died for reasons unrelated to cessation of employment are not precluded from qualifying as special immigrants, provided they can demonstrate that the employee demonstrated at least one form of “exceptional circumstances” while still employed. The changes also highlight that the processes to qualify for eligibility are the same for a surviving spouse or child as they are for employees. These changes make necessary amendments to 22 CFR 42.34 to provide for the issuance of SIVs to qualified surviving spouses and children of U.S. Government employees, and to reflect the amended citations in INA section 101(a)(27)(D) under the ESSAA.</P>
                <P>
                    This rule also makes corrections throughout 22 CFR 42.34 to replace the term “alien” with the term “applicant” or “employee,” as appropriate. This change is consistent with current Department practice.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See</E>
                         88 FR 45072 (July 14, 2023).
                    </P>
                </FTNT>
                <P>Finally, this rule also amends the certification, required as part of the principal officer's recommendation, that the individual being recommended is prepared to pursue an immigrant visa application “within one year of the Department's notification to the post of approval of special immigrant status.” As applicants in numerically limited immigrant visa categories, including INA section 203(b)(4), may not pursue an immigrant visa application until such time that a visa number becomes available in that category, this requirement has been changed to reflect that the recommended individual must be prepared to pursue their application “within one year of the Department's notification to the post of approval of special immigrant status, or of an immigrant visa becoming available, whichever is later.”</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <HD SOURCE="HD2">A. Administrative Procedure Act</HD>
                <P>
                    This rule is exempted from the notice and comment and delayed effective date rulemaking procedures set forth in 5 U.S.C. 553 because the rule involves a foreign affairs function. 5 U.S.C. 553(a)(1). This exemption applies when the rule's subject matter “is clearly and directly involved in a foreign affairs function.” 
                    <E T="03">Mast Indus.</E>
                     v. 
                    <E T="03">Regan,</E>
                     596 F. Supp. 1567, 1582 (C.I.T. 1984) (quotation marks omitted). In addition, although the text of the APA does not require an agency invoking this exemption to show that rulemaking with public notice and comment would result in “definitely undesirable international consequences,” some courts have required such a showing. 
                    <E T="03">See, e.g., Yassini</E>
                     v. 
                    <E T="03">Crosland,</E>
                     618 F.2d 1356, 1360 n.4 (9th Cir. 1980). This rule satisfies both standards.
                    <PRTPAGE P="99078"/>
                </P>
                <P>This rule extends the authority to grant special immigrant status to the surviving spouse or child of a U.S. Government employee who performed faithful service for at least fifteen years or was killed in the line of duty. As with the availability of special immigrant status to qualifying locally employed staff, eligibility for employees' surviving spouses and children encourages employees to remain in their jobs and to provide long-term, institutional memory to U.S. Government agencies abroad. This is particularly essential in countries where local staff members and their families face retribution by the host government, making it even more challenging to recruit and retain a locally employed workforce. For this reason, extending eligibility to the employee's surviving spouse and children critically impacts the willingness of foreign nationals to become, and remain, employees of the U.S. Government in overseas posts, and hence directly impacts the effectiveness of U.S. diplomatic efforts in those countries.</P>
                <P>The Department's establishment of criteria for surviving spouses and child(ren) to qualify for special immigrant status under ESSAA clearly and directly relates to U.S. foreign affairs, because the criteria itself is critical for the U.S. Government to recruit and retain loyal, valuable local staff outside the United States, without whom the Department could not fulfill its diplomatic functions overseas. The Department alone employs approximately 50,000 local staff at over 200 Foreign Service posts overseas. Expanded qualifications for surviving spouses and child(ren) is critical to recruitment, retention, and morale of these locally employed staff who help the Department carry out its foreign affairs functions overseas. For example, following the 2013 death of Mustafa Akarsu, a member of the local guard force for U.S. Embassy Ankara for 22 years, when he confronted a suicide bomber outside the Embassy, Department employee organizations including the American Foreign Service Association, advocated for passage of legislation eventually enacted in ESSAA to provide SIVs to the surviving spouses and children of U.S. Government employees killed in the line of duty. Consequently, implementation of these standards for surviving family members clearly and directly involves a U.S. foreign affairs function.</P>
                <P>
                    Finally, the Department considers that providing the opportunity for public notice and comment would provide “definitely undesirable international consequences,” in that conducting and resolving a public debate regarding the safety of surviving spouses and children of U.S. Government employees killed abroad would risk impairing U.S. relations with other countries. 
                    <E T="03">See, e.g., Rajah</E>
                     v. 
                    <E T="03">Mukasey,</E>
                     544 F.3d 427, 437 (2d Cir. 2008). The loss of United States local employees in the line of duty has previously had the effect of straining bilateral relations, and has the continued potential to do so, particularly when such losses involve local foreign authorities or other parties over which the host country exercises control. This may be even more so in countries with which the United States already has sensitive or strained relations, which may oppose the availability of immigrant visas to the surviving spouses and children of such staff, who are usually nationals of the host country. Accordingly, the promulgation of standards for approval under the Secretary of State's authority in INA 101(a)(27)(D) involves an inherently foreign affairs function of the Department of State.
                </P>
                <HD SOURCE="HD2">B. Regulatory Flexibility Act/Executive Order 13272: Small Business</HD>
                <P>
                    As this final rule is exempt from notice and comment rulemaking under 5 U.S.C. 553(a)(1), it is exempt from the regulatory flexibility analysis requirements set forth by the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ). Nonetheless, as this action only directly impacts visa applicants, the Department certifies that this rule will not have a significant economic impact on a substantial number of small U.S. entities.
                </P>
                <HD SOURCE="HD2">C. Congressional Review Act of 1996</HD>
                <P>This rule is not a major rule as defined in 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies in domestic and import markets.</P>
                <HD SOURCE="HD2">D. Executive Orders 12866 (Regulatory Planning and Review), 13563 (Improving Regulation and Regulatory Review), and 14094 (Modernizing Regulatory Review)</HD>
                <P>This rule has been drafted in accordance with the principles of Executive Orders 12866 (as amended by Executive Order 14094) and 13563. The Department has submitted this rule to OIRA for review and it has been deemed a significant regulatory action.</P>
                <HD SOURCE="HD2">E. Executive Order 12988: Civil Justice Reform</HD>
                <P>The Department of State has reviewed the rule considering sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burdens.</P>
                <HD SOURCE="HD2">F. Executive Order 13175—Consultation and Coordination With Indian Tribal Governments</HD>
                <P>The Department of State has determined that this rulemaking will not have Tribal implications, will not impose substantial direct compliance costs on Indian Tribal Governments, and will not pre-empt Tribal law. Accordingly, the requirements of Section 5 of Executive Order 13175 do not apply to this rulemaking.</P>
                <HD SOURCE="HD2">G. Paperwork Reduction Act</HD>
                <P>This rule does not impose any new reporting or record-keeping requirements subject to the Paperwork Reduction Act (PRA), 44 U.S.C. Chapter 35. The Form DS-1884, Petition to Classify Special Immigrant under INA 203(b)(4) as an Employee or Former Employee of the U.S. Government Abroad, is approved under the PRA (OMB Control No. 1405-0082).</P>
                <HD SOURCE="HD2">H. Other</HD>
                <P>The Department has also considered the Unfunded Mandates Reform Act of 1995 and Executive Orders 12372 and 13132 and affirms this rule is consistent with the applicable mandates or guidance therein.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 22 CFR Part 42</HD>
                    <P>Administrative practice and procedure, Aliens, Passports and visas.</P>
                </LSTSUB>
                <P>Accordingly, for the reasons set forth in the preamble, 22 CFR part 42 is amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 42—VISAS: DOCUMENTATION OF IMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED</HD>
                </PART>
                <REGTEXT TITLE="22" PART="42">
                    <AMDPAR>1. The authority citation for part 42 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 8 U.S.C. 1104 and 1182; Pub. L. 105-277, 112 Stat. 2681; Pub. L. 108-449, 118 Stat. 3469; The Convention on Protection of Children and Co-operation in Respect of Intercountry Adoption (done at the Hague, May 29, 1993), S. Treaty Doc. 105-51 (1998), 1870 U.N.T.S. 167 (Reg. No. 31922 (1993)); 42 U.S.C. 14901-14954 (Pub. L. 106-279, 114 Stat. 825); 8 U.S.C. 1101 (Pub L. 117-31, 135 Stat. 309); 8 U.S.C. 1154 (Pub. L. 109-162, 119 Stat. 2960); 8 U.S.C. 1201 (Pub. L. 114-70, 129 Stat. 561).</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="22" PART="42">
                    <AMDPAR>
                        2. Section 42.11 is amended in table 1 to § 42.11 under the undesignated 
                        <PRTPAGE P="99079"/>
                        center heading “Employment 4th Preference (Certain Special Immigrants)” by:
                    </AMDPAR>
                    <AMDPAR>a. Revising the entries for SE1, SE2, SE3, and SS1; and</AMDPAR>
                    <AMDPAR>b. Adding entries for SS2 and SS3 in alphanumeric order.</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 42.11</SECTNO>
                        <SUBJECT>Classification symbols.</SUBJECT>
                        <STARS/>
                        <GPOTABLE COLS="3" OPTS="L1,nj,i1" CDEF="xs60,r75,r50">
                            <TTITLE>Table 1 to § 42.11</TTITLE>
                            <BOXHD>
                                <CHED H="1">Symbol</CHED>
                                <CHED H="1">Class</CHED>
                                <CHED H="1">Section of Law</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW EXPSTB="02" RUL="s">
                                <ENT I="21">
                                    <E T="02">Employment 4th Preference (Certain Special Immigrants)</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">SE1</ENT>
                                <ENT>Certain Employee or Former Employee of the U.S. Government Abroad</ENT>
                                <ENT>INA 101(a)(27)(D)(i) &amp; INA 203(b)(4).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">SE2</ENT>
                                <ENT>Spouse of SE1</ENT>
                                <ENT>INA 101(a)(27)(D)(i) &amp; INA 203(b)(4).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">SE3</ENT>
                                <ENT>Child of SE1</ENT>
                                <ENT>INA 101(a)(27)(D)(i) &amp; INA 203(b)(4).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">SS1</ENT>
                                <ENT>Surviving Spouse or Child of an Employee of the United States Government Abroad</ENT>
                                <ENT>INA 101(a)(27)(D)(ii) &amp; INA 203(b)(4).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">SS2</ENT>
                                <ENT>Current Spouse of SS1</ENT>
                                <ENT>INA 101(a)(27)(D)(ii), INA 203(b)(4) &amp; INA 203(d).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">SS3</ENT>
                                <ENT>Child of SS1 (Excludes Surviving Child of an Employee of the United States Government Abroad), provided the child meets the definition of 101(b)(1) of the INA</ENT>
                                <ENT>INA 101(a)(27)(D)(ii), INA 1101(b)(1), 203(b)(4), &amp; INA 203(d).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="22" PART="42">
                    <AMDPAR>3. Section 42.34 is revised to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 42.34</SECTNO>
                        <SUBJECT>Special immigrant visas-certain U.S. Government employees.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">General.</E>
                             An applicant is classifiable under INA 203(b)(4) as a special immigrant described in INA 101(a)(27)(D) provided:
                        </P>
                        <P>(1) (i) The applicant has performed faithful service to the United States Government abroad, or the American Institute in Taiwan, for a total of fifteen years or more; or</P>
                        <P>(ii) The applicant is the surviving spouse or child of an employee of the United States Government abroad who performed faithful service for a total of not less than 15 years or was killed in the line of duty; and</P>
                        <P>(2) The principal officer of a Foreign Service establishment (or, in the case of the American Institute in Taiwan, the Director), recommends granting special immigrant status to such person in exceptional circumstances; and</P>
                        <P>(3) The Secretary of State, or designee, approves such recommendation and finds that it is in the national interest to grant such status.</P>
                        <P>
                            (b) 
                            <E T="03">Petition requirement.</E>
                             An applicant who seeks classification as a special immigrant described in paragraph (a) of this section must file a Form DS-1884, Petition to Classify Special Immigrant under INA 203(b)(4) as an Employee or Former Employee of the U.S. Government Abroad, or the Surviving Spouse or Child of an Employee of the U.S. Government Abroad, with the Department of State. An applicant described in INA 101(a)(27)(D) may file such a petition only after, but within one year of, notification from the Department that the Secretary of State or designee has approved a recommendation from the principal officer that special immigrant status be accorded the applicant in exceptional circumstances and has found it in the national interest to do so.
                        </P>
                        <P>
                            (1) 
                            <E T="03">Petition fees.</E>
                             The Secretary of State shall establish a fee for the filing of a petition to accord status under INA 203(b)(4) which shall be collected following notification that the Secretary of State, or designee, has approved the recommendation that the applicant be granted status as a special immigrant under INA 101(a)(27)(D).
                        </P>
                        <P>
                            (2) 
                            <E T="03">Establishing priority date.</E>
                             The priority date of an applicant seeking status under INA 203(b)(4) as a special immigrant described in INA 101(a)(27)(D) shall be the date on which the petition to accord such classification, the DS-1884, is filed. The filing date of the petition is the date on which a properly completed form and the required fee are accepted by a Foreign Service post. Pursuant to INA 203(d), and whether named in the petition, the current spouse or child who meets the definition of “child” under INA 101(b)(1) of an applicant classified under INA 203(b)(4), if not otherwise entitled to an immigrant status and the immediate issuance of a visa, is entitled to the classification and priority date of the beneficiary of the petition.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Delegation of authority to approve petitions.</E>
                             The authority to approve petitions to accord status under INA 203(b)(4) to an applicant described in INA 101(a)(27)(D) is hereby delegated to the chief consular officer at the post of recommendation or, in the absence of the consular officer, to any alternate approving officer designated by the principal officer. Such authority may not be exercised until the Foreign Service post has received formal notification of the Secretary of State or designee's approval of special immigrant status for the petitioning applicant.
                        </P>
                        <P>
                            (4) 
                            <E T="03">Petition validity.</E>
                             Except as noted in this paragraph, the validity of a petition approved for classification under INA 203(b)(4) shall be six months beyond the date of the Secretary of State's approval thereof or the availability of a visa number, whichever is later.
                        </P>
                        <P>
                            (5) 
                            <E T="03">Extension of special immigrant status and petition validity.</E>
                             If the principal officer of a post concludes that circumstances in a particular case are such that an extension of validity of the Secretary of State or designee's approval of the principal officer's recommendation or of the petition would be in the national interest, the 
                            <PRTPAGE P="99080"/>
                            principal officer shall recommend to the Secretary of State or designee that such validity be extended for not more than one additional year.
                        </P>
                        <P>
                            (c) 
                            <E T="03">Definitions</E>
                            —(1) 
                            <E T="03">Full-time service.</E>
                             Where 15 years of service is the minimum time required for eligibility for a special immigrant visa, the employee must have been employed for a total of at least 15 full-time years, or the equivalent thereof, in the service of the U.S. Government abroad. The number of hours per week that qualify an employee as full-time is dependent on local law and prevailing practice in the country where the individual is or was employed, as reflected in the employment documentation submitted with the application for special immigrant status. The years of service may be met based on employment abroad with one, or more than one, agency of the U.S. Government provided the total amount of full-time service with the U.S. Government is 15 years or more, or the equivalent thereof.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Faithful service.</E>
                             Where faithful service is required for eligibility for a special immigrant visa, an employee must have performed faithfully in the position held. The principal officer has the primary responsibility for determining whether the employee's service meets this requirement. A record of disciplinary actions that have been taken against the employee does not automatically disqualify the applicant. The principal officer must assess the record of disciplinary actions considering the extent and gravity of the misconduct and when the incidents occurred, and determine whether the record as a whole, notwithstanding disciplinary actions, is one of faithful service.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Continuity.</E>
                             Where 15 years of service is the minimum time required for eligibility for a special immigrant visa, the employee's period of service need not have been continuous but must have an aggregate total of 15 years of service to qualify.
                        </P>
                        <P>
                            (4) 
                            <E T="03">Abroad.</E>
                             The service must have occurred anywhere outside the United States, as the term “United States” is defined in INA 101(a)(38).
                        </P>
                        <P>
                            (5) 
                            <E T="03">Employment at the American Institute in Taiwan.</E>
                             INA 101(a)(27)(D) permits both present and former employees of the American Institute in Taiwan to apply for special immigrant status. An employee's service before and after the founding of the American Institute in Taiwan is counted toward the minimum 15 years of service requirement.
                        </P>
                        <P>
                            (6) 
                            <E T="03">Honorably retired.</E>
                             Separations within the meaning of “honorably retired” include, for example, those resulting from mandatory or voluntary retirement, reduction-in-force, or resignation for personal reasons. Separations not within the meaning of “honorably retired” would include a termination for cause or an involuntary termination or resignation in lieu of a termination for cause.
                        </P>
                        <P>
                            (7) 
                            <E T="03">Exceptional circumstances for employees of the United States Government abroad.</E>
                             For classification as a special immigrant under INA 101(a)(27)(D)(i), the principal officer must determine that an employee demonstrates at least one form of “exceptional circumstances” to support an application for special immigrant status.
                        </P>
                        <P>
                            (i) 
                            <E T="03">Prima facie indicators of exceptional circumstances.</E>
                             In the following situations, an employee's service with the U.S. Government generally will be deemed to have met exceptional circumstances.
                        </P>
                        <P>(A) Diplomatic relations between the employee's country of nationality and the United States have been severed;</P>
                        <P>(B) Diplomatic relations between the country in which the employee was employed and the United States have been severed;</P>
                        <P>(C) The country in which the employee was employed and the United States have strained relations and the employee may be subjected to retribution by the local, State, Federal, or other official government body merely because of association with the U.S. Government, or the employee may be pressured to divulge information contrary to U.S. national interests; or</P>
                        <P>(D) The employee was hired at the Consulate General at Hong Kong on or before July 1, 1999.</P>
                        <P>
                            (ii) 
                            <E T="03">Strong indicators of exceptional circumstances.</E>
                             (A) It is believed that continued service to the U.S. Government might endanger the life of the employee;
                        </P>
                        <P>(B) The employee has fulfilled responsibilities or given service in a manner that approaches the heroic;</P>
                        <P>(C) The employee has been awarded a global or a regional “Foreign Service National of the Year” Award;</P>
                        <P>(D) The employee has disclosed waste, fraud or abuse, a substantial and specific danger to public health or safety, or a violation of law, rule, or regulation within the Department or other U.S. Government agency, if such disclosure results in significant action by the Department or other U.S. Government agency against an offending party, such as termination or severance of a contractual relationship, or criminal charges against any person or entity.</P>
                        <P>(E) The employee has served the U.S. Government for a period of twenty years or more.</P>
                        <P>
                            (8) 
                            <E T="03">Exceptional circumstances for surviving spouses and children.</E>
                             For classification as a special immigrant under INA 101(a)(27)(D)(ii), the principal officer must determine that the deceased employee:
                        </P>
                        <P>(i) Was killed in the line of duty; or</P>
                        <P>(ii) Performed faithful service to the United States Government abroad for a total of not less than 15 years; and</P>
                        <P>(A) Was employed by the U.S. Government as of the date of their death or in the immediately preceding period as defined in paragraph (c)(9) of this section, or</P>
                        <P>(B) Was an honorably retired former employee who, prior to their death, demonstrated at least one form of “exceptional circumstances” as defined in paragraph (c)(7) of this section.</P>
                        <P>
                            (9) 
                            <E T="03">Immediately preceding period.</E>
                             (i) As provided in paragraph (c)(8)(ii)(A) of this section, a deceased employee is considered to have been employed by the U.S. Government in the period immediately preceding their death if such employment ceased due to circumstances that resulted in their death.
                        </P>
                        <P>(ii) A deceased employee is presumed to not meet the criteria in paragraph (c)(8)(ii)(A) of this section if the employee's death occurred more than five years following cessation of employment. This presumption can be rebutted if the applicant establishes, to the satisfaction of the principal officer, that the employment ceased due to circumstances that resulted in the employee's death, and the Secretary or appropriate designee finds it in the national interest to grant such status. The principal officer has the primary responsibility for determining whether the applicant meets this criterion, taking into consideration as informed by the circumstances of the cessation of employment, the cause of the employee's death as documented by the applicant, and other relevant evidence the applicant presents that demonstrates that the cessation of employment was for reasons that ultimately resulted in the employee's death.</P>
                        <P>
                            (10) 
                            <E T="03">Immediate intent to immigrate.</E>
                             (i) The recommendation of the principal officer must certify that the applicant being recommended is prepared to file a petition within one year of the Department's notification to the post of approval of special immigrant status, and to pursue an immigrant visa application within six months of the Secretary of State's approval of the petition or of an immigrant visa becoming available, whichever is later. 
                            <PRTPAGE P="99081"/>
                            If the applicant is an employee who is not yet honorably retired, the recommendation must also certify that the employee intends permanent separation from U.S. Government employment abroad no later than the date of departure for the United States following issuance of an immigrant visa.
                        </P>
                        <P>(ii) Employees of Hong Kong Consulate General hired on or before July 1, 1999, are not required to establish immediate intent to immigrate. Employees of the Hong Kong Consulate General who received or were approved for special immigrant status before July 1, 1999, also may continue employment with the U.S. Government.</P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <NAME>Julie M. Stufft,</NAME>
                    <TITLE>Deputy Assistant Secretary, Consular Affairs, Department of State.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28846 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4710-06-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF STATE</AGENCY>
                <CFR>22 CFR Parts 122 and 129</CFR>
                <DEPDOC>[Public Notice: 12542]</DEPDOC>
                <RIN>RIN 1400-AF78</RIN>
                <SUBJECT>International Traffic in Arms Regulations: Registration Fees</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of State.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of State published a proposed rule on April 24, 2024, requesting comment on proposals to amend the International Traffic in Arms Regulations (ITAR) by increasing and specifying the fees required for registration with the Directorate of Defense Trade Controls (DDTC). The Department now responds to the public comments received in response to that proposed rule and issues this final rule.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective January 9, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Allison Smith, Director, Office of Defense Trade Controls Management, Department of State, telephone (202) 663-1282; email 
                        <E T="03">DDTCCustomerService@state.gov.</E>
                         ATTN: Registration Fee Change.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Overview</HD>
                <P>This final rule implements a change and increase in registration fees for certain persons required under 22 U.S.C. 2778(b) to register with the Department of State's Directorate of Defense Trade Controls (DDTC) and pay a registration fee. It also returns the amount of fees registrants must pay to the International Traffic in Arms Regulations (ITAR) (22 CFR parts 120 through 130) and makes clarifying revisions to part 122 of the ITAR. This final rule follows a proposed rule (89 FR 31119), published on April 24, 2024, which included the proposed revisions to DDTC's registration fees and corresponding amendments to the ITAR.</P>
                <P>As noted in its proposed rule, for the first time in fifteen years, the Department proposed to revise and increase the registration fees (also referred to as “fees”) charged to those required to register with DDTC. This increase is necessary because DDTC operations are primarily funded by fees. Without a sufficient increase to meet operational costs that have significantly risen since 2008, DDTC would be faced with untenable budget deficits and would be forced to reduce its services.</P>
                <P>In accordance with section 38(b) of the Arms Export Control Act (AECA) (22 U.S.C. 2778(b)) and ITAR § 122.1 (22 CFR 122.1), every person who engages in the business of manufacturing, exporting, temporarily importing, or brokering any defense articles or defense services is required to register with DDTC, the agency charged with administering the relevant sections of the AECA. Section 38(b) of the AECA also requires that every person required to register pay a registration fee. As the ITAR implements section 38 of the AECA, and as its parts 122 and 129 (22 CFR parts 122 and 129) address registration, the Department proposed to revise those provisions to restate registration requirements without substantive change, to revise the Department's methodology for determining the fees paid by certain registrants, to increase registration fees, and to reinsert the actual amount of fees within the ITAR itself. The Department now provides responses to comments received on the proposed rule and amends the ITAR as of the effective date of this rule, with one correction from the proposed rule.</P>
                <HD SOURCE="HD1">Summary of Changes From the Proposed Rule</HD>
                <P>In this final rule, the Department makes the changes it previously proposed, with one minor change. Due to a typographical error, the Tier 3 fee multiplier for favorable determinations was misidentified in two places as $1,110 instead of the correct amount of $1,100. The Tier 3 fee multiplier was correctly introduced in the preamble as $1,100 (89 FR 31121), but a subsequent preamble reference to the Tier 3 fee multiplier was misidentified as $1,110 (89 FR 31122). In addition, the incorrect reference was carried forward to amendatory instruction 3 of the proposed rule and identified the Tier 3 fee multiplier at proposed § 122.3(a)(3) as $1,110 (89 FR 31124). This final rule adopts the correct Tier 3 fee multiplier of $1,100 at ITAR § 122.3(a)(3).</P>
                <HD SOURCE="HD1">Response to Comments</HD>
                <P>During the 45-day public comment period (April 24, 2024, through June 10, 2024) DDTC received 19 separate submissions from individuals, corporations, and industry associations in response to the notice of proposed rulemaking, some of which discussed more than one aspect of the proposed rule. All relevant comments addressed only ITAR § 122.3, which included proposed changes to the registration fees. The Department received no questions or comments on other changes in the proposed rule.</P>
                <P>Several commenters expressed a view that the proposed increase is an unjust burden on small business and may be a barrier to entry for new small business registrants. One commenter in particular claimed that the increase in registration fees would be especially difficult for manufacturers who do not export but are required by large corporations to be registered with DDTC to do business with them and advised the new registration fee would subject their company to paying 1 percent of their gross revenue to be able to sell products domestically for DoD end-use. As a threshold matter, the Department is aware that some private sector businesses elect to have their own separate requirement for businesses with which they contract to be registered with DDTC, even when those contracting businesses are not legally required to register with DDTC under ITAR § 122.1. Such varying requirements by some private sector businesses are outside of the scope of ITAR § 122.1. Pursuant to ITAR § 122.1, persons who are not engaged in the business of manufacturing, exporting, or temporarily importing defense articles are not required by ITAR § 122.1 to register with DDTC. With respect to the fee amount, the Department notes that registrants who do not export fall within Tier 1 and pay the base fee of $3,000. That base fee represents a 33.1 percent increase from the prior Tier 1 fee, which is approximately 12 percent less than the increase for Tier 2 and is slightly less than it would have been had the Department used the 40.1 percent inflation adjustment based on 2008 dollars, when the registration fees were last amended.</P>
                <P>
                    The Department acknowledges and understands the commenters' concerns regarding small businesses. In response, 
                    <PRTPAGE P="99082"/>
                    the Department is instituting a planned one-year initiative for qualifying Tier 1 registrants, during which the Department will assess impact and consider extension. Tier 1 registrants may petition DDTC for consideration of a $500 discount (for a total registration fee of $2,500). To qualify, registrants must provide some form of proof that $3,000 was 1 percent or more of their total revenue for the last calendar year. “Total revenue” is the total amount of income and is not limited to sales of items controlled on the U.S. Munitions List (USML). Applicants must submit a complete request for special consideration to DDTC at least 30 calendar days prior to expiration of their current registration term. More information is available on the DDTC website, by searching “registration fee.” Moreover, as a result of the feedback received, the Department will review its registration fee structure more regularly to avoid large-percentage changes to registration fees.
                </P>
                <P>
                    In addition, the Department continues to have a process for registrants where they may address registration fee concerns. Tier 2 and Tier 3 registrants whose registration fees are greater than $3,500 may petition DDTC for a pre-set alternate payment schedule. To be considered for an alternate payment schedule, registrants must provide some form of proof that their registration fee is greater than 1 percent of their total sales in the given year. Total sales include domestic and international sales and are not limited to sales of items described on the USML. Additionally, the Department continues to have discounts available for Tier 3 renewals. To ensure fairness to those registrants in Tier 3, if the registrant timely shows that their total registration fee is greater than 3 percent of the total value of favorable determinations on license applications or other requests for authorization during the 12-month period ending 90 days prior to expiration of the current registration, the registration fee may be reduced to 3 percent of the value of such authorizations, or $4,000, whichever is greater. The Department also has discounts for exporters and temporary importers of low-value authorizations who fall under Tier 3, as described on the DDTC website (
                    <E T="03">https://www.pmddtc.state.gov;</E>
                     under Support &gt; Review FAQs &gt; DECCS—Registration &gt; “Understanding the Renewal Fee Download File”). Registrants who are wholly exempt from income taxation pursuant to 26 U.S.C. 501(c)(3) also qualify for the Tier 1 registration fee of $3,000.
                </P>
                <P>One commenter agreed the proposal is fair for Tier 3 registrants to pay more than Tier 1 and Tier 2 registrants as they consume more services from DDTC, while expressing overall concern about the higher registration fees for all tiers.</P>
                <P>Multiple commenters stated that the Tier 1 and Tier 2 inflationary adjustments are difficult for small businesses, citing negative economic impacts for their companies and that the registration fee increase is more than the rate of inflation increase since 2008. The Department appreciates that any increase in registration fees may cause difficulties for businesses, particularly small businesses. However, the Department assessed that after fifteen years of inflation, increasing technological improvements, and improved services, that an increase in the amount of registration fees is necessary for the continued and modernized operations of DDTC. Reflecting considerations such as those in the comments it expected to receive, DDTC set the Tier 1 and Tier 2 registration fee amounts to reflect an increase fairly consistent with inflation over the last fifteen years. Several commenters expressed concern that the Tier 3 proposed registration fee is significantly above the inflation rate when the additional fee multiplier for favorable determinations is factored in. The Department acknowledges this is accurate. The proposed registration fee structure allows DDTC to fund a large share of the many critical functions it provides to exporters, importers, brokers, manufacturers, and the public—such as the DDTC Response Team, Help Desk, commodity jurisdiction determinations, advisory opinions, guidance on brokering, and support for registration—all of which offer services for the approximately 14,500 current DDTC registrants and also for the general public. The Department has concluded that Tier 3 registrants have benefited the most from DDTC's improvements, specifically the Defense Export Control and Compliance System (DECCS) and customer service improvements, and that they are best positioned to contribute from their export-derived revenue to continue and improve DDTC's services. Additionally, Tier 3 registrants have more frequent interactions with DDTC and thus require more DDTC services. Because these improvements primarily benefit Tier 3 registrants, it is those registrants that will be asked to contribute more. Finally, the Department again notes the availability of discounted registration fees for high-volume, low-value Tier 3 registrants.</P>
                <P>One commenter asked for clarification of how favorable determinations are classified and defined, and whether the scope of other requests for authorization encompasses application amendments and proviso reconsiderations. The commenter also asked the following questions: Are proviso reconsiderations included in the total? Are agreement amendments included in the total? The Department acknowledges this comment and clarifies that a favorable determination is an approval, an approval with provisos (sometimes also referred to as an approval with conditions), or written authorization from DDTC to conduct an activity regulated by the ITAR. An application that is returned without action or denied is not a type of favorable determination. That said, amendment requests and requests for proviso reconsiderations are considered in the registration fee calculation when they are positively adjudicated.</P>
                <P>One commenter inquired how DDTC was able to temporarily reduce its Tier 1 and Tier 2 registration fees to $500 for 1 year due to the coronavirus (COVID-19) pandemic, yet the agency needs to increase its registration fees now. Given the extraordinary impact of COVID-19 on the national economy and Defense Industrial Base, DDTC temporarily reduced registration fees for registrants in Tier 1 and Tier 2 to $500 to help mitigate against the uncertain economic impact of the COVID-19 public health emergency. The temporary reduction in registration fees that occurred four years ago was a special circumstance and is unrelated to the current proposed registration fee changes.</P>
                <P>One commenter suggested that DDTC consider implementing pricing scales for different types of licenses or consider additional streams of revenue available outside of registration fees. For example, the commenter suggested that DSP-6, DSP-74, and DSP-62 may be billed at a lower rate due to the limited time and resources needed to review and approve applications. Further, the same commenter also suggested limited fee structures may be explored for foreign entities that request DSP-6004 for reexports or retransfers. The Department notes that under the Arms Export Control Act, DDTC is authorized to charge for registration fees, not a fee per license.</P>
                <P>
                    One commenter noted that as a risk mitigation practice, companies often apply for a license when the regulatory language or environment is unclear. DDTC's proposed license fee increases may disincentivize companies from submitting licenses when the regulatory requirements are ambiguous. The 
                    <PRTPAGE P="99083"/>
                    Department notes the ITAR requires a license for the export, temporary import, or furnishing of defense services. Industry may submit a request for an Advisory Opinion to get more information on regulatory language. The “Advisory Opinions (AO)” application in DECCS allows industry users to electronically submit inquiries pursuant to ITAR §§ 120.22(a) (for preliminary authorization determinations) and (c) (for interpretations of ITAR requirements other than brokering) and 129.9(a) (for guidance whether an activity is a brokering activity) and (c) (for guidance on other areas of brokering).
                </P>
                <P>
                    One commenter inquired how the new registration fees will increase the investments in DECCS and technology. The Department provides that DDTC plans include continuing to update DECCS with user-requested and other enhancements, specifically as it applies to the DECCS-Licensing application and its integrations with other external applications (
                    <E T="03">e.g.,</E>
                     USXports, Automated Export System). The DDTC IT Modernization Team is tracking these enhancements for continued improvements and meets periodically with the DECCS User Group (DUG) and the Defense Trade Advisory Group (DTAG) regarding information technology (IT) user matters and responds to feedback from both. The DDTC IT Modernization Team will continue to share periodic updates with and solicit feedback from both the DTAG and the DUG.
                </P>
                <P>One commenter suggested that DDTC take a phased approach to increasing its registration fees so that registrants may account for budgeting while mitigating their financial risks. The Department understands the need for entities to budget for this proposed increase and is therefore delaying the effective date and implementation of this new rule until January 2025. DDTC will continue to socialize the new registration fee structure so that registrants are aware of the new registration fees ahead of the implementation. All registrants will continue to receive a letter in DECCS that states their new registration fee 90 days ahead of their due date. Additionally, DDTC plans to conduct registration fee analyses every two-years, which should mitigate the need for a similarly significant increase in the future. DDTC will continue to solicit public comment to gather industry's point of view.</P>
                <P>The Department received a few comments asking for additional detail about how the Department determined the new registration fee costs. One commenter suggested that DDTC should disclose a budget for these increased estimated funds “and then justify that spend in how it will continue to serve and improve industry.” Based on the Department's analysis, the proposed increase in registration fees allows DDTC to adjust for inflation, to continue to make IT and other internal improvements, and to efficiently address industry's needs, as stated above. The increased registration fees are necessary to maintain the high level of service of the statutorily required export control system. DDTC will continue to engage with industry (via the DTAG, DUG, and industry events) to provide insights into how the organization serves the regulated community.</P>
                <P>In addition to the comments addressed above, the Department received several comments outside the scope of this rulemaking. The Department takes note of these comments but is not entertaining substantive revisions to other existing text of the ITAR in this rulemaking.</P>
                <HD SOURCE="HD1">Regulatory Analysis and Notices</HD>
                <HD SOURCE="HD2">Administrative Procedure Act</HD>
                <P>The Department has historically determined that rulemakings implementing the Arms Export Control Act or amending the ITAR involve a military or foreign affairs function of the United States under 5 U.S.C. 553(a). However, due to Department's interest in seeking public comment on this rule, the Department solicited comments during a 45-day comment period, to which it is now responding in this final rule.</P>
                <HD SOURCE="HD2">Regulatory Flexibility Act</HD>
                <P>Since this rule is exempt from the notice-and-comment rulemaking provisions of 5 U.S.C. 553, it does not require analysis under the Regulatory Flexibility Act.</P>
                <HD SOURCE="HD2">Unfunded Mandates Reform Act of 1995</HD>
                <P>This rulemaking does not involve a mandate that will result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.</P>
                <HD SOURCE="HD2">Executive Orders 12372 and 13132</HD>
                <P>This rulemaking does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this rulemaking.</P>
                <HD SOURCE="HD2">Congressional Review Act</HD>
                <P>
                    The Department does not believe that this rulemaking is a major rule, as defined by the Congressional Review Act, 5 U.S.C. 800 
                    <E T="03">et seq.</E>
                </P>
                <HD SOURCE="HD2">Executive Orders 12866, 14094, and 13563</HD>
                <P>Executive Orders 12866 (as amended by Executive Order 14094) and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributed impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has not been designated as a significant regulatory action by the Office of Information and Regulatory Affairs under Executive Order 12866, as amended.</P>
                <P>
                    As noted in the proposed rule, roughly 14,500 registrants in fiscal year (FY) 2023 contributed registration fees to DDTC's FY 2023 collections amounting to $33.8 million. Based on projections made from registrant data from recent years, the new registration fee structure, which presumes roughly the same number of registrants, is expected to bring in an overall total of roughly $67.2 million per year, which would be an overall increase of $33.4 million per year. Although this is a 99 percent projected increase in collections overall from current registration fees for FY 2025, DDTC's projected operational budget will be nearly $60 million, and that amount is expected to continue to increase based on inflation and other increases in expenses. DDTC's $60 million budget includes (but is not limited to) contract labor support, IT services, personnel salaries, outreach, and travel. Accordingly, the revised registration fee structure is necessary for DDTC to continue operating to meet its mission. No action or an insufficient increase would cause budget deficits or a cut in necessary services. Further to a qualitative benefit-cost analysis, the registration fee structure finalized here benefits DDTC by meeting its budget demands in a way that also reasonably accounts for unknown variables such as changes in the number of registrants, or potential exemptions that would not 
                    <PRTPAGE P="99084"/>
                    require specific license applications or approvals and therefore decreases the expected collections from Tiers 2 and 3. It also allows for benefits to the regulated community, enabling DDTC to address unexpected contingencies as it did in 2020, when it temporarily lowered registration fee amounts as a relief measure during the COVID-19 pandemic.
                </P>
                <P>
                    The largest increase, on a per-registrant basis, falls on Tier 3 registrants. The Department believes this increase is justified for the reasons discussed previously, including that Tier 3 registrants derive greater benefits from engaging in regulated activities while also consuming a disproportionate amount of DDTC support services. As stated above, the Department continues to have discounts available for Tier 3 renewals. To ensure fairness to those registrants in Tier 3, if they timely show that their total registration fee is greater than 3 percent of the total value of favorable determinations on license applications or other requests for authorization during the 12-month period ending 90 days prior to expiration of the current registration, the registration fee may be reduced to 3 percent of the total license value of such authorizations, or $4,000, whichever is greater, as described on the DDTC website (
                    <E T="03">https://www.pmddtc.state.gov</E>
                    ) under Support &gt; Review FAQs &gt; DECCS—Registration &gt; “Understanding the Renewal Fee Download File.” Because we project registrants in Tier 3 to account for over 22,000 of the roughly 26,000 applications expected to be adjudicated by DDTC, the Department believes that this is a more equitable distribution of financial costs. Tier 1 and Tier 2 registrants, on the other hand, will see a 33 percent and 45 percent increase, respectively, not far from the near 40 percent inflation rate in the over fifteen years since the registration fees were last adjusted.
                </P>
                <P>As mentioned above, the Department is putting a new consideration in place for Tier 1 registrants. This was done both in response to comments received and due to a resulting benefit-cost analysis. Qualitatively, the Department does not aim to impose unnecessary costs on registrants, particularly small-business registrants. On the other hand, quantitatively, the Department does not know how many registrants, let alone how many Tiers 1 registrants, are small businesses. Nor does it know their average sales or revenues. The Department does not collect any of this information. Moreover, North American Industry Classification System (NAICS) codes do not provide suitable estimates as there are many industry codes that may have certain companies become registrants based on their activities, and not based on any one or several codes. Consequently, estimating the impact of lower registration fees for such entities on DDTC's necessary revenues and operating budget is not possible. Despite the quantitative uncertainty and risk, the qualitative benefits and the chance to assist some small businesses outweighed the costs to DDTC when the scope of that assistance could be reasonably targeted. To that end, the $500 registration fee-discount petition process introduced above for Tier 1 registrants whose fees equal 1 percent or more of their total revenue in a given year is a way that the Department could mitigate against the burdens that come from the registration fee increase. Tier 1 registrants who receive this discount would end up with a registration fee increase of $250 more, or 11.1 percent more, than their current registration fee, which was last adjusted sixteen years ago in September 2008. The $500 registration fee discount would be 16.67 percent less than the usual Tier 1 registration fee this rule establishes. Because of the unknown volume and effect of this discount, the Department will offer the petition process for one year; however, based on how it affects the budget, the Department will reevaluate whether it may continue the process in future years. Additionally, a further-out delayed effective date until January 2025 for the new registration fee structure was part of the Department's benefit-cost analysis and was done so as to give more lead time to entities to plan for new costs.</P>
                <HD SOURCE="HD2">Executive Order 12988</HD>
                <P>The Department of State has reviewed this rulemaking in light of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.</P>
                <HD SOURCE="HD2">Executive Order 13175</HD>
                <P>The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian Tribal governments, and will not preempt Tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.</P>
                <HD SOURCE="HD2">Paperwork Reduction Act</HD>
                <P>This rulemaking does not impose or revise any information collections subject to 44 U.S.C. chapter 35.</P>
                <HD SOURCE="HD1">Signing Authority</HD>
                <P>
                    The Under Secretary, Arms Control and International Security, Bonnie D. Jenkins, having reviewed and approved this document, has delegated the authority to electronically sign this document to Stanley L. Brown, Acting Assistant Secretary, Bureau of Political-Military Affairs, for purposes of publication in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>22 CFR Part 122</CFR>
                    <P>Arms and munitions, Exports, Reporting and recordkeeping requirements.</P>
                    <CFR>22 CFR Part 129</CFR>
                    <P>Arms and munitions, Brokers, Exports, Technical assistance.</P>
                </LSTSUB>
                <P>For the reasons discussed in the preamble and under the authority of 22 U.S.C. 2778, the Department of State amends title 22, chapter I, subchapter M, parts 122 and 129 of the Code of Federal Regulations as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 122—REGISTRATION OF MANUFACTURERS AND EXPORTERS</HD>
                </PART>
                <REGTEXT TITLE="22" PART="122">
                    <AMDPAR>1. The authority citation for part 122 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> Sections 2 and 38, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778); 22 U.S.C. 2651a; E.O. 13637, 78 FR 16129.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="22" PART="122">
                    <AMDPAR>2. Amend § 122.1 by revising the section heading and adding a heading to paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 122.1</SECTNO>
                        <SUBJECT>Registration: requirements, exemptions, and purpose.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Requirement to register.</E>
                             * * *
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="22" PART="122">
                    <AMDPAR>3. Revise § 122.2 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 122.2</SECTNO>
                        <SUBJECT>Registration: submission of registration statement, certification, frequency, renewal, and lapse.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Submission of registration statement.</E>
                             An intended registrant must submit a Statement of Registration (Department of State form DS-2032) to the Office of Defense Trade Controls Compliance by following the electronic filing instructions available on the Directorate of Defense Trade Controls website at 
                            <E T="03">www.pmddtc.state.gov.</E>
                             The Statement of Registration may include subsidiaries and affiliates when more than 50 percent of the voting securities are owned by the registrant, or the subsidiaries and affiliates are otherwise controlled by the registrant (see § 120.66 of this subchapter). Registrants may not establish new entities for the purpose of reducing registration fees. The Statement of Registration must:
                        </P>
                        <P>
                            (1) Be signed by a U.S. person senior officer (
                            <E T="03">e.g.,</E>
                             chief executive officer, 
                            <PRTPAGE P="99085"/>
                            president, secretary, partner, member, treasurer, general counsel) who has been empowered by the intended registrant to sign such documents; and
                        </P>
                        <P>(2) Include documentation that demonstrates the registrant is incorporated or otherwise authorized to do business in the United States.</P>
                        <P>
                            (b) 
                            <E T="03">Statement of Registration Certification.</E>
                             The Statement of Registration of the intended registrant shall include a certification by an authorized senior officer of the following:
                        </P>
                        <P>
                            (1) Whether the intended registrant or its parent, subsidiary, or other affiliate listed in the Statement of Registration, or any of its chief executive officers, presidents, vice presidents, secretaries, partners, members, other senior officers or officials (
                            <E T="03">e.g.,</E>
                             comptroller, treasurer, general counsel), or any member of the board of directors of the intended registrant, or of any parent, subsidiary, or other affiliate listed in the Statement of Registration:
                        </P>
                        <P>
                            (i) Has ever been indicted or otherwise charged (
                            <E T="03">e.g.,</E>
                             charged by criminal information in lieu of indictment) for or has been convicted of violating any U.S. criminal statutes enumerated in § 120.6 of this subchapter or violating a foreign criminal law on exportation of defense articles where conviction of such law carries a minimum term of imprisonment of greater than 1 year; or (ii) Is ineligible to contract with, or to receive a license or other approval to import defense articles or defense services from, or to receive an export license or other approval from, any agency of the U.S. Government; and
                        </P>
                        <P>(2) Whether the intended registrant is foreign owned or foreign controlled (see § 120.65 of this subchapter). If the intended registrant is foreign owned or foreign controlled, the certification shall include an explanation of such ownership or control, including the identities of the foreign person or persons who ultimately own or control the registrant. This requirement applies to a registrant who is a U.S. person and is owned or controlled by a foreign person. It also applies to a registrant who is a foreign person and is owned or controlled by a foreign person from the same country or a foreign person from another country.</P>
                        <P>
                            (c) 
                            <E T="03">Incomplete registration submission.</E>
                             The Directorate of Defense Trade Controls will notify the registrant if the Statement of Registration is incomplete either by notifying the registrant of what information is required or through the return of the entire registration package.
                        </P>
                        <P>
                            (d) 
                            <E T="03">Frequency.</E>
                             A person who is required to register and pay a registration fee must renew the registration and pay a registration fee on an annual basis after initial registration.
                        </P>
                        <P>
                            (e) 
                            <E T="03">Renewal of registration.</E>
                             A registrant must submit its request for registration renewal at least 30 days but no earlier than 60 days prior to the expiration date. Notice of the fee due for the next year's registration will be sent to the registrant of record at least 60 days prior to its expiration date.
                        </P>
                        <P>
                            (f) 
                            <E T="03">Lapse in registration.</E>
                             A registrant who fails to renew a registration and, after an intervening period, seeks to register again must pay registration fees for any part of such intervening period during which the registrant engaged in the business of manufacturing or exporting defense articles or defense services.
                        </P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="22" PART="122">
                    <AMDPAR>4. Revise § 122.3 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 122.3</SECTNO>
                        <SUBJECT>Registration fees.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Registration fee.</E>
                             A person who is required to register must submit payment of a fee following the payment guidelines available on the Directorate of Defense Trade Controls website at 
                            <E T="03">www.pmddtc.state.gov.</E>
                             The fee to be paid shall be one of the following:
                        </P>
                        <P>
                            (1) 
                            <E T="03">Tier 1.</E>
                             The first tier is a set fee of $3,000 per year. This applies to new registrants. It also applies to those who are renewing their registrations and for whom the Department did not issue a favorable determination on a license application or other request for authorization during the 12-month period ending 90 days prior to the expiration of the current registration.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Tier 2.</E>
                             The second tier is a set fee of $4,000 for registrants renewing their registrations who have submitted license applications or other requests for authorization and received five or fewer favorable determinations during the 12-month period ending 90 days prior to the expiration of their current registration.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Tier 3.</E>
                             The third tier is a calculated fee for registrants who have submitted license applications or other requests for authorization and received more than five favorable determinations during the 12-month period ending 90 days prior to the expiration of their current registration. For these registrants, the fee calculation is $4,000 plus $1,100 times the total number of favorable determinations over five.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Website, discounts, and further guidance.</E>
                             Information on certain discounts for registrants who are wholly exempt from income tax pursuant to 26 U.S.C. 501(c)(3), and for Tier 3 registrants who are low-value exporters or temporary importers are available on the Directorate of Defense Trade Controls website at 
                            <E T="03">www.pmddtc.state.gov</E>
                             by selecting “Conduct Business” on the top heading bar, then selecting “Registration” from the left menu bar, and finally selecting “Payment of Registration” from the subsequent left menu bar. Other guidance and information relevant to the payment of registration fees is also available on the website.
                        </P>
                    </SECTION>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 129—REGISTRATION AND LICENSING OF BROKERS</HD>
                </PART>
                <REGTEXT TITLE="22" PART="129">
                    <AMDPAR>5. The authority citation for part 129 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> Section 38, Pub. L. 104-164, 110 Stat. 1437, (22 U.S.C. 2778); E.O. 13637, 78 FR 16129.</P>
                    </AUTH>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 129.8</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="22" PART="129">
                    <P>
                        6. Amend § 129.8, in the first sentence of paragraph (b)(1), by removing the text “and a fee following the fee guidelines available on the Directorate of Defense Trade Controls website at 
                        <E T="03">www.pmddtc.state.gov.”</E>
                         and adding in its place “and the Tier 1 fee specified in § 122.3(a)(1) of this subchapter, regardless of how many favorable determinations the person received during the 12-month period ending 90 days prior to the expiration of their current registration.”
                    </P>
                </REGTEXT>
                <SIG>
                    <NAME>Stanley L. Brown,</NAME>
                    <TITLE>Acting Assistant Secretary, Bureau of Political-Military Affairs, Department of State.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-29032 Filed 12-6-24; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 4710-25-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <CFR>30 CFR Parts 18 and 74</CFR>
                <DEPDOC>[Docket No. MSHA-2020-0018]</DEPDOC>
                <RIN>RIN 1219-AB93</RIN>
                <SUBJECT>Testing, Evaluation, and Approval of Electric Motor-Driven Mine Equipment and Accessories</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration (MSHA), Department of Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Mine Safety and Health Administration (MSHA) is revising its regulations that set out the testing, evaluation, and approval requirements for electric motor-driven mine equipment and accessories intended for use in gassy mines. Under this final rule, MSHA incorporates by reference 
                        <PRTPAGE P="99086"/>
                        eight ANSI-approved voluntary consensus standards that are suitable for gassy mining environments to protect against fire or explosion hazards, and accepts them as alternatives to the existing testing, evaluation, and approval requirements for electric motor-driven mine equipment and accessories. This final rule offers more flexibility in the testing, evaluation, and approval requirements that product designers and manufacturers must meet in seeking MSHA approvals. This final rule will promote the use of innovative and advanced technologies that lead to improvements in mine safety and health.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Effective date:</E>
                         January 9, 2025.
                    </P>
                    <P>
                        <E T="03">Incorporation by reference date:</E>
                         The incorporation by reference of the publications listed in the rule is approved by the Director of the Federal Register as of January 9, 2025.
                    </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P/>
                    <P>
                        <E T="03">Docket:</E>
                         Access rulemaking documents electronically at 
                        <E T="03">www.msha.gov/regsinfo.htm</E>
                         or 
                        <E T="03">www.regulations.gov</E>
                         [Docket No. MSHA-2020-0018]. Obtain a copy of a rulemaking document from the Office of Standards, Regulations, and Variances, MSHA, 201 12th Street South, Arlington, Virginia 22202-5452, by request to (202) 693-9440 (voice) or (202) 693-9441 (facsimile). These are not toll-free numbers.
                    </P>
                    <P>
                        <E T="03">Email Notification:</E>
                         To subscribe to receive email notification when the Agency publishes rulemaking documents in the 
                        <E T="04">Federal Register</E>
                        , go to 
                        <E T="03">www.msha.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Director, Office of Standards, Regulations, and Variances, MSHA, at 
                        <E T="03">Noe.Song-Ae.A@dol.gov</E>
                         (email), (202) 693-9440 (voice); or (202) 693-9441 (facsimile). These are not toll-free numbers.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Executive Summary</FP>
                    <FP SOURCE="FP1-2">A. Purpose of the Final Rule</FP>
                    <FP SOURCE="FP1-2">B. Summary of Major Provisions</FP>
                    <FP SOURCE="FP1-2">1. Accept and Use Voluntary Consensus Standards</FP>
                    <FP SOURCE="FP1-2">2. Incorporate by Reference Voluntary Consensus Standards</FP>
                    <FP SOURCE="FP1-2">3. Review and Update the Voluntary Consensus Standards</FP>
                    <FP SOURCE="FP-2">II. Legal Authority for Regulatory Action</FP>
                    <FP SOURCE="FP-2">III. Rulemaking History</FP>
                    <FP SOURCE="FP-2">IV. Background</FP>
                    <FP SOURCE="FP1-2">A. Product Approval Authority</FP>
                    <FP SOURCE="FP1-2">B. Product Approval Process</FP>
                    <FP SOURCE="FP1-2">C. Voluntary Consensus Standards</FP>
                    <FP SOURCE="FP1-2">1. Voluntary Consensus Standards in the Proposed Rule</FP>
                    <FP SOURCE="FP-2">V. Comments Received on the Proposed Rule</FP>
                    <FP SOURCE="FP-2">VI. Section-by-Section Analysis</FP>
                    <FP SOURCE="FP1-2">A. Section 18.2—Definitions</FP>
                    <FP SOURCE="FP1-2">B. Section 18.6—Applications</FP>
                    <FP SOURCE="FP1-2">C. Section 18.15—Changes After Approval or Certification</FP>
                    <FP SOURCE="FP1-2">D. Subpart F—Voluntary Consensus Standards</FP>
                    <FP SOURCE="FP1-2">1. Section 18.101—Acceptance and Use of Voluntary Consensus Standards</FP>
                    <FP SOURCE="FP1-2">2. Section 18.102—Approved (Incorporated by Reference) Voluntary Consensus Standards</FP>
                    <FP SOURCE="FP1-2">3. Section 18.103—Review and Update of Applicable Voluntary Consensus Standards</FP>
                    <FP SOURCE="FP1-2">E. Conforming Amendments</FP>
                    <FP SOURCE="FP-2">VII. Regulatory Impact Analysis</FP>
                    <FP SOURCE="FP1-2">A. Executive Orders 12866: Regulatory Planning and Review, as Amended by E.O. 14094: Modernizing Regulatory Review, and 13563: Improving Regulation and Regulatory Review</FP>
                    <FP SOURCE="FP-2">VIII. Feasibility</FP>
                    <FP SOURCE="FP-2">IX. Regulatory Flexibility Act; Small Business Regulatory Enforcement Fairness Act; and Executive Order 13272</FP>
                    <FP SOURCE="FP-2">X. Paperwork Reduction Act of 1995</FP>
                    <FP SOURCE="FP-2">XI. Other Regulatory Considerations</FP>
                    <FP SOURCE="FP1-2">A. National Environmental Policy Act</FP>
                    <FP SOURCE="FP1-2">B. The Unfunded Mandates Reform Act of 1995</FP>
                    <FP SOURCE="FP1-2">C. The Treasury and General Government Appropriations Act of 1999: Assessment of Federal Regulations and Policies on Families</FP>
                    <FP SOURCE="FP1-2">D. Executive Order 13132: Federalism</FP>
                    <FP SOURCE="FP1-2">E. Executive Order 12630: Government Actions and Interference With Constitutionally Protected Property Rights</FP>
                    <FP SOURCE="FP1-2">F. Executive Order 12988: Civil Justice Reform</FP>
                    <FP SOURCE="FP1-2">G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</FP>
                    <FP SOURCE="FP1-2">H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use</FP>
                    <FP SOURCE="FP1-2">I. Executive Order 13985: Advancing Racial Equity and Support for Underserved Communities Through the Federal Government</FP>
                    <FP SOURCE="FP1-2">J. Congressional Review Act</FP>
                    <FP SOURCE="FP1-2">K. Pay-As-You-Go Act of 2023</FP>
                    <FP SOURCE="FP1-2">L. Incorporation by Reference</FP>
                    <FP SOURCE="FP-2">XII. References</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Executive Summary</HD>
                <P>
                    This final rule revises MSHA's regulations under title 30, Code of Federal Regulations (CFR) part 18 (Part 18), concerning testing, evaluation, and approval specifications and requirements for electric motor-driven mine equipment and accessories intended for use in hazardous atmospheres encountered in gassy mines. While this final rule does not change MSHA's approval process, it offers more flexibility in the testing, evaluation, and approval requirements that product designers and manufacturers must meet in seeking MSHA approvals. Under the final rule, manufacturers that design and build electric motor-driven equipment and accessories conforming to voluntary consensus standards (VCS) may obtain MSHA approval without having to redesign or modify the equipment to meet MSHA-unique requirements.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         MSHA's approval regulations (30 CFR parts 6, 7, 18, 19, 20, 22, 23, 27, and 28) govern the process through which manufacturers may obtain MSHA approval, certification, extension, or acceptance of certain electrical products for use in underground mines. Each of these separate approval actions has specific application procedures and technical requirements for testing and evaluation. Along with “approval,” the terms “certification,” “extension,” and “acceptance” also denote MSHA approval.
                    </P>
                </FTNT>
                <P>This final rule incorporates by reference eight VCS approved by the American National Standards Institute (ANSI) and allows applicants seeking MSHA approvals to follow either Part 18 requirements that are unique to MSHA or the ANSI-approved VCS. While adding flexibility for product designers and manufacturers, this final rule maintains the safety measures associated with the Agency's testing, evaluation, and approval requirements for equipment used in gassy mines.</P>
                <HD SOURCE="HD2">A. Purpose of the Final Rule</HD>
                <P>This final rule will promote the use of innovative and advanced technologies for electrical equipment used in gassy mines, leading to improvements in mine safety and health. Until now, the introduction of innovative and advanced electrical equipment in U.S. mines may have been limited by the need to meet MSHA-unique requirements for approval. The final rule will allow manufacturers that design and build electric motor-driven equipment and accessories (hereafter referred to as electrical equipment) conforming to the VCS listed in Part 18 to obtain MSHA approval without having to redesign or modify the equipment to meet MSHA-unique requirements. The use of VCS will make the approval process more efficient for applicants seeking MSHA approval for their products. As a result, MSHA's acceptance and use of VCS will make technologically advanced equipment available for use in U.S. mines more quickly and cost-effectively than is possible under existing MSHA-unique requirements, without sacrificing the safety measures associated with MSHA approvals.</P>
                <P>
                    Additionally, the Office of Management and Budget (OMB) Circular A-119, entitled “Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities.” (Jan. 27, 2016 (81 FR 4673)) directs agencies to use VCS in lieu of 
                    <PRTPAGE P="99087"/>
                    government-unique standards except where doing so would be inconsistent with law or otherwise impractical. In response to Circular A-119 and stakeholder comments, MSHA is incorporating the use of VCS in this final rule. The VCS included in the final rule are suitable for gassy mining environments and provide protection against fire or explosion hazards.
                </P>
                <HD SOURCE="HD2">B. Summary of Major Provisions</HD>
                <P>The final rule has three major provisions: accepting and using VCS; incorporating by reference eight ANSI-approved VCS while also allowing the use of existing Part 18 requirements for MSHA approvals; and reviewing more recent versions of the approved VCS as well as other VCS for use in Part 18. Below is a summary of each of the three major provisions.</P>
                <HD SOURCE="HD3">1. Accept and Use Voluntary Consensus Standards</HD>
                <P>MSHA is accepting the use of VCS in lieu of existing Part 18 requirements in its approval process for products to be used in gassy mines. Specifically, MSHA is accepting VCS that the Agency has incorporated by reference and determined are suitable for gassy mining environments and that provide protection against fire or explosion, if used in their entirety and without modification, as alternatives to the requirements in subparts B through E in Part 18. Using and accepting VCS is also consistent with the principles and policies in Circular A-119.</P>
                <HD SOURCE="HD3">2. Incorporate by Reference Voluntary Consensus Standards</HD>
                <P>This final rule is incorporating by reference eight ANSI-approved VCS in their entirety and without modification. These eight VCS are ANSI 60079 series standards for explosive atmospheres. When product designers or manufacturers seek MSHA approval under Part 18, the specifications of these eight ANSI-approved VCS can be used, as applicable.</P>
                <P>The final rule is not incorporating by reference the six VCS from the International Electrotechnical Commission (IEC) that were included in the proposed rule. This change was made due to concerns that the IEC standards may not provide sufficient protection against fire or explosions when used for electric motor-driven mine equipment and accessories in U.S. mines because the IEC standards do not contain certain U.S.-specific electrical and safety requirements that are included in the ANSI-approved VCS.</P>
                <P>Also, unlike the proposed rule, the final rule is not restricting applicants to use only VCS after a transition period of 12 months. The final rule allows product designers and manufacturers to choose either existing Part 18 requirements or the ANSI-approved VCS when they seek approval for new products or for modification to MSHA-approved products. This change was made in response to public comments requesting more time for product designers and manufacturers to adapt their designs and equipment to the VCS specifications, as well as raising the concern that the mandatory transition to VCS would be problematic for some product manufacturers. The final rule provides more flexibility to both new applicants for product approval and current approval holders seeking product modifications.</P>
                <HD SOURCE="HD3">3. Review and Update the Voluntary Consensus Standards</HD>
                <P>Under this final rule, MSHA will review, in the future, more recent editions of the VCS listed in Part 18 to determine whether they can be used in their entirety and without modification for MSHA approval. Also, MSHA may review VCS not listed in Part 18 for possible future adoption.</P>
                <HD SOURCE="HD1">II. Legal Authority for Regulatory Action</HD>
                <P>This final rule is issued under section 508 of the Federal Mine Safety and Health Act of 1977 (Mine Act), as amended. 30 U.S.C. 957. Section 508 of the Mine Act gives the Secretary the authority to issue regulations to carry out any provision of the Mine Act.</P>
                <HD SOURCE="HD1">III. Rulemaking History</HD>
                <P>In 2018, MSHA sought stakeholders' assistance in identifying regulations that could be repealed, replaced, or modified without reducing miners' safety or health. As a result of this solicitation, MSHA received recommendations for the Agency's product approval regulations. Specifically, stakeholders recommended that MSHA replace Part 18 requirements with VCS to provide a clearer and timelier path for approval of new technologies that could improve the health and safety of miners.</P>
                <P>
                    On November 19, 2020, MSHA published in the 
                    <E T="04">Federal Register</E>
                     a notice of proposed rulemaking that would revise the existing testing, evaluation, and approval requirements for electric motor-driven mine equipment and accessories intended for use in gassy mines to include VCS (85 FR 73656). MSHA proposed to incorporate by reference 14 VCS (8 approved by ANSI and 6 by IEC) in their entirety and without modification to replace, as applicable, existing approval requirements in Part 18.
                </P>
                <P>
                    During the comment period, MSHA received 20 comments from product manufacturers, safety certification companies, industry associations, a representative of a voluntary consensus standards body, the National Institute of Occupational Safety and Health (NIOSH), and private citizens. All of the public comments are available at MSHA's website at 
                    <E T="03">www.msha.gov</E>
                     and at 
                    <E T="03">www.regulations.gov.</E>
                </P>
                <HD SOURCE="HD1">IV. Background</HD>
                <HD SOURCE="HD2">A. Product Approval Authority</HD>
                <P>The Mine Act requires MSHA to establish requirements for the technical design, construction, and testing of electrical products and to approve as “permissible” electrical equipment that meets MSHA's specifications. 30 U.S.C. 865. MSHA's requirements for product approval ensure that electrical equipment will not cause a fire or explosion if operated in hazardous atmospheres encountered in gassy mines, where, for example, methane-air mixtures are present. Before electrical equipment can be used in a gassy mine in the U.S., the equipment must first be approved for such use by MSHA. MSHA-approved equipment is affixed with an MSHA approval plate to indicate that the equipment is permitted for use in gassy mines.</P>
                <P>
                    MSHA approval requirements for mining or related equipment are organized by the type of equipment and are listed in different parts of 30 CFR.
                    <SU>2</SU>
                    <FTREF/>
                     Part 18 specifies the procedures and requirements for obtaining MSHA approval, certification, extension, or acceptance of electric motor-driven mine equipment and accessories intended for use in gassy mines. Examples of this equipment include remote control units for mining machinery, longwall mining systems, portable oxygen detectors, miner-wearable components for proximity detection systems, and powered air-purifying respirators (PAPRs).
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         For example, 30 CFR part 19 covers electric cap lamps, 30 CFR part 20 covers electric mine lamps other than standard cap lamps, 30 CFR part 22 covers portable methane detectors, 30 CFR part 23 covers telephones and signaling devices, and 30 CFR part 27 covers methane-monitoring systems.
                    </P>
                </FTNT>
                <P>
                    To avoid a fire or an explosion, Part 18 requires electrical equipment to be designed in one of two ways. One method is to design intrinsically safe electrical equipment, which cannot produce a spark strong enough or temperatures sufficient to ignite hazardous gasses such as flammable methane-air mixtures. The other method 
                    <PRTPAGE P="99088"/>
                    is to house electrical equipment in an explosion-proof or flameproof enclosure that will withstand internal explosions of methane-air mixtures, without damage to or excessive distortion of its walls or covers and will prevent ignition of surrounding methane-air mixtures.
                </P>
                <HD SOURCE="HD2">B. Product Approval Process</HD>
                <P>To market electrical equipment for use in U.S. gassy mines, product designers and manufacturers must obtain MSHA approval for these products. To obtain that approval, applicants must submit a sample of the completely assembled electrical machine or accessory, drawings and specifications of the product components, and any product-testing documentation, if available.</P>
                <P>
                    When MSHA receives an application for approval of a completely assembled electrical machine or accessory for use in gassy mines, MSHA reviews the application using the following general steps. MSHA first determines whether the applicant has met the technical requirements of Part 18 by examining the documents in the application package, which may include drawings, specifications, or photographs. These technical requirements, as described under subpart B of Part 18 (entitled 
                    <E T="03">Construction and Design Requirements</E>
                    ), address design and construction specifications (
                    <E T="03">e.g.,</E>
                     quality of material, workmanship and design, electrical clearances, design of enclosures, and electrical protection of circuits and equipment). MSHA also checks the product or parts of the product against the technical requirements of Part 18, which may require disassembling and examining parts of the product for conformity to the submitted drawings and specifications.
                </P>
                <P>
                    As part of the product approval process, the product must also undergo testing and evaluation, which may include testing for explosion-proof characteristics of an enclosure and impact tests. Testing and evaluation can be conducted by MSHA or an independent laboratory, pursuant to 30 CFR 6.10, 
                    <E T="03">Use of independent laboratories.</E>
                    <SU>3</SU>
                    <FTREF/>
                     If the applicant chooses MSHA to conduct the testing and evaluation of the product, then MSHA tests and evaluates the applicant's product to determine whether it performs according to the safety and testing requirements. Alternatively, if the applicant chooses an independent laboratory to conduct the testing and evaluation, then MSHA reviews the testing and evaluation results from the independent laboratory to determine whether the product performs according to the safety and testing requirements. MSHA will also verify the laboratory's independence and accreditation.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         An independent laboratory is defined in 30 CFR 6.2 as a laboratory that: (1) has been recognized by a laboratory accrediting organization to test and evaluate products to a product safety standard, and (2) is free from commercial, financial, and other pressures that may influence the results of the testing and evaluation process.
                    </P>
                </FTNT>
                <P>Once MSHA determines that the product meets all the approval requirements under Part 18 and is safe for use in gassy mines, the Agency issues an approval. The applicant then becomes an approval holder and must place an MSHA approval plate on the product to indicate that the product is permissible for use in gassy mines.</P>
                <P>The use of the MSHA approval plate obligates the approval holder to maintain the quality of the completely assembled product according to the requirements upon which the approval was based. If an approval holder wants to modify an approved product and maintain its approval, then the approval holder must submit the proposed changes to MSHA. If the proposed changes are approved, MSHA issues either an extension of approval or a notice of acceptance of the modified product to the approval holder.</P>
                <HD SOURCE="HD2">C. Voluntary Consensus Standards</HD>
                <P>The VCS that MSHA proposed to incorporate by reference were developed or approved by voluntary consensus standards bodies through the use of voluntary consensus standards development processes with the attributes described in OMB Circular A-119. According to Circular A-119, the VCS development process includes the following attributes or elements: openness; balance of interest; due process; appeals process; and consensus. Each of the 14 VCS considered by MSHA demonstrates these attributes because they were developed by standard-setting bodies through a transparent, open, and consensus-based process.</P>
                <P>Of the 14 VCS that MSHA considered, 6 were developed by the International Electrotechnical Commission and 8 were approved by the American National Standards Institute. This final rule refers to these as IEC VCS (or non-ANSI approved VCS) and ANSI-approved VCS. Below the two VCS bodies and their standard-development processes are discussed.</P>
                <HD SOURCE="HD3">International Electrotechnical Commission (IEC)</HD>
                <P>IEC is a global, not-for-profit membership organization that administers conformity assessment systems and publishes international standards used in testing and certification of devices, systems, installations, and services. IEC's international standards reflect the global consensus of technical experts who are delegated by their countries to participate in the IEC. Members are technical committee representatives, as well as experts nominated by their home countries' national committees in the areas of concern.</P>
                <P>IEC generally develops a standard in the following manner. A proposal for a new or revised standard is generally driven by needs of specific stakeholder groups in one or several countries. During the preparatory stage, a working draft of the standard or revision is developed by an IEC committee (IEC, 2024b). The committee draft is submitted to all IEC members, including those who participate actively in IEC work, and those who have observer status only for comment and approval. Each national committee can submit its comments and then the committee members work together to reach a consensus on the technical content. Once consensus is reached among the committee members, the standard is published as an IEC international standard (IEC, 2024b).</P>
                <HD SOURCE="HD3">American National Standards Institute (ANSI)</HD>
                <P>
                    ANSI is a non-profit organization that administers and coordinates the U.S. voluntary standards and conformity assessment system by working in close collaboration with stakeholders from industry and government to identify and develop American National Standards (ANSI, 2024b). ANSI accredits the procedures of VCS bodies including UL Solutions (UL), formerly Underwriters Laboratories, and the International Society of Automation (ISA) (ANSI, 2024c). ANSI accreditation ensures that standards developed by the VCS bodies meet the standard-development process requirements for openness, balance, consensus, and due process, and adhere to neutral oversight set by ANSI. The accredited VCS bodies are allowed to submit individual standards for approval as an American National Standard (ANSI, 2024d). For a standard to become ANSI-approved, its submission and review process must have met ANSI's requirements, and the standard must have achieved consensus (ANSI, 2024d). For example, those standards that are submitted by an ANSI-accredited VCS body like UL or ISA and are later approved by ANSI are classified as ANSI-approved standards and labeled as ANSI/UL or ANSI/ISA.
                    <PRTPAGE P="99089"/>
                </P>
                <HD SOURCE="HD3">1. Voluntary Consensus Standards in the Proposed Rule</HD>
                <P>In the notice of proposed rulemaking, MSHA proposed to incorporate by reference eight ANSI-approved and six IEC VCS in their entirety and without modification, to replace existing approval criteria in Part 18 for products covered by the VCS. These VCS included:</P>
                <FP SOURCE="FP-1">• ANSI/UL 60079-0 Ed. 7-2019, Explosive Atmospheres—Part 0: Equipment-General Requirements (Group I)</FP>
                <FP SOURCE="FP-1">• ANSI/UL 60079-1 Ed. 7-2015, Standard for Explosive Atmospheres—Part 1: Equipment Protection by Flameproof Enclosures “d” (Group I, Level of Protection `da')</FP>
                <FP SOURCE="FP-1">• ANSI/ISA 60079-11 (12.02.01)-2014 Standard for Explosive Atmospheres—Part 11: Equipment Protection by Intrinsic Safety “i” (Group I, Level of Protection `ia')</FP>
                <FP SOURCE="FP-1">• ANSI/UL 60079-11 Ed. 6-2013, Standard for Explosive Atmospheres—Part 11: Equipment Protection by Intrinsic Safety “i” (Group I, Level of Protection `ia')</FP>
                <FP SOURCE="FP-1">• ANSI/UL 60079-18, Ed. 4-2015, Standard for Explosive Atmospheres—Part 18: Equipment Protection by Encapsulation `m' (Group I, Level of Protection `ma')</FP>
                <FP SOURCE="FP-1">• ANSI/ISA 60079-25 (12.02.05)-2011 Standard for Explosive Atmospheres—Part 25: Intrinsically Safe Electrical Systems (Group I, Level of Protection `ia')</FP>
                <FP SOURCE="FP-1">• ANSI/UL 60079-25 Ed. 2-2011, Standard for Explosive Atmospheres—Part 25: Intrinsically Safe Electrical Systems (Group I, Level of Protection `ia')</FP>
                <FP SOURCE="FP-1">• ANSI/UL 60079-28 Ed. 2-2017, Standard for Explosive Atmospheres—Part 28: Protection of Equipment and Transmission Systems Using Optical Radiation (Group I, Equipment Protection Level `Ma')</FP>
                <FP SOURCE="FP-1">• IEC 60079-0, Ed. 7, Explosive atmospheres—Part 0: Equipment—General requirements (Group I)</FP>
                <FP SOURCE="FP-1">• IEC 60079-1 Ed. 7, Standard for Explosive Atmospheres—Part 1: Equipment Protection by Flameproof Enclosures “d” (Group I, Level of Protection `da')</FP>
                <FP SOURCE="FP-1">• IEC 60079-11, Ed. 6, Explosive Atmospheres—Part 11: Equipment Protection by Intrinsic Safety “i” (Group I, Level of Protection `ia')</FP>
                <FP SOURCE="FP-1">• IEC 60079-18, Ed. 4.1, Explosive Atmospheres—Part 18: Equipment Protection by Encapsulation `m' (Group I, Level of Protection `ma')</FP>
                <FP SOURCE="FP-1">• IEC 60079-25 Ed. 2, Explosive Atmospheres—Part 25: Intrinsically Safe Electrical Systems (Group I, Level of Protection `ia')</FP>
                <FP SOURCE="FP-1">• IEC 60079-28 Ed. 2, Standard for Explosive Atmospheres—Part 28: Protection of Equipment and Transmission Systems Using Optical Radiation (Group I, Equipment Protection Level `Ma')</FP>
                <P>The ANSI standards are based on the similarly numbered IEC standards. The ANSI standards include modifications of the IEC standards to account for U.S.-specific requirements (U.S. deviations). The U.S. deviations are developed by nationally recognized and vetted experts and are approved as American National Standards.</P>
                <P>Both the IEC and ANSI 60079 series standards listed above cover a wide array of topics concerning explosive atmosphere standards. The ANSI 60079 series standards are generally based on the IEC 60079 series standards but include U.S.-specific requirements to make them compatible or consistent with U.S. safety and industry specifications or practices.</P>
                <HD SOURCE="HD1">V. Comments Received on the Proposed Rule</HD>
                <P>
                    During the comment period of the notice of proposed rulemaking, MSHA received 20 comments from product manufacturers, safety certification companies, industry associations, a representative of a voluntary consensus standards body, NIOSH, and private citizens. This section presents public comments that are general in nature or crosscutting because they span multiple provisions of the proposed rule. Those comments that are specific and directly related to individual provisions are addressed in section VI, 
                    <E T="03">Section-by-Section Analysis.</E>
                </P>
                <P>
                    Generally, most commenters supported MSHA's acceptance of VCS in its approval process. Some commenters, including NIOSH, Komatsu, Rosebud Mining Company, National Mining Association (NMA), Fletcher, and Alliance Coal, agreed with MSHA that adopting VCS in Part 18 would promote the use of innovative and advanced technologies that lead to improvements in mine safety and health (Document ID 0015; 0013; 0012; 0020; 0019; 0027).
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         This and all subsequent parenthetical citations of this form provide a reference for public comments located in the docket of this MSHA rulemaking (Docket No. MSHA-2020-0018) maintained at 
                        <E T="03">Regulations.gov</E>
                        . The four digit document ID number in the parenthetical citation refers to the last four digits of the document ID number in the docket. For example, “Document ID 0015” refers to document ID “MSHA-2020-0018-0015” in Docket No. MSHA-2020-0018 for this rulemaking. When multiple public comments are being cited, each public comment is separately listed within the citation.
                    </P>
                </FTNT>
                <P>Several other commenters stated that MSHA should expand the use of VCS beyond Part 18. MSHA received comments from NIOSH, Dräger, and an individual that the Agency should use VCS for part 22 of title 30 of the CFR, which concerns portable methane detectors (Document ID 0015; 0023; 0016). NIOSH further suggested that MSHA consider adopting VCS for various types of electrical equipment approved for use in mines. Examples include electric cap lamps under 30 CFR part 19, electric mine lamps other than standard cap lamps under 30 CFR part 20, telephones and signaling devices under 30 CFR part 23, and methane-monitoring systems under 30 CFR part 27 (Document ID 0015).</P>
                <P>Any changes to other parts of title 30 are outside the scope of this rulemaking because the proposed rule addressed the use of VCS for product approvals only under Part 18 requirements. In future rulemakings, MSHA may address the expanded use of VCS that would be appropriate for other product approvals.</P>
                <P>The Essential Minerals Association (EMA, formerly the Industrial Minerals Association—North America, IMA-NA) encouraged MSHA to participate actively in the VCS development processes at various VCS bodies so that the Agency can persuade other participants in the standard-setting bodies to propose changes in a standard and have those proposed changes thoroughly studied by experts and adopted if justified (Document ID 0018). MSHA agrees that active participation in a standards development process is useful and will consider participating in appropriate standards-development processes.</P>
                <P>
                    MSHA also received comments disapproving of MSHA's use of VCS in general and of specific non-ANSI-approved VCS for Part 18. A private citizen stated that MSHA should not use VCS because of concerns about the lack of public participation and oversight in the VCS development process (Document ID 0026). The VCS in MSHA's proposed rule, the commenter argued, were developed and set mostly by manufacturers, including entities outside of the U.S. and outside of the U.S. mining industry. In this commenter's view, these entities change and modify the VCS without any cost-benefit analysis and with little or no regard for the impact on public safety. In addition, the commenter raised a concern about limited public access to the VCS because the VCS are not free of charge. Consol Energy, Inc. (Consol) 
                    <PRTPAGE P="99090"/>
                    stated that MSHA should make copies of standards available to operators by negotiating licensing agreements with the VCS bodies since there may be copyright issues with providing copies (Document ID 0014).
                </P>
                <P>
                    In response, MSHA points out that, as discussed earlier, all VCS listed above were developed and approved by voluntary consensus standards bodies through transparent, open, and consensus-based processes. The standard-development processes meet the attributes described in Circular A-119—openness, balance of interest, due process, an appeals process, and consensus. Regarding VCS being updated without any cost-benefit analysis, MSHA notes that final section 18.102 incorporates by reference eight voluntary consensus standards and identifies the specific edition of each VCS. Additionally, as indicated in final section 18.103, MSHA will review updated editions of the VCS and other VCS to determine whether they can be used to provide protection against fire or explosion. Following such review and determination, MSHA will use the appropriate rulemaking process. The rulemakings that MSHA conducts will include the assessment of potential impacts including societal costs and benefits, as required by Executive Order (E.O.) 12866, as amended by E.O. 14094, and E.O. 13563. Regarding public access to the VCS, MSHA notes that the VCS being incorporated by reference in the final rule will be available to the public for review at MSHA headquarters and at MSHA's Approval and Certification Center. More information on the availability of the VCS incorporated by reference in the final rule is presented in section XI.L, 
                    <E T="03">Incorporation by Reference.</E>
                </P>
                <P>UL opposed MSHA's proposal to accept non-ANSI standards, such as the IEC 60079 series (Document ID 0021). This commenter stated that the non-ANSI-approved standards do not include key explosion safety requirements specific to the U.S. One example UL cited was that the IEC 60079 series permit “less robust” electrical writing methods (Document ID 0021).</P>
                <P>
                    After careful consideration of this comment and further review of the VCS concerning explosive atmospheres, MSHA has determined that the final rule will accept the eight ANSI-approved VCS only. In the proposed rule, given that many products conforming to the ANSI-approved and IEC VCS are broadly recognized across various industries and in other countries, MSHA considered that both ANSI-approved and IEC VCS provide an appropriate level of safety for miners and others in work environments with hazards similar to those encountered in the mining industry. However, recognizing and agreeing with the commenter that the IEC VCS do not reflect U.S. explosion safety requirements, MSHA concluded that the six IEC VCS will not provide adequate protection against fire or explosion if used in their entirety and without modification. More discussion on this point is included in section VI, 
                    <E T="03">Section-by Section Analysis,</E>
                     of this preamble.
                </P>
                <P>Finally, MSHA received multiple comments regarding the Agency's approval process. Those comments generally concerned the following: (1) how the Agency's proposed acceptance of VCS affects the approval process; (2) whether the Agency should approve as “permissible” products that are tested by third-party entities, such as Nationally Recognized Test Laboratories (NRTLs) or other product-certification bodies; (3) whether the Agency should forgo the MSHA approval process and automatically accept products that are certified under VCS, and (4) whether the Agency should mandate third-party certification.</P>
                <P>First, commenters questioned how the Agency's acceptance of VCS would affect the approval process. NIOSH, Fletcher, Matrix Design Group (hereafter referred to as “Matrix”), and KH Controls requested clarification on how MSHA's proposed incorporation by reference of the VCS would affect the Agency's product approval process (Document ID 0015; 0019; 0024; 0025). Additionally, a private citizen expressed concern that this rulemaking would remove the MSHA approval process (Document ID 0026). Consol stated that they believe the rule does not address protracted delays caused by the current approval process and that under the proposed rule the approval will continue to follow the same approval process which results in delays and discourages manufacturers from seeking approval (Document ID 0014).</P>
                <P>
                    MSHA clarifies that the final rule does not remove the MSHA approval process. MSHA will continue to review and approve as “permissible” all electrical equipment used in gassy mines. As explained above, MSHA's approval process (as described in section IV, 
                    <E T="03">Background,</E>
                     of this preamble) will remain unchanged under the final rule and will continue to ensure that electrical equipment used in gassy mines can be safely operated by miners in hazardous environments. This means that, under the final rule, all product designers and manufacturers seeking MSHA approval must submit their application package for product approval, as specified in 30 CFR part 18. MSHA will continue to determine whether the electrical equipment is safe for use in gassy mines.
                </P>
                <P>
                    Second, MSHA received comments regarding whether to approve products that are tested by third-party entities, such as NRTLs or other product-certification bodies (Document ID 0010; 0015). Specifically, NIOSH commented that while MSHA must approve equipment, the mining community has expressed a strong preference for MSHA to accept testing and certification of equipment by NRTLs as the basis for the approval (Document ID 0015).
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         A Nationally Recognized Testing Laboratory (NRTL) is a private-sector organization that OSHA has recognized as meeting the legal requirements in 29 CFR 1910.7 to perform testing and certification of products using consensus-based test standards. To receive OSHA's recognition as an NRTL, an organization must have the necessary capability both as a product safety testing laboratory and as a product certification body (OSHA, 2019).
                    </P>
                </FTNT>
                <P>
                    MSHA notes that the Agency already accepts testing and evaluation by independent laboratories, including NRTLs, under its existing standards and approval process. As stated in section IV, 
                    <E T="03">Background,</E>
                     of this preamble, MSHA's existing approval process includes product testing and evaluation by either MSHA or an independent laboratory chosen by the applicant. Under 30 CFR 6.10, 
                    <E T="03">Use of independent laboratories,</E>
                     the Agency accepts testing and evaluation performed by an independent laboratory for purposes of MSHA product approval, provided that MSHA receives the information required by the application. Applicants that choose to use an independent laboratory for testing or evaluation must submit the test or evaluation results to MSHA for review, along with written evidence of the laboratory's independence and current recognition by an accrediting organization. MSHA will continue to accept, as part of a complete approval application under Part 18, testing and evaluation results from NRTLs or other independent laboratories.
                </P>
                <P>
                    Third, some commenters recommended that the Agency forgo the MSHA approval process when products are already certified under VCS (Document ID 0019; 0025; 0013). Fletcher expressed the opinion that certification to a listed VCS should be sufficient for MSHA approval (Document ID 0019). Matrix and Komatsu discussed the IEC Standards Relating to Equipment for Use in Explosive Atmospheres (IECEx) and the associated IEC certification system (IECEx System) (Document ID 0025, 
                    <PRTPAGE P="99091"/>
                    0013).
                    <SU>6</SU>
                    <FTREF/>
                     Matrix recommended that MSHA accept an approval certificate from accredited, independent IECEx Certification Bodies (ExCBs), under the IECEx System (Document ID 0025). Komatsu commented that, when more confidence is obtained in the IECEx scheme, MSHA should consider acceptance of the IECEx certification, removing the need for additional MSHA approvals (Document ID 0013).
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         The IECEx System is a conformity assessment system facilitated by the IEC and comprises the following: the IECEx Certified Equipment Scheme, the IECEx Certified Service Facilities Scheme, the IECEx Conformity Mark Licensing System, and the IECEx Certification of Personnel Competencies. 
                        <E T="03">www.iecex.com/information/about-iecex/</E>
                         (last accessed August 16, 2024).
                    </P>
                </FTNT>
                <P>MSHA does not automatically approve products that have laboratory approval certificates from certifying laboratories. Under the Mine Act, MSHA is responsible for safety standards for the protection of life and prevention of injuries in coal and other mines. 30 U.S.C. 811. To ensure safety, MSHA maintains oversight of the approval process. After MSHA determines that the product meets all the approval requirements and determines that the product is safe for use in gassy mines, the Agency will issue an approval and authorize the use of an MSHA approval plate.</P>
                <P>Fourth, MSHA received a comment regarding whether to mandate third-party certification. A private citizen stated that the typical costs of obtaining VCS certification, depending on the complexity of the component or machine, is extremely excessive, and therefore, MSHA should not require VCS certification for approval (Document ID 0026).</P>
                <P>MSHA does not and will not require VCS certification by a third-party laboratory for approvals. MSHA understands that some manufacturers have no intention to sell their products outside the U.S. mining industry or may be concerned with the costs of VCS certification in addition to the costs associated with MSHA approval. Under the final rule, when an application relies on the incorporated VCS as the basis for approval, VCS certification by a third-party laboratory is not mandated.</P>
                <HD SOURCE="HD1">VI. Section-by-Section Analysis</HD>
                <HD SOURCE="HD2">A. Section 18.2—Definitions.</HD>
                <P>
                    One definition is modified and two new definitions are added in final § 18.2, as in the proposed rule. MSHA received no comments on the three proposed definitions: 
                    <E T="03">permissible equipment, voluntary consensus standard,</E>
                     and 
                    <E T="03">voluntary consensus standards body.</E>
                </P>
                <P>
                    Under the final rule, the term 
                    <E T="03">permissible equipment</E>
                     is modified to mean “a completely assembled electrical machine or accessory for which an approval has been issued.” The reference to the Mining Enforcement and Safety Administration (MESA) is removed from the existing definition. Because MESA and all of its responsibilities were transferred to MSHA in 1978 under the Mine Act, the reference to MESA is no longer necessary (43 FR 12314, March 24, 1978).
                </P>
                <P>
                    Under the final rule, the new term 
                    <E T="03">voluntary consensus standard</E>
                     means “a safety standard that:
                </P>
                <P>(1) Is developed or adopted by a voluntary consensus standards body; and</P>
                <P>(2) Prescribes safety requirements applicable to equipment for which applicants are seeking approval, certification, extension, or acceptance under Part 18.”</P>
                <P>
                    Under the final rule, the new term v
                    <E T="03">oluntary consensus standards body</E>
                     means “a domestic or international organization that plans, develops, establishes, or coordinates voluntary consensus standards using agreed-upon procedures that are consistent with the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 3710) and the Office of Management and Budget's Circular A-119 (Jan. 27, 2016).” Under Circular A-119, a voluntary consensus standards body plans, develops, establishes, or coordinates voluntary consensus standards using a voluntary consensus standards development process that includes the following attributes or elements: openness, balance of interest, due process, appeals process, and consensus. This type of standards body typically adopts, publishes, and makes the VCS it adopts available to the public. Lastly, the voluntary consensus standards body must maintain each voluntary consensus standard through a schedule of review.
                </P>
                <HD SOURCE="HD2">B. Section 18.6—Applications</HD>
                <P>Final paragraph (e) of § 18.6 removes the existing requirement that each drawing an applicant submits under Part 18 include a warning stating that any changes in design must be authorized by MSHA before the changes are made to approved equipment. Final paragraph (e) of § 18.6 is unchanged from the proposal. MSHA did not receive any comments on this proposed change.</P>
                <P>MSHA has determined that the warning on each drawing is unnecessary since MSHA notifies successful applicants in its approval letters that approval holders cannot make changes to designs without MSHA approval. Furthermore, the Agency communicates with applicants during the approval process and ensures that they fully understand approval holders' responsibility to notify MSHA of changes to approved equipment.</P>
                <HD SOURCE="HD2">C. Section 18.15—Changes After Approval or Certification</HD>
                <P>Under the final rule, paragraph (c) of § 18.15 is revised to clarify the requirements for an application for a formal extension of approval or certification, or modification of an existing approval. In the proposed rule, MSHA would issue an approval if the changes in the equipment or component met: (1) the requirements applied to the last approval, certification, or formal extension; or (2) the VCS requirements listed in Part 18, as applicable. Under the proposed rule, any approval holder who chose to use VCS requirements for modifications of an existing approval could no longer go back and use the requirements in subparts B through E of Part 18 for future modifications. However, the final rule allows the approval holder to choose either existing Part 18 requirements or VCS requirements for each modification of an existing approval, irrespective of the last approval, certification, or formal extension. This means that under the final rule, for any modification of an existing approval, approval holders can choose either the existing Part 18 requirements or VCS requirements.</P>
                <P>MSHA received two comments on this proposed rule language relating to the timing of the approval. The NMA and Matrix recommended that MSHA approve applications for a formal extension of approval or certification, or for modifications of an existing approval, within 30 days (Document ID 0020, 0025).</P>
                <P>As stated previously, MSHA's approval process will remain unchanged under the final rule and will continue to ensure that electrical equipment used in gassy mines can be safely operated by miners in hazardous environments. However, MSHA revised the final § 18.15 language to conform with the final rule, which allows the approval holder to choose either existing Part 18 requirements or VCS requirements for each modification of an existing approval.</P>
                <HD SOURCE="HD2">D. Subpart F—Voluntary Consensus Standards</HD>
                <P>
                    Like the proposed rule, the final rule adds a new subpart entitled “subpart F Voluntary Consensus Standards.” The new subpart F, consisting of three 
                    <PRTPAGE P="99092"/>
                    sections—§§ 18.101 through 18.103—lays out how MSHA will generally accept, use, review, and update VCS, along with a list of specific VCS incorporated by reference in this final rule.
                </P>
                <HD SOURCE="HD3">1. Section 18.101—Acceptance and Use of Voluntary Consensus Standards</HD>
                <P>Final § 18.101 is changed from the proposal to allow product designers and manufacturers to choose either existing Part 18 requirements or the listed VCS requirements. Section 18.101 sets forth how MSHA will accept and use VCS. In the proposed rule, paragraph (a) included MSHA's intent to replace the requirements in subparts B through E of Part 18 with VCS in their entirety and without modification. In proposed paragraph (b), a transition period of 12 months was provided, during which product designers and manufacturers seeking MSHA approval would be allowed to use either existing Part 18 requirements or VCS requirements. Once the transition period ended, the use of VCS would have been required under proposed paragraph (c).</P>
                <P>In the final rule, final paragraphs (a) and (b) differ from the proposed rule to allow the use of either the VCS or the existing Part 18 requirements. Consequently, there is no 12-month transition period to using VCS only, so proposed paragraph (c) is not included in the final rule. Under the final rule, product designers and manufacturers can choose either existing Part 18 requirements or VCS requirements for MSHA approval because the final rule includes no requirement to transition to the use of only VCS for MSHA approvals. Under the final rule, the use of VCS is not and will not be mandatory.</P>
                <P>
                    As described in section V, 
                    <E T="03">Comments Received on the Proposed Rule,</E>
                     most commenters supported MSHA's acceptance of VCS in its approval process. Commenters, including NIOSH, Komatsu, Rosebud Mining Company, NMA, Fletcher, and Alliance Coal, agreed with MSHA that adopting VCS in Part 18 would promote the use of innovative and advanced technologies that lead to improvements in mine safety and health (Document ID 0015; 0013; 0012; 0020; 0019; 0027). MSHA agrees with these commenters.
                </P>
                <P>Under final paragraph (a) of § 18.101, the VCS that the Agency incorporates by reference and determines are suitable for gassy mining environments and provide protection against fire or explosion may be used as alternatives to the requirements in subparts B through E in Part 18 if used in their entirety and without modification. Using VCS is consistent with the principles and policies in Circular A-119. MSHA's acceptance of VCS will provide more mining product choices to mine operators and miners.</P>
                <P>Final paragraph (b) of § 18.101 allows manufacturers to choose between the requirements in subpart B through E or the requirements of the listed VCS as the basis for approvals at all times. By contrast, the proposed rule allowed manufacturers to choose between the requirements of the last approval or the listed VCS requirements only during a limited transition period of 12 months from the effective date, after which the use of listed VCS was mandatory for new MSHA approval applications.</P>
                <P>Several commenters, including Consol Energy, Inc. (Consol), NIOSH, and NMA, stated that the proposed 1-year transition period from Part 18 requirements to VCS for new applications should be extended (Document ID 0014; 0015; 0020). KH Controls recommended that the transition period be extended to 3 years (Document ID 0024). NIOSH suggested that MSHA consider accepting either the listed VCS or Part 18 requirements for 5 years or more for new applications, and indefinitely for modifications (Document ID 0015). NIOSH stated that the 1-year transition period to mandatory use of the listed VCS may be problematic for some manufacturers and that businesses involved in rebuilding and overhauling equipment could be harmed (Document ID 0015). NIOSH further commented that a potential issue arises when a small manufacturer needs to make changes to a product due to component obsolescence (Document ID 0015). If the changes are extensive, they may prefer to submit a new design. However, if the manufacturer already understands and builds their equipment to the Part 18 requirements, they may not have the resources or the willingness to fully transition their product engineering to the listed VCS and potentially redesign their products for such limited applications (Document ID 0015).</P>
                <P>Consol, with agreement by NMA, expressed concern that after the 1-year transition period, some manufacturers may be forced to leave the mining market because they do not believe it is economically feasible to change-over the equipment to comply with the listed VCS (Document ID 0014; 0020). The commenter stated that there are too few manufacturers in the market already and believes that the proposed rule should be modified to permit use of the previous approval requirements after the transition period (Document ID 0014).</P>
                <P>MSHA agrees with the commenters who stated that the mandatory transition to the VCS-only requirements could be problematic for certain manufacturers and product developers. Under the proposal, some product developers would have to rebuild and overhaul equipment to meet the listed VCS only, while other manufacturers may not have sufficient resources to transition their engineering to the listed VCS only. In response to these concerns, final paragraph (b) allows manufacturers to choose between the requirements in subparts B through E or the requirements of the listed VCS, if the listed VCS apply, as the basis for approvals starting on the effective date. Allowing both the existing Part 18 and VCS requirements eliminates the need for a mandatory transition period. Under the final rule, there is no transition period and manufacturers can decide which requirements, the requirements in subparts B through E or the requirements of the listed VCS, would best fit their business needs.</P>
                <P>Under final paragraph (b), new applications for approval may meet either subparts B through E requirements, or the requirements of the VCS listed in § 18.102. Also, applications for a modification of an existing approval or certification may meet either subparts B through E requirements, or the requirements of the VCS listed in § 18.102.</P>
                <P>Final paragraph (b)(2) contains non-substantive changes from the proposal. It includes the specific Group and Levels of Protection provisions, which are unchanged from proposed paragraphs 18.102(b)(2) and (b)(3). The specified Group and Levels of Protection to be used from each of the VCS listed in final paragraph 18.102 are suitable for gassy mining environments and will protect against fire or explosion hazards. MSHA has determined that the VCS which the Agency has incorporated by reference with the Group and Levels of Protection for hazardous locations designated as Group I, Zone 0, and highest Levels of Protection, “ma,” “da,” and “ia,” listed in final paragraph (b)(2) can be used as alternatives to requirements in subparts B through E of Part 18. The Groups and Zones for hazardous locations and Levels of Protection in the VCS are explained in the following paragraphs.</P>
                <P>
                    Several commenters, including manufacturers, NIOSH, a safety testing laboratory, and a coal mine operator stated that the Group and Levels of Protection for the VCS proposed by MSHA should be expanded to include other Group designations and Levels of Protection in addition to hazardous 
                    <PRTPAGE P="99093"/>
                    locations designated as Group I, Zone 0, and highest Levels of Protection, “ma,” “da,” and “ia” (Document ID 0005; 0011; 0013; 0015; 0017; 0024; 0025; 0027).
                </P>
                <P>
                    In the U.S., the hazardous location classification system is defined by the National Fire Protection Association® (NFPA®) 70®, NEC® (2023). The NFPA 70® NEC® Hazardous Locations Groups defines Group I as mines susceptible to firedamp (
                    <E T="03">i.e.,</E>
                     flammable mixture of gases naturally occurring in a mine). Also, NFPA 70® NEC® Hazardous Locations defines Zone 0 as an area where ignitable concentrations of flammable gases or vapors are present continuously or for long periods of time (NFPA®, 2023). In each instance, the Group I mines and Zone 0 areas are designated as the most hazardous when measuring explosive atmospheres.
                </P>
                <P>The “ma” designation is the highest Level of Protection against explosion protection for encapsulation (ANSI/UL, 2015b). Encapsulation of electrical equipment is a protection principle that encloses the equipment to prevent the potentially explosive atmosphere from reaching the ignition source (ANSI/UL 2015a).</P>
                <P>The “da” designation is the highest Level of Protection for a flameproof enclosure (ANSI, 2015b). The flameproof classification is a type of protection in which the machine parts or components that can ignite in an explosive atmosphere are placed within an enclosure that can withstand the force created and pressure developed during an internal explosion (NFPA®, 2023). Therefore, if an explosion should occur inside of the enclosure, it will either be contained within, or have a flame path that will arrest the propagation of the explosion. This reduces the risk of igniting an external explosive atmosphere.</P>
                <P>The “ia” designation offers the highest Level of Protection for intrinsic safety and is generally considered as being adequately safe for use in the most hazardous locations (Zone 0) because the possibility of two “faults” is in the safety assessment (ANSI, 2013). Intrinsic safety is an explosion protection concept in which the electrical energy within the equipment is restricted to a level which is below what may cause an ignition or to limit the heating of the surface of the hazardous area equipment (NFPA®, 2023).</P>
                <P>
                    Eickhoff Bergbautechnik and NIOSH both noted that the highest Levels of Protection are usually only applied to intrinsically safe methane monitors, cap lamps, and other equipment which need to be operated even in the presence of an explosive methane atmosphere (Document ID 0011; 0015). Eickhoff Bergbautechnik also noted that a typical intrinsically safe product intended for use in underground mining has the middle Level of Protection, “ib,” and must be switched off when an explosive atmosphere arises (Document ID 0011). Matrix stated that underground coal mines do not operate continuously in Zone 0 atmospheres and noted that mines are more likely described as Zone 1 or sometimes Zone 2 (Document ID 0025).
                    <SU>7</SU>
                    <FTREF/>
                     Matrix also suggested that, in addition to Zone 1, requiring middle Levels of Protection, MSHA should also include Zone 2, requiring the lowest Levels of Protection for some of the VCS.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         The NFPA 70® NEC® Hazardous Locations defines Zone 1 as a place in which an explosive atmosphere consisting of a mixture with air of flammable substances in the form of gas, vapor, or mist is likely to occur in normal operation occasionally (2023). Zone 2 is defined as a place in which an explosive atmosphere consisting of a mixture with air of flammable substances in the form of gas, vapor, or mist is not likely to occur in normal operation but, if it does occur, persists for a short period only (NFPA®, 2023).
                    </P>
                </FTNT>
                <P>
                    In response to the commenters above, MSHA believes that “ma,” “da,” and “ia” Levels of Protection, which are suitable for Group I, Zone 0 hazardous areas, for the listed VCS are appropriate. MSHA has determined, based on NIOSH research, that to provide at least the same degree of protection as the existing Part 18 requirements, Group I, Zone 0 required Levels of Protection are suitable and will not result in a diminution of safety. As discussed in the proposed rule, researchers at NIOSH presented a paper to the Institute of Electrical and Electronics Engineers' (IEEE) Industry Applications Society titled “Intrinsically Safe Systems: Equivalency of International Standards Compared to U.S. Mining Approval Criteria.” 
                    <SU>8</SU>
                    <FTREF/>
                     The researchers concluded that the relative Levels of Protection afforded to miners by the application of the ANSI/ISA 60079 two-fault Intrinsically Safe (IS) standard is a safe alternative to MSHA's requirements when such electrical equipment is installed in mines.
                    <SU>9</SU>
                    <FTREF/>
                     They also concluded that the use of such equipment would provide at least an equivalent level of safety as that provided by equipment approved under MSHA criteria.
                    <SU>10</SU>
                    <FTREF/>
                     MSHA believes that Levels of Protection consistent with Zones 1 and 2 provide less protection than the existing Part 18 requirements. Therefore, in this final rule, MSHA is allowing the use of the ANSI-approved VCS with the Group I, Zone 0 required Levels of Protection for intrinsic safety, as proposed.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         William Calder, David P. Snyder, John F. Burr, Intrinsically Safe Systems: Equivalency of International Standards Compared to U.S. Mining Approval Criteria, DOI 10.1109/TIA.2018.2804322, IEEE Transactions on Industry Applications.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">Ibid.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">Ibid.</E>
                    </P>
                </FTNT>
                <P>Komatsu proposed extending the adoption of the 60079-1 standard for flameproof enclosures to include equipment “db,” suitable for Zone 1 (Document ID 0013). The commenter stated flameproof equipment currently approved to MSHA standards would not meet the criteria to operate in Zone 0. The commenter also stated that accepting Level of Protection “db” would not compromise safety compared to what is currently enforced. The commenter explained that 30 CFR 27.24 requires that all equipment shut down automatically at a methane concentration of 2.0 volume percent and at all higher concentrations of methane. The commenter stated that this ensures that equipment will not be operating in a Zone 0 environment with methane present for an extended period.</P>
                <P>MSHA considered the commenter's statement that flameproof equipment currently approved to MSHA standards would not meet the criteria to operate in Zone 0, thus allowing Level of Protection “db”; however, such flameproof enclosures are beyond the scope of this rulemaking. In 2006, MSHA evaluated a comparison of enclosures certified as flameproof under IEC 60079-0, Fourth Edition, 2004-01, and IEC 60079-1, Fifth Edition, 2003-11, versus MSHA certified and approved explosion-proof products (71 FR 28581). (See 30 CFR 6.30). MSHA determined that flameproof equipment approved to IEC 60079-0 and IEC 60079-1 “db” must be modified to provide the same Level of Protection as the MSHA flameproof equipment. This equipment must meet additional requirements such as design requirements limiting the length of an enclosure and external surface temperature limits in 30 CFR 7.10(c)(1) for motors and in 30 CFR 18.6(a)(3) for enclosures. Accordingly, MSHA is not including Levels of Protection “db” and “dc” in this rule. The Agency will consider flameproof enclosures meeting the listed VCS using the Zone 0, “da” Level of Protection as providing at least an equivalent level of safety as that provided by equipment approved under the MSHA criteria in Part 18. Level of Protection “da” is only applicable to catalytic sensors of portable combustible gas detectors (Intertek, 2020).</P>
                <P>
                    NIOSH stated that MSHA should consider including language in the rule that states that the middle Levels of Protection for VCS are acceptable, 
                    <PRTPAGE P="99094"/>
                    subject to additional ventilation monitoring with integrated power cutoff or other supplementary safety measures acceptable to MSHA (Document ID 0015). NIOSH further recommended that the additional measures should be included in the MSHA-approved ventilation plan.
                </P>
                <P>In response to NIOSH suggesting that Zone 1 Levels of Protection may be appropriate under certain circumstances, and that Zone 1 Levels of Protection for certain machinery would only be appropriate if changes to mines' ventilation plans were made and that additional conditions of use would be required for the machinery, MSHA believes that implementing NIOSH's recommendations would require changes to 30 CFR part 75 and possibly other MSHA standards, which is outside the scope of this rulemaking. Therefore, MSHA will continue to require the highest Levels of Protection, “ma,” “da,” and “ia” for the VCS incorporated by reference in Part 18.</P>
                <P>Paragraph (c) of § 18.101 of the proposed rule is removed. To provide manufacturers flexibility to choose the best option for their needs, this final rule removes mandatory use of listed VCS for applicable components. As a result, paragraph (c) of § 18.101 is no longer necessary and is removed.</P>
                <HD SOURCE="HD3">2. Section 18.102—Approved Voluntary Consensus Standards</HD>
                <P>Final § 18.102 incorporates by reference eight ANSI-approved VCS. MSHA determined that the VCS listed in § 18.102 are suitable for gassy mining environments and provide protection against fire or explosion hazards if used in their entirety and without modification, in lieu of the requirements in subparts B through E of this part. The non-ANSI-approved VCS in the proposal are excluded.</P>
                <P>
                    Final paragraphs (a)(1) through (b)(6) contain non-substantive edits to the titles of the ANSI-approved VCS and clarify that the VCS must be used in in accordance with the Types of Protection and Levels of Protection in § 18.101. In this IBR section, each standard name is shown exactly as it appears on the cover of the standard.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         The Agency refers to the ANSI/UL standards in many of the regulatory text sections, but it does not do so in this IBR section.
                    </P>
                </FTNT>
                <P>Also, final paragraph (b) lists the name “UL Solutions” instead of “UL LLC,” which was in the proposed rule. This change is made to reflect the company's name change in 2022. Proposed paragraph (b)(4) has been redesignated as final Note 1 to § 18.102 and edited for clarity from the proposal because it only provides the public with information on obtaining copies of the listed VCS from ANSI. ANSI is an additional source for obtaining copies of the VCS in Part 18.</P>
                <P>
                    MSHA received multiple comments related to the use of and differences between ANSI-approved VCS and non-ANSI-approved VCS (
                    <E T="03">i.e.,</E>
                     IEC VCS). Some commenters, including manufacturers, mine operators, a trade association, and a private citizen, supported MSHA's proposal to incorporate by reference both ANSI-approved and IEC VCS (Document ID 0011; 0012; 0014; 0020; 0023; 0022; 0027). Eickhoff Bergbautechnik stated that by accepting these established standards, MSHA could enhance the efficiency and effectiveness of its approval process (Document ID 0011). Rosebud Mining Company stated that many companies have equipment approved under ANSI or IEC standards that would meet the hazard rating for use in underground coal mines but currently are not able to be used in mines due to the lack of MSHA approval under 30 CFR (Document ID 0012). They also stated that, with MSHA's acceptance of the proposed VCS (both ANSI and IEC standards), a significantly larger amount of equipment and technologies would be available for use in underground mining (Document ID 0012). Consol stated that manufacturers have become increasingly reluctant to seek approval of equipment because of the cost of MSHA's approval process (Document ID 0014). The NMA stated that it is likely that devices manufactured to be intrinsically safe under both MSHA-unique standards and VCS would incur additional costs because the manufacturing process would have to accommodate both designs. These costs would be avoided if a common standard were used (Document ID 0020).
                </P>
                <P>
                    The NMA stated that Australia, New Zealand, Canada, and South Africa allow miners and mine operators to use devices and equipment not currently approved in the U.S. but that have been evaluated as safe for use in underground gassy mines in those countries using the IEC standards (Document ID 0020). NMA gave an example that miners working at operations outside the U.S. are currently using PAPRs evaluated under VCS from IEC, ANSI, UL, and ATEX, and because of this MSHA should accept IEC VCS so that U.S. miners may use these PAPRs as well (Document ID 0020).
                    <SU>12</SU>
                    <FTREF/>
                     Dräger stated that its products are currently used in coal mining operations outside of the U.S., all of which recognize the proposed VCS (Document ID 0023). This commenter stated that they are unaware of a product-related incident due to any gap in the protection stipulated by the proposed VCS (Document ID 0023). Dräger further stated that, due to the nature of its products' use in mining and other hazardous applications such as firefighting, and the products' unique approval requirements, they have extensive experience with different types of explosion protection including intrinsic safety. Based on this experience, Dräger agreed that the proposed VCS would offer an equal level of safety and protection to MSHA's requirements, since the VCS undergo regular revision cycles, as well as new requirements based on technological advancements (Document ID 0023). A private citizen supported the use of the proposed VCS if the VCS are equally safe compared to existing MSHA requirements (Document ID 0022).
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         ATEX is an abbreviation from the French, atmosphere explosible (or explosive atmospheres, translated into English). ATEX certification is given to equipment that has gone through testing outlined by European Union (EU) directives and have been proved safe to use in specific environments with explosive atmospheres. ATEX certification ensures the free movement of goods throughout the EU by harmonizing compliance procedures.
                    </P>
                </FTNT>
                <P>However, a commenter from UL, which publishes the ANSI/UL 60079 series of VCS, stated that they do not support MSHA's inclusion of non-ANSI standards, such as the IEC 60079 series (Document ID 0021). The commenter stated that the non-ANSI-approved standards under the IECEx System do not reflect key U.S. explosion safety requirements such as:</P>
                <P>(1) The applicable requirements related to risk of fire, electric shock, and injury to persons: the IEC 60079 series permits self-declaration to these requirements, while the ANSI/UL 60079 series requires third-party declaration;</P>
                <P>(2) Wiring methods: the IEC 60079 series permits less robust wiring methods compared to the ANSI/UL 60079 series; and</P>
                <P>(3) Production control: the IEC 60079 series permits production control at a frequency of only every 18 months compared to the ANSI/UL 60079 series, which requires more frequent production control.</P>
                <P>
                    For UL's comment on non-ANSI-approved standards and their first example regarding declaration to the requirements of risk of fire, electric shock, and injury to persons, MSHA agrees that several of the IEC standards do not require third-party verification of compliance with relevant industrial standards. The ANSI versions require third-party verification of compliance, 
                    <PRTPAGE P="99095"/>
                    which MSHA believes is a key explosion safety requirement.
                </P>
                <P>Regarding UL's second example about wiring methods, MSHA also agrees with the commenter, and found that most national differences between the ANSI/UL 60079 series and the IEC 60079 series are based on `national regulations,' where the IEC lacks alignment with specific requirements of the National Electrical Code®, ANSI/NFPA® 70 (NEC®), which is a U.S. standard for safe electrical design, installation, and inspection to protect people and property from electrical hazards. The IEC 60079 series wiring methods does not align with NEC® requirements.</P>
                <P>Regarding UL's third example about production control, MSHA agrees that the IECEx scheme, which uses the IEC standards, mandates quality audits every 18 months, while the OSHA NRTL program, which specifies the ANSI standards, requires “no fewer than four (4) factory surveillance visits per year at manufacturing facilities.” MSHA will continue to apply the Quality Assurance requirements mandated in 30 CFR parts 6 and 18 for MSHA-approved equipment that is evaluated to the VCS.</P>
                <P>The final rule supports the introduction of existing equipment that manufacturers have already designed to acceptable VCS without redesigning those products to meet certain MSHA-unique requirements in Part 18. The Agency also accepts testing and evaluation performed by an independent laboratory for purposes of MSHA product approval through existing regulations under § 6.10. Consequently, MSHA agrees with commenters that stated both the ANSI-approved and the non-ANSI-approved VCS offer advantages such as enhancing the efficiency and effectiveness of the approval process, as well as allowing a greater amount of equipment and technologies to be available for use in U.S. gassy mining environments. However, MSHA also agrees with UL that the non-ANSI-approved standards do not reflect certain U.S. explosion safety requirements, since the development and approval of IEC standards differ from that of ANSI standards. The 60079 series ANSI-approved standards are based on IEC-developed standards; however, unlike the IEC standards, the 60079 series ANSI-approved standards include U.S.-specific adaptations to make them compatible with U.S. safety and industry practices. The IEC standards do not completely align with U.S. electrical safety practices. ANSI-approved standards are domestic VCS that establish quality and performance specifications for products, processes, personnel, and systems, and also typically include design and build requirements to ensure consistency of equipment from various manufacturers for specific use in the U.S.</P>
                <P>Electrical testing and ratings between ANSI and IEC generally are not the same or equivalent. IEC equipment may not pass the equivalent ANSI test, and vice versa, due to these differences. For example, ANSI and IEC differ in their approach to temperature rise testing, with higher or lower temperature restrictions required between ANSI and the IEC standards. Another example is enclosure types that do not compare among ANSI and IEC standards. The enclosure ratings used with ANSI standards do not compare directly to Ingress Protection ratings in IEC standards.</P>
                <P>MSHA recognizes that there can be safety and compatibility issues between ANSI-approved and non-ANSI-approved standards (BSEE, 2018). MSHA has not found such safety and compatibility issues between the existing Part 18 approval requirements and the ANSI-approved VCS included in this final rule. For instance, ANSI-approved electrical standards include general compliance with NEC® requirements, as described in the scope of the standards. The ANSI-approved standards dictate how the equipment must be installed, based on the NEC®. In comparison, installation of equipment and components meeting non-ANSI-approved IEC standards must be performed in accordance with IEC 60079-14, which is not based on the NEC®. U.S. mine electricians work with the NEC®, American Wire Gauge (AWG) sizing (the accepted standard in North America to denote electrically conducting wire sizes), and U.S. electrical system compatible components. U.S. mine electricians may not have sufficient electrotechnical knowledge and training on the non-ANSI-approved standards. However, the Part 18 approval for a machine or system will dictate the interconnection of certified components that mine electricians must follow.</P>
                <P>Another example is that non-ANSI-approved standards use metric/European wire gauges with compatible circuit breakers, which are not the same as U.S.-based AWG wire sizing and circuit breakers. MSHA is aware that mixing different wire gauges and circuit breakers could lead to inadequate overcurrent protection and increase the risk of a mine fire or explosion (Fowler and Miles, 2009). Some ANSI-approved standards have allowable temperature rises that are higher or lower than the non-ANSI-approved standards for different types of electrical contacts, leading to compatibility issues (Fuhrmann et al., 2014; Sim, J.H., 2007). Consequently, interconnecting components approved to ANSI-approved and non-ANSI-approved standards may create an electrical or fire hazard. A mine electrician may believe that they are connecting compatible components; however, one component could meet the testing requirements of an ANSI-approved VCS and an interconnected component could meet the testing requirements of a non-ANSI-approved VCS. In this example, it is possible for one or both of the components to fail because of issues with compatibility, causing fire, explosion, or electric shock hazards for miners.</P>
                <P>Based on these issues, MSHA agrees with UL that the IEC standards do not consider U.S. explosion safety requirements, and thus do not provide adequate protection if used in their entirety and without modification in U.S. mining environments.</P>
                <P>In addition, NIOSH recommended that MSHA accept the US-adopted version of the IEC standard as an alternative to the MSHA criteria for 2-fault intrinsic safety (Document ID 0015). MSHA understands NIOSH's reference to “US-adopted version of the IEC standard” to mean the ANSI 60079 series of VCS. Therefore, MSHA agrees with NIOSH that the US-adopted version of the IEC standard should be accepted as an alternative to the MSHA criteria for 2-fault intrinsic safety because it provides an equivalent Level of Protection.</P>
                <P>In agreement with UL and NIOSH, MSHA will only accept the ANSI-approved VCS in this final rule. The list of VCS that MSHA is incorporating by reference in final paragraphs (a) and (b) of §  18.102 does not include the IEC VCS that was in the proposed rule.</P>
                <P>
                    MSHA received comments from manufacturers and EMA regarding other standards that the Agency should consider as a VCS for incorporation by reference (Document ID 0010; 0013; 0016; 0019; 0018; 0020; 0023). MSA Safety, a manufacturer of safety products, recommended that the gas detection performance standards, such as ANSI/UL 60079-29-1, ANSI/FM 60079-29-1, IEC 60079-29-1, and ANSI/UL 121303, be added to the VCS list in § 18.102 (Document ID 0010). Komatsu recommended that MSHA consider adopting IEC 60079-7 and UL 60079-7 (Document ID 0013). Fletcher and NMA suggested that MSHA accept ATEX certified equipment and components (Document ID 0019; 0020). 
                    <PRTPAGE P="99096"/>
                    EMA requested that Factory Mutual (FM), an insurance company and testing laboratory for electrical equipment, be considered as a VCS, especially for the following testing standards: FM 3600, 3610, 3611, 3613 and 3615 (Document ID 0018).
                </P>
                <P>
                    MSHA has determined that some of these VCS, such as the gas detection performance standards in ANSI/FM 60079-29-1 and the ANSI/UL 121303 standards, are outside the scope of this final rule because the VCS are not applicable to Part 18 product approvals; they are related to 30 CFR parts 22 and 75. As discussed in section VI.D.3, 
                    <E T="03">Section 18.103—Review and update of applicable voluntary consensus standards,</E>
                     MSHA may consider incorporating by reference other VCS applicable to other MSHA product approval parts in future rulemakings.
                </P>
                <P>
                    MSHA analyzed IEC 60079-7 and UL 60079-7 and determined that these standards provide a Level of Protection for hazardous atmospheres encountered in gassy mines that is less protective than the Levels of Protection the Agency requires for VCS. The 60079-7 standard, “Increased Safety,” is for products in which electrical arcs and sparks do not occur in normal service (and in specific abnormal conditions) and in which surface temperatures are controlled below incendive values. Increased Safety is achieved by enhancing insulation values and creepage and clearance distances above those required for normal service, thus providing a safety factor against accidental breakdown. This protection is not as rigorous as the protection techniques that MSHA currently accepts; the enclosures are not as robust as MSHA-certified explosion-proof enclosures with circuits not considered as intrinsically safe. Furthermore, the final rule includes VCS that provide the highest level of protection (
                    <E T="03">e.g.,</E>
                     “ia”, “da”, and “ma”); Increased Safety is not one of those techniques. The Levels of Protection required by the VCS are discussed in § 18.101. TIEC 60079-7 and UL 60079-7 do not meet the Levels of Protection required by Part 18.
                </P>
                <P>MSHA understands that FM is a third-party global testing and certification agency focused on property loss prevention for use in commercial and industrial facilities. FM 3600, FM 3610, FM 3611, FM 3613, and FM 3615 do not appear to address the level of protection suitable for gassy mining environments for U.S. mines. The Scope of each of these documents note that they are intended for equipment for use in “Classes I, II &amp; III, Division 1 hazardous (classified) locations as defined in Article 500 of the NEC®.” Areas where permissibility is required in gassy underground mines are not included in those locations.</P>
                <P>MSHA also understands that ATEX is a mandatory directive that requires products used in hazardous atmospheres to comply with specified requirements within the European Union (Health and Safety Executive, n.d.). ATEX is intended for use in the European Union. MSHA has determined that it would not be applicable to U.S.-based product approvals because it does not address U.S. national standards.</P>
                <HD SOURCE="HD3">3. Section 18.103—Review and Update of Applicable Voluntary Consensus Standards</HD>
                <P>In final § 18.103, MSHA will review more recent editions of VCS and additional VCS that could lead to the use of innovative and advanced technologies in U.S. mines. Final § 18.103 is similar to the proposed rule, with minor changes in paragraphs (a) through (c) to align with §  18.101. The language in paragraphs (a) and (b) are revised because the final rule does not replace the Part 18 requirements in subparts B through E with VCS.</P>
                <P>Consol supported proposed § 18.103 concerning the Agency's commitment to review, update, and possibly expand the list of VCS in § 18.102 (Document ID 0014). EMA stated that for updates of applicable VCS, MSHA should do so in a rulemaking process with notice and comment rulemaking procedures equivalent to the procedures utilized to implement the original incorporation by reference. The commenter stated that stakeholders may not have participated in the development of an updated VCS and the MSHA rulemaking procedure may be the only opportunity they have to provide input on a proposed incorporation by reference (Document ID 0018).</P>
                <P>MSHA is aware that manufacturers of approved products currently used in mines may wish to design and manufacture products to more recent versions of MSHA-accepted VCS to keep products up-to-date for improvements and marketability. Under final paragraph (a) of § 18.103, MSHA will review more recent editions of the listed VCS and determine whether to use them to ensure timely updating of the VCS listed in § 18.102. Under final paragraph (b) of § 18.103, MSHA will review other VCS that are not listed in § 18.102 and determine whether they are suitable for gassy mining environments and provide protection against fire and explosion hazards. Under final paragraph (c) of § 18.103, MSHA will use the appropriate rulemaking process to update the list of VCS approved for incorporation by reference in lieu of approval requirements in subparts B through E in Part 18. MSHA may also remove a standard from the list in final § 18.102 if it is withdrawn by a voluntary consensus standards body or for other reasons.</P>
                <HD SOURCE="HD2">E. Conforming Amendments</HD>
                <HD SOURCE="HD3">Part 74—Coal Mine Dust Sampling Devices</HD>
                <P>Under the final rule, paragraph (b) of § 74.5 and paragraph (d) of § 74.11 are unchanged from the proposal. In the proposal, MSHA proposed conforming amendments to Coal Mine Dust Sampling Devices in existing part 74 based on the proposed changes in Part 18. Specifically, MSHA proposed to change cross-references in existing paragraph (b) of § 74.5 and paragraph (d) of § 74.11 for evaluation and testing for permissibility of Coal Mine Dust Sampling Devices from § 18.68 of Part 18. This change in part 74 would conform to the proposed changes in Part 18 and would allow the use of MSHA-designated VCS for the approval of coal mine dust sampling devices.</P>
                <P>MSHA received no comments on the proposed changes. The final rule makes technical changes to 30 CFR part 74 regarding the approval requirements for Coal Mine Dust Sampling Devices to conform to the proposed changes in Part 18, which will allow the use of MSHA-designated VCS for the approval of coal mine dust sampling devices.</P>
                <HD SOURCE="HD1">VII. Regulatory Impact Analysis</HD>
                <HD SOURCE="HD2">A. Executive Orders 12866: Regulatory Planning and Review, as Amended by E.O. 14094: Modernizing Regulatory Review, and 13563: Improving Regulation and Regulatory Review</HD>
                <P>
                    MSHA's Regulatory Impact Analysis assesses the costs and benefits of this final rule. Executive Order (E.O.) 12866, as amended by E.O. 14094, and E.O. 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Executive Order 12866 of September 30, 1993: Regulatory Planning and Review. 58 FR 51735. October 4, 1993. 
                        <E T="03">www.archives.gov/files/federal-register/executive-orders/pdf/12866.pdf</E>
                         (last accessed May 17, 2024).
                    </P>
                    <P>
                        Executive Order 14094 of April 6, 2023: Modernizing Regulatory Review. 88 FR 21879. April 11, 2023. 
                        <E T="03">www.federalregister.gov/documents/2023/04/11/2023-07760/modernizing-regulatory-review</E>
                         (last accessed May 17, 2024).
                        <PRTPAGE/>
                    </P>
                    <P>
                        Executive Order 13563 of January 18, 2011: Improving Regulation and Regulatory Review. January 18, 2011. 
                        <E T="03">www.regulations.gov/document/EPA-HQ-OA-2018-0259-0005</E>
                         (last accessed May 17, 2024).
                    </P>
                </FTNT>
                <PRTPAGE P="99097"/>
                <P>
                    Under E.O. 12866, OMB's Office of Information and Regulatory Affairs (OIRA) determines whether a regulatory action is significant and, therefore, subject to the requirements of the E.O. and review by OMB. As amended by E.O. 14094, section 3(f) of E.O. 12866 defines a “significant regulatory action” as a regulatory action that is likely to result in a rule that may: (1) have an annual effect on the economy of $200 million or more; or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, territorial, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees or loan programs or the rights and obligations of recipients thereof; or (4) raise legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in the E.O. OIRA has determined that this final rule is not a “significant regulatory action.” OMB has reviewed the final rule. Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, also known as the Congressional Review Act (5 U.S.C. 801 
                    <E T="03">et seq.</E>
                    ), OIRA has determined that this rule does not meet the criteria set forth in 5 U.S.C. 804(2) for major rules.
                </P>
                <P>E.O. 13563 recognizes that some benefits and costs are difficult to quantify and provides that, where appropriate and permitted by law, agencies may consider and discuss qualitative values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts. E.O. 13563 also emphasizes the importance of reducing costs, harmonizing rules, and promoting flexibility.</P>
                <P>This final rule incorporates by reference eight VCS, accepts those eight VCS requirements for MSHA approvals, and commits MSHA to reviewing and updating VCS provisions. The testing and evaluation of electrical equipment for which applicants seek MSHA approval for use in gassy mines is conducted by either MSHA or an independent laboratory. For new approvals, the final rule will allow applicants to use one of the following: (1) existing Part 18 requirements, or (2) listed VCS. Product designers and manufacturers holding MSHA approvals are allowed to market such equipment to mine operators as “MSHA approved” for use in gassy mines.</P>
                <P>The benefits of this final rule include:</P>
                <P>(1) enhanced health and/or safety of miners through the introduction of innovative and modern electrical equipment as a result of the additional equipment and technologies that will be made available for use in U.S. gassy mining environments; and</P>
                <P>(2) reduced burden for manufacturers applying for the approval to use electrical equipment in gassy mines, because manufacturers of equipment that already meet VCS requirements will not have to redesign those products to meet MSHA requirements.</P>
                <P>Under MSHA's current Part 18 regulations, existing manufacturer compliance costs include:</P>
                <P>(1) the time for manufacturers to go through an approval process, including filling out applications;</P>
                <P>(2) the costs of testing and evaluations of equipment by MSHA or independent laboratory pursuant to 30 CFR 6.10; and</P>
                <P>(3) fees paid by manufacturers to MSHA to have their applications reviewed.</P>
                <P>MSHA did not receive any public comments regarding direct costs. MSHA has determined that manufacturers will not incur any new direct costs from using the final rule for product approvals.</P>
                <HD SOURCE="HD1">Benefits</HD>
                <P>The final rule will provide societal benefits to manufacturers of electric motor-driven mine equipment and accessories and the consumers of those products (mine operators and miners). MSHA is not able to quantify the benefits due to a lack of access to proprietary product information and uncertainty about the type and amount of new electrical equipment that will be approved as a result of this final rule. MSHA expects that allowing for the use of VCS standards for electrical equipment will improve the safety and health of miners, through expanded product choices and lower cost burden of designing, building, and testing.</P>
                <P>Currently, some products that use modern technologies are not being introduced by manufacturers into the U.S. mining market. One reason may be that technical requirements set by MSHA for products for gassy mines differ from those which are marketed in other industries. MSHA's specific technical requirements could influence or impact manufacturers' decisions to apply for product approvals that would allow for introduction of new technologies in U.S. mines. This final rule promotes the introduction of additional products and technologies through the expansion of approval requirements to include VCS and lowering technical barriers to entry.</P>
                <P>Several commenters, including Komatsu, Consol, and NIOSH, suggested that this rule will allow mine operators to take advantage of all available safety and health technologies (Document ID 0013; 0014; 0015). They also commented that this rule will allow a greater variety of electrical equipment to be introduced into gassy mines, thereby giving miners and mine operators additional equipment options, including options that might be better suited to their unique mining conditions.</P>
                <P>Rosebud Mining Company stated that innovation in the underground coal mining sector is currently inhibited by the testing and evaluation provisions covering all equipment that must be approved under the current MSHA standards (Document ID 0012). The commenter said that many manufacturers have equipment that have been approved under ANSI or IEC standards, and that this rule would therefore expand the types of equipment allowed into gassy mines, thereby providing additional product options for mine operators and miners that would further the health and safety of miners.</P>
                <P>The final rule will allow manufacturers to choose to use either the applicable listed VCS or MSHA's existing approval requirements in subparts B through E for Part 18 approval. This will allow manufacturers to make a choice that minimizes the time and resource costs to them while still ensuring the same level of health and safety to miners using their equipment.</P>
                <P>In summary, MSHA expects to see two primary qualitative benefits as a result of this rule. First, the health and safety of miners will be improved because of the ability of mine operators and miners to choose from more innovative and technologically advanced equipment that works best for their unique mining conditions. Second, MSHA expects the rule to decrease the compliance burden for manufacturers through enhanced efficiency and effectiveness in the application process, because applicants will now have the option of using either existing MSHA requirements or VCS requirements for approval of their equipment.</P>
                <HD SOURCE="HD1">Costs</HD>
                <P>
                    The current regulations impose compliance costs on manufacturers of motor-driven mine electrical equipment and accessories. Manufacturers have to spend time to go through an approval 
                    <PRTPAGE P="99098"/>
                    process, spend money for the testing and evaluations of equipment, and pay fees to MSHA to review their applications as part of the approval process.
                </P>
                <P>MSHA understands that many products with MSHA approval are also accepted for other industries with similar safety standards where VCS certification is required, such as the oil and gas extraction industry. In order to market to a wide range of industries, equipment manufacturers with MSHA approval currently have to maintain two versions of the same product: one version for the U.S. mining industry and one version for other industries with similar safety standards. Under the final rule, these manufacturers submitting new product applications for MSHA approval will likely experience lower approval costs, because their products have already met the VCS requirements and will no longer need to meet MSHA-unique requirements. As a result, many applicants will not be required to submit additional technical drawings, documentation, and testing beyond the materials submitted elsewhere for VCS certification.</P>
                <P>The final rule allows manufacturers and mine operators to continue to sell or purchase all currently approved equipment. Currently approved equipment will still be allowed and in compliance based on its most recent approval. If, at a future date, a current approval holder wishes to make any modifications to a piece of approved equipment, the approval holder submitting an application for a modification would not incur substantive costs. Applicants will have the option of using the existing Part 18 requirements or the VCS requirements.</P>
                <P>MSHA does not anticipate additional compliance costs for new approvals in terms of time spent on the approval process. Based on MSHA's experience providing compliance assistance to manufacturers, MSHA believes that its own standards are generally more burdensome than VCS. Manufacturers going through the VCS process can therefore expect, on average, less time to prepare application materials than they face before the adoption of this rule. Many electrical machines and components that comply with the listed VCS requirements are readily available, since VCS are widely accepted in the U.S. In contrast, many electrical machines and components that meet existing Part 18 requirements are not widely available since the requirements are specific to underground gassy mines in the U.S. Therefore, MSHA expects no extra costs associated with this final rule because many products are already in use in markets outside of the U.S. mining industry. Furthermore, applicants whose products already meet the VCS requirements will likely experience cost reductions due to the expanded list of acceptable standards.</P>
                <P>Applicants will still have the option of using either MSHA or an independent laboratory for testing and evaluation of their electrical equipment, which means that costs related to this item will remain unchanged. Other costs, including fees paid by manufacturers to MSHA to review their applications, are not expected to be significantly affected by the final rule.</P>
                <P>MSHA has determined that the use of the listed VCS in addition to existing Part 18 requirements will not introduce additional direct costs for manufacturers; on the contrary, manufacturers introducing new technologies may experience fewer barriers for product entry into the mining industry, without any adverse impacts on safety. MSHA's acceptance of the listed VCS will provide more mining product choices to mine operators and miners.</P>
                <P>Under the final rule, current approval holders will not be required to alter equipment or incur any new costs. New applicants may choose the standards most beneficial to them. Overall, no substantive costs are expected to be incurred (they are likely to fall instead) because many approval holders and applicants already design and build products that meet the VCS requirements.</P>
                <HD SOURCE="HD1">VIII. Feasibility</HD>
                <P>Commenters, such as NMA and Dräger, noted that manufacturers of products for mining already successfully use VCS outside of the U.S. (Document ID 0020; 0023). The final rule will provide mining equipment manufacturers increased flexibility for approval of existing or new equipment for use in gassy mines through the allowance of the listed VCS as an alternative to the MSHA-unique requirements in Part 18. Additionally, the final rule allows manufacturers to continue to apply for approvals based on the existing MSHA-unique requirements in Part 18. Thus, the final rule does not require different technologies than those acceptable under existing requirements. MSHA concludes that the requirements of the final rule are technologically feasible.</P>
                <P>As discussed in the Regulatory Impact Analysis, MSHA determines that manufacturers will not incur any new substantive direct costs to meet the requirements of the final rule. For approved products, manufacturers have the option of continuing to use the requirements in subparts B through E of Part 18 or to start using listed VCS requirements. For new products, MSHA approval requires that an electrical machine or component be designed, built, and tested to existing MSHA-unique requirements in Part 18 or to the listed VCS, which results in no cost change if using existing MSHA requirements or a decrease in application costs from simplified application materials if the manufacturer chooses to meet VCS requirements. MSHA concludes that the requirements of the final rule are economically feasible.</P>
                <HD SOURCE="HD1">IX. Regulatory Flexibility Act; Small Business Regulatory Enforcement Fairness Act; and Executive Order 13272</HD>
                <P>The Regulatory Flexibility Act of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, hereafter jointly referred to as the RFA, requires that an agency consider the economic impact that a final rulemaking will have on small entities. E.O. 13272 requires Federal agencies to assess the economic impacts of a rule on small businesses, small governmental jurisdictions, and small organizations.</P>
                <P>NIOSH and an individual noted that switching from MSHA-unique technical requirements to the listed VCS could negatively affect small to medium companies (Document ID 0015; 0026). After considering the comments, MSHA has decided to allow manufacturers to use the existing requirements or the VCS for product approval. MSHA has determined that manufacturers will not incur any incremental direct compliance costs to meet the requirements of the final rule, and no small entities that are current approval holders will be required to make a product change due to the final rule. Therefore, MSHA certifies that the final rule will not have a significant economic impact on a substantial number of small entities.</P>
                <HD SOURCE="HD1">X. Paperwork Reduction Act of 1995</HD>
                <P>
                    The Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521) provides for the Federal Government's collection, use, and dissemination of information. The goals of the PRA include minimizing paperwork and reporting burdens and ensuring the maximum possible utility from the information that is collected under 5 CFR part 1320. The PRA requires Federal agencies to obtain approval from OMB before requesting or requiring “a collection of information” from the public.
                    <PRTPAGE P="99099"/>
                </P>
                <P>As part of the PRA process, MSHA solicited comments on the proposed rule, including information collection requirements, and provided an opportunity for comments to be sent directly to OMB, as required in 44 U.S.C. 3506(c)(2)(A). MSHA did not receive any comments regarding the necessity or burden related to information collection.</P>
                <P>Information collection costs associated with current MSHA-unique technical requirements are captured in the currently approved information collection request under OMB Control Number 1219-0066. Under this information collection request, MSHA collects information from mine operators regarding electric motor-driven mine equipment and accessories, including the following:</P>
                <P>• application for and extension of approval,</P>
                <P>• application for and extension of acceptance,</P>
                <P>• application for field modification of approved permissible equipment,</P>
                <P>• application for and extension of certification,</P>
                <P>• application for permit to use experimental electric face equipment in a gassy mine or tunnel,</P>
                <P>• application for and extension of simplified certification, and</P>
                <P>• application for Revised Approval Modification Program (RAMP).</P>
                <P>As discussed in the Regulatory Impact Analysis, MSHA has determined that manufacturers will not incur any incremental direct costs to meet the requirements of the final rule. Hence, there is no new information collection associated with this final rule.</P>
                <HD SOURCE="HD1">XI. Other Regulatory Considerations</HD>
                <HD SOURCE="HD2">A. National Environmental Policy Act</HD>
                <P>
                    The National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ), requires each Federal agency to consider the environmental effects of final actions and to prepare an environmental impact statement on major actions significantly affecting the quality of the environment. MSHA has reviewed the final rule in accordance with NEPA requirements, the regulations of the Council on Environmental Quality (40 CFR part 1500), and the Department of Labor's NEPA procedures (29 CFR part 11). As a result of this review, MSHA has determined that this final rule will not have a significant environmental impact. Accordingly, MSHA has not conducted an environmental assessment nor provided an environmental impact statement.
                </P>
                <HD SOURCE="HD2">B. The Unfunded Mandates Reform Act of 1995</HD>
                <P>
                    MSHA has determined that this final rule does not include any Federal mandate that will result in increased expenditures by State, local, or tribal governments under the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 
                    <E T="03">et seq.</E>
                    ). Since the final rule does not have any costs, the rule is not a major rule under the Unfunded Mandates Reform Act of 1995. Accordingly, the Unfunded Mandates Reform Act of 1995 requires no further Agency action or analysis.
                </P>
                <HD SOURCE="HD2">C. The Treasury and General Government Appropriations Act of 1999: Assessment of Federal Regulations and Policies on Families</HD>
                <P>Section 654 of the Treasury and General Government Appropriations Act of 1999 (5 U.S.C. 601 note) requires agencies to assess the impact of Agency action on family well-being. MSHA has determined that the final rule will have no effect on family stability or safety, marital commitment, parental rights and authority, or income or poverty of families and children, as defined in the Act. The final rule impacts the mining industry and does not impose requirements on states or families. Accordingly, MSHA certifies that this final rule will not impact family well-being, as defined in the Act.</P>
                <HD SOURCE="HD2">D. Executive Order 13132: Federalism</HD>
                <P>The final rule does not have “federalism implications” because it will not “have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Accordingly, under E.O. 13132, no further Agency action or analysis is required.</P>
                <HD SOURCE="HD2">E. Executive Order 12630: Government Actions and Interference With Constitutionally Protected Property Rights</HD>
                <P>The final rule does not implement a policy with takings implications. Accordingly, under E.O. 12630, no further Agency action or analysis is required.</P>
                <HD SOURCE="HD2">F. Executive Order 12988: Civil Justice Reform</HD>
                <P>The final rule was written to provide a clear legal standard for affected conduct and was carefully reviewed to eliminate drafting errors and ambiguities, to minimize litigation and undue burden on the Federal court system. Accordingly, the rule meets the applicable standards provided in section 3 of E.O. 12988, Civil Justice Reform.</P>
                <HD SOURCE="HD2">G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</HD>
                <P>This final rule does not have “tribal implications” because it will not “have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” Accordingly, under E.O. 13175, no further Agency action or analysis is required.</P>
                <HD SOURCE="HD2">H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use</HD>
                <P>E.O. 13211 requires agencies to publish a statement of energy effects when a rule has a significant energy action that adversely affects energy supply, distribution, or use. MSHA has reviewed this final rule for its energy effects. There are no costs associated with this final rule. For the energy analysis, this final rule will not exceed the relevant criteria for adverse impact.</P>
                <HD SOURCE="HD2">I. Executive Order 13985: Advancing Racial Equity and Support for Underserved Communities Through the Federal Government</HD>
                <P>
                    E.O. 13985 provides “that the Federal Government should pursue a comprehensive approach to advancing equity for all, including people of color and others who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality.” E.O. 13985 defines “equity” as “consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treatment, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.” To assess the impact of the final rule on equity, MSHA considered two factors: (1) the racial/ethnic distribution in mining in NAICS 212 (which does not include oil and gas extraction) compared to the racial/ethnic distribution of the U.S. workforce (Table XI-1), and (2) the extent to which 
                    <PRTPAGE P="99100"/>
                    mining may be concentrated within general mining communities (Table XI-2).
                </P>
                <P>
                    In 2008, NIOSH conducted a survey of mines, which entailed sending a survey packet to 2,321 mining operations to collect a wide range of information, including demographic information on miners. NIOSH's 2012 report, entitled “National Survey of the Mining Population: Part I: Employees” reported the findings of this survey (NIOSH, 2012a). Race and ethnicity information about U.S. mine workers is presented in Table XI-1. Of all mine workers, including miners as well as administrative employees at mines, 93.4 percent of mine workers were white, compared to 80.6 percent of all U.S workers.
                    <SU>14</SU>
                    <FTREF/>
                     There were larger percentages of American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander people in the mining industry compared to all U.S. workers, while there were smaller percentages of Asian, Black or African American, and Hispanic/Latino people in the mining industry compared to all U.S. workers.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         National data on workers by race were not available for the year 2008; comparable data for 2012 are provided for comparison under the assumption that there would not be major differences in distributions between these two years.
                    </P>
                </FTNT>
                <P>
                    Table XI-2 shows that there are 22 mining communities, defined as counties where at least 2 percent of the population is working in the mining industry.
                    <SU>15</SU>
                    <FTREF/>
                     Although the total population in this table represents only 0.15 percent of the U.S. population, it represents 12.0 percent of all mine workers. The average per capita income in these communities in 2020, $47,977,
                    <SU>16</SU>
                    <FTREF/>
                     was lower than the U.S. average, $59,510, representing 80.6 percent of the U.S. average. However, each county's average per capita income varied substantially, ranging from 56.4 percent of the U.S. average to 146.8 percent.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         Although 2 percent may appear to be a small number for identifying a mining community, one might consider that if the average household with one parent working as a miner has five members in total, then approximately 10 percent of households in the area would be directly associated with mining. While 10 percent may also appear small, this refers to the county. There are likely particular areas that have a heavier concentration of mining households.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         This is a simple average rather than a weighted average by population.
                    </P>
                </FTNT>
                <P>MSHA determined that the final rule would not impose costs that would influence the mining industry's demand of labor, and therefore, the rule would have no impact on mining employment in underserved communities. MSHA determined that the final rule is consistent with the goals of E.O. 13985 and would support the advancement of equity for all workers at mines, including those who are historically underserved and marginalized.</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,15,15,15">
                    <TTITLE>
                        Table XI-1—Racial and Ethnic Distribution of Mine Workers 
                        <SU>1</SU>
                    </TTITLE>
                    <TDESC>[2012]</TDESC>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1">
                            Number of 
                            <LI>workers in mining</LI>
                            <LI>(except oil and gas)</LI>
                            <LI>(NAICS code 212)</LI>
                        </CHED>
                        <CHED H="1">
                            As a percent of total mine workers who self-identified in these 
                            <LI>categories</LI>
                            <LI>(latest data for 2008)</LI>
                        </CHED>
                        <CHED H="1">
                            Percent of all workers in the United States for comparison
                            <LI>
                                (latest data 2012) 
                                <SU>4</SU>
                            </LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="22">Ethnicity:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Hispanic/Latino</ENT>
                        <ENT>26,622</ENT>
                        <ENT>12.1</ENT>
                        <ENT>15.0</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="03">Non-Hispanic or Latino</ENT>
                        <ENT>192,839</ENT>
                        <ENT>87.9</ENT>
                        <ENT>85.0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="05">Total</ENT>
                        <ENT>219,461</ENT>
                        <ENT>100.0</ENT>
                        <ENT>100.0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">
                            Race: 
                            <SU>2</SU>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">
                            American Indian or Alaska Native 
                            <SU>3</SU>
                        </ENT>
                        <ENT>4,050</ENT>
                        <ENT>1.9</ENT>
                        <ENT>0.8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Asian</ENT>
                        <ENT>183</ENT>
                        <ENT>0.1</ENT>
                        <ENT>5.4</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Black or African American</ENT>
                        <ENT>8,893</ENT>
                        <ENT>4.3</ENT>
                        <ENT>13.0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Native Hawaiian or Other Pacific Islander</ENT>
                        <ENT>634</ENT>
                        <ENT>0.3</ENT>
                        <ENT>0.2</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="03">White</ENT>
                        <ENT>194,016</ENT>
                        <ENT>93.4</ENT>
                        <ENT>80.6</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="05">Total</ENT>
                        <ENT>207,776</ENT>
                        <ENT>100.0</ENT>
                        <ENT>100.0</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         Mine workers includes miners and other workers at mines such as administrative employees.
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         Does not include mine workers who did not self-report in one of these categories. Some of the surveyed mine workers may not have self-reported in one of these categories if they are affiliated with more than one race, or if they chose not to respond to this survey question.
                    </TNOTE>
                    <TNOTE>
                        <SU>3</SU>
                         Includes mine workers who self-identified as an American Indian or Alaskan Native as a single race, not in combination with any other races. No other data on mine workers in this racial group were available from this source. In other employment statistics often reported on American Indians and Alaska Natives, their population is based on self-reporting as being American Indian or Alaska Native in combination with any other race, which has resulted in the reporting of much higher employment levels. See Bureau of Labor Statistics (BLS), 
                        <E T="03">Monthly Labor Review,</E>
                         “Alternative Measurements of Indian Country: Understanding Their Implications for Economic, Statistical, and Policy Analysis,” 
                        <E T="03">www.bls.gov/opub/mlr/2021/article/alternative-measurements-of-indian-country.htm.</E>
                    </TNOTE>
                    <TNOTE>
                        <SU>4</SU>
                         More recent data from the 2020 Decennial Census were not available in September 2022.
                    </TNOTE>
                    <TNOTE>
                        <E T="02">Sources:</E>
                         National Institute for Occupational Safety and Health (NIOSH). 2012a. National Survey of the Mining Population Mining Publication: Part 1: Employees, DHHS (NIOSH) Pub. No. 2012-152, June 2012; U.S. Census Bureau, 2012 American Community Survey (ACS).
                    </TNOTE>
                </GPOTABLE>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="xs50,r50,25,25,25">
                    <TTITLE>Table XI-2—Mining Counties—Counties in the United States With Relatively High Concentrations of Mine Workers</TTITLE>
                    <TDESC>[At least 2 percent of the county population]</TDESC>
                    <BOXHD>
                        <CHED H="1">No.</CHED>
                        <CHED H="1">County</CHED>
                        <CHED H="1">
                            Number of mine workers
                            <LI>(first quarter 2022)</LI>
                        </CHED>
                        <CHED H="1">
                            Population of county
                            <LI>(latest data in 2021)</LI>
                        </CHED>
                        <CHED H="1">
                            Estimated percent of 
                            <LI>population who are mine </LI>
                            <LI>workers</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">1</ENT>
                        <ENT>White Pine County, Nevada</ENT>
                        <ENT>1,288</ENT>
                        <ENT>9,182</ENT>
                        <ENT>14.0</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="99101"/>
                        <ENT I="01">2</ENT>
                        <ENT>Pershing County, Nevada</ENT>
                        <ENT>771</ENT>
                        <ENT>6,741</ENT>
                        <ENT>11.4</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3</ENT>
                        <ENT>Humboldt County, Nevada</ENT>
                        <ENT>1,549</ENT>
                        <ENT>17,648</ENT>
                        <ENT>8.8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4</ENT>
                        <ENT>Campbell County, Wyoming</ENT>
                        <ENT>3,547</ENT>
                        <ENT>46,401</ENT>
                        <ENT>7.6</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">5</ENT>
                        <ENT>Winkler County, Texas</ENT>
                        <ENT>513</ENT>
                        <ENT>7,415</ENT>
                        <ENT>6.9</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">6</ENT>
                        <ENT>Mercer County, North Dakota</ENT>
                        <ENT>555</ENT>
                        <ENT>8,323</ENT>
                        <ENT>6.7</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">7</ENT>
                        <ENT>Chase County, Kansas</ENT>
                        <ENT>166</ENT>
                        <ENT>2,598</ENT>
                        <ENT>6.4</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">8</ENT>
                        <ENT>Shoshone County, Idaho</ENT>
                        <ENT>723</ENT>
                        <ENT>13,612</ENT>
                        <ENT>5.3</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">9</ENT>
                        <ENT>Logan County, West Virginia</ENT>
                        <ENT>1,643</ENT>
                        <ENT>31,909</ENT>
                        <ENT>5.1</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10</ENT>
                        <ENT>Sweetwater County, Wyoming</ENT>
                        <ENT>2,050</ENT>
                        <ENT>41,614</ENT>
                        <ENT>4.9</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">11</ENT>
                        <ENT>Glasscock County, Texas</ENT>
                        <ENT>56</ENT>
                        <ENT>1,149</ENT>
                        <ENT>4.9</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12</ENT>
                        <ENT>Livingston County, Kentucky</ENT>
                        <ENT>431</ENT>
                        <ENT>8,959</ENT>
                        <ENT>4.8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">13</ENT>
                        <ENT>Buchanan County, Virginia</ENT>
                        <ENT>946</ENT>
                        <ENT>19,816</ENT>
                        <ENT>4.8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">14</ENT>
                        <ENT>McDowell County, West Virginia</ENT>
                        <ENT>660</ENT>
                        <ENT>18,363</ENT>
                        <ENT>3.6</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">15</ENT>
                        <ENT>Big Horn County, Wyoming</ENT>
                        <ENT>413</ENT>
                        <ENT>11,632</ENT>
                        <ENT>3.6</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">16</ENT>
                        <ENT>Sevier County, Utah</ENT>
                        <ENT>601</ENT>
                        <ENT>21,906</ENT>
                        <ENT>2.7</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">17</ENT>
                        <ENT>Boone County, West Virginia</ENT>
                        <ENT>582</ENT>
                        <ENT>21,312</ENT>
                        <ENT>2.7</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">18</ENT>
                        <ENT>Moffat County, Colorado</ENT>
                        <ENT>349</ENT>
                        <ENT>13,185</ENT>
                        <ENT>2.6</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">19</ENT>
                        <ENT>Nye County, Nevada</ENT>
                        <ENT>1,062</ENT>
                        <ENT>43,946</ENT>
                        <ENT>2.4</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">20</ENT>
                        <ENT>Raleigh County, West Virginia</ENT>
                        <ENT>1,647</ENT>
                        <ENT>73,771</ENT>
                        <ENT>2.2</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21</ENT>
                        <ENT>Wyoming County, West Virginia</ENT>
                        <ENT>456</ENT>
                        <ENT>21,051</ENT>
                        <ENT>2.2</ENT>
                    </ROW>
                    <ROW RUL="n,n,s">
                        <ENT I="01">22</ENT>
                        <ENT>Elko County, Nevada</ENT>
                        <ENT>1,090</ENT>
                        <ENT>53,915</ENT>
                        <ENT>2.0</ENT>
                    </ROW>
                    <ROW RUL="n,n,s">
                        <ENT I="01">Total</ENT>
                        <ENT/>
                        <ENT>20,963</ENT>
                        <ENT>494,448</ENT>
                        <ENT>4.2</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">All U.S. Counties</ENT>
                        <ENT/>
                        <ENT>174,387</ENT>
                        <ENT>331,893,745</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="01">Mine Workers in Mining Counties as a Percent of All U.S. Mine Workers</ENT>
                        <ENT/>
                        <ENT>12.0%</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Population of Mine Counties as a Percent of U.S. Population</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>0.15%</ENT>
                    </ROW>
                    <TNOTE>
                        <E T="02">Source:</E>
                         BLS, Quarterly Employment and Wages First Quarter 2022 (2022); Bureau of Economic Analysis, Personal Income by County, Metro, and Other Areas 2020 (2020); U.S. Census Bureau, “Annual Estimates of the Resident Population for Counties: April 1, 2020 to July 1, 2021 (CO-EST2021-POP).” available at: 
                        <E T="03">www.census.gov/data/tables/time-series/demo/popest/2020s-counties-total.html (last accessed Jan. 11, 2024); U.S. Census Bureau, Quick Facts, available at:</E>
                          
                        <E T="03">w</E>
                        <E T="03">ww.census.gov/quickfacts/fact/table/US/PST045221 (last accessed Jan. 11, 2024).</E>
                    </TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD2">J. Congressional Review Act</HD>
                <P>
                    Pursuant to the Congressional Review Act (5 U.S.C. 801 
                    <E T="03">et seq.</E>
                    ), this final rule is not a “major rule,” as defined by 5 U.S.C. 804(2).
                </P>
                <HD SOURCE="HD2">K. Pay-As-You-Go-Act of 2023</HD>
                <P>In accordance with the Administrative Pay-As-You-Go Act of 2023 (Fiscal Responsibility Act of 2023, Pub. L. 118-5, div.B, title III) and OMB Memorandum (M-23-21) dated September 1, 2023, MSHA has determined that this final rule is exempt from the Act because this rule only affects discretionary funding. Therefore, no further Agency action or analysis is required.</P>
                <HD SOURCE="HD2">L. Incorporation by Reference</HD>
                <P>The Office of the Federal Register (OFR) has regulations concerning incorporation by reference. In accordance with the OFR's requirements (1 CFR part 51), the following discussion summarizes briefly the VCS that MSHA incorporates by reference and the availability of each VCS.</P>
                <HD SOURCE="HD3">International Society of Automation (ISA)</HD>
                <P>
                    The two ISA standards being incorporated by reference in this final rule are summarized in this section below. ISA provides free online public access to view read-only copies of ISA standards that are incorporated into Federal regulations through an agreement with ANSI. These standards 
                    <PRTPAGE P="99102"/>
                    are available to the public for free viewing online in the ANSI Incorporated by Reference Portal website at: 
                    <E T="03">https://ibr.ansi.org/Standards/isa.aspx.</E>
                     In addition to the free online availability of these standards for viewing on the ANSI website, hardcopies and printable versions are available for purchase from ISA. The ISA website address to purchase standards is: 
                    <E T="03">www.isa.org/standards-and-publications/isa-standards/find-isa-standards-in-numerical-order.</E>
                     Interested persons may also contact ISA directly at International Society of Automation (ISA), 67 T.W. Alexander Drive, P.O. Box 12277, Research Triangle Park, NC 27709, Tel: (919) 549-8411. In addition, upon finalization of this rule, ISA standards will be available for review free of charge at MSHA headquarters at 201 12th Street South, Arlington, VA 22202-5450 (202-693-9440) and at MSHA's Approval and Certification Center (A&amp;CC) at 765 Technology Drive, Triadelphia, WV 26059 (304-547-0400).
                </P>
                <P>ANSI/ISA 60079-11 (12.02.01)—2014 Standard for Explosive Atmospheres—Part 11: Equipment Protection by Intrinsic Safety “i” (Group I, Level of Protection `ia'), dated March 28, 2014, specifies the construction and testing of intrinsically safe apparatus intended for use in an explosive atmosphere and for associated apparatus that is intended for connection to intrinsically safe circuits which enter such atmospheres. This standard is also applicable to electrical equipment or parts of electrical equipment located outside the explosive atmosphere or protected where the intrinsic safety of the electrical circuits in the explosive atmosphere may depend upon the design and construction of such electrical equipment or parts of such electrical equipment. The electrical circuits exposed to the explosive atmosphere are evaluated for use in such an atmosphere by applying this standard.</P>
                <P>ANSI/ISA 60079-25 (12.02.05)—2011 Standard for Explosive Atmospheres—Part 25: Intrinsically Safe Electrical Systems (Group I, Level of Protection `ia'), dated December 2, 2011, contains the specific requirements for construction and assessment of intrinsically safe electrical systems, type of protection “i,” intended for use, as a whole or in part, in Class I, Zone 0, 1, or 2, or Zone 20, 21, or 22 hazardous (classified) locations as defined by the NEC®, ANSI/NFPA 70®.</P>
                <HD SOURCE="HD3">UL</HD>
                <P>
                    The six UL standards being incorporated by reference in this final rule are summarized in this section below. UL provides free online public access to view read-only copies of UL standards that are incorporated into Federal regulations. These standards are available to the public for free viewing online on UL's website at: 
                    <E T="03">www.ulstandards.com/IBR/logon.aspx.</E>
                     In addition to the free online availability of these standards for viewing on UL's website, hardcopies and printable versions are available for purchase from UL. The UL website address to purchase standards is: 
                    <E T="03">www.shopulstandards.com.</E>
                     Interested persons may also contact UL directly at UL Solutions, Comm 2000, 151 Eastern Avenue, Bensenville, IL 60106, Tel: (888) 853-3503. In addition, upon finalization of this rule, UL standards will be available for review free of charge at MSHA headquarters at 201 12th Street South, Arlington, VA 22202-5450 (202-693-9440) and at MSHA's A&amp;CC at 765 Technology Drive, Triadelphia, WV 26059 (304-547-0400).
                </P>
                <P>ANSI/UL 60079-0 Ed. 7-2019, Standard for Explosive Atmospheres—Part 0: Equipment-General Requirements (Group I), dated March 26, 2019, specifies the general requirements for construction, testing and marking of Ex Equipment and Ex Components intended for use in explosive atmospheres. This standard is an adoption of IEC 60079-0, Explosive atmospheres—Part 0: Equipment—General requirements, (seventh edition issued by IEC December 2017) as a new IEC-based UL standard with U.S. national differences.</P>
                <P>ANSI/UL 60079-1 Ed. 7-2015, Standard for Explosive Atmospheres—Part 1: Equipment Protection by Flameproof Enclosures “d” (Group I, Level of Protection `da'), dated September 18, 2015, contains specific requirements for the construction and testing of electrical equipment with the type of protection flameproof enclosure “d”, intended for use in explosive gas atmospheres. This standard is an adoption of IEC 60079-1, Explosive Atmospheres—Part 1: Equipment Protection by Flameproof Enclosures “d” (seventh edition, issued June 2014) with U.S. national differences.</P>
                <P>ANSI/UL 60079-11 Ed. 6-2013, Standard for Explosive Atmospheres—Part 11: Equipment Protection by Intrinsic Safety “i” (Group I, Level of Protection `ia'), dated February 15, 2013, specifies the construction and testing of intrinsically safe apparatus intended for use in an explosive atmosphere and for associated apparatus, which is intended for connection to intrinsically safe circuits which enter such atmospheres. This standard is also applicable to electrical equipment or parts of electrical equipment located outside the explosive atmosphere or protected where the intrinsic safety of the electrical circuits in the explosive atmosphere may depend upon the design and construction of such electrical equipment or parts of such electrical equipment. The electrical circuits exposed to the explosive atmosphere are evaluated for use in such an atmosphere by applying this standard. This standard incorporates all of the U.S. national differences for UL 60079-11 and is based on IEC 60079-11, Edition 6, published in 2011.</P>
                <P>ANSI/UL 60079-18, Ed. 4-2015, Standard for Explosive Atmospheres—Part 18: Equipment Protection by Encapsulation “m” (Group I, Level of Protection `ma'), dated December 14, 2015, provides the specific requirements for the construction, testing and marking of electrical equipment, parts of electrical equipment and Ex components with the type of protection encapsulation “m” intended for use in explosive gas atmospheres or explosive dust atmospheres. This standard applies only for encapsulated electrical equipment, encapsulated parts of electrical equipment, and encapsulated Ex components where the rated voltage does not exceed 11 kV. This standard incorporates all of the U.S. national differences and is based on IEC 60079-18, Explosive Atmospheres—Part 18: Equipment Protection by Encapsulation “m”, (fourth edition issued December 2014).</P>
                <P>ANSI/UL 60079-25 Ed. 2-2011, Standard for Explosive Atmospheres—Part 25: Intrinsically Safe Electrical Systems (Group I, Level of Protection 'ia'), dated December 2, 2011, contains the specific requirements for construction and assessment of intrinsically safe electrical systems, type of protection “i,” intended for use, as a whole or in part, in Class I, Zone 0, 1, or 2 hazardous (classified) locations as defined by the NEC®, ANSI/NFPA 70®. This standard is an adoption of ANSI/ISA 60079-25, Standard for Explosive Atmospheres—Part 25: Intrinsically Safe Electrical Systems.</P>
                <P>
                    ANSI/UL 60079-28 Ed. 2-2017, Standard for Explosive Atmospheres—Part 28: Protection of Equipment and Transmission Systems Using Optical Radiation (Group I, Equipment Protection Level `Ma'), dated September 15, 2017, specifies the requirements, testing and marking of equipment emitting optical radiation intended for use in explosive atmospheres. It also covers equipment located outside the explosive atmosphere or protected, but which generates optical radiation that is intended to enter an explosive 
                    <PRTPAGE P="99103"/>
                    atmosphere. This standard incorporates all of the U.S. national differences for UL 60079-28 and is based on IEC 60079-28, Edition 2.0 published May 2015.
                </P>
                <HD SOURCE="HD1">XII. References</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        American National Standard Institute (ANSI). 2024a. IBR Standards portal. Standards incorporated by reference. Accessed May 29, 2024. Retrieved from: 
                        <E T="03">https://ibr.ansi.org/.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        American National Standard Institute (ANSI). 2024b. Introduction. Accessed May 31, 2024. Retrieved from: 
                        <E T="03">www.ansi.org/about/introduction.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        American National Standard Institute (ANSI). 2024c. Roles. Accessed May 31, 2024. Retrieved from: 
                        <E T="03">www.ansi.org/about/roles.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        American National Standard Institute (ANSI). 2024d. Submitting standards for approval AS ANS. Accessed May 31, 2024. Retrieved from: 
                        <E T="03">www.ansi.org/american-national-standards/info-for-standards-developers/ans-approval.</E>
                    </FP>
                    <FP SOURCE="FP-2">ANSI/ISA. 2014. 60079-11 (12.02.01)—Standard for Explosive Atmospheres—Part 11: Equipment Protection by Intrinsic Safety “i” (Group I, Level of Protection `ia')</FP>
                    <FP SOURCE="FP-2">ANSI/ISA. 2011a. 60079-25 (12.02.05)—Standard for Explosive Atmospheres—Part 25: Intrinsically Safe Electrical Systems (Group I, Level of Protection `ia')</FP>
                    <FP SOURCE="FP-2">ANSI/UL. 2019. 60079-0 Ed. 7—. Standard for Explosive Atmospheres—Part 0: Equipment-General Requirements (Group I)</FP>
                    <FP SOURCE="FP-2">ANSI/UL. 2015b. 60079-1 Ed. 7—. Standard for Explosive Atmospheres—Part 1: Equipment Protection by Flameproof Enclosures “d” (Group I, Level of Protection `da')</FP>
                    <FP SOURCE="FP-2">ANSI/UL. 2013. 60079-11 Ed. 6—. Standard for Explosive Atmospheres—Part 11: Equipment Protection by Intrinsic Safety “i” (Group I, Level of Protection `ia')</FP>
                    <FP SOURCE="FP-2">ANSI/UL. 2015a. 60079-18, Ed. 4.Standard for Explosive Atmospheres—Part 18: Equipment Protection by Encapsulation “m” (Group I, Level of Protection `ma')</FP>
                    <FP SOURCE="FP-2">ANSI/UL. 2011b. 60079-25 Ed. 2 Standard for Explosive Atmospheres—Part 25: Intrinsically Safe Electrical Systems (Group I, Level of Protection `ia')</FP>
                    <FP SOURCE="FP-2">ANSI/UL. 2017. 60079-28 Ed. 2. Standard for Explosive Atmospheres—Part 28: Protection of Equipment and Transmission Systems Using Optical Radiation (Group I, Equipment Protection Level `Ma')</FP>
                    <FP SOURCE="FP-2">
                        Bureau of Labor Statistics (BLS). 2021. “Alternative Measurements of Indian Country: Understanding Their Implications for Economic, Statistical, and Policy Analysis” Monthly Labor Review. Accessed May 31, 2024. Retrieved from: 
                        <E T="03">www.bls.gov/opub/mlr/2021/article/alternative-measurements-of-indian-country.htm.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Bureau of Labor Statistics (BLS). 2022. Quarterly Employment and Wages First Quarter 2022.Accessed May 31, 2024. Retrieved from: 
                        <E T="03">www.bls.gov/cew/publications/employment-and-wages-annual-averages/2022/home.htm</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Bureau of Safety and Environmental Enforcement (BSEE). 2018. “Comparative Assessment of Electrical Standards and Practices: Final Report.” Accessed June 14, 2024. Retrieved from: 
                        <E T="03">www.bsee.gov/sites/bsee.gov/files/782aa.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">Calder, W., Snyder, D.P. and Burr, J.F., 2018. Intrinsically safe systems: equivalency of international standards compared to US mining approval criteria. IEEE transactions on industry applications, 54(3), pp.2975-2980</FP>
                    <FP SOURCE="FP-2">
                        Congressional Review of Agency Rulemaking 5 U.S.C. 801. Retrieved from: 
                        <E T="03">https://uscode.house.gov/view.xhtml?path=/prelim@title5/part1/chapter8&amp;edition=prelim</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        International Electrotechnical Commission (IEC). 2024a. Understanding standards. Accessed May 31, 2024. Retrieved from: 
                        <E T="03">www.iec.ch/understanding-standards</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        International Electrotechnical Commission (IEC). 2024b. Standards development stages. Accessed May 31, 2024. Retrieved from: 
                        <E T="03">www.iec.ch/standards-development/stages</E>
                    </FP>
                    <FP SOURCE="FP-2">Intertek. 2020. Standards update notice (SUN). Accessed May 31, 2024. Retrieved from: UL 60079-1 Rev 9-18-2015 ED 10-1-2020 (intertek.com)</FP>
                    <FP SOURCE="FP-2">
                        Executive Order 12866 of September 30, 1993: Regulatory Planning and Review. 58 FR 51735. October 4, 1993. Accessed January 5, 2023. Retrieved from: 
                        <E T="03">https://www.archives.gov/files/federal-register/executive-orders/pdf/12866.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Executive Order 13272 of August 13, 2002: Proper Consideration of Small Entities in Agency Rulemaking. August 13, 2002. Accessed May 17, 2024. Retrieved from: 
                        <E T="03">www.federalregister.gov/documents/2002/08/16/02-21056/proper-consideration-of-small-entities-in-agency-rulemaking</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Executive Order 13563 of January 18, 2011: Improving Regulation and Regulatory Review. January 18, 2011. Accessed May 17, 2024. Retrieved from: 
                        <E T="03">www.regulations.gov/document/EPA-HQ-OA-2018-0259-0005</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Executive Order 14094 of April 6, 2023: Modernizing Regulatory Review. 88 FR 21879. April 11, 2023. Accessed May 17, 2024. Retrieved from: 
                        <E T="03">www.federalregister.gov/documents/2023/04/11/2023-07760/modernizing-regulatory-review</E>
                    </FP>
                    <FP SOURCE="FP-2">Fowler, T.W. and Miles, K.K. 2009. Electrical safety. Safety and health for electrical trades. Student manual. National Institute of Occupational Safety and Health.</FP>
                    <FP SOURCE="FP-2">Fuhrmann, T., Schlegel, S., Grobmann, S., Hoidis, M.. 2014. Investigations on stationary electrical joints with a bare and a silver or nickel coated contact partner regarding the permissible temperature limit according to ANSI IEE and IEO. IEEE 60th Holm Conference on Electrical Contacts (HOLM), New Orleans, LA. 1-8.</FP>
                    <FP SOURCE="FP-2">
                        Health and Safety Executive. N.d. ATEX and explosive atmospheres. Accessed May 31, 2024. Retrieved from: 
                        <E T="03">www.hse.gov.uk/fireandexplosion/atex.htm#whatatex</E>
                    </FP>
                    <FP SOURCE="FP-2">Mine Safety and Health Administration. 1978. Technical, Nonsubstantive Revisions and Miscellaneous Amendments. 43 FR 12314</FP>
                    <FP SOURCE="FP-2">
                        National Institute for Occupational Safety and Health (NIOSH). 2012a. National Survey of the Mining Population Mining Publication: Part 1: Employees, DHHS (NIOSH) Pub. No. 2012-152, June 2012. 
                        <E T="03">www.cdc.gov/niosh/mining/UserFiles/works/pdfs/2012-152.pdf</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        National Technology Transfer and Advancement Act of 1995. 15 U.S.C. 3710. 
                        <E T="03">www.congress.gov/bill/104th-congress/house-bill/2196/text</E>
                    </FP>
                    <FP SOURCE="FP-2">National Fire Protection Association®. 2023. NFPA 70®: National Electric Code®. International electrical code series.</FP>
                    <FP SOURCE="FP-2">
                        Office of Management and Budget's (OMB). 2017. Circular A-119 Revised. Accessed May 31, 2024. Retrieved from: 
                        <E T="03">www.whitehouse.gov/wp-content/uploads/2017/11/Circular-119-1.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Occupational Safety and Health Administration (OSHA). 2019. NRTL Program policies, procedures, and guidelines. CPL-01-00-0004. Accessed May 31, 2024. Retrieved from: 
                        <E T="03">www.osha.gov/sites/default/files/enforcement/directives/CPL_019-00-004.pdf</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Sim, H.J. 2007. Comparisons of standards- ANSI/IEEE and IEC. Waukesha electrical systems. Accessed July 5, 2024. Retrieved from: 
                        <E T="03">https://grouper.ieee.org/groups/transformers/subcommittees/STNP/private/IEEE_IEC_Comparison-OLD.pdf</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        U.S. Census Bureau. 2012 American Community Survey (ACS).Accessed May 31, 2024. Retrieved from: 
                        <E T="03">www.census.gov/programs-surveys/acs/data.html</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        U.S. Census Bureau. “Annual Estimates of the Resident Population for Counties: April 1, 2020 to July 1, 2021 (CO-EST2021-POP).” Accessed January 11, 2024 Retrieved from: 
                        <E T="03">www.census.gov/data/tables/time-series/demo/popest/2020s-counties-total.html</E>
                    </FP>
                </EXTRACT>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>30 CFR Part 18</CFR>
                    <P>Incorporation by reference, Mine safety and health, Reporting and recordkeeping requirements.</P>
                    <CFR>30 CFR Part 74</CFR>
                    <P>Mine safety and health, Occupational safety and health. </P>
                </LSTSUB>
                <SIG>
                    <NAME>Christopher J. Williamson,</NAME>
                    <TITLE>Assistant Secretary of Labor for Mine Safety and Health.</TITLE>
                </SIG>
                <P>For the reasons set out in the preamble, and under the authority of the Federal Mine Safety and Health Act of 1977, as amended, the Mine Safety and Health Administration amends chapter I of title 30 of the Code of Federal Regulations as follows:</P>
                <PART>
                    <PRTPAGE P="99104"/>
                    <HD SOURCE="HED">PART 18—ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES</HD>
                </PART>
                <REGTEXT TITLE="30" PART="18">
                    <AMDPAR>1. The authority citation for part 18 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 30 U.S.C. 957, 961.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="30" PART="18">
                    <AMDPAR>2. Amend § 18.2 by:</AMDPAR>
                    <AMDPAR>a. Revising the definition for “Permissible equipment”; and</AMDPAR>
                    <AMDPAR>b. Adding in alphabetical order the definitions for “Voluntary consensus standard” and “Voluntary consensus standards body”.</AMDPAR>
                    <P>The revision and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 18.2</SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Permissible equipment</E>
                             means a completely assembled electrical machine or accessory for which an approval has been issued.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Voluntary consensus standard</E>
                             means a safety standard that:
                        </P>
                        <P>(1) Is developed or adopted by a voluntary consensus standards body; and</P>
                        <P>(2) Prescribes safety requirements applicable to equipment for which applicants are seeking approval, certification, extension, or acceptance under this part.</P>
                        <P>
                            <E T="03">Voluntary consensus standards body</E>
                             means a domestic or international organization that plans, develops, establishes, or coordinates voluntary consensus standards using agreed-upon procedures that are consistent with the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 3710) and the Office of Management and Budget's Circular A-119 (Jan. 27, 2016).
                        </P>
                    </SECTION>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 18.6</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="30" PART="18">
                    <AMDPAR>3. Amend § 18.6 by removing the third sentence in paragraph (e).</AMDPAR>
                </REGTEXT>
                <REGTEXT TITLE="30" PART="18">
                    <AMDPAR>4. Amend § 18.15 by revising paragraph (c) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 18.15</SECTNO>
                        <SUBJECT>Changes after approval or certification.</SUBJECT>
                        <STARS/>
                        <P>(c) An application for a formal extension of approval or certification must have a list of new or revised drawings, specifications, and information related to the changes to be added to those already on file for the original approval or certification. MSHA will issue a formal extension of approval or certification to a completely assembled electrical machine or accessory, if each component of such electrical machine or accessory:</P>
                        <P>(1) Meets the requirements in subparts B through E of this part; or</P>
                        <P>(2) Meets the requirements in approved voluntary consensus standards (see § 18.101).</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="30" PART="18">
                    <AMDPAR>5. Add subpart F, consisting of §§ 18.101 through 18.103, to read as follows:</AMDPAR>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart F—Voluntary Consensus Standards</HD>
                    </SUBPART>
                    <CONTENTS>
                        <SECHD>Sec.</SECHD>
                        <SECTNO>18.101</SECTNO>
                        <SUBJECT>Acceptance and use of voluntary consensus standards.</SUBJECT>
                        <SECTNO>18.102</SECTNO>
                        <SUBJECT>Approved voluntary consensus standards.</SUBJECT>
                        <SECTNO>18.103</SECTNO>
                        <SUBJECT>Review and update of applicable voluntary consensus standards.</SUBJECT>
                    </CONTENTS>
                    <SECTION>
                        <SECTNO>§ 18.101</SECTNO>
                        <SUBJECT>Acceptance and use of voluntary consensus standards.</SUBJECT>
                        <P>(a) Voluntary consensus standards that are suitable for gassy mining environments and that provide protection against fire or explosion, if used in their entirety and without modification, may be used in lieu of the requirements in subparts B through E of this part, if MSHA has incorporated those standards by reference.</P>
                        <P>(b) For applications submitted on or after January 9, 2025, an approval will be issued in accordance with subpart A of this part for a completely assembled electrical machine or accessory, if each component of such electrical machine or accessory:</P>
                        <P>(1) Meets the requirements in subparts B through E of this part; or</P>
                        <P>(2) Meets the Group I requirements in the following voluntary consensus standards (incorporated by reference, see § 18.102), as well as the associated Level of Protection, if specified, that apply to those components:</P>
                        <P>(i) ANSI/ISA 60079-11 (Level of Protection `ia');</P>
                        <P>(ii) ANSI/ISA 60079-25 (Level of Protection `ia');</P>
                        <P>(iii) ANSI/UL 60079-0;</P>
                        <P>(iv) ANSI/UL 60079-1 (Level of Protection `da');</P>
                        <P>(v) ANSI/UL 60079-11 (Level of Protection `ia');</P>
                        <P>(vi) ANSI/UL 60079-18 (Level of Protection `ma');</P>
                        <P>(vii) ANSI/UL 60079-25 (Level of Protection `ia'); and</P>
                        <P>(viii) ANSI/UL 60079-28 (Equipment Protection Level `Ma').</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 18.102</SECTNO>
                        <SUBJECT>Approved (incorporated by reference) voluntary consensus standards.</SUBJECT>
                        <P>
                            Certain material is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at U.S. Department of Labor, Mine Safety and Health Administration (MSHA) and at the National Archives and Records Administration (NARA). Contact MSHA at: 765 Technology Drive, Triadelphia, WV 26059, phone: (304) 547-0400; 
                            <E T="03">www.msha.gov/compliance-and-enforcement/equipment-approval-certification.</E>
                             For information on the availability of this material at NARA, visit 
                            <E T="03">www.archives.gov/federal-register/cfr/ibr-locations</E>
                             or email 
                            <E T="03">fr.inspection@nara.gov.</E>
                             The material is available as follows:
                        </P>
                        <P>
                            (a) International Society of Automation (ISA), 67 T.W. Alexander Drive, P.O. Box 12277, Research Triangle Park, NC 27709; phone: (919) 549-8411; website: 
                            <E T="03">www.isa.org.</E>
                        </P>
                        <P>(1) ANSI/ISA 60079-11 (12.02.01)-2014, American National Standard for Explosive Atmospheres—Part 11: Equipment protection by intrinsic safety “i”, Edition 6.2, Approved March 28, 2014; into § 18.101</P>
                        <P>(2) ANSI/ISA 60079-25 (12.02.05)-2011, American National Standard for Explosive Atmospheres—Part 25: Intrinsically safe electrical systems, Approved December 2, 2011; into § 18.101.</P>
                        <P>
                            (b) UL Solutions, Comm 2000, 151 Eastern Avenue, Bensenville, IL 60106; phone: (888) 853-3503; website: 
                            <E T="03">www.ul.com.</E>
                        </P>
                        <P>(1) UL 60079-0, Standard for Safety for Explosive Atmospheres—Part 0: Equipment—General Requirements, Seventh Edition, Dated March 26, 2019, including revisions through April 15, 2020 (ANSI/UL 60079-0); into § 18.101.</P>
                        <P>(2) UL 60079-1, Standard for Safety for Explosive Atmospheres—Part 1: Equipment Protection by Flameproof Enclosures “d”, Seventh Edition, Dated September 18, 2015, including revisions through January 23, 2020 (ANSI/UL 60079-1); into § 18.101.</P>
                        <P>(3) UL 60079-11, Standard for Safety for Explosive Atmospheres—Part 11: Equipment Protection by Intrinsic Safety “i”, Sixth Edition, Dated February 15, 2013, including revisions through September 14, 2018 (ANSI/UL 60079-11); into § 18.101.</P>
                        <P>(4) UL 60079-18, Standard for Safety for Explosive Atmospheres—Part 18: Equipment Protection by Encapsulation “m”, Fourth Edition, Dated December 14, 2015, including revisions through February 7, 2019 (ANSI/UL 60079-18); into § 18.101.</P>
                        <P>
                            (5) UL 60079-25, Standard for Safety for Explosive Atmospheres—Part 25: Intrinsically Safe Electrical Systems, Second Edition, Dated December 2, 2011, including revisions through June 12, 2020 (ANSI/UL 60079-25); into § 18.101.
                            <PRTPAGE P="99105"/>
                        </P>
                        <P>(6) UL 60079-28, Standard for Safety for Explosive Atmospheres—Part 28: Protection of Equipment and Transmission Systems Using Optical Radiation, Second Edition, Dated September 15, 2017, including revisions through December 7, 2021 (ANSI/UL 60079-28); into § 18.101.</P>
                        <NOTE>
                            <HD SOURCE="HED">Note 1 to § 18.102:</HD>
                            <P>
                                 The voluntary consensus standards listed in this section may also be obtained from the American National Standards Institute (ANSI), 1899 L Street NW, 11th Floor, Washington, DC 20036, phone: (202) 293-8020; website: 
                                <E T="03">www.ansi.org.</E>
                            </P>
                        </NOTE>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 18.103</SECTNO>
                        <SUBJECT>Review and update of applicable voluntary consensus standards.</SUBJECT>
                        <P>(a) MSHA will review more recent editions of voluntary consensus standards listed in §  18.102 to determine whether they can be used in their entirety and without modification, in lieu of the requirements in subparts B through E of this part.</P>
                        <P>(b) MSHA may review voluntary consensus standards not approved for incorporation by reference (IBR) in §  18.102 to determine whether such standards are suitable for gassy mining environments and whether they provide protection against fire or explosion, if substituted in their entirety and without modification, in lieu of the requirements in subparts B through E of this part.</P>
                        <P>(c) Following such review and determination, MSHA will use the appropriate rulemaking process to amend the list of voluntary consensus standards approved for IBR in lieu of the requirements in subparts B through E of this part.</P>
                    </SECTION>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 740—COAL MINE DUST SAMPLING DEVICES</HD>
                </PART>
                <REGTEXT TITLE="30" PART="74">
                    <AMDPAR>6. The authority citation for part 74 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>30 U.S.C. 957.</P>
                    </AUTH>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ § 74.5 and 74.11</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="30" PART="74">
                    <AMDPAR>7. In §§ 74.5(b) and 74.11(d), remove “30 CFR 18.68” and add in its place the term “30 CFR part 18.”</AMDPAR>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28315 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Parts 52, 75, 78, and 97</CFR>
                <DEPDOC>[EPA-HQ-OAR-2021-0668; FRL-8670.5-02-OAR]</DEPDOC>
                <RIN>RIN 2060-AW47</RIN>
                <SUBJECT>Federal “Good Neighbor Plan” for the 2015 Ozone National Ambient Air Quality Standards; Notice on Remand of the Record of the Good Neighbor Plan To Respond to Certain Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; supplemental response to comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is addressing certain comments that were submitted on the proposed Good Neighbor Plan that the Supreme Court of the United States concluded the EPA had likely not sufficiently addressed in the final Good Neighbor Plan. The EPA is providing a fuller explanation of its reasoning at the time of its action in response to these comments. The Good Neighbor Plan addressed 23 states' obligations to eliminate significant contribution to nonattainment or interference with maintenance of the 2015 ozone national ambient air quality standards (NAAQS), pursuant to the “good neighbor” provision of the Clean Air Act (CAA or Act). On September 12, 2024, the D.C. Circuit Court of Appeals remanded the record of the Good Neighbor Plan to the EPA to permit the Agency to further respond to comments related to the Good Neighbor Plan's operation if one or more upwind States were no longer participating. In this document, the EPA responds to the comments by more fully explaining why the Good Neighbor Plan appropriately defines each state's obligations, regardless of the status of the rule in other states, and can be implemented without modification in any individual state or combination of states covered by the rule.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>December 10, 2024.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this document under Docket ID No. EPA-HQ-OAR-2021-0668. All documents in the docket are listed on the 
                        <E T="03">https://www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">e.g.,</E>
                         Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Gwyndolyn Sofka, OAQPS-AQPD (C541-04), Environmental Protection Agency, 109 TW Alexander Dr, Research Triangle Park, NC 27711; telephone number: (919)-541-5121; email address: 
                        <E T="03">sofka.gwyndolyn@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>Throughout this document “we,” “us,” and “our” refer to the EPA.</P>
                <HD SOURCE="HD1">I. General Information</HD>
                <P>
                    The EPA is responding to a set of comments that together raise a question regarding the method by which the Agency developed the Good Neighbor Plan (88 FR 36654; June 5, 2023). Namely: would the conclusions the EPA reached regarding states' obligations under CAA section 110(a)(2)(D)(i)(I) for the 2015 ozone NAAQS have been different, had the rule been promulgated for, or if it covered, a smaller or different group of states than the 23 states that were included in that the rule? In short, for reasons that are provided in the record of the Good Neighbor Plan itself and elaborated upon in this document, the answer to that question is no. The EPA applied its 4-step interstate transport analytical framework in the Good Neighbor Plan to determine each included state's obligations. That framework, which accounts for the multistate “collective contribution” nature of ozone problems throughout the United States, nonetheless defines the amount of emissions from each state that constitutes “significant contribution to nonattainment or interference with maintenance” of the NAAQS in other states and implements programs to prohibit those emissions through federal implementation plans (FIPs) promulgated for each state accordingly. As the Good Neighbor Plan itself indicated, the EPA's methodology is designed to be applicable in any state that may become subject to a federal plan to address its “significant contribution” to other states' ozone problems for the 2015 ozone NAAQS; it provides an equitable and efficient solution to a “thorny causation problem,” 
                    <E T="03">EME Homer City,</E>
                     572 U.S. 489, 514 (2014), by holding any linked state's largest industrial NO
                    <E T="52">X</E>
                    -emitting sources to widely achievable emissions levels, and ensures fairness among states by not being dependent on the order in which they are addressed.
                </P>
                <P>
                    By issuing this document, the Agency is addressing a particular issue that the 
                    <PRTPAGE P="99106"/>
                    U.S. Supreme Court preliminarily found had been raised by commenters with reasonable specificity, but which the Court considered the Agency had likely failed to adequately address when it originally promulgated the rule. 
                    <E T="03">See Ohio</E>
                     v. 
                    <E T="03">EPA,</E>
                     144 S. Ct. 2040 (2024) (granting applications to stay enforcement of the Good Neighbor Plan pending judicial review). This document summarizes the relevant comments identified by the Supreme Court and, after summarizing our initial responses to these comments in section II.B., provides a fuller response in section III. of this document concerning how these comments relate or could be read as relating to the question of the Good Neighbor Plan's application and severability on a state-by-state basis, consolidating material and discussions from the existing administrative record at the time the EPA issued the action. To provide the most complete possible response to the issues identified by the Supreme Court, the Agency has considered these comments from all angles, even considering arguments that are not evident on the face of the comments themselves. For this reason, we do not concede that each of the topics discussed in this document was in fact raised with “reasonable specificity” by the commenters themselves, as required by CAA section 307(d)(7)(B), but the Agency views it to be appropriate in light of the Court's preliminary findings in 
                    <E T="03">Ohio</E>
                     to address all of the issues commenters potentially could be seen to have raised, to ensure a thorough and complete response to the commenters' concerns.
                </P>
                <P>
                    In responding to these comments, the Agency is relying solely on the information and data available in the record at the time the Good Neighbor Plan was signed by the EPA Administrator and promulgated on March 15, 2023 (88 FR 36654; June 5, 2023). 
                    <E T="03">See</E>
                     CAA section 307(d)(6)(C) (limiting the basis for CAA rules issued under section 307(d) to “information [and] data . . . placed in the docket as of the date of [ ] promulgation”). The purpose of this document is not to supplement the record of the Good Neighbor Plan with new findings, information, data, or new record support, but rather only to consolidate the existing material in the record to more fully respond to the relevant comments received during the public comment period following proposal of the Good Neighbor Plan. In this document, we provide an “amplified articulation” of the methodology underlying the design of the Good Neighbor Plan to more fully explain why, at the time the EPA issued the Good Neighbor Plan, it understood the Good Neighbor Plan's requirements to reasonably function on a state-by-state basis and therefore to be severable by state. 
                    <E T="03">See Dep't of Homeland Sec.</E>
                     v. 
                    <E T="03">Regents of the Univ. of Cal.,</E>
                     591 U.S. 1, 20-21 (2020) (quoting 
                    <E T="03">Alpharma, Inc.</E>
                     v. 
                    <E T="03">Leavitt,</E>
                     460 F. 3d 1, 5-6 (D.C. Cir. 2006)).
                </P>
                <P>Thus, in this document, we compile and present together discussions and components of the analysis that are already in the record and explain how they relate to one another and together demonstrate that the Good Neighbor Plan fulfills the statutory mandate for each state regardless of the number of states included in the rule at any given time.</P>
                <P>
                    As described in more detail in section II.A. of this document, following the Supreme Court's opinion in 
                    <E T="03">Ohio,</E>
                     the EPA sought a voluntary partial remand of the Good Neighbor Plan from the D.C. Circuit to provide the explanation that the Supreme Court concluded was likely lacking in the Good Neighbor Plan. The D.C. Circuit ordered “that the record be remanded to permit the Environmental Protection Agency to further respond to comments in the record.” 
                    <E T="03">State of Utah et al.</E>
                     v. 
                    <E T="03">EPA,</E>
                     No. 23-1157 (D.C. Cir. September 12, 2024).
                </P>
                <P>
                    The statutory authority for the Good Neighbor Plan is provided by the CAA as amended (42 U.S.C. 7401 
                    <E T="03">et seq.</E>
                    ). The most relevant portions of CAA section 110 are subsections 110(a)(1), 110(a)(2) (including 110(a)(2)(D)(i)(I)), and 110(c)(1). For further information, 
                    <E T="03">see</E>
                     section II.C. of the preamble for the Good Neighbor Plan, 88 FR 36667-68.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <HD SOURCE="HD2">A. Procedural History</HD>
                <P>
                    On March 15, 2023, in accordance with CAA sections 110(a)(2)(D)(i)(I) and 110(c)(1), the EPA promulgated the Good Neighbor Plan, a rule determining the good neighbor obligations of 23 states with respect to the 2015 ozone NAAQS and establishing for these states federal implementation plans (FIPs) for emissions sources in these states to address each state's obligations by reducing emissions of nitrogen oxides (NO
                    <E T="52">X</E>
                    ), an ozone precursor.
                    <SU>1</SU>
                    <FTREF/>
                     Prior to promulgating the Good Neighbor Plan, the EPA had disapproved state implementation plans for 21 of those states and had found that several states had failed to submit complete plans—predicates to EPA's authority to promulgate FIPs for those states.
                    <SU>2</SU>
                    <FTREF/>
                     Following the Good Neighbor Plan's promulgation, in response to judicial orders partially staying the SIP Disapproval as to several states, the EPA issued two sets of interim amendments (referred to here as the First and Second Interim Final Rules) staying the Good Neighbor Plan's effectiveness for emissions sources in those states pending the resolution of judicial review of that action and further EPA rulemaking.
                    <SU>3</SU>
                    <FTREF/>
                     As modified by the First and Second Interim Final Rules, the Good Neighbor Plan's FIPs applied to electric generating units (EGUs) within the borders of Illinois, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Virginia, and Wisconsin and to non-EGU sources within the borders of nine of the same ten states (all except Wisconsin) as well as California.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Federal “Good Neighbor Plan” for the 2015 Ozone National Ambient Air Quality Standards, 88 FR 36654 (June 5, 2023).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Air Plan Disapprovals; Interstate Transport of Air Pollution for the 2015 8-Hour Ozone National Ambient Air Quality Standards, 88 FR 9336 (February 13, 2023) (“SIP Disapproval”); Findings of Failure to Submit a Clean Air Act Section 110 State Implementation Plan for Interstate Transport for the 2015 Ozone National Ambient Air Quality Standards (NAAQS), 84 FR 66612 (December 5, 2019) (including Pennsylvania, Utah, and Virginia).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Federal “Good Neighbor Plan” for the 2015 Ozone National Ambient Air Quality Standards; Response to Judicial Stays of SIP Disapproval Action for Certain States, 88 FR 49295 (July 31, 2023); Federal “Good Neighbor Plan” for the 2015 Ozone National Ambient Air Quality Standards; Response to Additional Judicial Stays of SIP Disapproval Action for Certain States, 88 FR 67102 (September 29, 2023).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         The Good Neighbor Plan's emissions reduction requirements apply to all emissions sources meeting the Good Neighbor Plan's applicability criteria within the borders of each covered state, including sources in Indian country within the borders of the state. 
                        <E T="03">See</E>
                         88 FR 36690.
                    </P>
                </FTNT>
                <P>
                    In October 2023, after the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) denied motions to stay the Good Neighbor Plan pending judicial review,
                    <SU>5</SU>
                    <FTREF/>
                     four sets of parties submitted emergency applications to the United States Supreme Court seeking a stay of some or all of the Good Neighbor Plan's requirements.
                    <SU>6</SU>
                    <FTREF/>
                     In an opinion issued on 
                    <PRTPAGE P="99107"/>
                    June 27, 2024 (referred to here as the Stay Order), the Supreme Court granted the emergency applications and ordered that “[e]nforcement of EPA's rule against the applicants shall be stayed” while judicial review of the Good Neighbor Plan on the merits proceeds, first in the D.C. Circuit and then potentially in the Supreme Court.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Orders, 
                        <E T="03">Utah</E>
                         v. 
                        <E T="03">EPA,</E>
                         No. 23-1157 (D.C. Cir. September 25, 2023, and October 11, 2023); 
                        <E T="03">see also</E>
                         Order, 
                        <E T="03">Utah</E>
                         v. 
                        <E T="03">EPA,</E>
                         No. 23-1157 (D.C. Cir. December 4, 2023) (denying additional stay motions).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">Ohio</E>
                         v. 
                        <E T="03">EPA,</E>
                         No. 23A349 (U.S. docketed October 18, 2023) (other named applicants are Indiana and West Virginia); 
                        <E T="03">Kinder Morgan, Inc.</E>
                         v. 
                        <E T="03">EPA,</E>
                         No. 23A350 (U.S. docketed October 18, 2023) (other named applicants are Enbridge (U.S.) Inc., TransCanada PipeLine USA Ltd., Interstate Natural Gas Association of America, and American Petroleum Institute); 
                        <E T="03">American Forest &amp; Paper Association</E>
                         v. 
                        <E T="03">EPA,</E>
                         No. 23A351 (U.S. docketed October 18, 2023) (other named applicants are America's Power, Associated Electric Cooperative, Inc., Deseret Power Electric Cooperative, Midwest Ozone Group, National Mining Association, National Rural Electric Cooperative Association, 
                        <PRTPAGE/>
                        Ohio Valley Electric Corporation, Portland Cement Association, and Wabash Valley Power Alliance); 
                        <E T="03">United States Steel Corporation</E>
                         v. 
                        <E T="03">EPA,</E>
                         No. 23A384 (U.S. docketed October 31, 2023).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">Ohio</E>
                         v. 
                        <E T="03">EPA,</E>
                         144 S. Ct. 2040, 2058 (2024).
                    </P>
                </FTNT>
                <P>
                    The Court found that, with respect to the “explanation why the number and identity of participating States does not affect what measures maximize cost-effective downwind air-quality improvements,” the stay applicants “are likely to prevail on their argument that EPA's final rule was not `reasonably explained,' that the agency failed to supply `a satisfactory explanation for its action[,]' and that it instead ignored `an important aspect of the problem' before it”. 
                    <E T="03">Ohio</E>
                     v. 
                    <E T="03">EPA,</E>
                     144 S. Ct. 2040, 2054 (2024) (citations omitted). The Court focused in particular on the fact that the Good Neighbor Plan's FIPs had been stayed in several states pending judicial review of the EPA's disapproval of those states' state implementation plan (SIP) submissions. 144 S. Ct. at 2051-52. Stay applicants had argued that the “EPA's plan rested on an assumption that all 23 upwind States would adopt emissions-reduction tools up to a `uniform' level of `costs' to the point of diminishing returns” and the EPA had not explained how the rule was substantiated for a smaller number of states. 
                    <E T="03">Id.</E>
                     at 2053 (citations omitted). The Court preliminarily interpreted several comments filed on the proposed Good Neighbor Plan as raising this concern, 
                    <E T="03">i.e.,</E>
                     that if a different number or grouping of states were subject to the EPA's FIPs promulgated in the Good Neighbor Plan rulemaking, then the EPA's cost-effectiveness analysis would have changed, and therefore the obligations would or could be different for the remaining states. 
                    <E T="03">Id.</E>
                     at 2050-51. The Court did not conclude that the EPA's methodology was unlawful, or that petitioners were correct in their assessment that the Good Neighbor Plan's obligations could change depending on the number or group of states subject to it. Rather, the Court preliminarily found that the EPA had failed to adequately respond to the relevant comments and thus the rule was likely not “reasonably explained.” 
                    <E T="03">Id.</E>
                     at 2054. The Court noted that the rule's “severability” discussion did not adequately address the issue, since that discussion, in itself, contained no supporting analysis. 
                    <E T="03">Id.</E>
                     at 2054-55.
                </P>
                <P>
                    On March 27, 2024, several months before the Supreme Court issued this ruling, the EPA partially denied several petitions for reconsideration of the Good Neighbor Plan objecting to the rule on the basis that it had been stayed in certain states and was no longer lawful or workable in the remaining states, as well as objecting that the rule should not have been published at all following judicial stays of the SIP Disapproval as to certain states. The EPA's “basis for denial” addressed both issues and determined that these objections were not “centrally relevant” because, after examining the objections in detail, the EPA concluded they failed to establish that the rule should be revised. 
                    <E T="03">See</E>
                     89 FR 23526 (April 4, 2024) (providing notice of issuance of the partial denial).
                    <SU>8</SU>
                    <FTREF/>
                     The Supreme Court declined to consider the EPA's Denial in evaluating the applications for stay. 
                    <E T="03">See</E>
                     144 S. Ct. at 2068 n.11.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See also</E>
                         “Letter Enclosure: The EPA's Basis for Partially Denying Petitions for Reconsideration of the Good Neighbor Plan on Ground Related to Judicial Stays of the SIP Disapproval Act as to 12 States,” 
                        <E T="03">available at https://www.epa.gov/Cross-State-Air-Pollution/response-four-petitions-reconsideration</E>
                         and at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OAR-2021-0668-1255.</E>
                    </P>
                </FTNT>
                <P>
                    Following the Supreme Court's decision granting the applications to stay enforcement of the Good Neighbor Plan, the EPA implemented the Court's stay of the effectiveness of the Good Neighbor Plan's requirements for the sources that would have been subject to the rule pursuant to the 23 states' FIPs originally promulgated, pending judicial review. 
                    <E T="03">See</E>
                     89 FR 87960 (November 6, 2024). In addition, the EPA sought a voluntary partial remand of the Good Neighbor Plan. The D.C. Circuit granted a remand of the record of the rule so that the EPA might respond to the comments related to the rule's appropriateness for each state and operation. 
                    <E T="03">State of Utah et al.</E>
                     v. 
                    <E T="03">EPA,</E>
                     No. 23-1157 (D.C. Cir. September 12, 2024). The D.C. Circuit retains jurisdiction of the case, has placed the case in abeyance pending further order of the court, and has directed the parties to file motions to govern future proceedings in the case within 30 days after completion of this remand or December 30, 2024, whichever is earlier. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    The following section, II.B. of this document, summarizes the comments identified by the Supreme Court as relevant to the issue of the Good Neighbor Plan's operation if one or more upwind States were no longer participating and provides a summary of the EPA's responses to these comments in the Good Neighbor Plan with citations to the record.
                    <SU>9</SU>
                    <FTREF/>
                     The EPA does not intend to reopen its prior response to those comments through this document by summarizing those prior responses. Section III. of this document provides a fuller explanation in response to a specific issue identified by the Supreme Court derived from these comments: whether the Good Neighbor Plan would lawfully define and implement good neighbor obligations for any particular state if it were not in effect for some other state or states. As the EPA originally concluded based on the information in the record at the time of promulgation, the Good Neighbor Plan appropriately defines each state's obligations on an individual basis and is severable on a state-by-state basis. 
                    <E T="03">See</E>
                     88 FR 36693.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         We have focused specifically on the comments that the Supreme Court identified in 
                        <E T="03">Ohio</E>
                         v. 
                        <E T="03">EPA.</E>
                         While other commenters raised issues similar to these comments, these comments present a representative set of perspectives on those issues that the Supreme Court viewed as most closely related to the question of the Good Neighbor Plan's severability by state.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Summary of Comments Identified by the Supreme Court and Citation to Prior Responses to Comments</HD>
                <P>
                    <E T="03">Comment category 1 (SIP/FIP sequencing):</E>
                     Multiple commenters (the Missouri Department of Natural Resources (MO DNR), the Louisiana Department of Environmental Quality (LA DEQ), and the Texas Commission on Environmental Quality (TX CEQ)) expressed concern that the EPA had proposed FIPs prior to finalization of the SIP disapprovals for states included in the FIP rulemaking, without knowing which states would ultimately be covered by a FIP. Commenters state that this kept the EPA from being able to receive and consider the technical, procedural, and legal issues that they identified in their comments. Commenters state that the proposed FIPs presume the result of the proposed disapproval of SIPs even though the comment period for the SIP Disapproval action was ongoing at the time of the proposed FIPs.
                </P>
                <P>
                    Commenters (LA DEQ and TX CEQ) requested that the EPA withdraw both the proposed FIPs for their states and the proposed SIP disapproval so that both states could have a further opportunity to show that their respective SIPs address their supposed significant contribution to nonattainment or interference with maintenance in downwind states. One commenter (MO DNR) requested that the EPA withdraw the proposed FIP for 
                    <PRTPAGE P="99108"/>
                    Missouri and other states so that the EPA can consider and respond to all comments received on the SIP Disapproval action. The commenter goes on to request that the EPA respond to all comments on the proposed disapproval of the Missouri SIP in the final action for the Good Neighbor Plan if it does not withdraw the proposed FIP, as the SIP Disapproval action and the proposed FIP are “inextricably linked.” 
                    <SU>10</SU>
                    <FTREF/>
                     Relevant portions of the comment are included immediately below.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         the Missouri Department of Natural Resources June 17, 2022, comment letter Docket Id No. EPA-HQ-OAR-2021-0668-0289, at 4.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Missouri Department of Natural Resources</HD>
                <EXTRACT>
                    <P>
                        EPA is now proposing good neighbor FIPs, which are the subject of this comment letter, before even finalizing the SIP disapprovals for Missouri and numerous other states. The Air Program and several other entities submitted adverse comments on EPA's proposed SIP disapproval for Missouri's 2019 Good Neighbor SIP. Those comments were all submitted after the publication of EPA's proposed good neighbor FIP in the 
                        <E T="04">Federal Register</E>
                        . Therefore, EPA did not even give itself a chance to receive, and much less, consider all the technical, legal, and procedural issues for the proposed disapproval that were identified in those comments before it moved forward with the proposed FIP. It follows then, that EPA's proposed FIP is extremely premature, and EPA should withdraw the proposal and be obligated to consider and respond to all of the comments it received on the proposed disapprovals before it can propose FIPs for these states.
                        <SU>11</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             
                            <E T="03">See id.</E>
                             at 3.
                        </P>
                    </FTNT>
                </EXTRACT>
                <HD SOURCE="HD3">Louisiana Department of Environmental Quality</HD>
                <EXTRACT>
                    <P>The EPA's proposed FIP presumed the result of its proposed disapproval of Louisiana's SIP submission, even though public notice and comment were ongoing. EPA must consider comments received on its proposed actions. The EPA cannot consider LDEQ's comment on the proposed disapproval of the SIP in good faith, when it has already proposed a FIP prior to the close of the comment period . . .</P>
                    <P>
                        Louisiana requests that this proposed FIP be withdrawn, allowing the state to either prove its original SIP submittal through modeling or to provide specific enforceable measures to adequately prohibit the contribution of pollution to downwind states.
                        <SU>12</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             
                            <E T="03">See</E>
                             the Louisiana Department of Environmental Quality June 21, 2022, comment letter Docket Id No. EPA-HQ-OAR-2021-0668-0365, at 2.
                        </P>
                    </FTNT>
                </EXTRACT>
                <HD SOURCE="HD3">Texas Commission on Environmental Quality</HD>
                <EXTRACT>
                    <P>
                        Based on the numerous technical and legal errors discussed in our comments, the TCEQ respectfully requests that the EPA withdraw its proposed FIP, either in whole, or in part as it pertains to Texas. In the alternative, the TCEQ respectfully requests that the EPA address and remedy the numerous technical and legal errors identified by the TCEQ . . .
                        <SU>13</SU>
                        <FTREF/>
                         The inclusion of Texas in the proposed FIP is dependent on the EPA finalizing its proposed disapproval of the transport SIP that Texas timely submitted for the 2015 ozone NAAQS.
                        <SU>14</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             
                            <E T="03">See</E>
                             the Texas Commission on Environmental Quality June 21, 2022, comment letter Docket Id No. EPA-HQ-OAR-2021-0668-0505, at 1.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             
                            <E T="03">Id.</E>
                             at 2.
                        </P>
                    </FTNT>
                </EXTRACT>
                <P>
                    <E T="03">Citations to previous responses:</E>
                     The EPA explained that FIPs can be proposed before final action is taken on SIP disapprovals, because the statute provides that the EPA is required to promulgate a FIP “at any time within 2 years” of a SIP disapproval or a finding of failure to submit. This statutory sequence necessarily permits the 
                    <E T="03">proposal</E>
                     of a FIP before the finalization of a SIP disapproval. 
                    <E T="03">See</E>
                     88 FR 36689 (citing CAA section 110(c)(1); 
                    <E T="03">EME Homer City,</E>
                     572 U.S. 489, 509). The EPA was clear in both the proposed and final rulemaking documents that it was issuing FIPs on a state-by-state basis, with adjustments in the scope of states covered by the Good Neighbor Plan's uniform regulatory programs occurring from proposal to final based on changes in the underlying analytics, similar to changes in state coverage that had occurred under prior good neighbor rulemakings.
                    <SU>15</SU>
                    <FTREF/>
                     The EPA explained that it had predicate FIP authority for each of the 23 covered states at the time of signature and promulgation of the Good Neighbor Plan. 
                    <E T="03">See</E>
                     88 FR 36688-89 and the Good Neighbor Plan Response to Comments (RTC) Document at 6-8.
                    <SU>16</SU>
                    <FTREF/>
                     The EPA explained the timing of its action to promulgate FIPs in relation to the need to address good neighbor obligations as expeditiously as practicable, and to the extent possible by the 2023 ozone season, 88 FR 36690, and explained why we would not delay our action to afford states additional opportunities to develop new submissions or instead issue a call for SIP revisions, though we noted that states remain free to develop and submit SIP revisions at any time. 
                    <E T="03">See</E>
                     Good Neighbor Plan RTC at 12-15. The EPA further explained its reasoning concerning the sequencing of its actions and that this sequencing did not prejudice the Agency's evaluation of states' SIP submissions in the separate SIP Disapproval action. 
                    <E T="03">See</E>
                     Good Neighbor Plan RTC at 149-51. The EPA noted that it was not finalizing its proposed FIPs for several states, and the EPA acknowledged that several states remained to be addressed for which it either lacked predicate authority to issue a FIP or because further rulemaking proceedings were appropriate. 88 FR 36658. The EPA explained that specific technical or legal objections to the SIP Disapproval were addressed in that action and were out of scope of the Good Neighbor Plan. 
                    <E T="03">Id.</E>
                     at 144-45, 155.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See, e.g.,</E>
                         87 FR 20036, 20038, 20039, 20040 n.8, 20041, 20044, 20045, 20051 n.39, 20051-2-52, 20058, 20067 n.115, 20073, and 20140 (April 6, 2022); 88 FR 36654, 36656, 36657, 36658, 36659 n.9, 36659, 36662, 36664, 36668 n.41 &amp; 44, 36668/3, 36669, 36673/2, 36688 n.99, and 36689 (June 5, 2023).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         Available in the docket at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OAR-2021-0668-1127.</E>
                    </P>
                </FTNT>
                <P>
                    <E T="03">Comment category 2 (potential for new modeling at Steps 1 and 2):</E>
                     Comments from the Air Stewardship Coalition (ASC) and the Portland Cement Association (PCA) asserted that if the EPA took different action on SIPs than contemplated in the FIP rulemaking proposal, the EPA would be required to conduct a new assessment and modeling of contribution and subject those findings to public comment. In a section titled “EPA Step Two Screening is Premised on the Premature Disapproval of 19 Upwind States Good Neighbor SIPs” (sections III.C. and II.C. of their respective comments) the ASC and the PCA stated that the EPA's screening at Step 2 of the 4-step interstate transport framework for the Proposed Good Neighbor Plan included states that already had good neighbor SIPs for the 2015 ozone NAAQS. Commenters state the EPA should not have included these states in this proposed rule's screening as the final disapproval of said SIPs was not issued prior to the proposed FIP. The commenters claim that the EPA rushed to take final action on its good neighbor SIPs when the EPA proposed to disapprove 19 good neighbor SIP submissions and four findings of failure to issue a complete SIP on February 22, 2022. Commenters state that in doing so the EPA prejudged the outcome of the pending SIP actions in their separate FIP action and did not account for the possibility that the EPA may take a different course of action at final than what was proposed in the SIP Disapproval action.
                </P>
                <P>
                    Commenters indicate that as a consequence of this prejudgment the EPA may need to conduct a new assessment and modeling of contribution at Step 2 of the 4-step interstate transport framework if the EPA chooses to take a different action on any of the SIPs they have proposed to disapprove or found as having failed to issue a complete SIP. As such, 
                    <PRTPAGE P="99109"/>
                    commenters urged the EPA to stay action on the proposals and coordinate with states to ensure the appropriate sequence of actions is taken. The relevant text of the ASC's comment is included immediately below.
                    <SU>17</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Portland Cement Association's June 21, 2022, comment letter Docket Id No. EPA-HQ-OAR-2021-0668-0516, at 7, for section II.C. of the PCA comment as referenced.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        Yet, it appears EPA is rushing to take final action as EPA on February 22, 2022, proposed to disapprove 19 Good Neighbor SIP submissions. EPA also issued proposed findings of failure to issue a complete SIP for NM, PA, UT, and VA. The proposed FIP essentially prejudges the outcome of those pending SIP actions and, in the event EPA takes a different action on those SIPs than contemplated in this proposal, it would be required to conduct a new assessment and modeling of contribution and subject those findings to public comment.
                        <SU>18</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             
                            <E T="03">See</E>
                             Air Stewardship Coalition's June 21, 2022, comment letter Docket Id No. EPA-HQ-OAR- 2021-0668-0518, at 13-14.
                        </P>
                    </FTNT>
                </EXTRACT>
                <P>
                    <E T="03">Citations to previous responses:</E>
                     The EPA explained that, partially in response to comments concerning technical issues with the modeling used at proposal for Steps 1 and 2, it conducted a new round of modeling and air quality analysis at Steps 1 and 2 in taking final action on the SIP Disapproval and the Good Neighbor Plan. 88 FR 36673-74; 88 FR 9339. The EPA explained that it also reviewed recent ozone monitoring data indicating persistent elevated ozone levels at many locations throughout the country. 
                    <E T="03">Id.</E>
                     at 36704-05. The EPA explained that for most states its updated air quality analysis for the final rule was confirmatory of its proposed findings concerning which states contribute to downwind receptors at Step 2, and even its older 2011-based modeling. 
                    <E T="03">Id.</E>
                     at 36674, 36707. The EPA explained that where its updated analysis at Steps 1 and 2 indicated that a state was not contributing or that the basis for finding contribution had changed, it was not finalizing a FIP for that state in the Good Neighbor Plan; the EPA indicated its intent to address these and other states in subsequent actions. 
                    <E T="03">Id.</E>
                     at 36656, 36658, 36689; 
                    <E T="03">see also</E>
                     SIP Disapproval, 88 FR 9354.
                    <SU>19</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         The EPA has conducted or is in the process of conducting additional notice-and-comment rulemaking to address the obligations of those states. 
                        <E T="03">See</E>
                         88 FR 87720 (December 19, 2023) (Wyoming); 89 FR 12666 (February 16, 2024) Supplemental Air Plan Actions: Interstate Transport of Air Pollution for the 2015 8-Hour Ozone National Ambient Air Quality Standards and Supplemental Federal “Good Neighbor Plan” Requirements for the 2015 8- Hour Ozone National Ambient Air Quality Standards (“Supplemental Rulemaking”) (proposing action for Arizona, Iowa, Kansas, New Mexico, and Tennessee).
                    </P>
                </FTNT>
                <P>
                    <E T="03">Comment category 3 (cost-effectiveness at Step 3):</E>
                     Comments from ASC, PCA, the Indiana Municipal Power Agency (IMPA), the Lower Colorado River Authority (LCRA), and the Wisconsin Paper Council (WPC) question the methodology by which the EPA identified a cost-threshold used to establish the cost-effectiveness of the proposed controls.
                </P>
                <P>
                    Commenters (ASC and PCA) both ask the EPA to reconsider the $7,500/ton average marginal cost-effectiveness threshold used for non-EGUs stating that it is too high and a departure from past practices. Both commenters state the EPA has failed to explain why the EPA relied on a “knee in the curve” approach instead of the past “clear breakpoint” approach to determine the $7,500/ton number. Commenters state that there is no noticeable break at that point for Tier 1 industries but there is a break at $1,600/ton mark; however, commenters concede there is a difference at $7,500/ton in Tier 2 industries and the combined Tier 1 and 2 industries line. In addition, commenters question why the EPA departed from the cost-effectiveness threshold used in the 2021 Revised CSAPR Update Rule ($2,000/ton in $2016) as it appears to commenters that the EPA had not collected any new information on costs or technologies or used different implementation timelines since the Revised CSAPR Update Rule. The relevant text of the Air Stewardship Coalition's comment is included immediately below.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         The Portland Cement Association's comment on this topic is nearly identical and can be found at Docket Id No. EPA-HQ-OAR-2021-0668-0516, at 22.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>The Agency's sole analysis is that there was a “knee in the curve” that identified $7,500 per ton, but that is not obvious to a reviewer. There is no noticeable difference around $7,500 in the plotted line for Tier 1 industries, instead the Tier 1 line reflects a break around the $1,600 mark. While the Tier 2 and combined Tier 1 and 2 lines show some difference around $7,500 mark, there is no explanation for EPA's reliance on a “knee in the curve” as opposed to past transport rules that have relied upon a “clear break point” at this step. Further, EPA has provided no explanation for why the Tier 1 and 2 industries were subject to different contribution thresholds, as described above, yet they were combined when developing the cost-effective control threshold.</P>
                    <P>
                        In addition, EPA fails to explain why the threshold departs from prior transport rule cost-effectiveness thresholds for non-EGUs. In particular, less than one year before EPA released the Proposed Rule, in the 2021 Revised CSAPR Update Rule, EPA said the non-EGU data demonstrated “a clear break point” (versus a “knee in the curve”) at approximately $2,000 (in $2016) per ton. According to EPA, EPA adopted “that analysis using the best available current data,” including the “identified available control technologies,” their “costs and potential emissions reductions,” and “the information it has regarding control technology implementation timeframes, including information on such timeframes provided by commenters on the proposed rule.” Further, to identify levels of control for non-EGUs, EPA used the Control Strategy Tool (CoST) and the projected 2023 inventory from the 2016v1 modeling platform, just as EPA has done in this Proposed Rule. Indeed, there is no indication in the Proposed Rule that EPA collected any new information on costs or technologies or implementation timelines that differed in any material way from the information it analyzed in the Revised CSAPR Update Rule.
                        <SU>21</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             
                            <E T="03">See</E>
                             Air Stewardship Coalition's June 21, 2022, comment letter Docket Id No. EPA-HQ-OAR-2021-0668-0518, at 27.
                        </P>
                    </FTNT>
                </EXTRACT>
                <P>Other commenters (IMPA, LCRA, and the WPC) state that cost-effectiveness varies based on operational characteristics of the unit in question, that installing controls on existing EGUs may not be cost-effective, and that emissions from certain industries (specifically pulp and paper mills) would have a negligible effect on air quality.</P>
                <P>One commenter (IMPA) objected that requiring a specific type of emissions control will result in a lack of flexibility. They state that the cost-effectiveness of employing selective non-catalytic reduction (SNCR) will be highly variable, and that units employed at peak timeframes will not see similar emissions reductions to those that are used as base load generation. The commenter then states that technology specific dictates are not the best means of emissions control but would prefer controls that maintain flexibility.</P>
                <P>
                    To support their claim that the EPA's EGU controls are unlawful because they are not cost-effective, another commenter (LCRA) states that the installation of controls on existing sources (as compared to new sources) is not “per se reasonable or cost-effective.” 
                    <SU>22</SU>
                    <FTREF/>
                     The commenter goes on to state that EGUs that have already invested in state-of-the-art combustion controls have already undertaken significant costs and will have less to gain from additional controls such as an selective catalytic reduction (SCR) retrofit.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See</E>
                         Lower Colorado River Authority's June 21, 2022, comment letter Docket Id No. EPA-HQ-OAR-2021-0668-0395, at 21.
                    </P>
                </FTNT>
                <P>
                    Finally, one commenter (WPC) states that the emissions reductions coming from adding controls to pulp and paper mills “would have a negligible effect on 
                    <PRTPAGE P="99110"/>
                    air quality.” 
                    <SU>23</SU>
                    <FTREF/>
                     The commenter states that this, coupled with a continued decreasing trend of Wisconsin-based stationary source NO
                    <E T="52">X</E>
                     emissions, anticipated mobile source NO
                    <E T="52">X</E>
                     reductions, and additional reductions that they assert were not accounted for in the EPA's analysis, indicates that inclusion of Wisconsin pulp and paper mills are not needed to achieve downwind air quality improvement.
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         Wisconsin Paper Council's June 21, 2022, comment letter Docket Id No. EPA-HQ-OAR-2021-0668-0338, at 2.
                    </P>
                </FTNT>
                <P>The relevant text of the various commenters is included immediately below.</P>
                <HD SOURCE="HD3">Indiana Municipal Power Agency</HD>
                <EXTRACT>
                    <P>
                        Not every unit can install or activate SNCR in a way that is cost effective, relative to the actual emissions reductions that the units will experience. Inflated assumptions as to achievable emissions reductions, and underestimated implementation costs have led EPA to presume that compelling the use of SNCR with no regard for the individual circumstances of the EGU in question will be a cost effective means of reducing NO
                        <E T="52">X</E>
                         emissions. This is not always the case. In IMPA's experience, the effectiveness of SNCR system is highly variable depending on the operational characteristics of the unit, and the level and consistency of its load. Units deployed during peak timeframes, such as IMPA's WWVS units, will not see the same emissions reductions as base load generation. The cost effectiveness of the requirement to employ SNCR will be highly variable, and is unlikely to meet EPA expectations in even the most optimistic case.
                        <SU>24</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             
                            <E T="03">See</E>
                             Indiana Municipal Power Agency's June 20, 2022, comment letter Docket Id No. EPA-HQ-OAR-2021-0668-0361, at 9.
                        </P>
                    </FTNT>
                </EXTRACT>
                <HD SOURCE="HD3">Lower Colorado River Authority</HD>
                <EXTRACT>
                    <P>It is clear that Congress believed existing source standards would never exceed new source standards: “[m]ore stringent requirements are imposed on new sources because engineering considerations allow for cheaper and more effective pollution control when the effort is incorporated in the design and construction of the facility.” In fact, EPA has previously recognized that less (not more) stringent standards are appropriate for existing units because “controls cannot be included in the design of an existing facility and because physical limitations may make installation of particular control systems impossible or unreasonably expensive in some cases.” Controls identified as part of a transport plan should take into account the difficulties of installing controls at existing facilities, but EPA does not do so in this Proposal.</P>
                    <P>
                        While installing selective catalytic reduction may be the common practice for a 
                        <E T="03">new</E>
                         fossil-fueled EGU, that does not mean that it is 
                        <E T="03">per se</E>
                         reasonable or cost-effective for existing plants, especially those that have already invested in other controls to lower their NO
                        <E T="52">X</E>
                         emissions. Due to the lower emission rate starting point, plants that have already invested in state-of-the-art combustion controls, such as low-NO
                        <E T="52">X</E>
                         burners and overfire air, have already undertaken significant costs to achieve NO
                        <E T="52">X</E>
                         reductions and have less to gain from additional control installation, such as SCR and SNCR.
                        <SU>25</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             
                            <E T="03">See</E>
                             Lower Colorado River Authority's June 21, 2022, comment letter Docket Id No. EPA-HQ-OAR-2021-0668-0395, at 2 (footnotes omitted).
                        </P>
                    </FTNT>
                </EXTRACT>
                <HD SOURCE="HD3">Wisconsin Paper Council</HD>
                <EXTRACT>
                    <P>
                        Furthermore, pulp and paper mill boilers contribute a small amount of the overall NO
                        <E T="52">X</E>
                    </P>
                    <P>
                        emissions from sources in the 23 states identified by EPA for emission reductions. Based upon the 2017 National Emissions Inventory, point sources in those states emitted approximately 1.5 million tons of NO
                        <E T="52">X</E>
                        , while pulp and paper mill boilers emitted only about 35,000 tons in those states (2% of point source emissions). In addition, those states also have mobile source emissions of approximately 3.3 million tons per year of NO
                        <E T="52">X</E>
                        , and another 1 million tons of NO
                        <E T="52">X</E>
                         emissions from biogenic sources, wildfires and prescribed burns.
                    </P>
                    <P>
                        It is also important to note that the reduction in emissions from pulp and paper mills would have a negligible effect on air quality. For example, the maximum estimated improvement at any receptor for emission controls on 25 pulp and paper mills is 0.0117 ppb, which is significantly below the detection limit of ambient air quality monitors. Thus, the benefit in air quality is too small to even measure.
                        <SU>26</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             
                            <E T="03">See</E>
                             Wisconsin Paper Council's June 21, 2022, comment letter Docket Id No. EPA-HQ-OAR-2021-0668-0338, at 2.
                        </P>
                    </FTNT>
                </EXTRACT>
                <P>
                    <E T="03">Citations to previous responses:</E>
                     The EPA explained that, as it had in all prior good neighbor rulemakings for ozone, it was establishing uniform emissions control levels for all covered states, using a comparative analysis of the cost-effectiveness of different emissions control technologies as a key metric to establish the appropriate degree of stringency to define “significant contribution.” 88 FR 36675-77, 36678-79, 36683, 36718-19, 36741. The EPA explained that it determined in the final Good Neighbor Plan it would require controls up to the $11,000/ton representative cost threshold identified for EGUs associated with retrofit of SCR post-combustion control technology and that non-EGU costs on a per ton basis were generally commensurate with this level of control stringency. 88 FR 36746-47. The EPA explained there could be variation in costs for particular units depending on their configurations or level of operation but that this variation did not impact its selection of the overall appropriate level of stringency. 
                    <E T="03">Id.; id.</E>
                     at 36740-41. The EPA explained it was not relying on the $7,500/ton preliminary threshold identified in the Non-EGU Screening Assessment, recognizing costs were more heterogeneous than that single figure, and that nonetheless, the Screening Assessment adequately served its function of helping the EPA target the most impactful non-EGU emissions control strategies in defining “significant contribution.” 
                    <E T="03">Id.;</E>
                     Good Neighbor Plan RTC at 113-15. The EPA explained that for EGUs, the trading program would allow for cost-efficient compliance planning for all sources and adjusted its proposed trading program “enhancements” to preserve greater flexibility for EGUs through the 2020s, 
                    <E T="03">id.</E>
                     at 36729-30, 36684, while for non-EGUs, the EPA made available flexibilities such as alternative emissions limits for any units facing excessively high costs or technical infeasibility, 
                    <E T="03">id.</E>
                     at 36818-19. The EPA explained that it believed its selected level of stringency as compared to prior transport rules was appropriate in light of the more protective 2015 ozone NAAQS and its projections of persistent elevated ozone levels. 
                    <E T="03">Id.</E>
                     at 36660. It explained how its analysis compared and was consistent with the determinations in the Revised CSAPR Update and other previous rulemakings taken pursuant to CAA section 110(a)(2)(D)(i)(I). 88 FR 36660; Good Neighbor Plan RTC at 37-39, 92-93. The EPA explained how it had derived its estimates of representative costs for both EGUs and non-EGUs, which accounted for a range of costs associated with retrofit of controls on existing sources. 88 FR at 36720-31, 36738-40. The EPA explained how its selected level of control was also roughly commensurate with the level of control required of existing sources in downwind states. Good Neighbor Plan RTC at 62-63.
                </P>
                <P>
                    The EPA explained how it evaluated the air quality factor in its Step 3 analysis, viewing it as serving a confirmatory role that an appropriate level of emissions control stringency would be achieved overall, that (based on available information) no cost-effective strategies had been overlooked, and that if the identified cost-effective level of control stringency were applied uniformly across the linked upwind states, there would be, on average and in the aggregate, widespread reductions in ozone levels at downwind receptors. 
                    <E T="03">Id.</E>
                     at 36683, 36741, 36748-50.
                </P>
                <P>
                    The EPA explained that it generally focused on large stationary sources of NO
                    <E T="52">X</E>
                     emissions in upwind states, consistent with the science of regional-scale ozone transport and all of its prior good neighbor rulemakings for ozone. 
                    <E T="03">Id.</E>
                     at 36660, 36671, 36719. The EPA explained it recognized that air quality improvement from any particular source 
                    <PRTPAGE P="99111"/>
                    or group of sources may appear relatively small, but this is simply an expression of the “collective contribution” problem that ozone presents. Good Neighbor Plan RTC at 98, 103-04. The EPA explained why, given this problem and the need to control many sources over a wide area, it makes sense to define obligations for each state subject to a FIP through the application of a uniform level of emissions control across the linked states and to regulate on an industry-by-industry basis across those states, as a matter of both efficiency and equity. 88 FR 36673, 36675-76, 36677, 36680, 36683, 36691, 36719, 36741; Good Neighbor Plan RTC at 8, 48, 56-58, 83, 92-93, 118.
                </P>
                <P>
                    The EPA explained that it considered boilers in several industries to be impactful and controllable non-EGU types and that boilers in the pulp and paper industry were among those sources with well-demonstrated, cost-effective NO
                    <E T="52">X</E>
                    -emissions control options. 88 FR 36681-82, 36736, 36739-40; Good Neighbor Plan RTC at 93, 97, 99-100, 107, 119-21. The EPA explained that it was nevertheless not including non-EGU requirements for Wisconsin in the final rule because based on the updated modeling used for the final rule, Wisconsin was no longer projected to be linked to downwind receptors in the 2026 analytic year. 
                    <E T="03">Id.</E>
                     at 118.
                </P>
                <P>
                    The EPA addressed SNCR operating characteristics and effectiveness for existing EGUs, both in terms of optimizing SNCR controls that had already been installed, and in terms of installing new SNCRs on existing EGUs. 88 FR 36725-26. The EPA evaluated comments concerning SNCR performance where specifically raised, 
                    <E T="03">see, e.g.,</E>
                     Good Neighbor Plan RTC at 229. The EPA also gave consideration to certain EGUs that have widely varying operating levels because they serve a “peaking” function rather than supplying baseload power to the grid and did not include them in setting the stringency of the rule for EGUs at Step 3. 88 FR 36732.
                </P>
                <HD SOURCE="HD1">III. Analysis of Severability in Response to Comments</HD>
                <P>In this section, the EPA provides a fuller explanation why the Good Neighbor Plan can and should apply on a state-by-state basis for any state for which the EPA has a responsibility to promulgate a FIP, regardless of the number of states covered at any given time. Drawing together the Agency's legal and technical reasoning, based on the information and data available at the time, provided in the record when the Good Neighbor Plan was signed and promulgated, the EPA provides a more thorough response to the relevant comments that together can be read to have raised that issue.</P>
                <HD SOURCE="HD2">A. Summary of Response</HD>
                <P>
                    As the EPA stated in the final rule, the Good Neighbor Plan by design is severable by state. 88 FR 36693. The rule implements the statute's prohibition on “significant contribution” under CAA section 110(a)(2)(D)(i)(I) for the 2015 ozone NAAQS by promulgating state-level FIPs that require the industries in each contributing upwind state to achieve at least minimum levels of emissions performance deemed to be cost-effective. 
                    <E T="03">Id.</E>
                     at 36741. So long as they meet that level of performance, the industries in any state regulated under the Good Neighbor Plan are understood to have lawfully addressed good neighbor obligations and eliminated that portion of a state's significant contribution to downwind air pollution. While the EPA must necessarily account for the multi-state nature of the interstate-ozone problem, consistent with the statute and case law, the Good Neighbor Plan imposes obligations on sources in each individual state that are appropriate for those sources and are achievable.
                </P>
                <P>
                    Those requirements result from the application of a longstanding analytical framework that the EPA has applied when evaluating interstate transport obligations for multiple prior ozone NAAQS. 88 FR 36660, 36668-69. Shaped through the years by input from state air agencies 
                    <SU>27</SU>
                    <FTREF/>
                     and other stakeholders on the EPA's prior interstate transport rulemakings and SIP submission actions,
                    <SU>28</SU>
                    <FTREF/>
                     as well as court decisions, the EPA has developed and used a “4-step interstate transport framework” to evaluate states' obligations to eliminate interstate transport emissions under the interstate transport provision for each prior ozone NAAQS: (Step 1) identify monitoring sites that are projected to have problems attaining and/or maintaining the NAAQS (
                    <E T="03">i.e.,</E>
                     nonattainment and/or maintenance receptors); (Step 2) identify states that impact those air quality problems in other (
                    <E T="03">i.e.,</E>
                     downwind) states sufficiently such that the states are considered to “contribute” (
                    <E T="03">i.e.,</E>
                     are considered “linked”) to those receptors and whose emissions therefore warrant further review and analysis; (Step 3) identify the emissions reductions necessary (if any), applying a multifactor analysis, to eliminate each linked upwind State's significant contribution to nonattainment or interference with maintenance of the NAAQS at the locations identified in Step 1; and (Step 4) adopt permanent and enforceable measures needed to achieve those emissions reductions. The EPA does not require states to use the 4-step interstate transport framework in good neighbor SIP submissions, nor has the EPA ever maintained that this is the 
                    <E T="03">only</E>
                     way states could satisfy their obligations under CAA section 110(a)(2)(D)(i)(I). However, it is a useful organizational tool and evaluation framework that comports with the statutory text and structure of the Act. The application of uniform levels of emissions control stringency at Step 3 across all linked states has been upheld by the Supreme Court as “permissible, workable, and equitable.” 
                    <E T="03">EPA</E>
                     v. 
                    <E T="03">EME Homer City Generation, L.P.,</E>
                     572 U.S. 489, 524 (2014). The Supreme Court there expressly rejected that the Act mandates a definition of “significance” that is directly proportional to each state's contribution, finding that reading “appears to work neither mathematically nor in practical application.” 
                    <E T="03">Id.</E>
                     at 516. As the EPA explained in the Good Neighbor Plan, the 4-step interstate transport framework, including the application of uniform minimum control stringency, remains a particularly fair and equitable approach to apply in the case of a multistate pollution problem like ozone, characterized by “collective contribution” and in which widespread emissions reductions of a single precursor pollutant (nitrogen oxides or NO
                    <E T="52">X</E>
                    ) over a wide geographic area are known to be effective in improving ozone levels downwind. 88 FR 36719.
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">See</E>
                         63 FR 57356, 57361 (October 27, 1998).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         In addition to CSAPR rulemakings, other regional rulemakings addressing ozone transport include the “NO
                        <E T="52">X</E>
                         SIP Call,” 63 FR 57356 (October 27, 1998), and the “Clean Air Interstate Rule” (CAIR), 70 FR 25162 (May 12, 2005).
                    </P>
                </FTNT>
                <P>
                    Because the methodology for defining those obligations ultimately relies on a determination regarding what level of widely available emissions performance each type of regulated source can cost-effectively achieve, the obligations set for sources in each state are independent of the number of states included in the Good Neighbor Plan. Accordingly, the fact that obligations may be suspended or not yet operative with regard to some states does not impact the Good Neighbor Plan's conclusions as they apply in other states. Rather, as the EPA explained, the framework yields an “amount” of pollution for “each State” that the EPA is authorized to “prohibit,” CAA section 110(a)(2)(D)(i), standing in the shoes of 
                    <PRTPAGE P="99112"/>
                    a state, CAA section 110(c)(1), based on the amounts of pollution that would be avoided in that state by applying the control technologies the EPA determined were cost-effective for the covered industries. 88 FR 36675. The amounts to be prohibited are thus premised on reasonable levels of pollution control upwind rather than on a specific, aggregate quantum of ozone reduction that must be achieved downwind. 
                    <E T="03">Michigan</E>
                     v. 
                    <E T="03">EPA,</E>
                     213 F.3d 663, 674-80 (D.C. Cir. 2000).
                </P>
                <P>
                    Under this framework, while the emissions-control requirements are uniform across the same types of sources in each state, the size of each state's total incremental emissions-reductions obligation under the Good Neighbor Plan, and the resulting improvement in air quality downwind, depends on the particular sources present in that state and the level of pollution reduction those sources are already achieving. 88 FR 36683. If a state's sources are already well-controlled, they will have less to do to meet the EPA's defined level of control stringency; if the state's sources are not already well-controlled, they will have to do more. But these state-specific obligations derive from the application of common, uniform levels of emissions control stringency calculated for each type of source based on the demonstrated performance of pollution control technologies that can be replicated in any linked upwind state. 
                    <E T="03">EME Homer City,</E>
                     572 U.S. at 519-20. Calculating “significance” according to source type and concluding that the good neighbor provision can be reasonably implemented by bringing all covered sources up to a common level of control ensures the EPA can fairly administer the program in any state that becomes subject to a need for federal regulation, while avoiding inequities that could arise if state plans (and relevant sources) were addressed seriatim. 
                    <E T="03">See</E>
                     88 FR 36749 (explaining the need to avoid a “which state goes first” problem). The achievement of that level of performance for any particular state is not dependent on the number of states in the Good Neighbor Plan, nor on the order in which the states are addressed. In this way, the Good Neighbor Plan prohibits each covered state's “significant contribution” to downwind ozone problems in a “permissible, workable, and equitable” manner. 572 U.S. at 524.
                </P>
                <P>Given this statutory structure and regulatory framework, the Good Neighbor Plan is “modular” by nature, defining and implementing the obligations for each state.</P>
                <P>
                    First, in line with the statutory text, structure, and case law, the EPA determines the “significant contribution” that must be prohibited at the individual state level. 
                    <E T="03">See</E>
                     88 FR 36687 (citing 
                    <E T="03">North Carolina</E>
                     v. 
                    <E T="03">EPA,</E>
                     531 F.3d 896, 906-08, 921 (D.C. Cir. 2008)). None of the steps in the 4-step interstate transport framework differ based on the number of states included in the Good Neighbor Plan. For example, the control technologies and cost-effectiveness figures the EPA considers at Step 3 do not depend on the number of states included. Instead, the Good Neighbor Plan regulates certain relatively large emitting sources in each included state (including both new and existing sources meeting the relevant criteria), up to a uniform level of pollution control that is common across sources of that type in all potentially contributing states. Once the “amount” of pollution for each state is determined, whether the 4-step interstate transport framework is applied to one state or fifty, it would yield the same emissions control obligations for the included states. That means that when the number of states whose sources are included in the Good Neighbor Plan's regulatory programs for EGUs or non-EGUs changes from the number included at promulgation, which is historically common in interstate transport rules and consistent with states' authority under the Act to replace federal plans with state plans, the emissions reduction obligations of the states remaining in the Good Neighbor Plan's programs stay the same, and the obligations of states joining the Good Neighbor Plan's programs are the same as those that were applied to the states already included.
                </P>
                <P>
                    Second, given the state-specific statutory mandate, for those components of the Good Neighbor Plan that necessitate consideration of multi-state effects, the EPA is careful to avoid creating any interdependency among the particular states included, both in the Agency's analytical methodology and in the Good Neighbor Plan's regulatory requirements. As the EPA explained in the rule, interstate ozone pollution continues to present a “collective contribution” challenge wherein many sources of emissions over a wide geographic area comprise a substantial portion of the ozone problems downwind. 88 FR 36678, 36712. Where the EPA is called upon to fill a gap in state planning efforts, it must therefore develop solutions for the relevant state(s) that reasonably account for the efforts other states may undertake, even in the face of uncertainty concerning what those states may do. 
                    <E T="03">Id.</E>
                     at 36695-96. For example, when evaluating the Good Neighbor Plan to ensure it did not “overcontrol” (
                    <E T="03">i.e.,</E>
                     yield more reductions than necessary), the EPA did not just look at the states included in the original Good Neighbor Plan, but also looked at all of the other states the modeling showed were potentially affecting downwind air quality above the “contribution” threshold (as well as each receptor's “home” state), even if those states were not included in the Good Neighbor Plan.
                    <SU>29</SU>
                    <FTREF/>
                      
                    <E T="03">See infra</E>
                     note 47 supra and accompanying text (providing record citations). Taking this broad view, the EPA found that even making all cost-effective reductions available in all linked upwind states, and assuming equivalent emissions reductions from the two downwind states not included in the Good Neighbor Plan, the rule would not constitute overcontrol. 88 FR 36749-50. Accordingly, because the overcontrol analysis already assumes the emissions reductions that can reasonably be anticipated from the implementation of the good neighbor provision for a given NAAQS, requiring available emissions reductions in any subset of those states does not constitute overcontrol of those upwind states. 
                    <E T="03">See</E>
                     section III.B.2.c. of this document (providing record citations). Finally, the Good Neighbor Plan's regulatory requirements, including the emissions trading program for power plants, are designed to be fully implementable in each individual state and do not depend on participation from a minimum number of states. 
                    <E T="03">See</E>
                     section III.B.3. of this document (providing record citations). In these ways, the EPA's methodological approach to devising good neighbor FIPs for ozone ensures against inter-dependency among states, through accounting for the effects of emissions reductions within a web of “overlapping and interwoven” linkages among many states, 
                    <E T="03">EME Homer City,</E>
                     572 U.S. at 496-97, while at the same time setting technology-based emissions limits and other control measures that the sources in each state can meet. 88 FR 36741, 36749.
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         These states are now included in a supplemental rulemaking to address their obligations. 
                        <E T="03">See supra</E>
                         note 19.
                    </P>
                </FTNT>
                <P>
                    Third, while equity and consistency in obligations among states are at the core of the statute and the EPA's 4-step interstate transport framework, the suspension or removal of the Good Neighbor Plan's requirements in some states does not provide a lawful basis to suspend them in others. Just as each state has an individual obligation to 
                    <PRTPAGE P="99113"/>
                    satisfy the good neighbor requirements of CAA section 110(a)(2)(D), regardless of whether other states have done so, the EPA has a statutory obligation to address the good neighbor obligations of “each State” where it has a federal responsibility to act. CAA section 110(c)(1). Indeed, the goals of equity and consistency extend to the downwind states for whom the good neighbor provision was enacted. The good neighbor provision's requirement of consistency with the rest of the CAA, 
                    <E T="03">see</E>
                     CAA section 110(a)(2)(D)(i), including the air quality attainment schedules that are the “heart” of the Act, 
                    <E T="03">Train</E>
                     v. 
                    <E T="03">NRDC,</E>
                     421 U.S. 60, 66 (1975), means that each downwind state with identified air quality problems has a statutory right to timely relief from the public health and regulatory burdens of upwind pollution. 
                    <E T="03">See</E>
                     88 FR 36694 (discussing case law). It would be contrary to this statutory purpose to revise or suspend the Good Neighbor Plan as to upwind states for which the EPA is under a statutory requirement to act because the Good Neighbor Plan's requirements were suspended for other states.
                </P>
                <P>
                    These principles are applicable in a variety of circumstances where the EPA may approve a state's SIP as sufficiently meeting its good neighbor obligations even if the state's approach is different than the EPA's approach, for that state or for other states. The EPA's interstate ozone transport actions are typically taken on a national basis and with the goal of ensuring consistency, including in terms of alignment of the timing of obligations, because doing so ensures equitable treatment of all states and is administratively efficient given the commonality in analysis and obligations across many states, particularly in the case of interstate ozone transport. In addition, the establishment of interstate emissions trading programs has allowed for more cost-efficient compliance activities, and it is far more efficient to establish these programs through a consolidated, multistate rulemaking action. Historically, this has also been coupled with the EPA's practice of seeking consolidated judicial review of such actions in the D.C. Circuit to ensure that a consistent caselaw regime applies across the entire country on matters of interstate ozone pollution and is not varied by which federal judicial circuit a state happens to be located in. 88 FR 36859-60.
                    <SU>30</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         
                        <E T="03">See also, e.g.,</E>
                         86 FR 23054, 23163-64 (April 30, 2021); 84 FR 56058, 56093 (October 18, 2019); 83 FR 65878, 65923-24 (December 21, 2018); 83 FR 50444, 50472 (October 5, 2018); 81 FR 74504, 74585-86 (October 26, 2016); 76 FR 80760, 80773-74 (December 27, 2011); 76 FR 48208, 48352 (August 8, 2011); 71 FR 25328, 25329 (April 28, 2006); 70 FR 25162, 25316 (May 12, 2005); 65 FR 2674, 2725 (January 18, 2000); 63 FR 57356, 57480 (October 27, 1998).
                    </P>
                </FTNT>
                <P>
                    Nonetheless, the EPA acknowledged states' ability to develop alternative, potentially approvable approaches to meeting their good neighbor obligations. 
                    <E T="03">See</E>
                     88 FR 36838-43. In evaluating alternative approaches, the EPA must consider interstate consistency, 88 FR 36839-40; 
                    <E T="03">id.</E>
                     n.405; 87 FR 9338, 9380-81, but it has never been the Agency's view that its methodology for defining one state's obligations would have to be redone simply because it found an approach in another state also approvable.
                </P>
                <P>Thus, as explained in more detail in section III.B., the comments asserting that the EPA should stay, revise, or withdraw the Good Neighbor Plan for any particular state depending on the status of implementation of good neighbor obligations of other upwind states cannot be squared with the state-specific mandate of the Act, nor would this be compelled as a result of any element of the EPA's 4-step interstate transport framework. For those states where the Good Neighbor Plan may be currently suspended, good neighbor obligations will ultimately be met, either through an approved state plan or a federal plan as necessary. Meanwhile, sources in upwind states regulated by the Good Neighbor Plan would be under the same legal obligation to control their pollution even if the EPA developed a federal plan containing just those states or some subset of them or separate federal plans for each state.</P>
                <HD SOURCE="HD2">B. Step-by-Step Review of the 4-Step Interstate Transport Framework</HD>
                <P>
                    A review of the EPA's methodology demonstrates why each upwind state would bear the same emissions reduction obligations, regardless of how many states were included in a particular rulemaking. The EPA's method for defining good neighbor obligations, while applied consistently across the nation and respectful of the multistate “collective contribution” nature of the interstate ozone problem, produces a definition of “significant contribution” 
                    <SU>31</SU>
                    <FTREF/>
                     for the sources in each individual state, and provides for the prohibition of such emissions in a manner that is not dependent on the inclusion of any particular number or grouping of states. As tested and refined through case law over the past quarter-century, the EPA's methodology is consistent with the state-specific structure of the Act and the fundamental statutory obligation to define and prohibit each state's own significant contribution. 
                    <E T="03">See</E>
                     CAA section 110(a)(1) and 110(a)(2)(D); 
                    <E T="03">Wisconsin</E>
                     v. 
                    <E T="03">EPA,</E>
                     938 F.3d 303, 324-25 (D.C. Cir. 2019); 
                    <E T="03">North Carolina,</E>
                     531 F.3d at 906-08, 920-21.
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         “Significant contribution” is often used as a shorthand to refer to the identification of those amounts of emissions that significantly contribute to nonattainment or interfere with maintenance of the NAAQS in other states and therefore must be prohibited under the good neighbor provision. 
                        <E T="03">See</E>
                         CAA section 110(a)(2)(D)(i)(I).
                    </P>
                </FTNT>
                <P>
                    Consistent with the statutory text and structure and judicial precedent, the EPA's 4-step interstate transport framework was designed to be independent of the number or scope of included states. Because the statute allows states to replace a FIP with a SIP—and because as a practical matter the EPA does not necessarily receive or act on each state's SIP submission at the same time—the Good Neighbor Plan is expressly designed to allow states to be added to or removed from the federal emissions control program over time, as circumstances require (including where a state submits an approvable SIP to replace their FIP, 
                    <E T="03">see</E>
                     88 FR 36838-39). The Good Neighbor Plan does so primarily by setting good neighbor obligations based on the available, cost-effective technologies that can be applied to each type of high-emitting source—a technology-focused definition of “significant contribution” that the Supreme Court upheld in 
                    <E T="03">EME Homer City</E>
                     and that can be evenhandedly applied to existing sources and those that may be newly located in any contributing State in the future. 88 FR 36675-77, 36678-79, 36683, 36718-19, 36741. This ensures fairness and consistency across all states when the EPA must act pursuant to its FIP authority to implement CAA section 110(a)(2)(D)(i)(I), regardless of when any particular state is addressed—it avoids the problem of “which state goes first”; that is, it avoids producing unfairly varying levels of emissions-control stringency depending on the order in which states' obligations are addressed. 88 FR 36749. As the Supreme Court aptly illustrated in 
                    <E T="03">EME Homer City,</E>
                     where multiple states contribute to multiple other states (as remains the case across the contiguous U.S. for the 2015 ozone NAAQS), addressing each state's obligations in proportion to its contribution to each receptor in seriatim fashion becomes mathematically unworkable and economically inefficient. 572 U.S. at 516. The EPA's approach to developing ozone good neighbor FIPs avoids these pitfalls, avoids interdependence, and avoids unfairness—it works for each state that may need federal regulation of its 
                    <PRTPAGE P="99114"/>
                    sources. Accordingly, under each step of the 4-step interstate transport framework discussed further later, a change in the number of states covered does not impact the obligations of the states or sources that remain covered.
                </P>
                <HD SOURCE="HD3">1. Steps 1 and 2</HD>
                <P>
                    The EPA identifies receptors based on nationwide modeling and monitoring data and evaluates each state's contribution to receptors in downwind states on an individual-state basis to identify upwind-state-to-downwind-state linkages. The air quality modeling and the monitoring data the EPA considered for Steps 1 and 2 cover the contiguous United States. 
                    <E T="03">See</E>
                     88 FR 36696.
                </P>
                <P>
                    At Step 1, the EPA identified downwind receptors that are expected to have problems attaining or maintaining the NAAQS. For a detailed explanation of what receptors are and how the EPA identified them, 
                    <E T="03">see</E>
                     88 FR 36703-08. At Step 2, the EPA identified which upwind states contribute to the identified receptors in amounts that would be sufficient in the EPA's interpretation of “contribution” to “link” the individual upwind states to downwind air quality problems. For a detailed explanation of how the EPA identified these linkages, 
                    <E T="03">see</E>
                     88 FR 36708-12.
                </P>
                <P>
                    The nationwide identification of receptors expected to have problems attaining or maintaining the NAAQS and of states “contributing” to those receptors does not rely upon nor necessarily dictate the number of states included in a particular rulemaking. The EPA historically has applied a common numerical threshold for determining which states “contribute” to downwind air quality problems, and the contributions from each state are evaluated independently with respect to this threshold. 88 FR 36677-78. The modeling of baseline conditions did not contain or rely on the emissions reductions in the Good Neighbor Plan, and the monitoring data were based on measurements during years prior to when the Good Neighbor Plan was final and thus these data do not reflect the impacts of emissions reductions from the Good Neighbor Plan.
                    <SU>32</SU>
                    <FTREF/>
                     This approach creates a level playing field from which to assess each state's level of contribution. 88 FR 36713.
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         Both the EPA and States can use air quality modeling and monitoring information on ozone concentrations and contribution levels to make individual determinations for each state concerning whether it is contributing to any out-of-state receptors. 
                        <E T="03">See, e.g.,</E>
                         88 FR 9365 n.286 (identifying individualized approvals of SIPs using modeling at Steps 1 and 2).
                    </P>
                </FTNT>
                <P>
                    In addition to promoting national consistency, the EPA has explained that using a single contribution threshold avoids creating potential inter-dependencies among states. When the EPA had previously considered whether to approve individual states' use of a higher contribution threshold, it had proposed (for the State of Iowa) to consider the effects of other states' efforts to reduce their pollution at shared receptors. 
                    <E T="03">See</E>
                     88 FR 36715. On further consideration, however, the EPA found this would have introduced an interdependency. 
                    <E T="03">Id.</E>
                     When the EPA gave consideration to this approach in its SIP Disapproval action disapproving 21 state implementation plans (88 FR 9336; February 13, 2023), in response to comments, it explained that this factor would inappropriately introduce an inequity in which some states could evade obligations through reliance on the incidental effects of other states' efforts.
                    <SU>33</SU>
                    <FTREF/>
                      
                    <E T="03">See also</E>
                     88 FR at 36713 (explaining that “use of alternative thresholds would allow certain states to avoid further evaluation of potential emissions controls while other states must proceed to a Step 3 analysis. This could create significant equity and consistency problems among states.”).
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         
                        <E T="03">See</E>
                         2015 Ozone NAAQS Interstate Transport SIP Disapprovals—Response to Comments (RTC) Document at 296, available at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OAR-2021-0663-0083.</E>
                    </P>
                </FTNT>
                <P>The EPA's analytical methodology at Steps 1 and 2 ensures the EPA can impose FIP obligations, where they may be needed, according to a common rubric that maintains equity and consistency between the potentially subject states. Thus, the analytic methods in both Step 1 and Step 2 to determine “contributing” states rely on emissions and air quality data that are independent of which or how many states are covered by the Good Neighbor Plan.</P>
                <P>
                    We note that comments from ASC and PCA in Comment Category 2 summarized in section II.B. of this document contained several statements the meaning of which the EPA could not clearly ascertain. Those comments said the EPA's Step 2 screening analysis included states that “already had Good Neighbor SIPs for the 2015 ozone NAAQS.” 
                    <E T="03">See</E>
                     ASC Comment Letter at 13. The meaning of this statement is unclear. States may have made SIP 
                    <E T="03">submissions</E>
                     for these obligations, but at the time of this comment, the EPA had not approved all of those submissions and was in the process of disapproving many of them, and so the statement read that way (
                    <E T="03">i.e.,</E>
                     to suggest that the States already had approved SIPs) is factually incorrect.
                    <SU>34</SU>
                    <FTREF/>
                     The sentence in the ASC comment letter goes on to state that the EPA “prematurely disapproved” these SIPs, but the disapprovals had only been 
                    <E T="03">proposed</E>
                     at the time the comment was submitted. The commenter did not explain what made the EPA's proposed disapprovals “premature.”
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         The commenter also asserted that the EPA had “proposed” findings of failure to submit for four states, New Mexico, Pennsylvania, Utah, and Virginia. That statement was incorrect insofar as the EPA issued a 
                        <E T="03">final</E>
                         finding of failure to submit for these states in December of 2019, effective January 6, 2020, had an obligation to promulgate FIPs for these states pursuant to CAA section 110(c)(1) by January 6, 2022, and was subject to a consent decree deadline to promulgate FIPs for these states (excluding New Mexico) by March 15, 2023. 
                        <E T="03">See</E>
                         88 FR 36689 n.106.
                    </P>
                </FTNT>
                <P>This comment might be read as in relation to the previous approvals of SIPs for certain states, and thus an argument that these states' emissions should be excluded from modeling analyses. Or the comment might be read in relation to a subsequent statement in the comment, that states should not be included in the Good Neighbor Plan's “screening” at Step 2 if final action on the SIP submission had not yet been taken. In either of these cases, the comment would be misplaced, in that our analysis of the Steps 1 and 2 modeling looks at the transport of pollution as a factual matter and does not remove from consideration the emissions of states based on the procedural status of their SIP submissions. In addition, as explained in section III.B.1., the EPA's baseline air quality and contribution modeling for Steps 1 and 2 is conducted for a modeling domain that includes the entire contiguous United States and accounts for all emissions sources. 88 FR 36696. Removing emissions from certain states from this modeling would produce erroneous, unrealistic, and counterfactual results.</P>
                <P>
                    These comments also stated that the EPA may need to conduct a new analysis at Step 2 in the event the EPA takes a different action on those SIPs than contemplated in the proposed Good Neighbor Plan. In that case, according to commenter, the EPA “would need to conduct a new assessment and modeling of contribution and subject those findings to public comment.” ASC Comment Letter at 14. On the one hand, the EPA agrees with the commenter to the extent they are suggesting that if updated modeling the EPA conducted (
                    <E T="03">e.g.,</E>
                     the 2016v3 modeling used in the final Good Neighbor Plan) showed a state was no longer contributing at Step 2, and the 
                    <PRTPAGE P="99115"/>
                    EPA approved that state's SIP submission or had deferred taking action, then the EPA would not promulgate a FIP for that state given that disapproval (or a finding of failure to submit) is a necessary predicate to FIP authority. This is precisely how the EPA proceeded in the final SIP Disapproval and Good Neighbor Plan and in taking subsequent rulemaking actions for states where its final analysis at Steps 1 and 2 had materially changed from its proposed SIP and FIP actions. 
                    <E T="03">See</E>
                     88 FR 36656, 36658, 36689; 
                    <E T="03">see also</E>
                     SIP Disapproval, 88 FR 9354.
                    <SU>35</SU>
                    <FTREF/>
                     On the other hand, the comment might be read to suggest that if the EPA's analysis changed for any particular state at Steps 1 or 2, then it would have to conduct a whole new analysis of every other state at Steps 1 or 2. If so, that comment is in error because the EPA's baseline air quality and contribution analysis at Steps 1 and 2 already accounts for emissions across all states regardless of their inclusion in the rule, and the results of that analysis would not change for one state simply because the results indicated that another state had fallen below the Step 2 contribution threshold.
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See also supra</E>
                         note 19.
                    </P>
                </FTNT>
                <P>Taken as a whole, this set of comments appears to be primarily about the need for the EPA to ensure consistency in how it analyzed each state's obligations between the separate SIP and FIP rulemakings (a consistency that the EPA agrees is important and abided by). The commenter did not state that the EPA's analysis must be redone if for reasons beyond the Agency's control the Good Neighbor Plan were stayed or not in effect for any particular state; rather, the commenter emphasized the need for consistency in the EPA's own, substantive analytical determinations. If the commenter intended to argue that a change in analysis at Steps 1 or 2 for one state would necessarily alter the EPA's substantive assessment for other states and would need to be subjected to additional notice and comment, the commenter did not state that, nor provide a theory or reasoning as to why that would be the case, and for the reasons explained in this section (III.B.1.), such an assertion would reflect a misunderstanding of how baseline air quality and contribution analysis is conducted at Steps 1 and 2.</P>
                <HD SOURCE="HD3">2. Step 3</HD>
                <P>
                    The Act requires each state to eliminate its “significant contribution” to downwind nonattainment or interference with maintenance of air quality standards. To determine which emissions from contributing states are “significant” at Step 3, the EPA analyzes available emissions control strategies and their costs. Based on that analysis, the EPA then identifies a uniform degree of emissions control stringency that is reasonable to require from upwind sources, calculated based on the emissions performance those sources would achieve through the application of the technologies the EPA found were most cost-effective. Step 3 is a multi-factor analysis, with its primary focus on technology availability and associated cost, the level of emissions reductions that are thereby achieved, and the associated air quality benefits delivered to downwind receptors. The approach applies uniform levels of emissions control stringency across all upwind states, with the objective of bringing the covered sources in each state up to a minimum level of emissions performance to reduce ozone-precursor emissions. 
                    <E T="03">See</E>
                     88 FR 36675-77, 36678-79, 36683, 36718-19, 36741. This approach is tailored to a pollution problem characterized by collective contribution from many similar sources all emitting a similar precursor pollutant (NO
                    <E T="52">X</E>
                    ) over a wide geographic area; it ensures an efficient and equitable solution that avoids interdependency. 
                    <E T="03">Id.</E>
                     at 36719, 36741, 36749.
                </P>
                <P>
                    Thus, when the EPA uses the term “uniform” in the context of Step 3, it is not referring to the division of a specific “pie” of air pollution, total emissions, or total cost divided proportionally among the upwind states; rather it is referring to application of a pollution technology applied equally across all applicable units of a common size and type. 88 FR at 36746-47. One example of a uniform control stringency level is the assumption that all EGU units with already-installed selective catalytic reduction (SCR) technology operate and optimize the performance of these controls. 
                    <E T="03">Id.</E>
                     at 36720-21. The EPA estimated that this would be realized through emissions rates (on average across the fleet) of 0.08 pounds per million British thermal units at costs of about $1,600 per ton of NOx removed. 
                    <E T="03">Id.</E>
                     The translation of this technology stringency into the definition of significant contribution is specific to each state's unique group of sources and the operating characteristics of the affected units at those sources. 
                    <E T="03">Id.</E>
                     at 36683. In no way is the amount of emissions mitigation required of sources in each state interdependent on another state's mitigation responsibility. The “amount” of pollution that is identified for elimination at Step 3 of the 4-step interstate transport framework is therefore that amount of emissions that is above the level of emissions remaining after the cost-effective emissions control strategies are implemented. 
                    <E T="03">Id.</E>
                     at 36676. Because it is possible that a uniform level of stringency may produce more emissions reductions than is necessary to fully resolve a particular upwind state's linkages to all downwind receptors, the EPA tests its identified level of stringency for “overcontrol.” For a detailed explanation of how the EPA applies Step 3, 
                    <E T="03">see</E>
                     88 FR 36718-54.
                </P>
                <P>Acknowledging that some of the factors considered in the Step 3 analysis are considered at a national scale while certain components of that analysis account for state-level or linkage-specific data, the EPA here explains in more detail why the selected levels of control stringency for particular industries, and therefore the particular obligations of individual states, do not vary depending on the number of states subject to FIPs under the Good Neighbor Plan.</P>
                <P>
                    The EPA identified potential levels of emissions control stringency that could be applied for each industry, and thus for the set of sources found in each state, regardless of the number of States covered by an approved SIP or a FIP or not yet covered by either. In evaluating those potential levels of stringency, the EPA conducted a wide-ranging survey of emissions control technologies (and associated cost data) used throughout the United States and even internationally. Then, the EPA conducted the air-quality-improvement and overcontrol analyses considering the effects of the potential uniform stringency levels at each identified receptor. The primary way in which the EPA conducts that assessment is to apply the potential stringency levels across all of the states linked to each particular receptor as well as the downwind, “home” state for that receptor. The EPA then assesses the average resulting improvements across all receptors as well as tabulates the aggregate effects. This allowed the EPA to ascertain whether a selected level of stringency was effective at achieving improvements in the air quality downwind that were reasonable in relation to the identified costs, while also ensuring a selected stringency level is not more stringent than necessary to bring any given receptor into attainment. 88 FR 36741, 36749-50. But given the overlapping linkages among multiple upwind and downwind states, as well as varying levels of baseline emissions control in each state, further 
                    <PRTPAGE P="99116"/>
                    complicated by the year-to-year variability in ozone levels due to meteorology, 
                    <E T="03">id.</E>
                     at 36750, the EPA's methodology, going back to the original NO
                    <E T="52">X</E>
                     SIP Call in 1998, has never attempted to pinpoint a precise level of emissions control for each state that maximizes cost-effectiveness in relation to each specific linkage. 
                    <E T="03">See</E>
                     88 FR 36748 (finding the aggregate and average air quality effects of the combined EGU and non-EGU strategies across all receptors would achieve “meaningful downwind air quality improvements”).
                </P>
                <P>
                    Expressed in simpler terms, the EPA's long-standing interpretation of CAA section 110(a)(2)(D)(i)(I)—an approach that the Supreme Court expressly upheld in 
                    <E T="03">EME Homer City—</E>
                    is that a state may satisfy its good neighbor obligations by ensuring that its emissions do not exceed what would result from the application of cost-effective emissions controls. The purpose of Step 3 is to identify a set of widely available and well-established, cost-effective emissions controls that can be applied in any upwind state, while checking to ensure that those emissions controls will achieve downwind improvements in air quality without overcontrol.
                </P>
                <P>
                    As described in more detail in sections III.B.2.a.-III.B.2.c., none of the determinations that underlie Step 3 are contingent on a particular state or set of states being covered by the Good Neighbor Plan. Accordingly, the EPA's Step 3 analysis can be extended to states not covered by the Good Neighbor Plan either because the state is covered by an approved SIP or prior FIP or because the EPA has not yet taken action to review a SIP or impose a FIP. By identifying cost-effective approaches to reducing multi-state ozone pollution in a manner that does not depend on the participation of any particular state or set of states, the EPA's approach reasonably fulfills Congress's direction in CAA section 110(a)(2)(D)(i)(I) to address the multi-state ozone problem in a way that defines each state's obligations on an individualized basis.
                    <SU>36</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Just as the EPA's analytical approach allows for it to develop a good neighbor FIP for any state that may require one that reasonably establishes emissions control obligations in the face of uncertainty regarding what other states will do, it also allows states themselves to conduct a similar analysis of their own obligations in the context of developing a SIP without definitive knowledge of what other states will do to fulfill their own obligations. At Step 3 of the EPA's 4-step interstate transport framework, each state found to be contributing to one or more receptors can conduct an analysis of emissions control technologies or measures that would be cost-effective within the state. If each state linked to a given receptor (and the downwind state where that receptor is located, to account for that state's own fair share), made pollution-control efforts at these levels, a state could demonstrate that ozone levels at the downwind receptors would be measurably improved (without undertaking more emissions reductions than necessary). In the context of a FIP, this approach to evaluating air quality improvements at downwind receptors is necessary, because to avoid overcontrol, the EPA must consider whether applying a given control stringency level to other states would achieve more emissions reductions than necessary to bring a receptor into attainment.
                    </P>
                </FTNT>
                <P>Specifically, the EPA took the following steps in conducting its Step 3 analysis in the Good Neighbor Plan:</P>
                <HD SOURCE="HD3">a. Technology, Cost, and Emissions Reduction Analyses</HD>
                <P>
                    The EPA's analysis started by examining emissions control technologies (sometimes also referred to as “strategies”) and their associated costs and emissions reductions. The Good Neighbor Plan identified conventional, at-the-source, NO
                    <E T="52">X</E>
                     emissions control technologies that have been available in the covered industries for many years. 
                    <E T="03">See, e.g.,</E>
                     88 FR 36738 (identifying control technologies for EGUs); 
                    <E T="03">id.</E>
                     at 36739 (identifying control technologies for non-EGUs). These analyses were not specific to the particular group of upwind states whose inclusion the EPA had proposed or finalized in the Good Neighbor Plan but looked instead at demonstrated technologies and associated estimated costs across each industry and technology type as a whole, without any geographic limitation. The EPA reasonably considered a wide range of technology and cost information (including information from examples and technical literature throughout the U.S. or even internationally) rather than just the data available in any particular state or regional grouping, since this allows for a more comprehensive assessment of the technologies available and associated costs for each source type.
                    <SU>37</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         In response to comments, the EPA conducted a sensitivity analysis for EGUs to see if looking at control costs on a regional basis would change the results and found that it would not. EGU NO
                        <E T="52">X</E>
                         Mitigation Strategies Final Rule TSD at 49-50. The fact that the EPA conducted this as a sensitivity analysis to address a comment further illustrates that the primary technology and cost analysis the EPA conducted, as described earlier, was not limited to a 23-state geography and would not be altered if that geography were different.
                    </P>
                </FTNT>
                <P>
                    For EGUs, the EPA conducted an inquiry nearly identical to prior good neighbor rules, looking at several widely available and well-understood NO
                    <E T="52">X</E>
                     control strategies that can be and have been applied to EGUs for decades throughout the United States. 
                    <E T="03">See</E>
                     88 FR 36720. For non-EGUs, the EPA similarly consulted a wide range of sources of information, starting with national databases like the National Emissions Inventory and the Control Measures Database (CMDB), and proceeding from there to additional national and international technical literature, as well as a variety of existing state and federal NO
                    <E T="52">X</E>
                     control requirements. 
                    <E T="03">See id.</E>
                     at 36732-33; 
                    <E T="03">see generally</E>
                     Non-EGU Sectors Final Rule Technical Support Document (TSD); 
                    <SU>38</SU>
                    <FTREF/>
                     EGU NO
                    <E T="52">X</E>
                     Mitigation Strategies Final Rule TSD.
                    <SU>39</SU>
                    <FTREF/>
                     These included trade association literature; academic studies; multi-state regional organization publications; state rules and publications; contractor studies; EPA rules, publications, and databases like the RACT/BACT/LAER Clearinghouse; European Commission publications; operating permits; and data on what emissions limits specific facilities or companies were achieving. 
                    <E T="03">See, e.g.,</E>
                     Non-EGU Sectors Final Rule TSD at 9-11 (reciprocating internal combustion engines (RICE)), 27-29 (cement kilns), 35-39 (reheat furnaces), 42-43, 45-47 (glass furnaces), 62-65, 68-84 (boilers), 92-94 (Municipal Waste Combustors (MWCs)).
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         Available in the docket at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OAR-2021-0668-1110.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         Available in the docket at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OAR-2021-0668-1092.</E>
                    </P>
                </FTNT>
                <P>
                    The EPA derived estimated “representative” costs for particular control strategies for EGUs through a wide-ranging analysis of the likely costs associated with capital, material, equipment, and labor. 
                    <E T="03">See generally</E>
                     EGU NO
                    <E T="52">X</E>
                     Mitigation Strategies Final Rule TSD. The EPA derived its cost estimates for non-EGUs primarily from the CMDB, which contains a compilation of a variety of sources of technical literature and examples.
                    <SU>40</SU>
                    <FTREF/>
                     The “representative” costs that the EPA identified for different levels of control stringency and for different industries were derived from this nationwide analysis and were not specific to the particular states included in the proposed or final Good Neighbor Plan. 
                    <E T="03">See</E>
                     88 FR 36727 (explaining derivation of $11,000/ton estimate). The EPA reasonably considered a wider range of cost information than the data that might be available in any particular state since it allows for a more comprehensive assessment of the costs each source type might be expected to 
                    <PRTPAGE P="99117"/>
                    face.
                    <SU>41</SU>
                    <FTREF/>
                     While the EPA provided for more individualized consideration of the costs particular facilities might bear and made available alternative emissions limits through its implementing regulations that could be justified on the basis of excessive cost, 
                    <E T="03">see</E>
                     88 FR 36818-19, the EPA explained that cost in the Step 3 analysis “is not intended to represent the maximum cost any facility may need to expend but is rather intended to be a representative figure for evaluating technologies to allow for a relative comparison between different levels of control stringency.” 88 FR 36740.
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">See</E>
                         Summary of Final Rule Applicability Criteria and Emissions Limits for Non-EGU Emissions Units, Assumed Control Technologies for Meeting the Final Emissions Limits, and Estimated Emissions Units, Emissions Reductions, and Costs at 5-7 (Non-EGU Memorandum), available in the docket at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OAR-2021-0668-0956.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         In response to comments, the EPA conducted a sensitivity analysis for EGUs to see if looking at control costs on a regional basis would change the results and found that it would not. EGU NO
                        <E T="52">X</E>
                         Mitigation Strategies Final Rule TSD at 49-50. The fact that the EPA conducted this as a sensitivity analysis to address a comment further illustrates that the primary technology and cost analysis the EPA conducted, as described in section III.B.2.a., was not limited to a 23-state geography and would not be altered if that geography were different.
                    </P>
                </FTNT>
                <P>The EPA also used its technology analysis to calculate the anticipated emissions reductions that could be achieved if those strategies were applied to the population of sources in each state potentially contributing to at least one downwind receptor. 88 FR 36737-40. At this stage of the analysis, the EPA's assessment of the emissions reductions expected from particular control strategies under consideration again did not depend on the number or identity of the states included in the Good Neighbor Plan rulemaking itself. Rather, these estimates provided the inputs by which air quality benefits and overcontrol could then be assessed in the next stages of the Step 3 analysis (discussed next).</P>
                <HD SOURCE="HD3">b. Air Quality Benefits</HD>
                <P>After compiling the data on available technologies, their relative cost-per-ton, and the expected emissions reductions that would result from each state, the EPA's Step 3 methodology then proceeded to evaluate the effect those emissions control strategies would have on downwind ozone levels. 88 FR 36741-42. This component of the EPA's analysis looked at the incremental ozone improvement that would be accomplished at each receptor from the reductions accruing from the upwind states linked to that particular receptor (whether included in a particular rule or not) at each of the assessed stringency levels. The analysis of air quality improvement as the EPA has conducted it (in the Good Neighbor Plan and in the prior CSAPR rulemakings) displays the improvements that are incremental to an uneven baseline in which states have imposed differing levels of control stringency. Another way to think about the level of air quality benefit achieved would be to assume an uncontrolled baseline across all states and then apply the different levels of control stringency that were evaluated. This would illustrate far higher levels of air quality benefit as the uniform stringency levels are increased but would not credit the achievements in emissions control that some states have already adopted compared to others.</P>
                <P>
                    To calculate air quality change for any given upwind state-receptor linkage, the relevant group of states assumed to make comparable emissions reductions will vary, and in the EPA's primary method of analysis, it does not matter whether the other upwind states or the downwind state are in fact subject to the same emissions control requirements. Rather the purpose of the analytical exercise is to isolate, for comparative purposes, the effects of the potential stringency levels just to the states that are linked to a receptor while also assuming that the “home” state undertakes an equivalent level of stringency with respect to its own sources. 
                    <E T="03">See</E>
                     88 FR 36742, 36748-50. Thus, the total number of states where the EPA has assumed emissions control stringencies as part of its Step 3 air quality assessment for purposes of the Good Neighbor Plan is 30 states. That is, the total of the 23 states included in the Good Neighbor Plan, the five other states that the EPA's analysis identified as potentially or likely to be linked at Step 2, plus, for their own receptors, Colorado and Connecticut as home states, even though they are not linked to other states' receptors.
                </P>
                <P>
                    The EPA's conclusions in the Good Neighbor Plan did not depend on a particular improvement at each individual receptor, but rather on an assessment that there would be widespread improvement in ozone levels across receptors in the aggregate and on average when the selected level of control stringency is applied uniformly across upwind states. 
                    <E T="03">See</E>
                     88 FR 36742-43, 36747-48. In the Good Neighbor Plan, as relevant metrics, the EPA displayed how ozone levels would be expected to change at each receptor, what the average effect of the potential stringency levels would be across all receptors, and what the aggregated effect of the potential stringency levels would be across all receptors. 
                    <E T="03">Id.</E>
                     at 36742-43, 36747-48. This analytical exercise allowed the EPA to evaluate what level of stringency was appropriate in terms of delivering an acceptable level of air quality benefit to downwind receptors considering associated costs.
                </P>
                <P>
                    The role of the air-quality factor in the Good Neighbor Plan is essentially no different than in CSAPR. 88 FR 36678. The CSAPR analysis was conducted on a nationwide scale and focused on cost-breakpoints of different technologies, while also accounting for multiple factors other than a singular “knee-in-the-curve;” CSAPR looked holistically at both the “pattern” of linkages and the “average” air quality benefits that could be realized at representative cost/ton thresholds if those technologies were applied uniformly; CSAPR selected stringency levels that appeared to deliver the greatest air quality improvement on average, not state- or linkage-specific. 
                    <E T="03">See id.;</E>
                     76 FR 48255-59. Likewise, in the Good Neighbor Plan, the Agency focused on mandating those NO
                    <E T="52">X</E>
                     reduction strategies across contributing states that were found to be relatively widely-adopted and cost-effective on a per-ton basis, with the understanding that if these strategies were implemented uniformly across the upwind-state region, widespread air quality improvement would be achieved—without tethering that conclusion to some precise knee-in-the-curve specific to each linkage or receptor. 
                    <E T="03">See</E>
                     88 FR 36741.
                </P>
                <P>Commenters allege that this analysis necessarily depends on the specific group of states for which it is conducted, since different groups of states would have different sets of sources, with varying levels of emissions control already installed, and the application of emissions control strategies will have varying effects on downwind air quality. Effectively, these commenters seem to assert, for its methodology to function on an individual basis for each state, the EPA must determine for each state what level of emissions control applied only to its own sources would maximize cost-effectiveness relative to reducing ozone levels at a given downwind receptor. Under this theory, if the EPA conducted such an analysis, the appropriate level of stringency would vary for any particular state from what the EPA determined was appropriate in the Good Neighbor Plan on a uniform basis across states—and perhaps a lesser degree of stringency would be warranted for particular states.</P>
                <P>
                    Fundamentally, these comments misapprehend the role of air quality improvement in the EPA's Step 3 analysis and are, in effect, at odds with the EPA's historical approach that the Supreme Court's opinion in 
                    <E T="03">EME Homer City</E>
                     upheld, 
                    <E T="03">i.e.,</E>
                     the use of uniform control stringency (using cost as a proxy for technology type and compliance burden) to allocate responsibility across 
                    <PRTPAGE P="99118"/>
                    multiple upwind states despite varying effects of that stringency to downwind receptors. 572 U.S. at 518-19. Consistent with the same statutory interpretation and methodology the EPA has applied throughout each of its prior good neighbor rulemakings for ozone, the Good Neighbor Plan is not premised on accomplishing a precise, aggregate air quality result at each receptor, such that the omission of some states (even if they were legally exempted from obligations rather than simply under a temporary stay order or did not yet have their obligations addressed through a SIP or FIP) would increase the “share” of the problem that must be addressed by the remaining states. Rather, the Good Neighbor Plan holds the industries in each contributing upwind state subject to a federal plan to a uniform, minimum level of emissions performance deemed to be cost-effective. So long as they meet that level of performance, the industries in any state regulated under the Good Neighbor Plan are understood to have lawfully addressed good neighbor obligations and eliminated that portion of a state's significant contribution to downwind air pollution.
                </P>
                <P>
                    Even though this methodology does not purport to achieve attainment at all downwind receptors, it is consistent with the EPA's and the courts' understanding of the good neighbor provision. Under that provision, it is not upwind states' responsibility to ensure that downwind receptors are brought into attainment; each state must only eliminate its own significant contribution to nonattainment or interference with maintenance of the NAAQS in other states. CAA section 110(a)(2)(D)(i)(I). In reviewing the division of responsibility under this contribution standard, courts have upheld the EPA's approach as a reasonable way to allocate good neighbor obligations among multiple states for regional-scale pollutants like ozone, even though the air quality benefits resulting from a particular degree of control stringency will necessarily vary by state and receptor. This variation in effect is the consequence of an approach that respects several well-understood characteristics of the interstate ozone problem: the “overlapping and interwoven linkages between upwind and downwind States,” “the vagaries of the wind” (
                    <E T="03">i.e.,</E>
                     the variability in meteorological conditions that makes precise ozone projections impossible), and the wide variation in the degree of baseline levels of emissions control that different states have already achieved. 
                    <E T="03">EME Homer City,</E>
                     572 U.S. at 496-97, 519-20; 
                    <E T="03">see also Wisconsin,</E>
                     938 F.3d at 322; 
                    <E T="03">Michigan,</E>
                     213 F.3d at 679-80. Commenters may believe that the EPA could at least establish different levels of cost-effective control stringency for each group of states linked to a particular receptor, rather than considering air quality improvement in the aggregate across all receptors—
                    <E T="03">i.e.,</E>
                     to pick a knee in the curve that is specific to each particular receptor. Setting aside the problem of meteorological variability, this still presents the same problem the EPA faced in CSAPR, as recognized in 
                    <E T="03">EME Homer City:</E>
                     each set of states for one receptor has overlap with a different set of states for a different receptor.
                    <SU>42</SU>
                    <FTREF/>
                     Thus, for any given state, there cannot mathematically be a single, “correct” “knee-in-the-curve” that defines a maximally cost-effective stringency. 
                    <E T="03">EME Homer City,</E>
                     572 U.S. at 514-18. Thus, as was the case in CSAPR, an approach that requires high-emitting sources in each state to come up to a uniform level of cost-effective emissions control, so long as it does not overcontrol, functions as a reasonable definition of each covered state's “significant contribution,” and fulfills those covered upwind states' legal obligations under the good neighbor provision. 88 FR 36675-76, 36741.
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         Air Quality Modeling Final Rule TSD, 2015 ozone NAAQS Good Neighbor Plan, appendix E, available in the docket at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OAR-2021-0668-1157.</E>
                    </P>
                </FTNT>
                <P>
                    Both the Supreme Court and the D.C. Circuit have recognized that variation in what a good neighbor rule will achieve at any particular receptor is a logical consequence of defining “significance” through identifying a uniform level of emissions control based on cost-effectiveness. As the Supreme Court explained in 
                    <E T="03">EME Homer City,</E>
                     “by imposing uniform cost thresholds on regulated States, EPA's rule subjects to stricter regulation those States that have done relatively less in the past to control their pollution” and ensures that “[u]pwind States that have not yet implemented pollution controls of the same stringency as their neighbors will be stopped from free riding on their neighbors' efforts to reduce pollution.” 
                    <E T="03">EME Homer City,</E>
                     572 U.S. at 519. The fact that a particular state may have a very small emissions reduction obligation, and so improve downwind air quality by a very small amount, does not call the approach into question. The fact that a state may have less to do to meet the EPA's selected levels of emissions control may reflect that its sources are already well controlled. But whether a state's required reductions under a FIP applying this methodology are large or small, the approach allows for a fair alignment of investments in pollution control across all of the contributing states, which is at the heart of the methodological construct the Court approved in 
                    <E T="03">EME Homer City. See Wisconsin,</E>
                     938 F.3d at 322 (concluding that the EPA reasonably regulated sources in Wisconsin, a contributing upwind state whose available cost-effective reductions would only benefit downwind air quality “by just two ten-thousandths of a part per billion”).
                </P>
                <P>
                    This is not to say that delivering air quality improvement to the downwind receptors is not important—indeed, it is, as the EPA described in the Good Neighbor Plan, a “central component” of the EPA's analysis. 88 FR 36741. If the identified control strategies that were cost-effective on a cost-per-ton basis did not have any effect on downwind air quality at any receptors, this may call into question whether requiring those strategies was worth it.
                    <SU>43</SU>
                    <FTREF/>
                     Thus, the Good Neighbor Plan explains that the purpose of the EPA's air quality analysis at Step 3 is to check on whether a level of emissions reduction that appeared cost-effective on a cost-per-ton basis would in fact deliver measurable progress toward attainment of the 2015 ozone NAAQS at the downwind receptors. “These analytical findings cement EPA's identification of the selected EGU and non-EGU mitigation measures as the appropriate control stringency . . . .” 88 FR 36741.
                </P>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         Even here, however, caution is in order. A highly cost-effective strategy may not deliver incremental air quality improvement from a given baseline because that strategy has already been adopted by sources in a particular state or states. In that case, a rule imposing that strategy would not create new emissions reduction obligations but would be appropriate to prevent backsliding. 
                        <E T="03">Cf. EME Homer,</E>
                         572 U.S. at 519-20 (noting the uniform approach appropriately treats states where sources have already invested in pollution control). Likewise, the EPA's good neighbor rules have always applied to both new and existing sources. 
                        <E T="03">See</E>
                         88 FR 36685. If a particular industry is not currently present in a particular state but could have high uncontrolled emissions if it located there, good neighbor rules serve as a backstop to ensure a minimum level of emissions performance will be maintained from those sources, in those states that have been deemed to contribute to another state's nonattainment or maintenance issues. Nonetheless, the basic emissions-performance requirements of a good neighbor rule in those cases should not be onerous for a new source.
                    </P>
                </FTNT>
                <P>
                    The EPA's analysis in the Good Neighbor Plan demonstrates that with each incremental increase in the stringency of the assessed control strategies, there is also incremental improvement in air quality at the receptors. 
                    <E T="03">See, e.g.,</E>
                     88 FR 36743, 36747-
                    <PRTPAGE P="99119"/>
                    48 (tables showing air quality improvement at each receptor); Ozone Transport Policy Analysis Final Rule TSD at 70 (table C-12) (Ozone Policy TSD) (showing reductions in the maximum contribution of each upwind State to receptors in 2026).
                    <SU>44</SU>
                    <FTREF/>
                     Further, the Agency explained that it could not identify a point of diminishing returns within the suite of emissions control strategies that it ultimately selected. 88 FR 36741. The Agency also cautioned that the purpose of this exercise was not to pinpoint a precise “knee-in-the-curve” but to serve as “a useful indicator for informing potential stopping points.” 
                    <E T="03">Id.</E>
                     Thus, the EPA's review of the effects of different emissions-reduction strategies on air quality primarily helps the Agency ensure that no impactful emissions reduction strategies have been overlooked and that those selected can be anticipated to deliver reductions in ozone at the identified receptors if applied consistently across all of the upwind states linked to each receptor (including each receptor's home state).
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         Available in the docket at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OAR-2021-0668-1080.</E>
                    </P>
                </FTNT>
                <P>
                    Commenters have not put forward an alternative, more cost-effective methodology or set of emissions-control strategies for reducing ozone at the downwind receptors; rather, they seek to avoid emissions control obligations in one state on the basis that the Good Neighbor Plan may not be operative in another. However, the EPA has an ongoing statutory obligation to issue FIPs for those states where it has issued a SIP disapproval or made a finding of failure to submit. In the absence of information detailing that cost-effective emissions reduction opportunities have been overlooked that would have an even greater benefit on ozone levels at downwind receptors, the EPA reasonably concluded that its identification of emissions limitations consistent with the cost-effective emissions control technologies that it has identified to be widely available at the new and existing EGU and non-EGU sources in the states covered by the Good Neighbor Plan passed its Step 3 air quality check, and these measures would constitute a sufficient and appropriate definition of “significant contribution” for these states.
                    <SU>45</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         As always, states remain free to identify different emissions control measures through a SIP than the EPA has included in a FIP, and it may be possible for a state to demonstrate that it can control other sources to obtain equivalent or greater air quality results at its receptors. A SIP submission to the EPA obtaining those emissions reductions through permanent and enforceable measures applied to its in-state emissions sources accompanied by the appropriate analytical and technical justifications would likely be approvable to replace a good neighbor FIP.
                    </P>
                </FTNT>
                <P>
                    Although the air quality benefits to downwind receptors anticipated in the Good Neighbor Plan would not be fully realized so long as certain states have not yet fulfilled their obligations, this does not serve as a justification for allowing these obligations for those states where the EPA has a responsibility to act to go unaddressed or to be altered. Simply put, the CAA requires each state to address its own contributions to downwind air quality problems, regardless of whether other states have taken action to do so under a SIP or a FIP. That other states contributing to downwind receptors may have their good neighbor obligations stayed or not yet addressed does not relieve other states covered by the Good Neighbor Plan of their own good neighbor obligations under CAA section 110. Given the state-by-state procedural framework of the Act and the need for the EPA to develop equitable and consistent FIPs, it cannot be the case that the EPA must successfully simultaneously resolve all states' good neighbor obligations at once or lose the authority to act. Though the EPA has done its best to achieve consistent, timely, and concordant implementation of these obligations, like the construction of a jigsaw puzzle, each individual piece (
                    <E T="03">i.e.,</E>
                     each individual state's obligations) is necessary to complete the whole picture, and not every piece may be connected at once.
                </P>
                <P>Commenters attempt to fault the EPA for developing a methodology that they claim necessarily depends on the inclusion of other states. Setting aside that for the reasons explained here the methodology does not depend on simultaneous inclusion (or even full inclusion, if states address their good neighbor obligations in some other adequate way through a SIP), the problem commenters identify is not in the particular methodology that the EPA uses but in the science of ozone transport as a multistate problem characterized by meteorological variability and overlapping linkages, coupled with the state-by-state implementation structure of the Act. Under these constraints, any methodology would need to take into account the relative contributions of and the effects of air pollution control technologies in other states.</P>
                <P>
                    To perform the air quality check for any particular receptor, it makes sense to consider the effect of emissions reductions from all of the states linked to that receptor, not just those covered by a particular FIP rulemaking, because all states must ultimately discharge their good neighbor obligations whether through an approved SIP or a FIP. Thus, the Step 3 air quality analysis is a “test” that serves to confirm that an appropriate degree of emissions-control stringency has been reached for any given state without overcontrolling. It does not depend on the actual, simultaneous inclusion of a certain number of states in a given rulemaking; however, it appropriately accounts for the reality that multiple states are linked to multiple other states and that the amount of emissions reduction necessary to achieve attainment varies among receptors. This complexity, recognized for years by the EPA and by the Supreme Court in 
                    <E T="03">EME Homer City,</E>
                     572 U.S. at 514-17, makes it analytically inappropriate if not impossible to assign an obligation to each state that is simply proportional to its contribution to a particular receptor. 
                    <E T="03">See</E>
                     88 FR 36683.
                    <SU>46</SU>
                    <FTREF/>
                     Nonetheless, that does not prevent the EPA (or for that matter an individual upwind State) from being able to conduct a Step 3 test looking at the effects of uniform control stringencies using a publicly available tool such as the Air Quality Assessment Tool (AQAT). Given the multistate nature of the interstate ozone pollution problem, analysis of the air quality benefit produced by regulating sources in any particular upwind state assumes that other states linked to a common receptor and the home state of that receptor make emissions reductions at a comparable level of emissions control 
                    <PRTPAGE P="99120"/>
                    regardless of whether they are covered by the Good Neighbor Plan.
                </P>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         The EPA has previously evaluated Step 3 alternatives to the “uniform approach” taken in the Good Neighbor Plan and prior ozone transport rules, including an evaluation of methods such as a receptor-specific proportionality approach. The alternative methods, as well as potential issues that the Agency identified can be found in the “Alternative Significant Contribution Approaches Evaluated TSD” included in the CSAPR rulemaking docket (Docket ID No. EPA-HQ-OAR-2009-0491-0077). In responding to comments in that rulemaking about “proportionality” approaches, the Agency identified concerns that included, but were not limited to, requirements of an “extremely high level of accuracy in both the emissions modeling . . . and the air quality modeling” and that “finer-scale emissions data from all sectors . . . . and fine-scale air quality modeling could be needed to resolve differences in cost per air quality impact.” The EPA explained that “these data and modeling techniques do not exist and/or are too computationally demanding to be operationally implemented.” The EPA continued, “A second challenge for this approach was to identify a single reduction requirement for a particular upwind State, since the reduction requirements relevant to different downwind receptors would vary significantly.” 
                        <E T="03">See</E>
                         CSAPR “Transport Rule Primary RTC” document 743 (Docket ID No. EPA-HQ-OAR-2009-0491-0077).
                    </P>
                </FTNT>
                <P>
                    It is true that the EPA's analysis of air quality change at Step 3 uses state-specific data and calibration factors. 
                    <E T="03">See</E>
                     Ozone Transport Policy Analysis Final Rule TSD at 43. Commenters may have had uncertainty concerning the respective roles of state-level versus national-level analytical determinations within the air quality analysis at Step 3, with a potential concern being that if the EPA was relying on state-level determinations, then the stringency of the Good Neighbor Plan would be dependent on particular state groupings. But this would over-interpret the role of these particular datapoints in the larger analysis. State-level emissions data and calibration factors ensure an accurate representation of the effects of emissions reductions across the different States. However, this does not imply the Good Neighbor Plan fails to define obligations on a reasonable basis for each state. To the contrary, it confirms that the EPA's analysis already accounts for the emissions reductions and air quality change that can be anticipated from each state individually, rather than merely treating them as an undifferentiated regional mass specific to the group of states included in a particular rulemaking. More importantly, as described above, the regulatory conclusions the EPA drew from the AQAT analysis focused not on the individualized outcomes of each linkage but rather on the averaged and aggregated data drawn from that analysis for the entire country, which “cemented” the EPA's finding that an overall appropriate level of stringency was obtained, without overcontrolling. 88 FR 36741, 36747-48.
                    <SU>47</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         Notably, the EPA highlighted that its forward-looking air quality projections are subject to inherent uncertainty given the many factors that influence ozone formation. 88 FR 36750. And the EPA acknowledged that states in the future may conduct updated air quality analysis that may differ from its own analytics in the rule. 
                        <E T="03">Id.</E>
                         at 36839-40; 
                        <E T="03">id.</E>
                         n. 405. Still, in the absence of particularized evidence of overcontrol and faced with a concomitant duty to avoid 
                        <E T="03">under</E>
                        -control, 
                        <E T="03">id.</E>
                         at 36684 (citing 572 U.S. at 523), the EPA's approach yields a set of emissions reduction obligations that would be reasonable in a robust way across all covered large-emitting sources in any contributing state that may eventually become subject to a good neighbor FIP for the ozone NAAQS.
                    </P>
                </FTNT>
                <P>
                    Illustrating that the Good Neighbor Plan's regulatory conclusions were drawn from this nationwide assessment of air quality effects of different control stringencies, rather than from the particulars of the 23-state grouping included in the Good Neighbor Plan, the EPA's primary Step 3 air quality and overcontrol analysis in the Good Neighbor Plan included any other linked upwind states found at Steps 1 and 2 of the EPA's framework, regardless of whether or not they were included in the Good Neighbor Plan, on the view that this was the most appropriate way to analyze the collective effects of identified stringency levels at Step 3. 
                    <E T="03">See</E>
                     Ozone Policy TSD at 46, 55 (explaining that the EPA included all upwind states modeled to be contributing in this assessment, 
                    <E T="03">i.e.,</E>
                     including states that were not presently included in the Good Neighbor Plan but might be through a future rule, such as Iowa, New Mexico, and Arizona 
                    <SU>48</SU>
                    <FTREF/>
                    ). Accordingly, the EPA's Step 3 air quality analysis did not rely on a 23-state scope of coverage, and nowhere in the record for the Good Neighbor Plan did the EPA state or imply that its methodology relied on a 23-state scope of coverage.
                    <SU>49</SU>
                    <FTREF/>
                     For any particular receptor, the EPA's analysis looked at the group of upwind states linked to that receptor in the modeling (the numbers of which vary), and also assigned the home state for that receptor a “fair share” (
                    <E T="03">i.e.,</E>
                     the same stringency that would be imposed in the upwind states for that receptor). 88 FR 36742 n.238. The analysis did not depend on the actual inclusion of those particular states in the Good Neighbor Plan; it simply looked at what the effect would be if, for any given upwind state and any given receptor, the other upwind linked states and the downwind state were held to the same stringency level.
                </P>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         Due to data limitations at the time of finalizing the Good Neighbor Plan, the analysis did not include an assessment of the effects from non-EGUs in Arizona, even though Arizona is linked through the 2026 analytic year. Otherwise, in the AQAT analysis of the Good Neighbor Plan, data informing the EPA's Step 3 air quality evaluation included every monitor in the contiguous United States, with contributions adjusted for each state that was either linked above 1 percent of the NAAQS in the relevant analytic year or was a home state for the receptor.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         The EPA acknowledges that certain language in the Ozone Policy TSD for the Final Good Neighbor Plan may have been inartful or unclear on this point. For example, that document stated at page 3 that it was focused on the “23 upwind States that were linked” and included in that rule. This was true in a sense, because the TSD was done in support of that rule, which covered 23 states. However, the underlying data and evaluation of the effects of emissions change on air quality encompassed the entire contiguous U.S., and the TSD displayed anticipated air quality improvement at identified receptors by reference to all upwind states (and “home” states) and was not limited only to the 23 states included in that rule. Results for Kansas and Tennessee were not displayed in the TSD because a final determination had not been made to consider these states linked based solely on violating-monitor receptors. 
                        <E T="03">See</E>
                         88 FR 36707. However, the underlying AQAT spreadsheets used for the Ozone Policy TSD analysis included the reductions from these states in the data made available to understand the effects of the evaluated emissions control strategies. 
                        <E T="03">See, e.g.,</E>
                         Ozone AQAT Results, tab: “2023_step3_newSCR_wIRA”, cols. I-BF, available in the docket at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OAR-2021-0668-1116.</E>
                    </P>
                </FTNT>
                <P>
                    Stated differently, the EPA's analysis identified a total of 28 states as contributing at Step 2. 88 FR 36709-12. As such, subject to the caveats in notes 48 and 49 
                    <E T="03">supra</E>
                     concerning certain limitations in the data, the EPA appropriately assessed the effect of applying the uniform levels of emissions control stringency across all contributing States to any given receptor (
                    <E T="03">i.e.,</E>
                     varying combinations of the 28 states plus home state for each receptor)—regardless of their inclusion in the Good Neighbor Plan—in evaluating whether the Good Neighbor Plan reasonably addresses the “significant contribution” of any particular state.
                </P>
                <P>
                    The emissions control measures identified at Step 3 do not depend on which particular states adopt cost-effective controls as part of the EPA's analysis of air quality benefits. The role of the air quality analysis is simply to verify that the cost-effective controls identified by the EPA for any particular state would, in fact, have an impact on downwind receptors 
                    <E T="03">if</E>
                     they were uniformly adopted in all states contributing to that receptor (and the home state), without overcontrolling. Whether all of those states ultimately adopt those emissions controls, or do so simultaneously, or adopt equivalent controls but on different sources, or may otherwise develop an alternative approach that is approvable for that particular state, does not affect the EPA's determination at Step 3 that those controls, as to the state(s) where the EPA applies them through FIP(s), are cost-effective—and that the sets of sources within any individual state must achieve performance consistent with those controls to satisfy the state's good neighbor obligations.
                </P>
                <P>
                    Thus, the EPA's analysis of air quality benefits at Step 3 was not limited to the specific set of states expected to be covered by a FIP, but appropriately considered the cost-effective emissions reductions available from all upwind states linked to each downwind receptor (as well as the receptor's home state). Consistent with the Act, that methodology functions as an appropriate analytical method to define any particular state's good neighbor obligations for ozone and does so without requiring, or possessing definitive knowledge, that the same methodology would be applied in other states.
                    <PRTPAGE P="99121"/>
                </P>
                <HD SOURCE="HD3">c. Overcontrol Assessment</HD>
                <P>
                    Finally, at Step 3, the EPA “tests” whether its selected uniform emissions-control stringency levels result in any “overcontrol.” 88 FR 36749-50. In 
                    <E T="03">EME Homer City,</E>
                     the Supreme Court held that the EPA cannot “require[] an upwind State to reduce emissions by more than the amount necessary to achieve attainment in every downwind State to which it is linked.” 572 U.S. at 521. To find overcontrol, the EPA must conclude that the uniform control stringencies the EPA selected produced more emissions reductions and resulting air quality improvements than necessary to resolve all of any state's linkages to downwind receptors, or more than necessary to bring receptors into attainment. In that case, under the overcontrol holding in 
                    <E T="03">EME Homer City,</E>
                     the EPA would need to adjust the requirements of the rule to avoid overcontrol. This overcontrol assessment is conducted using the same air quality effects analysis derived from AQAT, described in section III.B.2.b.
                </P>
                <P>
                    If the Good Neighbor Plan were to be suspended from operation in some number of upwind states, this could not result in overcontrol, because the analysis (presented in the Ozone Policy TSD) demonstrates no overcontrol even when all upwind states found to be contributing are included—much less the 23 states included in the originally promulgated Good Neighbor Plan itself.
                    <SU>50</SU>
                    <FTREF/>
                     As long as fewer states are making fewer emissions reductions, the downwind receptors cannot be cleaner than they were under the Good Neighbor Plan's original scope. 
                    <E T="03">See</E>
                     88 FR 36749-50.
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         As explained in section III.B.2.b., the primary air quality assessment at Step 3, including for purposes of evaluating overcontrol, looks at the effects on ozone levels of different levels of emissions control across all upwind states found to be contributing to a particular receptor (plus the home state), not just the states included in a particular rulemaking. In the Good Neighbor Plan, the EPA ran the AQAT analysis for a total of 28 linked upwind states, not just the 23 states included in the rule. 
                        <E T="03">See</E>
                         note 49 
                        <E T="03">supra.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">d. Other Elements of the Non-EGU Step 3 Analysis</HD>
                <P>
                    To ensure a complete response to the commenters, the EPA has reviewed in greater detail all elements of the Step 3 methodology of the Good Neighbor Plan to evaluate whether any components of its analysis pose a concern that the EPA's analytical findings are not severable among the various states. Two elements of the EPA's technology and cost analysis for non-EGUs in the Good Neighbor Plan incorporate analytical methodologies related to some extent to the upwind region covered by the rule and warrant further discussion here. These are: (1) the identification of potentially impactful industries in the “Screening Assessment” used in the Good Neighbor Plan to assist the EPA in narrowing the scope of industries to be included in its non-EGU regulations; and (2) the “weighting” of average costs for two non-EGU industries and a specific emissions unit type (boilers) where multiple control technologies were identified at Step 3. The EPA has reviewed, based on the record for the Good Neighbor Plan, whether either of those elements materially influenced the determination of each state's “significant contribution.” As explained in the “
                    <E T="03">Use of Screening Assessment to Identify Potentially Impactful Industries”</E>
                     and “
                    <E T="03">Weighted Averaging Costs”</E>
                     below, they did not. Neither of these aspects of the analysis suggest that the EPA should reach different conclusions as to each covered state's “significant contribution” while the Good Neighbor Plan applies in a different group of States.
                </P>
                <HD SOURCE="HD3">Use of Screening Assessment To Identify Potentially Impactful Industries</HD>
                <P>
                    For non-EGUs, the EPA elected to screen for industries and emissions-unit types appropriate for analysis of cost-effective NO
                    <E T="52">X</E>
                     reductions. While power plants have consistently been understood to have high levels of controllable NO
                    <E T="52">X</E>
                     emissions and have been included in each good neighbor rulemaking, non-EGUs have not been consistently addressed. 
                    <E T="03">See</E>
                     88 FR 36720. Certain non-EGU industries and emissions units/sources were included in the 1998 NO
                    <E T="52">X</E>
                     SIP Call, but not in subsequent rules, although the EPA had acknowledged that such sources may necessitate regulation to prohibit significant contribution and had in the past analyzed such sources on a “parallel track” to its EGU analysis at Step 3. 
                    <E T="03">See</E>
                     88 FR 36719. For the 2015 ozone NAAQS, the EPA concluded that it could not determine it could eliminate the entirety of the covered states' “significant contributions” to downwind nonattainment by addressing power plants alone. 88 FR 36680-82. To that end, the EPA was required to look beyond the power sector, and when it did so, the EPA determined that certain large industrial sources have substantial amounts of ozone-precursor emissions that could be cost-effectively controlled and therefore, consistent with its longstanding methodology, should be obligated to reduce those emissions, so long as such measures would not result in “overcontrol.” 
                    <E T="03">Id.</E>
                     at 36660-61. Because the potential number of industries and source types is large, the EPA used a screening methodology to assist in narrowing the scope of industries to be potentially regulated to those with potential cost-effective NO
                    <E T="52">X</E>
                     reductions.
                </P>
                <P>
                    To screen for industries and emissions-unit types to further assess for cost-effective NO
                    <E T="52">X</E>
                     emissions reductions, the EPA prepared a “Screening Assessment.” 
                    <SU>51</SU>
                    <FTREF/>
                     In the Screening Assessment, the EPA used emissions and control technology information to screen for industries and emissions unit types where emissions reductions were more likely to be cost-effective and to screen out industries where emissions reductions were less likely to be cost-effective. As part of this analysis, the EPA used air quality criteria to identify how emissions reductions from industries and emissions units would likely benefit downwind areas. 
                    <E T="03">See</E>
                     Screening Assessment at 1-3. This analysis used modeled nonattainment and maintenance receptors in 2023 and an inventory of sources in those upwind states that were identified using the air quality modeling that was available at the time the EPA was developing the assessment.
                    <SU>52</SU>
                    <FTREF/>
                      
                    <E T="03">See</E>
                     Screening Assessment, appendix A (table A-3). This modeling had identified 27 states as upwind contributors to at least one downwind receptor. In conducting its screening analysis, the EPA took these states to be broadly representative and appropriate for the purpose of screening non-EGU NO
                    <E T="52">X</E>
                     sources by industry across a large set of upwind states, as identified by the then-available modeling.
                    <SU>53</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         Screening Assessment of Potential Emissions Reductions, Air Quality Impacts, and Costs from Non-EGU Emissions Units for 2026, available in the docket at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OAR-2021-0668-0150.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         We developed the Screening Assessment using inputs from the air quality modeling for the Revised CSAPR Update for 2023 (2016v1), as well as the projected 2023 annual emissions inventory from the 2016v2 emissions platform that was used for the air quality modeling for the proposed Good Neighbor Plan. Screening Assessment at 1-2.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         The differences in states identified in the 2016v1 modeling compared to the states the EPA identified as linked for the 2023 analytic year using 2016v3 modeling and the violating-monitor receptor identification methodology are as follows: Delaware and Wyoming were linked in 2016v1 and Arizona, Kansas, and New Mexico were not. The linkages used in the Screening Assessment (for 2023) also reflected a slightly different set of states than the EPA expected, at the time of proposal, to be linked in 2026. 
                        <E T="03">Compare</E>
                         Screening Assessment at 2 
                        <E T="03">with</E>
                         87 FR 20036, 20041 (proposing to apply non-EGU measures in 23 states, not including Alabama, Delaware, Iowa, or Tennessee).
                    </P>
                </FTNT>
                <P>
                    The EPA concluded in finalizing the Good Neighbor Plan that this portion of the non-EGU analysis did not need to be redone on the basis of changes in the scope of coverage of the rule. 
                    <E T="03">See</E>
                     Good 
                    <PRTPAGE P="99122"/>
                    Neighbor Plan RTC at 104 (“The purpose [of the Screening Assessment] is not a precise replication of exactly which sources contributed exactly how much to any particular receptor during a particular high-ozone event. The purpose is to identify those industries with relatively large emissions sufficient to have interstate effects on ozone levels, and to analyze emissions units within those industries further for cost-effective emissions reduction opportunities.”). Thus, the EPA was clear in the record of the Good Neighbor Plan that the Screening Assessment served an important but limited purpose: to screen for industries and emissions-unit types where further analysis was likely to identify more impactful and less costly emissions reduction opportunities. 
                    <E T="03">See also</E>
                     88 FR 36740; Good Neighbor Plan RTC at 90-92.
                </P>
                <P>
                    Consistent with the statutory language of the good neighbor provision, the EPA could have chosen to forgo this analysis, which assisted the Agency in narrowing the set of non-EGU industries and emissions source types it considered for inclusion in the Good Neighbor Plan, and include more stationary industrial sources of NO
                    <E T="52">X</E>
                    . 
                    <E T="03">See</E>
                     CAA section 110(a)(2)(D) (authorizing regulation of “any source or other type of emissions activity” for significant contribution); 
                    <E T="03">see also</E>
                     88 FR 36680-81.
                    <SU>54</SU>
                    <FTREF/>
                     However the EPA might have proceeded, in the rule the Agency was appropriately informed by a longstanding understanding of regional-scale ozone transport, which is that the control of any large sources of NO
                    <E T="52">X</E>
                     emissions in linked upwind states will generally beneficially affect downwind ozone levels. 88 FR 36719. While states are afforded discretion under the Act to select the control measures they would prefer to use to meet the Act's requirements, such discretion devolves to the EPA when it steps into the shoes of a state under CAA section 110(c). 
                    <E T="03">Id.</E>
                     at 36675 (collecting case law). Within the exercise of that discretion, the EPA's method of proceeding made sense. The EPA's approach provided a technically rigorous method for narrowing the industries in a manner that treated each industry similarly. As the EPA explained in rejecting comments that its modeling projections in the Screening Assessment were too imprecise, the Assessment was done not for the purpose of “project[ing] changes in air quality in an absolute sense,” but rather to “conduct a comparative analysis among different industries,” where the EPA's modeling techniques “would apply consistently and equally to each industry the EPA evaluated.” Good Neighbor Plan RTC at 105.
                    <SU>55</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         Had the EPA approached the identification of “significant contribution” from non-EGU emissions sources differently, it still would have needed to assess overcontrol and would have excluded emissions reduction measures falling outside the range of technologies deemed cost-effective.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         Again, illustrating the EPA's consistent understanding of this comparative purpose, the Agency rejected other comments calling for the Screening Assessment to be redone on the basis of updated information concerning specific non-EGU facilities, which various commenters attempted to use to argue the EPA's data were out-of-date. “Even if some amount of the emissions identified as potentially controllable in the Screening Assessment are already being achieved, or such potentially controllable emissions cannot be feasibly controlled and are not being required in this final rule, 
                        <E T="03">that does not undermine the Agency's conclusions in the Screening Assessment regarding the potential impact of a given industry.”</E>
                         Good Neighbor Plan RTC at 120 (emphasis added).
                    </P>
                </FTNT>
                <P>
                    This approach of identifying uniform emissions control opportunities at the industry-level rather than based on a state-by-state or unit-by-unit impact analysis accords with the way the EPA has analyzed emissions control opportunities from both EGUs and non-EGUs throughout the history of implementation of the good neighbor provision. 
                    <E T="03">See id.</E>
                     at 92 (quoting 63 FR 57399 (uniformity at industry level “assure[s] equity among the various source categories and the industries they represent”)); 88 FR 36683 (explaining that the EPA's analysis of non-EGUs sources “parallels the analysis previously conducted only for EGUs” and “relies on evaluation of uniform levels of control stringency across all upwind states”). When commenters argued that the EPA had not adequately established that their particular facilities were sufficiently impactful to be worth regulating, the EPA rejected this mode of analysis: 
                </P>
                <EXTRACT>
                    <P>
                        [I]t was entirely reasonable, and consistent with prior transport rulemakings to focus the analysis at the industry-level rather than attempt to identify air quality impact thresholds at the unit- or source-specific level. To build on the response above, it is important to keep in mind that regional interstate ozone transport is a “collective contribution” problem, in which the ozone-precursor emissions of many sources combine to create ozone nonattainment and maintenance problems at potentially great distances from individual source emissions points. Attribution of responsibility for this problem is complicated by varying meteorological conditions from year to year and even from day to day. The EPA's Step 1 and Step 2 analysis within the 4-step interstate transport framework is designed to robustly identify where ozone problems are located and which states' anthropogenic emissions contribute to those problems. At Step 3, the analysis shifts to an evaluation of which emissions reductions from those contributing states would be most cost-effective to achieve to eliminate that portion of the states' emissions that are deemed “significant” and thus must be eliminated. Focusing on entire industries (as the EPA has done in prior rules with its focus on EGUs (
                        <E T="03">e.g.,</E>
                         CAIR and CSAPR)) and other industry categories in addition to EGUs (as we did in the NO
                        <E T="52">X</E>
                         SIP Call) presents an efficient and equitable methodology for identifying where the most cost-effective emissions reductions can be identified at the regional scale.
                    </P>
                </EXTRACT>
                <P>
                    Good Neighbor Plan RTC at 98 (citing 63 FR 57386); 
                    <E T="03">see also</E>
                     88 FR 36685 (similar reasoning supports including new sources of the same type as existing sources in good neighbor implementation plans); 
                    <E T="03">id.</E>
                     at 36746-47 (explaining that uniform control by unit type avoids risk of production and emissions shifting). In short, when the EPA must devise a federal solution to interstate ozone transport for one or more states, its objective is to implement measures that are comprehensive, durable, and robust, not to engage in a never-ending game of whack-a-mole at each emissions point.
                </P>
                <P>
                    The Screening Assessment was one step along the way of focusing the Agency's limited resources and narrowing the scope of the regulation of NO
                    <E T="52">X</E>
                     emissions “sources” and “activities”; it was not intended to dictate final determinations regarding “significant contribution.” 
                    <E T="03">See, e.g.,</E>
                     Good Neighbor Plan RTC at 97-99, 101. The EPA concluded when finalizing the Good Neighbor Plan that its initial Screening Assessment—although based on a slightly different group of states than at final (and the use of other data regarding baseline emissions levels and air quality conditions that was subject to change)—had served its purpose in helping to identify a reasonable starting point for further analysis of non-EGU emissions-control opportunities and did not need to be redone. 
                    <E T="03">See</E>
                     88 FR 36685, 36719.
                </P>
                <P>
                    The Screening Assessment served that purpose for each state where it had a responsibility to regulate non-EGU emissions, and the Good Neighbor Plan's ultimate identification of non-EGU emissions control strategies to eliminate “significant contribution” is likewise sound for any state or grouping of states that may necessitate such federal regulation. Nonetheless, as is always the case with regard to meeting the CAA's requirements, states remain free to address a different set of sources than the EPA identified in the Good Neighbor Plan if they prefer to regulate through a SIP in a manner different than the EPA proceeded in the FIP. 
                    <E T="03">Id.</E>
                     at 36842.
                    <PRTPAGE P="99123"/>
                </P>
                <HD SOURCE="HD3">“Weighted” Averaging of Costs</HD>
                <P>In the EPA's final analysis of non-EGU representative costs in the Good Neighbor Plan, for two industries (Pipeline Transportation of Natural Gas and Solid Waste Combustors and Incinerators) and a specific emissions unit type (boilers), the Agency identified a weighted average of costs to address multiple control technologies identified in the Step 3 analysis, rather than a single control technology. 88 FR 36739-40 (table V.C.2-3). For those industries and for boilers, the analysis weighted the average cost according to the control technologies that certain sources, anticipated to be subject to the Good Neighbor Plan across the 20 states with non-EGU requirements, might select as their method of compliance. Representative costs for these sources were calculated by weighting the average costs derived from national data sources by estimated emissions reductions for the applicable control technologies. Non-EGU Memorandum at 5-7. For these industries and for boilers, looking at different groupings of states could result in a different “representative” cost (as displayed in the Non-EGU Memorandum at 10 (table 6)).</P>
                <P>
                    However, any differences in the identified “representative” costs for these sources would not affect the outcome of the analysis. For each of these types of sources, the record shows that the costs associated with each of the different control technologies falls within the range of costs that the EPA had concluded were reasonable to impose. 
                    <E T="03">See</E>
                     88 FR 36746-47. In other words, even if a different group of states produces a higher representative cost when weighted by those states' population of sources, the results still fall within the upper bound of the cost-per-ton that the EPA found appropriate. The EPA's conclusion—that the representative cost was reasonable—would be the same.
                </P>
                <P>For example, for RICE, the following table shows the data sources and cost-per-ton estimates the EPA adapted from the CMDB to inform its determination of representative cost for these sources. These were the figures, adjusted to 2016 dollars, that informed the EPA's average cost derived from national data sources used in the weighting to generate a representative cost figure of $4,981/ton for RICE.</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,r50,r50">
                    <TTITLE>Table I—Data Sources and Cost Estimates for RICE Controls</TTITLE>
                    <BOXHD>
                        <CHED H="1">Control technology/engine type</CHED>
                        <CHED H="1">Original reference</CHED>
                        <CHED H="1">$/Ton value</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">SCR, 4 Stroke Natural Gas Engines, Lean Burn 17% (of engines in analysis population)</ENT>
                        <ENT>2003, cost information from CARB 2001 report</ENT>
                        <ENT>$2,900 (2001 dollars).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Non-Selective Catalytic Reduction or Layered Combustion, for SCCs where the firing technology is not specified as to Rich Burn or Lean Burn 36%</ENT>
                        <ENT>
                            2009/2000 (from 2009 ERLE study and 2000 Pechan Phase II NO
                            <E T="0732">X</E>
                             SIP call report)
                        </ENT>
                        <ENT>4,538 (2013 dollars).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Layered Combustion, 2 Stroke Natural Gas, Lean Burn 44%</ENT>
                        <ENT>2009 (ERLE study)</ENT>
                        <ENT>4,900 (2010 dollars).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Non-Selective Catalytic Reduction, 4 Cycle Natural Gas, Rich Burn 3%</ENT>
                        <ENT>
                            2000 (Pechan, Phase II NO
                            <E T="0732">X</E>
                             SIP call report)
                        </ENT>
                        <ENT>422 (1999 dollars).</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Likewise, for MWCs in the Solid Waste Combustors and Incinerators industry, the EPA provided the cost assumptions used for the different control types in appendix B of the Non-EGU Memorandum.</P>
                <P>For boilers, the EPA explained that its cost estimates were derived from the CMDB, and the EPA identified a number of assumptions used in developing representative cost figures, which the EPA was clear may not be reflective of all sources' circumstances. Non-EGU Memorandum at 7. Noting that boilers have the highest representative costs among the non-EGU source types, the EPA explained in the Good Neighbor Plan that for individual sources, costs on a per-ton basis could well be higher than the estimated $14,595/ton representative cost, but still be commensurate with the range of costs that informed the identification of the most stringent control strategy selected in the Good Neighbor Plan for EGUs (for which costs at the 90th percentile ran as high as $20,900/ton). 88 FR 36746.</P>
                <P>
                    The EPA also emphasized that cost-per-ton figures are only one factor in the Step 3 multi-factor analysis, can vary widely depending on the assumptions used, and the conclusions in the Good Neighbor Plan regarding appropriate stringency levels were informed by a broader review of how widely adopted and proven various control strategies had become. 
                    <E T="03">Id.</E>
                     at 36746-47. Because of this, the determinations in the Good Neighbor Plan regarding the appropriate level of emissions control that could be expected of a particular type of source considered not just cost-per-ton estimates, but analysis of which technologies were already in wide use or on which existing standards had been based. Good Neighbor Plan RTC at 62-63. Still, recognizing that individual sources may face circumstances of extreme economic hardship or infeasibility, the EPA also provided a mechanism for sources to obtain alternative emissions limits, among other mechanisms for flexibility in the Good Neighbor Plan, to address outlier cases. 
                    <E T="03">See</E>
                     40 CFR 52.40(e). These provisions are adequate to cover any potential gap in the Good Neighbor Plan's estimate of representative costs.
                </P>
                <P>Accordingly, recalculating the weighted average representative cost for these particular non-EGU sources for any particular state or state grouping would not produce a representative cost falling outside the acceptable range. Thus, any change in the weighted average used to derive “representative” costs for these industries and emissions unit types resulting from looking at some subset of states would not materially affect the analysis.</P>
                <HD SOURCE="HD3">3. Step 4</HD>
                <P>At Step 4, the EPA establishes regulatory requirements to achieve the “prohibition” of significant contribution identified at Step 3. CAA section 110(a)(2)(D)(i). Under the Good Neighbor Plan, implementation of these requirements occurs through compliance activities at the source level, for both EGUs and for non-EGUs. Contrary to commenters' allegations, and as explained in more detail here, in section III.B.3., the trading program for EGUs, which is a compliance flexibility, does not depend on an interstate trading region for viability. Because all of the obligations of the Good Neighbor Plan can be met by the sources in each state regardless of the application of the Good Neighbor Plan in any other state, the implementation framework at Step 4 is severable on a state-by-state basis.</P>
                <P>
                    This can be seen in the structure of the regulations themselves. The Good Neighbor Plan determines on a state-by-state basis which of the EGU and the non-EGU emissions-control programs (or both) should be applied through 
                    <PRTPAGE P="99124"/>
                    state-specific FIPs. 
                    <E T="03">See</E>
                     40 CFR 52.38(b)(2) (as amended by 88 FR 36862-63) (identifying states subject to the Good Neighbor Plan's “Group 3” EGU emissions trading program promulgated at 40 CFR part 97, subpart GGGGG); 40 CFR 52.40(c)(2) (as promulgated at 88 FR 36869) (identifying states subject to non-EGU emissions control requirements promulgated at 
                    <E T="03">id.</E>
                     52.41-46). The regulations at 40 CFR part 97, subpart GGGGG and 40 CFR 52.41-46 are uniform in nature. But states are “enrolled” via FIPs into these requirements based on state-specific findings regarding the level of their contribution to other states' ozone problems and how long that contribution is projected to continue into the future.
                    <SU>56</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         This is identical in structure to how the EPA has promulgated federal good neighbor requirements through multiple prior rulemakings. 
                        <E T="03">See</E>
                         40 CFR 52.38-39 (identifying the enrollment of states into emissions trading programs for ozone season NO
                        <E T="52">X</E>
                        , annual NO
                        <E T="52">X</E>
                        , and annual sulfur dioxide promulgated as subparts to 40 CFR part 97, as necessary to address good neighbor obligations for other ozone and particulate matter NAAQS).
                    </P>
                </FTNT>
                <P>It is through the application of those uniform programs, as appropriate, in each state, via FIPs, that the Good Neighbor Plan eliminates each covered state's significant contribution, as required by CAA section 110(a)(2)(D)(i)(I). The state-specific coverage of the Good Neighbor Plan (for the 23 states for which originally promulgated), by regulatory program, is as follows:</P>
                <P>• EGUs in all covered states except California (22 States total) are required to participate in the Group 3 EGU emissions trading program at the level of stringency associated with near term emissions-control strategies that the EPA found can be implemented in 2023 and 2024.</P>
                <P>• EGUs in Alabama, Minnesota, and Wisconsin are only subject to this “near-term” stringency level within the Group 3 Trading Program, and no more, because the EPA found these states are no longer linked to downwind ozone problems in the 2026 analytic year.</P>
                <P>• EGUs in 19 States (excluding the three states listed in the preceding bullet) that are covered by the Group 3 trading program, are subject to the enhanced stringency in the budgets that takes effect over 2026 and 2027 because these states are linked through the 2026 analytic year.</P>
                <P>• The EPA found California has no cost-effective fossil-fuel fired EGU emissions reductions available at the stringency levels determined in the Good Neighbor Plan and so is not subject to the Group 3 Trading Program at all.</P>
                <P>
                    • Non-EGUs in 20 states are subject to the uniform emissions control regulations. Because the EPA found these requirements may take up to three years to be implemented (
                    <E T="03">i.e.,</E>
                     until 2026), this number excludes Alabama, Minnesota, and Wisconsin, for the same reason as above: these states are not “linked” in 2026.
                </P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,14C,14C,12C">
                    <TTITLE>Table II—Coverage of the Good Neighbor Plan Regulatory Programs</TTITLE>
                    <BOXHD>
                        <CHED H="1">State</CHED>
                        <CHED H="1">
                            EGU program—
                            <LI>near term</LI>
                            <LI>stringency</LI>
                        </CHED>
                        <CHED H="1">
                            EGU program—
                            <LI>long term</LI>
                            <LI>stringency</LI>
                        </CHED>
                        <CHED H="1">Non-EGU</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Alabama</ENT>
                        <ENT>X</ENT>
                        <ENT/>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="01">Arkansas</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">California</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Illinois</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Indiana</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Kentucky</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Louisiana</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Maryland</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Michigan</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Minnesota</ENT>
                        <ENT>X</ENT>
                        <ENT/>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="01">Mississippi</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Missouri</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Nevada</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">New Jersey</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">New York</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Ohio</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Oklahoma</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Pennsylvania</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Texas</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Utah</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Virginia</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">West Virginia</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                        <ENT>X</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wisconsin</ENT>
                        <ENT>X</ENT>
                        <ENT/>
                        <ENT/>
                    </ROW>
                </GPOTABLE>
                <P>These state groupings illustrate how the application of each set of regulatory requirements promulgated in the Good Neighbor Plan depends on the circumstances of each state, as determined through the analytical application of the 4-step interstate transport framework on a nationwide basis. No particular requirement is applicable in all 23 states, and the workability of the Good Neighbor Plan is not premised on an assumption that it must be applicable in specifically 23 states or any particular number of states.</P>
                <P>
                    As a practical matter, compliance is achievable through the at-the-source control technologies on which the EPA's determination of “significant contribution” at Step 3 rested (or their equivalents, because the Good Neighbor Plan does not mandate the use of particular control technologies). For non-EGUs, all requirements are established at the source-specific level. 
                    <E T="03">See</E>
                     88 FR 36675. The same is true of EGUs: the stringency of the Good Neighbor Plan is premised on at-the-source, conventional control technologies. 
                    <E T="03">See</E>
                     88 FR 36737-39 (tables identifying technology types). The EPA also designed a market-based, interstate emissions trading program to allow EGU sources to achieve their 
                    <PRTPAGE P="99125"/>
                    required emissions reductions as efficiently and cost-effectively as possible, but that trading program is merely a more flexible means of implementing the source-specific requirements that otherwise apply under the Good Neighbor Plan. Indeed, the enhancements the EPA established for the Good Neighbor Plan's trading program (as compared to prior good neighbor trading programs) were meant to ensure the flexibility of the trading program did not undermine the benefits of defining source-specific emissions controls in the first place, which helps assure that EGU sources in each state have eliminated their own significant contribution and thus provided improvements in air quality to the downwind receptors to which their home states are linked. 
                    <E T="03">See</E>
                     88 FR at 36657, 36684, 36752.
                    <SU>57</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         Even before the Good Neighbor Plan, following 
                        <E T="03">North Carolina,</E>
                         the EPA took measures to ensure that interstate trading does not undermine the obligation to eliminate each state's significant contribution. 
                        <E T="03">See North Carolina,</E>
                         531 F.3d at 921, 
                        <E T="03">modified on reh'g,</E>
                         550 F.3d 1176. 
                        <E T="03">See, e.g.,</E>
                         Cross-State Air Pollution Rule (CSAPR), 76 FR 48208, 48268-71 (August 8, 2011); 88 FR 36752-53.
                    </P>
                </FTNT>
                <P>Commenters may be concerned that without the participation of all states originally included in the Good Neighbor Plan, market liquidity will be affected, allowance prices will increase, and/or there will not be sufficient allowances available for compliance. But the record of the Good Neighbor Plan shows that these concerns are unjustified.</P>
                <P>
                    While interstate trading—especially among sources in a large group of states—would generally increase the size of the allowance trading market and thus may increase market liquidity in ways that can improve market efficiency, the use of a trading program does not render implementation of a good neighbor rule in a smaller group of states, or even a single state, unreasonable. That is because, in the first instance, the good neighbor provision regulates EGU sources, not states. Even within a single state, there would be multiple participating sources to populate and benefit from an emissions trading program. Moreover, the history of the EPA's good neighbor rulemakings shows that these trading programs have continued to provide valuable, effective compliance flexibility even where they cover a smaller group of states.
                    <SU>58</SU>
                    <FTREF/>
                     Indeed, each state's budget is set in the Good Neighbor Plan at levels that provide sufficient allowances for each state, assuming EGUs achieve a level of reduction equivalent to what can be achieved by the at-the-source technologies identified to eliminate significant contribution. 88 FR 36680. And as explained further in section III.C., all of the EPA's good neighbor rules, including the Good Neighbor Plan, are designed with the understanding that states have the option to develop SIPs that remove their sources from a trading program, which necessarily changes the number of states subject to the FIP, and that the number of states covered by FIPs may otherwise change.
                </P>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         The size of the trading region is not the only determinant of liquidity; the relative magnitude of demand for allowances compared to supply is an important factor. For example, inclusion in the program of states with sources that are not well-controlled for NO
                        <E T="52">X</E>
                         would tend to put upward pressure on allowance prices (and potentially reduce liquidity). If states with such sources are removed from that program (
                        <E T="03">e.g.,</E>
                         due to stays), this may put downward pressure on allowance prices (and potentially increase liquidity).
                    </P>
                </FTNT>
                <P>
                    As a consequence, the size of the trading regions used to implement the good neighbor provision has both varied between rules and regularly changed within trading programs over time. This has never posed a challenge to compliance feasibility, nor does the EPA have any evidence of allowance shortages occurring in any of these programs. 
                    <E T="03">See</E>
                     88 FR 36687 (noting opposite problem of banked-allowance surpluses). For example:
                </P>
                <P>
                    • Currently, Georgia is the only state whose EGUs remain in the original CSAPR “Group 1” ozone season NO
                    <E T="52">X</E>
                     trading program, which originally included 25 states.
                </P>
                <P>
                    • In 2021, the Revised CSAPR Update created a 12-state trading region to complete the remedy to significant contribution for the 2008 ozone NAAQS (
                    <E T="03">i.e.,</E>
                     the original “Group 3” program).
                </P>
                <P>• With the Revised CSAPR Update in place, the 2016 CSAPR Update “Group 2” program trading region was reduced from 22 states to 10 states.</P>
                <FP>
                    <E T="03">See</E>
                     88 FR 36668-69 (reviewing regulatory history).
                </FP>
                <P>
                    In light of these successful implementation experiences and given the at-the-source technologies on which the Good Neighbor Plan's EGU budgets are premised, coupled with other flexibilities, even individual-state trading programs would not be expected to unduly affect market liquidity or make allowances either scarce or unaffordable. To the extent the comments may be read as asserting that smaller trading regions would undermine grid reliability, the EPA disagrees for the same reasons. These comments did not present any data or analysis in support of that contention. The EPA thoroughly explained how the Good Neighbor Plan's regulatory program for EGUs is designed to avoid interfering with resource adequacy and grid reliability, 
                    <E T="03">see</E>
                     88 FR 36771-75.
                </P>
                <P>In short, under the Good Neighbor Plan, the sources in each individual state are fully able to comply without regard to what sources in other states are doing—and even where cooperative market-based mechanisms are available to aid in that compliance, those mechanisms remain sound for smaller state groupings or even at the individual-state level despite a smaller marketplace. 88 FR 36760-61, 36817.</P>
                <P>
                    Commenters may also be concerned that the application of the Good Neighbor Plan in some upwind states if not operative in others may create a dynamic of competitive disadvantage. However, even if this were the case (and commenters supplied no evidence that it would be), this would not be sufficient justification to suspend the operation of the rule in states where it lawfully could be in effect. As an initial matter, because the good neighbor provision imposes legal obligations on each state individually, it does not allow individual states to defer compliance with their legal obligations based on circumstances in other upwind states. That is consistent with the provision's purpose, which is intended to ensure equity and fairness among states by prohibiting harmful upwind state emissions that impose regulatory, economic, and health burdens on downwind states. 
                    <E T="03">See</E>
                     88 FR 36658, 36687, 36741; 
                    <E T="03">see also</E>
                     64 FR 28250, 28258-62 (May 25, 1999) (reviewing legislative history of the good neighbor provision and related statutory provisions, which reflects an intent to “equalize the positions of the States with respect to interstate pollution by making a source at least as responsible for polluting another State as it would be for polluting its own State”). The inaction of some upwind states is not an appropriate justification for further relaxing all upwind states' obligations, when it is downwind states who will suffer. That burden will fall not just on downwind communities, but on industries in downwind states with ozone nonattainment problems, who will likely bear greater competitive disadvantages vis-à-vis their competitors in upwind states whose pollution is contributing to the enhanced regulatory burdens they already face under the Act. 
                    <E T="03">See EME Homer City,</E>
                     489 U.S. at 519; 
                    <E T="03">Maryland,</E>
                     958 F.3d at 1200-01, 1203-04. This consideration is particularly acute given the August 3, 2024, attainment date for compliance with the 2015 ozone NAAQS for Moderate nonattainment 
                    <PRTPAGE P="99126"/>
                    areas located throughout the country, and the Good Neighbor Plan's objective of further assisting downwind states in time for the 2027 Serious area attainment date. 88 FR 36690, 36695.
                    <SU>59</SU>
                    <FTREF/>
                     In any case, in light of the unique ability of the power sector to shift generation among sources in supplying electricity to the power grid, the EPA conducted an analysis in the Good Neighbor Plan of the potential for power generators to shift production and emissions from EGUs in states covered by the Good Neighbor Plan to states not covered by the Good Neighbor Plan and found that the risk, while not zero, was relatively small. Good Neighbor Plan RTC at 604-05. Further, that risk is attendant and unavoidable at the boundaries of any multistate or regional program, regardless of its size and regardless of whether that program uses emissions trading or is based on source-specific emissions limitations, and so not particular to the circumstances here.
                </P>
                <FTNT>
                    <P>
                        <SU>59</SU>
                         This is also consistent with the EPA's determination that it is necessary and appropriate to extend the Good Neighbor Plan's requirements to CAA section 301(d) FIP areas located within the borders of states whose sources were found to be significantly contributing. The EPA explained in the Good Neighbor Plan that not doing so would pose a risk that such areas would then be targeted for the siting of polluting facilities to avoid the Good Neighbor Plan's requirements, frustrating the purpose of the Good Neighbor Plan and the statute. 88 FR 36691. This concern exists at the “intra-State” level. Second, while it is generally appropriate that equity and consistency should be maintained across all similarly situated jurisdictions, that does not extend to excusing one upwind state of its statutory obligations simply on the basis that the obligations of another upwind state are still pending or unresolved.
                    </P>
                </FTNT>
                <P>In short, the implementation of the regulatory requirements of the Good Neighbor Plan, at Step 4, is achievable by the sources in each state and is therefore severable by state.</P>
                <HD SOURCE="HD2">C. Other Features of the Statute and Good Neighbor Plan Supporting Severability</HD>
                <P>
                    In light of the statutory text and context, the Good Neighbor Plan, like prior interstate transport rules, is designed to be modular—
                    <E T="03">i.e.,</E>
                     to apply on a state-by-state basis and to whichever states are presently subject to the EPA's responsibility to issue a FIP. That the Good Neighbor Plan functions to appropriately define and prohibit significant contribution on a state-by-state basis, regardless of the number of states covered, can be seen in a number of other features and elements of the Good Neighbor Plan and by reviewing the history of implementation of the good neighbor provision for ozone across prior rulemakings and case law.
                </P>
                <P>
                    First, as directed by the statute and relevant precedent, the EPA must define significant contribution in such a way that sources in “each State” are held responsible for the elimination of their own significant contribution. CAA section 110(a)(2)(D); 
                    <E T="03">see</E>
                     88 FR 36687-88, 36762. The D.C. Circuit's review of a good neighbor rule invalidated in 
                    <E T="03">North Carolina</E>
                     v. 
                    <E T="03">EPA,</E>
                     and the EPA's subsequent action to address a specific holding in 
                    <E T="03">North Carolina</E>
                     concerning regional- versus state-level compliance, helpfully illustrates why, and how, the EPA's current approach avoids any inter-dependency among states' obligations.
                </P>
                <P>
                    In an earlier good neighbor rule, the Clean Air Interstate Rule (CAIR), the EPA quantified emissions reduction requirements at the regional level based on a regional analysis, and then apportioned the responsibility for reducing each pollutant among the contributing states based on either the total allowance allocations for the states' EGUs under the Acid Rain Program (ARP) (in the case of required sulfur dioxide reductions) or the total historical heat input amounts for the states' EGUs, adjusted for the types of fuels used (in the case of required NO
                    <E T="52">X</E>
                     reductions). 
                    <E T="03">See</E>
                     70 FR 25162, 25176 (May 12, 2005); 
                    <E T="03">see also</E>
                     88 FR 36668.
                </P>
                <P>
                    In 
                    <E T="03">North Carolina,</E>
                     the D.C. Circuit found that CAIR had unlawfully defined “significant contribution” at a regional level rather than on a state-specific basis. 531 F.3d at 906-08, 919-21. After this ruling, the EPA took care to ensure the successor rule to CAIR, CSAPR, defined and prohibited significant contribution for each State. 
                    <E T="03">See</E>
                     76 FR 48271. It did this by evaluating and selecting appropriate uniform levels of control stringency for the set of upwind states linked to identified downwind receptors and then quantifying and implementing the required emissions reductions resulting from the selected control stringencies independently for each upwind state. 
                    <E T="03">See id.</E>
                     In other words, at this point in the analysis, the EPA removed from CSAPR (and all subsequent good neighbor rules) the interdependency of a regional solution that 
                    <E T="03">North Carolina</E>
                     had found in CAIR, as this interdependency resulted in a failure to identify each state's own obligations. In CSAPR, each receptor and the states linked to that receptor were evaluated independently, which led the EPA to establish different regional groupings of states with different levels of emissions control stringency (
                    <E T="03">e.g.,</E>
                     in that case, the Group 1 and Group 2 SO
                    <E T="52">2</E>
                     control programs). 
                    <E T="03">See</E>
                     76 FR 48252. The courts reviewing CSAPR in 
                    <E T="03">EME Homer City</E>
                     further required that the EPA evaluate each state to ensure an otherwise permissible uniform emissions control stringency does not overcontrol the emissions of any particular upwind state. 572 U.S. 489, 521. Taken together, these refinements from CAIR opened up the potential that individual states could be assigned different cost/stringency levels based on whether their receptors (or their linkages to those receptors) would fully resolve at different cost/stringency levels or would fully resolve before additional emissions control measures could be implemented. This state-specific treatment can be seen in the Good Neighbor Plan's recognition that control strategies only available by the 2026 analytic year are not required in Alabama, Minnesota, or Wisconsin, given that their specific linkages were projected to resolve by that year. For the remaining 20 states in the Good Neighbor Plan, no overcontrol was observed in the 2026 analytic year and so no adjustments in the program's stringency were needed. 88 FR 36749.
                    <SU>60</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>60</SU>
                         Likewise, in the Good Neighbor Plan, we observed a receptor projected to resolve using an emissions control stringency level not requiring non-EGU emissions controls. The Larimer County, Colorado, receptor's maximum design value drops below 71 ppb when the highest EGU stringency is applied (but before non-EGU controls are applied). Thus, if any state were linked only to this receptor, the EGU-only level of stringency would have been the stopping point. However, all states linked to this receptor were also linked to other receptors for which application of both the EGU and non-EGU emissions control stringency did not produce overcontrol. 
                        <E T="03">See</E>
                         Ozone Policy TSD, appendix H, at 115.
                    </P>
                </FTNT>
                <P>
                    At Step 4, CSAPR maintained an interstate EGU trading program, but the EPA took steps to ensure that this too complied with 
                    <E T="03">North Carolina</E>
                     and the statutory obligation to define and prohibit each state's significant contribution. To ensure that each state would eliminate its own significant contribution within the flexible compliance mechanism of an interstate trading program for EGUs, the EPA imposed a constraint on interstate trading within the trading program, through “assurance provisions” that imposed a 3-to-1 allowance-surrender ratio for emissions in excess of a certain percentage of each state's budget. As explained in the Good Neighbor Plan, “The establishment [in CSAPR] of assurance levels with associated extra allowance surrender requirements was intended to respond to the D.C. Circuit's holding in 
                    <E T="03">North Carolina</E>
                     requiring the EPA to ensure within the context of an interstate trading program that sources in each State are required to address their good neighbor obligations within the State and may not simply shift those obligations to other States by failing to reduce their own emissions and instead surrendering surplus allowances 
                    <PRTPAGE P="99127"/>
                    purchased from sources in other States.” 88 FR 36786.
                </P>
                <P>
                    The features of CSAPR included to address the 
                    <E T="03">North Carolina</E>
                     decision have been retained in the Good Neighbor Plan and enhanced to further ensure that each state remains responsible for elimination of its own significant contribution.
                    <SU>61</SU>
                    <FTREF/>
                      
                    <E T="03">See id.</E>
                     at 36687-88, 36762 (citing 
                    <E T="03">North Carolina,</E>
                     at 906-08, 921; 
                    <E T="03">see also</E>
                     Good Neighbor Plan RTC at 42 (“[T]he D.C. Circuit has held that the EPA may not implement an emissions reduction program under the good neighbor provision that fails to ensure that each State has eliminated its own significant contribution. 
                    <E T="03">North Carolina,</E>
                     531 F.3d at 921.”); 
                    <E T="03">id.</E>
                     at 48 (same).
                </P>
                <FTNT>
                    <P>
                        <SU>61</SU>
                         For example, by strengthening incentives for individual units to optimize operation of their emissions controls, the backstop daily NO
                        <E T="52">X</E>
                         emissions rate provisions and the secondary emissions limitation provisions also both increase assurance that each State's significant contribution will be eliminated within that State. 
                        <E T="03">See, e.g.,</E>
                         88 FR 36767-68 and 36799-800.
                    </P>
                </FTNT>
                <P>
                    Second, also consistent with the state-by-state structure of CAA section 110, as recognized in 
                    <E T="03">North Carolina,</E>
                     the EPA made specific findings regarding its authority to promulgate a FIP for each individual state covered by the Good Neighbor Plan. 88 FR 36689 n.109. Notably, the EPA had originally proposed that the Good Neighbor Plan rulemaking would promulgate FIPs for 26 states, not 23. 
                    <E T="03">See</E>
                     87 FR 20036, 20038 (April 6, 2022). The modeling that informed the final rule indicated that Delaware and Wyoming were not linked to any out-of-state receptors, and that Tennessee would only be linked to a new class of “violating monitor” receptors. Thus, these three states were excluded from the final Good Neighbor Plan. Including fewer states in the final rule than were included in the proposal did not alter the approach to defining each remaining states' significant contribution, nor cause any change in each covered state's obligations or the requirements imposed on emitting sources in those covered states. The final modeling also indicated that several additional states were potentially linked and may “contribute significantly,” and thus the EPA acknowledged in the final Good Neighbor Plan that these states' obligations still needed to be addressed. 
                    <E T="03">See</E>
                     88 FR 36658 (identifying Arizona, Iowa, Kansas, New Mexico, Tennessee, and Wyoming as needing to be further addressed in a subsequent action).
                    <SU>62</SU>
                    <FTREF/>
                     Critically, under the EPA's analytical approach to the Good Neighbor Plan, the absence of these states from the final Good Neighbor Plan did not, in the Agency's view at the time, pose any challenge to finalizing and moving forward with implementing the Good Neighbor Plan for the states included.
                </P>
                <FTNT>
                    <P>
                        <SU>62</SU>
                         
                        <E T="03">See</E>
                         supra note 19.
                    </P>
                </FTNT>
                <P>
                    Third, the Good Neighbor Plan, consistent with the statute and like all prior good neighbor federal rulemakings, recognizes that states may choose to replace their FIP with a SIP. 
                    <E T="03">See, e.g.,</E>
                     88 FR 36838-42 (discussing in detail various options states have for developing SIPs). When the EPA approves a replacement SIP, that state is withdrawn from the FIP, thus changing the number of states subject to Good Neighbor Plan FIPs. In developing SIPs, states may opt to leave the interstate trading program for EGUs in favor of an adequate, alternative approach to addressing their good neighbor obligations. 
                    <E T="03">Id.</E>
                     at 36841-42. This echoes nearly identical discussions included in prior good neighbor rules, 
                    <E T="03">see, e.g.,</E>
                     CSAPR, 76 FR 48328. Both the proposed and final Good Neighbor Plan contained an extended discussion of how states could exit the Good Neighbor Plan through several options for submitting approvable SIPs. 87 FR 20149-51; 
                    <E T="03">see also id.</E>
                     at 20040 (“[T]his proposal will provide States with as much information as the EPA can supply at this time to support their ability to submit SIP revisions to achieve the emissions reductions the EPA believes necessary to eliminate significant contribution.”). In the final Good Neighbor Plan, the EPA explained that it encouraged states to replace their FIP with an approvable SIP, specifically identifying that states could choose to exit the trading program, regulate different sources, or devise adequate alternative methodologies to defining “significant contribution.” 
                    <E T="03">See</E>
                     88 FR 36839.
                </P>
                <P>
                    Fourth, the EPA's experience with prior good neighbor rules informs its determinations concerning the ability of the Good Neighbor Plan to function sensibly regardless of the number of states included. The EPA has removed states from coverage of prior good neighbor rules (including from interstate trading programs) in the past without any loss of program viability. 
                    <E T="03">See</E>
                     88 FR 36669. In addition, at times the EPA has been required to remove specific states from a good neighbor program as a result of adverse court decisions. For example, CSAPR was remanded as to multiple states based on overcontrol concerns in the aftermath of the Supreme Court's decision in 
                    <E T="03">EME Homer City,</E>
                     but the D.C. Circuit expressly declined to vacate CSAPR, even as to those states. 
                    <E T="03">See EME Homer City Generation, LP</E>
                     v. 
                    <E T="03">EPA,</E>
                     795 F.3d 118, 132 (D.C. Cir. 2015). Subsequent rulemakings moved several states out of the original CSAPR programs, without any issues concerning the feasibility or propriety of the remaining states' obligations. 
                    <E T="03">See, e.g.,</E>
                     81 FR 74504, 74506-07 (October 26, 2016); 
                    <E T="03">see also</E>
                     86 FR 23056-57. Similarly, in 
                    <E T="03">Michigan,</E>
                     213 F.3d at 695, the D.C. Circuit vacated the NO
                    <E T="52">X</E>
                     SIP Call as to Wisconsin, Missouri, and Georgia, but left the rule in place and remanded without vacatur as to certain issues as to other states.
                    <SU>63</SU>
                    <FTREF/>
                     The modular nature of past good neighbor rules has functioned well and ensured that when the scope of a rule might change based on issues specific to particular states, the rule can continue to function properly for the states that remain covered by the rule.
                </P>
                <FTNT>
                    <P>
                        <SU>63</SU>
                         The D.C. Circuit has in fact emphasized that the important public health benefits of the EPA's interstate transport rules, as well as the potential disruption to emissions trading markets, counsel against vacatur even when some aspect of the rules may be found unlawful or necessitate re-analysis. 
                        <E T="03">See North Carolina,</E>
                         550 F.3d 1176, 1178 (D.C. Cir. 2008); 
                        <E T="03">Wisconsin,</E>
                         938 F.3d at 336-37; 
                        <E T="03">EME Homer City,</E>
                         795 F.3d at 132.
                    </P>
                </FTNT>
                <P>
                    Finally, there are no statements in the record of the Good Neighbor Plan that suggest the EPA considered the Good Neighbor Plan interdependent among states or dependent on exactly 23 states or any other minimum number of states' participation.
                    <SU>64</SU>
                    <FTREF/>
                     To the contrary, the severability section in the Good Neighbor Plan preamble indicated the Agency's expectation that the Good Neighbor Plan could be implemented in individual states as necessary. 88 FR 36693. While in one instance, the Good Neighbor Plan did refer to the “interdependent nature of interstate 
                    <PRTPAGE P="99128"/>
                    pollution transport,” 
                    <E T="03">see</E>
                     88 FR 36860, this was in reference to the nature of the pollution problem, not the nature of the EPA's solution. While the variable, interstate nature of ozone transport certainly presents a “thorny causation problem,” 
                    <E T="03">EME Homer City,</E>
                     489 U.S. at 514, the EPA's solution to that problem when promulgating FIPs, through a consistent application of the 4-step interstate transport framework to each state, is expressly designed to avoid the creation of unworkable interdependencies.
                </P>
                <FTNT>
                    <P>
                        <SU>64</SU>
                         To the extent any discussions in the Good Neighbor Plan's preamble or its technical support documents suggested that some particular substantive component of the methodology was dependent on a specific 23-state coverage, the Agency clarifies here that such statements were inartful or incorrect. For example, the Agency has reviewed the methodology underlying the graphs displayed in appendix I of the Ozone Policy TSD. We have confirmed that despite headings describing the graphs as being for 22 or for 19 states, respectively, in fact Figures 1 and 2 were compiled using the “Step 3 Configuration” in AQAT that compiled the reductions of all linked states and the home state for each receptor. Figure 3 likewise reflected a compilation of data that was not limited to the states subject to the original Good Neighbor Plan. The references to 22 and 19 states (for 2023 and 2026 EGU stringency, respectively) were simply intended to indicate the number of states in the Good Neighbor Plan for which the data informed obligations being finalized in that rule. 
                        <E T="03">See</E>
                         88 FR 36744-45 (explaining that Figures 1 and 2 reflected the AQAT data used to inform the Step 3 determinations concerning EGUs, while Figure 3 was intended to illustrate why further EGU emissions-reduction strategies 
                        <E T="03">not</E>
                         included in that analysis appeared to be well beyond a notable breakpoint in cost-effectiveness and thus not worth pursuing in the context of defining good neighbor obligations for the 2015 ozone NAAQS).
                    </P>
                </FTNT>
                <P>
                    By contrast, commenters' apparent view that the analysis underlying the Good Neighbor Plan would change depending on its scope of coverage at any given moment misapprehends how the Good Neighbor Plan is designed and operates. If commenters were correct that the EPA had designed a good neighbor rule that was contingent for any particular state on whether the rule covered other states, this would seemingly introduce an interdependency problem and render the rule invalid under 
                    <E T="03">North Carolina.</E>
                     It could also require that the EPA revise a good neighbor rule every time a state opted to impose a SIP to exit its FIP or was moved into a new FIP for a revised NAAQS or to fully address its obligations. The practical problems of such an approach reinforce why this would be an unreasonable way to define states' obligations. It would render good neighbor obligations an ever-shifting target, undermining regulatory certainty for sources and states. The Good Neighbor Plan is designed to avoid such complications.
                </P>
                <HD SOURCE="HD2">D. Whether Judicial Stays Would Justify Re-Analysis of the Good Neighbor Plan</HD>
                <P>The comments discussed in section II.B. may be interpreted to argue that the Good Neighbor Plan must be re-analyzed where a court stays, as to a particular state or states, either the rule itself or an antecedent action such as the SIP Disapproval that is a predicate to the exercise of FIP authority under CAA section 110(c)(1). Courts may enter temporary stays of agency actions pending judicial review to preserve the status quo. A stay order is not a final judgment and in itself does not alter or force a change in the substantive analysis an agency has applied in taking the action under review. Thus, stay orders would not alter the analysis of good neighbor obligations for the 2015 ozone NAAQS for any particular state, and the EPA would come to the same result as was already reached, because the analytical underpinnings and the implementation of the Good Neighbor Plan do not depend on the specific number of states that it covers.</P>
                <P>The comments may also be interpreted as an assertion that the Good Neighbor Plan would not function or would be unreasonable because stays may be put in place, or because a large amount of the emissions reductions that the Good Neighbor Plan calls for would become unenforceable pending judicial review. However, this does not serve to identify what technical and analytical conclusions the Agency reached through its notice-and-comment rulemaking were flawed or must be changed. The obligations as defined for each state remain promulgated even if they are stayed pending judicial review.</P>
                <P>Similarly, the effects of merits holdings in the SIP Disapproval litigation or a vacatur of the SIP Disapproval as to a particular state would not necessarily require a change in the way the EPA may lawfully define that state's good neighbor obligations in a FIP, much less those of other states. To be sure, in general a vacatur of a SIP disapproval would at a minimum require that the FIP remain stayed as to that state, pending action on remand (if that disapproval had been the only basis for the exercise of FIP authority). And the EPA will always comply with the final judgments of the courts. However, the degree to which a change in analysis for a particular state, with respect to the EPA's action on its SIP submission, would be required following any merits holdings in the various cases challenging the SIP Disapproval would depend on the nature of those holdings, as to that state, which is speculative at this time. Whether such holdings would in turn require a change in the EPA's analysis or outcomes concerning other states' SIP submissions is still more speculative, and whether any such changes could then separately impact the EPA's approach to defining the obligations of the state in question through a FIP, much less the obligations of other states via FIPs, is more speculative still.</P>
                <P>
                    Several commenters urge that the EPA must simply accept their view, or the view of commenters on the SIP Disapproval, that either or both of the rules are legally or procedurally flawed and will not survive judicial review. The EPA has addressed the substantive arguments raised in such comments elsewhere in the record of the Good Neighbor Plan, or it has indicated that it had addressed those issues in the SIP Disapproval and those matters are not within scope of the rule. 
                    <E T="03">See</E>
                     Good Neighbor Plan RTC at 6-8, 149-51, 155; 
                    <E T="03">see also</E>
                     section II.B. supra (summarizing responses to comments in the original Good Neighbor Plan record). Where the Agency has reviewed such comments and is satisfied that it is acting lawfully, mere speculation that a reviewing court may disagree cannot supply a reasoned basis for the Agency to stay, modify, or withdraw its rule.
                </P>
                <P>
                    Thus, the methodology and regulatory programs of the Good Neighbor Plan are reasonably designed and operate to define the obligations of each state, in a manner that is severable on a state-by-state basis. While the analytical methods, technical analyses, and policy judgments that informed the Good Neighbor Plan were developed and conducted consistently across the nation, they ultimately produced a determination of significant contribution at the state level. The implementation of the measures necessary to eliminate significant contribution is achievable by the sources within each state, irrespective of other states' participation. It would not matter if there were one state or 50 states in the Good Neighbor Plan—the methodology and the result for any particular state—
                    <E T="03">i.e.,</E>
                     the definition of “significant contribution to nonattainment and interference with maintenance” under CAA section 110(a)(2)(D)(i)(I) for the 2015 ozone NAAQS—would remain the same.
                </P>
                <P>
                    The EPA acknowledges that although the substantive circumstances of the states remain constant, the circumstances of the rulemaking and litigation are likely to remain in flux in the short-to-near term. Courts that may grant stays pending judicial review may later affirm the SIP Disapproval or may remand the SIP Disapproval as to particular states, with or without vacatur. Indeed, both the NO
                    <E T="52">X</E>
                     SIP Call and CSAPR were ultimately implemented despite initial stay orders, and notwithstanding that some elements of each rule were remanded without vacatur. 
                    <E T="03">See, e.g., EME Homer City,</E>
                     795 F.3d at 138; 
                    <E T="03">Michigan,</E>
                     213 F.3d at 695. Should there be any remand of the SIP Disapproval, the EPA will have to act on that state's SIP submission again, in accordance with the court's holdings. 
                    <E T="03">See Calcutt</E>
                     v. 
                    <E T="03">Federal Deposit Ins. Corp.,</E>
                     598 U.S. 623, 629 (2023). And, at any point, any state may submit a new SIP to the EPA, and the EPA will review that SIP. Ultimately, under the statute, every state will need to be covered by either an approved SIP or a FIP that meets the requirements of the good neighbor provision—with the number subject to each potentially changing at any point.
                </P>
                <P>
                    Finally, the EPA's conclusion that the Good Neighbor Plan is severable also reflected the important public health 
                    <PRTPAGE P="99129"/>
                    and environmental benefits of the rule in eliminating significant contribution and to ensure to the greatest extent possible the ability of both upwind states and downwind states and other relevant stakeholders to be able to rely on the rule in their planning. 88 FR 36693. 
                    <E T="03">Cf. Wisconsin,</E>
                     938 F.3d at 336-37 (“As a general rule, we do not vacate regulations when doing so would risk significant harm to the public health or the environment.”); 
                    <E T="03">North Carolina</E>
                     v. 
                    <E T="03">EPA,</E>
                     550 F.3d 1176, 1178 (D.C. Cir. 2008) (noting the need to preserve public health benefits).
                </P>
                <HD SOURCE="HD1">IV. Statutory and Executive Orders Reviews</HD>
                <P>
                    The EPA's determinations under the relevant statutory and Executive Order reviews for the Good Neighbor Plan can be found at 88 FR 36856-60. This document provides further explanation in response to comments concerning a particular aspect of the Good Neighbor Plan and does not alter or amend any of the requirements of the rule. Additional information about the relevant statutes and Executive Orders can be found at 
                    <E T="03">https://www.epa.gov/laws-regulations/laws-and-executive-orders.</E>
                </P>
                <HD SOURCE="HD2">A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review</HD>
                <P>The Office of Management and Budget (OMB) has determined that this document is significant for purposes of review under Executive Order 12866, as amended by Executive Order 14094. Accordingly, the EPA submitted this document to the OMB for Executive Order 12866 review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket.</P>
                <HD SOURCE="HD2">B. Judicial Review</HD>
                <P>
                    Judicial review of the Good Neighbor Plan is in the United States Court of Appeals for the District of Columbia Circuit for the reasons stated in the final rulemaking document. 
                    <E T="03">See</E>
                     88 FR 36859-60. Petitions for review of the Good Neighbor Plan are currently pending in that court, and this document completes proceedings on remand of the record as ordered by that court. 
                    <E T="03">State of Utah et al.</E>
                     v. 
                    <E T="03">EPA,</E>
                     No. 23-1157 (D.C. Cir. September 12, 2024). The D.C. Circuit retains jurisdiction over the case.
                </P>
                <SIG>
                    <NAME>Michael S. Regan,</NAME>
                    <TITLE>Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28739 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Fish and Wildlife Service</SUBAGY>
                <CFR>50 CFR Part 17</CFR>
                <DEPDOC>[Docket No. FWS-HQ-ES-2023-0067; FXES1111090FEDR-256-FF09E21000]</DEPDOC>
                <RIN>RIN 1018-BG69</RIN>
                <SUBJECT>Endangered and Threatened Wildlife and Plants; Endangered Species Status for the Fluminense Swallowtail Butterfly, Harris' Mimic Swallowtail Butterfly, and Hahnel's Amazonian Swallowtail Butterfly</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Fish and Wildlife Service, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        We, the U.S. Fish and Wildlife Service (Service), determine endangered species status under the Endangered Species Act of 1973 (Act), as amended, for three butterflies endemic to Brazil: the Fluminense swallowtail (
                        <E T="03">Parides ascanius</E>
                        ), Harris' mimic swallowtail (
                        <E T="03">Eurytides</E>
                         (=
                        <E T="03">Mimoides</E>
                        ) 
                        <E T="03">lysithous harrisianus</E>
                        ), and Hahnel's Amazonian swallowtail (
                        <E T="03">Parides hahneli</E>
                        ). This rule extends the Act's protections to these species.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective January 9, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        This final rule, comments and materials we received on the proposed rule, and supporting materials that we used in preparing this rule, such as the species status assessment report, are available at 
                        <E T="03">https://www.regulations.gov</E>
                         at Docket No. FWS-HQ-ES-2023-0067.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Rachel London, Manager, Branch of Delisting and Foreign Species, Ecological Services Program, U.S. Fish and Wildlife Service, MS: ES, 5275 Leesburg Pike, Falls Church, VA 22041-3803; telephone 703-358-2171. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Previous Federal Actions</HD>
                <P>Please refer to the proposed listing rule (88 FR 48414, July 27, 2023) for the Fluminense swallowtail butterfly, Harris' mimic swallowtail butterfly, and Hahnel's Amazonian swallowtail butterfly for a detailed description of previous Federal actions concerning these species. Hereafter in this document, we will abbreviate their common names by removing the word “butterfly” and referring to these species as “swallowtails.”</P>
                <HD SOURCE="HD1">Peer Review</HD>
                <P>A species status assessment (SSA) team prepared an SSA report for the Fluminense swallowtail, Harris' mimic swallowtail, and Hahnel's Amazonian swallowtail. The SSA team was composed of Service biologists, in consultation with other species experts. The SSA report represents a compilation of the best scientific and commercial data available concerning the status of the species, including the impacts of past, present, and future factors (both negative and beneficial) affecting the species.</P>
                <P>
                    In accordance with our joint policy on peer review published in the 
                    <E T="04">Federal Register</E>
                     on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review in listing actions under the Act, we solicited independent scientific review of the information contained in the Fluminense swallowtail, Harris' mimic swallowtail, and Hahnel's Amazonian swallowtail SSA report. As discussed in the proposed rule, we sent the SSA report to seven independent peer reviewers and received four responses. The peer reviews can be found at 
                    <E T="03">https://www.regulations.gov.</E>
                     In preparing the proposed rule, we incorporated the results of these reviews, as appropriate, into the SSA report, which was the foundation for the proposed rule and this final rule. A summary of the peer review comments and our responses can be found in the proposed rule (88 FR 48414).
                </P>
                <HD SOURCE="HD1">Summary of Changes From the Proposed Rule</HD>
                <P>
                    In preparing this final rule, we reviewed and fully considered all public comments received during the comment period, and we make no substantive changes from the July 27, 2023, proposed rule (88 FR 48414). We considered all relevant references provided by commenters in our final determination and incorporated them into this final rule (see 
                    <E T="03">Habitat Loss and Degradation</E>
                     and 
                    <E T="03">Capture,</E>
                     below).
                </P>
                <HD SOURCE="HD1">Summary of Comments and Recommendations</HD>
                <P>
                    In the proposed rule published on July 27, 2023 (88 FR 48414), we requested that all interested parties submit written comments on the proposal by September 25, 2023. We also contacted appropriate Federal 
                    <PRTPAGE P="99130"/>
                    agencies, scientific experts and organizations, range country CITES authorities and other appropriate agencies, and other interested parties and invited them to comment on the proposal. We did not receive any requests for a public hearing. All substantive information received during the comment period has either been incorporated directly into this final determination or is addressed below.
                </P>
                <HD SOURCE="HD2">Public Comments</HD>
                <P>
                    <E T="03">(1) Comment:</E>
                     One commenter suggested that the length of time between when we were petitioned to list the three swallowtails in 1994 and the proposed listing in 2023 is too long, particularly because we had determined the species warranted listing in 1994 but was precluded by other priorities.
                </P>
                <P>
                    <E T="03">Our response:</E>
                     We recognize the length of time between first making the three Brazilian swallowtails candidate species and this final listing rule. For more information on our process and progress making listing decisions with foreign species, see the most recently published annual review of candidate species, annual notification of findings on resubmitted petitions, and description of progress on listing actions (88 FR 41560; June 27, 2023).
                </P>
                <P>
                    <E T="03">(2) Comment:</E>
                     One commenter claims there is not sufficient evidence and data to list the three swallowtails.
                </P>
                <P>
                    <E T="03">Our response:</E>
                     We are required to make our determination based on the best scientific and commercial data available at the time of our rulemaking. We considered the best scientific and commercial data available regarding the Fluminense swallowtail, Harris' mimic swallowtail, and Hahnel's Amazonian swallowtail to evaluate their status under the Act. We solicited peer review of our evaluation of the available data, and our peer reviewers supported our analysis. Science is a cumulative process, and the body of knowledge is ever-growing. In light of this, the Service will always take new research into consideration.
                </P>
                <P>
                    <E T="03">(3) Comment:</E>
                     One commenter claims the Service needs to assess the economic impact of listing and designating critical habitat for the three swallowtails.
                </P>
                <P>
                    <E T="03">Our response:</E>
                     The Act requires us to use the best scientific and commercial data available in our listing determinations. The Act does not allow us to consider the impacts of listing on economics or human activities over the short term, long term, or cumulatively. No critical habitat will be designated for the Fluminense swallowtail, Harris' mimic swallowtail, nor Hahnel's Amazonian swallowtail. Under our regulations at 50 CFR 424.12(g), we do not designate critical habitat within foreign countries or in areas outside the jurisdiction of the United States.
                </P>
                <HD SOURCE="HD1">Final Listing Determination</HD>
                <HD SOURCE="HD1">Background</HD>
                <HD SOURCE="HD2">Taxonomy and Physical Description</HD>
                <P>
                    The Fluminense swallowtail, Harris' mimic swallowtail, and Hahnel's Amazonian swallowtail are all butterflies belonging to the Papilonidae family. Swallowtail butterflies get their name from extended tails on their hindwings; however, not all swallowtails possess this feature. The Fluminense swallowtail (
                    <E T="03">Parides ascanius</E>
                    ) and Hahnel's Amazonian swallowtail (
                    <E T="03">Parides hahneli</E>
                    ) are both full species in the multi-species genus 
                    <E T="03">Parides</E>
                     (Tyler et al. 1994, pp. 179, 185; Racheli and Olmisani 1998, p. 126; Racheli et al. 2006, pp. 73, 77; Bánki et al. 2022, unpaginated). The Harris's mimic swallowtail, 
                    <E T="03">Eurytides</E>
                     (=
                    <E T="03">Mimoides or Graphium</E>
                    ) 
                    <E T="03">lysithous harrisianus</E>
                     (Swainson 1822), is a subspecies of 
                    <E T="03">E.</E>
                     (=
                    <E T="03">M.</E>
                    ) 
                    <E T="03">lysithou</E>
                    s (D'Abrera 1981 and D'Almeida 1966 as cited in Collins and Morris 1985, p. 208; Zhang et al. 2019, p. 3).
                </P>
                <P>All three swallowtails are endemic to Brazil. The Fluminense swallowtail is a black-white-and-red butterfly with a 45-millimeter (mm) (1.77-inch (in)) wingspan (Otero and Brown 1984, p. 2). Mimicking the Fluminense swallowtail, Harris' mimic swallowtail is a similar-looking medium-sized black-white-and-red butterfly with narrow and relatively short tails (Collins and Morris 1985, p. 208). Hahnel's Amazonian swallowtail is a large black-and-yellow butterfly with a wingspan of 80-100 mm (3.14-3.93 in) (Collins and Morris 1985, p. 242).</P>
                <HD SOURCE="HD2">Fluminense Swallowtail Ecology</HD>
                <P>
                    The Fluminense swallowtail, endemic to sand forests or “restingas,” currently occupies an estimated 36 to 288 square kilometers (km
                    <SU>2</SU>
                    ) of sparse habitat fragments across the swampy coastal forests of the State of Rio de Janeiro and the southern part of the State of Espírito Santo (Soares et al. 2011, p. 69; Seraphim et al. 2016, p. 534; H. Grice et al. 2019b, p. 2; Almeida 2023, unpaginated; Brant 2023, pers. comm.; Rosa et al. 2023, p. 8). Larvae feed exclusively on pipevine (also known as Dutchman's pipe) (
                    <E T="03">Aristolochia trilobata</E>
                    ), which grows primarily in rich, wet soils and is endemic to restinga habitats (Almeida 2015a, unpaginated; Seraphim et al. 2016, p. 534). Adult Fluminense swallowtails have been documented to feed on more than 30 flowering plant species from more than 12 families (Almeida 2015a, unpaginated).
                </P>
                <P>The Fluminense swallowtail typically has six generations per year and develops from egg to adult in approximately 50-58 days, with adult male life expectancy averaging 12.3 days (Otero and Brown 1984, pp. 5-6, 8-9; Herkenhoff et al. 2013, pp. 29-32; Almeida 2015b, p. 387). Adult males can travel distances of 400 to 1,000 meters (m) but are not found above 60 m of altitude (Soares et al. 2011, p. 69; Herkenhoff et al. 2013, pp. 29, 32; Seraphim et al. 2016, p. 544).</P>
                <P>Fluminense swallowtails are known to have a sparse distribution throughout their range; sex ratios are male-dominated; and population numbers increase in the austral spring, peaking in October, correlated with warmer temperatures and lower relative humidity (Herkenhoff et al. 2013, p. 32; dos Santos Pereira et al. 2020, pp. 371-372). The Fluminense swallowtail currently occupies at least eight sites in the State of Rio de Janeiro where the species exhibits a metapopulation structure (a group of separate subpopulations that has some level of mixing) (Seraphim et al. 2016, pp. 534, 544). The species has also recently been seen in the southern part of the State of Espírito Santo, but records of this occurrence are not yet published (Brant 2023, unpaginated). Both the number of subpopulations as well as the numbers of individuals within each subpopulation have continually declined, but total population estimates do not currently exist (Seraphim et al. 2016, p. 535; Almeida 2017, unpaginated; H. Grice et al. 2019b, p. 4).</P>
                <HD SOURCE="HD2">Harris' Mimic Swallowtail Ecology</HD>
                <P>
                    The Harris' mimic swallowtail currently occupies approximately 96 km
                    <SU>2</SU>
                     in Rio de Janeiro city, Barra de São João, Poço das Antas Biological Reserve, Jurubatiba National Park, and possibly near Vitória City in the State of Espírito Santo. In these areas, the Harris' mimic swallowtail inhabits sand-forest habitats composed of mixed dense and open vegetation adjacent to and in the lowland restinga swamps and in sandy flats above the tidal margins of the coastal Atlantic Forest (Otero and Brown, 1984, p. 10; Collins and Morris 1985, p. 209; Tyler, Hamilton A., Brown, and Wilson 1994, p. 179; Brown, Jr. 2004, pers. comm.; Monteiro et al. 2004, entire; Brant 2023, pers. comm.; Rosa, Ribeiro, and Freitas 2023, p. 8).
                </P>
                <P>
                    Harris' mimic swallowtail feeds on several plant species in the larval stage, and adults feed on nectar from flowering plants (Collins and Morris 
                    <PRTPAGE P="99131"/>
                    1985, p. 209; Tyler, Hamilton A., Brown, and Wilson 1994, p. 179; Xerces Society 2006, unpaginated). The Harris' mimic swallowtail has one brood per year, and individuals can remain in the pupal stage for 9 months to a year (Collins and Morris 1985, p. 209; Tyler, Hamilton A., Brown, and Wilson 1994, p. 179; Almeida 2015a, unpaginated). The adult flight season is from September to February, and flight activity is strongly associated with high humidity and sunshine (Collins and Morris 1985, p. 209).
                </P>
                <P>Population ecology data are limited for Harris' mimic swallowtail. While new and unpublished information indicates more colonies may have recently been discovered, the current best available data indicates only five known colonies of the subspecies, with abundance estimates for only one site from the early 2000s (Tyler, Hamilton A., Brown, and Wilson 1994, p. 179; Brown, Jr. 2004, pers. comm.; Monteiro et al. 2004, entire; Almeida 2015a, unpaginated; Brant 2023, pers. comm.). Information on sex ratio, population structure, and total population size is unknown, but the best available data indicates the total population size is decreasing due to ongoing habitat loss and degradation.</P>
                <HD SOURCE="HD2">Hahnel's Amazonian Swallowtail Ecology</HD>
                <P>
                    Hahnel's Amazonian swallowtail is very rare with a patchy distribution, inhabiting old sand strips (
                    <E T="03">i.e.,</E>
                     stranded beaches) in remote regions along the tributaries of the middle and lower Amazon River basin in the States of Amazonas and Pará (Brown in litt. 1982, as cited in Collins and Morris 1985, p. 242; New and Collins 1991, p. 29; Tyler et al. 1994, p. 178; Racheli et al. 2006, p. 77; H. Grice et al. 2019c, p. 4). Hahnel's Amazonian swallowtail's location records span a wide range, and, due to lack of recent surveys, it is unknown whether the species persists in these locations (Brown, Jr. 2004, pers. comm.; H. Grice et al. 2019c, p. 2).
                </P>
                <P>
                    Very limited information is available on the ecology, population size, population trends, or sex ratio of Hahnel's Amazonian swallowtail due to its extremely low densities and occurrence in remote regions. We are unaware of any information on the number of generations per year, life span, or duration of each life stage. The species likely feeds on only one or a few larval host plants, and while it has not been identified to species, it is believed to be in the Dutchman's pipe genus, either 
                    <E T="03">Aristolochia lanceolato-lorato</E>
                     or 
                    <E T="03">A. acutifolia</E>
                     (Collins and Morris 1985, p. 242; Tyler et al. 1994, p. 337; Racheli et al. 2006, p. 13). Like other swallowtail butterflies, it has been seen flying high, at or above the canopy (Brown, Jr. 2004, pers. comm.). The species is known to have a linear and patchy distribution, which might limit gene flow (Collins and Morris 1985, p. 242; H. Grice et al. 2019c, p. 4).
                </P>
                <P>A thorough review of the taxonomy, life history, and ecology of the Fluminense, Harris' mimic, and Hahnel's Amazonian swallowtails is presented in the SSA report (Service 2023, pp. 1-11).</P>
                <HD SOURCE="HD1">Regulatory and Analytical Framework</HD>
                <HD SOURCE="HD2">Regulatory Framework</HD>
                <P>
                    Section 4 of the Act (16 U.S.C. 1533) and the implementing regulations in title 50 of the Code of Federal Regulations set forth the procedures for determining whether a species is an endangered species or a threatened species, issuing protective regulations for threatened species, and designating critical habitat for endangered and threatened species. On April 5, 2024, jointly with the National Marine Fisheries Service (NMFS), the Service issued a final rule that revised the regulations in 50 CFR part 424 regarding how we add, remove, and reclassify endangered and threatened species and what criteria we apply when designating listed species' critical habitat (89 FR 24300). On the same day, the Service published a final rule revising our protections for endangered species and threatened species at 50 CFR part 17 (89 FR 23919). These final rules are now in effect and are incorporated into the current regulations. Our analysis for this final decision applied our current regulations. Given that we proposed listing this species under our prior regulations (revised in 2019), we have also undertaken an analysis of whether our decision would be different if we had continued to apply the 2019 regulations; we concluded that the decision would be the same. The analyses under both the regulations currently in effect and the 2019 regulations are available on 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether any species is an endangered species or a threatened species because of any of the following factors:</P>
                <P>(A) The present or threatened destruction, modification, or curtailment of its habitat or range;</P>
                <P>(B) Overutilization for commercial, recreational, scientific, or educational purposes;</P>
                <P>(C) Disease or predation;</P>
                <P>(D) The inadequacy of existing regulatory mechanisms; or</P>
                <P>(E) Other natural or manmade factors affecting its continued existence.</P>
                <P>These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects.</P>
                <P>We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself.</P>
                <P>However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the species' expected response and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, then analyze the cumulative effect of all of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species, such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species.</P>
                <P>
                    The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations 
                    <PRTPAGE P="99132"/>
                    at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis, which is further described in the 2009 Memorandum Opinion on the foreseeable future from the Department of the Interior, Office of the Solicitor (M-37021, January 16, 2009; “M-Opinion,” available online at 
                    <E T="03">https://www.doi.gov/sites/doi.opengov.ibmcloud.com/files/uploads/M-37021.pdf</E>
                    ). The foreseeable future extends as far into the future as the Service and NMFS can make reasonably reliable predictions about the threats to the species and the species' responses to those threats. We need not identify the foreseeable future in terms of a specific period of time. We will describe the foreseeable future on a case-by-case basis, using the best available data and taking into account considerations such as the species' life-history characteristics, threat-projection timeframes, and environmental variability. In other words, the foreseeable future is the period of time over which we can make reasonably reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction, in light of the conservation purposes of the Act.
                </P>
                <HD SOURCE="HD2">Analytical Framework</HD>
                <P>The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data regarding the status of the species, including an assessment of the potential threats to the species. The SSA report does not represent our decision on whether the species should be listed as an endangered or threatened species under the Act. However, it does provide the scientific basis that informs our regulatory decisions, which involve the further application of standards within the Act and its implementing regulations and policies.</P>
                <P>To assess the Fluminense, Harris' mimic, and Hahnel's Amazonian swallowtails' viability, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency is the ability of the species to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years); redundancy is the ability of the species to withstand catastrophic events (for example, droughts, large pollution events), and representation is the ability of the species to adapt to both near-term and long-term changes in its physical and biological environment (for example, climate conditions, pathogens). In general, species viability will increase with increases in (or decrease with decreases in) resiliency, redundancy, and representation (Smith et al. 2018, p. 306). Using these principles, we identified the species' ecological requirements for survival and reproduction at the individual, population, and species levels, and described the beneficial and risk factors influencing the species' viability.</P>
                <P>The SSA process can be categorized into three sequential stages. During the first stage, we evaluated the individual species' life-history needs. The next stage involved an assessment of the historical and current condition of the species' demographics and habitat characteristics, including an explanation of how the species arrived at its current condition. The final stage of the SSA involved making predictions about the species' responses to positive and negative environmental and anthropogenic influences. Throughout all of these stages, we used the best available data to characterize viability as the ability of a species to sustain populations in the wild over time. We use this information to inform our regulatory decision.</P>
                <P>
                    The following is a summary of the key results and conclusions from the SSA report; the full SSA report can be found at Docket FWS-HQ-ES-2023-0067 on 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <HD SOURCE="HD1">Summary of Biological Status and Threats</HD>
                <P>In this discussion, we review the biological condition of each of these three species and their resources, and the threats that influence the species' current and future conditions, in order to assess the species' overall viability and the risks to that viability.</P>
                <HD SOURCE="HD2">Species Needs</HD>
                <P>Based on each species' biology described above (see discussion under Background) and in the SSA report (Service 2023, pp. 1-11), the three Brazilian swallowtails all need sufficient quantity, quality, and connectivity of their respective specialized habitats; host plants for larval development and food sources; an abundance of flowering plants for nectar sources for the adult butterflies; and like most species, sufficient conspecific individuals to find a mate. Owing to the limited data available, our assessment of species-level needs is developed further based on general principles as they apply to butterfly biology.</P>
                <P>
                    Butterfly viability is fostered—and thereby extinction risk reduced—by having multiple, connected demographically and genetically robust populations distributed widely across heterogeneous environmental conditions (referred to as spatial heterogeneity) and the breadth of diversity (genetic, morphological, physiological, and ecological variation). Spatial heterogeneity fosters asynchronous fluctuations among populations, guarding against concurrent population declines. Maintaining historical patterns and levels of gene flow maintains genetic health (increases heterozygosity), while continued connectivity allows for demographic rescue following population decline or extirpation and supports dispersal in response to shifting conditions. Gene flow and spatial heterogeneity also support continuing adaptive responses, as does conserving genetic diversity across the landscape. Conversely, butterfly species composed of reduced or isolated populations are vulnerable to genetic drift and have reduced adaptive capacity, or the ability to respond to (
                    <E T="03">i.e.,</E>
                     cope with, accommodate, or evolve in response to) environmental change (Forester et al. 2022, p. 507). Habitat loss, degradation, and fragmentation are the main factors that affect all three species' viability throughout their ranges, with additional impacts from climate change, fire, and capture. The Fluminense swallowtail's viability is further impacted by parasitism.
                </P>
                <HD SOURCE="HD2">Habitat Loss and Degradation</HD>
                <P>
                    Habitat loss and degradation is the primary factor negatively impacting the three Brazilian swallowtails, with all species experiencing high levels of deforestation in their ranges (Collins and Morris 1985, pp. 22, 67, 152, 209, 242; Tyler et al. 1994, p. 179; Brown, Jr. 1996, pp. 45-46, 52, 57; Seraphim et al. 2016, p. 534). The Fluminense and Harris' mimic swallowtails both occupy the Atlantic Forest, which has experienced an estimated 88 to 95 percent deforestation, and the remaining tracts of its habitat are severely fragmented (Saatchi et al. 2001, p. 868; Monteiro et al. 2004, p. 786; Tabarelli et al. 2005, p. 695; Ribeiro et al. 2009, pp. 1141-1145). Within the Atlantic Forest, the highly specialized restinga habitat required by the Fluminense and Harris' mimic swallowtails comprises only 0.4 percent of its historical distribution, and the remaining patches of restinga habitat are under strong pressure from anthropogenic disturbance (Otero and Brown 1984, pp. 3-6, 10-12; Brown, Jr. 2004, pers. comm.; Rocha et al. 2007, entire; Uehara-Prado and Fonseca 2007, pp. 264-266). The States of Pará and Amazonas, where the Hahnel's Amazonian swallowtail occurs, have 
                    <PRTPAGE P="99133"/>
                    also experienced and are continuing to experience high rates of deforestation, losing 66 percent and 11 percent of forests, respectively, over less than three decades (Soares-Filho et al. 2006, p. 250; The Economist 2013, unpaginated; Fraser 2015, unpaginated; Instituto Nacional de Pesquisas Espaciais (INPE) 2017, unpaginated). Deforestation in areas of Pará has continued and accelerated in more recent years, with indication of a threefold increase in yearly rates of deforestation in the period 2018-2021 compared to 2011-2018 (Kuschnig et al. 2023, pp. 4-5). Considering the life history and biology of all three swallowtails, increased and ongoing habitat loss and deforestation has and is continuing to decrease their viability throughout their ranges due to their specialized habitat requirements and patchy distributions.
                </P>
                <HD SOURCE="HD2">Climate Change</HD>
                <P>Across Brazil, climate change is expected to increase temperatures and alter precipitation patterns as well as increase heatwaves and the length of the dry season in the Amazon (The World Bank Group 2021, unpaginated). Studies of butterflies in other fragmented tropical landscapes indicate an adverse effect on species richness as a result of altered precipitation patterns (Shuey 2022, pers. comm.). As progressing global climate change increases storm surge and causes sea level to rise (Intergovernmental Panel on Climate Change (IPCC) 2022, pp. 6-13), the extent of the Fluminense and Harris' mimic swallowtails' habitats is projected to be further reduced. Given the narrow distribution and habitat fragmentation of all three of these Brazilian swallowtails, coupled with reliance on specialized habitat, they are likely to be increasingly susceptible to negative impacts from climatic changes with limited adaptive capacity (Bellaver et al. 2022, p. 654).</P>
                <HD SOURCE="HD2">Fire</HD>
                <P>Fire is another factor impacting all three swallowtails' viability. The Poco das Antas Biological Reserve, a large reserve where both the Fluminense and Harris' mimic swallowtails occur, has experienced frequent fire since the 1980s following drainage and damming projects in the region (Herkenhoff et al. 2013, p. 29; Sansevero et al. 2020, p. 32). Regarding the Hahnel's Amazonian swallowtail, fire in the Amazon has increased in recent years and is correlated with increased deforestation (Silveira et al. 2020, entire; 2022, entire). Fire has and will likely continue to cause habitat fragmentation and reduce the availability of specialized habitat for the three swallowtails.</P>
                <HD SOURCE="HD2">Capture</HD>
                <P>Rare and aesthetic butterflies and moths are highly prized by collectors, and all three swallowtails have been collected and sold internationally (Collins and Morris 1985, pp. 155-179; Morris et al. 1991, pp. 332-334; Wang et al. 2023, entire; Williams 1996, entire). Despite some protections under Brazilian and European laws, monitoring the trade of insects is difficult and these existing regulations have minimal impact on regulating trade or collection (H. Grice et al. 2019a, p. 4; 2019b, p. 4; 2019c, p. 4). Both the Fluminense and Harris' mimic swallowtail occur near urban areas, increasing opportunity and ease of capture (Brown, Jr. 2004, pers. comm.). Additionally, species such as these three swallowtails with restricted distributions or localized populations tend to be more vulnerable to overcollection than those with a wider distribution (Brown, Jr. 2004, pers. comm.).</P>
                <HD SOURCE="HD2">Parasitism</HD>
                <P>Parasitism has been identified as another stressor of the Fluminense swallowtail, with several parasites known to target the species and some colonies experiencing annual patterns of parasitism (Tavares et al. 2006, entire; Almeida 2015b, p. 388; 2017, pers. comm.). While impacts of parasitism on the species are unknown, parasitism and subsequent mortality of early life stages could potentially contribute to local extirpations of the remaining small, fragmented subpopulations.</P>
                <HD SOURCE="HD2">Conservation Efforts and Regulatory Mechanisms</HD>
                <P>Our evaluation of the status of the species takes into account the extent to which threats are reduced or removed as a result of conservation efforts or existing regulatory mechanisms.</P>
                <P>All three swallowtails are afforded some protections under Brazilian and international laws, including Brazilian environmental laws for endangered species (Fluminense and Harris' mimic swallowtails), protections in the State of Pará through its list of threatened species (Hahnel's Amazonian swallowtail), and inclusion in Annex B of the European Union (EU) Wildlife Trade Regulations (Fluminense and Hahnel's Amazonian swallowtails) (Snt'Anna et al. 2016, unpaginated; European Commission 2017, p. 802; Biodiversidade 2022, unpaginated). However, due to the difficulty in monitoring the insect trade, these existing regulations have minimal impact, and none of the three swallowtails is listed in the Appendices to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) (H. Grice et al. 2019a, p. 4; 2019b, p. 4; 2019c, p. 4).</P>
                <P>Habitat protection is generally lacking for all three swallowtails, although there is some overlap of protected areas in the Fluminense and Harris' mimic swallowtails' ranges. While most extant subpopulations of the Fluminense swallowtail exist outside protected areas, it is afforded some protection where it occurs in small municipal parks and conservation units as well as in one protected reserve, Poço das Antas Biological Reserve (Seraphim et al. 2016, p. 536; Almeida 2017, pers. comm.). The Harris' mimic swallowtail also is afforded some protections from conservation units and the Poço das Antas Biological Reserve, in addition to occupying Jurubatiba National Park, which holds the largest remaining remnant of restinga habitat (Critical Ecosystem Partnership Fund (CEPF) 2001, p. 9; Rocha et al. 2007, pp. 263-269). While some habitat protections are in place in known occurrence locations for the Fluminense and Harris' mimic swallowtail, they occupy a highly urbanized matrix undergoing continuing development pressures (International Finance Corporation (IFC) 2002, entire; Khalip 2007, unpaginated). It is unknown if the Hahnel's Amazonian swallowtail currently occurs in any protected areas, but limited resources for conservation application minimize effectiveness of protected areas in the Amazon (Collins and Morris 1985, p. 234; Laurance and Williamson 2001, p. 1533; H. Grice et al. 2019c, p. 4).</P>
                <P>Captive-reared Fluminense swallowtails were released over several years throughout the city of Rio de Janeiro in an attempt to increase subpopulation sizes and genetic diversity, but limited post-release monitoring took place to determine the success of this effort (Instituto Chico Mendes De Conservação Da Biodiversidade (ICMBio) 2007, pp. 82-89; Almeida 2017, pers. comm.; Monteiro 2017, pers. comm.). Captive-rearing may be reinitiated in the future, but it is unclear when or how effective it might be at conserving the species (Almeida 2017, pers. comm.). No captive-rearing efforts for the Harris' mimic swallowtail or the Hahnel's Amazonian swallowtail are known.</P>
                <HD SOURCE="HD2">Current Condition: Fluminense Swallowtail</HD>
                <P>
                    The best available scientific and commercial data indicate the 
                    <PRTPAGE P="99134"/>
                    Fluminense swallowtail is a narrow endemic with low genetic diversity composed of a single metapopulation that occupies an estimated 36 to 288 km
                    <SU>2</SU>
                     (Tyler et al. 1994, p. 179; Seraphim et al. 2016, p. 534; Almeida 2017, pers. comm.). The remnant subpopulations occur in a highly urbanized landscape undergoing increased isolation from habitat loss, degradation, and fragmentation, with the majority occurring in small habitat patches under high risk of local extinction (Almeida 2015a, unpaginated; Almeida 2017, pers. comm.; Seraphim et al. 2016, p. 534; Monteiro 2017, pers. comm.). While some of the subpopulations occur in protected areas, most are afforded limited or no protections (Soares et al. 2011, entire; Seraphim et al. 2016, pp. 536, 544).
                </P>
                <P>The Fluminense swallowtail's small and isolated colonies are at increased risk of extirpation due to stochasticity and catastrophic events, and although we cannot quantify the level of risk, their vulnerability increases the longer they remain in this impaired condition. The requisite restinga habitat of the Fluminense swallowtail, once the dominant habitat type along the eastern coast of Brazil, was reduced to less than 1 percent of its former range by 2007. Past deforestation resulted in extirpation of multiple colonies and fragmentation and isolation of remaining sites. Considering the severe reduction in the specialized requisite habitat for the Fluminense swallowtail and its reliance on a single larval host plant, the species has limited resiliency and ability to withstand environmental and demographic stochasticity. With only a single metapopulation and a reduced number of subpopulations inhabiting a highly urbanized and fragmented landscape, the Fluminense swallowtail has minimal redundancy to safeguard against catastrophic events. Lastly, while the species is already known to have low genetic diversity and an inherently limited ability to adapt (owing to its specialized habitat requirements, a single larval host plant, and a narrow climatic niche breadth), as subpopulations are increasingly isolated from habitat loss and fragmentation the species' representation and ability to adapt to changing and shifting environmental conditions is further constrained.</P>
                <HD SOURCE="HD2">Current Condition: Harris' Mimic Swallowtail</HD>
                <P>
                    The Harris' mimic swallowtail is a narrow endemic that occupies an estimated 96 km
                    <SU>2</SU>
                     across approximately six sites in the State of Rio de Janeiro and possibly one site in the State of Espírito Santo (Collins and Morris 1985, p. 208; Tyler et al. 1994, p. 179; Brown, Jr. 2004, pers. comm.; Monteiro et al. 2004, p. 153; Almeida 2015a, unpaginated; H. Grice et al. 2019a, p. 2; Brant 2023, pers. comm.; Rosa et al. 2023, p. 8). Current population estimates do not exist for any of these sites, and whether Harris' mimic swallowtail still occurs in these locations is uncertain. Two colonies in the City of Rio de Janeiro occur in small patches of vegetation possibly under high risk of local extirpation, and recent observations are scarce of the colony in Barra de São João, which was previously characterized as vigorous and stable (Tyler et al. 1994, p. 179; Brown, Jr. 2004, pers. comm.; Almeida 2015a, unpaginated; H. Grice et al. 2019a, p. 2).
                </P>
                <P>By the early 2000s, the restinga habitat was reduced to only 0.4 percent of its historical distribution with restinga remnants already generally small and surrounded by areas undergoing rapid urbanization or already urbanized (Ribeiro et al. 2009, as cited in Seraphim et al. 2016, p. 534; Rocha et al. 2007, pp. 263, 265). This severely reduced habitat has continued to decline. Over the last 20 years, the forest in the Harris' mimic swallowtail's remaining range has experienced an estimated 2.14 percent loss, and at times protected areas experienced higher rates of deforestation than outside protected areas (Service 2023, p. 21).</P>
                <P>In the absence of historical or current population data, the large quantities of habitat loss seen in the range of the Harris' mimic swallowtail suggest the population has likely experienced comparable declines in size. The subspecies has been extirpated from portions of its historical range, and in its once strongest colony it now appears to be scarce. While the Harris' mimic swallowtail occupies two protected areas of intact restinga habitat, has some diversity in habitat types used, and has larva that feed on multiple host plants, its extent of occurrence is severely reduced and is within a highly urbanized landscape, limiting the subspecies' resiliency and ability to withstand environmental and demographic stochasticity. The subspecies' reliance on a severely reduced specialized habitat in a highly urbanized and fragmented landscape with only a few known colonies indicates the Harris' mimic swallowtail has limited redundancy to safeguard against catastrophic events. Finally, the highly urbanized and fragmented landscape that the Harris' mimic swallowtail inhabits likely limits migration and gene flow between colonies, which, coupled with the subspecies' reliance on specialized habitat, hinders the Harris' mimic swallowtail's representation and leaves it vulnerable to changing and shifting environmental conditions.</P>
                <HD SOURCE="HD2">Current Condition: Hahnel's Amazonian Swallowtail</HD>
                <P>
                    The Hahnel's Amazonian swallowtail has an estimated extent of occurrence of 189,015 km
                    <SU>2</SU>
                    , has an unknown area of occupancy, and is known from a linear and patchy distribution along the tributaries of the middle and lower Amazon River basin (Collins and Morris 1985, p. 242; New and Collins 1991, p. 29; Tyler et al. 1994, p. 178; Racheli et al. 2006, p. 77; H. Grice et al. 2019c, p. 2). The species is known to be scarce; however, even when rarity is natural, rarer species are at higher risk of extinction than those that are common (Flather and Sieg 2007, entire; Johnson 1998, entire).
                </P>
                <P>Regions where the Hahnel's Amazonian swallowtail was previously known to occur have experienced continued and increasing rates of deforestation (H. Grice et al. 2019a, p. 4). In the period 2000-2020, the range of the Hahnel's Amazonian swallowtail experienced 5.65 percent forest cover loss, and similar trends in forest loss occurred between protected areas and non-protected areas (Service 2023, p. 24). About 85 percent of forest cover remains in the species' known extent of occurrence; however, the species is inherently rare, restricted to a highly specialized habitat, and likely has only a single larval host plant, which limits the species' resiliency and ability to withstand environmental and demographic stochasticity. While the large extent of occurrence provides some level of redundancy to safeguard against catastrophic events, the species has been found in only a few locations, suggesting that localized extirpations from habitat loss or other factors would likely be detrimental to the species. Finally, considering the species' scarcity and patchy linear distribution, gene flow between populations is unlikely, limiting the species' representation and making it vulnerable to changing and shifting environmental conditions.</P>
                <HD SOURCE="HD2">Future Scenarios and Cumulative Effects</HD>
                <P>
                    As part of the SSA report, we developed future-condition scenarios to capture the range of uncertainties regarding future threats and the projected responses by the Fluminense, Harris' mimic, and Hahnel's Amazonian swallowtails. Our future scenarios reflect the conclusion from our analysis that the primary factor influencing the 
                    <PRTPAGE P="99135"/>
                    future viability of all three of these swallowtails is habitat loss and degradation resulting from (1) deforestation from land-use change and urbanization and (2) climate-change impacts on the species' climatic niche breadths and habitat availability. The best available data indicates that all three swallowtails' populations and distributions will decline in the future. However, because we have determined that the Fluminense, Harris' mimic, and Hahnel's Amazonian swallowtails meet the Act's definition of endangered species based on their current conditions (see Determination of Status for the Fluminense Swallowtail, Harris' Mimic Swallowtail, and Hahnel's Amazonian Swallowtail, below), we are not presenting the results of the future scenarios in this rule. Please refer to the SSA report (Service 2023, entire) for the full analysis of future scenarios.
                </P>
                <P>We note that, by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have analyzed the cumulative effects of identified threats and conservation actions on these species. To assess the current and future condition of the species, we evaluate the effects of all the relevant factors that may be influencing the species, including threats and conservation efforts. Because the SSA framework considers not just the presence of the factors, but to what degree they collectively influence risk to the entire species, our assessment integrates the cumulative effects of the factors and replaces a standalone cumulative effects analysis.</P>
                <HD SOURCE="HD1">Determination of Status for the Fluminense Swallowtail, Harris' Mimic Swallowtail, and Hahnel's Amazonian Swallowtail</HD>
                <P>Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species meets the definition of an endangered species or a threatened species. The Act defines an “endangered species” as a species in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether a species meets the definition of endangered species or threatened species because of any of the following factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence.</P>
                <HD SOURCE="HD2">Status Throughout All of Its Range—Fluminense Swallowtail</HD>
                <P>After evaluating threats to the species and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, we determined that the Fluminense swallowtail's distribution and population have been reduced across its range as evidenced by the extensive loss and degradation of its requisite specialized habitat. The remnant subpopulations occur in a highly urbanized landscape undergoing increased isolation from habitat loss, degradation, and fragmentation and consequently are at increased risk of extirpation due to stochasticity and catastrophic events. Coupled with the species' specialized habitat requirements, the isolation and fragmentation of the remaining subpopulations, which make up a single metapopulation, have left the species with insufficient resiliency, redundancy, and representation for its continued existence to be secure.</P>
                <P>Thus, after assessing the best scientific and commercial data available regarding threats to the species and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, we determine that the Fluminense swallowtail is in danger of extinction throughout all of its range primarily due to historical and ongoing habitat loss and degradation from development and urbanization (Factor A) and the additive threat from capture (Factor B). The existing regulatory mechanisms and other conservation measures are inadequate to address the identified threats to the species (Factor D). The species does not fit the statutory definition of a threatened species because it is currently in danger of extinction, whereas threatened species are those likely to become in danger of extinction within the foreseeable future.</P>
                <HD SOURCE="HD2">Status Throughout All of Its Range—Harris' Mimic Swallowtail</HD>
                <P>After evaluating threats to the species and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, we determined the Harris' mimic swallowtail's distribution and population have been reduced across its range as evidenced by the extensive loss and degradation of its requisite specialized habitat. The remnant colonies occur in a highly urbanized landscape undergoing increased isolation from habitat loss, degradation, and fragmentation and consequently are at increased risk of extirpation due to stochasticity and catastrophic events. Coupled with the species' specialized habitat requirements, the isolation and fragmentation of the remaining colonies have left the subspecies with insufficient resiliency, redundancy, and representation for its continued existence to be secure.</P>
                <P>Thus, after assessing the best scientific and commercial data available regarding threats to the species and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, we determine that the Harris' mimic swallowtail is in danger of extinction throughout all of its range due to historical and ongoing habitat loss and degradation from anthropogenic activities (Factor A) and the additive threat from capture (Factor B). The existing regulatory mechanisms and other conservation measures are inadequate to address the identified threats to the species (Factor D). The species does not fit the statutory definition of a threatened species because it is currently in danger of extinction, whereas threatened species are those likely to become in danger of extinction within the foreseeable future.</P>
                <HD SOURCE="HD2">Status Throughout All of Its Range—Hahnel's Amazonian Swallowtail</HD>
                <P>After evaluating threats to the species and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, we determined that the viability of the Hahnel's Amazonian swallowtail is limited as a result of extensive habitat loss and degradation coupled with the species' rarity and patchy distribution. The species is inherently rare, is restricted to a highly specialized habitat, and likely has only a single larval host plant, which, when coupled with habitat loss and degradation, makes the species vulnerable to changing and shifting environmental conditions and catastrophic events and has left it with insufficient resiliency, redundancy, and representation for the species' continued existence to be secure.</P>
                <P>
                    Thus, after assessing the best scientific and commercial data available regarding threats to the species and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, we determine that the Hahnel's Amazonian swallowtail is in danger of extinction throughout all of its range primarily due to ongoing and increasing habitat loss and degradation from deforestation and fire (Factor A) and the additive threat from capture (Factor B). The existing regulatory mechanisms and 
                    <PRTPAGE P="99136"/>
                    other conservation measures are inadequate to address the identified threats to the species (Factor D). The species does not fit the statutory definition of a threatened species because it is currently in danger of extinction, whereas threatened species are those likely to become in danger of extinction within the foreseeable future.
                </P>
                <HD SOURCE="HD2">Status Throughout a Significant Portion of Their Ranges</HD>
                <P>
                    Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so in the foreseeable future throughout all or a significant portion of its range. We have determined that the Fluminense swallowtail, Harris' mimic swallowtail, and Hahnel's Amazonian swallowtail are in danger of extinction throughout all of their ranges and accordingly did not undertake an analysis of any significant portion of their ranges. Because the Fluminense swallowtail, Harris' mimic swallowtail, and Hahnel's Amazonian swallowtail warrant listing as endangered throughout all of their ranges, our determination does not conflict with the decision in 
                    <E T="03">Center for Biological Diversity</E>
                     v. 
                    <E T="03">Everson,</E>
                     435 F. Supp. 3d 69 (D.D.C. 2020), which vacated the provision of the Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (Final Policy) (79 FR 37578; July 1, 2014) providing that if the Service determines that a species is threatened throughout all of its range, the Service will not analyze whether the species is endangered in a significant portion of its range.
                </P>
                <HD SOURCE="HD2">Fluminense Swallowtail, Harris' Mimic Swallowtail, and Hahnel's Amazonian Swallowtail—Determination of Status</HD>
                <P>Our review of the best available scientific and commercial data indicates that the Fluminense swallowtail, Harris' mimic swallowtail, and Hahnel's Amazonian swallowtail meet the definition of an endangered species. Therefore, we are listing the Fluminense swallowtail, Harris' mimic swallowtail, and Hahnel's Amazonian swallowtail as endangered species in accordance with sections 3(6) and 4(a)(1) of the Act.</P>
                <HD SOURCE="HD1">Available Conservation Measures</HD>
                <P>The purposes of the Act are to provide a means whereby the ecosystems upon which endangered species and threatened species depend may be conserved, to provide a program for the conservation of such endangered species and threatened species, and to take such steps as may be appropriate to achieve the purposes of the treaties and conventions set forth in the Act. Under the Act, a number of steps are available to advance the conservation of species listed as endangered or threatened species. As explained further below, these conservation measures include: (1) recognition, (2) recovery actions, (3) requirements for Federal protection, (4) financial assistance for conservation programs, and (5) prohibitions against certain activities.</P>
                <P>Recognition through listing results in public awareness, as well as in conservation by Federal, State, Tribal, and local agencies, foreign governments, private organizations, and individuals. The Act encourages cooperation with the States and other countries and calls for recovery actions to be carried out for listed species.</P>
                <P>Section 7 of the Act is titled, “Interagency Cooperation,” and it mandates all Federal action agencies to use their existing authorities to further the conservation purposes of the Act and to ensure that their actions are not likely to jeopardize the continued existence of listed species or adversely modify critical habitat. Regulations implementing section 7 are codified at 50 CFR part 402.</P>
                <P>Section 7(a)(2) states that each Federal action agency shall, in consultation with the Secretary, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat.</P>
                <P>A Federal “action” that is subject to the consultation provisions of section 7(a)(2) is defined in our implementing regulations at 50 CFR 402.02 as all activities or programs of any kind authorized, funded, or carried out, in whole or in part, by Federal agencies in the United States or upon the high seas. With respect to the Fluminense swallowtail, Harris' mimic swallowtail, and Hahnel's Amazonian swallowtail, no known actions would require consultation under section 7(a)(2) of the Act. Given the regulatory definition of “action,” which clarifies that it applies to activities or programs “in the United States or upon the high seas,” the Fluminense swallowtail, Harris' mimic swallowtail, and Hahnel's Amazonian swallowtail are unlikely to be the subject of section 7 consultations, because the entire life cycles of these species occur in terrestrial areas outside of the United States and are unlikely to be affected by U.S. Federal actions. Additionally, no critical habitat will be designated for these species because, under 50 CFR 424.12(g), we will not designate critical habitat within foreign countries or in other areas outside of the jurisdiction of the United States.</P>
                <P>Section 8(a) of the Act (16 U.S.C. 1537(a)) authorizes the provision of limited financial assistance for the development and management of programs that the Secretary of the Interior determines to be necessary or useful for the conservation of endangered or threatened species in foreign countries. Sections 8(b) and 8(c) of the Act (16 U.S.C. 1537(b) and (c)) authorize the Secretary to encourage conservation programs for foreign listed species, and to provide assistance for such programs, in the form of personnel and the training of personnel.</P>
                <P>The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to endangered wildlife. The prohibitions of section 9(a)(1) of the Act, and implementing regulations codified at 50 CFR 17.21, make it illegal for any person subject to the jurisdiction of the United States to commit, to attempt to commit, to solicit another to commit or to cause to be committed any of the following acts with regard to any endangered wildlife: (1) import into, or export from, the United States; (2) take (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct) within the United States, within the territorial sea of the United States, or on the high seas; (3) possess, sell, deliver, carry, transport, or ship, by any means whatsoever, any such wildlife that has been taken illegally; (4) deliver, receive, carry, transport, or ship in interstate or foreign commerce, by any means whatsoever and in the course of commercial activity; or (5) sell or offer for sale in interstate or foreign commerce. Certain exceptions to these prohibitions apply to employees or agents of the Service, NMFS, other Federal land management agencies, and State conservation agencies.</P>
                <P>
                    We may issue permits to carry out otherwise prohibited activities involving endangered wildlife species under certain circumstances. Regulations governing permits for endangered wildlife are codified at 50 CFR 17.22, and general Service permitting regulations are codified at 50 CFR part 13. With regard to endangered wildlife, a permit may be issued for scientific purposes, for enhancing the propagation or survival of the species, or for take incidental to otherwise lawful activities. The statute also contains certain exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.
                    <PRTPAGE P="99137"/>
                </P>
                <P>The Service may also register persons subject to the jurisdiction of the United States through its captive-bred wildlife (CBW) program if certain established requirements are met under the CBW regulations (see 50 CFR 17.21(g)). Through a CBW registration, the Service may allow a registrant to conduct certain otherwise prohibited activities under certain circumstances to enhance the propagation or survival of the affected species, including take; export or re-import; delivery, receipt, carriage, transport, or shipment in interstate or foreign commerce in the course of a commercial activity; or sale or offer for sale in interstate or foreign commerce. A CBW registration may authorize interstate purchase and sale only between entities that both hold a registration for the taxon concerned. The CBW program is available for species having a natural geographic distribution not including any part of the United States and other species that the Service Director has determined to be eligible by regulation. The individual specimens must have been born in captivity in the United States.</P>
                <P>
                    It is our policy, as published in the 
                    <E T="04">Federal Register</E>
                     on July 1, 1994 (59 FR 34272), to identify, to the extent known at the time a species is listed, specific activities that would or would not constitute a violation of section 9 of the Act. The intent of this policy is to increase public awareness of the effects of a listing on proposed and ongoing activities within the range of the species.
                </P>
                <P>At this time, we are unable to identify specific activities that would not be considered likely to result in a violation of section 9 of the Act beyond what is already clear from the descriptions of prohibitions or already excepted through our regulations at 50 CFR 17.21. Also, at this time, we are unable to identify specific activities that would be considered likely to result in a violation of section 9 of the Act beyond what is already clear from the descriptions of the prohibitions at 50 CFR 17.21.</P>
                <P>
                    Applicable wildlife import/export requirements established under the Act (16 U.S.C. 1538(d)-(f)), the Lacey Act Amendments of 1981 (16 U.S.C. 3371 
                    <E T="03">et seq.</E>
                    ), and 50 CFR part 14 must also be met for imports and exports of the Fluminense swallowtail, Harris' mimic swallowtail, and Hahnel's Amazonian swallowtail. Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the Service's Division of Management Authority (
                    <E T="03">managementauthority@fws.gov;</E>
                     703-358-2104).
                </P>
                <HD SOURCE="HD1">Required Determinations</HD>
                <HD SOURCE="HD2">National Environmental Policy Act (42 U.S.C. 4321 et seq.)</HD>
                <P>
                    We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act (42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ), need not be prepared in connection with listing a species as an endangered or threatened species under the Endangered Species Act. We published a notice outlining our reasons for this determination in the 
                    <E T="04">Federal Register</E>
                     on October 25, 1983 (48 FR 49244).
                </P>
                <HD SOURCE="HD1">References Cited</HD>
                <P>
                    A complete list of references cited in this rulemaking is available on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     in Docket No. FWS-HQ-ES-2023-0067 and upon request from the Branch of Delisting and Foreign Species (see 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    ).
                </P>
                <HD SOURCE="HD1">Authors</HD>
                <P>The primary authors of this rule are the staff members of the Fish and Wildlife Service's Species Assessment Team and the Branch of Delisting and Foreign Species.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 50 CFR Part 17</HD>
                    <P>Endangered and threatened species, Exports, Imports, Plants, Reporting and recordkeeping requirements, Transportation, Wildlife.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Regulation Promulgation</HD>
                <P>Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:</P>
                <PART>
                    <HD SOURCE="HED">PART 17—ENDANGERED AND THREATENED WILDLIFE AND PLANTS</HD>
                </PART>
                <REGTEXT TITLE="50" PART="17">
                    <AMDPAR>1. The authority citation for part 17 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="50" PART="17">
                    <AMDPAR>2. In § 17.11, in paragraph (h), amend the List of Endangered and Threatened Wildlife by adding entries for “Butterfly, Fluminense swallowtail”, “Butterfly, Hahnel's Amazonian swallowtail”, and “Butterfly, Harris' mimic swallowtail” in alphabetical order under INSECTS to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 17.11</SECTNO>
                        <SUBJECT>Endangered and threatened wildlife.</SUBJECT>
                        <STARS/>
                        <P>(h) * * *</P>
                        <GPOTABLE COLS="5" OPTS="L1,nj,tp0,i1" CDEF="s50,r50,r50,10C,r75">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">Common name</CHED>
                                <CHED H="1">Scientific name</CHED>
                                <CHED H="1">Where listed</CHED>
                                <CHED H="1">Status</CHED>
                                <CHED H="1">Listing citations and applicable rules</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="21">
                                    <E T="04">Insects</E>
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Butterfly, Fluminense swallowtail</ENT>
                                <ENT>
                                    <E T="03">Parides ascanius</E>
                                </ENT>
                                <ENT>Wherever found</ENT>
                                <ENT>E</ENT>
                                <ENT>
                                    89 FR [INSERT 
                                    <E T="02">FEDERAL REGISTER</E>
                                     PAGE WHERE THE DOCUMENT BEGINS], December 10, 2024.
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Butterfly, Hahnel's Amazonian swallowtail</ENT>
                                <ENT>
                                    <E T="03">Parides hahneli</E>
                                </ENT>
                                <ENT>Wherever found</ENT>
                                <ENT>E</ENT>
                                <ENT>
                                    89 FR [INSERT 
                                    <E T="02">FEDERAL REGISTER</E>
                                     PAGE WHERE THE DOCUMENT BEGINS], December 10, 2024.
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Butterfly Harris' mimic swallowtail</ENT>
                                <ENT>
                                    <E T="03">Eurytides</E>
                                     (=
                                    <E T="03">Mimoides</E>
                                    ) 
                                    <E T="03">lysithous harrisianus</E>
                                </ENT>
                                <ENT>Wherever found</ENT>
                                <ENT>E</ENT>
                                <ENT>
                                    89 FR [INSERT 
                                    <E T="02">FEDERAL REGISTER</E>
                                     PAGE WHERE THE DOCUMENT BEGINS], December 10, 2024.
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <PRTPAGE P="99138"/>
                    <NAME>Gary Frazer,</NAME>
                    <TITLE>Acting Director, U.S. Fish and Wildlife Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28430 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4333-15-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Part 648</CFR>
                <DEPDOC>[Docket No. 231215-0305; RTID 0648-XE515]</DEPDOC>
                <SUBJECT>Fisheries of the Northeastern United States; Summer Flounder Fishery; 2024 Commercial Quota Harvested for the State of Connecticut</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Temporary rule; closure.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS announces that the 2024 summer flounder commercial quota allocated to the State of Connecticut has been harvested. Vessels issued a commercial Federal fisheries permit for the summer flounder fishery may not land summer flounder in Connecticut for the remainder of calendar year 2024, unless additional quota becomes available through a transfer from another state. Regulations governing the summer flounder fishery require publication of this notification to advise Connecticut that the quota has been harvested, and to advise vessel permit holders and dealer permit holders that no Federal commercial quota is available for landing summer flounder in Connecticut.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective 0001 hours December 10, 2024, through 2400 hours December 31, 2024.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Matthew Rigdon, (978) 281-9336, or 
                        <E T="03">matthew.rigdon@noaa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Regulations governing the summer flounder fishery are found at 50 CFR 648.100 through 648.111. The regulations require annual specification of a commercial quota that is apportioned on a percentage basis among the coastal states from Maine through North Carolina. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.102.</P>
                <P>The commercial quota for summer flounder for 2024 was set equal to 8,789,830 pounds (lb; 3,987,000 kilograms (kg)) (88 FR 88266, December 23, 2023). The amount allocated to vessels landing summer flounder in Connecticut is 198,394 lb (89,990 kg).</P>
                <P>
                    The NMFS Regional Administrator for the Greater Atlantic Region monitors the state commercial landings and determines when a state's commercial quota has been harvested. NMFS is required to publish notification in the 
                    <E T="04">Federal Register</E>
                     advising and notifying commercial vessels and dealer permit holders that, effective upon a specific date, the state's commercial quota has been harvested and no commercial quota is available for landing summer flounder in that state. Based on dealer reports and other available information, the Regional Administrator has determined that the available quota has been harvested. The Marine Fisheries Program of the Connecticut Department of Energy and Environmental Protection determined that its 2024 commercial summer flounder quota has been harvested and closed the state fishery on December 1, 2024. This action promotes consistency between state and Federal management measures.
                </P>
                <P>
                    The regulations at 50 CFR 648.14(n) prohibit federally permitted vessels from landing summer flounder for sale in a state, and prohibit all persons from purchasing or otherwise receiving summer flounder for a commercial purpose after the effective date published in the 
                    <E T="04">Federal Register</E>
                     notification that commercial quota is no longer available in that state. Therefore, effective 0001 hours on December 10, 2024, landing of summer flounder in Connecticut by vessels holding Federal summer flounder commercial fishery permits is prohibited for the remainder of the 2024 calendar year, unless additional quota becomes available through a transfer and is announced in the 
                    <E T="04">Federal Register</E>
                    . Effective 0001 hours on December 10, 2024, federally permitted dealers are also notified that they may not purchase summer flounder from federally permitted vessels that land in Connecticut for the remainder of the calendar year, or until additional quota becomes available through a transfer from another state.
                </P>
                <HD SOURCE="HD1">Classification</HD>
                <P>This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.</P>
                <P>The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because it would be contrary to the public interest. This action closes the commercial summer flounder fishery for Connecticut until January 1, 2025, under current regulations. The regulations at 50 CFR 648.103(b) require such action to ensure that summer flounder vessels do not exceed quotas allocated to the states. If implementation of this closure was delayed to solicit prior public comment, the quota for this fishing year will be exceeded, thereby undermining the conservation objectives of the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan. The Assistant Administrator further finds, pursuant to 5 U.S.C. 553(d)(3), good cause to waive the 30-day delayed effectiveness period for the reason stated above.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        16 U.S.C. 1801 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Karen H. Abrams,</NAME>
                    <TITLE>Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28889 Filed 12-5-24; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Part 648</CFR>
                <DEPDOC>[Docket No. 241203-0308]</DEPDOC>
                <RIN>RTID 0648-XE226</RIN>
                <SUBJECT>Fisheries of the Northeastern United States; 2025 Specifications for the Summer Flounder, Scup, Black Sea Bass, and Bluefish Fisheries</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS announces 2025 specifications for the summer flounder, scup, black sea bass, and bluefish fisheries. The implementing regulations for the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP) and the Bluefish Fishery Management Plan require us to publish specifications for the upcoming fishing year for each of these species. The specifications for these species are intended to establish allowable harvest levels that will prevent overfishing, consistent with the most recent scientific information, for the 2025 fishing year.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective January 1, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        A Supplemental Information Report (SIR) was prepared for the 2025 black sea bass specifications. An Environmental Assessment (EA) was prepared for the 
                        <PRTPAGE P="99139"/>
                        2024 and projected 2025 summer flounder and scup specifications and 2024 and projected 2025 bluefish specifications. Copies of the SIR and EAs are available on request from Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 North State Street, Dover, DE 19901. The EAs are also accessible via the internet at 
                        <E T="03">https://www.mafmc.org/supporting-documents.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Laura Deighan, Fishery Policy Analyst, (978) 281-9184, 
                        <E T="03">Laura.Deighan@noaa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">General Background</HD>
                <P>
                    The Mid-Atlantic Fishery Management Council (Council) and the Atlantic States Marine Fisheries Commission (Commission) cooperatively develop management measures for the summer flounder, scup, black sea bass, and bluefish fisheries. The Council, pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) develops recommendations regarding fisheries in Federal waters seaward of New York, New Jersey, Delaware, Pennsylvania, Maryland, Virginia, and North Carolina. The Commission, pursuant to the Atlantic Coastal Fisheries Cooperative Management Act, addresses fisheries in state waters from Florida to Maine. These bodies work together in the development of complementary FMPs for species like summer flounder, scup, black sea bass, and bluefish that are harvested in both Federal and state waters, and each year, these bodies work together to develop specifications for these fisheries. The Council provides its recommendations to NMFS, and NMFS engages in a Federal rulemaking process by which the agency adopts specifications that become binding on the Federal fisheries. Specifications in these fisheries include various catch and landing subdivisions, such as the commercial and recreational sector annual catch limits (ACL), annual catch targets (ACT), and sector-specific landing limits (
                    <E T="03">i.e.,</E>
                     the commercial fishery quota and recreational harvest limit (RHL)) established for 1 to 3 years at a time. Adjustments to commercial management measures are also considered in the specifications process. The process for measures used to manage the recreational fisheries (
                    <E T="03">i.e.,</E>
                     minimum fish sizes, seasonal closures, and possession restrictions) for these four species occurs separately and is not discussed further in this final rule. This action implements 2025 acceptable biological catches (ABC), as well as the recreational and commercial ACLs, ACTs, commercial quotas, and RHLs for all four species.
                </P>
                <HD SOURCE="HD1">Final 2025 Specifications</HD>
                <HD SOURCE="HD2">Summer Flounder Specifications</HD>
                <P>This action adopts the Council and the Commission's Summer Flounder Board-recommended 2025 summer flounder catch and landings limits shown in table 1.</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,14,12">
                    <TTITLE>Table 1—Summary of 2025 Summer Flounder Fishery Specifications</TTITLE>
                    <BOXHD>
                        <CHED H="1">Specifications</CHED>
                        <CHED H="1">
                            Million pounds
                            <LI>(lb)</LI>
                        </CHED>
                        <CHED H="1">
                            Metric ton
                            <LI>(mt)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Overfishing Limit (OFL)</ENT>
                        <ENT>24.97</ENT>
                        <ENT>11,325</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ABC</ENT>
                        <ENT>19.32</ENT>
                        <ENT>8,761</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Commercial ACL = ACT</ENT>
                        <ENT>10.62</ENT>
                        <ENT>4,819</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Commercial Quota</ENT>
                        <ENT>8.79</ENT>
                        <ENT>3,987</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Recreational ACL = ACT</ENT>
                        <ENT>8.69</ENT>
                        <ENT>3,942</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Recreational Harvest Limit</ENT>
                        <ENT>6.35</ENT>
                        <ENT>2,879</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The final 2025 state-by-state summer flounder quotas are provided in table 2. As required in Amendment 21 (85 FR 80661), if the commercial quota in any year is higher than 9.55 million lb (4,332 mt), the first 9.55 million lb (4,322 mt) is distributed according to the baseline formula found in the regulations at 50 CFR 648.102(c)(1)(i) (the baseline allocations were established through Amendment 2 (57 FR 57358) and modified by Amendment 4 (58 FR 49937)). Any additional quota is distributed in equal shares to all states except Maine, Delaware, and New Hampshire, which split 1 percent of the additional quota. Because this year's quota is below 9.55 million lb (4,322 mt), the state-by-state allocations are based on the baseline allocations. This final rule includes adjustments for previously unaccounted for 2023 and preliminary 2024 overages to determine the final state quotas.</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s100,18,19,19">
                    <TTITLE>Table 2—Final 2025 Summer Flounder State-by-State Quotas</TTITLE>
                    <BOXHD>
                        <CHED H="1">State</CHED>
                        <CHED H="1">
                            Percent share up
                            <LI>to 9.55 million lb</LI>
                        </CHED>
                        <CHED H="1">
                            Final 2025 quotas 
                            <SU>1</SU>
                            <LI>(lb)</LI>
                        </CHED>
                        <CHED H="1">
                            Final 2025 quotas 
                            <SU>1</SU>
                            <LI>(mt)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">ME</ENT>
                        <ENT>0.04756</ENT>
                        <ENT>4,180</ENT>
                        <ENT>1.9</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NH</ENT>
                        <ENT>0.00046</ENT>
                        <ENT>40</ENT>
                        <ENT>0.02</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MA</ENT>
                        <ENT>6.82046</ENT>
                        <ENT>571,147</ENT>
                        <ENT>259.07</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RI</ENT>
                        <ENT>15.68298</ENT>
                        <ENT>1,378,507</ENT>
                        <ENT>625.28</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            CT 
                            <SU>2</SU>
                        </ENT>
                        <ENT>2.25708</ENT>
                        <ENT>198,393</ENT>
                        <ENT>89.99</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NY</ENT>
                        <ENT>7.64699</ENT>
                        <ENT>672,157</ENT>
                        <ENT>304.89</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NJ</ENT>
                        <ENT>16.72499</ENT>
                        <ENT>1,470,098</ENT>
                        <ENT>666.83</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DE</ENT>
                        <ENT>0.01779</ENT>
                        <ENT>1,564</ENT>
                        <ENT>0.71</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MD</ENT>
                        <ENT>2.0391</ENT>
                        <ENT>179,233</ENT>
                        <ENT>81.3</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VA</ENT>
                        <ENT>21.31676</ENT>
                        <ENT>1,873,707</ENT>
                        <ENT>849.9</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">NC</ENT>
                        <ENT>27.44584</ENT>
                        <ENT>2,412,443</ENT>
                        <ENT>1,094.27</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT>100</ENT>
                        <ENT>8,761,471</ENT>
                        <ENT>3,974.14</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         Totals may differ slightly from the sums of the quotas due to rounding.
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         This table corrects a typographical error from the proposed rule that misstated Connecticut's final quota as 198,394 lb (89.9mt).
                    </TNOTE>
                </GPOTABLE>
                <PRTPAGE P="99140"/>
                <P>This action makes no changes to the current commercial management measures, including the minimum fish size (14-inch (36-centimeter (cm)) total length), gear requirements, and possession limits.</P>
                <HD SOURCE="HD2">Black Sea Bass Specifications</HD>
                <P>At the August 2024 meeting, the Council and the Commission's Black Sea Bass Board were unable to agree on the 2025 black sea bass specifications. The Black Sea Bass Board adopted a coastwide quota for black sea bass that is the same as the 2024 quota, while the Council adopted a quota that represents a 20-percent reduction from 2024. If implemented, the differing quotas would likely have significant negative socioeconomic impacts on Federal black sea bass permit holders. In the case where the two bodies propose different specifications, the regulations at 50 CFR 648.143(e) require the Regional Administrator to take administrative action to align measures to prevent differential effects on Federal permit holders.</P>
                <P>According to the 2024 Black Sea Bass Management Track Assessment, the biomass of the black sea bass stock is more than double the target level with an increasing trend, recent recruitment is high, and recent fishing mortality has been well below the threshold level. Given the current status of the black sea bass stock and the potentially significant social and economic harm to Federal permit holders that would result from divergent state and Federal quotas, we are implementing 2025 black sea bass catch limits consistent with those adopted by the Commission.</P>
                <P>The final 2025 black sea bass catch and landings limits are shown in table 3.</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,12,12">
                    <TTITLE>Table 3—2025 Black Sea Bass Catch and Landings Limits</TTITLE>
                    <BOXHD>
                        <CHED H="1">Specifications</CHED>
                        <CHED H="1">Million lb</CHED>
                        <CHED H="1">mt</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">ABC</ENT>
                        <ENT>16.66</ENT>
                        <ENT>7,557</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Expected Commercial Discards</ENT>
                        <ENT>1.50</ENT>
                        <ENT>680</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Expected Recreational Discards</ENT>
                        <ENT>2.89</ENT>
                        <ENT>1,311</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Commercial ACL = ACT</ENT>
                        <ENT>7.50</ENT>
                        <ENT>3,401</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Commercial Quota</ENT>
                        <ENT>6.00</ENT>
                        <ENT>2,721</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Recreational ACL = ACT</ENT>
                        <ENT>9.16</ENT>
                        <ENT>4,156</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RHL</ENT>
                        <ENT>6.27</ENT>
                        <ENT>2,845</ENT>
                    </ROW>
                </GPOTABLE>
                <P>No changes are being made to the 2025 commercial management measures for black sea bass, including the commercial minimum fish size (11-inch (27.94-cm) total length) and gear requirements. Any changes to recreational management measures for black sea bass would be considered through a separate action following the joint meeting of the Council and Commission in December 2024.</P>
                <P>On October 1, 2024 (89 FR 79778), we implemented the approved measure of Amendment 23 to the Summer Flounder, Scup, and Black Sea Bass FMP. The approved measure changes the Federal coastwide commercial in-season accountability measure such that the black sea bass commercial fishery will now close when the quota plus an additional buffer of up to 5 percent is projected to be landed. The intent of this buffer is to minimize negative economic impacts when the coastwide quota is reached before all states have fully harvested their allocations due to overages in individual states.</P>
                <P>Pursuant to the Amendment 23 measure, the Council and Black Sea Bass Board may recommend a buffer from 0 to 5 percent each year through the specification process. This action adopts the Council and Black Sea Bass Board-recommended 5-percent commercial in-season closure buffer. Given recent patterns in the fishery, an in-season closure is not expected for 2025; however, in the unlikely event it is needed, a 5-percent buffer could have socioeconomic benefits with little risk to stock status.</P>
                <HD SOURCE="HD2">Scup Specifications</HD>
                <P>This action adopts the Council and Scup Board-recommended 2025 scup catch and landings limits shown in table 4.</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,12,12">
                    <TTITLE>Table 4—2025 Scup Catch and Landing Limits</TTITLE>
                    <BOXHD>
                        <CHED H="1">Specifications</CHED>
                        <CHED H="1">Million lb</CHED>
                        <CHED H="1">mt</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">OFL</ENT>
                        <ENT>42.19</ENT>
                        <ENT>19,135</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ABC</ENT>
                        <ENT>41.31</ENT>
                        <ENT>18,740</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Expected Commercial Discards</ENT>
                        <ENT>7.38</ENT>
                        <ENT>3,318</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Expected Recreational Discards</ENT>
                        <ENT>2.08</ENT>
                        <ENT>944</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Commercial ACL = ACT</ENT>
                        <ENT>26.85</ENT>
                        <ENT>12,181</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Commercial Quota</ENT>
                        <ENT>19.54</ENT>
                        <ENT>8,863</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Recreational ACL = ACT</ENT>
                        <ENT>14.46</ENT>
                        <ENT>6,559</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RHL</ENT>
                        <ENT>12.31</ENT>
                        <ENT>5,585</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The commercial scup quota is divided into three commercial fishery quota periods, as outlined in table 5.</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s100,13,12,12">
                    <TTITLE>Table 5—Commercial Scup Quota Allocations for 2025 by Quota Period</TTITLE>
                    <BOXHD>
                        <CHED H="1">Quota period</CHED>
                        <CHED H="1">Percent share</CHED>
                        <CHED H="1">lb</CHED>
                        <CHED H="1">mt</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Winter I</ENT>
                        <ENT>45.11</ENT>
                        <ENT>8,814,300</ENT>
                        <ENT>3,998</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Summer</ENT>
                        <ENT>38.95</ENT>
                        <ENT>7,610,663</ENT>
                        <ENT>3,452</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <PRTPAGE P="99141"/>
                        <ENT I="01">Winter II</ENT>
                        <ENT>15.94</ENT>
                        <ENT>3,114,608</ENT>
                        <ENT>1,413</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT>100.00</ENT>
                        <ENT>19,539,570</ENT>
                        <ENT>8,863</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The current quota period possession limits are not changed by this action and are outlined in table 6.</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,12,12">
                    <TTITLE>Table 6—Commercial Scup Possession Limits by Quota Period</TTITLE>
                    <BOXHD>
                        <CHED H="1">Quota period</CHED>
                        <CHED H="1">
                            Federal possession limits
                            <LI>(per trip)</LI>
                        </CHED>
                        <CHED H="2">lb</CHED>
                        <CHED H="2">kg</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Winter I</ENT>
                        <ENT>50,000</ENT>
                        <ENT>22,680</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Summer</ENT>
                        <ENT>N/A</ENT>
                        <ENT>N/A</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Winter II</ENT>
                        <ENT>12,000</ENT>
                        <ENT>5,443</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    The Winter I scup commercial possession limit will drop to 1,000 lb (454 kg) when 80 percent of that period's allocation is landed. If the Winter I quota is not fully harvested, the remaining quota is transferred to the Winter II period. The Winter II possession limit may be adjusted in association with a transfer of unused Winter I quota to the Winter II period via announcement in the 
                    <E T="04">Federal Register</E>
                    . The regulations specify that the Winter II possession limit increases to different levels consistent with the increase in the quota, as described in table 7.
                </P>
                <GPOTABLE COLS="8" OPTS="L2,p7,7/8,i1" CDEF="10,10,21,17,10,10,10,10">
                    <TTITLE>Table 7—Potential Increase in Winter II Possession Limits Based on the Amount of Unused Scup Rolled Over From Winter I to Winter II</TTITLE>
                    <BOXHD>
                        <CHED H="1">
                            Initial Winter II
                            <LI>possession limit</LI>
                        </CHED>
                        <CHED H="2">lb</CHED>
                        <CHED H="2">kg</CHED>
                        <CHED H="1">Rollover from Winter I to Winter II</CHED>
                        <CHED H="2">lb</CHED>
                        <CHED H="2">kg</CHED>
                        <CHED H="1">
                            Increase in initial
                            <LI>Winter II possession limit</LI>
                        </CHED>
                        <CHED H="2">lb</CHED>
                        <CHED H="2">kg</CHED>
                        <CHED H="1">
                            Final Winter II
                            <LI>possession limit</LI>
                            <LI>after rollover from</LI>
                            <LI>Winter I to Winter II</LI>
                        </CHED>
                        <CHED H="2">lb</CHED>
                        <CHED H="2">kg</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">12,000</ENT>
                        <ENT>5,443</ENT>
                        <ENT>0-499,999</ENT>
                        <ENT>0-226,796</ENT>
                        <ENT>0</ENT>
                        <ENT>0</ENT>
                        <ENT>12,000</ENT>
                        <ENT>5,443</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12,000</ENT>
                        <ENT>5,443</ENT>
                        <ENT>500,000-999,999</ENT>
                        <ENT>226,796-453,592</ENT>
                        <ENT>1,500</ENT>
                        <ENT>680</ENT>
                        <ENT>13,500</ENT>
                        <ENT>6,123</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12,000</ENT>
                        <ENT>5,443</ENT>
                        <ENT>1,000,000-1,499,999</ENT>
                        <ENT>453,592-680,388</ENT>
                        <ENT>3,000</ENT>
                        <ENT>1,361</ENT>
                        <ENT>15,000</ENT>
                        <ENT>6,804</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12,000</ENT>
                        <ENT>5,443</ENT>
                        <ENT>1,500,000-1,999,999</ENT>
                        <ENT>680,389-907,184</ENT>
                        <ENT>4,500</ENT>
                        <ENT>2,041</ENT>
                        <ENT>16,500</ENT>
                        <ENT>7,484</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12,000</ENT>
                        <ENT>5,443</ENT>
                        <ENT>2,000,000-* 2,500,000</ENT>
                        <ENT>907,185-1,133,981</ENT>
                        <ENT>6,000</ENT>
                        <ENT>2,722</ENT>
                        <ENT>18,000</ENT>
                        <ENT>8,165</ENT>
                    </ROW>
                    <TNOTE>* This process of increasing the possession limit in 1,500 lb (680 kg) increments would continue past 2,500,000 lb (1,122,981 kg), but ends here for the purpose of this example.</TNOTE>
                </GPOTABLE>
                <P>This action makes no changes to the 2025 commercial management measures for scup, including the minimum fish size (9-inch (22.9-cm) total length), gear requirements, and quota period possession limits.</P>
                <HD SOURCE="HD2">Bluefish Specifications</HD>
                <P>This action approves the Council- and the Commission's Bluefish Board-recommended 2025 bluefish catch and landings limits as shown in table 8.</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,12,12">
                    <TTITLE>Table 8—Summary of 2025 Bluefish Fishery Specifications</TTITLE>
                    <BOXHD>
                        <CHED H="1">Specifications</CHED>
                        <CHED H="1">Million lb</CHED>
                        <CHED H="1">mt</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">OFL</ENT>
                        <ENT>27.49</ENT>
                        <ENT>12,467</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ABC</ENT>
                        <ENT>21.83</ENT>
                        <ENT>9,903</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Commercial ACL = ACT</ENT>
                        <ENT>3.06</ENT>
                        <ENT>1,386</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Commercial Quota</ENT>
                        <ENT>3.03</ENT>
                        <ENT>1,375</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Recreational ACL = ACT</ENT>
                        <ENT>18.78</ENT>
                        <ENT>8,517</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Recreational Harvest Limit</ENT>
                        <ENT>15.70</ENT>
                        <ENT>7,121</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    The coastwide commercial quota is allocated to coastal states from Maine to Florida based on percent shares specified in the Bluefish FMP and regulations at § 648.162(d). Table 9 provides the final commercial state allocations based on the Council-recommended coastwide commercial quota for 2025 and the phased-in changes to the percent share allocations to the states specified in Amendment 7. No states exceeded their allocated quota 
                    <PRTPAGE P="99142"/>
                    in 2023 or are projected to do so in 2024; therefore, no accountability measures for the commercial fishery are required for the 2025 fishing year based on the data available at this time.
                </P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s100,13,12,12">
                    <TTITLE>Table 9—2025 Final Bluefish State Commercial Quota Allocations</TTITLE>
                    <BOXHD>
                        <CHED H="1">State</CHED>
                        <CHED H="1">Percent share</CHED>
                        <CHED H="1">
                            Quota
                            <LI>(lb)</LI>
                        </CHED>
                        <CHED H="1">
                            Quota
                            <LI>(kg)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Maine</ENT>
                        <ENT>0.35</ENT>
                        <ENT>10,582</ENT>
                        <ENT>4,800</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">New Hampshire</ENT>
                        <ENT>0.30</ENT>
                        <ENT>9,123</ENT>
                        <ENT>4,138</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Massachusetts</ENT>
                        <ENT>8.66</ENT>
                        <ENT>262,663</ENT>
                        <ENT>119,142</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Rhode Island</ENT>
                        <ENT>8.41</ENT>
                        <ENT>255,061</ENT>
                        <ENT>115,694</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Connecticut</ENT>
                        <ENT>1.16</ENT>
                        <ENT>35,309</ENT>
                        <ENT>16,016</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">New York</ENT>
                        <ENT>15.74</ENT>
                        <ENT>477,518</ENT>
                        <ENT>216,598</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">New Jersey</ENT>
                        <ENT>14.26</ENT>
                        <ENT>432,630</ENT>
                        <ENT>196,238</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Delaware</ENT>
                        <ENT>1.09</ENT>
                        <ENT>32,990</ENT>
                        <ENT>14,964</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Maryland</ENT>
                        <ENT>2.38</ENT>
                        <ENT>72,265</ENT>
                        <ENT>32,779</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Virginia</ENT>
                        <ENT>8.44</ENT>
                        <ENT>256,125</ENT>
                        <ENT>116,176</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">North Carolina</ENT>
                        <ENT>32.04</ENT>
                        <ENT>972,012</ENT>
                        <ENT>440,897</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">South Carolina</ENT>
                        <ENT>0.07</ENT>
                        <ENT>2,250</ENT>
                        <ENT>1,021</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Georgia</ENT>
                        <ENT>0.06</ENT>
                        <ENT>1,897</ENT>
                        <ENT>860</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">Florida</ENT>
                        <ENT>7.04</ENT>
                        <ENT>213,625</ENT>
                        <ENT>96,899</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT>100</ENT>
                        <ENT>3,033,561</ENT>
                        <ENT>1,376,000</ENT>
                    </ROW>
                </GPOTABLE>
                <P>This action does not make any changes to the 2025 commercial or recreational management measures for bluefish.</P>
                <HD SOURCE="HD1">Comments and Responses</HD>
                <P>The public comment period for the proposed rule ended on October 31, 2024. We received 11 comments on the proposed rule. No changes to the final rule are necessary as a result of these comments. One of the comments focused on wind energy development and whales and is not germane to this action. Six comments from five industry organizations and one individual supported the proposed specifications. Four comments from two industry organizations and five conservation organizations opposed the proposed 2025 black sea bass catch limits. In general, recurring themes in these four comments included the risk of overfishing on black sea bass, the use of the best scientific information available in setting the black sea bass specifications, and requests for clarifications on the SIR.</P>
                <HD SOURCE="HD1">Overfishing</HD>
                <P>
                    <E T="03">Comment 1:</E>
                     Two commenters who opposed the 2025 black sea bass catch limits stated that NMFS was allowing for a situation in which overfishing on the black sea bass stock would occur. These commenters noted that the projected fishing mortality rate (F) that would result from the status quo black sea bass catch limits (1.87), as described in the SIR, is greater than the F rate threshold of 1.071 (note that one of these comments incorrectly cited the F rate threshold as 0.82; however, that number is the terminal year (2023) F estimate).
                </P>
                <P>
                    <E T="03">Response:</E>
                     The Magnuson-Stevens Act defines the terms “overfishing” and “overfished” as a fishing mortality rate that jeopardizes the capacity of a fishery to produce the maximum sustainable yield (MSY) on a continuing basis. The black sea bass stock biomass is currently more than 200 percent of its biomass target, the biomass associated with maximum sustainable yield. In plain language, the stock is more than double the ideal biomass that would maximize long-term benefits. F
                    <E T="52">MSY</E>
                     is the fishing mortality rate that, if applied over the long term, would result in the maximum sustainable yield. For stocks above their biomass target, fishing at F
                    <E T="52">MSY</E>
                     should gradually reduce biomass (B) to the biomass target (B
                    <E T="52">MSY</E>
                    ). For the black sea bass fishery, fishing above F
                    <E T="52">MSY</E>
                     for 1 year may increase the rate at which the stock approaches B
                    <E T="52">MSY</E>
                    . However, with the stock well above B
                    <E T="52">MSY</E>
                    , this would not jeopardize the long-term sustainability of the stock. Based on projections using status quo catch provided by the NOAA Northeast Fisheries Science Center (Center; see table 5 in the SIR), spawning stock biomass is expected to decline to 148 percent of its target in 2025 under status quo catch limits, well above B
                    <E T="52">MSY</E>
                    .
                </P>
                <P>In addition, previous black sea bass stock assessments have revealed a retrospective pattern indicating that preceding assessments routinely underestimated stock size and overestimated fishing mortality. These assessments have consistently indicated that the stock size is higher and the fishing mortality rate is lower than predicted in the previous assessment. This pattern reflects catch limits that are set lower than what is actually available to the fishery. In turn, this can result in higher than anticipated harvest and exceedance of the OFL compared to the previous assessment's projections—while the updated assessment subsequently indicates that overfishing did not occur based on the updated understanding of what the allowable catch and OFL should have been. The 2024 Management Track Assessment represents a change in stock assessment models; previously, black sea bass were assessed using the Age-Structured Assessment Program but transitioned to the Woods Hole Assessment Model for the first time this year. At this time, it is unclear if this retrospective pattern remains with the new model.</P>
                <P>
                    In this specific context, fishing at a rate that is slightly higher than F
                    <E T="52">MSY</E>
                     is not expected to result in overfishing—that is, to jeopardize the capacity of the black sea bass fishery to produce the maximum sustainable yield on a continuing basis—based on the disconnect in the stock assessments' projections of a decline in biomass and the current high biomass. The 2023 total catch of 16.94 million lb (7,684 mt) resulted in a realized fishing mortality rate of only 85 percent of F
                    <E T="52">MSY</E>
                    ; therefore, maintaining the slightly lower status quo quotas for 2025 with an ABC of 16.66 million lb (7,557 mt) does not risk long-term biological harm to the black sea bass stock. The 2025 black sea bass catch limits are expected to reduce the stock biomass to a level that is closer to, but still above, B
                    <E T="52">MSY</E>
                     than the Council's recommended catch limits 
                    <PRTPAGE P="99143"/>
                    would. However, this does not constitute overfishing as defined by the Magnuson-Stevens Act. A new stock assessment will be available in 2025 and will be used to set future specifications.
                </P>
                <P>
                    <E T="03">Comment 2:</E>
                     Four commenters who opposed the 2025 black sea bass catch limits due to overfishing concerns asserted that the Magnuson-Stevens Act National Standard 1 Guidelines define the ACL as a limit on catch that cannot exceed the ABC (50 CFR 600.310(f)(1)(iii) and (f)(4)) and identify the SSC as the body charged with determining the ABC (§ 600.310(f)(3) and (b)(2)(V)(B)).
                </P>
                <P>
                    <E T="03">Response:</E>
                     The commenter is correct that the SSC is tasked with recommending an ABC to the Council, per the regulations cited. Similarly, the Council must recommend to NMFS black sea bass catch specifications (§ 648.142(b)) that do not exceed the SSC's recommendation (§ 600.315(c)(6)). However, this requirement is specific to the Council's process and does not extend to NMFS. The regulations at § 648.142(b) require the Regional Administrator to review the Council's recommendations and any recommendations of the Commission and, after that review, to publish a proposed rule in the 
                    <E T="04">Federal Register</E>
                     to implement a commercial quota, a recreational harvest limit, and additional management measures for the commercial fishery. NMFS, on behalf of the Secretary of Commerce, is obligated to independently consider the recommendation of the Council along with other information and requirements including, but not limited to, other applicable laws, the National Standards, and the governing regulations within the FMP (see also 
                    <E T="03">Comment 6</E>
                    ). National Standard 1 requires NMFS to prevent overfishing while achieving optimum yield on a continuing basis. As described above (see 
                    <E T="03">Comment 1</E>
                    ), NMFS has determined that the 2025 black sea bass catch limits set forth in this final rule will not result in overfishing as defined in the Magnuson-Stevens Act.
                </P>
                <P>In addition, for black sea bass, this action includes an ABC of 16.66 million lb (7,557 mt), a commercial ACL of 7.50 million lb (3,402 mt), and a recreational ACL of 9.16 million lb (4,155 mt). This is consistent with the National Standard 1 Guidelines' ACL definition, as the combined commercial and recreational ACLs do not exceed the ABC.</P>
                <P>
                    <E T="03">Comment 3:</E>
                     One commenter noted that the Center's status quo projections, as described in the SIR, indicate that if the 2024 black sea bass catch limits are maintained in 2025, the result will be the potential reduction of B/B
                    <E T="52">MSY</E>
                     from close to 2 to 1.03 in 2 years.
                </P>
                <P>
                    <E T="03">Response:</E>
                     The projections estimate a ratio of spawning stock biomass (SSB) to the spawning stock biomass at MSY (SSB
                    <E T="52">MSY</E>
                    ) of 1.03 in 2026 if the status quo catch limits were implemented in fishing years 2025 and 2026. This action only sets the black sea bass catch limits for the 2025 fishing year. The projections estimate SSB will remain well above the target under status quo catch limits in 2025, with an estimated SSB/SSB
                    <E T="52">MSY</E>
                     ratio of 1.48 in 2025. A new stock assessment will be available in 2025 and will be used to set the 2026 specifications.
                </P>
                <HD SOURCE="HD1">Use of Best Scientific Information Available</HD>
                <P>
                    <E T="03">Comment 4:</E>
                     Five commenters who opposed the 2025 black sea bass catch limits noted that the Council's recommended specifications, and the 20-percent reduction included therein, were based on the most recent management track assessment, which constituted the best scientific information available as required under National Standard 2. The commenters noted that the most recent assessment showed declining biomass and asserted that the 2025 black sea bass catch limits are not based on the best available science.
                </P>
                <P>
                    <E T="03">Response:</E>
                     This action relies upon the best available science in the development of the 2025 black sea bass specifications. According to the 2024 Management Track Assessment, the black sea bass stock is not overfished and overfishing was not occurring in 2023. Spawning stock biomass was estimated at 2.19 times the target level and fishing mortality was estimated to be 23 percent below F
                    <E T="52">MSY</E>
                     in 2023. However, the assessment's projections suggested that the 2025 OFL be set 20 percent below the 2024 (status quo) OFL. Members of the Advisory Panel, Monitoring and Technical Committees, Council, and Commission raised concerned that the stock assessment projections were underestimating future biomass, resulting in a 2025 black sea bass ABC that is too low (see 
                    <E T="03">https://www.mafmc.org/s/SFSBSB-MC-1Aug2024-summary.pdf</E>
                     for additional information about concerns raised).
                </P>
                <P>
                    The Center re-ran black sea bass projections based on status quo catch in 2025 and 2026, using the same methodology and underlying information that is described in the 2024 management track assessment. This methodology, and the resulting projections, is the best scientific information available. These projections are the basis for the 2025 black sea bass catch limits and indicate that maintaining status quo catch in fishing year 2025 will maintain SSB above SSB
                    <E T="52">MSY</E>
                     and will not result in overfishing as defined in the Magnuson-Stevens Act (see 
                    <E T="03">Comment 1</E>
                    ). Additionally, the single-point biomass estimate in the terminal year of the assessment does not reflect a declining biomass trend. To the contrary, the overall trend is a black sea bass stock that has been well above its biomass target for the last 10 years and a history of assessments that have routinely underestimated the stock size and overestimated fishing mortality (see 
                    <E T="03">Comment 1</E>
                    ).
                </P>
                <P>
                    <E T="03">Comment 5:</E>
                     One commenter opposed to the 2025 black sea bass catch limits stated that the SSC's recommended ABC and OFL took into account more components of stock health, including recruitment and size structure.
                </P>
                <P>
                    <E T="03">Response:</E>
                     As previously described (see 
                    <E T="03">Comments 1 and 4</E>
                    ), the decision to implement the 2025 black sea bass catch limits is based on the Center's projections using status quo catch and the same methodology described in the most recent management track assessment. Members of the Advisory Panel, Monitoring and Technical Committees, Council, and Commission raised significant concerns about the original projected 2025 OFL and ABC based on recent trends in biomass, recruitment, and fishing mortality. The 2025 black sea bass catch limits are intended to prevent overfishing while taking into account recent trends in stock health (see 
                    <E T="03">Comment 1</E>
                    ) and the socio-economic impacts that would occur if the Federal catch limits differed from those set by the Commission (see also 
                    <E T="03">Comment 15</E>
                    ).
                </P>
                <HD SOURCE="HD1">Legal Authority</HD>
                <P>
                    <E T="03">Comment 6:</E>
                     Five commenters raised issue with NMFS setting black sea bass catch limits greater than those recommended by the SSC. Four commenters contended that NMFS' stance that the requirement for science-based catch limits that do not exceed the SSC's catch advice in section 302(h)(6) of the Magnuson-Steven Act “applies only to the Councils, and NMFS can set an ABC higher than the SSC recommendation in some circumstances” “runs counter to the language, case law, and history of the Magnuson-Stevens Act and the agency's own regulations.” The other commenter requested a detailed explanation of the rationale and legal authority for overruling the SSC's advice. It argued that the Agency appears to be placing more weight on alleviating discrepancies between state and Federal 
                    <PRTPAGE P="99144"/>
                    waters such that no “differential effects occur to Federal permit holders” (§ 648.143(e)) than on the Magnuson-Stevens Act requirement that the ABC must not exceed the recommendation of the SSC and that the Center appears to be substituting its own judgment for that of the SSC.
                </P>
                <P>
                    <E T="03">Response:</E>
                     Section 302(h) of the Magnuson-Steven Act specifies “Each Council shall, . . .” Therefore, the requirements listed in section 302(h) apply to the Councils. Furthermore, the Magnuson-Stevens Act regulations at § 600.10, list the SSC as an advisory group. The regulations at § 600.133(b) require the SSC to “. . . provide its 
                    <E T="03">Council</E>
                     ongoing scientific advice for fishery management decisions, including recommendations for acceptable biological catch, preventing overfishing, maximum sustainable yield, and achieving rebuilding targets, and reports on stock status and health, bycatch, habitat status, social and economic impacts of management measures, and sustainability of fishing practices” (emphasis added). The Council is bound to the SSC's recommendations and would be in violation of the Magnuson-Stevens Act if it recommended catch limits to NMFS that were greater than the ABC recommended by the SSC (§ 600.315(c)). NMFS, however, on behalf of the Secretary of Commerce, is obligated to independently consider the recommendations of the Councils along with other information and guidance, including, but not limited to, other applicable laws, the National Standards, and the governing regulations within the FMP. This allows the Agency to balance the needs of a fishery, including potentially significant social and economic disruptions, in an effort to achieve optimal yield, provided doing so does not pose an unacceptable risk to the health of the resource. This action is being taken pursuant to section 305(d) of the Magnuson-Stevens Act, which requires NMFS to carry out FMPs and amendments in accordance with the provisions of the Magnuson-Stevens Act, and the black sea bass regulations at 50 CFR part 648 subpart I as developed pursuant to sections 304(a) and (b) of the Magnuson-Stevens Act.
                </P>
                <P>
                    Here, the black sea bass stock is well above its biomass target, and the 2025 catch limits are not expected to result in overfishing (see 
                    <E T="03">Comment 1</E>
                    ). The black sea bass regulations at § 648.143(e) require NMFS to take administrative action to “. . . achieve alignment through consistent state and Federal measures such that no differential effects occur to Federal permit holders.” In setting the 2025 black sea bass catch limits, NMFS considered both the requirement to prevent overfishing and the negative effects that would result from lower Federal catch limits than those set by the Commission (see 
                    <E T="03">Comment 15</E>
                    ). Therefore, NMFS is not circumventing advice from the SSC or the Council but is following its obligation to independently consider the National Standards and the governing regulations within the FMP to make the best decision for the fishery, in line with available biological and socioeconomic information.
                </P>
                <P>
                    <E T="03">Comment 7:</E>
                     Five commenters asserted that, per the Magnuson-Stevens Act, the appropriate process to implement catch limits that differ from the Council and SSC's recommendation would be for NMFS to partially disapprove the Council specifications and to send it back to the Council for additional consideration, with an opportunity for the SSC to weigh in on the Center's analysis that was used to justify setting catch limits exceeding the SSC's recommendation.
                </P>
                <P>
                    <E T="03">Response:</E>
                     While section 304(a)(3) of the Magnuson-Stevens Act requires NMFS to (1) notify a Council regarding the approval, disapproval, or partial approval of an FMP or amendment; (2) provide the basis for any such disapproval; and (3) offer recommendations to conform the plan or amendment to the requirements of applicable law, this process is specific to development of FMPs and FMP amendments undertaken pursuant to section 304(a). This action to set the 2025 summer flounder, scup, black sea bass, and bluefish specifications is being taken pursuant to section 305(d), which requires NMFS to carry out FMPs and amendments in accordance with the provisions of the Magnuson-Stevens Act and the black sea bass regulations. Specifically, the regulations at § 648.142(b) require the Council to make recommendations to the Regional Administrator on measures projected to constrain the sectors to the applicable limit or target as prescribed in the FMP and require NMFS to publish a proposed rule in the 
                    <E T="04">Federal Register</E>
                     to implement catch limits after review of the Council's recommendations and any recommendations of the Commission. As previously described (see 
                    <E T="03">Comment 6</E>
                    ), NMFS is not bound to the recommendation of the Council and SSC when implementing these catch limits, but must ensure compliance with other applicable laws, the National Standards, and the governing regulations within the FMP.
                </P>
                <P>In addition, the action taken by the Commission is final and will be implemented on January 1, 2025. Any delay in implementing complementary Federal catch limits could put Federal permit holders at a disadvantage for a portion of fishing year 2025. NMFS implemented the current black sea bass specifications for fishing year 2024, which ends December 31, 2024. The black sea bass regulations do not include a rollover provision that would allow the previously implemented Federal coastwide catch limits to carry over if new Federal catch limits have not been implemented at the start of the new fishing year.</P>
                <P>
                    <E T="03">Comment 8:</E>
                     Four commenters argue that: (1) The regulation requiring NMFS to prevent differential effects to state and Federal permit holders is codified as a “state/Federal disconnect accountability measure” and is found within the accountability measures regulations for black sea bass; (2) that NMFS defines accountability measures as controls to prevent ACL overages; and (3) that the proposal to liberalize the black sea bass ABC cannot be described as an accountability measure. A fifth commenter expressed concern that NMFS chose to set an ABC that exceeded the SSC's advice based on an accountability measure provision in the black sea bass regulations.
                </P>
                <P>
                    <E T="03">Response:</E>
                     The National Standard 1 guidelines define accountability measures as “measures to ensure accountability” (§ 600.310(b)(1)(iii)) and require Councils to take an approach that considers “. . . uncertainty in scientific information and management control of the fishery” (§ 600.310(b)(3)). While most accountability measures are direct management controls (
                    <E T="03">e.g.,</E>
                     closures or paybacks) designed to prevent exceedance of ACLs and to correct or mitigate overages, they also should “. . . correct the problems that caused the overage in as short a time as possible” (§ 600.310(g)(1)).
                </P>
                <P>
                    The “state/Federal disconnect” accountability measure at § 648.143(e), which requires the Regional Administrator to take administrative action to align measures to prevent differential effects on Federal permit holders, is responsive to this latter requirement and reflects the Magnuson-Stevens Act's National Standard 6 that fishery management plans take into account variations among and contingencies in fisheries. The Council and the Commission cooperatively manage the black sea bass fishery, and both bodies are required to prevent overfishing. While the Commission is not bound by the Magnuson-Stevens Act, the Atlantic Coastal Fisheries Cooperative Management Act requires the Commission to manage fisheries throughout their range based on the best 
                    <PRTPAGE P="99145"/>
                    available science, and the Commission's Interstate Fishery Management Program Charter requires conservation programs and management measures to be “. . . designed to prevent overfishing and maintain over time, abundant, self-sustaining stocks of coastal fishery resources.” If the two bodies implement ACLs that are not aligned, overages of the lower ACL may occur. This results in an exceedance of the ACL due to misalignment of the management measures but does not necessarily result in a conservation concern within the fishery. For example, if the Commission sets higher ACLs than the Council does, catch in the black sea bass fishery may exceed the Council's ACL while being under the Commission's ACL. With an abundant stock such as black sea bass that is well above its biomass target, such an exceedance would create socioeconomic concerns rather than conservation or biological concerns. The “state/Federal disconnect” accountability measure exists to prevent such a circumstance and is, therefore, consistent with the purpose of an accountability measure. NMFS has used this provision of the regulations, which applies directly to the situation at hand, appropriately.
                </P>
                <P>
                    <E T="03">Comment 9:</E>
                     One commenter questioned whether NMFS intends to make it possible for the Commission to be the sole authority for setting specifications for the demersal fisheries.
                </P>
                <P>
                    <E T="03">Response:</E>
                     NMFS has not ceded authority to the Commission but has used its authority under section 305(d) of the Magnuson-Stevens Act to set catch limits consistent with the Commission's limits, per the regulations at § 648.143(e), as described in response to 
                    <E T="03">Comment 8.</E>
                </P>
                <HD SOURCE="HD1">Supplemental Information Report</HD>
                <P>
                    <E T="03">Comment 10:</E>
                     One commenter requested clarification as to why the projection table in the SIR differed from that included in the July 16, 2024, memorandum from Council staff to the Executive Director.
                </P>
                <P>
                    <E T="03">Response:</E>
                     The “2024 Assessment Projections” in table 5 of the SIR are taken from table 3 of the 2024 Black Sea Bass Management Track Assessment, which uses the ABC as the assumed catch for fishing year 2024 and the catch that would occur under F
                    <E T="52">MSYproxy</E>
                     (equal to the OFL) as the assumed catch for 2025 and 2026. The “2024 Status Quo Catch Projections” in table 5 of the SIR and the projections provided in table 7 of the July 16, 2024, memorandum use the ABC as the assumed catch for all years. The “2024 Status Quo Catch Projections” in the SIR uses the 2024 ABC for all 3 years. The July 16, 2024, memorandum uses the Council's recommended ABCs for each year. The final SIR includes this clarification.
                </P>
                <P>
                    <E T="03">Comment 11:</E>
                     One commenter asked why NMFS provided the SIR as a draft.
                </P>
                <P>
                    <E T="03">Response:</E>
                     Draft NEPA documents are available at the proposed rule stage to allow for public comment on both the proposed rule and the NEPA document. Comments on the NEPA document may further inform the analysis and/or result in other clarifications within the document. The final version becomes available when the final rule is published.
                </P>
                <HD SOURCE="HD1">Other</HD>
                <P>
                    <E T="03">Comment 12:</E>
                     One commenter requested additional information on the Center's analysis that the status quo projections show a 5-percent difference in SSB. The commenter stated that the 
                    <E T="04">Federal Register</E>
                     notice for the proposed rule lacked sufficient detail to support this claim.
                </P>
                <P>
                    <E T="03">Response:</E>
                     The “2024 Status Quo Catch Projection” provided in table 5 of the SIR uses the same methodology as described in the 2024 Management Track Assessment, but with the 2025 and 2026 assumed catch equal to the assumed catch for 2024 (see 
                    <E T="03">Comment 4</E>
                    ). The projected 2025 SSB from the “2024 Status Quo Catch Projection” (16,680 mt) is 5-percent lower than the projected 2025 SSB from the “2024 Assessment Projection” (17,442 mt) as shown in table 5 of the SIR.
                </P>
                <P>
                    <E T="03">Comment 13:</E>
                     One commenter asked whether the agency took action to make its concerns regarding the potential OFL and ABC reductions known.
                </P>
                <P>
                    <E T="03">Response:</E>
                     Members of the Advisory Panel, Monitoring and Technical Committees, Council, and Commission, which include NMFS staff, raised concerns about the projected 2025 OFL and ABC during public meetings. Members of the Monitoring Committee expressed concern about the proposed reductions, given the increasing trend in biomass, recent high recruitment, and recent fishing mortality levels below the target. Overall, the Monitoring and Technical Committees were concerned that the stock assessment projections underestimate future biomass and that the 2025 black sea bass ABC is too low (see also 
                    <E T="03">Comment 1</E>
                    ). Additional detail on these comments can be found in the August 2024 Council meeting report (
                    <E T="03">https://www.mafmc.org/s/2024-08_MAFMC-Report.pdf</E>
                    ), the August 2024 Monitoring Committee meeting summary (
                    <E T="03">https://www.mafmc.org/s/SFSBSB-MC-1Aug2024-summary.pdf</E>
                    ), and the August 2024 Advisory Panel meeting summary (
                    <E T="03">https://www.mafmc.org/s/SFSBSB-AP-5Aug2024-summary-v2.pdf</E>
                    ).
                </P>
                <P>
                    <E T="03">Comment 14:</E>
                     One commenter asked whether the Agency would take action to stop reductions in the future if catch reductions are required.
                </P>
                <P>
                    <E T="03">Response:</E>
                     This action sets catch limits for 1 year and is responsive to the current circumstances in which (1) projections indicate status quo catch in 2025 is expected to maintain the black sea bass stock well above the biomass target, (2) the 2025 catch limits are not expected to result in overfishing, and (3) implementation of Federal catch limits that differ from those set by the Commission would negatively impact Federal permit holders. An updated black sea bass management track assessment will be available in 2025 and will be used to set future specifications. Comments on catch limits beyond 2025 and any related management measures, which will be determined based on the circumstances and record of those actions, are outside of the scope of this action and not addressed further.
                </P>
                <P>
                    <E T="03">Comment 15:</E>
                     One commenter requested additional information regarding the negative impacts to Federal permit holders referred to in the 
                    <E T="04">Federal Register</E>
                     notice for the proposed rule (89 FR 83440, October 16, 2024). The commenter asked whether NMFS decided these potential impacts are “so serious that it is worth risking the status of the Black Sea Bass stocks” and requested additional analysis.
                </P>
                <P>
                    <E T="03">Response:</E>
                     As described above, particularly in response to 
                    <E T="03">Comment 1,</E>
                     the 2025 black sea bass catch limits are projected to maintain the black sea bass stock well above B
                    <E T="52">MSY</E>
                    , are not expected to result in overfishing, and do not risk the status of the black sea bass stock.
                </P>
                <P>
                    However, implementing catch limits for Federal permit holders that are lower than those implemented by the Commission would be expected to have negative socio-economic effects. The Commission allocates the commercial quota into state-by-state quotas that control landings in each state. Under the Council-recommended quota, NMFS could be required to close the Federal commercial coastwide black sea bass fishery while several states have state-level quota remaining (because the sum of the Commission's state quotas would exceed the Council's recommended coastwide quota). Early closure of the Federal fishery could impinge on Federal permit holders' ability to fully participate in the commercial fishery; create a race to fish if permit holders preemptively fish to avoid an early closure; create distributional effects regionally, depending on when and where the black sea bass are initially 
                    <PRTPAGE P="99146"/>
                    available; and create potential long-term negative impacts if paybacks are required for any quota overages. In addition, some states further allocate their state quota into individual transferable quotas (ITQ) that are assigned to individual permit holders. ITQ holders may not be able to harvest quota that they have purchased or leased if the Federal fishery closes, potentially resulting in economic harm.
                </P>
                <P>In addition to the issues the commercial industry would potentially encounter, the recreational harvest limits would also differ between the Federal fishery and the states, which would complicate the process for setting recreational measures and make it nearly impossible for us to approve conservation equivalency under the FMP, as is the normal approach. Abandoning conservation equivalency could result in more restrictive recreational management measures in Federal waters than those that the states would implement in state waters, which, in addition to creating confusion among participants, would disadvantage federally permitted for-hire vessels. As with the commercial fishery, differing recreational catch limits could have long-term impacts if estimates of overall harvest (which include state waters) exceed the Council's recommended recreational harvest limit.</P>
                <P>
                    <E T="03">Comment 16:</E>
                     Six commenters supported the proposed specifications. Two of these commenters noted the socio-economic importance of the summer flounder, scup, black sea bass, and bluefish fisheries and their contribution to increasing the diversity of recreational fishing participants by providing an entrypoint into recreational fishing. In addition to expressly supporting the proposed specifications, three commenters also noted that the specifications are not reflective of the abundance seen on the water. Two of these commenters indicated they would also support higher quotas. Other commenters noted an appreciation for the stability the specifications provided and that there would not be value in shifting mortality to discards.
                </P>
                <P>
                    <E T="03">Response:</E>
                     NMFS notes the commenters' support and is implementing the catch limits as proposed.
                </P>
                <P>
                    <E T="03">Comment 17:</E>
                     One commenter discussed the approach to setting recreational management measures and requested additional information on the recreational target.
                </P>
                <P>
                    <E T="03">Response:</E>
                     This action sets catch limits, including RHLs, for summer flounder, scup, black sea bass, and bluefish for the 2025 fishing year. Recreational measures for black sea bass will be developed through a separate action. Comments on the recreational management measure-setting approach, which was implemented through a previous rule (88 FR 14499, March 9, 2023), are outside the scope of this action, but more information can be found in the NEPA document prepared for that action (
                    <E T="03">https://www.mafmc.org/s/SFSBSB_BF_HCR_EA_submission2.pdf</E>
                    ).
                </P>
                <P>
                    <E T="03">Comment 18:</E>
                     One commenter asked whether NMFS is ceding its authority to the Commission based on the disapproval of specific measures in Amendment 23 to the Summer Flounder, Scup, and Black Sea Bass FMP.
                </P>
                <P>
                    <E T="03">Response:</E>
                     This action sets catch limits for summer flounder, scup, black sea bass, and bluefish for the 2025 fishing year. Comments on the measures in Amendment 23, which was addressed through a previous rule (89 FR 79778, October 1, 2024), are outside the scope of this action.
                </P>
                <P>
                    <E T="03">Comment 19:</E>
                     One commenter who supported the proposed specifications noted a disconnect between bluefish rebuilding and fishing mortality and hoped to see future specifications set with the understanding that they have little impact on the stock status or achieving the rebuilding target.
                </P>
                <P>
                    <E T="03">Response:</E>
                     The bluefish rebuilding plan was implemented under Amendment 7 to the Bluefish FMP (86 FR 66977, November 24, 2021). Amendment 7 implemented a 7-year constant fishing mortality to rebuild the bluefish stock by 2028. The 7-year rebuilding period was selected over both 4-year and 5-year rebuilding alternatives, allowing for a higher ABC. This action sets bluefish specifications for fishing year 2025 in accordance with the rebuilding plan and the recommendation of the Council. Comments on the rebuilding plan, which is not proposed to be modified here, and future bluefish specifications are outside the scope of this action.
                </P>
                <P>
                    <E T="03">Comment 20:</E>
                     One commenter expressed that offshore wind energy development poses a risk to North Atlantic right whales.
                </P>
                <P>
                    <E T="03">Response:</E>
                     This action sets catch limits for summer flounder, scup, black sea bass, and bluefish for the 2025 fishing year. Comments on wind energy development are outside the scope of this action.
                </P>
                <HD SOURCE="HD1">Changes From the Proposed Rule</HD>
                <P>This final rule includes adjustments to the summer flounder state-by-state commercial quotas to account for prior overages identified in the final catch information for fishing year 2023 and preliminary catch information for fishing year 2024.</P>
                <HD SOURCE="HD1">Classification</HD>
                <P>This action is taken pursuant to section 305(d) of the Magnuson-Stevens Act. The NMFS Assistant Administrator has determined that this final rule is consistent with the Summer Flounder, Scup, and Black Sea Bass FMP, the Bluefish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.</P>
                <P>The Assistant Administrator for Fisheries finds that the need to implement these measures in a timely manner constitutes good cause, under the authority contained in 5 U.S.C. 553(d)(3), to waive the 30-day delay in effective date of this action. This action implements 2025 specifications for the summer flounder, scup, black sea bass, and bluefish fisheries. These specifications should be effective by the start of the fishing year for all four species on January 1, 2025. It must be published on or before December 31, 2024.</P>
                <P>
                    This rule is being issued at the earliest possible date. Preparation of the final rule is dependent on the analysis of commercial summer flounder landings for the prior fishing year (2023) and the current fishing year through October 31, 2024, to determine whether any overages have occurred and adjustments are needed to the final state quotas. This process is codified in the summer flounder regulations and, therefore, cannot be performed earlier. A proposed rule was published on October 16, 2024, with a public comment period through October 31, 2024. This final rule is being published as soon as possible following closure of the comment period. Annual publication of the summer flounder quotas prior to the start of the fishing year, by December 31, is required by Court Order in 
                    <E T="03">North Carolina Fisheries Association</E>
                     v. 
                    <E T="03">Daley.</E>
                </P>
                <P>
                    NMFS has determined that this action would not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes; therefore, consultation with Tribal officials under Executive Order (E.O.) 13175 is not required, and the requirements of sections (5)(b) and (5)(c) of E.O. 13175 also do not apply. A Tribal summary impact statement under section (5)(b)(2)(B) and section (5)(c)(2)(B) of E.O. 13175 is not required and has not been prepared.
                    <PRTPAGE P="99147"/>
                </P>
                <P>The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.</P>
                <P>This final rule is exempt from the procedures of E.O. 12866 because this action contains no implementing regulations.</P>
                <P>This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 50 CFR Part 648</HD>
                    <P>Fisheries, Fishing, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Samuel D. Rauch III,</NAME>
                    <TITLE>Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28845 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Part 697</CFR>
                <DEPDOC>[Docket No. 211101-0222; RTID 0648-XE493]</DEPDOC>
                <SUBJECT>Fisheries of the Atlantic; Atlantic Migratory Group Cobia; 2024 Commercial Closure for Atlantic Migratory Group Cobia</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Temporary rule; closure.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS implements a closure in Federal waters off Georgia through New York for Atlantic migratory group cobia (Atlantic cobia) that are harvested and sold (commercial). Commercial landings of Atlantic cobia are projected to reach the commercial quota on December 18, 2024. Therefore, NMFS closes the commercial sector for Atlantic cobia in Federal waters. This closure is necessary to protect the Atlantic cobia resource.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This temporary rule is effective from December 18, 2024, through December 31, 2024.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Frank Helies, NMFS Southeast Regional Office, telephone: 727-824-5305, email: 
                        <E T="03">frank.helies@noaa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The fishery for Atlantic cobia in Federal waters is managed under the authority of the Atlantic Coastal Fisheries Cooperative Management Act (Atlantic Coastal Act) by regulations at 50 CFR part 697.</P>
                <P>Separate migratory groups of cobia are managed in the Gulf of Mexico and Atlantic. Atlantic cobia is managed from Georgia through New York [50 CFR 697.2(a)]. The southern boundary for Atlantic cobia is a line that extends due east of the Florida and Georgia state border at 30°42′45.6″ N latitude. The northern boundary for Atlantic cobia is the jurisdictional boundary between the Mid-Atlantic and New England Fishery Management Councils, as specified in 50 CFR 600.105(a). The fishing year for Atlantic cobia is January 1 through December 31 [50 CFR 697.28(a)].</P>
                <P>Amendment 31 to the Fishery Management Plan (FMP) for Coastal Migratory Pelagic Resources of the Gulf of Mexico and Atlantic Region and the implementing final rule removed Atlantic cobia from Federal management under the Magnuson-Stevens Fishery Conservation and Management Act, while also implementing comparable regulations in Federal waters under the Atlantic Coastal Act (84 FR 4733, February 19, 2019).</P>
                <P>The Atlantic States Marine Fisheries Commission (ASMFC) approved Amendment 1 to the Interstate FMP for Atlantic Cobia in 2019 and Addendum 1 to Amendment 1 in 2020. Amendment 1 and Addendum 1 provided for an increase in the commercial quota and transferred quota monitoring responsibility to the ASMFC. NMFS subsequently issued comparable regulations for Amendment 1 and Addendum 1 on November 8, 2021 (86 FR 61714, November 8, 2021). That final rule increased the commercial quota to 73,116 pounds (lb) or 33,165 kilograms (kg) and transferred quota monitoring responsibility from NMFS to the ASMFC [50 CFR 697.28(f)(1)]. Additionally as described in that final rule, during the fishing year if the ASMFC estimates that the sum of commercial landings (cobia that are sold), reaches or is projected to reach the commercial quota, then the ASMFC will notify NMFS of the need for a commercial closure in Atlantic Federal waters for Atlantic cobia [50 CFR 697.28(f)(1)].</P>
                <P>Atlantic cobia are unique among federally managed species in the U.S. southeast region, because no commercial permit is required to harvest and sell them, and so the distinction between the commercial and recreational sectors is not as clear as with other federally managed stocks. However, for purposes of this temporary rule, Atlantic cobia that are harvested and sold are considered commercially caught, and those that are harvested and not sold are considered recreationally caught.</P>
                <P>On November 18, 2024, the ASMFC notified NMFS that commercial landings information indicated that the commercial quota is estimated to be met by December 18, 2024. Accordingly, the ASMFC requested that NMFS close commercial harvest of Atlantic cobia in Atlantic Federal waters on December 18, 2024, to prevent the commercial quota from being exceeded.</P>
                <P>Regulations for the commercial sector of Atlantic cobia at 50 CFR 697.28(f)(1) require that NMFS file a notification with the Office of the Federal Register to prohibit the harvest, sale, trade, barter, or purchase of Atlantic cobia for the remainder of the fishing year when commercial landings reach or are projected to reach the commercial quota specified in 50 CFR 697.28(f)(1). Accordingly, the commercial sector for Atlantic cobia is closed in Federal waters beginning on December 18, 2024, and will remain closed until the start of the next fishing year on January 1, 2025.</P>
                <P>The recreational bag and possession limits for Atlantic cobia apply while the recreational sector is open [50 CFR 697.28(e)]. The prohibition on sale and purchase does not apply to Atlantic cobia that were harvested, landed ashore, and sold before December 18, 2024, and were held in cold storage by a dealer or processor.</P>
                <HD SOURCE="HD1">Classification</HD>
                <P>NMFS issues this action pursuant to the Atlantic Coastal Act. This action is required by 50 CFR 697.28(f)(1) and is exempt from review under Executive Order 12866.</P>
                <P>These measures are exempt from the procedures of the Regulatory Flexibility Act, because the temporary rule is issued without opportunity for prior notice and comment.</P>
                <P>
                    Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment, as such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the regulations associated with the 
                    <PRTPAGE P="99148"/>
                    commercial quota and closure provisions for Atlantic cobia have already been subject to notice and comment, and all that remains is to notify the public of the commercial closure for the remainder of the 2024 fishing year. Prior notice and opportunity for public comment on this action is contrary to the public interest because of the need to immediately implement the commercial closure to protect Atlantic cobia, since the capacity of the fishing fleet allows for rapid harvest of the commercial quota. Prior notice and opportunity for public comment would require time and would likely result in a harvest that exceeds the commercial quota.
                </P>
                <P>For the reasons just stated, there is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in the effective date of this action.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        16 U.S.C. 5101 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Karen H. Abrams,</NAME>
                    <TITLE>Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28943 Filed 12-5-24; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
    </RULES>
    <VOL>89</VOL>
    <NO>237</NO>
    <DATE>Tuesday, December 10, 2024</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <PRORULES>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="99149"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Agricultural Marketing Service</SUBAGY>
                <CFR>7 CFR Part 1240</CFR>
                <DEPDOC>[Doc. No. AMS-LP-21-0028]</DEPDOC>
                <RIN>RIN 0581-AE07</RIN>
                <SUBJECT>Natural Grass Sod Promotion, Research, and Information Order</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Agricultural Marketing Service, USDA.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule order and referendum.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This document proposes to establish an industry-funded promotion, research, and information program for natural grass sod products. The proposed program, the Natural Grass Sod Promotion, Research, and Information Order (Order), was submitted to the U.S. Department of Agriculture (USDA) by Turfgrass Producers International (TPI), a group of natural grass sod producers. The purpose of the program would be to maintain and expand markets for natural grass sod products and the program would be financed by an assessment on domestic sod producers. This proposed Order also announces that USDA is conducting a referendum among eligible producers to determine whether they favor establishing the program. The program would be established if it is favored by a majority of industry producers voting in the referendum. A separate final rule on referendum procedures is published in this issue of the 
                        <E T="04">Federal Register</E>
                        . This proposed Order also announces the Agricultural Marketing Service's (AMS) intent to request approval from the Office of Management and Budget (OMB) of new information collection requirements to implement the program.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The voting period is January 13, 2025 through February 11, 2025. To be eligible to vote, current natural grass sod producers must have sold natural grass sod products in the United States during the representative period from January 1, 2024 through December 31, 2024. Anyone who believes that they are eligible to vote in the referendum must request a ballot from the Referendum Agents by emailing the contact provided in the 
                        <E T="02">ADDRESSES</E>
                         section below. Eligible producers must provide evidence of natural grass sod sales during the representative period. Ballots will be mailed to all known eligible natural grass sod producers on or before January 10, 2025. Ballots must be received by the Referendum Agents no later than the close of business 5 p.m. (Eastern Standard Time) on February 11, 2025.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Copies of the proposed Order may be obtained from the Referendum Agents, Research and Promotion Division; Livestock and Poultry Program, AMS, USDA; Room 2092-S, STOP 0249; 1400 Independence Avenue SW, Washington, DC 20250-0249; Telephone: (202) 302-1139; Email: 
                        <E T="03">Maribel.Reyna@usda.gov</E>
                         or can be viewed at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Maribel Reyna; Director; Research and Promotion Division; Telephone: (202) 302-1139 or Email: 
                        <E T="03">maribel.reyna@usda.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This proposed rule is issued pursuant to the Commodity Promotion, Research, and Information Act of 1996 (1996 Act or Act) (7 U.S.C. 7411-7425).</P>
                <P>
                    As part of this rulemaking process, a proposed rule inviting comments was published in the 
                    <E T="04">Federal Register</E>
                     on October 16, 2023 (88 FR 71306) that provided for a 60-day comment period which ended on December 15, 2023. AMS received 174 comments, the majority of which (151), favored the establishment of a natural grass sod promotion, research, and information program. The comments are addressed later in this document.
                </P>
                <HD SOURCE="HD1">Executive Orders 12866, 13563, and 14094</HD>
                <P>Executive Orders (E.O.) 12866 and 13563 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. E.O. 14094 updates and modernizes E.O. 12866 and directs agencies to conduct proactive outreach to engage interested and affected parties through a variety of means, such as through field offices, and alternative platforms and media. This rulemaking has been designated as not a “significant regulatory action” under section 3(f) of E.O. 12866. Accordingly, OMB has not reviewed this action.</P>
                <HD SOURCE="HD1">Executive Order 12988</HD>
                <P>This action has been reviewed under E.O. 12988, Civil Justice Reform. It is not intended to have retroactive effect. Section 524 of the 1996 Act (7 U.S.C. 7423) provides that it shall not affect or preempt any other Federal or State law authorizing promotion or research relating to an agricultural commodity.</P>
                <P>Under section 519 of the 1996 Act (7 U.S.C. 7418), a person subject to an order may file a petition with the Secretary of Agriculture (Secretary) stating that the order, any provision of the order, or any obligation imposed in connection with the order, is not established in accordance with the law and requesting a modification of the order or an exemption from the order. Any petition filed challenging the order, any provision of the order, or any obligation imposed in connection with the order, shall be filed within 2 years after the effective date of the order, provision, or obligation subject to challenge in the petition. The petitioner will have the opportunity for a hearing on the petition. Thereafter, the Secretary will issue a ruling on the petition. The Act provides that the district court of the United States for any district in which the petitioner resides or conducts business shall have jurisdiction to review a final ruling on the petition, if the petitioner files a complaint for that purpose not later than 20 days after the date of the entry of the Secretary's final ruling.</P>
                <HD SOURCE="HD1">Executive Order 13175</HD>
                <P>
                    This action has been reviewed under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, which requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on: (1) policies that have Tribal implications, including regulations, legislative comments, or proposed 
                    <PRTPAGE P="99150"/>
                    legislation; and (2) other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
                </P>
                <P>AMS has assessed the impact of this action on Indian Tribes and determined that this rulemaking would not have Tribal implications that require consultation under E.O. 13175. AMS hosts a quarterly teleconference with Tribal leaders where matters of mutual interest regarding the marketing of agricultural products are discussed. Information about the proposed regulation will be shared during an upcoming quarterly call, and Tribal leaders will be informed about the proposed regulation and referendum procedures. AMS will work with the USDA Office of Tribal Relations to ensure meaningful consultation is provided as needed with regards to the regulations.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>This proposed Order is an industry effort to establish a national program with a board composed of natural grass sod producers and one public member to promote and strengthen consumer demand for natural grass. Initially, producers would pay one-tenth (1/10th) of one penny ($0.01) per square foot of natural grass products sold in the United States, which would be calculated by multiplying the square footage, or the equivalent thereof, of natural grass products sold in the United States by $0.001. No natural grass sod producer would be exempt from paying the assessment unless producing a certified organic product under the National Organic Program. A referendum to determine whether producers favor the Order would take place before the Order would go into effect. This proposed Order also announces AMS's intent to request approval by OMB of new information collection requirements to implement the program.</P>
                <HD SOURCE="HD1">Authority in the 1996 Act</HD>
                <P>The proposed Order is authorized by the 1996 Act (7 U.S.C. 7411-7425), which authorizes USDA to establish agricultural commodity research and promotion orders that may include a combination of promotion, research, industry information, and consumer information activities funded by mandatory assessments. These programs are designed to maintain and expand existing markets and develop new markets and uses for agricultural commodities. As defined in section 513 of the Act (7 U.S.C. 7412), the term “agricultural commodity” includes agricultural and horticultural products and “products processed or manufactured from [agricultural and horticultural products], as determined appropriate by the Secretary.” 7 U.S.C. 7412(1)(F). The Act's definition of an agricultural commodity thus includes natural grass sod.</P>
                <P>The 1996 Act includes provisions that authorize the Secretary to tailor programs to the specific characteristics of different commodities. Section 514 of the Act (7 U.S.C. 7413) provides USDA discretion in determining to whom an order should apply among the following: (1) producers, (2) first handlers and others in the marketing chain as appropriate, and (3) importers (if imports are subject to assessments). Natural grass sod producers fall within the categories of “first handlers” and “other persons in the marketing chain.”</P>
                <P>In addition, while section 515 of the 1996 Act (7 U.S.C. 7414) directs that each order must establish an administrative board, the board may be composed of producers, first handlers and others in the marketing chain as appropriate, or importers (if imports are subject to assessments). A board may also include one or more members of the general public. Section 516 of the Act (7 U.S.C. 7415) states that an order may include different payment and reporting schedules; authority for research, promotion, and information activities to expand, improve, or make more efficient the marketing or use of an agricultural commodity in both domestic and foreign markets; provision for reserve funds; and provision for credits for generic and branded activities.</P>
                <P>Section 518 of the 1996 Act (7 U.S.C. 7417) provides for a referendum to ascertain approval of an order to be conducted either prior to it going into effect or within 3 years after assessments first begin under the order. The Act also provides three different methods for determining approval of an order in a referendum: (1) by a majority of those persons voting, (2) by persons voting for approval who represent a majority of the volume of the agricultural commodity, or (3) by a majority of those persons voting for approval who also represent a majority of the volume of the agricultural commodity.</P>
                <HD SOURCE="HD1">Industry Overview</HD>
                <P>The 2022 USDA Census of Agriculture places the value of the U.S. natural grass sod industry at over $2.2 billion, and natural grass sod is produced on 1,447 farms in the United States, totaling 376,227 acres. These farms exist nationwide with documented active natural grass sod farms in no fewer than 49 States. The widespread distribution of natural grass sod farms is due in part to the diversity of natural grass species, allowing them to adapt to different climates. Grass species such as Bentgrass, Fine fescue, Tall fescue, and Kentucky bluegrass thrive in USDA plant hardiness zones 1a through 6a, while Bermudagrass, Buffalograss, Centipedegrass, Seashore Paspalum, Saint Augustinegrass, and Zoysiagrass perform well in zones 7a through 10a. There are also various species of native grasses and other adapted grasses that are gaining popularity in various regions. All these products are produced by natural grass sod farmers throughout the United States and are included in the definition of natural grass sod products in the proposed Order.</P>
                <P>The $2.2 billion of natural grass sod produced in 2022 by U.S. natural grass sod farms enters the market where it contributes significantly to industries that focus on sustainable growth through public and private initiatives supporting environmentally responsible investments, as well as those industries that support it. These sectors include the home lawn care, sports field, golf course, roadside, and other markets that are essential components of local economies nationwide. Seed industries, primarily in the Midwest and Pacific Northwest, supply seed for sod farms growing cool-season grasses including ryegrass, fescues, bluegrasses, and native or adapted mixtures. This industry produces over 600 million pounds of natural grass seed in Oregon alone, much of which is distributed to U.S. natural grass sod farms to produce sod that is then sold to other segments of the green industry.</P>
                <P>
                    In addition to contributing to rural agricultural economies, natural grass sod also contributes significantly to urban economies. In States that track sod sales data, landscape contractors in urban and suburban areas purchase between 39.2 percent and 68.2 percent of total sales, followed by sales to athletic complexes and golf courses that make up between 18.2 percent and 44.5 percent of total sales.
                    <SU>1</SU>
                    <FTREF/>
                     The natural grass 
                    <PRTPAGE P="99151"/>
                    sod supply chain contributes to local economies through home improvement centers, lawn and landscaping services, equipment and materials purchases, and more. It is estimated that the U.S. lawn care industry alone was worth up to $93 billion in 2018, employed more than 1 million people, and represented 513,305 businesses.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Waltz, Clint, 
                        <E T="03">2018 Sod Producers Report, Annual Survey Examines Inventory and Price.</E>
                         UAC Winter Magazine, Winter 2018, at 44. 
                        <E T="03">See also</E>
                         Miller, Grady, 
                        <E T="03">2018 Sod Producers Report for North Carolina,</E>
                          
                        <E T="03">Turffiles.ncsu.edu, https://www.turffiles.ncsu.edu/2018/04/2018-sod-producers-report-for-north-carolina/</E>
                         (last visited Aug. 30, 2024); Richards, Steve. 
                        <E T="03">2018 SC Sod Producers Survey Results (2018, Clemson University).</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         National Association of Landscape Professionals (NALP), 
                        <E T="03">Landscape Industry Statistics,</E>
                          
                        <E T="03">Landscapeprofessionals.org, https://www.landscapeprofessionals.org/LP/News/LP/Media/landscape-industry-statistics.aspx</E>
                         (last visited Aug. 30, 2024).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Need for a Program</HD>
                <P>The need for a national research and promotion program is evidenced by trends that discourage consumers from using natural grass products. Natural grass sod producers in many areas of the United States are experiencing social and market trends that are increasingly impacting consumer perception and the value of natural grass. These trends minimize the value of natural grass lawns and athletic fields in urban and suburban environments and have resulted in consumers reducing the amount of grass they manage and/or replacing it with other products.</P>
                <P>As proposed by the industry, a natural sod checkoff would help educate consumers and other stakeholders about the value that plants, including natural grass, impart on urban and suburban areas. Plants, including natural grass, are often viewed as requiring large amounts of inputs from water, fertilizer, and chemicals, with few valuable outputs. This view frequently results in an inaccurate determination that natural grasses are resource intensive. However, when accounting for new technologies such as drought-tolerant varieties, reduced mowing, and improvements in irrigation, as well as the many ecosystem services (carbon sequestration, oxygen production, groundwater recharge, filtering of pollutants, stormwater, and runoff reduction) that are provided by lawns, parks, and roadsides, a more accurate characterization is that managed landscapes, including natural grass sod, provide many benefits in urban and suburban areas.</P>
                <P>The aforementioned perception of natural grass is embedded in language used by numerous governing bodies that produce building codes and standards for private and public spaces. These codes provide incentives for builders to reduce or remove natural grass from residential, business, and public spaces with the intent of reducing inputs. However, many such codes do not factor in the benefits that plants, including natural grasses, provide to these areas or recognize that simply eliminating them from the system is not a sustainable approach for urban and suburban construction.</P>
                <P>
                    Plastic, artificial turf is the primary competitor and most common alternative to natural grass for athletic fields on school grounds, public parks, and collegiate or professional sports venues. In home lawns and other public spaces, alternative products also include patios, decks, mulch, concrete or brick pavers, and rubberized playgrounds. Data from the 2020 Synthetic Turf Council Market Report for North America indicates that the synthetic turf industry has grown 15 percent since 2017 with a current value of $2.7 billion. The data also predicts continued growth at a rate of 5.7 percent through 2022, with sports fields representing 63 percent of the market and rapid growth in landscape applications.
                    <SU>3</SU>
                    <FTREF/>
                     The landscape and sports field markets represent the two largest customer segments for natural grass sod producers for those who report data. However, the growth of the artificial turf market is reducing the market for natural grass landscapes and sports fields.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Synthetic Turf Council, 
                        <E T="03">2020 Synthetic Turf Market Report for North America, https://www.syntheticturfcouncil.org/news/512350/Synthetic-Turf-Council-STC-Releases-2020-Synthetic-Turf-Market-Report-for-North-America.htm</E>
                         (last visited Aug. 30, 2024).
                    </P>
                </FTNT>
                <P>TPI is the proponent group that submitted the proposed Order to USDA on June 18, 2021, requesting the establishment of a natural grass sod research and promotion program. Since at least 2013, U.S. natural grass sod producers have been considering the implementation of a natural grass sod research and promotion program. Although State and local sod associations have explored the option of establishing voluntary research and promotion programs in previous years, they were deemed impractical and unsustainable without the administration and enforcement provided by AMS through the authority provided in the 1996 Act. In 2017, TPI, a trade association representing natural grass sod farmers, equipment manufacturers, seed producers, and other industry participants with members located in almost every U.S. State and over 30 countries, formally investigated AMS's research and promotion programs. From 2017 to 2019, TPI spoke with representatives at trade associations with aligned interests, AMS, a public policy consultant, and legal counsel to determine if a research and promotion program for the U.S. natural grass sod industry was feasible. After much deliberation and interest from U.S. natural grass sod producers, the industry, led by TPI, decided that the time was right for the natural grass sod industry to pursue a national research and promotion program.</P>
                <P>
                    In 2019, after visiting with the trade associations with aligned interests and AMS, the industry decided to host a webinar to get feedback from natural grass sod producers regarding their interest in developing a national grass sod research and promotion program. On May 19, 2020, U.S. sod producers participated in a 2-hour online seminar to learn more about AMS's Research and Promotion Programs. After this webinar, attendees were polled to determine their interest in developing a program for the natural grass sod industry and 64 percent stated they were very interested, 20 percent stated they were interested, 13 percent stated they were interested in learning more, and only 3 percent stated they were not interested.
                    <SU>4</SU>
                    <FTREF/>
                     Attendees in this webinar were also polled to determine their interest in serving on a sod research and promotion drafting committee, and 14 sod producers were selected.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Turfgrass Producers International, Industry Analysis and Justification for Natural Grass Sod Promotion, Research, and Information Order, 
                        <E T="03">https://www.ams.usda.gov/sites/default/files/media/SodIndustryAnalysisandJustificationDraft.pdf</E>
                         (last visited Aug. 30, 2024).
                    </P>
                </FTNT>
                <P>This drafting committee has finalized the proposed Order contained herein for submission to AMS. The proposed Order contains all the relevant information on a natural grass sod research and promotion program, including the proposed assessment rate that was determined through an analysis of U.S. natural grass sod production farm and acreage data from the 2017 USDA-NASS Census of Agriculture along with internal data from TPI. A wide range of farm sizes, annual acres harvested, and assessment rates were assembled for analysis to determine an assessment rate that would (1) be amenable to sod producers; (2) not be overly burdensome; and (3) result in enough funds to carry out activities that would have an impact on the market. The formation committee of 14 members of different farm sizes, regions, and products all agreed that the proposed assessment rate met each of those conditions.</P>
                <HD SOURCE="HD1">Specific Provisions</HD>
                <P>
                    The proposed Order is authorized under the 1996 Act, which authorizes USDA to establish agricultural commodity research and promotion orders and is consistent with existing orders for other commodities. The 
                    <PRTPAGE P="99152"/>
                    proposed Order is also a part of an industry effort to establish a national program with a board composed of natural grass sod producers and one public member to promote and strengthen consumer demand for natural grass. Many parties, including AMS, a public policy consultant, and private legal counsel, were consulted and determined that a research and promotion program for the U.S. natural grass sod industry was feasible. In addition to this determination, the industry hosted a 2-hour webinar where feedback was given from natural grass sod producers regarding their interest in developing a national grass sod research and promotion program. More than a majority (64 percent) of the attendees stated that they were very interested in establishing a research and promotion program for U.S. natural grass sod while only 3 percent stated they were not interested. Fourteen sod producers who attended the webinar created the sod research and promotion drafting committee, which drafted the proposed Order containing the relevant information on research and promotion programs.
                </P>
                <P>This proposed Order includes revisions to the regulatory text of the proposed rule published on October 16, 2023 (88 FR 71302). These revisions were made to improve organization and clarity only. In addition, § 1240.48 was added to address the exemption from assessment for sales of organic sod products. Since the regulatory text proposed herein contains the complete proposed Order, this section will highlight key proposed provisions.</P>
                <HD SOURCE="HD1">Definitions</HD>
                <P>Pursuant to section 513 of the 1996 Act (7 U.S.C. 7412), § 1240.20 of the proposed Order would define certain terms that would be used throughout the Order. Several of the terms are common to all research and promotion programs authorized under the Act while other terms are specific to the proposed natural grass sod Order.</P>
                <P>Proposed § 1240.20 would define the term “Act” to mean the Commodity Promotion, Research, and Information Act of 1996 (7 U.S.C. 7411-7425), and any amendments thereto.</P>
                <P>The term “natural grass” would be defined as a plant species in the Poaceae family or living plants in other taxa serving a similar purpose, as often found in sites such as lawns, sports fields, golf courses, parks, cemeteries, roadsides, and others.</P>
                <P>The term “natural grass sod producer” would be defined as any person who produces natural grass sod products in the United States.</P>
                <P>The term “natural grass sod product” would refer to natural grass produced for retail, wholesale, or commercial sale, including monostands or blends or mixtures of Bentgrass, Bermudagrass, Buffalograss, Centipedegrass, Fine fescue, Kentucky bluegrass, Ryegrass, Seashore Paspalum, Saint Augustinegrass, Tall fescue, Zoysiagrass, Bahiagrass, other native or adapted plants harvested and sold as sod, and products containing natural grass with artificial elements that are sold as sod. For purposes of the proposed Order, the term “natural grass sod product” would exclude all artificial and synthetic turf or grass products, natural grass seed, sprigs, and plugs.</P>
                <HD SOURCE="HD1">Establishment of the Board</HD>
                <P>Pursuant to section 515 of the 1996 Act (7 U.S.C. 7414), §§ 1240.30 through 1240.39 of the proposed Order would detail the establishment and membership of the proposed Natural Grass Sod Promotion, Research, and Information Board (Board), nominations and appointments, the term of office, removal and vacancies, procedures, reimbursement and attendance, powers and duties, and prohibited activities.</P>
                <P>Section 1240.30(b) specifies that the Board would be composed of 11 members. Three members would represent the North/Cool-Season Region, four would represent the South/Warm-Season Region, three would represent the Transition Zone/California Region, and one would be a public member. See Table 1 below for a list of States in each region. The total number of Board members could not be changed without rulemaking. The apportionment of Board members among the regions would be intended to reflect the geographical distribution of the production of natural grass sod products in the United States, as well as the relative percentage of assessments paid by natural grass sod producers into the research and promotion program. Table 1 summarizes the geographical distribution of natural grass sod farms, acres of natural grass sod produced, and sales. At least once every 5 years but no more frequently than once every 3 years, the Board would review the geographical distribution of the production of natural grass sod products in the United States. Any changes in Board composition implemented by the Secretary would be made through rulemaking. All Board members would be appointed by the Secretary from nominations as set forth in proposed § 1240.31.</P>
                <GPOTABLE COLS="6" OPTS="L2,nj,i1" CDEF="s40,10,r100,10,10,15">
                    <TTITLE>
                        Table 1—Farms, Acres and Sales by Proposed Regions 
                        <SU>5</SU>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">Region</CHED>
                        <CHED H="1">Number of members</CHED>
                        <CHED H="1">States</CHED>
                        <CHED H="1">Farms</CHED>
                        <CHED H="1">Acres</CHED>
                        <CHED H="1">
                            Sales 
                            <SU>6</SU>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">North/Cool Season</ENT>
                        <ENT>3</ENT>
                        <ENT>AK, CO, CT, DE, ID, IL, IN, IA, ME, MA, MI, MN, MT, NE, NH, NJ, NY, ND, OH, OR, PA, RI, SD, UT, VT, WA, WI, WY</ENT>
                        <ENT>454</ENT>
                        <ENT>78,076</ENT>
                        <ENT>$447,031,503</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">South/Warm Season</ENT>
                        <ENT>4</ENT>
                        <ENT>AL, AZ, FL, GA, HI, LA, MS, NM, SC, TX, U.S. Territories</ENT>
                        <ENT>579</ENT>
                        <ENT>192,722</ENT>
                        <ENT>1,067,649,331</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Transition Zone/California</ENT>
                        <ENT>3</ENT>
                        <ENT>AR, CA, DC, KS, KY, MD, MO, NC, NV, OK, TN, VA, WV</ENT>
                        <ENT>414</ENT>
                        <ENT>102,101</ENT>
                        <ENT>676,343,293</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    Any
                    <FTREF/>
                     natural grass sod producer who does not owe outstanding assessments may seek nomination for any vacant position in the region they produce and sell natural grass sod products. Nominees that produce and sell in multiple regions may seek nomination in one region of their choice. To seek nomination to the Board, an interested natural grass sod producer would provide the Board a short background statement outlining their qualifications. Any public member interested in seeking nomination would also provide the Board a short background statement outlining their qualifications.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See 2022 Census of Agriculture,</E>
                         USDA National Agricultural Statistics Service 
                        <E T="03">https://www.nass.usda.gov/Publications/AgCensus/2022/Full_Report/Volume_1,_Chapter_2_US_State_Level/st99_2_034_034.pdf</E>
                         (last visited Aug.30, 2024).
                    </P>
                    <P>
                        <SU>6</SU>
                         Sales are counted in the place where the natural grass sod product was produced.
                    </P>
                </FTNT>
                <P>
                    Section 1240.32 of the proposed Order would specify the nominee's agreement to serve. Natural grass sod 
                    <PRTPAGE P="99153"/>
                    producers and public members nominated to serve on the Board would be required to submit to the Secretary a written agreement to serve on the Board if appointed by the Secretary, disclose any relationship with any natural grass sod promotion entity or organization that has been or is being considered for a contractual relationship with the Board, and withdraw from participation in deliberations, decision-making, and voting on matters that concern the relationship of the entity or organization considered for a contractual relationship.
                </P>
                <P>Section 1240.33 of the proposed Order would specify the terms of office of Board members. Except for the initial Board, each Board member would serve for 3 years or until the Secretary selects his or her successor. The initial Board member terms would be staggered at 1, 2, and 3 years. Each region would initially have one member who serves a 2-year term and two members who serve 3-year terms. Additionally, the South/Warm-Season Region would initially have one member who serves a 1-year term. The public member initial term would be a 3-year term. The Secretary would determine which of the initial members would serve a term of 1, 2, or 3 years. Generally, a member could not serve more than two consecutive terms. However, members who serve on the initial Board for 1 or 2 years and members who serve the remainder of a term could serve two additional, consecutive 3-year terms.</P>
                <P>Sections 1240.34 and 1240.35 of the proposed Order would specify reasons for removal and how vacancies would be filled. The Secretary would be able to remove a Board member if he or she determines there is a failure or refusal by the Board member to perform his or her duties properly or if the Board member engages in an act of dishonesty or willful misconduct. Refusing to follow the Act's and Order's purpose would also be a reason for removal. If a member is removed from office or resigns, the position would automatically become vacant. If a member becomes disqualified for ceasing to produce natural grass or ceases to do business in the region he or she represents, their position would be vacated within 6 months from the date of disqualifying event.</P>
                <P>
                    Section 1240.36 of the proposed Order would specify procedures of the Board. A majority of the total number of Board members would constitute a quorum at any meeting of the Board. Each voting member of the Board would be entitled to one vote on any matter put to the Board and the motion would carry if supported by a majority (50 percent plus one vote) of Board members. However, recommendations to change the assessment rate, adopt a budget, or call for a referendum would require affirmation by two-thirds (
                    <FR>2/3</FR>
                    ) of the Board members. When, in the opinion of the chairperson of the Board, such action is considered necessary, the members could vote by internet service, videoconference, teleconference, or any other means of communication. Actions taken under these procedures would be valid only if all members were notified of the meeting and all members were provided the opportunity to vote. Proxy voting would not be permitted. All votes would be recorded in Board minutes. The procedures for conducting Board meetings would be established by the Board and approved by the Secretary.
                </P>
                <P>Section 1240.37 of the proposed Order would specify that all members of the Board would serve without compensation; however, reimbursement for reasonable travel expenses incurred when performing Board duties would be provided as approved by the Board.</P>
                <P>Section 1240.38 of the proposed Order would specify the powers and duties of the Board. These powers and duties would include, among other things, the power and duty to administer the Order and collect assessments; to develop bylaws and recommend rulemaking necessary to administer the Order; to select a chairperson and other Board officers; to form other committees and subcommittees as necessary; to hire staff or contractors as appropriate to carry out the Board's duties; to develop and carry out generic promotion, research, and information activities related to natural grass products; to develop and administer programs, plans, and projects to benefit the natural grass industry; to submit a budget to AMS for approval prior to the start of the fiscal year; to borrow funds necessary to cover startup costs of the Order; to maintain records and books available to the Secretary for inspection and audit upon request; to have its books audited by an outside certified public accountant at the end of each fiscal period and at other times as requested by the Secretary; to notify natural grass sod producers and the Secretary of all Board meetings through press releases or other means; to act as intermediary between the Secretary and any natural grass sod producer; to furnish to the Secretary any information or records he or she may request; to receive, investigate and report to the Secretary complaints of violations of the Order; to recommend to the Secretary changes to the Order as the Board considers appropriate; to strengthen and provide maximum benefits to the natural grass sod industry; to invest Board funds appropriately; to pay the cost of activities with assessments collected under the Order and earnings from invested assessments and other funds; to recommend changes to assessments as appropriate; to appoint and convene committees to assist in the development of research, promotion, advertising, and information programs for natural grass; to periodically prepare and make public reports of program activities and, at least once each fiscal period, to make public an accounting of funds received and expended; and to allocate a percentage of the assessments collected on the sale of natural grass sod products in a State or a region to one or more programs proposed by a qualified organization, under contract, to receive funding.</P>
                <P>Section 1240.39 of the proposed Order specify prohibited activities that are common to all promotion programs authorized under the 1996 Act. Under this provision, Board members and employees could not engage in any actions that would be a conflict of interest; use funds collected by the Board to lobby (influencing any legislation or governmental action or policy by local, State, national, and foreign governments, or subdivisions thereof, other than recommending to the Secretary amendments to the Order); or engage in any advertising, including promotion, research, or information activities authorized to be carried out under the Order, that may be false, misleading, or disparaging to another agricultural commodity.</P>
                <HD SOURCE="HD1">Expenses and Assessments</HD>
                <P>
                    Pursuant to sections 515, 516, and 517 of the 1996 Act (7 U.S.C. 7414, 7415, and 7416), §§ 1240.45 through 1240.48 of the proposed Order detail requirements regarding the Board's budget and expenses, financial statements, assessments, and the exemption from assessment for sales of organic sod products. At least 60 calendar days before the start of the fiscal period, and as necessary during the year, the Board would submit a budget to the Secretary detailing its projected expenses. The budget would include a list of objectives and strategies, a summary of anticipated revenue, and expenses for each program along with a breakdown of staff and administrative expenses. Except for the initial budget, the Board's budgets would include comparative data for at least one preceding fiscal period. Each budget would provide for adequate funds to cover the Board's anticipated expenses. Any amendment or addition 
                    <PRTPAGE P="99154"/>
                    to an approved budget would have to be approved by the Secretary, except that shifts of funds from one program, plan, or project to another that do not result in an increase in the Board's approved budget and are consistent with its bylaws need not have prior approval by the Secretary. The Board would reimburse the Secretary for all expenses incurred in the implementation, administration, enforcement, and supervision of the Order, including all referendum costs in connection with the Order.
                </P>
                <P>During the first year of the Board's operation, the Board could borrow money for the payment of startup expenses limited to the first year of operation. The Board could accept voluntary contributions to carry out activities so long as the contributions are identified in the Board's annual operating budget and are free from any encumbrance by the donor or the Board. The Board would retain control over use of any funds. The Board could also receive funds from Federal or State grants with approval of the Secretary for specific authorized projects.</P>
                <P>Beginning 3 years after establishment of the Board, the Board would be limited to spending no more than 15 percent of its available funds for administration, maintenance, and functioning of the Board. Reimbursements to USDA would not be considered administrative costs. As an example, if the Board received $2 million in assessments during a fiscal period, and had available $500,000 in reserve funds, the Board's available funds would be $2,500,000. In this scenario, the Board would be limited to spending no more than $375,000 (0.15 × $2.5 million) on administrative costs. The 15 percent spending limit is consistent with section 515 of the 1996 Act (7 U.S.C. 7414).</P>
                <P>The Board could establish an operating monetary reserve and carry over excess funds from one fiscal period to the next, provided the funds did not exceed two fiscal years' budgeted expenses. For example, if the Board's budgeted expenses for a fiscal period were $2 million, it could carry over no more than $4 million in reserve.</P>
                <P>Section 1240.46 of the proposed Order would specify the financial statement requirements. The Board would be required to submit to USDA financial statements on a quarterly basis, or at any other time requested by the Secretary. Financial statements would include, at a minimum, a balance sheet, an income statement, investments, and an expense budget.</P>
                <P>Section 1240.47 of the proposed Order would specify the assessments. The Board's programs and expenses would be funded by assessments on natural grass sod products and other funds available to the Board. Under the proposed Order, natural grass sod producers would pay one-tenth (1/10th) of one penny ($0.01) per square foot, or the equivalent thereof, of all natural grass sod products that the natural grass sod producer sells in the United States. For example, a farm that harvested 10,000 square feet of sod would pay $10 in assessments (10,000 × .001). This assessment rate was determined through an analysis of U.S. natural grass sod production farm and acreage data from the 2017 USDA-National Agricultural Statistics Service's (NASS) Census of Agriculture along with internal data from TPI. A wide range of farm sizes, annual acres harvested, and assessment rates were assembled for analysis to determine an assessment rate that would (1) be amenable to sod producers; (2) not be overly burdensome; and (3) result in enough funds to have an impact on the market. At the end of these discussions, the entire formation committee of 14 members of different farm sizes, regions, and products all agreed that the proposed assessment rate met each of those conditions.</P>
                <P>
                    Twenty-four months after the Order becomes effective and periodically thereafter, the Board would review the assessment rate and, if approved by a vote of at least two-thirds (
                    <FR>2/3</FR>
                    ) of the Board, submit a recommendation for a change in the assessment rate to the Secretary. The assessment rate could not exceed one-eighth (1/8th) of one penny ($0.01) per square foot of natural grass sod products sold without approval by a majority of natural grass sod producers voting in a referendum.
                </P>
                <P>In terms of assessment collection, each natural grass sod producer would remit to the Board assessments for natural grass sod products sold every quarter with a remittance form.</P>
                <P>Based on 2017 USDA NASS production acreage, TPI estimates assessments would be valued at approximately $14.9 million annually. Assessments would be collected from approximately 1,447 natural grass sod producers.</P>
                <P>In addition, proposed § 1240.48, which was added in this version of the proposed rule, would allow individuals and entities producing certified organic natural grass sod, according to 7 CFR part 205, to be exempt from paying assessments on sales of organic sod. Organic producers would apply to the Board annually for a certificate of exemption using a form provided by the Board. If a producer sells organic sod and non-organic sod, then that producer would be exempt from paying assessments only on its sales of organic sod. The producer would still be required to pay assessments on its sales of non-organic sod.</P>
                <P>Pursuant to section 517(f) of the 1996 Act (7 U.S.C. 7416(f)) and § 1240.45(j) of the proposed Order, the Board would be permitted to invest assessments collected under the Order in the following: (1) obligations of the United States or any agency of the United States; (2) general obligations of any State or any political subdivision of a State; (3) interest-bearing accounts or certificates of deposit of financial institutions that are members of the Federal Reserve System; and (4) obligations fully guaranteed as to principal and interest by the United States.</P>
                <P>
                    The proposed program would be funded by the industry through assessments paid by natural grass sod producers, as defined in the proposed Order. Based on the proposed assessment rate and an analysis of industry statistics provided by USDA and maintained by TPI, publicly available farm statistics, and TPI data, it is estimated that the program would collect approximately $14,900,000 annually in assessments, which would be used to conduct research, marketing, and promotion programs that would benefit the entire industry. The benefits of the program are expected to outweigh its costs. Evaluations of similar research and promotion programs by independent economists, required to be conducted every 5 years, have shown positive financial benefits with benefit-cost ratios in the range of $2.14 to $17.40 for every dollar invested in the programs.
                    <SU>7</SU>
                    <FTREF/>
                     After reviewing and considering all relevant information, AMS has determined that the assessments proposed to be collected from natural grass sod producers would be relatively small in comparison to their revenue.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         U.S. Gov't Accountability Office, GAO-18-54, AGRICULTURAL PROMOTION PROGRAMS: USDA Could Build on Existing Efforts to Further Strengthen Its Oversight (2017), 
                        <E T="03">https://www.gao.gov/assets/690/688519.pdf</E>
                         (last visited Aug. 30, 2024).
                    </P>
                </FTNT>
                <P>
                    Unlike voluntary programs, in which the universe of assessment payers does not always include all the industry participants who would likely benefit from generic research and promotion activities, all natural grass sod producers would be required to contribute assessments under the proposed research and promotion program. Therefore, the proposed program would be best positioned to have the greatest industry impact with 
                    <PRTPAGE P="99155"/>
                    the broadest level of industry support by eliminating free riders. A free rider is an entity who benefits from a service without having to pay for it. The research and promotion program would be able to combine assessment funds from natural grass sod producers and have a broad impact on the industry by developing new markets, strengthening existing markets, conducting important consumer and scientific research, and promoting industry initiatives and activities.
                </P>
                <HD SOURCE="HD1">Promotion, Research, and Information</HD>
                <P>Pursuant to section 516 of the 1996 Act (7 U.S.C. 7415), §§ 1240.50 through 1240.52 of the proposed Order would describe the promotion, research, and information projects authorized by the Order. The Board would develop and submit to the Secretary for approval programs, plans, or projects that would provide promotion, research, and information to support natural grass sod products, including consumer and industry information and advertising. The Board could implement a program or project only upon approval by the Secretary. The Board would evaluate each program to ensure it contributes to an effective promotion program and complies with the Act and Order.</P>
                <P>At least once every 5 years, the Board would fund an independent evaluation to determine the effectiveness of the Order and programs pursuant to the 1996 Act. The findings of the evaluation would be made available to the Secretary and the general public. Finally, the proposed Order would specify that any patents, copyrights, trademarks, inventions, product formulations, and publications developed with funds received by the Board would be the property of the U.S. Government, as represented by the Board. These, along with any rents, royalties, and the like from their use would be considered income subject to the same fiscal, budget, and audit controls as other funds of the Board, and could be licensed with approval of the Secretary.</P>
                <HD SOURCE="HD1">Report, Books, and Records</HD>
                <P>Pursuant to section 515 of the 1996 Act (7 U.S.C. 7414), §§ 1240.60 through 1240.62 of the proposed Order would specify the reporting and recordkeeping requirements under the proposed Order as well as requirements regarding confidentiality of information. Each natural grass sod producer would be required to submit an assessment remittance form and assessments to the Board on a quarterly basis. The information required in the form would include, but not be limited to, the name and contact information of the natural grass sod producer, the quantity of natural grass sod products sold, and the natural grass sod producer's identification numbers, as applicable. Records would be made available to the Board or USDA during normal business hours and retained for at least 3 years past the fiscal year.</P>
                <P>The proposed Order would also require that all information obtained from persons subject to the Order as a result of the proposed recordkeeping and reporting requirements would be kept confidential by all officers, employees, and agents of the Board and AMS. Pursuant to the 1996 Act, such information could be disclosed only if the Secretary considered it relevant, and the information were revealed in a judicial proceeding or administrative hearing brought at the direction or at the request of the Secretary or to which the Secretary or any officer of USDA was a party. Other exceptions for disclosure of confidential information would allow the issuance of general statements based on reports or information relating to a number of persons subject to the proposed Order, if the statements did not identify the information furnished by any person; or the publication, by direction of the Secretary, of the name of any person violating the Order and a statement of the particular provisions of the Order violated.</P>
                <HD SOURCE="HD1">Regulatory Flexibility Act</HD>
                <P>In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS is required to examine the impact of this rulemaking on small entities. Accordingly, AMS has prepared this regulatory flexibility analysis.</P>
                <P>The purpose of RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened. The affected industry falls under the North American Industry Classification System (NAICS) code: 111421—Nursery and Tree Production. The Small Business Administration (SBA) defines, in 13 CFR part 121, small agricultural producers in this industry as those having annual receipts of no more than $3,250,000.</P>
                <HD SOURCE="HD1">Need for a Program</HD>
                <P>TPI, which represents natural grass sod farmers, equipment manufacturers, seed producers, and other industry participants, is the proponent group that submitted the proposed Order to USDA on June 18, 2021, requesting the establishment of a natural grass sod promotion, research, and information program. In 2017, TPI began to explore the creation of a promotion and research program. TPI worked with natural grass sod producers and other industry organizations to gauge interest in the development of such a program. In 2020, a drafting committee was formed to develop a draft Order. The drafting committee comprised fourteen natural grass sod producers representing a wide variety of natural grass sod farms. The producers represented a range of farm sizes, years in business, and familiarity with other research and promotion programs. The drafting committee's proposed Order was part of the submission by TPI to USDA for consideration of a program. The proposed Order submitted by TPI is intended to educate the public on the value of natural grass products, market and promote the benefits of natural grass on a national scale, provide U.S. sod farmers with marketing tools, and provide information to organizations for use in the development of model codes and standards for building codes.</P>
                <P>
                    The synthetic turf industry is estimated to have a current value of $2.7 billion. The market has grown 15 percent since 2017 and has continued to grow at a rate of 5.7 percent through 2022, with sports fields representing 63 percent of the market and rapid growth in landscape applications.
                    <SU>8</SU>
                    <FTREF/>
                     The rise in synthetic turf numbers comes from social and market trends that have driven consumer perception of natural grass lawns and athletic fields in urban and suburban environments. These trends have caused consumers to misunderstand the value of natural grass lawns and athletic fields in urban and suburban environments. This has caused consumers to reduce the amount of grass they manage and/or replace it with other products like plastic, artificial turf, patios, decks, mulch, concrete, brick pavers, and rubberized playgrounds. These misconceptions have had a significant impact on natural grass sod producers in many areas of the United States.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Synthetic Turf Council, 
                        <E T="03">2020 Synthetic Turf Market Report for North America, https://www.syntheticturfcouncil.org/news/512350/Synthetic-Turf-Council-STC-Releases-2020-Synthetic-Turf-Market-Report-for-North-America.htm</E>
                         (last visited Aug. 30, 2024).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Objectives of the Action</HD>
                <P>
                    As noted in the preamble above, the program would conduct research, marketing, and promotion activities that would benefit the entire industry. Primary goals of the program include educating consumers and stakeholders of the benefits of natural grass and providing producers with marketing 
                    <PRTPAGE P="99156"/>
                    tools they can use to grow their business. The purpose of the program would be to strengthen the position of natural grass sod in the marketplace, maintain and expand markets for natural grass sod, and develop new uses for natural grass sod.
                </P>
                <HD SOURCE="HD1">Legal Basis for the Proposed Rule</HD>
                <P>The proposed Order is authorized by the 1996 Act, which provides that USDA may establish research and promotion programs for agricultural commodities. Under section 513 of the Act (7 U.S.C. 7412), “agricultural commodities” are defined to include agricultural and horticultural products as well as “products processed or manufactured from [agricultural and horticultural products], as determined appropriate by the Secretary.” The Act also includes provisions that authorize the Secretary to tailor programs to the specific characteristics of each different commodity, including section 514 of the Act (7 U.S.C. 7413), which provides USDA discretion in determining to whom an order should apply among the following: “(A) the producers of an agricultural commodity; (B) the first handlers of the agricultural commodity and other persons in the marketing chain as appropriate; and (C) the importers of the agricultural commodity, if imports of the agricultural commodity are subject to assessment.”</P>
                <P>Natural grass sod products fall within the 1996 Act's definition of an agricultural commodity and natural grass sod producers, as defined in the proposed Order, fall within the categories of “first handlers” and “other persons in the marketing chain.” The proposed Order would establish a program of promotion, research, and information to promote consumer demand for natural grass sod products and strengthen the position of the natural grass sod industry in the marketplace, is consistent with the congressional intent of the Act to maintain and expand existing markets as well as develop new markets and uses for agricultural commodities. As such, USDA is authorized to establish the proposed Natural Grass Sod Promotion, Research, and Information Order upon its approval as specified under the Act.</P>
                <P>As part of the approval process set forth in the 1996 Act, the industry must formulate an Order and submit it to USDA for review and final approval. Implementation of the Order, like all rulemaking, is subject to public notice and comment, and is subject to ongoing referenda where participants are given the opportunity to vote to determine whether the program would continue to operate. If approved by USDA and through the ongoing referenda, the proposed Order would become a regulation codified in the U.S. Code of Federal Regulations and would carry the force of law.</P>
                <P>There are no known Federal rules that duplicate, overlap, or conflict with the proposed Order.</P>
                <HD SOURCE="HD1">Alternatives to the Proposed Rule</HD>
                <P>USDA considered the alternative of no action; that is, the status quo. This alternative, however, would leave the natural grass sod industry without the tools of a research and promotion program to strengthen its position in the marketplace, maintain and expand markets, and develop new uses for natural grass sod.</P>
                <P>Although there has been sporadic success attempting to fund efforts at the local level with pooled resources of producers and/or associations, voluntary research and promotion efforts at the national level have historically been marginally successful due to the lack of funds available to undertake larger programs. There are several entities that fund natural grass research and promotion efforts at State and regional levels, but none have the capacity to fund these efforts on a large scale. For instance, many States sod associations fund research and promotion at levels under $10,000 annually. TPI funds research and promotion through its foundation, The Lawn Institute, at up to $50,000 to $100,000 annually. However, these types of funds are raised through voluntary contributions and fundraising efforts such as auctions, raffles, activities, etc., and, while they have impacted natural grass research and promotion on a small scale, none of these efforts can achieve what is proposed through a natural grass sod checkoff. A natural grass sod checkoff would not only be able to raise significant funds for these efforts, but the checkoff could also respond to changing needs in research and promotion. Through the collection of an assessment on all natural grass sod products sold in the United States, the proposed research and promotion program would leverage pooled assessment funds on a national scale and would have a more consistent and wider industry impact.</P>
                <P>The natural grass sod production industry has been discussing a research and promotion program since at least 2013. TPI and other interested stakeholders have held numerous meetings and conducted outreach across the industry to gauge interest in a research and promotion program for natural grass sod products. As noted above, a majority of the natural grass sod producers who actively participated in the May 19, 2020, webinar supported the development of such a program for consideration. This resulted in the creation of the sod research and promotion drafting committee, which drafted the proposed Order that is under consideration in this proposed rule.</P>
                <P>After careful analysis and discussions, the natural grass sod industry has determined that a research and promotion program would be best positioned to have the greatest industry impact with the broadest level of industry support.</P>
                <HD SOURCE="HD1">Impact on Small Businesses</HD>
                <P>
                    The SBA defines, in 13 CFR part 121, small agricultural producers for industries classified as falling under NAICS 111421 (Nursery and Tree Production) as those having annual receipts of no more than $3,250,000. According to data from the 2022 USDA Census of Agriculture, 1,447 firms—nearly 80 percent of producers—would be classified as small agricultural producers based on the value of sales per farm. Table 2 compares the average value of sales per farm to the proposed average assessment per farm for each category. Since the assessment would be calculated based on the volume of a producer's sales, the proportionate burden of the assessment would be the same across the industry, regardless of firm size. On a farm basis, small natural grass sod producers would pay between $205 and $13,138 in assessments annually per firm, while large natural grass sod producers would pay between $23,176 and $66,387 annually.
                    <PRTPAGE P="99157"/>
                </P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,15,15,15,15">
                    <TTITLE>
                        Table 2 
                        <SU>9</SU>
                        —Number of Farms, Acres, Average Value of Sales, and Average Proposed Assessment per Farm
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">NAICS Code 111421</CHED>
                        <CHED H="2"> </CHED>
                        <CHED H="2">Farms</CHED>
                        <CHED H="2">Acres</CHED>
                        <CHED H="1">(2022 dollars)</CHED>
                        <CHED H="2">
                            Avg. value of
                            <LI>sales per farm</LI>
                        </CHED>
                        <CHED H="2">
                            Avg. annual
                            <LI>assessment per</LI>
                            <LI>farm</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Total Industry</ENT>
                        <ENT>1,447</ENT>
                        <ENT>376,227</ENT>
                        <ENT>$1,534,184</ENT>
                        <ENT>$11,326</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Small Firms (&lt;$3,250,000)</ENT>
                        <ENT>1,150</ENT>
                        <ENT>113,030</ENT>
                        <ENT>587,719</ENT>
                        <ENT>4,283</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Large Firms (&gt;$3,250,000)</ENT>
                        <ENT>297</ENT>
                        <ENT>263,167</ENT>
                        <ENT>5,198,948</ENT>
                        <ENT>38,598</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    The
                    <FTREF/>
                     proposed assessment rate of 1/10th of one penny per square foot of natural grass products sold in the United States was decided upon by the industry in part because it was determined that rate would not create any undue burdens to sod farms of any size, including small businesses. Data from the National Quarterly Sod Report, 2023-24 Winter Quarter,
                    <SU>10</SU>
                    <FTREF/>
                     indicate a range of natural grass sod prices across the United States from $0.14 to $0.81 per square foot. Thus, the proposed assessment rate would result in additional costs to sod producers of between 0.71 percent and 0.12 percent. Furthermore, when evaluating the prices based on weighted averages instead of ranges, the additional costs incurred would be between 0.38 percent and 0.13 percent.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         USDA, 2022 USDA NASS Census, 
                        <E T="03">https://www.nass.usda.gov/Publications/AgCensus/2022/Full_Report/Volume_1,_Chapter_1_US/st99_1_039_039.pdf</E>
                         (last visited Aug. 30, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         USDA, Agricultural Marketing Service, Livestock, Poultry, and Grain Market News, 
                        <E T="03">https://www.ams.usda.gov/mnreports/ams_2930.pdf</E>
                         (last visited Aug. 30, 2024).
                    </P>
                </FTNT>
                <P>This level of assessment should have minimal impact on sod farms of any size, large or small, and this consideration is one of the reasons the drafting committee supported the proposed rate. For instance, a sod farm that is considered a small business may harvest as little as 10 acres annually. At the proposed assessment rate and using pricing data from the National Sod Report, the annual contribution of that farm to the research and promotion program would be $436 per year, while generating sales revenue between $60,984 and $352,836.</P>
                <HD SOURCE="HD1">Required Reporting and Recordkeeping</HD>
                <P>The proposed reporting and recordkeeping requirements would not require specialized skills or training. The transactional documentation would be added to documents already generated and maintained by natural grass sod producers. Reporting requirements are expected to be the same for both large and small entities.</P>
                <P>
                    The primary reporting requirement under the proposed Order is the requirement that producers submit quarterly remittance forms. It is estimated that it would take approximately 2 hours annually, or 30 minutes every quarter, to complete and submit the remittance form to the Board. This is estimated to cost each natural grass sod producer $112.36 per year. For the purpose of estimating the cost of reporting and recordkeeping, this proposed rule uses $56.18 per hour. To arrive at this amount, AMS used the mean hourly earnings of farmers, ranchers, and other agricultural managers from the U.S. Department of Labor, Bureau of Labor Statistics, May 2023 National Occupational Employment and Wages Estimates,
                    <SU>11</SU>
                    <FTREF/>
                     that is, $43.35 and added an additional 29.6 percent to account for benefits and compensation.
                    <SU>12</SU>
                    <FTREF/>
                     This calculation results in a total hourly wage of $56.18. Costs of benefits and compensation guidance was obtained from the Bureau of Labor Statistics News Release issued March 13, 2023.
                    <SU>13</SU>
                    <FTREF/>
                     For additional discussion of the costs of the reporting and recordkeeping requirements under the proposed Order, please see the Paperwork Reduction Act section below.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         U.S. Department of Labor, Bureau of Labor Statistics, Occupational Employment and Wages, May 2023; 11-9013 Farmers, Ranchers, and Other Agricultural Managers, 
                        <E T="03">https://www.bls.gov/oes/current/oes119013.htm</E>
                         (last visited Aug. 30, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         U.S. Department of Labor, Bureau of Labor Statistics, News Release, Employer Costs for Employee Compensation—December 2023, 
                        <E T="03">https://www.bls.gov/news.release/pdf/ecec.pdf</E>
                         (last visited Aug. 30, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         U.S. Department of Labor, Bureau of Labor Statistics, Economic News Release: Employer Costs for Employee Compensation Summary for December 2023, 
                        <E T="03">https://www.bls.gov/news.release/pdf/ecec.pdf</E>
                         (last visited Aug. 30, 2024).
                    </P>
                </FTNT>
                <P>AMS is committed to complying with the E-Government Act to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.</P>
                <P>Regarding outreach efforts, USDA would keep natural grass sod producers informed throughout the program implementation and referendum processes to ensure that they are aware of and are able to participate in those processes. USDA would also publicize information regarding the referendum process so that trade associations and related industry media can be kept informed.</P>
                <HD SOURCE="HD1">Paperwork Reduction Act</HD>
                <P>In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), AMS announces its intention to request approval for a new information collection for the proposed natural grass sod program.</P>
                <P>
                    <E T="03">Title:</E>
                     Natural Grass Sod Promotion, Research, and Information Order.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     0581-0349.
                </P>
                <P>
                    <E T="03">Expiration Date of Approval:</E>
                     3 years from approval date.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     New information collection for research and promotion program.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The information collection requirements are essential to carry out the intent of the 1996 Act. The information collection pertains to a proposal submitted by TPI for the development of a national research and promotion program for natural grass sod. The program would be administered by a board of producer members (and one public member) appointed by the Secretary. The program would be financed by an assessment on natural grass sod products sold by natural grass sod producers. The program would provide an exemption from assessment for any organic natural grass products sold under the National Organic Program (7 CFR part 205). The purpose of the proposed program is to help build the market for natural grass sod products.
                </P>
                <P>The proposed forms would require the minimum information necessary to effectively carry out the requirements of the proposed Order, and their use is necessary to fulfill the intent of the 1996 Act.</P>
                <P>
                    The information collection requirements under the program address Board nominations, collection of assessments and reports, and the organic exemption. For Board nominations, natural grass sod producers and the public member would need to complete the 
                    <PRTPAGE P="99158"/>
                    “Nomination for Appointment” form to identify nominees for appointment as members of the Board. Nominees would also need to complete a “Nominee's Agreement to Serve” form to disclose any relationship that could create a conflict of interest while serving on the Board. And the Background Information Form, AD-755ensures the individual is qualified to serve on the Board. Assessments and reports would be collected using the “Quarterly Report and Remittance of Amount Due” form. In addition, producers of organic sod would need to complete the “Organic Exemption Request” form to obtain an exemption from assessment for any organic natural grass sod products sold under the National Organic Program.
                </P>
                <P>
                    For the purpose of estimating the cost of reporting and recordkeeping, this proposed rule uses $56.18 per hour. To arrive at this amount, AMS used the mean hourly earnings of farmers, ranchers, and other agricultural managers from the U.S. Department of Labor, Bureau of Labor Statistics, May 2023 National Occupational Employment and Wages Estimates,
                    <SU>14</SU>
                    <FTREF/>
                     that is, $43.35 and added an additional 29.6 percent to account for benefits and compensation.
                    <SU>15</SU>
                    <FTREF/>
                     This calculation results in total hourly earnings of $56.18, which was used to calculate annual costs.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         U.S. Department of Labor, Bureau of Labor Statistics, Occupational Employment and Wages, May 2023; 11-9013 Farmers, Ranchers, and Other Agricultural Managers, 
                        <E T="03">https://www.bls.gov/oes/current/oes_nat.htm</E>
                         (last visited Aug. 30, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         News Release for Employer Costs for Employee Compensation—June 2024, 
                        <E T="03">https://www.bls.gov/news.release/pdf/ecec.pdf</E>
                         (last visited Aug. 30, 2024).
                    </P>
                </FTNT>
                <P>Information collection requirements included in this proposal are:</P>
                <HD SOURCE="HD2">(1) LP-7 Application for Self-Certification of Nominating Organizations (OMB Form No. 0581-0349)</HD>
                <P>
                    <E T="03">Estimate of Burden:</E>
                     Public reporting burden for this collection of information is estimated to average 0.5 hours per response for each nominating organization.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Natural grass sod producers and State or regional sod associations (15 State or regional sod associations).
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     25.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses per Respondent:</E>
                     (Estimate recertification every 5 years) 0.2.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden on Respondents:</E>
                     (25 organizations and producers × 0.2 responses × 0.5 hours per response) 2.50 hours.
                </P>
                <P>
                    <E T="03">Total Cost:</E>
                     (2.50 hours × $56.18) $140.45.
                </P>
                <HD SOURCE="HD2">(2) LP-4 Nomination for Appointment to the Board (OMB Form No. 0581-0349)</HD>
                <P>
                    <E T="03">Estimate of Burden:</E>
                     Public reporting burden for this collection of information is estimated to average 0.5 hours per response.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Natural grass sod producers.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     20.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses per Respondent:</E>
                     One per year.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden on Respondents:</E>
                     (20 responses × 0.5 hour per response) 10 hours.
                </P>
                <P>
                    <E T="03">Total Cost:</E>
                     (10 hours × $56.18) $561.80.
                </P>
                <HD SOURCE="HD2">(3) LP-6 Quarterly Report and Remittance of Amount Due for Assessment (OMB Form No. 0581-0349)</HD>
                <P>
                    <E T="03">Estimate of Burden:</E>
                     Public reporting burden for this collection of information is estimated to average 0.5 hours per form.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Natural grass sod producers.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     1,447.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses per Respondent:</E>
                     Four per year.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden on Respondents:</E>
                     (1,447 Number of respondents × 4 total number of reports × 0.50 hour per report) 2,894 hours.
                </P>
                <P>
                    <E T="03">Total Cost:</E>
                     (2,894 hours × $56.18) $162,585.
                </P>
                <HD SOURCE="HD2">(4) AMS-15 Organic Exemption (OMB Form No. 0581-0093)</HD>
                <P>
                    <E T="03">Estimate of Burden:</E>
                     Public recordkeeping burden for this collection of information is estimated to average 0.25 hours per exemption form.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Natural grass sod producers.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     10.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses per Respondent:</E>
                     (Annual organic exemption required) 1.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden on Respondents:</E>
                     (10 Number of respondents × 1 total number of reports × 0.25 hours per report) 2.50 hours.
                </P>
                <P>
                    <E T="03">Total Cost:</E>
                     (2.50 hours × $56.18) $140.45.
                </P>
                <HD SOURCE="HD2">(5) AD-755 Background Information Form (OMB Form No. 0505-0001)</HD>
                <P>
                    <E T="03">Estimate of Burden:</E>
                     Public reporting for this collection of information is estimated to average 0.5 hours per response for each natural grass sod producer and public member nominated to serve on the Board.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Natural grass sod producer nominees and public member nominees.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     14.33 (20 for initial nominations to the Board, 12 every year except 14 every third year in subsequent years).
                </P>
                <P>
                    <E T="03">Estimated Number of Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden on Respondents:</E>
                     10 hours for the initial nominations to the Board and 7 hours annually thereafter.
                </P>
                <P>
                    <E T="03">Total Cost:</E>
                     (Number of respondents × responses per respondent × $56.18) $561.80 initial, and $393.26 annually thereafter.
                </P>
                <HD SOURCE="HD2">(6) Requirement To Maintain Records Sufficient To Verify Reports Submitted Under the Order</HD>
                <P>
                    <E T="03">Estimate of Burden:</E>
                     Public recordkeeping burden for keeping this information is estimated to average 2 hours per recordkeeper maintaining such records.
                </P>
                <P>
                    <E T="03">Recordkeepers:</E>
                     Natural grass sod producers.
                </P>
                <P>
                    <E T="03">Estimated Number of Recordkeepers:</E>
                     1,447.
                </P>
                <P>
                    <E T="03">Estimated Total Recordkeeping Hours:</E>
                     (1,447 Number of recordkeepers × 2 hours) 2,894 hours.
                </P>
                <P>
                    <E T="03">Total Cost:</E>
                     (1,447 Number of recordkeepers × 2 hours per recordkeeper × $56.18) $162,585.
                </P>
                <P>As described above, under the proposed Order, natural grass sod producers would be required to pay assessments and file reports and forms with the Board. While the proposed Order would impose certain recordkeeping requirements on natural grass sod producers, information required under the proposed Order could be compiled from records currently maintained. The Order would require such records to be retained for at least 3 years beyond the fiscal year of their applicability.</P>
                <P>The proposed Order's provisions have been carefully reviewed, and every effort has been made to minimize recordkeeping costs and requirements, including by considering information already submitted under other programs administered by USDA and other State programs.</P>
                <P>
                    The proposed forms would require the minimum information necessary to effectively carry out the requirements of the program, and their use is necessary to fulfill the intent of the 1996 Act. Such information can be supplied without data processing equipment or outside technical expertise. In addition, there are no additional training requirements for individuals filling out reports and remitting assessments to the Board. The 
                    <PRTPAGE P="99159"/>
                    forms would be simple, easy to understand, and place as small a burden as possible on the person required to file the information.
                </P>
                <P>Collecting information quarterly would coincide with normal industry business practices. The timing and frequency of collecting information are intended to meet the needs of the industry while minimizing the amount of work necessary to fill out the required reports. The requirement to keep records for 3 years is consistent with normal industry practices. In addition, the information to be included on these forms is not available from other sources because such information relates specifically to individual domestic producers who are subject to the provisions of the 1996 Act. Therefore, there is no practical method for collecting the required information without the use of these forms.</P>
                <HD SOURCE="HD1">Comment Analysis</HD>
                <P>
                    A proposed rule for the Natural Grass Sod Promotion, Research, and Information Order was published in the 
                    <E T="04">Federal Register</E>
                     on October 16, 2023 (88 FR 71306). A notice to trade was announced by AMS and the proposed rule provided a 60-day comment period ending December 15, 2023. A total of 174 comments were received. Of those, 151 comments supported the proposed Order as written, and seven comments supported the proposed Order but suggested some edits. Eight commentors opposed the proposed Order and did not believe there was a need to establish a research, promotion, and education checkoff program. Two comments did not support the proposed Order and provided additional recommendations. Six comments neither supported nor opposed the proposed Order.
                </P>
                <HD SOURCE="HD2">Comments in Full Support</HD>
                <P>The 151 comments that fully supported the proposed Order as written explained that the proposed checkoff program would be vital in funding research to improve the sod varieties that currently exist as well as educating consumers on the benefits of natural grass sod. Other comments agreed, the program could help create a united voice that is representative of their diverse industry members. And some comments held that with the collected funding, the industry could develop educational resources to differentiate natural grass sod from synthetic turf as well as identify environmentally friendly management practices.</P>
                <HD SOURCE="HD2">Comments in Support, With Modifications</HD>
                <P>Seven commentors supported the proposed Order but suggested modifications. Of the seven, five commentors expressed concerns about the amount of funds that could potentially be returned to States under proposed § 1240.38(f). The commentors explained that a 50 percent maximum rate of return to States seemed excessive. Three of the five commentors suggested a lower maximum rate of return such as 25 percent, while the other two commentors suggested the maximum rate of return should not exceed 30 percent.</P>
                <P>Section 1240.38(f) of the proposed Order describes permitted allocations of assessment funds to States. Specifically, this section provides the Board with the ability to allocate “up to” 50 percent of assessments collected on the sale of natural grass sod products in a State or group of States to programs proposed by a qualified organization that represents the State or group of States. The drafters of this provision included natural grass sod producers from throughout the United States. They determined that a 50 percent maximum rate of return for State programs is appropriate because of the significant variations in regional and local markets for sod, and the consequent need for the Order to be flexible enough to offer programs tailored to address those variations in different parts of the country. Therefore, we believe that proposed § 1240.38(f) provides for a reasonable allocation to State programs while maintaining a sufficient level of funding for national programs. Accordingly, these suggestions are not adopted.</P>
                <P>Two comments expressed support for the proposed Order but provided further recommendations on referendum voting procedures and Board representation. One commentor objected to the proposed Order's allocation of one vote to each producer and suggested that votes should be weighted according to the percentage of total assessments the producer would pay under the program. The commentor also suggested that Board seats should be proportionate in representation to what producers would pay into the program. Another commentor suggested that the program should be implemented only if 60 percent of producers voting in the referendum, rather than a simple majority, favor the proposed Order.</P>
                <P>The 1996 Act authorizes the Secretary to conduct an initial referendum among persons to be subject to an assessment to determine whether they favor issuance of a proposed order. Additionally, the Act provides that approval of a proposed order may be determined in a referendum (1) by a majority of those persons voting, (2) by persons voting for approval who represent a majority of the volume of the agricultural commodity, or (3) by a majority of those persons voting for approval who also represent a majority of the volume of the agricultural commodity. TPI conducted outreach sessions to gather early industry approval and determined that the one-producer one-vote method was the most agreed upon approach by the industry. The commentors suggesting an alternative method for assigning votes did not provide data or information to suggest otherwise.</P>
                <P>Additionally, consistent with section 515(b)(2)(D) of the 1996 Act (7 U.S.C. 7414(b)(2)(D)), the composition of the Board is based on the geographical distribution of the quantity of natural grass sod products produced (and sold) in the United States. Furthermore, the proposed Order requires a review of the geographical distribution of the production of sod at least every five years and, if warranted, a reapportionment of Board membership to reflect changes in the geographical distribution of the production of sod. These procedures are mandated by the statute to ensure fair and equitable representation of the natural grass sod industry on the Board.</P>
                <HD SOURCE="HD2">Comments Opposed</HD>
                <P>Seven comments received were opposed to the proposed program for various reasons.</P>
                <P>Some commentors stated that the program would be redundant because the industry already has associations that perform similar roles. To be sure, there are currently voluntary programs dedicated to the promotion and research of natural grass sod products that have achieved impactful results. However, a nationally established research and promotion program would have the capacity to fund existing efforts on a larger scale. For instance, many States sod associations fund research and promotion at levels under $10,000 annually. TPI funds research and promotion through its foundation, The Lawn Institute, at up to $50,000 to $100,000 annually.</P>
                <P>
                    However, these types of funds are raised through voluntary contributions and fundraising efforts such as auctions, raffles, activities, etc., and, while they have successfully been able to impact natural grass research and promotion on a small scale, none of these efforts can achieve the potential $14.9 million of funding that would come through a 
                    <PRTPAGE P="99160"/>
                    natural grass sod checkoff. A natural grass sod checkoff would not only be able to raise significant funds for these efforts, but the checkoff could also respond to changing needs in research and promotion. The proposed natural grass sod checkoff board, like other checkoff boards, would have the flexibility to modify how assessment funds are administered to various research and promotion projects. At the direction of the industry and with USDA approval, they would also be able to modify the program as needed within the guidelines of the Act and the oversight of USDA-AMS. Additionally, an industry-wide vote will be conducted to determine whether the industry is in favor of the program. Accordingly, these suggestions are not adopted.
                </P>
                <P>Other commentors stated that the program would discriminate between the cool season grass states and the warm season grass states due to the frequency of harvest of the warmer states versus the cooler states and the varying size of production between the warmer and cooler states. There is some merit to this position. Generally, warm-season grasses can be laid year-round since they are typically planted in warm regions with few winter freezes, while cool-season grass sod is typically planted only in the fall season. Thus, there is a possibility that warm-season grass sod producers could pay into the checkoff more often if they choose to harvest their sod year-round or longer than the typical season for cool-season grass sod producers.</P>
                <P>
                    However, commodity checkoff programs have been established to “operate as `self-help' mechanisms for producers and processors to fund generic promotions,” 
                    <SU>16</SU>
                    <FTREF/>
                     which allow producers to enjoy the benefit associated with pooling their money together to create economies of scale in their promotional efforts.
                    <SU>17</SU>
                    <FTREF/>
                     The aim of the checkoff is that everyone benefits equally and proportionally, no matter their individual contributions. Accordingly, these suggestions are not adopted.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         7 U.S.C. 7401(b)(8).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         7 U.S.C. 7401(b)(10).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Comments Opposed, With Further Recommendations</HD>
                <P>Two commentors opposed the proposed Order but also offered recommendations for USDA consideration. Both commentors suggested that the referendum is being conducted prematurely given that the last time the industry provided educational sessions on the proposed Order was in May 2020.</P>
                <P>TPI conducted extensive industry engagement, providing educational outreach to local organizations and individual producers, and soliciting input on interest in a national checkoff program, and determined that there was substantial interest in moving forward with a national program. Additionally, the industry hosted a webinar to get feedback from natural grass sod producers regarding their interest in developing a national grass sod checkoff program. On May 19, 2020, U.S. sod producers participated in a 2-hour online seminar to learn more about USDA research and promotion programs. After this webinar, attendees were polled to determine their interest in developing a national checkoff program for the natural grass sod industry and 64 percent stated they were very interested, 20 percent stated they were interested, 13 percent stated they were interested in learning more, and only 3 percent stated they were not interested. Since the industry formally submitted its proposed Order on June 18, 2021, USDA has been conducting various required steps to offer a new research and promotion program for industry consideration. These steps have included the preparation and review of various documents, including those announcing the agency's intent to propose a new program through OMB's regulatory review process, and the drafting and ultimate publication of a proposed rule and proposed referendum procedures on October 16, 2023.</P>
                <P>TPI also submitted industry letters of support that confirmed the industry's desire to pursue a research, promotion, and education sod order to fund research and communicate the benefits of natural grass to the public. Further, if in the future the industry determines that the Order is no longer in its best interests, the Order may be amended through the regulatory process or terminated.</P>
                <P>
                    The commentors also stated that AMS should ensure that every sod producer in the United States is identified and informed about the proposed Order prior to any referendum. Further, the commentors encouraged AMS to conduct a remedial round of public outreach to re-assess industry support for the program following a 3-year period (from May 2020, when a program webinar was held, to December 2023, when AMS published the proposed program in the 
                    <E T="04">Federal Register</E>
                    ) when they claim the proposed Order was not visible or part of regular industry discussions. AMS will use several methods to identify as many eligible natural grass sod producers as possible, to include self-identification from producers and industry input. In addition to the industry outreach that was previously conducted, AMS will conduct its own outreach to ensure that as many eligible natural grass sod producers as possible are informed of the referendum, the referendum schedule, instructions, and any other items related to the potential implementation of the proposed Order.
                </P>
                <P>Additionally, the commentors encouraged USDA to establish a clear schedule and procedures for the referendum. AMS, through public notice on its website, post cards, letters, and through its external networks, will make a referendum schedule, instructions, and other relevant information available to all eligible producers, trade associations and related industry media, which can further disseminate the information.</P>
                <P>The commentors also requested that USDA complete an improved analysis to consider various factors such as the cost to collect, report, and remit assessments, particularly on operations with multiple farms, in multiple States. AMS is aware that each industry is diverse in various ways, such as size, method of production and distribution, business practices, marketing strategies, staff size, and region. The updated regulatory analysis in this proposed rule did not factor every unique method of collecting assessments but rather focused on the number of farms reported and square foot of sod sold nationwide according to the 2022 U.S. Census. Furthermore, the commentors did not include any information or data to show that USDA's analysis of the impact of assessments on sod producers under the proposed program is inaccurate. Conducting the upfront referendum will provide eligible sod producers the ability to submit a vote and determine if the sod industry favors the establishment of the checkoff program.</P>
                <P>The commentors also opposed the apportionment of Board members among the regions in proposed § 1240.30(b) and argued that the South Region should be assigned more members. They stated that, according to Table 1, the South Region represents 63.7 percent of total U.S. sales. They therefore argued that the South Region should be allocated 6 members instead of 4 members out of the 10 total producer members on the Board.</P>
                <P>
                    As an initial matter, we note that the commentors' calculation appears to be inaccurate. In addition, the version of Table 1 that appeared in the first proposed rule (88 FR 71306) reflected numbers reported in the 2017 Census. In this second proposed rule, Table 1 has been updated to reflect the most recent 
                    <PRTPAGE P="99161"/>
                    numbers reported in the 2022 Census. The updated 2022 Census data indicates that the South Region accounts for approximately 49 percent of sod sales and 52 percent of the volume of sod produced in the United States.
                </P>
                <P>Section 515(b)(2)(D) of the 1996 Act (7 U.S.C. 7414(b)(2)(D)) states that “[t]o ensure fair and equitable representation of the agricultural commodity industry covered by an order, the composition of each board shall reflect the geographical distribution of the production of the agricultural commodity involved in the United States.” Thus, AMS recognizes that the 2022 Census data could be cited to support re-assigning one Board member from the North Region to the South Region.</P>
                <P>AMS agrees that commodity sales and production data are important to consider in determining the composition of the Board. However, AMS also recognizes that other factors are relevant to ensure “fair and equitable representation” of natural grass sod producers on the Board, including factors such as the number and size of sod farms in a State or region, as well as the types of natural grass sod produced in the State or region.</P>
                <P>AMS examined other options for allocating Board seats among the regions. However, when all the relevant data is considered (number of farms, size of farms, types of natural grass sod grown, production data, and sales data), AMS believes that the proposed composition of the Board, which allocates 3 members to the North Region, 4 members to the South Region, and 3 members to the Transition Zone Region, should remain unchanged.</P>
                <P>The proposed 3-4-3 Board structure allows each producer member on the Board to represent approximately the same number of farms in their assigned region. If the Board composition is modified to re-assign one member from the North Region to the South Region, resulting in a 2-5-3 Board structure, the two remaining members from the North Region would be asked to represent almost twice as many farms as the Board members from the South Region. As a result, this structure would not allow for equal representation of Board members per number of farms in each region.</P>
                <P>
                    Additionally, sod producers in the Transition Zone Region grow both warm and cool season grasses. However, most farmers in these States, especially in Arkansas, California, North Carolina, Oklahoma, and Tennessee, exist in USDA Plant Hardiness Zones 8a-b and grow predominately warm-season grasses.
                    <SU>18</SU>
                    <FTREF/>
                     As a result, they would likely make Board decisions similar to those that would be made by sod producers from the South Region. AMS policy is that the diversity of the Board should reflect the diversity of the industry in terms of the experience of members, methods of production and distribution, marketing strategies, and other distinguishing factors that will bring different perspectives and ideas to the Board's attention. In addition, AMS policy is that both larger and smaller production States should contribute to Board decision making about how resources are used for research and promotion programs.
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         USDA, 2023 USDA Plant Hardiness Zone Map, 
                        <E T="03">https://planthardiness.ars.usda.gov.</E>
                    </P>
                </FTNT>
                <P>Furthermore, proposed § 1240.30(b)(4) includes a provision that would ensure each of the three highest production States have at least one producer member on the Board in their respective region. Finally, proposed § 1240.30(c) includes a measure to adjust seats every three to five years based on changes in production, and the Board is authorized to recommend changes to the Order—which could include the way that seats are allocated—should they determine a need in the future. Therefore, the proposed composition of the Board will remain unchanged.</P>
                <P>The commentors also argued that proposed § 1240.38(f) does not ensure enough money is funneled back to State programs, as that section permits a maximum of 50 percent to go back to States but does not include a minimum amount that must be allocated to State programs. The commentors pointed out that this would allow a 0 percent return to States and suggested that there should be a minimum allocation to States. The provision for allocating funds to State programs is not intended to be a funding mechanism for State checkoff boards but, rather, a method to fund research and promotion initiatives specific to State markets that might otherwise be addressed insufficiently by national research and promotion initiatives. In addition to the State funding allocation under proposed § 1240.38(f), qualified State programs could apply for and receive additional funding from the Board on a project-by-project basis. We believe that the provision provides for a reasonable allocation for State generic programs while maintaining an appropriate level of funding for the national program.</P>
                <P>The two commentors also objected to the rule in proposed § 1240.71 allocating only one vote per producer. One commentor stated that votes from larger producers should count more, and the other commentor stated that the proposed Order should be approved only if favored by either a majority of all producers in the United States or by a majority of all sod-producing acres in the United States.</P>
                <P>Section 518(e) of the 1996 Act (7 U.S.C. 7417(e)) provides for three options by which a proposed order may provide for its approval in a referendum: (1) by a majority of those persons voting, (2) by persons voting for approval who represent a majority of the volume of the agricultural commodity, or (3) by a majority of those persons voting for approval who also represent a majority of the volume of the agricultural commodity. Assigning one vote to each producer, regardless of size, ensures that small businesses as well as large firms have a voice in the referendum. Furthermore, as noted above, this method, combined with a voting procedure in which a majority of those persons voting in a referendum determines approval of an order, is authorized by statute. Accordingly, the proposed Order will be approved in the referendum if it is favored by a simple majority (50 percent + one vote) of the natural grass sod producers voting that have been engaged in the production and sale of natural grass sod products in the United States during a representative period determined by the Secretary.</P>
                <P>Lastly, the commentors argued that AMS's analysis of local sod markets is insufficient, and they asserted that a national sod program would not benefit sod producers because their local markets are so different from each other. AMS reviewed the industry analysis and justification and determined that it was an accurate depiction of the sod industry and local sod markets. Additionally, AMS received 151 comments that fully supported the proposed Order as written. These comments explained that the proposed checkoff program would be vital in funding research to improve the sod varieties that currently exist as well as educating consumers on the benefits of natural grass sod. The program could help create a united voice that is representative of their diverse industry members. With the collected funding the industry could develop educational resources to differentiate natural grass sod from synthetic turf as well as identify environmentally friendly management practices.</P>
                <P>Accordingly, these suggestions are not adopted.</P>
                <HD SOURCE="HD2">Neither Agree or Disagree</HD>
                <P>
                    Six comments received neither supported nor opposed the proposed 
                    <PRTPAGE P="99162"/>
                    Order. Most of these comments included questions about the benefits of natural grass sod and how certain regions could restore native plants that do not require irrigation.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 7 CFR Part 1240</HD>
                    <P>Administrative practice and procedure, Advertising, Consumer information, Marketing agreements, Natural grass sod, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <P>For the reasons discussed in the preamble, AMS proposes to add subpart A to 7 CFR part 1240 to read as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 1240—NATURAL GRASS SOD PROMOTION, RESEARCH, AND INFORMATION ORDER</HD>
                    <CONTENTS>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart A—Natural Grass Sod Promotion, Research, and Information Order</HD>
                            <SECHD>Sec.</SECHD>
                            <SECTNO>1240.10 </SECTNO>
                            <SUBJECT>General.</SUBJECT>
                            <SECTNO>1240.20 </SECTNO>
                            <SUBJECT>Definitions.</SUBJECT>
                            <HD SOURCE="HD1">Natural Grass Sod Promotion, Research, and Information Board</HD>
                            <SECTNO>1240.30 </SECTNO>
                            <SUBJECT>Establishment and membership.</SUBJECT>
                            <SECTNO>1240.31 </SECTNO>
                            <SUBJECT>Nominations and appointments.</SUBJECT>
                            <SECTNO>1240.32 </SECTNO>
                            <SUBJECT>Nominee's agreement to serve.</SUBJECT>
                            <SECTNO>1240.33 </SECTNO>
                            <SUBJECT>Term of office.</SUBJECT>
                            <SECTNO>1240.34 </SECTNO>
                            <SUBJECT>Removal.</SUBJECT>
                            <SECTNO>1240.35 </SECTNO>
                            <SUBJECT>Vacancies.</SUBJECT>
                            <SECTNO>1240.36 </SECTNO>
                            <SUBJECT>Procedure.</SUBJECT>
                            <SECTNO>1240.37 </SECTNO>
                            <SUBJECT>Reimbursement and attendance.</SUBJECT>
                            <SECTNO>1240.38 </SECTNO>
                            <SUBJECT>Powers and duties.</SUBJECT>
                            <SECTNO>1240.39 </SECTNO>
                            <SUBJECT>Prohibited activities.</SUBJECT>
                            <HD SOURCE="HD1">Expenses and Assessments</HD>
                            <SECTNO>1240.45 </SECTNO>
                            <SUBJECT>Budget and expenses.</SUBJECT>
                            <SECTNO>1240.46 </SECTNO>
                            <SUBJECT>Financial statements.</SUBJECT>
                            <SECTNO>1240.47 </SECTNO>
                            <SUBJECT>Assessments.</SUBJECT>
                            <SECTNO>1240.48 </SECTNO>
                            <SUBJECT>Exemptions from assessments</SUBJECT>
                            <HD SOURCE="HD1">Promotion, Research, and Information</HD>
                            <SECTNO>1240.50 </SECTNO>
                            <SUBJECT>Programs.</SUBJECT>
                            <SECTNO>1240.51 </SECTNO>
                            <SUBJECT>Independent evaluation.</SUBJECT>
                            <SECTNO>1240.52 </SECTNO>
                            <SUBJECT>Patents, copyrights, trademarks, inventions, product formulations, and publications.</SUBJECT>
                            <HD SOURCE="HD1">Reports, Books, and Records</HD>
                            <SECTNO>1240.60 </SECTNO>
                            <SUBJECT>Reports.</SUBJECT>
                            <SECTNO>1240.61 </SECTNO>
                            <SUBJECT>Books and records.</SUBJECT>
                            <SECTNO>1240.62 </SECTNO>
                            <SUBJECT>Confidential treatment.</SUBJECT>
                            <SECTNO>1240.63 </SECTNO>
                            <SUBJECT>Qualification of natural grass sod organizations.</SUBJECT>
                            <HD SOURCE="HD1">Miscellaneous</HD>
                            <SECTNO>1240.70 </SECTNO>
                            <SUBJECT>Right of the Secretary.</SUBJECT>
                            <SECTNO>1240.71 </SECTNO>
                            <SUBJECT>Referenda.</SUBJECT>
                            <SECTNO>1240.72 </SECTNO>
                            <SUBJECT>Suspension or termination.</SUBJECT>
                            <SECTNO>1240.73 </SECTNO>
                            <SUBJECT>Proceedings after termination.</SUBJECT>
                            <SECTNO>1240.74 </SECTNO>
                            <SUBJECT>Effect of termination or amendment.</SUBJECT>
                            <SECTNO>1240.75 </SECTNO>
                            <SUBJECT>Personal liability.</SUBJECT>
                            <SECTNO>1240.76 </SECTNO>
                            <SUBJECT>Severability.</SUBJECT>
                            <SECTNO>1240.77 </SECTNO>
                            <SUBJECT>Amendments.</SUBJECT>
                            <SECTNO>1240.78 </SECTNO>
                            <SUBJECT>OMB control number.</SUBJECT>
                        </SUBPART>
                    </CONTENTS>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>7 U.S.C. 7411-7425; 7 U.S.C. 7401.</P>
                    </AUTH>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart A—Natural Grass Sod Promotion, Research, and Information Order</HD>
                        <SECTION>
                            <SECTNO>§ 1240.10 </SECTNO>
                            <SUBJECT> General.</SUBJECT>
                            <P>The terms defined/specified in this subpart shall apply to the Natural Grass Sod Promotion, Research, and Information Order authorized under the Act.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.20 </SECTNO>
                            <SUBJECT>Definitions.</SUBJECT>
                            <P>
                                <E T="03">Act</E>
                                 means the Commodity Promotion, Research, and Information Act of 1996 (7 U.S.C. 7411-7425), and any amendments thereto.
                            </P>
                            <P>
                                <E T="03">Board</E>
                                 means the Natural Grass Sod Promotion, Research, and Information Board established pursuant to § 1240.30, or such other name as recommended by the Board and approved by USDA.
                            </P>
                            <P>
                                <E T="03">Conflict of interest</E>
                                 means a situation in which a member or employee of the Board has a direct or indirect financial interest in a person who performs a service for, or enters into a contract with, the Board for anything of economic value.
                            </P>
                            <P>
                                <E T="03">Department or USDA</E>
                                 means the U.S. Department of Agriculture, or any officer or employee of the Department to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in the Secretary's stead.
                            </P>
                            <P>
                                <E T="03">Eligible natural grass sod producer</E>
                                 refers to a natural grass sod producer that has sold natural grass sod products in the United States during the representative period and is eligible to vote in the initial referendum or subsequent referenda.
                            </P>
                            <P>
                                <E T="03">Fiscal year and marketing year</E>
                                 means the 12-month period ending on December 31 or such other period as recommended by the Board and approved by the Secretary.
                            </P>
                            <P>
                                <E T="03">Information</E>
                                 means information and programs for consumers, customers, architects, city planners, and various industry participants and trades personnel, including educational activities, information, and programs designed to enhance and broaden the understanding of the use and attributes of natural grass, increase efficiency in producing natural grass sod products, maintain and expand existing markets, and develop new markets and marketing strategies. These include:
                            </P>
                            <P>(1) Consumer education and information, which means any action taken to provide information to, and broaden the understanding of, the general public regarding natural grass sod; and</P>
                            <P>(2) Industry information, which means information and programs that would enhance the image of the natural grass sod industry.</P>
                            <P>
                                <E T="03">Initial referendum</E>
                                 refers to the referendum required to approve this subpart as outlined in § 1240.71.
                            </P>
                            <P>
                                <E T="03">Natural grass sod</E>
                                 refers to plant species in the Poaceae family or living plants in other taxa serving a similar purpose, as often found in sites such as lawns, sports fields, golf courses, parks, cemeteries, roadsides and others.
                            </P>
                            <P>
                                <E T="03">Natural grass sod producer</E>
                                 means any person who produces natural grass sod products in the United States.
                            </P>
                            <P>
                                <E T="03">Natural grass sod product</E>
                                 refers to natural grass produced for retail, wholesale, or commercial sale, including monostands or blends or mixtures of Bentgrass, Bermudagrass, Buffalograss, Centipedegrass, Fine fescue, Kentucky bluegrass, Ryegrass, Seashore Paspalum, Saint Augustinegrass, Tall fescue, Zoysiagrass, Bahiagrass, other native or adapted plants harvested and sold as sod, and products containing natural grass with artificial elements that are sold as sod. For purposes of this Order, natural grass sod product excludes all artificial and synthetic turf or grass products, natural grass seed, sprigs, and plugs.
                            </P>
                            <P>
                                <E T="03">Order</E>
                                 means an order issued by the Secretary under section 514 of the Act (7 U.S.C. 7413) that provides for a program of generic promotion, research, and information regarding agricultural commodities authorized under the Act.
                            </P>
                            <P>
                                <E T="03">Part</E>
                                 means the Natural Grass Sod Promotion, Research, and Information Order and all rules, regulations, and supplemental orders issued pursuant to the Act and the Order. The Order shall be a subpart of such part.
                            </P>
                            <P>
                                <E T="03">Person</E>
                                 means any individual, group of individuals, partnership, corporation, association, cooperative, or any other legal entity.
                            </P>
                            <P>
                                <E T="03">Produce</E>
                                 means the process of growing and/or harvesting natural grass sod products for the purpose of selling such products either individually or in combination with other products, real property, or services in the United States.
                            </P>
                            <P>
                                <E T="03">Programs</E>
                                 means those generic research, promotion, and information programs, plans, or projects established pursuant to the Order.
                            </P>
                            <P>
                                <E T="03">Promotion</E>
                                 means any action, including paid advertising and the dissemination of information, utilizing public relations or other means, to enhance and broaden the understanding of the use and attributes of natural grass for the purpose of maintaining and expanding markets for natural grass sod products.
                                <PRTPAGE P="99163"/>
                            </P>
                            <P>
                                <E T="03">Qualified organization</E>
                                 means any organization that has the primary purpose of representing natural grass sod producers, has natural grass sod producers as members, has a board of directors composed of a majority of natural grass sod producers, and is approved by the Secretary pursuant to the qualification process set forth in § 1240.63.
                            </P>
                            <P>
                                <E T="03">Quarterly period</E>
                                 means one of the four 3-month periods that are based upon a calendar year cycle (
                                <E T="03">i.e.,</E>
                                 January 1-March 31, April 1-June 30, July 1-September 30, and October 1-December 31).
                            </P>
                            <P>
                                <E T="03">Representative period</E>
                                 means the time period designated by the Secretary pursuant to section 518 of the Act (7 U.S.C. 7417).
                            </P>
                            <P>
                                <E T="03">Research</E>
                                 means any type of test, study, or analysis designed to enhance the image, desirability, use, marketability, production, environmental quality, or sustainability of natural grass, including research directed to product characteristics and product development like new products or improved technology in the production of natural grass sod products.
                            </P>
                            <P>
                                <E T="03">Secretary</E>
                                 means the Secretary of Agriculture of the United States, or any other officer or employee of the Department to whom authority has been delegated, or to whom authority may hereafter be delegated, to act in the Secretary's stead.
                            </P>
                            <P>
                                <E T="03">State</E>
                                 means any of the 50 States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, or any territory or possession of the United States.
                            </P>
                            <P>
                                <E T="03">Subsequent referenda</E>
                                 refers to any referendum conducted pursuant to § 1240.71 of this subpart after this subpart becomes effective.
                            </P>
                            <P>
                                <E T="03">Suspend</E>
                                 means to issue a rule under 5 U.S.C. 553 to temporarily prevent the operation of an order or part thereof during a particular period of time specified in the rule.
                            </P>
                            <P>
                                <E T="03">Terminate</E>
                                 means to issue a rule under 5 U.S.C. 553 to cancel permanently the operation of an order or part thereof beginning on a date specified in the rule.
                            </P>
                            <P>
                                <E T="03">United States</E>
                                 means collectively the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, and the territories and possessions of the United States.
                            </P>
                            <HD SOURCE="HD1">Natural Grass Sod Promotion, Research, and Information Board</HD>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.30</SECTNO>
                            <SUBJECT> Establishment and membership.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Establishment of the Board.</E>
                                 There is hereby established a Natural Grass Sod Promotion, Research, and Information Board to administer the terms and provisions of this part. The Board shall be composed of natural grass sod producers that sell natural grass sod products in the United States during a marketing year and a public member. Seats on the Board shall be apportioned as set forth in paragraph (b) of this section based on the geographical distribution of the production of natural grass sod products in the United States.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Composition of the Board.</E>
                                 The Board shall be composed of 11 members, including 10 members who are natural grass sod producers and one public member. The Board shall be established as follows:
                            </P>
                            <P>
                                (1) 
                                <E T="03">North/Cool-Season Region.</E>
                                 Three members shall be appointed from the North/Cool-Season Region, which includes the following States: Alaska, Colorado, Connecticut, Delaware, Idaho, Illinois, Indiana, Iowa, Maine, Massachusetts, Michigan, Minnesota, Montana, Nebraska, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Utah, Vermont, Washington, Wisconsin, and Wyoming.
                            </P>
                            <P>
                                (2) 
                                <E T="03">South/Warm-Season Region.</E>
                                 Four members shall be appointed from the South/Warm-Season Region, which includes the following States: Alabama, Arizona, Florida, Georgia, Hawaii, Louisiana, Mississippi, Nevada, New Mexico, South Carolina, Texas, and all territories and possessions of the United States, including but not limited to, the Commonwealth of Puerto Rico.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Transition Zone/California Region.</E>
                                 Three members shall be appointed from the Transition Zone/California Region, which includes the following States: Arkansas, California, the District of Columbia, Kansas, Kentucky, Maryland, Missouri, North Carolina, Oklahoma, Tennessee, Virginia, and West Virginia.
                            </P>
                            <P>
                                (4) 
                                <E T="03">States with the highest volume of natural grass sod production.</E>
                                 Each of the three States with the highest volume of natural grass sod production, as determined by the Secretary on an annual basis, shall have at least one natural grass sod producer to serve as a representative on the Board in their respective region.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Public member.</E>
                                 The Board shall have one public member. The public member may not be a natural grass sod producer or have a financial interest in the production, sales, marketing, or distribution of natural grass sod.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Reapportionment.</E>
                                 At least once in every 5-year period, but not more frequently than once in every 3-year period, the Board will review the geographical distribution of the square footage of natural grass sod products produced within the United States. The review will be conducted using the Board's annual assessment receipts, industry data provided by USDA, and, if available, other reliable reports from the industry. If warranted, the Board will recommend to the Secretary that the membership, geographical regions, and/or size of the Board be adjusted to reflect changes in geographical distribution of the square footage of natural grass sod products produced in the United States. Any changes in Board composition shall be implemented by the Secretary through rulemaking.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.31 </SECTNO>
                            <SUBJECT>Nominations and appointments.</SUBJECT>
                            <P>(a) Initial nominations shall be submitted to the Secretary by industry organizations that have a board composed of a majority of natural grass sod producers; by individual natural grass sod producers; and from members of the public. The Secretary shall select the initial members of the Board from the nominations submitted.</P>
                            <P>(b) Subsequent nominations shall be conducted as follows:</P>
                            <P>(1) The Board shall conduct outreach to all known natural grass sod producers that sell natural grass sod products in a marketing year as well as any known industry organizations that have a board composed of a majority of natural grass sod producers. Natural grass sod producers and industry organizations may submit nominations to the Board;</P>
                            <P>(2) Natural grass sod producer nominees and the public member nominee may provide the Board a short background statement outlining their qualifications to serve on the Board;</P>
                            <P>(3) Nominees may seek nomination to the Board for all open or vacant seats for which they are qualified;</P>
                            <P>(4) Natural grass sod producers must produce and sell natural grass sod products in the region for which they seek nomination. Nominees that produce and sell in multiple regions may seek nomination in one region of their choice. The Board will issue the call for nominations to all known natural grass sod producers and to any known industry organizations that have a board composed of a majority of natural grass sod producers and recommend nominees for each open seat and the additional nominees to the Secretary;</P>
                            <P>
                                (5) The public member may be nominated by a qualified organization or through self-nomination to the Board. The public member shall have no direct financial interest in the commercial production or marketing of natural grass sod except as a consumer and shall not be a director, stockholder, officer, or 
                                <PRTPAGE P="99164"/>
                                employee of any person engaged in the production or sale of natural grass sod.
                            </P>
                            <P>(6) The Board may prescribe such additional qualifications, administrative rules and procedures for selection and voting for each candidate as it deems necessary, and the Secretary approves.</P>
                            <P>(7) The Board will evaluate all the nominees and recommend at least two names for each open seat. Other qualified persons interested in serving in the open seats, but not recommended by the Board, will be designated by the Board as additional nominees for consideration by the Secretary;</P>
                            <P>(8) The Board must submit nominations to the Secretary at least 90 days before the new Board term begins. From the nominations submitted by the Board, the Secretary shall select the members of the Board. If the Board fails to submit nominations for the public member position, the Secretary may appoint such member;</P>
                            <P>(9) Any natural grass sod producer and public member nominated to serve on the Board shall file with the Secretary at the time of the nomination a background questionnaire;</P>
                            <P>(10) From the nominations made pursuant to this section, the Secretary shall appoint members of the Board on the basis of representation provided in § 1240.30(b);</P>
                            <P>(11) No two Board members shall be employed by a single corporation, company, partnership, or any other legal entity that pays assessments under this subpart; and,</P>
                            <P>(12) The Board may recommend to the Secretary modifications to its nomination procedures as it deems appropriate. Any such modification shall be implemented through rulemaking by the Secretary.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.32 </SECTNO>
                            <SUBJECT>Nominee's agreement to serve.</SUBJECT>
                            <P>Any producer or person nominated to serve on the Board shall file with the Secretary at the time of the nomination a written agreement to:</P>
                            <P>(a) Serve on the Board if appointed;</P>
                            <P>(b) Disclose any relationship with any national grass sod producer or with any organization that has or is being considered for a contractual relationship with the Board; and</P>
                            <P>(c) Withdraw from participation in deliberations, decision-making, or voting on matters that concern the relationship disclosed.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.33</SECTNO>
                            <SUBJECT>Term of office.</SUBJECT>
                            <P>(a) With the exception of the initial Board, each Board member shall serve for a term of 3 years or until the Secretary selects his or her successor. Each term of office shall begin and end on dates determined by the Board. No member may serve more than two consecutive terms, except as provided in paragraph (c) of this section.</P>
                            <P>(b) For the initial Board, the terms of the Board members shall be staggered for 1, 2, and 3 years. Each region initially shall have one member who serves a 2-year term and two members who serve 3-year terms. In addition, the South/Warm-Season Region shall have one member who serves a 1-year term. The Secretary shall determine which of the initial members shall serve a term of 1, 2, or 3 years. The public member shall serve an initial 3-year term.</P>
                            <P>(c) Members serving terms of 1 or 2 years on the initial Board and members who are appointed to serve the remainder of a term are eligible to serve two additional consecutive 3-year terms.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.34</SECTNO>
                            <SUBJECT>Removal.</SUBJECT>
                            <P>The Board may recommend to the Secretary that a member be removed from office if the member consistently fails or refuses to perform his or her duties properly or engages in dishonest acts or willful misconduct, which removal is subject to the Secretary's approval. If the Secretary determines that a member consistently fails or refuses to perform his or her duties properly or engages in acts of dishonesty or willful misconduct, the Secretary shall remove the person from office. A member may also be removed by the Secretary if the Secretary determines that the person's continued service would be detrimental to the purposes of the Act.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.35</SECTNO>
                            <SUBJECT>Vacancies.</SUBJECT>
                            <P>(a) If a member is removed from office or resigns, or in the event of death of any member, such position shall automatically become vacant.</P>
                            <P>(b) If a member becomes disqualified for ceasing to produce natural grass sod products or ceasing to do business in the region he or she represents, such position shall be vacated within a period of 6 months from the date of the disqualifying event.</P>
                            <P>(c) If a position becomes vacant, nominations to fill the vacancy will be conducted using the nominations process set forth in this subpart or the Board may recommend to the Secretary that he or she appoint a successor from the most recent list of nominations for the position.</P>
                            <P>(d) A vacancy will not be required to be filled if the unexpired term is less than 6 months.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.36</SECTNO>
                            <SUBJECT>Procedure.</SUBJECT>
                            <P>(a) The Board shall publicly announce all scheduled Board meetings through a direct communication, press release, or other means and give the Secretary the same notice of meetings of the Board (including committees, subcommittees, and the like) as is given to members so that the Secretary's representative(s) may attend such meetings.</P>
                            <P>(b) A majority (50 percent plus one) of the Board members shall constitute a quorum at any meeting of the Board.</P>
                            <P>(c) Each member of the Board shall be entitled to one vote on any matter put to the Board and the motion will carry if supported by a majority (50 percent plus one vote) of Board members, except for recommendations to change the assessment rate, adopt a budget, or call for a referendum, which require affirmation by two-thirds of the total number of Board members.</P>
                            <P>(d) At an assembled meeting, all votes shall be cast in person. At a meeting in which some or all members attend via an internet service, videoconference, or teleconference, members may cast votes remotely by using available technology according to procedures that shall be established by the Board.</P>
                            <P>(e) In lieu of voting at an assembled meeting and, when in the opinion of the chairperson of the Board such action is considered necessary, the Board may take action if supported by a majority of members (unless two-thirds is required under the Order) by mail, telephone, electronic mail, facsimile, or any other means of communication. In that event, all members must be notified and provided the opportunity to vote. Any action so taken shall have the same force and effect as though such action had been taken at an assembled meeting. All votes shall be recorded in Board minutes.</P>
                            <P>(f) There shall be no proxy voting.</P>
                            <P>(g) The organization of the Board and the procedures for conducting meetings of the Board shall be in accordance with its bylaws, which shall be established by the Board and approved by the Secretary.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.37</SECTNO>
                            <SUBJECT>Reimbursement and attendance.</SUBJECT>
                            <P>Board members shall serve without compensation, but shall be reimbursed for reasonable travel expenses, as approved by the Board, which they incur when performing Board business.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.38</SECTNO>
                            <SUBJECT>Powers and duties.</SUBJECT>
                            <P>The Board shall have the following powers and duties:</P>
                            <P>(a) To administer this subpart in accordance with its terms and conditions and to collect assessments;</P>
                            <P>
                                (b) To develop and recommend to the Secretary for approval such bylaws as may be necessary for the functioning of the Board, and such rules and regulations as may be necessary to 
                                <PRTPAGE P="99165"/>
                                administer the Order, including activities authorized to be carried out under the Order;
                            </P>
                            <P>(c) To meet not less than annually, organize, and select from among the members of the Board a chairperson, vice chairperson, secretary/treasurer, other officers, and committees and subcommittees, as the Board determines to be appropriate. The committees and subcommittees may include persons other than Board members, including representatives of natural grass sod producers, as the Board deems necessary and appropriate, provided Board members constitute a majority of all committees and subcommittees;</P>
                            <P>(d) To employ or contract with persons, other than the Board members, as the Board considers necessary to assist the Board in carrying out its duties, and to determine the compensation and specify the duties of the persons;</P>
                            <P>(e) To develop and submit programs to the Secretary for the Secretary's approval and enter into contracts or agreements related to such programs, which must be approved by the Secretary before becoming effective, for the development and carrying out of programs of promotion, research, and information. The payment of costs for such activities shall be from funds collected pursuant to the Order. Each contract or agreement shall provide that:</P>
                            <P>(1) The contractor or agreeing party shall develop and submit to the Board a program together with a budget or budgets that shall show the estimated cost to be incurred for such program;</P>
                            <P>(2) The contractor or agreeing party shall keep accurate records of all its transactions and make periodic reports to the Board of activities conducted, submit accounting for funds received and expended, and make such other reports as the Secretary or the Board may require;</P>
                            <P>(3) The Secretary may audit the records of the contracting or agreeing party periodically; and</P>
                            <P>(4) Any subcontractor who enters into a contract with a Board contractor and who receives or otherwise uses funds allocated by the Board shall be subject to the same provisions as the contractor; and</P>
                            <P>(5) Any other provisions required by the Secretary.</P>
                            <P>(f) To allocate, to the extent practicable, up to 50 percent of the assessments collected on the sale of natural grass sod products in a State or group of States, as defined in § 1240.20, less administrative costs, to one or more programs proposed by a qualified organization representing such State or group of States. On an annual basis, the Board shall solicit proposals for programs, select the programs that shall receive funding, and enter into contracts only with the entities that will directly implement the programs. If the qualified organization is not the entity that will implement the program, the Board may reimburse the qualified organization for reasonable administrative costs incurred while making such proposal. For purposes of this section, the Secretary shall have the authority to approve an organization that the Board nominates to be a “qualified organization” pursuant to the qualification process set forth in § 1240.63;</P>
                            <P>(g) To prepare and submit for the approval of the Secretary fiscal year budgets in accordance with § 1240.45;</P>
                            <P>(h) To borrow funds necessary for startup expenses or other capital outlays of the Board as set forth in this subpart;</P>
                            <P>(i) To invest assessments collected and other funds received pursuant to this subpart and use earnings from invested assessments to pay for activities carried out pursuant to this subpart;</P>
                            <P>(j) To recommend changes to the assessment rates as provided in this subpart;</P>
                            <P>(k) To cause its books to be audited by an independent auditor at the end of each fiscal year and at such other times as the Secretary may request, and to submit a report of the audit directly to the Secretary;</P>
                            <P>(l) To periodically prepare and make public reports of program activities and, at least once each fiscal year, to make public an accounting of funds received and expended;</P>
                            <P>(m) To maintain such minutes, books and records, and prepare and submit such reports and records from time-to-time to the Secretary as the Secretary may prescribe; to make appropriate accounting with respect to the receipt and disbursement of all funds entrusted to it; and to keep records that accurately reflect the actions and transactions of the Board;</P>
                            <P>(n) To act as an intermediary between the Secretary and any natural grass sod producer;</P>
                            <P>(o) To receive, investigate, and report to the Secretary complaints of violations of this subpart;</P>
                            <P>(p) To recommend to the Secretary such amendments to this subpart as the Board considers appropriate; and</P>
                            <P>(q) To work to achieve an effective, continuous, and coordinated program of promotion, research, and information and to carry out programs designed to provide maximum benefits to the natural grass sod industry.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.39</SECTNO>
                            <SUBJECT>Prohibited activities.</SUBJECT>
                            <P>The Board may not engage in, and shall prohibit the employees and agents of the Board from engaging in:</P>
                            <P>(a) Any action that would be a conflict of interest;</P>
                            <P>(b) Using funds collected by the Board under the Order to undertake any action for the purpose of influencing legislation or governmental action or policy, by local, State, national, and foreign governments or subdivision thereof, other than recommending to the Secretary amendments to this subpart; and</P>
                            <P>(c) Any program or advertising that is false, misleading, or disparaging to another agricultural commodity. Natural grass sod products of all geographic origins shall be treated equally.</P>
                            <HD SOURCE="HD1">Expenses and Assessments</HD>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.45</SECTNO>
                            <SUBJECT>Budget and expenses.</SUBJECT>
                            <P>(a) At least 60 calendar days prior to the beginning of each fiscal year, and as may be necessary thereafter, the Board shall prepare and submit to the Department a budget for the fiscal year covering its anticipated expenses and disbursements in administering this part. The budget for the Board may not be implemented prior to approval by the Secretary. Each such budget shall include:</P>
                            <P>(1) A statement of objectives and strategy for each program;</P>
                            <P>(2) A summary of anticipated revenue, with comparative data for at least one preceding fiscal year, except for the initial budget;</P>
                            <P>(3) A summary of proposed expenditures for each program; and</P>
                            <P>(4) Staff and administrative expense breakdowns, with comparative data for at least one preceding fiscal year, except for the initial budget.</P>
                            <P>(b) Each budget shall provide adequate funds to defray its proposed expenditures and to provide for a reserve as set forth in this subpart.</P>
                            <P>(c) Subject to this section, any amendment or addition to an approved budget must be approved by the Department. Shifts of funds that do not result in an increase in the Board's approved budget and are consistent with governing bylaws need not have prior approval by the Department.</P>
                            <P>
                                (d) The Board is authorized to incur such expenses, including provision for a reserve, as the Secretary finds reasonable and likely to be incurred by the Board for its maintenance and functioning, and to enable it to exercise its powers and perform its duties in accordance with the provisions of this subpart. Such expenses shall be paid from funds received by the Board.
                                <PRTPAGE P="99166"/>
                            </P>
                            <P>(e) With approval from the Department, the Board may borrow funds necessary for startup expenses or other capital outlays of the Board as set forth in the subpart, which funds shall be subject to the same fiscal, budget, and audit controls as other funds of the Board.</P>
                            <P>(f) The Board may accept voluntary contributions. Such contributions shall be free from any encumbrance by the donor and the Board shall retain complete control of their use. The Board may receive funds from outside sources with approval of the Secretary for specific authorized projects.</P>
                            <P>(g) The Board shall reimburse the Secretary for all expenses incurred by the Secretary in the implementation, administration, enforcement, and supervision of this subpart, including all referendum costs in connection with this subpart.</P>
                            <P>(h) For fiscal years beginning 3 years after the date of the establishment of the Board, the Board may not expend for administration, maintenance, and the functioning of the Board an amount that is greater than 15 percent of the assessment and other income received by and available to the Board for the fiscal year. For purposes of this limitation, reimbursements to the Secretary, and other Board expenses outlined in guidance provided by the Secretary, shall not be considered administrative costs.</P>
                            <P>(i) The Board may establish an operating monetary reserve and may carry over to subsequent fiscal years excess funds in any reserve so established; provided that, the funds in the reserve do not exceed two fiscal years' budget of expenses. Subject to approval by the Secretary, such reserve funds may be used to defray any expenses authorized under this subpart.</P>
                            <P>(j) Pending disbursement of assessments and all other revenue under a budget approved by the Secretary, the Board may invest assessments, and all other revenues collected under this subpart in:</P>
                            <P>(1) Obligations of the United States or any agency of the United States;</P>
                            <P>(2) General obligations of any State or any political subdivision of a State;</P>
                            <P>(3) Interest bearing accounts or certificates of deposit of financial institutions that are members of the Federal Reserve System;</P>
                            <P>(4) Obligations fully guaranteed as to principal and interest by the United States; or</P>
                            <P>(5) Other investments as authorized by the Secretary.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.46</SECTNO>
                            <SUBJECT>Financial statements.</SUBJECT>
                            <P>(a) The Board shall prepare and submit financial statements to the Department on a quarterly basis, or at any other time as requested by the Secretary. Each such financial statement shall include, but not be limited to, a balance sheet, income statement, and expense budget. The expense budget shall show expenditures during the time period covered by the report, year-to-date expenditures, and the unexpended budget.</P>
                            <P>(b) Each financial statement shall be submitted to the Department within 30 calendar days after the end of the time period to which it applies.</P>
                            <P>(c) The Board shall submit to the Department an annual financial statement within 90 calendar days after the end of the fiscal year to which it applies.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.47</SECTNO>
                            <SUBJECT>Assessments.</SUBJECT>
                            <P>(a) The Board's programs and expenses shall be paid by assessments on producers of natural grass sod products in the United States, other income of the Board, and other funds available to the Board.</P>
                            <P>
                                (b) Each natural grass sod producer shall be required to pay an assessment to the Board in the amount of one-tenth (
                                <FR>1/10</FR>
                                 th) of one penny ($0.01) per square foot, or the equivalent thereof, of all natural grass sod products that the natural grass sod producer sells in the United States.
                            </P>
                            <P>
                                (c) Twenty-four months after this subpart becomes effective and periodically thereafter, the Board shall review the assessment rate and, if so approved by a vote of at least two-thirds (
                                <FR>2/3</FR>
                                ) of the Board, submit a recommendation for a change in the assessment rate to the Secretary. The assessment rate may not exceed one-eighth (
                                <FR>1/8</FR>
                                 th) of one penny ($0.01) per square foot of natural grass sod products sold without approval by a majority of natural grass sod producers in a referendum conducted pursuant to the procedures in this part.
                            </P>
                            <P>(d) Upon the effective date of this subpart, all natural grass sod producers shall be responsible for maintaining proper and sufficient sales receipts and records in order to accurately calculate their assessments owed to the Board pursuant to this subpart. After each quarterly period, or such other time period set by the Board, natural grass sod producers shall calculate the amount of assessments they owe the Board and remit such payment to the Board no later than the last calendar day of the month following the end of the quarterly period, or such other time period set by the Board, in which the natural grass sod products were sold.</P>
                            <P>(e) If any natural grass sod producer fails to pay the assessment within 60 calendar days of the date it is due, the Board may impose a late payment charge and interest. The one-time late payment charge shall be equal to 10 percent of the assessments due before interest charges have accrued. In addition to the late payment charge, 1.5 percent per month interest on the outstanding balance, including any late payment charge and accrued interest, will be added to any accounts for which payment has not been received by the Board within 60 calendar days after the assessments are due. Such interest will continue to accrue monthly until the outstanding balance is paid to the Board. Persons failing to remit total assessments due in a timely manner may also be subject to actions under Federal debt collection procedures or other means as the Board recommends to the Secretary.</P>
                            <P>(f) The Board may accept advance payment of assessments from any natural grass sod producer that will be credited toward any amount for which that person may become liable. The Board may not pay interest on any advance payment.</P>
                            <P>(g) If the Board is not in place by the date the first assessments are to be collected, the Secretary shall receive assessments and shall return such assessments, and any interest earned to the Board when it is formed.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.48</SECTNO>
                            <SUBJECT>Exemptions from assessments.</SUBJECT>
                            <P>(a) A natural grass sod producer (producer) who operates under an approved National Organic Program (7 CFR part 205) (NOP) organic production or handling system plan may be exempt from the payment of assessments under this part, provided that:</P>
                            <P>(1) Only agricultural products certified as “organic” or “100 percent organic” (as defined in the NOP) are eligible for exemption;</P>
                            <P>(2) The exemption shall apply to all certified “organic” or “100 percent organic” (as defined in the NOP) products of a producer regardless of whether the agricultural commodity subject to the exemption is produced by a person that also produces conventional or nonorganic agricultural products of the same agricultural commodity as that for which the exemption is claimed;</P>
                            <P>
                                (3) The producer maintains a valid certificate of organic operation as issued under the Organic Foods Production Act of 1990 (7 U.S.C. 6501-6522) (OFPA) and the NOP regulations issued under OFPA (7 CFR part 205); and
                                <PRTPAGE P="99167"/>
                            </P>
                            <P>(4) Any producer so exempted shall continue to be obligated to pay assessments under this part that are associated with any agricultural products that do not qualify for an exemption under this section.</P>
                            <P>
                                (b) To apply for exemption under this section, a producer shall submit a request to the Board on an 
                                <E T="03">Organic Exemption Request Form</E>
                                 (form AMS-15) at any time during the year initially, and annually thereafter on or before January 1, for as long as the producer continues to be eligible for the exemption.
                            </P>
                            <P>(c) The request for exemption shall include the following:</P>
                            <P>(1) The applicant's full name, company name, address, telephone and fax numbers, and email address;</P>
                            <P>(2) Certification that the applicant maintains a valid certificate of organic operation issued under OFPA and NOP;</P>
                            <P>(3) Certification that the applicant produces organic products eligible to be labeled “organic” or “100 percent organic” under NOP;</P>
                            <P>(4) A requirement that the applicant attach a copy of their certificate of organic operation issued by a USDA-accredited certifying agent under OFPA and NOP;</P>
                            <P>(5) Certification, as evidenced by signature and date, that all information provided by the applicant is true; and</P>
                            <P>(6) Such other information as may be required by the Board, with the approval of the Secretary.</P>
                            <P>(d) If a producer complies with the requirements of this section, the Board will grant an assessment exemption and issue a Certificate of Exemption to the producer within 30 days. If the application is disapproved, the Board will notify the applicant of the reason(s) for disapproval within the same timeframe.</P>
                            <P>(e) An exempt producer shall provide a copy of the Certificate of Exemption to each person to whom the producer sells natural grass sod products.</P>
                            <P>(f) The producer shall maintain records showing the exempt producer's name and address and the exemption number assigned by the Board.</P>
                            <P>(g) The exemption will apply at the first reporting period following the issuance of the Certificate of Exemption.</P>
                            <HD SOURCE="HD1">Promotion, Research, and Information</HD>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.50</SECTNO>
                            <SUBJECT>Programs.</SUBJECT>
                            <P>(a) The Board shall develop and submit to the Secretary for approval programs authorized by this subpart. Such programs shall provide for promotion, research, information and other activities, including consumer and industry information and advertising.</P>
                            <P>(b) No program shall be implemented prior to its approval by the Secretary. Once a program is so approved, the Board shall take appropriate steps to implement it.</P>
                            <P>(c) The Board must evaluate each program authorized under this subpart to ensure that it contributes to an effective and coordinated program of research, promotion, and information. The Board must submit the evaluations to the Secretary. If the Board finds that a program does not contribute to an effective program of promotion, research, or information, then the Board shall terminate such program.</P>
                            <P>(d) No program authorized under this subpart shall reference a brand or trade name of any natural grass sod product without the approval of the Board and the Secretary.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.51</SECTNO>
                            <SUBJECT>Independent evaluation.</SUBJECT>
                            <P>At least once every 5 years, the Board shall authorize and fund from funds otherwise available to the Board, an independent evaluation of the effectiveness of this subpart and the programs conducted by the Board pursuant to the Act. The Board shall submit to the Secretary, and make available to the public, the results of each periodic independent evaluation conducted under this section.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.52</SECTNO>
                            <SUBJECT>Patents, Copyrights, Trademarks, Inventions, Product Formulations, and Publications.</SUBJECT>
                            <P>(a) Any patents, copyrights, trademarks, inventions, product formulations, and publications developed through the use of funds received by the Board under this subpart shall be the property of the U.S. Government, as represented by the Board, and shall along with any rents, royalties, residual payments, or other income from the rental, sales, leasing, franchising, or other uses of such patents, copyrights, trademarks, inventions, product formulations, or publications, inure to the benefit of the Board, shall be considered income subject to the same fiscal, budget, and audit controls as other funds of the Board, and may be licensed subject to approval by the Secretary. Upon termination of this subpart, § 1240.73 shall apply to determine disposition of all such property.</P>
                            <P>(b) Should patents, copyrights, trademarks, inventions, product formulations, or publications be developed through the use of funds collected by the Board under this subpart together with funds contributed by another organization or person, the ownership and related rights to such patents, copyrights, trademarks, inventions, product formulations, or publications shall be determined by an agreement between the Board and the party contributing funds toward the development of such patents, copyrights, trademarks, inventions, product formulations, or publications in a manner consistent with paragraph (a) of this section, subject to the approval by the Secretary.</P>
                            <HD SOURCE="HD1">Reports, Books, and Records</HD>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.60</SECTNO>
                            <SUBJECT>Reports.</SUBJECT>
                            <P>(a) Natural grass sod producers will be required to provide periodically to the Board such information as the Board, with the approval of the Secretary, may require. Such information may include, but not be limited to:</P>
                            <P>(1) The name and contact information of the natural grass sod producer;</P>
                            <P>(2) The quantity of natural grass sod products sold;</P>
                            <P>(3) The date that any assessments were paid; and</P>
                            <P>(4) The natural grass sod producer's taxpayer identification number (TIN), employer identification number (EIN), or other identification as may be applicable.</P>
                            <P>(b) Such information shall be reported to the Board no later than the 30th calendar day of the month following the end of the quarterly period in which the natural grass sod products were sold and shall accompany the collected payment of assessments as specified in § 1240.47. First quarter data (January-March) shall be reported to the Board no later than the April 30th; second quarter data (April-June) shall be reported no later than July 31st; third quarter data (July-September) shall be reported no later than October 31st; and fourth quarter data (October-December) shall be reported no later than January 31st of the following marketing year.</P>
                            <P>(c) In addition to the information required to be regularly reported to the Board, the Board may request additional information from natural grass sod producers as deemed necessary by the Board, subject to approval by the Secretary.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.61</SECTNO>
                            <SUBJECT>Books and records.</SUBJECT>
                            <P>Each natural grass sod producer shall maintain any books and records necessary to carry out the provisions of this subpart and regulations issued thereunder, including such records as are necessary to verify any required reports. Such books and records must be made available during normal business hours for inspection by the Board's or Secretary's employees or agents. Natural grass sod producers must maintain the books and records for 3 years beyond the fiscal year to which they apply.</P>
                        </SECTION>
                        <SECTION>
                            <PRTPAGE P="99168"/>
                            <SECTNO>§ 1240.62</SECTNO>
                            <SUBJECT>Confidential treatment.</SUBJECT>
                            <P>All information obtained from books, records, or reports under the Act, this subpart, and the regulations issued thereunder shall be kept confidential by all persons, including all employees and former employees of the Board and all officers and employees and former officers and employees of contracting and subcontracting agencies or agreeing parties having access to such information. Such information shall not be available to Board members or natural grass sod producers. Only those persons having a specific need for such information solely to effectively administer the provisions of this subpart shall have access to such information. Only such information so obtained as the Secretary deems relevant shall be disclosed by them, and then only in a judicial proceeding or administrative hearing brought at the direction, or at the request, of the Secretary, or to which the Secretary or any officer of the United States is a party and involving this subpart. Nothing in this section shall be deemed to prohibit:</P>
                            <P>(a) The issuance of general statements based upon the reports of the number of persons subject to this subpart or statistical data collected therefrom, which statements do not identify the information furnished by any person; and</P>
                            <P>(b) The publication, by direction of the Secretary, of the name of any person who has been adjudged to have violated this part, together with a statement of the particular provisions of this part or subpart violated by such person.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.63</SECTNO>
                            <SUBJECT>Qualification of natural grass sod organizations.</SUBJECT>
                            <P>(a) Organizations receiving qualification from the Secretary will be entitled to submit requests for funding to the Board pursuant to § 1240.38. Only one natural grass sod producer organization per State may be qualified and only one natural grass sod producer organization per group of States may be qualified.</P>
                            <P>(b) Any natural grass sod producer organization whose primary purpose is to represent natural grass sod producers within a State or group of States may request qualification.</P>
                            <P>(c) Qualification shall be based, in addition to other available information, upon a factual report submitted by the organization that shall contain such information as the Secretary deems relevant for making such determination, including the following:</P>
                            <P>(1) The geographic territory covered by the organization's active membership;</P>
                            <P>(2) The nature and size of the organization's active membership and proportion of active membership accounted for by natural grass sod producers;</P>
                            <P>(3) The extent to which natural grass sod producers are represented on the organization's board of directors;</P>
                            <P>(4) Evidence of stability and permanency of the organization;</P>
                            <P>(5) Sources from which the organization's operating funds are derived;</P>
                            <P>(6) The functions of the organization; and</P>
                            <P>(7) The ability and willingness of the organization to further the purpose and objectives of the Act.</P>
                            <P>(d) The primary consideration in determining the eligibility of an organization shall be whether its natural grass sod producer membership consists of a sufficiently large number of natural grass sod producers who produce a relatively significant volume of sod as to reasonably warrant its qualification to submit requests for funding to the Board. In addition, only those organizations having a board of directors composed of a majority of natural grass sod producers shall be eligible. Any natural grass sod producer organization found eligible by the Secretary under this section will be qualified by the Secretary, and the Secretary's determination as to eligibility shall be final.</P>
                            <HD SOURCE="HD1">Miscellaneous</HD>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.70 </SECTNO>
                            <SUBJECT>Right of the Secretary.</SUBJECT>
                            <P>All fiscal matters, programs, contracts, rules or regulations, reports, or other substantive actions proposed and prepared by the Board shall be submitted to the Secretary for approval.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.71 </SECTNO>
                            <SUBJECT> Referenda.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Initial referendum.</E>
                                 The Order shall not become effective unless the Order is approved by a simple majority (50 percent plus one vote) of the natural grass sod producers voting in the initial referendum that have been engaged in the production and sale of natural grass sod products in the United States during a representative period determined by the Secretary. Each natural grass sod producer may cast one vote in the initial referendum.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Subsequent referenda.</E>
                                 The Secretary shall conduct subsequent referenda:
                            </P>
                            <P>(1) Not later than 7 years after this Order becomes effective and every 7 years thereafter, to determine whether natural grass sod producers favor the continuation of this subpart. This subpart shall continue if it is approved by a simple majority (50 percent plus one vote) of natural grass sod producers voting in the subsequent referendum that have been engaged in the production and sale of natural grass sod products in the United States during a representative period determined by the Secretary. Each natural grass sod producer may cast one vote in the subsequent referenda;</P>
                            <P>(2) At the request of two-thirds of the members of the Board established in this subpart;</P>
                            <P>(3) At the request of 10 percent or more of the total number of eligible natural grass sod producers; or</P>
                            <P>(4) At any time as determined by the Secretary.</P>
                            <P>
                                (c) 
                                <E T="03">Referendum procedures.</E>
                                 The initial referendum and all subsequent referenda shall be conducted pursuant to the procedures outlined in subpart B.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.72 </SECTNO>
                            <SUBJECT>Suspension or termination.</SUBJECT>
                            <P>(a) The Secretary shall suspend or terminate this part or subpart or a provision thereof, if the Secretary finds that this part or subpart or a provision thereof obstructs or does not tend to effectuate the purposes of the Act, or if the Secretary determines that this subpart or a provision thereof is not favored by eligible natural grass sod producers in a subsequent referendum.</P>
                            <P>(b) The Secretary shall suspend or terminate this subpart at the end of the fiscal year whenever the Secretary determines that its suspension or termination is favored by a simple majority of eligible natural grass sod producers voting in a subsequent referendum.</P>
                            <P>(c) If, as a result of a subsequent referendum, the Secretary determines that this subpart is not approved, the Secretary shall:</P>
                            <P>(1) Not later than 180 calendar days after making the determination, suspend or terminate the collection of assessments under this subpart.</P>
                            <P>(2) As soon as practical, suspend or terminate activities under this subpart in an orderly manner.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.73 </SECTNO>
                            <SUBJECT>Proceedings after termination.</SUBJECT>
                            <P>(a) Upon termination of this subpart, the Board shall recommend to the Secretary up to five of its members to serve as trustees for the purpose of liquidating the Board's affairs. Such persons, upon designation by the Secretary, shall become trustees of all funds and property then in the possession or under control of the Board, including claims for any funds unpaid or property not delivered, or any other existing claim at the time of such termination.</P>
                            <P>(b) The said trustees shall:</P>
                            <P>
                                (1) Continue in such capacity until discharged by the Secretary;
                                <PRTPAGE P="99169"/>
                            </P>
                            <P>(2) Carry out the obligations of the Board under any contracts or agreements entered into pursuant to this subpart;</P>
                            <P>(3) From time to time account for all receipts and disbursements and deliver all property on hand, together with all books and records of the Board and trustees, to such person or persons as the Secretary directs; and</P>
                            <P>(4) Upon request of the Secretary, execute such assignments or other instruments necessary or appropriate to vest in such persons title and right to all funds, property, and claims vested in the Board or the trustees pursuant to this subpart.</P>
                            <P>(c) Any person to whom funds, property, or claims have been transferred or delivered pursuant to this subpart shall be subject to the same obligations imposed upon the Board and upon the trustees.</P>
                            <P>(d) Any residual funds not required to defray the necessary expenses of liquidation shall be turned over to the Secretary to be disposed of, to the extent practical, to one or more organizations in the United States whose mission is generic natural grass sod promotion, research, and information programs.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.74 </SECTNO>
                            <SUBJECT> Effect of termination or amendment.</SUBJECT>
                            <P>Unless otherwise expressly provided by the Secretary, the termination of this subpart or of any regulation issued pursuant thereto, or the issuance of any amendment to either thereof, shall not:</P>
                            <P>(a) Affect or waive any right, duty, obligation, or liability which shall have arisen, or which may thereafter arise in connection with any provision of this subpart, or any regulation issued thereunder;</P>
                            <P>(b) Release or extinguish any violation of this subpart or any regulation issued thereunder; or</P>
                            <P>(c) Affect or impair any rights or remedies of the United States, or of the Secretary or of any other persons, with respect to any such violation.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.75 </SECTNO>
                            <SUBJECT>Personal liability.</SUBJECT>
                            <P>No member or employee of the Board shall be held personally responsible, either individually or jointly with others, in any way whatsoever, to any person for errors in judgment, mistakes, or other acts, either of commission or omission, as such member or employee, except for acts of dishonesty or willful misconduct.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.76</SECTNO>
                            <SUBJECT> Severability.</SUBJECT>
                            <P>If any provision of this subpart is declared invalid or the applicability of it to any person or circumstances is held invalid, the validity of the remainder of this subpart, or the applicability thereof to other persons or circumstances shall not be affected thereby.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.77</SECTNO>
                            <SUBJECT> Amendments.</SUBJECT>
                            <P>Amendments to this subpart may be proposed from time to time by the Board or any interested person affected by the provisions of the Act, including the Secretary.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1240.78 </SECTNO>
                            <SUBJECT> OMB control number.</SUBJECT>
                            <P>The control numbers assigned to the information collection requirements by the OMB pursuant to the PRA of 1995, 44 U.S.C. chapter 35, are OMB control numbers 0505-0001 (Background Information Form), 0581-0093 (Organic Exemption), and 0581-0349.</P>
                            <STARS/>
                        </SECTION>
                    </SUBPART>
                    <SIG>
                        <NAME>Melissa Bailey,</NAME>
                        <TITLE>Associate Administrator, Agricultural Marketing Service.</TITLE>
                    </SIG>
                </PART>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28389 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2024-2552; Project Identifier MCAI-2022-01243-R]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Airbus Helicopters</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA proposes to supersede Airworthiness Directive (AD) 2021-09-14, which applies to certain Airbus Helicopters (Airbus) Model SA330J helicopters. AD 2021-09-14 requires repetitively inspecting for a gap between the main gearbox (MGB) oil cooling fan assembly (fan) rotor blade and the upper section of the guide vane bearing housing, installing improved MGB fan rotor shaft bearings, and repetitively inspecting the improved MGB fan rotor shaft bearings. Since the FAA issued AD 2021-09-14, Airbus has developed modifications to the components of the MGB fan bearing assembly and issued new material regarding these modifications. This proposed AD would retain the actions required by AD 2021-09-14 and would also require installing the improved MGB fan rotor bearing assembly, which would constitute terminating action for the repetitive inspections. These actions are specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference. The FAA is proposing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The FAA must receive comments on this NPRM by January 24, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202) 493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        <E T="03">AD Docket:</E>
                         You may examine the AD docket at 
                        <E T="03">regulations.gov</E>
                         under Docket No. FAA-2024-2552; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the mandatory continuing airworthiness information (MCAI), any comments received, and other information. The street address for Docket Operations is listed above.
                    </P>
                    <P>
                        <E T="03">Material Incorporated by Reference:</E>
                    </P>
                    <P>
                        • For EASA material identified in this proposed AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email: 
                        <E T="03">ADs@easa.europa.eu;</E>
                         website: 
                        <E T="03">easa.europa.eu.</E>
                         You may find this material on the EASA website at 
                        <E T="03">ad.easa.europa.eu.</E>
                    </P>
                    <P>
                        • You may view this material at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Parkway, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110. It is also available at 
                        <E T="03">regulations.gov</E>
                         under Docket No. FAA-2024-2552.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Hal Jensen, Aviation Safety Engineer, FAA; 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (303) 342-1080; email: 
                        <E T="03">hal.jensen@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the 
                    <E T="02">ADDRESSES</E>
                     section. Include “Docket No. FAA-2024-2552; Project 
                    <PRTPAGE P="99170"/>
                    Identifier MCAI-2022-01243-R” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend the proposal because of those comments.
                </P>
                <P>
                    Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to 
                    <E T="03">regulations.gov,</E>
                     including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.
                </P>
                <HD SOURCE="HD1">Confidential Business Information</HD>
                <P>
                    CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Hal Jensen, Aviation Safety Engineer, FAA; 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (303) 342-1080; email: 
                    <E T="03">hal.jensen@faa.gov.</E>
                     Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>The FAA issued AD 2021-09-14, Amendment 39-21528 (86 FR 26829, May 18, 2021) (AD 2021-09-14), for Airbus Model SA330J helicopters with MGB fan rotor shaft bearings (both rear and front) part number (P/N) 704A33651114 (manufacturer P/N (MP/N) 205FFTX74K6-G33) or P/N 704A33651268 (MP/N 594918), installed. AD 2021-09-14 was prompted by an MCAI originated by EASA, which is the Technical Agent for the Member States of the European Union. EASA issued EASA AD 2020-0171, dated July 28, 2020 (EASA AD 2020-0171), to correct an unsafe condition.</P>
                <P>AD 2021-09-14 requires repetitively inspecting for a gap between the MGB fan rotor blade and the upper section of the guide vane bearing housing and, depending on the results or within a specified compliance time, installing improved MGB fan rotor shaft bearings and repetitively inspecting the improved MGB fan rotor shaft bearings. The FAA issued AD 2021-09-14 to prevent rotor burst of the MGB fan, damage to the hydraulic lines and flight controls, and subsequent loss of control of the helicopter.</P>
                <HD SOURCE="HD1">Actions Since AD 2021-09-14 Was Issued</HD>
                <P>Since the FAA issued AD 2021-09-14, EASA superseded EASA AD 2020-0171 and issued EASA AD 2022-0191, dated September 15, 2022 (EASA AD 2022-0191), to correct an unsafe condition on Airbus Helicopters Model SA 330 J helicopters. EASA AD 2022-0191 states since EASA AD 2020-0171 was issued, Airbus has developed modifications (mod) 0776102 and mod 0776104, which introduce a new Kevlar protection on the fan bearing rectifier and a new flexible duct. Additionally, Airbus issued revised material to provide in-service modification instructions.</P>
                <P>
                    The FAA is proposing this AD to prevent rotor burst of the MGB fan, damage to the hydraulic lines and flight controls, and subsequent loss of control of the helicopter. See EASA AD 2022-0191 for additional background information. You may examine EASA AD 2022-0191 in the AD docket at 
                    <E T="03">regulations.gov</E>
                     under Docket No. FAA-2024-2552.
                </P>
                <P>Lastly, this NPRM uses an updated format. As a result, the applicability paragraph has changed.</P>
                <HD SOURCE="HD1">Material Incorporated by Reference Under 1 CFR Part 51</HD>
                <P>The FAA reviewed EASA AD 2022-0191, which requires repetitively inspecting for play (a gap) on the MGB fan rotor shaft bearings (both rear and front) between the MGB fan rotor blade and the upper section of the guide vane bearing housing. If there is play that does not meet the minimum requirement or at a specified compliance time, EASA AD 2022-0191 requires replacing the affected MGB fan rotor shaft bearings with serviceable MGB fan rotor shaft bearings (both rear and front) as defined in EASA AD 2022-0191. Additionally, EASA AD 2022-0191 allows credit for performing these inspections and corrective action, provided specific requirements are met.</P>
                <P>EASA AD 2022-0191 also requires modifying the MGB fan bearing assembly, which would constitute terminating action for the repetitive inspections.</P>
                <P>Lastly, EASA AD 2022-0191 only allows installing serviceable MGB fan rotor shaft bearings as defined in EASA AD 2022-0191 and installing an improved MGB fan bearing assembly as defined in EASA AD 2022-0191, provided certain requirements are met.</P>
                <P>
                    This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">FAA's Determination</HD>
                <P>These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the EASA AD referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.</P>
                <HD SOURCE="HD1">Proposed AD Requirements in This NPRM</HD>
                <P>This proposed AD would retain all the requirements of AD 2021-09-14 and would require accomplishing the actions specified in EASA AD 2022-0191 described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD and except as discussed under “Differences Between this Proposed AD and EASA AD 2022-0191.”</P>
                <HD SOURCE="HD1">Explanation of Required Compliance Information</HD>
                <P>
                    In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2022-0191 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2022-0191 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section of 
                    <PRTPAGE P="99171"/>
                    EASA AD 2022-0191 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2022-0191. Material referenced in EASA AD 2022-0191 for compliance will be available at 
                    <E T="03">regulations.gov</E>
                     under Docket No. FAA-2024-2552 after the FAA final rule is published.
                </P>
                <HD SOURCE="HD1">Differences Between This Proposed AD and EASA AD 2022-0191</HD>
                <P>The inspection material referenced in EASA AD 2022-0191 specifies returning certain parts to the manufacturer, whereas this proposed AD would require removing those parts from service instead. The inspection material referenced in EASA AD 2022-0191 specifies completing a response form, whereas this proposed AD would not require that action.</P>
                <P>The modification material referenced in EASA AD 2022-0191 specifies sending the fan-bearing assembly to an approved D-level maintenance center for modification, whereas this proposed AD would require installing modification 0776102, and as applicable, modification 0725373.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD would affect 6 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates that operators may incur the following costs in order to comply with this proposed AD.</P>
                <P>Inspecting for a gap between the MGB fan rotor blade and the upper section of the guide vane bearing housing would take 2 work-hours for an estimated cost of $170 per helicopter and $1,020 for the U.S. fleet, per inspection cycle.</P>
                <P>Replacing the MGB fan rotor shaft bearings would take 6 work-hours and parts would cost $1,938 for an estimated cost of $2,448 per helicopter and $14,688 for the U.S. fleet.</P>
                <P>Removing the flexible duct, installing new flexible duct MOD 0776104, removing the fan-bearing assembly, and installing the modified fan-bearing assembly would take 8 work-hours and parts would cost $10,000 for an estimated cost of $10,680 per helicopter and $64,080 for the U.S. fleet.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.</P>
                <P>For the reasons discussed above, I certify that the proposed regulation:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866,</P>
                <P>(2) Would not affect intrastate aviation in Alaska, and</P>
                <P>(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 39</HD>
                    <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 39 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(g), 40113, 44701.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 39.13</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The FAA amends § 39.13 by:</AMDPAR>
                <AMDPAR>a. Removing Airworthiness Directive 2021-09-14, Amendment 39-21528 (86 FR 26829, May 18, 2021); and</AMDPAR>
                <AMDPAR>b. Adding the following new airworthiness directive:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">Airbus Helicopters:</E>
                         Docket No. FAA-2024-2552; Project Identifier MCAI-2022-01243-R.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this airworthiness directive (AD) by January 24, 2025.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>This AD replaces AD 2021-09-14, Amendment 39-21528 (86 FR 26829, May 18, 2021) (AD 2021-09-14).</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to Airbus Helicopters Model SA330J helicopters, certificated in any category.</P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Joint Aircraft System Component (JASC) Code 6322, Main Gearbox Oil Cooler.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>This AD was prompted by the development of a modification for an improved MGB fan rotor bearing assembly. The FAA is issuing this AD to prevent rotor burst of the MGB fan, damage to the hydraulic lines and flight controls, and subsequent loss of control of the helicopter.</P>
                    <HD SOURCE="HD1">(f) Compliance</HD>
                    <P>Comply with this AD within the compliance times specified, unless already done.</P>
                    <HD SOURCE="HD1">(g) Requirements</HD>
                    <P>Except as specified in paragraphs (h) and (i) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation Safety Agency (EASA) AD 2022-0191, dated September 15, 2022 (EASA AD 2022-0191).</P>
                    <HD SOURCE="HD1">(h) Exceptions to EASA AD 2022-0191</HD>
                    <P>(1) Where EASA AD 2022-0191 refers to August 11, 2020 (the effective date of EASA AD 2020-0171, dated July 28, 2020) and to its effective date, this AD requires using the effective date of this AD.</P>
                    <P>(2) Where EASA AD 2022-0191 refers to flight hours (FH), this AD requires using hours time-in-service.</P>
                    <P>(3) Where “the inspection ASB” material referenced in EASA AD 2022-0191 specifies to return certain parts to Airbus Helicopters, this AD requires removing those parts from service.</P>
                    <P>(4) Where “the inspection ASB” material referenced in EASA AD 2022-0191 specifies completing the response form in Appendix 4, this AD does not require that action.</P>
                    <P>(5) Where the “the modification ASB” material referenced in EASA AD 2022-0191 specifies sending the fan-bearing assembly to an approved D-level maintenance center to integrate modification 0776102 and where applicable, modification 0725373, this AD requires installing modification 0776102, and as applicable, modification 0725373.</P>
                    <P>(6) This AD does not adopt the “Remarks” section of EASA AD 2022-0191.</P>
                    <HD SOURCE="HD1">(i) No Reporting Requirement</HD>
                    <P>
                        Although the material referenced in EASA AD 2022-0191 specifies to submit certain 
                        <PRTPAGE P="99172"/>
                        information to the manufacturer, this AD does not require that action.
                    </P>
                    <HD SOURCE="HD1">(j) Special Flight Permits</HD>
                    <P>Special flight permits may be issued in accordance with 14 CFR 21.197 and 21.199 to operate the helicopter to a location where the actions of this AD can be performed, provided there are no passengers onboard.</P>
                    <HD SOURCE="HD1">(k) Alternative Methods of Compliance (AMOCs)</HD>
                    <P>
                        (1) The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the International Validation Branch, send it to the attention of the person identified in paragraph (l) of this AD. Information may be emailed to: 
                        <E T="03">AMOC@faa.gov.</E>
                    </P>
                    <P>(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local Flight Standards District Office/certificate holding district office.</P>
                    <HD SOURCE="HD1">(l) Additional Information</HD>
                    <P>
                        For more information about this AD, contact Hal Jensen, Aviation Safety Engineer, FAA; 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (303) 342-1080; email: 
                        <E T="03">hal.jensen@faa.gov.</E>
                    </P>
                    <HD SOURCE="HD1">(m) Material Incorporated by Reference</HD>
                    <P>(1) The Director of the Federal Register approved the incorporation by reference of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                    <P>(2) You must use this material as applicable to do the actions required by this AD, unless the AD specifies otherwise.</P>
                    <P>(i) European Union Aviation Safety Agency (EASA) AD 2022-0191, dated September 15, 2022.</P>
                    <P>(ii) [Reserved]</P>
                    <P>
                        (3) For EASA material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email: 
                        <E T="03">ADs@easa.europa.eu;</E>
                         website: 
                        <E T="03">easa.europa.eu.</E>
                         You may find the EASA material on the EASA website at 
                        <E T="03">ad.easa.europa.eu.</E>
                    </P>
                    <P>(4) You may view this material at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Parkway, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.</P>
                    <P>
                        (5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit 
                        <E T="03">www.archives.gov/federal-register/cfr/ibr-locations</E>
                         or email 
                        <E T="03">fr.inspection@nara.gov.</E>
                    </P>
                    <SIG>
                        <DATED>Issued on December 3, 2024.</DATED>
                        <NAME>Steven W. Thompson,</NAME>
                        <TITLE>Acting Deputy Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                    </SIG>
                </EXTRACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28831 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 71</CFR>
                <DEPDOC>[Docket No. FAA-2024-2391; Airspace Docket No. 24-ANM-108]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Establishment of Class E Airspace; Stanford/Biggerstaff Field, Stanford, MT</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action proposes to establish Class E airspace extending upward from 700 feet above the surface at Stanford/Biggerstaff Field, Stanford, MT. This action would support the airport's transition from visual flight rules (VFR) to instrument flight rules (IFR) operations.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before January 24, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Send comments identified by FAA Docket No. FAA-2024-2391 and Airspace Docket No. 24-ANM-108 using any of the following methods:</P>
                    <P>
                        * 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">www.regulations.gov</E>
                         and follow the online instructions for sending your comments electronically.
                    </P>
                    <P>
                        * 
                        <E T="03">Mail:</E>
                         Send comments to Docket Operations, M-30; U.S. Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.
                    </P>
                    <P>
                        * 
                        <E T="03">Hand Delivery or Courier:</E>
                         Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        * 
                        <E T="03">Fax:</E>
                         Fax comments to Docket Operations at (202) 493-2251.
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         Background documents or comments received may be read at 
                        <E T="03">www.regulations.gov</E>
                         at any time. Follow the online instructions for accessing the docket or go to the Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        FAA Order JO 7400.11J, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at 
                        <E T="03">www.faa.gov/air_traffic/publications/.</E>
                         You may also contact the Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Nathan A. Chaffman, Federal Aviation Administration, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198; telephone (206) 231-3460.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would establish Class E airspace extending upward from 700 feet above the surface to support IFR operations at Stanford/Biggerstaff Field, Stanford, MT.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.</P>
                <P>
                    The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
                    <PRTPAGE P="99173"/>
                </P>
                <P>
                    <E T="03">Privacy:</E>
                     In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov,</E>
                     as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
                    <E T="03">www.dot.gov/privacy.</E>
                </P>
                <HD SOURCE="HD1">Availability of Rulemaking Documents</HD>
                <P>
                    An electronic copy of this document may be downloaded through the internet at 
                    <E T="03">www.regulations.gov.</E>
                     Recently published rulemaking documents can also be accessed through the FAA's web page at 
                    <E T="03">www.faa.gov/air_traffic/publications/airspace_amendments/.</E>
                </P>
                <P>
                    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see 
                    <E T="02">ADDRESSES</E>
                     section for address, phone number, and hours of operations). An informal docket may also be examined during normal business hours at the office at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198.
                </P>
                <HD SOURCE="HD1">Incorporation by Reference</HD>
                <P>
                    Class E5 airspace designations are published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11J, dated July 31, 2024 and effective September 15, 2024. These updates would be published in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document.
                </P>
                <P>FAA Order JO 7400.11J lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.</P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 to establish Class E airspace extending upward from 700 feet above the surface at Stanford/Biggerstaff Field, Stanford, MT.</P>
                <P>Class E airspace extending upward from 700 feet should be established within a 6.4-mile radius of the airport. Additionally, the Class E airspace should extend to the northwest to contain arriving IFR operations below 1,500 feet above the surface.</P>
                <HD SOURCE="HD1">Regulatory Notices and Analyses</HD>
                <P>The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <HD SOURCE="HD1">Environmental Review</HD>
                <P>This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” prior to any FAA final regulatory action.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 71</HD>
                    <P>Airspace, Incorporation by reference, Navigation (air).</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>In consideration of the foregoing, the Federal Aviation Administration proposes to  amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for 14 CFR part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11J, Airspace Designations and Reporting Points, dated July 31, 2024, and effective September 15, 2024, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">ANM MT E5 Stanford, MT [New]</HD>
                    <FP SOURCE="FP-2">Stanford/Biggerstaff Field, MT</FP>
                    <FP SOURCE="FP1-2">(Lat. 47°08′49″ N, long. 110°13′48″ W)</FP>
                    <P>That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of the airport and within 2.5 miles on either side of the 303° bearing extending from the 6.4-mile radius to 10.1 miles northwest of the airport.</P>
                    <STARS/>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Des Moines, Washington, on December 3, 2024.</DATED>
                    <NAME>B.G. Chew,</NAME>
                    <TITLE>Group Manager, Operations Support Group, Western Service Center.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28869 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 71</CFR>
                <DEPDOC>[Docket No. FAA-2024-2456; Airspace Docket No. 24-ANM-71]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Modification of Class D and Class E Airspace; Cheyenne Regional/Jerry Olson Field, Cheyenne, WY</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action proposes to modify the Class E airspace extending upward from 700 feet above the surface and remove the Class E airspace extending upward from 1,200 feet above the surface at Cheyenne Regional/Jerry Olson Field, Cheyenne, WY. Additionally, this action proposes administrative amendments to update the airport's legal descriptions for its Class D airspace and Class E airspace designated as a surface area. These actions would support the safety and management of visual flight rules (VFR) and instrument flight rules (IFR) operations at the airport.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before January 24, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Send comments identified by FAA Docket No. FAA-2024-2456 and Airspace Docket No. 24-ANM-71 using any of the following methods:</P>
                    <P>
                        * 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">www.regulations.gov</E>
                         and follow the online instructions for sending your comments electronically.
                    </P>
                    <P>
                        * 
                        <E T="03">Mail:</E>
                         Send comments to Docket Operations, M-30; U.S. Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.
                    </P>
                    <P>
                        * 
                        <E T="03">Hand Delivery or Courier:</E>
                         Take comments to Docket Operations in 
                        <PRTPAGE P="99174"/>
                        Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        * 
                        <E T="03">Fax:</E>
                         Fax comments to Docket Operations at (202) 493-2251.
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         Background documents or comments received may be read at 
                        <E T="03">www.regulations.gov</E>
                         at any time. Follow the online instructions for accessing the docket or go to the Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        FAA Order JO 7400.11J, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at 
                        <E T="03">www.faa.gov/air_traffic/publications/.</E>
                         You may also contact the Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Nathan A. Chaffman, Federal Aviation Administration, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198; telephone (206) 231-3460.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify Class D and Class E airspace to support VFR and IFR operations at Cheyenne Regional/Jerry Olson Field, Cheyenne, WY.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.</P>
                <P>The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.</P>
                <P>
                    <E T="03">Privacy:</E>
                     In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov,</E>
                     as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
                    <E T="03">www.dot.gov/privacy.</E>
                </P>
                <HD SOURCE="HD1">Availability of Rulemaking Documents</HD>
                <P>
                    An electronic copy of this document may be downloaded through the internet at 
                    <E T="03">www.regulations.gov.</E>
                     Recently published rulemaking documents can also be accessed through the FAA's web page at 
                    <E T="03">www.faa.gov/air_traffic/publications/airspace_amendments/.</E>
                </P>
                <P>
                    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see 
                    <E T="02">ADDRESSES</E>
                     section for address, phone number, and hours of operations). An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198.
                </P>
                <HD SOURCE="HD1">Incorporation by Reference</HD>
                <P>
                    Class D, E2, and E5 airspace designations are published in paragraphs 5000, 6002, and 6005, respectively, of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11J, dated July 31, 2024 and effective September 15, 2024. These updates would be published in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document.
                </P>
                <P>FAA Order JO 7400.11J lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.</P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 that would modify the Class E airspace extending upward from 700 feet above the surface, remove the Class E airspace extending upward from 1,200 feet above the surface, and update the legal descriptions for the Class D airspace and Class E airspace designated as a surface area at Cheyenne Regional/Jerry Olson Field, Cheyenne, WY.</P>
                <P>The westward portion of the Class E airspace extending upward from 700 feet above the surface should be widened to be within a 9.1-mile radius of the airport between the airport's 209° bearing clockwise to its 336° bearing due to rising terrain. This additional Class E airspace would better contain diverse IFR departure operations until they reach 1,200 feet above the surface.</P>
                <P>The Class E airspace extending upward from 1,200 feet above the surface at the airport is redundant and should be removed. The Denver Class E6 en route domestic airspace provides sufficient containment of arriving IFR operations at 1,500 feet and higher above the surface and departing IFR operations from the point they reach 1,200 feet above the surface until reaching overlying or adjacent controlled airspace.</P>
                <P>Finally, the FAA proposes administrative modifications to update the airport's legal descriptions for their Class D airspace and Class E airspace designated as a surface area. Both descriptions should be updated to replace the outdated use of the phrase “Notice to Airmen.” This phrase should read “Notice to Air Missions” to align with the FAA's current nomenclature.</P>
                <HD SOURCE="HD1">Regulatory Notices and Analyses</HD>
                <P>
                    The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as 
                    <PRTPAGE P="99175"/>
                    the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
                </P>
                <HD SOURCE="HD1">Environmental Review</HD>
                <P>This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 71</HD>
                    <P>Airspace, Incorporation by reference, Navigation (air).</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>In consideration of the foregoing, the Federal Aviation Administration proposes to  amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for 14 CFR part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO 7400.11J, Airspace Designations and Reporting Points, dated July 31, 2024, and effective September 15, 2024, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 5000 Class D Airspace.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">ANM WY D Cheyenne, WY [Amended]</HD>
                    <FP SOURCE="FP-2">Cheyenne Regional/Jerry Olson Field, WY</FP>
                    <FP SOURCE="FP1-2">(Lat. 41°09′20″ N, long. 104°48′38″ W)</FP>
                    <P>That airspace extending upward from the surface to and including 8,700 feet MSL within a 5.6-mile radius of Cheyenne Regional/Jerry Olson Field. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Air Missions. The effective date and time will thereafter be continuously published in the Chart Supplement.</P>
                    <STARS/>
                    <HD SOURCE="HD2">Paragraph 6002 Class E Airspace Areas Designated as a Surface Area.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">ANM WY E2 Cheyenne, WY [Amended]</HD>
                    <FP SOURCE="FP-2">Cheyenne Regional/Jerry Olson Field, WY</FP>
                    <FP SOURCE="FP1-2">(Lat. 41°09′20″ N, long. 104°48′38″ W)</FP>
                    <P>That airspace extending upward from the surface within a 5.6-mile radius of Cheyenne Regional/Jerry Olson Field. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Air Missions. The effective date and time will thereafter be continuously published in the Chart Supplement.</P>
                    <STARS/>
                    <HD SOURCE="HD2">Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">ANM WY E5 Cheyenne, WY [Amended]</HD>
                    <FP SOURCE="FP-2">Cheyenne Regional/Jerry Olson Field, WY</FP>
                    <FP SOURCE="FP1-2">(Lat. 41°09′20″ N, long. 104°48′38″ W)</FP>
                    <P>That airspace extending upward from 700 feet above the surface within an 8.1-mile radius of Cheyenne Regional/Jerry Olson Field, within a 9.1-mile radius of the airport between its 209° bearing clockwise to its 336° bearing, within 2.4 miles each side of the airport's 028° bearing extending from its 8.1-mile radius to 10.8 miles northeast of the airport, and within 2.2 miles each side of the airport's 275° bearing extending from its 9.1-mile radius to 10.6 miles west of the airport.</P>
                    <STARS/>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Des Moines, Washington, on December 3, 2024.</DATED>
                    <NAME>B.G. Chew,</NAME>
                    <TITLE>Group Manager, Operations Support Group, Western Service Center.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28872 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <CFR>17 CFR Chapter II</CFR>
                <DEPDOC>[Release Nos. 33-11330; 34-101769; 39-2558; File No. S7-2024-08]</DEPDOC>
                <SUBJECT>List of Rules To Be Reviewed Pursuant to the Regulatory Flexibility Act</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Securities and Exchange Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Publication of list of rules scheduled for review.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Securities and Exchange Commission is publishing a list of rules to be reviewed pursuant to the Regulatory Flexibility Act. The list is published to provide the public with notice that these rules are scheduled for review by the agency and to invite public comment on whether the rules should be continued without change, or should be amended or rescinded to minimize any significant economic impact of the rules upon a substantial number of small entities.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments should be submitted by January 9, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Comments may be submitted by any of the following methods:</P>
                </ADD>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's internet comment form (
                    <E T="03">https://www.sec.gov/rules/submitcomments.html</E>
                    ); or
                </P>
                <P>
                    • Send an email to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include File Number S7-2024-08 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments to Secretary, U.S. Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to File Number S7-2024-08. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method of submission. The Commission will post all comments on the Commission's website (
                    <E T="03">https://www.sec.gov/comments/s7-2024-08/s7202408.htm</E>
                    ). Comments also are available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Operating conditions may limit access to the Commission's Public Reference Room. Do not include personal identifiable information in submissions; you should submit only information that you wish to make available publicly. We may redact in part or withhold entirely from publication submitted material that is obscene or subject to copyright protection. Studies, memoranda, or other substantive items may be added by the Commission or staff to the comment file during this rulemaking. A notification of the inclusion in the comment file of any such materials will be made available on our website. To ensure direct electronic receipt of such notifications, sign up through the “Stay Connected” option at 
                    <E T="03">www.sec.gov</E>
                     to receive notifications by email.
                </FP>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sandra Sojka, General Attorney, Office of the General Counsel, 202-551-4928.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Regulatory Flexibility Act (“RFA”), codified at 5 U.S.C. 601-612, requires an agency to review its rules that have a significant economic impact upon a substantial number of small entities within ten years of the publication of such rules as final rules. 5 U.S.C. 610(a). The purpose of the review is “to determine whether such rules should be continued without change, or should be 
                    <PRTPAGE P="99176"/>
                    amended or rescinded . . . to minimize any significant economic impact of the rules upon a substantial number of such small entities.” 5 U.S.C. 610(a). The RFA sets forth specific considerations that must be addressed in the review of each rule:
                </P>
                <P>• the continued need for the rule;</P>
                <P>• the nature of complaints or comments received concerning the rule from the public;</P>
                <P>• the complexity of the rule;</P>
                <P>• the extent to which the rule overlaps, duplicates or conflicts with other federal rules, and, to the extent feasible, with state and local governmental rules; and</P>
                <P>• the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. 5 U.S.C. 610(b).</P>
                <P>The list below includes rules adopted in 2015 that may have a significant economic impact on a substantial number of small entities (but excludes rules that have been substantially changed since adoption, rules that are minor amendments to previously adopted rules, and rules that are ministerial, procedural, or technical in nature). Where the Commission has previously made a determination of a rule's impact on small businesses, the determination is noted on the list.</P>
                <P>The Commission particularly solicits public comment on whether the rules listed below affect small businesses in new or different ways than when they were first adopted. The rules and forms listed below are scheduled for review by staff of the Commission.</P>
                <P>
                    <E T="03">Title:</E>
                     Crowdfunding.
                </P>
                <P>
                    <E T="03">Citation:</E>
                     17 CFR 230-1, 17 CFR 227.100, 17 CFR 227.201, 17 CFR 227.202, 17 CFR 227.203, 17 CFR 227.204, 17 CFR 227.205, 17 CFR 227.300, 17 CFR 227.301, 17 CFR 227.302, 17 CFR 227.303, 17 CFR 227.304, 17 CFR 227.305, 17 CFR 227.400, 17 CFR 227.401, 17 CFR 227.402, 17 CFR 227.403, 17 CFR 227.404, 17 CFR 227.501, 17 CFR 227.502, 17 CFR 227.503, 17 CFR 232.101, 17 CFR 239.900, 17 CFR 240.12g-6, 17 CFR 249.2000, 17 CFR 269, and 17 CFR 274.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     15 U.S.C. 77c, 77d, 77d-1, 77f, 77g, 77h, 77j, 77
                    <E T="03">o,</E>
                     77s, 77s
                    <E T="03">(a),</E>
                     77z-2, 77z-3, 77ddd, 77ddd(c), 77eee, 77ggg, 77hhh, 77iii, 77jjj, 77nnn, 77sss, 77ttt, 77sss(a), 78a 
                    <E T="03">et seq.,</E>
                     78c, 78c-3, 78c-5, 78c(b), 78d, 78d-1, 78d-2, 78e, 78f, 78g, 78i, 78j, 78j-1, 78k, 78k-1, 78l, 78m, 78n, 78n-1, 78
                    <E T="03">o,</E>
                     78
                    <E T="03">o</E>
                    (d), 78
                    <E T="03">o</E>
                    -4, 78
                    <E T="03">o</E>
                    -7 note, 78
                    <E T="03">o</E>
                    -10, 78p, 78q, 78q-1, 78s, 78u-5, 78w, 78w(a), 78x, 78ll, 78ll(d), 78mm, 80a-2(a), 80a-3, 80a-6(c), 80a-8, 80a-9, 80a-10, 80a-13, 80a-20, 80a-23, 80a-24, 80a-26, 80a-29, 80a-30, 80a-37, 80b-3, 80b-4, 80b-11, 7201 
                    <E T="03">et seq.,</E>
                     7202, 7211 
                    <E T="03">et seq.,</E>
                     8302; 7 U.S.C. 2(c)(2)(E); 12 U.S.C. 5221(e)(3); 12 U.S.C. 5461 
                    <E T="03">et seq.;</E>
                     18 U.S.C. 1350; Pub. L. 111-203, 939A, 124 Stat. 1376 (2010); and Pub. L. 112-106, secs. 301-305, 126 Stat. 306 (2012), unless otherwise noted.
                </P>
                <P>
                    <E T="03">Description:</E>
                     The Securities and Exchange Commission adopted new Regulation Crowdfunding under the Securities Act of 1933 and the Securities Exchange Act of 1934 to implement the requirements of Title III of the Jumpstart Our Business Startups Act. Regulation Crowdfunding prescribes rules governing the offer and sale of securities under new Section 4(a)(6) of the Securities Act of 1933. Regulation Crowdfunding also provides a framework for the regulation of registered funding portals and broker-dealers that issuers are required to use as intermediaries in the offer and sale of securities in reliance on Section 4(a)(6). In addition, Regulation Crowdfunding conditionally exempts securities sold pursuant to Section 4(a)(6) from the registration requirements of Section 12(g) of the Securities Exchange Act of 1934.
                </P>
                <P>
                    <E T="03">Prior RFA Analysis:</E>
                     When the Commission adopted the rule on October 30, 2015, it published a Final Regulatory Flexibility Analysis in the adopting release, Release Nos. 33-9974/34-76324, available at: 
                    <E T="03">https://www.federalregister.gov/documents/2015/11/16/2015-28220/crowdfunding.</E>
                     The Commission solicited comment on its Initial Regulatory Flexibility Analysis published in the proposing release, Release Nos. 33-9470/34-70741 (Oct. 23, 2013), available at: 
                    <E T="03">https://www.federalregister.gov/documents/2013/11/05/2013-25355/crowdfunding,</E>
                     and considered comments received at the time.
                </P>
                <STARS/>
                <P>
                    <E T="03">Title:</E>
                     Amendments for Small and Additional Issues Exemptions Under the Securities Act (Regulation A).
                </P>
                <P>
                    <E T="03">Citation:</E>
                     17 CFR 200.30-1, 17 CFR 230.157, 17 CFR 230.251, 17 CFR 230.252, 17 CFR 230.253, 17 CFR 230.254, 17 CFR 230.255, 17 CFR 230.256, 17 CFR 230.257, 17 CFR 230.258, 17 CFR 230.259, 17 CFR 230.260, 17 CFR 230.261, 17 CFR 230.262, 17 CFR 230.263, 17 CFR 230.505, 17 CFR 232.101, 17 CFR 239.90, 17 CFR 239.91, 17 CFR 239.92, 17 CFR 239.93, 17 CFR 239.94, 17 CFR 240.12g5-1, 17 CFR 240.15c2-11, 17 CFR 249.208a, and 17 CFR 260.4a-1.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     15 U.S.C. 77b, 77b note, 77c, 77d, 77f, 77g, 77h, 77j, 77
                    <E T="03">o,</E>
                     77r, 77s, 77s(a), 77z-2, 77z-3, 77ddd, 77eee, 77ggg, 77nnn, 77sss, 77sss(a), 77ttt, 78a 
                    <E T="03">et seq.,</E>
                     78c, 78c-3, 78c-5, 78c(b), 78d, 78d-1, 78d-2, 78e, 78f, 78g, 78i, 78j, 78j-1, 78k, 78k-1, 78
                    <E T="03">l,</E>
                     78m, 78n, 78n-1, 78
                    <E T="03">o,</E>
                     78
                    <E T="03">o</E>
                    (d), 78
                    <E T="03">o</E>
                    -4, 78
                    <E T="03">o</E>
                    -7 note, 78
                    <E T="03">o</E>
                    -10, 78p, 78q, 78q-1, 78s, 78t, 78u-5, 78w, 78w(a), 78x, 78
                    <E T="03">ll,</E>
                     78
                    <E T="03">ll</E>
                    (d), 78mm, 80a-2(a), 80a-3, 80a-6(c), 80a-8, 80a-9, 80a-10, 80a-13, 80a-20, 80a-23, 80a-24, 80a-26, 80a-28, 80a-29, 80a-30, 80a-37, 80b-3, 80b-4, 80b-11, 7201 
                    <E T="03">et seq.;</E>
                     7202, 7211 
                    <E T="03">et seq.,</E>
                     8302; 7 U.S.C. 2(c)(2)(E); 12 U.S.C. 5221(e)(3); 12 U.S.C. 5461 
                    <E T="03">et seq.;</E>
                     18 U.S.C. 1350; Pub. L. 111-203, 939A, 124 Stat. 1376, (2010); and Pub. L. 112-106, sec. 201(a), sec. 401, 126 Stat. 313 (2012), unless otherwise noted.
                </P>
                <P>
                    <E T="03">Description:</E>
                     The Commission adopted amendments to Regulation A and other rules and forms to implement Section 401 of the Jumpstart Our Business Startups (JOBS) Act. Section 401 of the JOBS Act added Section 3(b)(2) to the Securities Act of 1933, which directs the Commission to adopt rules exempting from the registration requirements of the Securities Act offerings of up to $50 million of securities annually. The final rules include issuer eligibility requirements, content and filing requirements for offering statements, and ongoing reporting requirements for issuers in Regulation A offerings.
                </P>
                <P>
                    <E T="03">Prior RFA Analysis:</E>
                     When the Commission adopted the amendments and forms on March 25, 2015, it published a Final Regulatory Flexibility Analysis in the adopting release, Release Nos. 33-9741/34-74578/39-2501, available at: 
                    <E T="03">https://www.federalregister.gov/documents/2015/04/20/2015-07305/amendments-for-small-and-additional-issues-exemptions-under-the-securities-act-regulation-a.</E>
                     The Commission solicited comment on the Initial Regulatory Flexibility Analysis published in the proposing release, Release Nos. 33-9497/34-71120/39-2493 (Dec. 18, 2013), available at: 
                    <E T="03">https://www.federalregister.gov/documents/2014/01/23/2013-30508/proposed-rule-amendments-for-small-and-additional-issues-exemptions-under-section-3b-of-the,</E>
                     and considered comments received at that time.
                </P>
                <STARS/>
                <SIG>
                    <P>By the Commission.</P>
                    <DATED>Dated: November 27, 2024.</DATED>
                    <NAME>Stephanie J. Fouse,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28353 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="99177"/>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R10-OAR-2024-0373; FRL-12413-01-R10]</DEPDOC>
                <SUBJECT>Air Plan Approval; WA; Southwest Clean Air Agency; Revisions to Excess Emissions, Startup, Shutdown, and General Requirements</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is proposing to approve Washington State Implementation Plan (SIP) revisions to the Southwest Clean Air Agency (SWCAA) air quality regulations submitted by the State of Washington, through the Department of Ecology (Ecology) on June 22, 2023. The revisions were submitted in part to respond to the EPA's June 12, 2015 “SIP call” in which the EPA found a provision in the Washington SIP applicable in the area regulated by SWCAA to be substantially inadequate, providing affirmative defenses that operate to limit the jurisdiction of the Federal court in an enforcement action related to excess emissions during startup, shutdown, and malfunction (SSM) events. The EPA is proposing approval of the SIP revisions and proposing to determine that the submitted revisions to the substantially inadequate provision corrects the deficiency identified in the 2015 SSM SIP call and the EPA's January 2022 finding of failure to submit. Washington withdrew some portions of the revisions submitted that were not identified in the 2015 SSM SIP call and therefore the EPA is not proposing action on those withdrawn portions.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before January 9, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by Docket ID No. EPA-R10-OAR-2024-0373, at 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from 
                        <E T="03">Regulations.gov</E>
                        . EPA may publish any comment received to its public docket. Do not electronically submit any information you consider to be Confidential Business Information (CBI) or other information the disclosure of which is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (
                        <E T="03">i.e.,</E>
                         on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit 
                        <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Randall Ruddick, EPA Region 10, 1200 Sixth Avenue (Suite 155), Seattle, WA 98101, (206) 553-1999; or email 
                        <E T="03">ruddick.randall@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document whenever “we,” or “our,” is used, it refers to EPA.</P>
                <HD SOURCE="HD1">Table of Contents </HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Background</FP>
                    <FP SOURCE="FP-2">II. Analysis of SIP Submission</FP>
                    <FP SOURCE="FP1-2">A. The Provision Subject to the 2015 SSM SIP Call</FP>
                    <FP SOURCE="FP1-2">B. Additional SIP Revisions Submitted But Not Specified in the 2015 SSM SIP Call</FP>
                    <FP SOURCE="FP-2">III. Proposed Action</FP>
                    <FP SOURCE="FP-2">IV. Incorporation by Reference</FP>
                    <FP SOURCE="FP-2">V. Statutory and Executive Orders Review</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Background</HD>
                <P>On June 12, 2015, pursuant to Clean Air Act (CAA) section 110(k)(5), the EPA finalized “State Implementation Plans: Response to Petition for Rulemaking; Restatement and Update of EPA's SSM Policy Applicable to SIPs; Findings of Substantial Inadequacy; and SIP Calls to Amend Provisions Applying to Excess Emissions During Periods of Startup, Shutdown and Malfunction,” (80 FR 33840, June 12, 2015), hereinafter referred to as the “2015 SSM SIP Action.” The 2015 SSM SIP Action clarified, restated, and updated EPA's interpretation that SSM exemption and affirmative defense SIP provisions are inconsistent with CAA requirements. The 2015 SSM SIP Action found that certain SIP provisions in 36 States (including Washington State) were substantially inadequate to meet CAA requirements and issued a SIP call to those States to submit SIP revisions to address the inadequacies. EPA established an 18-month deadline by which the affected States had to submit such SIP revisions. States were required to submit corrective revisions to their SIPs in response to the SIP calls by November 22, 2016.</P>
                <P>With regard to the Washington SIP, EPA determined that, to the extent that Washington Administrative Code (WAC) 173-400-107 was intended to be an affirmative defense, it was not consistent with the requirements of the CAA. Therefore, the EPA issued a SIP call to Washington Department of Ecology with respect to this provision in their jurisdiction. In response to the EPA's 2015 SSM SIP call, Ecology removed WAC 173-400-107 from the SIP. The EPA approved this SIP revision, along with others, on December 28, 2023 (88 FR 89582).</P>
                <P>
                    On January 12, 2022, the EPA issued Findings of Failure to Submit (FFS) to 12 air agencies, including SWCAA, that had not submitted SIPs responding to the 2015 SSM SIP call by the November 22, 2016, deadline per the requirements of section 110(k)(5) of the Act.
                    <SU>1</SU>
                    <FTREF/>
                     In response, on June 22, 2023, Washington submitted revisions to SWAPCA Rule 400-107 to comport with EPA's SSM Policy Applicable to SIPs along with other SIP revisions not identified in the 2015 SSM SIP call.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Findings of Failure To Submit State Implementation Plan Revisions in Response to the 2015 Findings of Substantial Inadequacy and SIP Calls To Amend Provisions Applying To Excess Emissions During Periods of Startup, Shutdown, and Malfunction, 87 FR 1680 (January 12, 2022), available at 
                        <E T="03">www.regulations.gov,</E>
                         Docket ID No. EPA-HQ-OAR-2021-0863.
                    </P>
                </FTNT>
                <P>
                    On March 1, 2024, the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) issued a decision in 
                    <E T="03">Environ. Comm. Fl. Elec. Power</E>
                     v. 
                    <E T="03">EPA,</E>
                     No. 15-1239 (“D.C. Circuit decision”).
                    <SU>2</SU>
                    <FTREF/>
                     The case was a consolidated set of petitions for review of the 2015 SSM SIP Action. The Court granted the petitions in part, vacating the SIP call with respect to SIP provisions that the EPA identified as automatic exemptions, director's discretion provisions, and affirmative defenses that are functionally exemptions; and denied the petitions as to other provisions that the EPA identified as overbroad enforcement discretion provisions, or affirmative defense provisions that would preclude or limit a court from imposing relief in the case of violations, which the Court also refers to as “specific relief.”
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         See 
                        <E T="03">Environ. Comm. Fl. Elec. Power</E>
                         v. 
                        <E T="03">EPA,</E>
                         94 F.4th 77, 115 (D.C. Cir. 2024).
                    </P>
                </FTNT>
                <P>
                    With respect to affirmative defense provisions against specific relief, the Court reaffirmed that States cannot limit courts' discretion to determine and apply appropriate civil penalties for violations of SIPs and denied the petitions for review as to affirmative defenses against monetary damages.
                    <SU>3</SU>
                    <FTREF/>
                     This is in keeping with the EPA's interpretation of the CAA in our 2015 SSM SIP call that States do not have authority to create, and thus the EPA does not have authority to approve, SIP provisions that include an affirmative defense that would operate to alter the 
                    <PRTPAGE P="99178"/>
                    jurisdiction of Federal courts to assess penalties or other forms of relief authorized in sections 113 and 304.
                    <SU>4</SU>
                    <FTREF/>
                     As explained in the 2015 SSM SIP call, SWAPCA Rule 400-107 provides affirmative defenses that operate to limit the jurisdiction of the Federal court in an enforcement action to assess monetary penalties or impose injunctive relief under certain circumstances as contemplated in CAA sections 113 and 304.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">Id.</E>
                         at 114-15.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         As stated in our supplemental notice of proposed rulemaking 79 FR 55920 at 55929. 
                        <E T="03">See also</E>
                         80 FR 33840 at 33853, 33870.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         79 FR 55920 at 55952. 
                        <E T="03">See also</E>
                         80 FR 33974.
                    </P>
                </FTNT>
                <P>
                    Southwest Clean Air Agency (SWCAA), a local air agency within the State of Washington primarily adopts, implements, and enforces State rules within its jurisdiction.
                    <SU>6</SU>
                    <FTREF/>
                     In some instances, however, SWCAA 
                    <SU>7</SU>
                    <FTREF/>
                     adopts its own rules and standards in lieu of statewide provisions. As also stated in our 2015 SSM SIP call, “SWAPCA 400-107 Excess Emissions” is nearly identical to WAC 173-400-107. Therefore, the EPA issued a SIP call with respect to “SWAPCA 400-107 Excess Emissions” as well. The detailed rationale for issuing the SIP call to Washington can be found in the 2015 SSM SIP Action and preceding proposed actions.
                    <E T="51">8 9</E>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         SWCAA has jurisdiction over most air pollution sources in Clark, Cowlitz, Lewis, Skamania, and Wahkiakum Counties, except for sources located on Tribal lands and sources subject to Federal or State jurisdiction.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         SWCAA was formerly known as Southwest Air Pollution Control Authority (SWAPCA).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         State Implementation Plans: Response to Petition for Rulemaking; Findings of Substantial Inadequacy; and SIP Calls To Amend Provisions Applying to Excess Emissions During Periods of Startup, Shutdown, and Malfunction, 78 FR 12460 (February 22, 2013).
                    </P>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         SNPR (“State Implementation Plans: Response to Petition for Rulemaking; Findings of Substantial Inadequacy; and SIP Calls To Amend Provisions Applying to Excess Emissions During Periods of Startup, Shutdown and Malfunction; Supplemental Proposal To Address Affirmative Defense Provisions in States Included in the Petition for Rulemaking and in Additional States; Supplemental notice of proposed rulemaking,” 79 FR 55919, September 17, 2014).
                    </P>
                </FTNT>
                <P>We are proposing to approve SWCAA's revisions to SWAPCA Rule 400-107 submitted on June 22, 2023, along with additional SIP revisions discussed below. The SIP revisions subject to this action are only applicable within SWCAA's jurisdiction, do not change State or other local air agency regulations, nor do they relax existing Federal protections under the CAA.</P>
                <HD SOURCE="HD1">II. Analysis of SIP Submission</HD>
                <HD SOURCE="HD2">A. The Provision Subject to the 2015 SSM SIP Call</HD>
                <P>In the 2015 SSM SIP Action, the EPA identified SWAPCA Rule 400-107 as inconsistent with CAA requirements because it provides affirmative defenses that operate to limit the jurisdiction of the Federal court in an enforcement action to assess monetary penalties or impose injunctive relief under certain circumstances as contemplated in CAA sections 113 and 304. Subsequent to the EPA's January 2022 FFS, Washington, on behalf of SWCAA, submitted a SIP revision on June 22, 2023, that revises the version of SWAPCA Rule 400-107 in the SIP to be consistent with the 2015 SSM policy articulated in the 2015 SSM SIP Action.</P>
                <P>The EPA last approved SWAPCA Rule 400-107 on February 26, 1997 (60 FR 8264). On September 1, 2016, SWCAA recodified “SWAPCA” Rule 400-107 to “SWCAA” Rule 400-107 reflecting the agency name change from “Southwest Air Pollution Control Authority” (SWAPCA) to “Southwest Clean Air Agency” (SWCAA). Accordingly, the June 22, 2023 SIP submittal references “SWCAA” Rule 400-107 rather than the “SWAPCA” Rule 400-107 we referenced in our 2015 SSM SIP call.</P>
                <P>
                    We reviewed Washington's June 22, 2023, SIP submittal regarding revisions to SWCAA Rule 400-107 and found the submission technically and administratively complete. We subsequently issued a completeness determination letter to Washington on August 8, 2023.
                    <SU>10</SU>
                    <FTREF/>
                     This completeness determination stopped the 18-month sanctions clock for SWCAA's jurisdiction that was started by the January 2022 FFS. This completeness determination did not address the other SIP revisions included in the June 22, 2023 SIP submittal.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         See 
                        <E T="03">301_SWCAA SSM SIP Call FFS Completeness Letter.pdf,</E>
                         included in the docket for this action.
                    </P>
                </FTNT>
                <P>
                    The EPA has assessed the impact of the D.C. Circuit decision with respect to the specific affirmative defense provision at issue in SWAPCA Rule 400-107. We have concluded that the previously stated basis for including SWAPCA Rule 400-107 in the 2015 SSM SIP call is consistent with the recent D.C. Circuit decision. The Court upheld the EPA's 2015 SSM SIP Action with regard to affirmative defenses against specific relief, finding that because CAA 304(a) and 113(b) authorize citizens and the EPA to seek injunctive relief and monetary penalties against sources that violate a SIP's emission rules, such an affirmative defense would “block that aspect of the Act's enforcement regime.” 
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         See 94 F.4th at 114-15.
                    </P>
                </FTNT>
                <P>
                    We are proposing to determine that the revised SWCAA Rule 400-107 is consistent with EPA's 2015 SSM policy articulated in the 2015 SSM SIP Action. Specifically, SWCAA's revisions clarify that all excess emissions are violations of the applicable statute, rule, permit or regulatory order. SWCAA also removed the language in Rule 400-107 stating that excess emissions determined to be unavoidable are not subject to penalty and added language making it clear that unavoidable excess emissions are subject to SWCAA's order authorities in SWCAA Rule 400-230(3), (4), and (6), but not subject to 
                    <E T="03">SWCAA's</E>
                     civil penalty authority. Finally, SWCAA Rule 400-107 now states that in any Federal enforcement action under 42 U.S.C. 7413 (Federal enforcement) or 7604 (Citizen suits) the court may determine what weight, if any, to assign the permitting authority's determination that an excess emissions event does or does not qualify as unavoidable under the criteria in SWCAA Rule 400-107.
                </P>
                <P>We are also proposing to find that the revisions to SWCAA Rule 400-107 satisfy the 2015 SSM SIP call as it will no longer provide an affirmative defense that may operate to limit the jurisdiction of the Federal court in an enforcement action.</P>
                <HD SOURCE="HD2">B. Additional SIP Revisions Submitted But Not Specified in the 2015 SSM SIP Call</HD>
                <P>
                    Washington also included SIP revisions for SWCAA in the June 22, 2023 SIP submittal that are not subject to the 2015 SSM SIP call. On July 26, 2024, Washington submitted a letter dated July 24, 2024, to the EPA withdrawing SWCAA Rule 400-040(1).
                    <SU>12</SU>
                    <FTREF/>
                     Therefore, the EPA is not proposing action on the withdrawn provision and will not cover it here. The remaining SIP revisions not subject to the 2015 SSM SIP call in SWCAA Rules 400-040, 400-070, and 400-081 clarify applicability, remove redundant language, revise cross-references as necessary to align with the recodification of RCW,
                    <SU>13</SU>
                    <FTREF/>
                     and remove excess emission provisions not 
                    <PRTPAGE P="99179"/>
                    consistent with EPA's 2015 SSM policy.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         See 
                        <E T="03">201_state submittal supplement_SWCAA Partial Withdrawal Request Letter—Ecology.pdf</E>
                         and 
                        <E T="03">202_state submittal supplement_SWCAA Partial Withdrawal Request Letter—SWCAA.pdf</E>
                         included in the docket for this action.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         The Revised Code of Washington (RCW), previously RCW 70.94 was recodified as RCW 70A.15.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         See Appendix B of 
                        <E T="03">102_state submittal_SWCAA 400 (SSM)—SIP Revision.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    In its June 22, 2023 SIP submittal, Washington requests approval of revisions to SWCAA Rule 400-040, 
                    <E T="03">General Standards for Maximum Emissions;</E>
                     SWCAA Rule 400-070, 
                    <E T="03">General Requirements for Certain Source Categories;</E>
                     and SWCAA Rule 400-081, 
                    <E T="03">Startup and Shutdown.</E>
                     Many of the revisions submitted are non-substantive changes such as adding quotation marks for clarity and updating the State effective date to September 10, 2021.
                </P>
                <HD SOURCE="HD3">SWCAA Rule 400-040, General Standards for Maximum Emissions</HD>
                <P>
                    The EPA last approved portions of SWCAA Rule 400-040 on April 10, 2017 (82 FR 17139). Our 2017 approval did not revise our February 26, 1997, approval (62 FR 8624) of SWCAA Rule 400-040(1)(a), State effective September 21, 1995. Similarly, the revisions we are proposing to approve in this action do not revise SWCAA Rule 400-040(1) as approved in 1997 and 2017 because Washington withdrew the revisions to SWCAA Rule 400-040(1) from their submission in a letter dated July 24, 2024. The remaining submitted revisions to SWCAA Rule 400-040 SIP provisions make grammatical changes to improve clarity, broaden the scope of the requirement to take reasonable precautions to prevent fugitive dust from becoming airborne to any “activity that generates” fugitive dust rather than just any “source,” and update the State effective date of all provisions to September 9, 2021. Consistent with past practice, SWCAA Rules 400-040(2) and (4) were not submitted for approval, and therefore outside the scope of this action.
                    <SU>15</SU>
                    <FTREF/>
                     The EPA is proposing to approve the remaining submitted SIP revisions to SWCAA Rule 400-040 that were not withdrawn with a State effective date of September 10, 2021.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         See 40 CFR 52.2470(c), Table 8.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">SWCAA Rule 400-070, General Requirements for Certain Source Categories</HD>
                <P>
                    The EPA last approved portions of SWCAA Rule 400-070 on April 10, 2017 (82 FR 17139). Our 2017 approval did not revise our February 26, 1997, approval (62 FR 8624) of SWCAA Rule 400-070(2)(a), State effective September 21, 1995. Washington has since revised SWCAA Rule 400-070(2)(a) removing a limited exception (15 minute per eight consecutive hours) for hog fuel boilers in subparagraph (2)(a) from otherwise applicable opacity standards in SWCAA Rule 400-040 and SWCAA Rule 400-050(1) to be consistent with the 2015 SSM policy articulated in the EPA's 2015 SSM SIP action. Washington requests the 1995 version of SWCAA Rule 400-070(2)(a) be removed from the SIP and replaced with this revised version.
                    <SU>16</SU>
                    <FTREF/>
                     Washington also updated the State effective date for all of SWCAA Rule 400-070 to September 10, 2021.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         EPA approved the 1995 version of SWCAA Rule 400-070(2)(a) on September 21, 1997 (62 FR 8264).
                    </P>
                </FTNT>
                <P>
                    Consistent with past practice, Washington did not submit the following SWCAA Rules subsections for approval into the SIP: 400-070(3)(b); 400-070(5); 400-070(6); 400-070(7); 400-070(8)(c); 400-070(9); 400-070(10); 400-070(11); 400-070(12); 400-070(14); 400-070(15)(c); and 400-070(16).
                    <SU>17</SU>
                    <FTREF/>
                     Those previously excluded provisions, along with the newly added 400-070(16), were not submitted for approval, and therefore outside the scope of this action. The EPA is proposing to approve the remaining submitted SIP revisions to SWCAA Rule 400-070 with a State effective date of September 10, 2021.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         See 40 CFR 52.2470(c), Table 8.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">SWCAA Rule 400-081, Startup and Shutdown</HD>
                <P>The EPA last approved portions of SWCAA Rule 400-081 on April 10, 2017 (82 FR 17139). Non-substantive changes were made removing redundant language and to clarify terms used. No substantive changes were made to SWCAA Rule 400-081 since our 2017 approval. The EPA is proposing to approve the revisions to SWCAA Rule 400-081 (State effective September 10, 2021) with no exceptions.</P>
                <HD SOURCE="HD1">III. Proposed Action</HD>
                <P>
                    The EPA is proposing to approve and incorporate by reference into the Washington SIP the revisions submitted on June 22, 2023, except for those withdrawn by Washington in a letter dated July 24, 2024.
                    <SU>18</SU>
                    <FTREF/>
                     We are also proposing to remove the 1995 version of SWCAA Rule 400-070(2)(a) as described in section II of this preamble. Specifically, we are proposing to approve and incorporate by reference in 40 CFR 52.2470(c)—
                    <E T="03">Table 8—Additional Regulations Approved for the Southwest Clean Air Agency (SWCAA) Jurisdiction,</E>
                     the following revised regulations with the exception of those subsections either withdrawn or not submitted:
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         See 
                        <E T="03">201_state submittal supplement_SWCAA Partial Withdrawal Request Letter—Ecology.pdf</E>
                         and 
                        <E T="03">202_state submittal supplement_SWCAA Partial Withdrawal Request Letter—SWCAA.pdf</E>
                         included in the docket for this action.
                    </P>
                </FTNT>
                <P>
                    • SWCAA Rule 400-040, 
                    <E T="03">General Standards for Maximum Emissions</E>
                     (State effective September 10, 2021);
                </P>
                <P>
                    • SWCAA Rule 400-070, 
                    <E T="03">General Requirements for Certain Source Categories</E>
                     (State effective September 10, 2021);
                </P>
                <P>
                    • SWCAA Rule 400-081, 
                    <E T="03">Startup and Shutdown</E>
                     (State effective September 10, 2021);
                </P>
                <P>
                    • SWCAA Rule 400-107, 
                    <E T="03">Excess Emissions</E>
                     (State effective September 10, 2021).
                </P>
                <P>The proposed revisions, upon finalization, will apply specifically to the jurisdictions of the Southwest Clean Air Agency in Washington State.</P>
                <HD SOURCE="HD1">IV. Incorporation by Reference</HD>
                <P>
                    In this document, the EPA proposes to include in a final rule, regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, the EPA proposes to incorporate by reference the provisions described in sections II and III of this document. The EPA is also proposing to remove regulatory text as described in sections II and III of this document that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA proposes to remove a 1995 version of SWCAA Rule 400-070(2)(a) from the incorporation by reference at 40 CFR 52.2470. The EPA has made, and will continue to make, these documents generally available through 
                    <E T="03">https://www.regulations.gov</E>
                     and at the EPA Region 10 Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information).
                </P>
                <HD SOURCE="HD1">V. Statutory and Executive Orders Review</HD>
                <P>Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this proposed action:</P>
                <P>
                    • Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);
                    <PRTPAGE P="99180"/>
                </P>
                <P>
                    • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>
                    • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);</P>
                <P>• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
                <P>• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;</P>
                <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);</P>
                <P>• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and</P>
                <P>Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on communities with environmental justice (EJ) concerns to the greatest extent practicable and permitted by law. The EPA defines EJ as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” The EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.” The air agency did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. The EPA did not perform an EJ analysis and did not consider EJ in this action. Due to the nature of the action being taken here, this action is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving environmental justice for communities with EJ concerns.</P>
                <P>The SIP is not approved to apply on any Indian reservation land in Washington except as specifically noted below and is also not approved to apply in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rulemaking does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on Tribal governments or preempt Tribal law.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.</P>
                </LSTSUB>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        42 U.S.C. 7401 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: December 3, 2024.</DATED>
                    <NAME>Casey Sixkiller,</NAME>
                    <TITLE>Regional Administrator, Region 10.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28804 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R04-OAR-2024-0006; FRL-12050-01-R4]</DEPDOC>
                <SUBJECT>Air Plan Approval; SC; Updates to the Cross-State Air Pollution Rule</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted through the South Carolina Department of Health and Environmental Control (SC DHEC) on September 26, 2023, regarding updates to the State's Cross-State Air Pollution Rule (CSAPR) emissions trading programs. The SIP revision incorporates by reference (IBRs) certain amendments EPA has made to the regulations for the Federal CSAPR trading programs for annual emissions of nitrogen oxides (NO
                        <E T="52">X</E>
                        ) and sulfur dioxide (SO
                        <E T="52">2</E>
                        ) for large electric generating units (EGUs). EPA created these Federal trading programs in 2011 as market-based mechanisms for South Carolina and certain other States to address their obligations to downwind States under the Clean Air Act (CAA or Act)'s good neighbor provision with respect to the national ambient air quality standards (NAAQS) for fine particulate matter (PM
                        <E T="52">2.5</E>
                        ). EPA is proposing to approve South Carolina's September 26, 2023, SIP revision because it is consistent with EPA's good neighbor CSAPR trading programs and the CAA.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before January 9, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by Docket ID No. EPA-R04-OAR-2024-0006 at 
                        <E T="03">www.regulations.gov.</E>
                         Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from 
                        <E T="03">Regulations.gov</E>
                        . EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (
                        <E T="03">i.e.,</E>
                         on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit 
                        <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Josue Ortiz Borrero, Air Regulatory Management Section, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. Mr. Ortiz can be reached via phone number (404) 562-8085 or via electronic mail at 
                        <E T="03">ortizborrero.josue@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Overview</HD>
                <P>
                    EPA is proposing to approve the portions of SC DHEC's 
                    <SU>1</SU>
                    <FTREF/>
                     September 26, 
                    <PRTPAGE P="99181"/>
                    2023, SIP submission that updates South Carolina's State trading programs at Regulation 61-62.97, Cross-State Air Pollution Rule (CSAPR) Trading Program, Subpart A—South Carolina CSAPR NO
                    <E T="52">X</E>
                     Annual Trading Program, and Subpart B—South Carolina CSAPR SO
                    <E T="52">2</E>
                     Group 2 Trading Program. Large EGUs in South Carolina are subject to these two State CSAPR trading programs for annual NO
                    <E T="52">X</E>
                     and SO
                    <E T="52">2</E>
                     emissions, which are precursors to PM
                    <E T="52">2.5</E>
                    , to address the State's good neighbor obligation for the 1997 annual PM
                    <E T="52">2.5</E>
                     NAAQS. The State CSAPR trading programs are integrated with the Federal CSAPR NO
                    <E T="52">X</E>
                     Annual Trading Program and the Federal CSAPR SO
                    <E T="52">2</E>
                     Group 2 Trading Program established by EPA's regulations at 40 CFR part 97, subparts AAAAA and DDDDD, respectively. As adopted by the State before this SIP revision and as previously approved by EPA into the SIP, the State's CSAPR trading program regulations generally IBR the Federal CSAPR trading program regulations as the Federal regulations had been amended through October 26, 2016. The September 26, 2023, SIP submission would update the IBR language to reflect amendments EPA made to the Federal CSAPR trading program regulations in the 2021 Revised CSAPR Update 
                    <SU>2</SU>
                    <FTREF/>
                     and the 2022 Recordation Rule.
                    <SU>3</SU>
                    <FTREF/>
                     The SIP revision would also correct two cross-references in the State's rule. Section II, below, briefly summarizes the framework of the CSAPR trading programs and how those programs are implemented in South Carolina.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         On July 1, 2024, SC DHEC was restructured into a health agency, the Department of Public Health, and an environmental agency, the Department of Environmental Services (DES). In a letter dated June 20, 2024, South Carolina represented to EPA that all the functions, powers, and duties of the environmental divisions, offices, and programs of DHEC, including the authority to administer and 
                        <PRTPAGE/>
                        enforce State Implementation Plans, are retained and continued in full force and effect under DES. The letter is in the docket for this proposed rulemaking. The State agency will simply be referred to as the State or South Carolina for the remainder of this document.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Revised Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS, 86 FR 23054 (Apr. 30, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Deadlines for Submission and Recordation of Allowance Allocations Under the Cross-State Air Pollution Rule (CSAPR) Trading Programs and the Texas SO
                        <E T="52">2</E>
                         Trading Program, 87 FR 52473 (Aug. 26, 2022).
                    </P>
                </FTNT>
                <P>
                    EPA is proposing to approve South Carolina's September 26, 2023, SIP revision because it is consistent with EPA's good neighbor CSAPR trading programs and the CAA.
                    <SU>4</SU>
                    <FTREF/>
                     Please refer to the 
                    <E T="04">Federal Register</E>
                     citations referenced herein, for additional detailed background on the CSAPR and subsequent rulemakings.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         EPA is not taking action on changes reflected in this submittal to South Carolina Regulation 61-62.60, subpart XXX, subpart IIII, subpart JJJJ, and South Carolina Regulation 61-62.63, subpart C, subpart AAAA, subpart YYYY, subpart ZZZZ, subpart DDDDD, subpart GGGGG, subpart IIIII, and subpart HHHHHH, since these rules are not part of the SIP.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Background on CSAPR and CSAPR-Related Rulemakings</HD>
                <P>
                    EPA published the original CSAPR in August 2011 to address the requirements of CAA section 110(a)(2)(D)(i)(I), known as the “good neighbor” provision, concerning interstate transport of air pollution.
                    <SU>5</SU>
                    <FTREF/>
                      
                    <E T="03">See</E>
                     42 U.S.C. 7410(a)(2)(D)(i)(I). Acting to address the same statutory provision, EPA published the CSAPR Update 
                    <SU>6</SU>
                    <FTREF/>
                     in October 2016 and the Revised CSAPR Update in April 2021. The three rules collectively require 27 southern, midwestern, and eastern States to limit their statewide emissions of SO
                    <E T="52">2</E>
                     and/or NO
                    <E T="52">X</E>
                     in order to mitigate transported air pollution unlawfully impacting other States' ability to attain or maintain one or more of the following four NAAQS: the 1997 annual PM
                    <E T="52">2.5</E>
                     NAAQS, the 2006 24-hour PM
                    <E T="52">2.5</E>
                     NAAQS, the 1997 8-hour ozone NAAQS, and the 2008 8-hour ozone NAAQS. To implement the required emissions reductions, the rules include Federal implementation plans (FIPs) that require EGUs in each covered State to participate in one or more of six Federal emissions trading programs established under regulations set forth at 40 CFR part 97, subparts AAAAA through EEEEE and GGGGG.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Federal Implementation Plans: Interstate Transport of Fine Particulate Matter and Ozone and Correction of SIP Approvals, 76 FR 48208 (Aug. 8, 2011).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS, 81 FR 74504 (Oct. 26, 2016).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         The trading programs established under CSAPR, the CSAPR Update, and the Revised CSAPR Update include a program for annual NO
                        <E T="52">X</E>
                         emissions; two geographically separate programs for annual SO
                        <E T="52">2</E>
                         emissions; and three geographically separate programs for ozone-season NO
                        <E T="52">X</E>
                         emissions. While some of the requirements set forth in these three rules have been amended in subsequent rules, the subsequent amendments are not relevant to the South Carolina SIP revision addressed in this action.
                    </P>
                </FTNT>
                <P>
                    As part of the original CSAPR in 2011, EPA determined that emissions from South Carolina significantly contributed to nonattainment or interference with maintenance of the 1997 ozone NAAQS and the 1997 24-hour PM
                    <E T="52">2.5</E>
                     NAAQS in other States.
                    <SU>8</SU>
                    <FTREF/>
                     To address South Carolina's good neighbor obligations with respect to the 1997 ozone NAAQS, the State's large EGUs became subject to the Federal CSAPR NO
                    <E T="52">X</E>
                     Ozone Season Trading Program established in subpart BBBBB of 40 CFR part 97, and to address the State's good neighbor obligations with respect to the 1997 PM
                    <E T="52">2.5</E>
                     NAAQS, the State's large EGUs because subject to the Federal CSAPR NO
                    <E T="52">X</E>
                     Annual Trading Program established in subpart AAAAA of 40 CFR part 97 and the Federal CSAPR SO
                    <E T="52">2</E>
                     Group 2 Trading Program established in subpart DDDDD of 40 CFR part 97.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         76 FR at 48212.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         76 FR at 48373-74.
                    </P>
                </FTNT>
                <P>
                    In the 2016 CSAPR Update, EPA determined that emissions from South Carolina do not significantly contribute to nonattainment or interfere with maintenance of the 1997 or 2008 ozone NAAQS in other States.
                    <SU>10</SU>
                    <FTREF/>
                     As a result, EGUs in South Carolina ceased to be subject to the Federal CSAPR NO
                    <E T="52">X</E>
                     Ozone Season Trading Program requirements starting with the 2017 ozone season.
                    <SU>11</SU>
                    <FTREF/>
                     The CSAPR Update included technical corrections to all the trading programs established in CSAPR but did not otherwise address the 1997 or 2006 PM
                    <E T="52">2.5</E>
                     NAAQS. South Carolina's EGUs that meet the CSAPR applicability criteria therefore continued to be subject to the CSAPR requirements to participate in the Federal CSAPR NO
                    <E T="52">X</E>
                     Annual Trading Program and the Federal CSAPR SO
                    <E T="52">2</E>
                     Group 2 Trading Program to address the State's good neighbor obligation with respect to the 1997 annual PM
                    <E T="52">2.5</E>
                     NAAQS.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         81 FR at 74555.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    CSAPR includes provisions under which States may submit and EPA will approve SIP revisions to modify or replace the CSAPR FIP requirements while allowing States to continue to meet their good neighbor obligations using either CSAPR's Federal emissions trading programs or State emissions trading programs integrated with the Federal programs.
                    <SU>12</SU>
                    <FTREF/>
                     South Carolina took advantage of these provisions in 2017. That year, South Carolina submitted and EPA approved revisions to South Carolina's SIP establishing two State CSAPR trading programs that replaced the two Federal CSAPR trading programs regarding South Carolina EGUs for annual emissions of NO
                    <E T="52">X</E>
                     and SO
                    <E T="52">2</E>
                    .
                    <SU>13</SU>
                    <FTREF/>
                     EPA approved South Carolina's 2017 SIP submission in an action published on October 13, 2017, which added Regulation 61-62.97, 
                    <E T="03">Cross-State Air Pollution Rule (CSAPR) Trading Program,</E>
                     to the South Carolina SIP. This rule contains two subparts: 61-62.97, Subpart A—South Carolina CSAPR NO
                    <E T="52">X</E>
                     Annual Trading Program, and 61-62.97, Subpart B—South Carolina CSAPR SO
                    <E T="52">2</E>
                     Group 2 Trading Program. In general, each subpart in South Carolina's CSAPR 
                    <PRTPAGE P="99182"/>
                    State trading program rule was designed to replace the corresponding Federal trading program regulations.
                    <SU>14</SU>
                    <FTREF/>
                     South Carolina's CSAPR trading programs are integrated with the Federal CSAPR NO
                    <E T="52">X</E>
                     Annual Trading Program and the Federal CSAPR SO
                    <E T="52">2</E>
                     Group 2 Trading Program. The State trading programs are substantively identical to the Federal trading programs as amended in the CSAPR Update.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See</E>
                         40 CFR 52.38, 52.39. States also retain the ability to submit SIP revisions to meet their good neighbor obligations using mechanisms other than the CSAPR Federal trading programs or integrated State trading programs.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See</E>
                         Air Plan Approval; South Carolina; Cross-State Air Pollution Rule, 82 FR 47936 (October 13, 2017).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         South Carolina Regulation 61-62.97, Subpart A—South Carolina CSAPR NO
                        <E T="52">X</E>
                         Annual Trading program is designed to IBR most of subpart AAAAA of 40 CFR part 97, while separately listing the Phase 2 annual NO
                        <E T="52">X</E>
                         trading budgets, set-asides, and variability limits found at 40 CFR 97.410(a)(18)(iv) through (vi) and (b)(18). Regulation 61-62.97, Subpart B—South Carolina CSAPR SO
                        <E T="52">2</E>
                         Group 2 Trading Program is designed to IBR most of subpart DDDDD of 40 CFR part 97, while separately listing the Phase 2 annual SO
                        <E T="52">2</E>
                         budgets, set-asides, and variability limits found at 40 CFR and 97.710(a)(6)(iv) through (vi) and (b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         South Carolina retains EPA's default allowance allocation methodology, and EPA remains the implementing authority for administration of the trading program.
                    </P>
                </FTNT>
                <P>
                    Since EPA's approval of the two State CSAPR trading programs into South Carolina's SIP in 2017, EPA has promulgated changes to the Federal CSAPR trading programs at 40 CFR part 97, subparts AAAAA and DDDDD, in the Revised CSAPR Update in 2021 and the Recordation Rule in 2022. The primary purpose of the Revised CSAPR Update rulemaking was to complete the evaluation of good neighbor obligations of certain States (not including South Carolina) with respect to the 2008 ozone NAAQS.
                    <SU>16</SU>
                    <FTREF/>
                     However, that rule also made certain amendments to subparts AAAAA and DDDDD of part 97, including adjustments to the procedures for allocating allowances from the portions of the States' emissions budgets set aside for potential allocation to new units (with conforming adjustments to the assurance provisions) 
                    <SU>17</SU>
                    <FTREF/>
                     as well as extensions to the deadlines for EPA to record allocations of allowances in sources' compliance accounts and for sources to hold allowances after each control period, whether the sources participate in the integrated trading programs under FIPs or under approved SIP revisions. The Recordation Rule further extended the deadlines for EPA to record allocations of allowances in sources' compliance accounts.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         The Revised CSAPR Update did not reopen EPA's determination in the CSAPR Update that South Carolina does not contribute significantly to nonattainment in, or interfere with maintenance by, any other State with respect to the 2008 ozone NAAQS. 
                        <E T="03">See</E>
                         86 FR 23067 &amp; n.60.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         The CSAPR trading programs' “assurance provisions” require the surrender of additional allowances if total emissions from a state's sources in a control period exceed the state's “assurance level,” which equals the state's emissions budget plus a defined “variability limit.” 
                        <E T="03">See, e.g.,</E>
                         40 CFR 97.406(c)(2) and 97.425.
                    </P>
                </FTNT>
                <P>
                    South Carolina's current September 26, 2023, SIP revision would update the State's Air Pollution Control Regulations and Standards at Regulation 61-62.97 to align with the changes made by EPA to the Federal CSAPR NO
                    <E T="52">X</E>
                     Annual Trading Program at 40 CFR part 97, subpart AAAAA, and the Federal CSAPR SO
                    <E T="52">2</E>
                     Group 2 Trading Program at 40 CFR part 97, subpart DDDDD, in the Revised CSAPR Update and the Recordation Rule.
                </P>
                <HD SOURCE="HD1">III. South Carolina's SIP Submission and EPA's Analysis</HD>
                <HD SOURCE="HD2">A. South Carolina's SIP Submittal</HD>
                <P>
                    As described in section II of this preamble, EPA approved South Carolina's CSAPR SIP revision adopting the State rule at Regulation 61-62.97 in an action published on October 13, 2017, replacing the Federal CSAPR NO
                    <E T="52">X</E>
                     Annual and SO
                    <E T="52">2</E>
                     Group 2 trading programs at 40 CFR part 97, subparts AAAAA and DDDDD, for South Carolina EGUs with State CSAPR trading programs that are integrated with and substantively identical to the Federal trading programs.
                    <SU>18</SU>
                    <FTREF/>
                     South Carolina's September 26, 2023, SIP submission seeks approval into the SIP of the State's revisions to its State CSAPR trading program rules that incorporate by reference more recent amendments to the Federal CSAPR trading program regulations. Specifically, the September 26, 2023, SIP submission revises the IBR language at Regulation 61-62.97, subpart A, paragraph 1, and subpart B, paragraph 1, to IBR specified revisions to the Federal CSAPR trading programs made after the previous October 26, 2016, IBR date and through August 26, 2022. The submission also corrects existing cross-references in Regulation 61-62.97, subpart A, paragraph 3, and subpart B, paragraph 3.
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See</E>
                         82 FR 47936.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. EPA's Analysis of South Carolina's SIP Submission</HD>
                <P>
                    EPA is proposing to approve the portions of South Carolina's September 26, 2023, SIP submission that update Regulation 61-62.97 by incorporating the amendments to the Federal CSAPR NO
                    <E T="52">X</E>
                     Annual and SO
                    <E T="52">2</E>
                     Group 2 trading programs at 40 CFR part 97 made in the Revised CSAPR Update and the Recordation Rule and by making technical corrections to cross-references. EPA's analysis below describes the specific changes included in the portions of the SIP submission that EPA is proposing to approve.
                </P>
                <P>
                    South Carolina's September 26, 2023, SIP revision makes two distinct updates to the State CSAPR trading program rules at Regulation 61-62.97. First, the SIP submission updates the IBR language at subpart A, paragraph 1, and subpart B, paragraph 1. The previously approved language IBRs “the provisions of the July 1, 2016, edition” of 40 CFR part 97, subparts AAAAA and DDDDD, “as amended at 81 FR [74604-07 or 74618-21] (October 26, 2016),” where the referenced amendment is a citation to specific pages of the CSAPR Update. The September 26, 2023, SIP revision removes the phrase “as amended at 81 FR [74604-07 or 74618-21] (October 26, 2016)” and replaces it with the new language “. . . as subsequently amended upon publication in the 
                    <E T="04">Federal Register</E>
                     as listed below . . .” and then adds tables 
                    <SU>19</SU>
                    <FTREF/>
                     with citations to the CSAPR Update (81 FR 74504; October 26, 2016), the Revised CSAPR Update (86 FR 23054; April 30, 2021), and the Recordation Rule (87 FR 52473; August 26, 2022). The revised IBR language also adds the phrase “as if fully repeated herein” to clarify that the text of the Federal regulations covered by the IBR is to be interpreted as if that text was repeated verbatim in the State's own regulations. The revisions align the format and phrasing of the IBR language in the State's CSAPR trading program regulations with the format and phrasing of the IBR language in the State's existing New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) regulations.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         This revised IBR table format lists the CSAPR rulemakings that amended the Federal NO
                        <E T="52">X</E>
                         annual and SO
                        <E T="52">2</E>
                         Group 2 trading programs at part 97 subpart AAAAA and DDDDD, respectively, and establishes August 26, 2022, as the new date by which part 97 amendments are incorporated into Regulation 61-62.97.
                    </P>
                </FTNT>
                <P>
                    The second update to the State CSAPR trading program rules at Regulation 61-62.97 in South Carolina's SIP submission revises subpart A, paragraph 3, and subpart B, paragraph 3, to correct existing cross-references. As originally adopted into the State's regulations, these paragraphs provided for “40 CFR 97.404(a)(1) and (b)(1)” and “40 CFR 97.704(a)(1) and (b)(1)” in the Federal trading program regulations covered by the IBR to be interpreted with specified wording changes needed to ensure that any EGUs in areas of Indian country within the State's borders continue to be covered by the Federal trading program regulations rather than the State trading program 
                    <PRTPAGE P="99183"/>
                    regulations. While EPA agreed with the State's wording changes, the paragraph citations were not entirely correct. The revisions included in this SIP revision retain the same wording changes but correct the paragraph citations so that the wording changes apply to “40 CFR 97.404(a)(1) and (b)” and “40 CFR 97.704(a)(1) and (b)” instead.
                </P>
                <P>
                    The changes included in the September 26, 2023, SIP submission make the State CSAPR trading program regulations more consistent with the current Federal CSAPR trading program regulations by incorporating amendments that EPA made to the Federal trading program regulations after approving South Carolina's CSAPR trading program regulations into the SIP and by correcting cross-references. EPA therefore is proposing to approve the portions of South Carolina's September 26, 2023, SIP submission that revise Regulation 61-62.97. EPA believes these portions of the SIP submission are consistent with the Federal CSAPR NO
                    <E T="52">X</E>
                     Annual and SO
                    <E T="52">2</E>
                     Group 2 trading program regulations and the implementing provisions that govern a full CSAPR SIP revision and that the SIP as revised would continue to satisfy the State's good neighbor obligation pursuant to CAA section 110(a)(2)(D)(i)(I) to prohibit emissions which will significantly contribute to nonattainment or interfere with maintenance of the 1997 annual PM
                    <E T="52">2.5</E>
                     NAAQS in any other State.
                </P>
                <HD SOURCE="HD1">IV. Incorporation by Reference</HD>
                <P>
                    In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, and as discussed in section III of this preamble, EPA is proposing to incorporate by reference South Carolina Regulation 61-62.97, State effective August 25, 2023, which adopts and incorporates by reference Federal amendments to 40 CFR part 97, subpart AAAAA—CSAPR NO
                    <E T="52">X</E>
                     Annual Trading Program and subpart DDDDD—CSAPR SO
                    <E T="52">2</E>
                     Group 2 Trading Program promulgated after October 26, 2016, through August 26, 2022. EPA has made, and will continue to make, these materials generally available through 
                    <E T="03">www.regulations.gov</E>
                     and at the EPA Region 4 office (please contact the person identified in the 
                    <E T="02">For Further Information Contact</E>
                     section of this preamble for more information).
                </P>
                <HD SOURCE="HD1">V. Proposed Action</HD>
                <P>EPA is proposing to approve the September 26, 2023, South Carolina SIP revision consisting of changes to Regulation 61-62.97, CSAPR Trading Program, in the South Carolina SIP for the reasons discussed above.</P>
                <HD SOURCE="HD1">VI. Statutory and Executive Order Reviews</HD>
                <P>
                    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 
                    <E T="03">See</E>
                     42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this proposed action merely proposes to approve State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this proposed action:
                </P>
                <P>• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);</P>
                <P>
                    • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>
                    • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);</P>
                <P>• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
                <P>• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;</P>
                <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and</P>
                <P>• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.</P>
                <P>Because this proposed action merely proposes to approve State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law, this proposed action for the State of South Carolina does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). Therefore, this proposed action will not impose substantial direct costs on Tribal governments or preempt Tribal law. The Catawba Indian Nation (CIN) Reservation is located within the boundary of York County, South Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120 (Settlement Act), “all State and local environmental laws and regulations apply to the [Catawba Indian Nation] and Reservation and are fully enforceable by all relevant State and local agencies and authorities.” The CIN also retains authority to impose regulations applying higher environmental standards to the Reservation than those imposed by State law or local governing bodies, in accordance with the Settlement Act.</P>
                <P>Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on communities with environmental justice (EJ) concerns to the greatest extent practicable and permitted by law. Executive Order 14096 (Revitalizing Our Nation's Commitment to Environmental Justice for All, 88 FR 25251, April 26, 2023) builds on and supplements E.O. 12898 and defines EJ as, among other things, the just treatment and meaningful involvement of all people regardless of income, race, color, national origin, or Tribal affiliation, or disability in agency decision-making and other Federal activities that affect human health and the environment.</P>
                <P>South Carolina did not evaluate EJ considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this proposed action. Due to the nature of the action being proposed here, this proposed action is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this proposed action, and there is no information in the record inconsistent with the stated goal of E.O. 12898/14096 of achieving EJ for communities with EJ concerns.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.</P>
                </LSTSUB>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        42 U.S.C. 7401 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <PRTPAGE P="99184"/>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>César Zapata,</NAME>
                    <TITLE>Acting Regional Administrator, Region 4.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28873 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 180</CFR>
                <DEPDOC>[EPA-HQ-OPP-2024-0431; FRL-12415-01-OCSPP]</DEPDOC>
                <SUBJECT>Chlorpyrifos; Tolerance Revocation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>EPA is proposing to revoke all tolerances for residues of chlorpyrifos, except for those associated with the use of chlorpyrifos on the following crops: alfalfa, apple, asparagus, tart cherry, citrus, cotton, peach, soybean, strawberry, sugar beet, and spring and winter wheat. This proposal also addresses the request to revoke all chlorpyrifos tolerances contained in the September 12, 2007, petition submitted by the Natural Resources Defense Council (NRDC) and Pesticide Action Network North America (PANNA).</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before February 10, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2024-0431, through the Federal eRulemaking Portal at 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at 
                        <E T="03">https://www.epa.gov/dockets.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Biggio, Pesticide Re-Evaluation Division (7508M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-566-0700; email address: 
                        <E T="03">OPPChlorpyrifosInquiries@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. General Information</HD>
                <HD SOURCE="HD2">A. Does this action apply to me?</HD>
                <P>This action is directed to the public in general and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.</P>
                <HD SOURCE="HD2">B. How can I get electronic access to other related information?</HD>
                <P>
                    You may access a frequently updated electronic version of 40 CFR part 180 through the Office of the Federal Register's e-CFR site at 
                    <E T="03">https://www.ecfr.gov/current/title-40.</E>
                </P>
                <HD SOURCE="HD2">C. What action is the Agency proposing?</HD>
                <P>
                    EPA is proposing to revoke all tolerances for residues of the insecticide chlorpyrifos as contained in 40 CFR 180.342, except for those tolerances associated with 11 uses that were proposed for retention in the Agency's December 2020 C
                    <E T="03">hlorpyrifos Proposed Interim Decision</E>
                     (2020 PID). (Ref. 1) As a result of voluntary cancellations and label amendments, registrations of chlorpyrifos will be limited in terms of food uses to these crops within certain states, as proposed in the 2020 PID and EPA's 
                    <E T="03">Updated Chlorpyrifos Refined Drinking Water Assessment for Registration Review</E>
                     (September 2020) (“2020 DWA”) as described in Unit III below. (Ref. 2)
                </P>
                <P>Therefore, the Agency is proposing to revoke all other tolerances that are not needed as a result of the cancellations, including uses in food handling establishments and food service establishments. This proposal will also address the request to revoke chlorpyrifos tolerances in the pending 2007 Petition from NRDC and PANNA.</P>
                <HD SOURCE="HD2">D. What is EPA's authority for taking this action?</HD>
                <P>
                    Pursuant to its authority under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a (
                    <E T="03">https://www.govinfo.gov/link/uscode/21/346a</E>
                    ), EPA may respond to a petition filed with the Agency under FFDCA section 408(d) by issuing a proposed and final rule under FFDCA section 408(e). The 2007 Petition requested that EPA revoke chlorpyrifos tolerances, as well as cancel chlorpyrifos registrations. EPA is proposing to revoke chlorpyrifos tolerances that will no longer be necessary due to the cancellation of domestic uses on those commodities. Under section 408(e) of the FFDCA, EPA may issue a rule revoking tolerances after providing notice of a proposed rulemaking and a period of not less than 60 days for public comment. 21 U.S.C. 346a(e).
                </P>
                <HD SOURCE="HD2">E. What is the expected impact of this action?</HD>
                <P>The revocations of these tolerances are not expected to present extraordinary circumstances because the registrants have requested, pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 6(f) (7 U.S.C. 136d(f)), to voluntarily cancel uses associated with these tolerances. EPA is in the process of approving those cancellation requests under FIFRA, which means that soon the tolerances will no longer be needed to cover residues of chlorpyrifos in or on those food commodities.</P>
                <P>The revocations of tolerances could impact foreign producers who use chlorpyrifos to control insect pests and importers of those commodities. Shipments found to have residues could not be sold in the United States, which may represent a loss to importers or their trading partners. It is possible that these effects could have downstream effects, such as raising costs to U.S. consumers of these commodities. Regardless of the potential impacts of this action, tolerances can only be maintained if they are safe, which is a risk-only analysis under the FFDCA.</P>
                <HD SOURCE="HD2">F. What can I do if I want the Agency to maintain, for import purposes, a tolerance that the Agency proposes to revoke?</HD>
                <P>
                    This proposed rule provides a 60-day public comment period. All chlorpyrifos registrants have already voluntarily requested cancellation of all the uses of chlorpyrifos associated with the tolerances proposed for revocation in this notice. Once those cancellations are effective, those uses of chlorpyrifos on these commodities will no longer be registered in the United States, and once use terminates under the applicable existing stocks provisions, the tolerances will no longer be necessary to cover residues from use of the pesticide. Any food being moved through interstate commerce after tolerances are revoked would be covered by the FFDCA channels of trade provision, 21 U.S.C. 346a(l)(5), as described in Unit VII.A. The Agency's typical process, 
                    <E T="03">e.g.,</E>
                     during registration review, is to remove tolerances from the regulations that are no longer necessary. This avoids confusion among the regulated community by reflecting registered uses and label directions and helps with consistency in enforcement under the FFDCA and FIFRA.
                </P>
                <P>
                    The only reason to retain a tolerance in such circumstances is for import purposes. Any commenter seeking to retain tolerances for import purposes 
                    <PRTPAGE P="99185"/>
                    must provide a comment to that effect and include information demonstrating the need for retaining a specific tolerance for specific imports, even if they have previously provided this information; a hypothetical need based on the potential for some commodities containing chlorpyrifos residues to one day be imported into the United States is insufficient.
                </P>
                <P>
                    If any data are necessary to retain the tolerances for import purposes, EPA will issue an order in the 
                    <E T="04">Federal Register</E>
                     under FFDCA section 408(f). The order would specify data needed and the timeframes for submission of the data and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FFDCA.
                </P>
                <P>After considering comments that are received in response to this proposed rule, EPA will issue a final rule.</P>
                <HD SOURCE="HD2">G. What should I consider as I prepare my comments for EPA?</HD>
                <P>
                    1. 
                    <E T="03">Submitting CBI.</E>
                     Do not submit CBI information to EPA through 
                    <E T="03">https://www.regulations.gov</E>
                     or email. If you wish to include CBI in your comment, please follow the applicable instructions at 
                    <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets#rules</E>
                     and clearly mark the part or all of the information that you claim to be CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
                </P>
                <P>
                    2. 
                    <E T="03">Tips for preparing your comments.</E>
                     When preparing and submitting your comments, see the commenting tips at 
                    <E T="03">https://www.regulations.gov/faq.</E>
                </P>
                <P>
                    3. 
                    <E T="03">Environmental justice.</E>
                     EPA seeks to achieve environmental justice—the just treatment and meaningful involvement of all people, regardless of income, race, color, national origin, Tribal affiliation, or disability, in Agency decision-making and other Federal activities that affect human health and the environment so that people are fully protected from disproportionate and adverse human health and environmental effects (including risks). To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionate and adverse human health impacts or environmental effects from exposure to chlorpyrifos, compared to the general population.
                </P>
                <HD SOURCE="HD2">H. What is contained in this proposed rule?</HD>
                <P>The following provides a brief roadmap of the Units in this proposed rule.</P>
                <P>• Unit II contains an overview of the relevant statutory background under the FFDCA and FIFRA as well as the regulatory status of chlorpyrifos. This Unit also provides a summary of the various recent legal challenges to the chlorpyrifos tolerances.</P>
                <P>• Unit III describes the Agency's proposal to revoke tolerances that will not be needed as a result of the approval of registrants' requests to cancel chlorpyrifos uses on certain food commodities.</P>
                <P>• Unit IV contains a safety determination that supports the tolerances that are not proposed for revocation.</P>
                <P>• Unit V contains the Agency's responses to specific claims raised in the 2007 Petition not otherwise addressed in the rest of the proposed rule.</P>
                <P>• Units VI, VII, and VIII contain EPA's request for public comment, discuss EPA's intention for phasing out the tolerances, and consistency with other statutory requirements and executive orders.</P>
                <HD SOURCE="HD1">II. Background</HD>
                <HD SOURCE="HD2">A. What is a tolerance?</HD>
                <P>
                    A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on food, which includes raw agricultural commodities, processed foods, and feed for animals. Under the FFDCA, residues of a pesticide chemical that are not covered by a tolerance or exemption from the requirement of a tolerance are considered unsafe. 
                    <E T="03">See</E>
                     21 U.S.C. 346a(a)(1). Foods containing unsafe residues are deemed adulterated and may not be distributed in interstate commerce. 
                    <E T="03">See</E>
                     21 U.S.C. 331(a), 342(a)(2)(B). This applies to both food treated domestically with a pesticide registered in the United States or treated in another country and imported into the United States. Thus, before registering any food-use pesticide (
                    <E T="03">i.e.,</E>
                     a pesticide use that is likely to result in residues in or on food) under FIFRA, 7 U.S.C. 136 
                    <E T="03">et seq.,</E>
                     EPA ensures that any necessary tolerances or exemptions are in place. 40 CFR 152.112(g). EPA also establishes tolerances or exemptions for pesticides not registered in the United States in order for commodities treated with those pesticides to be imported.
                </P>
                <HD SOURCE="HD2">B. FFDCA/FIFRA Background</HD>
                <HD SOURCE="HD3">1. FFDCA</HD>
                <P>
                    FFDCA section 408(b) authorizes EPA to establish a tolerance, if the Agency determines that a tolerance is safe. 
                    <E T="03">See</E>
                     21 U.S.C. 346a(b). If EPA determines that a tolerance is not safe, EPA must modify or revoke that tolerance. The FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” 21 U.S.C. 346a(b)(2)(A)(ii). This includes exposure through drinking water and in residential settings but does not include occupational exposure.
                </P>
                <P>
                    FFDCA section 408(b)(2)(C) requires EPA to give special consideration to the exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue[s].” 21 U.S.C. 346a(b)(2)(C). This provision also creates a presumption that EPA will use an additional safety factor for the protection of infants and children. Specifically, it directs that “in the case of threshold effects, . . . an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children.” (21 U.S.C. 346a(b)(2)(C)) EPA is permitted to “use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children.” (
                    <E T="03">Id.</E>
                    ) Due to Congress's focus on both prenatal and post-natal toxicity, EPA has interpreted this additional safety factor as pertaining to risks to infants and children that arise due to prenatal exposure as well as to exposure during childhood years. This section providing for the special consideration of infants and children in section 408(b)(2)(C) was added to the FFDCA by the Food Quality Protection Act (FQPA) in 1996; therefore, this additional margin of safety is referred to throughout this proposed rule as the FQPA safety factor (SF).
                </P>
                <P>
                    Finally, FFDCA section 408(b)(2)(D) contains several factors that EPA considers when making determinations about establishing, modifying, or 
                    <PRTPAGE P="99186"/>
                    revoking tolerances. 21 U.S.C. 346a(b)(2)(D).
                </P>
                <P>Any person may file a petition requesting that EPA establish, modify, or revoke a tolerance. 21 U.S.C. 346a(d)(1). After publishing notice of receipt of that petition and after giving due consideration, EPA may issue a final or proposed rule establishing, modifying, or revoking the tolerances or issue an order denying the petition. 21 U.S.C. 346a(d)(4)(A).</P>
                <HD SOURCE="HD3">2. FIFRA</HD>
                <P>
                    Under FIFRA (7 U.S.C. 136 
                    <E T="03">et seq.</E>
                    ), EPA regulates the sale, distribution, and use of pesticides. While FFDCA authorizes the establishment of legal limits for pesticide residues in food, FIFRA generally requires the approval of pesticides prior to their sale and distribution (
                    <E T="03">id.</E>
                     at section 136a(a)) and establishes a registration regime for regulating the use of pesticides. In order for a pesticide to be registered, EPA must determine that a pesticide “will not generally cause unreasonable adverse effects on the environment,” among other things. (
                    <E T="03">Id.</E>
                     at section 136a(c)(5)) The term “unreasonable adverse effects on the environment” is defined to include “a human dietary risk from residues that results from a use of a pesticide in or on any food inconsistent with the standard under section 346a of Title 21.” (
                    <E T="03">Id.</E>
                     at section 136(bb)) The FFDCA safety standard was integrated into the FIFRA registration standard through the FQPA, which also directed that EPA coordinate, to the extent practicable, revocations of tolerances with pesticide cancellations under FIFRA. (21 U.S.C. 346a(l)(1)).
                </P>
                <P>
                    Also under FIFRA, EPA is required to re-evaluate existing registered pesticides every 15 years in a process called “registration review.” (7 U.S.C. 136(a)(g)) The purpose of registration review is “to ensure that each pesticide registration continues to satisfy the FIFRA standard for registration,” (40 CFR 155.40(a)(1)) taking into account changes that have occurred since the last registration decision, including any new relevant scientific information and any changes in the law or regulations, policy, risk-assessment procedures or methods, and data requirements. (40 CFR 155.53(a)) To ensure that a pesticide continues to meet the standard for registration, EPA must determine, based on the available data, including any additional information that has become available since the pesticide was originally registered or previously re-evaluated, that the pesticide does not cause “unreasonable adverse effects on the environment.” (7 U.S.C. 136a(c)(1), (5); 
                    <E T="03">see also</E>
                     40 CFR 152.50) As part of the registration review of a pesticide, EPA also evaluates whether existing tolerances are safe and whether any changes to existing tolerances are necessary or appropriate. Pesticide products that do not meet the FIFRA standard for registration may be cancelled pursuant to the procedures in FIFRA section 6, 7 U.S.C. 136d. That provision of FIFRA also provides a mechanism for registrants to request voluntary cancellation of registered products or to request termination of specific uses on any registered product, at any time for any reason. 7 U.S.C. 136d(f). If a registrant requests such cancellation or use termination, EPA publishes notice of that request and allows for a public comment period. 7 U.S.C. 136d(f)(1)(B) and (C). After the public comment period, EPA may approve or deny the request. 7 U.S.C. 136d(f)(1)(D).
                </P>
                <HD SOURCE="HD2">C. Chlorpyrifos Background</HD>
                <P>Chlorpyrifos (0,0-diethyl-0-3,5,6-trichloro-2-pyridyl phosphorothioate) is a broad-spectrum, chlorinated organophosphate (OP) insecticide. Chlorpyrifos also forms the more toxic and potent acetylcholinesterase (AChE) inhibitor, chlorpyrifos oxon.</P>
                <P>
                    Chlorpyrifos has been registered for use in the United States since 1965. These uses have included a wide range of food crops (
                    <E T="03">e.g.,</E>
                     soybean, wheat) and non-food use sites (
                    <E T="03">e.g.,</E>
                     tobacco, ornamental flowering plants, turf), as well as public health uses (
                    <E T="03">e.g.,</E>
                     aerial and ground-based fogger mosquito adulticide treatments) and residential uses (
                    <E T="03">e.g.,</E>
                     roach bait products, and individual fire ant mound treatments). In 2000, chlorpyrifos registrants reached an agreement with EPA to voluntarily cancel all residential use products except those registered for ant and roach baits in child-resistant packaging and fire ant mound treatments. Most recently, as discussed later in this document, chlorpyrifos registrants have voluntarily requested to cancel all food uses except the 11 uses described in Unit III. Pursuant to those requests, EPA has already cancelled most of those registered food uses and expects to process the remaining cancellation requests by the end of this calendar year (2024). (Ref. 3-8).
                </P>
                <P>
                    EPA is currently working to complete the registration review of chlorpyrifos. As part of that process, EPA has completed multiple human health risk assessments (HHRAs) since 2011. As additional data became available for chlorpyrifos and its metabolite of concern, chlorpyrifos oxon, EPA completed revised draft human health risk assessments in 2014, 2016, and 2020. A refined drinking water assessment (DWA) was completed in 2016 (2016 DWA), and the Updated DWA was completed in 2020 (2020 DWA). In December 2020, EPA issued the 
                    <E T="03">Chlorpyrifos Proposed Interim Decision</E>
                     (2020 PID). (Ref. 1) At this time, EPA is working on responding to comments received on the 2020 PID and supporting risk assessments and on preparing an updated human health risk assessment and amended proposed interim registration review decision. EPA anticipates issuing an amended PID in 2026 followed by the Chlorpyrifos Interim Decision.
                </P>
                <P>It should be noted that there has been an international effort to develop a battery of new approach methodologies (NAMs) to inform the developmental neurotoxicity (DNT) potential for individual chemicals. The assays in this battery are expected to provide a mechanistic understanding of the underlying biological processes that may be vulnerable to chemically-induced disruption. Since the integration of data from the DNT NAM battery for the chlorpyrifos risk assessment is in progress, it has not been incorporated into the risk assessment that supports this rulemaking. It is intended to be incorporated into the amended human health risk assessment anticipated for release in 2025 in support of registration review, and the Agency will provide any updates on the status of this effort through the ongoing registration review of chlorpyrifos.</P>
                <HD SOURCE="HD2">D. 2007 Petition and Associated Litigation</HD>
                <P>In September 2007, PANNA and the NRDC jointly submitted to EPA a petition under FFDCA section 408(d), seeking revocation of all chlorpyrifos tolerances. The 2007 Petition also sought the cancellation of all chlorpyrifos pesticide product registrations under FIFRA section 6, 7 U.S.C. 136d. The 2007 Petition raised several claims, which are discussed in Unit V., regarding both EPA's 2006 FIFRA reregistration eligibility decision (RED) and active registrations of chlorpyrifos in support of the request for tolerance revocations and product cancellations.</P>
                <P>
                    In March 2009, EPA decided it would be appropriate to address these issues and the 2007 Petition claims in connection with the registration review of chlorpyrifos under FIFRA section 3(g) and decided to expedite that review, intending to finalize it several years in advance of the registration review deadline at that time, October 1, 2022.
                    <PRTPAGE P="99187"/>
                </P>
                <P>
                    On July 16, 2012, EPA denied the one FIFRA claim in a letter to the Petitioners and offered a partial response on several of the FFDCA claims; however, because the complexity of these scientific issues precluded EPA from finishing its review according to EPA's original timeline, the Petitioners brought legal action in the U.S. Court of Appeals for the Ninth Circuit to compel EPA to either issue an order denying the 2007 Petition or to grant the 2007 Petition by initiating the tolerance revocation process. On August 10, 2015, the Ninth Circuit ordered EPA to “issue either a proposed or final revocation rule or a full and final response to the administrative [P]etition by October 31, 2015.” 
                    <E T="03">In re Pesticide Action Network N. Am.,</E>
                     798 F.3d 809, 815 (9th Cir. 2015).
                </P>
                <P>
                    In response to that 2015 order, EPA issued a proposed rule to revoke all tolerances for chlorpyrifos on October 28, 2015 (published in the 
                    <E T="04">Federal Register</E>
                     on November 6, 2015 (80 FR 69080)). Although EPA noted that further evaluation might enable more tailored risk mitigation, EPA was unable to conclude, based on the information before EPA at the time, that the tolerances were safe, since the aggregate exposure to chlorpyrifos, driven by drinking water exposures, exceeded safe levels. In November 2016, EPA issued a notice of data availability announcing the availability of a revised human health risk assessment. (81 FR 81049) (Nov. 17, 2016) (Ref. 9)
                </P>
                <P>
                    In the meantime, the Ninth Circuit ordered EPA to take final action on its proposed revocation rule and issue its final response to the Petition by December 30, 2016. 
                    <E T="03">In re Pesticide Action Network N. Am.,</E>
                     808 F.3d 402 (9th Cir. 2015). EPA requested an extension of the deadline in order to be able to fully consider the July 2016 FIFRA Scientific Advisory Panel (SAP) report regarding chlorpyrifos toxicology, but the Ninth Circuit ordered EPA to complete its final action by March 31, 2017. 
                    <E T="03">In re Pesticide Action Network of North America</E>
                     v. 
                    <E T="03">EPA,</E>
                     840 F.3d 1014 (9th Cir. 2016).
                </P>
                <P>
                    Accordingly, EPA issued a formal denial of the FFDCA claims in the 2007 Petition in an order issued in March 2017. (Ref. 10) In that 2017 Petition Denial, EPA concluded that it was not required to complete—and would not complete—any tolerance revocation of chlorpyrifos without resolution of those issues during the ongoing FIFRA registration review of chlorpyrifos. 
                    <E T="03">Chlorpyrifos; Order Denying PANNA and NRDC's Petition to Revoke Tolerances,</E>
                     82 FR 16581 (April 5, 2017) (“2017 Petition Denial”). EPA also denied objections filed in response to the 2017 Petition Denial on July 24, 2019. 
                    <E T="03">See Chlorpyrifos; Final Order Denying Objections to March 2017 Petition Denial Order,</E>
                     84 FR 35555 (July 24, 2019) (“2019 Objections Denial”). In the 2019 Objections Denial, EPA concluded that it was appropriate to deny the objections related to new issues raised after EPA's 2006 tolerance reassessment and reregistration of chlorpyrifos as these issues are being addressed according to the schedule for EPA's ongoing registration review of chlorpyrifos.
                </P>
                <P>
                    The 2019 Objections Denial was challenged by several farmworker advocacy groups and States, and in April 2021, the Ninth Circuit issued its decision, finding that EPA's denial was arbitrary and capricious based on the record before the court. 
                    <E T="03">See League of United Latin Am. Citizens, et al.,</E>
                     v. 
                    <E T="03">Regan,</E>
                     996 F.3d 673 (9th Cir. 2021). The Ninth Circuit vacated EPA's petition response and ordered EPA to grant the 2007 Petition; to issue a final rule either revoking all chlorpyrifos tolerances or modifying the chlorpyrifos tolerances, provided EPA could make a determination that those modified tolerances met the safety standard mandated by the FFDCA; and to cancel registered chlorpyrifos products or uses associated with the revoked tolerances. The Ninth Circuit ordered EPA to issue that final rule within 60 days of the issuance of the mandate and to cancel the registered pesticides in a timely manner. Frustrated with the “[then-] thirteen years of interminable delay,” the Ninth Circuit concluded that “further factfinding” would not be reasonable and that “immediate issuance of a final regulation is the only reasonable action,” citing the FFDCA provision authorizing issuance of a final rule “ `
                    <E T="03">without further notice and without further period for public comment.' ” See id.</E>
                     at 702, citing 21 U.S.C. 136a(d)(4)(A)(i) (emphasis in original).
                </P>
                <P>
                    On August 30, 2021, EPA complied with the Ninth Circuit's ruling by granting the 2007 Petition and issuing the Final Tolerance Rule for Chlorpyrifos, which revoked all tolerances for chlorpyrifos. 
                    <E T="03">See</E>
                     86 FR 48315 (Aug. 30, 2021) (“2021 Final Rule”). EPA explained in the 2021 Final Rule that it was unable to determine that there was a reasonable certainty of no harm for aggregate exposure, including food, drinking water, and residential exposure, based on the available data and the anticipated exposures from all of the then-currently registered uses of chlorpyrifos. EPA's analysis indicated that risk from aggregate exposures from all of the then-registered uses would exceed the Agency's levels of concern. To satisfy international trade considerations, the 2021 Final Rule allowed the tolerances to remain in effect for six months until February 28, 2022, at which time the tolerances expired. Pursuant to FFDCA section 408(g), registrants and grower groups, among others, filed objections to the 2021 Final Rule, which EPA denied on February 28, 2022. 
                    <E T="03">See Chlorpyrifos; Final Order Denying Objections, Requests for Hearings, and Requests for a Stay of the August 2021 Tolerance Final Rule.</E>
                     87 FR 11222 (Feb. 28, 2022) (“2022 Objections Denial”).
                </P>
                <P>The 2021 Final Rule and 2022 Objections Denial were challenged by a chlorpyrifos registrant, Gharda Chemicals International, Inc. (Gharda), and 19 grower groups in the U.S. Court of Appeals for the Eighth Circuit. The grower groups included Red River Valley Sugarbeet Growers Association, U.S. Beet Sugar Association, American Sugarbeet Growers Associations, Southern Minnesota Better Sugar Cooperative, American Crystal Sugar Company, Minn-Dak Farmer Cooperative, American Farm Bureau Federation, American Soybean Association, Iowa Soybean Association, Minnesota Soybean Growers Association, Missouri Soybean Association, Nebraska Soybean Association, South Dakota Soybean Association, North Dakota Soybean Growers Association, National Association of Wheat Growers, Cherry Marketing Institute, Florida Fruit and Vegetable Association, Georgia Fruit and Vegetable Growers Association, and the National Cotton Council of America. These petitioners argued, among other things, that EPA should have modified tolerances by leaving tolerances in place consistent with the 11 uses proposed the 2020 PID, rather than revoking all tolerances.</P>
                <P>
                    On November 2, 2023, the Eighth Circuit issued its decision, vacating the 2021 Final Rule (and EPA's response to the 2007 Petition once again) and remanding the matter to EPA for further proceedings. 
                    <E T="03">See Red River Valley Sugarbeet Growers Ass'n, et al.</E>
                     v. 
                    <E T="03">Regan,</E>
                     85 F.4th 881 (8th Cir. 2023). The Eighth Circuit's decision noted that the Agency had “identified 11 specific candidates” of food and feed crop uses in the 2020 PID as part of Registration Review. Although the 2021 Final Rule (and the 2022 Objections Denial) explained why EPA was not modifying the tolerances consistent with the 2020 PID, the Eighth Circuit concluded that the 2021 Final Rule ignored modification of tolerances as an option for addressing the Ninth Circuit's 
                    <PRTPAGE P="99188"/>
                    mandate and thus was arbitrary and capricious. The Eighth Circuit's mandate issued on December 28, 2023, at which time all chlorpyrifos tolerances were automatically reinstated. EPA amended the Code of Federal Regulations on February 5, 2024, to reflect the Eighth Circuit's reinstatement of chlorpyrifos tolerances. 
                    <E T="03">See Chlorpyrifos; Reinstatement of Tolerances,</E>
                     89 FR 7625 (Feb. 5, 2024).
                </P>
                <HD SOURCE="HD1">III. Proposed Rule</HD>
                <P>In this document, EPA is proposing to revoke tolerances to reflect registrants' requests to voluntarily cancel food uses and submission of label amendments consistent with the 2020 PID and supporting documents. EPA anticipates approving all submitted cancellation requests by the end of 2024. After approval of the cancellation requests and label amendments, the only food uses that will remain on federally registered chlorpyrifos products are listed below and will be limited to the following States:</P>
                <P>1. Alfalfa: Arizona, Colorado, Iowa, Idaho, Illinois, Kansas, Michigan, Minnesota, Missouri, Montana, North Dakota, Nebraska, New Mexico, Nevada, Oklahoma, Oregon, South Dakota, Texas, Utah, Washington, Wisconsin, and Wyoming.</P>
                <P>2. Apple: Alabama, Delaware, Georgia, Idaho, Indiana, Kentucky, Maryland, Michigan, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Virginia, Vermont, Washington, West Virginia, and Washington, DC.</P>
                <P>3. Asparagus: Michigan.</P>
                <P>4. Tart cherry: Michigan.</P>
                <P>5. Citrus: Alabama, Florida, Georgia, North Carolina, South Carolina, and Texas.</P>
                <P>6. Cotton: Alabama, Florida, Georgia, North Carolina, South Carolina, and Virginia.</P>
                <P>7. Peach: Alabama, Delaware, Florida, Georgia, Maryland, Michigan, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Vermont, West Virginia, and Washington, DC.</P>
                <P>8. Soybean: Alabama, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Mexico, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Wisconsin, West Virginia, and Wyoming.</P>
                <P>9. Strawberry: Oregon</P>
                <P>10. Sugar beet: Iowa, Idaho, Illinois, Michigan, Minnesota, North Dakota, Oregon, Washington, Wisconsin.</P>
                <P>11. Wheat:</P>
                <P>a. Spring wheat: Colorado, Kansas, Missouri, Montana, North Dakota, Nebraska, South Dakota, and Wyoming.</P>
                <P>b. Winter wheat: Colorado, Iowa, Kansas, Minnesota, Missouri, Montana, North Dakota, Nebraska, Oklahoma, South Dakota, Texas, and Wyoming.</P>
                <P>EPA notes that not all chlorpyrifos products are registered for these uses in all of the above listed States. If the use is not registered on a particular chlorpyrifos product, it must be added via the FIFRA section 3 registration process in order for that product to be used in a particular State. Moreover, EPA notes that since the issuance of the 2020 PID, several States have prohibited use of chlorpyrifos, including California, Hawaii, New York, Maryland, and Oregon. States may regulate the sale or use of federally registered pesticides within their State. Although these particular States have adopted additional restrictions, the voluntary cancellation requests for the federally registered uses only reflected EPA's proposal in the 2020 PID and did not incorporate any additional restrictions at the State level. As a result, EPA's proposed tolerance revocations reflect only the adjustments to the federal registrations, but the continued registration review of chlorpyrifos allows for further consideration of this issue.</P>
                <P>In addition, the submitted label amendments are consistent with the reduced application frequency and rates for these uses that were used in the 2020 DWA and support the Estimated Drinking Water Concentration (EDWC) calculations. (Ref. 2) EPA expects to approve the last of these label amendments by the end of 2024. Consistent with the terms of the cancellation orders, use of these previously registered chlorpyrifos products on any crops beyond the 11 uses listed above and restricted as described herein will be prohibited after June 30, 2025.</P>
                <P>To cover residues of chlorpyrifos in food from these remaining food uses, the following existing tolerances are not being revoked: alfalfa, forage; alfalfa, hay; apple, apple, wet pomace; beet, sugar, dried pulp; beet, sugar, molasses; beet, sugar, roots; beet, sugar, tops; cattle, fat; cattle, meat; cattle, meat byproducts; cherry, tart; citrus, dried pulp; citrus, oil; cotton, undelinted cotton seed; egg; fruit, citrus, group 10; goat, fat; goat, meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts; horse, meat; horse, meat byproducts; milk, fat (reflecting 0.01 ppm in whole milk); peach; poultry, fat; poultry, meat; poultry, meat byproducts; sheep, fat; sheep, meat; sheep, meat byproducts; soybean, seed; strawberry; wheat, forage; wheat, grain; and wheat, straw in section 40 CFR 180.342(a) and asparagus in 180.342(c).</P>
                <P>EPA is proposing to revoke all other tolerances for residues of chlorpyrifos on specific food commodities (40 CFR 180.342(a)(1)); on all food commodities treated in food handling and food service establishments in accordance with prescribed conditions (40 CFR 180.342(a)(2) and(a)(3)); and on grape when used under regional registrations (40 CFR 180.342(c)).</P>
                <P>EPA is proposing these tolerance revocations because all the registrants have submitted voluntary cancellation requests for all food uses that trigger the need for those tolerances. Moreover, all registrants retaining any of the 11 food uses listed above have submitted label amendments that limit uses to the specific States listed above and restrict application rates and application frequency consistent with the assumptions supporting the 2020 DWA. As of the publication of this proposed rule, 41 products have been cancelled, and 12 products have had all food uses but the 11 uses identified above cancelled. EPA has approved amended labels for 15 products. EPA is currently working to process and expects to complete its issuance of cancellation orders by the end of 2024, at which time no food uses beyond the 11 identified above will remain registered.</P>
                <P>
                    Because of the cancellation of these uses, these tolerances will no longer be needed to cover residues from use of the pesticide within the United States. Removing unnecessary tolerances helps to avoid confusion among stakeholders about where the pesticide can be used and improves coordination under FIFRA and the FFDCA. EPA's typical practice when tolerances are no longer needed due to the cancellation of registered uses or products is to remove them from the Code of Federal Regulations, usually carried out after being discovered as not necessary in registration review. 
                    <E T="03">See, e.g., Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Implementing Registration Review Decisions for Certain Pesticides; Aluminum tris (O-ethylphosphonate), Carbon disulfide, et al.,</E>
                     (88 FR 46077) (July 19, 2023). (Ref. 11) There is no requirement, however, to wait until the conclusion of registration review, and since EPA is aware of the lack of necessity of these tolerances now, EPA's current proposed rule facilitates a more-timely reflection of the actual use status within the tolerance regulation to provide greater clarity to stakeholders, including growers and States, to avoid confusion 
                    <PRTPAGE P="99189"/>
                    about what is allowed under the FFDCA and FIFRA. Moreover, although the EPA's conclusions and rationale for the revocation of these tolerances differ from the claims outlined in the Petitioner's 2007 request to revoke all tolerances, the EPA is, in part, taking the action requested by the 2007 Petition.
                </P>
                <P>
                    In some cases, the registrants' requests to terminate these food uses or cancel registered chlorpyrifos products included requests to continue sale, distribution, and use of existing stocks for a certain period of time after cancellation. Existing stocks are those stocks of registered pesticide products that were in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Under those applicable cancellation orders, some existing stocks of previously registered chlorpyrifos products may be used on food until June 30, 2025. Therefore, EPA is proposing that the final rule revoking the unnecessary tolerances set an expiration date for those tolerances being revoked of July 1, 2025. This approach would align the permissible use period allowed under the cancellation orders with the coverage of the existing tolerance to allow for clearer coverage under section 408(l)(5) of the FFDCA. Under that provision, residues of a pesticide chemical in or on food will not render that food adulterated despite the revocation of a tolerance as long as the residue is present as a result of a lawful application of the pesticide and does not exceed the tolerance level that was authorized at the time of the application. 
                    <E T="03">See</E>
                     21 U.S.C. 346a(l)(5). In addition, this approach would provide for a reasonable interval for exporting countries to adjust to the new tolerance restrictions consistent with the United States' obligations under the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement).
                </P>
                <HD SOURCE="HD1">IV. Safety of the Remaining Tolerances</HD>
                <P>As noted in the previous Unit, in a typical revocation action following the cancellation of registered products or uses, EPA would propose to remove tolerances that are no longer necessary. Those actions typically do not require a rationale for justifying retention of the tolerances that are not affected by that action, as revocation does not impact the prior safety determinations made for the tolerances left in place.</P>
                <P>Chlorpyrifos, however, presents an unusual situation due to the litigation history and the pending 2007 Petition. The last formal determination that EPA made concerning chlorpyrifos tolerances was in the 2021 Final Rule, in which EPA concluded that aggregate exposure to chlorpyrifos, based on all registered food uses on chlorpyrifos products at that time, was unsafe. That rule was issued in response to a Ninth Circuit order, which vacated EPA's 2017 Petition Denial and 2019 Objections Denial in full and ordered EPA to issue a final rule revoking all tolerances or modifying tolerances, as long as a safety determination supported those modified tolerances. Then the Eighth Circuit reinstated those tolerances through vacatur of the 2021 Final Rule, despite EPA's finding that those tolerances were unsafe based on uses that were registered at that time and noted that EPA should have considered the option of retaining tolerances for the 11 uses proposed in the 2020 PID in its 2021 Final Rule. In addition, the 2007 Petition asserted that all chlorpyrifos tolerances were unsafe and should be revoked. Because EPA's proposed rule does not revoke all chlorpyrifos tolerances, EPA is providing an updated determination of safety supporting the tolerances that are not being revoked. This approach and the related FIFRA cancellation actions satisfy the Eighth Circuit's remand for further proceedings and the Ninth Circuit's directive to ensure that any modified tolerances are safe, without further factfinding and delay.</P>
                <P>
                    As indicated in Unit III., all chlorpyrifos registrants have submitted requests to voluntarily cancel all but 11 food uses of chlorpyrifos and to amend labels that limit those food uses in several ways, 
                    <E T="03">i.e.,</E>
                     limiting uses to specific States and restricting application rates and application frequency. After cancellation of all uses but the 11 food uses listed in Unit III, amendment of those uses on labels as described, and the termination of existing stocks terms, which EPA expects no later than June 30, 2025, EPA anticipates that exposure to chlorpyrifos in food and drinking water will align with the calculations in the 2020 DWA, the 2020 human health risk assessment, and the proposed determinations in the 2020 PID. The cancellations and label amendments are reducing the amount of chlorpyrifos being used—and thus being applied to food and getting into drinking water.
                </P>
                <P>
                    The safety determination in this document is based on the anticipated aggregate exposures expected as a result of the cancellation of most of the registered food uses and, on the analysis conducted in the 2020 HH DRA and the 2020 DWA. As noted above, the registration review process is ongoing, and there is a possibility that additional information may alter the Agency's conclusions once that process has been completed. However, for purposes of this rule and in an effort not to further delay progress on this rulemaking or in responding to the FFDCA petition, EPA is relying on the currently available scientific documents to conclude that the tolerances not being revoked are safe, 
                    <E T="03">i.e.,</E>
                     that there is a reasonable certainty that no harm will result from the aggregate exposure to chlorpyrifos. As noted in this Unit, the aggregate exposures assessed reflect the anticipated exposures to chlorpyrifos residues in drinking water after the cancellation of most food uses of chlorpyrifos, rather than chlorpyrifos residues in drinking water based on the wider set of previously registered food uses as was done in the 2021 Final Rule.
                </P>
                <P>
                    EPA's full risk conclusions supporting this proposed response are set forth in 
                    <E T="03">Chlorpyrifos: Third Revised Human Health Risk Assessment for Registration Review</E>
                     (September 2020) (“2020 HH DRA”) and the 2020 DWA. (Ref. 12 and 2) EPA's assessment supports a conclusion that aggregate exposures (including residential exposures and food and drinking water exposures anticipated from the remaining registered chlorpyrifos uses after the cancellation orders are issued and amended labels are approved under FIFRA) are safe.
                </P>
                <HD SOURCE="HD2">A. EPA's Hazard Assessment for Chlorpyrifos</HD>
                <HD SOURCE="HD3">1. General Approach to Hazard Identification, Dose-Response Assessment, and Extrapolation</HD>
                <P>
                    Any risk assessment begins with an evaluation of a chemical's inherent properties, and whether those properties have the potential to cause adverse effects (
                    <E T="03">i.e.,</E>
                     a hazard identification). In evaluating toxicity or hazard, EPA reviews toxicity data, typically from studies with laboratory animals, to identify any adverse effects on the test subjects. Where available and appropriate, EPA will also take into account studies involving humans, including human epidemiological studies. The animal toxicity database for a conventional, food use pesticide usually consists of studies investigating a broad range of endpoints including potential for carcinogenicity, mutagenicity, developmental and reproductive toxicity, and neurotoxicity. These studies include gross and microscopic effects on organs and tissues, functional effects on bodily organs and systems, effects on blood 
                    <PRTPAGE P="99190"/>
                    parameters (such as red blood cell (RBC) count, hemoglobin concentration, hematocrit, and a measure of clotting potential), effects on the concentrations of normal blood chemicals (including glucose, total cholesterol, urea nitrogen, creatinine, total protein, total bilirubin, albumin, hormones, and enzymes such as alkaline phosphatase, alanine aminotransferase and cholinesterase), and behavioral or other gross effects identified through clinical observation and measurement. EPA examines whether adverse effects are caused by different durations of exposure ranging from short-term (acute) to long-term (chronic) pesticide exposure and different routes of exposure (oral, dermal, inhalation). Further, EPA evaluates potential adverse effects in different age groups (adults as well as fetuses and juveniles). (Ref. 13 at 8-10).
                </P>
                <P>Once a pesticide's potential hazards are identified, EPA determines a toxicological level of concern for evaluating the risk posed by human exposure to the pesticide. In this step of the risk assessment process, EPA essentially evaluates the levels of exposure to the pesticide at which effects might occur. An important aspect of this determination is assessing the relationship between exposure (dose) and response (often referred to as the dose-response analysis). In evaluating a chemical's dietary risks, EPA uses a reference dose (RfD) approach, which typically involves a number of considerations including:</P>
                <P>
                    • 
                    <E T="03">A “point of departure” (PoD):</E>
                     Typically, the PoD is the value from a dose-response curve that is at the low end of the observable data in laboratory animals and that is the toxic dose that serves as the “starting point” in extrapolating a risk to the human population, although a PoD can also be derived from human data as well. PoDs are selected to be protective of the most sensitive adverse toxic effect for each exposure scenario and are chosen from toxicity studies that show clearly defined No Observed Adverse Effect Levels (NOAELs) or Lowest Observed Adverse Effect Levels (LOAELs), dose-response relationships, and relationships between the chemical exposure and effect. EPA will select separate PoDs, as needed, for each expected exposure duration (
                    <E T="03">e.g.,</E>
                     acute, chronic, short-term, intermediate-term) and route of exposure (
                    <E T="03">e.g.,</E>
                     oral, dermal, inhalation). For chlorpyrifos, as discussed later in this Unit, EPA derived PoDs based on 10% RBC AChE inhibition in the 2020 HH DRA.
                </P>
                <P>
                    • 
                    <E T="03">Interspecies extrapolation:</E>
                     Because most PoDs are derived from toxicology studies in laboratory animals, there is a need to extrapolate from animals to humans. In typical risk assessments, a default tenfold (10X) uncertainty factor is used to address the potential for a difference in toxic response between humans and animals used in toxicity tests. For chlorpyrifos, as described further below, EPA used a sophisticated model called a physiologically based pharmacokinetic-pharmacodynamic (PBPK-PD) model that accounts for differences in laboratory animals and humans, thereby obviating the need for the default interspecies factor.
                </P>
                <P>
                    • 
                    <E T="03">Intraspecies extrapolation:</E>
                     To address the potential for differences in sensitivity in the toxic response across the human population, EPA conducts intraspecies extrapolation. In typical risk assessments, a 10X default uncertainty factor is used. For chlorpyrifos, the PBPK-PD model used to derive PoDs also accounts for differences in metabolism and toxicity response across the human population for some age groups and some subpopulations, which allows the default factor of 10X to be refined in accordance with EPA's 2014 
                    <E T="03">Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation.</E>
                </P>
                <P>
                    • 
                    <E T="03">Food Quality Protection Act safety factor (FQPA SF):</E>
                     The FFDCA section 408(b)(2)(C) instructs EPA, in making its “reasonable certainty of no harm” finding, that in “the case of threshold effects, an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of data with respect to exposure and toxicity to infants and children.” Section 408(b)(2)(C) further states that “the Administrator may use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children.” For chlorpyrifos, EPA is retaining the default 10X FQPA SF as discussed later in this Unit.
                </P>
                <P>In the human health risk assessment process, as indicated above, EPA uses the selected PoD to calculate a RfD for extrapolating risk. The RfD is calculated by dividing the selected PoD by any applicable interspecies and intraspecies factors and other relevant uncertainty factors such as LOAEL to NOAEL factor or database uncertainty factor.</P>
                <P>
                    After calculating the RfD, as indicated above, EPA retains an additional safety factor of 10X to protect infants and children (the FQPA SF), unless reliable data support selection of a different factor, as required under the FFDCA. As described in EPA's policy for determining the appropriate FQPA SF, this additional safety factor often overlaps with other traditional uncertainty factors (
                    <E T="03">e.g.,</E>
                     LOAEL to NOAEL factor or database uncertainty factor), but it might also account for residual concerns related to pre- and post-natal toxicity or exposure. (Ref. 14 at 13-16) In implementing FFDCA section 408, EPA calculates a variant of the RfD referred to as a Population Adjusted Dose (PAD), by dividing the RfD by the FQPA SF. Risk estimates less than 100% of the PAD are safe.
                </P>
                <HD SOURCE="HD3">2. Toxicological Effects of Chlorpyrifos</HD>
                <P>
                    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information for chlorpyrifos in support of this action. For over two decades, EPA has evaluated the scientific evidence surrounding the different health effects associated with chlorpyrifos. The Agency has conducted extensive reviews of the scientific literature on health outcomes associated with chlorpyrifos and presented approaches for evaluating and using that information to the FIFRA Scientific Advisory Panel (SAP), on several occasions, as discussed in Unit V of the 2021 Final Rule. 
                    <E T="03">See</E>
                     86 FR at 48320-21. (
                    <E T="03">Note:</E>
                     The FIFRA SAP is a federal advisory committee created by FIFRA section 25(d), 7 U.S.C. 136w(d), and serves as EPA's primary source of external, independent, scientific peer review for significant regulatory and policy matters involving pesticides).
                </P>
                <P>
                    Chlorpyrifos has been tested in toxicological studies for the potential to cause numerous different adverse outcomes (
                    <E T="03">e.g.,</E>
                     reproductive toxicity, developmental toxicity, cancer, genotoxicity, dermal toxicity, endocrine toxicity, inhalation toxicity, and immunotoxicity). Chlorpyrifos has an established neurotoxic mode of action, and neurotoxicity is the most sensitive effect in all species, routes, and lifestages. The hazard characterization for chlorpyrifos and its oxon is based on adverse health effects in animals and humans related to two different neurotoxic endpoints: AChE inhibition and potential for neurodevelopmental effects. AChE inhibition is being used to derive the PODs for risk assessment. These PODs are protective for neurotoxic effects related to AChE inhibition and potential downstream neurotoxic effects. A weight-of-the-evidence (WOE) analysis on the potential for neurodevelopmental effects following chlorpyrifos exposure considered (1) whether chlorpyrifos 
                    <PRTPAGE P="99191"/>
                    causes long-term effects from prenatal and/or early lifestage exposure and (2) whether adverse effects can be attributed to doses lower than those which elicit 10% inhibition of RBC AChE. (Ref. 12 at 6) The FIFRA SAP reports have rendered numerous recommendations for additional study and sometimes conflicting advice for how EPA should consider (or not consider) the available data in conducting EPA's registration review human health risk assessment for chlorpyrifos.
                </P>
                <P>The remainder of this Unit IV.A.2. discusses the Agency's assessment of the science relating to AChE inhibition and the potential for neurodevelopmental effects. Other adverse outcomes besides AChE inhibition and neurodevelopment are less sensitive and are thus not discussed in detail here. Further information concerning those effects can be found in the 2000 human health risk assessment which supported the RED and the 2011 preliminary human health risk assessment. (Ref. 15 and 16).</P>
                <HD SOURCE="HD3">a. Acetylcholinesterase (AChE) Inhibition</HD>
                <P>Chlorpyrifos, like other organophosphate pesticides, affects the nervous system by inhibiting AChE, an enzyme necessary for the proper functioning of the nervous system and ultimately leading to signs of neurotoxicity. This mode of action, in which AChE inhibition leads to neurotoxicity, is well-established, and thus has been used as basis for the PoD for organophosphate human health risk assessments, including chlorpyrifos. This science policy is based on decades of work, which shows that AChE inhibition is the initial event in the pathway to cholinergic neurotoxicity.</P>
                <P>
                    The Agency has conducted a comprehensive review of the available data and public literature regarding this adverse effect from chlorpyrifos. (Ref. 17 at 24-25, Ref. 16 at 25-27) There are many chlorpyrifos studies evaluating RBC AChE inhibition or the brain in multiple lifestages (gestational, fetal, post-natal, and non-pregnant adult), multiple species (rat, mouse, rabbit, dog, human), methods of oral administration (oral gavage with corn oil, dietary, gavage via milk) and routes of exposure (oral, dermal, inhalation via vapor and via aerosol). In addition, chlorpyrifos is unique in the availability of AChE data from peripheral tissues in some studies (
                    <E T="03">e.g.,</E>
                     heart, lung, liver). There are also literature studies comparing the 
                    <E T="03">in vitro</E>
                     AChE response to a variety of tissues which show similar sensitivity and intrinsic activity. Across the database, brain AChE tends to be less sensitive than RBC AChE or peripheral AChE. In oral studies, RBC AChE inhibition is generally similar in response to peripheral tissues. Thus, the 
                    <E T="03">in vitro</E>
                     data and oral studies combined support the continued use of RBC AChE inhibition as the critical effect for quantitative dose-response assessment.
                </P>
                <P>
                    For chlorpyrifos, there are data from multiple studies which provide robust RBC AChE data, including studies in pregnant, lactating, and non-pregnant female rats from oral exposure (
                    <E T="03">e.g.,</E>
                     developmental neurotoxicity (DNT), reproductive, and subchronic data). In addition, studies are available in juvenile pups that show age-dependent differences, particularly following acute exposures, in sensitivity to chlorpyrifos and its oxon metabolite. This sensitivity is not derived from differences in the AChE enzyme itself but instead are derived largely from the immature metabolic clearance capacity in the juveniles.
                </P>
                <HD SOURCE="HD3">b. Neurodevelopmental Toxicity</HD>
                <P>In addition to information on the effects of chlorpyrifos on AChE, there is an extensive body of information (in the form of laboratory animal studies, epidemiological studies, and mechanistic studies) studying the potential effects on neurodevelopment in infants and children following exposure to organophosphates, including chlorpyrifos.</P>
                <P>There are numerous laboratory animal studies on chlorpyrifos in the literature that have evaluated the impact of chlorpyrifos exposure in pre- and post-natal dosing on the developing brain. These studies vary substantially in their study design, but all involve gestational and/or early post-natal dosing with behavioral evaluation from adolescence to adulthood. The data provide qualitative support for chlorpyrifos to potentially impact the developing mammalian brain with adverse outcomes in several neurological domains including cognitive, anxiety and emotion, social interactions, and neuromotor function. It is, however, important to note that there is little consistency in patterns of effects across studies. In addition, most of these studies use doses that far exceed EPA's 10% benchmark response level for RBC AChE inhibition. There are only a few studies with doses at or near the 10% brain or RBC AChE inhibition levels; among these only studies from Carr laboratory at Mississippi State University are considered by EPA to be high quality. In the 2020 HH DRA, EPA concluded that the laboratory animal studies on neurodevelopmental outcomes are not sufficient for quantitatively establishing a PoD. EPA further concluded that the laboratory animal studies do not support a conclusion that adverse neurodevelopmental outcomes are more sensitive than 10% RBC AChE inhibition. (Ref. 17 at 25-31, Ref. 12 at 88-89).</P>
                <P>EPA evaluated numerous epidemiological studies on chlorpyrifos and other organophosphate pesticides in accordance with the “Framework for Incorporating Human Epidemiologic &amp; Incident Data in Health Risk Assessment.” (Ref. 17, 18, and 19) The most robust epidemiologic research comes from three prospective birth cohort studies. These include: (1) The Mothers and Newborn Study of North Manhattan and South Bronx performed by the Columbia Children's Center for Environmental Health (CCCEH) at Columbia University; (2) the Mount Sinai Inner-City Toxicants, Child Growth and Development Study or the “Mt. Sinai Child Growth and Development Study;” and (3) the Center for Health Assessment of Mothers and Children of Salinas Valley (CHAMACOS) conducted by researchers at University of California Berkeley. (Ref. 17 at 32-43).</P>
                <P>
                    In the case of the CCCEH study, which specifically evaluated the possible connections between chlorpyrifos levels in cord blood and neurodevelopmental outcomes on a specific cohort, there are a number of notable associations. (Ref. 17 at 36-38) Regarding infant and toddler neurodevelopment, the CCCEH authors reported statistically significant deficits of 6.5 points on the Psychomotor Development Index at three years of age when comparing high to low exposure groups. Notably, these decrements persist even after adjustment for group and individual level socioeconomic variables. These investigators also observed increased odds of mental delay and psychomotor delay at age three when comparing high to low exposure groups. The CCCEH authors also report strong, consistent evidence of a positive association for attention disorders, attention deficit hyperactivity disorder (ADHD), and pervasive development disorder (PDD) when comparing high to low chlorpyrifos exposure groups. Moreover, it was reported that for children in the CCCEH cohort at age seven for each standard deviation increase in chlorpyrifos cord blood exposure, there is a 1.4% reduction in Full-Scale IQ and a 2.8% reduction in Working Memory. In addition, the CCCEH authors evaluated the relationship between pre-natal 
                    <PRTPAGE P="99192"/>
                    chlorpyrifos exposure and motor development/movement and reported elevated risks of arm tremor in children around 11 years of age in the CCCEH cohort.
                </P>
                <P>Notwithstanding the observed associations, EPA and the 2012 and 2016 FIFRA SAP reports identified multiple uncertainties in the CCCEH epidemiology studies. (Ref. 17 and 20) Some of these include the relatively modest sample sizes, which limited the statistical power; exposure at one point in pre-natal time with no additional information regarding post-natal exposures; representativeness of a single point exposure where time-varying exposures or the ability to define cumulative exposures would be preferable; lack of specificity of a critical window of effect and the potential for misclassification of individual exposure measures; and lack of availability of the raw data from the studies that would allow verification of study conclusions.</P>
                <P>
                    One of the notable uncertainties in the CCCEH epidemiology studies identified by EPA and the 2016 FIFRA SAP report is the lack of specific exposure information on the timing, frequency, and magnitude of chlorpyrifos application(s) in the apartments of the women in the study. Since 2012, despite extensive effort by EPA to obtain or infer this exposure information from various sources, the lack of specific exposure data remains a critical uncertainty. EPA made efforts in 2014 and 2016 to develop dose reconstruction of the exposures to these women. These dose reconstruction activities represent the best available information and tools but are highly uncertain. In addition, the pregnant women and children in the CCCEH studies were exposed to multiple chemicals, including multiple potent AChE-inhibiting organophosphates and 
                    <E T="03">N</E>
                    -methyl carbamates. Moreover, using EPA's dose reconstruction methods from 2014 suggest that the pregnant women likely did not exhibit RBC AChE inhibition above 10%. The 2012 and 2016 FIFRA SAP reports expressed concern that it is likely that the CCCEH findings occurred at exposure levels below those that result in 10% RBC AChE inhibition. (Ref. 17 and 20) However, given the limitations of the available CCCEH exposure information and the exposures to multiple potent AChE inhibiting pesticides, EPA has been unable to definitively conclude the level of AChE inhibition occurring in the CCCEH studies. Consistent with the 2016 SAP report, EPA remains unable to make a causal linkage between chlorpyrifos exposure and the outcomes reported by CCCEH investigators. (Ref. 12 and 17) Given the uncertainties, particularly in the exposure information available from CCCEH (single timepoints, lack of time varying exposure, lack of knowledge about application timing), uncertainties remain about the dose-response relationships from the epidemiology studies, which EPA noted in the 2020 HH DRA. (Ref. 12)
                </P>
                <P>
                    Finally, there are several lines of evidence for modes of action of chlorpyrifos distinct from the classical mode of action of AChE inhibition. This information has been generated from model systems representing different levels of biological organization and provide support for molecular initiating events (binding to the morphogenic site of AChE, muscarinic receptors, or tubulin), cellular responses (alterations in neuronal proliferation, differentiation, neurite growth, or intracellular signaling), and responses at the level of the intact nervous system (serotonergic tone, axonal transport). Among the many 
                    <E T="03">in vitro</E>
                     studies on endpoints relevant to the developing brain available for chlorpyrifos, only three have identified outcomes in picomole concentrations, including concentrations lower than those that elicit AChE inhibition 
                    <E T="03">in vitro.</E>
                     However, as is the case for many other developmental neurotoxicants, most of these studies have not been designed with the specific goal of construction or testing an adverse outcome pathway. Thus, as discussed in the 2020 HHRA, there are not sufficient data available to test rigorously the causal relationship between effects of chlorpyrifos at the different levels of biological organization in the nervous system. (Ref. 17 at 27-31), so until there are any updates to the state of the science for chlorpyrifos, the Agency is relying on the 2020 HHRA for this rule.
                </P>
                <HD SOURCE="HD3">3. Hazard Identification: Using AChE as the Toxicological Endpoint for Deriving PADs</HD>
                <P>
                    In its 2020 HH DRA assessment, based on its review of all available data, EPA determined that AChE inhibition has the most robust quantitative dose-response data and, thus, was chosen as the critical effect for the quantitative risk assessment. The Agency typically uses a 10% response level for AChE inhibition in human health risk assessments. This longstanding approach, 
                    <E T="03">see</E>
                     2006 RED, is consistent with the advice of the FIFRA SAP from 2008 and 2012 and has been applied in the 2006 OP cumulative risk assessment and other single-chemical OP risk assessments. (Ref. 21 and 22).
                </P>
                <P>During the ongoing registration review of chlorpyrifos and consideration of the 2007 Petition, the Agency has received comments concerning whether the use of the 10% AChE inhibition is sufficiently health protective. In one effort to take those comments into consideration, EPA conducted an additional hazard analysis and convened the 2016 FIFRA SAP to evaluate a proposal of using cord blood data from the CCCEH epidemiology studies as the source of data for PoDs. The 2016 FIFRA SAP report did not support the “direct use” of the cord blood and working memory data for deriving the regulatory endpoint, due to insufficient information about timing and magnitude of chlorpyrifos applications in relation to cord blood concentrations at the time of birth, uncertainties about the pre-natal window(s) of exposure linked to reported effects, and lack of a second laboratory to reproduce the analytical blood concentrations. (Ref. 17) Despite their critiques regarding uncertainties in the CCCEH studies, the 2016 FIFRA SAP report expressed concern that 10% RBC AChE inhibition may not be sufficiently protective of human health.</P>
                <P>The 2016 FIFRA SAP report, however, did present an alternative approach for EPA to consider. This report was supportive of EPA's use of the PBPK-PD model as a tool for assessing internal dosimetry from typical pesticide exposure scenarios. Use of the PBPK-PD model coupled with typical exposure scenarios provides the strongest scientific foundation for chlorpyrifos human health risk assessment. Given that the window(s) of susceptibility are currently not known for the observed neurodevelopmental effects, and the uncertainties associated with quantitatively interpreting the CCCEH cord blood data, the 2016 FIFRA SAP report recommended that the Agency use a time weighted average (TWA) blood concentration of chlorpyrifos for the CCCEH study cohort as the PoD for risk assessment. Thus, in 2016, EPA attempted, using the PBPK-PD model, to determine the TWA blood level expected from post-application exposures from the chlorpyrifos indoor crack-and-crevice use scenario. Despite that effort, EPA concluded in the 2020 HH DRA that the shortcomings of the data with regard to the dose-response relationship and lack of exposure information discussed above, continue to raise issues that make quantitative use of the CCCEH data in risk assessment not scientifically sound. (Ref. 12)</P>
                <P>
                    Thus, taking into consideration the robustness of the available data at this 
                    <PRTPAGE P="99193"/>
                    time, EPA has determined in the 2020 HH DRA that the most appropriate toxicological endpoint for deriving points of departure for assessing risks of chlorpyrifos is 10% RBC AChE inhibition. The Agency is not ignoring or dismissing the extensive data concerning the potential for adverse neurodevelopmental outcomes. As discussed later in this Unit, the Agency is addressing the uncertainties surrounding the potential for adverse neurodevelopmental outcomes by retaining the default 10X FQPA SF.
                </P>
                <HD SOURCE="HD3">a. Durations of Exposure</HD>
                <P>
                    As noted in Unit IV.A.1., EPA establishes PoDs for each expected exposure duration likely to result from pesticide exposure. For chlorpyrifos, exposure can occur from a single event or on a single day or from repeated days of exposure. With respect to AChE inhibition, effects can occur from a single exposure or from repeated exposures. For organophosphates, repeated exposures generally result in more AChE inhibition at a given administered dose compared to acute exposures. Moreover, AChE inhibition in repeated dosing guideline toxicology studies with most organophosphates show a consistent pattern of inhibition reaching a “steady state” of inhibition at or around 2 to 3 weeks of exposure in adult laboratory animals. (Ref. 23) This pattern observed with repeated dosing is a result of the amount of inhibition coming to equilibrium with production of new enzyme. As such, AChE studies of 2 to 3 weeks generally show the same degree of inhibition with those of longer duration (
                    <E T="03">i.e.,</E>
                     up to two years of exposure). Thus, for most of the human health risk assessments for the organophosphates, the Agency is focusing on the critical durations ranging from a single day up to 21 days (
                    <E T="03">i.e.,</E>
                     the approximate time to reach steady state for most organophosphates). As such, EPA has calculated PoDs for the acute and steady-state durations. As described below, these PoDs have been derived for various lifestages, routes, and exposure scenarios.
                </P>
                <HD SOURCE="HD3">b. Deriving PoDs, Interspecies and Intraspecies Extrapolation: Use of the PBPK Model</HD>
                <P>The process for developing RfDs and PADs typically involves first deriving PoDs directly from laboratory animal studies, followed by dividing the PoD by the default uncertainty factors of 10X each for interspecies extrapolation and intraspecies extrapolation, and the FQPA safety factor. For chlorpyrifos, EPA has developed a sophisticated PBPK-PD model to derive PoDs. Numerous federal advisory committees and external review panels have encouraged the use of such a modeling approach to reduce inherent uncertainty in the risk assessment and facilitate more scientifically sound extrapolations across studies, species, routes, and dose levels. The PBPK-PD model for chlorpyrifos has undergone extensive peer review by various individual or groups, including the FIFRA SAPs. Significant improvements have been made to the model over the years in response to recommendations from the 2008, 2011, and 2012 FIFRA SAPs and comments from both internal and external peer reviewers. (Ref. 12 at 20) As a result, EPA has concluded that the current PBPK-PD model is sufficiently robust and is using it for deriving PoDs for chlorpyrifos.</P>
                <HD SOURCE="HD3">i. Derivation of PoDs</HD>
                <P>As noted above, the PoDs for chlorpyrifos are based on the levels at which 10% RBC AChE inhibition is observed. The PBPK-PD model accounts for pharmacokinetic and pharmacodynamic characteristics to derive age, duration, and route-specific PoDs. Separate PoDs have been calculated for dietary (food, drinking water) and residential exposures by varying inputs on types of exposures and populations exposed. Specifically, the following characteristics have been evaluated: (1) Duration (24-hour (acute), 21-day (steady-state)); (2) route (dermal, oral, inhalation); (3) body weights which vary by lifestage; (4) exposure duration (hours per day, days per week); and (5) exposure frequency (events per day (eating, drinking)). For each exposure scenario, the appropriate body weight for each age group or sex was modeled as identified from the Exposure Factors Handbook for residential exposures and from the U.S. Department of Agriculture's (USDA) National Health and Nutrition Examination Survey (NHANES)/What We Eat in America (WWEIA) Survey for dietary exposures. (Ref. 24).</P>
                <P>Using the PBPK-PD model, the Agency evaluated the following exposure scenarios: (1) drinking water exposures to oxon (chlorpyrifos metabolite)—acute and steady-state exposures for infants, children, youths, and female adults; (2) food exposures to chlorpyrifos—acute and steady-state exposures for infants, children, youths, and female adults; (3) residential dermal exposures to chlorpyrifos—steady-state exposures for children, youths, and female adults; (4) residential hand-to-mouth ingestion exposures—steady-state for children 1 to 2 years old; and (5) residential inhalation exposures—steady-state for children 1 to 2 years old and female adults. (Ref. 12 at 22-25).</P>
                <P>Steady-state dietary exposure was estimated daily for 21 days. For drinking water exposure, infants and young children (infants &lt;1 year old, children between 1 to 2 years old, and children between 6 to 12 years old) were assumed to consume water 6 times per day, with a total consumption volume of 0.69 L/day. For youths and female adults, they were assumed to consume water 4 times per day, with a total consumption volume of 1.71 L/day.</P>
                <P>For all residential dermal exposures to chlorpyrifos, the dermal PoDs were estimated assuming 50% of the skin's surface was exposed. Exposure times for dermal exposure assessment were consistent with those recommended in the 2012 Residential Standard Operating Procedures (SOPs). (Ref. 22) For residential inhalation exposures following public health mosquitocide application, the exposure duration was set to 1 hour per day for 21 days. The incidental oral PoDs for children 1 to &lt;2 years old for other turf activities were estimated assuming that there were six events, 15 minutes apart, per day.</P>
                <P>The PBPK-modeled PoDs derived for the various lifestages, routes, and exposure scenarios discussed above, can be found in table 4.2.2.1.2 of the 2020 HH DRA. (Ref. 12).</P>
                <HD SOURCE="HD3">ii. Interspecies Extrapolation</HD>
                <P>As indicated above, the PBPK-PD model directly predicts human PoDs based on human physiology and biochemistry; thus, there is no need for an interspecies uncertainty factor to extrapolate from animal PoDs.</P>
                <HD SOURCE="HD3">iii. Intraspecies Extrapolation</HD>
                <P>The PBPK-PD model can account for variability of critical physiological, pharmacokinetic, and pharmacodynamic parameters in a population to estimate, using the Monte Carlo analysis, the distribution of doses that result in 10% RBC AChE inhibition. Therefore, Data-Derived Extrapolation Factors (DDEF) for intraspecies extrapolation have been estimated to replace the default intraspecies uncertainty factor for some groups. (Ref. 25).</P>
                <P>
                    According to EPA's DDEF guidance, when calculating a DDEF intraspecies extrapolation factor, administered doses leading to the response level of interest (in the case of chlorpyrifos, the 10% change in RBC AChE inhibition) are compared between a measure of average response and response at the tail of the distribution representing sensitive individuals. The tail of the distribution 
                    <PRTPAGE P="99194"/>
                    may be selected at the 95th, 97.5th, and 99th percentile.
                </P>
                <P>As for chlorpyrifos, the 99th percentile was used in risk assessment to provide the most conservative measure. (Ref. 26) In addition to estimating DDEF using the above approach for specific age groups, intraspecies DDEF were also calculated by comparing average responses between adults and 6-month-old infants. For the 2020 HHRA, the largest calculated DDEFs, 4X for chlorpyrifos and 5X for the oxon metabolite, were used for intraspecies extrapolation for all groups except women of childbearing age. There was a slightly higher variability between adults and infants when considering the distributions for the oxon metabolite, thus, the slightly higher intraspecies factor. For women of childbearing age, the Agency is applying the standard 10X intraspecies extrapolation factor due to limitations in the PBPK-PD model to account for physiological, anatomical, and biochemical changes associated with pregnancy. (Ref. 12 at 21-22).</P>
                <HD SOURCE="HD3">iv. Summarizing the PoDs, Interspecies and Intraspecies Extrapolation Factors</HD>
                <P>In summary, for assessing the risks from exposure to chlorpyrifos, the human PBPK-PD model has been used to derive PoDs based on 10% RBC AChE inhibition for various populations, durations, and routes. The model, which calculates a human PoD directly, obviates the need for an interspecies extrapolation factor since animal data are not used. To account for variations in sensitivities, the Agency has determined that an intraspecies factor of 4X for chlorpyrifos and 5X for the oxon is appropriate for all groups except women of childbearing age. For women of childbearing age, the typical 10X intraspecies factor is being applied, due the lack of appropriate information and algorithms to characterize physiological changes during pregnancy.</P>
                <HD SOURCE="HD3">c. FQPA Safety Factor</HD>
                <P>
                    As noted above, the FFDCA requires EPA, in making its safety finding, that in “the case of threshold effects, an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of data with respect to exposure and toxicity to infants and children.” 21 U.S.C. 346a(b)(2)(C). Section 408(b)(2)(C) further states that “the Administrator may use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children.” 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In applying the FQPA SF provision, EPA has interpreted it as imposing a presumption in favor of retaining it as an additional 10X SF. (Ref. 27 at 4, 11) Thus, EPA generally refers to the 10X factor as a presumptive or default 10X factor. EPA has also made clear, however, that this presumption or default in favor of the 10X is only a presumption. The presumption can be overcome if reliable data demonstrate that a different factor is safe for children. (
                    <E T="03">Id.</E>
                    ). In determining whether a different factor is safe for children, EPA focuses on the three factors listed in FFDCA section 408(b)(2)(C)—the completeness of the toxicity database, the completeness of the exposure database, and potential pre- and post-natal toxicity. In examining these factors, EPA strives to make sure that its choice of a SF, based on a weight-of-the-evidence evaluation, does not understate the risk to children. (
                    <E T="03">Id.</E>
                     at 24-25, 35).
                </P>
                <P>In the 2020 HH DRA, the default 10X FQPA SF was retained, and the assessment did not adopt or offer support for reducing the factor to 1X. However, the 2020 HH DRA does present potential risks from exposures to chlorpyrifos with retention of the default 10X FQPA SF and with reduction of the FQPA SF to 1X. The purpose of presenting both values was to provide an indication of what the potential risk estimates would be under either scenario. To reduce the FQPA SF to 1X, the FFDCA requires that EPA determine that reliable data demonstrate that the 1X would be safe for infants and children. The 2020 HH DRA did not make that determination. For chlorpyrifos, of the three factors mentioned in the previous paragraph, the primary factor that undercuts a determination that a different SF would be safe for children is the uncertainty around the potential for pre- and post-natal toxicity for infants and children in the area of neurodevelopmental outcomes.</P>
                <P>Based on the weight of the evidence concerning the potential for neurodevelopmental outcomes as discussed in this Unit above, there is ample qualitative evidence of a potential effect on the developing brain; however, there remains uncertainty around the levels at which these potential neurodevelopmental outcomes occur. Although the laboratory animal studies do not support a conclusion that neurodevelopmental outcomes are more sensitive than AChE inhibition, there remains some uncertainty in the dose-response relationship between chlorpyrifos and adverse neurodevelopmental outcomes based on the epidemiology data, and the mechanistic data are, at this time, incomplete in their characterization of dose-response. Because the data available at this time indicate remaining uncertainties concerning pre- and post-natal toxicity due to insufficient clarity on the levels at which these outcomes occur, the Agency is unable to conclude, at this time, that a different SF would be safe for infants and children. Thus, the Agency is retaining the default 10X FQPA SF at this time.</P>
                <HD SOURCE="HD3">d. Total Uncertainty Factors and PADs</HD>
                <P>In conclusion, the Agency used a total uncertainty factor of 100X for determining the food and drinking water PADs for females of childbearing age (1X interspecies factor, 10X intraspecies factor, and 10X FQPA SF); 40X for determining the food PADs for remaining populations (1X interspecies factor, 4X intraspecies factor, and 10X FQPA SF); and 50X for determining the PADs for drinking water for remaining populations (1X interspecies factor, 5X intraspecies factor, and 10X FQPA SF).</P>
                <P>Taking into consideration the PoDs, intraspecies extrapolation factors, and FQPA SF, the Agency calculated acute PADs (aPADs) and steady-state PADs (ssPADs) for infants (less than 1 year old), children (1 to 2 years old), children/youth (6 to 12 years old), and females (13 to 49 years old); these subpopulations will be protective of other subpopulations. While PADs were calculated for youths (13 to 19 years old), these PADs were not used in the dietary/aggregate assessments because females (13 to 49 years old) are considered protective of this sub-population. (Ref. 12 at 30-32) Risk estimates can be found in table 5.0.1 in the 2020 HH DRA.</P>
                <HD SOURCE="HD2">B. EPA's Exposure Assessment for Chlorpyrifos</HD>
                <P>
                    Risk is a function of both hazard and exposure. Thus, equally important to the risk assessment process as determining the hazards posed by a pesticide and the toxicological endpoints for those hazards is estimating human exposure. Under FFDCA section 408, EPA must evaluate the aggregate exposure to a pesticide chemical residue, which includes “all anticipated dietary exposures and all other exposures for which there is reliable information.” 21 U.S.C. 346a(b)(2)(A)(ii). This means that EPA is concerned not only with exposure to pesticide residues in food but also exposure resulting from pesticide contamination of drinking water 
                    <PRTPAGE P="99195"/>
                    supplies and from use of pesticides in the home or other non-occupational settings. (See 21 U.S.C. 346a(b)(2)(D)(vi)).
                </P>
                <P>
                    Pursuant to FFDCA section 408(b), EPA has evaluated chlorpyrifos's risks based on “aggregate exposure” to chlorpyrifos. By “aggregate exposure,” EPA is referring to exposure to chlorpyrifos by multiple pathways of exposure, 
                    <E T="03">i.e.,</E>
                     food, drinking water, and residential. EPA uses available data and standard analytical methods, together with assumptions designed to be protective of public health, to produce separate estimates of exposure for a highly exposed subgroup of the general population, for each potential pathway and route of exposure.
                </P>
                <P>The following analysis reflects a summary of the Agency's exposure assessment from the 2020 HH DRA unless otherwise specified. (Ref. 2).</P>
                <HD SOURCE="HD3">1. Exposure From Food</HD>
                <HD SOURCE="HD3">a. General Approach for Estimating Food Exposures</HD>
                <P>
                    There are two critical variables in estimating exposure in food: (1) the types and amount of food that is consumed; and (2) the residue level in that food. Consumption is estimated by EPA based on scientific surveys of individuals' food consumption in the United States conducted by the U.S. Department of Agriculture (USDA). (Ref. 28 at 12) Information on residue values can come from a range of sources including crop field trials; data on pesticide reduction (or concentration) due to processing, cooking, and other practices; information on the extent of usage of the pesticide; and monitoring of the food supply. (
                    <E T="03">Id.</E>
                     at 17).
                </P>
                <P>Data on the residues of chlorpyrifos in foods are available from both field trial data and monitoring data, primarily the USDA's Pesticide Data Program (PDP) monitoring data. Monitoring data generally provide a characterization of pesticide residues in or on foods consumed by the U.S. population that closely approximates real-world exposures because they are sampled closer to the point of consumption in the chain of commerce than field trial data, which are generated to establish the maximum level of legal residues that could result from maximum permissible use of the pesticide immediately after harvest.</P>
                <P>
                    EPA used a computer program known as the Dietary Exposure Evaluation Model and Calendex software with the Food Commodity Intake Database (DEEM-FCID version 3.16/Calendex) to estimate chlorpyrifos exposure by combining data on human consumption amounts with residue values in food commodities. This version of the model incorporated 2003-2008 consumption data from USDA's NHANES/WWEIA. The data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days. Foods “as consumed” (
                    <E T="03">e.g.,</E>
                     apple pie) are linked to EPA-defined food commodities (
                    <E T="03">e.g.,</E>
                     apples, peeled fruit—cooked; fresh or N/S (Not Specified); baked; or wheat flour—cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA Agricultural Research Service (ARS) and EPA. For chronic exposure assessment (or in the case of chlorpyrifos, for steady-state exposure assessment), consumption data are averaged for the entire U.S. population and within population subgroups; however, for acute exposure assessment, consumption data are retained as individual consumption events. Using this consumption information and residue data, the exposure estimates are calculated for the general U.S. population and specific subgroups based on age, sex, ethnicity, and region.
                </P>
                <P>For chlorpyrifos, EPA determined that acute and steady-state exposure durations were relevant for assessing risk from food consumption. EPA calculates potential risk by using probabilistic techniques to combine distributions of potential exposures in sentinel populations. The resulting probabilistic assessments present a range of dietary exposure/risk estimates.</P>
                <P>Because probabilistic assessments generally present a realistic range of residue values to which the population may be exposed, EPA's starting point for estimating exposure and risk for such assessments is the 99.9th percentile of the population under evaluation. When using a probabilistic method of estimating acute dietary exposure, EPA typically assumes that, when the 99.9th percentile of acute exposure is equal to or less than the aPAD, the level of concern for acute risk has not been exceeded. By contrast, where the analysis indicates that estimated exposure at the 99.9th percentile exceeds the aPAD, EPA would generally conduct one or more sensitivity analyses to determine the extent to which the estimated exposures at the high-end percentiles may be affected by unusually high food consumption or residue values. (The same assumptions apply to estimates for steady-state dietary exposure and the ssPAD.) To the extent that one or a few values seem to “drive” the exposure estimates at the high-end of exposure, EPA would consider whether these values are reasonable and should be used as the primary basis for regulatory decision making. (Ref. 29).</P>
                <HD SOURCE="HD3">b. Estimating Chlorpyrifos Exposures in Food</HD>
                <P>The residue of concern, for tolerance expression and risk assessment, in plants (food and feed) and livestock commodities is the parent compound chlorpyrifos. EPA has determined that the metabolite chlorpyrifos oxon is not a residue of concern in food or feed, based on available field trial data and metabolism studies that indicate that the oxon is not present in the edible portions of the crops. This conclusion is supported by USDA PDP monitoring data, which did not find residues of chlorpyrifos oxon on food samples. Furthermore, the oxon metabolite was not found in milk or livestock tissues. (Ref. 12 at 33).</P>
                <P>Acute and steady-state dietary (food only) exposure analyses for chlorpyrifos were conducted using the DEEM-FCID version 3.16/Calendex software. (Ref. 30) These analyses were performed for the purpose of obtaining food exposure values for comparison to the chlorpyrifos doses predicted by the PBPK-PD model to cause 10% RBC AChE inhibition. The acute and steady-state dietary (food only) exposure analyses do not include drinking water exposures, which were assessed separately, as discussed in the next section.</P>
                <P>The assessments include exposures to residues on all field crops and livestock use resulting from uses registered at the time of the dietary risk assessment as well as residues on imported commodities, but the assessments do not include potential exposure from food handling establishments as those were considered negligible. (Ref. 26) Both the acute and steady-state dietary (food only) exposure analyses are highly refined. The large majority of food residues used were based upon PDP monitoring data except in a few instances where no appropriate PDP data were available. In those cases, field trial data or tolerance-level residues were assumed. EPA also used food-processing factors from submitted studies as appropriate. In addition, EPA's acute and steady-state dietary (food only) exposure assessments used percent crop treated (PCT) information. (Ref. 30).</P>
                <P>
                    The chlorpyrifos acute dietary (food only) exposure analysis was conducted using the DEEM-FCID, version 3.16. The acute risk estimates were presented for the sentinel populations for infants (less than 1 year old); children (1-2 years old); youths (6-12 years old); and 
                    <PRTPAGE P="99196"/>
                    adults (females 13-49 years old). The assessment of these index lifestages is protective of other population subgroups.
                </P>
                <P>The chlorpyrifos steady-state dietary (food only) exposure analysis was conducted using the Calendex component of DEEM-FCID (with 2003-2008 survey consumption data from USDA's NHANES/WWEIA). Calendex provides a focus detailed profile of potential exposures to individuals across a calendar year. A calendar-based approach provides the ability to estimate daily exposures from multiple sources over time to an individual and is in keeping with two key tenets of aggregate risk assessment: (1) that exposures when aggregated are internally consistent and realistic; and (2) that appropriate temporal and geographic linkages or correlations/associations between exposure scenarios are maintained.</P>
                <P>The chlorpyrifos steady-state dietary (food only) assessment considers the potential risk from a 21-day exposure duration using a 3-week rolling average (sliding by day) across the year. For this assessment, the same food residue values used in the acute assessment were used for the 21-day duration. In the Calendex software, one diary for each individual in the WWEIA is selected to be paired with a randomly selected set of residue values for each food consumed. The steady-state analysis calculated exposures for the sentinel populations for infants (less than 1 year old); children (1 to 2 years old); youths (6 to 12 years old); and adults (females 13 to 49 years old). The assessment of these index lifestages is protective of other population subgroups.</P>
                <HD SOURCE="HD3">2. Exposure From Drinking Water</HD>
                <HD SOURCE="HD3">a. General Approach for Assessing Exposure From Drinking Water</HD>
                <HD SOURCE="HD3">i. Modeling and Monitoring Data</HD>
                <P>
                    Monitoring and modeling are both important tools for estimating pesticide concentrations in water and can provide different types of information. Monitoring data can provide estimates of pesticide concentrations in water that are representative of the specific agricultural or residential pesticide practices in specific locations, under the environmental conditions associated with a sampling design (
                    <E T="03">i.e.,</E>
                     the locations of sampling, the times of the year samples were taken, and the frequency by which samples were collected). Although monitoring data can provide a direct measure of the concentration of a pesticide in water, it does not always provide a reliable basis for estimating spatial and temporal variability in exposures because sampling may not occur in areas with any pesticide use, with the highest pesticide use, when the pesticides are being used, and/or at an appropriate sampling frequency to detect high concentrations of a pesticide that occur over the period of a day to several days.
                </P>
                <P>
                    Because of the limitations in most monitoring studies, EPA's standard approach is to use water exposure models as the primary means to estimate pesticide exposure levels in drinking water. Modeling is a useful tool for characterizing vulnerable sites and can be used to estimate upper-end pesticide water concentrations in surface water and groundwater. EPA's computer models use detailed information on soil properties, crop characteristics, and weather patterns to estimate water concentrations in vulnerable locations where the pesticide could be used according to its label. (Ref. 31 at 27-28) EPA's models calculate estimated water concentrations of pesticides using laboratory data that describe how fast the pesticide breaks down to other chemicals and how it moves in the environment at these vulnerable locations. Depending on the modeling algorithm (
                    <E T="03">e.g.,</E>
                     surface water modeling scenarios), daily concentrations can be estimated continuously over long periods of time, and for places that are of most interest for any particular pesticide.
                </P>
                <P>
                    EPA relies on models it has developed for estimating pesticide concentrations in both surface water and ground water. The most common model used to conduct drinking water assessments is the Pesticide in Water Calculator (PWC). PWC couples the Pesticide Root Zone Model (PRZM) and Variable Volume Water Model (VVWM) together to simulate pesticide fate and transport from the field of application to an adjacent reservoir. (Ref. 31 at 27-28). The PWC estimates pesticide concentrations for an index reservoir that is modeled for site-specific scenarios (
                    <E T="03">i.e.,</E>
                     weather and soil data) in different areas of the country. A detailed description of the models routinely used for exposure assessment is available from the EPA OPP Aquatic Models website. 
                    <E T="03">See</E>
                     EPA's aquatic models for estimating pesticide concentrations in food, water, non-target organisms, and residential and occupational environments. (Ref. 2).
                </P>
                <P>In modeling potential surface water concentrations, EPA models areas of the country that are vulnerable to surface water contamination. Consequently, EPA models exposures occurring in small highly agricultural watersheds in different growing areas throughout the country, over a 30-year period. The scenarios are designed to capture residue levels in drinking water from reservoirs with small watersheds with a large percentage of land use in agricultural production. EPA believes these assessments are likely reflective of a small subset of watersheds across the country and represent a drinking water source generally considered to be the most vulnerable to frequent high concentrations of pesticides.</P>
                <P>When monitoring data meet certain data quantity criteria, EPA has tools available to quantify the uncertainty in available monitoring data such that it can be used quantitively to estimate pesticide concentrations in drinking water. (Ref. 32) Furthermore, monitoring data can be used in a weight of evidence approach with model estimated concentrations to increase confidence in the conclusions of a drinking water assessment.</P>
                <HD SOURCE="HD3">ii. Drinking Water Level of Comparison (DWLOC)</HD>
                <P>The drinking water level of comparison (DWLOC) is a benchmark that can be used to guide refinements of the DWA. For a drinking water assessment that utilizes a DWLOC, the calculated DWLOC is compared to the EDWC. When the EDWC is greater than the DWLOC, there may be a risk concern. Conversely, when the EDWC is less than the DWLOC, there are no risks of concern.</P>
                <P>
                    The DWLOC relates to the concept of the “risk cup,” which EPA developed to facilitate risk refinement when considering aggregate human health risk to a pesticide. (Ref. 33) The risk cup is the total exposure allowed for a pesticide considering its toxicity and required safety factors. The risk cup represents the maximum safe exposure for the duration and population being considered. Exposures exceeding the risk cup are of potential concern. There are risk cups for each pertinent duration of exposure (
                    <E T="03">e.g.,</E>
                     acute, short-term, chronic). For chlorpyrifos, EPA is using exposure durations of acute (single day, 24 hours) and steady state (21-day). (Ref. 32).
                </P>
                <P>
                    In practice, EPA calculates the total exposure from food consumption and residential (or other non-occupational) exposures and subtracts this value from the maximum safe exposure level. The resulting value is the allowable remaining exposure that can come from drinking water without the potential for adverse health effects. Knowing this allowable remaining exposure and the water consumption for each population 
                    <PRTPAGE P="99197"/>
                    subgroup (
                    <E T="03">e.g.,</E>
                     infants), the Agency can calculate the DWLOC, which is the estimate of safe concentration of pesticides in drinking water. Using this process of DWLOC calculation allows EPA to determine a target maximum safe drinking water concentration, thereby identifying instances where drinking water estimates require refinement or estimates that may be indicative of risk. (Ref. 31 at 19-20).
                </P>
                <HD SOURCE="HD3">iii. Scale of Drinking Water Assessment</HD>
                <P>Although food is distributed nationally and pesticide residue values on food are therefore not expected to vary substantially throughout the country, drinking water is locally derived and concentrations of pesticides in source water fluctuate over time and location for a variety of reasons. Pesticide residues in water fluctuate daily, seasonally, and yearly because of the timing of the pesticide application, the vulnerability of the water supply to pesticide loading through runoff, spray drift and/or leaching, and changes in the weather. Concentrations are also affected by the method of application, the location, and characteristics of the sites where a pesticide is used, the climate, and the type and degree of pest pressure, which influences the application timing, rate used, and number of treatments in a crop production cycle.</P>
                <P>EPA may conduct a DWA for a national scale depending on the pesticide use under evaluation. A national scale DWA may use a single upper-end pesticide concentration as a starting point for assessing whether additional refinements are needed or estimated pesticide concentrations for certain site-specific scenarios that are associated with locations in the United States vulnerable to pesticide contamination based on pesticide use patterns. (Ref. 31 at 22).</P>
                <P>
                    EPA may also conduct a regional scale DWA to focus on areas where pesticide concentrations may be higher than the DWLOC. Under this assessment, EPA estimates pesticide concentrations across different regions in the United States that are subdivided into different areas called hydrologic units, identified by a two-digit hydrologic unit code (HUC 2) number. There are 21 HUC 2 regions in the United States, with 18 of them within the contiguous United States. These areas contain either the drainage area of a major river or a combined drainage of a series of rivers. 
                    <E T="03">See</E>
                     United States Geological Survey (USGS) Water Resources of the United States. (Ref. 34) Estimated pesticide concentrations under this approach would be associated with a vulnerable pesticide use area somewhere within the evaluated region. (Ref. 31 at 23).
                </P>
                <HD SOURCE="HD3">iv. Drinking Water Refinements</HD>
                <P>EPA has defined four assessment tiers for drinking water assessments. Lower-tiered assessments are more conservative based on the defaults or upper bound assumptions and may compound conservatisms, while higher tiers integrate more available data and provide more realistic estimates of environmental pesticide concentrations.</P>
                <P>
                    These four tiers vary in the level of resources, the amount of data considered, the spatial scale, and the refinement in the estimated pesticide concentration. Tier 1 requires the least amount of resources and the least amount of data, whereas Tier 4 is resource intensive, considers a wide range of sources and types of data, and is spatially explicit, resulting in high confidence in the reported pesticide concentration. Each successive tier integrates more focused pesticide, spatial, temporal, agronomic, and crop-specific information. The order in which refinements are considered (
                    <E T="03">i.e.,</E>
                     the order in which the assessment is refined) is pesticide-specific and depends on the nature and quality of the available data used to support the refinement. Additional information on the conduct of drinking water assessments can be found in the “Framework for Conducting Pesticide Drinking Water Assessment for Surface Water” (USEPA, 2020) (“DWA Framework document”). (Ref. 31).
                </P>
                <P>
                    As discussed in the DWA Framework document, EPA can incorporate several refinements in higher tiered modeling. Two such refinements are the percent cropped area (PCA) and the PCT. These are described in the document titled 
                    <E T="03">“Integrating a Distributional Approach to Using Percent Crop Area (PCA) and Percent Crop Treated (PCT) into Drinking Water Assessment.”</E>
                     (Ref. 35) The PCA refers to the amount of area in a particular community water system that is planted with the crop of interest (
                    <E T="03">e.g.,</E>
                     the default assumption is that the entire watershed is planted with a crop of interest). The PCT refers to the amount of the cropped area that is treated with the pesticide of interest (
                    <E T="03">e.g.,</E>
                     the default is that the entire cropped area is treated with the pesticide of interest). With additional use and usage data, EPA can refine assumptions about the application rate and PCT for use in modeling to generate EDWCs that are appropriate for human health risk assessment and more accurately account for the contribution from individual use patterns in the estimation of drinking water concentrations.
                </P>
                <HD SOURCE="HD3">b. Drinking Water Assessment for Chlorpyrifos</HD>
                <P>
                    For the chlorpyrifos drinking water assessment, the metabolite chlorpyrifos oxon—which forms during water treatment, 
                    <E T="03">e.g.,</E>
                     chlorination, of source water containing chlorpyrifos and is more toxic than chlorpyrifos—was selected as the residue of concern. (Ref. 36 and 37) The range of conversion from parent to oxon depends upon the type of water treatment and other conditions. Based on available information regarding the potential effects of certain water treatments (
                    <E T="03">e.g.,</E>
                     chlorination appears to hasten transformation of chlorpyrifos-to-chlorpyrifos oxon), EPA assumed that all chlorpyrifos in source water is converted to chlorpyrifos oxon upon treatment.
                </P>
                <P>The Agency used a DWLOC approach for assessing aggregate risk from chlorpyrifos. EPA calculated DWLOCs for different age groups for both the acute aggregate assessment and the steady-state aggregate assessment, taking into consideration the food and residential contributions to the risk cup. These numbers were provided as a benchmark for evaluating drinking water contributions from uses of chlorpyrifos across the United States, and whether such concentrations would result in aggregate exposures to chlorpyrifos that exceeded the Agency's levels of concern. The lowest acute DWLOC calculated was for exposure to chlorpyrifos oxon to infants (&lt;1 year old) at 23 ppb; the lowest steady-state DWLOC calculated was also for exposure to chlorpyrifos oxon to infants (&lt;1 year old) at 4.0 ppb. (Ref. 12 at 45) In other words, EDWCs for infants of chlorpyrifos oxon greater than 23 ppb from a single exposure or 4.0 ppb for a 21-day average would exceed EPA's DWLOC and present a risk that exceeds the Agency's level of concern.</P>
                <P>
                    In its 2014 DWA, EPA concluded that there were multiple uses of chlorpyrifos that could lead to exposures to chlorpyrifos oxon in drinking water that exceed the DWLOC. (Ref. 38) The 2014 DWA provided the basis for the Agency's proposal to revoke tolerances in 2015. (Ref. 39) In 2016, EPA conducted a refined DWA that estimated drinking water concentrations based on modeling of all registered uses, as well as all available surface water monitoring data. That 2016 DWA considered several refinement strategies in a two-step process to derive exposure estimates for chlorpyrifos and chlorpyrifos oxon across the country. The first step was an assessment of 
                    <PRTPAGE P="99198"/>
                    potential exposure based on the current maximum label rates at a national level. This indicated that the EDWCs could be above the DWLOC.
                </P>
                <P>
                    Because estimated concentrations at the national level exceeded the DWLOC, the Agency conducted a more refined assessment of uses on a regional level. (Ref. 36 at 73-86) This more refined analysis derived EDWCs using the PWC modeling for maximum labeled rates and 1 pound per acre by region for each use. The analysis indicated that approved uses of chlorpyrifos in certain vulnerable watersheds in every region of the country would result in EDWCs that exceed the DWLOC. For example, table 25 of EPA's 2016 DWA, which provides the range of estimated concentrations of chlorpyrifos in drinking water from uses on golf courses and agricultural or production crops, shows EDWCs that exceed the DWLOC in vulnerable watersheds in every region in the country. While the lower end of some of the ranges provided in that table are below the DWLOC, those lower numbers reflect a single use (
                    <E T="03">i.e.,</E>
                     single crop) and do not reflect potential exposure from other uses where applications occur at higher rates, more frequently, or in more locations made more vulnerable due to soil type, weather, or agronomic practices—all of which were permitted by labeling that was approved at that time. The relevant estimated concentration for risk assessment purposes was the highest concentration across all uses because it reflects concentrations that may occur in vulnerable sources of drinking water based on approved use instructions. (Ref. 36 at 73-74).
                </P>
                <P>In addition, a robust quantitative analysis of the monitoring data was conducted resulting in concentrations consistent with model-estimated concentrations above the DWLOC. (Ref. 36 at 90-121) Considering both monitoring data and modeling estimates together supported the conclusion that drinking water concentrations in regions across the country exceeded the DWLOC. (Ref. 36 at 121-123).</P>
                <P>After the EPA's 2016 DWA showed that the DWLOC exceedances are possible from several uses, EPA developed refinement strategies to examine those estimated regional/watershed drinking water concentrations to pinpoint community drinking water systems where exposure to chlorpyrifos oxon as a result of chlorpyrifos applications may pose an exposure concern. At that time, it was anticipated that a more refined drinking water assessment might allow EPA to better identify where at-risk watersheds are located throughout the country to support more targeted risk mitigation through the registration review process. The refinements better account for variability in the use area treated within a watershed that may contribute to a drinking water intake (referred to as PCA or percent use area when considering non-agricultural uses) and incorporate data on the amount of a pesticide that is actually applied within a watershed for agricultural and non-agricultural uses (referred to as PCT). These refinement approaches underwent external peer review and were issued for public comment in January 2020. (Ref. 39 and 40) In addition, EPA used average application rates, average numbers of annual applications for specific crops, and estimated typical application timing at the state-level based on pesticide usage data derived from a statistically reliable private market survey database, publicly available survey data collected by the USDA, and state-specific scientific literature from crop extension experts. (Ref. 1)</P>
                <P>The refinements were integrated in the 2020 DWA. The updated assessment applied the new methods for considering the entire distribution of community water systems, PCA adjustment factors, integrated state level PCT data, incorporated refined usage and application data, and included quantitative use of surface water monitoring data in addition to considering state level usage rate and data information. In addition, given the 2016 DWA calculation of EDWCs exceeding the DWLOC of 4.0 ppb, the Agency decided to focus its refinements for the 2020 DWA on a subset of uses in specific regions of the United States. The purpose of the focus on this subset of uses was to determine if limiting use of chlorpyrifos to only certain food uses and regions would yield EDWCs below the DWLOC. The subset of uses assessed were selected because they were identified as critical uses by the registrant and/or high benefit uses to growers. That subset of registered uses included the 11 identified crops in the specific geographical areas listed in Unit III, and the assessment of those uses assumed application rate and timing/frequency restrictions based on available usage data as described in the previous paragraph. The results of this analysis indicated that the EDWCs from this limited subset of uses are below both the acute and chronic DWLOCs. (Ref. 2 at 16-17) The 2020 DWA refined estimates did not include chlorpyrifos exposures from uses beyond that subset and expressly noted that a separate assessment would be needed in order to evaluate whether other uses could be added to or substituted for the crops and areas already identified and still maintain concentrations below the DWLOC.</P>
                <HD SOURCE="HD3">3. Residential Exposure to Pesticides</HD>
                <HD SOURCE="HD3">a. General Approach to Assessing Residential Exposures</HD>
                <P>
                    Residential assessments examine exposure to pesticides in non-occupational or residential settings (
                    <E T="03">e.g.,</E>
                     homes, parks, schools, athletic fields or any other areas frequented by the general public), based on registered uses of the pesticide. Exposures to pesticides may occur to persons who apply pesticides (which is referred to as residential handler exposure) or to persons who enter areas previously treated with pesticides (which is referred to as post-application exposure). Such exposures may occur through oral, inhalation, or dermal routes and may occur over different exposure durations (
                    <E T="03">e.g.,</E>
                     short-term, intermediate-term, long-term), depending on the type of pesticide and particular use pattern.
                </P>
                <P>
                    Residential assessments are conducted through examination of significant exposure scenarios (
                    <E T="03">e.g.,</E>
                     children playing on treated lawns or homeowners spraying their gardens) using a combination of generic and pesticide-specific data. EPA has prepared SOPs for conducting residential assessments on a wide array of scenarios that are intended to address the most common uses by which individuals could be exposed to pesticides in a non-occupational environment. (Ref. 22) The SOPs identify relevant generic data and construct algorithms for calculating exposure amounts using these generic data in combination with pesticide-specific information. The generic data generally involve survey data on behavior patterns (
                    <E T="03">e.g.,</E>
                     activities conducted on turf and time spent on these activities) and transfer coefficient data. Transfer coefficient data measure the amount of pesticide that transfers from the environment to humans from a defined activity (
                    <E T="03">e.g.,</E>
                     hand contact with a treated surface or plant). Specific information on pesticides can include information on residue levels as well as information on environmental fate such as degradation data.
                </P>
                <P>
                    Typically, once EPA assesses potential exposures from all applicable exposure scenarios, EPA selects the highest exposure scenario for each exposed lifestage to calculate representative risk estimates for use in the aggregate exposure assessment. 
                    <PRTPAGE P="99199"/>
                    Those specific exposure values are then combined with the lifestage appropriate exposure values provided for food and drinking water to determine whether a safety finding can be made. As described above, since EPA used a DWLOC approach for assessing risks for chlorpyrifos, EPA combined food exposures covered by all chlorpyrifos tolerances with residential exposures to identify the DWLOC and compared the DWLOC to EDWCs to determine whether a safety finding could be made. The end result is the same since both methods aggregate food, drinking water, and residential exposure estimates to determine whether a safety finding can be made.
                </P>
                <HD SOURCE="HD3">b. Residential Exposure Assessment for Chlorpyrifos</HD>
                <P>
                    Most chlorpyrifos products registered for residential treatment were voluntarily cancelled or phased out by the registrants between 1997 and 2001; however, some uses of chlorpyrifos remain that may result in non-occupational, non-dietary (
                    <E T="03">i.e.,</E>
                     residential) exposures, specifically roach bait products, fire ant mound treatments, and uses on golf courses. The roach bait product is designed such that the active ingredient is contained within a bait station, which eliminates the potential for contact with the chlorpyrifos containing bait material; therefore, residential exposures from the roach bait product were determined to be negligible. Since the ant mound treatments can only be applied professionally and direct exposure with treated mounds is not anticipated, residential exposures from the ant mound use were also determined to be negligible. (Ref. 12 at 36-44).
                </P>
                <P>For the golf course use, the Agency does not anticipate residential handler exposures, although there is a potential for residential post-application exposures that would aggregate with dietary exposures from the registered use on golf courses. Based on the anticipated use patterns reviewed under the SOP, EPA assessed these exposures as steady-state residential post-application exposures, which would be protective of shorter durations of exposure. There is a potential for dermal post-application exposures from the golf course uses for adults (females 13 to 49 years old); youths (11 to less than 16 years old); and children (6 to less than 11 years old). Although EPA did not identify any post-application risks of concern from use on golf courses, EPA used the post-application exposures and risk estimates resulting from the golfing scenarios in EPA's aggregate exposure and risk assessment.</P>
                <HD SOURCE="HD3">4. Cumulative Risk</HD>
                <P>FFDCA section 408(b)(2)(D)(v), 21 U.S.C. 346a(b)(2)(D)(v), requires EPA to consider “available information concerning the cumulative effects of [pesticide chemical] residues and other substances that have a common mechanism of toxicity.”</P>
                <P>
                    Chlorpyrifos belongs to a class of pesticides called organophosphates (OPs), which share the ability to inhibit AChE through phosphorylation of the serine residue on the enzyme leading to accumulation of acetylcholine and ultimately cholinergic neurotoxicity. This shared mode of action/adverse outcome pathway (MOA/AOP) is the basis for the OP common mechanism grouping per OPP's 
                    <E T="03">Guidance for Identifying Pesticide Chemicals and Other Substances that have a Common Mechanism of Toxicity</E>
                     (USEPA, 1999). The 2006 cumulative risk assessment for organophosphates (2006 OP CRA) used brain AChE inhibition in female rats as the source of dose response data for the relative potency factors and PODs for each OP, including chlorpyrifos. After considering the potential for cumulative risks of concern from the OPs, EPA concluded that the tolerances were safe. (Ref. 21).
                </P>
                <P>
                    After completion of the single-chemical OP assessments for this round of registration review, but prior to the issuance of a final registration review decision for chlorpyrifos (and the other OPs), EPA will determine whether any updates to the 2006 OP CRA on AChE inhibition are necessary. In the meantime, no additional uses have been approved since that document was completed (
                    <E T="03">i.e.,</E>
                     no additional exposures), and many uses have been (or are in the process of being) cancelled or reduced (
                    <E T="03">e.g.,</E>
                     the current reduction of chlorpyrifos uses). As such, EPA expects the potential for cumulative risks and any cumulative risk estimates will likely be lower than assessed in 2006, when EPA concluded that the results of the cumulative assessment support a reasonable certainty of no harm finding as required by FQPA.
                </P>
                <HD SOURCE="HD2">C. Aggregate Risk Assessment and Determination of Safety for Chlorpyrifos</HD>
                <P>
                    The final step in the risk assessment is the aggregate exposure assessment and risk characterization. In this step, EPA combines information from the first three steps (hazard identification, level of concern (LOC)/dose-response analysis, and human exposure assessment) to quantitatively estimate the risks posed by a pesticide. The aggregated exposure assessment process considers exposure through multiple pathways or routes of exposure (
                    <E T="03">e.g.,</E>
                     food, water, and residential) for different sub-populations (
                    <E T="03">e.g.,</E>
                     infants, children ages 1-2) and exposure duration or types of effects (
                    <E T="03">e.g.,</E>
                     acute (single dose) noncancer effects, chronic noncancer effects, and cancer). The aggregated exposure assessments can be deterministic (levels of exposure for each pathway are point estimates), probabilistic (levels of exposure are a distribution for a given population), or a combination of the two and are dependent on the level of refinement or assessment tier.
                </P>
                <P>
                    As noted above, EPA evaluates aggregate exposure by comparing combined exposure from all relevant sources to the safe level. Where exposures exceed the safe level (
                    <E T="03">i.e.,</E>
                     the risk cup), they present potential risks of concern. There are risk cups for each pertinent duration of exposure for a pesticide because the amount of exposure that can be incurred without adverse health effects will vary by duration (
                    <E T="03">e.g.,</E>
                     acute, short-term, chronic).
                </P>
                <P>
                    Whether risks will exceed the risk cup (
                    <E T="03">i.e.,</E>
                     whether exposures are expected to exceed safe levels) is expressed differently, depending on the type of level of concern the Agency has identified. For dietary assessments, the risk is expressed as a percentage of the acceptable dose (
                    <E T="03">i.e.,</E>
                     the dose which EPA has concluded will be “safe”). Dietary exposures greater than 100% of the acceptable dose are generally cause for concern and would be considered “unsafe” within the meaning of FFDCA section 408(b)(2)(B). For non-dietary (and combined dietary and non-dietary) risk assessments of threshold effects, the toxicological level of concern is typically not expressed as an RfD/PAD, but rather in terms of an acceptable (or target) Margin of Exposure (MOE) between human exposure and the PoD. The “margin” that is being referred to in the term MOE is the ratio between the PoD and human exposure, which is calculated by dividing human exposure into the PoD. An acceptable MOE is generally considered to be a margin at least as high as the product of all applicable safety factors for a pesticide. For example, when the Agency retains the default uncertainty factors for dietary or aggregate risk (a 10X interspecies uncertainty factor, a 10X intraspecies uncertainty factor, and a 10X FQPA safety factor), the total uncertainty factor (or level of concern) is 1,000, and any MOE above 1,000 represents exposures that are not of concern. Like RfD/PADs, specific target MOEs are selected for exposures of different durations and routes. For non-
                    <PRTPAGE P="99200"/>
                    dietary exposures, EPA typically examines short-term, intermediate-term, and long-term exposures. Additionally, target MOEs may be selected based on both the duration of exposure and the various routes of non-dietary exposure—dermal, inhalation, and oral. Target MOEs for a given pesticide can vary depending on the characteristics of the studies relied upon in choosing the PoD for the various duration and route scenarios.
                </P>
                <P>In addition, in a DWLOC aggregate risk assessment, the calculated DWLOC is compared to the EDWC. Where EPA has calculated a DWLOC, it can determine whether drinking water exposures will result in aggregate risks of concern by comparing estimated pesticide concentrations in drinking water to the DWLOC. As noted above, an aggregate DWLOC represents the amount of allowable safe residues of pesticide in drinking water because it represents the room remaining in the risk cup after accounting for the food and residential exposures. The DWLOC provides an estimate of the allowable safe concentrations of pesticides in drinking water for comparison to EDWCs. When the EDWC is less than the DWLOC, there are no risk concerns for aggregate exposures because the Agency can conclude that the contribution from drinking water when aggregated with food and residential/non-occupational exposures will not exceed save levels of exposure. Conversely, an EDWC at or exceeding the DWLOC would indicate a risk of concern, as those exposures to chlorpyrifos in drinking water, when aggregated with exposures from food and residential exposures, would exceed safe levels of exposure. (Ref. 41).</P>
                <HD SOURCE="HD3">1. Dietary Risks From Food Exposures</HD>
                <P>As noted above, EPA's acute and steady-state dietary (food only) exposure assessments for chlorpyrifos were highly refined and incorporated monitoring data for almost all foods. The Agency assessed food exposures based on all food uses of chlorpyrifos for which tolerances have been established, including all uses registered at the time of the 2020 HH DRA. It did not include potential exposure from food handling establishment uses since the Agency did not identify any actual usage under the registered food handling establishment uses. Previous assessments of the food handling establishment uses had indicated negligible residues. (Ref. 12 at 33-36 and 31 at 3).</P>
                <P>
                    Considering food exposures alone, the Agency did not identify risks of concern for either acute or steady-state exposures. (Ref. 12 at 34-36) Acute dietary (food only) risk estimates, which are based on risk from a single exposure event in the 2020 HH DRA, were all below 100% of the acute population adjusted dose for food (aPAD
                    <E T="52">food</E>
                    ) at the 99.9th percentile of exposure and are not of concern. The population with the highest risk estimate was females (13 to 49 years old) at 3.2% aPAD
                    <E T="52">food</E>
                    . Steady-state dietary (food only) risk estimates, which are based on the potential risk from a 21-day exposure duration using a 3-week rolling average (sliding by day) across the year, were also all below 100% of the steady-state PAD for food (ssPAD
                    <E T="52">food</E>
                    ) at the 99.9th percentile of exposure and are not of concern. The population with the highest risk estimate was children (1 to 2 years old) at 9.7% ssPAD
                    <E T="52">food</E>
                    . Note: Because the Agency has retained the 10X FQPA SF, as indicated in Unit VI.C.3., the relevant risk estimates are those associated with the retention of the 10X FQPA SF. The risk estimates associated with a 1X FQPA SF were provided solely to identify a range of risk estimates to characterize the risk in the event that EPA identified reliable data to support another FQPA SF that would be safe for infants and children, but no such data has been identified.
                </P>
                <P>Following the approval of the product and use cancellation requests, the Agency has not conducted a separate quantitative assessment of the anticipated risk from food exposures from the 11 food uses remaining. Given that the cancellation actions will reduce exposure from residues in food and the current assessment with all currently registered food uses indicates there is no risk of concern from exposure to residues on all food for which there are tolerances, the Agency concludes that there will still be no risks of concern from exposure to residues of chlorpyrifos on food after most of the food uses are cancelled.</P>
                <HD SOURCE="HD3">2. Non-Occupational, Non-Dietary (Residential) Risks</HD>
                <P>Because there are some uses of chlorpyrifos that may result in residential exposures, EPA assessed risk from those uses. All residential post-application risk estimates for the registered uses of chlorpyrifos were below the Agency's level of concern. (Ref. 12 at 38) The residential post-application LOC for children is 40, and the lowest risk estimate for children (11 to less than 16 years old) was 1,200. The residential post-application LOC for adults is 100, and the lowest risk estimate is 1,000. Because the calculated MOEs are above the Agency's level of concern, there are no risks of concern from residential exposures.</P>
                <HD SOURCE="HD3">3. Risks From Drinking Water</HD>
                <P>
                    As noted above, the Agency aggregated exposures to chlorpyrifos from food and residential exposures and calculated the DWLOC, 
                    <E T="03">i.e.,</E>
                     the amount of drinking water exposures that would be considered safe, based on how much room was left in the risk cup after accounting for food and residential/non-occupational exposures. The Agency calculated acute and steady-state DWLOCs for infants (less than 1 year old); children (1 to 2 years old); youths (6 to 12 years old), and adults (females 13 to 49 years old), which would be protective of other subpopulations. The most sensitive acute DWLOC was 23 ppb chlorpyrifos oxon, and the most sensitive steady-state DWLOC was 4.0 ppb chlorpyrifos oxon.
                </P>
                <P>As indicated above in Unit IV.B.2., the Agency estimated drinking water contributions from the 11 food uses identified in Unit III. above in its 2020 DWA for both acute and steady-state exposure durations. Those estimates were based on limiting those uses to specific states and were modeled based on usage data concerning application frequency and application rates. These application rate and maximum number of application-per-year restrictions vary by use site, as specified in the 2020 DWA. (Ref. 2) That document indicated that EDWCs for those food uses with those specific limitations would be below the acute DWLOC of 23 ppb and the steady-state DWLOC of 4.0 ppb. The underlying assumption of the 2020 DWA was that there would be no other food uses contributing to drinking water exposures. As indicated in Unit III., all chlorpyrifos registrants have submitted requests to cancel all other food uses and to amend products for use on food consistent with the restrictions identified in Unit III; EPA has completed approval of the label amendments and expects to finalize the cancellations by the end of 2024, prior to the time this rule is finalized. Under the terms of those cancellation orders, use of chlorpyrifos will not be permitted on food except on the 11 remaining uses in accordance with the new label restrictions after June 30, 2025. As a result, EPA anticipates that use of chlorpyrifos products with the more restrictive labeling will result in drinking water exposures below the DWLOC.</P>
                <HD SOURCE="HD3">4. Aggregate Exposure and Determination Concerning Safety</HD>
                <P>
                    As noted above, in accordance with FFDCA section 408(b)(2), EPA must, 
                    <PRTPAGE P="99201"/>
                    when establishing or leaving in effect tolerances for residues of a pesticide chemical, determine that the tolerances are safe. That is, EPA must determine that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” (21 U.S.C. 346a(b)(2)).
                </P>
                <P>
                    As discussed earlier in this Unit, exposures from food and residential/non-occupational exposures, taken separately or together, do not exceed EPA's levels of concern. The Agency determined that risks from exposures to chlorpyrifos residues in food (from all food uses registered at the time of the 2020 HHRA) comprised 3.2% of the aPAD for females (13 to 49 years old) and 9.7% of the ssPAD for children (1 to 2 years old), the highest exposed subpopulations. Combining those exposures with relevant residential exposures, which did not exceed the Agency's levels of concern, the Agency calculated the levels of drinking water concentrations that would be safe, 
                    <E T="03">i.e.,</E>
                     the DWLOCs. The lowest DWLOC for acute exposures (for infants) is 23 ppb, and the lowest DWLOC for steady-state exposures (for infants) is 4.0 ppb; therefore, any EDWCs of chlorpyrifos oxon exceeding 23 ppb in an acute scenario or 4.0 ppb in a steady-state exposure scenario indicate that aggregate exposures of chlorpyrifos would be unsafe.
                </P>
                <P>
                    The Agency's 2020 DWA demonstrates that the DWLOCs will not be exceeded for the 11 uses as assessed in that document, 
                    <E T="03">i.e.,</E>
                     where those uses are limited to specific geographic areas and with restrictions on application rates and frequency. Those restrictions are described in Unit III. Because the registrants have, under FIFRA, requested cancellation of all other food uses and have submitted label amendments that reflect the necessary restrictions on the remaining food uses for consistency with the assumptions in the 2020 DWA, EPA considers the more limited exposure to be reasonably anticipated at this time, unlike at the time of the 2021 Final Rule when no such requests had been submitted. Use consistent with the amended labels will result in drinking water exposures that are below the DWLOC, and consequently, there is a reasonable certainty that no harm will result from aggregate exposure (including food, drinking water, and residential/non-occupational exposures) to chlorpyrifos. Therefore, EPA concludes that the tolerances remaining in place will be safe.
                </P>
                <HD SOURCE="HD1">V. Petition Response</HD>
                <P>As noted in Unit II.D., PANNA and NRDC submitted a petition to EPA in September 2007, seeking revocation of all chlorpyrifos tolerances and cancellation of all chlorpyrifos registrations (“2007 Petition”). The 2007 Petition raised the following claims in support of that request:</P>
                <P>1. EPA has ignored genetic evidence of vulnerable populations.</P>
                <P>2. EPA has needlessly delayed a decision regarding endocrine disrupting effects.</P>
                <P>3. EPA has ignored data regarding cancer risks.</P>
                <P>4. EPA's 2006 OP CRA misrepresented risks and failed to apply the 10X FQPA Safety Factor.</P>
                <P>5. EPA has over-relied on registrant data.</P>
                <P>6. EPA has failed to properly address the exporting hazard in foreign countries from chlorpyrifos.</P>
                <P>7. EPA has failed to quantitatively incorporate data demonstrating long-lasting effects from early life exposure to chlorpyrifos in children.</P>
                <P>8. EPA has disregarded data demonstrating that there is no evidence of a safe level of exposure during pre-birth and early life stages.</P>
                <P>9. EPA has failed to cite or quantitatively incorporate studies and clinical reports suggesting potential adverse effects below 10% cholinesterase inhibition.</P>
                <P>10. EPA has failed to incorporate inhalation routes of exposure.</P>
                <P>In a response dated July 16, 2012, EPA explained that all but one of the issues raised in the 2007 Petition relate to EPA's establishment of the chlorpyrifos tolerances under the FFDCA that would be addressed in either a rule or an order issued under the FFDCA. (Ref. 42) The one issue that was not related to the safety of the tolerances was claim 6, which EPA denied in that July 16, 2012, response. EPA expressly noted that its denial of claim 6 was a final agency action subject to judicial review under section 16 of FIFRA; that denial was never challenged.</P>
                <P>The only claims remaining in the 2007 Petition, therefore, are claims related to the safety of the chlorpyrifos tolerances that must be addressed under the FFDCA. Because of the integration of the safety standard into the FIFRA registration standard, if EPA were to determine that the tolerances were unsafe, then the corresponding food uses would not meet the FIFRA standard for registration and must be cancelled. If, however, EPA were to determine that the 2007 Petition does not provide a basis for determining that the tolerances associated with the 11 remaining food uses are unsafe, as EPA is proposing to do in this document, there would be no separate basis in the 2007 Petition for a cancellation action under FIFRA. Section 408(h)(5) prohibits the review of issues under other statutes, for which review is obtainable under the FFDCA. 21 U.S.C. 346a(h)(5). Accordingly, EPA intended, as indicated in its July 2012 response, and intends currently to treat the final rule of this rulemaking as its final response to the remaining claims in the 2007 Petition.</P>
                <P>Regarding the remaining claims, which must be reviewed under the FFDCA, EPA denied the rest of the claims in the 2017 Denial Order and denied the objections to that order in the 2019 Denial Order. (Ref. 10 and 43) After the 2017 and 2019 Denial Orders were vacated by the Ninth Circuit in 2021, EPA granted the 2007 Petition as part of the 2021 Final Rule, as directed by the Ninth Circuit, but that 2021 Final Rule (and petition response) was subsequently vacated by the Eighth Circuit in 2023.</P>
                <P>As noted above, however, EPA is taking action in this rulemaking to revoke most tolerances, which is consistent, in part, with the 2007 Petition's request. Based on the available data, use of chlorpyrifos has been decreasing (also noted in section IV.B.4 of this rule). Cancelling all food uses but the 11 mentioned in Unit III. above—along with geographic limitations and additional application restrictions—will contribute to the decrease of chlorpyrifos applied in the United States compared to historical usage. In addition, to address concerns about whether the rest of the tolerances should be revoked as requested by the 2007 Petition, EPA has provided a safety determination in Unit IV. above. To the extent the Petition's request to revoke tolerances is not fully addressed above, EPA is clarifying its responses to the specific claims in this Unit.</P>
                <P>
                    EPA provided responses to the specific claims 1-5 and 10 in the 2017 Denial Order. EPA's position on those issues has not changed, and thus EPA is incorporating those responses into this document by reference. Those responses can be found in Unit V.1-5 and 10 of the 2017 Petition Denial. 
                    <E T="03">See</E>
                     82 FR at 16585-91.
                </P>
                <P>
                    EPA has grouped claims 7-9 together because they fundamentally all raise the same issue: Whether the potential exists for chlorpyrifos to cause neurodevelopmental effects in infants and children from exposures (either to mothers during pregnancy or directly to 
                    <PRTPAGE P="99202"/>
                    infants and children) that are lower than those resulting in 10% cholinesterase inhibition—the basis for EPA's long-standing point of departure in regulating chlorpyrifos and other OPs.
                </P>
                <P>The petitioners assert that human epidemiology and rodent developmental neurotoxicity data suggest that pre-natal and early life exposure to chlorpyrifos can result in long-lasting, possibly permanent damage to the nervous system and that these effects are likely occurring at exposure levels below 10% cholinesterase inhibition, EPA's existing regulatory standard for chlorpyrifos and other OPs. They assert that EPA has therefore used the wrong endpoint as a basis for regulation and that, taking into account the full spectrum of toxicity, chlorpyrifos does not meet the FFDCA safety standard (and thus does not meet the FIFRA standard for registration, which integrates the FFDCA safety standard).</P>
                <P>
                    EPA initiated a science evaluation of the potential effects on neurodevelopment in 2007 following the receipt of the 2007 Petition. EPA has three times presented approaches and proposals to the FIFRA SAP for evaluating epidemiologic, laboratory animal, and mechanistic data exploring the possible connection between 
                    <E T="03">in utero</E>
                     and early childhood exposure to chlorpyrifos and adverse neurodevelopmental effects. The FIFRA SAP reports have rendered numerous recommendations for additional study and sometimes conflicting advice for how EPA should consider (or not consider) the epidemiology data in conducting EPA's registration review human health risk assessment for chlorpyrifos. For over two decades, EPA has evaluated the scientific evidence surrounding the different health effects associated with chlorpyrifos. The Agency's position on the strengths and weaknesses of the available epidemiological, laboratory animal, and mechanistic data as laid out in the 2020 HH DRA is discussed in Unit IV.A.2.b above.
                </P>
                <P>As noted in that section and in Unit IV.A.3., EPA concludes that the available epidemiological data does not provide a sufficient basis for calculating a PoD nor does it support a conclusion that PoDs based on the 10% AChE inhibition are not protective. Nevertheless, as discussed in Unit IV.A.3.c., EPA has retained the 10X FQPA SF to account for the uncertainties around the dose-response level for neurodevelopmental effects for the purpose of this rule.</P>
                <P>Through this proposal, EPA is proposing to take action to revoke most chlorpyrifos tolerances as requested in the 2007 Petition but is not proposing to revoke tolerances associated with the remaining registered uses because the Agency's analysis in the 2020 HH DRA and the 2020 DWA support a conclusion that those tolerances are safe. The voluntary cancellations will effectuate a reduction in exposures, and because exposures will be reduced, the underlying assessment, even with the retention of the default 10X FQPA SF, supports the retention of the remaining tolerances.</P>
                <P>EPA is proposing that the claims in the 2007 Petition do not provide a basis for concluding that the tolerances not being revoked are unsafe.</P>
                <HD SOURCE="HD1">VI. Request for Public Comment</HD>
                <P>The Agency is requesting comments on this proposal.</P>
                <P>During the lengthy pendency of the 2007 Petition to revoke tolerances and the registration review process for chlorpyrifos, the public has had numerous opportunities to comment on EPA's scientific conclusions, risk assessments, regulatory proposals, and rules. Hundreds of thousands of comments have been submitted, and those comments have informed EPA's subsequent assessments and regulatory decision making.</P>
                <P>As this is a proposed rule, EPA is providing an opportunity to comment on issues related to this proposal, and EPA will consider significant comments in the final rule. Comments on this particular proposal must be submitted at this time, even if that person has submitted comments at other times during the history of chlorpyrifos regulatory actions.</P>
                <HD SOURCE="HD1">VII. Other Administrative Considerations</HD>
                <HD SOURCE="HD2">A. Tolerance Expiration Date</HD>
                <P>EPA is proposing to set an expiration date for the chlorpyrifos tolerances being revoked so that those tolerances will expire on July 1, 2025. This date would align with the existing stocks provisions for the related cancellation actions, which allow use of existing stocks of some cancelled chlorpyrifos products on food until June 30, 2025. This approach is also intended to satisfy the U.S. commitments under the SPS Agreement, requiring Members to provide a “reasonable interval” between the publication of a regulation subject to the Agreement and its entry into force to allow time for producers in exporting Member countries to adapt to the new requirement.</P>
                <P>Any commodities treated with chlorpyrifos that are in the channels of trade and impacted by the tolerance revocations shall be subject to FFDCA section 408(1)(5). That section provides that any residues of the subject pesticide in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:</P>
                <P>1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and</P>
                <P>2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food.</P>
                <P>The tolerance revocations in this proposed rule are not discriminatory and are designed to ensure that both domestically produced and imported foods meet the food safety standard established by the FFDCA. The same food safety standards apply to domestically produced and imported foods.</P>
                <HD SOURCE="HD2">B. Severability</HD>
                <P>This proposed rule includes two distinct actions concerning chlorpyrifos tolerances. Specifically, the Agency is proposing: (1) to revoke all tolerances associated with use cancellations as those tolerances are no longer needed and (2) that the tolerances not being revoked are safe. The Agency intends that these two actions be severable from each other, although for purposes of expediency and to fully address the pending 2007 Petition, EPA is proposing to include all parts in one rulemaking. (21 U.S.C. 346a(l)(1)). However, EPA retains the discretion to take each of these actions separately, with each implementing a portion or portions of this proposed rule.</P>
                <P>
                    The revocation of tolerances that are no longer needed is an almost entirely ministerial action. Because those uses of chlorpyrifos on these commodities will no longer be registered in the United States, the corresponding tolerances are considered unnecessary. The Agency's typical process is to automatically remove tolerances from the regulations that are no longer necessary. The only element of agency discretion involved in revocation of most tolerances would arise from a hypothetical request that EPA retain certain tolerances for purposes of importing food treated with chlorpyrifos. The proposal to revoke all tolerances except for those on the 11 specified crops depends neither on the Agency making a safety finding for the remaining tolerances nor on the Agency's response to the 2007 Petition. 
                    <PRTPAGE P="99203"/>
                    Even if safety of the tolerances not being revoked is challenged, the revocation of unnecessary tolerances would not be affected and would stand on its own right; EPA could re-evaluate the safety of the remaining tolerances and either provide additional justification for its safety determination or take other action—if needed—to address the safety of chlorpyrifos tolerances. The tolerances proposed for revocation in this document would remain revoked in such circumstances.
                </P>
                <P>This discussion of separate actions proposed in this document is not intended to be exhaustive and should not be viewed as an intention by EPA to consider other actions or determinations proposed herein as non-severable from other parts of the proposed rule.</P>
                <HD SOURCE="HD1">VIII. Statutory and Executive Order Reviews</HD>
                <P>
                    In this proposed rule, EPA is proposing to revoke specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action (
                    <E T="03">e.g.,</E>
                     tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). These revocations are not expected to present extraordinary circumstances because the registrants have requested to voluntarily cancel uses associated with these tolerances, which means that the tolerances will no longer be needed to cover residues of chlorpyrifos in or on those food commodities. Because this proposed rule has been exempted from review under Executive Order 12866, this proposed rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001).
                </P>
                <P>
                    This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 
                    <E T="03">et seq.</E>
                    ). Nor does it require any special considerations as required by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). However, EPA considered the best available science in order to protect children against environmental health risks and this proposed rule is consistent with EPA's 2021 Policy on Children's Health (Oct. 5, 2021). (Ref. 43).
                </P>
                <P>This proposed rule does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). In addition, the Agency has determined that this proposed rule will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999). This proposed rule directly regulates growers, food processors, food handlers, and food retailers, not states, including a state's ability to register pesticide products. This proposed rule does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this proposed rule does not have any “tribal implications” as described in Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000).</P>
                <P>
                    In addition, pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ), the Agency hereby certifies that the revocation of these tolerances in response to the cancellation of associated food uses will not have a significant impact on a substantial number of small entities. The certification presented above is based on the following rationale. In the case of domestically grown food, the tolerance revocations contained in this notice, as is generally the case, will have no economic impact. The associated pesticide registered uses are in the process of being canceled at this time, as requested by the registrants. By the time this rule is finalized, EPA intends to have approved all requested cancellations, and use will only be permitted on food consistent with the existing stocks provisions of those orders. Pursuant to the cancellation orders, U.S. growers will be prohibited from using chlorpyrifos on the foods for which this rule proposes revoking tolerances after June 30, 2025. Accordingly, revoking the tolerances themselves will have no effect on food grown in the United States. As for food grown in the United States, it will not be considered adulterated if it was treated in a way that complied with the tolerance in effect at the time of treatment and the use is consistent with the applicable cancellation order. The revocation of a pesticide tolerance generally has a greater potential to affect foreign-grown food, since the uses of the pesticide prohibited in the United States may still be lawful in other countries. If foreign growers use the pesticide after the tolerances are revoked, the food they grow will be considered adulterated and cannot be imported.
                </P>
                <HD SOURCE="HD1">IX. References</HD>
                <P>EPA has established an official record for this rulemaking. The official record includes all information considered by EPA in developing this proposed rule. This official record includes all information physically located in docket ID number EPA-HQ-OPP-2024-0431, any documents identified in this proposal, and documents referenced in documents in the docket. The public version of the official record does not include any information claimed as CBI.</P>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        1. U.S. EPA (2020). Chlorpyrifos Proposed Interim Registration Review Decision. Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0971.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        2. U.S. EPA (2020). Chlorpyrifos Updated Drinking Water Assessment for Registration Review. Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0941.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        3. U.S. EPA (2022). Cancellation Order for Certain Chlorpyrifos Registrations. Available at: 
                        <E T="03">https://www.federalregister.gov/documents/2022/08/31/2022-18838/cancellation-order-for-certain-chlorpyrifos-registrations.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        4. U.S. EPA (2023). Final Cancellation Order for Certain Chlorpyrifos Registrations and Uses. Available at: 
                        <E T="03">https://www.federalregister.gov/documents/2023/11/06/2023-24462/final-cancellation-order-for-certain-chlorpyrifos-registrations-and-uses.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        5. U.S. EPA (2023). Cancellation Order for Certain Chlorpyrifos Registrations and Uses. Available at: 
                        <E T="03">https://www.federalregister.gov/documents/2023/05/04/2023-09396/cancellation-order-for-certain-chlorpyrifos-registrations-and-uses.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        6. U.S. EPA (2023). Final Cancellation Order for Certain Chlorpyrifos Registrations and Uses. Available at: 
                        <E T="03">https://www.federalregister.gov/documents/2023/11/06/2023-24462/final-cancellation-order-for-certain-chlorpyrifos-registrations-and-uses.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        7. U.S. EPA (2024). Final Cancellation Order for Certain Chlorpyrifos Registrations 
                        <PRTPAGE P="99204"/>
                        and Uses. Available at: 
                        <E T="03">https://www.federalregister.gov/documents/2024/06/24/2024-13779/final-cancellation-order-for-cancelling-certain-pesticide-registrations-and-uses.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        8. U.S. EPA (2024) Chlorpyrifos; Final Cancellation Order for Certain Pesticide Registrations and Amendment of Certain Pesticide Registrations to Terminate Certain Uses. Available at: 
                        <E T="03">https://www.federalregister.gov/documents/2024/08/07/2024-17453/chlorpyrifos-final-cancellation-order-for-certain-pesticide-registrations-and-amendment-of-certain.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        9. U.S. EPA (2016). Chlorpyrifos: Revised Human Health Risk Assessment for Registration Review (November 3, 2016). Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2015-0653-0454.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        10. U.S. EPA (2017) Chlorpyrifos; Order Denying PANNA and NRDC's Petition to Revoke Tolerances. Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2007-1005-0100.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        11. U.S. EPA (2023) Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Implementing Registration Review Decisions for Certain Pesticides; Aluminum tris (O-ethylphosphonate), Carbon disulfide, 
                        <E T="03">et al.</E>
                         Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2017-0128-0005.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        12. U.S. EPA (2020) Chlorpyrifos: Third Revised Human Health Risk Assessment for Registration Review. Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0944.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        13. A User's Guide to Available EPA Information on Assessing Exposure to Pesticides in Food (June 21, 2000). Available at: 
                        <E T="03">https://www.doh.wa.gov/Portals/1/Documents/4000/PASW_exposurefood.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        14. U.S. EPA (2002) Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment. Available at: 
                        <E T="03">https://www.epa.gov/sites/default/files/2015-07/documents/determ.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        15. U.S. EPA (2000). Chlorpyrifos Human Health Risk Assessment. Available at: 
                        <E T="03">https://archive.epa.gov/scipoly/sap/meetings/web/pdf/hed_ra.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        16. U.S. EPA (2011). Chlorpyrifos: Preliminary Human Health Risk Assessment for Registration Review. Available in docket number EPA-HQ-OPP-2008-0850, 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0025.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        17. U.S. EPA (2016). Scientific Advisory Panel for Chlorpyrifos: Analysis of Biomonitoring Data. Available at: 
                        <E T="03">https://www.epa.gov/sites/default/files/2016-07/documents/chlorpyrifos_sap_april_2016_final_minutes.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        18. U.S. EPA (2016). Summary Reviews for Additional Epidemiological Literature Studies from Prospective Birth Cohort Studies. Available in docket number EPA-HQ-OPP-2015-0653 at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2015-0653-0438.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        19. U.S. EPA (2020). The Use of New Approach Methodologies (NAMs) to Derive Extrapolation Factors and Evaluate Developmental Neurotoxicity for Human Health Risk Assessment. Available in docket number EPA-HQ-OPP-2020-0263 at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2020-0263-0033.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        20. FIFRA Scientific Advisory Panel (2012). “Scientific Issues Associated with Chlorpyrifos”. Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2012-0040-0029.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        21. U.S. EPA (2006). Revised Organophosphorous Pesticide Cumulative Risk Assessment. Available at 
                        <E T="03">https://downloads.regulations.gov/EPA-HQ-OPP-2006-0618-0002/content.pdf</E>
                        .
                    </FP>
                    <FP SOURCE="FP-2">
                        22. U.S. EPA (2012). Standard Operating Procedures for Residential Pesticide Exposure Assessment 
                        <E T="03">https://www.epa.gov/sites/default/files/2015-08/documents/usepa-opp-hed_residential_sops_oct2012.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        23. FIFRA Scientific Advisory Panel (2002). “Organophosphate Pesticides: Preliminary OP Cumulative Risk Assessment.” Information on how to obtain the meeting report is available at 
                        <E T="03">https://www.epa.gov/sap/fifra-scientific-advisory-panel-meetings.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        24. EPA's Exposure Factors Handbook. Available at: 
                        <E T="03">https://www.epa.gov/expobox/about-exposure-factors-handbook.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        25. U.S. EPA (2014). Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation. Available at: 
                        <E T="03">https://www.epa.gov/sites/default/files/2015-01/documents/ddef-final.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        26. U.S. EPA (2014). Chlorpyrifos: Revised Human Health Risk Assessment for Registration Review. Available in docket number EPA-HQ-OPP-2008-0850, 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0195.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        27. U.S. EPA (2016). Office of Pesticide Programs' Framework for Incorporating Human Epidemiologic &amp; Incident Data in Risk Assessments for Pesticides. (2016) Available at: 
                        <E T="03">https://www3.epa.gov/pesticides/EPA-HQ-OPP-2008-0316-DRAFT-0075.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        28. A User's Guide to Available EPA Information on Assessing Exposure to Pesticides in Food (June 21, 2000). Available at: 
                        <E T="03">https://www.doh.wa.gov/Portals/1/Documents/4000/PASW_exposurefood.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        29. U.S. EPA (2000). Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern. Available at: 
                        <E T="03">https://www.epa.gov/sites/production/files/2015-07/documents/trac2b054_0.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        30. U.S. EPA (2014). Chlorpyrifos Acute and Steady Dietary (Food Only) Exposure Analysis to Support Registration Review. Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0197.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        31. U.S. EPA (2020). Framework for Conducting Pesticide Drinking Water Assessments for Surface Water. Environmental Fate and Effects Division. Office of Pesticide Programs. Office of Chemical Safety and Pollution Prevention. U.S. Environmental Protection Agency. Available at: 
                        <E T="03">https://www.epa.gov/sites/default/files/2020-09/documents/framework-conducting-pesticide-dw-sw.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        32. FIFRA Scientific Advisory Panel (2019) “Approaches for Quantitative Use of Surface Water Monitoring Data in Pesticide Drinking Water Assessments.” Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2019-0417-0019.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        33. U.S. EPA (2001). General Principles for Performing Aggregate Exposure and Risk Assessments. Available at: 
                        <E T="03">https://www.epa.gov/sites/default/files/2015-07/documents/aggregate.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        34. United States Geological Survey (USGS) Water Resources of the United States 
                        <E T="03">https://water.usgs.gov/GIS/huc.html.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        35. U.S. EPA (2020). Appendix B. Case Study for Integrating a Distributional Approach to Using Percent Crop Area (PCA) and Percent Crop Treated (PCT) into Drinking Water Assessment. Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2020-0279-0002.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        36. U.S. EPA (2016). Chlorpyrifos Refined Drinking Water Assessment for Registration Review. Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2015-0653-0437.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        37. U.S. EPA (2014). Chlorpyrifos Updated Drinking Water Assessment for Registration Review. Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0198.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        38. U.S. EPA (2015). Proposed Rule: Tolerance Revocations: Chlorpyrifos. Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2015-0653-0001.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        39. U.S. EPA (2019). Documents on PCA/PCT and New Scenario Methods for Estimating Pesticide Concentration in Drinking Water. Available at 
                        <E T="03">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/documents-pcapct-and-new-scenario-methods.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        40. U.S. EPA (2020). Pesticide Drinking Water Assessment Improvements. Available at 
                        <E T="03">https://www.regulations.gov/docket/EPA-HQ-OPP-2020-0279/document.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        41. U.S. EPA (2011). Finalization of Guidance on Incorporation of Water Treatment Effects on Pesticide Removal and Transformations in Drinking Water Exposure Assessments. Available at: 
                        <E T="03">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/finalization-guidance-incorporation-water-treatment.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        42. U.S. EPA (2012) EPA's Partial Response to Chlorpyrifos Petition by NRDC &amp; PANNA. Available at: 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2007-1005-0095.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        43. U.S. EPA (2019) Chlorpyrifos; Final Order Denying Objections to March 2017 Petition Denial Order. Available at 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2007-1005-0527.</E>
                    </FP>
                </EXTRACT>
                <LSTSUB>
                    <PRTPAGE P="99205"/>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 180</HD>
                    <P>Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: November 27, 2024.</DATED>
                    <NAME>Edward Messina,</NAME>
                    <TITLE>Director, Office of Pesticide Programs.</TITLE>
                </SIG>
                <P>Therefore, for the reasons stated in the preamble the Environmental Protection Agency proposes to amend 40 CFR part 180 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 180 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 21 U.S.C. 321(q), 346a and 371.</P>
                </AUTH>
                <AMDPAR>2. Revise §  180.342 to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§  180.342</SECTNO>
                    <SUBJECT> Chlorpyrifos; tolerances for residues.</SUBJECT>
                    <P>
                        (a) 
                        <E T="03">General.</E>
                         (1) Tolerances are established for residues of the pesticide chlorpyrifos 
                        <E T="03">per se</E>
                         (
                        <E T="03">O,</E>
                        O-diethyl-
                        <E T="03">O</E>
                        -(3,5,6-trichloro-2-pyridyl) phosphorothioate) in or on the following food commodities:
                    </P>
                    <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s150,16,16">
                        <TTITLE>
                            Table 1 to Paragraph (
                            <E T="01">a</E>
                            )(1)
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">Commodity</CHED>
                            <CHED H="1">
                                Parts per
                                <LI>million</LI>
                            </CHED>
                            <CHED H="1">
                                Tolerance
                                <LI>expiration</LI>
                                <LI>date</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Alfalfa, forage</ENT>
                            <ENT>3.0</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Alfalfa, hay</ENT>
                            <ENT>13</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Almond</ENT>
                            <ENT>0.2</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Almond, hulls</ENT>
                            <ENT>12</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Apple</ENT>
                            <ENT>0.01</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Apple, wet pomace</ENT>
                            <ENT>0.02</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Banana</ENT>
                            <ENT>0.1</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Beet, sugar, dried pulp</ENT>
                            <ENT>5.0</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Beet, sugar, molasses</ENT>
                            <ENT>15</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Beet, sugar, roots</ENT>
                            <ENT>1.0</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Beet, sugar, tops</ENT>
                            <ENT>8.0</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Cattle, fat</ENT>
                            <ENT>0.3</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Cattle, meat</ENT>
                            <ENT>0.05</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Cattle, meat byproducts</ENT>
                            <ENT>0.05</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Cherry, sweet</ENT>
                            <ENT>1.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Cherry, tart</ENT>
                            <ENT>1.0</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Citrus, dried pulp</ENT>
                            <ENT>5.0</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Citrus, oil</ENT>
                            <ENT>20</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Corn, field, forage</ENT>
                            <ENT>8.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Corn, field, grain</ENT>
                            <ENT>0.05</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Corn, field, refined oil</ENT>
                            <ENT>0.25</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Corn, field, stover</ENT>
                            <ENT>8.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Corn, sweet, forage</ENT>
                            <ENT>8.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Corn, sweet, kernel plus cob with husk removed</ENT>
                            <ENT>0.05</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Corn, sweet, stover</ENT>
                            <ENT>8.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Cotton, undelinted seed</ENT>
                            <ENT>0.2</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Cranberry</ENT>
                            <ENT>1.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Cucumber</ENT>
                            <ENT>0.05</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Egg</ENT>
                            <ENT>0.01</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Fig</ENT>
                            <ENT>0.01</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Fruit, citrus, group 10</ENT>
                            <ENT>1.0</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Food commodities (other than those already covered by a higher tolerance as a result of use on growing crops) in food service establishments where food and food products are prepared and served, as a result of the application of chlorpyrifos in microencapsulated form</ENT>
                            <ENT>0.1</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Goat, fat</ENT>
                            <ENT>0.2</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Goat, meat</ENT>
                            <ENT>0.05</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Goat, meat byproducts</ENT>
                            <ENT>0.05</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Hazelnut</ENT>
                            <ENT>0.2</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Hog, fat</ENT>
                            <ENT>0.2</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Hog, meat</ENT>
                            <ENT>0.05</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Hog, meat byproducts</ENT>
                            <ENT>0.05</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Horse, fat</ENT>
                            <ENT>0.25</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Horse, meat</ENT>
                            <ENT>0.25</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Horse, meat byproducts</ENT>
                            <ENT>0.25</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Kiwifruit</ENT>
                            <ENT>2.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Milk, fat (Reflecting 0.01 ppm in whole milk)</ENT>
                            <ENT>0.25</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Nectarine</ENT>
                            <ENT>0.05</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Onion, bulb</ENT>
                            <ENT>0.5</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Peach</ENT>
                            <ENT>0.05</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Peanut</ENT>
                            <ENT>0.2</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Peanut, refined oil</ENT>
                            <ENT>0.2</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Pear</ENT>
                            <ENT>0.05</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Pecan</ENT>
                            <ENT>0.2</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Pepper</ENT>
                            <ENT>1.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Peppermint, tops</ENT>
                            <ENT>0.8</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Peppermint, oil</ENT>
                            <ENT>8.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="99206"/>
                            <ENT I="01">Plum, prune, fresh</ENT>
                            <ENT>0.05</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Poultry, fat</ENT>
                            <ENT>0.1</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Poultry, meat</ENT>
                            <ENT>0.1</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Poultry, meat by products</ENT>
                            <ENT>0.1</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Pumpkin</ENT>
                            <ENT>0.05</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Radish</ENT>
                            <ENT>2.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Rutabaga</ENT>
                            <ENT>0.5</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sheep, fat</ENT>
                            <ENT>0.2</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sheep, meat</ENT>
                            <ENT>0.05</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sheep, meat byproducts</ENT>
                            <ENT>0.05</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Spearmint, tops</ENT>
                            <ENT>0.8</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Spearmint, oil</ENT>
                            <ENT>8.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sorghum, grain, forage</ENT>
                            <ENT>0.5</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sorghum, grain, grain</ENT>
                            <ENT>0.5</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sorghum, grain, stover</ENT>
                            <ENT>2.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Soybean, seed</ENT>
                            <ENT>0.3</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Strawberry</ENT>
                            <ENT>0.2</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sunflower, seed</ENT>
                            <ENT>0.1</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sweet potato, roots</ENT>
                            <ENT>0.05</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Turnip, roots</ENT>
                            <ENT>1.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Turnip, tops</ENT>
                            <ENT>0.3</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vegetable, brassica, leafy, group 5</ENT>
                            <ENT>1.0</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vegetable, legume, group 6, except soybean</ENT>
                            <ENT>0.05</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Walnut</ENT>
                            <ENT>0.2</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Wheat, forage</ENT>
                            <ENT>3.0</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Wheat, grain</ENT>
                            <ENT>0.5</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Wheat, straw</ENT>
                            <ENT>6.0</ENT>
                            <ENT>None</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>(2) Chlorpyrifos [O,O-diethyl O-(3,5,6-trichloro-2-pyridyl) phosphorothioate] may be safely used up until and including June 30, 2025 in accordance with the following prescribed conditions. On and after July 1, 2025, chlorpyrifos may not be used as described below:</P>
                    <P>(i) Application shall be limited solely to spot and/or crack and crevice treatment in food handling establishments where food and food products are held, processed, prepared or served. Contamination of food or food contact surfaces shall be avoided. Food must be removed or covered during treatment.</P>
                    <P>(ii) Spray concentration for spot treatment shall be limited to a maximum of 0.5 percent of the active ingredient by weight. A course, low-pressure spray shall be used to avoid atomization or splashing of the spray.</P>
                    <P>(iii) Paint-on application for spot treatment shall be limited to a maximum of 2 percent of the active ingredient by weight.</P>
                    <P>(iv) Crack and crevice treatment shall be limited to a maximum of 2 percent of the active ingredient by weight. Equipment capable of delivering a pin-stream of insecticide shall be used.</P>
                    <P>(v) Application via adhesive strips shall contain a maximum of 10% by weight of the controlled-release product in food-handling establishments where food and food products are held, processed, prepared, or served. A maximum of 36 strips (or 5.15 grams of chlorpyrifos) is to be used per 100 square feet of floor space. The strips are not to be placed in exposed areas where direct contact with food, utensils, and food-contact surfaces would be likely to occur.</P>
                    <P>(vi) To assure safe use of the insecticide, its label and labeling shall conform to that registered by the U.S. Environmental Protection Agency, and it shall be used in accordance with such label and labeling.</P>
                    <P>
                        (3) A tolerance of 0.1 part per million is established for residues of chlorpyrifos, 
                        <E T="03">per se,</E>
                         in or on food commodities (other than those already covered by a higher tolerance as a result of use on growing crops) in food service establishments where food and food products are prepared and served, as a result of the application of chlorpyrifos in microencapsulated form. This tolerance expires on July 1, 2025.
                    </P>
                    <P>(i) Application of a microencapsulated product shall be limited solely to spot and/or crack and crevice treatment in food handling establishments where food and food products are prepared and served. All treatments shall be applied in such a manner as to avoid contamination of food or food contact surfaces.</P>
                    <P>(ii) Spray concentrations shall be limited to a maximum of 0.5 percent of the active ingredient by weight.</P>
                    <P>(iii) For crack and crevice treatment, equipment capable of delivering a pin stream of spray directly into cracks and crevices or capable of applying small amounts of insecticide into cracks and crevices shall be used.</P>
                    <P>(iv) For spot treatment, an individual spot shall not exceed 2 square feet.</P>
                    <P>(v) To assure safe use of the insecticide, its label and labeling shall conform to that registered by the U.S. Environmental Protection Agency, and it shall be used in accordance with such label and labeling.</P>
                    <P>(b) [Reserved]</P>
                    <P>
                        (c) 
                        <E T="03">Tolerances with regional registrations.</E>
                         Tolerances with regional registration, as defined in 180.1(l), are established for residues of the pesticide chlorpyrifos 
                        <E T="03">per se</E>
                         (O,O-diethyl- O-(3,5,6-trichloro-2-pyridyl) phosphorothioate) in or on the following food commodities:
                        <PRTPAGE P="99207"/>
                    </P>
                    <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s150,12,16">
                        <TTITLE>
                            Table 2 to Paragraph (
                            <E T="01">c</E>
                            )
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">Commodity</CHED>
                            <CHED H="1">
                                Parts per
                                <LI>million</LI>
                            </CHED>
                            <CHED H="1">
                                Tolerance
                                <LI>expiration</LI>
                                <LI>date</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Asparagus</ENT>
                            <ENT>5.0</ENT>
                            <ENT>None</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Grape</ENT>
                            <ENT>0.01</ENT>
                            <ENT>7/1/2025</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>(d) [Reserved]</P>
                </SECTION>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28332 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Fish and Wildlife Service</SUBAGY>
                <CFR>50 CFR Part 17</CFR>
                <DEPDOC>[Docket No. FWS-R2-ES-2024-0193; FXES1111090FEDR-256-FF09E21000]</DEPDOC>
                <SUBJECT>Endangered and Threatened Wildlife and Plants; 12-Month Not-Warranted Finding for the Rio Grande Cutthroat Trout</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Fish and Wildlife Service, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notification of finding.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the Rio Grande cutthroat trout (
                        <E T="03">Oncorhynchus clarkii virginalis</E>
                        ) as an endangered or threatened species under the Endangered Species Act of 1973, as amended (Act). Rio Grande cutthroat trout, a subspecies of cutthroat trout (
                        <E T="03">Oncorhynchus clarkii</E>
                        ), inhabit high-elevation streams in New Mexico and southern Colorado. After a thorough review of the best available scientific and commercial information, we find that listing the Rio Grande cutthroat trout as an endangered or threatened species is not warranted at this time. However, we ask the public to submit to us at any time any new information relevant to the status of the Rio Grande cutthroat trout or its habitat.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The finding in this document was made on December 10, 2024.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        A detailed description of the basis for this finding is available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         under Docket No. FWS-R2-ES-2024-0193. Supporting information used to prepare this finding is also available for public inspection, by appointment, during normal business hours at the New Mexico Ecological Services Office. Please submit any new information, materials, comments, or questions concerning this finding to the person listed under 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Shawn Sartorius, Field Supervisor, New Mexico Ecological Services Office, 505-346-2525, 
                        <E T="03">shawn_sartorius@fws.gov.</E>
                         Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Under section 4(b)(3)(B) of the Act (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ), we are required to make a finding on whether or not a petitioned action is warranted within 12 months after receiving any petition that we have determined contains substantial scientific or commercial information indicating that the petitioned action may be warranted (“12-month finding”). We must make a finding that the petitioned action is: (1) Not warranted; (2) warranted; or (3) warranted, but precluded by other listing activity. We must publish a notification of the 12-month finding in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD1">Summary of Information Pertaining to the Five Factors</HD>
                <P>Section 4 of the Act (16 U.S.C. 1533) and the implementing regulations at part 424 of title 50 of the Code of Federal Regulations (50 CFR part 424) set forth procedures for adding species to, removing species from, or reclassifying species on the Lists of Endangered and Threatened Wildlife and Plants (Lists). The Act defines “species” as including any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature. The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether any species is an endangered species or a threatened species because of any of the following factors:</P>
                <P>(A) The present or threatened destruction, modification, or curtailment of its habitat or range;</P>
                <P>(B) Overutilization for commercial, recreational, scientific, or educational purposes;</P>
                <P>(C) Disease or predation;</P>
                <P>(D) The inadequacy of existing regulatory mechanisms; or</P>
                <P>(E) Other natural or manmade factors affecting its continued existence.</P>
                <P>These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects.</P>
                <P>We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself.</P>
                <P>
                    However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the species' expected response and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, then analyze the cumulative effect of all of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive 
                    <PRTPAGE P="99208"/>
                    effects on the species, such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species.
                </P>
                <P>
                    The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis which is further described in the 2009 Memorandum Opinion on the foreseeable future from the Department of the Interior, Office of the Solicitor (M-37021, January 16, 2009; “M-Opinion,” available online at 
                    <E T="03">https://www.doi.gov/sites/doi.opengov.ibmcloud.com/files/uploads/M-37021.pdf</E>
                    ). The foreseeable future extends as far into the future as the U.S. Fish and Wildlife Service and National Marine Fisheries Service (hereafter, the Services) can make reasonably reliable predictions about the threats to the species and the species' responses to those threats. We need not identify the foreseeable future in terms of a specific period of time. We will describe the foreseeable future on a case-by-case basis, using the best available data and taking into account considerations such as the species' life-history characteristics, threat projection timeframes, and environmental variability. In other words, the foreseeable future is the period of time over which we can make reasonably reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction, in light of the conservation purposes of the Act.
                </P>
                <P>In conducting our evaluation of the five factors provided in section 4(a)(1) of the Act to determine whether the Rio Grande cutthroat trout meets the Act's definition of an “endangered species” or a “threatened species,” we considered and thoroughly evaluated the best scientific and commercial information available regarding the past, present, and future stressors and threats. We reviewed the petition, information available in our files, and other available published and unpublished information for the species. Our evaluation may include information from recognized experts; Federal, State, and Tribal governments; academic institutions; foreign governments; private entities; and other members of the public.</P>
                <P>In accordance with the regulations at 50 CFR 424.14(h)(2)(i), this document announces the not-warranted finding on a petition to list the Rio Grande cutthroat trout. We have also elected to include a brief summary of the analysis on which this finding is based. We provide the full analysis, including the reasons and data on which the finding is based, in the decisional file for the Rio Grande cutthroat trout. The following is a description of the documents containing this analysis.</P>
                <P>
                    The species assessment form for the Rio Grande cutthroat trout contains more detailed biological information, a thorough analysis of the listing factors, a list of literature cited, and an explanation of why we determined that the subspecies does not meet the Act's definition of an “endangered species” or a “threatened species.” To inform our status review, we completed a species status assessment (SSA) report for the subspecies. The SSA report contains a thorough review of the taxonomy, life history, ecology, current status, and projected future status for the Rio Grande cutthroat trout. This supporting information can be found on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     under the Docket No. FWS-R2-ES-2024-0193.
                </P>
                <HD SOURCE="HD1">Previous Federal Actions</HD>
                <P>The Service was petitioned to list the Rio Grande cutthroat trout as an endangered or threatened species under the Act in 1998. On September 14, 1998, we published a 90-day finding (63 FR 49062) that the petition did not present substantial information indicating that the petitioned action may be warranted. On June 9, 1999, the Southwest Center for Biological Diversity sued the Service in regard to our 90-day petition finding. While this litigation was pending, we received information (particularly related to the presence of whirling disease in hatchery fish in the wild) that led us to believe that further review of the status of the subspecies was warranted. On November 8, 2001, the Service and the Southwest Center for Biological Diversity entered into a settlement agreement stipulating that the Service would initiate a status review for the Rio Grande cutthroat trout. On May 14, 2008, we found the subspecies was warranted for listing but precluded by higher priority actions (73 FR 27900), and the Rio Grande cutthroat trout was added to our list of candidate species at that time. After completing a species status assessment in 2014 (SSA; Service 2014, entire), we subsequently published a 12-month petition finding determining that the Rio Grande cutthroat trout was not warranted for listing as endangered or threatened under the Act (79 FR 59140; October 1, 2014). The 2014 decision was challenged in court and vacated and remanded by the judge on October 31, 2020, when a motion clarifying our decision was denied. In response to that decision, we initiated another status review of the subspecies for listing as a threatened or endangered species under the Act. This document constitutes our new 12-month finding.</P>
                <HD SOURCE="HD1">Summary of Finding</HD>
                <P>Rio Grande cutthroat trout, a subspecies of cutthroat trout, inhabit high-elevation streams in New Mexico and southern Colorado. The subspecies is generally assumed to have occupied all streams capable of supporting them in the Rio Grande, Pecos, and Canadian River basins (Alves et al. 2007, p. 9). The range of the Rio Grande cutthroat trout has been divided into five geographic management units (GMUs) that reflect the hydrologic divisions of the Rio Grande cutthroat trout's historical range by river drainage: Canadian, Rio Grande Headwaters, Lower Rio Grande, Caballo, and Pecos.</P>
                <P>
                    To maintain overall viability, populations of the Rio Grande cutthroat trout must have sufficient resiliency, representation, and redundancy. Adequately resilient Rio Grande cutthroat trout populations must be of sufficient size to withstand demographic and genetic stochasticity. General guidelines for trout are that effective population sizes above 500 have a low risk of negative genetic outcomes and retain long-term adaptive potential, and those below 50 are highly vulnerable to inbreeding depression and genetic drift. For populations to be sufficiently resilient, they must occupy stream reaches long enough to provide the range of habitats needed to complete their life cycle (
                    <E T="03">i.e.,</E>
                     spawning habitat, nursery habitat, adult habitat, refugial habitat). Streams longer than about 9.7 kilometers (km) (6 miles (mi)) are generally assumed to be long enough to encompass the habitat complexity necessary for the population to survive stochastic events. Streams shorter than 2.8 km (1.7 mi) are unlikely to have enough habitat variability for a population to be able to survive stochastic events. The longer an unobstructed reach of stream, the more habitat variability is likely to be represented, which increases the likelihood of survival of various life stages. There are some natural events, such as wildfires and stream drying, that can be catastrophic in their impact. The Rio Grande cutthroat trout needs to have multiple resilient populations 
                    <PRTPAGE P="99209"/>
                    distributed throughout its historical range to provide for rangewide redundancy. Maintaining representation in the form of genetic or ecological diversity is important to maintain the adaptive capacity of the Rio Grande cutthroat trout to future environmental changes. The Rio Grande cutthroat trout needs to retain populations across the diversity of its range to maintain the overall potential genetic and life history attributes that can buffer the subspecies' response to environmental changes over time.
                </P>
                <P>We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to the Rio Grande cutthroat trout, and we evaluated all relevant factors under the five listing factors, including any regulatory mechanisms and conservation measures addressing these threats. The primary threat affecting the Rio Grande cutthroat trout's biological status is hybridization, competition, and predation from nonnative trout. The introduction of nonnative trout species has accounted for most of the loss of the subspecies from its historical range. The Rio Grande cutthroat trout is also affected by environmental threats such as wildfires, stream drying, water temperature changes, and flooding, all of which may be exacerbated by climate change. Most populations of Rio Grande cutthroat trout are potentially exposed to these threats, but their likelihood of occurring and magnitude of impact are highly variable and dependent on local conditions. Past threats, such as land management practices, disease, and overharvest, are not significantly impacting the subspecies currently and are unlikely to do so in the future. A multi-agency conservation agreement between the States of Colorado and New Mexico, Forest Service, multiple Tribes, and the Service, among others (known as the Conservation Team), has improved the resiliency of existing populations and restored the Rio Grande cutthroat trout to areas where it has been extirpated, primarily through construction of barriers, removal of nonnative trout, and habitat improvements. This agreement has been ongoing since 2003 when it was first signed, having been renewed in 2013 and 2024. Central to the agreement is the development of the Conservation Strategy, which outlines specific plans and strategies to improve conditions for the subspecies over the course of the agreement.</P>
                <P>Currently there are 119 Rio Grande cutthroat trout populations across all five GMUs. These populations currently occupy 1,197 river km (744 mi)); this represents an 82 percent reduction from the presumed historical range. Rangewide, 60 populations (50 percent) have a complete barrier, 14 (12 percent) have a partial barrier, and 45 (38 percent) do not have a barrier in place. Barriers are a key conservation measure to prevent colonization by nonnative trout. Fifty populations (40 percent) currently co-occur with nonnative trout. The remaining 60 percent of populations are not currently exposed to this threat.</P>
                <P>
                    The 119 populations are distributed across a wide geographic area, providing sufficient redundancy to reduce the likelihood of large-scale extirpation due to a single catastrophic event. Furthermore, the Rio Grande cutthroat trout Conservation Team has a demonstrated track record of responding to negative events to protect and even expand populations in the aftermath of large-scale changes to streams. Populations cover the breadth of the historical range, ensuring retention of adaptive capacity (
                    <E T="03">i.e.,</E>
                     representation) to promote short-term adaption to environmental change. The SSA report describes the uncertainties associated with potential threats and the subspecies' response to these potential threats, but the best available information indicates the risk of extinction is low. Therefore, we conclude that the Rio Grande cutthroat trout is not in danger of extinction throughout all of its range and does not meet the definition of an endangered species.
                </P>
                <P>
                    Thus, we proceed with determining whether the subspecies is likely to become endangered within the foreseeable future throughout all of its range (
                    <E T="03">i.e.,</E>
                     threatened). The SSA report includes an analysis of two future scenarios based on conditions projected for the 2040s and 2080s, which encompasses the best available information for future projections of population resiliency (Service 2024 pp. 44-63). The future scenarios indicate that nonnative trout are the most significant threat to the future persistence of Rio Grande cutthroat trout populations. Populations currently invaded by nonnative trout and/or lacking barriers have an elevated risk of extirpation. Other threats are projected to have less of an impact on population persistence, although cumulatively they can increase the probability of extirpation.
                </P>
                <P>Despite the risks posed by nonnative trout, conservation measures will improve the resiliency of existing populations, mainly through barrier construction and nonnative species removal. We anticipate that the Conservation Team will continue to promote the viability of the subspecies and mitigate threats given their commitment to the conservation agreement and track record of success. Continued application of these measures could increase the number of resilient populations by the 2080s. Thus, we project at minimum there will be multiple resilient populations (between 40 to 70) that will continue to exist in the future. In both future scenarios, the subspecies is expected to maintain redundancy and representation because populations will continue to be distributed throughout most of its known historical range, including multiple GMUs. Therefore, after assessing the best available information, we conclude that the Rio Grande cutthroat trout does not meet the definition of a threatened species because it is not likely to become endangered within the foreseeable future throughout all of its range.</P>
                <P>Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so in the foreseeable future throughout all or a significant portion of its range. Having determined that the Rio Grande cutthroat trout is not in danger of extinction or likely to become so in the foreseeable future throughout all of its range, we now consider whether it may be in danger of extinction or likely to become so in the foreseeable future in a significant portion of its range—that is, whether there is any portion of the subspecies' range for which it is true that both (1) the portion is significant; and (2) the subspecies is in danger of extinction now or likely to become so in the foreseeable future in that portion. Depending on the case, it might be more efficient for us to address the “significance” question or the “status” question first. We can choose to address either question first. Regardless of which question we address first, if we reach a negative answer with respect to the first question that we address, we do not need to evaluate the other question for that portion of the subspecies' range.</P>
                <P>In undertaking this analysis for the Rio Grande cutthroat trout, we began by identifying portions of the range where the biological status of the subspecies may be different from its biological status elsewhere in its range. For this purpose, we considered information pertaining to the geographic distribution of (a) populations of the subspecies, (b) the threats that the subspecies faces, and (c) the resiliency condition of populations.</P>
                <P>
                    We evaluated the range of the Rio Grande cutthroat trout to determine if 
                    <PRTPAGE P="99210"/>
                    the subspecies is in danger of extinction or likely to become so within the foreseeable future in any portion of its range. Because the range of a species can theoretically be divided into portions in an infinite number of ways, we focus our analysis on portions of the species' range that contribute to the conservation of the species in a biologically meaningful way. For Rio Grande cutthroat trout, we considered whether the threats or their effects on the species are greater in any portion of the subspecies' range than in other portions such that the subspecies is in danger of extinction now or likely to become so within the foreseeable future in that portion.
                </P>
                <P>For the purposes of considering portions of Rio Grande cutthroat trout's range, we reviewed the GMUs we identified in the SSA Report. These units correspond to different watersheds and genetic lineages and function as independent clusters of populations. They are also the scale at which management actions are directed. Thus, in evaluating extinction risk, we did so at the scale of individual GMUs.</P>
                <P>
                    We first considered whether the subspecies may be in danger of extinction in any one of these GMUs. As discussed above, the primary current threats to the Rio Grande cutthroat trout are hybridization, predation, and competition with nonnative trout species. We examined those threats along with the effects from habitat loss, degradation, and fragmentation due to hydrological changes (stream drying and flooding), wildfire, land management practices, overharvest (
                    <E T="03">i.e.,</E>
                     angling), and disease, including cumulative effects and considered whether conservation efforts and regulatory mechanisms ameliorated any of the effects.
                </P>
                <P>In general, there are no differences in exposure to primary threats across the GMUs. Each contains a mix of populations that are invaded by nonnative trout and there are no notable differences in risk posed by near-term environmental threats. This is evidenced by the results of the model developed by the Conservation Team: the distribution of persistence probabilities in the near-term does not vary between the GMUs, with the exception of the Caballo GMU, which has a single population. The greatest difference in extinction risk across the GMUs is not due to threats or patterns of population resiliency, but instead the number of populations that contribute to redundancy. The Caballo (1 population), Canadian (10 populations), and Pecos (11 populations) GMUs are at inherently higher risk due to the smaller number of populations they contain, which is exacerbated by threats such as nonnative trout. Mirroring the rangewide trends, these GMUs are a mix of invaded and noninvaded populations, meaning only a subset of populations are at low risk of near-term extirpation. Thus, these GMUs have inherently low redundancy that elevates their risk of extinction.</P>
                <P>After identifying a portion of the range (Caballo, Canadian, and Pecos GMUs), where the subspecies has a potentially different status than within the remainder of the range, we then proceed to assess whether the portion constitutes a significant portion of the range. To do so, we examined the occupied stream lengths within each GMU. Currently, the Caballo, Canadian, and Pecos GMUs contain 3, 147, and 59 km (2, 91, 37 mi), respectively, of occupied stream length. Rangewide, the Rio Grande cutthroat trout occupies 1,197 km (744 mi) of stream length, meaning combined these three GMUs constitute around 17 percent of the subspecies' range. With the vast majority of the occupied range in the Rio Grande Headwaters and Lower Rio Grande GMUs, the remaining three GMUs, on their own or combined, do not contain a significant portion of the occupied range. Furthermore, these three GMUs do not possess unique or high-quality habitat that would promote the conservation of the subspecies. As this is not a significant portion of the Rio Grande cutthroat trout range, we determined the species is not in danger of extinction throughout a significant portion of its range.</P>
                <P>We next considered whether the Rio Grande cutthroat trout is likely to become an endangered species within the foreseeable future throughout a significant portion of its range. Again, threats are projected to be similar across the range, with no disparities in exposure to nonnative species, wildfire, stream drying, or flooding. GMUs have a mix of populations that have barriers and some that do not, and the Conservation Team has been and is projected to perform conservation activities in all five GMUs. The most recent iteration of the Conservation Strategy places an emphasis on the Pecos and Canadian GMUs, acknowledging their more precarious status. As with the near-term, projections in the 2040s and 2080s are that each GMU will be a mix of populations with varying levels of extirpation risk.</P>
                <P>Similar to the near-term analysis, the main difference in extinction risk for each GMU is the disparity in the number of populations, which influences redundancy. In our assessment, we did not assume that more populations would be added to a GMU via reintroduction. Therefore, the current number of populations in each GMU (1 for Caballo, 10 for Canadian, and 11 for Pecos) would be the maximum number of populations present in the future. Thus, these GMUs will continue to have limited redundancy in the future and at heightened extinction risk. Looking into the future, further extirpations would erode the number and distribution of populations in the Caballo, Canadian, and Pecos GMUs, reducing redundancy even more and increasing the risk that a single catastrophic event could result in extinction of the Rio Grande cutthroat trout from a GMU.</P>
                <P>After identifying a portion of the range (Caballo, Canadian, and Pecos GMUs) where the subspecies will potentially have different status in the future, we then proceed with whether these areas constitute a significant portion of the range. Although we did not project the addition of more populations in our assessment that would adjust the proportion of overall subspecies range contained within each GMU, most of the ongoing major restoration projects would add populations and river miles to the Rio Grande Headwaters and Lower Rio Grande GMUs. Thus, the percentage of the occupied range for the subspecies within the Caballo, Canadian, and Pecos GMUs will not change substantially in the future. The 17 percent of the future range contained within these GMUs does not constitute a large portion of the range. Furthermore, these three GMUs will not possess unique or high-quality habitat that would promote the conservation of the subspecies.</P>
                <P>
                    These areas do not represent a significant portion of the range; therefore, we find that the subspecies is not in danger of extinction now or likely to become so within the foreseeable future in any significant portion of its range. This does not conflict with the courts' holdings in 
                    <E T="03">Desert Survivors</E>
                     v. 
                    <E T="03">Department of the Interior,</E>
                     321 F. Supp. 3d 1011, 1070-74 (N.D. Cal. 2018), and 
                    <E T="03">Center for Biological Diversity</E>
                     v. 
                    <E T="03">Jewell,</E>
                     248 F. Supp. 3d 946, 959 (D. Ariz. 2017), because, in reaching this conclusion, we did not apply the aspects of the Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (79 FR 37577; July 1, 2014), including the definition of “significant” that those court decisions held to be invalid.
                    <PRTPAGE P="99211"/>
                </P>
                <P>
                    After assessing the best available information, we concluded that the Rio Grande cutthroat trout is not in danger of extinction or likely to become in danger of extinction throughout all of its range or in any significant portion of its range. Therefore, we find that listing the Rio Grande cutthroat trout as an endangered species or threatened species under the Act is not warranted. A detailed discussion of the basis for this finding can be found in the Rio Grande cutthroat trout species assessment form and other supporting documents on 
                    <E T="03">https://www.regulations.gov</E>
                     under Docket No. FWS-R2-ES-2024-0193 (see 
                    <E T="02">ADDRESSES</E>
                    , above).
                </P>
                <HD SOURCE="HD1">Peer Review</HD>
                <P>
                    In accordance with our joint policy on peer review published in the 
                    <E T="04">Federal Register</E>
                     on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review in listing actions under the Act, we solicited independent scientific reviews of the information contained in the Rio Grande cutthroat trout SSA report. We sent the SSA report to five independent peer reviewers and received five responses. Results of this structured peer review process can be found at 
                    <E T="03">https://www.regulations.gov</E>
                     under Docket No. FWS-R2-ES-2024-0193. We incorporated the results of these reviews, as appropriate, into the SSA report, which is the foundation for this finding.
                </P>
                <HD SOURCE="HD1">New Information</HD>
                <P>
                    We request that you submit any new information concerning the taxonomy of, biology of, ecology of, status of, or stressors to the Rio Grande cutthroat trout to the person specified above under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    , whenever it becomes available. New information will help us monitor the subspecies and make appropriate decisions about its conservation and status. We encourage local agencies and stakeholders to continue cooperative monitoring and conservation efforts.
                </P>
                <HD SOURCE="HD1">References</HD>
                <P>
                    A complete list of the references used in this petition finding is available in the species assessment form, which is available on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     under Docket No. FWS-R2-ES-2024-0193 (see 
                    <E T="02">ADDRESSES</E>
                    , above) and upon request from the field office (see 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    , above).
                </P>
                <HD SOURCE="HD1">Authors</HD>
                <P>The primary authors of this document are the staff members of the Species Assessment Team, Ecological Services Program.</P>
                <HD SOURCE="HD1">Authority</HD>
                <P>
                    The authority for this action is section 4 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <SIG>
                    <NAME>Martha Williams,</NAME>
                    <TITLE>Director, U.S. Fish and Wildlife Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28749 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4333-15-P</BILCOD>
        </PRORULE>
    </PRORULES>
    <VOL>89</VOL>
    <NO>237</NO>
    <DATE>Tuesday, December 10, 2024</DATE>
    <UNITNAME>Notices</UNITNAME>
    <NOTICES>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="99212"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBJECT>Submission for OMB Review; Comment Request; Reinstatement</SUBJECT>
                <P>The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and reinstatement under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.</P>
                <P>
                    Comments regarding this information collection received by January 9, 2025 will be considered. Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website 
                    <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                     Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                </P>
                <P>An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.</P>
                <HD SOURCE="HD1">Food Safety and Inspection Service</HD>
                <P>
                    <E T="03">Title:</E>
                     Foodborne Illness Outbreak Surveys for the FSIS Public Health Partners.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     0583-0175.
                </P>
                <P>
                    <E T="03">Summary of Collection:</E>
                     The Food Safety and Inspection Service (FSIS) has been delegated the authority to exercise the functions of the Secretary as provided in the Federal Meat Inspection Act (FMIA) (21 U. S.C. 601 
                    <E T="03">et seq.</E>
                    ), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, 
                    <E T="03">et seq.</E>
                    ), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031). These statues mandate that FSIS protect the public by ensuring that meat, poultry, and egg products are safe, wholesome, unadulterated, and properly labeled and packaged. FSIS intends to collect information from state and territorial government partners on ways to strengthen the collaborative response to illness outbreaks associated with FSIS-regulated food products.
                </P>
                <P>
                    <E T="03">Need and Use of the Information:</E>
                     FSIS will administer a series of surveys regarding foodborne illness outbreak investigation to state and territorial government partners. The results of these surveys will help FSIS assess communication trends and prioritize outreach efforts.
                </P>
                <P>
                    <E T="03">Description of Respondents:</E>
                     State, Local or Tribal Government.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     200.
                </P>
                <P>
                    <E T="03">Frequency of Responses:</E>
                     Reporting: Annually.
                </P>
                <P>
                    <E T="03">Total Burden Hours:</E>
                     67.
                </P>
                <SIG>
                    <NAME>Levi S. Harrell,</NAME>
                    <TITLE>Departmental Information Collection Clearance Officer.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28941 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3410-DM-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Commodity Credit Corporation Farm Service Agency</SUBAGY>
                <DEPDOC>[Docket ID FSA-2024-0011]</DEPDOC>
                <SUBJECT>Notice of Funds Availability (NOFA); Marketing Assistance for Specialty Crops</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Commodity Credit Corporation and Farm Service Agency, U.S. Department of Agriculture (USDA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notification of funds availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Farm Service Agency (FSA) is announcing the availability of Marketing Assistance for Specialty Crops (MASC), which will provide eligible specialty crop producers with marketing assistance payments that will help them engage in activities that aid in expanding domestic specialty crop markets or in developing new markets for their specialty crops.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Applications Due Date:</E>
                         We will accept applications from December 10, 2024, through January 8, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kathy Sayers; telephone: (202) 720-6870; email: 
                        <E T="03">Kathy.Sayers@usda.gov.</E>
                         Individuals with disabilities who require alternative means for communication should contact the USDA Target Center at (202) 720-2600 (voice and text telephone (TTY)) or dial 711 for Telecommunications Relay Service (both voice and text telephone users can initiate this call from any telephone).
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Specialty crop growers have typically faced higher marketing costs relative to non-specialty crop producers due to the tenderness and perishability of fruits, vegetables, floriculture, nursery crops, and herbs. They must invest in specialized handling and transport equipment that control for temperature and humidity, invest in packaging equipment and materials that prevent damage to commodities, and confront the need to get perishable products to market quickly. They also face labor costs that are nearly 45 percent of total variable 
                    <SU>1</SU>
                    <FTREF/>
                     costs—far higher than the 9 percent average across all the agricultural sector.
                    <SU>2</SU>
                    <FTREF/>
                     Labor costs have increased steadily in recent years and input costs, in general, remain elevated in comparison with pre-pandemic levels.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Variable costs are out-of-pocket expenses that change in proportion to how much of a commodity is produced.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         USDA, Economic Research Service. 2022 Agricultural Resource Management Survey (ARMS) data.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Coppess, Jonathan. “Measuring Farm Policy, Part 4: Basic Input Costs and Payments.” farmdoc daily (14):66. April 4, 2024. 
                        <E T="03">
                            https://
                            <PRTPAGE/>
                            farmdocdaily.illinois.edu/2024/04/measuring-farm-policy-part-4-basic-input-costs-and-payments.html.
                        </E>
                    </P>
                </FTNT>
                <PRTPAGE P="99213"/>
                <P>
                    Specialty crop operations have limited ability to pass along these high labor, input (seed, fertilizer, pesticide), and marketing costs to retailers or consumers given global competition for markets. Further, cash receipts for fruits and nuts—which reflect the income from sales of those specialty crops to purchasers—are down. For example, fruit and nut cash receipts 
                    <SU>4</SU>
                    <FTREF/>
                     in calendar year 2024 are 25 percent below the previous inflation-adjusted 10-year average—a greater reduction over that 10-year period than for any commodity grouping other than tobacco. In contrast, for crops overall (including corn, soybeans, etc.), cash receipts in 2024 are forecast up 10 percent relative to the 10-year inflation-adjusted average.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Cash receipts reflect the gross income from the sale of a commodity during a given calendar year. U.S. Department of Agriculture, Economic Research Service. (2024, September 5). “Farm Income and Wealth Statistics.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         U.S. Department of Agriculture, Economic Research Service. (2024, September 5). “Farm Income and Wealth Statistics.”
                    </P>
                </FTNT>
                <P>
                    High costs—combined with lower cash receipts—have, in many cases, reduced net cash farm income (NCFI),
                    <SU>6</SU>
                    <FTREF/>
                     especially among operations that do not have the ability to take advantage of economies of scale. Data from a USDA survey of farm operators shows NCFI for specialty crop growers in 2022 was 11 percent below the average for the previous 10 years, and 4.6 percent below 2021 reported levels. For small-scale growers (those with less than $100,000 in NCFI and the least able to take advantage of economies of scale), the situation is even more dire: NCFI has been negative for 3 of the 5 years between 2018 and 2022.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         NCFI is defined as cash receipts from farming as well as cash farm-related income (including Federal Government payments) minus cash expenses.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Economic Research Service and National Agricultural Statistics Service, Agricultural Resource Management Survey (ARMS), “Tailored reports: Farm Structure and Finance” data product available at 
                        <E T="03">https://my.data.ers.usda.gov/arms/tailored-reports.</E>
                    </P>
                </FTNT>
                <P>
                    Specialty crops are important from an economic perspective to many states, as illustrated by the 2022 Census of Agriculture.
                    <SU>8</SU>
                    <FTREF/>
                     For 127 counties (or county equivalents), specialty crop farms accounted for more than 40 percent of all farms within the county. Most of these counties are in states along the west and east coasts (including Alaska and Hawaii) and in or near metropolitan areas. Half of the counties with the highest concentration of farms primarily engaged in growing specialty crops were in California, New York, Florida, and New Jersey.
                    <SU>9</SU>
                    <FTREF/>
                     Specialty crops form the backbone of the agriculture sector in such states and, as a result, maintaining grower viability is important for those states' economies.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         The information in this paragraph is from USDA, National Agricultural Statistics Service. “2022 Census of Agriculture: Most U.S. Counties with High Concentration of Specialty Crop Farms are Located along Coasts.” 
                        <E T="03">https://www.ers.usda.gov/data-products/chart-gallery/gallery/chart-detail/?chartId=109079#:~:text=Half%20of%20the%20counties%20with,farm%20growing%20primarily%20specialty%20crops.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         In California, 8 of the top 10 commodities for cash receipts are specialty crops. In Florida and New Jersey, 5 of the top 10 commodities in terms of cash receipts are specialty crops. For New York, 2 of the top 10 commodities in terms of cash receipts are specialty crops. See the USDA, Economic Research Service Farm Income and Wealth Statistics, Cash Receipts by State: 
                        <E T="03">https://data.ers.usda.gov/reports.aspx?ID=17843#Pc9e3d09f30b1439aa5787fc201b399ae_5_17iT0R0x22.</E>
                    </P>
                </FTNT>
                <P>
                    Expanding domestic markets and increasing U.S. consumption of fruits and vegetables to improve diets is also a critical impetus for providing assistance under MASC. Fruits and vegetables supply energy, nutrients, and fiber—all of which contribute to greater health. A diet rich in vegetables and fruits can lower blood pressure, reduce the risk of heart disease and stroke, prevent some types of cancer, lower risk of eye and digestive problems, and have a positive effect upon blood sugar.
                    <SU>10</SU>
                    <FTREF/>
                     While Americans are consuming more fruits and vegetables than in 1970, the average U.S. diet still falls short of the recommendations in the “2020-2025 Dietary Guidelines for Americans ” 
                    <SU>11</SU>
                    <FTREF/>
                     for these major food groups. Fruit and vegetable per capita consumption are at only 40 percent and 70 percent, respectively, of the recommendation levels found in the Dietary Guidelines. Increasing the domestic consumption of specialty crops benefits consumers and can expand U.S. specialty crop markets. MASC payments are being provided in order to expand existing markets and develop new markets. As a result of such market expansion, specialty crop consumption is expected to increase. With greater consumption, and a greater focus on healthy eating, sector profitability is also expected to improve over the long term.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Harvard T.H. Chan School of Public Health. “The Nutrition Source: Vegetables and Fruits.” Accessed October 9, 2024. 
                        <E T="03">https://nutritionsource.hsph.harvard.edu/what-should-you-eat/vegetables-and-fruits/.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         U.S. Department of Agriculture and the U.S. Department of Health and Human Services. “Dietary Guidelines for Americans, 2020-2025.” 
                        <E T="03">https://www.dietaryguidelines.gov/sites/default/files/2020-12/Dietary_Guidelines_for_Americans_2020-2025.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    Other factors complicate the viability of the sector further, as noted in an October 2024 Congressional Research Service (CRS) report.
                    <SU>12</SU>
                    <FTREF/>
                     Specifically, pandemic-era supply chain disruptions and higher input costs have contributed to increased market volatility since 2020. Further, the increase in disaster events has exacerbated uncertainty and the likelihood that disruptions affect farm losses, and potentially consumer access to specialty crops. Small-scale specialty crop growers (those with less than $100,000 in sales per year) are less able to take advantage of economies of scale than larger growers, and small-scale growers often have the greatest marketing and related challenges (such as outreach, advertising, and the need for refrigerated trucks).
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Johnson, Renee. “Marketing and Pricing in the U.S. Fruit and Vegetable Industry.” Congressional Research Service. October 4, 2024. 
                        <E T="03">https://crsreports.congress.gov/product/pdf/R/R48213.</E>
                    </P>
                </FTNT>
                <P>In response to these economic and health-based factors, USDA will use section 5(e) of the Commodity Credit Corporation (CCC) Charter Act (7 U.S.C. 714c(e)) to make payments to eligible producers in order to increase consumption of specialty crops by aiding expansion of domestic markets or aiding in the development of new and additional markets. Without intervention to support producers' activities to expand domestic markets and develop new and additional markets for their specialty crops in calendar year 2025, high marketing costs and challenges may be a barrier to such expansion and development in 2025, which may result in the exit of many operations, reducing domestic availability of fruits, vegetables, and other specialty crops, to the detriment of many local economies. Further, assistance to this sector will create additional market opportunities, including those for local foods, such as setting up farmer's markets near the geographic area of production.</P>
                <P>
                    FSA will administer MASC on behalf of CCC. MASC payments will provide eligible specialty crop producers with marketing assistance that gives them the ability to engage in activities that aid in expanding domestic specialty crop markets or in developing new markets for their crops, such as outreach, marketing, and investing in packaging, storage, and transportation equipment and supplies that are necessary to protect perishable specialty crops. MASC will use up to $2 billion 
                    <SU>13</SU>
                    <FTREF/>
                     in CCC funding to provide assistance to producers of specialty crops, subject to a payment limitation of $125,000. MASC payments are based on a 
                    <PRTPAGE P="99214"/>
                    producer's sales of specialty crops, as described below, and adjustments will be made to ensure that payments do not exceed the available funding.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Funding of $1,886,000,000 is available for MASC after sequestration of 5.7 percent. Individual MASC payments will not be subject to further sequestration.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Definitions</HD>
                <P>The following definitions apply to this notice:</P>
                <P>
                    <E T="03">Average adjusted gross farm income</E>
                     means the average of the person or legal entity's adjusted gross income (AGI) derived from farming, ranching, and forestry operations, including losses, for the base period consisting of the 2021, 2022, and 2023 tax years.
                </P>
                <P>If the resulting average adjusted gross farm income derived from items 1 through 12 of the definition of income derived from farming, ranching, and forestry operations is at least 66.66 percent of the average AGI of the person or legal entity, then the average adjusted gross farm income may also take into consideration income or benefits derived from the following:</P>
                <P>(1) The sale, trade, or other disposition of equipment to conduct farm, ranch, or forestry operations; and</P>
                <P>(2) The provision of production inputs and production services to farmers, ranchers, foresters, and farm operations.</P>
                <P>For legal entities not required to file a Federal income tax return, or a person or legal entity that did not have taxable income in 1 or more tax years during the base period, the average will be the adjusted gross farm income, including losses, averaged for the 2021, 2022, and 2023 tax years, as determined by FSA. A new legal entity will have its adjusted gross farm income averaged only for those years of the base period for which it was in business; however, a new legal entity will not be considered “new” to the extent it takes over an existing operation and has any elements of common ownership interest and land with the preceding person or legal entity from which it took over. When there is such commonality, income of the previous person or legal entity will be averaged with that of the new legal entity for the base period. For a person filing a joint tax return, the certification of average adjusted gross farm income may be reported as if the person had filed a separate Federal tax return and the calculation is consistent with the information supporting the filed joint return.</P>
                <P>
                    <E T="03">Average AGI</E>
                     means the average of the adjusted gross income as defined under 26 U.S.C. 62 or comparable measure of the person or legal entity. The relevant tax years for the 2025 program year are 2021, 2022, and 2023.
                </P>
                <P>
                    <E T="03">Crop year</E>
                     means:
                </P>
                <P>(1) For insured crops, the crop year as defined according to the applicable Federal crop insurance policy; and</P>
                <P>(2) For NAP-covered crops, the crop year as defined in 7 CFR 1437.3.</P>
                <P>
                    <E T="03">Deputy Administrator</E>
                     means the FSA Deputy Administrator for Farm Programs.
                </P>
                <P>
                    <E T="03">Farming operation</E>
                     means a business enterprise engaged in the production of agricultural products, commodities, or livestock, operated by a person, legal entity, or joint operation. A person or legal entity may have more than one farming operation if the person or legal entity is a member of one or more legal entity or joint operation.
                </P>
                <P>
                    <E T="03">Federal crop insurance</E>
                     means an insurance policy reinsured by the Federal Crop Insurance Corporation administered by RMA under the provisions of the Federal Crop Insurance Act (7 U.S.C. 1501-1524), as amended. It does not include private plans of insurance.
                </P>
                <P>
                    <E T="03">Federal crop insurance indemnity</E>
                     means the payment to a participant for crop losses covered under Federal crop insurance administered by RMA in accordance with the Federal Crop Insurance Act.  
                </P>
                <P>
                    <E T="03">Floriculture</E>
                     means the commercial production of flowers and cut greenery that are field-grown or grown in a controlled environment, including those planted in containers or other growing mediums.
                </P>
                <P>
                    <E T="03">Fruit</E>
                     means the edible reproductive body of a seed plant or tree nut (such as apple, orange, and almond) such that fruit means the harvestable or harvested part of a plant developed from a flower.
                </P>
                <P>
                    <E T="03">Income derived from farming, ranching, and forestry operations</E>
                     means income of a person or legal entity derived from:
                </P>
                <P>(1) Production of crops and unfinished raw forestry products;</P>
                <P>(2) Production of livestock, aquaculture products used for food, honeybees, and products derived from livestock;</P>
                <P>(3) Production of farm-based renewable energy;</P>
                <P>(4) Selling (including the sale of easements and development rights) of farm, ranch, and forestry land, water or hunting rights, or environmental benefits;</P>
                <P>(5) Rental or lease of land or equipment used for farming, ranching, or forestry operations, including water or hunting rights;</P>
                <P>(6) Processing, packing, storing, and transportation of farm, ranch, or forestry commodities including for renewable energy;</P>
                <P>(7) Feeding, rearing, or finishing of livestock;</P>
                <P>(8) Payments of benefits, including benefits from risk management practices, Federal crop insurance indemnities, and catastrophic risk protection plans;</P>
                <P>(9) Sale of land that has been used for agricultural purposes;</P>
                <P>(10) Benefits (including, but not limited to, cost-share assistance and other payments) from any Federal program made available and applicable to payment eligibility and payment limitation rules, as provided in 7 CFR part 1400;</P>
                <P>(11) Income reported on IRS Schedule F or other schedule, approved by the Deputy Administrator for Farm Programs, used by the person or legal entity to report income from such operations to the IRS;</P>
                <P>(12) Wages or dividends received from a closely held corporation, an Interest Charge Domestic International Sales Corporation (IC-DISC), or legal entity comprised entirely of family members when more than 50 percent of the legal entity's gross receipts for each tax year are derived from farming, ranching, and forestry activities as defined in this document; and</P>
                <P>(13) Any other activity related to farming, ranching, or forestry, as determined by the Deputy Administrator.</P>
                <P>
                    <E T="03">IRS</E>
                     means the Department of the Treasury, Internal Revenue Service.
                </P>
                <P>
                    <E T="03">Legal entity</E>
                     means a corporation, joint stock company, association, limited partnership, limited liability company, irrevocable trust, estate, charitable organization, general partnership, joint venture, or other similar organization created under Federal or State law including any such organization participating in a business structure as a partner in a general partnership, a participant in a joint venture, a grantor of a revocable trust, or as a participant in a similar organization. A business operating as a sole proprietorship is considered a legal entity.
                </P>
                <P>
                    <E T="03">NAP</E>
                     means the Noninsured Crop Disaster Assistance Program under section 196 of the Federal Agriculture Improvement and Reform Act of 1996 (7 U.S.C. 7333) and 7 CFR part 1437.
                </P>
                <P>
                    <E T="03">Nursery crops</E>
                     means decorative or nondecorative plants grown in a container or controlled environment for commercial sale.
                </P>
                <P>
                    <E T="03">Ownership interest</E>
                     means to have either a legal ownership interest or a beneficial ownership interest in a legal entity. For the purposes of administering MASC, a person or legal entity that owns a share or stock in a legal entity that is a corporation, limited liability company, limited partnership, or similar type entity where members 
                    <PRTPAGE P="99215"/>
                    hold a legal ownership interest and shares in the profits or losses of such entity is considered to have an ownership interest in such legal entity. A person or legal entity that is a beneficiary of a trust or heir of an estate who benefits from the profits or losses of such entity is also considered to have a beneficial ownership interest in such legal entity.
                </P>
                <P>
                    <E T="03">Person</E>
                     means an individual who is a natural person and does not include a legal entity.
                </P>
                <P>
                    <E T="03">Production inputs</E>
                     mean material to conduct farming operations, such as seeds, chemicals, and fencing supplies.
                </P>
                <P>
                    <E T="03">Production services</E>
                     mean services provided to support a farming operation, such as custom farming, custom feeding, and custom fencing.
                </P>
                <P>
                    <E T="03">United States</E>
                     means all 50 States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, and any other territory or possession of the United States.
                </P>
                <P>
                    <E T="03">USDA</E>
                     means the U.S. Department of Agriculture.
                </P>
                <P>
                    <E T="03">Vegetable</E>
                     means the edible part of an herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a fungus (such as white button or shiitake) grown for an edible part such that vegetable means the harvestable or harvested part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, bulbs, stems, leaves, or flower parts are used as food and includes mushrooms, sprouts, and herbs (such as basil or cilantro).
                </P>
                <HD SOURCE="HD1">Specialty Crops</HD>
                <P>For MASC, “specialty crop” includes only the following crops:</P>
                <P>• fruits, including, but not limited to, dried fruits;</P>
                <P>• vegetables, including, but not limited to, dry edible beans and peas, mushrooms, and vegetable seed;</P>
                <P>• tree nuts;</P>
                <P>• nursery crops;</P>
                <P>• Christmas trees;</P>
                <P>• floriculture;</P>
                <P>• culinary and medicinal herbs and spices;</P>
                <P>• honey;</P>
                <P>• hops;</P>
                <P>• maple sap;</P>
                <P>• tea;</P>
                <P>• turfgrass; and</P>
                <P>• grass seed.</P>
                <P>
                    Common examples of specialty crops can be found at 
                    <E T="03">https://www.ams.usda.gov/sites/default/files/media/USDASpecialtyCropDefinition.pdf.</E>
                </P>
                <P>The following crops are not specialty crops for MASC:</P>
                <P>• field and grain crops, such as amaranth (for grain), barley (including malting barley), buckwheat, corn (other than sweet corn), millet, oats, quinoa, rice, rye, sorghum, triticale, wheat, and wild rice);</P>
                <P>• forage, hay, and cover crops, such as alfalfa, birdsfoot trefoil, clover, hay, grasses, mixed forage, perennial peanuts, sunn hemp, and vetch;</P>
                <P>• oilseed crops, such as camelina, canola, crambe, flax, flaxseed, linseed, mustard seed, rapeseed, safflower, sesame, soybeans, and sunflower seed;</P>
                <P>• other crops such as cotton, cottonseed, hemp, kochia (prostrata), lespedeza, milkweed, peanuts, primrose, seed of ineligible crops (other than grass seed), sugar beets, sugarcane, tobacco, and crops with an intended use of fallow, forage, grazing, green manure, or left standing; and</P>
                <P>• other agricultural products such as aquatic animal species (such as fish and shellfish), dairy products, eggs, livestock products, and tofu.</P>
                <HD SOURCE="HD1">Eligible Producers</HD>
                <P>To be eligible for MASC, a producer must be in the business of farming at the time of application and be entitled to an ownership share and share in the risk of producing a specialty crop that will be sold in calendar year 2025. To be considered in the business of farming at the time of application, a producer must have an active business operation with assets and resources needed to grow, harvest, and market a specialty crop in calendar year 2025. Producers who previously grew a specialty crop but have ceased operation at the time of application (for example, through the sale of land and equipment needed to produce a crop) are not eligible for MASC.</P>
                <P>In addition, consistent with other FSA assistance programs, a producer must be one of the following to be eligible:</P>
                <P>• Citizen of the United States;</P>
                <P>• Resident alien, which for purposes of MASC means “lawful alien” as defined in 7 CFR 1400.3;</P>
                <P>• Partnership organized under State law;</P>
                <P>• Corporation, limited liability company, or other organizational structure organized under State law;</P>
                <P>• Indian Tribe or Tribal organization, as defined in section 4(b) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304); or</P>
                <P>• Foreign person or foreign entity who meets all requirements as described in 7 CFR part 1400.  </P>
                <P>The regulations in 7 CFR part 1400, subpart E, are applicable to foreign persons and legal entities (foreign and domestic) containing members, stockholders, or partners who are not U.S. citizens or resident aliens that own more than 10 percent of the legal entity.</P>
                <P>Federal, State, and local governments, including public schools, are not eligible for MASC payments.</P>
                <HD SOURCE="HD1">Eligible Specialty Crop Sales and Required Documentation</HD>
                <P>MASC payments are based on a producer's total specialty crop sales in calendar year 2023 or 2024 (except for new producers, as described below) because the amount of sales reflects a producer's existing market and operation size, which impacts their ability to take advantage of economies of scale. Marketing economies of scale are achieved when an operation has the ability to spread marketing costs, such as advertising, over larger outputs. In lieu of a complex production-based calculation, FSA is using prior year sales as an alternative indicator of output, which simplifies the application process by using information that is easily determined by producers. Using prior year sales as a proxy for output to calculate MASC assistance provides specialty crop growers with additional resources to address increased marketing costs associated with expanded or new markets which directly impacts their ability to realize greater economies of scale.</P>
                <P>Eligible specialty crop sales only include sales of commercially marketed raw specialty crops grown in the United States by the producer. The portion of sales derived from adding value to a specialty crop, such as sorting, processing, or packaging, is not included in a producer's eligible sales. For example, the eligible sales for a producer who grows cucumbers and sells raw cucumbers and cucumber pickles at a local farmer's market would be the sales of raw cucumbers sold at the market plus the raw value of the cucumbers used in the pickles. The value of the cucumbers used in the pickles would be determined by multiplying the quantity of cucumbers processed into pickles by the price of raw cucumbers sold at the market. Sales of specialty crops purchased for resale may be included only if there is a change in characteristic due to the time held (for example, a 2-inch plant that was sold as an 18-inch plant after 4 months). Eligible producers who market their specialty crops through a subscription or membership-based service, such as a community-supported agriculture (CSA) model, may include the portion of the membership or subscription fees received for specialty crops in their eligible sales.</P>
                <P>
                    MASC is providing assistance to specialty crop producers in order to 
                    <PRTPAGE P="99216"/>
                    increase domestic consumption of such crops, which is intended to expand domestic specialty crop markets or develop new markets for such crops in 2025; therefore, MASC assistance will be based on a producer's anticipated sales in the 2025 calendar year. For most producers, FSA will use a producer's specialty crop sales in calendar year 2023 or 2024 as a proxy for expected specialty crop sales in the 2025 calendar year. Allowing producers to choose between 2023 and 2024 calendar year sales is intended to provide flexibility for producers who had reduced sales in one of those years due to disaster events or other impacts such as price fluctuations or loss of markets.
                </P>
                <P>For producers who grew and sold specialty crops in either the 2023 or 2024 calendar year, for the purpose of calculating payments under MASC, the total specialty crop sales certified on the MASC application will be equal to one of the following, as elected by the producer:</P>
                <P>• 2023 calendar year sales of specialty crops, plus Federal crop insurance indemnities and NAP payments for such specialty crops for the 2023 crop year; or</P>
                <P>• 2024 calendar year sales of specialty crops, plus Federal crop insurance indemnities and NAP payments for such specialty crops for the 2024 crop year.</P>
                <P>To be considered a 2023 or 2024 calendar year sale, the producer must have received payment for the specialty crop during the applicable calendar year. Federal crop insurance indemnities and NAP payments for the 2023 or 2024 crop year will be included for 2023 or 2024, respectively, regardless of when they were received by the producer, and are included in eligible sales to more accurately represent what a producer would expect to sell in calendar year 2025 by taking into account crops that would have been sold in the selected year if not for losses due to disaster events covered by Federal crop insurance and NAP.</P>
                <P>
                    If requested by FSA, producers must provide documentation to substantiate their reported 2023 or 2024 calendar year sales and Federal crop insurance indemnities.
                    <SU>14</SU>
                    <FTREF/>
                     Acceptable documentation must show the crop, quantity sold, and the dollar amount received. Acceptable documentation to substantiate total specialty crop sales includes, but is not limited to:
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         Producers are not required to submit documentation of 2023 or 2024 crop year NAP payments included in their eligible sales because FSA has that information on file.
                    </P>
                </FTNT>
                <P>• sales receipts;</P>
                <P>• sales records;</P>
                <P>• ledgers of income;</P>
                <P>• contract or sales agreements;</P>
                <P>• income statements of deposit slips;</P>
                <P>• register tapes with supporting documentation acceptable to FSA;</P>
                <P>• purchase orders;</P>
                <P>• third party processor or distributor statements;</P>
                <P>• contemporaneous diaries that are determined acceptable by USDA,</P>
                <P>• other sales documents indicating the crop was sold; and</P>
                <P>• IRS Schedule F accompanied by documentation to support that the reported amounts are from sales of specialty crops.</P>
                <P>If requested by FSA, the producer must also provide acceptable evidence that the producer grew and harvested the crop and was in the business of farming at the time of application. Such evidence may include, but is not limited to:</P>
                <P>• acreage reports;</P>
                <P>• land use records, such as lease agreements or ownership records;</P>
                <P>• field inspection or certification records, such as reports from organic certification inspections or other third party inspections;</P>
                <P>• shipping or transportation receipts;</P>
                <P>• packaging or processing records;</P>
                <P>• photographic evidence;</P>
                <P>• Federal crop insurance records;</P>
                <P>• NAP records;</P>
                <P>• labor records;</P>
                <P>• records of agricultural inputs, such as seed, fertilizer, and pesticides;</P>
                <P>• contemporaneous harvest records; and</P>
                <P>• invoices for custom harvesting.</P>
                <P>Producers must submit requested documentation to FSA within 15 days of the request.</P>
                <P>FSA is allowing certain producers (collectively referred to as “new producers”) to use an estimate of their 2025 calendar year specialty crop sales, in lieu of actual 2023 or 2024 calendar year sales, if the producer:</P>
                <P>• Began producing specialty crops in 2023 or 2024 but did not have sales due to the immaturity of the crop;  </P>
                <P>• Began producing specialty crops in 2024 but did not have a complete year of sales; or</P>
                <P>• Is beginning to grow specialty crops in 2025.</P>
                <P>New producers have no or limited sales and will need to develop new markets for their specialty crops in order to be successful, and MASC payments are intended to provide assistance to these producers that will help them create or develop markets for their specialty crops in calendar year 2025. To be eligible for MASC, a new producer must have one of the following:</P>
                <P>• A legally binding contract or agreement wherein the producer has agreed to sell a specialty crop during calendar year 2025; or</P>
                <P>• Evidence that, at the time of application, a specialty crop has been planted and is expected to be harvested and sold in the 2025 calendar year.</P>
                <P>All new producers must provide acceptable documentation that shows the producer is in the business of farming at time of application and intends to sell a specialty crop in the 2025 calendar year. Expected 2025 sales must be based on realistic projections that are supported by acceptable documentation demonstrating the producer's ability to achieve the expected sales and their ability to grow, harvest, and market the expected yield or inventory. For new producers who have entered into a legally binding sales contract or purchase agreement for the sale of their specialty crop, their 2025 expected specialty crop sales must be based on the terms of their contract or agreement regarding the total sale amount or the price and amount of inventory or production. For new producers who are growing a specialty crop intended for sale in 2025 who do not have a contract or agreement, their expected 2025 specialty crop sales must be based on their specialty crop acreage or inventory that is planted at the time of application and published yields and prices such as Federal Crop Insurance Corporation-established data, FSA-established National Crop Table data, and National Agricultural Statistic Service data, or published local data sources.</P>
                <P>New producers must submit form FSA-1141, Marketing Assistance for Specialty Crops (MASC) New Producer Expected Sales Worksheet, and provide documentation to substantiate their expected 2025 calendar year sales by January 8, 2025.</P>
                <HD SOURCE="HD1">Payment Factors and Calculation</HD>
                <P>
                    FSA will calculate MASC payments based on the producer's total specialty crop sales for the calendar year elected by the producer (either 2023 or 2024, or expected 2025 sales for new producers), as described above. The total specialty crop sales reported by the producer will be separated into the sales ranges shown in Table 1. The sales ranges are based on the traditional Agricultural Resource Management Survey (ARMS) groupings.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         ARMS is the U.S. Department of Agriculture's primary source of information on the production practices, resource use, and economic well-being of America's farms and ranches. See 
                        <E T="03">
                            https://www.ers.usda.gov/data-products/arms-farm-
                            <PRTPAGE/>
                            financial-and-crop-production-practices/
                        </E>
                         for more information.
                    </P>
                </FTNT>
                <PRTPAGE P="99217"/>
                <P>
                    After the end of the application period, FSA will determine a percent payment factor for each sales range (referred to as “
                    <E T="03">a</E>
                    ” through “
                    <E T="03">e</E>
                    ” in Table 1). These factors are necessary to ensure that payments do not exceed the $2 billion in allocated funding. The factors will depend on the number of eligible MASC applicants, the total sales reported by those applicants for each sales range, and the payment limitation per person or legal entity. Therefore, factors are unknown and cannot be determined until after the application period closes.
                </P>
                <P>
                    In order to streamline MASC assistance and provide payments quickly, FSA will use the CFAP 2 modelling approach to develop MASC percent payment factors; the CFAP 2 approach relied on statistical analysis of the ratio of variable costs per farm to sales per farm.
                    <E T="51">16 17</E>
                    <FTREF/>
                     According to general convention, a farm's expenses per unit of production or sales tends to decrease as farm size increases.
                    <SU>18</SU>
                    <FTREF/>
                     Larger farms tend to have lower costs of production per unit of sales; hence, MASC payments as a share of total sales fall as sales per farm increase. The regression analysis used for CFAP2 confirmed that the ratio of variable expenses to sales decreases as farm size (sales range) increases.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         Coronavirus Food Assistance Program 2 Cost-Benefit Analysis (September 15, 2020), available at 
                        <E T="03">https://www.regulations.gov/document/FSA-2020-0006-0002.</E>
                    </P>
                    <P>
                        <SU>17</SU>
                         The second through fourth sales range groupings in Table 1 are the traditional groupings used by USDA to summarize ARMS data by farm size. However, for sales values per farm of $49,000 or less, the USDA data summaries are further broken down into $9,999 or less and $10,000 to $49,999; for sales of $100,000 to $499,999 the USDA sales summaries were further broken down into $100,000 to $249,999 and $250,000 to $499,000; and for sales values of $1,000,000 or more, into $1,000,000 to $4,900,000 and $5,000,000 or more. For CFAP 2, USDA collapsed the lower two, middle two, and upper two ranges into one range each in order to simplify the payment design.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         The decrease in costs of production per unit of output or sales as farm size increases is known as economies of scale, see for example, C. Morrison Paul, R. Nehring, D. Banker, and A. Somwaru. 2004. “Scale Economies and Efficiency in U.S. Agriculture: Are Traditional Farms History?” Journal of Productivity Analysis vol 22: pp 185-205; Gardner, B. 2002. “American Agriculture in the Twentieth Century: How it Flourished and What it Cost,” Harvard University Press.
                    </P>
                </FTNT>
                <P>As explained in more detail below, the predicted ratio of variable expenses to sales per farm for each sales class determines the relationship between the payment rates for each of the five sales ranges. Information on the number of farms and sales per farm in each sales range, and on applicants hitting the payment limit, will be used to re-adjust the payment rates for each range so that total payments stay within the $2 billion. As a result, estimated payment factors will likely differ than those shown as examples in Table 2.</P>
                <P>Note that estimated payment factors for each sales range automatically adjust per the mathematical equations that maintain the ratio between each payment factor and the predicted variable expenses to sales per farm. For example, as the number of eligible producers increases, the $2 billion will be distributed across more producers, causing the payment factors for each sales range to decrease.</P>
                <P>
                    The payment factors will decrease as the sales range increases, meaning the first sales range (up to $49,999) will have the largest factor and the fifth sales range (all sales over $1 million) will have the smallest payment factor. While the actual payment factors cannot be determined before the end of the application period, Table 2 provides examples of estimated payment factors for four scenarios.
                    <SU>19</SU>
                    <FTREF/>
                     The second column contains the ratio of variable costs to sales per farm that was predicted from the statistical analysis used for CFAP2, which will also be used for MASC. The 57,000 applications in the third column are the number of specialty crop farms (from ARMS) that applied for the CFAP 2 program design, with applications in the three successive columns being multiples, and the applications in the last columns being roughly the numbers of specialty crops farms in the 2022 Census of Agriculture. Each column of payment factors assumes the same $2 billion in total payments.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         The examples of MASC payment factors for each sales range are based on CFAP 2 program data for specialty crop producers. Therefore, the data represent those producers who self-selected and applied for CFAP 2 and do not necessarily represent those specialty crop producers who may apply for MASC. While CFAP 2 was similar to MASC in terms of producer and specialty crop eligibility, estimated MASC payment factors extrapolated from CFAP 2 data are shown only as illustrative examples and final payment factors will be announced in a news release and may be different from those shown here. To develop the scenarios for Table 2, the 57,000 CFAP 2 applications were assumed to provide an estimate of the minimum number of applicants. Higher applicant scenarios (up to 227,000 applicants) were developed while preserving the underlying distribution of the CFAP 2 data. For the sake of simplicity, the examples in Table 2 do not account for payment limitations per person or legal entity.
                    </P>
                </FTNT>
                <P>
                    As shown in Table 2, the second column is essential to determining the other table values. If the variable costs to sales ratio in the first row of numbers (for example, 0.903) is divided by that in the second row (for example, 0.849), then it yields a ratio that is approximately equal to the payment factor relationships between the first and second sales category rows (for example, 11.3 divided by 10.6).
                    <SU>20</SU>
                    <FTREF/>
                     This relationship holds across all rows and columns. The factors are expected to range between 2 to 11 percent, depending on the number of potential applications but could go higher or lower depending on how many eligible producers apply.
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         For any given pair of rows, differences across the columns between the ratios of the pair of rows is due to rounding error in moving from the computer software's level of precision to the one decimal place used in the actual payment rates.
                    </P>
                </FTNT>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s25,9C">
                    <TTITLE>Table 1—Sales Ranges</TTITLE>
                    <BOXHD>
                        <CHED H="1">Sales range</CHED>
                        <CHED H="1">
                            Percent 
                            <LI>payment </LI>
                            <LI>factor</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01" O="xl">Up to $49,999</ENT>
                        <ENT>
                            <E T="03">a</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01" O="xl">$50,000-$99,999</ENT>
                        <ENT>
                            <E T="03">b</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01" O="xl">$100,000-$499,999</ENT>
                        <ENT>
                            <E T="03">c</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01" O="xl">$500,000-$999,999</ENT>
                        <ENT>
                            <E T="03">d</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01" O="xl">All sales over $1 million</ENT>
                        <ENT>
                            <E T="03">e</E>
                        </ENT>
                    </ROW>
                </GPOTABLE>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,15,12,12,12,12">
                    <TTITLE>Table 2—Estimated Payment Factor Examples Assuming $2 Billion in Payments</TTITLE>
                    <BOXHD>
                        <CHED H="1">Sales range</CHED>
                        <CHED H="1">
                            Predicted ratio 
                            <LI>of variable </LI>
                            <LI>costs to sales </LI>
                            <LI>per farm</LI>
                        </CHED>
                        <CHED H="1">Example of estimated percent payment factors</CHED>
                        <CHED H="2">
                            57,000 
                            <LI>applicants</LI>
                        </CHED>
                        <CHED H="2">
                            113,000 
                            <LI>applicants</LI>
                        </CHED>
                        <CHED H="2">
                            170,000 
                            <LI>applicants</LI>
                        </CHED>
                        <CHED H="2">
                            227,000 
                            <LI>applicants</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01" O="xl">Up to $49,999</ENT>
                        <ENT>0.903</ENT>
                        <ENT>11.3</ENT>
                        <ENT>5.7</ENT>
                        <ENT>3.8</ENT>
                        <ENT>2.8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01" O="xl">$50,000-$99,999</ENT>
                        <ENT>0.849</ENT>
                        <ENT>10.6</ENT>
                        <ENT>5.3</ENT>
                        <ENT>3.6</ENT>
                        <ENT>2.7</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01" O="xl">$100,000-$499,999</ENT>
                        <ENT>0.826</ENT>
                        <ENT>10.3</ENT>
                        <ENT>5.2</ENT>
                        <ENT>3.5</ENT>
                        <ENT>2.6</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01" O="xl">$500,000-$999,999</ENT>
                        <ENT>0.771</ENT>
                        <ENT>9.6</ENT>
                        <ENT>4.9</ENT>
                        <ENT>3.2</ENT>
                        <ENT>2.4</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01" O="xl">All sales over $1 million</ENT>
                        <ENT>0.748</ENT>
                        <ENT>9.3</ENT>
                        <ENT>4.7</ENT>
                        <ENT>3.1</ENT>
                        <ENT>2.3</ENT>
                    </ROW>
                </GPOTABLE>
                <PRTPAGE P="99218"/>
                <P>To calculate a producer's MASC payment, FSA will:</P>
                <P>(1) Multiply the amount of sales in each range in Table 1 by the corresponding percent payment factor for that range; and</P>
                <P>(2) Calculate the sum of the results for each sales range.</P>
                <P>For example, if a producer reported $450,000 of total specialty crop sales for their elected year, FSA would calculate a payment equal to the sum of the following:</P>
                <P>
                    • $49,999 (the amount of sales in the first range) multiplied by percent payment factor 
                    <E T="03">a;</E>
                </P>
                <P>
                    • $50,000 (the amount of sales in the second range) multiplied by percent payment factor 
                    <E T="03">b;</E>
                     and
                </P>
                <P>
                    • $350,001 (the amount of sales in the third range) multiplied by percent payment factor 
                    <E T="03">c.</E>
                </P>
                <P>Payments are subject to a payment limitation of $125,000, as described below. FSA will issue MASC payments after the end of the application period. If demand for MASC payments exceeds available funding, either MASC payments may be prorated, the payment limitation may be lowered, or both. If proration or a reduction of the payment limitation is necessary, the reduction or lowered payment limitation will apply equally to all MASC participants. If additional funding remains available after MASC payments are issued and any appeals and requests for equitable relief have been resolved, FSA may issue an additional payment.</P>
                <HD SOURCE="HD1">Average AGI Limitation and Payment Limitation</HD>
                <P>A person or legal entity, other than a joint venture or general partnership, will not be eligible to receive, directly or indirectly, a MASC payment if the average adjusted gross income of the person or legal entity exceeds $900,000 for 2021, 2022, and 2023, unless the person or legal entity's average adjusted gross farm income is at least 75 percent of their average AGI.</P>
                <P>A person or legal entity, other than a joint venture or general partnership, cannot receive, directly or indirectly, more than $125,000 in MASC payments. This payment limitation is consistent with the payment limitation used in other FSA programs such as the Agriculture Risk Coverage and Price Loss Coverage programs, the Livestock Forage Disaster Program, NAP at the basic coverage level, and the Rice Production Program.</P>
                <P>A payment made to a legal entity will be attributed to those members who have a direct or indirect ownership interest in the legal entity, unless the payment of the legal entity has been reduced by the proportionate ownership interest of the member due to that member's ineligibility.</P>
                <P>
                    Attribution of payments made to legal entities will be tracked through four levels of ownership in legal entities 
                    <SU>21</SU>
                    <FTREF/>
                     as follows:
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         Attribution of payments through four levels of ownership in legal entities is consistent with the approach used in other FSA programs specified in 7 CFR 1400.1.
                    </P>
                </FTNT>
                <P>
                    • First level of ownership—any payment made to a legal entity that is owned in whole or in part by a person will be attributed to the person in an amount that represents the direct ownership interest in the first level or payment legal entity; 
                    <SU>22</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         The “first level or payment legal entity” means that the payment entity will have a reduction applied, and if the payment entity happens to be a joint venture, that reduction is applied to the first level, or highest level, for payments. The “first level or payment legal entity” is the highest level of ownership of the applicant to whom payments can be attributed or limited. If the applicant is a business type that does not have a limitation or attribution, the reduction is applied to the first level, but if the business type can have the reduction applied directly to it, then the limitation applies.
                    </P>
                </FTNT>
                <P>• Second level of ownership—any payment made to a first-level legal entity that is owned in whole or in part by another legal entity (referred to as a second-level legal entity) will be attributed to the second-level legal entity in proportion to the ownership of the second-level legal entity in the first-level legal entity; if the second-level legal entity is owned in whole or in part by a person, the amount of the payment made to the first-level legal entity will be attributed to the person in the amount that represents the indirect ownership in the first-level legal entity by the person;</P>
                <P>• Third and fourth levels of ownership—except as provided in the second level of ownership bullet above and in the fourth level of ownership bullet below, any payments made to a legal entity at the third and fourth levels of ownership will be attributed in the same manner as specified in the second level of ownership bullet above; and</P>
                <P>• Fourth-level of ownership—if the fourth level of ownership is that of a legal entity and not that of a person, a reduction in payment will be applied to the first-level or payment legal entity in the amount that represents the indirect ownership in the first level or payment legal entity by the fourth-level legal entity.</P>
                <P>Payments made directly or indirectly to a person who is a minor child will be combined with the earnings of the minor's parent or legal guardian.</P>
                <P>A person or legal entity must provide the name, address, valid taxpayer identification number, and ownership share of each person, or the name, address, valid taxpayer identification number, and ownership share of each legal entity, that holds or acquires an ownership interest in the legal entity. MASC payments to a legal entity will be reduced in proportion to a member's ownership share when a valid taxpayer identification number for a person or legal entity that holds a direct or indirect ownership interest of less than 10 percent at or above the fourth level of ownership in the business structure is not provided to USDA. A legal entity will not be eligible to receive payment when a valid taxpayer identification number for a person or legal entity that holds a direct or indirect ownership interest of 10 percent or greater at or above the fourth level of ownership in the business structure is not provided to USDA.</P>
                <P>If a person or legal entity is not eligible to receive MASC payments due to the person or legal entity failing to satisfy payment eligibility provisions, the payment made either directly or indirectly to the person or legal entity will be reduced to zero. The amount of the reduction for the direct payment to the producer will be commensurate with the direct or indirect ownership interest of the ineligible person or ineligible legal entity.</P>
                <P>Like other programs administered by FSA, payments made to an Indian Tribe or Tribal organization, as defined in section 4(b) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304), will not be subject to payment limitation.</P>
                <HD SOURCE="HD1">How To Apply</HD>
                <P>
                    Applicants must submit FSA-1140, Marketing Assistance for Specialty Crops (MASC) Application, to their local FSA county office 
                    <SU>23</SU>
                    <FTREF/>
                     by January 8, 2025. Applicants will submit 1 application that includes their total specialty crop sales in all counties nationwide. New producers must also submit all required documentation and FSA-1141 by January 8, 2025. FSA will not take action on applications from new producers that are submitted without FSA-1141 and required documentation.
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         To locate the nearest FSA county office, visit the USDA Service Center locator at 
                        <E T="03">https://www.farmers.gov/working-with-us/service-center-locator.</E>
                    </P>
                </FTNT>
                <P>Applicants must also submit the following eligibility forms to FSA by January 8, 2026, if not already on file with FSA for the 2025 program year:</P>
                <P>
                    • AD-2047, Customer Data Worksheet, for new applicants and 
                    <PRTPAGE P="99219"/>
                    applicants who need to update their information;
                </P>
                <P>• CCC-901, Member Information for Legal Entities, if applicable;</P>
                <P>• CCC-902E, Farm Operating Plan for an Entity; if applicable;</P>
                <P>• CCC-902I, Farm Operating Plan for an Individual, if applicable;</P>
                <P>• CCC-941, Averaged Adjusted Gross Income (AGI) and Consent to Disclosure of Tax Information, for the producer and members of entities;</P>
                <P>• CCC-942, Certification of Income from Farming, Ranching and Forestry Operations, if applicable, for the producer and members of entities; and</P>
                <P>• AD-1026 Highly Erodible Land Conservation (HELC) and Wetland Conservation (WC) Certification, for the producer and affiliated persons, as specified in 7 CFR 12.8.</P>
                <HD SOURCE="HD1">Other Provisions</HD>
                <P>
                    General requirements that apply to other FSA-administered commodity programs also apply to MASC. Producers that receive MASC payments must be in compliance with the provisions of 7 CFR part 12, “Highly Erodible Land and Wetland Conservation,” 
                    <SU>24</SU>
                    <FTREF/>
                     for the 2025 crop year, and the provisions of 7 CFR 718.6, which address ineligibility for benefits for offenses involving controlled substances, for the 2025 program year.
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         To comply with the requirements of 7 CFR part 12, producers and affiliates must establish a detailed farm record with FSA, unless the producer or affiliate does not have interest in land devoted to agriculture (for example, beekeepers who place their hives on another person's land and producers of crops grown in greenhouses who do not own or lease any agricultural land themselves).
                    </P>
                </FTNT>
                <P>All information provided to FSA for program eligibility and payment calculation purposes is subject to spot check. Participants are required to retain documentation in support of their application for 3 years after the date of approval. Participants receiving MASC payments or any other person who furnishes such information to USDA must permit authorized representatives of USDA or the Government Accountability Office, during regular business hours, to enter the operation and to inspect, examine, and allow representatives to make copies of books, records, or other items for the purpose of confirming the accuracy of the information provided by the participant.</P>
                <P>If a MASC payment resulted from erroneous information provided by a participant, or any person acting on their behalf, the payment will be recalculated and the participant must refund any excess payment to FSA with interest calculated from the date of the disbursement of the payment. If FSA determines that the applicant intentionally misrepresented information provided on their application, the application will be disapproved and the applicant must refund the full payment to FSA with interest from the date of disbursement.</P>
                <P>Applicants have a right to a decision in response to their application. If an applicant submits an application or required documentation to an FSA county office after the deadline, the submission will be considered a request to waive the deadline. Requests to waive or modify program provisions, including requests to waive the deadline, are at the discretion of the Deputy Administrator. The Deputy Administrator has the authority to waive or modify application deadlines and other requirements or program provisions not specified in law, in cases where the Deputy Administrator determines: (1) it is equitable to do so; and (2) the lateness or failure to meet such other requirements or program provisions do not adversely affect the operation of MASC. Applicants who request to waive or modify MASC provisions do not have a right to a decision on those requests. The Deputy Administrator's refusal to exercise discretion on requests to waive or modify MASC provisions will not be considered an adverse decision and is, by itself, not appealable.</P>
                <P>Equitable relief and finality provisions specified in 7 CFR part 718, subpart D, apply to determinations under MASC. Persons and legal entities who file an application with FSA have the right to an administrative review of any FSA adverse decision with respect to the application under the appeals procedures at 7 CFR parts 780 and 11. The determination of matters of general applicability that are not in response to, or do not result from, an individual set of facts in an individual participant's application are not matters that can be appealed. Such matters of general applicability include, but are not limited to, eligible specialty crops, the payment calculation, payment limitation, and payment factors.</P>
                <P>Any payment under MASC will be made without regard to questions of title under State law and without regard to any claim or lien. The regulations governing offsets in 7 CFR part 3 apply to MASC payments.</P>
                <P>In either applying for or participating in MASC, or both, the applicant is subject to laws against perjury (including but not limited to 18 U.S.C. 1621). If the applicant willfully makes and represents as true any verbal or written declaration, certification, statement, or verification that the applicant knows or believes not to be true, in the course of either applying for or participating in MASC, or both, then the applicant may be found to be guilty of perjury. Except as otherwise provided by law, if guilty of perjury the applicant may be fined, imprisoned for not more than 5 years, or both, regardless of whether the applicant makes such verbal or written declaration, certification, statement, or verification within or outside the United States.</P>
                <P>For the purposes of the effect of a lien on eligibility for Federal programs (28 U.S.C. 3201(e)), USDA waives the restriction on receipt of funds under MASC but only as to beneficiaries who, as a condition of the waiver, agree to apply the MASC payments to reduce the amount of the judgment lien.</P>
                <P>In addition to any other Federal laws that apply to MASC, the following laws apply: 18 U.S.C. 286, 287, 371, and 1001.</P>
                <HD SOURCE="HD1">Paperwork Reduction Act Requirements</HD>
                <P>In compliance with the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35), the information collection request has been approved by OMB under the control number of 0503-0028. FSA will provide financial assistance to specialty crop producers, if eligible, to help them engage in activities that aid in expanding domestic specialty crop markets or in developing new markets for their crops as described in this NOFA.</P>
                <HD SOURCE="HD1">Environmental Review</HD>
                <P>The environmental impacts of this notice have been considered in a manner consistent with the provisions of the National Environmental Policy Act (NEPA, 42 U.S.C. 4321-4347), the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and the FSA regulations for compliance with NEPA (7 CFR part 799).</P>
                <P>
                    The purpose of MASC is to provide assistance to specialty crop operations to expand domestic specialty crop markets or develop new markets for their crops. The Categorical Exclusions in 7 CFR 799.31 apply, specifically 7 CFR 799.31(b)(6)(iii) (that is, financial assistance to supplement income). No Extraordinary Circumstances (7 CFR 799.33) exist. FSA has determined that this notice does not constitute a major Federal action that would significantly affect the quality of the human environment, individually or cumulatively. Therefore, FSA will not prepare an environmental assessment or environmental impact statement for this regulatory action.
                    <PRTPAGE P="99220"/>
                </P>
                <HD SOURCE="HD1">Federal Assistance Programs</HD>
                <P>
                    The title and number of the Federal assistance programs, as found in the Assistance Listing,
                    <SU>25</SU>
                    <FTREF/>
                     to which this document applies is 10.096, Marketing Assistance for Specialty Crops (MASC).
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         See 
                        <E T="03">https://sam.gov/content/assistance-listings.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">USDA Non-Discrimination Policy</HD>
                <P>In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family or parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.</P>
                <P>Individuals who require alternative means of communication for program information (for example, braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA TARGET Center at (202) 720-2600 (voice and text telephone (TTY)) or dial 711 for Telecommunications Relay Service (both voice and text telephone users can initiate this call from any telephone). Additionally, program information may be made available in languages other than English.</P>
                <P>
                    To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at 
                    <E T="03">https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint</E>
                     and at any USDA office or write a letter addressed to USDA and provide in the letter all the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by mail to: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410 or email: 
                    <E T="03">OAC@usda.gov.</E>
                </P>
                <P>USDA is an equal opportunity provider, employer, and lender.</P>
                <SIG>
                    <NAME>Zach Ducheneaux,</NAME>
                    <TITLE>Administrator, Farm Service Agency, and Executive Vice President, Commodity Credit Corporation.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-29017 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3411-E2-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Forest Service</SUBAGY>
                <SUBJECT>Wallowa-Whitman National Forest, Oregon; Wallowa-Whitman National Forest Travel Management Plan; Withdrawal</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Forest Service, Agriculture (USDA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; withdrawal.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Wallowa-Whitman National Forest is withdrawing its notice of intent to prepare an environmental impact statement (EIS) for the Wallowa-Whitman Travel Management Project. The original notice of intent was published in the 
                        <E T="04">Federal Register</E>
                         on May 3, 2007, and the notice of availability for the draft EIS was published on June 19, 2009. The Wallowa-Whitman National Forest's decision to withdraw the notice of intent is based on prioritization of agency resources toward forest plan revision.
                    </P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Questions concerning this notice should be directed to Wallowa-Whitman Forest Supervisor, Shaun McKinney, at 
                        <E T="03">shaun.mckinney@usda.gov</E>
                         or (503) 273-2413.
                    </P>
                    <P>Individuals who use telecommunications devices for the hearing impaired may call 711 to reach the Telecommunications Relay Service, 24 hours a day, every day of the year, including holidays.</P>
                    <SIG>
                        <NAME>JoLynn Anderson,</NAME>
                        <TITLE>Federal Register Liaison.</TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28920 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3411-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">COMMISSION ON CIVIL RIGHTS</AGENCY>
                <SUBJECT>Notice of Public Meeting of the Utah Advisory Committee to the U.S. Commission on Civil Rights</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Commission on Civil Rights.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the Utah Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a public meeting via Zoom at 2 p.m. MT on Tuesday, December 17, 2024. The purpose of the meeting is to debrief the testimony received on the topic, 
                        <E T="03">The Civil Rights Implications of Disparate Outcomes in Utah's K-12 Education System.</E>
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Tuesday, December 17, 2024, from 2 p.m.-3:30 p.m. mountain time.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>The meeting will be held via Zoom Webinar.</P>
                    <FP SOURCE="FP-1">
                        <E T="03">Registration Link (Audio/Visual): https://www.zoomgov.com/webinar/register/WN_-oVCRrbnSbalP8yFF7s52g</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Join by Phone (Audio Only):</E>
                         (833) 435-1820 USA Toll-Free; Meeting ID: 160 947 5042
                    </FP>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        David Barreras, Designated Federal Officer, at 
                        <E T="03">dbarreras@usccr.gov</E>
                         or (202) 656-8937.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available by selecting “CC” in the meeting platform. To request additional accommodations, please email 
                    <E T="03">lschiller@usccr.gov</E>
                     at least 10 business days prior to the meeting.
                </P>
                <P>
                    Members of the public are entitled to submit written comments; the comments must be received within 30 days following the meeting. Written comments may be emailed to David Barreras at 
                    <E T="03">dbarreras@usccr.gov.</E>
                     Persons who desire additional information may contact the Regional Programs Coordination Unit at (202) 656-8937.
                </P>
                <P>
                    Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit, as they become available, both before and after the meeting. Records of the meeting will be available via the file 
                    <PRTPAGE P="99221"/>
                    sharing website, 
                    <E T="03">www.box.com.</E>
                     Persons interested in the work of this Committee are directed to the Commission's website, 
                    <E T="03">www.usccr.gov,</E>
                     or may contact the Regional Programs Coordination Unit at the above phone number.
                </P>
                <HD SOURCE="HD1">Agenda</HD>
                <FP SOURCE="FP-2">I. Welcome &amp; Roll Call</FP>
                <FP SOURCE="FP-2">II. Discussion: Civil Rights Implications of Disparate Outcomes in Utah's K-12 Education System</FP>
                <FP SOURCE="FP-2">III. Public Comment</FP>
                <FP SOURCE="FP-2">IV. Next Steps</FP>
                <FP SOURCE="FP-2">V. Adjournment</FP>
                <P>
                    <E T="03">Exceptional Circumstance:</E>
                     Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting due to the availability of staff and the Committee.
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>David Mussatt,</NAME>
                    <TITLE>Supervisory Chief, Regional Programs Unit.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28893 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">COMMISSION ON CIVIL RIGHTS</AGENCY>
                <SUBJECT>Notice of Public Meetings of the U.S. Virgin Islands Advisory Committee to the U.S. Commission on Civil Rights</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Commission on Civil Rights.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of virtual business meetings.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the U.S. Virgin Islands Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold three public meetings via Zoom. The purpose of these meetings is to identify and potentially hear from subject-matter experts who can testify on voting access and participation in the U.S. Virgin Islands.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                </DATES>
                <FP SOURCE="FP-1">• Wednesday, January 22, 2025, from 11:00 a.m.-12:30 p.m. Atlantic Time</FP>
                <FP SOURCE="FP-1">• Wednesday, February 19, 2025, from 11:00 a.m.-12:30 p.m. Atlantic Time</FP>
                <FP SOURCE="FP-1">• Wednesday, March 26, 2025, from 11:00 a.m.-12:30 p.m. Atlantic Time</FP>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>These meetings will be held via Zoom.</P>
                    <P>
                        <E T="03">January 22nd Meeting:</E>
                    </P>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Registration Link (Audio/Visual): https://bit.ly/3OBfZmX</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Join by Phone (Audio Only):</E>
                         1-833-435-1820 USA Toll Free; Webinar ID: 161 479 5110#
                    </FP>
                    <P>
                        <E T="03">February 19th Meeting:</E>
                    </P>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Registration Link (Audio/Visual): https://bit.ly/4fRktlf</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Join by Phone (Audio Only):</E>
                         1-833-435-1820 USA Toll Free; Webinar ID: 161 982 0466#
                    </FP>
                    <P>
                        <E T="03">March 26th Meeting:</E>
                    </P>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Registration Link (Audio/Visual): https://bit.ly/49h5Ipn</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        • 
                        <E T="03">Join by Phone (Audio Only):</E>
                         1-833-435-1820 USA Toll Free; Webinar ID: 160 775 7606#
                    </FP>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        David Barreras, Designated Federal Officer, at 
                        <E T="03">dbarreras@usccr.gov</E>
                         or 1-202-656-8937.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    These Committee meetings are available to the public through the registration links above. Any interested members of the public may attend these meetings. An open comment period will be provided to allow members of the public to make oral statements as time allows. Pursuant to the Federal Advisory Committee Act, public minutes of each meeting will include a list of persons who are present. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning is available by selecting “CC” in the meeting platform. To request additional accommodations, please email 
                    <E T="03">ebohor@usccr.gov</E>
                     at least 10 business days prior to the meeting.
                </P>
                <P>
                    Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the scheduled meeting. Written comments may be emailed to Evelyn Bohor at 
                    <E T="03">ebohor@usccr.gov.</E>
                     Persons who desire additional information may contact the Regional Programs Coordination Unit at 1-202-656-8937.
                </P>
                <P>
                    Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via the file sharing website, 
                    <E T="03">https://bit.ly/3BrSCZO.</E>
                     Persons interested in the work of this Committee are directed to the Commission's website, 
                    <E T="03">http://www.usccr.gov,</E>
                     or may contact the Regional Programs Coordination Unit at 
                    <E T="03">ebohor@usccr.gov.</E>
                </P>
                <HD SOURCE="HD1">Agenda</HD>
                <FP SOURCE="FP-2">I. Welcome and Roll Call</FP>
                <FP SOURCE="FP-2">II. Committee Discussion</FP>
                <FP SOURCE="FP-2">III. Public Comment</FP>
                <FP SOURCE="FP-2">IV. Next Steps</FP>
                <FP SOURCE="FP-2">V. Adjournment</FP>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>David Mussatt,</NAME>
                    <TITLE>Supervisory Chief, Regional Programs Unit.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28894 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6335-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[A-570-067]</DEPDOC>
                <SUBJECT>Forged Steel Fittings From the People's Republic of China: Final Results of the Antidumping Duty Administrative Review; 2022-2023</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Department of Commerce (Commerce) determines that Yingkou Guangming Pipeline Industry Co., Ltd. (Yingkou Guangming), the sole mandatory respondent in this review, and Jiangsu Forged Pipe Fittings Co., Ltd. (Jiangsu Forged), are not eligible for a separate rate in the above-referenced administrative review of the antidumping duty order on forged steel fittings from the People's Republic of China (China), and are to be considered part of the China-wide entity The period of review (POR) is November 1, 2022, through October 31, 2023.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable December 10, 2024.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Hannah Lee or Robert Palmer, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1216 and (202) 482-9068, respectively.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Commerce published the 
                    <E T="03">Preliminary Results</E>
                     on August 13, 2024, and invited interested parties to comment.
                    <SU>1</SU>
                    <FTREF/>
                     We received no comments on the 
                    <E T="03">Preliminary Results</E>
                     and have made no changes to the 
                    <E T="03">Preliminary Results.</E>
                     Accordingly, no decision memoranda accompany this notice, and the final results are unchanged from the 
                    <E T="03">Preliminary Results.</E>
                     Commerce 
                    <PRTPAGE P="99222"/>
                    conducted this administrative review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Forged Steel Fittings from the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review and Rescission of Review, in Part; 2022-2023,</E>
                         89 FR 65860 (August 13, 2024) (
                        <E T="03">Preliminary Results</E>
                        ), and accompanying Preliminary Decision Memorandum (PDM).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">
                    Scope of the Order 
                    <E T="01">
                        <SU>2</SU>
                    </E>
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See Forged Steel Fittings from Italy and the People's Republic of China: Antidumping Duty Orders,</E>
                         83 FR 60397 (November 26, 2018) (
                        <E T="03">Order</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    The merchandise covered by the 
                    <E T="03">Order</E>
                     is carbon and alloy forged steel fittings, whether unfinished (commonly known as blanks or rough forgings) or finished. Such fittings are made in a variety of shapes including, but not limited to, elbows, tees, crosses, laterals, couplings, reducers, caps, plugs, bushings, unions, and outlets. Forged steel fittings are covered regardless of end finish, whether threaded, socket-weld or other end connections.
                </P>
                <P>While these fittings are generally manufactured to specifications ASME B16.11, MSS SP-79, MSS SP-83, MSS SP-97, ASTM A105, ASTM A350 and ASTM A182, the scope is not limited to fittings made to these specifications.</P>
                <P>The term forged is an industry term used to describe a class of products included in applicable standards, and does not reference an exclusive manufacturing process. Forged steel fittings are not manufactured from casting. Pursuant to the applicable specifications, subject fittings may also be machined from bar stock or machined from seamless pipe and tube.</P>
                <P>
                    All types of fittings are included in the scope regardless of nominal pipe size (which may or may not be expressed in inches of nominal pipe size), pressure rating (usually, but not necessarily expressed in pounds of pressure/PSI, 
                    <E T="03">e.g.,</E>
                     2,000 or 2M; 3,000 or 3M; 6,000 or 6M; 9,000 or 9M), wall thickness, and whether or not heat treated. Excluded from this scope are all fittings entirely made of stainless steel. Also excluded are flanges, butt weld fittings, butt weld outlets, nipples, and all fittings that have a maximum pressure rating of 300 pounds of pressure/PSI or less. Also excluded are fittings certified or made to the following standards, so long as the fittings are not also manufactured to the specifications of ASME B16.11, MSS SP-79, MSS SP-83, MSS SP-97, ASTM A105, ASTM A350, and ASTM A182:
                </P>
                <FP SOURCE="FP-1">• American Petroleum Institute (API) 5CT, API 5L, or API 11B</FP>
                <FP SOURCE="FP-1">• Society of Automotive Engineering (SAE) J476, SAE J514, SAE J516, SAE J517, SAE J518, SAE J1026, SAE J1231, SAE J1453, SAE J1926, J2044, or SAE AS 35411</FP>
                <FP SOURCE="FP-1">• Underwriter's Laboratories (UL) certified electrical conduit fittings</FP>
                <FP SOURCE="FP-1">• ASTM A153, A536, A576, or A865</FP>
                <FP SOURCE="FP-1">• Casing Conductor Connectors 16-42 inches in diameter made to proprietary specifications</FP>
                <FP SOURCE="FP-1">• Military Specification (MIL) MIL-C-4109F and MIL-F-3541</FP>
                <FP SOURCE="FP-1">• International Organization for Standardization (ISO) ISO6150-B</FP>
                <P>
                    To be excluded from the scope, products must have the appropriate standard or pressure markings and/or be accompanied by documentation showing product compliance to the applicable standard or pressure, 
                    <E T="03">e.g.,</E>
                     “API 5CT” mark and/or a mill certification report. Subject carbon and alloy forged steel fittings are normally entered under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7307.99.1000, 7307.99.3000, 7307.99.5045, and 7307.99.5060. They also may be entered under HTSUS subheadings 7307.92.3010, 7307.92.3030, 7307.92.9000, and 7326.19.0010. The HTSUS subheadings and specifications are provided for convenience and customs purposes; the written description of the scope is dispositive.
                </P>
                <HD SOURCE="HD1">Final Results of Review</HD>
                <P>
                    In the 
                    <E T="03">Preliminary Results,</E>
                     Commerce preliminarily determined that Jiangsu Forged and Yingkou Guangming had not established their eligibility for a separate rate.
                    <SU>3</SU>
                    <FTREF/>
                     As such, we preliminarily determined that Jiangsu Forged and Yingkou Guangming were part of the China-wide entity.
                    <SU>4</SU>
                    <FTREF/>
                     Because we received no comments, we made no changes from the 
                    <E T="03">Preliminary Results</E>
                     and we continue to find that Jiangsu Forged and Yingkou Guangming are part of the China-wide entity.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See Preliminary Results</E>
                         PDM at 6.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    Commerce's policy regarding conditional review of the China-wide entity applies to this administrative review.
                    <SU>5</SU>
                    <FTREF/>
                     Under this policy, the China-wide entity will not be under review unless a party specifically requests and Commerce initiates, or Commerce self-initiates, a review of the China-wide entity.
                    <SU>6</SU>
                    <FTREF/>
                     Because no party requested a review of the China-wide entity and Commerce did not self-initiate a review of the China-wide entity for this review period, the China-wide entity is not under review and the China-wide entity's rate (
                    <E T="03">i.e.,</E>
                     142.72 percent 
                    <SU>7</SU>
                    <FTREF/>
                    ) is not subject to change.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See Antidumping Proceedings: Announcement of Change in Department Practice for Respondent Selection in Antidumping Proceedings and Conditional Review of the Nonmarket Economy Entity in NME Antidumping Duty Proceedings,</E>
                         78 FR 65963 (November 4, 2013).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See Order,</E>
                         83 FR 60399.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Disclosure</HD>
                <P>
                    Normally, Commerce discloses to interested parties the calculations of the final results of an administrative review within five days of a public announcement or, if there is no public announcement, within five days of the date of publication of the notice of final results in the 
                    <E T="04">Federal Register</E>
                    , in accordance with 19 CFR 351.224(b). However, because we made no changes from the 
                    <E T="03">Preliminary Results,</E>
                     there are no calculations to disclose.
                </P>
                <HD SOURCE="HD1">Assessment Rates</HD>
                <P>
                    Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the 
                    <E T="04">Federal Register</E>
                    . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired (
                    <E T="03">i.e.,</E>
                     within 90 days of publication).
                </P>
                <P>
                    We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review, when the company-specific weighted-average dumping margin is not zero or 
                    <E T="03">de minimis</E>
                     (
                    <E T="03">i.e.,</E>
                     less than 0.50 percent), or when the importer-specific assessment rate calculated in the final results of this review is not zero or 
                    <E T="03">de minimis.</E>
                     
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.106(c)(2).
                    </P>
                </FTNT>
                <P>
                    Because Commerce finds both companies are part of the China-wide entity in the final results, Commerce will instruct CBP to apply an 
                    <E T="03">ad valorem</E>
                     assessment rate of 142.72 percent to all entries of subject merchandise during the POR which were exported by the China-wide entity, which includes Jiangsu Forged and Yingkou Guangming.
                </P>
                <HD SOURCE="HD1">Cash Deposit Requirements</HD>
                <P>
                    The following cash deposit requirements will be effective upon publication of the final results of this administrative review for shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) for previously examined Chinese and non-Chinese exporters for which a review was not requested and that received a separate rate in a prior segment of this 
                    <PRTPAGE P="99223"/>
                    proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (2) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the rate for the China-wide entity (
                    <E T="03">i.e.,</E>
                     142.72 percent); and (3) for all non-Chinese exporters of subject merchandise which have not received their own separate rate, the cash deposit rate will be the rate applicable to the Chinese exporter that supplied that non-Chinese exporter. These cash deposit requirements, when imposed, shall remain in effect until further notice.
                </P>
                <HD SOURCE="HD1">Notification to Importers</HD>
                <P>This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties, and/or an increase in the amount of antidumping duties by the amount of the countervailing duties.</P>
                <HD SOURCE="HD1">Administrative Protective Order (APO)</HD>
                <P>This notice also serves as a reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation subject to sanction.</P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>These final results and notice are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h) and 19 CFR 351.221(b)(5).</P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Abdelali Elouaradia,</NAME>
                    <TITLE>Deputy Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28928 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[C-533-902]</DEPDOC>
                <SUBJECT>Organic Soybean Meal From India: Final Results of Countervailing Duty Administrative Review; 2021-2022</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Department of Commerce (Commerce) determines that countervailable subsidies were provided to certain producers and exporters of organic soybean meal from India. The period of review (POR) is September 3, 2021, through December 31, 2022.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable December 10, 2024.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Peter Shaw, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0697.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On May 30, 2024, Commerce published the 
                    <E T="03">Preliminary Results</E>
                     of this administrative review in the 
                    <E T="04">Federal Register</E>
                     and invited interested parties to comment.
                    <SU>1</SU>
                    <FTREF/>
                     On July 22, 2024, Commerce tolled certain deadlines in this administrative proceeding by seven days.
                    <SU>2</SU>
                    <FTREF/>
                     On September 30, 2024, we extended the time limit for these final results to December 3, 2024.
                    <SU>3</SU>
                    <FTREF/>
                     For a complete description of the events that occurred since the publication of the 
                    <E T="03">Preliminary Results, see</E>
                     the Issues and Decision Memorandum.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Organic Soybean Meal from India: Preliminary Results and Partial Rescission of Countervailing Duty Administrative Review; 2021-2022,</E>
                         89 FR 46864 (May 30, 2024) (
                        <E T="03">Preliminary Results</E>
                        ), and accompanying Preliminary Decision Memorandum.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Tolling of Deadlines for Antidumping and Countervailing Duty Proceedings,” dated July 22, 2024.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Extension of Deadline for Final Results,” September 30, 2024.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Issues and Decision Memorandum for the Final Results of the Countervailing Duty Administrative Review of Organic Soybean Meal from India; 2021-2022,” dated concurrently with, and hereby adopted by, this notice (Issues and Decision Memorandum).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">
                    Scope of the Order 
                    <E T="01">
                        <SU>5</SU>
                    </E>
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See Organic Soybean Meal from India: Countervailing Duty Order,</E>
                         87 FR 29735 (May 16, 2022) (
                        <E T="03">Order</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    The merchandise covered by this 
                    <E T="03">Order</E>
                     is organic soybean meal from India. For a complete description of the scope of the 
                    <E T="03">Order, see</E>
                     the Issues and Decision Memorandum.
                </P>
                <HD SOURCE="HD1">Analysis of Comments Received</HD>
                <P>
                    All issues raised by the interested parties in their case and rebuttal briefs are addressed in the Issues and Decision Memorandum. A list of topics discussed in the Issues and Decision Memorandum is provided in the appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at 
                    <E T="03">https://access.trade.gov.</E>
                     In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at 
                    <E T="03">https://access.trade.gov/public/FRNoticesListLayout.aspx.</E>
                </P>
                <HD SOURCE="HD1">Changes Since the Preliminary Results</HD>
                <P>
                    Based on our analysis of comments from interested parties, we made certain changes to Shri Sumati Industries Private Limited's countervailable subsidy rate calculations from the 
                    <E T="03">Preliminary Results.</E>
                     For a full description of these changes, 
                    <E T="03">see</E>
                     the Issues and Decision Memorandum.
                </P>
                <HD SOURCE="HD1">Methodology</HD>
                <P>
                    Commerce is conducting this administrative review in accordance with section 751(a)(l)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found to be countervailable, we determine that there is a subsidy, 
                    <E T="03">i.e.,</E>
                     a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.
                    <SU>6</SU>
                    <FTREF/>
                     For a full description of the methodology underlying our conclusions, including our reliance on facts available with adverse inferences, pursuant to sections 776(a) and (b) of the Act, 
                    <E T="03">see</E>
                     the Issues and Decision Memorandum.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and section 771(5A) of the Act regarding specificity.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Final Results of Review</HD>
                <P>
                    As a result of this review, Commerce determines the following net countervailable subsidy rates exist for the period September 3, 2021, through December 31, 2022:
                    <PRTPAGE P="99224"/>
                </P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s100,20,20">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Company</CHED>
                        <CHED H="1">
                            Subsidy rate 2021
                            <LI>(percent ad valorem)</LI>
                        </CHED>
                        <CHED H="1">
                            Subsidy rate 2022
                            <LI>(percent ad valorem)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Shri Sumati Industries Private Limited</ENT>
                        <ENT>8.82</ENT>
                        <ENT>5.15</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Shanti Worldwide</ENT>
                        <ENT>261.80</ENT>
                        <ENT>261.80</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Disclosure</HD>
                <P>Commerce intends to disclose its calculations and analysis performed in connection with these final results to interested parties within five days of its public announcement, or if there is no public announcement, within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b).</P>
                <HD SOURCE="HD1">Assessment Rates</HD>
                <P>
                    Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(2), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries of subject merchandise covered by this review. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the 
                    <E T="04">Federal Register</E>
                    . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired (
                    <E T="03">i.e.,</E>
                     within 90 days of publication).
                </P>
                <HD SOURCE="HD1">Cash Deposit Requirements</HD>
                <P>In accordance with section 751(a)(1) of the Act, Commerce also intends to instruct CBP to collect cash deposits of estimated countervailing duties in the amounts shown for each of the companies listed above for shipments of subject merchandise which entered, or were withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review. For all non-reviewed firms, we will instruct CBP to continue to collect cash deposits of estimated countervailing duties at the all-others rate or most recent company-specific rate applicable to the company, as appropriate. These cash deposit requirements, when imposed, shall remain in effect until further notice.</P>
                <HD SOURCE="HD1">Administrative Protective Order (APO)</HD>
                <P>This notice also serves as the final reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.</P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>We are issuing and publishing these final results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213 and 351.221(b)(5).</P>
                <SIG>
                    <DATED>Dated: December 3, 2024.</DATED>
                    <NAME>Abdelali Elouaradia,</NAME>
                    <TITLE>Deputy Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Appendix</HD>
                <EXTRACT>
                    <HD SOURCE="HD1">List of Topics Discussed in the Issues and Decision Memorandum</HD>
                    <FP SOURCE="FP-2">I. Summary</FP>
                    <FP SOURCE="FP-2">II. Background</FP>
                    <FP SOURCE="FP-2">
                        III. Scope of the 
                        <E T="03">Order</E>
                    </FP>
                    <FP SOURCE="FP-2">IV. Subsidies Valuation</FP>
                    <FP SOURCE="FP-2">V. Use of Facts Otherwise Available and Adverse Inferences</FP>
                    <FP SOURCE="FP-2">VI. Analysis of Programs</FP>
                    <FP SOURCE="FP-2">VII. Discussion of the Issues</FP>
                    <FP SOURCE="FP1-2">Comment 1: Whether To Apply Adverse Facts Available (AFA) to the Duty Drawback Scheme (DDB)</FP>
                    <FP SOURCE="FP1-2">Comment 2: Whether To Apply AFA to the Interest Equalization Scheme (IES)</FP>
                    <FP SOURCE="FP1-2">Comment 3: Whether To Treat Transport and Marketing Assistance for Specified Agricultural Products (TMA) as a Non-Recurring Grant Program</FP>
                    <FP SOURCE="FP-2">VIII. Recommendation</FP>
                </EXTRACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28991 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[C-580-888]</DEPDOC>
                <SUBJECT>Certain Carbon and Alloy Steel Cut-to-Length Plate From the Republic of Korea: Final Results of Countervailing Duty Administrative Review; 2022</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Department of Commerce (Commerce) determines that countervailable subsidies were provided to POSCO Co., Ltd. (POSCO), a producer and exporter of certain carbon and alloy steel cut-to-length plate (CTL plate) from the Republic of Korea (Korea), during the period of review (POR) from January 1, 2022, through December 31, 2022.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable December 10, 2024.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Faris Montgomery or Laurel Smalley, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1537 or (202) 482-3456, respectively.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On May 31, 2024, Commerce published the 
                    <E T="03">Preliminary Results</E>
                     of this administrative review in the 
                    <E T="04">Federal Register</E>
                    , and invited interested parties to comment.
                    <SU>1</SU>
                    <FTREF/>
                     On July 22, 2024, Commerce tolled certain deadlines in this administrative proceeding by seven days.
                    <SU>2</SU>
                    <FTREF/>
                     On September 6, 2024, Commerce extended the deadline for the final results of this review to no later than December 4, 2024.
                    <SU>3</SU>
                    <FTREF/>
                     For a complete description of the events that followed the 
                    <E T="03">Preliminary Results, see</E>
                     the Issues and Decision Memorandum.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Certain Carbon and Alloy Steel Cut-to-Length Plate from the Republic of Korea: Preliminary Results and Partial Rescission of Countervailing Duty Administrative Review; 2022,</E>
                         89 FR 47131 (May 31, 2024) (
                        <E T="03">Preliminary Results</E>
                        ), and accompanying Preliminary Decision Memorandum.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Tolling of Deadlines for Antidumping and Countervailing Duty Proceedings,” dated July 22, 2024.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Extension of Deadline for Final Results of Countervailing Duty Administrative Review,” dated September 6, 2024.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Issues and Decision Memorandum for the Final Results of the Countervailing Duty Administrative Review: Certain Carbon and Alloy Steel Cut-to-Length Plate from the Republic of Korea; 2022,” dated concurrently with, and hereby adopted by, this notice (Issues and Decision Memorandum).
                    </P>
                </FTNT>
                <P>We conducted this review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).</P>
                <HD SOURCE="HD1">
                    Scope of the Order 
                    <E T="01">
                        <SU>5</SU>
                    </E>
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See Certain Carbon and Alloy Steel Cut-to-Length Plate from the Republic of Korea: Countervailing Duty Order,</E>
                         82 FR 24103 (May 25, 2017) (
                        <E T="03">Order</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    The merchandise covered by the 
                    <E T="03">Order</E>
                     is CTL plate. For a complete description of the scope of the 
                    <E T="03">Order, see</E>
                     the Issues and Decision Memorandum.
                    <PRTPAGE P="99225"/>
                </P>
                <HD SOURCE="HD1">Analysis of Comments Received</HD>
                <P>
                    All issues raised in interested parties' briefs are addressed in the Issues and Decision Memorandum. A list of the issues addressed is attached at the appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at 
                    <E T="03">https://access.trade.gov.</E>
                     In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at 
                    <E T="03">https://access.trade.gov/public/FRNoticesListLayout.aspx.</E>
                </P>
                <HD SOURCE="HD1">Changes Since the Preliminary Results</HD>
                <P>
                    Based on our analysis of the case and rebuttal briefs and the evidence on the record, we made certain changes to POSCO's countervailable subsidy calculations from the 
                    <E T="03">Preliminary Results.</E>
                     These changes are explained in the Issues and Decision Memorandum.
                </P>
                <HD SOURCE="HD1">Methodology</HD>
                <P>
                    Commerce conducted this review in accordance with section 751(a)(1)(A) of the Act. For each of the subsidy programs found countervailable, we find that there is a subsidy, 
                    <E T="03">i.e.,</E>
                     a government-provided financial contribution that gives rise to a benefit to the recipient, and that the subsidy is specific.
                    <SU>6</SU>
                    <FTREF/>
                     The Issues and Decision Memorandum contains a full description of the methodology underlying Commerce's conclusions.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and section 771(5A) of the Act regarding specificity.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Final Results of Review</HD>
                <P>In accordance with 19 CFR 351.221(b)(5), we calculated an individual net countervailable subsidy rate for POSCO. Commerce determines that, during the POR, the net countervailable subsidy rate for the producers/exporter under review is as follows:</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s25,18C">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Producer/exporter</CHED>
                        <CHED H="1">
                            Subsidy rate
                            <LI>
                                (percent 
                                <E T="03">ad valorem</E>
                                )
                            </LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            POSCO Co., Ltd.
                            <SU>7</SU>
                        </ENT>
                        <ENT>1.47</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">
                    Disclosure
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         As discussed in the 
                        <E T="03">Preliminary Results,</E>
                         Commerce found the following companies to be cross-owned with POSCO: POSCO Chemical Co., Ltd.; POSCO Holdings Inc.; POSCO Mobility Solution Co., Ltd.; POSCO M-Tech Co., Ltd.; and POSCO Nippon Steel RHF Joint Venture Co., Ltd. The subsidy rate applies to all cross-owned companies. We note that POSCO has an affiliated trading company through which it exported certain subject merchandise during the POR, POSCO International (aka POSCO International Corporation). POSCO International was not selected as a mandatory respondent but was examined in the context of POSCO. Therefore, there is not an established countervailing duty rate for POSCO International; POSCO International's subsidies are accounted for in POSCO's total subsidy rate. Instead, entries of subject merchandise exported by POSCO International will receive the rate of the producer listed on the U.S. Customs and Border Protection (CBP) entry form. Thus, the subsidy rate applied to POSCO and POSCO's cross-owned companies is also applied to POSCO International for entries of subject merchandise produced by POSCO.
                    </P>
                </FTNT>
                <P>Commerce intends to disclose its calculations and analysis performed in connection with these final results to interested parties within five days of its public announcement, or if there is no public announcement, within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b)</P>
                <HD SOURCE="HD1">Assessment Rates</HD>
                <P>
                    Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(2), Commerce has determined, and CBP shall assess, countervailing duties on all appropriate entries of subject merchandise in accordance with the final results of this review, for the above-listed company at the applicable 
                    <E T="03">ad valorem</E>
                     assessment rate. We intend to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the 
                    <E T="04">Federal Register</E>
                    . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired (
                    <E T="03">i.e.,</E>
                     within 90 days of publication).
                </P>
                <HD SOURCE="HD1">Cash Deposit Requirements</HD>
                <P>
                    In accordance with section 751(a)(1) of the Act, Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties in the amount shown for the company listed above based on shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review.
                    <SU>8</SU>
                    <FTREF/>
                     For all non-reviewed firms subject to the 
                    <E T="03">Order,</E>
                     we will instruct CBP to continue to collect cash deposits of estimated countervailing duties at the most recent company-specific rate or the all-others rate (
                    <E T="03">i.e.,</E>
                     3.72 percent), as appropriate.
                    <SU>9</SU>
                    <FTREF/>
                     These cash deposit requirements, effective upon publication of these final results, shall remain in effect until further notice.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See, e.g., Honey from Argentina: Results of Countervailing Duty Administrative Review,</E>
                         69 FR 29518 (May 24, 2004), and accompanying Issues and Decision Memorandum at Issue 4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See Order,</E>
                         82 FR 24103.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Administrative Protective Order (APO)</HD>
                <P>This notice also serves as a reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.</P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>We are issuing and publishing these final results of administrative review and notice in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.221(b)(5).</P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Abdelali Elouaradia,</NAME>
                    <TITLE>Deputy Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Appendix</HD>
                <EXTRACT>
                    <HD SOURCE="HD1">List of Topics Discussed in the Issues and Decision Memorandum</HD>
                    <FP SOURCE="FP-2">I. Summary</FP>
                    <FP SOURCE="FP-2">II. Background</FP>
                    <FP SOURCE="FP-2">
                        III. Scope of the 
                        <E T="03">Order</E>
                    </FP>
                    <FP SOURCE="FP-2">IV. Subsidies Valuation Information</FP>
                    <FP SOURCE="FP-2">V. Analysis of Programs</FP>
                    <FP SOURCE="FP-2">VI. Discussion of the Comments</FP>
                    <FP SOURCE="FP1-2">Comment 1: Whether Electricity Is Subsidized by the Government of Korea (GOK)</FP>
                    <FP SOURCE="FP1-2">Comment 2: Whether the Provision of Korea Emissions Trading System (K-ETS) Permits Is Countervailable</FP>
                    <FP SOURCE="FP1-2">Comment 3: Whether Local Tax Deductions Under the Restriction of Special Local Taxation Act (RSLTA) Article 57-2 Are Countervailable</FP>
                    <FP SOURCE="FP1-2">Comment 4: Whether the Benchmark Calculation for Electricity for More Than Adequate Remuneration (MTAR) Correctly Reflects the Volume of Electricity Purchased</FP>
                    <FP SOURCE="FP1-2">
                        Comment 5: Whether the Quota Tariff Import Duty Exemptions Under Article 71 of the Customs Act Program Is 
                        <E T="03">De Facto</E>
                         Specific
                    </FP>
                    <FP SOURCE="FP1-2">Comment 6: Whether Certain Tax Exemptions, Import Duty Exemptions, and Loans Are Tied to the Production of Non-Subject Merchandise</FP>
                    <FP SOURCE="FP-2">VII. Recommendation</FP>
                </EXTRACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28990 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="99226"/>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[A-570-093]</DEPDOC>
                <SUBJECT>Refillable Stainless Steel Kegs From the People's Republic of China: Notice of Court Decision Not in Harmony With the Final Determination of Antidumping Investigation; Notice of Amended Final Determination; and Notice of Amended Antidumping Duty Order</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        On November 25, 2024, the U.S. Court of International Trade (CIT) issued its final judgment in 
                        <E T="03">New American Keg</E>
                         v. 
                        <E T="03">United States,</E>
                         Court No. 20-00008, sustaining the U.S. Department of Commerce's (Commerce) third remand redetermination pertaining to the less-than-fair-value (LTFV) investigation of refillable stainless steel kegs (kegs) from the People's Republic of China (China) covering the period of investigation (POI) January 1, 2018, through June 30, 2018. Commerce is notifying the public that the CIT's final judgment is not in harmony with Commerce's final determination in that investigation, and that Commerce is amending the final determination and the resulting antidumping duty (AD) order with respect to the dumping margin for certain respondents eligible for a separate rate, 
                        <E T="03">i.e.,</E>
                         Ningbo Master International Trade Co., Ltd. (Ningbo Master), Guangzhou Jingye Machinery Co., Ltd. (Guangzhou Jingye), and Guangzhou Ulix Industrial &amp; Trading Co., Ltd. (Guangzhou Ulix). The merchandise exported by these three exporters is included in the amended AD order.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable December 5, 2024.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Dmitry Vladimirov, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0665.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On October 24, 2019, Commerce published its 
                    <E T="03">Final Determination</E>
                     in the LTFV investigation of kegs from China.
                    <SU>1</SU>
                    <FTREF/>
                     On December 16, 2019, Commerce subsequently published the AD order on kegs from China.
                    <SU>2</SU>
                    <FTREF/>
                     New American Keg, d/b/a American Keg Company appealed Commerce's 
                    <E T="03">Final Determination.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Refillable Stainless Steel Kegs from the People's Republic of China: Final Affirmative Determination of Sales at Less Than Fair Value and Final Affirmative Determination of Critical Circumstances, in Part,</E>
                         84 FR 57010 (October 24, 2019) (
                        <E T="03">Final Determination</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See Refillable Stainless Steel Kegs from the Federal Republic of Germany and the People's Republic of China: Antidumping Duty Orders,</E>
                         84 FR 68405 (December 16, 2019) (
                        <E T="03">Order</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    On March 23, 2021, the CIT remanded the 
                    <E T="03">Final Determination</E>
                     to Commerce, ordering Commerce to reconsider or further explain: (1) its selection of the Malaysian surrogate labor data over the Brazilian surrogate labor data to value factors of production (FOPs) for labor; and (2) whether Guangzhou Ulix is eligible for a separate rate.
                    <SU>3</SU>
                    <FTREF/>
                     In the 
                    <E T="03">First Redetermination,</E>
                     Commerce determined that “Malaysian data does not constitute the best available information for valuing Ningbo Master's labor FOPs because it is linked to forced labor.” 
                    <SU>4</SU>
                    <FTREF/>
                     Commerce further determined that “based on the information on the record, {it}selected the Mexican labor {surrogate value (SV)} from {Conference Board's International Labor Comparisons (ILC)} as the best information available to value Ningbo Master's labor FOPs” and “inflated the Mexican labor SV from ILC to the {POI using Brazilian inflator} and recalculated Ningbo Master's margin.” 
                    <SU>5</SU>
                    <FTREF/>
                     In the 
                    <E T="03">First Redetermination,</E>
                     Commerce also examined certain evidence requested by the CIT and determined that Guangzhou Ulix remained eligible for a separate rate.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See New American Keg</E>
                         v. 
                        <E T="03">United States,</E>
                         Court No. 20-00008, Slip Op. 21-30 (CIT March 23, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See Final Results of Redetermination Pursuant to Court Remand, New American Keg</E>
                         v. 
                        <E T="03">United States,</E>
                         Court No. 20-00008, Slip Op. 21-30 (CIT March 23, 2021), dated July 7, 2021 (
                        <E T="03">First Redetermination</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    On September 13, 2022, the CIT remanded the 
                    <E T="03">First Redetermination</E>
                     and ordered Commerce to reconsider or further explain: (1) the use of the Mexican surrogate labor data inflated with Brazilian consumer price index (CPI) when the Brazilian surrogate labor data are available on the record; and (2) the evidence in the administrative record that supports granting Guangzhou Ulix a separate rate.
                    <SU>7</SU>
                    <FTREF/>
                     In the 
                    <E T="03">Second Redetermination,</E>
                     after filing the 
                    <E T="03">First Redetermination</E>
                     and requesting a voluntary remand, Commerce acknowledge that it was improper to inflate the Mexican labor wage rate from the ILC using Brazilian CPI.
                    <SU>8</SU>
                    <FTREF/>
                     Notwithstanding, Commerce continued to determine that the Mexican labor wage data are superior to the Brazilian labor wage data and, in order to achieve an accurate calculation, Commerce re-opened the record and placed on the record data from the International Labour Organization (ILO).
                    <SU>9</SU>
                    <FTREF/>
                     Consequently, in the 
                    <E T="03">Second Redetermination,</E>
                     Commerce used the Mexican wage rate from the ILO data for 2018 (contemporaneous with the POI) and recalculated Ningbo Master's margin accordingly.
                    <SU>10</SU>
                    <FTREF/>
                     In the 
                    <E T="03">Second Redetermination,</E>
                     Commerce also determined that Guangzhou Ulix has met its burden for a separate rate status.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See New American Keg</E>
                         v. 
                        <E T="03">United States,</E>
                         Court No. 20-00008, Slip Op. 22-106 (CIT September 13, 2022).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See Final Results of Redetermination Pursuant to Court Remand, New American Keg</E>
                         v. 
                        <E T="03">United States,</E>
                         Court No. 20-00008, Slip Op. 22-106 (CIT September 13, 2022), dated November 10, 2022 (
                        <E T="03">Second Redetermination</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    On January 31, 2024, the CIT remanded the 
                    <E T="03">Second Redetermination,</E>
                     holding that Commerce abused its discretion in reopening the record to use Mexican ILO wage data, because Commerce made no showing that the Brazilian wage information on the record was inaccurate or otherwise unsuitable for the calculation of Ningbo Master's margin.
                    <SU>12</SU>
                    <FTREF/>
                     In its third final remand redetermination, Commerce used the Brazilian labor SV from 2016, inflated to the POI, and recalculated Ningbo Master's margin.
                    <SU>13</SU>
                    <FTREF/>
                     On November 25, 2024, the CIT sustained Commerce's third final remand redetermination.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See New American Keg</E>
                         v. 
                        <E T="03">United States,</E>
                         Court No. 20-00008, Slip Op. 24-11 (CIT January 31, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See Final Results of Redetermination Pursuant to Court Remand, New American Keg</E>
                         v. 
                        <E T="03">United States,</E>
                         Court No. 20-00008, Slip Op. 24-11 (CIT January 31, 2024), dated March 25, 2024.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See New American Keg</E>
                         v. 
                        <E T="03">United States,</E>
                         Court No. 20-00008, Slip Op. 24-129 (CIT November 25, 2024).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Timken Notice</HD>
                <P>
                    In its decision in 
                    <E T="03">Timken,</E>
                    <SU>15</SU>
                    <FTREF/>
                     as clarified by 
                    <E T="03">Diamond Sawblades,</E>
                    <SU>16</SU>
                    <FTREF/>
                     the U.S. Court of Appeals for the Federal Circuit held that, pursuant to section 516A(c) and (e) of the Tariff Act of 1930, as amended (the Act), Commerce must publish a notice of court decision that is not “in harmony” with a Commerce determination and must suspend liquidation of entries pending a “conclusive” court decision. The CIT's November 25, 2024, judgment constitutes a final decision of the CIT 
                    <PRTPAGE P="99227"/>
                    that is not in harmony with Commerce's 
                    <E T="03">Final Determination.</E>
                     Thus, this notice is published in fulfillment of the publication requirements of 
                    <E T="03">Timken.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See Timken Co.</E>
                         v. 
                        <E T="03">United States,</E>
                         893 F.2d 337 (Fed. Cir. 1990) (
                        <E T="03">Timken</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See Diamond Sawblades Manufacturers Coalition</E>
                         v. 
                        <E T="03">United States,</E>
                         626 F.3d 1374 (Fed. Cir. 2010) (
                        <E T="03">Diamond Sawblades</E>
                        ).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Amended Final Determination</HD>
                <P>
                    Because there is now a final court judgment, Commerce is amending its 
                    <E T="03">Final Determination</E>
                     with respect to the following exporter-producer combinations:
                </P>
                <GPOTABLE COLS="4" OPTS="L2,nj,tp0,i1" CDEF="s50,r50,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Exporter</CHED>
                        <CHED H="1">Producer</CHED>
                        <CHED H="1">
                            Weighted
                            <LI>average dumping</LI>
                            <LI>margin</LI>
                            <LI>
                                (percent 
                                <E T="03">ad valorem</E>
                                )
                            </LI>
                        </CHED>
                        <CHED H="1">
                            Cash deposit rate (adjusted for subsidy
                            <LI>offsets)</LI>
                            <LI>
                                (percent 
                                <E T="03">ad valorem</E>
                                )
                            </LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Ningbo Master International Trade Co., Ltd</ENT>
                        <ENT>Ningbo Major Draft Beer Equipment Co., Ltd</ENT>
                        <ENT>4.23</ENT>
                        <ENT>
                            <SU>17</SU>
                             3.96
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Guangzhou Jingye Machinery Co., Ltd</ENT>
                        <ENT>Guangzhou Jingye Machinery Co., Ltd</ENT>
                        <ENT>4.23</ENT>
                        <ENT>3.96</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Guangzhou Ulix Industrial &amp; Trading Co., Ltd</ENT>
                        <ENT>Guangzhou Jingye Machinery Co., Ltd</ENT>
                        <ENT>4.23</ENT>
                        <ENT>3.96</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">
                    Amended Antidumping Duty Order
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See Refillable Stainless Steel Kegs from the People's Republic of China: Final Affirmative Countervailing Duty Determination and Final Affirmative Determination of Critical Circumstances, in Part,</E>
                         84 FR 57005 (October 24, 2019), and accompanying Issues and Decision Memorandum at 5 for the export subsidy rate.
                    </P>
                </FTNT>
                <P>
                    Pursuant to section 735(a)(4) of the Act, Commerce “shall disregard any weighted average dumping margin that is 
                    <E T="03">de minimis</E>
                     as defined in section 733(b)(3) of the Act” 
                    <SU>18</SU>
                    <FTREF/>
                     and pursuant to section 735(c)(2) of the Act, Commerce shall “issue an antidumping duty order under section 736” of the Act when the final determination is affirmative. In the 
                    <E T="03">Final Determination,</E>
                     the exporter-producer combination identified above for respondent Ningbo Master received a zero percent margin. As a result of this amended final determination, in which Commerce calculated an estimated weighted-average dumping margin above 
                    <E T="03">de minimis</E>
                     for the exporter-producer combination identified above for Ningbo Master, Commerce is hereby including entries of subject merchandise that were produced by Ningbo Major Draft Beer Equipment Co., Ltd., and exported by Ningbo Master International Trade Co., Ltd., within the 
                    <E T="03">Order.</E>
                     However, Commerce recently revoked the 
                    <E T="03">Order</E>
                     effective December 16, 2024.
                    <SU>19</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         Section 733(b)(3) of the Act defines a 
                        <E T="03">de minimis</E>
                         dumping margin as “less than 2 percent ad valorem or the equivalent specific rate for the subject merchandise.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">See Refillable Stainless-Steel Kegs from Mexico and the People's Republic of China: Final Results of Sunset Reviews and Revocation of Orders,</E>
                         89 FR 92095, 92096 (November 21, 2024) (
                        <E T="03">Order Revocation</E>
                        ).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Cash Deposit Requirements</HD>
                <P>Commerce will issue revised cash deposit instructions to U.S. Customs and Border Protection (CBP) for Ningbo Master.</P>
                <P>
                    Because Guangzhou Jingye and Guangzhou Ulix have a superseding cash deposit rate, 
                    <E T="03">i.e.,</E>
                     there have been final results published in a subsequent administrative review,
                    <SU>20</SU>
                    <FTREF/>
                     Commerce will not issue revised cash deposit instructions for those companies. This notice will not affect the current cash deposit rate for these companies. However, as stated in the 
                    <E T="03">Order Revocation,</E>
                     in accordance with section 751(c)(3)(A) of the Act and 19 CFR 351.222(i)(2)(i), Commerce intends to instruct CBP to terminate the suspension of liquidation of the merchandise subject to the 
                    <E T="03">Order</E>
                     entered, or withdrawn from the warehouse, on or after December 16, 2024.
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See Refillable Stainless Steel Kegs from the People's Republic of China: Final Results of the Antidumping Duty Administrative Review; 2021-2022,</E>
                         89 FR 25564 (April 11, 2024) (Commerce denied separate rate eligibility for Guangzhou Jingye and Guangzhou Ulix and treated them as part of the China-wide entity.).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See Order Revocation,</E>
                         89 FR 92095-96.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>This notice is issued and published in accordance with sections 516A(c) and (e) and 777(i)(1) of the Act.</P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Abdelali Elouaradia,</NAME>
                    <TITLE>Deputy Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28946 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XE475]</DEPDOC>
                <SUBJECT>Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Marine Site Characterization Surveys Off Rhode Island and Massachusetts</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; proposed modification of an incidental harassment authorization; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        NMFS is proposing to modify an existing incidental harassment authorization (IHA) issued to Bay State Wind, LLC (Bay State Wind) on October 3, 2024, authorizing take of marine mammals incidental to marine site characterization surveys conducted off the coasts of Rhode Island and Massachusetts in the Bureau of Ocean Energy Management (BOEM) Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS) Lease Area OCS-A 0500 and the associated export cable route (ECR) area. While conducting said marine site characterization surveys, Bay State Wind has encountered common dolphins (
                        <E T="03">Delphinus delphis</E>
                        ) at a rate greater than anticipated under the analysis for that IHA and, therefore, requests that NMFS modify the IHA to increase the number of authorized take by Level B harassment for that species only. No other changes to the IHA were requested or are proposed herein, and the expiration date remains unchanged. NMFS will consider public comments on the requested modification prior to making any final decision and agency responses will be summarized in the final notice of our decision.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments and information must be received no later than December 26, 2024.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Written comments should be submitted via email to 
                        <E T="03">ITP.hilt@noaa.gov.</E>
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         NMFS is not responsible for comments sent by any other method, to any other address or individual, or received after the end of the comment period. Comments, including all attachments, must not exceed a 25-megabyte file size. All comments 
                        <PRTPAGE P="99228"/>
                        received are a part of the public record and will generally be posted online at 
                        <E T="03">https://www.fisheries.noaa.gov/permit/incidental-take-authorizations-under-marine-mammal-protection-act</E>
                         without change. All personal identifying information (
                        <E T="03">e.g.,</E>
                         name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Rachel Hilt, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the original application and supporting documents (including NMFS 
                        <E T="04">Federal Register</E>
                         notices of the original proposed and final authorizations, and the previous IHA), as well as a list of the references cited in this document, may be obtained online at: 
                        <E T="03">https://www.fisheries.noaa.gov/permit/incidental-take-authorizations-under-marine-mammal-protection-act.</E>
                         In case of problems accessing these documents, please call the contact listed above.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 
                    <E T="03">et seq.</E>
                    ) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed incidental take authorization may be provided to the public for review.
                </P>
                <P>Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.</P>
                <HD SOURCE="HD1">History of Request</HD>
                <P>
                    On March 27, 2024, NMFS received a request from Bay State Wind for an IHA to take marine mammals incidental to conducting high-resolution geophysical (HRG) surveys off the coasts of Rhode Island and Massachusetts in OCS-A 0500 (
                    <E T="03">i.e.,</E>
                     Ørsted's planned Bay State Wind development) and the associated ECR area. Following NMFS' review of the application, Bay State Wind submitted a revised version on June 10, 2024. After additional NMFS review of the revised application, Bay State Wind submitted another revised version on July 29, 2024. That application was deemed adequate and complete on August 1, 2024. Bay State Wind's request was for the take of 17 species of marine mammals by Level B harassment only. Notice of proposed IHA and request for comments were published in the 
                    <E T="04">Federal Register</E>
                     on August 21, 2024 (89 FR 67597). The IHA was issued on October 3, 2024 (89 FR 81458, October 8, 2024), with effective dates October 6, 2024 to October 5, 2025.
                </P>
                <P>On November 1, 2024, NMFS received a request from Bay State Wind for a modification to the existing IHA. Bay State Wind informed NMFS that they were encountering common dolphins during the marine site characterization surveys at a rate greater than anticipated. Bay State Wind expressed concern that this elevated encounter rate could potentially result in the authorized take for common dolphins being exceeded. Therefore, Bay State Wind requested that NMFS modify the existing IHA by increasing the number of authorized take of that species only. NMFS is proposing to modify the IHA to increase the number of authorized take by Level B harassment of common dolphin only. No other changes to the IHA are proposed.</P>
                <HD SOURCE="HD1">Description of the Proposed Activity and Anticipated Impacts</HD>
                <P>
                    The proposed modified IHA would include the same HRG surveys in the same geographic locations that were described in the analysis for the initial IHA. The nature of the specified activity that could result in take of marine mammals (
                    <E T="03">i.e.,</E>
                     underwater sound from Bay State Wind's marine site characterization surveys), including the types of equipment planned for use, the methods, the duration of the specified activity (up to 350 survey days in one year), and number of vessels planned for use are identical to those previously analyzed. The mitigation, monitoring, and reporting measures, as well as the expiration date of the IHA, also remain the same. With the exception of the number of estimated take of common dolphin, no increased number of take of other species is estimated or proposed for authorization. NMFS refers the reader to the documents related to the initial IHA issued on October 3, 2024 (89 FR 81458, October 8, 2024), for more detailed description of the project activities. Other relevant documents include the notice of proposed IHA and request for comments (89 FR 67597, August 21, 2024).
                </P>
                <HD SOURCE="HD2">Detailed Description of the Action</HD>
                <P>A detailed description of the survey activities is found in these previous documents. The location, timing, and nature of the activities, including the types of HRG equipment planned for use, daily trackline distances and number of survey vessels (four) are identical to those described in the previous notices.</P>
                <HD SOURCE="HD2">Description of Marine Mammals</HD>
                <P>A description of the marine mammals in the area of the activities is found in these previous documents, which remains applicable to the proposed issuance of the modified IHA as well. In addition, NMFS has reviewed recent draft Stock Assessment Reports, information on relevant Unusual Mortality Events, and recent scientific literature, and determined that no new information affects our original analysis of impacts under the initial IHA.</P>
                <HD SOURCE="HD2">Potential Effects on Marine Mammals and Their Habitat</HD>
                <P>A description of the potential effects of the specified activities on marine mammals and their habitat may be found in the documents supporting the initial IHA (89 FR 81458, October 8, 2024), which remains applicable to the issuance of the modified IHA. There is no new information on potential effects.</P>
                <HD SOURCE="HD2">Estimated Take</HD>
                <P>A detailed description of the methods and inputs used to estimate take for the specified activity are found in the notice of IHA for the initial authorization (89 FR 81458, October 8, 2024). The HRG equipment that may result in take, as well as the source levels, marine mammal stocks taken, marine mammal density data, and the methods of take estimation applicable to this authorization remain unchanged from the initial IHA. With the exception of the common dolphin, the number of estimated take of marine mammal species remains unchanged.</P>
                <P>
                    The initial IHA issued to Bay State Wind on October 3, 2024 (89 FR 81458, 
                    <PRTPAGE P="99229"/>
                    October 8, 2024) authorized take of 17 species of marine mammals, including 1,485 common dolphins, incidental to marine site characterization surveys conducted in the Lease Area and ECR over the course of a single year, requiring up to 350 survey days. The take estimate, used to calculate the number of authorized take for each species, was based on the best available scientific evidence, including sighting data from Protected Species Observer (PSO) reports (Smultea Environmental Sciences, 2020) and NOAA's Atlantic Marine Assessment Program for Protected Species (AMAPPS) (
                    <E T="03">https://www.fisheries.noaa.gov/new-england-mid-atlantic/population-assessments/atlantic-marine-assessment-program-protected</E>
                    ) group sizes. AMAPPS group sizes are based on data from a multi-agency research program, including seasonal distribution and abundance data collected over multiple years using aerial and shipboard surveys. Bay State Wind commenced survey activities on October 6, 2024. After 20 days of surveys, Bay State Wind had recorded 1,045 common dolphins within the estimated Level B harassment zone (as shown in table 1). Sighting events have included group sizes ranging from 3 to 110 with a mean group size 32.6. All potential exposures have been reported from a single vessel working in water depths averaging 45 meters, and detections of this species have occurred nearly daily, and often multiple times per day. Many of the observed common dolphin encounters have included animals approaching the vessel for both bow riding and swimming alongside as well as foraging in the area. The duration of these sighting events have varied from several minutes to many hours.
                </P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="16C,21C,23C,8C,8C,18C">
                    <TTITLE>Table 1—Common Dolphin Detection Events During Bay State Wind HRG Survey Activities</TTITLE>
                    <BOXHD>
                        <CHED H="1">
                            Total number of
                            <LI>common dolphin</LI>
                            <LI>detection events</LI>
                        </CHED>
                        <CHED H="1">
                            Total number of
                            <LI>groups within Level B</LI>
                            <LI>harassment zone</LI>
                        </CHED>
                        <CHED H="1">
                            Total number of
                            <LI>dolphins within Level B</LI>
                            <LI>harassment zone</LI>
                        </CHED>
                        <CHED H="1">
                            Min pod
                            <LI>size</LI>
                        </CHED>
                        <CHED H="1">
                            Max pod
                            <LI>size</LI>
                        </CHED>
                        <CHED H="1">
                            Average group size
                            <LI>for detections</LI>
                            <LI>within Level B</LI>
                            <LI>harassment zone</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">55</ENT>
                        <ENT>38</ENT>
                        <ENT>1,045</ENT>
                        <ENT>3</ENT>
                        <ENT>110</ENT>
                        <ENT>32.6</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    According to Roberts 
                    <E T="03">et al.</E>
                     (2023) monthly marine mammal density data, estimated common dolphin occurrence in the region appears to be seasonal with the highest monthly density occurring during the months of October (0.1652 animals km
                    <E T="51">− 2</E>
                    <SU>2</SU>
                    ) and September (0.1224 km
                    <E T="51">− 2</E>
                    ). Density data for the months of November and December begin to decrease (0.1034 km
                    <E T="51">− 2</E>
                     and 0.1155 km
                    <E T="51">− 2</E>
                     respectively). Density for the months of January-August decreases further and remains under 0.0800 km
                    <E T="51">− 2</E>
                    . Density does not exceed 0.0800 km
                    <E T="51">− 2</E>
                    until the month of September.
                </P>
                <P>
                    The 1,045 common dolphin sightings over 20 days averages to approximately 52 sightings per day. This high number of sightings is unanticipated and has occurred during the month of October when, as previously mentioned, common dolphin density is expected to be highest. As the common dolphin density is expected to decrease in November and December (0.1034 km
                    <E T="51">− 2</E>
                     and 0.1155 km
                    <E T="51">− 2</E>
                    , respectively) and remain relatively low (below 0.0800 km
                    <E T="51">− 2</E>
                    ) through the month of August. NMFS anticipates the encounter rate will likely subside after the peak density in October (0.1652 animals km
                    <E T="51">− 2</E>
                    ) and September (0.1224 km
                    <E T="51">− 2</E>
                    ). Given the expected decrease in common dolphin encounter rate, Bay State Wind has requested authorization of an additional 1,485 additional takes for the remaining 330 survey days. NMFS concurs and is proposing to modify the IHA to increase the total number of authorized take of common dolphin by Level B harassment from 1,485 to 2,970. The proposed updated total take represents 3.2 percent (table 2) of the best available abundance estimate for the western North Atlantic stock of common dolphin. The expiration date of the IHA would remain unchanged (October 5, 2025). Authorized takes remain unchanged for all other marine mammal species.
                </P>
                <GPOTABLE COLS="4" OPTS="L2,nj,i1" CDEF="s50,18C,r50,18C">
                    <TTITLE>Table 2—Total Numbers of Authorized Takes by Level B Harassment of Common Dolphin and as a Percentage of Population</TTITLE>
                    <BOXHD>
                        <CHED H="1">Species</CHED>
                        <CHED H="1">Totals</CHED>
                        <CHED H="2">
                            Take authorization
                            <LI>(No.)</LI>
                        </CHED>
                        <CHED H="2">
                            Stock abundance
                            <LI>
                                (CV, N
                                <E T="0732">min</E>
                                , most recent abundance survey) 
                                <SU>1</SU>
                            </LI>
                        </CHED>
                        <CHED H="2">
                            Instances of take
                            <LI>as percentage</LI>
                            <LI>of population</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Common dolphin</ENT>
                        <ENT>2,970</ENT>
                        <ENT>93,100 (0.56, 59,897, 2021)</ENT>
                        <ENT>3.20</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         NMFS marine mammal stock assessment reports online at: 
                        <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports-region.</E>
                         CV is coefficient of variation; N
                        <E T="52">min</E>
                         is the minimum estimate of stock abundance.
                    </TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD2">Description of Proposed Mitigation, Monitoring and Reporting Measures</HD>
                <P>
                    The mitigation, monitoring, and reporting measures described here are identical to those included in the 
                    <E T="04">Federal Register</E>
                     notices announcing the issuance of the initial IHA authorization (89 FR 81458, October 8, 2024) as well as the discussions of the least practicable adverse impact included in those documents remain accurate.
                </P>
                <HD SOURCE="HD1">Preliminary Determinations</HD>
                <P>
                    Bay State Wind's survey activities and the mitigation, monitoring, and reporting requirements are unchanged from those covered in the initial IHA. The effects of the activity, taking into consideration the mitigation and related monitoring measures, remain unchanged from those stated in the initial IHA, notwithstanding the increase to the authorized amount of common dolphin take. Specifically, the Level B harassment authorized for common dolphins is expected to be of low severity, predominantly in the form of behavioral disturbance (
                    <E T="03">i.e.,</E>
                     avoidance of the sound source and potential occasional interruption of foraging). With approximately 330 survey days remaining, NMFS is proposing to increase authorized common dolphin take by Level B 
                    <PRTPAGE P="99230"/>
                    harassment from 1,485 to 2,970. Even in consideration of the increased estimated numbers of take by Level B harassment, the impacts of these lower severity exposures are not expected to adversely impact the fitness of any individuals, and, therefore no impacts are expected to adversely affect the species or stock through effects on annual rates of recruitment or survival. Further, the proposed take amount of common dolphin still would be of small numbers relative to the population size (3.2 percent) as take is less than one third of the species or stock abundance which is considered by NMFS to be small numbers. In conclusion, there is no new information suggesting that our effects analysis or negligible impact finding for common dolphins should change.
                </P>
                <P>Based on the information contained here and in the referenced documents, NMFS has preliminarily reaffirmed the following: (1) the required mitigation measures will affect the least practicable impact on marine mammal species or stocks and their habitat; (2) the proposed authorized takes will have a negligible impact on the affected marine mammal species or stocks; (3) the proposed authorized takes represent small numbers of marine mammals relative to the affected stock abundances; and (4) Bay State Wind's activities will not have an unmitigable adverse impact on taking for subsistence purposes as no relevant subsistence uses of marine mammals are implicated by this action, and (5) appropriate monitoring and reporting requirements are included.</P>
                <HD SOURCE="HD1">Endangered Species Act (ESA)</HD>
                <P>
                    Section 7(a)(2) of the ESA of 1973 (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ) requires that each Federal agency insure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of IHAs, NMFS OPR consults internally whenever we propose to authorize take for endangered or threatened species.
                </P>
                <P>For the initial IHA, NMFS Office of Protected Resources authorized the incidental take of four species of marine mammals which are listed under the ESA, including the North Atlantic right, fin, sei, and sperm whale, and determined that these activities fall within the scope of activities analyzed in Greater Atlantic Regional Fisheries Office's programmatic consultation regarding geophysical surveys along the U.S. Atlantic coast in the three Atlantic Renewable Energy Regions (completed June 29, 2021; revised September 2021). This modification of the IHA does not modify or change any take of listed species and therefore the prior determination remains unchanged.</P>
                <HD SOURCE="HD1">National Environmental Policy Act</HD>
                <P>
                    To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action (
                    <E T="03">i.e.,</E>
                     the modification of an IHA) with respect to potential impacts on the human environment.
                </P>
                <P>This action is consistent with categories of activities identified in Categorical Exclusion B4 (IHAs with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has preliminarily determined that the issuance of the modified IHA continues to qualify to be categorically excluded from further NEPA review.</P>
                <P>We will review all comments submitted in response to this notice prior to concluding our NEPA process or making a final decision on the IHA request.</P>
                <HD SOURCE="HD1">Proposed Authorization</HD>
                <P>
                    As a result of these preliminary determinations, NMFS proposes to modify the IHA to Bay State Wind for incidental take of marine mammals associated with marine site characterization surveys off the coast of Rhode Island and Massachusetts effective from the date of issuance until October 5, 2025. The only change is an increase in the authorized take by Level B harassment of common dolphins from 1,485 to 2,970. The previously described mitigation, monitoring, and reporting requirements are incorporated. A draft of the proposed modified IHA can be found at 
                    <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-other-energy-activities-renewable.</E>
                </P>
                <HD SOURCE="HD1">Request for Public Comments</HD>
                <P>We request comment on our proposed modification of the IHA for Bay State Wind's marine site characterization surveys. We also request comment on the potential for renewal of this proposed IHA as described in the paragraph below. Please include with your comments any supporting data or literature citations to help inform our final decision on the request for MMPA authorization.</P>
                <SIG>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>Kimberly Damon-Randall,</NAME>
                    <TITLE>Director, Office of Protected Resources, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28994 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Patent and Trademark Office</SUBAGY>
                <DEPDOC>[Docket No.: PTO-C-2024-0054]</DEPDOC>
                <SUBJECT>Anti-Piracy Symposium</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>United States Patent and Trademark Office, Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of symposium.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The United States Patent and Trademark Office (USPTO) seeks to improve intellectual property (IP) enforcement and reduce IP crime and infringement (USPTO 2022-2026 Strategic Plan, Goal 3, Objectives 3.3 and 3.4). As part of this effort, the USPTO will bring interested stakeholders together for an Anti-Piracy Symposium on Thursday, January 23, 2025, held at the USPTO in person and virtually.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The symposium will be held on Thursday, January 23, 2025, from 9 a.m.-3 p.m. Interested parties wishing to attend the symposium in person must register by Thursday, January 16, 2025. Registration for remote attendance will be available through January 23, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The symposium will be held in person at the USPTO in the Clara Barton Auditorium (South), 600 Dulany Street, Alexandria, Virginia 22314. The symposium will be physically accessible to people with disabilities. Individuals requiring accommodation, such as sign language interpretation or other ancillary aids, should communicate their needs at least seven business days prior to the symposium to Velica Dunn in the USPTO's Office of Policy and International Affairs at 571-272-9300, 
                        <E T="03">Velica.Dunn@uspto.gov,</E>
                         or by postal mail addressed to: Mail Stop OPIA, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22314-1450, ATTN: Velica Dunn. Attendees joining in person should arrive at least a half hour prior to the start of the symposium and must present valid government-issued photo identification upon arrival.
                    </P>
                    <P>
                        The symposium will also be available in a virtual format for those wishing to attend remotely. Prior to the 
                        <PRTPAGE P="99231"/>
                        symposium, information on how to register for in-person and remote attendance will be posted on the Office of Policy and International Affairs (OPIA) section of the USPTO website, 
                        <E T="03">https://www.uspto.gov/about-us/organizational-offices/office-policy-and-international-affairs.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Holly Lance, USPTO, Office of Policy and International Affairs, at 
                        <E T="03">holly.lance@uspto.gov.</E>
                         Please direct media inquiries to the Office of the Chief Communications Officer, USPTO, at 571-272-8400.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The core copyright industries—which include film and television, music, publishing, and video games—employ 9.6 million American workers and account for 3.79% of the entire U.S. workforce. These industries generate $1.8 trillion of value to the U.S. GDP, which is 7.76% of the U.S. economy. 
                    <E T="03">See</E>
                     International Intellectual Property Alliance, Copyright Industries in the U.S. Economy, 2022 report, available at 
                    <E T="03">https://www.iipa.org/files/uploads/2022/12/IIPA-Report-2022_Interactive_12-12-2022-1.pdf.</E>
                </P>
                <P>
                    Copyright piracy threatens the success of these industries and the Americans they employ, costing the U.S. economy at least $29.2 billion in lost revenue annually and reducing employment in the motion picture and television industry between 230,000 and 560,000 jobs. 
                    <E T="03">See</E>
                     David Blackburn, Ph.D., Jeffrey A. Eisenach, Ph.D., David Harrison, Jr., Ph.D., NERA Economic Consulting and the U.S. Chamber of Commerce, Impacts of Digital Video Piracy on the U.S. Economy, June 2019, available at 
                    <E T="03">https://www.theglobalipcenter.com/wp-content/uploads/2019/06/Digital-Video-Piracy.pdf.</E>
                </P>
                <P>Digital technologies have shifted the way we consume copyrighted content and have created new opportunities for criminal syndicates to source customers and drive revenue away from lawful owners. At the same time, technologies like artificial intelligence offer a tremendous opportunity to combat piracy and trace the source of unauthorized content.</P>
                <P>The USPTO will facilitate a discussion to examine the challenges piracy poses and identify potential solutions.</P>
                <P>Interested members of the public are invited to attend the Anti-Piracy Symposium on Thursday, January 23, 2025, from 9 a.m.-3 p.m. The program will include briefings on recent copyright case law, the latest tools and techniques for investigating and addressing copyright piracy, and international copyright piracy updates.</P>
                <SIG>
                    <NAME>Katherine K. Vidal,</NAME>
                    <TITLE>Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28133 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-16-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">CONSUMER PRODUCT SAFETY COMMISSION</AGENCY>
                <DEPDOC>[Docket No. CPSC-2012-0030]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Extension of Collection; Comment Request; Testing and Recordkeeping Requirements for Carpets and Rugs</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Consumer Product Safety Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>As required by the Paperwork Reduction Act of 1995, the Consumer Product Safety Commission (CPSC or Commission) requests comments on a proposed extension of approval of information collection requirements for manufacturers and importers of carpets and rugs in the Standard for the Surface Flammability of Carpets and Rugs and the Standard for the Surface Flammability of Small Carpets and Rugs, issued under the Flammable Fabrics Act (FFA). The Office of Management and Budget (OMB) previously approved the collection of information under control number 3041-0017. OMB's most recent extension of approval will expire on March 31, 2025. The Commission will consider all comments received in response to this notice before requesting an extension of this collection of information from OMB.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on the collection of information by February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by Docket No. CPSC-2012-0030, within 60 days of publication of this notice by any of the following methods:</P>
                    <P>
                        <E T="03">Electronic Submissions:</E>
                         Submit electronic comments to the Federal eRulemaking Portal at: 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments. Do not submit through this website: confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. The Commission typically does not accept comments submitted by email, except as described below.
                    </P>
                    <P>
                        <E T="03">Mail/hand delivery/courier/written submissions:</E>
                         CPSC encourages you to submit electronic comments by using the Federal eRulemaking Portal. You may, however, submit comments by mail/hand delivery/courier to: Office of the Secretary, Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; telephone (301) 504-7923.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name and docket number for this notice. CPSC may post all comments without change, including any personal identifiers, contact information, or other personal information provided, to: 
                        <E T="03">http://www.regulations.gov.</E>
                         If you wish to submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public, you may submit such comments by mail, hand delivery, or courier, or you may email them to 
                        <E T="03">cpsc-os@cpsc.gov.</E>
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         For access to the docket to read background documents or comments received, go to: 
                        <E T="03">https://www.regulations.gov,</E>
                         insert Docket Number CPSC-2012-0030 into the “Search” box, and follow the prompts.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Cynthia Gillham, Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; (301) 504-7791, or by email to: 
                        <E T="03">pra@cpsc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>CPSC seeks to renew the following currently approved collection of information:</P>
                <P>
                    <E T="03">Title:</E>
                     Standard for the Flammability of Carpets and Rugs (FF-1-70), 16 CFR 1630, and Standard for the Flammability of Small Carpets and Rugs (FF 2-70), 16 CFR 1631.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     3041-0017.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Renewal of collection.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Manufacturers and importers of carpets and rugs.
                </P>
                <P>
                    <E T="03">General Description of Collection:</E>
                     Under the FFA, the Standard for the Surface Flammability of Carpets and Rugs (16 CFR part 1630) and the Standard for the Surface Flammability of Small Carpets and Rugs (16 CFR part 1631) establish requirements to reduce the flammability of carpets and rugs. 15 U.S.C. 1191-1204. The standards' provisions include requirements for testing and recordkeeping for manufacturers and importers who furnish guaranties subject to the carpet and rug flammability standards. The Consumer Product Safety Improvement 
                    <PRTPAGE P="99232"/>
                    Act of 2008 (CPSIA) established product certification requirements for applicable consumer product safety standards and rules. 15 U.S.C. 2063. Manufacturers and importers of carpets and rugs intended for general use must certify in a general conformity certificate (GCC) that the product complies with the applicable standards based on testing or a reasonable testing program. 16 CFR part 1110. Manufacturers and importers of children's carpets and rugs must certify in a children's product certificate (CPC) that the product complies with the applicable standards based on testing by a CPSC accredited third-party conformity assessment body. 
                    <E T="03">Id.</E>
                     Under the FFA, a manufacturer or importer can issue a guaranty of compliance, based on reasonable and representative testing, to retailers, distributors, or other manufacturers to declare that a product conforms with the applicable flammability standards. 15 U.S.C. 1197. 16 CFR 1608.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     Approximately 120 manufacturers and importers of carpets and rugs are subject to the information collection requirements under the FFA. An estimated 100 manufacturers and importers of carpets and rugs issue a GCC or a CPC. In addition, an estimated 20 such firms elect to issue a guaranty of compliance with the FFA. Staff estimates that the average firm issuing a GCC, CPC, or guaranty under the FFA is required to conduct, on average, 100 tests per year, although the actual number of tests required by a given firm may vary, depending upon the number of carpet styles and the annual production volume.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     For firms issuing a GCC or CPC, staff estimates that the time to conduct each test is two hours, including the time required to establish and maintain the test records. For firms issuing a guaranty of compliance, staff estimates that the time to conduct each test is 2.5 hours, including the time required to establish and maintain the test records.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Burden:</E>
                     The total estimated annualized burden to respondents is 25,000 hours (20,000 hours for firms that issue a GCC/CPC plus 5,000 hours for firms that issue a guaranty of compliance).
                </P>
                <P>
                    <E T="03">Total Estimated Annual Cost to Respondents:</E>
                     The total annualized costs to all respondents for the hour burden for the collection of information is estimated to be as high as $1,840,250, using a mean hourly employer cost-per-hour-worked of $73.61 (Bureau of Labor Statistics: Total compensation rates for private industry workers in management, professional, and related occupations, Table 4, June 2024, 
                    <E T="03">https://www.bls.gov/news.release/archives/ecec_09102024.pdf</E>
                    ) (25,000 hours × $73.61).
                </P>
                <HD SOURCE="HD1">Request for Comments</HD>
                <P>The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:</P>
                <P>• whether the collection of information described above is necessary for the proper performance of the Commission's functions, including whether the information would have practical utility;</P>
                <P>• whether the estimated burden of the proposed collection of information is accurate;</P>
                <P>• whether the quality, utility, and clarity of the information to be collected could be enhanced; and</P>
                <P>• whether the burden imposed by the collection of information could be minimized by use of automated, electronic or other technological collection techniques, or other forms of information technology.</P>
                <SIG>
                    <NAME>Alberta E. Mills,</NAME>
                    <TITLE>Secretary, Consumer Product Safety Commission.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28898 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6355-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Department of the Air Force</SUBAGY>
                <DEPDOC>[Docket ID: USAF-2024-HQ-0012]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of the Air Force, Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-day information collection notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In compliance with the 
                        <E T="03">Paperwork Reduction Act of 1995,</E>
                         the Department of the Air Force announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by docket number and title, by any of the following methods:</P>
                    <P>
                        <E T="03">Federal eRulemaking Portal:</E>
                          
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Mail:</E>
                         Department of Defense, Office of the Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency, Regulatory Directorate, 4800 Mark Center Drive, Mailbox #24 Suite 05F16, Alexandria, VA 22350-1700.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name, docket number and title for this 
                        <E T="04">Federal Register</E>
                         document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         as they are received without change, including any personal identifiers or contact information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to DFAC, J3, Joint Personnel Recovery Agency, 10244 Burbeck Rd., Ft Belvoir, VA 22060. POC: Mr. David Morey, 703-704-2447.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title; Associated Form; and OMB Number:</E>
                     Isolated Personnel Report and Personnel Recovery Mission Software Web Application; DD Form 1833; OMB Control Number 0701-0166.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     Information collected using the DD Form 1833 is necessary to positively identify, authenticate, support and recover isolated or missing DoD persons of interest. The Isolated Personnel Report (ISOPREP) collects controlled unclassified information in the form of full name and associates the name with sensitive personal identifiable information including date of birth, Social Security number, DoD Identification number, pictures and fingerprints. The ISOPREP also collects confidential information in the form of personal authentication statements and codes known only to the individual who completes the ISOPREP. All personnel completing an initial ISOPREP are required to utilize the Personnel Recovery Mission Software (PRMS) web 
                    <PRTPAGE P="99233"/>
                    application. In rare instances where personnel do not have access to PRMS, a hardcopy DD Form 1833 can be completed. In the interest of protecting the force and returning personnel who support the DoD to their units, families and country, the information collected for the ISOPREP is a force requirement for DoD military and civilians serving overseas.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     716.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     2,864.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     2,864.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     15 minutes.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <SIG>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>Stephanie J. Bost,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28967 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6001-FR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE </AGENCY>
                <SUBAGY>Department of the Air Force</SUBAGY>
                <SUBJECT>Department of the Air Force Scientific Advisory Board; Notice of Federal Advisory Committee Meeting </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of the Air Force Scientific Advisory Board, Department of the Air Force. </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of Federal advisory committee meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Defense (DoD) is publishing this notice, in accordance with Federal law, to announce that the following meeting of the Department of the Air Force Scientific Advisory Board will take place. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Closed to the public. Applicable 30 January 2025 from 1:30 p.m. to 5 p.m. (eastern time) and 31 January 2025 from 8 a.m. to 12 p.m. (eastern time). </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>The meeting will be held at Gen. Jacob E. Smart Conference Center, Joint Base Andrews, 1359 Arkansas Road, Joint Base Andrews, MD 20762.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Lt Col Steven Ingraham, (240) 470-4566 (Voice), 
                        <E T="03">steven.ingraham@us.af.mil</E>
                         (Email). Mailing address is 1500 West Perimeter Road, Ste. #3300, Joint Base Andrews, MD 20762. Website: 
                        <E T="03">https://www.scientificadvisoryboard.af.mil/.</E>
                         The most up-to-date changes to the meeting agenda can be found on the website. 
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This meeting is being held under the provisions of chapter 10 of title 5, United States Code (as enacted on Dec. 27, 2022, by section 3(a) of Pub. L. 117-286) (commonly known as the “Federal Advisory Committee Act” or “FACA”), section 552b of title 5, United States Code (popularly known as the “Government in the Sunshine Act”), and 41 CFR 102-3.140 and 102-3.150. </P>
                <P>
                    <E T="03">Purpose of the Meeting:</E>
                     The purpose of this Department of the Air Force Scientific Advisory Board meeting is to conduct midterm reviews of the Department of the Air Force Scientific Advisory Board's FY25 Secretary of the Air Force directed studies.
                </P>
                <P>
                    <E T="03">Agenda:</E>
                     [All times are eastern time] 
                </P>
                <P>
                    <E T="03">Thursday, 30 January 2025:</E>
                </P>
                <FP SOURCE="FP-1">1:30 p.m.-3:00 p.m. FY25 Study #1 Update </FP>
                <FP SOURCE="FP-1">3:20 p.m.-5:00 p.m. FY25 Study #2 Update </FP>
                <P>
                    <E T="03">Friday, 31 January 2025:</E>
                </P>
                <FP SOURCE="FP-1">08:00 a.m.-09:30 a.m. FY25 Study #3 Update </FP>
                <FP SOURCE="FP-1">09:45 a.m.-11:15 a.m. FY25 Study #4 Update </FP>
                <FP SOURCE="FP-1">11:15 a.m.-12:00 p.m. FY25 Study/Closing Remarks/Q&amp;As</FP>
                <P>In accordance with section 1009(d) of title 5, United States Code and 41 CFR 102-3.155, the Administrative Assistant of the Air Force, in consultation with the Air Force General Counsel, has agreed that the public interest requires this meeting of the United States Department of the Air Force Scientific Advisory Board be closed to the public because it will involve discussions involving classified matters covered by section 552b(c)(1) of title 5, United States Code.</P>
                <P>
                    <E T="03">Written Statements:</E>
                     Any member of the public wishing to provide input to the United States Department of the Air Force Scientific Advisory Board should submit a written statement in accordance with 41 CFR 102-3.140(c), section 1009(a)(3) of title 5, United States Code, and the procedures described in this paragraph. Written statements can be submitted to the Designated Federal Officer at the address detailed above at any time. The Designated Federal Officer will review all submissions with the Department of the Air Force Scientific Advisory Board Chairperson and ensure they are provided to members of the Department of the Air Force Scientific Advisory Board. Written statements received after the meeting that is the subject of this notice may not be considered by the Scientific Advisory Board until the next scheduled meeting.
                </P>
                <SIG>
                    <NAME>Tommy W. Lee,</NAME>
                    <TITLE>Acting Air Force Federal Register Liaison Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28919 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3911-44-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Department of the Army</SUBAGY>
                <DEPDOC>[Docket ID: USA-2024-HQ-0016]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of the Army, Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day information collection notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In compliance with the 
                        <E T="03">Paperwork Reduction Act of 1995,</E>
                         the United States Military Academy (USMA) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by docket number and title, by any of the following methods:</P>
                    <P>
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Mail:</E>
                         Department of Defense, Office of the Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency, Regulatory Directorate, 4800 Mark Center Drive, Mailbox #24, Suite 05F16, Alexandria, VA 22350-1700.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name, docket number and title for this 
                        <E T="04">Federal Register</E>
                         document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         as they are 
                        <PRTPAGE P="99234"/>
                        received without change, including any personal identifiers or contact information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Army Records Management Directorate, 9301 Chapek Road, Ft. Belvoir, VA 22060-5605, ATTN: Mr. Douglas Fravel, or call 571-515-0220.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title; Associated Form; and OMB Number:</E>
                     United States Military Academy Candidate Admission Procedures; OMB Control Number 0702-0060.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     This information collection is required to guide qualified candidates through the successful completion of the USMA Admissions Process. The data assists the USMA Department of Admissions, the Admissions Committee, and the Academic Board in determining the candidates who will annually fill the incoming USMA class.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households.
                </P>
                <HD SOURCE="HD1">Pre-Candidate Procedures</HD>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     10,000.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     75,000.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     75,000.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     8 minutes.
                </P>
                <HD SOURCE="HD1">Candidate Procedures</HD>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     16,650.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     28,000.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     28,000.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     35.68 minutes.
                </P>
                <HD SOURCE="HD1">Accepted Candidate Procedures</HD>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     896.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     1,250.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     1,250.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     43 minutes.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <SIG>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>Stephanie J. Bost,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28968 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3710-08-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Office of the Secretary</SUBAGY>
                <DEPDOC>[Docket ID: DoD-2024-HA-0093]</DEPDOC>
                <SUBJECT>Submission for OMB Review; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)), Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>30-Day information collection notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The DoD has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Reginald Lucas, (571) 372-7574, 
                        <E T="03">whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title; Associated Form; and OMB Number:</E>
                     TRICARE Young Adult Application; DD Form 2947; OMB Control Number 0720-0049.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Reinstatement.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     7,164.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     7,164.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     15 minutes.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     1,791.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     The National Defense Authorization Act for Fiscal Year 2011, section 702, aligns TRICARE Program eligibility by providing a means to extend the age of eligibility of TRICARE dependents from age 21 or 23 up to age 26 to allow the purchase of extended dependent medical coverage across existing TRICARE program options (Select and Prime). This is consistent with the intent of the Patient Protection and Affordable Care Act, the implementing Health and Human Services regulations, and the limitations of chapter 55 of title 10. Section 702 allows qualified adult children not eligible for medical coverage at age 21 (23 if enrolled in a full-time course of study at an institution of higher learning approved by the Secretary of Defense) and under age 26 to qualify to purchase medical coverage unless the dependent is enrolled in or eligible to purchase employer sponsored insurance per section 5000A(f)(2) of the Internal Revenue Code of 1986 or is married. The dependents shall be able to purchase either the TRICARE Prime or Select benefits depending on if they meet specific program requirements and the availability of a desired plan in their geographic location.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     As required.
                </P>
                <P>
                    <E T="03">Respondent's Obligation:</E>
                     Voluntary.
                </P>
                <P>
                    <E T="03">DoD Clearance Officer:</E>
                     Mr. Reginald Lucas.
                </P>
                <SIG>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>Stephanie J. Bost,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28975 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6001-FR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Office of the Secretary of Defense</SUBAGY>
                <DEPDOC>[Docket ID: DOD-2024-OS-0128]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Under Secretary of Defense for Personnel and Readiness (OUSD(P&amp;R)), Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day information collection notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In compliance with the 
                        <E T="03">Paperwork Reduction Act of 1995,</E>
                         the Office of the Under Secretary of Defense for Personnel and Readiness, Department of Defense (DoD) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by February 10, 2025.</P>
                </DATES>
                <ADD>
                    <PRTPAGE P="99235"/>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by docket number and title, by any of the following methods:</P>
                    <P>
                        <E T="03">Federal eRulemaking Portal: http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Mail:</E>
                         Department of Defense, Office of the Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency, Regulatory Directorate, 4800 Mark Center Drive, Mailbox #24 Suite 05F16, Alexandria, VA 22350-1700.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name, docket number and title for this 
                        <E T="04">Federal Register</E>
                         document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at 
                        <E T="03">http://www.regulations.gov</E>
                         as they are received without change, including any personal identifiers or contact information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Military-Civilian Transition Office, 4800 Mark Center Drive, Suite 05E25, Alexandria, VA, 22311, Dr. Nathan D. Ainspan, Ph.D., Senior Research Psychologist, email: 
                        <E T="03">nathan.d.ainspan.civ@mail.mil,</E>
                         phone: (703) 647-9273.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title; Associated Form; and OMB Number:</E>
                     SkillBridge Application, OMB Control Number 0704-DSBP.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     DoD's SkillBridge program is an opportunity for Service members to gain valuable civilian work experience through specific industry training, apprenticeships, or internships during their last 180 days of service. DoD SkillBridge connects transitioning Service members with industry partners in real-world job experiences. For Service members, SkillBridge provides an invaluable chance to work and learn in civilian career areas. For industry partners, SkillBridge is an opportunity to access and leverage the world's most highly trained and motivated workforce at no cost. Service members participating in DoD SkillBridge programs continue receiving their military compensation and benefits, while industry partners provide the civilian training and work experience. Some SkillBridge partners may offer skills training and employment opportunities for military spouses and veterans as well as transitioning Service members.
                </P>
                <P>
                    The authorities for SkillBridge are 10 United States Code section 1143 and DoDI 1322.29 (Jobs Training, Employment Skills Training, Apprenticeships, and Internships for Eligible Service Members. In addition, the proposed information collection addresses many of the recommendations made by the Government Accountability Office in its August 2024 report 
                    <E T="03">Better Collection and Analysis of Military Service Data Needed to Improve Oversight of the Skillbridge Program</E>
                     (GAO-24-107352).
                </P>
                <P>
                    DoD is applying for the OMB review of the Skillbridge Application. Organizations that are interested in becoming industry partners will download the application from the DoD Skillbridge website, complete the application, and submit it to DoD. The Department will review the application to determine if the applicant meets the established criteria, consents to the policies outlined in the application, and if DoD approves the application, contact the applicant, and establish the relationship. As part of their agreement with DoD, all Skillbridge partners are required to provide regular updates on their Service member participants (
                    <E T="03">e.g.,</E>
                     how many Service members applied to them, how many were accepted into the organization, and if they were offered employment at the end of the program).
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Federal, state, and local agencies, private business or other for-profit; non-profit organizations, individuals, or households.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     300.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     1,200.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     1,200.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     15 minutes.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     Once.
                </P>
                <P>All the information collection will be executed with information technology. All records are stored in an electronic format retrievable by approved participating organizations directly via a token sign in, and/or electronically emailed to approved participants.</P>
                <SIG>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>Stephanie J. Bost,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28973 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6001-FR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Office of the Secretary</SUBAGY>
                <DEPDOC>[Docket ID: DOD-2024-OS-0126]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Under Secretary of Defense for Personnel and Readiness (OUSD(P&amp;R)), Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day information collection notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In compliance with the 
                        <E T="03">Paperwork Reduction Act of 1995,</E>
                         the Office of the Under Secretary of Defense for Personnel and Readiness announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by docket number and title, by any of the following methods:</P>
                    <P>
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Mail:</E>
                         Department of Defense, Office of the Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency, Regulatory Directorate, 4800 Mark Center Drive, Mailbox #24 Suite 05F16, Alexandria, VA 22350-1700.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name, docket number and title for this 
                        <E T="04">Federal Register</E>
                         document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         as they are received without change, including any personal identifiers or contact information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request more information on this proposed information collection or to 
                        <PRTPAGE P="99236"/>
                        obtain a copy of the proposal and associated collection instruments, please write to Defense Manpower Data Center (DMDC), 420 Gigling Rd., Seaside, CA 93955-6772, Malcolm Mejia, (703)-475-4371.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title; Associated Form; and OMB Number:</E>
                     Non-combatant Tracking System (NTS) &amp; Evacuation Tracking and Accountability System (ETAS); OMB Control Number 0704-0629.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     This information collection is needed to collect the required evacuee information necessary to document the movement of an evacuee from a foreign country to an announced safe haven and to assist the evacuee in meeting their needs. In addition, this information collection is needed to ensure that Federal and State agencies receive proper reimbursement for costs incurred during these very expensive operations. The primary purpose of this information collection is personnel accountability of evacuees who have been repatriated through designated processing sites. By identifying what services have been provided to respective evacuees during initial processing and where they have gone, Federal agencies may ensure that their personnel receive safe haven entitlements and notification of change in status.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals and households.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     7,083 hours.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     85,000.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     85,000.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     5 minutes.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <SIG>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>Stephanie J. Bost,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28972 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6001-FR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Office of the Secretary</SUBAGY>
                <DEPDOC>[Docket ID: DoD-2024-OS-0124]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>United States Transportation Command (USTRANSCOM), Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day information collection notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In compliance with the 
                        <E T="03">Paperwork Reduction Act of 1995,</E>
                         the United States Transportation Command (USTRANSCOM) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by docket number and title, by any of the following methods:</P>
                    <P>
                        <E T="03">Federal eRulemaking Portal: http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Mail:</E>
                         Department of Defense, Office of the Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency, Regulatory Directorate, 4800 Mark Center Drive, Mailbox #24 Suite 05F16, Alexandria, VA 22350-1700.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name, docket number and title for this 
                        <E T="04">Federal Register</E>
                         document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at 
                        <E T="03">http://www.regulations.gov</E>
                         as they are received without change, including any personal identifiers or contact information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Commander, United States Transportation Command, USTRANSCOM-J4, 508 Scott Dr., AFB IL, 62225-1437, Mr. Brian Paul, (618) 817-6701.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title; Associated Form; and OMB Number:</E>
                     Tender of Service for Personal Property Household Goods and Unaccompanied Baggage Shipments; DD Form 619; OMB Control Number 0704-0531.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     The information collection requirement is necessary for private sector commercial transportation service providers, who are under contract with the DoD for shipment/storage of personal property, to identify ownership, and to schedule pickup and delivery of personal property.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     11,462.5.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     917.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     250.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     229,250.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     3 minutes.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <SIG>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>Stephanie J. Bost,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28970 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6001-FR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Office of the Secretary</SUBAGY>
                <DEPDOC>[Docket ID: DoD-2024-OS-0127]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Washington Headquarters Services (WHS), Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day information collection notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In compliance with the 
                        <E T="03">Paperwork Reduction Act of 1995,</E>
                         the Washington Headquarters Services (WHS) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by docket number and title, by any of the following methods:</P>
                    <P>
                        <E T="03">Federal eRulemaking Portal: http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Mail:</E>
                         Department of Defense, Office of the Assistant to the Secretary of Defense 
                        <PRTPAGE P="99237"/>
                        for Privacy, Civil Liberties, and Transparency, Regulatory Directorate, 4800 Mark Center Drive, Mailbox #24 Suite 05F16, Alexandria, VA 22350-1700.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name, docket number and title for this 
                        <E T="04">Federal Register</E>
                         document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at 
                        <E T="03">http://www.regulations.gov</E>
                         as they are received without change, including any personal identifiers or contact information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Pentagon Athletic Center, 1155 Defense Pentagon, Washington, DC 20301-1155, ATTN: Shai Cummings, (703) 614-6710.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>Title; Associated Form; and OMB Number: Pentagon Athletic Center Membership Application; WHS Form 19; OMB Control Number 0704-PACM.</P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     The WHS Form 19 is necessary to obtain information from respondents who seek to become a member of the Pentagon Athletic Center. Information that is collected includes home address, email, and full name, to build a profile for each member in the membership database. Respondents of the WHS-19 are government civilians, contractors, active duty, and retired personnel in the National Capital Region.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     572.67.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     3,436.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     3,436.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     10 minutes.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On Occasion.
                </P>
                <SIG>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>Stephanie J. Bost,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28974 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6001-FR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Office of the Secretary</SUBAGY>
                <DEPDOC>[Docket ID: DoD-2024-OS-0125]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the General Counsel (OGC), Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day information collection notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In compliance with the 
                        <E T="03">Paperwork Reduction Act of 1995,</E>
                         the Office of the General Counsel announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by docket number and title, by any of the following methods:</P>
                    <P>
                        <E T="03">Federal eRulemaking Portal:</E>
                          
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Mail:</E>
                         Department of Defense, Office of the Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency, Regulatory Directorate, 4800 Mark Center Drive, Mailbox #24 Suite 05F16, Alexandria, VA 22350-1700.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name, docket number and title for this 
                        <E T="04">Federal Register</E>
                         document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         as they are received without change, including any personal identifiers or contact information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to DoD Standards of Conduct Office, Office of the General Counsel, Department of Defense, 1600 Defense Pentagon, Washington, DC 20301-1600. POC: Mr. Jeff Green, 703-695-3422.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title; Associated Form; and OMB Number:</E>
                     Office of the Secretary of Defense Confidential Conflict-of-Interest Statement for the Advisory Committee Members; SD Form 830; OMB Control Number 0704-0551.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     The information requested on this form is required by title I of the Ethics in Government Act of 1978 (5 United States Code app.), Executive Order 12674, and 5 Code of Federal Regulations part 2634, subpart I, of the Office of Government Ethics regulations. Respondents are members of or potential members of the Office of the Secretary of Defense Advisory Committees. SD Form 830 will assist in identifying potential conflicts of interest due to personal financial interests or affiliations. The collection of requested information will satisfy a Federal regulatory requirement and assist the DoD in complying with applicable Federal conflict of interest laws and regulations.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     125.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     125.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     125.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     1 hour.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     Annually.
                </P>
                <SIG>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>Stephanie J. Bost,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28971 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6001-FR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Department of the Navy</SUBAGY>
                <DEPDOC>[Docket ID: USN-2024-HQ-0016]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of the Navy, Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day information collection notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In compliance with the 
                        <E T="03">Paperwork Reduction Act of 1995,</E>
                         the Commander, Navy Installation Command announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is 
                        <PRTPAGE P="99238"/>
                        necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by docket number and title, by any of the following methods:</P>
                    <P>
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Mail</E>
                        : Department of Defense, Office of the Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency, Regulatory Directorate, 4800 Mark Center Drive, Mailbox #24 Suite 05F16, Alexandria, VA 22350-1700.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name, docket number and title for this 
                        <E T="04">Federal Register</E>
                         document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         as they are received without change, including any personal identifiers or contact information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the OPNAV Forms/Information Collections Office (DNS-14), 2000 Navy Pentagon, Room 4E563, Washington, DC 20350-2000, ATTN: Ms. Ashley Alford, or call 703-614-7585.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title; Associated Form; and OMB Number:</E>
                     Navy Family Ombudsman Program; OMB Control Number 0703-0070.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     The information collection requirement is necessary to solicit and select a spouse for the volunteer Ombudsman position in Navy components. An Ombudsman is the spouse of an active duty or Selected Reserve member of the command, enlisted or officer. This requirement can be waived if, after a diligent search, no appropriate spouse volunteer is available. Family members, civilian employees affiliated with the command, and active-duty service members may be considered for a waiver. As part of the selection process, prospective Ombudsmen will be notified of the request for an interview by either the commanding officer or another member of the Command Support Team. Prospective Ombudsmen may be interviewed by phone, or in person with the commanding officer. The information collection is also necessary to provide Ombudsmen with program information; communicate during natural disasters and crisis; collect program contact numbers and workload data; and maintain records of program training received. Numbers provided from the collection help identify the issues and concern of the families, trends during deployment and identify training which may be beneficial to the command families.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     2,250.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     4,500.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     4,500.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     30 minutes.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <SIG>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>Stephanie J. Bost,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28969 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6001-FR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF EDUCATION</AGENCY>
                <SUBJECT>National Advisory Committee on Institutional Quality and Integrity</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Department of Education, National Advisory Committee on Institutional Quality and Integrity (NACIQI)</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of membership.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice lists the members of the National Advisory Committee on Institutional Quality and Integrity (NACIQI). This notice is required under section 114(e)(1) of the Higher Education Act of 1965, as amended (HEA).</P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>U.S. Department of Education, Office of Postsecondary Education, 400 Maryland Ave. SW, Washington, DC 20202.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        George Alan Smith, Ed.D., Executive Director/Designated Federal Official, NACIQI, U.S. Department of Education, 400 Maryland Ave. SW, Washington, DC 20202, telephone: (202) 453-7757, or email 
                        <E T="03">george.alan.smith@ed.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">NACIQI's Statutory Authority and Functions</HD>
                <P>The NACIQI is established under section 114 of the HEA and is composed of a maximum of 18 members who are appointed—</P>
                <P>(A) On the basis of the individuals' experience, integrity, impartiality, and good judgment;</P>
                <P>(B) From among individuals who are representatives of, or knowledgeable concerning, education and training beyond secondary education, representing all sectors and types of institutions of higher education; and</P>
                <P>(C) On the basis of the individuals' technical qualifications, professional standing, and demonstrated knowledge in the fields of accreditation and administration of higher education.</P>
                <P>The NACIQI meets at least twice a year and advises the Secretary of Education with respect to:</P>
                <P>• The establishment and enforcement of the standards of accrediting agencies or associations under subpart 2, part H of title IV of the HEA;</P>
                <P>• The recognition of specific accrediting agencies or associations;</P>
                <P>• The preparation and publication of the list of nationally recognized accrediting agencies and associations;</P>
                <P>• The eligibility and certification process for institutions of higher education under title IV of the HEA, together with recommendations for improvements in such process;</P>
                <P>• The relationship between (1) accreditation of institutions of higher education and the certification and eligibility of such institutions, and (2) State licensing responsibilities with respect to such institutions; and</P>
                <P>• Any other advisory functions relating to accreditation and institutional eligibility that the Secretary of Education may prescribe by regulation.</P>
                <HD SOURCE="HD1">What are the terms of office for the committee members?</HD>
                <P>The term of office for each member is six years. Any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member's predecessor was appointed shall be appointed for the remainder of such term.</P>
                <HD SOURCE="HD1">Who are the current members of the committee?</HD>
                <P>The current members of the NACIQI are:</P>
                <P>
                    Members Appointed by the Secretary of Education with Terms Expiring September 30, 2025:
                    <PRTPAGE P="99239"/>
                </P>
                <P>• Wallace E. Boston, Ph.D., President Emeritus, American Public University System, Inc., Charles Town, West Virginia. Appointed by Secretary Betsy DeVos.</P>
                <P>• Keith Curry, Ed.D., President/Chief Executive Officer, Compton College and Compton Community College District, Compton, California. Appointed by Secretary Miguel Cardona.</P>
                <P>• David A. Eubanks, Ph.D., Assistant Vice President for Assessment and Institutional Effectiveness, Furman University, Greenville, South Carolina. Appointed by Secretary Betsy DeVos.</P>
                <P>• Molly E. Hall-Martin, Ph.D., Director, W-SARA, Western Interstate Commission for Higher Education (WICHE), Boulder, Colorado. Appointed by Secretary Miguel Cardona.</P>
                <P>• D. Michael Lindsay, Ph.D., President, Taylor University, Upland, Indiana. Appointed by Secretary Betsy DeVos.</P>
                <P>• Mary Ellen Petrisko, Ph.D., Former President, WASC Senior College and University Commission, Pittsburgh, Pennsylvania. Appointed by Secretary Betsy DeVos.</P>
                <P>Members Appointed by the Speaker of the House of Representatives with Terms Expiring September 30, 2026:</P>
                <P>• Kathleen Sullivan Alioto, Ed.D., Strategic Advisor, Fundraiser, and Consultant, New York, New York, San Francisco, California, and Boston, Massachusetts. Appointed by Representative Nancy Pelosi.</P>
                <P>• Roslyn Clark Artis, J.D., Ed.D., President, Benedict College, Columbia, South Carolina. Appointed by Representative Nancy Pelosi.</P>
                <P>• Jennifer Blum, J.D., Principal, Blum Higher Education Advising, PLLC, Washington, DC. Appointed by Representative Kevin McCarthy.</P>
                <P>• Arthur E. Keiser, Ph.D., Chancellor, Keiser University, Fort Lauderdale, Florida. Appointed by Representative Kevin McCarthy.</P>
                <P>• Robert Mayes, Jr., CEO, Columbia Southern Education Group, Elberta, Alabama. Appointed by Representative Kevin McCarthy.</P>
                <P>• Robert Shireman, Senior Fellow, The Century Foundation, Berkeley, California. Appointed by Representative Nancy Pelosi.</P>
                <P>Members Appointed by the President Pro Tempore of the Senate with Terms Expiring September 30, 2028:</P>
                <P>• Debbie Cochrane, Bureau Chief, California Bureau for Private Postsecondary Education, Alameda, California. Appointed by Senator Chuck Schumer.</P>
                <P>• Zakiya Smith Ellis, Ed.D., Principal, Education Counsel, Atlanta, Georgia. Appointed by Senator Chuck Schumer.</P>
                <P>• Michael Poliakoff, Ph.D., President, American Council of Trustees and Alumni, Washington, DC. Appointed by Senator Mitch McConnell.</P>
                <P>• Claude O. Pressnell Jr., Ed.D., Former President, Tennessee Independent Colleges and Universities Association, Nashville, Tennessee. Appointed by Senator Mitch McConnell.</P>
                <P>• José Luis Cruz Rivera, Ph.D., President, Northern Arizona University, Flagstaff, Arizona. Appointed by Senator Chuck Schumer.</P>
                <P>
                    <E T="03">Electronic Access to this Document:</E>
                     The official version of this document is the document published in the 
                    <E T="04">Federal Register</E>
                    . Free internet access to the official edition of the 
                    <E T="04">Federal Register</E>
                     and the Code of Federal Regulations is available via the Federal Digital System at 
                    <E T="03">www.gpo.gov/fdsys.</E>
                     At this site you can view this document, as well as all other documents of the U.S. Department of Education (Department) published in the 
                    <E T="04">Federal Register</E>
                    , in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site.
                </P>
                <P>
                    You may also access documents of the Department published in the 
                    <E T="04">Federal Register</E>
                     by using the article search feature at: 
                    <E T="03">www.federalregister.gov.</E>
                     Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.
                </P>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>20 U.S.C. 1011c.</P>
                </AUTH>
                <HD SOURCE="HD1">Signing Authority</HD>
                <P>
                    This document of the U.S. Department of Education was signed on November 8, 2024, by Miguel A. Cardona, Secretary of Education. That document with the original signature and date is maintained by the U.S. Department of Education. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned has been authorized to sign the document in electronic format for publication, as an official document of the U.S. Department of Education. This administrative process in no way alters the legal effect of this document upon publication in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <NAME>Tracey St. Pierre,</NAME>
                    <TITLE>Director, Office of the Executive Secretariat, Office of the Secretary, U.S. Department of Education.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28979 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF EDUCATION</AGENCY>
                <SUBJECT>President's Board of Advisors on Historically Black Colleges and Universities</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>President's Board of Advisors on Historically Black Colleges and Universities, Office of the Secretary, U.S. Department of Education.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Announcement of an open meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice sets forth the agenda for the final meeting of the President's Board of Advisors on Historically Black Colleges and Universities (Board) under the Biden Administration and provides information to members of the public about how to attend the meeting, request to make oral comments at the meeting, and submit written comments pertaining to the work of the Board.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>On Tuesday, January 7, 2025, the Board will hold a virtual meeting from 10 a.m. to 11:30 a.m. eastern daylight time.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Sedika Franklin, Associate Director/Designated Federal Official, U.S. Department of Education, White House Initiative on Historically Black Colleges and Universities, 400 Maryland Avenue SW, Washington, DC 20202. Telephone: 202-744-1336. Email at 
                        <E T="03">sedika.franklin@ed.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">The Board's Statutory Authority and Function:</E>
                     The Board is established by 20 U.S.C. 1063e (the HBCUs Partners Act) and Executive Order 14041 (September 3, 2021) and is continued by Executive Order 14109 (September 29, 2023). The Board is also governed by the provisions of 5 U.S.C. chapter 10 (commonly known as the Federal Advisory Committee Act), which sets forth standards for the formation and use of advisory committees. The purpose of the Board is to advise the President, through the White House Initiative on Historically Black Colleges and Universities (Initiative), on all matters pertaining to strengthening the educational capacity of Historically Black Colleges and Universities (HBCUs).
                </P>
                <P>
                    The Board advises the President in the following areas: (i) improving the identity, visibility, and distinctive capabilities and overall competitiveness of HBCUs; (ii) engaging the philanthropic, business, government, military, homeland-security, and education communities in a national dialogue regarding new HBCU programs and initiatives; (iii) improving the 
                    <PRTPAGE P="99240"/>
                    ability of HBCUs to remain fiscally secure institutions that can assist the Nation in achieving its educational goals and in advancing the interests of all Americans; (iv) elevating the public awareness of, and fostering appreciation of, HBCUs; (v) encouraging public-private investments in HBCUs; and (vi) improving government-wide strategic planning related to HBCU competitiveness to align Federal resources and provide the context for decisions about HBCU partnerships, investments, performance goals, priorities, human capital development, and budget planning. Notice of the meeting is required by 5 U.S.C. chapter 10 (commonly known as the Federal Advisory Committee Act) and is intended to notify the public of an opportunity to attend the meeting.
                </P>
                <P>
                    <E T="03">Meeting Agenda:</E>
                     The meeting agenda will include roll call; approval of the minutes from the September 19, 2024, Board meeting; discussion on the addendum to the Board's 2023 report to the President; and acknowledgements of the Board's work. The public comment period will begin immediately following the conclusion of such discussions. The Board will hold a vote on the addendum, which will serve as its 2024 report to the President.
                </P>
                <P>
                    <E T="03">Access to the Meeting:</E>
                     An advance RSVP is not required to attend the meeting. The public may join the meeting by computer at the following link: 
                    <E T="03">https://ed-gov.zoomgov.com/webinar/register/WN_3ERLW9n8QOerxPqd3Bt9_A.</E>
                </P>
                <P>To virtually join the meeting, please click on the link, enter your name, email address, and organization, and follow the prompts to connect to the meeting audio by computer or telephone. Members of the public may virtually join the meeting 5 minutes prior to its start time. Members of the public joining by phone will be automatically placed in listen only mode.</P>
                <P>
                    <E T="03">Submission of requests to make an oral comment:</E>
                     There will be an allotted time for oral comment at the meeting. The public may submit a request to make oral comment by sending a note via the chat function to the Host of the meeting. Please include “Oral Comment Request” in the note and provide the name, title, organization/affiliation, and email address of the person requesting to speak. The Designated Federal Official will call upon each requestor in the order in which the requests were received. Each individual who makes a request will have an opportunity to speak for up to two minutes. All oral comments will become part of the official record of the meeting.
                </P>
                <P>
                    <E T="03">Submission of written comments:</E>
                     Written comments pertaining to the work of the Board may be submitted to the 
                    <E T="03">whirsvps@ed.gov</E>
                     mailbox. Please include in the subject line “Written Comments: Public Comment.” The email must include the name(s), title, organization/affiliation, mailing address, email address, and telephone number of the person(s) making the comment. Comments should be submitted as a Microsoft Word document or in a medium compatible with Microsoft Word (not a PDF file) that is attached to the email or provided in the body of the email message. Please do not send material directly to the members of the Board. Written comments will become part of the official record of the meeting.
                </P>
                <P>
                    <E T="03">Access to Records of the Meeting:</E>
                     The Department will post the official report of the meeting on the Board's website, 
                    <E T="03">https://sites.ed.gov/whhbcu/policy/presidents-board-of-advisors-pba-on-hbcus,</E>
                     no later than 90 days after the meeting. Pursuant to 5 U.S.C. 1009(b), the public may also inspect the meeting materials and other Board records at 400 Maryland Avenue SW, Washington, DC, by emailing 
                    <E T="03">oswhi-hbcu@ed.gov</E>
                     to schedule an appointment.
                </P>
                <P>
                    <E T="03">Reasonable Accommodations:</E>
                     The meeting site is accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the meeting (
                    <E T="03">e.g.,</E>
                     interpreting service, assistive listening device, or materials in an alternate format), notify the contact person listed in this notice at least two weeks before the meeting date. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.
                </P>
                <P>
                    <E T="03">Electronic Access to this Document:</E>
                     The official version of this document is the document published in the 
                    <E T="04">Federal Register</E>
                    . Free internet access to the official edition of the 
                    <E T="04">Federal Register</E>
                     and the Code of Federal Regulations is available via the Federal Digital System at: 
                    <E T="03">www.gpo.gov/fdsys.</E>
                     At this site you can view this document, as well as all other documents of this Department published in the 
                    <E T="04">Federal Register</E>
                    , in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site.
                </P>
                <P>
                    You may also access documents of the Department published in the 
                    <E T="04">Federal Register</E>
                     by using the article search feature at: 
                    <E T="03">www.federalregister.gov.</E>
                     Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     HBCUs Partners Act, Presidential Executive Order 14041, continued by Executive Order 14109.
                </P>
                <SIG>
                    <NAME>Alexis Barret,</NAME>
                    <TITLE>Chief of Staff, Office of the Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28944 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <SUBJECT>Combined Notice of Filings</SUBJECT>
                <P>Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:</P>
                <HD SOURCE="HD1">Filings Instituting Proceedings</HD>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP24-971-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Vector Pipeline L.P.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Vector Pipeline L.P. submits Cost and Revenue Study.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/3/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241203-5268.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/16/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP25-265-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     NEXUS Gas Transmission, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     4(d) Rate Filing: Negotiated Rates—DTE 860002 and 860003 eff 12-1-24 to be effective 12/1/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/3/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241203-5241.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/16/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP25-266-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Greylock Production, LLC, Pillar Energy, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Joint Petition for Limited Waiver of Capacity Release Regulations, et al. of Greylock Production, LLC, et al.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/3/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241203-5266.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/16/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP25-267-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Ruby Pipeline, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     4(d) Rate Filing: RP 2024-12-04 Negotiated Rate Agreement Amendment to be effective 12/4/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5108.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/16/24.
                </P>
                <P>
                    Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
                    <PRTPAGE P="99241"/>
                </P>
                <P>
                    The filings are accessible in the Commission's eLibrary system (
                    <E T="03">https://elibrary.ferc.gov/idmws/search/fercgensearch.asp</E>
                    ) by querying the docket number.
                </P>
                <P>
                    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: 
                    <E T="03">http://www.ferc.gov/docs-filing/efiling/filing-req.pdf.</E>
                     For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.
                </P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28955 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <SUBJECT>Notice of Effectiveness of Exempt Wholesale Generator and Foreign Utility Company Status</SUBJECT>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s50,xs60">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1">Docket Nos.</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Westlands Transmission Project Owner, LLC</ENT>
                        <ENT>EG24-272-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BRP Avila BESS LLC </ENT>
                        <ENT>EG24-273-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BRP Cachi BESS LLC </ENT>
                        <ENT>EG24-274-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BRP Castor BESS LLC </ENT>
                        <ENT>EG24-275-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BRP Desna BESS LLC </ENT>
                        <ENT>EG24-276-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BRP Zeya BESS LLC </ENT>
                        <ENT>EG24-277-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Platinum Energy Storage LLC </ENT>
                        <ENT>EG24-278-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tanzanite Energy Storage, LLC </ENT>
                        <ENT>EG24-279-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Ridgely Energy Farm, LLC </ENT>
                        <ENT>EG24-280-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Long Lake Solar, LLC </ENT>
                        <ENT>EG24-281-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Limewood Bell Renewables LLC </ENT>
                        <ENT>EG24-282-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Eldorado Solar Project, LLC </ENT>
                        <ENT>EG24-283-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wheatridge East Wind, LLC </ENT>
                        <ENT>EG24-284-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Kalamazoo Generating Station, LLC </ENT>
                        <ENT>EG24-285-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Livingston Generating Station, LLC </ENT>
                        <ENT>EG24-286-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Coffeen Solar BESS LLC </ENT>
                        <ENT>EG24-287-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Baldwin Solar BESS LLC </ENT>
                        <ENT>EG24-288-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Dan's Mountain Wind Force, LLC </ENT>
                        <ENT>EG24-289-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Silver State South Storage, LLC </ENT>
                        <ENT>EG24-290-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Prairie Center Energy LLC </ENT>
                        <ENT>EG24-291-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Henrietta BESS LLC </ENT>
                        <ENT>EG24-292-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hanford BESS LLC </ENT>
                        <ENT>EG24-293-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Malaga BESS LLC </ENT>
                        <ENT>EG24-294-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Caballero CA Storage, LLC </ENT>
                        <ENT>EG24-295-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fort Duncan BESS LLC </ENT>
                        <ENT>EG24-296-000. </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Ashwood Solar I, LLC </ENT>
                        <ENT>EG24-297-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Richland Township Solar, LLC </ENT>
                        <ENT>EG24-298-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BCD 2024 Fund 4 Lessee, LLC </ENT>
                        <ENT>EG24-299-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">West River Solar, LLC </ENT>
                        <ENT>EG24-300-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Blackford Solar Energy, LLC </ENT>
                        <ENT>EG24-301-000. </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Blackford Wind Energy, LLC </ENT>
                        <ENT>EG24-302-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Kearsarge Riverpark I LLC </ENT>
                        <ENT>EG24-303-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Rocking R Solar, LLC </ENT>
                        <ENT>EG24-304-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Speedway Solar, LLC </ENT>
                        <ENT>EG24-305-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hoosier Line Energy, LLC </ENT>
                        <ENT>EG24-306-000.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">St Leon Wind Energy LP</ENT>
                        <ENT> FC24-4-000.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Take notice that during the month of November 2024, the status of the above-captioned entities as Exempt Wholesale Generators or Foreign Utility Companies became effective by operation of the Commission's regulations. 18 CFR 366.7(a) (2024).</P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28952 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 6619-023]</DEPDOC>
                <SUBJECT>Lake Upchurch Dam Preservation Association; Notice of Application for Surrender of Exemption Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests</SUBJECT>
                <P>Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:</P>
                <P>
                    a. 
                    <E T="03">Application Type:</E>
                     Surrender of Exemption.
                </P>
                <P>
                    b. 
                    <E T="03">Project No:</E>
                     6619-023.
                </P>
                <P>
                    c. 
                    <E T="03">Date Filed:</E>
                     September 23, 2024, as supplemented on November 19, 2024.
                </P>
                <P>
                    d. 
                    <E T="03">Applicant:</E>
                     Lake Upchurch Dam Preservation Association.
                </P>
                <P>
                    e. 
                    <E T="03">Name of Project:</E>
                     Raeford Hydroelectric Project.
                </P>
                <P>
                    f. 
                    <E T="03">Location:</E>
                     The project is located on Rockfish Creek, at Upchurch Pond, in Hanover County, North Carolina. The project does not occupy any Federal lands.
                </P>
                <P>
                    g. 
                    <E T="03">Filed Pursuant to:</E>
                     Public Utility Regulatory Policies Act of 1978, 16 U.S.C. 2705, 2708.
                </P>
                <P>
                    h. 
                    <E T="03">Applicant Contact:</E>
                     Jeremy Calhoun, President, Lake Upchurch Dam Preservation Association, 2662 Lake Upchurch Drive, Parkton, NC 28371, 
                    <E T="03">marlinjsc1@yahoo.com.</E>
                </P>
                <P>
                    i. 
                    <E T="03">FERC Contact:</E>
                     Kelly Fitzpatrick, (202) 502-8435, 
                    <E T="03">kelly.fitzpatrick@ferc.gov.</E>
                </P>
                <P>
                    j. 
                    <E T="03">Cooperating agencies:</E>
                     With this notice, the Commission is inviting Federal, State, local, and Tribal agencies with jurisdiction and/or special expertise with respect to environmental issues affected by the proposal, that wish to cooperate in the preparation of any environmental document, if applicable, to follow the instructions for filing such requests described in item k below. Cooperating agencies should note the Commission's policy that agencies that cooperate in the preparation of any environmental document cannot also intervene. 
                    <E T="03">See</E>
                     94 FERC ¶ 61,076 (2001).
                </P>
                <P>
                    k. 
                    <E T="03">Deadline for filing comments, motions to intervene, and protests:</E>
                     January 6, 2025.
                </P>
                <P>
                    The Commission strongly encourages electronic filing. Please file comments, motions to intervene, and protests using the Commission's eFiling system at 
                    <E T="03">http://www.ferc.gov/docs-filing/efiling.asp.</E>
                     Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at 
                    <E T="03">http://www.ferc.gov/docs-filing/ecomment.asp.</E>
                     For assistance, please contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, you may submit a paper copy. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852. The first page of any filing should include the docket number P-6619-023. Comments emailed to Commission staff are not considered part of the Commission record.
                </P>
                <P>
                    The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. 
                    <PRTPAGE P="99242"/>
                    Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
                </P>
                <P>
                    l. 
                    <E T="03">Description of Request:</E>
                     The applicant proposes to surrender the project exemption. The generating equipment has not operated since 2016, when the reservoir was lowered due to storm damage to the auxiliary spillway. No significant modifications to the existing dam, buildings, or structures and no ground disturbing activities are proposed. The applicant proposes to remove the electrical connections to the generators within the powerhouse and remove the electrical substation outside of the powerhouse to prevent future generation. There will be no work on the dam or spillways. Upon surrender of the exemption, the applicant proposes to pass all inflow at the dam. Historic pond elevations will be maintained subject to inflow.
                </P>
                <P>
                    m. 
                    <E T="03">Locations of the Application:</E>
                     This filing may be viewed on the Commission's website at 
                    <E T="03">http://www.ferc.gov</E>
                     using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. You may also register online at 
                    <E T="03">http://www.ferc.gov/docs-filing/esubscription.asp</E>
                     to be notified via email of new filings and issuances related to this or other pending projects. For assistance, call 1-866-208-3676 or email 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     for TTY, call (202) 502-8659. Agencies may obtain copies of the application directly from the applicant.
                </P>
                <P>n. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.</P>
                <P>
                    o. 
                    <E T="03">Comments, Protests, or Motions to Intervene:</E>
                     Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214, respectively. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
                </P>
                <P>
                    p. 
                    <E T="03">Filing and Service of Documents:</E>
                     Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person commenting, protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis. Any filing made by an intervenor must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 385.2010.
                </P>
                <P>
                    q. The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28956 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 2347-064]</DEPDOC>
                <SUBJECT>Midwest Hydro, LLC; Notice of Application Accepted for Filing, Soliciting Motions To Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Terms and Conditions, and Fishway Prescriptions</SUBJECT>
                <P>Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.</P>
                <P>
                    a. 
                    <E T="03">Type of Application:</E>
                     Subsequent License.
                </P>
                <P>
                    b. 
                    <E T="03">Project No.:</E>
                     2347-064.
                </P>
                <P>
                    c. 
                    <E T="03">Date filed:</E>
                     August 30, 2022.
                </P>
                <P>
                    d. 
                    <E T="03">Applicant:</E>
                     Midwest Hydro, LLC (Midwest Hydro).
                </P>
                <P>
                    e. 
                    <E T="03">Name of Project:</E>
                     Janesville Hydroelectric Project (Janesville Project).
                </P>
                <P>
                    f. 
                    <E T="03">Location:</E>
                     On the Rock River near the City of Janesville in Rock County, Wisconsin.
                </P>
                <P>
                    g. 
                    <E T="03">Filed Pursuant to:</E>
                     Federal Power Act 16 U.S.C. 791(a)-825(r).
                </P>
                <P>
                    h. 
                    <E T="03">Applicant Contact:</E>
                     Mr. David Fox, Senior Director of Regulatory Affairs, Eagle Creek RE Management, LLC, 7315 Wisconsin Avenue, Suite 1100W, Bethesda, Maryland 20814, (240) 724-8765, 
                    <E T="03">david.fox@eaglecreekre.com.</E>
                </P>
                <P>
                    i. 
                    <E T="03">FERC Contact:</E>
                     Laura Washington (202) 502-6072, 
                    <E T="03">Laura.Washington@ferc.gov.</E>
                </P>
                <P>
                    j. 
                    <E T="03">Deadline for filing motions to intervene and protests, comments, recommendations, terms and conditions, and fishway prescriptions:</E>
                     60 days from the issuance date of this notice; reply comments are due 105 days from the issuance date of this notice.
                </P>
                <P>
                    The Commission strongly encourages electronic filing. Please file motions to intervene and protests, comments, recommendations, terms and conditions, and fishway prescriptions using the Commission's eFiling system at 
                    <E T="03">https://www.ferc.gov/docs-filing/efiling.asp.</E>
                     Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at 
                    <E T="03">https://www.ferc.gov/docs-filing/ecomment.asp.</E>
                     For assistance, please contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, you may submit a paper copy. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. All filings must clearly identify the project name and docket number on the first page: Janesville Hydroelectric Project (P-2347-064).
                </P>
                <P>The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.</P>
                <P>
                    k. This application has been accepted for filing and is now ready for environmental analysis.
                    <PRTPAGE P="99243"/>
                </P>
                <P>l. The Janesville Project consists of the following existing facilities: (1) a 131-acre reservoir with a gross storage capacity of 655 acre-feet at a maximum reservoir surface elevation of 769.8 feet National Geodetic Vertical Datum of 1929; (2) a 65-foot-wide, 8.25-foot-deep forebay structure located on the upstream side of the powerhouse; (3) a 321.6-foot-long dam including three sections from left to right looking downstream: (i) a 207-foot-long overflow spillway topped with 22-inch flashboards, (ii) a 38.3-foot-long gated spillway, and (iii) a 76.3-foot-long powerhouse integral with the dam that contains 76.25-foot-wide by 9-foot-high trashracks with 4.0-inch clear spacing; (4) two vertical-shaft turbine-generating units, each with a maximum hydraulic capacity of 600 cubic feet per second, and a total installed capacity of 500 kilowatts; (5) a 330-foot-long by 480-foot-wide tailrace; (6) a 55-foot-long, 312.5-kilovolt (kV) transmission line connecting the powerhouse to the point of interconnection via a 4.1-kV/12.4-kV step-up transformer; and (7) appurtenant facilities.</P>
                <P>Project recreation facilities at the Janesville Project include a take-out and portage trail. The Janesville Project is currently operated in a run-of-river mode and generates an annual average of approximately 2,285 megawatt-hours. Midwest Hydro proposes to continue operating the project as a run-of-river facility and does not propose any new construction.</P>
                <P>Midwest Hydro proposes modifications to the current project boundary. The proposed project boundary would include Midwest Hydro-owned lands that include project facilities near the Janesville Dam and downstream to include Midwest-owned lands on the right side of the Rock River, as well as the City of Janesville-owned canoe portage put-in.</P>
                <P>The current project boundary encompasses 503.57 acres, which includes 36.97 acres of project land and 466.6 acres of submerged land. The proposed project boundary would include approximately 144.39 acres, which includes 10.15 acres of project land and 134.24 acres of submerged land.</P>
                <P>
                    m. A copy of the application can be viewed on the Commission's website at 
                    <E T="03">https://www.ferc.gov</E>
                     using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document (
                    <E T="03">i.e.,</E>
                     P-2347). For assistance, contact FERC Online Support.
                </P>
                <P>n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.</P>
                <P>All filings must (1) bear in all capital letters the title “PROTEST”, “MOTION TO INTERVENE”, “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “TERMS AND CONDITIONS,” or “FISHWAY PRESCRIPTIONS”; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.</P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <P>
                    You may also register online at 
                    <E T="03">https://ferconline.ferc.gov/FERCOnline.aspx</E>
                     to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.
                </P>
                <P>o. The license applicant must file no later than 60 days following the date of issuance of this notice: (1) a copy of the water quality certification; (2) a copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.</P>
                <P>
                    p. 
                    <E T="03">Procedural schedule:</E>
                     The application will be processed according to the following schedule. Revisions to the schedule will be made as appropriate.
                </P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s100,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Milestone</CHED>
                        <CHED H="1">Target date</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Deadline for filing comments, recommendations, terms and conditions, and prescriptions</ENT>
                        <ENT>February 2025.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Deadline for filing reply comments</ENT>
                        <ENT>March 2025.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>q. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.</P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28961 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Docket No. AD24-7-000]</DEPDOC>
                <SUBJECT>Federal and State Current Issues Collaborative; Notice Inviting Post-Meeting Comments</SUBJECT>
                <P>On November 12, 2024, the Federal and State Current Issues Collaborative convened for a public meeting.</P>
                <P>All interested persons are invited to file post-meeting comments to address issues raised during the meeting. Comments must be submitted on or before 30 days from the date of this Notice.</P>
                <P>
                    Comments may be filed electronically via the internet.
                    <SU>1</SU>
                    <FTREF/>
                     Instructions are available on the Commission's website 
                    <E T="03">https://www.ferc.gov/docs-filing/efiling.asp.</E>
                     For assistance, please contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov</E>
                     or toll free at 1-866-208-3676, or for TTY, (202) 502-8659. Although the Commission strongly encourages electronic filing, documents may also be paper-filed. To paper-file, submissions sent via the U.S. Postal Service must be addressed to: Federal Energy Regulatory Commission, Office of the Secretary, 888 First Street NE, Washington, DC 
                    <PRTPAGE P="99244"/>
                    20426. Submissions sent via any other carrier must be addressed to: Federal Energy Regulatory Commission, Office of the Secretary, 12225 Wilkins Avenue, Rockville, Maryland 20852.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See</E>
                         18 CFR 385.2001(a)(1)(iii) (2021).
                    </P>
                </FTNT>
                <P>
                    For more information about this Notice, please contact: Cecelia Coffey (Legal Information), Office of the General Counsel, (202) 502-8040, 
                    <E T="03">Cecelia.Coffey@Ferc.Gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28965 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Docket Nos. AD22-11-000; AD21-9-000]</DEPDOC>
                <SUBJECT>Office of Public Participation Fundamentals for Participating in FERC Matters; Notice of Video Workshop: “WorkshOPP on FERC's Role in Regulating the Construction and Restoration of Interstate Natural Gas Transmission Pipeline Projects”</SUBJECT>
                <P>The Office of Public Participation's (OPP) “WorkshOPP on FERC's Role in Regulating the Construction and Restoration of Interstate Natural Gas Transmission Pipeline Projects” video is now available. The WorkshOPP outlines FERC staff's oversight role during the construction and restoration phases of interstate natural gas transmission pipeline projects and associated facilities. The video provides an overview of post-certificate reviews, staff's efforts to ensure environmental compliance during construction, restoration of affected lands, and publicly available resources for landowners and concerned citizens.</P>
                <P>
                    The video is available on FERC's YouTube channel under OPP's Playlist at 
                    <E T="03">https://www.youtube.com/@FERC/playlists.</E>
                     It includes captioning in English and Spanish and is compliant with section 508 of the Rehabilitation Act of 1973.
                </P>
                <P>
                    OPP supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28962 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 2373-016]</DEPDOC>
                <SUBJECT>Midwest Hydro, LLC; Notice of Application Accepted for Filing, Soliciting Motions To Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Terms and Conditions, and Fishway Prescriptions</SUBJECT>
                <P>Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.</P>
                <P>
                    a. 
                    <E T="03">Type of Application:</E>
                     Subsequent License.
                </P>
                <P>
                    b. 
                    <E T="03">Project No.:</E>
                     2373-016.
                </P>
                <P>
                    c. 
                    <E T="03">Date filed:</E>
                     August 30, 2022.
                </P>
                <P>
                    d. 
                    <E T="03">Applicant:</E>
                     Midwest Hydro, LLC (Midwest Hydro).
                </P>
                <P>
                    e. 
                    <E T="03">Name of Project:</E>
                     Rockton Hydroelectric Project (Rockton Project).
                </P>
                <P>
                    f. 
                    <E T="03">Location:</E>
                     On the Rock River near the Township of Rockton in Winnebago, County, Illinois.
                </P>
                <P>
                    g. 
                    <E T="03">Filed Pursuant to:</E>
                     Federal Power Act 16 U.S.C. 791(a)-825(r).
                </P>
                <P>
                    h. 
                    <E T="03">Applicant Contact:</E>
                     Mr. David Fox, Senior Director of Regulatory Affairs, Eagle Creek RE Management, LLC, 7315 Wisconsin Avenue, Suite 1100W, Bethesda, Maryland 20814, (240) 724-8765, 
                    <E T="03">david.fox@eaglecreekre.com.</E>
                </P>
                <P>
                    i. 
                    <E T="03">FERC Contact:</E>
                     Laura Washington (202) 502-6072, 
                    <E T="03">Laura.Washington@ferc.gov.</E>
                </P>
                <P>
                    j. 
                    <E T="03">Deadline for filing motions to intervene and protests, comments, recommendations, terms and conditions, and fishway prescriptions:</E>
                     60 days from the issuance date of this notice; reply comments are due 105 days from the issuance date of this notice.
                </P>
                <P>
                    The Commission strongly encourages electronic filing. Please file motions to intervene and protests, comments, recommendations, terms and conditions, and fishway prescriptions using the Commission's eFiling system at 
                    <E T="03">https://www.ferc.gov/docs-filing/efiling.asp.</E>
                     Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at 
                    <E T="03">https://www.ferc.gov/docs-filing/ecomment.asp.</E>
                     For assistance, please contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, you may submit a paper copy. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. All filings must clearly identify the project name and docket number on the first page: Rockton Hydroelectric Project (P-2373-016).
                </P>
                <P>The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.</P>
                <P>k. This application has been accepted for filing and is now ready for environmental analysis.</P>
                <P>
                    l. The Rockton Project consists of the following existing facilities: (1) a 40.67-acre reservoir with a gross storage capacity of 207.4 acre-feet at a maximum reservoir surface elevation of 725.48 feet National Geodetic Vertical Datum of 1929; (2) a succession of dam structures including, from left to right looking downstream: (i) an 84-foot-long gated headworks structure located upstream of the power canal, (ii) a 1,000-foot-long concrete overflow dam located about 300 feet upstream of the headworks structure that creates a bypassed reach (
                    <E T="03">i.e.,</E>
                     Rockton bypassed reach), (iii) a 1,600-foot-long earthen dike extending north from the east abutment of the concrete overflow dam, and (iv) a 5,000-foot-long power canal dike; (3) a 5,000-foot-long power canal running from the gated headworks structure to the powerhouse; (4) an intake structure consisting of 64-foot-wide by 15-foot-high trash racks with 3.5-inch clear spacing; (5) a 64.25-foot-long, 33.25-foot-wide powerhouse; (6) two vertical-shaft turbine-generator units, each with a maximum hydraulic capacity of 810 cubic feet per second, for a total installed capacity of 1.10 megawatts; (7) a 85-foot-wide tailrace that extends downstream for 215 feet where it meets the Rockton bypassed 
                    <PRTPAGE P="99245"/>
                    reach; (8) three 4.1-kilovolt (kV)/12.4-kV step-up transformers; and (9) appurtenant facilities. The project interconnects with the electrical grid via 4.1-kV bus cables and the three step-up transformers.
                </P>
                <P>Project recreation facilities at the Rockton Project include a canoe portage, an overflow dam and power canal bank fishing area, and a tailrace fishing area.</P>
                <P>The Rockton Project is currently operated in a run-of-river mode and generates an annual average of approximately 5,076 megawatt-hours. Midwest Hydro proposes to continue operating the project as a run-of-river facility and does not propose any new construction.</P>
                <P>Midwest Hydro proposes modifications to the current project boundary. The proposed project boundary would include Midwest Hydro-owned land that includes the entire power canal dike, tailrace bank fishing area, and tailrace that extends downstream from the powerhouse to its confluence with the Rock River.</P>
                <P>The current project boundary encompasses 174.1 acres, which includes 27.72 acres of project lands and 146.38 acres of submerged land. The proposed project boundary would include approximately 76.24 acres, which includes 22.85 acres of project land and 53.39 acres of submerged land.</P>
                <P>
                    m. A copy of the application can be viewed on the Commission's website at 
                    <E T="03">https://www.ferc.gov</E>
                     using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document (
                    <E T="03">i.e.,</E>
                     P-2373). For assistance, contact FERC Online Support.
                </P>
                <P>n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.</P>
                <P>All filings must (1) bear in all capital letters the title “PROTEST”, “MOTION TO INTERVENE”, “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “TERMS AND CONDITIONS,” or “FISHWAY PRESCRIPTIONS”; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.</P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <P>
                    You may also register online at 
                    <E T="03">https://ferconline.ferc.gov/FERCOnline.aspx</E>
                     to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.
                </P>
                <P>o. The license applicant must file no later than 60 days following the date of issuance of this notice: (1) a copy of the water quality certification; (2) a copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.</P>
                <P>
                    p. 
                    <E T="03">Procedural schedule:</E>
                     The application will be processed according to the following schedule. Revisions to the schedule will be made as appropriate.
                </P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s100,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Milestone</CHED>
                        <CHED H="1">Target date</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Deadline for filing comments, recommendations, terms and conditions, and prescriptions</ENT>
                        <ENT>February 2025.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Deadline for filing reply comments</ENT>
                        <ENT>March 2025.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>q. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.</P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28966 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 2348-050]</DEPDOC>
                <SUBJECT>Midwest Hydro, LLC; Notice of Application Accepted for Filing, Soliciting Motions To Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Terms and Conditions, and Fishway Prescriptions</SUBJECT>
                <P>Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.</P>
                <P>
                    a. 
                    <E T="03">Type of Application:</E>
                     Subsequent License.
                </P>
                <P>
                    b. 
                    <E T="03">Project No.:</E>
                     2348-050.
                </P>
                <P>
                    c. 
                    <E T="03">Date filed:</E>
                     August 30, 2022.
                </P>
                <P>
                    d. 
                    <E T="03">Applicant:</E>
                     Midwest Hydro, LLC (Midwest Hydro).
                </P>
                <P>
                    e. 
                    <E T="03">Name of Project:</E>
                     Beloit Hydroelectric Project (Beloit Project).
                </P>
                <P>
                    f. 
                    <E T="03">Location:</E>
                     On the Rock River near the City of Beloit in Rock County, Wisconsin.
                </P>
                <P>
                    g. 
                    <E T="03">Filed Pursuant to:</E>
                     Federal Power Act 16 U.S.C. 791(a)-825(r).
                </P>
                <P>
                    h. 
                    <E T="03">Applicant Contact:</E>
                     Mr. David Fox, Senior Director of Regulatory Affairs, Eagle Creek RE Management, LLC, 7315 Wisconsin Avenue, Suite 1100W, Bethesda, Maryland 20814, (240) 724-8765, 
                    <E T="03">david.fox@eaglecreekre.com.</E>
                </P>
                <P>
                    i. 
                    <E T="03">FERC Contact:</E>
                     Laura Washington (202) 502-6072, 
                    <E T="03">Laura.Washington@ferc.gov.</E>
                </P>
                <P>
                    j. 
                    <E T="03">Deadline for filing motions to intervene and protests, comments, recommendations, terms and conditions, and fishway prescriptions:</E>
                     60 days from the issuance date of this notice; reply comments are due 105 days from the issuance date of this notice.
                </P>
                <P>
                    The Commission strongly encourages electronic filing. Please file motions to intervene and protests, comments, recommendations, terms and conditions, and fishway prescriptions using the Commission's eFiling system at 
                    <E T="03">https://www.ferc.gov/docs-filing/efiling.asp.</E>
                     Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at 
                    <E T="03">
                        https://
                        <PRTPAGE P="99246"/>
                        www.ferc.gov/docs-filing/ecomment.asp.
                    </E>
                     For assistance, please contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, you may submit a paper copy. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. All filings must clearly identify the project name and docket number on the first page: Beloit Hydroelectric Project (P-2348-050).
                </P>
                <P>The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.</P>
                <P>k. This application has been accepted for filing and is now ready for environmental analysis.</P>
                <P>l. The Beloit Project consists of the following existing facilities: (1) a 606.47-acre reservoir with a gross storage capacity of 3,032 acre-feet at a maximum reservoir surface elevation of 745.0 feet National Geodetic Vertical Datum of 1929; (2) a 315.9-foot-long dam including four sections from left to right looking downstream: (i) a 42-foot-long non-overflow section, (ii) a 91.1-foot-long Tainter-type gate and stoplog section, (iii) an 81.2-foot-long needle section, and (iv) a 101.6-foot-long slide gate section; (3) a 37-foot-long, 34.5-foot-wide concrete powerhouse with 32-foot-wide by 9-foot-high trashracks with 5.5-inch clear spacing; (4) one vertical-shaft turbine-generator unit with a maximum hydraulic capacity of 725 cubic feet per second and an installed capacity of 480 kilowatts; (5) a 375-foot-wide by 400-foot-long tailrace; (6) a 60-foot-long, 68-kilovolt (kV) transmission line connecting the powerhouse to the point of interconnection via a 4.1-kV/12.4-kV step-up transformer; and (7) appurtenant facilities.</P>
                <P>There are no project recreation facilities at the Beloit Project.</P>
                <P>The Beloit Project is currently operated in a run-of-river mode and generates an annual average of approximately 3,035 megawatt-hours. Midwest Hydro proposes to continue operating the project as a run-of-river facility and does not propose any new construction.</P>
                <P>Midwest Hydro proposes modifications to the current project boundary to add lands that are necessary for project operation. The proposed project boundary would include Midwest Hydro-owned lands that include project facilities near the Beloit Dam and downstream to provide a 400-foot buffer where dam operation turbulence may occur.</P>
                <P>The current project boundary encompasses 619.3 acres, which includes 42.41 acres of project lands and 576.89 acres of submerged lands. The proposed project boundary would include approximately 689.21 acres, which includes 79.21 acres of project lands and 610.0 acres of submerged land.</P>
                <P>
                    m. A copy of the application can be viewed on the Commission's website at 
                    <E T="03">http://www.ferc.gov</E>
                     using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document (
                    <E T="03">i.e.,</E>
                     P-2348). For assistance, contact FERC Online Support.
                </P>
                <P>n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.</P>
                <P>All filings must (1) bear in all capital letters the title “PROTEST”, “MOTION TO INTERVENE”, “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “TERMS AND CONDITIONS,” or “FISHWAY PRESCRIPTIONS”; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.</P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <P>
                    You may also register online at 
                    <E T="03">https://ferconline.ferc.gov/FERCOnline.aspx</E>
                     to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.
                </P>
                <P>o. The license applicant must file no later than 60 days following the date of issuance of this notice: (1) a copy of the water quality certification; (2) a copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.</P>
                <P>
                    p. 
                    <E T="03">Procedural schedule:</E>
                     The application will be processed according to the following schedule. Revisions to the schedule will be made as appropriate.
                </P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s100,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Milestone</CHED>
                        <CHED H="1">Target date </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Deadline for filing comments, recommendations, terms and conditions, and prescriptions</ENT>
                        <ENT>February 2025.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Deadline for filing reply comments</ENT>
                        <ENT>March 2025.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>q. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.</P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28963 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="99247"/>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Docket No. CP24-512-000]</DEPDOC>
                <SUBJECT>Texas Connector Pipeline, LLC; Notice of Schedule for the Preparation of an Environmental Assessment for the Texas Connector Amendment Project</SUBJECT>
                <P>
                    On August 12, 2024, Texas Connector Pipeline, LLC (Texas Connector) filed an application with the Federal Energy Regulatory Commission (Commission or FERC), in Docket No. CP24-512-000, requesting authorization pursuant to Section 7(c) of the Natural Gas Act to construct and operate certain natural gas facilities in Jefferson and Orange Counties, Texas. The Commission had authorized the Port Arthur Liquefaction Project (PALP, Docket No. CP17-20-000), on April 18, 2019. On May 25, 2023, in Docket No. CP17-21-003 et al., the Commission issued an 
                    <E T="03">Order Issuing Certificate, Amending Certificate, and Approving Abandonment,</E>
                     authorizing among other things, the abandonment by transfer from PALP of the Texas Connector Project (Project) to Texas Connector. The current application seeks to amend those Project facilities.
                </P>
                <P>On August 16, 2024, the FERC issued its Notice of Application for the amended Project. Among other things, that notice alerted agencies issuing Federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a Federal authorization within 90 days of the date of issuance of the Commission staff's environmental document for the Project.</P>
                <P>
                    This notice identifies Commission staff's intention to prepare an environmental assessment (EA) for the Project and the planned schedule for the completion of the environmental review.
                    <SU>1</SU>
                    <FTREF/>
                     The EA will be issued for a 30-day comment period.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         In accordance with the Council on Environmental Quality's regulations, the unique identification number for documents relating to this environmental review is EAXX-019-20-000-1731674078. 40 CFR 1501.5(c)(4) (2024).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Schedule for Environmental Review</HD>
                <FP SOURCE="FP-1">Issuance of EA March 21, 2025</FP>
                <FP SOURCE="FP-1">
                    90-day Federal Authorization Decision Deadline 
                    <SU>2</SU>
                    <FTREF/>
                     June 19, 2025
                </FP>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         The Commission's deadline applies to the decisions of other Federal agencies, and State agencies acting under federally delegated authority, that are responsible for Federal authorizations, permits, and other approvals necessary for proposed projects under the Natural Gas Act. Per 18 CFR 157.22(a), the Commission's deadline for other agency's decisions applies unless a schedule is otherwise established by Federal law.
                    </P>
                </FTNT>
                <P>If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.</P>
                <HD SOURCE="HD1">Project Description</HD>
                <P>Texas Connector seeks to modify the Project facilities originally authorized in 2019 as follows.</P>
                <P>• The Southern Compressor Station would not be constructed, and the original site of the Southern Compressor Station would be utilized for a laydown yard and access road.</P>
                <P>• The southern pipeline segment (Southern Segment) would decrease in length from 7.6 miles to 1.4 miles.</P>
                <P>• Compression at the Northern Compressor Station (renamed Orangefield Compressor Station) would increase from three natural gas-driven turbine compressors rated at 16,684 hp each, to four SolarTitan 130 Gas Turbine driven compressors rated at approximately 24,009 hp each.</P>
                <P>• The footprint and configuration of the Orangefield Compressor Station would shift slightly north and west and increase in size from 40 acres to 82.4 acres.</P>
                <P>• The northern pipeline segment (Northern Segment) would increase in length from 26.6 miles to 29.6 miles and include several modifications to the alignment and workspace to accommodate landowner requests and development within the previously authorized right-of-way.</P>
                <P>• Texas Connector proposes to use about 16,320 feet of the Big Hill Bayou south of Taylor Bayou and South Mansfield Ferry Road Canal as a water access routes. Big Hill Bayou would require dredging to facilitate vessel transit.</P>
                <P>• The KMPL Meter Station would not be constructed.</P>
                <P>The purpose of Project is to implement construction efficiencies to enhance the overall constructability of the previously authorized Texas Connector Project at various locations.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On November 18, 2024, the Commission issued a 
                    <E T="03">Notice of Scoping Period Requesting Comments on Environmental Issues for the Proposed Texas Connector Amendment Project</E>
                     (Notice of Scoping). The Notice of Scoping was sent to affected landowners; Federal, State, and local government agencies; elected officials; environmental and public interest groups; potentially interested Indian tribes; other interested parties; and local libraries and newspapers. As of today's notice, the Commission has received no comments from any parties in response to the Notice of Scoping.
                </P>
                <P>No agencies volunteered to cooperate with the FERC in the preparation of the EA. All substantive environmental issues identified by staff will be addressed in the EA.</P>
                <HD SOURCE="HD1">Additional Information</HD>
                <P>
                    In order to receive notification of the issuance of the EA and to keep track of formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This service provides automatic notification of filings made to subscribed dockets, document summaries, and direct links to the documents. Go to 
                    <E T="03">https://www.ferc.gov/ferc-online/overview</E>
                     to register for eSubscription.
                </P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <P>
                    Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (
                    <E T="03">www.ferc.gov</E>
                    ). Using the “eLibrary” link, select “General Search” from the eLibrary menu, enter the selected date range and “Docket Number” excluding the last three digits (
                    <E T="03">i.e.,</E>
                     CP24-512), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at 
                    <E T="03">FERCOnlineSupport@ferc.gov.</E>
                     The eLibrary link on the FERC website also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28964 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="99248"/>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <SUBJECT>Combined Notice of Filings #1</SUBJECT>
                <P>Take notice that the Commission received the following exempt wholesale generator filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     EG25-51-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Woodward Energy Storage, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Woodward Energy Storage, LLC submits Notice of Self-Certification of Exempt Wholesale Generator Status.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5135.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>Take notice that the Commission received the following electric rate filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER20-1977-007.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Versant Power.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Compliance filing: Joint Offer of Settlement Regarding MPD 2024-2025 Charges (ER20-1977-) to be effective N/A.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5128.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-331-001.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Southwestern Public Service Company.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Tariff Amendment: 2024.12.04 Errata Production FERC Order 898 to be effective 1/1/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5162.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-635-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Mid-Atlantic Interstate Transmission, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: MAIT submits Construction Agmnt, SA No. 7168 to be effective 2/3/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5023.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-636-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Southwest Power Pool, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: 2900R25 KMEA NITSA NOA to be effective 12/1/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5027.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-637-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Midcontinent Independent System Operator, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: 2024-12-04_SA 4405 Cleco Power-Cleco Power GIA (Rodemacher) to be effective 11/25/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5029.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-638-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Midcontinent Independent System Operator, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: 2024-12-04_SA 4408 Cleco Power-Cleco Power GIA (Nesbitt) to be effective 11/26/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5033.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-639-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: Amendment to ISA, SA No. 5561; Queue No. AC1-043/AD1-115 (amend) to be effective 2/3/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5035.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-640-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     AEP Texas Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: AEPTX-Lunis Creek Solar Project 2nd Amended Generation Interconnection Agreement to be effective 11/8/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5038.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-641-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Southwest Power Pool, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: 1266R17 Kansas Municipal Energy Agency NITSA and NOA to be effective 12/1/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5040.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-642-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     New York Independent System Operator, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: NYISO 205: Withdrawing Customer Credit Requirements to be effective 2/3/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5047.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-643-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: Original CSA Service Agreement No. 7421; Project Identifier #Q387 to be effective 11/4/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5089.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-644-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: Original CSA Service Agreement No. 7422; Project Identifier #NYISO-Q421 to be effective 11/4/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5098.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-646-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Dominion Energy South Carolina, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: Columbia Hydro CIAC Amendment to be effective 2/3/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5113.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-648-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Horizon West Transmission, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: HWT TRBAA 2025 Annual Update to be effective 1/1/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5126.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-649-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Nevada Power Company.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: NITSA-24-00065_NOA-24-00065_TIA-24-00067 Filing to be effective 12/5/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5158.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-650-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Midcontinent Independent System Operator, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: 2024-12-04_SA 3193 Ameren Illinois-Hickory Solar 2nd Rev GIA (J644) to be effective 11/25/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/4/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241204-5196.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 12/26/24.
                </P>
                <P>
                    The filings are accessible in the Commission's eLibrary system (
                    <E T="03">https://elibrary.ferc.gov/idmws/search/fercgensearch.asp</E>
                    ) by querying the docket number.
                </P>
                <P>Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.</P>
                <P>
                    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: 
                    <E T="03">https://www.ferc.gov/docs-filing/efiling/filing-req.pdf.</E>
                     For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.
                </P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help 
                    <PRTPAGE P="99249"/>
                    members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28957 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Docket No. AD22-7-000]</DEPDOC>
                <SUBJECT>Oil Pipeline Capacity Allocation Issues and Anomalous Conditions</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Energy Regulatory Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Termination of notice of inquiry proceeding.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Energy Regulatory Commission (Commission) is terminating the notice of inquiry (NOI) proceeding considering oil pipeline capacity allocation issues that arise under anomalous conditions.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The NOI proceeding is terminated as of December 10, 2024.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <FP SOURCE="FP-1">
                        Adrianne Cook (Technical Information), Office of Energy Market Regulation, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. (202) 502-8849. 
                        <E T="03">Adrianne.Cook@ferc.gov.</E>
                    </FP>
                    <FP SOURCE="FP-1">
                        Caitlin Tweed (Legal Information), Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. (202) 502-8073. 
                        <E T="03">Caitlin.Tweed@ferc.gov.</E>
                    </FP>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On February 17, 2022, the Commission issued a Notice of Inquiry (NOI) in the captioned proceeding to explore oil pipeline capacity allocation issues that arise when anomalous conditions affect the demand for oil pipeline capacity and, in particular, the availability of pipeline capacity for transporting jet fuel to supply airports following the onset of the COVID-19 pandemic. The Commission sought comment on what actions, if any, the Commission should consider to address those allocation issues.
                    <SU>1</SU>
                    <FTREF/>
                     Specifically, the Commission requested comment on: (a) historical examples of anomalous conditions; (b) whether current prorationing policies sufficiently address anomalous conditions; (c) whether the Commission should take actions to mitigate the effects of anomalous conditions; and (d) whether secondary market transactions could improve access to pipeline capacity during anomalous conditions.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">Oil Pipeline Capacity Allocation Issues &amp; Anomalous Conditions,</E>
                         87 FR 10355 (Feb. 24, 2022), 178 FERC ¶ 61,105 (2022) (NOI).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">Id.</E>
                         P 9, A1-A4.
                    </P>
                </FTNT>
                <P>For the reasons set forth below, we exercise our discretion to terminate the proceeding in Docket No. AD22-7-000.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    As detailed in the NOI,
                    <SU>3</SU>
                    <FTREF/>
                     interstate oil pipelines are regulated as common carriers under the Interstate Commerce Act (ICA).
                    <SU>4</SU>
                    <FTREF/>
                     Oil pipelines use prorationing to allocate capacity among shippers when their total nominations exceed the pipeline's capacity. The Commission does not prescribe a particular prorationing methodology but requires any such methodology to be consistent with the ICA. As relevant to this proceeding, a history-based methodology gives preference to shippers with a history of shipping on the pipeline.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">Id.</E>
                         P 2.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         49 U.S.C. app. 1 (1988).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">Suncor Mktg. Inc.</E>
                         v. 
                        <E T="03">Platte Pipe Line Co.,</E>
                         132 FERC ¶ 61,242, at P 25 (2010). In contrast, a 
                        <E T="03">pro rata</E>
                         methodology awards available capacity to shippers in proportion to their nominations each nomination cycle, regardless of how much service, if any, they have taken in the past. 
                        <E T="03">Id.</E>
                         P 26; 
                        <E T="03">see also,</E>
                         NOI, 178 FERC ¶ 61,105 at P 4 nn.6-7 (providing simplified examples of 
                        <E T="03">pro rata</E>
                         and history-based methodologies).
                    </P>
                </FTNT>
                <P>
                    The COVID-19 pandemic significantly impacted the demand for oil pipeline capacity. In particular, some industry participants raised concerns that the demand for jet fuel disproportionately decreased as compared with other oil products such as road fuels, which could have reduced allocations of capacity to jet fuel transportation on pipelines that used a history-based prorationing methodology.
                    <SU>6</SU>
                    <FTREF/>
                     The issue was raised formally in two Commission proceedings. First, in May 2021, SFPP, L.P. (SFPP) filed a tariff revision proposing a temporary change to its prorationing policy that would allow jet fuel shippers to obtain access to additional capacity that its tariff reserves for new shippers.
                    <SU>7</SU>
                    <FTREF/>
                     Other SFPP shippers protested the proposal, and SFPP subsequently withdrew the filing. Second, in August 2021, Airlines 
                    <SU>8</SU>
                    <FTREF/>
                     filed a request for emergency relief, asking the Commission to direct SFPP to prioritize jet fuel shipments on its North Line to the Reno terminal serving Reno-Tahoe International Airport to prevent jet fuel shortages. The filing was protested, and the Commission denied the request for emergency relief because Airlines did not establish that the circumstances constituted a public health emergency warranting extraordinary relief under section 1(15) of the ICA.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         NOI, 178 FERC ¶ 61,105 at P 7.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Docket No. IS21-322-000 (Withdrawn).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Airlines include Airlines for America; Airlines Council International-North America; American Association of Airport Executives; International Air Transport Association; National Air Carrier Association; Regional Airline Association; and Southwest Airlines Pilots Association.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">Airlines for Am.,</E>
                         176 FERC ¶ 61,065, at PP 14-16 (2021).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. NOI and Comments</HD>
                <P>
                    On February 17, 2022, the Commission issued the NOI seeking comments on oil pipeline capacity allocation issues that arise under anomalous conditions, and in particular, the availability of pipeline capacity for transporting jet fuel to supply airports following the onset of the COVID-19 pandemic.
                    <SU>10</SU>
                    <FTREF/>
                     Fifteen commenters—including pipelines, Airlines, and non-jet fuel shippers—filed comments in response to the NOI.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         The Commission sought comment on: (a) pipelines and airports where airlines anticipate receiving capacity below their anticipated fuel needs; (b) pipelines that were not in prorationing over the prior 12 months that would have been in prorationing if jet fuel had shipped at 2019 levels; (c) total capacity on pipelines that transport jet fuel; (d) how nominations and capacity awarded for non-jet fuel products have changed during the COVID-19 pandemic; (e) actions the Commission should consider to address concerns regarding pipeline capacity to airport destinations; and (f) whether expansions on pipelines serving airports would help address jet fuel needs. NOI, 178 FERC ¶ 61,105 at P 9, B1-B7.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         Comments were filed by: Airlines; the American Fuel &amp; Petrochemical Manufacturers (AFPM); Liquid Energy Pipeline Association (LEPA) (formerly known as Association of Oil Pipe Lines or AOPL); Buckeye Partners, L.P.; the Canadian Association of Petroleum Producers (CAPP); Chevron Products Company (a Chevron U.S.A. Division), HollyFrontier Refining &amp; Marketing LLC, and Valero Marketing and Supply Company (collectively, CHV Shippers); Colonial Pipeline Company (Colonial); Enterprise Products Partners L.P. (Enterprise); Explorer Pipeline Company (Explorer); ConocoPhillips Company, Devon Gas Services, L.P., Marathon Oil Company, Murphy Exploration and Production Company-USA, Ovintiv Marketing Inc., and Pioneer Natural Resources USA, Inc. (collectively, Liquids Shippers Group); Magellan Midstream Partners, L.P. (Magellan); SIGMA: America's Leading Fuel Marketers, and the National Association of Truckstop Operators (SIGMA/NATSO); QT Fuels Incorporated, Pilot Travel Centers LLC, Saratoga Rack Marketing LLC, Southern Counties Oil Co. dba SC Fuels, Pro Petroleum LLC, RaceTrac, Inc., and Love's Travel 
                        <PRTPAGE/>
                        Stops &amp; Country Stores, Inc. (collectively Surface Transportation Fuel Shippers); and Tallgrass Energy, LP (Tallgrass). In addition, the City of Phoenix Aviation Department, a member of Airlines through its trade association, filed separate comments.
                    </P>
                </FTNT>
                <PRTPAGE P="99250"/>
                <P>
                    In general, Airlines contend that existing policies are not suited to addressing the conditions created by the COVID-19 pandemic and claim that further action is necessary to prevent jet fuel supply constraints; Airlines state, however, that industry-wide action is not necessary at this time. Airlines state that because the pandemic disrupted jet fuel shipping patterns on a sustained yet temporary basis, shipper histories adjusted to reflect shippers' temporarily reduced demand. Because history-based prorationing policies are designed to preserve shippers' relative capacity allocations, Airlines argue that jet fuel shippers will be unable to rebuild their shipper histories to pre-pandemic levels absent Commission action.
                    <SU>12</SU>
                    <FTREF/>
                     Moreover, Airlines contend that shippers cannot rely upon secondary market transactions to restore lost shipper histories 
                    <SU>13</SU>
                    <FTREF/>
                     and that Airlines have limited ability to ship on behalf of others to maintain history during periods of reduced demand.
                    <SU>14</SU>
                    <FTREF/>
                     Airlines request that the Commission remain receptive to case-specific proposals to resolve capacity constraints.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Airlines Initial Comments at 10-11; Airlines Reply Comments at 16-17.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Airlines Initial Comments at 19-24; Airlines Reply Comments at 26-27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         Airlines Initial Comments at 9-10; 
                        <E T="03">see also</E>
                         Airlines Reply Comments at 17-19.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">E.g.,</E>
                         Airlines Initial Comments at 8, 11-12; Airlines Reply Comments at 3-4.
                    </P>
                </FTNT>
                <P>
                    In addition, Airlines argue that the Commission should consider taking three generic actions to address the effects of the COVID-19 pandemic upon jet fuel capacity allocations. First, Airlines request that the Commission confirm that it could exercise authority to direct pipelines to reset shipper histories to 2019 levels.
                    <SU>16</SU>
                    <FTREF/>
                     Second, Airlines request that the Commission require pipelines to provide data from 2019 to the present regarding volumes of products nominated and shipped, available pipeline capacity, and months when the pipeline was in prorationing.
                    <SU>17</SU>
                    <FTREF/>
                     Third, Airlines request that the Commission take action to encourage expansions by emphasizing that pipelines can conduct expansions for one product and by increasing the annual reporting requirements on Form No. 6.
                    <SU>18</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         Airlines Initial Comments at 13-14, 29; Airlines Reply Comments at 6-9. Airlines state that for purposes of future anomalous conditions, the Commission could direct pipelines to freeze shipper histories when it is recognized that anomalous conditions are occurring. Airlines Initial Comments at 13.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         Airlines Initial Comments at 15-19.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">Id.</E>
                         at 31-32 (citing 
                        <E T="03">SFPP, L.P.,</E>
                         169 FERC ¶ 61,001, at PP 44-46, 51 (2019); 
                        <E T="03">SFPP, L.P.,</E>
                         168 FERC ¶ 61,058, at P 15 (2019); 
                        <E T="03">CHS Inc.</E>
                         v. 
                        <E T="03">Enter. TE Prods. Pipeline Co.,</E>
                         155 FERC ¶ 61,178, at P 15 (2016)); Airlines Reply Comments at 9-10. Airlines request that the Commission require pipelines to provide additional information on Form No. 6 to aid in identifying where declining to expand capacity may reflect an abuse of market power. Airlines Initial Comments at 33-34.
                    </P>
                </FTNT>
                <P>
                    By contrast, pipelines and non-jet fuel shippers urge the Commission to take no action.
                    <SU>19</SU>
                    <FTREF/>
                     They argue that existing history-based prorationing policies sufficiently address the allocation of capacity during anomalous conditions. Commenters argue that pipeline capacity is finite and that any action to increase the capacity allocated to jet fuel shippers will reduce the capacity allocated to other products, which could produce fuel shortages, market disruptions, and increased costs for consumers.
                    <SU>20</SU>
                    <FTREF/>
                     Commenters contend that this result would confer an undue preference upon jet fuel shippers, violate pipelines' obligation to provide service upon reasonable request, and conflict with Commission precedent.
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">E.g.,</E>
                         LEPA Reply Comments at 2, 5; CHV Shippers Initial Comments at 3; Colonial Initial Comments at 1, 3; Enterprise Initial Comments at 7; SFPP Reply Comments at 1, 8; SIGMA/NATSO Initial Comments at 1, 4; Surface Transportation Fuel Shippers Initial Comments at 1, 17, 20, 22.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">E.g.,</E>
                         AOPL Initial Comments at 6-7; Enterprise Initial Comments at 2-5, 7; Explorer Comments at 4; SIGMA/NATSO Initial Comments at 3; Surface Transportation Fuel Shippers Initial Comments at 1, 14; Tallgrass Initial Comments at 3-4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">E.g.,</E>
                         AFPM Initial Comments at 3; AOPL Initial Comments at 3-4; Colonial Initial Comments at 2, 15, 18, 20; Magellan Initial Comments at 5; CHV Shippers Initial Comments at 4-5 (citing 
                        <E T="03">Suncor,</E>
                         132 FERC ¶ 61,242 at P 24); Liquids Shippers Group Initial Comments at 3-4 (same); Surface Transportation Fuel Shippers Initial Comments at 1-2, 7, 21 (same).
                    </P>
                </FTNT>
                <P>
                    Airlines provided data from 2019 through April 2022 related to jet fuel pipeline deliveries and jet fuel use at certain airports in order to allow the Commission to compare jet fuel deliveries from before the COVID-19 pandemic to 2021 and the first half of 2022.
                    <SU>22</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See</E>
                         Airlines Initial Comments, Ex. A and Ex. C; Airlines Reply Comments at Ex. A.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Discussion</HD>
                <P>
                    At this time and based upon this record, we are not persuaded to take further action in this proceeding related to oil pipeline capacity allocation issues arising from the COVID-19 pandemic and other anomalous conditions. The record provides an insufficient basis for initiating industry-wide policy changes. In particular, the record may no longer reflect market conditions.
                    <SU>23</SU>
                    <FTREF/>
                     Accordingly, we exercise our discretion to terminate the proceeding in Docket No. AD22-7-000.
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         The most recent actual data in the record is from April 2022.
                    </P>
                </FTNT>
                <P>Although we are not taking further action in this proceeding, we are committed to working with pipeline and shipper groups to address problems related to oil pipeline capacity constraints and allocation issues as they may arise. We continue to monitor and evaluate the Commission's policies governing the allocation of oil pipeline capacity. Interested entities are encouraged to contact the Commission with any concerns regarding the effects of anomalous conditions on oil pipeline capacity allocation that may arise in the future.</P>
                <SIG>
                    <P>By the Commission.</P>
                    <DATED>Issued: December 4, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28960 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 2446-052]</DEPDOC>
                <SUBJECT>STS Hydropower, LLC; Notice of Application Accepted for Filing, Soliciting Motions To Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Terms and Conditions, and Fishway Prescriptions</SUBJECT>
                <P>Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.</P>
                <P>
                    a. 
                    <E T="03">Type of Application:</E>
                     New Major License.
                </P>
                <P>
                    b. 
                    <E T="03">Project No.:</E>
                     2446-052.
                </P>
                <P>
                    c. 
                    <E T="03">Date filed:</E>
                     August 30, 2022.
                </P>
                <P>
                    d. 
                    <E T="03">Applicant:</E>
                     STS Hydropower, LLC (STS Hydropower).
                </P>
                <P>
                    e. 
                    <E T="03">Name of Project:</E>
                     Dixon Hydroelectric Project (Dixon Project).
                </P>
                <P>
                    f. 
                    <E T="03">Location:</E>
                     On the Rock River near the City of Dixon in Lee and Ogle Counties, Illinois.
                </P>
                <P>
                    g. 
                    <E T="03">Filed Pursuant to:</E>
                     Federal Power Act 16 U.S.C. 791(a)-825(r).
                </P>
                <P>
                    h. 
                    <E T="03">Applicant Contact:</E>
                     Mr. David Fox, Senior Director of Regulatory Affairs, Eagle Creek RE Management, LLC, 7315 Wisconsin Avenue, Suite 1100W, Bethesda, Maryland 20814, (240) 724-8765, 
                    <E T="03">david.fox@eaglecreekre.com.</E>
                </P>
                <P>
                    i. 
                    <E T="03">FERC Contact:</E>
                     Laura Washington (202) 502-6072, 
                    <E T="03">Laura.Washington@ferc.gov</E>
                    .
                </P>
                <P>
                    j. 
                    <E T="03">
                        Deadline for filing motions to intervene and protests, comments, 
                        <PRTPAGE P="99251"/>
                        recommendations, terms and conditions, and fishway prescriptions:
                    </E>
                     60 days from the issuance date of this notice; reply comments are due 105 days from the issuance date of this notice.
                </P>
                <P>
                    The Commission strongly encourages electronic filing. Please file motions to intervene and protests, comments, recommendations, terms and conditions, and fishway prescriptions using the Commission's eFiling system at 
                    <E T="03">https://www.ferc.gov/docs-filing/efiling.asp.</E>
                     Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at 
                    <E T="03">https://www.ferc.gov/docs-filing/ecomment.asp.</E>
                     For assistance, please contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, you may submit a paper copy. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. All filings must clearly identify the project name and docket number on the first page: Dixon Hydroelectric Project (P-2446-052).
                </P>
                <P>The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.</P>
                <P>k. This application has been accepted for filing and is now ready for environmental analysis.</P>
                <P>
                    l. 
                    <E T="03">The Dixon Hydroelectric Project consists of the following existing facilities:</E>
                     (1) a 305.9-acre reservoir with a gross storage capacity of 1,530 acre-feet at a maximum reservoir surface elevation of 647.08 feet National Geodetic Vertical Datum of 1929 (NGVD 29); (2) a 130-foot-wide by 18-foot-deep forebay located immediately upstream of the powerhouse; (3) a succession of dam structures including, from left to right looking downstream: (i) a 250-foot-long powerhouse integral with the dam equipped with 200-foot-wide by 15-foot-high trash racks with 5-inch clear spacing, (ii) a 114-foot-long by 24-foot-high forebay wall set perpendicular to the dam that ties the powerhouse and fender wall to the dam, (iii) a 286-foot-long fender wall located upstream of the project forebay extending from the upstream end of the fender wall to the south riverbank, and (iv) a 610-foot-long north overflow dam extending from the forebay wall to the north riverbank, topped with 16-inch flashboards; (4) five vertical-shaft turbine-generating units, each with a maximum hydraulic capacity of 1,100 cubic feet per second, for a total installed capacity of 3,200 kilowatts; (5) a 30-foot-long, 34.5-kilovolt (kV) transmission line conveying project power to the point of interconnection via two 2.3-kV transformers; and (6) appurtenant facilities.
                </P>
                <P>The Dixon Project includes one project recreation facility, the Dixon canoe portage.</P>
                <P>The Dixon Project is currently operated in a run-of-river mode and generates an annual average of approximately 14,995 megawatt-hours. STS Hydropower proposes to continue operating the project as a run-of-river facility and does not propose any new construction.</P>
                <P>STS Hydropower proposes modifications to the current project boundary. The proposed project boundary would include STS Hydropower-owned lands that include project facilities. The proposed project boundary has been modified to: (1) extend 400 feet downstream to include all STS Hydropower-owned lands that include the tailrace fishing area; (2) remove lands that are over elevation 647.04 feet NGVD 29 that are not necessary for project operation; and (3) remove several archeological sites that are not impounded by the project dam.</P>
                <P>The current project boundary encompasses 2583.17 acres, which includes 806.67 acres of project lands and 1,776.5 acres of submerged land. The proposed project boundary would include approximately 399.14 acres, 84.84 acres of which is land and 314.3 acres of which is inundated.</P>
                <P>
                    m. A copy of the application can be viewed on the Commission's website at 
                    <E T="03">https://www.ferc.gov</E>
                     using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document (
                    <E T="03">i.e.,</E>
                     P-2446). For assistance, contact FERC Online Support.
                </P>
                <P>n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.</P>
                <P>All filings must (1) bear in all capital letters the title “PROTEST”, “MOTION TO INTERVENE”, “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “TERMS AND CONDITIONS,” or “FISHWAY PRESCRIPTIONS”; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.</P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <P>
                    You may also register online at 
                    <E T="03">https://ferconline.ferc.gov/FERCOnline.aspx</E>
                     to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.
                </P>
                <P>
                    o. 
                    <E T="03">The license applicant must file no later than 60 days following the date of issuance of this notice:</E>
                     (1) a copy of the water quality certification; (2) a copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) 
                    <PRTPAGE P="99252"/>
                    evidence of waiver of water quality certification.
                </P>
                <P>
                    p. 
                    <E T="03">Procedural schedule:</E>
                     The application will be processed according to the following schedule. Revisions to the schedule will be made as appropriate.
                </P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s100,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Milestone </CHED>
                        <CHED H="1">Target date</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Deadline for filing comments, recommendations, terms and conditions, and prescriptions</ENT>
                        <ENT>February 2025.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Deadline for filing reply comments</ENT>
                        <ENT>March 2025.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>q. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.</P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28958 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[FRL-12464-01-OEJECR; EPA-HQ-OEJECR-2024-0147]</DEPDOC>
                <SUBJECT>White House Environmental Justice Advisory Council; Notification of Public Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notification for a public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Pursuant to the Federal Advisory Committee Act (FACA), the U.S. Environmental Protection Agency (EPA) hereby provides notice that the White House Environmental Justice Advisory Council (WHEJAC) will meet on the dates and times described below. Due to unforeseen administrative circumstances, EPA is announcing this meeting with less than 15 calendar days public notice. This meeting is open to the public. For additional information about registering to attend the meeting or provide public comment, please see “REGISTRATION” under 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        . Pre-registration is required.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The WHEJAC will convene an in-person public meeting with a virtual option on Tuesday, December 17, 2024, from approximately 1 p.m. to 7:30 p.m. eastern time. Meeting discussions will focus on several topics including, but not limited to, workgroup activities, panel discussions, updates from the White House Council on Environmental Quality (CEQ) and other Federal agencies, and new formal charges for the WHEJAC. The WHEJAC invites public comments at the meeting on the subjects listed below (see 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        ). Members of the public who wish to participate in the public comment period must register by 11:59 p.m. eastern time, Friday, December 13, 2024.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>The meeting will be held virtually.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Audrie Washington, WHEJAC Designated Federal Officer, U.S. EPA; email: 
                        <E T="03">whejac@epa.gov;</E>
                         telephone: (202) 441-7295. For additional information about the WHEJAC, visit 
                        <E T="03">https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council#meetings.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Charter of the WHEJAC (available at 
                    <E T="03">https://www.epa.gov/system/files/documents/2024-05/whejac-amended-charter-jan-5-2024.pdf</E>
                    ) states that the advisory committee “will provide independent advice and recommendations to the Chair of the Council on Environmental Quality (CEQ) and to the White House Environmental Justice Interagency Council (IAC) on how to increase the Federal Government's efforts to address current and historic environmental injustice. The WHEJAC will provide advice and recommendations about broad cross-cutting issues related, but not limited, to issues of environmental justice and pollution reduction, energy, climate change mitigation and resiliency, environmental health, and racial inequity. The WHEJAC's efforts will include a broad range of strategic, scientific, technological, regulatory, community engagement, and economic issues related to environmental justice.”
                </P>
                <P>
                    <E T="03">Registration:</E>
                     Individual registration is required for the public meeting. Information on how to register is located at 
                    <E T="03">https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council.</E>
                     Registration for the meeting is available until the scheduled end time of the meeting. Registration to speak during the public comment period will close at 11:59 p.m., eastern time, Tuesday, December 13, 2024. When registering, please provide your name, organization, city and state, and email address for follow up. Please also indicate whether you would like to provide public comment during the meeting, or if you are submitting written comments.
                </P>
                <P>
                    <E T="03">A. Public Comment:</E>
                     The WHEJAC is interested in receiving public comments relevant to the following charges and topics:
                </P>
                <P>(1) National Science and Technology Council (NSTC) Environmental Justice Science, Data, and Research Plan: What metrics or indicators would prove most useful in evaluating whether the recommendations in the current Research Plan have been meaningfully integrated and used to support the advancement of environmental justice; what types of feedback mechanisms could be implemented to meaningfully capture community responses and integrate them into the planning of the NSTC Environmental Justice Subcommittee; what key areas should receive increased or decreased attention in the next iteration of the plan; and what innovative approaches or emerging technologies, should the Subcommittee consider in future Research Plans?</P>
                <P>(2) Place-Based and Community-Focused Initiatives: What models of community-focused, multiagency collaboration have worked effectively; what methods, processes, principles, or other components have made these models effective in strengthening health or environmental protection or reducing environmental injustice affecting a specific local community or region; and in what ways could multiagency efforts at the Federal level incorporate effective partnership or input from State, territorial, and local governments, consultation with Tribal governments, and engagement with communities with environmental justice concerns, community organizations, businesses, and members of the public?</P>
                <P>(3) Environmental Justice Issues Affecting Indigenous Peoples and Tribal Nations.</P>
                <P>
                    More information on WHEJAC Workgroup charges is located online at: 
                    <E T="03">https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council,</E>
                     under WHEJAC Membership, Workgroups, and Charges.
                </P>
                <P>
                    Individuals or groups making remarks during the oral public comment period will be limited to three (3) minutes. EPA will give priority to speak during the meeting to public commenters with comments relevant to the topics and questions listed above. The WHEJAC will make every effort to hear from each public commenter who has registered to provide oral comments during the time specified on the agenda but, in the interest of time, commenters are strongly encouraged to consider submitting written comments for the record. You can submit your written comments by visiting 
                    <E T="03">http://www.regulations.gov</E>
                     and opening Docket ID No. EPA-HQ-OEJECR-2024-0147, by using the webform at 
                    <E T="03">
                        https://www.epa.gov/environmentaljustice/
                        <PRTPAGE P="99253"/>
                        forms/white-house-environmental-justice-advisory-council-whejac-public-comment;
                    </E>
                     or by emailing comments to 
                    <E T="03">whejac@epa.gov.</E>
                     The WHEJAC will accept written comments through Tuesday, December 31, 2024.
                </P>
                <P>
                    <E T="03">B. Information About Services for Individuals With Disabilities or Requiring English Language Translation Assistance:</E>
                     For information about access or services for individuals requiring assistance, contact Audrie Washington at 
                    <E T="03">whejac@epa.gov.</E>
                     mailto:To request special accommodations for a disability or other assistance, please submit your request at least seven (7) working days prior to the meeting to give EPA sufficient time to process your request.
                </P>
                <SIG>
                    <NAME>Deeohn Ferris,</NAME>
                    <TITLE>Director, Office of Policy, Partnerships and Program Development (OPPPD), Office of Environmental Justice and External Civil Rights.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28953 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OPP-2024-0520; FRL-12406-01-OCSPP]</DEPDOC>
                <SUBJECT>Pesticide Registration Review; Proposed Decisions for Several Pesticides; Notice of Availability and Request for Comment</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This notice announces the availability of and solicits comments on EPA's proposed decisions for the following pesticides: alpha methyl mannoside; 
                        <E T="03">Duddingtonia flagrans</E>
                         strain IAH 1297; Pepino mosaic virus, strain CH2, isolate 1906; and sheep fat. EPA is proposing that no further review is necessary for these pesticides at this time based on its previous determinations that these pesticides meet the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard for registration.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by the registration review case name and number for the specific pesticide of interest provided in Table 1 of Unit II., through the 
                        <E T="03">Federal eRulemaking Portal</E>
                         at 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at 
                        <E T="03">https://www.epa.gov/dockets.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        <E T="03">For pesticide-specific information, contact:</E>
                         The Chemical Review Manager for the pesticide of interest identified in Table 1 of Unit II.
                    </P>
                    <P>
                        <E T="03">For general information on the registration review program, contact:</E>
                         Jeannine Kausch, Biopesticides and Pollution Prevention Division (7511M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW, Washington, DC 20460-0001; telephone number: (202) 566-1533; email address: 
                        <E T="03">kausch.jeannine@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. Does this action apply to me?</HD>
                <P>This action is directed to the public in general and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, EPA has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager identified in Table 1 of Unit II.</P>
                <HD SOURCE="HD1">II. What action is the Agency taking?</HD>
                <P>Consistent with 40 CFR 155.46, this notice announces the availability of EPA's proposed registration review decisions for the pesticides shown in Table 1 and opens a 60-day public comment period on these proposed decisions. The proposed decisions for the pesticides and their associated rationale follow in Unit IV.</P>
                <GPOTABLE COLS="2" OPTS="L2,nj,i1" CDEF="s100,r100">
                    <TTITLE>Table 1—Proposed Registration Review Decisions Being Issued</TTITLE>
                    <BOXHD>
                        <CHED H="1">Registration review case name and No.</CHED>
                        <CHED H="1">Chemical review manager and contact information</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Alpha Methyl Mannoside; Case Number 6332</ENT>
                        <ENT>
                            James Parker, 
                            <E T="03">parker.james@epa.gov</E>
                            , (202) 566-1594.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">Duddingtonia flagrans</E>
                             strain IAH 1297; Case Number 6534
                        </ENT>
                        <ENT>
                            Joseph Mabon, 
                            <E T="03">mabon.joseph@epa.gov</E>
                            , (202) 566-1535.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Pepino mosaic virus, strain CH2, isolate 1906; Case Number 6528</ENT>
                        <ENT>
                            Joseph Mabon, 
                            <E T="03">mabon.joseph@epa.gov</E>
                            , (202) 566-1535.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Sheep Fat; Case Number 6339</ENT>
                        <ENT>
                            James Parker, 
                            <E T="03">parker.james@epa.gov</E>
                            , (202) 566-1594.
                        </ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">III. Registration Review Background</HD>
                <P>
                    Section 3(g) of the FIFRA requires EPA to periodically review registered pesticides to ensure that each pesticide continues to satisfy the statutory standard for registration; that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. 
                    <E T="03">See</E>
                     7 U.S.C. 136a(g); 40 CFR 155.40(a). Through its registration review program, EPA reevaluates each pesticide's registration based on current scientific and other knowledge about the pesticide, including its effects on human health and the environment, taking into consideration any changes in law, regulations, or policy since the last review. EPA has promulgated regulations governing the registration review process in 40 CFR part 155, subpart C.
                </P>
                <P>
                    Pursuant to 40 CFR 155.46, EPA may decide that registration review is complete and additional review is not needed for certain pesticides. That regulation provides the following: “The Agency may determine that there is no need to reconsider a previous decision that a pesticide satisfies the standard of registration in FIFRA. In such cases, instead of establishing a pesticide registration review case docket as described in § 155.50, the Agency may propose that, based on its determination that a pesticide meets the FIFRA standard for registration, no further review will be necessary. In such circumstances, the Agency will publish a notice in the 
                    <E T="04">Federal Register</E>
                     announcing the availability of the proposed decision and provide a comment period of at least 60 calendar days. The Agency will publish a notice in the 
                    <E T="04">Federal Register</E>
                     announcing the availability of a final version of the decision, an explanation of any changes to the proposed decision and its response to any comments. The date of the final notice of availability would be used as the date of the latest registration 
                    <PRTPAGE P="99254"/>
                    review for the purpose of scheduling subsequent registration reviews.”
                </P>
                <P>
                    When EPA promulgated the procedural regulations for registration review in 2006 (published in the 
                    <E T="04">Federal Register</E>
                     on August 9, 2006 (71 FR 45720) (FRL-8080-4)), the Agency explained that “[t]he purpose of this provision [section 155.46] is to give the Agency flexibility to not schedule a pesticide for registration review if the pesticide has such low toxicity, exposure, or risk that another review would not change the Agency's position and would not be an effective use of resources. The Agency may also use this provision for a pesticide that has recently undergone a comprehensive review. In proposed decisions issued under § 155.46, the Agency generally would explain why it believes that no additional review is necessary and reference, as appropriate, publicly available documentation to support the Agency's position.”
                </P>
                <P>As stated in section 155.46, the final notice serves as the date for the registration review cycle for the specified pesticide(s) and is used for purposes of scheduling the next registration review under FIFRA section 3(g). The next round of registration review for any chemical that goes through the 40 CFR 155.46 process would need to be completed within 15 years after the final determination.</P>
                <HD SOURCE="HD1">IV. EPA's Proposed Decisions</HD>
                <P>
                    EPA has determined that the pesticides identified in Table 1 of Unit II. (alpha methyl mannoside; 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297; Pepino mosaic virus, strain CH2, isolate 1906; and sheep fat) present very low toxicity, exposure, and risks to human health and the environment. No human health or environmental incidents have been reported since the registration of the first products containing these pesticides. Additionally, each of the listed pesticides underwent a comprehensive review during the registration of products containing those pesticides, in which EPA concluded that the products met the FIFRA standard for registration. No changes in use pattern, exposure, or toxicity have occurred, no new data have become available, and no other data have been identified since the first products containing these pesticides were registered that would result in changes in the risk profile of the pesticides. Accordingly, the Agency has determined that there is no need to reconsider those previous decisions. Since another review would not change the Agency's position and would not be an effective use of resources, EPA is proposing that further review is unnecessary at this time and that the registration review for alpha methyl mannoside; 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297; Pepino mosaic virus, strain CH2, isolate 1906; and sheep fat be completed. The specific proposed decision for each pesticide is described below.
                </P>
                <HD SOURCE="HD2">A. Alpha Methyl Mannoside (Case Number 6332)</HD>
                <P>Alpha methyl mannoside is a naturally occurring mannoside carbohydrate present in a variety of plant-based foods in the form of mannose polymers. As a pesticide, it is used as a plant regulator to increase growth in a variety of plants such as vegetable, fruit, peanut, and bulb and root crops; ornamentals, potted plants, bedding plants, and cut flowers in greenhouses; and turfgrass.</P>
                <P>
                    EPA has determined its previous decision for two products containing alpha methyl mannoside does not need to be reconsidered. That decision document and supporting documents are posted to docket identification (ID) number EPA-HQ-OPP-2017-0419 on 
                    <E T="03">https://www.regulations.gov.</E>
                     As stated in that document, EPA determined that use of the pesticide would not cause unreasonable adverse effects to human health or the environment, based primarily on the low toxicity and exposure expected from the pesticide as described below:
                </P>
                <P>
                    1. 
                    <E T="03">FIFRA—Human Health Risk.</E>
                     The database of studies required to support the assessment of risk to human health of alpha methyl mannoside is complete. EPA does not expect dietary (food and drinking water) or other non-occupational risks from use of alpha methyl mannoside as an active ingredient in pesticide products. Data demonstrated that alpha methyl mannoside is of low toxicity through all routes of exposure, and no toxicological endpoints have been identified. No risks of concern are expected from occupational exposures when used according to label directions. Residues of alpha methyl mannoside are exempt from the requirement of a tolerance in or on all raw agricultural commodities under 40 CFR 180.1352. The pesticide is of low risk to humans (including pesticide handlers and people exposed post-application) due to both low toxicity and exposure. No additional risk assessments are needed.
                </P>
                <P>
                    2. 
                    <E T="03">FIFRA—Ecological Risk.</E>
                     No risks of concern were identified in the previous ecological assessment. Risks of concern are not anticipated to birds, mammals, freshwater fish, aquatic invertebrates, nontarget plants, or nontarget insects (including honey bees) from the pesticidal use of alpha methyl mannoside as a plant regulator to increase growth. Since the products were registered, there has been no change in use patterns that would prompt reevaluation of risk. The pesticide is of low risk to nontarget species due to both low toxicity and exposure. No additional risk assessments are needed.
                </P>
                <P>
                    3. 
                    <E T="03">155.46 Proposal.</E>
                     EPA has determined that the products containing alpha methyl mannoside satisfy the FIFRA standard for registration. The pesticide is of such low toxicity, exposure, and risk that additional review would not be an effective use of Agency resources. All applicable data requirements have been satisfied. There have been no changes in use pattern, exposure, or toxicity since the first products containing this pesticide were registered, nor have any new data been identified that would result in changes in the risk profile of the pesticide. In addition, no human health or environmental incidents have been reported since the registration of the first products containing this pesticide. Finally, EPA is not aware of any changes in law, regulation, or policy in relation to this pesticide that need to be considered at this time. Therefore, EPA is proposing that no further review of alpha methyl mannoside is necessary and registration review can be completed at this time because the pesticide continues to meet the FIFRA registration standard.
                </P>
                <P>
                    4. 
                    <E T="03">Other Actions.</E>
                </P>
                <P>
                    i. 
                    <E T="03">Endangered Species Act (ESA).</E>
                     EPA is making a “May Affect, Not Likely to Adversely Affect” determination for listed plants for products containing alpha methyl mannoside because (1) there is potential for beneficial effects to listed plants within the spray drift zone due to alpha methyl mannoside's effect as a plant regulator, and (2) EPA does not expect any contemporaneous adverse effects to listed species based on low toxicity and limited environmental exposure. This potential for beneficial effects is based on alpha methyl mannoside's mode of action, and EPA has determined that any such effects are likely to be negligible. EPA is developing an assessment to support informal consultation under ESA section 7(a)(2) for the products that contain active ingredients with the potential for beneficial effects, including alpha methyl mannoside. EPA will complete this informal consultation before or concurrent with issuing a final registration review decision for alpha methyl mannoside.
                    <PRTPAGE P="99255"/>
                </P>
                <P>
                    ii. 
                    <E T="03">The Endocrine Disruptor Screening Program (EDSP).</E>
                     Because the available data indicate that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogen, EPA intends to seek consensus from its internal peer review process to determine whether an exemption from the requirements of the EDSP under Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(p)(4) is appropriate. If so, EPA will issue that exemption before or concurrent with issuing a final registration review decision for alpha methyl mannoside.
                </P>
                <HD SOURCE="HD2">B. Duddingtonia Flagrans Strain IAH 1297 (Case Number 6534)</HD>
                <P>
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297 is an animal feed-through fungal pesticide that forms filamentous structures that trap/kill nematodes in manure. This limits the presence of parasitic nematodes in pastureland, thereby reducing the cycle of nematode infection in grazing animals.
                </P>
                <P>
                    EPA has determined that its previous registration decision for two products containing 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297 does not need to be reconsidered. That decision document and supporting documents are posted to docket ID number EPA-HQ-OPP-2017-0276 on 
                    <E T="03">https://www.regulations.gov.</E>
                     As stated in that document, EPA determined that use of the pesticide would not cause unreasonable adverse effects to human health or the environment, based primarily on the low toxicity/pathogenicity and exposure expected from the pesticide as described below:
                </P>
                <P>
                    1. 
                    <E T="03">FIFRA—Human Health Risk.</E>
                     The toxicology database required to support the assessment of risk to human health is complete and demonstrates that 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297 is not associated with significant toxicity, irritation, pathogenicity, or other adverse effects. EPA does not expect dietary (food or drinking water) or other non-occupational risks from use of 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297 due to low toxicity/pathogenicity and exposure potential. No risks of concern are expected from occupational exposures when used according to label directions. 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297 is also exempt from the requirement of a tolerance in or on all food commodities under 40 CFR 180.1355. The pesticide is of low risk to humans (including pesticide handlers and people exposed post-application) due to both low toxicity/pathogenicity and exposure. No additional risk assessments are needed.
                </P>
                <P>
                    2. 
                    <E T="03">FIFRA—Ecological Risk.</E>
                     The 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297 database of studies and information required to support the ecological risk assessment is complete and deemed adequate for making a risk determination. 
                    <E T="03">Duddingtonia flagrans</E>
                     is a ubiquitous organism that will not be present above background levels, except during application, at which point it is then expected to rapidly degrade and return to background levels. 
                    <E T="03">Duddingtonia flagrans</E>
                     also has a high host specificity for certain nematodes, proliferates poorly in soil, and does not spread well beyond treated locations. Based on low exposure from feed-through applications, as well as specificity to nematodes and lack of effects to other taxa, risks of concern to nontarget organisms are not anticipated from the use of the pesticide products containing 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297. The pesticide is of low risk to nontarget species due to both low toxicity/pathogenicity and exposure. No additional risk assessments are needed.
                </P>
                <P>
                    3. 
                    <E T="03">155.46 Proposal.</E>
                     EPA has determined that products containing 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297 satisfy the FIFRA standard for registration. The pesticide is of such low toxicity/pathogenicity, exposure, and risk that additional review would not be an effective use of Agency resources. All applicable data requirements have been satisfied. There have been no changes in use pattern, exposure, or toxicity/pathogenicity since the first products containing this pesticide were registered, nor have any new data been identified that would result in changes in the risk profile of the pesticide. In addition, no human health or environmental incidents have been reported since the registration of the first products containing the pesticide. Finally, EPA is not aware of any changes in law, regulation, or policy in relation to this pesticide that need to be considered at this time. Therefore, EPA is proposing that no further review of 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297 is necessary and registration review can be completed at this time because the pesticide continues to meet the FIFRA registration standard.
                </P>
                <P>
                    4. 
                    <E T="03">Other Actions.</E>
                </P>
                <P>
                    i. 
                    <E T="03">ESA.</E>
                     EPA is making a “No Effect” determination under the ESA for the labeled uses of 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297 based on the low toxicity/pathogenicity of and limited environmental exposure to the pesticide. The reasons for this determination are the same grounds as those described in review of the first products containing 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297 registered by EPA (see the decision document and supporting ecological risk assessment posted to docket ID number EPA-HQ-OPP-2017-0276 on 
                    <E T="03">https://www.regulations.gov</E>
                    ).
                </P>
                <P>
                    ii. 
                    <E T="03">EDSP.</E>
                     Because the available data indicate that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogen, EPA intends to seek consensus from its internal peer review process to determine whether an exemption from the requirements of the EDSP under FFDCA section 408(p)(4) is appropriate. If so, EPA will issue that exemption before or concurrent with issuing a final registration review decision for 
                    <E T="03">Duddingtonia flagrans</E>
                     strain IAH 1297.
                </P>
                <HD SOURCE="HD2">C. Pepino Mosaic Virus, Strain CH2, Isolate 1906 (Case Number 6528)</HD>
                <P>Pepino mosaic virus, strain CH2, isolate 1906 is an attenuated strain of the plant pathogen Pepino mosaic virus that causes a heightened defense response in treated plants, resulting in resistance when those treated plants encounter more pathogenic strains of Pepino mosaic virus. Applications of Pepino mosaic virus, strain CH2, isolate 1906 are made only to tomato plants in greenhouses.</P>
                <P>
                    EPA has determined that its previous registration decision for one product containing Pepino mosaic virus, strain CH2, isolate 1906 does not need to be reconsidered. That decision document and supporting documents are posted to docket ID number EPA-HQ-OPP-2017-0527 on 
                    <E T="03">https://www.regulations.gov.</E>
                     As stated in that document, EPA determined that use of the pesticide would not cause unreasonable adverse effects to human health or the environment, based primarily on the low toxicity/pathogenicity and exposure expected from the pesticide as described below:
                </P>
                <P>
                    1. 
                    <E T="03">FIFRA—Human Health Risk.</E>
                     The database required to support the assessment of risk to human health is complete, and the data demonstrate that Pepino mosaic virus, strain CH2, isolate 1906 is not associated with significant toxicity, irritation, pathogenicity, or other adverse effects. EPA does not expect dietary (food and drinking water) or other non-occupational risks from use of Pepino mosaic virus, strain CH2, isolate 1906 as an active ingredient in the pesticide product. No risks of concern are expected from occupational exposures when used according to label directions. Pepino mosaic virus, strain CH2, isolate 1906 is also exempt from the requirement of a tolerance in or on tomato under 40 CFR 180.1361. The pesticide is of low risk to humans 
                    <PRTPAGE P="99256"/>
                    (including pesticide handlers and people exposed post-application) due to both low toxicity/pathogenicity and exposure. No additional risk assessments are needed.
                </P>
                <P>
                    2. 
                    <E T="03">FIFRA—Ecological Risk.</E>
                     The Pepino mosaic virus, strain CH2, isolate 1906 database of studies and information required to support the ecological risk assessment is complete. Further, environmental exposure is anticipated to be very low since Pepino mosaic virus, strain CH2, isolate 1906 is for use in greenhouses only with a label requirement to disinfect greenhouse drainage water. Based on the low exposure potential, supporting data, and acceptable scientific rationale, risks of concern are not anticipated for nontarget organisms as a result of the labeled uses of the product containing Pepino mosaic virus, strain CH2, isolate 1906. The pesticide is of low risk to nontarget species due to both low toxicity and exposure. No additional risk assessments are needed.
                </P>
                <P>
                    3. 
                    <E T="03">155.46 Proposal.</E>
                     EPA has determined that the product containing Pepino mosaic virus, strain CH2, isolate 1906 satisfies the FIFRA standard for registration. The pesticide is of such low toxicity/pathogenicity, exposure, and risk that additional review would not be an effective use of Agency resources. All applicable data requirements have been satisfied. There have been no changes in use pattern, exposure, or toxicity/pathogenicity since the first product containing this pesticide was registered, nor have any new data been identified that would result in changes in the risk profile of the pesticide. In addition, no human health or environmental incidents have been reported since the registration of the first product containing the pesticide. Finally, EPA is not aware of any changes in law, regulation, or policy in relation to this pesticide that need to be considered at this time. Therefore, EPA is proposing that no further review of Pepino mosaic virus, strain CH2, isolate 1906 is necessary and registration review can be completed at this time because the pesticide continues to meet the FIFRA registration standard.
                </P>
                <P>
                    4. 
                    <E T="03">Other Actions.</E>
                </P>
                <P>
                    i. 
                    <E T="03">ESA.</E>
                     EPA is making a “No Effect” determination under the ESA for the labeled uses of Pepino mosaic virus, strain CH2, isolate 1906 based on the low toxicity/pathogenicity of and limited environmental exposure to the pesticide. The reasons for this determination are the same grounds as those described in review of the first product containing Pepino mosaic virus, strain CH2, isolate 1906 registered by EPA (see the decision document and supporting ecological risk assessment posted to docket ID number EPA-HQ-OPP-2017-0527 on 
                    <E T="03">https://www.regulations.gov</E>
                    ).
                </P>
                <P>
                    ii. 
                    <E T="03">EDSP.</E>
                     Because the available data indicate that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogen, EPA intends to seek consensus from its internal peer review process to determine whether an exemption from the requirements of the EDSP under FFDCA section 408(p)(4) is appropriate. If so, EPA will issue that exemption before or concurrent with issuing a final registration review decision for Pepino mosaic virus, strain CH2, isolate 1906.
                </P>
                <HD SOURCE="HD2">D. Sheep Fat (Case Number 6339)</HD>
                <P>
                    Sheep fat is derived from the body fat of slaughtered sheep. Due to its rancid odor and taste, this active ingredient is used to repel deer, rabbits, elk, and moose. It is applied as a spray in a variety of use sites, 
                    <E T="03">e.g.,</E>
                     agricultural areas, nurseries, forests, and commercial and residential landscapes.
                </P>
                <P>
                    EPA has determined that its previous registration decision for two products containing sheep fat does not need to be reconsidered. That decision document and supporting documents are posted to docket ID number EPA-HQ-OPP-2019-0410 on 
                    <E T="03">https://www.regulations.gov.</E>
                     As stated in that document, EPA determined that use of the pesticide would not cause unreasonable adverse effects to human health or the environment, based primarily on the low toxicity and exposure expected from the pesticide as described below:
                </P>
                <P>
                    1. 
                    <E T="03">FIFRA—Human Health Risk.</E>
                     The database of information required to support the assessment of risk to human health of sheep fat is complete. EPA does not expect dietary (food and drinking water) or other non-occupational risks from use of sheep fat as an active ingredient in pesticide products. Data demonstrated that sheep fat is of low acute toxicity through all routes of exposure, and no toxicological end points have been identified. No risks of concern are expected from occupational exposures when used according to label directions. Residues of sheep fat are exempt from the requirement of a tolerance in or on all food commodities under 40 CFR 180.950(c). The pesticide is of low risk to humans (including pesticide handlers and people exposed post-application) due to both low toxicity and exposure. No additional risk assessments are needed.
                </P>
                <P>
                    2. 
                    <E T="03">FIFRA—Ecological Risk.</E>
                     No risk concerns were identified in previous ecological assessments based primarily on the low toxicity and natural occurrence of components in sheep fat. The application methods include hand-held, knapsack, or garden sprayers with a flat fan or cone nozzle to directly treat impacted plants and therefore greatly limit the exposure of nontarget taxa to sheep fat. EPA further noted that the active ingredient has a nontoxic mode of action, its components (fatty acids) are ubiquitous in the environment, and its components have a history of exposure with no adverse effects to nontarget organisms. Risks of concern are not anticipated for nontarget organisms as a result of the labeled uses of the pesticide products containing sheep fat. The pesticide is of low risk to nontarget species due to both low toxicity and exposure. No additional risk assessments are needed.
                </P>
                <P>
                    3. 
                    <E T="03">155.46 Proposal.</E>
                     EPA has determined that the products containing sheep fat satisfy the FIFRA standard for registration. The pesticide is of such low toxicity, exposure, and risk that additional review would not be an effective use of Agency resources. All applicable data requirements have been satisfied. There have been no changes in use pattern, exposure, or toxicity since the first products containing this pesticide were registered, nor have any new data been identified that would result in changes in the risk profile of the pesticide. In addition, no human health or environmental incidents have been reported since the registration of the first products containing the pesticide. Finally, EPA is not aware of any changes in law, regulation, or policy in relation to this pesticide that need to be considered at this time. Therefore, EPA is proposing that no further review of sheep fat is necessary and registration review can be completed at this time because the pesticide continues to meet the FIFRA registration standard.
                </P>
                <P>
                    4. 
                    <E T="03">Other Actions.</E>
                </P>
                <P>
                    i. 
                    <E T="03">ESA.</E>
                     EPA is making a “No Effect” determination under the ESA for the labeled uses of sheep fat based on the low toxicity of and limited environmental exposure to the pesticide. The reasons for this determination are the same grounds as those described in review of the first products containing sheep fat registered by EPA (see the decision document and supporting ecological risk assessment posted to docket ID number EPA-HQ-OPP-2019-0410 on 
                    <E T="03">https://www.regulations.gov</E>
                    ).
                </P>
                <P>
                    ii. 
                    <E T="03">EDSP.</E>
                     Because the available data indicate that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogen, EPA intends to seek consensus from its 
                    <PRTPAGE P="99257"/>
                    internal peer review process to determine whether an exemption from the requirements of the EDSP under FFDCA section 408(p)(4) is appropriate. If so, EPA will issue that exemption before or concurrent with issuing a final registration review decision for sheep fat.
                </P>
                <HD SOURCE="HD1">V. What is EPA's authority for taking this action?</HD>
                <P>EPA is issuing these proposals pursuant to 40 CFR 155.46 to comply with its statutory mandate to periodically review all registered pesticides under section 3(g) of FIFRA. 7 U.S.C. 136a(g).</P>
                <HD SOURCE="HD1">VI. What should I consider as I prepare comment for EPA?</HD>
                <P>
                    1. 
                    <E T="03">Submitting CBI.</E>
                     Do not submit CBI to EPA through email or 
                    <E T="03">https://www.regulations.gov.</E>
                     If you wish to include CBI in your comment, please follow the applicable instructions at 
                    <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets#rules</E>
                     and clearly mark the information that you claim to be CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
                </P>
                <P>
                    2. 
                    <E T="03">Tips for Preparing Your Comments.</E>
                     When preparing and submitting your comments, see the commenting tips at: 
                    <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E>
                </P>
                <P>
                    3. 
                    <E T="03">Environmental Justice.</E>
                     EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, EPA seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.
                </P>
                <P>
                    All comments should be submitted using the method in 
                    <E T="02">ADDRESSES</E>
                     and must be received by EPA on or before the closing date. These comments will become part of the docket for the pesticides included in Table 1 in Unit II. EPA will consider all comments received by the closing date and may respond to comments in a “Response to Comments Memorandum” in the docket and/or in any subsequent final registration review decision, as appropriate.
                </P>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        7 U.S.C. 136 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Edward Messina,</NAME>
                    <TITLE>Director, Office of Pesticide Programs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28976 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">EXPORT-IMPORT BANK</AGENCY>
                <DEPDOC>[Public Notice: 2024-6125]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Comment Request; EIB 18-05, Itemized Statement of Payments Long-Term Guarantee and Direct Loan—Local Costs</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Export-Import Bank of the United States.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Submission for OMB review and comments request.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Export-Import Bank of the United States (EXIM), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments should be received on or before February 10, 2025 to be assured of consideration.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be submitted electronically on 
                        <E T="03">www.regulations.gov</E>
                         (EIB 18-02), by email to 
                        <E T="03">donna.schneider@exim.gov,</E>
                         or by mail to Donna Schneider, Export-Import Bank of the United States, 811 Vermont Ave. NW, Washington, DC 20571. The form can be viewed at: 
                        <E T="03">https://img.exim.gov/s3fs-public/pub/pending/EIB+18-05_itemized_statement_of_payments-local_cost_form_2025.xlsx.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request additional information, please contact Donna Schneider, 202-565-3612.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This form is to be completed by EXIM borrowers as required under certain EXIM long-term guarantee and direct loan transactions in conjunction with a borrower's request for disbursement for local cost goods and services. It is used to summarize disbursement documents submitted with a borrower's request and to calculate the requested financing amount. It will enable EXIM to identify the specific details of the amount of disbursement requested for approval to ensure that the financing request is complete and in compliance with EXIM's disbursement requirements. This form will be uploaded into an electronic disbursement portal.</P>
                <P>
                    <E T="03">Titles and Form Number:</E>
                     EIB 18-05, Itemized Statement of Payments Long-term Guarantee and Direct Loan—Local Costs.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     3048-0057.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Regular.
                </P>
                <P>
                    <E T="03">Need and Use:</E>
                     The information collected will assist in determining compliance of disbursement requests for local cost goods and services submitted to EXIM through an electronic disbursement portal under certain long-term guarantee and direct loan transactions.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     This form affects EXIM borrowers involved in financing local cost goods and services under certain long-term guarantee and direct loan transactions.
                </P>
                <P>
                    <E T="03">Annual Number of Respondents:</E>
                     30.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     30 minutes.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     15 hours.
                </P>
                <P>
                    <E T="03">Frequency of Reporting or Use:</E>
                     As needed.
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Andrew Smith,</NAME>
                    <TITLE>Records Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28904 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6690-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">EXPORT-IMPORT BANK</AGENCY>
                <DEPDOC>[Public Notice: 2024-6121]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Comment Request; EIB 11-05, Exporter's Certificate for Loan Guarantee &amp; MT Insurance Programs</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Export-Import Bank of the United States.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Submission for OMB review and comments request.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Export-Import Bank of the United States (EXIM), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before February 10, 2025 to be assured of consideration.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be submitted electronically on 
                        <E T="03">www.regulations.gov</E>
                         (EIB 11-05), by email to Donna Schneider, 
                        <E T="03">donna.schneider@exim.gov,</E>
                         or by mail to Donna Schneider, Export-Import Bank, 811 Vermont Ave. NW, Washington, DC 20571. The information 
                        <PRTPAGE P="99258"/>
                        collection tool can be reviewed at: 
                        <E T="03">https://img.exim.gov/s3fs-public/pub/pending/EIB 11-05 Exporter's+Certificate+November+ 2024.pdf.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request additional information, please contact Donna Schneider, 
                        <E T="03">donna.schneider@exim.gov,</E>
                         202-565-3612.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>EXIM's borrowers, financial institution policy holders and guaranteed lenders provide this form to U.S. exporters, who certify to the eligibility of their exports for EXIM support. For direct loans and loan guarantees, the completed form is required to be submitted at time of disbursement and held by either the guaranteed lender or EXIM. For MT insurance, the completed forms are held by the financial institution, only to be submitted to EXIM in the event of a claim filing. EXIM uses the referenced form to obtain information from exporters regarding the export transaction and content sourcing. These details are necessary to determine the value and legitimacy of EXIM financing support and claims submitted. It also provides the financial institutions a check on the export transaction's eligibility at the time it is fulfilling a financing request.</P>
                <P>
                    <E T="03">Title and Form Number:</E>
                     EIB 11-05, Exporter's Certificate for Loan Guarantee &amp; MT Insurance Programs.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     3048-0043.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Regular.
                </P>
                <P>
                    <E T="03">Need and Use:</E>
                     The information collected will allow EXIM to determine compliance and content for transaction requests submitted to the Export-Import Bank under its insurance, guarantee, and direct loan programs.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     This form affects entities involved in the export of U.S. goods and services.
                </P>
                <P>
                    <E T="03">Annual Number of Respondents:</E>
                     1,500.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     30 minutes.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     750 hours.
                </P>
                <P>
                    <E T="03">Frequency of Reporting of Use:</E>
                     As required.
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Andrew Smith,</NAME>
                    <TITLE>Records Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28915 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6690-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">EXPORT-IMPORT BANK</AGENCY>
                <DEPDOC>[Public Notice: 2024-6123]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Comment Request; EIB 18-03, Itemized Statement of Payments—Local Costs for EXIM Credit Guarantee Facility</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Export-Import Bank of the United States.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Submission for OMB review and comments request.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Export-Import Bank of the United States (EXIM), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments should be received on or before February 10, 2025 to be assured of consideration.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be submitted electronically on 
                        <E T="03">www.regulations.gov</E>
                         (EIB 18-02), by email to 
                        <E T="03">donna.schneider@exim.gov,</E>
                         or by mail to Donna Schneider, Export-Import Bank of the United States, 811 Vermont Ave. NW, Washington, DC 20571. The form can be viewed at: 
                        <E T="03">https://img.exim.gov/s3fs-public/pub/pending/EIB18-03_itemized_statement_of_payments-local_costs_for_exim_cgf_2025.xlsx.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request additional information, please contact Donna Schneider, 202-565-3612.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This form is to be completed by EXIM borrowers as required under EXIM Credit Guarantee Facility (CGF) transactions in conjunction with a borrower's request for disbursement for local cost goods and services. It is used to summarize disbursement documents submitted with a borrower's request and to calculate the requested financing amount. It will enable EXIM lenders to identify the specific details of the amount of disbursement requested for approval to ensure that the financing request is complete and in compliance with EXIM's disbursement requirements.</P>
                <P>
                    <E T="03">Titles and Form Number:</E>
                     EIB 18-03 Itemized Statement of Payments—Local Costs for EXIM Credit Guarantee Facility.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     3048-0055.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Regular.
                </P>
                <P>
                    <E T="03">Need and Use:</E>
                     The information collected will assist in determining compliance of disbursement requests for local cost goods and services submitted to EXIM lenders under CGF transactions.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     This form affects EXIM borrowers involved in financing local cost goods and services under CGF transactions.
                </P>
                <P>
                    <E T="03">Annual Number of Respondents:</E>
                     12.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     30 minutes.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     6 hours.
                </P>
                <P>
                    <E T="03">Frequency of Reporting or Use:</E>
                     As needed.
                </P>
                <P>This form is submitted by the borrower to the CGF lender for review. The lender reports information regarding the disbursement electronically to EXIM using OMB Number 3048-0046 CGF (EIB 12-02) Disbursement Approval Request Report.</P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Andrew Smith,</NAME>
                    <TITLE>Records Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28906 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6690-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">EXPORT-IMPORT BANK</AGENCY>
                <DEPDOC>[Public Notice: 2024-6124]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Comment Request; EIB 18-04, Itemized Statement of Payments—Long-Term Guarantees and Direct Loans—U.S. Costs</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Export-Import Bank of the United States.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Submission for OMB review and comments request.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Export-Import Bank of the United States (EXIM), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments should be received on or before February 10, 2025 to be assured of consideration.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be submitted electronically on 
                        <E T="03">www.regulations.gov</E>
                         (EIB 18-02), by email to 
                        <E T="03">donna.schneider@exim.gov,</E>
                         or by mail to Donna Schneider, Export-Import Bank of the United States, 811 Vermont Ave. NW, Washington, DC 20571. The form can be viewed at: 
                        <E T="03">https://img.exim.gov/s3fs-public/pub/pending/EIB+18-04_itemized_statement_of_payments-us_costs_form_2025.xlsx.</E>
                    </P>
                </ADD>
                <FURINF>
                    <PRTPAGE P="99259"/>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request additional information, please contact Donna Schneider at 202-565-3612.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This form is to be completed by EXIM borrowers as required under certain EXIM long-term guarantee and direct loan transactions in conjunction with a borrower's request for disbursement for U.S. goods and services. It is used to summarize disbursement documents submitted with a borrower's request and to calculate the requested financing amount. It will enable EXIM to identify the specific details of the amount of disbursement requested for approval to ensure that the financing request is complete and in compliance with EXIM's disbursement requirements. This form will be uploaded into an electronic disbursement portal.</P>
                <P>
                    <E T="03">Titles and Form Number:</E>
                     EIB 18-04, Itemized Statement of Payments—Long-term Guarantees and Direct Loans—US Costs.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     3048-0056.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Regular.
                </P>
                <P>
                    <E T="03">Need and Use:</E>
                     The information collected will assist in determining compliance of disbursement requests for U.S. goods and services submitted to EXIM through an electronic disbursement portal under certain long-term guarantee and direct loan transactions.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     This form affects EXIM borrowers involved in financing U.S. goods and services under certain long-term guarantee and direct loan transactions.
                </P>
                <P>
                    <E T="03">Annual Number of Respondents:</E>
                     150.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     90 minutes.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     225 hours.
                </P>
                <P>
                    <E T="03">Frequency of Reporting or Use:</E>
                     As needed.
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <TITLE>Andrew Smith,</TITLE>
                    <NAME>Records Officer.</NAME>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28905 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6690-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">EXPORT-IMPORT BANK</AGENCY>
                <DEPDOC>[Public Notice: 2024-6128]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Comment Request; EIB18-01, Multi-Buyer Select Risk Policy (MBSR) Exclusions Worksheet</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Export-Import Bank of the United States.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Submission for OMB review and comments request.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Export-Import Bank of the United States (EXIM), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments should be received on or before February 10, 2025 to be assured of consideration.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be submitted electronically on 
                        <E T="03">www.regulations.gov</E>
                         (EIB 18-01), by email to Cristina Conti 
                        <E T="03">cristina.conti@exim.gov,</E>
                         or by mail to Cristina Conti, Export-Import Bank of the United States, 811 Vermont Ave. NW, Washington, DC 20571.
                    </P>
                    <P>
                        The form can be viewed at: 
                        <E T="03">https://img.exim.gov/s3fs-public/pub/pending/eib18-01_2025+MBSR_Exclusions_Worksheet_OMB+No._3048-0053_508.pdf.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request additional information, please contact Cristina Conti 
                        <E T="03">cristina.conti@exim.gov,</E>
                         202-565-3804.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Titles and Form Number:</E>
                     EIB18-01, Multi-Buyer Select Risk Policy (MBSR) Exclusions Worksheet.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     3048-0053.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Regular.
                </P>
                <P>
                    <E T="03">Need and Use:</E>
                     The Multi-Buyer Select Risk Policy (MBSR) Exclusions Worksheet will be used by external customers, current policyholders and portfolio managers to determine eligibility of Export-Import Bank support under the MBSR Policy. Program changes that were made in 2017 have resulted in revitalized demand of the MBSR product in the marketplace. This form will be available on EXIM's website and will standardize the collection of required information into a user-friendly format that can be submitted electronically via email or as an attachment to an EXIM Online application.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     This form affects entities involved in the export of U.S. goods and services.
                </P>
                <P>
                    <E T="03">Annual Number of Respondents:</E>
                     60.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     15 minutes.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     15 hours.
                </P>
                <P>
                    <E T="03">Frequency of Reporting or Use:</E>
                     As needed.
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Andrew Smith,</NAME>
                    <TITLE>Records Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28902 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6690-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">EXPORT-IMPORT BANK</AGENCY>
                <DEPDOC>[Public Notice: 2023-6126]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Comment Request; EIB 21-02, Co-Financing Certificate</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Export-Import Bank of the United States.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Submission for OMB review and comments request.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Export-Import Bank of the United States (EXIM), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before February 10, 2025 to be assured of consideration.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        <E T="01">Comments may be submitted electronically on</E>
                          
                        <E T="03">www.regulations.gov</E>
                         (EIB 21-02), by email to Donna Schneider, 
                        <E T="03">donna.schneider@exim.gov,</E>
                         or by mail to Donna Schneider, Export-Import Bank, 811 Vermont Ave. NW, Washington, DC 20571. The information collection tool can be reviewed at: 
                        <E T="03">https://img.exim.gov/s3fs-public/pub/pending/EIB+21-02+Co-financing+Certificate+(EXIM+follow)+November+2024.pdf.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request additional information, please contact Donna Schneider, 
                        <E T="03">donna.schneider@exim.gov,</E>
                         202-565-3612.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    EXIM's borrowers, financial institution policy holders and guaranteed lenders provide this form to U.S. exporters, who certify to the eligibility of their exports for EXIM support. For direct loans and loan guarantees, the completed form is required to be submitted at time of disbursement and held by either the guaranteed lender or EXIM. For MT insurance, the completed forms are held by the financial institution, only to be submitted to EXIM in the event of a claim filing. EXIM uses the referenced form to obtain information from exporters regarding the export transaction and content sourcing. These details are necessary to determine the value and legitimacy of EXIM financing support and claims submitted. It also provides the financial institutions a check on the export transaction's 
                    <PRTPAGE P="99260"/>
                    eligibility at the time it is fulfilling a financing request.
                </P>
                <P>
                    <E T="03">Title and Form Number:</E>
                     EIB 21-02, Co-financing Certificate.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     3048-0059.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Regular.
                </P>
                <P>
                    <E T="03">Need and Use:</E>
                     The information collected will allow EXIM to determine compliance and content for transaction requests submitted to the Export-Import Bank under its insurance, guarantee, and direct loan programs.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     This form affects entities involved in the export of U.S. goods and services.
                </P>
                <P>
                    <E T="03">Annual Number of Respondents:</E>
                     25.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     30 minutes.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     12.5 hours.
                </P>
                <P>
                    <E T="03">Frequency of Reporting of Use:</E>
                     As required.
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Andrew Smith,</NAME>
                    <TITLE>Records Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28903 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6690-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">EXPORT-IMPORT BANK</AGENCY>
                <DEPDOC>[Public Notice: 2024-6122]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Comment Request; EIB 18-02, Itemized Statement of Payments—U.S. Costs for EXIM Credit Guarantee Facility</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Export-Import Bank of the United States.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Submission for OMB review and comments request.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Export-Import Bank of the United States (EXIM), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments should be received on or before February 10, 2025 to be assured of consideration.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be submitted electronically on 
                        <E T="03">www.regulations.gov</E>
                         (EIB 18-02) or by email to 
                        <E T="03">donna.schneider@exim.gov</E>
                        , or by mail to Donna Schneider, Export-Import Bank of the United States, 811 Vermont Ave. NW, Washington, DC 20571. The form can be viewed at: 
                        <E T="03">https://img.exim.gov/s3fs-public/pub/pending/EIB+18-02_itemized_statement_of_payments-us_costs_for_exim_cgf_2025.xlsx.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request additional information, please contact Donna Schneider, 202-565-3612.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This form is to be completed by EXIM borrowers as required under EXIM Credit Guarantee Facility (CGF) transactions in conjunction with a borrower's request for disbursement for U.S. goods and services. It is used to summarize disbursement documents submitted with a borrower's request and to calculate the requested financing amount. It will enable EXIM lenders to identify the specific details of the amount of disbursement requested for approval to ensure that the financing request is complete and in compliance with EXIM's disbursement requirements.</P>
                <P>
                    <E T="03">Titles and Form Number:</E>
                     EIB 18-02, Itemized Statement of Payments—US Costs for EXIM Credit Guarantee Facility.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     3048-0054.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Regular.
                </P>
                <P>
                    <E T="03">Need and Use:</E>
                     The information collected will assist in determining compliance of disbursement requests for U.S. goods and services submitted to EXIM lenders under CGF transactions.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     This form affects EXIM borrowers involved in financing U.S. goods and services under CGF transactions. This form is submitted by the borrower to the CGF lender for review. The lender reports information regarding the disbursement electronically to EXIM using OMB Number 3048-0046 CGF (EIB 12-02) Disbursement Approval Request Report.
                </P>
                <P>
                    <E T="03">Annual Number of Respondents:</E>
                     12.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     30 minutes.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     6 hours.
                </P>
                <P>
                    <E T="03">Frequency of Reporting or Use:</E>
                     As needed.
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Andrew Smith,</NAME>
                    <TITLE>Records Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28907 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6690-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL FINANCIAL INSTITUTIONS EXAMINATION COUNCIL</AGENCY>
                <DEPDOC>[Docket No. AS24-23]</DEPDOC>
                <SUBJECT>Appraisal Subcommittee; Notice of Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Appraisal Subcommittee of the Federal Financial Institutions Examination Council.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of special closed meeting.</P>
                </ACT>
                <P>
                    <E T="03">Description:</E>
                     In accordance with section 1104(b) of title XI of the Financial Institutions Reform, Recovery, and Enforcement Act of 1989, codified at 12 U.S.C. 3333(b), notice is hereby given that the Appraisal Subcommittee (ASC) met for a Special Closed Meeting on this date.
                </P>
                <P>
                    <E T="03">Location:</E>
                     Virtual meeting via Teams.
                </P>
                <P>
                    <E T="03">Date:</E>
                     October 23, 2024.
                </P>
                <P>
                    <E T="03">Time:</E>
                     10:31 a.m. ET.
                </P>
                <HD SOURCE="HD1">Discussion Item</HD>
                <HD SOURCE="HD2">Personnel Matter</HD>
                <P>The ASC convened a Special Closed Meeting to discuss a personnel matter pursuant to section 1104(b) of title XI (12 U.S.C. 3333(b)). No action was taken by the ASC.</P>
                <SIG>
                    <NAME>Loretta Schuster,</NAME>
                    <TITLE>Management &amp; Program Analyst.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28916 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6700-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL FINANCIAL INSTITUTIONS EXAMINATION COUNCIL</AGENCY>
                <DEPDOC>[Docket No. AS24-24]</DEPDOC>
                <SUBJECT>Appraisal Subcommittee; Notice of Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Appraisal Subcommittee of the Federal Financial Institutions Examination Council.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of special closed meeting.</P>
                </ACT>
                <P>
                    <E T="03">Description:</E>
                     In accordance with section 1104(b) of title XI of the Financial Institutions Reform, Recovery, and Enforcement Act of 1989, codified at 12 U.S.C. 3333(b), notice is hereby given that the Appraisal Subcommittee (ASC) met for a Special Closed Meeting on this date.
                </P>
                <P>
                    <E T="03">Location:</E>
                     Virtual meeting via Teams.
                </P>
                <P>
                    <E T="03">Date:</E>
                     October 28, 2024.
                </P>
                <P>
                    <E T="03">Time:</E>
                     2:01 p.m. ET.
                </P>
                <HD SOURCE="HD1">Discussion Item</HD>
                <HD SOURCE="HD2">Personnel Matter</HD>
                <P>The ASC convened a Special Closed Meeting to discuss a personnel matter pursuant to section 1104(b) of title XI (12 U.S.C. 3333(b)). No action was taken by the ASC.</P>
                <SIG>
                    <NAME>Loretta Schuster,</NAME>
                    <TITLE>Management &amp; Program Analyst.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28917 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6700-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="99261"/>
                <AGENCY TYPE="S">FEDERAL FINANCIAL INSTITUTIONS EXAMINATION COUNCIL</AGENCY>
                <DEPDOC>[Docket No. AS24-28]</DEPDOC>
                <SUBJECT>Appraisal Subcommittee; Notice of Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Appraisal Subcommittee of the Federal Financial Institutions Examination Council.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of special closed meeting.</P>
                </ACT>
                <P>
                    <E T="03">Description:</E>
                     In accordance with section 1104(b) of title XI of the Financial Institutions Reform, Recovery, and Enforcement Act of 1989, codified at 12 U.S.C. 3333(b), notice is hereby given that the Appraisal Subcommittee (ASC) met for a Special Closed Meeting on this date.
                </P>
                <P>
                    <E T="03">Location:</E>
                     Virtual meeting via Teams.
                </P>
                <P>
                    <E T="03">Date:</E>
                     November 13, 2024.
                </P>
                <P>
                    <E T="03">Time:</E>
                     11:54 a.m. ET.
                </P>
                <HD SOURCE="HD1">Discussion Item</HD>
                <HD SOURCE="HD2">Personnel Matter</HD>
                <P>The ASC convened a Special Closed Meeting to discuss a personnel matter pursuant to section 1104(b) of title XI (12 U.S.C. 3333(b)). No action was taken by the ASC.</P>
                <SIG>
                    <NAME>Loretta Schuster,</NAME>
                    <TITLE>Management &amp; Program Analyst.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28909 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6700-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL FINANCIAL INSTITUTIONS EXAMINATION COUNCIL</AGENCY>
                <DEPDOC>[Docket No. AS24-25]</DEPDOC>
                <SUBJECT>Appraisal Subcommittee; Notice of Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Appraisal Subcommittee of the Federal Financial Institutions Examination Council.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of special meeting.</P>
                </ACT>
                <P>
                    <E T="03">Description:</E>
                     In accordance with section 1104(b) of title XI of the Financial Institutions Reform, Recovery, and Enforcement Act of 1989, codified at 12 U.S.C. 3333(b), notice is hereby given that the Appraisal Subcommittee (ASC) met for a Special Meeting on this date.
                </P>
                <P>
                    <E T="03">Location:</E>
                     Virtual meeting via Teams.
                </P>
                <P>
                    <E T="03">Date:</E>
                     October 28, 2024.
                </P>
                <P>
                    <E T="03">Time:</E>
                     2:20 p.m. ET.
                </P>
                <HD SOURCE="HD1">Action and Discussion Item</HD>
                <HD SOURCE="HD2">Personnel Matter</HD>
                <P>The ASC convened a Special Meeting to discuss and take a vote on a personnel matter.</P>
                <SIG>
                    <NAME>Loretta Schuster,</NAME>
                    <TITLE>Management &amp; Program Analyst.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28912 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6700-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL FINANCIAL INSTITUTIONS EXAMINATION COUNCIL</AGENCY>
                <DEPDOC>[Docket No. AS24-27]</DEPDOC>
                <SUBJECT>Appraisal Subcommittee; Notice of Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Appraisal Subcommittee of the Federal Financial Institutions Examination Council.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of special meeting.</P>
                </ACT>
                <P>
                    <E T="03">Description:</E>
                     In accordance with section 1104(b) of title XI of the Financial Institutions Reform, Recovery, and Enforcement Act of 1989, codified at 12 U.S.C. 3333(b), notice is hereby given that the Appraisal Subcommittee (ASC) met for a Special Meeting on this date.
                </P>
                <P>
                    <E T="03">Location:</E>
                     Virtual meeting via Teams.
                </P>
                <P>
                    <E T="03">Date:</E>
                     November 13, 2024.
                </P>
                <P>
                    <E T="03">Time:</E>
                     11:50 a.m. ET.
                </P>
                <HD SOURCE="HD1">Action and Discussion Item</HD>
                <HD SOURCE="HD2">Personnel Matter</HD>
                <P>The ASC convened a Special Meeting to discuss and take a vote on a personnel matter.</P>
                <SIG>
                    <NAME>Loretta Schuster,</NAME>
                    <TITLE>Management &amp; Program Analyst.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28908 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6700-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL FINANCIAL INSTITUTIONS EXAMINATION COUNCIL</AGENCY>
                <DEPDOC>[Docket No. AS24-26]</DEPDOC>
                <SUBJECT>Appraisal Subcommittee; Notice of Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Appraisal Subcommittee of the Federal Financial Institutions Examination Council.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of special closed meeting.</P>
                </ACT>
                <P>
                    <E T="03">Description:</E>
                     In accordance with section 1104(b) of title XI of the Financial Institutions Reform, Recovery, and Enforcement Act of 1989, codified at 12 U.S.C. 3333(b), notice is hereby given that the Appraisal Subcommittee (ASC) met for a Special Closed Meeting on this date.
                </P>
                <P>
                    <E T="03">Location:</E>
                     Virtual meeting via Teams.
                </P>
                <P>
                    <E T="03">Date:</E>
                     November 13, 2024.
                </P>
                <P>
                    <E T="03">Time:</E>
                     11:30 a.m. ET.
                </P>
                <HD SOURCE="HD1">Discussion Item</HD>
                <HD SOURCE="HD2">Personnel Matter</HD>
                <P>The ASC convened a Special Closed Meeting to discuss a personnel matter pursuant to section 1104(b) of title XI (12 U.S.C. 3333(b)). No action was taken by the ASC.</P>
                <SIG>
                    <NAME>Loretta Schuster,</NAME>
                    <TITLE>Management &amp; Program Analyst.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28913 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6700-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL MARITIME COMMISSION</AGENCY>
                <DEPDOC>[FMC 2024-0008]</DEPDOC>
                <SUBJECT>Closure of Investigation Into Conditions Affecting United States Carriers in Connection With Canadian Ballast Water Regulation in the United States/Canada Great Lakes Trade</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Maritime Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of closure of investigation.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Maritime Commission (Commission) has closed its investigation, initiated pursuant to chapter 423, into conditions created by the Government of Canada (Canada) in connection with regulation of ballast water management systems that may adversely affect the operation of United States carriers in the United States/Canada Great Lakes trade. Although sufficient short-term improvements have been made to the conditions under review, the Commission's parallel long-term investigation of those conditions pursuant to chapter 421 will remain open.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For questions regarding this Notice, contact David Eng, Secretary; Phone: (202) 523-5725; Email: 
                        <E T="03">Secretary@fmc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>
                    On May 22, 2024, the Federal Maritime Commission (Commission) initiated an investigation, pursuant to 46 U.S.C. 42302, of whether conditions created by the Government of Canada (Canada) in connection with regulation of ballast water management systems adversely affected the operation of United States carriers in the United States/Canada Great Lakes trade, in particular the carriers operating vessels that were to become subject to regulation in September 2024, within the meaning of 46 U.S.C. chapter 423 
                    <PRTPAGE P="99262"/>
                    (Foreign Shipping Practices) (46 U.S.C. 42301-42307). With respect to those vessels, Canada has now granted exemptions from the regulation, or issued determinations that exemptions were not needed. As a result, the Commission has determined to close this investigation but to keep open its parallel investigation pursuant to 46 U.S.C. chapter 421 (Regulations Affecting Shipping in Foreign Trade) (46 U.S.C. 42101-42109) in order to address potential longer-term issues involving Canadian ballast water management regulation.
                </P>
                <HD SOURCE="HD1">II. Summary of Status of Investigation</HD>
                <P>
                    In 2020, the Commission opened an investigation under 46 U.S.C. chapter 421 following a petition by the Lake Carriers Association (LCA). 
                    <E T="03">See</E>
                     FMC Docket No. 20-10. That petition alleged that Canadian regulation set to take effect in September 2024 would create conditions unfavorable to shipping by requiring U.S. vessels to install new ballast water management systems. It became apparent that only a small group of U.S. Lakers built after 2008 would be affected by the Canadian regulation in 2024, with about 50 older Lakers not subject to it until 2030. 
                    <E T="03">See</E>
                     Investigation into Conditions Affecting United States Carriers in Connection with Canadian Ballast Water Regulation in the United States/Canada Great Lakes Trade, FMC-2024-0008, 89 FR 44979 (May 22, 2024) (May 2024 Notice of Investigation).
                </P>
                <P>
                    It also became apparent that the U.S. Environmental Protection Agency (EPA), in its rulemaking to implement the Vessel Incidental Discharge Act (VIDA), would likely issue rules as to ballast water management equipment that would be less restrictive than those of Canada. 
                    <E T="03">See</E>
                     May 2024 Notice of Investigation, 89 FR 44979. In October 2024, the EPA did issue such rules. Vessel Incidental Discharge National Standards of Performance, 89 FR 82074, 82094-82095 (Oct. 9, 2024).
                </P>
                <P>
                    Meanwhile, in May 2024 the Commission on its own motion initiated a chapter 423 investigation into whether Canadian ballast water management regulation in the Great Lakes adversely affected the operation of United States carriers in violation of 46 U.S.C. 42302(a). 
                    <E T="03">See</E>
                     May 2024 Notice of Investigation, 89 FR 44979. Under the 120-day time limit set by 46 U.S.C. 42302(c), the initial deadline for the Commission to complete the chapter 423 investigation was in September 2024.
                </P>
                <P>In response to the May 2024 Notice of Investigation, the Commission received 14 comments. The Canadian government and those representing the interests of Canadian carriers, as well as those representing environmental interests, opposed the potential imposition of sanctions. On the other hand, those representing the interests of U.S. carriers and workers were supportive of such measures.</P>
                <P>
                    In late July 2024 Transport Canada, the responsible Canadian agency, made available to U.S. carriers a procedure for seeking exemptions to the relevant ballast water management requirements, although the Commission understands that a comparable process had been available to Canadian carriers much earlier. 
                    <E T="03">See</E>
                     Procedure to request an exemption to install Ballast Water Management Systems under Ballast Water Regulations for foreign-flagged vessels in Canadian waters, Transport Canada (July 25, 2024) (Exemption Procedure), available at 
                    <E T="03">https://tc.canada.ca/en/marine-transportation/marine-safety-management-system-tp-13585-e-tier-ii-procedures/tier-ii-procedure-request-exemption-install-ballast-water-management-systems-under-ballast-water-regulations-foreign-flagged-vessels-canadian-waters.</E>
                     At the time this detailed exemption procedure for U.S. carriers was established, there was relatively little time to complete the application process before the relevant compliance date of the Canadian rule, which was September 8, 2024.
                </P>
                <P>
                    Accordingly, also in September 2024, the Commission extended the time for decision in its chapter 423 investigation by 90 days, to December 18, 2024. Extension of Time for Decision in Investigation Into Conditions Affecting United States Carriers in Connection With Canadian Ballast Water Regulation in the United States/Canada Great Lakes Trade, 89 FR 74273 (Sept. 12, 2024) (September 2024 Notice). At the same time, the Commission established a new comment period to gather more information on the apparent disparity between the exemption processes available to U.S. and Canadian carriers, and on whether those processes may have themselves led to adverse conditions in violation of 46 U.S.C. 42302(a). 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In response to the September 2024 Notice, the Commission received comments from six entities. 
                    <E T="03">See</E>
                     Comments, Investigation Into Conditions Affecting United States Carriers in Connection With Canadian Ballast Water Regulation in the United States/Canada Great Lakes Trade, Docket No. FMC-2024-0008, available at 
                    <E T="03">https://www.regulations.gov/document/FMC-2024-0008-0018/comment.</E>
                     Comments from those representing the interests of U.S. entities argued that the Canadian exemption processes did create disparate effects, particularly in that the U.S. process was not available until late July 2024, shortly before the early September compliance date. There were also statements that the process for U.S. Lakers was more complex and time-consuming. But Canada and those representing Canadian carriers argued that there was no unlawful disparity. Canada asserted generally that there had been no differential treatment with regard to exemptions, although it did not specifically dispute the difference in the application availability dates.
                </P>
                <P>Information received to date indicates that the Canadian regulation at issue in this chapter 423 investigation may create conditions that adversely affect the operation of the U.S. Lakers, in a way that Canadian carriers do not face under current U.S. law, within the meaning of 46 U.S.C. 42302(a). First, such adverse conditions may exist as a result of the substantive Canadian regulation involved here. There appears to be no dispute that the EPA does not currently require, at least as part of its VIDA implementation, that U.S. Lakers meet the same ballast water management equipment standards as Canada does, although Canada and some other commenters have argued that the U.S. has imposed comparably burdensome ballast water regulation on Canadian carriers through other rules. Second, it may be that the procedures for exemptions from Canada's rule have themselves created such disparate conditions, most notably in the failure until late July 2024 to establish a detailed process for U.S. Lakers that is arguably comparable to the one available to Canadian carriers. That delay appears to have prevented the completion of the process by the early September 2024 compliance date for post-2008 Lakers.</P>
                <P>
                    However, due in part to the statutorily imposed deadline of December 18, 2024, the Commission will not, at this time, make an affirmative determination as to disparate treatment under 46 U.S.C. 42302(a). The immediate concerns that prompted this investigation have been temporarily resolved. Information received indicates that Canada has granted exemptions for certain U.S. vessels affected in September 2024, and has determined that the other affected vessels would not be subject to the rule in 2024. In its most recent comments, Canada stated that three of the six exemption requests by U.S. carriers were granted on October 14, 2024, and that the other three vessels “will be informed that they do not require an exemption based on the regulations.” 
                    <PRTPAGE P="99263"/>
                    Comments of Canada (Oct. 15, 2024) at 2. The LCA, in a public submission, provided an email attaching a chain of recent communications with Transport Canada. That email chain confirms that three of the six U.S. vessels had been granted exemptions and that two of the remaining vessels had been determined not to need an exemption. 
                    <E T="03">See</E>
                     LCA Submission (Oct. 28, 2024) at 2-6. The LCA's late October submission indicated that the sixth vessel had not yet received a final determination, but the Commission understands that that vessel received an exemption in early November 2024. However, the exemptions are only temporary in nature, so the vessels will be in a similar precarious operating position when the exemptions expire.
                </P>
                <P>The Commission notes that the exemption process, due both to the lateness of its availability and the seeming onerousness of its process, may have imposed negative effects on certain U.S. carriers. Accordingly, there are ongoing concerns with respect to specific elements of the above exemption determinations. Those issues will be pursued in the agency's longer-term chapter 421 investigation, which remains open. The Commission will continue to investigate these concerns and strongly encourages affected entities or anyone with relevant information to participate in the ongoing chapter 421 proceeding.</P>
                <HD SOURCE="HD1">III. Closure of Investigation</HD>
                <P>For the above reasons, the Commission has closed its Investigation into Conditions Affecting United States Carriers in Connection with Canadian Ballast Water Regulation in the United States/Canada Great Lakes Trade, FMC-2024-0008, 89 FR 44979 (opened May 22, 2024).</P>
                <SIG>
                    <P>By the Commission.</P>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>David Eng,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28996 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6730-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL RESERVE SYSTEM</AGENCY>
                <SUBJECT>Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company</SUBJECT>
                <P>The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).</P>
                <P>
                    The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at 
                    <E T="03">https://www.federalreserve.gov/foia/request.htm.</E>
                     Interested persons may express their views in writing on the standards enumerated in paragraph 7 of the Act.
                </P>
                <P>Comments received are subject to public disclosure. In general, comments received will be made available without change and will not be modified to remove personal or business information including confidential, contact, or other identifying information. Comments should not include any information such as confidential information that would not be appropriate for public disclosure.</P>
                <P>Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue, NW, Washington DC 20551-0001, not later than December 26, 2024.</P>
                <P>
                    <E T="03">A. Federal Reserve Bank of Atlanta</E>
                     (Erien O. Terry, Assistant Vice President) 1000 Peachtree Street NE, Atlanta, Georgia 30309. Comments can also be sent electronically to 
                    <E T="03">Applications.Comments@atl.frb.org:</E>
                </P>
                <P>
                    1. 
                    <E T="03">Oliver Beaman Triplett, IV, George Beaman Triplett, Olivia Triplett Harrell, and the Bank of Forest Employee Stock Ownership Trust, all of Forest, Mississippi;</E>
                     as a group acting in concert, to retain voting shares of First Forest Corporation, and thereby indirectly retain voting shares of Bank of Forest, both of Forest, Mississippi.
                </P>
                <SIG>
                    <P>Board of Governors of the Federal Reserve System.</P>
                    <NAME>Benjamin McDonough, </NAME>
                    <TITLE>Deputy Secretary of the Board.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28992 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL RESERVE SYSTEM</AGENCY>
                <SUBJECT>Privacy Act of 1974; System of Records</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Board of Governors of the Federal Reserve System.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of a modified system of records.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Pursuant to the provisions of the Privacy Act of 1974, notice is given that the Board of Governors of the Federal Reserve System (Board) proposes to modify an existing system of records entitled BGFRS-25, “FRB—Multi-Rater Feedback Records.” The modified system of records, which will now be called “FRB—360 Assessment Records,” includes 360 Assessment questionnaires completed by the employee being evaluated and his or her evaluators, analyses of the questionnaires, and associated feedback reports.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before January 9, 2025. This modified system of records will become effective January 9, 2025, without further notice, unless comments dictate otherwise.</P>
                    <P>
                        The Office of Management and Budget (OMB), which has oversight responsibility under the Privacy Act, requires a 30-day period prior to publication in the 
                        <E T="04">Federal Register</E>
                         in which to review the system and to provide any comments to the agency. The public is then given a 30-day period in which to comment, in accordance with 5 U.S.C. 552a(e)(4) and (11).
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments, identified by 
                        <E T="03">BGFRS-25 “FRB—360 Assessment Records,”</E>
                         by any of the following methods:
                    </P>
                    <P>
                        • 
                        <E T="03">Agency Website: https://www.federalreserve.gov.</E>
                         Follow the instructions for submitting comments at 
                        <E T="03">https://www.federalreserve.gov/apps/foia/proposedregs.aspx.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Email: regs.comments@federalreserve.gov.</E>
                         Include SORN name and number in the subject line of the message.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202) 452-3819 or (202) 452-3102.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Ann E. Misback, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.
                    </P>
                    <P>
                        In general, all public comments will be made available on the Board's website at 
                        <E T="03">https://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm</E>
                         as submitted, and will not be modified to remove confidential, contact or any identifiable information. Public comments may also be viewed electronically or in paper in Room M-4365A, 2001 C St. NW, Washington, DC 20551, between 9:00 a.m. and 5:00 p.m. during federal business weekdays.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Alye Foster, Associate General Counsel, (202) 
                        <PRTPAGE P="99264"/>
                        452-5289, or 
                        <E T="03">alye.s.foster@frb.gov;</E>
                         Legal Division, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551. For users of telephone systems via text telephone (TTY) or any TTY-based Telecommunications Relay Services, please call 711 from any telephone anywhere in the United States.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Board proposes to modify BGFRS-25 to reflect a change in the system name, changes to the contractors selected to conduct 360 Assessments, and to update the record schedule. The Board is modifying this system of records to reflect a change in the system name from BGFRS-25, “FRB—Multi-Rater Feedback Records” to “FRB—360 Assessment Records,” to better reflect the records contained in the system. The Board has also changed the contractors the Board has selected to conduct 360 Assessments and is updating the system accordingly. In addition, the Board is updating the record retention schedule that applies to the records. Rather than retaining the records for four years, the Board will now retain records until the record is superseded, one year after the evaluated employee separates from employment, or three years—whichever occurs first. To reflect these changes, the Board is updating the system name, system location, the practices for retrieval, and the practices for retention and disposal. In addition, the Board is also updating the system manager information, adding a link to the Board's general routine uses and updating the administrative, technical, and physical safeguards. The Board is not amending or establishing any new routine uses.</P>
                <P>The Board is also making technical changes to BGFRS-25 consistent with the template laid out in OMB Circular No. A-108. Accordingly, the Board has made technical corrections and non-substantive language revisions to the following categories: “Policies and Practices for Storage of Records,” “Policies and Practices for Retrieval of Records,” “Policies and Practices for Retention and Disposal of Records,” “Administrative, Technical and Physical Safeguards,” “Record Access Procedures,” “Contesting Record Procedures,” and “Notification Procedures.” The Board has also created the following new fields: “Security Classification” and “History.”</P>
                <PRIACT>
                    <HD SOURCE="HD2">SYSTEM NAME AND NUMBER:</HD>
                    <P>BGFRS-25 “FRB—360 Assessment Records.”</P>
                    <HD SOURCE="HD2">SECURITY CLASSIFICATION:</HD>
                    <P>Unclassified.</P>
                    <HD SOURCE="HD2">SYSTEM LOCATION:</HD>
                    <P>Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551. The completed 360 Assessment questionnaires and the resulting feedback reports are collected and maintained, on behalf of the Board, by contractors. Based on the information provided by the completed questionnaires, the contractors provide an individual feedback report to the individual under evaluation. With the exception of the feedback report provided to the individual under evaluation, no individually identifiable information is maintained on the Board's premises. The names and addresses of the contractors engaged to design, facilitate, and report the results of the 360 Assessment process at the Board within the past three years are as follows:</P>
                    <P>BlessingWhite, 11000 Broken Land Parkway, Suite 200, Columbia, MD 20144;</P>
                    <P>Center for Creative Leadership, 1 Leadership Place, Greensboro, NC 27410;</P>
                    <P>ChangeFusion, LLC, 6402 Arlington Blvd., Falls Church, VA 22042;</P>
                    <P>Communications Training Analysis Corp., 3120 Fairview Park Drive, Suite 600, Falls Church, VA 22041;</P>
                    <P>Information PathWaves, Inc., 18 Torrance Court, Kensington, MD 20895;</P>
                    <P>Innolect, Inc., 2764 Pleasant Road #11503, Fort Mill, SC 29708;</P>
                    <P>IVY Planning Group, LLC, 6701 Democracy Blvd., Bethesda, MD 20817;</P>
                    <P>Korn Ferry, 12012 Sunset Hills Road, Reston, VA 20190;</P>
                    <P>Otto Kroeger Associates, 3605 Chain Bridge Road, Fairfax, VA 22030;</P>
                    <P>Uniplus Consultants, Inc., 8140 Ashton Ave., Suite 210, Manassas, VA 20109;</P>
                    <P>WiseWays Consulting, Inc., 2207 Greywing Street, Woodbridge, VA 22191.</P>
                    <HD SOURCE="HD2">SYSTEM MANAGER(S):</HD>
                    <P>
                        Ethel Bulluck, Learning and Development Manager, Human Resources, Management Division, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551, (202) 452-3749, or 
                        <E T="03">ethel.g.bulluck@frb.gov.</E>
                    </P>
                    <HD SOURCE="HD2">AUTHORITY FOR MAINTENANCE OF THE SYSTEM:</HD>
                    <P>Sections 10 and 11 of the Federal Reserve Act (12 U.S.C. 244 and 248).</P>
                    <HD SOURCE="HD2">PURPOSE(S) OF THE SYSTEM:</HD>
                    <P>These records are collected and maintained to assist the Board in administering its personnel functions and improving the management skills of its employees.</P>
                    <HD SOURCE="HD2">CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:</HD>
                    <P>Past and present employees of the Board who have participated in the 360 Assessment program.</P>
                    <HD SOURCE="HD2">CATEGORIES OF RECORDS IN THE SYSTEM:</HD>
                    <P>This system contains 360 Assessment questionnaires completed by the individual under evaluation and his or her evaluators, analyses of the questionnaires, and feedback reports compiled by the contractor based upon the analyses.</P>
                    <HD SOURCE="HD2">RECORD SOURCE CATEGORIES:</HD>
                    <P>Information is provided by the individual being evaluated and his or her evaluators.</P>
                    <HD SOURCE="HD2">ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND PURPOSES OF SUCH USES:</HD>
                    <P>
                        General routine uses A, C, D, F, G, H, I, and J apply to this system. These general routine uses are located at 
                        <E T="03">https://www.federalreserve.gov/files/SORN-page-general-routine-uses-of-board-systems-of-records.pdf</E>
                         and are published in the 
                        <E T="04">Federal Register</E>
                         at 83 FR 43872 at 43873-74 (August 28, 2018). Records may also be used to disclose information to an arbitrator to resolve disputes under a negotiated grievance procedure or to officials of labor organizations recognized under applicable law, regulation, or policy when relevant and necessary to their duties of exclusive representation concerning personnel policies, practices, and matters affecting working conditions.
                    </P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR STORAGE OF RECORDS:</HD>
                    <P>Paper records in this system are stored in locked file cabinets with access limited to staff with a need to know. Electronic records are stored on a secure server with access limited to staff with a need to know.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:</HD>
                    <P>Records can be retrieved by one or more personal identifiers depending on the contractor engaged by the Board for a particular 360 Assessment. These identifiers may include the name, email address, role, and demographic information (age, gender, etc.) of the individuals being evaluated and of the individuals performing the evaluations.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:</HD>
                    <P>
                        All records are retained either until the record is superseded, one year after 
                        <PRTPAGE P="99265"/>
                        the individual under evaluation's separation from employment, or three years—whichever occurs first. Longer retention is authorized if required for business use.
                    </P>
                    <HD SOURCE="HD2">ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:</HD>
                    <P>Paper records are secured by lock and key and electronic files are stored on secure servers. The system has the ability to track individual user actions within the system. The audit and accountability controls are based on National Institute of Standards and Technology (NIST) and Board standards, which, in turn, are based on applicable laws and regulations. The controls assist in detecting security violations and performance or other issues in the system. Access to the system is restricted to authorized users within the Board who require access for official business purposes. Users are classified into different roles and common access and usage rights are established for each role. User roles are used to delineate between the different types of access requirements such that users are restricted to data that is required in the performance of their duties. Periodic assessments and reviews are conducted to determine whether users still require access, have the appropriate role, and whether there have been any unauthorized changes.</P>
                    <HD SOURCE="HD2">RECORD ACCESS PROCEDURES:</HD>
                    <P>The Privacy Act allows individuals the right to access records maintained about them in a Board system of records. Your request for access must: (1) contain a statement that the request is made pursuant to the Privacy Act of 1974; (2) provide either the name of the Board system of records expected to contain the record requested or a concise description of the system of records; (3) provide the information necessary to verify your identity; and (4) provide any other information that may assist in the rapid identification of the record you seek.</P>
                    <P>Current or former Board employees may make a request for access by contacting the Board office that maintains the record. The Board handles all Privacy Act requests as both a Privacy Act request and as a Freedom of Information Act request. The Board does not charge fees to a requestor seeking to access or amend his/her Privacy Act records.</P>
                    <P>You may submit your Privacy Act request to the—Secretary of the Board, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.</P>
                    <P>
                        You may also submit your Privacy Act request electronically by filling out the required information at: 
                        <E T="03">https://foia.federalreserve.gov/.</E>
                    </P>
                    <HD SOURCE="HD2">CONTESTING RECORD PROCEDURES:</HD>
                    <P>The Privacy Act allows individuals to seek amendment of information that is erroneous, irrelevant, untimely, or incomplete and is maintained in a system of records that pertains to them. To request an amendment to your record, you should clearly mark the request as a “Privacy Act Amendment Request.” You have the burden of proof for demonstrating the appropriateness of the requested amendment and you must provide relevant and convincing evidence in support of your request.</P>
                    <P>Your request for amendment must: (1) provide the name of the specific Board system of records containing the record you seek to amend; (2) identify the specific portion of the record you seek to amend; (3) describe the nature of and reasons for each requested amendment; (4) explain why you believe the record is not accurate, relevant, timely, or complete; and (5) unless you have already done so in a related Privacy Act request for access or amendment, provide the necessary information to verify your identity.</P>
                    <HD SOURCE="HD2">NOTIFICATION PROCEDURES:</HD>
                    <P>Same as “Access procedures” above. You may also follow this procedure in order to request an accounting of previous disclosures of records pertaining to you as provided for by 5 U.S.C. 552a(c).</P>
                    <HD SOURCE="HD2">EXEMPTIONS PROMULGATED FOR THE SYSTEM:</HD>
                    <P>Certain portions of this system of records may be exempted from 5 U.S.C. 552a(c)(3), (d), (e)(1), (e)(4)(G), (H), and (I), and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(5).</P>
                    <HD SOURCE="HD2">HISTORY:</HD>
                    <P>
                        This SORN was previously published in the 
                        <E T="04">Federal Register</E>
                         at 73 FR 24984 at 25003-04 (May 6, 2008). The SORN was also amended to incorporate two new routine uses required by OMB at 83 FR 43872 (August 28, 2018).
                    </P>
                </PRIACT>
                <FP>Board of Governors of the Federal Reserve System.</FP>
                <SIG>
                    <NAME>Ann E. Misback,</NAME>
                    <TITLE>Secretary of the Board.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28926 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6210-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Agency for Healthcare Research and Quality</SUBAGY>
                <SUBJECT>Supplemental Evidence and Data Request on Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Agency for Healthcare Research and Quality (AHRQ), HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for supplemental evidence and data submission.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on 
                        <E T="03">Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies,</E>
                         which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Submission Deadline</E>
                         on or before January 9, 2025.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P/>
                    <P>
                        <E T="03">Email submissions: epc@ahrq.hhs.gov.</E>
                    </P>
                    <P>
                        <E T="03">Print submissions:</E>
                    </P>
                    <FP SOURCE="FP-1">
                        <E T="03">Mailing Address:</E>
                         Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
                    </FP>
                    <FP SOURCE="FP-1">
                        <E T="03">Shipping Address (FedEx, UPS, etc.):</E>
                         Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857.
                    </FP>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kelly Carper, Telephone: 301-427-1656 or Email: 
                        <E T="03">epc@ahrq.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for 
                    <E T="03">Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies.</E>
                     AHRQ is conducting this review pursuant to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
                </P>
                <P>
                    The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for 
                    <PRTPAGE P="99266"/>
                    each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (
                    <E T="03">e.g.,</E>
                     details of studies conducted). We are looking for studies that report on 
                    <E T="03">Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies.</E>
                     The entire research protocol is available online at: 
                    <E T="03">https://effectivehealthcare.ahrq.gov/products/kidney-stones/protocol.</E>
                </P>
                <P>
                    This is to notify the public that the EPC Program would find the following information on 
                    <E T="03">Recurrent Nephrolithiasis in Adults and Children: Comparative Effectiveness of Preventive Medical Strategies</E>
                     helpful:
                </P>
                <P>
                     A list of completed studies that your organization has sponsored for this topic. In the list, please 
                    <E T="03">indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.</E>
                </P>
                <P>
                      
                    <E T="03">For completed studies that do not have results on ClinicalTrials.gov,</E>
                     a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.
                </P>
                <P>
                      
                    <E T="03">A list of ongoing studies that your organization has sponsored for this topic.</E>
                     In the list, please provide the 
                    <E T="03">ClinicalTrials.gov</E>
                     trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.
                </P>
                <P>
                     Description of whether the above studies constitute 
                    <E T="03">ALL Phase II and above clinical trials</E>
                     sponsored by your organization for this topic and an index outlining the relevant information in each submitted file.
                </P>
                <P>Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.</P>
                <P>
                    The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: 
                    <E T="03">https://effectivehealthcare.ahrq.gov/email-updates.</E>
                </P>
                <P>The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.</P>
                <HD SOURCE="HD1">Key Questions (KQ)</HD>
                <P>
                    <E T="03">KQ 1:</E>
                     What is the comparative effectiveness of preventive treatment with diet or pharmacologic agents in nonpregnant children and adults with history of nephrolithiasis?
                </P>
                <P>a. Does effectiveness vary by stone composition, diet assessment, blood or urine chemistry, or genetic testing performed prior to treatment?</P>
                <P>b. Does effectiveness vary by blood or urine chemistry or genetic testing performed as followup after treatment is initiated?</P>
                <P>
                    <E T="03">KQ 2:</E>
                     What are the comparative harms of preventive treatment with diet or pharmacologic agents in nonpregnant children and adults with history of nephrolithiasis?
                </P>
                <P>a. Do harms vary by stone composition, diet assessment, blood or urine chemistry, or genetic testing performed prior to treatment?</P>
                <P>b. Do harms vary by blood or urine chemistry or genetic testing performed as followup after treatment is initiated?</P>
                <P>
                    <E T="03">KQ 3:</E>
                     What is the comparative effectiveness of surveillance imaging strategies in nonpregnant children and adults with history of nephrolithiasis?
                </P>
                <P>a. Does effectiveness vary with preventive treatment?</P>
                <P>b. Does effectiveness vary by timing of imaging?</P>
                <P>
                    <E T="03">KQ 4:</E>
                     What are the comparative harms of surveillance imaging strategies in nonpregnant children and adults with history of nephrolithiasis?
                </P>
                <P>a. Do harms vary with preventive treatment?</P>
                <P>b. Do harms vary by timing of imaging?</P>
                <HD SOURCE="HD1">Contextual Question (CQ)</HD>
                <P>
                    <E T="03">CQ 1:</E>
                     What is the natural history of kidney stone recurrence in children and adults?
                </P>
                <HD SOURCE="HD1">PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)</HD>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s50,r150,r150">
                    <TTITLE>Detailed Inclusion and Exclusion Criteria for Systematic Review</TTITLE>
                    <BOXHD>
                        <CHED H="1">Category</CHED>
                        <CHED H="1">Include</CHED>
                        <CHED H="1">Exclude</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Populations</ENT>
                        <ENT>
                            <E T="03">All KQs:</E>
                             Nonpregnant children and adults with a history of nephrolithiasis
                        </ENT>
                        <ENT>
                            <E T="03">All KQs:</E>
                             Children and adults without a history of nephrolithiasis; pregnant persons; persons receiving treatment for acute renal colic or for stone removal or expulsion.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Interventions</ENT>
                        <ENT>
                            <E T="03">KQ 1, 1a, 1b, 2, 2a, 2b:</E>
                             Dietary and/or pharmacological treatment, including dietary supplements and FDA-approved prescription or OTC drugs (Appendix A)
                            <LI>
                                <E T="03">KQ 1a, 2a:</E>
                                 Eligible interventions along with evaluation of stone composition, dietary intake, genetic testing, or blood or urine chemistries before treatment is started
                            </LI>
                            <LI>
                                <E T="03">KQ 1b, 2b:</E>
                                 Eligible interventions along with evaluation of genetic testing or blood and urine chemistries after treatment initiation
                            </LI>
                            <LI>
                                <E T="03">KQ 3, 3a, 3b, 4, 4a, 4b:</E>
                                 Followup imaging when used for routine surveillance (CT scan, renal ultrasound, abdominal radiograph) to detect radiographic stone recurrence, size, composition, location, or shape
                            </LI>
                        </ENT>
                        <ENT>
                            <E T="03">KQs 1, 2:</E>
                             Nondietary and nonpharmacological interventions, including behavioral interventions aimed to improve treatment adherence; interventions for the acute treatment of kidney stones (
                            <E T="03">e.g.,</E>
                             surgery, lithotripsy, medical expulsion therapy). Prescriptions drugs and OTC medications that are not FDA-approved or available in the United States.
                            <LI>
                                <E T="03">KQ 3, 4:</E>
                                 Imaging not used specifically for surveillance of kidney stones.
                            </LI>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Comparators</ENT>
                        <ENT>
                            <E T="03">KQ 1, 1a, 1b, 2, 2a, 2b:</E>
                             Placebo, usual diet, no preventive treatment (for effectiveness); other eligible intervention (for comparative effectiveness)
                        </ENT>
                        <ENT>
                            <E T="03">All KQs:</E>
                             No comparator (single arm study).
                        </ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="99267"/>
                        <ENT I="22"> </ENT>
                        <ENT>
                            <E T="03">KQ 3, 3a, 3b, 4, 4a, 4b:</E>
                             Eligible followup imaging for routine surveillance of kidney stones, no followup imaging
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Outcomes</ENT>
                        <ENT>
                            <E T="03">All KQs:</E>
                             Patient-centered health outcomes: Incident symptomatic stones, urinary tract obstruction with acute renal impairment, end-stage renal disease, urinary tract infection, stone-removal procedures/surgery, procedure-related morbidity, emergency department visits and hospitalizations, quality of life, missed school or work, preventive treatment-related adverse events, imaging-related adverse events, serious adverse events, discontinuations due to adverse events
                        </ENT>
                        <ENT>
                            <E T="03">KQ 1, 1a, 1b, 3, 3a, 3b:</E>
                             Blood or urine chemistry measures, urine supersaturation measures, acute pain.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>
                            <E T="03">Intermediate outcomes:</E>
                             Growth of existing stones, incident radiographic stones, radiation exposure, incidental imaging findings
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Timing</ENT>
                        <ENT>
                            <E T="03">KQ 1, 3:</E>
                             Studies that measure outcomes at least 12 months after baseline
                            <LI O="xl">
                                <E T="03">KQ 2, 4:</E>
                                 Followup not limited.
                            </LI>
                        </ENT>
                        <ENT>
                            <E T="03">KQ 1, 3:</E>
                             Studies of less than 12-months duration.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Setting</ENT>
                        <ENT>
                            Outpatient clinical settings including primary care, urology, nephrology, or other specialty stone clinics; countries with HDI
                            <SU>12</SU>
                             of 
                            <E T="03">very high</E>
                             (Appendix B)
                        </ENT>
                        <ENT>
                            Inpatient settings; Countries with HDI other than 
                            <E T="03">very high.</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Study Designs, Publication Types, and Language</ENT>
                        <ENT>
                            <E T="03">All KQs:</E>
                             Published in peer-reviewed literature, unpublished studies with enough information about methods to determine risk of bias; English language. RCTs; for comparisons lacking sufficient RCT evidence, NRSIs with concurrent comparator group and primary study aim/outcome to assess a dietary or pharmacologic intervention or surveillance imaging approach are eligible
                        </ENT>
                        <ENT>
                            <E T="03">All KQs:</E>
                             Interrupted time series, case series, narrative reviews, editorials, and commentaries are not eligible; systematic reviews are not eligible but will be reviewed to determine whether any included studies are eligible. Studies with fewer than 30 participants at baseline per study arm. Studies published in languages other than English.
                            <LI>
                                <E T="03">KQ 2:</E>
                                 Studies designed to report epidemiologic associations between dietary factors and stone incidence.
                            </LI>
                        </ENT>
                    </ROW>
                    <TNOTE>CT = computed tomography; FDA = U.S. Food and Drug Administration; HDI = United Nations Development Programme Human Development Index; KQ = key question; NRSI = nonrandomized study of intervention; OTC = over-the-counter; RCT = randomized controlled trial.</TNOTE>
                </GPOTABLE>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Marquita Cullom,</NAME>
                    <TITLE>Associate Director.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28933 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4160-90-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>Government-Owned Materials; Availability for Access</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Institute of Allergy and Infectious Diseases, National Institutes of Health, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The material listed below is owned by an agency of the U.S. Government and is available for transfer to achieve expeditious use and/or commercialization of results of federally funded research and development.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Access information may be obtained by communicating with the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852 by contacting Benjamin Hurley at 240-669-5092 or 
                        <E T="03">benjamin.hurley@nih.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Royalty-Free Starting Material (MVA-clone 1) for the Clinical Development, Evaluation, and Commercialization of a Viable Mpox Vaccine</HD>
                <P>Worldwide, leading health authorities have cited the growing need for a commitment to equitable vaccine access and its role in curtailing future epidemics—a vision that cannot be realized without significant improvements in the speed, scale, and access of vaccine manufacturing and deployment in historically underserved regions. For at-risk populations and those with contraindications to commonly deployed vaccines, such initiatives are even more vital.</P>
                <P>Modified vaccinia virus Ankara (MVA), developed more than 30 years ago as a highly attenuated candidate smallpox vaccine, was recloned at the U.S. National Institute of Allergy and Infectious Diseases (NIAID) (referred to here as “MVA clone-1”) from a 1974-originating passage and evaluated for safety and immunogenicity in both normal and partially immune-deficient animals. Subsequent studies verified the protective ability of this attenuated vaccine against mpox in non-human primates, and clinical efforts since have resulted in FDA approval and availability of a two-dose MVA vaccine in the U.S.</P>
                <P>
                    In support of the global humanitarian effort to achieve equitable vaccine access and in light of the current public health emergency of international concern (PHEIC) declared by the World Health Organization in 2024—which has resulted in more than 500 deaths in the Democratic Republic of the Congo since the beginning of this year—the National Institute of Allergy and Infectious Diseases (NIAID) is seeking inquiries from parties interested in independent R&amp;D and/or collaborative research to further develop, evaluate, and commercialize a viable mpox vaccine for distribution (particularly in developing nations/regions currently having minimal access to mpox vaccines) using NIH-provided starting material (MVA clone-1). While traditional licensing opportunities related to mpox detection are also available (
                    <E T="03">e.g.,</E>
                     antibodies, neutralization assays), NIAID will transfer the MVA clone-1 material in question on a royalty-free basis to qualified partners in an effort to combat the current PHEIC. In the event that NIAID has limited ability to distribute material, or if supply approaches exhaustion, priority will be given to collaborators with a proposed plan demonstrating, in 
                    <PRTPAGE P="99268"/>
                    NIAID's sole judgment, the ability to develop a viable vaccine. Potential collaborators considered equally competitive in terms of capacity will also be evaluated based on their plans and intent to distribute in areas with immediate need, followed by the likelihood of the proposed plan contributing to the achievement of a self-sustaining vaccine ecosystem in developing nations.
                </P>
                <P>This material is available for access for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration agreement.</P>
                <P>
                    <E T="03">Potential Commercial Applications:</E>
                </P>
                <FP SOURCE="FP-1">• Prophylaxis against mpox in normal or high-risk populations</FP>
                <FP SOURCE="FP-1">• Vaccine research</FP>
                <P>
                    <E T="03">Competitive Advantages:</E>
                </P>
                <FP SOURCE="FP-1">• MVA clone-1 material is believed to be functionally and genetically similar to FDA-approved vaccine material</FP>
                <FP SOURCE="FP-1">• Identification of vaccine candidates that can elicit protective antibodies against mpox in normal or high-risk populations</FP>
                <FP SOURCE="FP-1">• Royalty-free access for vaccine development and/or research</FP>
                <P>
                    <E T="03">Development Stage:</E>
                </P>
                <P>• Pre-clinical</P>
                <P>
                    <E T="03">NIH Contributor:</E>
                     Bernard Moss, MD, Ph.D.
                </P>
                <P>
                    <E T="03">Publications:</E>
                </P>
                <P>
                    • Earl PL, et al. (2004) Immunogenicity of a highly attenuated MVA smallpox vaccine and protection against monkeypox. 
                    <E T="03">Nature.</E>
                     428:182.
                </P>
                <P>
                    • Wyatt LS, et al. (2004) Highly attenuated smallpox vaccine protects mice with and without immune deficiencies against pathogenic vaccinia virus challenge. 
                    <E T="03">Proc Nat Acad Sci USA.</E>
                    101:4590.
                </P>
                <P>
                    • Earl PL, et al. (2003) Development and use of a vaccinia virus neutralization assay based on flow cytometric detection of green fluorescent protein. 
                    <E T="03">J Virol.</E>
                     77:10684.
                </P>
                <P>
                    <E T="03">Intellectual Property:</E>
                     N/A.
                </P>
                <P>
                    <E T="03">Technology Transfer Specialist:</E>
                     To discuss access to this technology, please contact Benjamin Hurley at (
                    <E T="03">benjamin.hurley@nih.gov</E>
                    ).
                </P>
                <P>
                    <E T="03">Collaborative Research Opportunity:</E>
                     The National Institute of Allergy and Infectious Diseases is seeking inquiries from parties interested in independent R&amp;D and/or collaborative research to further develop, evaluate, and commercialize a viable mpox vaccine for distribution using this material. Please contact Benjamin Hurley at 240-669-5092 or 
                    <E T="03">benjamin.hurley@nih.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Jeremiah D. Mitzelfelt,</NAME>
                    <TITLE>Acting Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28924 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[LLHQ430000.L12200000.PM0000; OMB Control No. 1004-0217]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Surveys and Focus Groups To Support Outcomes-Focused Management (Recreation Survey and Focus Groups)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Land Management (BLM) has submitted an information collection request (ICR) to the Office of Management and Budget (OMB) for review.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request additional information about this ICR, contact Matt Blocker, Outdoor Recreation Planner, by email at 
                        <E T="03">mblocker@blm.gov,</E>
                         or by telephone at (385) 341-3403. Individuals who are hearing or speech impaired may call the Federal Relay Service at 1-800-877-8339 for TTY assistance. You may also view the ICR at 
                        <E T="03">http://www.reginfo.gov/public/do/PRAMain.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    In accordance with the PRA (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) and 5 CFR 1320.8(d)(1)), we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
                </P>
                <P>
                    A 
                    <E T="04">Federal Register</E>
                     notice with a 60-day public comment period soliciting comments on this collection of information was published on July 5, 2024 (89 FR 55653). No comments were received.
                </P>
                <P>As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:</P>
                <P>(1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;</P>
                <P>(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;</P>
                <P>(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>
                    (4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of response.
                </P>
                <P>Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <P>
                    <E T="03">Abstract:</E>
                     Information will be collected from visitors of public lands and community members near public lands. Information gathered from visitors and local community residents will be used to inform planning decisions in support of BLM's Planning for Recreation and Visitor Services Handbook H-8320-1. This request is for OMB to renew these surveys and focus groups for three (3) years.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Surveys and Focus Groups to Support Outcomes-Focused 
                    <PRTPAGE P="99269"/>
                    Management (Recreation Survey and Focus Groups).
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1004-0217.
                </P>
                <P>
                    <E T="03">Form Numbers:</E>
                     None.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Respondents/Affected Public:</E>
                     Individuals or households.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Respondents:</E>
                     5,330.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     7,230.
                </P>
                <P>
                    <E T="03">Estimated Completion Time per Response:</E>
                     Varies from 1 minute to answer an on-site survey to 90 minutes to participate in a focus group.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     2,046.
                </P>
                <P>
                    <E T="03">Respondent's Obligation:</E>
                     Voluntary.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Nonhour Burden Cost:</E>
                     $0.
                </P>
                <P>An agency may not conduct or sponsor and, notwithstanding any other provision of law, a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.</P>
                <P>
                    The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <SIG>
                    <NAME>Darrin King,</NAME>
                    <TITLE>Information Collection Clearance Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28951 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4331-84-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[L19900000.PO0000.LLHQ320000.25X; OMB Control No. 1004-0025]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Mineral Surveys, Mineral Patent Applications, Adverse Claims, Protests, and Contests</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Land Management (BLM) proposes to renew an information collection.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for this information collection request (ICR) should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request additional information about this ICR, contact John Grasso by email at 
                        <E T="03">jgrasso@blm.gov,</E>
                         or by telephone at (303) 239-3777. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States. You may also view the ICR at 
                        <E T="03">http://www.reginfo.gov/public/do/PRAMain.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    In accordance with the PRA (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) and 5 CFR 1320.8(d)(1), we invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps the BLM assess impacts of its information collection requirements and minimize the public's reporting burden. It also helps the public understand BLM information collection requirements and ensure requested data are provided in the desired format.
                </P>
                <P>
                    A 
                    <E T="04">Federal Register</E>
                     notice with a 60-day public comment period soliciting comments on this collection of information was published on August 9, 2024 (89 FR 65390).
                </P>
                <P>As part of our continuing effort to reduce paperwork and respondent burdens, we are again inviting the public and other Federal agencies to comment on the proposed ICR described below. The BLM is especially interested in public comment addressing the following:</P>
                <P>(1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;</P>
                <P>(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;</P>
                <P>(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>
                    (4) How the agency could minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of response.
                </P>
                <P>Comments submitted in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <P>
                    <E T="03">Abstract:</E>
                     The General Mining Law (30 U.S.C. 29, 30, and 39) authorizes a holder of an unpatented claim for hardrock minerals to apply for fee title (patent) to the federal land (as well as minerals) embraced in the claim. Division E, Title I of the Consolidated Appropriations Act, 2024 (Pub. L. 118-42), the annual appropriation bill for the Department of the Interior, prevents the BLM from processing mineral patent applications unless the applications were grandfathered under the initial legislation. While grandfathered applications are rare at present, the approval to collect the information continues to be necessary because of the possibility that the moratorium will be lifted and applicable regulations that contain the information are still part of the Code of Federal Regulations. OMB control number 1004-0025 is scheduled to expire on July 31, 2025. This request is for OMB to renew this OMB control number for an additional three (3) years.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Mineral Surveys, Mineral Patent Applications, Adverse Claims, Protests, and Contests (43 CFR parts 3860 and 3870).
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1004-0025.
                </P>
                <P>
                    <E T="03">Form Numbers:</E>
                     3860-2 and 3860-5.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Respondents/Affected Public:</E>
                     Owners of unpatented mining claims and mill sites upon the public lands, and of reserved mineral lands of the United States, National Forests, and National Parks.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Respondents:</E>
                     1.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     10.
                </P>
                <P>
                    <E T="03">Estimated Completion Time per Response:</E>
                     Varies from 1-100 hours, depending on activity.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     559.
                </P>
                <P>
                    <E T="03">Respondent's Obligation:</E>
                     Required to obtain or retain a benefit.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Non-hour Burden Cost:</E>
                     $259,035.
                    <PRTPAGE P="99270"/>
                </P>
                <P>An agency may not conduct or sponsor and, notwithstanding any other provision of law, a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.</P>
                <P>
                    The authority for this action is the PRA of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <SIG>
                    <NAME>Darrin King,</NAME>
                    <TITLE>Information Collection Clearance Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28948 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4310-84-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[BLM_HQ_FRN_MO4500183156]</DEPDOC>
                <SUBJECT>Notice of Lease Sale and Notice of Availability of the Detailed Statement of Sale for the Coastal Plain 2025 Oil and Gas Lease Sale</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Bureau of Land Management's (BLM) Alaska State Office will hold an oil and gas lease sale bid opening for twelve tracts in the Coastal Plain of the Arctic National Wildlife Refuge.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The oil and gas lease sale bid opening will be at 10 a.m. (AKST) on January 9, 2025. The BLM must receive all sealed bids by 4 p.m. (AKST), January 6th, 2025. The Detailed Statement of Sale for the Coastal Plain Oil and Gas Lease Sale 2025 will be available to the public on BLM's website on the date of this Notice's publication in the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Sealed bids must be received at the BLM-Alaska State Office, ATTN: Wayne Svejnoha (AK932); 222 West 7th Avenue, #13; Anchorage, AK 99513-7504. The Detailed Statement of Sale is available from the BLM Alaska website at 
                        <E T="03">https://www.blm.gov/alaska.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Wayne Svejnoha, Supervisory Minerals and Energy Specialist, phone 907-271-4407 or email, 
                        <E T="03">wsvejnoh@blm.gov.</E>
                         Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services for contacting Mr. Svejnoha. Individuals outside the United States should use the relay services within their country to make international calls to the point-of-contact in the United States.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Bidder Disclosure</HD>
                <P>
                    Several tracts available for bid in the sale are the subject of ongoing litigation in the U.S. District Court for the District of Alaska. Tract 29 covers the Staines-Canning River area along the northwestern boundary of the Arctic Refuge, which the State of Alaska claims an entitlement to under the Alaska Statehood Act in 
                    <E T="03">State of Alaska</E>
                     v. 
                    <E T="03">U.S. Department of the Interior, et al.</E>
                     (Case No. 3:22-cv-00078-SLG). Tracts 16, 17, 24, 26, 27, 30 and 31 were leased to the Alaska Industrial Development and Export Authority (AIDEA) in January 2021, but those leases were subsequently cancelled by the U.S. Department of the Interior in September 2023 due to pre-leasing legal defects. AIDEA challenges those cancellations and seeks reinstatement of the leases in 
                    <E T="03">Alaska Industrial Development and Export Authority</E>
                     v. 
                    <E T="03">United States Department of the Interior</E>
                     (Case No. 3:24-cv-00051-SLG). In the event that one or more of these cases results in a decision adverse to the Department and a remedy that changes the status quo, a court or the Department may ultimately determine the validity of any lease issued in this sale to the extent it is for a disputed tract.
                </P>
                <P>The 2025 Coastal Plain Oil and Gas Lease Sale will include 12 tracts (approximately 400,000 acres) that are available for leasing under the Coastal Plain Environmental Impact Statement Record of Decision issued in December 2024.</P>
                <P>
                    The opening and reading of the bids for the 2025 lease sale will be available for online public viewing via video livestreaming at 
                    <E T="03">https://www.blm.gov/live.</E>
                </P>
                <P>The Detailed Statement of Sale includes a description of the areas the BLM is offering for lease, as well as the lease terms, conditions, special stipulations, required operating procedures, and directions for how to submit bids. If you plan to submit a bid(s), please note that all bids must be sealed in accordance with the provisions identified in the Detailed Statement of Sale.</P>
                <P>The United States reserves the right to withdraw any tract from this sale prior to issuance of a written acceptance of a bid.</P>
                <P>
                    <E T="03">Authority:</E>
                     Section 20001 of the Tax Cuts and Jobs Act of 2017 (Pub. L. 115-97); 43 CFR 3131.4-1.
                </P>
                <SIG>
                    <NAME>Steven M. Cohn,</NAME>
                    <TITLE>State Director, Alaska.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28989 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4310-JA-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[LLHQ310000.L13100000.PP0000; OMB Control No. 1004-0137]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Onshore Oil and Gas Operations and Production</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Land Management (BLM) has submitted to the Office of Management and Budget (OMB) a request to renew an information collection with revisions.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed Information Collection Request (ICR) should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request additional information about this ICR, contact Jennifer Spencer by email at 
                        <E T="03">j35spenc@blm.gov,</E>
                         or by telephone at 202-912-7146. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States. You may also view the ICR at 
                        <E T="03">http://www.reginfo.gov/public/do/PRAMain.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    In accordance with the PRA (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                     and 5 CFR 1320.8(d)(1)), we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information 
                    <PRTPAGE P="99271"/>
                    collection requirements and provide the requested data in the desired format.
                </P>
                <P>
                    A 
                    <E T="04">Federal Register</E>
                     notice with a 60-day public comment period soliciting comments on this collection of information was published on August 28, 2024 (89 FR 68923).
                </P>
                <P>As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:</P>
                <P>(1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;</P>
                <P>(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;</P>
                <P>(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>
                    (4) How the agency could minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of response.
                </P>
                <P>Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <P>
                    <E T="03">Abstract:</E>
                     Various Federal and Indian mineral leasing statutes authorize the BLM to grant and manage onshore oil and gas leases on Federal and Indian (except Osage Tribe) lands. In order to fulfill its responsibilities under these statutes, the BLM needs to perform the information collection activities set forth in the regulations at 43 CFR part 3170. There are no program or policy changes associated with this ICR. The changes involve moving burdens associated with 43 CFR part 3160 to OMB control number 1004-0220 and clarifying certain remaining burden estimates. The ICR submitted to OMB contains a detailed explanation of these changes. This OMB control number is currently scheduled to expire January 31, 2025. The BLM requests that OMB renew this OMB control number for an additional three (3) years.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Onshore Oil and Gas Operations and Production (43 CFR part 3170).
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1004-0137.
                </P>
                <P>
                    <E T="03">Form Numbers:</E>
                     BLM Form 3160-005.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension with revision of a currently approved collection.
                </P>
                <P>
                    <E T="03">Respondents/Affected Public:</E>
                     Oil and gas operators on public lands and some Indian lands.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Respondents:</E>
                     864.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     102,439.
                </P>
                <P>
                    <E T="03">Estimated Completion Time per Response:</E>
                     Varies depending on activity.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     278,904.
                </P>
                <P>
                    <E T="03">Respondent's Obligation:</E>
                     Required to obtain or retain a benefit.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     On occasion; One-time; and Monthly.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Non-hour Burden Cost:</E>
                     None.
                </P>
                <P>An agency may not conduct or sponsor and, notwithstanding any other provision of law, a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.</P>
                <P>
                    The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <SIG>
                    <NAME>Darrin A. King,</NAME>
                    <TITLE>Information Collection Clearance Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28950 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4331-84-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[BLM_AZ_FRN; AZAZ105869032]</DEPDOC>
                <SUBJECT>Notice of Application for Withdrawal and Opportunity for Public Meeting; John R. Fox Range, Fort Huachuca, Arizona</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The United States Army (Army) has filed an application with the Bureau of Land Management (BLM) requesting that the Secretary of the Interior (Secretary) withdraw 1,840 acres of Federal subsurface estate lands from location and entry under the United States mining laws, and from leasing under the mineral and geothermal leasing laws, but not from disposal under the Mineral Materials Act of 1947, subject to valid existing rights, for a 20-year period. Additionally, the Army requests that the Secretary withdraw 53.48 acres of non-Federal lands, upon Federal acquisition, from all forms of appropriation under the public land laws, including the United States mining laws and mineral leasing laws, and reserved for use by the Army for military purposes (except as indicated in Public Land Order No. 1471), subject to valid existing rights, for an indefinite period. The purpose of the withdrawal requested is to protect the John R. Fox Range, located on Fort Huachuca, Arizona, from potential adverse impacts from mining. Publication of this notice temporarily segregates the lands for up to two years, initiates a 90-day public comment period, and announces to the public an opportunity to request a public meeting on the Army's withdrawal application.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received by March 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        All comments or requests for a public meeting should be sent to the BLM Arizona State Office, 1 North Central Avenue, Suite 800, Phoenix, AZ 85004; or sent by email to 
                        <E T="03">BLM_AZ_Withdrawal_Comments@blm.gov.</E>
                         The BLM will not consider comments via telephone calls.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael Ouellett, Realty Specialist, BLM Arizona State Office, telephone (602) 417-9561, email at 
                        <E T="03">mouellett@blm.gov;</E>
                         or you may contact the BLM office at the address noted above. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States. You will receive a reply during normal business hours.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Army requests this withdrawal to protect the military training and testing mission at Fort Huachuca's John R. Fox Range. This request is for a new 20-year withdrawal encompassing 1,840 acres of Army lands previously withdrawn by Public Land Order (PLO) No. 6788 (expired August 8, 2010). The Army has also identified an additional 53.48 acres (both the surface and subsurface estate) of non-Federal lands within the John R. Fox Range that the Army is requesting be withdrawn, upon Federal acquisition, and reserved for use by the Department of the Army for military 
                    <PRTPAGE P="99272"/>
                    purposes (except as indicated in PLO No. 1471), subject to valid existing rights, for an indefinite period or for such period as the Secretary of the Interior deems appropriate.
                </P>
                <P>The Secretary of the Interior has been authorized by Congress to acquire these 53.48 acres as part of a larger tract of State of Arizona owned lands under section 2872(a) of Public Law (Pub. L.) 106-65. The Secretary of the Interior is also authorized under section 2872(g) of Public Law 106-65 to withdraw and reserve these lands after acquisition for the use of the Army “for military training and testing in the same manner as other Federal lands located in the Fort Huachuca East Range (now John R. Fox Range) that were withdrawn and reserved for Army use through Public Land Order 1471 of 1957.” As PLO No. 1471 established an indefinite withdrawal, the Army is requesting these additional 53.48 acres for indefinite withdrawal, as well.</P>
                <P>The following described Army lands are the subject of the Army's withdrawal application and are temporarily segregated for a period of up to two years from location and entry under the U.S. mining laws, from leasing under the mineral leasing laws or geothermal leasing laws but not from disposal under the Mineral Materials Act of 1947, subject to valid existing rights:</P>
                <P>(Federal Subsurface Estate)</P>
                <EXTRACT>
                    <HD SOURCE="HD1">Gila and Salt River Meridian, Arizona</HD>
                    <P>T. 20 S., R. 20 E.,</P>
                    <P>sec. 33, S1/2SE1/4;</P>
                    <P>sec. 34, S1/2NW1/4 and SE1/4.</P>
                    <P>T. 21 S., R. 20 E.,</P>
                    <P>sec. 10, SE1/4;</P>
                    <P>sec. 11, NE1/4;</P>
                    <P>sec. 13, SE1/4;</P>
                    <P>sec. 15, NE1/4;</P>
                    <P>sec. 24, NE1/4.</P>
                    <P>T. 20 S., R. 21 E.,</P>
                    <P>sec. 19, SE1/4;</P>
                    <P>sec. 31, NE1/4, E1/2NW1/4, and S1/2.</P>
                    <P>The areas described aggregate 1,840 acres.</P>
                </EXTRACT>
                <P>Additionally, the Army is requesting the following described lands be withdrawn, upon Federal acquisition, from all forms of appropriation under the public land laws, including the United States mining laws and mineral leasing laws, and reserved for use by the Army for military purposes (except as indicated in PLO No. 1471), subject to valid existing rights, for an indefinite period or for such period as the Secretary of the Interior deems appropriate:</P>
                <P>(Surface and Subsurface Estate—Lands Withdrawn Upon Federal Acquisition)</P>
                <EXTRACT>
                    <HD SOURCE="HD1">Gila and Salt River Meridian, Arizona</HD>
                    <P>T. 21 S., R. 20 E.,</P>
                    <P>sec. 4, lot 1.</P>
                    <P>The area described contains 53.48 acres.</P>
                </EXTRACT>
                <P>The use of a right-of-way, interagency agreement, or cooperative agreement would not provide adequate protection of the specified lands.</P>
                <P>No additional water rights are needed to fulfill the purpose of this requested withdrawal.</P>
                <P>There are no suitable alternative sites since the requested withdrawal area is within the John R. Fox Range.</P>
                <P>Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <P>
                    For a period of two years from the date of publication in the 
                    <E T="04">Federal Register</E>
                    , the lands will be segregated as specified above unless the application is denied or canceled.
                </P>
                <P>This application will be processed in accordance with the regulations at 43 CFR 2300.</P>
                <P>
                    <E T="03">Authority:</E>
                      
                </P>
                <P>43 U.S.C. 1714(b)(1) and 43 CFR 2310.3-1 and Public Law 106-65.</P>
                <SIG>
                    <NAME>Gera Ashton,</NAME>
                    <TITLE>Acting State Director, Arizona State Office.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28938 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3711-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[BLM_NV_FRN_MO#4540000406; NVNV-106316914]</DEPDOC>
                <SUBJECT>Public Land Order No. 7953; Withdrawal Revocation; Restoration of Public Lands; Transfer Into Trust; Nevada</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Public Land Order.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This order revokes in part a withdrawal created by a Secretary's Order dated November 26, 1906, which withdrew all lands within one mile of the high-water mark of Walker Lake in Mineral County, Nevada and reserved them for the Bureau of Reclamation's Truckee-Carson Project. The Bureau of Reclamation (BOR) no longer needs 109.60 acres for project purposes. The Bureau of Land Management (BLM) has evaluated the lands and determined they are suitable for return to the public domain. In addition, this order permanently withdraws and transfers 69.60 of the 109.60 acres, as well as 103.65 acres of other public lands, as an addition to the Walker River Indian Reservation under the authority of the Act of June 22, 1936.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This Public Land Order (PLO) takes effect on December 10, 2024.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Joseph Palma, BLM Stillwater Field Office, (775) 885-6131 or 
                        <E T="03">jpalma@blm.gov</E>
                         during regular business hours, 8 a.m. to 4:30 p.m. Mountain Time, Monday through Friday, except holidays. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>These 109.60 acres were included as part of the larger Truckee-Carson Project withdrawal established by a Secretary's Order dated November 26, 1906, which withdrew all lands within one mile of the high-water mark of Walker Lake in Mineral County, Nevada. The subject lands were omitted from the legal description in a Secretary's Order dated May 25, 1942, that revoked the 1906 withdrawal order. These lands are no longer needed by the BOR for project purposes. The BLM has determined the lands are suitable for return to the public domain.</P>
                <P>
                    In addition, the Western Regional Office of the Bureau of Indian Affairs (BIA) submitted an application for the BLM to process on behalf of the Secretary for the permanent withdrawal and transfer of some of these lands, once restored, into trust as an addition to the Walker River Indian Reservation under the authority of Public Law 74-748 (49 Stat. 1806), dated June 22, 1936 (1936 Act). By this Order, the Secretary is restoring the relinquished lands to the public domain and transfering 69.60 acres of the restored lands, as well as 103.65 acres of other public lands, that are surrounded by Reservation lands into trust for the Walker River Paiute Tribe as an addition to the Reservation under the 1936 Act. Forty acres of the restored lands overlap a previous withdrawal for the Reservation; these acres transfer to Tribal management by operation of law upon Secretarial revocation of the 1906 withdrawal.
                    <PRTPAGE P="99273"/>
                </P>
                <HD SOURCE="HD1">Order</HD>
                <P>By virtue of the authority vested in the Secretary of the Interior by section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714 and Public Law 74-748 (49 Stat. 1806), dated June 22, 1936, it is ordered as follows:</P>
                <P>1. The withdrawal created by Secretary's Order dated November 26, 1906, is hereby revoked in part as to the following described lands:</P>
                <EXTRACT>
                    <HD SOURCE="HD1">Mount Diablo Meridian, Nevada</HD>
                    <FP SOURCE="FP-2">T. 12 N., R. 28 E.,</FP>
                    <FP SOURCE="FP1-2">sec. 25, lot 4.</FP>
                    <FP SOURCE="FP-2">T. 11 N., R. 29 E.,</FP>
                    <FP SOURCE="FP1-2">sec. 9, NE1/4SW1/4;</FP>
                    <FP SOURCE="FP1-2">sec. 18, NE1/4NE1/4.</FP>
                    <P>The areas described aggregate 109.60 acres.</P>
                </EXTRACT>
                <P>2. Subject to valid existing rights, the following described public lands and reserved public minerals are hereby permanently withdrawn from settlement, sale, location, and entry under the general land laws, including the United States mining laws, mineral and geothermal leasing laws, and disposal under the mineral materials laws, and jurisdiction over such lands and minerals is hereby permanently transferred to the Bureau of Indian Affairs to be held in trust, in perpetuity, for the benefit of the Walker River Paiute Tribe as an addition to the Walker River Indian Reservation, under the authority of Public Law 74-748 (49 Stat. 1806). The lands are described as follows:</P>
                <EXTRACT>
                    <HD SOURCE="HD1">Mount Diablo Meridian, Nevada</HD>
                    <FP SOURCE="FP-2">T. 12 N., R. 28 E.,</FP>
                    <FP SOURCE="FP1-2">sec. 25, lot 4.</FP>
                    <FP SOURCE="FP-2">T. 11 N., R. 29 E.,</FP>
                    <FP SOURCE="FP1-2">sec. 18, NE1/4NE1/4.</FP>
                    <FP SOURCE="FP-2">T. 12 N., R. 29 E.,</FP>
                    <FP SOURCE="FP1-2">sec. 27, lots 1 and 2, and SE1/4SE1/4.</FP>
                    <P>The areas described aggregate 173.25 acres.</P>
                </EXTRACT>
                <EXTRACT>
                    <FP>(Authority: 43 U.S.C. 1714 and Public Law 74-748, June 22, 1936)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Robert T. Anderson,</NAME>
                    <TITLE>Solicitor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28949 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4331-21-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>National Park Service</SUBAGY>
                <DEPDOC>[NPS-WASO-PPFL-37193; PPWOPPFLF0; PPMVSIE1Y.Y00000; 244P103601]</DEPDOC>
                <SUBJECT>Notice of Availability and Request for Comments on Draft Director's Order #42 Concerning National Park Service Policies and Procedures Governing Accessibility of National Park Service Facilities, Programs, Services, and Activities</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Park Service, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability, request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Park Service (NPS) has prepared Director's Order #42 to set forth its policies and procedures for making facilities, transportation systems, information and communication technology, interpretive and educational programs and services, and commercial services accessible to visitors with disabilities. Once adopted, the policies and procedures in Director's Order #42 and the accompanying Reference Manual 42 (RM-42) will supersede and replace the policies and procedures issued in Director's Order #42: Accessibility for Visitors with Disabilities, dated November 3, 2000.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Written comments will be accepted until January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Draft Director's Order #42 is available online at 
                        <E T="03">https://www.nps.gov/subjects/policy/new.htm</E>
                         where readers may submit comments electronically.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jeremy Buzzell, Accessibility Program Manager, National Park Service, at 
                        <E T="03">jeremy_buzzell@nps.gov,</E>
                         or by telephone at 202-768-4894.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The NPS is updating its current system of internal written instructions. When these documents contain new policy or procedural requirements that may affect parties outside the NPS, they are first made available for public review and comment before being adopted. Director's Order #42 and a reference manual (subsequent to the Director's Order) will be issued. The draft Director's Order provides direction to NPS managers and employees with responsibilities for ensuring visitor use opportunities (facilities, transportation systems, information and communication technology, interpretive and educational programs and services, and commercial services) are accessible and inclusive to visitors with disabilities.</P>
                <P>
                    <E T="03">Public Disclosure of Comments:</E>
                     Before including your address, telephone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     54 U.S.C. 100101(a) 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <NAME>Alma Ripps,</NAME>
                    <TITLE>Chief, Office of Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28942 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4312-52-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>National Park Service</SUBAGY>
                <DEPDOC>[NPS-WASO-NRNHL-DTS#-39182; PPWOCRADI0, PCU00RP14.R50000]</DEPDOC>
                <SUBJECT>National Register of Historic Places; Notification of Pending Nominations and Related Actions</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Park Service, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Park Service is soliciting electronic comments on the significance of properties nominated before November 30, 2024, for listing or related actions in the National Register of Historic Places.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments should be submitted electronically by December 26, 2024.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments are encouraged to be submitted electronically to 
                        <E T="03">National_Register_Submissions@nps.gov</E>
                         with the subject line “Public Comment on &lt;property or proposed district name, (County) State&gt;.” If you have no access to email, you may send them via U.S. Postal Service and all other carriers to the National Register of Historic Places, National Park Service, 1849 C Street NW, MS 7228, Washington, DC 20240.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Sherry A. Frear, Chief, National Register of Historic Places/National Historic Landmarks Program, 1849 C Street NW, MS 7228, Washington, DC 20240, 
                        <E T="03">sherry_frear@nps.gov,</E>
                         202-913-3763.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before November 30, 2024. Pursuant to Section 60.13 of 36 CFR part 60, comments are being accepted concerning the significance of 
                    <PRTPAGE P="99274"/>
                    the nominated properties under the National Register criteria for evaluation.
                </P>
                <P>Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <P>Nominations submitted by State or Tribal Historic Preservation Officers</P>
                <P>
                    <E T="03">Key:</E>
                     State, County, Property Name, Multiple Name(if applicable), Address/Boundary, City, Vicinity, Reference Number.
                </P>
                <EXTRACT>
                    <HD SOURCE="HD1">ALABAMA</HD>
                    <HD SOURCE="HD1">Geneva County</HD>
                    <FP SOURCE="FP-1">Slocomb Commercial District, Approx. 101-149 Commerce/Dalton Street. 113-180 Slocomb Street. Both sides east of Commerce/Dalton Street and the north side of Slocomb Street. 121-169 Lawrence Harris Highway on either side of Commerce/Dalton Street, Slocomb, SG100011226</FP>
                    <HD SOURCE="HD1">Houston County</HD>
                    <FP SOURCE="FP-1">Ashford Commercial District, Roughly bounded by Adams Street to the N, the CSX railroad to the S, Fifth Avenue to the E, and Third Avenue and Ice House Lane to the W, Ashford, SG100011228</FP>
                    <HD SOURCE="HD1">Montgomery County</HD>
                    <FP SOURCE="FP-1">Court Square Urban Renewal Area Historic District, Generally bounded by Madison Avenue, N Lawrence Street, Church Street, and Lee Street, Montgomery, SG100011227</FP>
                    <HD SOURCE="HD1">ARIZONA</HD>
                    <HD SOURCE="HD1">Maricopa County</HD>
                    <FP SOURCE="FP-1">Stoneman Road Military Trail Segment (Warfare Between Indians and Americans in Arizona MPS), Parcel bounded by Cave Creek Road, Mule Train Road, Stagecoach Pass, and Windmill Road, Carefree, MP100011210</FP>
                    <HD SOURCE="HD1">CALIFORNIA</HD>
                    <HD SOURCE="HD1">El Dorado County</HD>
                    <FP SOURCE="FP-1">United States Post Office—Main Street Branch (US Post Office in California 1900-1941 TR), 515 Main Street, Placerville, MP100011215</FP>
                    <HD SOURCE="HD1">San Bernardino County</HD>
                    <FP SOURCE="FP-1">Chemehuevi Cemetery, Adobe Road, just northeast of the intersection with Sullivan Road. Twentynine Palms, SG100011256</FP>
                    <HD SOURCE="HD1">Santa Barbara County</HD>
                    <FP SOURCE="FP-1">Ballard Adobes, 2411 Alamo Pintado Road, Ballard vicinity, SG100011216</FP>
                    <HD SOURCE="HD1">DELAWARE</HD>
                    <HD SOURCE="HD1">Sussex County</HD>
                    <FP SOURCE="FP-1">Isaacs &amp; Sons Cold Storage Building, 107 Depot Stret, Georgetown, SG100011239</FP>
                    <HD SOURCE="HD1">DISTRICT OF COLUMBIA</HD>
                    <HD SOURCE="HD1">District of Columbia</HD>
                    <FP SOURCE="FP-1">House of Mercy, 2000 Rosemount Avenue NW, Washington, SG100011245</FP>
                    <FP SOURCE="FP-1">Shackleton, Pauline “Polly” House, 3232 Reservoir Road NW, Washington, SG100011255</FP>
                    <HD SOURCE="HD1">IDAHO</HD>
                    <HD SOURCE="HD1">Ada County</HD>
                    <FP SOURCE="FP-1">Brookover, J. Gordon and Barbara J., House, 4704 Hillcrest View Drive, Boise, SG100011242</FP>
                    <HD SOURCE="HD1">ILLINOIS</HD>
                    <HD SOURCE="HD1">Cook County</HD>
                    <FP SOURCE="FP-1">James C. Curtis &amp; Co. Building, 1214-1222 W Van Buren Street, Chicago, SG100011204</FP>
                    <FP SOURCE="FP-1">2678 W Washington Boulevard, 2678 W Washington Boulevard, Chicago, SG100011219</FP>
                    <HD SOURCE="HD1">MAINE</HD>
                    <HD SOURCE="HD1">Hancock County</HD>
                    <FP SOURCE="FP-1">Crosby Lodge, 15 Oak Street, Hancock, SG100011223</FP>
                    <HD SOURCE="HD1">Lincoln County</HD>
                    <FP SOURCE="FP-1">Averill—Philbrick House, 134 Golden Ridge Road, Alna, SG100011224</FP>
                    <HD SOURCE="HD1">MICHIGAN</HD>
                    <HD SOURCE="HD1">Wayne County</HD>
                    <FP SOURCE="FP-1">Dearborn Country Club, 800 North Military Street, Dearborn, SG100011221</FP>
                    <HD SOURCE="HD1">NEW MEXICO</HD>
                    <FP SOURCE="FP-1">Orogrande School (New Deal in New Mexico MPS), 1158 Carroll Street, Orogrande, MP100011237</FP>
                    <HD SOURCE="HD1">Quay County</HD>
                    <FP SOURCE="FP-1">Hurley, Arch and Ola, House, 117 West High Street, Tucumcari, SG100011238</FP>
                    <HD SOURCE="HD1">OHIO</HD>
                    <HD SOURCE="HD1">Hamilton County</HD>
                    <FP SOURCE="FP-1">Atlas National Bank Building, 530 Walnut Street, Cincinnati, SG100011243</FP>
                    <HD SOURCE="HD1">Lucas County</HD>
                    <FP SOURCE="FP-1">Webster School, 424 E Manhattan Boulevard, Toledo, SG100011235</FP>
                    <HD SOURCE="HD1">Medina County</HD>
                    <FP SOURCE="FP-1">McDowell, R.M. and Elizabeth, House, 205 South Prospect Street, Medina, SG100011234</FP>
                    <HD SOURCE="HD1">Union County</HD>
                    <FP SOURCE="FP-1">Marysville Light and Water Company Plant, 409 North Main Street, Marysville, SG100011257</FP>
                    <HD SOURCE="HD1">PENNSYLVANIA</HD>
                    <HD SOURCE="HD1">Allegheny County</HD>
                    <FP SOURCE="FP-1">Schenley Farms Historic District (Boundary Increase II), Approx. intersection of Bigelow Blvd. and N Dithridge St., Pittsburgh, BC100011241</FP>
                    <HD SOURCE="HD1">Armstrong County</HD>
                    <FP SOURCE="FP-1">Kittanning Passenger Station and Freight Depot, N Grant Avenue and Reynolds Avenue, Kittanning, SG100011233</FP>
                    <HD SOURCE="HD1">Lehigh County</HD>
                    <FP SOURCE="FP-1">Valley of Allentown Scottish Rite Cathedral, 1533 Hamilton Street, Allentown, SG100011246</FP>
                    <HD SOURCE="HD1">Philadelphia County</HD>
                    <FP SOURCE="FP-1">Continental Building, 400 Market Street, Philadelphia, SG100011231</FP>
                    <FP SOURCE="FP-1">St. Elisabeth's Episcopal Church, 1900 S 16th Street, Philadelphia, SG100011232</FP>
                    <FP SOURCE="FP-1">Willow Steam Plant, 411-419 N 9th Street, Philadelphia, SG100011244</FP>
                    <HD SOURCE="HD1">SOUTH CAROLINA</HD>
                    <HD SOURCE="HD1">Aiken County</HD>
                    <FP SOURCE="FP-1">Commercial Hotel, 235 Richland Avenue West, Aiken, SG100011230</FP>
                    <HD SOURCE="HD1">Greenwood County</HD>
                    <FP SOURCE="FP-1">Edgewood School (Equalization Schools in South Carolina, 1951-1960), 200 Edgewood Street, Ninety Six, MP100011212</FP>
                    <HD SOURCE="HD1">Richland County</HD>
                    <FP SOURCE="FP-1">Bob Russell Realty Building, 1931 Assembly Street and 1022 Calhoun Street, Columbia, SG100011213</FP>
                    <HD SOURCE="HD1">WISCONSIN</HD>
                    <HD SOURCE="HD1">Vilas County</HD>
                    <FP SOURCE="FP-1">Eagle River Downtown Historic District, 100-114 E Division St., 105-128 S Railroad St., 100-218 and 221-223 E Wall St., 118-123 S Main St., and 6 W Wall St., Eagle River, SG100011229</FP>
                </EXTRACT>
                <P>Additional documentation has been received for the following resource(s):</P>
                <EXTRACT>
                    <HD SOURCE="HD1">ARIZONA</HD>
                    <HD SOURCE="HD1">Maricopa County</HD>
                    <FP SOURCE="FP-1">Story, F.Q., Neighborhood Historic District (Boundary Increase) (Additional Documentation), Roughly bounded by 17th Ave., Culver St., 15th Ave. and Lynwood St., also lots on Roosevelt St. and McDowell Rd., Phoenix, AD92001834</FP>
                    <HD SOURCE="HD1">DISTRICT OF COLUMBIA</HD>
                    <HD SOURCE="HD1">District of Columbia</HD>
                    <FP SOURCE="FP-1">Lockkeeper's House, C &amp; O Canal Extension (Additional Documentation), SW corner of 17th St. and Constitution Ave. NW, Washington, AD73000218</FP>
                    <HD SOURCE="HD1">ILLINOIS</HD>
                    <HD SOURCE="HD1">Cook County</HD>
                    <FP SOURCE="FP-1">Immaculata High School (Additional Documentation), 600 W Irving Park Rd., Chicago, AD77000476</FP>
                    <HD SOURCE="HD1">INDIANA</HD>
                    <HD SOURCE="HD1">Marion County</HD>
                    <FP SOURCE="FP-1">
                        Washington Street-Monument Circle Historic District (Additional Documentation), 
                        <PRTPAGE P="99275"/>
                        Roughly bounded by Delaware, Ohio, Capitol, and W Maryland Sts., Indianapolis, AD97001179
                    </FP>
                    <HD SOURCE="HD1">MAINE</HD>
                    <HD SOURCE="HD1">Washington County</HD>
                    <FP SOURCE="FP-1">McCurdy Smokehouse (Additional Documentation), Water St., E side, at jct. with School St., Lubec, AD93000638</FP>
                    <HD SOURCE="HD1">MINNESOTA</HD>
                    <HD SOURCE="HD1">Dakota County</HD>
                    <FP SOURCE="FP-1">St. Stefan's Romanian Orthodox Church (Additional Documentation), 350 5th Ave. N, South St. Paul, AD04000461</FP>
                    <HD SOURCE="HD1">St. Louis County</HD>
                    <FP SOURCE="FP-1">Duluth Commercial Historic District (additional Documentation) (Duluth's Central Business District, MPS), Superior and 1st bet. 4th Ave. W and 4th Ave. E, Duluth, AD06000455</FP>
                    <HD SOURCE="HD1">PENNSYLVANIA</HD>
                    <HD SOURCE="HD1">Allegheny County</HD>
                    <FP SOURCE="FP-1">Schenley Farms Historic District (Additional Documentation), Roughly bounded by Andover Terr., Centre, Bellefield, and Parkman Aves., Ditbridge, Thackeray, Forbes and Mawhinney, Pittsburgh, AD83002213</FP>
                    <HD SOURCE="HD1">VIRGINIA</HD>
                    <HD SOURCE="HD1">Petersburg INDEPENDENT CITY</HD>
                    <FP SOURCE="FP-1">Petersburg Old Town Historic District (Additional Documentation), Bounded by Appomattox River and Norfolk Southern RR tracks; I95 and N Madison St.; to Bollingbrook St,. E Bank and W Bank St., Brick House Run, and Commerce St.; and to Dunlop St. and railroad bed of Seaboard Coast Line and piers Seaboard Air Line, Petersburg (Independent City), AD80004314</FP>
                    <HD SOURCE="HD1">WISCONSIN</HD>
                    <HD SOURCE="HD1">Milwaukee County</HD>
                    <FP SOURCE="FP-1">Pabst, Frederick and Maria, House, 2000 W Wisconsin Ave., Milwaukee, AD75000073</FP>
                </EXTRACT>
                <HD SOURCE="HD1">Nomination(s) Submitted by Federal Preservation Officers</HD>
                <P>The State Historic Preservation Officer reviewed the following nomination(s) and responded to the Federal Preservation Officer within 45 days of receipt of the nomination(s) and supports listing the properties in the National Register of Historic Places.</P>
                <EXTRACT>
                    <HD SOURCE="HD1">ARIZONA</HD>
                    <HD SOURCE="HD1">Yavapai County</HD>
                    <FP SOURCE="FP-1">Tuzigoot Developed Area Historic District (National Park Service Mission 66 Era Resources MPS), 25 West Tuzigoot Road, Tuzigoot National Monument (TUZI), Clarkdale, MP100011217</FP>
                </EXTRACT>
                <P>
                    <E T="03">Authority:</E>
                     Section 60.13 of 36 CFR part 60.
                </P>
                <SIG>
                    <NAME>Sherry A. Frear,</NAME>
                    <TITLE>Chief, National Register of Historic Places/National Historic Landmarks Program.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28981 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4312-52-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Office of Natural Resources Revenue</SUBAGY>
                <DEPDOC>[Docket No. ONRR-2011-0002; DS63636400 DRT000000.CH7000 256D1113RT]</DEPDOC>
                <SUBJECT>States' Decisions on Participating in Accounting and Auditing Relief for Federal Oil and Gas Marginal Properties</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Natural Resources Revenue, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with Office of Natural Resources Revenue (ONRR) regulations, ONRR provides two types of accounting and auditing relief for Federal oil and gas production from marginal properties: the cumulative royalty reports and payments relief option, which allows a lessee or designee to submit one royalty report and payment for the calendar year's production; and other requested relief, which allows a lessee or designee to request any type of accounting and auditing relief that is appropriate for production from the marginal property and meets certain requirements. By October 1 of each calendar year, ONRR provides a list of qualifying marginal Federal oil and gas properties to the States receiving a portion of Federal royalties from those properties. Each State then decides whether to participate in neither, one, or both relief options. This notice provides the public each State's decision on whether to participate in marginal property relief.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable January 1, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Mr. Robert Sudar, Market &amp; Spatial Analytics, Research, Enforcement, Guidance, and Appeals, ONRR, at (303) 231-3511; or by email to 
                        <E T="03">Robert.Sudar@onrr.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Pursuant to the Federal Oil and Gas Royalty Simplification and Fairness Act of 1996 (30 U.S.C. 1726) and 30 CFR part 1204, subpart C, ONRR and States can relieve the lessee of a marginal Federal oil and gas property from certain reporting, accounting, and auditing requirements. ONRR's rules under 30 CFR 1204.202 and 1204.203 authorize two relief options: (1) cumulative royalty reports and payments relief option, which allows a lessee or designee to submit one royalty report and payment during a calendar year; and (2) other requested relief, which allows a lessee or designee to request any type of appropriate marginal property accounting and auditing relief that meets the requirements under § 1204.5 and is not prohibited under § 1204.204.</P>
                <P>
                    To qualify for the first relief option, 
                    <E T="03">cumulative royalty reports and payments relief option,</E>
                     properties must produce less than 1,000 barrels-of-oil-equivalent (BOE) per year for the base period (July 1, 2023, through June 30, 2024). Annual reporting relief will begin January 1, 2025, with the annual report and payment due February 28, 2026. If a lessee has an estimated payment on file, the payment due date is March 31, 2026. To qualify for the second relief option, 
                    <E T="03">other requested relief,</E>
                     the combined equivalent production of the marginal properties during the base period must equal an average daily well production of less than 15 BOE per well per day, as calculated under 30 CFR 1204.4(c).
                </P>
                <P>
                    Each State makes an annual determination as to whether it will participate in neither, one, or both relief options. This notice fulfills the requirement in ONRR's rules to publish a notice of each State's “intent to allow or not allow certain relief options . . . in the 
                    <E T="04">Federal Register</E>
                     no later than 30 days before the beginning of the applicable calendar year.” 
                    <E T="03">See</E>
                     30 CFR 1204.208(f).
                </P>
                <P>The following table shows the States with qualifying marginal properties and those States' decisions on whether to participate in neither, one, or both relief options for calendar year 2025. An “N/A” means that no properties within the State met that condition for that type of relief:</P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s100,xs80,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">State</CHED>
                        <CHED H="1">
                            Cumulative
                            <LI>royalty report and</LI>
                            <LI>payment relief</LI>
                            <LI>(less than 1,000 BOE per year)</LI>
                        </CHED>
                        <CHED H="1">
                            Other accounting and auditing relief
                            <LI>(less than 15 BOE per well per day)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Alabama</ENT>
                        <ENT>No</ENT>
                        <ENT>No.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Arkansas</ENT>
                        <ENT>N/A</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="99276"/>
                        <ENT I="01">California</ENT>
                        <ENT>No</ENT>
                        <ENT>No.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Colorado</ENT>
                        <ENT>No</ENT>
                        <ENT>No.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Kansas</ENT>
                        <ENT>No</ENT>
                        <ENT>No.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Louisiana</ENT>
                        <ENT>Yes</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Montana</ENT>
                        <ENT>No</ENT>
                        <ENT>No.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Nebraska</ENT>
                        <ENT>Yes</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Nevada</ENT>
                        <ENT>Yes</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">New Mexico</ENT>
                        <ENT>No</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">North Dakota</ENT>
                        <ENT>Yes</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Oklahoma</ENT>
                        <ENT>Yes</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">South Dakota</ENT>
                        <ENT>Yes</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Utah</ENT>
                        <ENT>No</ENT>
                        <ENT>No.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wyoming</ENT>
                        <ENT>Yes</ENT>
                        <ENT>No.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Pursuant to 30 U.S.C. 1726(c), a Federal oil and gas property located in a State where ONRR does not share a portion of Federal royalties with that State (that is, for 2025, a State not listed in the table above) is eligible for relief if it qualifies as a marginal property. For more information on how to obtain relief, please refer to 30 CFR 1204.205.</P>
                <P>
                    Unless the information that ONRR receives is proprietary data, all correspondence, records, or information received in response to this notice may be subject to disclosure under the Freedom of Information Act (FOIA, 5 U.S.C. 552 
                    <E T="03">et seq.</E>
                    ). If applicable, please highlight the proprietary portions, including any supporting documentation, or mark the page(s) containing proprietary data. ONRR protects proprietary information under the Trade Secrets Act (18 U.S.C. 1905), FOIA Exemption 4 (5 U.S.C. 552(b)(4)), and the Department of the Interior's FOIA regulations (43 CFR part 2).
                </P>
                <P>
                    <E T="03">Authority:</E>
                     Federal Oil and Gas Royalty Management Act of 1982, 30 U.S.C. 1701 
                    <E T="03">et seq.,</E>
                     as amended by Federal Oil and Gas Royalty Simplification and Fairness Act of 1996 (RSFA, Pub. L. 104-185—Aug. 13, 1996, as corrected by Pub. L. 104-200—Sept. 22, 1996).
                </P>
                <SIG>
                    <NAME>Howard M. Cantor,</NAME>
                    <TITLE>Director, Office of Natural Resources Revenue.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28876 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4335-30-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Office of Surface Mining Reclamation and Enforcement</SUBAGY>
                <DEPDOC>[S1D1S SS08011000 SX064A000 256S180110; S2D2S SS08011000 SX064A000 25XS501520; OMB Control Number 1029-0089]</DEPDOC>
                <SUBJECT>Submission to the Office of Management and Budget for Review and Approval; Exemption for Coal Extraction Incidental to the Extraction of Other Minerals</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Surface Mining Reclamation and Enforcement, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are proposing to renew an information collection.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send your comments on this information collection request (ICR) by mail to Mark Gehlhar, Office of Surface Mining Reclamation and Enforcement, 1849 C Street NW, Room 1544-MIB, Washington, DC 20240, or by email to 
                        <E T="03">mgehlhar@osmre.gov.</E>
                         Please reference OMB Control Number 1029-0089 in the subject line of your comments.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request additional information about this ICR, contact Mark Gehlhar by email at 
                        <E T="03">mgehlhar@osmre.gov,</E>
                         or by telephone at 202-208-2716. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States. You may also view the ICR at 
                        <E T="03">http://www.reginfo.gov/public/do/PRAMain.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) and 5 CFR 1320.8(d)(1), we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
                </P>
                <P>We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) is the collection necessary to the proper functions of the agency; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the agency enhance the quality, utility, and clarity of the information to be collected; and (5) how might the agency minimize the burden of this collection on the respondents, including through the use of information technology.</P>
                <P>
                    Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may 
                    <PRTPAGE P="99277"/>
                    be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This Part implements the requirement in section 701(28) of the Surface Mining Control and Reclamation Act of 1977 (SMCRA), which grants an exemption from the requirements of SMCRA to operators extracting not more than 16
                    <FR>2/3</FR>
                     percentage tonnage of coal incidental to the extraction of other minerals. This information will be used by the regulatory authorities to make that determination.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Exemption for Coal Extraction Incidental to the Extraction of Other Minerals.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1029-0089.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     None.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Respondents/Affected Public:</E>
                     State and Tribal governments.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Respondents:</E>
                     67.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     206.
                </P>
                <P>
                    <E T="03">Estimated Completion Time per Response:</E>
                     Varies 1 hour to 30 hours, depending on activity.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     734.
                </P>
                <P>
                    <E T="03">Respondent's Obligation:</E>
                     Required to obtain or retain a benefit.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     One time.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Nonhour Burden Cost:</E>
                     $800.
                </P>
                <P>An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.</P>
                <P>
                    The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <SIG>
                    <NAME>Mark J. Gehlhar,</NAME>
                    <TITLE>Information Collection Clearance Officer, Office of Surface Mining Reclamation and Enforcement.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28997 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4310-05-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">INTERNATIONAL TRADE COMMISSION</AGENCY>
                <DEPDOC>[Investigation No. 337-TA-1391]</DEPDOC>
                <SUBJECT>Certain Networking Equipment Supporting NETCONF; Notice of the Commission's Determination To Review and Affirm Order No. 19 Granting Summary Determination Finding No Infringement, Review and Vacate Order No. 23, and Grant in Part Third Party Xenogenic Development, LLC's Motion To Intervene; Termination of the Investigation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. International Trade Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Notice is hereby given that the U.S. International Trade Commission (“Commission”) has determined that no violation of section 337 in the above-captioned investigation has occurred. The Commission has determined to review an initial determination granting summary determination of non-infringement (Order No. 19) and affirm the Order No. 19 finding of no infringement with supplemented reasoning. The Commission has further determined to review and vacate Order No. 23, and grant in part third party Xenogenic Development, LLC's (“Xenogenic”) motion to intervene. The investigation is terminated.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jonathan Link, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-3103. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission's electronic docket (EDIS) at 
                        <E T="03">https://edis.usitc.gov.</E>
                         For help accessing EDIS, please email 
                        <E T="03">EDIS3Help@usitc.gov.</E>
                         General information concerning the Commission may also be obtained by accessing its internet server at 
                        <E T="03">https://www.usitc.gov.</E>
                         Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Commission instituted this investigation on March 4, 2024, based on a complaint filed by Optimum Communications Services, Inc. of Jersey City, New Jersey (“Complainant”). 89 FR 15611-12 (Mar. 4, 2024). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain network equipment supporting NETCONF by reason of infringement of certain claims of U.S. Patent Nos. 10,567,474 and 10,848,546 (“Asserted Patents”). 
                    <E T="03">Id.</E>
                     The complaint further alleges that a domestic industry exists. 
                    <E T="03">Id.</E>
                     The Commission's notice of investigation named as respondents: Changsha Silun Network Technology Co., Ltd. of Hunan, China; Hunan Maiqiang Network Technology Company Limited of Hunan, China; Hunan Zikun Information Technology Co., Ltd. of Hunan, China; and Guangzhou Qiton Electronics Technology Co., Ltd. of Guangdong, China (collectively, “Respondents”). 
                    <E T="03">Id.</E>
                     OUII is participating as a party in this investigation. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    On June 13, 2024, the Commission found the Respondents in default for failing to respond to the complaint, notice of investigation, or previous order to show cause (Order No. 8). Order No. 9, 
                    <E T="03">unreviewed by</E>
                     Comm'n Notice (June 13, 2024).
                </P>
                <P>On June 28, 2024, Complainant filed a motion for summary determination of violation and requested the issuance of a general exclusion order. On July 10, 2024, OUII filed a confidential response opposing the summary determination motion.</P>
                <P>
                    On September 19, 2024, the Commission determined not to review an initial determination declassifying OUII's response to Complainant's motion for summary determination and supporting memorandum. Order No. 13, 
                    <E T="03">unreviewed by,</E>
                     Comm'n Notice (September 20, 2024).
                </P>
                <P>On August 8, 2024, third party Xenogenic Development LLC (“Xenogenic”) filed a motion to intervene, stay the proceedings on the merits, and dismiss the investigation. On August 16, 2024, Complainant filed a response opposing the motion. On August 20, 2024, OUII filed a response in support of Xenogenic's motion to intervene and for termination of the investigation but opposed a stay of the investigation. On August 23, 2024, Xenogenic filed a reply in support of its motion. On August 27, 2024, Complainant filed a sur-reply opposing the motion.</P>
                <P>
                    On September 18, 2024, OUII filed a motion for summary determination arguing that Complainant cannot show that the accused products infringe the asserted claims of the Asserted Patents, and that the investigation should be terminated with a finding of no violation of section 337. On September 26, 2024, Complainant filed an 
                    <PRTPAGE P="99278"/>
                    opposition to the motion. OUII filed its reply on October 1, 2024.
                </P>
                <P>On October 18, 2024, the ALJ issued Order No. 19 granting-in-part OUII's motion for summary determination and finding no violation. On October 25, 2024, Complainant filed a petition for review of the ID in Order No. 19. On November 1, 2024, OUII filed a response to Complainant's petition for review of the ID in Order No. 19.</P>
                <P>On October 18, 2024, the ALJ also issued Order No. 20, asking the parties to brief whether the investigation should be terminated in its entirety and whether all remaining motions are moot and/or withdrawn in light of Order No. 19. On October 28, 2024, Complainant responded to Order No. 20, opposing terminating the investigation. On October 28, 2024, OUII responded to Order No. 20 supporting termination of the investigation and Xenogenic responded requesting the ALJ to grant its motion to intervene. On November 4, 2024, Complainant filed a reply regarding Order No. 20, opposing terminating the investigation.</P>
                <P>On November 8, 2024, the ALJ issued Order No. 23 granting Xenogenic's motion to intervene and terminating the investigation. On November 9, 2024, Complainant filed a petition to review the ID in Order No. 23. On November 18, 2024, OUII filed a response in opposition to Complainant' petition to review of Order No. 23.</P>
                <P>Having considered the record in this investigation, including the complaint, the filings before the ALJ and the Commission, the Commission has determined to review Order No. 19. On review, the Commission affirms Order No. 19 finding no infringement of the asserted patents with the following supplementation: (1) on page 18 of the ID, the Commission supplements the citation to 19 CFR 210.18(a)-(b) to also include 19 CFR 210.18(c); and (2) on page 26 of the ID, the Commission adds a citation to Exhibit 14 of OUII's motion for summary determination, which is RFC 7950 entitled “The YANG 1.1 Data Modeling Language” (in addition to already cited Exhibits 13, 15, and 16 from OUII's motion for summary determination).</P>
                <P>The Commission has further determined to review and vacate Order No. 23. Order No. 19 finds that there is no infringement of the Asserted Patents and that no violation of section 337 has occurred. Affirmance of Order No. 19 would result in termination of the investigation, and thereby, the Commission finds that as of the time of issuance of Order No. 23 the investigation was already pending before the Commission. However, the Commission has determined to grant third party Xenogenic's motion to intervene for the limited purpose of addressing ownership of the Asserted Patents. Regardless of ownership, the Commission's finding of no infringement results in a finding of no violation and the investigation is terminated.</P>
                <P>The Commission vote for this determination took place on December 4, 2024.</P>
                <P>The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).</P>
                <SIG>
                    <P>By order of the Commission.</P>
                    <DATED>Issued: December 4, 2024.</DATED>
                    <NAME>Lisa Barton,</NAME>
                    <TITLE>Secretary to the Commission.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28925 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7020-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">INTERNATIONAL TRADE COMMISSION</AGENCY>
                <DEPDOC>[Investigation No. 337-TA-1370]</DEPDOC>
                <SUBJECT>Certain Power Converter Modules and Computing Systems Containing the Same; Notice of a Commission Determination To Review in Part a Final Initial Determination Finding a Violation of Section 337; Request for Written Submissions on the Issues Under Review and on Remedy, the Public Interest, and Bonding</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. International Trade Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Notice is hereby given that the U.S. International Trade Commission has determined to review in part a final initial determination (“final ID”) issued by the presiding administrative law judge (“ALJ”) on September 24, 2024, finding a violation of section 337 in the above referenced investigation. The Commission requests written submissions from the parties on certain issues under review, as indicated in this notice, and submissions from the parties, interested government agencies, and other interested persons on the issues of remedy, the public interest, and bonding, under the schedule set forth below.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Joelle Justus, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2593. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission's electronic docket (EDIS) at 
                        <E T="03">https://edis.usitc.gov.</E>
                         For help accessing EDIS, please email 
                        <E T="03">EDIS3Help@usitc.gov.</E>
                         General information concerning the Commission may also be obtained by accessing its internet server at 
                        <E T="03">https://www.usitc.gov.</E>
                         Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On August 17, 2023, the Commission instituted this investigation under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”), based on a complaint filed by Vicor Corporation (“Complainant” or “Vicor”) of Andover, Massachusetts. 
                    <E T="03">See</E>
                     88 FR 56050 through 56051 (Aug. 17, 2023). The complaint, as supplemented, alleges a violation of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain power converter modules and computing systems containing the same by reason of the infringement of certain claims of U.S. Patent Nos. 9,166,481; 9,516,761; and 10,199,950. 
                    <E T="03">See id.</E>
                     The notice of investigation names the following respondents: Delta Electronics, Inc. of Taipei, Taiwan; Delta Electronics (Americas) Ltd. of Fremont, California; Delta Electronics (USA) Inc. of Plano, Texas; Cyntec Co., Ltd. of Hsinchu, Taiwan; Quanta Computer Inc. and Quanta Cloud Technology Inc., both of Taoyuan City, Taiwan; Quanta Cloud Technology USA LLC of San Jose, California; Quanta Computer USA Inc. of Fremont, California; Hon Hai Precision Industry Co. Ltd. (d/b/a, Foxconn Technology Group) of Taipei City, Taiwan; Foxconn Industrial internet Co. Ltd. of Shenzhen, China; FII USA Inc. (a/k/a Foxconn Industrial, internet USA Inc.) of Milwaukee, Wisconsin; Ingrasys Technology Inc. of Taoyuan City, Taiwan; and Ingrasys Technology USA Inc. of Fremont, California (collectively, “Respondents”). 
                    <E T="03">See id.</E>
                     The Office of Unfair Import Investigations (“OUII”) is also a party to the investigation. 
                    <E T="03">See id.</E>
                </P>
                <P>
                    On January 25, 2024, the Commission partially terminated the investigation as to respondents Delta Electronics (USA) Inc., Quanta Cloud Technology Inc., and Quanta Cloud Technology USA LLC based on withdrawal of the complaint as to those respondents. 
                    <E T="03">See</E>
                     Order No. 16 (Dec. 22, 2023), 
                    <E T="03">unreviewed by</E>
                     Comm'n Notice (Jan. 25, 2024).
                    <PRTPAGE P="99279"/>
                </P>
                <P>
                    On January 26, 2024, the Commission amended the complaint and notice of investigation to add DET Logistics (USA) Corporation of Fremont, California as a respondent. 
                    <E T="03">See</E>
                     Order No. 18 (Jan. 2, 2024), 
                    <E T="03">unreviewed by</E>
                     Comm'n Notice (Jan. 26, 2024).
                </P>
                <P>
                    On March 22, 2024, the ALJ granted in part Respondents' motion for summary determination, specifically as to no infringement of any patent under the doctrine of equivalents. 
                    <E T="03">See</E>
                     Order No. 37. The Commission determined not to review the partial grant of summary determination. 
                    <E T="03">See</E>
                     Comm'n Notice (Apr. 23, 2024).
                </P>
                <P>
                    On September 27, 2024, the ALJ issued the final ID finding that a violation of section 337 has occurred. The Final ID finds, 
                    <E T="03">inter alia:</E>
                     (1) as to the '481 patent, the accused Cyntec products infringe asserted claim 1 but that the accused Delta products and certain asserted redesign products do not infringe claim 1, asserted claim 1 is not invalid, and certain asserted domestic industry products practice asserted claim 1; (2) as to the '761 patent, the accused Delta products infringe asserted claims 1-7, claims 1-3 and 7 are invalid as anticipated, claims 4-6 are not invalid for obviousness or indefiniteness, and the asserted domestic industry products practice claims 1-7; (3) as to the '950 patent, the accused Delta and Cyntec products do not infringe asserted claims 9, 13, 14, and 33-38, the asserted claims are not invalid for obviousness, and the domestic industry products do not practice any asserted claim; (4) Respondents do not have a license to practice the asserted patents; and (5) Vicor has satisfied the domestic industry requirement of section 337 with respect to each of the asserted patents.
                </P>
                <P>The ALJ also issued a Recommended Determination on remedy and bonding (“RD”). The RD recommends that, if the Commission finds a violation, it should issue a limited exclusion order. The RD also recommends the issuance of cease and desist orders as to all Respondents. The RD further recommended that the Commission set no bond as to Cyntec's products and various bond amounts as to the other infringing products during the period of Presidential review.</P>
                <P>
                    On October 29, 2024, Complainant and respondent FII USA submitted public interest comments pursuant to Commission Rule 210.50(a)(4) (19 CFR 210.50(a)(4)). No submissions were filed in response to the Commission's 
                    <E T="04">Federal Register</E>
                     notice seeking submissions on the public interest. 
                    <E T="03">See</E>
                     89 FR 80604 through 80605 (Oct. 3, 2024).
                </P>
                <P>On October 11, 2024, Vicor filed a petition for review of the Final ID's findings concerning: (1) as to the '481 patent, no infringement by the Delta accused products, and certain aspects of the Final ID's validity analysis; (2) as to the '761 patent, that certain claims are invalid as anticipated and certain subsidiary aspect of the Final ID's remaining validity analysis; (3) as to the '950 patent, no infringement, no technical domestic industry, and certain aspects of the Final ID's economic prong analysis; and (4) as to all patents, no copying (secondary indicia of non-obviousness). Also on October 11, 2024, Respondents filed a petition for review of the Final ID's findings concerning: (1) as to the '481 patent, that claim 1 is not invalid as obvious; (2) as to the '761 patent, that the accused products infringe the asserted claims and claims 4-6 are not invalid as obvious; (3) as to the '950 patent, that the asserted claims are not invalid as obvious; (4) certain of the ALJ's pre-hearing orders; and (5) that Vicor has satisfied the economic prong as to each Asserted Patent. On October 21, 2024, OUII filed a combined response to the petitions. On October 22, 2024, Vicor and Respondents each filed responses to the other party's petition.</P>
                <P>
                    Having examined the record in this investigation, including the final ID, the petitions for review, and the responses thereto, the Commission has determined to review the final ID in part. Specifically, the Commission has determined to review the final ID's findings regarding: (1) as to the '481 patent, whether the accused Delta products 
                    <SU>1</SU>
                    <FTREF/>
                     infringe claim 1 and whether Vicor has demonstrated commercial success to overcome a finding of prima facie obviousness; (2) as to the '761 patent, whether the accused Delta products infringe asserted claims 1-7 and whether the asserted claims are valid; (3) as to the '950 patent, whether the accused Delta and Cyntec products and redesigned products infringe asserted claims 9, 13, 14, and 33-36 and whether Vicor has satisfied the technical prong of the domestic industry requirement; (4) whether Vicor has satisfied the economic prong of the domestic industry requirement as to all of the asserted patents; and (5) the license defense asserted by respondents FII USA, Inc., Ingrasys Technology, Inc., and Ingrasys Technology USA Inc. (collectively, “Foxconn”). The Commission has determined not to review the remainder of the Final ID's findings.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Unless otherwise indicated “accused products” does not include redesigned products. 
                        <E T="03">See</E>
                         Final ID at 9-10.
                    </P>
                </FTNT>
                <P>In connection with its review, the Commission requests responses to the following questions. The parties are requested to brief their positions with reference to the applicable law and the existing evidentiary record.</P>
                <P>1. With respect to the '761 patent:</P>
                <P>a. What is the proper claim construction of the term “magnetically coupled”? Applying the proper construction, do the accused products infringe claim 1?</P>
                <P>b. Do the terms “dissipate power” and “heat generation” as recited in claim 1 have distinct meanings? Do the accused products practice both limitations?</P>
                <P>
                    c. With reference to 
                    <E T="03">Fox Factory, Inc.</E>
                     v. 
                    <E T="03">SRAM, LLC,</E>
                     944 F.3d 1366 (Fed. Cir. 2019), are the domestic industry products “coextensive” with the claimed invention for purposes of commercial success?
                </P>
                <P>2. With respect to the '950 patent:</P>
                <P>a. What is the proper claim construction of the terms “input circuit” and “output circuit” as recited in the asserted claims? Applying the proper construction, do the accused and redesigned products infringe the asserted claims?</P>
                <P>
                    b. How, if at all, is the phase of operation relevant to the determination of whether the accused and redesigned products satisfy the limitation that “an input voltage V
                    <E T="52">IN</E>
                     is applied to the input circuit”?
                </P>
                <P>3. With respect to the economic prong of the domestic industry requirement:</P>
                <P>
                    Does the record permit allocation of the overall payments made by Complainant to foreign IC Vendors, 
                    <E T="03">see</E>
                     Final ID at 198, to the DI products for each of the Asserted Patents? If so, please provide such allocations.
                </P>
                <P>4. With respect to Foxconn's license defense:</P>
                <P>
                    a. With citation to legal authority (binding or persuasive) interpreting Massachusetts General Law (“MGL”) 106 section 2-207, Uniform Commercial Code section 2-207, or any other relevant provision, is there a binding agreement between Complainant and the Foxconn respondents that includes the license provision set forth in General Term 10 of the Foxconn purchase orders (
                    <E T="03">see</E>
                     RX-1630C.0002; RX-1635C.0002; RX-16359.0002)? If such an agreement exists, does MGL 106 section 2-207(2) or 2-207(3) govern what terms are part of the agreement?
                </P>
                <P>
                    b. In addition to any issues the parties deem relevant, the parties should address whether the purported acceptance of the alleged offers was “sent within a reasonable time” (MGL 106 section 2-207(1)) in light of Note 3 
                    <PRTPAGE P="99280"/>
                    of the Foxconn purchase orders (
                    <E T="03">see</E>
                     RX-1630C.0001; RX-1635C.0001; RX-1639C.0001).
                </P>
                <P>c. If there is a binding agreement between Complainant and the Foxconn respondents including the license provision, to which Respondents, Asserted Patents, and accused products does that license apply?</P>
                <P>The parties are invited to brief only the discrete issues requested above. The parties are not to brief other issues on review, which are adequately presented in the parties' existing filings.</P>
                <P>
                    In connection with the final disposition of this investigation, the statute authorizes issuance of, 
                    <E T="03">inter alia,</E>
                     (1) an exclusion order that could result in the exclusion of the subject articles from entry into the United States; and/or (2) a cease and desist order that could result in the respondent being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see 
                    <E T="03">Certain Devices for Connecting Computers via Telephone Lines,</E>
                     Inv. No. 337-TA-360, USITC Pub. No. 2843, Comm'n Op. at 7-10 (Dec. 1994).
                </P>
                <P>The statute requires the Commission to consider the effects of that remedy upon the public interest. The public interest factors the Commission will consider include the effect that an exclusion order and cease and desist order would have on: (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.</P>
                <P>
                    If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve, disapprove, or take no action on the Commission's determination. 
                    <E T="03">See</E>
                     Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005). During this period, the subject articles would be entitled to enter the United States under bond, in an amount determined by the Commission and prescribed by the Secretary of the Treasury. The Commission is therefore interested in receiving submissions concerning the amount of the bond that should be imposed if a remedy is ordered.
                </P>
                <P>
                    <E T="03">Written Submissions:</E>
                     The parties to the investigation are requested to file written submissions on the issues identified in this notice. Parties to the investigation, interested government agencies, and any other interested parties are encouraged to file written submissions on the issues of remedy, the public interest, and bonding. Such submissions should address the recommended determination by the ALJ on remedy and bonding.
                </P>
                <P>In its initial submission, Complainant is also requested to identify the remedy sought and to submit proposed remedial orders for the Commission's consideration. Complainant is further requested to provide the HTSUS subheadings under which the accused products are imported, and to supply the identification information for all known importers of the products at issue in this investigation. The initial written submissions and proposed remedial orders must be filed no later than close of business on December 18, 2024. Reply submissions must be filed no later than the close of business on December 27, 2024. No further submissions on these issues will be permitted unless otherwise ordered by the Commission. Opening submissions are limited to 50 pages. Reply submissions are limited to 30 pages. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission.</P>
                <P>
                    Persons filing written submissions must file the original document electronically on or before the deadlines stated above. The Commission's paper filing requirements in 19 CFR 210.4(f) are currently waived. 85 FR 15798 (Mar. 19, 2020). Submissions should refer to the investigation number (Inv. No. 337-TA-1370) in a prominent place on the cover page and/or the first page. (
                    <E T="03">See</E>
                     Handbook for Electronic Filing Procedures, 
                    <E T="03">https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf</E>
                    ). Persons with questions regarding filing should contact the Secretary, (202) 205-2000.
                </P>
                <P>Any person desiring to submit a document to the Commission in confidence must request confidential treatment by marking each document with a header indicating that the document contains confidential information. This marking will be deemed to satisfy the request procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) &amp; 210.5(e)(2)). Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. Any non-party wishing to submit comments containing confidential information must serve those comments on the parties to the investigation pursuant to the applicable Administrative Protective Order. A redacted non-confidential version of the document must also be filed with the Commission and served on any parties to the investigation within two business days of any confidential filing. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. appendix 3; or (ii) by U.S. Government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential written submissions will be available for public inspection on EDIS.</P>
                <P>The Commission vote for this determination took place on December 4, 2024.</P>
                <P>The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).</P>
                <SIG>
                    <P>By order of the Commission.</P>
                    <DATED>Issued: December 4, 2024.</DATED>
                    <NAME>Lisa Barton,</NAME>
                    <TITLE>Secretary to the Commission.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28935 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7020-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="99281"/>
                <AGENCY TYPE="S">INTERNATIONAL TRADE COMMISSION</AGENCY>
                <DEPDOC>[Investigation Nos. 731-TA-929-931 (Fourth Review)]</DEPDOC>
                <SUBJECT>Silicomanganese From India, Kazakhstan, and Venezuela Determinations</SUBJECT>
                <P>
                    On the basis of the record 
                    <SU>1</SU>
                    <FTREF/>
                     developed in the subject five-year reviews, the United States International Trade Commission (“Commission”) determines, pursuant to the Tariff Act of 1930 (“the Act”), that revocation of the antidumping duty orders on silicomanganese from India, Kazakhstan, and Venezuela would be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The record is defined in § 207.2(f) of the Commission's Rules of Practice and Procedure (19 CFR 207.2(f)).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Background</HD>
                <P>The Commission instituted these reviews on May 1, 2024 (89 FR 35247) and determined on August 5, 2024, that it would conduct expedited reviews (89 FR 77542, September 23, 2024).</P>
                <P>
                    The Commission made these determinations pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It completed and filed its determinations in these reviews on December 4, 2024. The views of the Commission are contained in USITC Publication 5567 (December 2024), entitled 
                    <E T="03">Silicomanganese from India, Kazakhstan, and Venezuela: Investigation Nos. 731-TA-929-931 (Fourth Review).</E>
                </P>
                <SIG>
                    <P>By order of the Commission.</P>
                    <DATED>Issued: December 5, 2024.</DATED>
                    <NAME>Lisa Barton,</NAME>
                    <TITLE>Secretary to the Commission.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28982 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7020-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">INTERNATIONAL TRADE COMMISSION</AGENCY>
                <DEPDOC>[Investigation Nos. 701-TA-741 and 731-TA-1718-1719 (Preliminary)]</DEPDOC>
                <SUBJECT>Paper File Folders From Cambodia and Sri Lanka</SUBJECT>
                <HD SOURCE="HD1">Determinations</HD>
                <P>
                    On the basis of the record 
                    <SU>1</SU>
                    <FTREF/>
                     developed in the subject investigations, the United States International Trade Commission (“Commission”) determines, pursuant to the Tariff Act of 1930 (“the Act”), that there is a reasonable indication that an industry in the United States is materially injured by reason of imports of paper file folders from Cambodia and Sri Lanka, provided for in subheading 4820.30.00 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value (“LTFV”) and imports of the subject merchandise from Cambodia that are alleged to be subsidized by the government of Cambodia.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The record is defined in § 207.2(f) of the Commission's Rules of Practice and Procedure (19 CFR 207.2(f)).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         89 FR 91322 and 91331 (November 19, 2024).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Commencement of Final Phase Investigations</HD>
                <P>
                    Pursuant to section 207.18 of the Commission's rules, the Commission also gives notice of the commencement of the final phase of its investigations. The Commission will issue a final phase notice of scheduling, which will be published in the 
                    <E T="04">Federal Register</E>
                     as provided in § 207.21 of the Commission's rules, upon notice from the U.S. Department of Commerce (“Commerce”) of affirmative preliminary determinations in the investigations under §§ 703(b) or 733(b) of the Act, or, if the preliminary determinations are negative, upon notice of affirmative final determinations in those investigations under §§ 705(a) or 735(a) of the Act. Parties that filed entries of appearance in the preliminary phase of the investigations need not enter a separate appearance for the final phase of the investigations. Any other party may file an entry of appearance for the final phase of the investigations after publication of the final phase notice of scheduling. Industrial users, and, if the merchandise under investigation is sold at the retail level, representative consumer organizations have the right to appear as parties in Commission antidumping and countervailing duty investigations. The Secretary will prepare a public service list containing the names and addresses of all persons, or their representatives, who are parties to the investigations. As provided in section 207.20 of the Commission's rules, the Director of the Office of Investigations will circulate draft questionnaires for the final phase of the investigations to parties to the investigations, placing copies on the Commission's Electronic Document Information System (EDIS, 
                    <E T="03">https://edis.usitc.gov</E>
                    ), for comment.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>On October 21, 2024, the Coalition of Domestic Folder Manufacturers, Hastings, Minnesota, and Naperville, Illinois, filed petitions with the Commission and Commerce, alleging that an industry in the United States is materially injured or threatened with material injury by reason of subsidized imports of paper file folders from Cambodia and LTFV imports of paper file folders from Cambodia and Sri Lanka. Accordingly, effective October 21, 2024, the Commission instituted countervailing duty investigation No. 701-TA-741 and antidumping duty investigation Nos. 731-TA-1718-1719 (Preliminary).</P>
                <P>
                    Notice of the institution of the Commission's investigations and of a public conference to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the 
                    <E T="04">Federal Register</E>
                     of October 25, 2024 (89 FR 85234). The Commission conducted its conference on November 12, 2024. All persons who requested the opportunity were permitted to participate.
                </P>
                <P>
                    The Commission made these determinations pursuant to §§ 703(a) and 733(a) of the Act (19 U.S.C. 1671b(a) and 1673b(a)). It completed and filed its determinations in these investigations on December 5, 2024. The views of the Commission are contained in USITC Publication 5570 (December 2024), entitled 
                    <E T="03">Paper File Folders from Cambodia and Sri Lanka: Investigation Nos. 701-TA-741 and 731-TA-1718-1719 (Preliminary).</E>
                </P>
                <SIG>
                    <P>By order of the Commission.</P>
                    <DATED>Issued: December 5, 2024.</DATED>
                    <NAME>Lisa Barton,</NAME>
                    <TITLE>Secretary to the Commission.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28983 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7020-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>United States Marshals Service</SUBAGY>
                <DEPDOC>[OMB Number 1105-0105]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension Without Change or a Currently Approved Collection; Comments Requested: Form CSO-005, Preliminary Background Check Form</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Marshals Service, Department of Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Department of Justice (DOJ), U.S. Marshals Service (USMS), 
                        <PRTPAGE P="99282"/>
                        will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments are encouraged and will be accepted for 60 days until February 10, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any additional information, please contact Assistant Chief Karl Slazer/Management Support Division, US Marshals Service Headquarters, 1215 S Clark St., Ste. 10005, Arlington, VA 22202-4387, by telephone at 703-740-2316 or by email at 
                        <E T="03">karl.slazer@usdoj.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:</P>
                <FP SOURCE="FP-1">—Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;</FP>
                <FP SOURCE="FP-1">—Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;</FP>
                <FP SOURCE="FP-1">—Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and</FP>
                <FP SOURCE="FP-1">
                    —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses.
                </FP>
                <HD SOURCE="HD1">Overview of This Information Collection</HD>
                <P>
                    1. 
                    <E T="03">Type of Information Collection (</E>
                    check justification or form 83): Extension without change or a currently approved collection.
                </P>
                <P>
                    2. 
                    <E T="03">The Title of the Form/Collection:</E>
                     Form CSO-005, Preliminary Background Check Form.
                </P>
                <P>
                    3. 
                    <E T="03">The agency form number, if any, and the applicable component of the Department sponsoring the collection:</E>
                </P>
                <P>
                    <E T="03">Form number (if applicable):</E>
                     Form CSO-005.
                </P>
                <P>
                    <E T="03">Component:</E>
                     U.S. Marshals Service, U.S. Department of Justice.
                </P>
                <P>
                    4. 
                    <E T="03">Affected public who will be asked or required to respond, as well as a brief abstract:</E>
                </P>
                <P>
                    <E T="03">Primary:</E>
                     Court Security Officers/Special Security Officer (CSO/SSO) Applicants Other (if applicable): [None]
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The CSO-005 Preliminary Background Check Form is used to collect applicant information for CSO/SSO positions. The applicant information provided to USMS from the Vendor gives information about which District and Facility the applicant will be working, the applicant's personal information, prior employment verification, employment performance and current financial status. The information allows the selecting official to hire applicants with a strong history of employment performance and financial responsibility. The questions on this form have been developed from the OPM, MSPB and DOJ “Best Practice” guidelines for reference checking.
                </P>
                <P>
                    5. 
                    <E T="03">An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:</E>
                     An estimated 750 respondents will utilize the form, and it will take each respondent approximately 60 minutes to complete the form.
                </P>
                <P>
                    6. 
                    <E T="03">An estimate of the total public burden (in hours) associated with the collection:</E>
                     The estimated annual public burden associated with this collection is 750 hours, which is equal to (750 (total # of annual responses) * 1 (60 mins).
                </P>
                <P>7. An estimate of the total annual cost burden associated with the collection, if applicable:</P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,12,12,12,12,12">
                    <TTITLE>Total Burden Hours</TTITLE>
                    <BOXHD>
                        <CHED H="1">Activity</CHED>
                        <CHED H="1">
                            Number of
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Frequency
                            <LI>(annually)</LI>
                        </CHED>
                        <CHED H="1">
                            Total
                            <LI>annual</LI>
                            <LI>responses</LI>
                        </CHED>
                        <CHED H="1">
                            Time per
                            <LI>response</LI>
                            <LI>(min)</LI>
                        </CHED>
                        <CHED H="1">
                            Total
                            <LI>annual</LI>
                            <LI>burden</LI>
                            <LI>(hours)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW RUL="n,s">
                        <ENT I="01">Ex: Survey (individuals or households)</ENT>
                        <ENT>750</ENT>
                        <ENT>1</ENT>
                        <ENT>1000</ENT>
                        <ENT>60</ENT>
                        <ENT>750 </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">
                            <E T="03">Unduplicated Totals</E>
                        </ENT>
                        <ENT>
                            <E T="03">1000</E>
                        </ENT>
                        <ENT/>
                        <ENT>
                            <E T="03">1000</E>
                        </ENT>
                        <ENT/>
                        <ENT>
                            <E T="03">750</E>
                        </ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">Estimated Total Annual Cost Burden:</E>
                     $14,651.00.
                </P>
                <P>
                    <E T="03">If additional information is required contact:</E>
                     Darwin Arceo, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC.
                </P>
                <SIG>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>Darwin Arceo,</NAME>
                    <TITLE>Department Clearance Officer for PRA, U.S. Department of Justice.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28954 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-04-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employment and Training Administration</SUBAGY>
                <SUBJECT>Notice of the Federal Unemployment Tax Act (FUTA) Credit Reductions Applicable for 2024</SUBJECT>
                <P>Sections 3302(c)(2)(A) and 3302(d)(3) of FUTA provide that employers in a State that has outstanding advances under title XII of the Social Security Act on January 1 of two or more consecutive years are subject to a reduction in credits otherwise available against the FUTA tax for the calendar year in which the most recent such January 1 occurs, if advances remain on November 10 of that year. Further, section 3302(c)(2)(C) of FUTA provides for an additional credit reduction for a year if a state has outstanding advances on five or more consecutive January 1 and has a balance on November 10 for such years. Section 3302(c)(2)(C) provides for waiver of this additional credit reduction and substitution of the credit reduction provided in section 3302(c)(2)(B) if a state meets certain conditions.</P>
                <P>
                    California, Connecticut, New York, and the US Virgin Islands (USVI) had outstanding advances on January 1 for two or more consecutive years and employers in these States were potentially subject to a FUTA credit reduction in 2024. Connecticut repaid 
                    <PRTPAGE P="99283"/>
                    their outstanding advances before November 10, 2024, and as a result, employers in this state are not subject to a FUTA credit reduction for 2024. California and New York did not repay their outstanding advances before November 10, 2024, and had outstanding advances on January 1 for four consecutive years. Therefore, employers in California and New York are subject to a FUTA credit reduction of 0.9 percent for 2024.
                </P>
                <P>USVI has had outstanding advances on January 1 for 15 consecutive years. As a result, employers in USVI were potentially liable for the additional credit reduction under section 3302(c)(2)(C) of FUTA. The jurisdiction applied for the waiver of this additional credit reduction and the Employment and Training Administration determined that USVI met each of the criteria necessary to qualify for the waiver of the additional credit reduction. Therefore, employers in USVI will have no additional credit reduction applied for calendar year 2024. However, because USVI has had an outstanding advance on each January 1 from 2010 through 2024, and maintained an outstanding balance on November 10, 2024, employers in USVI are subject to a FUTA credit reduction of 4.2 percent in 2024.</P>
                <SIG>
                    <NAME>José Javier Rodríguez,</NAME>
                    <TITLE>Assistant Secretary for Employment and Training Administration.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28880 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-FW-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBJECT>Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notification of Methane Detected in Underground Metal and Nonmetal Mine Atmospheres</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Labor (DOL) is submitting this Mine Safety and Health Administration (MSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The OMB will consider all written comments that the agency receives on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael Howell by telephone at 202-693-6782, or by email at 
                        <E T="03">DOL_PRA_PUBLIC@dol.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Title 30 CFR 57.22004(c) requires operators of underground M/NM mines to notify the Mine Safety and Health Administration (MSHA) as soon as possible if any of the following events occur: (a) there is an outburst that results in 0.25 percent or more methane in the mine atmosphere, (b) there is a blowout that results in 0.25 percent or more methane in the mine atmosphere, (c) there is an ignition of methane, or (d) air sample results indicate 0.25 percent or more methane in the mine atmosphere of a I-B, I-C, II-B, V-B, or Category VI mine. Under §§ 57.22239 and 57.22231, if methane reaches 2.0 percent in a Category IV mine or if methane reaches 0.25 percent in the mine atmosphere of a Subcategory I-B, II-B, V-B, or VI mine, MSHA shall be notified immediately. Although the standards do not specify how MSHA is to be notified, MSHA anticipates that the notifications would be made by telephone.</P>
                <P>
                    Title 30 CFR 57.22229 and 57.22230 require that the mine atmosphere be tested for methane and/or carbon dioxide at least once every seven days by a competent person or atmospheric monitoring system or a combination of both. Section 57.2229 applies to underground M/NM mines categorized as I-A, III, and V-A mines where the atmosphere is tested for both methane and carbon dioxide. Section 57.22230 applies to underground M/NM mines categorized as II-A mines where the atmosphere is tested for methane. Where examinations disclose hazardous conditions, affected miners must be informed. Title 30 CFR 57.22229(d) and 57.22230(c) require that the person performing the tests certify by signature and date that the tests have been conducted. Certifications of examinations shall be kept for at least one year and made available to authorized representatives of the Secretary of Labor. For additional substantive information about this ICR, see the related notice published in the 
                    <E T="04">Federal Register</E>
                     on August 15, 2024 (89 FR 66454).
                </P>
                <P>
                    <E T="03">Comments are invited on:</E>
                     (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
                </P>
                <P>
                    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. 
                    <E T="03">See</E>
                     5 CFR 1320.5(a) and 1320.6.
                </P>
                <P>
                    <E T="03">Agency:</E>
                     DOL-MSHA.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Notification of Methane Detected in Underground Metal and Nonmetal Mine Atmospheres.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1219-0103.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses or other for-profits.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     4.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Number of Responses:</E>
                     213.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     18 hours.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Other Costs Burden:</E>
                     $0.
                </P>
                <EXTRACT>
                    <FP>(Authority: 44 U.S.C. 3507(a)(1)(D))</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Michael Howell,</NAME>
                    <TITLE>Senior Paperwork Reduction Act Analyst.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28878 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBJECT>Agency Information Collection Activities; Submission for OMB Review; Comment Request; Diesel-Powered Equipment in Underground Coal Mines</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Department of Labor (DOL) is submitting this Mine Safety and Health Administration (MSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 
                        <PRTPAGE P="99284"/>
                        (PRA). Public comments on the ICR are invited.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The OMB will consider all written comments that the agency receives on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael Howell by telephone at 202-693-6782, or by email at 
                        <E T="03">DOL_PRA_PUBLIC@dol.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>MSHA requires mine operators to provide important safety and health protections to underground coal miners who work on and around diesel-powered equipment. The engines powering diesel equipment are potential contributors to fires and explosion hazards in the confined environment of an underground coal mine where combustible coal dust and explosive methane gas are present. Diesel equipment operating in underground coal mines also can pose serious health risks to miners from exposure to diesel exhaust emissions, including diesel particulates, oxides of nitrogen, and carbon monoxide. Diesel exhaust is a lung carcinogen in animals.</P>
                <P>This information collection includes maintenance and use of diesel equipment; tests and maintenance of fire suppression systems on both the equipment and at fueling stations; and exhaust gas sampling.</P>
                <P>Records are required to document that essential testing and maintenance of diesel-powered equipment are conducted regularly by qualified persons; that corrective actions are taken; and the persons performing the maintenance, repairs, examinations, and tests are trained and qualified to perform such tasks.</P>
                <P>Safety requirements for diesel equipment include many of the proven features required in existing standards for electric-powered mobile equipment, such as cabs or canopies, methane monitors, brakes and lights. Sampling of diesel exhaust emissions is required to protect miners from overexposure to carbon monoxide and nitrogen dioxide contained in diesel exhaust.</P>
                <P>
                    Information collection requirements are found in: section 75.1901(a), Diesel fuel requirements; section 75.1904(b)(4)(i), Underground diesel fuel tanks and safety cans; Section 75.1906(d), Transport of diesel fuel; section 75.1911(j), Fire suppression systems for diesel-powered equipment and fuel transportation units; section 75.1912(i), Fire suppression systems for permanent underground diesel fuel storage facilities; sections 75.1914(f)(2), (g), (h)(1), and (h)(2), Maintenance of diesel-powered equipment; sections 75.1915(b)(5), (c)(1), and (c)(2), Training and qualification of persons working on diesel-powered equipment. For additional substantive information about this ICR, see the related notice published in the 
                    <E T="04">Federal Register</E>
                     on August 26, 2024 (89 FR 68471).
                </P>
                <P>Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.</P>
                <P>
                    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. 
                    <E T="03">See</E>
                     5 CFR 1320.5(a) and 1320.6.
                </P>
                <P>
                    <E T="03">Agency:</E>
                     DOL-MSHA.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Diesel-Powered Equipment in Underground Coal Mines.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1219-0119.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses or other for-profits.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     161.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Number of Responses:</E>
                     218,811.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     17,673 hours.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Other Costs Burden:</E>
                     $398,170.
                </P>
                <EXTRACT>
                    <FP>(Authority: 44 U.S.C. 3507(a)(1)(D))</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Michael Howell,</NAME>
                    <TITLE>Senior Paperwork Reduction Act Analyst.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28888 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Consol Pennsylvania Coal Company, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0080 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0080.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov.</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, 4th Floor West, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
                    <PRTPAGE P="99285"/>
                </P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-055-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Consol Pennsylvania Coal Company, LLC, 275 Technology Drive, Suite 101, Canonsburg, PA 15317.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Bailey Mine, MSHA ID No. 36-07230, located in Greene County, Pennsylvania.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.507-1(a), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.507-1(a) as it pertains to use of battery-powered vibration analyzers and data collectors. Specifically, the petitioner is requesting to permit the use of battery-powered non-permissible SCOUT 140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer in the return air outby the last open crosscut.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) The petitioner is requesting to utilize the SCOUT 140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer in the return air outby the last open crosscut.</P>
                <P>(b) In approximately 2021, the SKF Microlog Analyzer CMXA 51, which was certified and approved by the U.S. Department of Labor's Mine Safety and Health Administration (“MSHA”) for use in hazardous “gassy” areas of all mine operations in the United States, was discontinued and is no longer available for purchase. An email from SKF Technical Support states that the CMXA-51-MSHA Microlog has been discontinued and is no longer available for purchase.</P>
                <P>(c) Currently, there is no other MSHA approved vibration analyzer and data collector still in production. Thus, there are no new MSHA approved vibration analyzers and data collectors that are available for purchase.</P>
                <P>(d) Currently, there is no other MSHA approved vibration analyzer and data collector that is still in production.</P>
                <P>(e) The SCOUT100EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports dual-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(f) The SCOUT140EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports four-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(g) The vb7 Portable Data Collector, Analyzer and Balancer instrument is a dual channel vibration data collector, analyzer and balancer. The device can be used for on-route and off-route data collection, machine-side analysis and diagnosis as well as on-site dynamic balance correction. The vb7 Portable Data Collector, Analyzer and Balancer is certified for Class 1 Division 2 hazardous areas.</P>
                <P>(h) The SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2 and internationally IECEx Zone 2, compliant and safe for use in hazardous areas.</P>
                <P>(i) Consol shall use these devices to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. Primarily, equipment contractors at Consol shall use these analyzers to take vibration readings on the shearing machine to predict and prevent gearing/motor failures while on the longwall face. A failure of a major component on the longwall face potentially poses many risks to miners when that particular component has to be changed out on the face.</P>
                <P>(j) Some equipment manufacturers have historically had gearing issues with their shearer ranging arms on the shearing machines as well as cutter head gearboxes on their continuous miners and these components are very large and heavy.</P>
                <P>(k) Consol relies on vibration collection to predict impending failures and successfully change individual parts and components before a catastrophic failure resulting in changing the entire ranging arm or cutter head gearcase.</P>
                <P>(l) The SCOUT 140EX, 100EX, and vb7 shall be used by trained personnel from Consol or the vendor to take readings while running the associated motor or gearbox being tested. The shearing machine shall be out of service from production during the vibration collection.</P>
                <P>(m) In addition, SCOUT 140EX, 100EX, and vb7 may be part of the weekly inspection of the shearing machines by the manufacturer representative or by Consol's mine maintenance staff. Regardless, the shearing machine shall not be producing coal or moving while in use unless it has to be trammed to take readings on the haulage/tram gearbox. Regardless, the machines shall not be cutting coal at the time of use.</P>
                <P>(n) Currently, SCOUT 140EX, 100EX, and vb7 are the only analyzers Consol has found to replace the older versions and the SKF versions, which are no longer manufactured and available for purchase. However, the SCOUT 140EX, 100EX, and vb7 are not approved under the applicable MSHA standards for permissibility.</P>
                <P>(o) Electronic equipment used in underground mines in potentially explosive atmospheres is required to be approved by MSHA per 30 CFR. Bently Nevada and other manufacturers do offer alternative products for many other environments and applications.</P>
                <P>(p) Given the benefits of the use of vibration analyzers, the application of the standard results in a diminution of safety at the mine. Consol petitions to permit the use of a SCOUT100EX, SCOUT140EX, and vb7 Vibration Data Collectors, Analyzers and Balancers.</P>
                <P>(q) The SCOUT100EX, SCOUT140EX, and vb7 Portable Intrinsically Safe Vibration Data Collector, Analyzer and Balancer batteries qualify as intrinsically safe in the U.S., Canada, and any other country accepting IECEx reports. IECEx is the International Electrotechnical Commissions System for Certification to Standards Relating to Equipment for Use in Explosive Atmosphere.</P>
                <P>(r) The vibration analyzers have an intrinsically safe (IS) rating of Division 1: IS Class I, II, III; Division 1 (includes Division 2) Groups C, D, E, F, G; T4, under the most current standard (UL 60079, 6th Edition, 2013). ATEX-certified with an intrinsically safe (IS) rating of “ia”</P>
                <P>
                    (s) Consol recognizes that (NIOSH) researchers have conducted studies on intrinsically safe (IS) equipment and believe that the International Electrotechnical Commission (IEC) document 60079-11, or the American National Standards Institute (ANSI)/International Society (ISA) document 60079-11 for two-fault equipment (marked as ia), would provide an equivalent level of safety as MSHA-approved equipment.
                    <PRTPAGE P="99286"/>
                </P>
                <P>(t) Consol also recognizes that MSHA does not consider all equipment that meets the 60079-11 standard as equivalent to MSHA approval at this time. However, MSHA also recognizes that use of equipment meeting the 60079-11 standard for two-fault equipment (and even, to a lesser extent, equipment meeting one-fault (marked as ib) or no-fault (marked as ic) standards) provides a level of safety that is not provided by equipment that does not meet the IEC/ANSI/ISA standards.</P>
                <P>(u) The battery is a Custom Lithium Ion Pack, 7.4V, 5000 mAh. There is internal charging with an external power pack 12V DC, 3A output.</P>
                <P>(v) The standards for approval of these Vibration Data Collectors, Analyzers and Balancers are an acceptable alternative to MSHA's standards and provide an equivalent level of protection.</P>
                <P>(w) The alternate method proposed by the Petitioner will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) The operator shall permit the use of the following Vibration Data Collectors, Analyzers and Balancers if they have an IP rating of 66 or greater in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces, subject to the conditions of the proposed decision and order (PDO) granted by MSHA: SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2.</P>
                <P>(b) All non-permissible Vibration Data Collectors, Analyzers and Balancers to be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall be examined by the person to operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These examinations shall include:</P>
                <P>(1) Check the instrument for any physical damage and the integrity of the case;</P>
                <P>(2) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(c) The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.153.</P>
                <P>(d) The operator shall ensure that any repairs or servicing for all non-permissible Vibration Data Collectors, Analyzers and Balancers will be done by the manufacturer.</P>
                <P>(e) The non-permissible Vibration Data Collectors, Analyzers and Balancers that will be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance with all the terms and conditions of the PDO granted by MSHA.</P>
                <P>(f) Non-permissible Vibration Data Collectors, Analyzers and Balancers shall not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more of methane is detected while the non-permissible surveying equipment is being used, the equipment shall be de-energized immediately and the non-permissible electronic equipment withdrawn outby the last open crosscut or out of the return. Prior to entering in or inby the last open crosscut, or within 150 feet of pillar workings or longwall faces, all requirements of 30 CFR 75.323 shall be complied with.</P>
                <P>(g) All hand-held methane detectors shall be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors shall provide visual and audible warnings when methane is detected at or above 1.0 percent.</P>
                <P>(h) Prior to energizing any of the non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, methane tests shall be made in accordance with 30 CFR 75.323(a).</P>
                <P>(i) All areas where Vibration Data Collectors, Analyzers and Balancers are to be used shall be pre-shifted according to 30 CFR 75.360. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 shall be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 30 CFR 75.361, additional examination is not required.</P>
                <P>(j) A qualified person as defined in existing 30 CFR 75.151 shall continuously monitor for methane immediately before and during the use of non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return.</P>
                <P>(k) Batteries contained in the Vibration Data Collectors, Analyzers and Balancers shall be “charged” in intake air outby the last open crosscut and out of the return. Before each shift requiring the use of Vibration Data Collectors, Analyzers and Balancers all batteries for the Vibration Data Collectors, Analyzers and Balancers shall be charged sufficiently that they are not expected to be charged on that shift.</P>
                <P>(l) When using non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, the operator shall confirm by measurement or by inquiry of the person in charge of the section, that the air quantity on the section, on that shift, in the last open crosscut is at least the minimum quantity that is required by the mine's ventilation plan.</P>
                <P>(m) Personnel engaged in the use of Vibration Data Collectors, Analyzers and Balancers shall be properly trained to recognize the hazards and limitations associated with the use of such equipment in areas where methane could be present.</P>
                <P>(n) All persons who use Vibration Data Collectors, Analyzers and Balancers shall receive specific training on the terms and conditions of the PDO granted by MSHA before using non-permissible electronic equipment in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces. A record of the training shall be kept with the other training records.</P>
                <P>(o) Within 60 days after the PDO granted by MSHA becomes final, the operator shall submit proposed revisions for its approved 30 CFR part 48 training plans to the Coal Mine Safety and Health District Manager. These proposed revisions shall specify initial and refresher training regarding the terms and conditions stated in the PDO granted by MSHA. When training is conducted on the terms and conditions in the PDO granted by MSHA, an MSHA Certificate of Training (Form 5000-23) shall be completed. Comments shall be included on the Certificate of Training indicating that it was surveyor training.</P>
                <P>(p) The operator is responsible for seeing that all contractors hired by the operator are using electronic equipment in accordance with the requirements of paragraph (s) above. The conditions of use in this Petition shall apply to all non-permissible Vibration Data Collectors, Analyzers and Balancers used in or inby the last open crosscut or in a return, or within 150 feet of pillar workings or longwall faces, regardless of whether the equipment is used by the operator or by an independent contractor.</P>
                <P>
                    (q) The operator shall post the PDO granted by MSHA in unobstructed locations on the bulletin boards and/or 
                    <PRTPAGE P="99287"/>
                    in other conspicuous places where notices to miners are ordinarily posted, for a period of not less than 60 consecutive days and shall remain on the mine bulletin board until such time as the ruling on the petition becomes final.
                </P>
                <P>(r) There are no representatives of miners at the Bailey Mine. A copy of this petition has been posted on the bulletin board as of September 30, 2024.</P>
                <P>In support of the proposed alternative method, the petitioner has also submitted: a SCOUT100EX Vibration Data Collector, Analyzer and Balancer datasheet, a SCOUT140EX Vibration Data Collector, Analyzer and Balancer datasheet, a vb7 Portable Data Collector, Analyzer and Balancer datasheet, and email communication from SKF Technical Support.</P>
                <P>The petitioner asserts that the alternative method will guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28885 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Rockwell Mining, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0101 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0101.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov.</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:</P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-076-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Rockwell Mining, LLC, 250 West Main Street, Suite 2000 Lexington, KY 40507.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Eagle #3 Mine, MSHA ID No. 46-09427, located in Wyoming County, West Virginia.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.500(d), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.500(d) to allow the use of unapproved Powered Air Purifying Respirators (PAPRs) taken into or used inby the last open crosscut. Specifically, the petitioner is requesting to utilize the CleanSpace EX PAPR and sealed motor/blower/battery power pack assembly, and the 3M Versaflo TR-800 Intrinsically Safe PAPR motor/blower and battery with battery pack.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) The 3M Versaflo TR-800 PAPR with motor/blower and battery qualifies as intrinsically safe.</P>
                <P>(b) The CleanSpace EX PAPR also qualifies as intrinsically safe.</P>
                <P>(c) Both the CleanSpace EX and the 3M Versaflo TR-800 PAPRs provide a constant flow of air inside the mask or helmet. This airflow provides respiratory protection and comfort in hot working conditions.</P>
                <P>(d) Neither the 3M Versaflo TR-800 nor the CleanSpace EX PAPR is MSHA-approved as permissible.</P>
                <P>(e) Neither the 3M nor the CleanSpace is pursuing MSHA approval.</P>
                <P>(f) Eagle #3 Mine currently makes available to all miners NIOSH-approved high efficiency l00 series respirators to protect the miners against potential exposure to respirable coal mine dust, including crystalline silica, during normal mining conditions. Eagle #3 Mine desires to expand the miners' option in choosing a respirator that provides the greatest degree of protection as well as comfort while being worn. Powered PAPRs provide a constant flow of filtered air and serve that purpose.</P>
                <P>
                    (g) On June 17, 2024, MSHA's final rule 
                    <E T="03">Lowering Miners' Exposure to Respirable Crystalline Silica and Improving Respiratory Protection</E>
                     took effect. The rule requires the mine operator to have a written respiratory protection program in place when miners are required to use respirators. Adding the CleanSpace EX and the 3M TR-800 Versaflo PAPRs to the respiratory protection program as additional options will provide the miners with alternatives to the series 100 high efficiency respirators already in use at the mine. The PAPRs will also serve as a respirator option to protect the miners with facial hair who may not be able to pass the “fit test” requirement of the program. In addition, the positive flow of filtered air provided by the PAPRs will provide a solution for the miners who are unable to wear a tight-fitting respirator.
                </P>
                <P>(h) Since the 3M Airstream Headgear-Mounted PAPR System has been discontinued by the manufacturer, there are no other MSHA-approved units available that can be taken into or used inby the last open crosscut.</P>
                <P>(i) The alternative method in the petition will at all times guarantee no less than the same measure of protection afforded to the miners by the standard.</P>
                <P>
                    The petitioner proposes the following alternative method:
                    <PRTPAGE P="99288"/>
                </P>
                <P>(a) All miners who will be involved with or affected by the use of the 3M Versaflo TR-800 or CleanSpace EX PAPRs shall receive training in accordance with 30 CFR 48.7 on the requirements of the Proposed Decision and Order (PDO) granted by MSHA and manufacturer guidelines. Such training shall be completed before any 3M Versaflo TR-800 or CleanSpace EX PAPR can be used inby the last open crosscut. The operator shall keep a record of such training and provide such record to MSHA upon request.</P>
                <P>(b) The PAPRs, battery packs, and all associated wiring and connections shall be inspected before use to determine if there is any damage to the units that would negatively impact intrinsic safety. If any defects are found, the PAPR shall be removed from service.</P>
                <P>(c) A separate logbook shall be maintained for the 3M Versaflo TR-800 and CleanSpace EX PAPRs that will be kept with the equipment, or in a location with other mine record books and shall be made available to MSHA upon request. The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.512-1 and the examination results recorded in the logbook. Examination records shall be maintained for one year.</P>
                <P>(d) All 3M Versaflo TR-800 and CleanSpace EX PAPRs to be used inby the last open crosscut shall be physically examined prior to initial use and each unit shall be assigned a unique identification number. Each unit shall be examined by the person to operate the equipment, prior to taking the equipment underground, to ensure that the equipment is used according to the original equipment manufacturer's recommendations and maintained in a safe operating condition. The examinations for the 3M Versaflo TR-800 PAPRs shall include:</P>
                <P>(1) Check the equipment for any physical damage and the integrity of the case.</P>
                <P>(2) Remove the battery and inspect for corrosion.</P>
                <P>(3) Inspect the contact points to ensure a secure connection to the battery.</P>
                <P>(4) Reinsert the battery and power up and shut down to ensure proper connections.</P>
                <P>(5) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(6) For equipment utilizing lithium type cells, ensure that lithium cells and/or packs are not damaged or swelled in size.</P>
                <P>The CleanSpace EX PAPR does not have an accessible/removable battery. The internal battery and motor/blower assembly are both contained within the “power unit” assembly, and the battery cannot be removed, reinserted or fastened. Therefore, examination of the CleanSpace EX PAPR shall include any indications of physical damage.</P>
                <P>(e) All 3M Versaflo TR-800 and CleanSpace EX PAPR units shall be serviced according to the manufacturer's recommendations.</P>
                <P>(f) Prior to energizing and during use of the 3M Versaflo TR-800 or the CleanSpace EX PAPR inby the last open crosscut, procedures in accordance with 30 CFR 75.323 shall be followed.</P>
                <P>(g) Only the 3M TR-830 Battery Pack, which meets lithium battery safety standard UL 1642 or IEC 62133, in the 3M Versaflo TR-800 PAPR shall be used. Only the CleanSpace EX Power Unit, which meets lithium battery safety standard UL 1642 or IEC 62133, in the CleanSpace EX shall be used.</P>
                <P>(h) If battery packs for the 3M Versaflo TR-800 PAPR are provided, all battery “change outs” shall occur in intake air outby the last open crosscut.  </P>
                <P>(i) The following maintenance and use conditions shall apply to equipment containing lithium type batteries:</P>
                <P>(1) Neither the 3M TR-830 Battery Pack nor the CleanSpace EX Power Unit shall be disassembled or modified by anyone other than permitted by the manufacturer of the equipment.</P>
                <P>(2) The 3M TR-830 Battery Pack shall be charged only in an area free of combustible material and in intake air outby the last open crosscut. The 3M TR-830 Battery Pack shall be charged only by a manufacturer's recommended battery charger, such as:</P>
                <P>(i) 3M Battery Charger Kit TR-641N, which includes one 3M Charger Cradle TR-640 and one 3M Power Supply TR-941N; or</P>
                <P>(ii) 3M 4-Station Battery Charger Kit TR-644N, which includes four 3M Charger Cradles TR-640 and one 3M 4-Station Battery Charger Base/Power Supply TR-944N.</P>
                <P>(3) The CleanSpace EX internal battery, which is contained within the power unit assembly, shall be charged in areas located outby the last open crosscut in intake air, and only the manufacturer's recommended battery chargers shall be used, such as the CleanSpace EX Battery Charger, Product Code PAF-0066.</P>
                <P>(4) Neither the 3M TR-830 Battery Pack nor the CleanSpace EX power unit which contains the internal battery, shall be exposed to water, allowed to get wet or immersed in liquid. This does not preclude incidental exposure of the 3M TR-830 Battery Pack or the CleanSpace EX power unit assembly.</P>
                <P>(5) Neither the 3M Versaflo TR-800 PAPR nor the CleanSpace EX PAPR, including the internal battery, shall be used, charged or stored in locations where the manufacturer's recommended temperature limits are exceeded. Neither the 3M Versaflo TR-800 PAPR or the CleanSpace EX PAPR shall be placed in direct sunlight nor stored near a source of heat.</P>
                <P>(j) Annual retraining shall be given to all miners who will be involved with or affected by the use of the 3M Versaflo TR-800 or CleanSpace EX PAPRs in accordance with 30 CFR 48.8. Training of new miners on the requirements of the PDO granted by MSHA in accordance with 30 CFR 48.5, and training of experienced miners on the requirements of the PDO granted by MSHA in accordance with 30 CFR 48.6 shall be given. The operator shall keep a record of such training and provide such record to MSHA upon request.</P>
                <P>(k) The miners at Rockwell Mining, LLC, Eagle #3 Mine, are not represented by a labor organization and there are no representatives of miners at the mine. A copy of this petition has been posted on the bulletin board at Rockwell Mining, LLC, Eagle #3 Mine, on November 21, 2024.</P>
                <P>The petitioner asserts that the alternative method in the petition will at all times guarantee no less than the same measure of protection afforded to the miners by the standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-29027 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Rockwell Mining, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments identified by Docket No. MSHA-2024-0099 by any of the following methods:
                        <PRTPAGE P="99289"/>
                    </P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0099.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov.</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:</P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-074-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Rockwell Mining, LLC, 54912 Pond Fork Road, Wharton, WV 25208.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Gateway Eagle Mine, MSHA ID No. 46-06618, located in Boone County, West Virginia.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.507-1(a), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.507-1(a) to allow the use of unapproved Powered Air Purifying Respirators (PAPRs) taken into or used inby the last open crosscut or used in the return air outby the last open crosscut. Specifically, the petitioner is requesting to utilize the CleanSpace EX PAPR and sealed motor/blower/battery power pack assembly, and the 3M Versaflo TR-800 Intrinsically Safe PAPR motor/blower and battery with battery pack.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) The 3M Versaflo TR-800 PAPR with motor/blower and battery qualifies as intrinsically safe.</P>
                <P>(b) The CleanSpace EX PAPR also qualifies as intrinsically safe.</P>
                <P>(c) Both the CleanSpace EX and the 3M Versaflo TR-800 PAPRs provide a constant flow of air inside the mask or helmet. This airflow provides respiratory protection and comfort in hot working conditions.</P>
                <P>(d) Neither the 3M Versaflo TR-800 nor the CleanSpace EX PAPR is MSHA-approved as permissible.</P>
                <P>(e) Neither the 3M nor the CleanSpace is pursuing MSHA approval.</P>
                <P>(f) Gateway Eagle Mine currently makes available to all miners NIOSH-approved high efficiency l00 series respirators to protect the miners against potential exposure to respirable coal mine dust, including crystalline silica, during normal mining conditions. Gateway Eagle Mine desires to expand the miners' option in choosing a respirator that provides the greatest degree of protection as well as comfort while being worn. Powered PAPRs provide a constant flow of filtered air and serve that purpose.</P>
                <P>
                    (g) On June 17, 2024, MSHA's final rule 
                    <E T="03">Lowering Miners' Exposure to Respirable Crystalline Silica and Improving Respiratory Protection</E>
                     took effect. The rule requires the mine operator to have a written respiratory protection program in place when miners are required to use respirators. Adding the CleanSpace EX and the 3M TR-800 Versaflo PAPRs to the respiratory protection program as additional options will provide the miners with alternatives to the series 100 high efficiency respirators already in use at the mine. The PAPRs will also serve as a respirator option to protect the miners with facial hair who may not be able to pass the “fit test” requirement of the program. In addition, the positive flow of filtered air provided by the PAPRs will provide a solution for the miners who are unable to wear a tight-fitting respirator.
                </P>
                <P>(h) Since the 3M Airstream Headgear-Mounted PAPR System has been discontinued by the manufacturer, there are no other MSHA-approved units available that can be taken into or used inby the last open crosscut or used in return air outby the last open crosscut.</P>
                <P>(i) The alternative method in the petition will at all times guarantee no less than the same measure of protection afforded to the miners by the standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) All miners who will be involved with or affected by the use of the 3M Versaflo TR-800 or CleanSpace EX PAPRs shall receive training in accordance with 30 CFR 48.7 on the requirements of the Proposed Decision and Order (PDO) granted by MSHA and manufacturer guidelines. Such training shall be completed before any 3M Versaflo TR-800 or CleanSpace EX PAPR can be used inby the last open crosscut or in the return air outby the last open crosscut. The operator shall keep a record of such training and provide such record to MSHA upon request.</P>
                <P>(b) The PAPRs, battery packs, and all associated wiring and connections shall be inspected before use to determine if there is any damage to the units that would negatively impact intrinsic safety. If any defects are found, the PAPR shall be removed from service.</P>
                <P>(c) A separate logbook shall be maintained for the 3M Versaflo TR-800 and CleanSpace EX PAPRs that will be kept with the equipment, or in a location with other mine record books and shall be made available to MSHA upon request. The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.512-1 and the examination results recorded in the logbook. Examination records shall be maintained for one year.  </P>
                <P>(d) All 3M Versaflo TR-800 and CleanSpace EX PAPRs to be used inby the last open crosscut or in the return air outby the last open crosscut shall be physically examined prior to initial use and each unit shall be assigned a unique identification number. Each unit shall be examined by the person to operate the equipment, prior to taking the equipment underground, to ensure that the equipment is used according to the original equipment manufacturer's recommendations and maintained in a safe operating condition. The examinations for the 3M Versaflo TR-800 PAPRs shall include:</P>
                <P>(1) Check the equipment for any physical damage and the integrity of the case.</P>
                <P>
                    (2) Remove the battery and inspect for corrosion.
                    <PRTPAGE P="99290"/>
                </P>
                <P>(3) Inspect the contact points to ensure a secure connection to the battery.</P>
                <P>(4) Reinsert the battery and power up and shut down to ensure proper connections.</P>
                <P>(5) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(6) For equipment utilizing lithium type cells, ensure that lithium cells and/or packs are not damaged or swelled in size.</P>
                <P>The CleanSpace EX PAPR does not have an accessible/removable battery. The internal battery and motor/blower assembly are both contained within the “power unit” assembly, and the battery cannot be removed, reinserted or fastened. Therefore, examination of the CleanSpace EX PAPR shall include any indications of physical damage.</P>
                <P>(e) All 3M Versaflo TR-800 and CleanSpace EX PAPR units shall be serviced according to the manufacturer's recommendations.</P>
                <P>(f) Prior to energizing and during use of the 3M Versaflo TR-800 or the CleanSpace EX PAPR inby the last open crosscut or in the return air outby the last open crosscut, procedures in accordance with 30 CFR 75.323 shall be followed.</P>
                <P>(g) Only the 3M TR-830 Battery Pack, which meets lithium battery safety standard UL 1642 or IEC 62133, in the 3M Versaflo TR-800 PAPR shall be used. Only the CleanSpace EX Power Unit, which meets lithium battery safety standard UL 1642 or IEC 62133, in the CleanSpace EX shall be used.</P>
                <P>(h) If battery packs for the 3M Versaflo TR-800 PAPR are provided, all battery “change outs” shall occur in intake air outby the last open crosscut.</P>
                <P>(i) The following maintenance and use conditions shall apply to equipment containing lithium type batteries:</P>
                <P>(1) Neither the 3M TR-830 Battery Pack nor the CleanSpace EX Power Unit shall be disassembled or modified by anyone other than permitted by the manufacturer of the equipment.</P>
                <P>(2) The 3M TR-830 Battery Pack shall be charged only in an area free of combustible material and in intake air outby the last open crosscut. The 3M TR-830 Battery Pack shall be charged only by a manufacturer's recommended battery charger, such as:</P>
                <P>(i) 3M Battery Charger Kit TR-641N, which includes one 3M Charger Cradle TR-640 and one 3M Power Supply TR-941N; or</P>
                <P>(ii) 3M 4-Station Battery Charger Kit TR-644N, which includes four 3M Charger Cradles TR-640 and one 3M 4-Station Battery Charger Base/Power Supply TR-944N.</P>
                <P>(3) The CleanSpace EX internal battery, which is contained within the power unit assembly, shall be charged in areas located outby the last open crosscut in intake air, and only the manufacturer's recommended battery chargers shall be used, such as the CleanSpace EX Battery Charger, Product Code PAF-0066.</P>
                <P>(4) Neither the 3M TR-830 Battery Pack nor the CleanSpace EX power unit which contains the internal battery, shall be exposed to water, allowed to get wet or immersed in liquid. This does not preclude incidental exposure of the 3M TR-830 Battery Pack or the CleanSpace EX power unit assembly.</P>
                <P>(5) Neither the 3M Versaflo TR-800 PAPR nor the CleanSpace EX PAPR, including the internal battery, shall be used, charged or stored in locations where the manufacturer's recommended temperature limits are exceeded. Neither the 3M Versaflo TR-800 PAPR nor the CleanSpace EX PAPR shall be placed in direct sunlight or stored near a source of heat.</P>
                <P>(j) Annual retraining shall be given to all miners who will be involved with or affected by the use of the 3M Versaflo TR-800 or CleanSpace EX PAPRs in accordance with 30 CFR 48.8. Training of new miners on the requirements of the PDO granted by MSHA in accordance with 30 CFR 48.5, and training of experienced miners on the requirements of the PDO granted by MSHA in accordance with 30 CFR 48.6 shall be given. The operator shall keep a record of such training and provide such record to MSHA upon request.</P>
                <P>(k) The miners at Rockwell Mining, LLC, Gateway Eagle Mine, are represented by a labor organization and a copy of this petition has been provided to the representative of the miners at the mine on November 21, 2024.</P>
                <P>The petitioner asserts that the alternative method in the petition will at all times guarantee no less than the same measure of protection afforded to the miners by the standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-29031 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Consol Pennsylvania Coal Company, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0081 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0081.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov.</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, 4th Floor West, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
                    <PRTPAGE P="99291"/>
                </P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-056-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Consol Pennsylvania Coal Company, LLC, 275 Technology Drive, Suite 101, Canonsburg, PA 15317.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Bailey Mine, MSHA ID No. 36-07230, located in Greene County, Pennsylvania.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.1002(a), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.1002(a) as it pertains to use of battery-powered vibration analyzers and data collectors. Specifically, the petitioner is requesting to permit the use of battery-powered non-permissible SCOUT 140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer within 150 feet of pillar workings or longwall faces.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) The petitioner is requesting to utilize the SCOUT 140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer within 150 feet of pillar workings or longwall faces.</P>
                <P>(b) In approximately 2021, the SKF Microlog Analyzer CMXA 51, which was certified and approved by the U.S. Department of Labor's Mine Safety and Health Administration (“MSHA”) for use in hazardous “gassy” areas of all mine operations in the United States, was discontinued and is no longer available for purchase. An email from SKF Technical Support states that the CMXA-51-MSHA Microlog has been discontinued and is no longer available for purchase.</P>
                <P>(c) Currently, there is no other MSHA approved vibration analyzer and data collector still in production. Thus, there are no new MSHA approved vibration analyzers and data collectors that are available for purchase.</P>
                <P>(d) Currently, there is no other MSHA approved vibration analyzer and data collector that is still in production.</P>
                <P>(e) The SCOUT100EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports dual-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(f) The SCOUT140EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports four-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(g) The vb7 Portable Data Collector, Analyzer and Balancer instrument is a dual channel vibration data collector, analyzer and balancer. The device can be used for on-route and off-route data collection, machine-side analysis and diagnosis as well as on-site dynamic balance correction. The vb7 Portable Data Collector, Analyzer and Balancer is certified for Class 1 Division 2 hazardous areas.</P>
                <P>(h) The SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2 and internationally IECEx Zone 2, compliant and safe for use in hazardous areas.</P>
                <P>(i) Consol shall use these devices to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. Primarily, equipment contractors at Consol shall use these analyzers to take vibration readings on the shearing machine to predict and prevent gearing/motor failures while on the longwall face. A failure of a major component on the longwall face potentially poses many risks to miners when that particular component has to be changed out on the face.</P>
                <P>(j) Some equipment manufacturers have historically had gearing issues with their shearer ranging arms on the shearing machines as well as cutter head gearboxes on their continuous miners and these components are very large and heavy.</P>
                <P>(k) Consol relies on vibration collection to predict impending failures and successfully change individual parts and components before a catastrophic failure resulting in changing the entire ranging arm or cutter head gearcase.</P>
                <P>(l) The SCOUT 140EX, 100EX, and vb7 shall be used by trained personnel from Consol or the vendor to take readings while running the associated motor or gearbox being tested. The shearing machine shall be out of service from production during the vibration collection.</P>
                <P>(m) In addition, SCOUT 140EX, 100EX, and vb7 may be part of the weekly inspection of the shearing machines by the manufacturer representative or by Consol's mine maintenance staff. Regardless, the shearing machine shall not be producing coal or moving while in use unless it has to be trammed to take readings on the haulage/tram gearbox. Regardless, the machines shall not be cutting coal at the time of use.</P>
                <P>(n) Currently, SCOUT 140EX, 100EX, and vb7 are the only analyzers Consol has found to replace the older versions and the SKF versions, which are no longer manufactured and available for purchase. However, the SCOUT 140EX, 100EX, and vb7 are not approved under the applicable MSHA standards for permissibility.</P>
                <P>(o) Electronic equipment used in underground mines in potentially explosive atmospheres is required to be approved by MSHA per 30 CFR. Bently Nevada and other manufacturers do offer alternative products for many other environments and applications.</P>
                <P>(p) Given the benefits of the use of vibration analyzers, the application of the standard results in a diminution of safety at the mine. Consol petitions to permit the use of a SCOUT100EX, SCOUT140EX, and vb7 Vibration Data Collectors, Analyzers and Balancers.</P>
                <P>(q) The SCOUT100EX, SCOUT140EX, and vb7 Portable Intrinsically Safe Vibration Data Collector, Analyzer and Balancer batteries qualify as intrinsically safe in the U.S., Canada, and any other country accepting IECEx reports. IECEx is the International Electrotechnical Commissions System for Certification to Standards Relating to Equipment for Use in Explosive Atmosphere.</P>
                <P>(r) The vibration analyzers have an intrinsically safe (IS) rating of Division 1: IS Class I, II, III; Division 1 (includes Division 2) Groups C, D, E, F, G; T4, under the most current standard (UL 60079, 6th Edition, 2013). ATEX-certified with an intrinsically safe (IS) rating of “ia.”</P>
                <P>
                    (s) Consol recognizes that (NIOSH) researchers have conducted studies on intrinsically safe (IS) equipment and believe that the International Electrotechnical Commission (IEC) document 60079-11, or the American National Standards Institute (ANSI)/International Society (ISA) document 60079-11 for two-fault equipment (marked as ia), would provide an 
                    <PRTPAGE P="99292"/>
                    equivalent level of safety as MSHA-approved equipment.
                </P>
                <P>(t) Consol also recognizes that MSHA does not consider all equipment that meets the 60079-11 standard as equivalent to MSHA approval at this time. However, MSHA also recognizes that use of equipment meeting the 60079-11 standard for two-fault equipment (and even, to a lesser extent, equipment meeting one-fault (marked as ib) or no-fault (marked as ic) standards) provides a level of safety that is not provided by equipment that does not meet the IEC/ANSI/ISA standards.</P>
                <P>(u) The battery is a Custom Lithium Ion Pack, 7.4V, 5000 mAh. There is internal charging with an external power pack 12V DC, 3A output.</P>
                <P>(v) The standards for approval of these Vibration Data Collectors, Analyzers and Balancers are an acceptable alternative to MSHA's standards and provide an equivalent level of protection.</P>
                <P>(w) The alternate method proposed by the Petitioner will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) The operator shall permit the use of the following Vibration Data Collectors, Analyzers and Balancers if they have an IP rating of 66 or greater in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces, subject to the conditions of the proposed decision and order (PDO) granted by MSHA: SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2.</P>
                <P>(b) All non-permissible Vibration Data Collectors, Analyzers and Balancers to be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall be examined by the person to operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These examinations shall include:</P>
                <P>(1) Check the instrument for any physical damage and the integrity of the case;</P>
                <P>(2) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(c) The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.153.</P>
                <P>(d) The operator shall ensure that any repairs or servicing for all non-permissible Vibration Data Collectors, Analyzers and Balancers will be done by the manufacturer.</P>
                <P>(e) The non-permissible Vibration Data Collectors, Analyzers and Balancers that will be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance with all the terms and conditions of the PDO granted by MSHA.</P>
                <P>(f) Non-permissible Vibration Data Collectors, Analyzers and Balancers shall not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more of methane is detected while the non-permissible surveying equipment is being used, the equipment shall be de-energized immediately and the non-permissible electronic equipment withdrawn outby the last open crosscut or out of the return. Prior to entering in or inby the last open crosscut, or within 150 feet of pillar workings or longwall faces, all requirements of 30 CFR 75.323 shall be complied with.</P>
                <P>(g) All hand-held methane detectors shall be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors shall provide visual and audible warnings when methane is detected at or above 1.0 percent.</P>
                <P>(h) Prior to energizing any of the non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, methane tests shall be made in accordance with 30 CFR 75.323(a).</P>
                <P>(i) All areas where Vibration Data Collectors, Analyzers and Balancers are to be used shall be pre-shifted according to 30 CFR 75.360. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 shall be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 30 CFR 75.361, additional examination is not required.</P>
                <P>(j) A qualified person as defined in existing 30 CFR 75.151 shall continuously monitor for methane immediately before and during the use of non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return.</P>
                <P>(k) Batteries contained in the Vibration Data Collectors, Analyzers and Balancers shall be “charged” in intake air outby the last open crosscut and out of the return. Before each shift requiring the use of Vibration Data Collectors, Analyzers and Balancers all batteries for the Vibration Data Collectors, Analyzers and Balancers shall be charged sufficiently that they are not expected to be charged on that shift.</P>
                <P>(l) When using non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, the operator shall confirm by measurement or by inquiry of the person in charge of the section, that the air quantity on the section, on that shift, in the last open crosscut is at least the minimum quantity that is required by the mine's ventilation plan.</P>
                <P>(m) Personnel engaged in the use of Vibration Data Collectors, Analyzers and Balancers shall be properly trained to recognize the hazards and limitations associated with the use of such equipment in areas where methane could be present.</P>
                <P>(n) All persons who use Vibration Data Collectors, Analyzers and Balancers shall receive specific training on the terms and conditions of the PDO granted by MSHA before using non-permissible electronic equipment in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces. A record of the training shall be kept with the other training records.</P>
                <P>(o) Within 60 days after the PDO granted by MSHA becomes final, the operator shall submit proposed revisions for its approved 30 CFR part 48 training plans to the Coal Mine Safety and Health District Manager. These proposed revisions shall specify initial and refresher training regarding the terms and conditions stated in the PDO granted by MSHA. When training is conducted on the terms and conditions in the PDO granted by MSHA, an MSHA Certificate of Training (Form 5000-23) shall be completed. Comments shall be included on the Certificate of Training indicating that it was surveyor training.</P>
                <P>
                    (p) The operator is responsible for seeing that all contractors hired by the operator are using electronic equipment in accordance with the requirements of paragraph (s) above. The conditions of use in this Petition shall apply to all non-permissible Vibration Data Collectors, Analyzers and Balancers used in or inby the last open crosscut or in a return, or within 150 feet of pillar workings or longwall faces, regardless of whether the equipment is used by the operator or by an independent contractor.
                    <PRTPAGE P="99293"/>
                </P>
                <P>(q) The operator shall post the PDO granted by MSHA in unobstructed locations on the bulletin boards and/or in other conspicuous places where notices to miners are ordinarily posted, for a period of not less than 60 consecutive days and shall remain on the mine bulletin board until such time as the ruling on the petition becomes final.</P>
                <P>(r) There are no representatives of miners at the Bailey Mine. A copy of this petition has been posted on the bulletin board as of September 30, 2024.</P>
                <P>In support of the proposed alternative method, the petitioner has also submitted: a SCOUT100EX Vibration Data Collector, Analyzer and Balancer datasheet, a SCOUT140EX Vibration Data Collector, Analyzer and Balancer datasheet, a vb7 Portable Data Collector, Analyzer and Balancer datasheet, and email communication from SKF Technical Support.</P>
                <P>The petitioner asserts that the alternative method will guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28890 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Consol Pennsylvania Coal Company, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0085 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0085.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov.</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, 4th Floor West, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:</P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-060-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Consol Pennsylvania Coal Company, LLC, 275 Technology Drive, Suite 101, Canonsburg, PA 15317.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Harvey Mine, MSHA ID No. 36-10045, located in Greene County, Pennsylvania.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.500(d), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.500(d) as it pertains to use of battery-powered vibration analyzers and data collectors. Specifically, the petitioner is requesting to permit the use of battery-powered non-permissible SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer in or inby the last open crosscut.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) The petitioner is requesting to utilize the SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer in or inby the last open crosscut.</P>
                <P>(b) In approximately 2021, the SKF Microlog Analyzer CMXA 51, which was certified and approved by the U.S. Department of Labor's Mine Safety and Health Administration (“MSHA”) for use in hazardous “gassy” areas of all mine operations in the United States, was discontinued and is no longer available for purchase. An email from SKF Technical Support states that the CMXA-51-MSHA Microlog has been discontinued and is no longer available for purchase.</P>
                <P>(c) Currently, there is no other MSHA approved vibration analyzer and data collector still in production. Thus, there are no new MSHA approved vibration analyzers and data collectors that are available for purchase.</P>
                <P>(d) Currently, there is no other MSHA approved vibration analyzer and data collector that is still in production.</P>
                <P>(e) The SCOUT100EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports dual-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(f) The SCOUT140EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports four-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(g) The vb7 Portable Data Collector, Analyzer and Balancer instrument is a dual channel vibration data collector, analyzer and balancer. The device can be used for on-route and off-route data collection, machine-side analysis and diagnosis as well as on-site dynamic balance correction. The vb7 Portable Data Collector, Analyzer and Balancer is certified for Class 1 Division 2 hazardous areas.</P>
                <P>
                    (h) The SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in 
                    <PRTPAGE P="99294"/>
                    North America as ATEX Zone 2 and internationally IECEx Zone 2, compliant and safe for use in hazardous areas.
                </P>
                <P>(i) Consol shall use these devices to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. Primarily, equipment contractors at Consol shall use these analyzers to take vibration readings on the shearing machine to predict and prevent gearing/motor failures while on the longwall face. A failure of a major component on the longwall face potentially poses many risks to miners when that particular component has to be changed out on the face.</P>
                <P>(j) Some equipment manufacturers have historically had gearing issues with their shearer ranging arms on the shearing machines as well as cutter head gearboxes on their continuous miners and these components are very large and heavy.</P>
                <P>(k) Consol relies on vibration collection to predict impending failures and successfully change individual parts and components before a catastrophic failure resulting in changing the entire ranging arm or cutter head gearcase.</P>
                <P>(l) The SCOUT140EX, 100EX, and vb7 shall be used by trained personnel from Consol or the vendor to take readings while running the associated motor or gearbox being tested. The shearing machine shall be out of service from production during the vibration collection.</P>
                <P>(m) In addition, SCOUT140EX, 100EX, and vb7 may be part of the weekly inspection of the shearing machines by the manufacturer representative or by Consol's mine maintenance staff. Regardless, the shearing machine shall not be producing coal or moving while in use unless it has to be trammed to take readings on the haulage/tram gearbox. Regardless, the machines shall not be cutting coal at the time of use.</P>
                <P>(n) Currently, SCOUT140EX, 100EX, and vb7 are the only analyzers Consol has found to replace the older versions and the SKF versions, which are no longer manufactured and available for purchase. However, the SCOUT140EX, 100EX, and vb7 are not approved under the applicable MSHA standards for permissibility.</P>
                <P>(o) Electronic equipment used in underground mines in potentially explosive atmospheres is required to be approved by MSHA per 30 CFR. Bently Nevada and other manufacturers do offer alternative products for many other environments and applications.</P>
                <P>(p) Given the benefits of the use of vibration analyzers, the application of the standard results in a diminution of safety at the mine. Consol petitions to permit the use of a SCOUT100EX, SCOUT140EX, and vb7 Vibration Data Collectors, Analyzers and Balancers.</P>
                <P>(q) The SCOUT100EX, SCOUT140EX, and vb7 Portable Intrinsically Safe Vibration Data Collector, Analyzer and Balancer batteries qualify as intrinsically safe in the U.S., Canada, and any other country accepting IECEx reports. IECEx is the International Electrotechnical Commissions System for Certification to Standards Relating to Equipment for Use in Explosive Atmosphere.</P>
                <P>(r) The vibration analyzers have an intrinsically safe (IS) rating of Division 1: IS Class I, II, III; Division 1 (includes Division 2) Groups C, D, E, F, G; T4, under the most current standard (UL 60079, 6th Edition, 2013). ATEX-certified with an intrinsically safe (IS) rating of “ia.”</P>
                <P>(s) Consol recognizes that (NIOSH) researchers have conducted studies on intrinsically safe (IS) equipment and believe that the International Electrotechnical Commission (IEC) document 60079-11, or the American National Standards Institute (ANSI)/International Society (ISA) document 60079-11 for two-fault equipment (marked as ia), would provide an equivalent level of safety as MSHA-approved equipment.</P>
                <P>(t) Consol also recognizes that MSHA does not consider all equipment that meets the 60079-11 standard as equivalent to MSHA approval at this time. However, MSHA also recognizes that use of equipment meeting the 60079-11 standard for two-fault equipment (and even, to a lesser extent, equipment meeting one-fault (marked as ib) or no-fault (marked as ic) standards) provides a level of safety that is not provided by equipment that does not meet the IEC/ANSI/ISA standards.</P>
                <P>(u) The battery is a Custom Lithium Ion Pack, 7.4V, 5,000 mAh. There is internal charging with an external power pack 12V DC, 3A output.</P>
                <P>(v) The standards for approval of these Vibration Data Collectors, Analyzers and Balancers are an acceptable alternative to MSHA's standards and provide an equivalent level of protection.</P>
                <P>(w) The alternate method proposed by the Petitioner will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) The operator shall permit the use of the following Vibration Data Collectors, Analyzers and Balancers if they have an IP rating of 66 or greater in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces subject to the conditions of the proposed decision and order (PDO) granted by MSHA: SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2.</P>
                <P>(b) All non-permissible Vibration Data Collectors, Analyzers and Balancers to be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall be examined by the person to operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These examinations shall include:</P>
                <P>(1) Check the instrument for any physical damage and the integrity of the case;</P>
                <P>(2) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(c) The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.153.</P>
                <P>(d) The operator shall ensure that any repairs or servicing for all non-permissible Vibration Data Collectors, Analyzers and Balancers will be done by the manufacturer.</P>
                <P>(e) The non-permissible Vibration Data Collectors, Analyzers and Balancers that will be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance with all the terms and conditions of the PDO granted by MSHA.</P>
                <P>(f) Non-permissible Vibration Data Collectors, Analyzers and Balancers shall not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more of methane is detected while the non-permissible surveying equipment is being used, the equipment shall be de-energized immediately and the non-permissible electronic equipment withdrawn outby the last open crosscut or out of the return. Prior to entering in or inby the last open crosscut, or within 150 feet of pillar workings or longwall faces, all requirements of 30 CFR 75.323 shall be complied with.</P>
                <P>
                    (g) All hand-held methane detectors shall be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors shall provide visual and audible warnings 
                    <PRTPAGE P="99295"/>
                    when methane is detected at or above 1.0 percent.
                </P>
                <P>(h) Prior to energizing any of the non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, methane tests shall be made in accordance with 30 CFR 75.323(a).</P>
                <P>(i) All areas where Vibration Data Collectors, Analyzers and Balancers are to be used shall be pre-shifted according to 30 CFR 75.360. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 shall be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 30 CFR 75.361, additional examination is not required.</P>
                <P>(j) A qualified person as defined in existing 30 CFR 75.151 shall continuously monitor for methane immediately before and during the use of non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return.</P>
                <P>(k) Batteries contained in the Vibration Data Collectors, Analyzers and Balancers shall be “charged” in intake air outby the last open crosscut and out of the return. Before each shift requiring the use of Vibration Data Collectors, Analyzers and Balancers all batteries for the Vibration Data Collectors, Analyzers and Balancers shall be charged sufficiently that they are not expected to be charged on that shift.</P>
                <P>(l) When using non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, the operator shall confirm by measurement or by inquiry of the person in charge of the section, that the air quantity on the section, on that shift, in the last open crosscut is at least the minimum quantity that is required by the mine's ventilation plan.</P>
                <P>(m) Personnel engaged in the use of Vibration Data Collectors, Analyzers and Balancers shall be properly trained to recognize the hazards and limitations associated with the use of such equipment in areas where methane could be present.</P>
                <P>(n) All persons who use Vibration Data Collectors, Analyzers and Balancers shall receive specific training on the terms and conditions of the PDO granted by MSHA before using non-permissible electronic equipment in or inby the last open crosscut or in the return. A record of the training shall be kept with the other training records.</P>
                <P>(o) Within 60 days after the PDO granted by MSHA becomes final, the operator shall submit proposed revisions for its approved 30 CFR part 48 training plans to the Coal Mine Safety and Health District Manager. These proposed revisions shall specify initial and refresher training regarding the terms and conditions stated in the PDO granted by MSHA. When training is conducted on the terms and conditions in the PDO granted by MSHA, an MSHA Certificate of Training (Form 5000-23) shall be completed. Comments shall be included on the Certificate of Training indicating that it was surveyor training.</P>
                <P>(p) The operator is responsible for seeing that all contractors hired by the operator are using electronic equipment in accordance with the requirements of paragraph (s) above. The conditions of use in this Petition shall apply to all non-permissible Vibration Data Collectors, Analyzers and Balancers used in or inby the last open crosscut or in a return, regardless of whether the equipment is used by the operator or by an independent contractor.</P>
                <P>(q) The operator shall post the PDO granted by MSHA in unobstructed locations on the bulletin boards and/or in other conspicuous places where notices to miners are ordinarily posted, for a period of not less than 60 consecutive days and shall remain on the mine bulletin board until such time as the ruling on the petition becomes final.</P>
                <P>(r) There are no representatives of miners at the Harvey Mine. A copy of this petition has been posted on the bulletin board as of September 30, 2024.</P>
                <P>In support of the proposed alternative method, the petitioner has also submitted: a SCOUT100EX Vibration Data Collector, Analyzer and Balancer datasheet, a SCOUT140EX Vibration Data Collector, Analyzer and Balancer datasheet, a vb7 Portable Data Collector, Analyzer and Balancer datasheet, and email communication from SKF Technical Support.</P>
                <P>The petitioner asserts that the alternative method will guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28882 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Consol Pennsylvania Coal Company, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0084 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0084.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov.</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, 4th Floor West, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
                    <PRTPAGE P="99296"/>
                </P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-059-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Consol Pennsylvania Coal Company, LLC, 275 Technology Drive, Suite 101, Canonsburg, PA 15317.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Enlow Fork Mine, MSHA ID No. 36-07416, located in Washington County, Pennsylvania.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.1002(a), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.1002(a) as it pertains to use of battery-powered vibration analyzers and data collectors. Specifically, the petitioner is requesting to permit the use of battery-powered non-permissible SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer within 150 feet of pillar workings or longwall faces. The petitioner states that:
                </P>
                <P>(a) The petitioner is requesting to utilize the SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer within 150 feet of pillar workings or longwall faces.</P>
                <P>(b) In approximately 2021, the SKF Microlog Analyzer CMXA 51, which was certified and approved by the U.S. Department of Labor's Mine Safety and Health Administration (“MSHA”) for use in hazardous “gassy” areas of all mine operations in the United States, was discontinued and is no longer available for purchase. An email from SKF Technical Support states that the CMXA-51-MSHA Microlog has been discontinued and is no longer available for purchase.</P>
                <P>(c) Currently, there is no other MSHA approved vibration analyzer and data collector still in production. Thus, there are no new MSHA approved vibration analyzers and data collectors that are available for purchase.</P>
                <P>(d) Currently, there is no other MSHA approved vibration analyzer and data collector that is still in production.</P>
                <P>(e) The SCOUT100EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports dual-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(f) The SCOUT140EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports four-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(g) The vb7 Portable Data Collector, Analyzer and Balancer instrument is a dual channel vibration data collector, analyzer and balancer. The device can be used for on-route and off-route data collection, machine-side analysis and diagnosis as well as on-site dynamic balance correction. The vb7 Portable Data Collector, Analyzer and Balancer is certified for Class 1 Division 2 hazardous areas.</P>
                <P>(h) The SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2 and internationally IECEx Zone 2, compliant and safe for use in hazardous areas.</P>
                <P>(i) Consol shall use these devices to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. Primarily, equipment contractors at Consol shall use these analyzers to take vibration readings on the shearing machine to predict and prevent gearing/motor failures while on the longwall face. A failure of a major component on the longwall face potentially poses many risks to miners when that particular component has to be changed out on the face.</P>
                <P>(j) Some equipment manufacturers have historically had gearing issues with their shearer ranging arms on the shearing machines as well as cutter head gearboxes on their continuous miners and these components are very large and heavy.</P>
                <P>(k) Consol relies on vibration collection to predict impending failures and successfully change individual parts and components before a catastrophic failure resulting in changing the entire ranging arm or cutter head gearcase.</P>
                <P>(l) The SCOUT140EX, 100EX, and vb7 shall be used by trained personnel from Consol or the vendor to take readings while running the associated motor or gearbox being tested. The shearing machine shall be out of service from production during the vibration collection.</P>
                <P>(m) In addition, SCOUT140EX, 100EX, and vb7 may be part of the weekly inspection of the shearing machines by the manufacturer representative or by Consol's mine maintenance staff. Regardless, the shearing machine shall not be producing coal or moving while in use unless it has to be trammed to take readings on the haulage/tram gearbox. Regardless, the machines shall not be cutting coal at the time of use.</P>
                <P>(n) Currently, SCOUT140EX, 100EX, and vb7 are the only analyzers Consol has found to replace the older versions and the SKF versions, which are no longer manufactured and available for purchase. However, the SCOUT140EX, 100EX, and vb7 are not approved under the applicable MSHA standards for permissibility.</P>
                <P>(o) Electronic equipment used in underground mines in potentially explosive atmospheres is required to be approved by MSHA per 30 CFR. Bently Nevada and other manufacturers do offer alternative products for many other environments and applications.</P>
                <P>(p) Given the benefits of the use of vibration analyzers, the application of the standard results in a diminution of safety at the mine. Consol petitions to permit the use of a SCOUT100EX, SCOUT140EX, and vb7 Vibration Data Collectors, Analyzers and Balancers.</P>
                <P>(q) The SCOUT100EX, SCOUT140EX, and vb7 Portable Intrinsically Safe Vibration Data Collector, Analyzer and Balancer batteries qualify as intrinsically safe in the US, Canada, and any other country accepting IECEx reports. IECEx is the International Electrotechnical Commissions System for Certification to Standards Relating to Equipment for Use in Explosive Atmosphere.</P>
                <P>(r) The vibration analyzers have an intrinsically safe (IS) rating of Division 1: IS Class I, II, III; Division 1 (includes Division 2) Groups C, D, E, F, G; T4, under the most current standard (UL 60079, 6th Edition, 2013). ATEX-certified with an intrinsically safe (IS) rating of “ia”</P>
                <P>
                    (s) Consol recognizes that (NIOSH) researchers have conducted studies on intrinsically safe (IS) equipment and believe that the International Electrotechnical Commission (IEC) document 60079-11, or the American National Standards Institute (ANSI)/International Society (ISA) document 60079-11 for two-fault equipment (marked as ia), would provide an equivalent level of safety as MSHA-approved equipment.
                    <PRTPAGE P="99297"/>
                </P>
                <P>(t) Consol also recognizes that MSHA does not consider all equipment that meets the 60079-11 standard as equivalent to MSHA approval at this time. However, MSHA also recognizes that use of equipment meeting the 60079-11 standard for two-fault equipment (and even, to a lesser extent, equipment meeting one-fault (marked as ib) or no-fault (marked as ic) standards) provides a level of safety that is not provided by equipment that does not meet the IEC/ANSI/ISA standards.</P>
                <P>(u) The battery is a Custom Lithium Ion Pack, 7.4V, 5,000 mAh. There is internal charging with an external power pack 12V DC, 3A output.</P>
                <P>(v) The standards for approval of these Vibration Data Collectors, Analyzers and Balancers are an acceptable alternative to MSHA's standards and provide an equivalent level of protection.</P>
                <P>(w) The alternate method proposed by the Petitioner will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) The operator shall permit the use of the following Vibration Data Collectors, Analyzers and Balancers if they have an IP rating of 66 or greater in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces, subject to the conditions of the proposed decision and order (PDO) granted by MSHA: SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2.</P>
                <P>(b) All non-permissible Vibration Data Collectors, Analyzers and Balancers to be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall be examined by the person to operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These examinations shall include:</P>
                <P>(1) Check the instrument for any physical damage and the integrity of the case;</P>
                <P>(2) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(c) The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.153.</P>
                <P>(d) The operator shall ensure that any repairs or servicing for all non-permissible Vibration Data Collectors, Analyzers and Balancers will be done by the manufacturer.</P>
                <P>(e) The non-permissible Vibration Data Collectors, Analyzers and Balancers that will be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance with all the terms and conditions of the PDO granted by MSHA.</P>
                <P>(f) Non-permissible Vibration Data Collectors, Analyzers and Balancers shall not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more of methane is detected while the non-permissible surveying equipment is being used, the equipment shall be de-energized immediately and the non-permissible electronic equipment withdrawn outby the last open crosscut or out of the return. Prior to entering in or inby the last open crosscut, or within 150 feet of pillar workings or longwall faces, all requirements of 30 CFR 75.323 shall be complied with.</P>
                <P>(g) All hand-held methane detectors shall be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors shall provide visual and audible warnings when methane is detected at or above 1.0 percent.</P>
                <P>(h) Prior to energizing any of the non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, methane tests shall be made in accordance with 30 CFR 75.323(a).</P>
                <P>(i) All areas where Vibration Data Collectors, Analyzers and Balancers are to be used shall be pre-shifted according to 30 CFR 75.360. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 shall be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 30 CFR 75.361, additional examination is not required.</P>
                <P>(j) A qualified person as defined in existing 30 CFR 75.151 shall continuously monitor for methane immediately before and during the use of non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return.</P>
                <P>(k) Batteries contained in the Vibration Data Collectors, Analyzers and Balancers shall be “charged” in intake air outby the last open crosscut and out of the return. Before each shift requiring the use of Vibration Data Collectors, Analyzers and Balancers all batteries for the Vibration Data Collectors, Analyzers and Balancers shall be charged sufficiently that they are not expected to be charged on that shift.</P>
                <P>(l) When using non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, the operator shall confirm by measurement or by inquiry of the person in charge of the section, that the air quantity on the section, on that shift, in the last open crosscut is at least the minimum quantity that is required by the mine's ventilation plan.</P>
                <P>(m) Personnel engaged in the use of Vibration Data Collectors, Analyzers and Balancers shall be properly trained to recognize the hazards and limitations associated with the use of such equipment in areas where methane could be present.</P>
                <P>(n) All persons who use Vibration Data Collectors, Analyzers and Balancers shall receive specific training on the terms and conditions of the PDO granted by MSHA before using non-permissible electronic equipment in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces. A record of the training shall be kept with the other training records.</P>
                <P>(o) Within 60 days after the PDO granted by MSHA becomes final, the operator shall submit proposed revisions for its approved 30 CFR part 48 training plans to the Coal Mine Safety and Health District Manager. These proposed revisions shall specify initial and refresher training regarding the terms and conditions stated in the PDO granted by MSHA. When training is conducted on the terms and conditions in the PDO granted by MSHA, an MSHA Certificate of Training (Form 5000-23) shall be completed. Comments shall be included on the Certificate of Training indicating that it was surveyor training.</P>
                <P>(p) The operator is responsible for seeing that all contractors hired by the operator are using electronic equipment in accordance with the requirements of paragraph(s) above. The conditions of use in this Petition shall apply to all non-permissible Vibration Data Collectors, Analyzers and Balancers used in or inby the last open crosscut or in a return, or within 150 feet of pillar workings or longwall faces, regardless of whether the equipment is used by the operator or by an independent contractor.</P>
                <P>
                    (q) The operator shall post the PDO granted by MSHA in unobstructed locations on the bulletin boards and/or 
                    <PRTPAGE P="99298"/>
                    in other conspicuous places where notices to miners are ordinarily posted, for a period of not less than 60 consecutive days and shall remain on the mine bulletin board until such time as the ruling on the petition becomes final.
                </P>
                <P>(r) There are no representatives of miners at the Enlow Fork Mine. A copy of this petition has been posted on the bulletin board as of September 30, 2024.</P>
                <P>In support of the proposed alternative method, the petitioner has also submitted: a SCOUT100EX Vibration Data Collector, Analyzer and Balancer datasheet, a SCOUT140EX Vibration Data Collector, Analyzer and Balancer datasheet, a vb7 Portable Data Collector, Analyzer and Balancer datasheet, and email communication from SKF Technical Support.</P>
                <P>The petitioner asserts that the alternative method will guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28887 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Consol Pennsylvania Coal Company, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0083 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0083.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov.</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, 4th Floor West, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:</P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-058-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Consol Pennsylvania Coal Company, LLC, 275 Technology Drive, Suite 101, Canonsburg, PA 15317.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Enlow Fork Mine, MSHA ID No. 36-07416, located in Washington County, Pennsylvania.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.507-1(a), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.507-1(a) as it pertains to use of battery-powered vibration analyzers and data collectors. Specifically, the petitioner is requesting to permit the use of battery-powered non-permissible SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer in the return air outby the last open crosscut.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) The petitioner is requesting to utilize the SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer in the return air outby the last open crosscut.</P>
                <P>(b) In approximately 2021, the SKF Microlog Analyzer CMXA 51, which was certified and approved by the U.S. Department of Labor's Mine Safety and Health Administration (“MSHA”) for use in hazardous “gassy” areas of all mine operations in the United States, was discontinued and is no longer available for purchase. An email from SKF Technical Support states that the CMXA-51-MSHA Microlog has been discontinued and is no longer available for purchase.</P>
                <P>(c) Currently, there is no other MSHA approved vibration analyzer and data collector still in production. Thus, there are no new MSHA approved vibration analyzers and data collectors that are available for purchase.</P>
                <P>(d) Currently, there is no other MSHA approved vibration analyzer and data collector that is still in production.</P>
                <P>(e) The SCOUT100EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports dual-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(f) The SCOUT140EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports four-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(g) The vb7 Portable Data Collector, Analyzer and Balancer instrument is a dual channel vibration data collector, analyzer and balancer. The device can be used for on-route and off-route data collection, machine-side analysis and diagnosis as well as on-site dynamic balance correction. The vb7 Portable Data Collector, Analyzer and Balancer is certified for Class 1 Division 2 hazardous areas.</P>
                <P>
                    (h) The SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2 and 
                    <PRTPAGE P="99299"/>
                    internationally IECEx Zone 2, compliant and safe for use in hazardous areas.
                </P>
                <P>(i) Consol shall use these devices to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. Primarily, equipment contractors at Consol shall use these analyzers to take vibration readings on the shearing machine to predict and prevent gearing/motor failures while on the longwall face. A failure of a major component on the longwall face potentially poses many risks to miners when that particular component has to be changed out on the face.</P>
                <P>(j) Some equipment manufacturers have historically had gearing issues with their shearer ranging arms on the shearing machines as well as cutter head gearboxes on their continuous miners and these components are very large and heavy.</P>
                <P>(k) Consol relies on vibration collection to predict impending failures and successfully change individual parts and components before a catastrophic failure resulting in changing the entire ranging arm or cutter head gearcase.</P>
                <P>(l) The SCOUT140EX, 100EX, and vb7 shall be used by trained personnel from Consol or the vendor to take readings while running the associated motor or gearbox being tested. The shearing machine shall be out of service from production during the vibration collection.</P>
                <P>(m) In addition, SCOUT140EX, 100EX, and vb7 may be part of the weekly inspection of the shearing machines by the manufacturer representative or by Consol's mine maintenance staff. Regardless, the shearing machine shall not be producing coal or moving while in use unless it has to be trammed to take readings on the haulage/tram gearbox. Regardless, the machines shall not be cutting coal at the time of use.</P>
                <P>(n) Currently, SCOUT140EX, 100EX, and vb7 are the only analyzers Consol has found to replace the older versions and the SKF versions, which are no longer manufactured and available for purchase. However, the SCOUT140EX, 100EX, and vb7 are not approved under the applicable MSHA standards for permissibility.</P>
                <P>(o) Electronic equipment used in underground mines in potentially explosive atmospheres is required to be approved by MSHA per 30 CFR. Bently Nevada and other manufacturers do offer alternative products for many other environments and applications.</P>
                <P>(p) Given the benefits of the use of vibration analyzers, the application of the standard results in a diminution of safety at the mine. Consol petitions to permit the use of a SCOUT100EX, SCOUT140EX, and vb7 Vibration Data Collectors, Analyzers and Balancers.</P>
                <P>(q) The SCOUT100EX, SCOUT140EX, and vb7 Portable Intrinsically Safe Vibration Data Collector, Analyzer and Balancer batteries qualify as intrinsically safe in the US, Canada, and any other country accepting IECEx reports. IECEx is the International Electrotechnical Commissions System for Certification to Standards Relating to Equipment for Use in Explosive Atmosphere.</P>
                <P>(r) The vibration analyzers have an intrinsically safe (IS) rating of Division 1: IS Class I, II, III; Division 1 (includes Division 2) Groups C, D, E, F, G; T4, under the most current standard (UL 60079, 6th Edition, 2013). ATEX-certified with an intrinsically safe (IS) rating of “ia”.</P>
                <P>(s) Consol recognizes that (NIOSH) researchers have conducted studies on intrinsically safe (IS) equipment and believe that the International Electrotechnical Commission (IEC) document 60079-11, or the American National Standards Institute (ANSI)/International Society (ISA) document 60079-11 for two-fault equipment (marked as ia), would provide an equivalent level of safety as MSHA-approved equipment.</P>
                <P>(t) Consol also recognizes that MSHA does not consider all equipment that meets the 60079-11 standard as equivalent to MSHA approval at this time. However, MSHA also recognizes that use of equipment meeting the 60079-11 standard for two-fault equipment (and even, to a lesser extent, equipment meeting one-fault (marked as ib) or no-fault (marked as ic) standards) provides a level of safety that is not provided by equipment that does not meet the IEC/ANSI/ISA standards.</P>
                <P>(u) The battery is a Custom Lithium Ion Pack, 7.4V, 5000 mAh. There is internal charging with an external power pack 12V DC, 3A output.</P>
                <P>(v) The standards for approval of these Vibration Data Collectors, Analyzers and Balancers are an acceptable alternative to MSHA's standards and provide an equivalent level of protection.</P>
                <P>(w) The alternate method proposed by the Petitioner will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) The operator shall permit the use of the following Vibration Data Collectors, Analyzers and Balancers if they have an IP rating of 66 or greater in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces, subject to the conditions of the proposed decision and order (PDO) granted by MSHA: SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2.</P>
                <P>(b) All non-permissible Vibration Data Collectors, Analyzers and Balancers to be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall be examined by the person to operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These examinations shall include:</P>
                <P>(1) Check the instrument for any physical damage and the integrity of the case;</P>
                <P>(2) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(c) The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.153.</P>
                <P>(d) The operator shall ensure that any repairs or servicing for all non-permissible Vibration Data Collectors, Analyzers and Balancers will be done by the manufacturer.</P>
                <P>(e) The non-permissible Vibration Data Collectors, Analyzers and Balancers that will be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance with all the terms and conditions of the PDO granted by MSHA.</P>
                <P>(f) Non-permissible Vibration Data Collectors, Analyzers and Balancers shall not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more of methane is detected while the non-permissible surveying equipment is being used, the equipment shall be de-energized immediately and the non-permissible electronic equipment withdrawn outby the last open crosscut or out of the return. Prior to entering in or inby the last open crosscut, or within 150 feet of pillar workings or longwall faces, all requirements of 30 CFR 75.323 shall be complied with.</P>
                <P>
                    (g) All hand-held methane detectors shall be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors shall provide visual and audible warnings when methane is detected at or above 1.0 percent.
                    <PRTPAGE P="99300"/>
                </P>
                <P>(h) Prior to energizing any of the non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, methane tests shall be made in accordance with 30 CFR 75.323(a).</P>
                <P>(i) All areas where Vibration Data Collectors, Analyzers and Balancers are to be used shall be pre-shifted according to 30 CFR 75.360. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 shall be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 30 CFR 75.361, additional examination is not required.</P>
                <P>(j) A qualified person as defined in existing 30 CFR 75.151 shall continuously monitor for methane immediately before and during the use of non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return.</P>
                <P>(k) Batteries contained in the Vibration Data Collectors, Analyzers and Balancers shall be “charged” in intake air outby the last open crosscut and out of the return. Before each shift requiring the use of Vibration Data Collectors, Analyzers and Balancers all batteries for the Vibration Data Collectors, Analyzers and Balancers shall be charged sufficiently that they are not expected to be charged on that shift.</P>
                <P>(l) When using non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, the operator shall confirm by measurement or by inquiry of the person in charge of the section, that the air quantity on the section, on that shift, in the last open crosscut is at least the minimum quantity that is required by the mine's ventilation plan.</P>
                <P>(m) Personnel engaged in the use of Vibration Data Collectors, Analyzers and Balancers shall be properly trained to recognize the hazards and limitations associated with the use of such equipment in areas where methane could be present.</P>
                <P>(n) All persons who use Vibration Data Collectors, Analyzers and Balancers shall receive specific training on the terms and conditions of the PDO granted by MSHA before using non-permissible electronic equipment in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces. A record of the training shall be kept with the other training records.</P>
                <P>(o) Within 60 days after the PDO granted by MSHA becomes final, the operator shall submit proposed revisions for its approved 30 CFR part 48 training plans to the Coal Mine Safety and Health District Manager. These proposed revisions shall specify initial and refresher training regarding the terms and conditions stated in the PDO granted by MSHA. When training is conducted on the terms and conditions in the PDO granted by MSHA, an MSHA Certificate of Training (Form 5000-23) shall be completed. Comments shall be included on the Certificate of Training indicating that it was surveyor training.</P>
                <P>(p) The operator is responsible for seeing that all contractors hired by the operator are using electronic equipment in accordance with the requirements of paragraph (s) above. The conditions of use in this Petition shall apply to all non-permissible Vibration Data Collectors, Analyzers and Balancers used in or inby the last open crosscut or in a return, or within 150 feet of pillar workings or longwall faces, regardless of whether the equipment is used by the operator or by an independent contractor.</P>
                <P>(q) The operator shall post the PDO granted by MSHA in unobstructed locations on the bulletin boards and/or in other conspicuous places where notices to miners are ordinarily posted, for a period of not less than 60 consecutive days and shall remain on the mine bulletin board until such time as the ruling on the petition becomes final.</P>
                <P>(r) There are no representatives of miners at the Enlow Fork Mine. A copy of this petition has been posted on the bulletin board as of September 30, 2024.</P>
                <P>In support of the proposed alternative method, the petitioner has also submitted: a SCOUT100EX Vibration Data Collector, Analyzer and Balancer datasheet, a SCOUT140EX Vibration Data Collector, Analyzer and Balancer datasheet, a vb7 Portable Data Collector, Analyzer and Balancer datasheet, and email communication from SKF Technical Support.</P>
                <P>The petitioner asserts that the alternative method will guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28891 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Rockwell Mining, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0100 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0100.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov.</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
                    <PRTPAGE P="99301"/>
                </P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-075-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Rockwell Mining, LLC, 54912 Pond Fork Road, Wharton, WV 25208.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Gateway Eagle Mine, MSHA ID No. 46-06618, located in Boone County, West Virginia.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.1002(a), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.1002(a) to allow the use of unapproved Powered Air Purifying Respirators (PAPRs) within 150 feet of pillar workings or longwall faces. Specifically, the petitioner is requesting to utilize the CleanSpace EX PAPR and sealed motor/blower/battery power pack assembly, and the 3M Versaflo TR-800 Intrinsically Safe PAPR motor/blower and battery with battery pack.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) The 3M Versaflo TR-800 PAPR with motor/blower and battery qualifies as intrinsically safe.</P>
                <P>(b) The CleanSpace EX PAPR also qualifies as intrinsically safe.</P>
                <P>(c) Both the CleanSpace EX and the 3M Versaflo TR-800 PAPRs provide a constant flow of air inside the mask or helmet. This airflow provides respiratory protection and comfort in hot working conditions.</P>
                <P>(d) Neither the 3M Versaflo TR-800 nor the CleanSpace EX PAPR is MSHA-approved as permissible.</P>
                <P>(e) Neither the 3M nor the CleanSpace is pursuing MSHA approval.</P>
                <P>(f) Gateway Eagle Mine currently makes available to all miners NIOSH-approved high efficiency l00 series respirators to protect the miners against potential exposure to respirable coal mine dust, including crystalline silica, during normal mining conditions. Gateway Eagle Mine desires to expand the miners' option in choosing a respirator that provides the greatest degree of protection as well as comfort while being worn. Powered PAPRs provide a constant flow of filtered air and serve that purpose.</P>
                <P>
                    (g) On June 17, 2024, MSHA's final rule 
                    <E T="03">Lowering Miners' Exposure to Respirable Crystalline Silica and Improving Respiratory Protection</E>
                     took effect. The rule requires the mine operator to have a written respiratory protection program in place when miners are required to use respirators. Adding the CleanSpace EX and the 3M TR-800 Versaflo PAPRs to the respiratory protection program as additional options will provide the miners with alternatives to the series 100 high efficiency respirators already in use at the mine. The PAPRs will also serve as a respirator option to protect the miners with facial hair who may not be able to pass the “fit test” requirement of the program. In addition, the positive flow of filtered air provided by the PAPRs will provide a solution for the miners who are unable to wear a tight-fitting respirator.
                </P>
                <P>(h) Since the 3M Airstream Headgear-Mounted PAPR System has been discontinued by the manufacturer, there are no other MSHA-approved units available that can be used within 150 feet of pillar workings or longwall faces.</P>
                <P>(i) The alternative method in the petition will at all times guarantee no less than the same measure of protection afforded to the miners by the standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) All miners who will be involved with or affected by the use of the 3M Versaflo TR-800 or CleanSpace EX PAPRs shall receive training in accordance with 30 CFR 48.7 on the requirements of the Proposed Decision and Order (PDO) granted by MSHA and manufacturer guidelines. Such training shall be completed before any 3M Versaflo TR-800 or CleanSpace EX PAPR can be used within 150 feet of pillar workings or longwall faces. The operator shall keep a record of such training and provide such record to MSHA upon request.</P>
                <P>(b) The PAPRs, battery packs, and all associated wiring and connections shall be inspected before use to determine if there is any damage to the units that would negatively impact intrinsic safety. If any defects are found, the PAPR shall be removed from service.</P>
                <P>(c) A separate logbook shall be maintained for the 3M Versaflo TR-800 and CleanSpace EX PAPRs that will be kept with the equipment, or in a location with other mine record books and shall be made available to MSHA upon request. The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.512-1 and the examination results recorded in the logbook. Examination records shall be maintained for one year.</P>
                <P>(d) All 3M Versaflo TR-800 and CleanSpace EX PAPRs to be used within 150 feet of pillar workings or longwall faces shall be physically examined prior to initial use and each unit shall be assigned a unique identification number. Each unit shall be examined by the person to operate the equipment, prior to taking the equipment underground, to ensure that the equipment is used according to the original equipment manufacturer's recommendations and maintained in a safe operating condition. The examinations for the 3M Versaflo TR-800 PAPRs shall include:</P>
                <P>(1) Check the equipment for any physical damage and the integrity of the case.</P>
                <P>(2) Remove the battery and inspect for corrosion.</P>
                <P>(3) Inspect the contact points to ensure a secure connection to the battery.</P>
                <P>(4) Reinsert the battery and power up and shut down to ensure proper connections.</P>
                <P>(5) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(6) For equipment utilizing lithium type cells, ensure that lithium cells and/or packs are not damaged or swelled in size.</P>
                <P>The CleanSpace EX PAPR does not have an accessible/removable battery. The internal battery and motor/blower assembly are both contained within the “power unit” assembly, and the battery cannot be removed, reinserted or fastened. Therefore, examination of the CleanSpace EX PAPR shall include any indications of physical damage.</P>
                <P>(e) All 3M Versaflo TR-800 and CleanSpace EX PAPR units shall be serviced according to the manufacturer's recommendations.</P>
                <P>(f) Prior to energizing and during use of the 3M Versaflo TR-800 or the CleanSpace EX PAPR within 150 feet of pillar workings or longwall faces, procedures in accordance with 30 CFR 75.323 shall be followed.</P>
                <P>(g) Only the 3M TR-830 Battery Pack, which meets lithium battery safety standard UL 1642 or IEC 62133, in the 3M Versaflo TR-800 PAPR shall be used. Only the CleanSpace EX Power Unit, which meets lithium battery safety standard UL 1642 or IEC 62133, in the CleanSpace EX shall be used.</P>
                <P>(h) If battery packs for the 3M Versaflo TR-800 PAPR are provided, all battery “change outs” shall occur in intake air outby the last open crosscut.  </P>
                <P>(i) The following maintenance and use conditions shall apply to equipment containing lithium type batteries:</P>
                <P>
                    (1) Neither the 3M TR-830 Battery Pack nor the CleanSpace EX Power Unit shall be disassembled or modified by 
                    <PRTPAGE P="99302"/>
                    anyone other than permitted by the manufacturer of the equipment.
                </P>
                <P>(2) The 3M TR-830 Battery Pack shall be charged only in an area free of combustible material and in intake air outby the last open crosscut. The 3M TR-830 Battery Pack shall be charged only by a manufacturer's recommended battery charger, such as:</P>
                <P>(i) 3M Battery Charger Kit TR-641N, which includes one 3M Charger Cradle TR-640 and one 3M Power Supply TR-941N; or</P>
                <P>(ii) 3M 4-Station Battery Charger Kit TR-644N, which includes four 3M Charger Cradles TR-640 and one 3M 4-Station Battery Charger Base/Power Supply TR-944N.</P>
                <P>(3) The CleanSpace EX internal battery, which is contained within the power unit assembly, shall be charged in areas located outby the last open crosscut in intake air, and only the manufacturer's recommended battery chargers shall be used, such as the CleanSpace EX Battery Charger, Product Code PAF-0066.</P>
                <P>(4) Neither the 3M TR-830 Battery Pack nor the CleanSpace EX power unit which contains the internal battery, shall be exposed to water, allowed to get wet or immersed in liquid. This does not preclude incidental exposure of the 3M TR-830 Battery Pack or the CleanSpace EX power unit assembly.</P>
                <P>(5) Neither the 3M Versaflo TR-800 PAPR nor the CleanSpace EX PAPR, including the internal battery, shall be used, charged or stored in locations where the manufacturer's recommended temperature limits are exceeded. Neither the 3M Versaflo TR-800 PAPR nor the CleanSpace EX PAPR shall be placed in direct sunlight or stored near a source of heat.</P>
                <P>(j) Annual retraining shall be given to all miners who will be involved with or affected by the use of the 3M Versaflo TR-800 or CleanSpace EX PAPRs in accordance with 30 CFR 48.8. Training of new miners on the requirements of the PDO granted by MSHA in accordance with 30 CFR 48.5, and training of experienced miners on the requirements of the PDO granted by MSHA in accordance with 30 CFR 48.6 shall be given. The operator shall keep a record of such training and provide such record to MSHA upon request.</P>
                <P>(k) The miners at Rockwell Mining, LLC, Gateway Eagle Mine, are represented by a labor organization and a copy of this petition has been provided to the representative of the miners at the mine on November 21, 2024.</P>
                <P>The petitioner asserts that the alternative method in the petition will at all times guarantee no less than the same measure of protection afforded to the miners by the standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-29033 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Rockwell Mining, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0098 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0098.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:</P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-073-C
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Rockwell Mining, LLC, 54912 Pond Fork Road, Wharton, WV 25208.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Gateway Eagle Mine, MSHA ID No. 46-06618, located in Boone County, West Virginia.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.500(d), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.500(d) to allow the use of unapproved Powered Air Purifying Respirators (PAPRs) taken into or used inby the last open crosscut. Specifically, the petitioner is requesting to utilize the CleanSpace EX PAPR and sealed motor/blower/battery power pack assembly, and the 3M Versaflo TR-800 Intrinsically Safe PAPR motor/blower and battery with battery pack.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) The 3M Versaflo TR-800 PAPR with motor/blower and battery qualifies as intrinsically safe.</P>
                <P>(b) The CleanSpace EX PAPR also qualifies as intrinsically safe.</P>
                <P>(c) Both the CleanSpace EX and the 3M Versaflo TR-800 PAPRs provide a constant flow of air inside the mask or helmet. This airflow provides respiratory protection and comfort in hot working conditions.</P>
                <P>(d) Neither the 3M Versaflo TR-800 nor the CleanSpace EX PAPR is MSHA-approved as permissible.</P>
                <P>(e) Neither the 3M nor the CleanSpace is pursuing MSHA approval.</P>
                <P>
                    (f) Gateway Eagle Mine currently makes available to all miners NIOSH-approved high efficiency l00 series respirators to protect the miners against potential exposure to respirable coal mine dust, including crystalline silica, 
                    <PRTPAGE P="99303"/>
                    during normal mining conditions. Gateway Eagle Mine desires to expand the miners' option in choosing a respirator that provides the greatest degree of protection as well as comfort while being worn. Powered PAPRs provide a constant flow of filtered air and serve that purpose.
                </P>
                <P>
                    (g) On June 17, 2024, MSHA's final rule 
                    <E T="03">Lowering Miners' Exposure to Respirable Crystalline Silica and Improving Respiratory Protection</E>
                     took effect. The rule requires the mine operator to have a written respiratory protection program in place when miners are required to use respirators. Adding the CleanSpace EX and the 3M TR-800 Versaflo PAPRs to the respiratory protection program as additional options will provide the miners with alternatives to the series 100 high efficiency respirators already in use at the mine. The PAPRs will also serve as a respirator option to protect the miners with facial hair who may not be able to pass the “fit test” requirement of the program. In addition, the positive flow of filtered air provided by the PAPRs will provide a solution for the miners who are unable to wear a tight-fitting respirator.
                </P>
                <P>(h) Since the 3M Airstream Headgear-Mounted PAPR System has been discontinued by the manufacturer, there are no other MSHA-approved units available that can be taken into or used inby the last open crosscut.</P>
                <P>(i) The alternative method in the petition will at all times guarantee no less than the same measure of protection afforded to the miners by the standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) All miners who will be involved with or affected by the use of the 3M Versaflo TR-800 or CleanSpace EX PAPRs shall receive training in accordance with 30 CFR 48.7 on the requirements of the Proposed Decision and Order (PDO) granted by MSHA and manufacturer guidelines. Such training shall be completed before any 3M Versaflo TR-800 or CleanSpace EX PAPR can be used inby the last open crosscut. The operator shall keep a record of such training and provide such record to MSHA upon request.</P>
                <P>(b) The PAPRs, battery packs, and all associated wiring and connections shall be inspected before use to determine if there is any damage to the units that would negatively impact intrinsic safety. If any defects are found, the PAPR shall be removed from service.</P>
                <P>(c) A separate logbook shall be maintained for the 3M Versaflo TR-800 and CleanSpace EX PAPRs that will be kept with the equipment, or in a location with other mine record books and shall be made available to MSHA upon request. The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.512-1 and the examination results recorded in the logbook. Examination records shall be maintained for one year.</P>
                <P>(d) All 3M Versaflo TR-800 and CleanSpace EX PAPRs to be used inby the last open crosscut shall be physically examined prior to initial use and each unit shall be assigned a unique identification number. Each unit shall be examined by the person to operate the equipment, prior to taking the equipment underground, to ensure that the equipment is used according to the original equipment manufacturer's recommendations and maintained in a safe operating condition. The examinations for the 3M Versaflo TR-800 PAPRs shall include:</P>
                <P>(1) Check the equipment for any physical damage and the integrity of the case.</P>
                <P>(2) Remove the battery and inspect for corrosion.</P>
                <P>(3) Inspect the contact points to ensure a secure connection to the battery.</P>
                <P>(4) Reinsert the battery and power up and shut down to ensure proper connections.</P>
                <P>(5) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(6) For equipment utilizing lithium type cells, ensure that lithium cells and/or packs are not damaged or swelled in size.</P>
                <P>The CleanSpace EX PAPR does not have an accessible/removable battery. The internal battery and motor/blower assembly are both contained within the “power unit” assembly, and the battery cannot be removed, reinserted or fastened. Therefore, examination of the CleanSpace EX PAPR shall include any indications of physical damage.</P>
                <P>(e) All 3M Versaflo TR-800 and CleanSpace EX PAPR units shall be serviced according to the manufacturer's recommendations.</P>
                <P>(f) Prior to energizing and during use of the 3M Versaflo TR-800 or the CleanSpace EX PAPR inby the last open crosscut, procedures in accordance with 30 CFR 75.323 shall be followed.</P>
                <P>(g) Only the 3M TR-830 Battery Pack, which meets lithium battery safety standard UL 1642 or IEC 62133, in the 3M Versaflo TR-800 PAPR shall be used. Only the CleanSpace EX Power Unit, which meets lithium battery safety standard UL 1642 or IEC 62133, in the CleanSpace EX shall be used.</P>
                <P>(h) If battery packs for the 3M Versaflo TR-800 PAPR are provided, all battery “change outs” shall occur in intake air outby the last open crosscut.  </P>
                <P>(i) The following maintenance and use conditions shall apply to equipment containing lithium type batteries:</P>
                <P>(1) Neither the 3M TR-830 Battery Pack nor the CleanSpace EX Power Unit shall be disassembled or modified by anyone other than permitted by the manufacturer of the equipment.</P>
                <P>(2) The 3M TR-830 Battery Pack shall be charged only in an area free of combustible material and in intake air outby the last open crosscut. The 3M TR-830 Battery Pack shall be charged only by a manufacturer's recommended battery charger, such as:</P>
                <P>(i) 3M Battery Charger Kit TR-641N, which includes one 3M Charger Cradle TR-640 and one 3M Power Supply TR-941N; or</P>
                <P>(ii) 3M 4-Station Battery Charger Kit TR-644N, which includes four 3M Charger Cradles TR-640 and one 3M 4-Station Battery Charger Base/Power Supply TR-944N.</P>
                <P>(3) The CleanSpace EX internal battery, which is contained within the power unit assembly, shall be charged in areas located outby the last open crosscut in intake air, and only the manufacturer's recommended battery chargers shall be used, such as the CleanSpace EX Battery Charger, Product Code PAF-0066.</P>
                <P>(4) Neither the 3M TR-830 Battery Pack nor the CleanSpace EX power unit which contains the internal battery, shall be exposed to water, allowed to get wet or immersed in liquid. This does not preclude incidental exposure of the 3M TR-830 Battery Pack or the CleanSpace EX power unit assembly.</P>
                <P>(5) Neither the 3M Versaflo TR-800 PAPR nor the CleanSpace EX PAPR, including the internal battery, shall be used, charged or stored in locations where the manufacturer's recommended temperature limits are exceeded. Neither the 3M Versaflo TR-800 PAPR nor the CleanSpace EX PAPR shall be placed in direct sunlight or stored near a source of heat.</P>
                <P>(j) Annual retraining shall be given to all miners who will be involved with or affected by the use of the 3M Versaflo TR-800 or CleanSpace EX PAPRs in accordance with 30 CFR 48.8. Training of new miners on the requirements of the PDO granted by MSHA in accordance with 30 CFR 48.5, and training of experienced miners on the requirements of the PDO granted by MSHA in accordance with 30 CFR 48.6 shall be given. The operator shall keep a record of such training and provide such record to MSHA upon request.</P>
                <P>
                    (k) The miners at Rockwell Mining, LLC, Gateway Eagle Mine, are 
                    <PRTPAGE P="99304"/>
                    represented by a labor organization and a copy of this petition has been provided to the representative of the miners at the mine on November 21, 2024.
                </P>
                <P>The petitioner asserts that the alternative method in the petition will at all times guarantee no less than the same measure of protection afforded to the miners by the standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-29030 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Consol Pennsylvania Coal Company, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0082 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0082.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, 4th Floor West, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:</P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-057-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Consol Pennsylvania Coal Company, LLC, 275 Technology Drive, Suite 101, Canonsburg, PA 15317.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Enlow Fork Mine, MSHA ID No. 36-07416, located in Washington County, Pennsylvania.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.500(d), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.500(d)
                </P>
                <P>as it pertains to use of battery-powered vibration analyzers and data collectors. Specifically, the petitioner is requesting to permit the use of battery-powered non-permissible SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer in or inby the last open crosscut.</P>
                <P>The petitioner states that:</P>
                <P>(a) The petitioner is requesting to utilize the SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer in or inby the last open crosscut.</P>
                <P>(b) In approximately 2021, the SKF Microlog Analyzer CMXA 51, which was certified and approved by the U.S. Department of Labor's Mine Safety and Health Administration (“MSHA”) for use in hazardous “gassy” areas of all mine operations in the United States, was discontinued and is no longer available for purchase. An email from SKF Technical Support states that the CMXA-51-MSHA Microlog has been discontinued and is no longer available for purchase.</P>
                <P>(c) Currently, there is no other MSHA approved vibration analyzer and data collector still in production. Thus, there are no new MSHA approved vibration analyzers and data collectors that are available for purchase.</P>
                <P>(d) Currently, there is no other MSHA approved vibration analyzer and data collector that is still in production.</P>
                <P>(e) The SCOUT100EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports dual-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(f) The SCOUT140EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports four-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(g) The vb7 Portable Data Collector, Analyzer and Balancer instrument is a dual channel vibration data collector, analyzer and balancer. The device can be used for on-route and off-route data collection, machine-side analysis and diagnosis as well as on-site dynamic balance correction. The vb7 Portable Data Collector, Analyzer and Balancer is certified for Class 1 Division 2 hazardous areas.</P>
                <P>(h) The SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2 and internationally IECEx Zone 2, compliant and safe for use in hazardous areas.</P>
                <P>(i) Consol shall use these devices to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. Primarily, equipment contractors at Consol shall use these analyzers to take vibration readings on the shearing machine to predict and prevent gearing/motor failures while on the longwall face. A failure of a major component on the longwall face potentially poses many risks to miners when that particular component has to be changed out on the face.</P>
                <P>
                    (j) Some equipment manufacturers have historically had gearing issues 
                    <PRTPAGE P="99305"/>
                    with their shearer ranging arms on the shearing machines as well as cutter head gearboxes on their continuous miners and these components are very large and heavy.
                </P>
                <P>(k) Consol relies on vibration collection to predict impending failures and successfully change individual parts and components before a catastrophic failure resulting in changing the entire ranging arm or cutter head gearcase.</P>
                <P>(l) The SCOUT140EX, 100EX, and vb7 shall be used by trained personnel from Consol or the vendor to take readings while running the associated motor or gearbox being tested. The shearing machine shall be out of service from production during the vibration collection.</P>
                <P>(m) In addition, SCOUT140EX, 100EX, and vb7 may be part of the weekly inspection of the shearing machines by the manufacturer representative or by Consol's mine maintenance staff. Regardless, the shearing machine shall not be producing coal or moving while in use unless it has to be trammed to take readings on the haulage/tram gearbox. Regardless, the machines shall not be cutting coal at the time of use.</P>
                <P>(n) Currently, SCOUT140EX, 100EX, and vb7 are the only analyzers Consol has found to replace the older versions and the SKF versions, which are no longer manufactured and available for purchase. However, the SCOUT140EX, 100EX, and vb7 are not approved under the applicable MSHA standards for permissibility.</P>
                <P>(o) Electronic equipment used in underground mines in potentially explosive atmospheres is required to be approved by MSHA per 30 CFR. Bently Nevada and other manufacturers do offer alternative products for many other environments and applications.</P>
                <P>(p) Given the benefits of the use of vibration analyzers, the application of the standard results in a diminution of safety at the mine. Consol petitions to permit the use of a SCOUT100EX, SCOUT140EX, and vb7 Vibration Data Collectors, Analyzers and Balancers.</P>
                <P>(q) The SCOUT100EX, SCOUT140EX, and vb7 Portable Intrinsically Safe Vibration Data Collector, Analyzer and Balancer batteries qualify as intrinsically safe in the US, Canada, and any other country accepting IECEx reports. IECEx is the International Electrotechnical Commissions System for Certification to Standards Relating to Equipment for Use in Explosive Atmosphere.</P>
                <P>(r) The vibration analyzers have an intrinsically safe (IS) rating of Division 1: IS Class I, II, III; Division 1 (includes Division 2) Groups C, D, E, F, G; T4, under the most current standard (UL 60079, 6th Edition, 2013). ATEX-certified with an intrinsically safe (IS) rating of “ia”</P>
                <P>(s) Consol recognizes that (NIOSH) researchers have conducted studies on intrinsically safe (IS) equipment and believe that the International Electrotechnical Commission (IEC) document 60079-11, or the American National Standards Institute (ANSI)/International Society (ISA) document 60079-11 for two-fault equipment (marked as ia), would provide an equivalent level of safety as MSHA-approved equipment.</P>
                <P>(t) Consol also recognizes that MSHA does not consider all equipment that meets the 60079-11 standard as equivalent to MSHA approval at this time. However, MSHA also recognizes that use of equipment meeting the 60079-11 standard for two-fault equipment (and even, to a lesser extent, equipment meeting one-fault (marked as ib) or no-fault (marked as ic) standards) provides a level of safety that is not provided by equipment that does not meet the IEC/ANSI/ISA standards.</P>
                <P>(u) The battery is a Custom Lithium Ion Pack, 7.4V, 5000 mAh. There is internal charging with an external power pack 12V DC, 3A output.</P>
                <P>(v) The standards for approval of these Vibration Data Collectors, Analyzers and Balancers are an acceptable alternative to MSHA's standards and provide an equivalent level of protection.</P>
                <P>(w) The alternate method proposed by the Petitioner will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) The operator shall permit the use of the following Vibration Data Collectors, Analyzers and Balancers if they have an IP rating of 66 or greater in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces subject to the conditions of the proposed decision and order (PDO) granted by MSHA: SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2.</P>
                <P>(b) All non-permissible Vibration Data Collectors, Analyzers and Balancers to be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall be examined by the person to operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These examinations shall include:</P>
                <P>(1) Check the instrument for any physical damage and the integrity of the case;</P>
                <P>(2) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(c) The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.153.</P>
                <P>(d) The operator shall ensure that any repairs or servicing for all non-permissible Vibration Data Collectors, Analyzers and Balancers will be done by the manufacturer.</P>
                <P>(e) The non-permissible Vibration Data Collectors, Analyzers and Balancers that will be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance with all the terms and conditions of the PDO granted by MSHA.</P>
                <P>(f) Non-permissible Vibration Data Collectors, Analyzers and Balancers shall not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more of methane is detected while the non-permissible surveying equipment is being used, the equipment shall be de-energized immediately and the non-permissible electronic equipment withdrawn outby the last open crosscut or out of the return. Prior to entering in or inby the last open crosscut, or within 150 feet of pillar workings or longwall faces, all requirements of 30 CFR 75.323 shall be complied with.</P>
                <P>(g) All hand-held methane detectors shall be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors shall provide visual and audible warnings when methane is detected at or above 1.0 percent.</P>
                <P>(h) Prior to energizing any of the non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, methane tests shall be made in accordance with 30 CFR 75.323(a).</P>
                <P>
                    (i) All areas where Vibration Data Collectors, Analyzers and Balancers are to be used shall be pre-shifted according to 30 CFR 75.360. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 shall be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 
                    <PRTPAGE P="99306"/>
                    75.360 or 30 CFR 75.361, additional examination is not required.
                </P>
                <P>(j) A qualified person as defined in existing 30 CFR 75.151 shall continuously monitor for methane immediately before and during the use of non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return.</P>
                <P>(k) Batteries contained in the Vibration Data Collectors, Analyzers and Balancers shall be “charged” in intake air outby the last open crosscut and out of the return. Before each shift requiring the use of Vibration Data Collectors, Analyzers and Balancers all batteries for the Vibration Data Collectors, Analyzers and Balancers shall be charged sufficiently that they are not expected to be charged on that shift.</P>
                <P>(l) When using non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, the operator shall confirm by measurement or by inquiry of the person in charge of the section, that the air quantity on the section, on that shift, in the last open crosscut is at least the minimum quantity that is required by the mine's ventilation plan.</P>
                <P>(m) Personnel engaged in the use of Vibration Data Collectors, Analyzers and Balancers shall be properly trained to recognize the hazards and limitations associated with the use of such equipment in areas where methane could be present.</P>
                <P>(n) All persons who use Vibration Data Collectors, Analyzers and Balancers shall receive specific training on the terms and conditions of the PDO granted by MSHA before using non-permissible electronic equipment in or inby the last open crosscut or in the return. A record of the training shall be kept with the other training records.</P>
                <P>(o) Within 60 days after the PDO granted by MSHA becomes final, the operator shall submit proposed revisions for its approved 30 CFR part 48 training plans to the Coal Mine Safety and Health District Manager. These proposed revisions shall specify initial and refresher training regarding the terms and conditions stated in the PDO granted by MSHA. When training is conducted on the terms and conditions in the PDO granted by MSHA, an MSHA Certificate of Training (Form 5000-23) shall be completed. Comments shall be included on the Certificate of Training indicating that it was surveyor training.</P>
                <P>(p) The operator is responsible for seeing that all contractors hired by the operator are using electronic equipment in accordance with the requirements of paragraph (s) above. The conditions of use in this Petition shall apply to all non-permissible Vibration Data Collectors, Analyzers and Balancers used in or inby the last open crosscut or in a return, regardless of whether the equipment is used by the operator or by an independent contractor.</P>
                <P>(q) The operator shall post the PDO granted by MSHA in unobstructed locations on the bulletin boards and/or in other conspicuous places where notices to miners are ordinarily posted, for a period of not less than 60 consecutive days and shall remain on the mine bulletin board until such time as the ruling on the petition becomes final.</P>
                <P>(r) There are no representatives of miners at the Enlow Fork Mine. A copy of this petition has been posted on the bulletin board as of September 30, 2024.</P>
                <P>In support of the proposed alternative method, the petitioner has also submitted: a SCOUT100EX Vibration Data Collector, Analyzer and Balancer datasheet, a SCOUT140EX Vibration Data Collector, Analyzer and Balancer datasheet, a vb7 Portable Data Collector, Analyzer and Balancer datasheet, and email communication from SKF Technical Support.</P>
                <P>The petitioner asserts that the alternative method will guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28886 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Consol Pennsylvania Coal Company, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0087 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0087.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, 4th Floor West, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:</P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-062-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Consol Pennsylvania Coal Company, LLC, 275 Technology Drive, Suite 101, Canonsburg, PA 15317.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Harvey Mine, MSHA ID No. 36-10045, located in Greene County, Pennsylvania.
                    <PRTPAGE P="99307"/>
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.1002(a), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.1002(a) as it pertains to use of battery-powered vibration analyzers and data collectors. Specifically, the petitioner is requesting to permit the use of battery-powered non-permissible SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer within 150 feet of pillar workings or longwall faces.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) The petitioner is requesting to utilize the SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer within 150 feet of pillar workings or longwall faces.</P>
                <P>(b) In approximately 2021, the SKF Microlog Analyzer CMXA 51, which was certified and approved by the U.S. Department of Labor's Mine Safety and Health Administration (“MSHA”) for use in hazardous “gassy” areas of all mine operations in the United States, was discontinued and is no longer available for purchase. An email from SKF Technical Support states that the CMXA-51-MSHA Microlog has been discontinued and is no longer available for purchase.</P>
                <P>(c) Currently, there is no other MSHA approved vibration analyzer and data collector still in production. Thus, there are no new MSHA approved vibration analyzers and data collectors that are available for purchase.</P>
                <P>(d) Currently, there is no other MSHA approved vibration analyzer and data collector that is still in production.</P>
                <P>(e) The SCOUT100EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports dual-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(f) The SCOUT140EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports four-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(g) The vb7 Portable Data Collector, Analyzer and Balancer instrument is a dual channel vibration data collector, analyzer and balancer. The device can be used for on-route and off-route data collection, machine-side analysis and diagnosis as well as on-site dynamic balance correction. The vb7 Portable Data Collector, Analyzer and Balancer is certified for Class 1 Division 2 hazardous areas.</P>
                <P>(h) The SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2 and internationally IECEx Zone 2, compliant and safe for use in hazardous areas.</P>
                <P>(i) Consol shall use these devices to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. Primarily, equipment contractors at Consol shall use these analyzers to take vibration readings on the shearing machine to predict and prevent gearing/motor failures while on the longwall face. A failure of a major component on the longwall face potentially poses many risks to miners when that particular component has to be changed out on the face.</P>
                <P>(j) Some equipment manufacturers have historically had gearing issues with their shearer ranging arms on the shearing machines as well as cutter head gearboxes on their continuous miners and these components are very large and heavy.</P>
                <P>(k) Consol relies on vibration collection to predict impending failures and successfully change individual parts and components before a catastrophic failure resulting in changing the entire ranging arm or cutter head gearcase.</P>
                <P>(l) The SCOUT140EX, 100EX, and vb7 shall be used by trained personnel from Consol or the vendor to take readings while running the associated motor or gearbox being tested. The shearing machine shall be out of service from production during the vibration collection.</P>
                <P>(m) In addition, SCOUT140EX, 100EX, and vb7 may be part of the weekly inspection of the shearing machines by the manufacturer representative or by Consol's mine maintenance staff. Regardless, the shearing machine shall not be producing coal or moving while in use unless it has to be trammed to take readings on the haulage/tram gearbox. Regardless, the machines shall not be cutting coal at the time of use.</P>
                <P>(n) Currently, SCOUT140EX, 100EX, and vb7 are the only analyzers Consol has found to replace the older versions and the SKF versions, which are no longer manufactured and available for purchase. However, the SCOUT140EX, 100EX, and vb7 are not approved under the applicable MSHA standards for permissibility.</P>
                <P>(o) Electronic equipment used in underground mines in potentially explosive atmospheres is required to be approved by MSHA per 30 CFR. Bently Nevada and other manufacturers do offer alternative products for many other environments and applications.</P>
                <P>(p) Given the benefits of the use of vibration analyzers, the application of the standard results in a diminution of safety at the mine. Consol petitions to permit the use of a SCOUT100EX, SCOUT140EX, and vb7 Vibration Data Collectors, Analyzers and Balancers.</P>
                <P>(q) The SCOUT100EX, SCOUT140EX, and vb7 Portable Intrinsically Safe Vibration Data Collector, Analyzer and Balancer batteries qualify as intrinsically safe in the US, Canada, and any other country accepting IECEx reports. IECEx is the International Electrotechnical Commissions System for Certification to Standards Relating to Equipment for Use in Explosive Atmosphere.</P>
                <P>(r) The vibration analyzers have an intrinsically safe (IS) rating of Division 1: IS Class I, II, III; Division 1 (includes Division 2) Groups C, D, E, F, G; T4, under the most current standard (UL 60079, 6th Edition, 2013). ATEX-certified with an intrinsically safe (IS) rating of “ia”</P>
                <P>(s) Consol recognizes that (NIOSH) researchers have conducted studies on intrinsically safe (IS) equipment and believe that the International Electrotechnical Commission (IEC) document 60079-11, or the American National Standards Institute (ANSI)/International Society (ISA) document 60079-11 for two-fault equipment (marked as ia), would provide an equivalent level of safety as MSHA-approved equipment.</P>
                <P>(t) Consol also recognizes that MSHA does not consider all equipment that meets the 60079-11 standard as equivalent to MSHA approval at this time. However, MSHA also recognizes that use of equipment meeting the 60079-11 standard for two-fault equipment (and even, to a lesser extent, equipment meeting one-fault (marked as ib) or no-fault (marked as ic) standards) provides a level of safety that is not provided by equipment that does not meet the IEC/ANSI/ISA standards.</P>
                <P>(u) The battery is a Custom Lithium Ion Pack, 7.4V, 5000 mAh. There is internal charging with an external power pack 12V DC, 3A output.</P>
                <P>
                    (v) The standards for approval of these Vibration Data Collectors, 
                    <PRTPAGE P="99308"/>
                    Analyzers and Balancers are an acceptable alternative to MSHA's standards and provide an equivalent level of protection.
                </P>
                <P>(w) The alternate method proposed by the Petitioner will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) The operator shall permit the use of the following Vibration Data Collectors, Analyzers and Balancers if they have an IP rating of 66 or greater in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces, subject to the conditions of the proposed decision and order (PDO) granted by MSHA: SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2.</P>
                <P>(b) All non-permissible Vibration Data Collectors, Analyzers and Balancers to be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall be examined by the person to operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These examinations shall include:</P>
                <P>(1) Check the instrument for any physical damage and the integrity of the case;</P>
                <P>(2) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(c) The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.153.</P>
                <P>(d) The operator shall ensure that any repairs or servicing for all non-permissible Vibration Data Collectors, Analyzers and Balancers will be done by the manufacturer.</P>
                <P>(e) The non-permissible Vibration Data Collectors, Analyzers and Balancers that will be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance with all the terms and conditions of the PDO granted by MSHA.</P>
                <P>(f) Non-permissible Vibration Data Collectors, Analyzers and Balancers shall not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more of methane is detected while the non-permissible surveying equipment is being used, the equipment shall be de-energized immediately and the non-permissible electronic equipment withdrawn outby the last open crosscut or out of the return. Prior to entering in or inby the last open crosscut, or within 150 feet of pillar workings or longwall faces, all requirements of 30 CFR 75.323 shall be complied with.</P>
                <P>(g) All hand-held methane detectors shall be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors shall provide visual and audible warnings when methane is detected at or above 1.0 percent.</P>
                <P>(h) Prior to energizing any of the non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, methane tests shall be made in accordance with 30 CFR 75.323(a).</P>
                <P>(i) All areas where Vibration Data Collectors, Analyzers and Balancers are to be used shall be pre-shifted according to 30 CFR 75.360. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 shall be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 30 CFR 75.361, additional examination is not required.</P>
                <P>(j) A qualified person as defined in existing 30 CFR 75.151 shall continuously monitor for methane immediately before and during the use of non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return.</P>
                <P>(k) Batteries contained in the Vibration Data Collectors, Analyzers and Balancers shall be “charged” in intake air outby the last open crosscut and out of the return. Before each shift requiring the use of Vibration Data Collectors, Analyzers and Balancers all batteries for the Vibration Data Collectors, Analyzers and Balancers shall be charged sufficiently that they are not expected to be charged on that shift.</P>
                <P>(l) When using non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, the operator shall confirm by measurement or by inquiry of the person in charge of the section, that the air quantity on the section, on that shift, in the last open crosscut is at least the minimum quantity that is required by the mine's ventilation plan.</P>
                <P>(m) Personnel engaged in the use of Vibration Data Collectors, Analyzers and Balancers shall be properly trained to recognize the hazards and limitations associated with the use of such equipment in areas where methane could be present.</P>
                <P>(n) All persons who use Vibration Data Collectors, Analyzers and Balancers shall receive specific training on the terms and conditions of the PDO granted by MSHA before using non-permissible electronic equipment in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces. A record of the training shall be kept with the other training records.</P>
                <P>(o) Within 60 days after the PDO granted by MSHA becomes final, the operator shall submit proposed revisions for its approved 30 CFR part 48 training plans to the Coal Mine Safety and Health District Manager. These proposed revisions shall specify initial and refresher training regarding the terms and conditions stated in the PDO granted by MSHA. When training is conducted on the terms and conditions in the PDO granted by MSHA, an MSHA Certificate of Training (Form 5000-23) shall be completed. Comments shall be included on the Certificate of Training indicating that it was surveyor training.</P>
                <P>(p) The operator is responsible for seeing that all contractors hired by the operator are using electronic equipment in accordance with the requirements of paragraph (s) above. The conditions of use in this Petition shall apply to all non-permissible Vibration Data Collectors, Analyzers and Balancers used in or inby the last open crosscut or in a return, or within 150 feet of pillar workings or longwall faces, regardless of whether the equipment is used by the operator or by an independent contractor.</P>
                <P>(q) The operator shall post the PDO granted by MSHA in unobstructed locations on the bulletin boards and/or in other conspicuous places where notices to miners are ordinarily posted, for a period of not less than 60 consecutive days and shall remain on the mine bulletin board until such time as the ruling on the petition becomes final.</P>
                <P>(r) There are no representatives of miners at the Harvey Mine. A copy of this petition has been posted on the bulletin board as of September 30, 2024.</P>
                <P>
                    In support of the proposed alternative method, the petitioner has also submitted: a SCOUT100EX Vibration Data Collector, Analyzer and Balancer datasheet, a SCOUT140EX Vibration Data Collector, Analyzer and Balancer datasheet, a vb7 Portable Data Collector, Analyzer and Balancer datasheet, and 
                    <PRTPAGE P="99309"/>
                    email communication from SKF Technical Support.
                </P>
                <P>The petitioner asserts that the alternative method will guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28879 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Consol Pennsylvania Coal Company, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0079 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-00XX79.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov.</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, 4th Floor West, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:</P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-054-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Consol Pennsylvania Coal Company, LLC, 275 Technology Drive, Suite 101, Canonsburg, PA 15317.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Bailey Mine, MSHA ID No. 36-07230, located in Greene County, Pennsylvania.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.500(d), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.500(d) as it pertains to use of battery-powered vibration analyzers and data collectors. Specifically, the petitioner is requesting to permit the use of battery-powered non-permissible SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer in or inby the last open crosscut.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) The petitioner is requesting to utilize the SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer in or inby the last open crosscut.</P>
                <P>(b) In approximately 2021, the SKF Microlog Analyzer CMXA 51, which was certified and approved by the U.S. Department of Labor's Mine Safety and Health Administration (“MSHA”) for use in hazardous “gassy” areas of all mine operations in the United States, was discontinued and is no longer available for purchase. An email from SKF Technical Support states that the CMXA-51-MSHA Microlog has been discontinued and is no longer available for purchase.</P>
                <P>(c) Currently, there is no other MSHA approved vibration analyzer and data collector still in production. Thus, there are no new MSHA approved vibration analyzers and data collectors that are available for purchase.</P>
                <P>(d) Currently, there is no other MSHA approved vibration analyzer and data collector that is still in production.</P>
                <P>(e) The SCOUT100EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports dual-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(f) The SCOUT140EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports four-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(g) The vb7 Portable Data Collector, Analyzer and Balancer instrument is a dual channel vibration data collector, analyzer and balancer. The device can be used for on-route and off-route data collection, machine-side analysis and diagnosis as well as on-site dynamic balance correction. The vb7 Portable Data Collector, Analyzer and Balancer is certified for Class 1 Division 2 hazardous areas.</P>
                <P>(h) The SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2 and internationally IECEx Zone 2, compliant and safe for use in hazardous areas.</P>
                <P>(i) Consol shall use these devices to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. Primarily, equipment contractors at Consol shall use these analyzers to take vibration readings on the shearing machine to predict and prevent gearing/motor failures while on the longwall face. A failure of a major component on the longwall face potentially poses many risks to miners when that particular component has to be changed out on the face.</P>
                <P>
                    (j) Some equipment manufacturers have historically had gearing issues with their shearer ranging arms on the shearing machines as well as cutter head gearboxes on their continuous 
                    <PRTPAGE P="99310"/>
                    miners and these components are very large and heavy.
                </P>
                <P>(k) Consol relies on vibration collection to predict impending failures and successfully change individual parts and components before a catastrophic failure resulting in changing the entire ranging arm or cutter head gearcase.</P>
                <P>(l) The SCOUT140EX, 100EX, and vb7 shall be used by trained personnel from Consol or the vendor to take readings while running the associated motor or gearbox being tested. The shearing machine shall be out of service from production during the vibration collection.</P>
                <P>(m) In addition, SCOUT140EX, 100EX, and vb7 may be part of the weekly inspection of the shearing machines by the manufacturer representative or by Consol's mine maintenance staff. Regardless, the shearing machine shall not be producing coal or moving while in use unless it has to be trammed to take readings on the haulage/tram gearbox. Regardless, the machines shall not be cutting coal at the time of use.</P>
                <P>(n) Currently, SCOUT140EX, 100EX, and vb7 are the only analyzers Consol has found to replace the older versions and the SKF versions, which are no longer manufactured and available for purchase. However, the SCOUT140EX, 100EX, and vb7 are not approved under the applicable MSHA standards for permissibility.</P>
                <P>(o) Electronic equipment used in underground mines in potentially explosive atmospheres is required to be approved by MSHA per 30 CFR. Bently Nevada and other manufacturers do offer alternative products for many other environments and applications.</P>
                <P>(p) Given the benefits of the use of vibration analyzers, the application of the standard results in a diminution of safety at the mine. Consol petitions to permit the use of a SCOUT100EX, SCOUT140EX, and vb7 Vibration Data Collectors, Analyzers and Balancers.</P>
                <P>(q) The SCOUT100EX, SCOUT140EX, and vb7 Portable Intrinsically Safe Vibration Data Collector, Analyzer and Balancer batteries qualify as intrinsically safe in the US, Canada, and any other country accepting IECEx reports. IECEx is the International Electrotechnical Commissions System for Certification to Standards Relating to Equipment for Use in Explosive Atmosphere.</P>
                <P>(r) The vibration analyzers have an intrinsically safe (IS) rating of Division 1: IS Class I, II, III; Division 1 (includes Division 2) Groups C, D, E, F, G; T4, under the most current standard (UL 60079, 6th Edition, 2013). ATEX-certified with an intrinsically safe (IS) rating of “ia”</P>
                <P>(s) Consol recognizes that (NIOSH) researchers have conducted studies on intrinsically safe (IS) equipment and believe that the International Electrotechnical Commission (IEC) document 60079-11, or the American National Standards Institute (ANSI)/International Society (ISA) document 60079-11 for two-fault equipment (marked as ia), would provide an equivalent level of safety as MSHA-approved equipment.</P>
                <P>(t) Consol also recognizes that MSHA does not consider all equipment that meets the 60079-11 standard as equivalent to MSHA approval at this time. However, MSHA also recognizes that use of equipment meeting the 60079-11 standard for two-fault equipment (and even, to a lesser extent, equipment meeting one-fault (marked as ib) or no-fault (marked as ic) standards) provides a level of safety that is not provided by equipment that does not meet the IEC/ANSI/ISA standards.</P>
                <P>(u) The battery is a Custom Lithium Ion Pack, 7.4V, 5000 mAh. There is internal charging with an external power pack 12V DC, 3A output.</P>
                <P>(v) The standards for approval of these Vibration Data Collectors, Analyzers and Balancers are an acceptable alternative to MSHA's standards and provide an equivalent level of protection.</P>
                <P>(w) The alternate method proposed by the Petitioner will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) The operator shall permit the use of the following Vibration Data Collectors, Analyzers and Balancers if they have an IP rating of 66 or greater in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces subject to the conditions of the proposed decision and order (PDO) granted by MSHA: SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2.</P>
                <P>(b) All non-permissible Vibration Data Collectors, Analyzers and Balancers to be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall be examined by the person to operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These examinations shall include:</P>
                <P>(1) Check the instrument for any physical damage and the integrity of the case;</P>
                <P>(2) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(c) The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.153.</P>
                <P>(d) The operator shall ensure that any repairs or servicing for all non-permissible Vibration Data Collectors, Analyzers and Balancers will be done by the manufacturer.</P>
                <P>(e) The non-permissible Vibration Data Collectors, Analyzers and Balancers that will be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance with all the terms and conditions of the PDO granted by MSHA.</P>
                <P>(f) Non-permissible Vibration Data Collectors, Analyzers and Balancers shall not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more of methane is detected while the non-permissible surveying equipment is being used, the equipment shall be de-energized immediately and the non-permissible electronic equipment withdrawn outby the last open crosscut or out of the return. Prior to entering in or inby the last open crosscut, or within 150 feet of pillar workings or longwall faces, all requirements of 30 CFR 75.323 shall be complied with.</P>
                <P>(g) All hand-held methane detectors shall be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors shall provide visual and audible warnings when methane is detected at or above 1.0 percent.</P>
                <P>(h) Prior to energizing any of the non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, methane tests shall be made in accordance with 30 CFR 75.323(a).</P>
                <P>
                    (i) All areas where Vibration Data Collectors, Analyzers and Balancers are to be used shall be pre-shifted according to 30 CFR 75.360. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 shall be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 30 CFR 75.361, additional examination is not required.
                    <PRTPAGE P="99311"/>
                </P>
                <P>(j) A qualified person as defined in existing 30 CFR 75.151 shall continuously monitor for methane immediately before and during the use of non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return.</P>
                <P>(k) Batteries contained in the Vibration Data Collectors, Analyzers and Balancers shall be “charged” in intake air outby the last open crosscut and out of the return. Before each shift requiring the use of Vibration Data Collectors, Analyzers and Balancers all batteries for the Vibration Data Collectors, Analyzers and Balancers shall be charged sufficiently that they are not expected to be charged on that shift.</P>
                <P>(l) When using non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, the operator shall confirm by measurement or by inquiry of the person in charge of the section, that the air quantity on the section, on that shift, in the last open crosscut is at least the minimum quantity that is required by the mine's ventilation plan.</P>
                <P>(m) Personnel engaged in the use of Vibration Data Collectors, Analyzers and Balancers shall be properly trained to recognize the hazards and limitations associated with the use of such equipment in areas where methane could be present.</P>
                <P>(n) All persons who use Vibration Data Collectors, Analyzers and Balancers shall receive specific training on the terms and conditions of the PDO granted by MSHA before using non-permissible electronic equipment in or inby the last open crosscut or in the return. A record of the training shall be kept with the other training records.</P>
                <P>(o) Within 60 days after the PDO granted by MSHA becomes final, the operator shall submit proposed revisions for its approved 30 CFR part 48 training plans to the Coal Mine Safety and Health District Manager. These proposed revisions shall specify initial and refresher training regarding the terms and conditions stated in the PDO granted by MSHA. When training is conducted on the terms and conditions in the PDO granted by MSHA, an MSHA Certificate of Training (Form 5000-23) shall be completed. Comments shall be included on the Certificate of Training indicating that it was surveyor training.</P>
                <P>(p) The operator is responsible for seeing that all contractors hired by the operator are using electronic equipment in accordance with the requirements of paragraph (s) above. The conditions of use in this Petition shall apply to all non-permissible Vibration Data Collectors, Analyzers and Balancers used in or inby the last open crosscut or in a return, regardless of whether the equipment is used by the operator or by an independent contractor.</P>
                <P>(q) The operator shall post the PDO granted by MSHA in unobstructed locations on the bulletin boards and/or in other conspicuous places where notices to miners are ordinarily posted, for a period of not less than 60 consecutive days and shall remain on the mine bulletin board until such time as the ruling on the petition becomes final.</P>
                <P>(r) There are no representatives of miners at the Bailey Mine. A copy of this petition has been posted on the bulletin board as of September 30, 2024.</P>
                <P>In support of the proposed alternative method, the petitioner has also submitted: a SCOUT100EX Vibration Data Collector, Analyzer and Balancer datasheet, a SCOUT140EX Vibration Data Collector, Analyzer and Balancer datasheet, a vb7 Portable Data Collector, Analyzer and Balancer datasheet, and email communication from SKF Technical Support.</P>
                <P>The petitioner asserts that the alternative method will guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28884 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Consol Pennsylvania Coal Company, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0086 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0086.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov</E>
                        .
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, 4th Floor West, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:</P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-061-C
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Consol Pennsylvania Coal Company, LLC, 275 Technology Drive, Suite 101, Canonsburg, PA 15317.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Harvey Mine, MSHA ID No. 36-10045, located in Greene County, Pennsylvania.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.507-1(a), Permissible electric equipment.
                    <PRTPAGE P="99312"/>
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.507-1(a) as it pertains to use of battery-powered vibration analyzers and data collectors. Specifically, the petitioner is requesting to permit the use of battery-powered non-permissible SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer in the return air outby the last open crosscut.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) The petitioner is requesting to utilize the SCOUT140EX and 100EX vibration analyzers and the vb7 Portable Data Collector, Analyzer and Balancer in the return air outby the last open crosscut.</P>
                <P>(b) In approximately 2021, the SKF Microlog Analyzer CMXA 51, which was certified and approved by the U.S. Department of Labor's Mine Safety and Health Administration (“MSHA”) for use in hazardous “gassy” areas of all mine operations in the United States, was discontinued and is no longer available for purchase. An email from SKF Technical Support states that the CMXA-51-MSHA Microlog has been discontinued and is no longer available for purchase.</P>
                <P>(c) Currently, there is no other MSHA approved vibration analyzer and data collector still in production. Thus, there are no new MSHA approved vibration analyzers and data collectors that are available for purchase.</P>
                <P>(d) Currently, there is no other MSHA approved vibration analyzer and data collector that is still in production.</P>
                <P>(e) The SCOUT100EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports dual-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(f) The SCOUT140EX Vibration Data Collector, Analyzer and Balancer is a portable hardware monitoring device that supports four-channel vibration data collection, analysis, and balancing. The device can be used to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. The SCOUT100EX is ATEX Zone 2 and IECEx Zone 2 compliant and safe for hazardous areas.</P>
                <P>(g) The vb7 Portable Data Collector, Analyzer and Balancer instrument is a dual channel vibration data collector, analyzer and balancer. The device can be used for on-route and off-route data collection, machine-side analysis and diagnosis as well as on-site dynamic balance correction. The vb7 Portable Data Collector, Analyzer and Balancer is certified for Class 1 Division 2 hazardous areas.</P>
                <P>(h) The SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2 and internationally IECEx Zone 2, compliant and safe for use in hazardous areas.</P>
                <P>(i) Consol shall use these devices to collect data from sensors on a route, for machine-side analysis and diagnosis, and on-site dynamic balance correction. Primarily, equipment contractors at Consol shall use these analyzers to take vibration readings on the shearing machine to predict and prevent gearing/motor failures while on the longwall face. A failure of a major component on the longwall face potentially poses many risks to miners when that particular component has to be changed out on the face.</P>
                <P>(j) Some equipment manufacturers have historically had gearing issues with their shearer ranging arms on the shearing machines as well as cutter head gearboxes on their continuous miners and these components are very large and heavy.</P>
                <P>(k) Consol relies on vibration collection to predict impending failures and successfully change individual parts and components before a catastrophic failure resulting in changing the entire ranging arm or cutter head gearcase.</P>
                <P>(l) The SCOUT140EX, 100EX, and vb7 shall be used by trained personnel from Consol or the vendor to take readings while running the associated motor or gearbox being tested. The shearing machine shall be out of service from production during the vibration collection.</P>
                <P>(m) In addition, SCOUT140EX, 100EX, and vb7 may be part of the weekly inspection of the shearing machines by the manufacturer representative or by Consol's mine maintenance staff. Regardless, the shearing machine shall not be producing coal or moving while in use unless it has to be trammed to take readings on the haulage/tram gearbox. Regardless, the machines shall not be cutting coal at the time of use.</P>
                <P>(n) Currently, SCOUT140EX, 100EX, and vb7 are the only analyzers Consol has found to replace the older versions and the SKF versions, which are no longer manufactured and available for purchase. However, the SCOUT140EX, 100EX, and vb7 are not approved under the applicable MSHA standards for permissibility.</P>
                <P>(o) Electronic equipment used in underground mines in potentially explosive atmospheres is required to be approved by MSHA per 30 CFR. Bently Nevada and other manufacturers do offer alternative products for many other environments and applications.</P>
                <P>(p) Given the benefits of the use of vibration analyzers, the application of the standard results in a diminution of safety at the mine. Consol petitions to permit the use of a SCOUT100EX, SCOUT140EX, and vb7 Vibration Data Collectors, Analyzers and Balancers.</P>
                <P>(q) The SCOUT100EX, SCOUT140EX, and vb7 Portable Intrinsically Safe Vibration Data Collector, Analyzer and Balancer batteries qualify as intrinsically safe in the US, Canada, and any other country accepting IECEx reports. IECEx is the International Electrotechnical Commissions System for Certification to Standards Relating to Equipment for Use in Explosive Atmosphere.</P>
                <P>(r) The vibration analyzers have an intrinsically safe (IS) rating of Division 1: IS Class I, II, III; Division 1 (includes Division 2) Groups C, D, E, F, G; T4, under the most current standard (UL 60079, 6th Edition, 2013). ATEX-certified with an intrinsically safe (IS) rating of “ia”</P>
                <P>(s) Consol recognizes that (NIOSH) researchers have conducted studies on intrinsically safe (IS) equipment and believe that the International Electrotechnical Commission (IEC) document 60079-11, or the American National Standards Institute (ANSI)/International Society (ISA) document 60079-11 for two-fault equipment (marked as ia), would provide an equivalent level of safety as MSHA-approved equipment.</P>
                <P>(t) Consol also recognizes that MSHA does not consider all equipment that meets the 60079-11 standard as equivalent to MSHA approval at this time. However, MSHA also recognizes that use of equipment meeting the 60079-11 standard for two-fault equipment (and even, to a lesser extent, equipment meeting one-fault (marked as ib) or no-fault (marked as ic) standards) provides a level of safety that is not provided by equipment that does not meet the IEC/ANSI/ISA standards.</P>
                <P>(u) The battery is a Custom Lithium Ion Pack, 7.4V, 5000 mAh. There is internal charging with an external power pack 12V DC, 3A output.</P>
                <P>
                    (v) The standards for approval of these Vibration Data Collectors, Analyzers and Balancers are an acceptable alternative to MSHA's standards and provide an equivalent level of protection.
                    <PRTPAGE P="99313"/>
                </P>
                <P>(w) The alternate method proposed by the Petitioner will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) The operator shall permit the use of the following Vibration Data Collectors, Analyzers and Balancers if they have an IP rating of 66 or greater in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces, subject to the conditions of the proposed decision and order (PDO) granted by MSHA: SCOUT100EX, SCOUT140EX, and vb7 are certified for Class 1 Division 2 hazardous areas, and are IP-rated in North America as ATEX Zone 2.</P>
                <P>(b) All non-permissible Vibration Data Collectors, Analyzers and Balancers to be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall be examined by the person to operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These examinations shall include:</P>
                <P>(1) Check the instrument for any physical damage and the integrity of the case;</P>
                <P>(2) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>(c) The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.153.</P>
                <P>(d) The operator shall ensure that any repairs or servicing for all non-permissible Vibration Data Collectors, Analyzers and Balancers will be done by the manufacturer.</P>
                <P>(e) The non-permissible Vibration Data Collectors, Analyzers and Balancers that will be used in or inby the last open crosscut, in the return, or within 150 feet of pillar workings or longwall faces shall not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance with all the terms and conditions of the PDO granted by MSHA.</P>
                <P>(f) Non-permissible Vibration Data Collectors, Analyzers and Balancers shall not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more of methane is detected while the non-permissible surveying equipment is being used, the equipment shall be de-energized immediately and the non-permissible electronic equipment withdrawn outby the last open crosscut or out of the return. Prior to entering in or inby the last open crosscut, or within 150 feet of pillar workings or longwall faces, all requirements of 30 CFR 75.323 shall be complied with.</P>
                <P>(g) All hand-held methane detectors shall be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors shall provide visual and audible warnings when methane is detected at or above 1.0 percent.</P>
                <P>(h) Prior to energizing any of the non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, methane tests shall be made in accordance with 30 CFR 75.323(a).</P>
                <P>(i) All areas where Vibration Data Collectors, Analyzers and Balancers are to be used shall be pre-shifted according to 30 CFR 75.360. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 shall be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 30 CFR 75.361, additional examination is not required.</P>
                <P>(j) A qualified person as defined in existing 30 CFR 75.151 shall continuously monitor for methane immediately before and during the use of non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return.</P>
                <P>(k) Batteries contained in the Vibration Data Collectors, Analyzers and Balancers shall be “charged” in intake air outby the last open crosscut and out of the return. Before each shift requiring the use of Vibration Data Collectors, Analyzers and Balancers all batteries for the Vibration Data Collectors, Analyzers and Balancers shall be charged sufficiently that they are not expected to be charged on that shift.</P>
                <P>(l) When using non-permissible Vibration Data Collectors, Analyzers and Balancers in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces, the operator shall confirm by measurement or by inquiry of the person in charge of the section, that the air quantity on the section, on that shift, in the last open crosscut is at least the minimum quantity that is required by the mine's ventilation plan.</P>
                <P>(m) Personnel engaged in the use of Vibration Data Collectors, Analyzers and Balancers shall be properly trained to recognize the hazards and limitations associated with the use of such equipment in areas where methane could be present.</P>
                <P>(n) All persons who use Vibration Data Collectors, Analyzers and Balancers shall receive specific training on the terms and conditions of the PDO granted by MSHA before using non-permissible electronic equipment in or inby the last open crosscut or in the return, or within 150 feet of pillar workings or longwall faces. A record of the training shall be kept with the other training records.</P>
                <P>(o) Within 60 days after the PDO granted by MSHA becomes final, the operator shall submit proposed revisions for its approved 30 CFR part 48 training plans to the Coal Mine Safety and Health District Manager. These proposed revisions shall specify initial and refresher training regarding the terms and conditions stated in the PDO granted by MSHA. When training is conducted on the terms and conditions in the PDO granted by MSHA, an MSHA Certificate of Training (Form 5000-23) shall be completed. Comments shall be included on the Certificate of Training indicating that it was surveyor training.</P>
                <P>(p) The operator is responsible for seeing that all contractors hired by the operator are using electronic equipment in accordance with the requirements of paragraph (s) above. The conditions of use in this Petition shall apply to all non-permissible Vibration Data Collectors, Analyzers and Balancers used in or inby the last open crosscut or in a return, or within 150 feet of pillar workings or longwall faces, regardless of whether the equipment is used by the operator or by an independent contractor.</P>
                <P>(q) The operator shall post the PDO granted by MSHA in unobstructed locations on the bulletin boards and/or in other conspicuous places where notices to miners are ordinarily posted, for a period of not less than 60 consecutive days and shall remain on the mine bulletin board until such time as the ruling on the petition becomes final.</P>
                <P>(r) There are no representatives of miners at the Harvey Mine. A copy of this petition has been posted on the bulletin board as of September 30, 2024.</P>
                <P>In support of the proposed alternative method, the petitioner has also submitted: a SCOUT100EX Vibration Data Collector, Analyzer and Balancer datasheet, a SCOUT140EX Vibration Data Collector, Analyzer and Balancer datasheet, a vb7 Portable Data Collector, Analyzer and Balancer datasheet, and email communication from SKF Technical Support.</P>
                <P>
                    The petitioner asserts that the alternative method will guarantee no less than the same measure of protection 
                    <PRTPAGE P="99314"/>
                    afforded the miners under the mandatory standard.
                </P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28883 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL LABOR RELATIONS BOARD</AGENCY>
                <SUBJECT>Notice of Appointments of Individuals To Serve as Members of Performance Review Boards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Labor Relations Board.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Updated notice; appointment to serve as members of performance review boards.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On October 23, 2024, the National Labor Relations Board published a notice of appointments of individuals to serve as members of performance review boards for the rating year beginning October 1, 2023 and ending September 30, 2024. Due to the addition of another alternate, the National Labor Relations Board is issuing this updated notice with current membership identified below.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Roxanne L. Rothschild, Executive Secretary, National Labor Relations Board, 1015 Half Street SE, Washington, DC 20570, (202) 273-1940 (this is not a toll-free number), 1-866-315-6572 (TTY/TDD).</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Name and Title</HD>
                <FP SOURCE="FP-1">Joan A. Sullivan—Associate General Counsel, Division of Operations Management</FP>
                <FP SOURCE="FP-1">Peter Sung Ohr—Associate General Counsel, Office of the General Counsel</FP>
                <FP SOURCE="FP-1">Nancy Kessler Platt—Associate General Counsel, Division of Legal Counsel</FP>
                <FP SOURCE="FP-1">Andrew Krafts—Executive Assistant to the Chairman (Chief of Staff), The Board</FP>
                <FP SOURCE="FP-1">Grant Kraus—Deputy Chief Counsel, The Board</FP>
                <FP SOURCE="FP-1">Ruth Burdick—(alternate) Deputy Associate General Counsel, Division of Enforcement Litigation, Appellate and Supreme Court Litigation Branch</FP>
                <FP SOURCE="FP-1">Roxanne L. Rothschild—(alternate) Executive Secretary, The Board</FP>
                <P>
                    <E T="03">Authority:</E>
                     5 U.S.C. 4314(c)(4).
                </P>
                <SIG>
                    <P>By Direction of the Board.</P>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Roxanne L. Rothschild,</NAME>
                    <TITLE>Executive Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28877 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7545-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL SCIENCE FOUNDATION</AGENCY>
                <SUBJECT>Advisory Committee for Technology, Innovation and Partnerships; Cancellation of Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Science Foundation.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; cancellation of meeting dates.</P>
                </ACT>
                <P>
                    The National Science Foundation published notices in the 
                    <E T="04">Federal Register</E>
                     November 15, 2024, in FR Doc. 2024-26634 at 89 FR 90318 and November 20, 2024, in FR Doc. 2024-27057 at 89 FR 91805, concerning meetings of the Advisory Committee for Technology, Innovation and Partnerships. The meetings scheduled for Tuesday, December 10, 2024, at 12 p.m. and Friday, December 13, 2024, at 11 a.m. (ET) are cancelled.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Please contact Crystal Robinson 
                        <E T="03">crrobins@nsf.gov</E>
                         or 703-292-8687.
                    </P>
                    <SIG>
                        <DATED>Dated: December 5, 2024.</DATED>
                        <NAME>Crystal Robinson,</NAME>
                        <TITLE>Committee Management Officer, National Science Foundation.</TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28977 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7555-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NUCLEAR REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[Docket No. 70-3103; NRC-2024-0176]</DEPDOC>
                <SUBJECT>Louisiana Energy Services, LLC, dba Urenco USA; National Enrichment Facility; Environmental Assessment and Finding of No Significant Impact</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Nuclear Regulatory Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; issuance.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Nuclear Regulatory Commission (NRC) is considering an amendment of Special Nuclear Materials (SNM) License No. SNM-2010, issued to Louisiana Energy Services, LLC, dba Urenco USA (UUSA) for the operation of the Urenco USA uranium enrichment facility in Eunice, New Mexico. The amended license would increase the allowed enrichment of uranium-235 (U-235) from the current limit of 5.5 weight percent U-235 (referred to as low-enriched uranium or LEU) to less than 10 weight percent U-235 (referred to as LEU+). For this proposed action, the NRC staff is issuing an environmental assessment (EA) and finding of no significant impact (FONSI).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The EA and FONSI referenced in this document are available on December 10, 2024.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Please refer to Docket ID NRC-2024-0176 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal Rulemaking Website:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov</E>
                         and search for Docket ID NRC-2024-0176. Address questions about Docket IDs in 
                        <E T="03">Regulations.gov</E>
                         to Stacy Schumann; telephone: 301-415-0624; email: 
                        <E T="03">Stacy.Schumann@nrc.gov.</E>
                         For technical questions, contact the individual listed in the 
                        <E T="02">For Further Information Contact</E>
                         section of this document.
                    </P>
                    <P>
                        • 
                        <E T="03">NRC's Agencywide Documents Access and Management System (ADAMS):</E>
                         You may obtain publicly available documents online in the ADAMS Public Documents collection at 
                        <E T="03">https://www.nrc.gov/reading-rm/adams.html.</E>
                         To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to 
                        <E T="03">PDR.Resource@nrc.gov.</E>
                         For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.
                    </P>
                    <P>
                        • 
                        <E T="03">NRC's PDR:</E>
                         The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to 
                        <E T="03">PDR.Resource@nrc.gov</E>
                         or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Christine Pineda, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6789; email: 
                        <E T="03">Christine.Pineda@nrc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>
                    The NRC is considering an amendment of Urenco USA's license SNM-2010 for the operation of the Urenco USA uranium enrichment facility in Eunice, New Mexico. If approved, the amendment would increase the allowed enrichment of 
                    <PRTPAGE P="99315"/>
                    uranium-235 (U-235) from the current limit of 5.5 weight percent U-235 (referred to as low-enriched uranium or LEU) to less than 10 weight percent U-235 (referred to as LEU+). As required in section 51.21 of title 10 of the 
                    <E T="03">Code of Federal Regulations</E>
                     (10 CFR), “Criteria for and identification of licensing and regulatory actions requiring environmental assessments,” the NRC developed an EA for the proposed license amendment. Based on the results of the EA summarized in this notice, the NRC has determined not to prepare an environmental impact statement (EIS) for the amendment and is issuing a FONSI.
                </P>
                <P>Urenco USA also submitted a separate request for an amendment to approve the use of the enrichment facility's recycling systems to process (or clean) components exposed to LEU+ to enable their reuse. The NRC accepted that application on November 26, 2024, and is conducting a technical review. The NRC will publish a separate environmental assessment for that proposed licensing action.</P>
                <HD SOURCE="HD1">II. Summary of Environmental Assessment</HD>
                <HD SOURCE="HD2">Description of the Proposed Action</HD>
                <P>
                    The proposed NRC action is to authorize Urenco USA to produce, store, and handle enriched uranium hexafluoride (UF
                    <E T="52">6</E>
                    ) at an enrichment of less than 10 weight percent U-235 at the UUSA enrichment facility. This would be an increase from the currently authorized limit of 5.5 weight percent U-235. Under the proposed action, UUSA would use the existing facilities and equipment. There would be no construction of new facilities or modifications to existing buildings. The amendment, if granted, would not allow the shipment or transportation of LEU+ product offsite.
                </P>
                <P>The proposed action is limited only to the processes, systems and components needed to produce, handle and store LEU+ at the UUSA site. The facility's gaseous effluent vent system (GEVS) would be used to collect potentially contaminated gaseous effluents in areas where LEU+ would be produced, handled and stored. The GEVS treats effluents through a filter system before releasing them to the atmosphere through a continuously-monitored vent stack. Material and components exposed to LEU+ that are removed from production process systems authorized for LEU+ would be segregated and stored in analyzed, inside storage locations.</P>
                <P>The proposed action is in accordance with the licensee's application dated November 30, 2023, as supplemented by letter dated August 1, 2024.</P>
                <HD SOURCE="HD2">Need for the Proposed Action</HD>
                <P>The proposed amendment, if approved, would enable Urenco USA to produce enriched U-235 to support industry pursuit of the use of LEU+ in applications such as accident tolerant fuel and extended fuel cycle fuels. Domestic nuclear commercial reactor operators and designers are pursuing advancements in fuel and enrichment alongside the development of reactor designs that include increasing U-235 enrichment.</P>
                <HD SOURCE="HD2">Environmental Impacts of the Proposed Action</HD>
                <P>The NRC staff assessed the potential environmental impacts from the proposed enrichment increase on land use; historic and cultural resources; visual and scenic resources; climatology, meteorology and air quality; geology and soils; water resources; ecological resources; socioeconomics; noise; traffic and transportation; public and occupational health and safety; and waste management. The NRC staff determined that the proposed action would not affect most resource areas and would not have significant impacts on air quality, transportation, public and occupational health and safety, and waste management. Impacts would remain bounded by the impacts assessed in the NRC's 2015 EA for the expansion of the facility. Occupational dose estimates associated with the proposed action would continue to be as low as reasonably achievable and fall within the limits identified in 10 CFR 20.1201. Approval of the proposed action is not expected to result in measurable radiation exposure to a member of the public. The annual release of uranium would be less than 260 microcuries per year, well below the conservative estimate in the NRC's 2015 EA of 29.7 million becquerel (800 microcuries) per year that the NRC determined would result in a small fraction of the NRC public dose limit of 1 millisievert per year (100 millirem per year) in 10 CFR 20.1301(a)(1).</P>
                <HD SOURCE="HD2">Environmental Impacts of the Alternatives to the Proposed Action</HD>
                <P>
                    The alternative considered in this EA is the no-action alternative. Under the no-action alternative, the NRC would deny Urenco USA's request to allow increased enrichment to less than 10 weight percent U-235, and the limit would remain at 5.5 weight percent. The potential environmental impacts of denying the request would be unchanged from the current facility impacts and the impacts as assessed in the NRC's 2015 EA for the expansion of the facility. Under this alternative, the nuclear industry would likely continue to pursue higher enriched UF
                    <E T="52">6</E>
                     for power reactors, and the increased enrichment would most likely be produced at another facility, resulting in similar environmental impacts.
                </P>
                <HD SOURCE="HD2">Agencies and Persons Consulted</HD>
                <P>In accordance with NRC policy, on November 5, 2024, the NRC staff provided a draft of the EA to the State of New Mexico for review. The NRC received no comments from the State.</P>
                <P>
                    Under the National Historic Preservation Act (NHPA), the NRC's approval of the proposed increase in the U-235 enrichment limit would constitute a Federal undertaking. In reviewing UUSA's application, the NRC staff concluded the proposed action to increase enrichment of enriched UF
                    <E T="52">6</E>
                     is not a type of activity that has the potential to cause effects on any historic properties that may be present. Therefore, following 36 CFR 800.3(a)(1), the NRC has no further obligations under Section 106 of the NHPA.
                </P>
                <P>Similarly, under the Endangered Species Act the staff determined that even if endangered or candidate species are present in the vicinity of the Urenco USA facility, the proposed increase in the enrichment limit would not affect such species or their habitats. The proposed action would not result in construction or land disturbance and operations would continue inside existing buildings. Therefore, the NRC has determined that no further consultation is required under Section 7 of the Endangered Species Act.</P>
                <HD SOURCE="HD1">III. Finding of No Significant Impact</HD>
                <P>
                    The NRC staff reviewed the proposed action in accordance with the requirements of 10 CFR part 51. The NRC staff concludes that approval of Urenco USA's proposed action to produce, store, and handle enriched UF
                    <E T="52">6</E>
                     at enrichment of less than 10 weight percent U-235 at the enrichment facility would not significantly affect the quality of the human environment. As described in section 3 of the EA, approval of the proposed action will not result in changes to land use; no construction or soil disturbance will take place; no visible changes to the facility or the viewshed will occur; and no staffing changes are anticipated that would affect socioeconomic indicators. Urenco USA would store LEU+-exposed, reusable materials and cascade components inside a designated, approved storage area until further 
                    <PRTPAGE P="99316"/>
                    disposition. The NRC does not expect significant radiological or non-radiological impacts from approval of the proposed action, and impacts would remain bounded by the impacts assessed in the NRC's 2015 EA for the expansion of the facility. Occupational dose estimates associated with the proposed action would continue to be as low as reasonably achievable and fall within the limits identified in 10 CFR 20.1201. Approval of the proposed action is not expected to result in measurable radiation exposure to a member of the public. Therefore, the NRC staff has determined that, pursuant to 10 CFR 51.31, preparation of an environmental impact statement is not required for this proposed action, and pursuant to 10 CFR 51.32, a finding of no significant impact is appropriate. In accordance with 10 CFR 51.32(a)(4), this FONSI incorporates the EA summarized in this notice by reference.
                </P>
                <HD SOURCE="HD1">IV. Availability of Documents</HD>
                <P>The documents identified in the following table are available to interested persons through ADAMS, as indicated.</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s200,xls64">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Document description</CHED>
                        <CHED H="1">
                            ADAMS
                            <LI>accession No.</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Environmental Assessment for Proposed License Amendment to Allow Urenco USA to Enrich Uranium to Less than 10 Weight Percent U-235, dated December 2024</ENT>
                        <ENT>ML24331A260</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UUSA License Amendment Request for Changes to License Conditions and Raise Enrichment Limit to Less Than 10 Weight Percent for LEU+ Production Systems (LAR-23-02), dated November 30, 2023</ENT>
                        <ENT>ML23334A122</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LAR-23-02 Enclosure 3—Safety Analysis Report Markups</ENT>
                        <ENT>ML23334A125</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LAR-23-02 Enclosure 8—Environmental Information</ENT>
                        <ENT>ML23334A130</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UUSA Responses to NRC Request for Additional Information, Enclosure 2: UUSA Responses to Human Factors Engineering and Environmental RAIs, dated August 1, 2024</ENT>
                        <ENT>ML24214A302</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NRC Environmental Assessment for the Proposed Louisiana Energy Services, Urenco USA Uranium Enrichment Facility Capacity Expansion in Lea County, New Mexico, dated March 2015</ENT>
                        <ENT>ML15072A016</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NRC Email to New Mexico Environment Department re: Request for State Review of Draft EA, dated November 5, 2024</ENT>
                        <ENT>ML24331A236</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UUSA License Amendment Request to Raise Enrichment Limit to the Licensed Limit for LEU+ Recycling and Support Systems (LAR-24-01), dated August 29, 2024</ENT>
                        <ENT>ML24242A197</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LAR-24-01 Enclosure 3—Safety Analysis Report Markups</ENT>
                        <ENT>ML24242A200</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LAR-24-01 Enclosure 6—Environmental Information</ENT>
                        <ENT>ML24242A203</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NRC Letter to UUSA re: Acceptance of LAR-24-01 for Technical Review, dated November 26, 2024</ENT>
                        <ENT>ML24327A210</ENT>
                    </ROW>
                </GPOTABLE>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <P>For the Nuclear Regulatory Commission.</P>
                    <NAME>Robert Sun,</NAME>
                    <TITLE>Chief, Environmental Project Management, Branch 2, Division of Rulemaking, Environmental, and Financial Support, Office of Nuclear Material Safety, and Safeguards.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28929 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">OFFICE OF PERSONNEL MANAGEMENT</AGENCY>
                <SUBJECT>President's Commission on White House Fellowships Advisory Committee: Closed Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>President's Commission on White House Fellowships, Office of Personnel Management.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The President's Commission on White House Fellowships (PCWHF) was established by an Executive Order in 1964. The PCWHF is an advisory committee composed of Special Government Employees appointed by the President. This notice announces the meeting of the PCWHF on January 9, 2025. The meeting is closed to the public.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Rosemarie Vela, 712 Jackson Place NW, Washington, DC 20503, Phone: 202-395-4522.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Name of Committee:</E>
                     President's Commission on White House Fellowships Mid-Year Meeting.
                </P>
                <P>
                    <E T="03">Date:</E>
                     January 9, 2025.
                </P>
                <P>
                    <E T="03">Time:</E>
                     9 a.m.-4 p.m.
                </P>
                <P>
                    <E T="03">Place:</E>
                     Office of Personnel Management, 1900 E Street NW, Washington, DC 20415.
                </P>
                <P>
                    <E T="03">Agenda:</E>
                     The Commission holds a mid-year meeting to talk with current Fellows on how their placements are going and discuss preparation for future events.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     Executive Orders 11183 and 14109.
                </P>
                <SIG>
                    <FP>Office of Personnel Management.</FP>
                    <NAME>Kayyonne Marston,</NAME>
                    <TITLE>Federal Register Liaison.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28940 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6325-69-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">POSTAL REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[Docket Nos. CP2023-162; MC2025-589 and K2025-588; MC2025-590 and K2025-589; MC2025-591 and K2025-590; MC2025-592 and K2025-591; MC2025-593 and K2025-592; MC2025-594 and K2025-593; MC2025-595 and K2025-594; MC2025-596 and K2025-595; and MC2025-597 and K2025-596]</DEPDOC>
                <SUBJECT>New Postal Products</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Postal Regulatory Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments are due:</E>
                         December 11, 2024.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit comments electronically via the Commission's Filing Online system at 
                        <E T="03">http://www.prc.gov.</E>
                         Those who cannot submit comments electronically should contact the person identified in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section by telephone for advice on filing alternatives.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>David A. Trissell, General Counsel, at 202-789-6820.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Introduction</FP>
                    <FP SOURCE="FP-2">II. Public Proceeding(s)</FP>
                    <FP SOURCE="FP-2">III. Summary Proceeding(s)</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>
                    Pursuant to 39 CFR 3041.405, the Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to Competitive negotiated service agreement(s). The request(s) may propose the addition of a negotiated service agreement from the Competitive product list or the modification of an existing product currently appearing on the Competitive product list.
                    <PRTPAGE P="99317"/>
                </P>
                <P>
                    The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
                    <E T="03">https://www.prc.gov</E>
                    ). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3011.301.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See</E>
                         Docket No. RM2018-3, Order Adopting Final Rules Relating to Non-Public Information, June 27, 2018, Attachment A at 19-22 (Order No. 4679).
                    </P>
                </FTNT>
                <P>Section II identifies the docket number(s) associated with each Postal Service request, if any, that will be reviewed in a public proceeding as defined by 39 CFR 3010.101(p), the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each such request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 and 39 CFR 3000.114 (Public Representative). Section II also establishes comment deadline(s) pertaining to each such request.</P>
                <P>The Commission invites comments on whether the Postal Service's request(s) identified in Section II, if any, are consistent with the policies of title 39. Applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3041. Comment deadline(s) for each such request, if any, appear in Section II.</P>
                <P>
                    Section III identifies the docket number(s) associated with each Postal Service request, if any, to add a standardized distinct product to the Competitive product list or to amend a standardized distinct product, the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. Standardized distinct products are negotiated service agreements that are variations of one or more Competitive products, and for which financial models, minimum rates, and classification criteria have undergone advance Commission review. 
                    <E T="03">See</E>
                     39 CFR 3041.110(n); 39 CFR 3041.205(a). Such requests are reviewed in summary proceedings pursuant to 39 CFR 3041.325(c)(2) and 39 CFR 3041.505(f)(1). Pursuant to 39 CFR 3041.405(c)-(d), the Commission does not appoint a Public Representative or request public comment in proceedings to review such requests.
                </P>
                <HD SOURCE="HD1">II. Public Proceeding(s)</HD>
                <P>
                    1. 
                    <E T="03">Docket No(s).:</E>
                     CP2023-162; 
                    <E T="03">Filing Title:</E>
                     USPS Notice of Amendment to Priority Mail, First-Class Package Service &amp; Parcel Select Contract 19, Filed Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     December 3, 2024; 
                    <E T="03">Filing Authority:</E>
                     39 CFR 3035.105, 39 CFR 3041.310, and 39 CFR 3041.505; 
                    <E T="03">Public Representative:</E>
                     Kenneth Moeller; 
                    <E T="03">Comments Due:</E>
                     December 11, 2024.
                </P>
                <P>
                    2. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-589 and K2025-588; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 867 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     December 3, 2024; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Almaroof Agoro; 
                    <E T="03">Comments Due:</E>
                     December 11, 2024.
                </P>
                <P>
                    3. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-590 and K2025-589; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail &amp; USPS Ground Advantage Contract 501 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     December 3, 2024; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Almaroof Agoro; 
                    <E T="03">Comments Due:</E>
                     December 11, 2024.
                </P>
                <P>
                    4. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-591 and K2025-590; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 868 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     December 3, 2024; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Jennaca Upperman; 
                    <E T="03">Comments Due:</E>
                     December 11, 2024.
                </P>
                <P>
                    5. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-592 and K2025-591; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 869 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     December 3, 2024; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Almaroof Agoro; 
                    <E T="03">Comments Due:</E>
                     December 11, 2024.
                </P>
                <P>
                    6. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-593 and K2025-592; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 870 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     December 3, 2024; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Christopher Mohr; 
                    <E T="03">Comments Due:</E>
                     December 11, 2024.
                </P>
                <P>
                    7. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-594 and K2025-593; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 871 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     December 3, 2024; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Christopher Mohr; 
                    <E T="03">Comments Due:</E>
                     December 11, 2024.
                </P>
                <P>
                    8. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-595 and K2025-594; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 872 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     December 3, 2024; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Christopher Mohr; 
                    <E T="03">Comments Due:</E>
                     December 11, 2024.
                </P>
                <P>
                    9. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-596 and K2025-595; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 873 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     December 3, 2024; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Kenneth Moeller; 
                    <E T="03">Comments Due:</E>
                     December 11, 2024.
                </P>
                <P>
                    10. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-597 and K2025-596; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 874 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     December 3, 2024; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Kenneth Moeller; 
                    <E T="03">Comments Due:</E>
                     December 11, 2024.
                </P>
                <HD SOURCE="HD1">III. Summary Proceeding(s)</HD>
                <P>
                    None. 
                    <E T="03">See</E>
                     Section II for public proceedings.
                </P>
                <P>
                    This Notice will be published in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <NAME>Erica A. Barker,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28901 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-FW-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="99318"/>
                <AGENCY TYPE="N">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-101811; File No. SR-NYSEARCA-2024-106]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 7.37-E</SUBJECT>
                <DATE>December 4, 2024.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) 
                    <SU>1</SU>
                    <FTREF/>
                     of the Securities Exchange Act of 1934 (the “Act”),
                    <SU>2</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>3</SU>
                    <FTREF/>
                     notice is hereby given that on December 2, 2024, NYSE Arca, Inc. (“NYSE Arca” or the “Exchange”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the self-regulatory organization. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         15 U.S.C. 78a.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    The Exchange proposes to amend Rule 7.37-E to specify the Exchange's source of data feeds from Investors' Exchange, LLC (“IEX”) for purposes of order handling, order execution, order routing, and regulatory compliance. The proposed rule change is available on the Exchange's website at 
                    <E T="03">www.nyse.com,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and the Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    The Exchange proposes to update and amend the use of data feeds table in Rule 7.37-E(d), which sets forth on a market-by-market basis the specific securities information processor (“SIP”) and proprietary data feeds that the Exchange utilizes for the handling, execution, and routing of orders, and for performing the regulatory compliance checks related to each of those functions. Specifically, the Exchange proposes to amend the table in Rule 7.37-E(d) to specify that, with respect to IEX, the Exchange will receive an IEX direct feed as its primary source of data for order handling, order execution, order routing, and regulatory compliance, and will use the SIP Data Feed as its secondary source for data from IEX.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         The Exchange previously filed a similar proposal, but inadvertently failed to seek waiver of the 30-day operative delay necessary to make the proposal operative by December 7, 2024, the date when the technology underlying the proposal will be launched on the Exchange's systems. 
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 101681 (November 21, 2024) (SR-NYSEARCA-2024-95). The Exchange subsequently attempted to cure that failure by making a supplemental filing to accelerate the operative date of SR-NYSEARCA-2024-95. 
                        <E T="03">See</E>
                         SR-NYSEARCA-2024-103. The Exchange has now withdrawn both SR-NYSEARCA-2024-95 and SR-NYSEARCA-2024-103 and has replaced them with the instant filing.
                    </P>
                </FTNT>
                <P>The Exchange proposes to make this change immediately operative upon filing so that the Exchange may deploy the change on or about December 7, 2024, the date when the technology underlying the proposal will be launched on the Exchange's systems.</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act, in general, and furthers the objectives of Section 6(b)(5), in particular, because it is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, to remove impediments to, and perfect the mechanism of, a free and open market and a national market system and, in general, to protect investors and the public interest. Additionally, the Exchange believes that the proposed rule change is consistent with the Section 6(b)(5) requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers.</P>
                <P>The Exchange believes its proposal to update the table in Rule 7.37-E(d) to include the IEX direct feed will ensure that the Rule correctly identifies and publicly states on a market-by-market basis all of the specific SIP and proprietary data feeds that the Exchange utilizes for the handling, execution, and routing of orders, and for performing the regulatory compliance checks for each of those functions. The proposed rule change also removes impediments to and perfects the mechanism of a free and open market and protects investors and the public interest by providing additional specificity, clarity, and transparency in the Exchange's rules.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Rather, the Exchange believes that the proposal will enhance competition because providing the public and market participants with up-to-date information about the data feeds the Exchange will use for the handling, execution, and routing of orders, as well as for regulatory compliance would enhance transparency and enable investors to better assess the quality of the Exchange's execution and routing services. The Exchange also believes the proposal would enhance competition because it would potentially enhance the performance of its order handling and execution of orders in equity securities by receiving market data directly from IEX. Finally, the proposed rule change would not impact competition between market participants because it will affect all market participants equally.</P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>No written comments were solicited or received with respect to the proposed rule change.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act 
                    <SU>5</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6) thereunder.
                    <SU>6</SU>
                    <FTREF/>
                     Because the proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative prior to 30 days from the date on which it was filed, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest, the 
                    <PRTPAGE P="99319"/>
                    proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>7</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6)(iii) thereunder.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         15 U.S.C. 78s(b)(3)(A)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6) requires a self-regulatory organization to give the Commission written notice of its intent to file the proposed rule change, along with a brief description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission. The Exchange has satisfied this requirement.
                    </P>
                </FTNT>
                <P>
                    A proposed rule change filed under Rule 19b-4(f)(6) 
                    <SU>9</SU>
                    <FTREF/>
                     normally does not become operative prior to 30 days after the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii),
                    <SU>10</SU>
                    <FTREF/>
                     the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange has asked the Commission to waive the 30-day operative delay so that the proposed rule change may become operative immediately upon filing. The Exchange states that it operates in a highly competitive environment and is launching a technology change that includes the improvement described in its proposed rule change on December 7, 2024. Since that December 7, 2024 date is imminent, the Exchange requests waiver of the 30-day operative delay with respect to this proposed rule change.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         17 CFR 240.19b-4(f0(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         17 CFR 240.19b-4(f)(6)(iii).
                    </P>
                </FTNT>
                <P>
                    The Commission believes that waiver of the operative delay is consistent with the protection of investors and the public interest. The Exchange states that the proposed rule change would enhance competition because it would potentially enhance the performance of its order handling and execution of orders in equity securities by receiving market data directly from IEX. In addition, a waiver of the operative delay will allow the Exchange to promptly implement the proposed rule change with other technology changes that are scheduled to be implemented on December 7, 2024. Accordingly, the Commission hereby waives the 30-day operative delay and designates the proposed rule change operative upon filing.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         For purposes only of waiver the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation. 
                        <E T="03">See</E>
                         15 U.S.C. 78c(f).
                    </P>
                </FTNT>
                <P>
                    At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B) 
                    <SU>12</SU>
                    <FTREF/>
                     of the Act to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         15 U.S.C. 78s(b)(2)(B).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
                <P>Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:</P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's internet comment form (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ); or
                </P>
                <P>
                    • Send an email to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include file number SR-NYSEARCA-2024-106 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to file number SR-NYSEARCA-2024-106. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. Do not include personal identifiable information in submissions; you should submit only information that you wish to make available publicly. We may redact in part or withhold entirely from publication submitted material that is obscene or subject to copyright protection. All submissions should refer to file number SR-NYSEARCA-2024-106 and should be submitted on or before December 31, 2024.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>13</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             17 CFR 200.30-3(a)(12), (59).
                        </P>
                    </FTNT>
                    <NAME>Sherry R. Haywood,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28896 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[SEC File No. 270-135, OMB Control No. 3235-0175]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request; Extension: Form N-8A</SUBJECT>
                <FP SOURCE="FP-1">
                    <E T="03">Upon Written Request, Copies Available From:</E>
                     Securities and Exchange Commission, Office of FOIA Services, 100 F Street NE, Washington, DC 20549-2736
                </FP>
                <P>
                    Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ), the Securities and Exchange Commission (the “Commission”) is soliciting comments on the collection of information summarized below. The Commission plans to submit this existing collection of information to the Office of Management and Budget (“OMB”) for extension and approval.
                </P>
                <P>
                    The Investment Company Act of 1940 (“Investment Company Act”) (15 U.S.C. 80a-1 
                    <E T="03">et seq.</E>
                    ) requires investment companies to register with the Commission before they conduct any business in interstate commerce. Section 8(a) of the Investment Company Act provides that an investment company shall be deemed to be registered upon receipt by the Commission of a notification of registration in such form as the Commission prescribes. Form N-8A (17 CFR 274.10) is the form for notification of registration that the Commission has adopted under section 8(a). The purpose of such notification of registration provided on Form N-8A is to notify the Commission of the existence of investment companies required to be registered under the Investment Company Act and to enable the Commission to administer the provisions of the Investment Company Act with respect to those companies. After an investment company has filed its notification of registration under 
                    <PRTPAGE P="99320"/>
                    section 8(a), the company is then subject to the provisions of the Investment Company Act which govern certain aspects of its organization and activities, such as the composition of its board of directors and the issuance of senior securities. Form N-8A requires an investment company to provide its name, state of organization, form of organization, classification, the name and address of each investment adviser of the investment company, the current value of its total assets, and certain other information readily available to the investment company. If the investment company is filing a registration statement as required by Section 8(b) of the Investment Company Act concurrently with its notification of registration, Form N-8A requires only that the registrant file the cover page (giving its name, address, and agent for service of process) and sign the form in order to effect registration.
                </P>
                <P>Based on recent filings of notifications of registration on Form N-8A, we estimate that about 99 investment companies file such notifications each year. An investment company must only file a notification of registration on Form N-8A once. The currently approved average hour burden per investment company of preparing and filing a notification of registration on Form N-8A is one hour. Based on the Commission staff's experience with the requirements of Form N-8A and with disclosure documents generally—and considering that investment companies that are filing notifications of registration on Form N-8A simultaneously with the registration statement under the Investment Company Act are only required by Form N-8A to file a signed cover page—we continue to believe that this estimate is appropriate. Therefore, we estimate that the total annual hour burden to prepare and file notifications of registration on Form N-8A is 99 hours. The currently approved cost burden of Form N-8A is $496. We are updating the estimated costs burden to $562 to account for the effects of inflation. Therefore, we estimate that the total annual cost burden associated with preparing and filing notifications of registration on Form N-8A is about $55,638.</P>
                <P>Estimates of average burden hours and costs are made solely for the purposes of the Paperwork Reduction Act, and are not derived from a comprehensive or even representative survey or study of the costs of Commission rules and forms. Compliance with the collection of information requirements of Form N-8A is mandatory. Responses to the collection of information will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.</P>
                <P>
                    <E T="03">Written comments are invited on:</E>
                     (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted by February 10, 2025.
                </P>
                <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.</P>
                <P>
                    Please direct your written comments to: Austin Gerig, Director/Chief Data Officer, Securities and Exchange Commission, c/o Tanya Ruttenberg, 100 F Street NE, Washington, DC 20549 or send an email to: 
                    <E T="03">PRA_Mailbox@sec.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 4, 2024.</DATED>
                    <NAME>Sherry R. Haywood,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28875 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-101812; File No. SR-NYSE-2024-67]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving a Proposed Rule Change To Amend NYSE Rule 7.31(f)(1)</SUBJECT>
                <DATE>December 4, 2024.</DATE>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>
                    On October 24, 2024, New York Stock Exchange LLC (the “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     a proposed rule change to amend NYSE Rule 7.31(f)(1). The proposed rule change was published for comment in the 
                    <E T="04">Federal Register</E>
                     on November 4, 2024.
                    <SU>3</SU>
                    <FTREF/>
                     The Commission has received no comment letters on the proposed rule change. This order approves the proposed rule change.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 101471 (October 29, 2024), 89 FR 87675 (“Notice”).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Description of the Proposal</HD>
                <P>
                    The Exchange has proposed to amend NYSE Rule 7.31(f)(1) regarding Directed Orders. NYSE Rule 7.31(f)(1) currently defines a Directed Order as a Limit Order with instructions to route on arrival at its limit price to a specified alternative trading system (“ATS”) with which the Exchange maintains an electronic linkage. According to the Exchange, Directed Orders are available for all securities eligible to trade on the Exchange, are not assigned a working time, and do not interact with interest on the Exchange Book.
                    <SU>4</SU>
                    <FTREF/>
                     NYSE Rule 7.31(f)(1) further provides that the ATS to which a Directed Order is routed is responsible for validating whether the order is eligible to be accepted, and if that ATS determines to reject the order, the order would be canceled.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See id.</E>
                         at 87675.
                    </P>
                </FTNT>
                <P>
                    The Exchange has proposed to amend NYSE Rule 7.31(f)(1) to provide for Directed Orders to be routed to a broker-dealer algorithm for execution. Specifically, the Exchange has proposed to permit Directed Orders to be designated by the entering member organization to route to a broker-dealer algorithm selected from of a set of broker-dealer algorithms with which the Exchange has established connectivity. The Exchange proposes to route Directed Orders only to a range of broker-dealer algorithms that have completed its onboarding process and established routing connectivity with the Exchange.
                    <SU>5</SU>
                    <FTREF/>
                     The Exchange represents that any FINRA-registered broker-
                    <PRTPAGE P="99321"/>
                    dealer 
                    <SU>6</SU>
                    <FTREF/>
                     will be eligible to complete this process, which is intended, among other things, to ensure that algorithm providers attest to compliance with applicable Exchange rules, FINRA rules, and federal securities laws and regulations and to confirm that the algorithm providers can meet the applicable technical specifications to connect to the Exchange. The Exchange states that algorithm providers will also be required to enter into routing agreements with the Exchange's routing broker, Archipelago Securities LLC (“ArcaSec”), to facilitate ArcaSec's routing of Directed Orders on behalf of member organizations to designated algorithms.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         All broker-dealer algorithms to which Directed Orders can be routed will operate on the broker-dealers' respective systems, not on Exchange systems. The Exchange represents that it does not currently have and will not enter into any financial or other arrangements with any algorithm provider with respect to the proposed Directed Orders. The member organization initiating a Directed Order to an algorithm has ultimate responsibility for any transaction fees associated with the execution of that order. The Exchange states that it may facilitate the process by which such fees are passed through from the algorithm providers to the member organizations utilizing Directed Orders, but will not determine, subsidize, or benefit from any such fees. Subject to approval and implementation of this proposed rule change, the Exchange states that it intends to adopt a routing fee for Directed Orders to an algorithm, similar to the existing routing fee for Directed Orders to an ATS. 
                        <E T="03">See</E>
                         New York Stock Exchange Price List 2024, available at 
                        <E T="03">https://www.nyse.com/publicdocs/nyse/markets/nyse/NYSE_Price_List.pdf</E>
                         (providing for Routing Fee for Directed Order to OneChronos LLC). 
                        <E T="03">See</E>
                         Notice, 
                        <E T="03">supra</E>
                         note 3, 89 FR 87675.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         The Exchange states that the ability to become an NYSE algorithm provider is open to all FINRA-registered broker-dealers, on an equal and non-discriminatory basis, regardless of whether they are also Exchange members. 
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <P>
                    As proposed, the member organization entering the Directed Order would select the algorithm to which the Directed Order would be routed and provide instructions for the handling of such order by the routing destination. The Exchange states that member organizations would select from the available algorithm providers without any input or control from the Exchange.
                    <SU>8</SU>
                    <FTREF/>
                     As with the existing Directed Order routing to an ATS, the Exchange states that its only role would be to route the order to the designated algorithm as instructed. The Exchange states that neither the Exchange nor ArcaSec will make any routing decisions and will only route Directed Orders to valid destinations as instructed by the member organization. The Exchange further states that it will not have any visibility into where or how a Directed Order is executed by an algorithm, including whether that order may be routed back to the Exchange or one of its affiliated exchanges, at the time of execution.
                    <SU>9</SU>
                    <FTREF/>
                     According to the Exchange, a Directed Order designated for an algorithm would not interact with the Exchange Book, and the Exchange would not exercise any discretion in determining where the order is routed.
                    <SU>10</SU>
                    <FTREF/>
                     Similarly, according to the Exchange, the algorithm selected by the member organization entering the Directed Order would be responsible for validating whether the order is eligible to be accepted, and if the algorithm determines to reject the order, the Directed Order would be canceled.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         The Consolidated Audit Trail (“CAT”) for a Directed Order would reflect entry of the order at the Exchange; ArcaSec's receipt of the order from the Exchange; ArcaSec's routing of the order to the designated algorithm; and the algorithm's routing of the order to the execution venue(s) selected to effectuate its strategy. The Exchange states that it will not be involved in the clearing or settlement of Directed Orders, except to the extent that it may submit certain trades to clearing on behalf of member organizations (similar to the capacity in which it participates in the clearing process for orders that it routes for Regulation NMS purposes). 
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         The Exchange represents that its systems would not be able to determine, upon receipt of a routed order, whether such order had originated in whole or in part from an algorithm or originated at the Exchange as a Directed Order to an algorithm. 
                        <E T="03">See</E>
                         Notice, 
                        <E T="03">supra</E>
                         note 3, 89 FR 87675-76.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         Notice, 
                        <E T="03">supra</E>
                         note 3, 89 FR 87676.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <P>To effect this change, the Exchange first has proposed to amend the definition of a Directed Order in NYSE Rule 7.31(f)(1) to provide that a Directed Order is a Limit Order with instructions to route on arrival to an ATS or algorithm with which the Exchange maintains an electronic linkage. According to the Exchange, Directed Orders would continue to be available for all securities eligible to trade on the Exchange and would not be assigned a working time or interact with interest on the Exchange Book. The Exchange has further proposed to amend NYSE Rule 7.31(f)(1) to specify that the ATS or algorithm to which the Directed Order is routed, as applicable, would validate whether the order is eligible to be accepted, and if it rejects the order, the order would be canceled.</P>
                <P>
                    The Exchange has proposed to permit Directed Orders designated to route to an algorithm to be Market Orders. The Exchange states that permitting these Directed Orders to be entered as Market Orders would facilitate market participants' existing functional workflows when routing to algorithms.
                    <SU>12</SU>
                    <FTREF/>
                     According to the Exchange, a member organization routing a Directed Order to an algorithm may, for example, wish to send a parent order with Market Order instructions for execution via smaller limited child orders over several hours of the trading day.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <P>
                    The Exchange has proposed to delete the first sentence of current NYSE Rule 7.31(f)(1)(A), which provides that Directed Orders must be designated for the Exchange's Core Trading Session. The Exchange has also proposed to delete current NYSE Rule 7.34(c)(1)(E), which provides that Directed Orders designated for the Early Trading Session will be rejected, and to make a conforming change in Rule 7.34(c)(1) to reference “paragraphs (c)(1)(A) through (D)” to reflect the deletion of Rule 7.34(c)(1)(E). The Exchange states that its proposal to permit Directed Orders to be routed during any trading session is intended to allow the routing destinations receiving such orders to determine whether they are eligible to trade in a given trading session.
                    <SU>13</SU>
                    <FTREF/>
                     The Exchange states that it will pass on the instructions provided by the member organization entering the Directed Order, and the routing destination will be responsible for validating whether the order will be accepted or rejected, as contemplated by NYSE Rule 7.31(f)(1).
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <P>Further, the Exchange has proposed to amend NYSE Rule 7.31(f)(1)(A) to provide that a Directed Order to an ATS must be designated as IOC or Day and would be routed as such, whereas a Directed Order to an algorithm may only be designated as Day and routed as such, consistent with market participants' existing functional workflows when routing to algorithms. The Exchange also has proposed to clarify language currently in NYSE Rule 7.31(f)(1)(A) providing that Directed Orders may not be combined with any other modifiers set forth in this Rule, to instead provide that Directed Orders would not be processed with any other modifiers set forth in this Rule.</P>
                <P>
                    The Exchange has also proposed to amend NYSE Rule 7.31(f)(1)(C) to specify that, during a trading halt or pause, Directed Orders routed to an ATS would continue to be rejected, whereas Directed Orders to an algorithm would be routed as specified. The Exchange states that it has proposed that Directed Orders routed to an algorithm would be routed during a trading halt or pause, consistent with market participants' existing functional workflows when routing to algorithms. The Exchange states that the proposed elimination of certain restrictions on Directed Orders currently set forth in Rules 7.31(f)(1)(A) and (C) would provide member organizations with additional flexibility when entering Directed Orders, which would remain subject to the rules and specifications of the destinations to which such orders are routed. As provided in Rule 7.31(f)(1), as amended, the ATS or algorithm to which a Directed Order is routed would validate whether the order is eligible to be accepted.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <P>Finally, the Exchange has proposed to amend Rule 7.31(f)(1)(D) to provide that a request to cancel a Directed Order designated Day will be routed to the ATS or algorithm to which the order was routed.</P>
                <P>
                    According to the Exchange, the proposed change would provide member organizations with a technology 
                    <PRTPAGE P="99322"/>
                    solution to leverage their existing Exchange connectivity to route Directed Orders to either an ATS or algorithm, thereby affording them increased access to execution tools and enhanced operational efficiency.
                    <SU>16</SU>
                    <FTREF/>
                     The Exchange states that the proposed change would offer member organizations greater choice and flexibility, and further believes that the proposed change could create efficiencies for member organizations by enabling them to send orders that they wish to route to an alternate destination through the Exchange, thereby leveraging order entry protocols and specifications already configured for their interactions with the Exchange.
                    <SU>17</SU>
                    <FTREF/>
                     The Exchange states that Directed Orders designated to route to an algorithm would generally operate in the same manner as Directed Orders that are currently eligible to be routed to an ATS selected by the member organization entering the order (except as proposed above). The Exchange further states that the Directed Order would continue to provide functionality similar to order types with specific execution instructions (such as the Auction Only Order defined in NYSE Rule 7.31(c)) or routing instructions (such as Primary Only Orders that route to the primary market that are available on the Exchange's affiliated equities exchanges).
                    <SU>18</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         The Exchange states that this proposed rule change could be particularly beneficial for smaller member organizations that cannot, for various reasons including cost, connect to multiple algorithm providers on their own. 
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Discussion and Commission Findings</HD>
                <P>
                    After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
                    <SU>19</SU>
                    <FTREF/>
                     In particular, the Commission finds that the proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>20</SU>
                    <FTREF/>
                     which requires, among other things, that the rules of a national securities exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         In approving this proposed rule change, the Commission notes that it has considered the proposed rule's impact on efficiency, competition, and capital formation. 
                        <E T="03">See</E>
                         15 U.S.C. 78c(f).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <P>The Commission finds that the proposed rule change is reasonably designed to remove impediments to and perfect the mechanism of a free and open market and a national market system because it is reasonably designed to offer member organizations greater choice and flexibility in executing orders by providing routing to broker-dealer algorithms that have established connectivity with the Exchange and to ensure that such connectivity is provided to broker-dealer algorithms on a fair and equitable basis. The Commission also believes that the proposed rule change would not permit unfair discrimination among customers, brokers, or dealers because Directed Orders will be available to all Exchange members on an equal basis and because the Exchange has represented that it would not direct orders to any algorithm with which the Exchange has a financial relationship.</P>
                <P>Based on the foregoing, the Commission finds that the proposed rule change is consistent with the Act.</P>
                <HD SOURCE="HD1">IV. Conclusion</HD>
                <P>
                    <E T="03">It is therefore ordered,</E>
                     pursuant to Section 19(b)(2) of the Act,
                    <SU>21</SU>
                    <FTREF/>
                     that the proposed rule change (SR-NYSE-2024-67) be, and hereby is, approved.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         15 U.S.C. 78s(b)(2).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>22</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>Sherry R. Haywood,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-28897 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <DEPDOC>[Disaster Declaration #20842 and #20843; HAVASUPAI TRIBE Disaster Number AZ-20008]</DEPDOC>
                <SUBJECT>Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the Havasupai Tribe</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Small Business Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Amendment 1.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the Havasupai Tribe (FEMA-4840-DR), dated October 25, 2024.</P>
                    <P>
                        <E T="03">Incident:</E>
                         Flooding.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Issued on December 3, 2024.</P>
                    <P>
                        <E T="03">Incident Period:</E>
                         August 22, 2024 through August 23, 2024.
                    </P>
                    <P>
                        <E T="03">Physical Loan Application Deadline Date:</E>
                         January 17, 2025.
                    </P>
                    <P>
                        <E T="03">Economic Injury (EIDL) Loan Application Deadline Date:</E>
                         July 25, 2025.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        <E T="03">Visit the MySBA Loan Portal at https://lending.sba.gov</E>
                         to apply for a disaster assistance loan.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Alan Escobar, Office of Disaster Recovery &amp; Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The notice of the President's major disaster declaration for Private Non-Profit organizations in the Havasupai Tribe, dated October 25, 2024, is hereby amended to extend the deadline for filing applications for physical damage as a result of this disaster to January 17, 2025.</P>
                <P>All other information in the original declaration remains unchanged.</P>
                <EXTRACT>
                    <FP>(Catalog of Federal Domestic Assistance Number 59008)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Alejandro Contreras,</NAME>
                    <TITLE>Acting Deputy Associate Administrator, Office of Disaster Recovery &amp; Resilience.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28923 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8026-09-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF STATE</AGENCY>
                <DEPDOC>[Public Notice: 12600]</DEPDOC>
                <SUBJECT>Notice of Determinations; Culturally Significant Objects Being Imported for Exhibition—Determinations: “Jack Whitten: The Messenger” Exhibition</SUBJECT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition “Jack Whitten: The Messenger” at The Museum of Modern Art, New York, New York, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Reed Liriano, Program Coordinator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email: 
                        <E T="03">
                            section2459@ 
                            <PRTPAGE P="99323"/>
                            state.gov
                        </E>
                        ). The mailing address is U.S. Department of State, L/PD, 2200 C Street, NW (SA-5), Suite 5H03, Washington, DC 20522-0505.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, 
                    <E T="03">et seq.;</E>
                     22 U.S.C. 6501 note, 
                    <E T="03">et seq.</E>
                    ), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000, and Delegation of Authority No. 523 of December 22, 2021.
                </P>
                <SIG>
                    <NAME>Nicole L. Elkon,</NAME>
                    <TITLE>Deputy Assistant Secretary for Professional and Cultural Exchanges, Bureau of Educational and Cultural Affairs, Department of State.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28918 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4710-05-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF STATE</AGENCY>
                <DEPDOC>[Public Notice: 12602]</DEPDOC>
                <SUBJECT>Notice of Determinations; Culturally Significant Objects Being Imported for Exhibition—Determinations: “Myth and Marble: Ancient Roman Sculpture From the Torlonia Collection” Exhibition</SUBJECT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to an agreement with their foreign owner or custodian for temporary display in the exhibition “Myth and Marble: Ancient Roman Sculpture from the Torlonia Collection” at The Art Institute of Chicago, in Chicago, Illinois; the Kimbell Art Museum, Fort Worth, Texas; and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Reed Liriano, Program Coordinator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email: 
                        <E T="03">section2459@state.gov</E>
                        ). The mailing address is U.S. Department of State, L/PD, 2200 C Street NW (SA-5), Suite 5H03, Washington, DC 20522-0505.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, 
                    <E T="03">et seq.;</E>
                     22 U.S.C. 6501 note, 
                    <E T="03">et seq.</E>
                    ), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000, and Delegation of Authority No. 523 of December 22, 2021.
                </P>
                <SIG>
                    <NAME>Nicole L. Elkon,</NAME>
                    <TITLE>Deputy Assistant Secretary for Professional and Cultural Exchanges, Bureau of Educational and Cultural Affairs, Department of State.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28911 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4710-05-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Highway Administration</SUBAGY>
                <DEPDOC>[Docket No. FHWA-2024-0082]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Notice of Request for Renewal of Currently Approved Information Collection</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Highway Administration (FHWA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of request for revision of currently approved information collection.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The FHWA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for renewal of an existing information collection that is summarized below under 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        . We are required to publish this notice in the 
                        <E T="04">Federal Register</E>
                         by the Paperwork Reduction Act of 1995.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Please submit comments by February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket ID Number 0082 by any of the following methods:</P>
                    <P>
                        <E T="03">Website:</E>
                         For access to the docket to read background documents or comments received go to the Federal eRulemaking Portal: Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Fax:</E>
                         1-202-493-2251.
                    </P>
                    <P>
                        <E T="03">Mail:</E>
                         Docket Management Facility, U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
                    </P>
                    <P>
                        <E T="03">Hand Delivery or Courier:</E>
                         U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Mark Glaze, (202) 366-4503, HEPN-10, Room E74-466, Federal Highway Administration, US Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590. Office hours are from 8 a.m. to 4:30 p.m., Monday through Friday, except Federal holidays.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title:</E>
                     Congestion Mitigation and Air Quality (CMAQ) Improvement Program.
                </P>
                <P>
                    <E T="03">OMB Control:</E>
                     2125-0614.
                </P>
                <P>
                    <E T="03">Background:</E>
                     The development and maintenance of a cumulative database of all CMAQ projects is required by 23 U.S.C. 149(i)(1). This database must include specific information about each project such as name, location, sponsor, cost, and to the extent already measured by the project sponsor, cost-effectiveness based on reductions in emissions and congestion. States provide annual reports on all CMAQ obligations and de-obligations taking place in each fiscal year. These reports include obligations of program funds; descriptions of individual projects; and potential impacts on air quality and congestion. The data provided in the annual reports and the CMAQ Public Access System allows for transparency, showing that the program continues to provide incremental benefits through enhanced regional and local air quality improvement, and through contributions to congestion relief.
                </P>
                <P>Information provided in the CMAQ project reporting system is useful for FHWA and FTA planning purposes, as well as reports to the U.S. Congress. The database is also the official data source for reporting on CMAQ emission measure performance under the transportation performance management requirements in 23 CFR part 490.</P>
                <P>
                    <E T="03">Respondents:</E>
                     There are 51 respondents, including 50 State Transportation Departments and the District of Columbia.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     Once every calendar year to record CMAQ project data from the previous fiscal, on or about March 1st.
                </P>
                <P>
                    <E T="03">Estimated Average Burden per Response:</E>
                     There is a total of 51 annual reports per year on a variable number of reported projects. Each project entry requires on average 15 to 20 minutes to complete.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     Total estimated average annual burden is 674 hours. (Based on the most recent ten year average of Annual Reporting projects.)
                </P>
                <P>
                    <E T="03">Public Comments Invited:</E>
                     You are asked to comment on any aspect of this 
                    <PRTPAGE P="99324"/>
                    information collection, including: (1) Whether the proposed collection is necessary for the FHWA's performance; (2) the accuracy of the estimated burdens; (3) ways for the FHWA to enhance the quality, usefulness, and clarity of the collected information; and (4) ways that the burden could be minimized, including the use of electronic technology, without reducing the quality of the collected information. The agency will summarize and/or include your comments in the request for OMB's clearance of this information collection.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     The Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended; and 49 CFR 1.48.
                </P>
                <SIG>
                    <DATED> Issued on December 5, 2024.</DATED>
                    <NAME>Jazmyne Lewis,</NAME>
                    <TITLE>Information Collection Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28947 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Highway Administration</SUBAGY>
                <SUBJECT>Notice of Availability of the Finding of No Significant Impact for the I-15; 24th Street Interchange Project in Utah and Final Federal Agency Actions</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Highway Administration (FHWA), Department of Transportation, Utah Department of Transportation (UDOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability and notice of limitations on claims for judicial review of actions by UDOT and other Federal agencies.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FHWA, on behalf of UDOT, is issuing this notice to announce the availability of the Finding of No Significant Impact (FONSI) for the Interstate 15 (I-15); 24th Street Interchange, in Ogden City, Weber County, Utah. In addition, this notice is being issued to announce actions taken by UDOT that are final Federal agency actions related to the project referenced above. Those actions grant licenses, permits and/or approvals for the project. The FONSI provides details on the Selected Alternative for the proposed improvements.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        This decision became operative on November 26, 2024. By this notice, FHWA, on behalf of UDOT, is advising the public of final agency actions subject to 23 U.S.C. 139(
                        <E T="03">l</E>
                        )(1). A claim seeking judicial review of the Federal agency actions on the highway project will be barred unless the claim is filed on or before May 9, 2025. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Brandon Weston, Environmental Program Manager, UDOT Environmental Services, PO Box 143600, Salt Lake City, UT 84114; (801)-965-4603; email: 
                        <E T="03">brandonweston@utah.gov.</E>
                         UDOT's normal business hours are 8 a.m. to 5 p.m. (mountain time zone), Monday through Friday, except State and Federal holidays.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The environmental review, consultation, and other actions required by applicable Federal environmental laws for this action are being, or have been, carried out by UDOT pursuant to 23 U.S.C. 327 and a Memorandum of Understanding (MOU) dated May 26, 2022, and executed by FHWA and UDOT. Actions taken by UDOT on FHWA's behalf pursuant to 23 U.S.C. 327 constitute Federal agency actions for purposes of Federal law. Notice is hereby given that UDOT has taken final agency actions subject to 23 U.S.C. 139(
                    <E T="03">l</E>
                    )(1) by issuing licenses, permits, and/or approvals for the I-15; 24th Street Interchange project in the State of Utah.
                </P>
                <P>The project proposes to modify the local roadway network and serve local travel by replacing the existing partial Interstate 15 (I-15)/24th Street interchange with a fully directional single point urban interchange (SPUI). The existing on- and off-ramps at 24th Street would be removed, but the existing I-15 underpass would be retained to provide local access. The intersection at Pennsylvania Avenue and New Midland Drive in Ogden City would be converted to a signalized intersection. The purpose of the project is to improve modal interrelationships between the local road network, the interstate, the railroad, sidewalks, and bike routes; and also improve level of service and reduce vehicle queues at intersections within the study area.</P>
                <P>These improvements were identified in the Environmental Assessment (EA) prepared for the project by UDOT as the Proposed Action. The project is identified in UDOT's adopted 2023-2028 State Transportation Improvement Program as project number 15683 with funding identified for right-of-way acquisition. The project is also included in the Wasatch Front Regional Council (WFRC) 2023-2050 Regional Transportation Plan approved in May 2024 (latest amendment August 2024) and the WFRC 2024-2029 Transportation Improvement Plan.</P>
                <P>
                    The actions by UDOT, and the laws under which such actions were taken, are described in the EA approved on March 12, 2024, and the FONSI (Finding of No Significant Impact for I-15; 24 Street Interchange; in Weber County, Utah) Project No. S-I15-8(158)343 approved on November 26, 2024, and other documents in the project records. The EA and FONSI are available for review by contacting UDOT at the address provided above. In addition, these documents can be viewed and downloaded from the project website at 
                    <E T="03">https://udotinput.utah.gov/24thstreetinterchange.</E>
                     This notice applies to the EA, the FONSI, the Section 4(f) determination, the NHPA Section 106 review, the Endangered Species Act determination, the noise review and noise abatement determination, and all other UDOT and federal agency decisions and other actions with respect to the project as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to the following laws (including their implementing regulations):
                </P>
                <P>
                    1. 
                    <E T="03">General:</E>
                     National Environmental Policy Act [42 U.S.C. 4321-4370m-12]; Federal-Aid Highway Act [23 U.S.C. 109 and 23 U.S.C. 128]; 23 U.S.C. 139.
                </P>
                <P>
                    2. 
                    <E T="03">Air:</E>
                     Clean Air Act [42 U.S.C. 7401-7671(q)].
                </P>
                <P>
                    3. 
                    <E T="03">Land:</E>
                     Section 4(f) of the Department of Transportation Act of 1966 [23 U.S.C. 138 and 49 U.S.C. 303]; Landscaping and Scenic Enhancement (Wildflowers) [23 U.S.C. 319].
                </P>
                <P>
                    4. 
                    <E T="03">Wildlife:</E>
                     Endangered Species Act [16 U.S.C. 1531-1544], Fish and Wildlife Coordination Act [16 U.S.C. 661-667d]; Migratory Bird Treaty Act [16 U.S.C. 703-712]; Bald and Golden Eagle Protection Act [16 U.S.C. 668-668d].
                </P>
                <P>
                    5. 
                    <E T="03">Historic and Cultural Resources:</E>
                     National Historic Preservation Act of 1966, as amended [54 U.S.C. 300101-307108]; Archaeological Resources Protection Act of 1979 [16 U.S.C. 470aa-470mm]; Archeological and Historic Preservation Act [54 U.S.C. 312501-312508]; Native American Grave Protection and Repatriation Act [25 U.S.C. 3001-3013].
                </P>
                <P>
                    6. 
                    <E T="03">Social and Economic:</E>
                     Title VI of Civil Rights Act of 1964 [42 U.S.C. 2000d-2000d-7]; American Indian Religious Freedom Act [42 U.S.C. 1996]; Farmland Protection Policy Act [7 U.S.C. 4201-4209].
                </P>
                <P>
                    7. 
                    <E T="03">Wetlands and Water Resources:</E>
                     Clean Water Act [33 U.S.C. 1251-1389]; Coastal Zone Management Act [16 U.S.C. 1451-1465]; Land and Water Conservation Fund Act [54 U.S.C. 200301-200310]; Safe Drinking Water Act [42 U.S.C. 300(f)-300(j)(6)]; Rivers and Harbors Appropriation Act of 1899, 
                    <PRTPAGE P="99325"/>
                    as amended [33 U.S.C. 401-418]; Emergency Wetlands Resources Act [16 U.S.C. 3921, 3931]; Flood Disaster Protection Act [42 U.S.C. 4001-4128].
                </P>
                <P>
                    8. 
                    <E T="03">Hazardous Materials:</E>
                     Comprehensive Environmental Response, Compensation, and Liability Act [42 U.S.C. 9601-9675]; Superfund Amendments and Reauthorization Act of 1986 [42 U.S.C. 9671-9675]; Resource Conservation and Recovery Act [42 U.S.C. 6901-6992k].
                </P>
                <P>
                    9. 
                    <E T="03">Noise:</E>
                     Noise Control Act of 1972 [42 U.S.C. 4901-4918].
                </P>
                <P>
                    10. 
                    <E T="03">Executive Orders:</E>
                     E.O. 11990 Protection of Wetlands; E.O. 11988 Floodplain Management; E.O. 12898 Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations; E.O. 11593 Protection and Enhancement of Cultural Resources; E.O. 13287 Preserve America; E.O. 13175 Consultation and Coordination with Indian Tribal Governments; E.O. 11514 Protection and Enhancement of Environmental Quality; E.O. 13112 Invasive Species; E.O. 13985 Advancing Racial Equity and Support for Underserved Communities Through the Federal Government; E.O. 13990 Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis; E.O. 14008 Tackling the Climate Crisis at Home and Abroad.
                </P>
                <EXTRACT>
                    <FP>(Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.)</FP>
                </EXTRACT>
                <P>
                    <E T="03">Authority:</E>
                     23 U.S.C. 139 (
                    <E T="03">l</E>
                    )(1).
                </P>
                <SIG>
                    <NAME>Ivan Marrero,</NAME>
                    <TITLE>Division Administrator, Federal Highway Administration, Salt Lake City, Utah.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28986 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-RY-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Railroad Administration</SUBAGY>
                <DEPDOC>[Docket No. FRA-2024-0007]</DEPDOC>
                <SUBJECT>Proposed Agency Information Collection Activities; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Railroad Administration (FRA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, this notice announces that FRA is forwarding the Information Collection Request (ICR) summarized below to the Office of Management and Budget (OMB) for review and comment. The ICR describes the information collection and its expected burden. On October 4, 2024, FRA published a notice providing a 60-day period for public comment on the ICR. FRA received no comments in response to the notice.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed ICR should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find the particular ICR by selecting “Currently under Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Arlette Mussington, Information Collection Clearance Officer, at email: 
                        <E T="03">arlette.mussington@dot.gov</E>
                         or telephone: (571) 609-1285 or Ms. Joanne Swafford, Information Collection Clearance Officer, at email: 
                        <E T="03">joanne.swafford@dot.gov</E>
                         or telephone: (757) 897-9908.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The PRA, 44 U.S.C. 3501-3520, and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages. 
                    <E T="03">See</E>
                     44 U.S.C. 3506, 3507; 5 CFR 1320.8 through 1320.12. On October 4, 2024, FRA published a 60-day notice in the 
                    <E T="04">Federal Register</E>
                     soliciting public comment on the ICR for which it is now seeking OMB approval. 
                    <E T="03">See</E>
                     89 FR 80983. FRA has received no comments related to the proposed collection of information.
                </P>
                <P>
                    Before OMB decides whether to approve this proposed collection of information, it must provide 30 days' notice for public comment. Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(d); 
                    <E T="03">see also</E>
                     60 FR 44978, 44983, Aug. 29, 1995. The 30-day notice informs the regulated community of its opportunity to file relevant comments and affords the agency adequate time to consider public comments before it renders a decision. 60 FR 44983, Aug. 29, 1995. Therefore, each respondent should submit their comments to OMB within 30 days of publication to best ensure having their full effect.
                </P>
                <P>
                    <E T="03">Comments are invited on the following ICR regarding:</E>
                     (1) whether the information collection activities are necessary for FRA to properly execute its functions, including whether the information will have practical utility; (2) the accuracy of FRA's estimates of the burden of the information collection activities, including the validity of the methodology and assumptions used to determine the estimates; (3) ways for FRA to enhance the quality, utility, and clarity of the information being collected; and (4) ways to minimize the burden of information collection activities on the public, including the use of automated collection techniques or other forms of information technology.
                </P>
                <P>The summary below describes the ICR that FRA will submit for OMB clearance as the PRA requires:</P>
                <P>
                    <E T="03">Title:</E>
                     Grants Management Requirements for Federal Railroad Administration. Grant Awards and Cooperative Agreements.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2130-0615.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     FRA solicits grant applications through a multitude of grant programs for projects including, but not limited to, preconstruction planning activities, safety improvements, congestion relief, improvement of grade crossings, rail line relocation, as well as projects that encourage development, expansion, and upgrades to passenger and freight rail infrastructure and services. FRA funds projects that meet FRA and government-wide evaluation standards and align with the DOT Strategic Plan.
                </P>
                <P>FRA requires systematic and uniform collection and submission of information, as approved by OMB, to ensure accountability of Federal assistance provided by FRA. Through this information collection, FRA will measure Federal award recipients' performance and results, including expenditures in support of agreed-upon activities and allowable costs outlined in the standard FRA Notice of Grant Award sent to the recipients.</P>
                <P>This information collection includes OMB-required reports and documentation, as well as additional forms and submissions to compile data relevant to addressing FRA's important policy challenges, promoting cost-effectiveness in FRA programs, and providing effective oversight of programmatic and financial performance. FRA issues and manages awards in compliance with 2 CFR part 200; Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.</P>
                <P>
                    In this 30-day notice, after a thorough review, FRA has adjusted the previously 
                    <PRTPAGE P="99326"/>
                    reported number of burden hours and responses that were published in the 60-day notice on October 4, 2024.
                    <SU>1</SU>
                    <FTREF/>
                     As a result, the adjustments have decreased the requested burden hours from 28,869 to 21,173, and responses from 11,001 to 4,762. Details of the adjustments are outlined in the following statements below:
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         89 FR 80983.
                    </P>
                </FTNT>
                <P>• In previously reported submissions, FRA determined that burden hours associated with Standard Forms SF 270; SF 424; SF 424A; SF 424B; SF 424C; SF 424D; SF 425; and SF LLL were included as part of the total estimated burden hours, which added additional hours to the ICR. However, FRA determined that it was more appropriate for the burden hours for the SF forms to accounted for only once under the host OMB control number. Accordingly, FRA has removed the previously reported burden hours of the Standard Forms from this ICR renewal submission.</P>
                <P>• Discontinuance of FRA F 6180.229 NIST Manufacturing Extension partnership Supplier Scouting. As part of the implementation of the Build America, Buy America (BABA), federal agencies are required to coordinate with the National Institute of Standards and Technology—Manufacturing Extension Partnership (NIST-MEP) to conduct supplier scouting efforts when federal agencies anticipate the need to waiver either BABA or Buy America requirements for federally funded projects. The NIST-MEP has requested that federal agencies direct project sponsors and the manufacturers of non-compliant components to engage directly with them to conduct this supplier scouting effort. As such, FRA no longer plans to collect information on the FRA F 6180.229 at this time and thus, proposes to remove the burden hours associated with the form, as this burden will be captured by the NIST-MEP.</P>
                <P>
                    <E T="03">Type of Request:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    <E T="03">Form(s): FRA F 6180.30; FRA F 6180.31</E>
                     (revised); 
                    <E T="03">FRA F 6180.32; FRA F 6180.33; FRA F 6180.34</E>
                     (revised); 
                    <E T="03">FRA F 6180.217; FRA F 6180.251; FRA F 6180.252; Plus, one new form FRA F 6180.288</E>
                     (new).
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Generally, includes States, local governments, and railroads.
                </P>
                <P>
                    <E T="03">Frequency of Submission:</E>
                     Varied; on occasion/monthly.
                </P>
                <P>
                    <E T="03">Reporting Burden:</E>
                     For transparency FRA is republishing the burden table to show the corrected burden table.
                </P>
                <GPOTABLE COLS="7" OPTS="L2(,0,),nj,tp0,p7,7/8,i1" CDEF="s100,r40,r40,12,12,12,15">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Form name</CHED>
                        <CHED H="1">Form No.</CHED>
                        <CHED H="1">
                            Grant activity/
                            <LI>process</LI>
                        </CHED>
                        <CHED H="1">Respondent universe</CHED>
                        <CHED H="1">
                            Average
                            <LI>time per</LI>
                            <LI>response</LI>
                            <LI>(in hours)</LI>
                        </CHED>
                        <CHED H="1">
                            Total annual
                            <LI>burden hours</LI>
                        </CHED>
                        <CHED H="1">
                            Total cost
                            <LI>equivalent in</LI>
                            <LI>U.S. dollar</LI>
                        </CHED>
                    </BOXHD>
                    <ROW RUL="s">
                        <ENT I="25"> </ENT>
                        <ENT O="xl"/>
                        <ENT O="xl"/>
                        <ENT>(A)</ENT>
                        <ENT>(B)</ENT>
                        <ENT>(C = A * B)</ENT>
                        <ENT>
                            (D = C * wage rates) 
                            <SU>2</SU>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Applicant Financial Capability Questionnaire</ENT>
                        <ENT>FRA F 6180.251</ENT>
                        <ENT>Application</ENT>
                        <ENT>1,000</ENT>
                        <ENT>2</ENT>
                        <ENT>2,000</ENT>
                        <ENT>$123,700</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FRA Assurances and Certifications Regarding Lobbying; Debarment, Suspension and Other Responsibility Matters and Drug-Free Workplace Requirements</ENT>
                        <ENT>FRA F 6180.30</ENT>
                        <ENT>Application</ENT>
                        <ENT>1,000</ENT>
                        <ENT>0.25</ENT>
                        <ENT>250</ENT>
                        <ENT>15,462.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Pre-Award Authority Request—Project Sponsors that wish to incur pre-award expenses can apply for pre-award authority. 
                            <E T="03">(New Form)</E>
                        </ENT>
                        <ENT>FRA F 6180.288</ENT>
                        <ENT>Pre-Award</ENT>
                        <ENT>100</ENT>
                        <ENT>3</ENT>
                        <ENT>300</ENT>
                        <ENT>18,555.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Payment Summary Spreadsheet</ENT>
                        <ENT>FRA F 6180.252</ENT>
                        <ENT>Awards &amp; Maintenance</ENT>
                        <ENT>860</ENT>
                        <ENT>0.50</ENT>
                        <ENT>430</ENT>
                        <ENT>26,595.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Quarterly Progress Report 
                            <SU>3</SU>
                             (FRA F 6180.34; new awards) 
                            <E T="03">Revised form</E>
                        </ENT>
                        <ENT>FRA F 6180.34</ENT>
                        <ENT>Awards &amp; Maintenance</ENT>
                        <ENT>500</ENT>
                        <ENT>2</ENT>
                        <ENT>1,000</ENT>
                        <ENT>61,850.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Quarterly Progress Report 
                            <SU>4</SU>
                             (FRA F 6180.34; existing recipients) 
                            <E T="03">Revised form</E>
                        </ENT>
                        <ENT>FRA F 6180.34</ENT>
                        <ENT>Awards &amp; Maintenance</ENT>
                        <ENT>864</ENT>
                        <ENT>2</ENT>
                        <ENT>1,728</ENT>
                        <ENT>106,876.80</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Grant Adjustment Request Form (GARF) 
                            <E T="03">Revised form</E>
                        </ENT>
                        <ENT>FRA F 6180.31</ENT>
                        <ENT>Awards &amp; Maintenance</ENT>
                        <ENT>212</ENT>
                        <ENT>1</ENT>
                        <ENT>212</ENT>
                        <ENT>13,112.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Service Outcome Agreement (SOA) Annual Reporting</ENT>
                        <ENT>FRA F 6180.32</ENT>
                        <ENT>Awards &amp; Maintenance</ENT>
                        <ENT>24</ENT>
                        <ENT>1</ENT>
                        <ENT>24</ENT>
                        <ENT>1,484.40</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Certification of Compliance or Non-Compliance with Buy America Requirements for Steel, Iron, Construction Materials, and Manufactured Products being produced by Awardee (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>15</ENT>
                        <ENT>4</ENT>
                        <ENT>60</ENT>
                        <ENT>3,711.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Certification of Compliance with Buy America for Rolling Stock (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>62</ENT>
                        <ENT>62</ENT>
                        <ENT>3,834.79</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Waivers—Requests/Applications for Waivers, excluding FRA Form 229 (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>15</ENT>
                        <ENT>80</ENT>
                        <ENT>1,200</ENT>
                        <ENT>74,220.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Awardee Investigations (including FRA initiated investigations)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>3</ENT>
                        <ENT>333</ENT>
                        <ENT>999</ENT>
                        <ENT>61,788.15</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Awardee direct reply to FRA after request to conduct investigation of bidder/offeror (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>2</ENT>
                        <ENT>1</ENT>
                        <ENT>2</ENT>
                        <ENT>123.70</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Additional Documents to FRA from Awardee/Investigated Party (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>4</ENT>
                        <ENT>4</ENT>
                        <ENT>247.40</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Transmission of Awardee/Bidder/Offeror Reply to Petitioner (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>4</ENT>
                        <ENT>4</ENT>
                        <ENT>247.40</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Awardee/Investigated Bidder/Offeror response to Petitioner Comment (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>8</ENT>
                        <ENT>8</ENT>
                        <ENT>494.80</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Written request to FRA for information bearing on substance of investigation which has been submitted by petitioner, interested parties, or awardees (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>4</ENT>
                        <ENT>4</ENT>
                        <ENT>247.40</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Detailed Statement to FRA Regarding Confidentiality of Previously Submitted Information to Agency (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>8</ENT>
                        <ENT>8</ENT>
                        <ENT>494.80</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="99327"/>
                        <ENT I="01">Awardee Determination to make award before resolution of investigation one of these sections specified reasons (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>40</ENT>
                        <ENT>40</ENT>
                        <ENT>2,474.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Notification to FRA by Awardee to make award during pendency of investigation (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>1</ENT>
                        <ENT>1</ENT>
                        <ENT>61.85</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Request to FRA for Reconsideration of Initial Decision by Party Involved in Investigations (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>80</ENT>
                        <ENT>80</ENT>
                        <ENT>4,948.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Pre-Award Audit (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>33</ENT>
                        <ENT>33</ENT>
                        <ENT>2,041.05</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Final Contract between Awardee and Bidder/Offeror (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>16</ENT>
                        <ENT>16</ENT>
                        <ENT>989.60</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Post Award Audit (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>256</ENT>
                        <ENT>256</ENT>
                        <ENT>15,833.60</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Rolling Stock Domestic Content Improvement Plans (narrative request)</ENT>
                        <ENT>Narrative Request</ENT>
                        <ENT>Buy America Component</ENT>
                        <ENT>1</ENT>
                        <ENT>120</ENT>
                        <ENT>120</ENT>
                        <ENT>7,422.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Categorical Exclusion (Worksheet)</ENT>
                        <ENT>FRA F 6180.217</ENT>
                        <ENT>Awards &amp; Maintenance</ENT>
                        <ENT>75</ENT>
                        <ENT>156</ENT>
                        <ENT>11,700</ENT>
                        <ENT>723,645.00</ENT>
                    </ROW>
                    <ROW RUL="n,n,n,s">
                        <ENT I="01">Final Performance Report</ENT>
                        <ENT>FRA F 33</ENT>
                        <ENT>Closeout</ENT>
                        <ENT>79</ENT>
                        <ENT>8</ENT>
                        <ENT>632</ENT>
                        <ENT>39,089.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">
                            Total 
                            <SU>5</SU>
                        </ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>4,762</ENT>
                        <ENT/>
                        <ENT>21,173</ENT>
                        <ENT>1,309,550</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">
                        Total Estimated
                        <FTREF/>
                         Annual Responses:
                    </E>
                     4,762.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         The dollar equivalent cost is derived from the May 2023 Department of Labor, Bureau of Labor Statistics (BLS), using the median hourly wage rate for a Management Analyst 13-1111 of 47.80, plus an overhead rate of 29.4% (Employer Costs for Employee Compensation—June 2023) for a fully burdened wage rate of 47.80 + 14.05 = 61.85.
                    </P>
                    <P>
                        <SU>3</SU>
                         125 new awardees submit each quarter—125 × 4 = 500 respondents.
                    </P>
                    <P>
                        <SU>4</SU>
                         216 existing awardees submit each quarter—216 × 4 = 864 respondents.
                    </P>
                    <P>
                        <SU>5</SU>
                         Total may not add up due to rounding.
                    </P>
                </FTNT>
                <P>
                    <E T="03">Total Estimated Annual Burden:</E>
                     21,173 hours.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Burden Hour Dollar Cost Equivalent:</E>
                     $1,309,550.
                </P>
                <P>FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information that does not display a currently valid OMB control number.</P>
                <P>
                    <E T="03">Authority:</E>
                     44 U.S.C. 3501-3520.
                </P>
                <SIG>
                    <NAME>Christopher S. Van Nostrand,</NAME>
                    <TITLE>Deputy Chief Counsel.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28921 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-06-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Pipeline and Hazardous Materials Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. PHMSA-2023-0134]</DEPDOC>
                <SUBJECT>National Environmental Policy Act Implementing Procedures; Proposed Categorical Exclusions</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Consistent with the National Environmental Policy Act and the Council on Environmental Quality regulations implementing the National Environmental Policy Act, PHMSA is proposing to establish new categorical exclusions and agency the National Environmental Policy Act implementing procedures. Categorical exclusions are categories of actions that an agency has determined normally do not have a significant effect on the human environment, individually or in the aggregate. Categorical exclusions are a form of review that agencies use to comply with the National Environmental Policy Act for proposed actions that normally have no or minimal environmental effects. PHMSA requests the views of the public on its proposal to establish these CEs and agency National Environmental Policy Act procedures.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit written comments on or before January 9, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>To ensure you do not duplicate your docket submissions, please submit comments by only one of the following means:</P>
                    <P>
                        <E T="03">Web: https://www.regulations.gov.</E>
                         This site allows the public to enter comments on any 
                        <E T="04">Federal Register</E>
                         notice issued by any agency. Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Fax:</E>
                         1-202-493-2251.
                    </P>
                    <P>
                        <E T="03">Mail:</E>
                         Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590-0001.
                    </P>
                    <P>
                        <E T="03">Hand Delivery:</E>
                         U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590-0001, between 9 a.m. and 5 p.m., EST, Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         Identify docket number PHMSA-2023-0134 at the beginning of your comments. To avoid duplication, please use only one of these four methods. Note that all comments received will be posted without change to 
                        <E T="03">http://www.regulations.gov,</E>
                         including any personal information provided. You should know that anyone is able to search the comments received in any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). Therefore, you may want to review DOT's complete Privacy Act Statement (65 FR 19477) in the 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         published on April 11, 2000, or visit 
                        <E T="03">http://www.regulations.gov</E>
                         before submitting any such comments.
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         For access to the docket or to read background documents or comments, go to 
                        <E T="03">http://www.regulations.gov</E>
                         or DOT's Docket Operations Office (see 
                        <E T="02">ADDRESSES</E>
                        ). If you wish to receive confirmation of receipt of your written comments, please include a self-addressed, stamped postcard with the following statement: “Comments on: PHMSA-2023-0134.” The Docket Clerk will date stamp the postcard prior to returning it 
                        <PRTPAGE P="99328"/>
                        to you via U.S. mail. Please note that due to delays in the delivery of U.S. mail to federal offices in Washington, DC, we recommend that persons consider an alternative method (internet, fax, or professional delivery service) for submitting comments to the docket and ensuring their timely receipt by DOT.
                    </P>
                    <P>
                        <E T="03">Privacy Act Statement:</E>
                         In accordance with 5 U.S.C. 553(c), DOT may solicit comments from the public regarding certain general notices. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                        <E T="03">www.regulations.gov,</E>
                         as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
                        <E T="03">www.dot.gov/privacy.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Carolyn Nelson, Office of Planning and Analytics, PHMSA, by email at 
                        <E T="03">Carolyn.Nelson@dot.gov</E>
                         or by phone at 202-860-6173.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>
                    The National Environmental Policy Act (NEPA), 42 U.S.C. 4321 
                    <E T="03">et seq.,</E>
                     requires Federal agencies to consider the environmental effects of their proposed actions in their decision-making processes and inform and engage the public in that process. Section 101(a) of NEPA sets forth a national policy to use all practicable means and measures, including financial and technical assistance, in a manner calculated to foster and promote the general welfare, to create and maintain conditions under which humans and nature can exist in productive harmony, and fulfill the social, economic, and other requirements of present and future generations of Americans. 42 U.S.C. 4331(a). Section 102 of NEPA directs agencies to interpret and administer Federal policies, regulations and laws consistent with NEPA's policies. 42 U.S.C. 4332.
                </P>
                <P>
                    NEPA also created the Council on Environmental Quality (CEQ), which has issued regulations implementing NEPA, 40 CFR parts 1500 through 1508 (CEQ regulations). CEQ also has issued numerous guidance documents to facilitate agency implementation of NEPA. 
                    <E T="03">See</E>
                     CEQ, CEQ Guidance Documents, 
                    <E T="03">https://ceq.doe.gov/guidance/guidance.html.</E>
                </P>
                <P>To comply with NEPA, agencies determine the appropriate level of review of any major Federal action—an environmental impact statement (EIS), environmental assessment (EA), or categorical exclusion (CE). 40 CFR 1501.3. If a proposed action is likely to have significant environmental effects, the agency must prepare an EIS and document its decision in a record of decision. 40 CFR 1501.3(c)(3), part 1502, 1505.2. If the proposed action is not likely to have significant environmental effects or the effects are unknown, the agency may instead prepare an EA, which is a concise public document used to support agency decision making. 40 CFR 1501.3(c)(2), 1501.5, 1508.1(j). After completing the analysis in the EA, the agency may conclude that the action will have no significant effects and document that conclusion in a finding of no significant impact, or conclude that the action is likely to have significant effects and therefore requires preparation of an EIS. 40 CFR 1501.6(a), 1508.1(j).</P>
                <P>
                    Under NEPA and the CEQ regulations, a Federal agency establishes categorical exclusions (CEs)—categories of actions that the agency has determined normally do not have a significant effect on the human environment, individually or in the aggregate—in its agency NEPA procedures. 42 U.S.C. 4336(e)(1); 40 CFR 1501.4(a), 1507.3(c)(8), 1508.1(e). If an agency determines that a CE covers a proposed action, it then evaluates the proposed action for extraordinary circumstances, which are factors or circumstances that indicate a normally categorically excluded action may have a significant effect. 40 CFR 1501.4(b), 1508.1(o). If an extraordinary circumstance exists, the agency nevertheless may apply the CE if it conducts an analysis and determines that the proposed action does not in fact have the potential to result in significant effects notwithstanding the extraordinary circumstance, or the agency modifies the action to avoid the potential to result in significant effects. 40 CFR 1501.4(b)(1). In these cases, the agency must document such determination. 
                    <E T="03">Id.</E>
                     If the agency cannot categorically exclude the proposed action, it will prepare an EA or EIS, as appropriate. 40 CFR 1501.4(b)(2).
                </P>
                <P>
                    The CEQ regulations require Federal agencies to develop procedures to implement NEPA and the CEQ regulations, facilitate efficient decision making, and ensure that the agencies make decisions in accordance with the policies and requirements of NEPA. 40 CFR 1507.3. As part of their procedures, agencies must establish CEs and identify extraordinary circumstances. 40 CFR 1507.3(c)(8). When establishing new or revising existing CEs in agency NEPA procedures, agencies must substantiate the proposed new or revised CEs with sufficient information to conclude that each category of actions does not have a significant effect, individually or in the aggregate, on the human environment, and provide this substantiation in a written record that is made publicly available as part of the notice and comment process for developing or revising proposed agency procedures. 
                    <E T="03">See</E>
                     40 CFR 1507.3(b), (c)(8). In developing NEPA procedures, agencies must consult with CEQ and provide an opportunity for public review. 40 CFR 1507.3(b)(1)-(2). Before publishing final procedures, agencies must receive a determination from CEQ that the procedures conform with NEPA and the CEQ regulations. 
                    <E T="03">See</E>
                     40 CFR 1507.3(b)(2).
                </P>
                <P>PHMSA's mission is to protect people and the environment by advancing the safe transportation of energy and other hazardous materials that are essential to our daily lives. To do this, the Agency establishes national policy, promulgates and enforces safety regulations, educates, and conducts research to prevent incidents. PHMSA also prepares the public and first responders to mitigate consequences if a hazardous materials incident does occur. PHMSA's Office of Planning and Analytics (OPA), Environmental Analysis and Compliance Division, conducts and manages the Agency's environmental review process to ensure compliance with NEPA and other relevant federal environmental laws; reviews and approves environmental documents; and issues associated decisions. PHMSA actions include rulemakings, special permits (also known as regulatory waivers), and certain grants. PHMSA does not have infrastructure siting or approval authority, and therefore does not conduct NEPA reviews for proposed new pipeline construction projects.</P>
                <P>The Infrastructure Investment and Jobs Act of 2021, also known as the Bipartisan Infrastructure Law (BIL), established the Natural Gas Distribution Infrastructure Safety and Modernization (NGDISM) Grant Program. The BIL authorized PHMSA to award $200 million per year in NGDISM Grant funding, for a total of $1 billion in grant funding over five years. The grant funding is available to a municipality- or community-owned utility (not including for-profit entities) to repair, rehabilitate, or replace its natural gas distribution pipeline systems or portions thereof, or to acquire equipment to (1) reduce incidents and fatalities, and (2) avoid economic losses.</P>
                <P>
                    In this notice, PHMSA proposes to establish its NEPA procedures as agency guidance to efficiently and effectively consider the environmental consequences of PHMSA's actions. PHMSA has not previously established Agency-specific NEPA procedures, 
                    <PRTPAGE P="99329"/>
                    including CEs. When conducting NEPA reviews, PHMSA complies with DOT Order 5610.1C, “Procedures for Considering Environmental Impacts,” which establishes NEPA implementing procedures that apply to all DOT operating administrations. PHMSA's distinct mission and the nature of its actions warrant establishing Agency-specific procedures. These Agency-specific procedures reflect how PHMSA will apply CEQ's NEPA regulations to PHMSA's unique programs and decision-making processes. At the same time, PHMSA will continue to comply with DOT Order 5610.1C or any successor DOT NEPA implementing procedures applicable to PHMSA. Due in part, to the significant increase in PHMSA actions as a result of the BIL's establishment of the NGDISM Grant Program, PHMSA is establishing Agency-specific NEPA procedures, including five CEs, to efficiently and effectively consider the environmental consequences of PHMSA's actions. CEs are listed in Appendix 1 of PHMSA's NEPA Implementing procedures.
                </P>
                <P>
                    PHMSA has prepared a record to substantiate the development of its new CEs, which is available for review in Docket No. PHMSA-2023-0134 or on PHMSA's website at 
                    <E T="03">https://www.phmsa.dot.gov/regulations-and-compliance.</E>
                     PHMSA invites comment on the substantiation record and supporting materials. The analyses in the record are built upon assessment of previous PHMSA actions as delineated in existing NEPA documentation and implemented by PHMSA; information from PHMSA professional staff, expert opinion, and scientific analysis; and benchmarking of other federal agencies' experiences. PHMSA also developed a list of extraordinary circumstances as part of its NEPA Implementing Procedures to provide additional safeguards to ensure that future proposed actions that are reviewed using the proposed CEs will not result in significant impacts. (See section 5. NEPA Implementing Procedures.) PHMSA has consulted with CEQ on its proposal and is seeking input from the public. PHMSA will consider input from the public and consult with CEQ for a conformity determination before finalizing its proposal.
                </P>
                <HD SOURCE="HD1">II. PHMSA NEPA Implementing Procedures for Considering Environmental Impacts</HD>
                <HD SOURCE="HD2">Section 1: Purpose and Applicability</HD>
                <P>
                    This document establishes policies, responsibilities, and procedures for the Pipeline and Hazardous Materials Safety Administration (PHMSA or Agency), an operating administration of the U.S. Department of Transportation (DOT), to consider the environmental effects of its proposed actions in its decision-making processes and inform and engage the public in that process as required by the National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4336e), and consistent with the Council on Environmental Quality (CEQ) 
                    <E T="03">Regulations for Implementing the Procedural Provisions of the National Environmental Policy Act</E>
                     (CEQ Regulations), 40 CFR parts 1500-1508, and DOT Order 5610.1C, 
                    <E T="03">Procedures for Considering Environmental Impacts.</E>
                     The CEQ Regulations establish procedures for complying with NEPA. Consistent with 40 CFR 1507.3 of the CEQ Regulations, this order contains the PHMSA's implementing procedures, which implement NEPA and supplement those regulations.
                </P>
                <P>PHMSA's mission is to protect people and the environment by advancing the safe transportation of energy and other hazardous materials that are essential to our daily lives. PHMSA regulates over three million miles of pipelines and oversees the safe and secure movement of over one million daily shipments of hazardous materials by all modes of transportation. PHMSA does not site, permit, or authorize transportation infrastructure. PHMSA's regulatory standards are intended to reduce the likelihood of a release of hazardous materials into the human environment during transportation.</P>
                <P>PHMSA's major Federal actions that are subject to NEPA review generally fall into three categories: regulatory actions, special permits, and natural gas distribution grant actions:</P>
                <P>
                    <E T="03">Regulatory Actions.</E>
                     PHMSA promulgates regulations to improve the safety of transportation of hazardous materials in all modes, including the Hazardous Materials Regulations (49 CFR parts 171-180) and the Pipeline Safety Regulations (49 CFR parts 190-199). PHMSA does not site, permit, or authorize transportation infrastructure or the transportation of hazardous materials. PHMSA's regulatory standards are intended to reduce the likelihood of release of hazardous materials into the human environment during ongoing transportation of hazardous materials.
                </P>
                <P>
                    <E T="03">Special Permits.</E>
                     A Special Permit sets forth alternative requirements, or variances, to the requirements in the Hazardous Materials Regulations (49 CFR parts 171-180) or Pipeline Safety Regulations (49 CFR parts 190-199). PHMSA may issue such variances if the applicant demonstrates an equivalent level of safety will be achieved or, if a required safety level does not exist, the alternative requirements are consistent with the public interest.
                </P>
                <P>
                    <E T="03">Natural Gas Distribution Grants.</E>
                     PHMSA awards grants under programs including the Natural Gas Distribution Infrastructure Safety and Modernization grant program. This program assists municipalities or community-owned utilities (not including for-profit entities) in the repair, rehabilitation, or replacement of their natural gas distribution pipeline systems or portions thereof or in the acquisition of equipment to (1) reduce incidents and fatalities and (2) avoid economic losses.
                </P>
                <P>Other PHMSA actions subject to NEPA review may include administrative actions, such as administrative procurements or personnel actions.</P>
                <P>Actions are not subject to NEPA review if they are exempted from NEPA by law; if compliance with NEPA would clearly and fundamentally conflict with the requirements of another provision of Federal law; or if any other factors stated in 40 CFR 1501.3(a) are identified. Consistent with 40 CFR 1507.3(a), the following actions by PHMSA are not subject to NEPA review pursuant to the statute and implementing CEQ Regulations:</P>
                <P>Administrative, organizational, or procedural actions that do not result in final agency actions (40 CFR 1501.3(a)(4)). Examples include day-to-day administrative operations; routine use of PHMSA facilities consistent with their intended purpose; required hazardous material or pipeline inspections; data collection and analysis, response to data requests, and statistical work; development of informational technology systems and portals; and community outreach.</P>
                <P>
                    Issuance of internal and external advisory or guidance actions to aid regulated entities in complying with existing regulatory obligations, but which otherwise does not change their substantive rights and obligations, including manuals, advisory circulars and bulletins, frequently asked questions, interpretations, and other guidance documents. Examples include supplemental instructions for agency compliance with NEPA procedures, PHMSA's 
                    <E T="03">Pipeline Safety Enforcement Procedures Manual,</E>
                     PHMSA's 
                    <E T="03">Part 192 Corrosion Enforcement Guidance,</E>
                     PHMSA's 
                    <E T="03">Operations &amp; Maintenance Enforcement Guidance Part 192 Subparts L and M,</E>
                     PHMSA's 
                    <E T="03">Operator Qualification Enforcement Guidance,</E>
                     and 
                    <E T="03">Emergency Response Guidebook.</E>
                     These actions are not subject to NEPA because they are not final agency actions (40 CFR 1501.3(a)(4)).
                    <PRTPAGE P="99330"/>
                </P>
                <P>Enforcement actions such as issuance of Corrective Action Orders, Notices of Proposed Safety Orders, Notices of Probable Violation, Warning Letters, and Notices of Amendments by PHMSA's Pipeline Safety Enforcement Program, and Emergency Order Authority by PHMSA's Office of Hazardous Materials and Safety (40 CFR 1508.1(w)(2)(v)).</P>
                <HD SOURCE="HD2">Section 2: Background</HD>
                <P>i. NEPA established certain policies and goals concerning the environment and requires that, to the fullest extent possible, the policies, regulations, and public laws of the United States shall be interpreted and administered in accordance with those policies and goals. Section 102 of NEPA establishes procedural requirements, applying that national policy to proposals for major federal actions significantly affecting the quality of the human environment.</P>
                <P>ii. The CEQ Regulations direct each agency to develop procedures that implement the CEQ Regulations for the agency's specific programs to facilitate efficient decision making, and ensure that the agency makes decisions in accordance with the policies and requirements of NEPA.</P>
                <P>iii. DOT has issued Department-wide Order 5610.1C that outlines the general processes and procedures for the Department to implement NEPA.</P>
                <P>iv. Consistent with 40 CFR 1507.3, these PHMSA procedures implement NEPA within PHMSA, consistent with CEQ Regulations, DOT Order 5610.1C, and implementing DOT regulations, policy, or order. These procedures provide that information on environmental effects of proposed actions will be evaluated through the appropriate level of review (namely, categorical exclusions (CEs), environmental assessments (EAs), and environmental impact statements (EISs)).</P>
                <P>v. PHMSA must adhere to all laws, regulations, and Executive Orders that address environmental protection, including environmental justice.</P>
                <HD SOURCE="HD2">Section 3: Responsibilities</HD>
                <P>i. The PHMSA Administrator is responsible for ensuring Agency compliance with NEPA pursuant to delegated authority under DOT regulation 49 CFR 1.81(a)(5).</P>
                <P>ii. The PHMSA Administrator has delegated authority to the Associate Administrator for the Office of Planning and Analytics to carry out NEPA functions. The Associate Administrator for Planning and Analytics must review and approve all final EISs (FEISs) and records of decision (RODs).</P>
                <P>iii. The Associate Administrator for the Office of Planning and Analytics must designate an Agency Environmental Coordinator within the Environmental Analysis and Compliance Division to manage day-to-day NEPA functions, including approval of any CE determination, EA, finding of no significant impact (FONSI), or draft EIS (DEIS). The Agency Environmental Coordinator, or their designee, must lead and review development of all CEs, EAs, FONSIs, EISs and RODs.</P>
                <P>iv. The Agency Environmental Coordinator must implement the provisions of NEPA, the CEQ Regulations, and DOT Order 5610.1C on behalf of the Associate Administrator for the Office of Planning and Analytics. This includes serving as an initial point of contact for interested parties to request information or status reports on environmental documents and other elements of the NEPA process consistent with 40 CFR 1507.3(c)(11). PHMSA must post the name and contact information of this individual on PHMSA's website.</P>
                <P>v. The Agency Environmental Coordinator must implement a training program to ensure all PHMSA personnel engaged in programs and projects that may include a federal action subject to NEPA are familiar and comply with these procedures, NEPA, DOT Order 5610.1C, and the CEQ Regulations.</P>
                <P>vi. The Associate Administrator for the Office of Planning and Analytics must designate a Lead Environmental Protection Specialist and a Federal Preservation Officer. The Lead Environmental Protection Specialist must coordinate NEPA activities for grant programs and is authorized to approve EAs, FONSIs, and CE determinations for these programs, following consultation with the Program Offices and PHMSA Office of Chief Counsel. The Federal Preservation Officer is authorized to act as the PHMSA agency official, consult on the behalf of PHMSA, sign PHMSA correspondence, and identify Program Alternatives for the purpose of compliance with section 106 of the National Historic Preservation Act and the Advisory Council on Historic Preservation's regulations at 36 CFR part 800.</P>
                <P>vii. Consistent with 40 CFR 1507.2(a), PHMSA must designate a Chief Public Engagement Officer to be responsible for facilitating community engagement across the agency and, where appropriate, the provision of technical assistance to communities. PHMSA must post the name and contact information of this individual on PHMSA's website.</P>
                <P>viii. The PHMSA Office of Chief Counsel will review all EAs, FONSIs, DEISs, FEISs, RODs, and analyses under section 4(f) of the U.S. Department of Transportation Act (49 U.S.C. 303). At its discretion, the Office of Chief Counsel may review any other environmental document, including CE determinations, to ensure legal compliance and assess legal risk.</P>
                <HD SOURCE="HD2">Section 4: Procedures: PHMSA Actions</HD>
                <P>i. The Associate Administrators, Office Directors, and Other Officials (“Program Managers”) must coordinate with the Agency Environmental Coordinator on all proposed actions under their jurisdiction that are, or may be, major federal actions subject to the requirements of NEPA.</P>
                <P>ii. PHMSA must engage, as appropriate, with other federal and state agencies, Tribes, and with the public when considering the scope of the proposed action and its effects to inform the agency's determination of the appropriate level of NEPA review (40 CFR 1501.3(b)).</P>
                <P>iii. PHMSA is responsible for the accuracy, scope, and content of all environmental documents, and must ensure they are prepared with professional and scientific integrity, using reliable data and resources. In accordance with section 107(f) of NEPA and consistent with 40 CFR 1507.3(c)(12), applicants, including applicant-directed contractors, may prepare EAs and EISs under PHMSA's supervision, subject to the following procedures.</P>
                <P>a. If an applicant chooses to use a contractor to prepare an environmental document, PHMSA must ensure that all costs of using a contractor will be borne by the applicant.</P>
                <P>b. PHMSA must participate in and supervise the document's preparation. PHMSA must assist contractors and applicants by providing guidance and outlining the types of information required for the preparation of the environmental document. Additionally, PHMSA must collaborate with the contractor to ensure the analysis is focused on areas where there is a higher potential for significant impacts.</P>
                <P>c. PHMSA must review and approve the statement of purpose and need and the alternatives that will be considered in the environmental document at an early time, before the applicant (or the applicant's contractor) prepares the rest of the environmental document.</P>
                <P>
                    d. PHMSA must independently evaluate the environmental document and take responsibility for its accuracy, scope, and contents. PHMSA may choose in its discretion to accept, edit, 
                    <PRTPAGE P="99331"/>
                    revise, or independently author sections of the document or the whole document.
                </P>
                <P>e. PHMSA must include a statement in any environmental document prepared by an applicant or contractor stating that PHMSA has independently evaluated the document for its accuracy, scope, and contents.</P>
                <P>f. The environmental document must include the names and qualifications of individuals responsible for preparing and reviewing the document, including those individuals from PHMSA responsible for conducting the Agency's independent evaluation.</P>
                <P>g. PHMSA must independently prepare FONSIs and RODs without the support of an applicant or their contractor.</P>
                <P>h. PHMSA must ensure that the applicant preserves and includes in a decision file all factual, scientific, or technical information used, developed, or considered by the applicant in the course of preparing the draft environmental document, including any correspondence with PHMSA or with third parties.</P>
                <P>iv. NEPA Applicability and Level of NEPA Review. The Agency Environmental Coordinator, or designated representative, must evaluate any proposed action being considered by the Agency pursuant to NEPA and these procedures to determine whether the action is subject to NEPA and determine the appropriate level of NEPA review, in consultation with the PHMSA Office of Chief Counsel and Program Offices, consistent with 40 CFR 1501.3.</P>
                <P>a. PHMSA must assess whether NEPA applies to a proposed activity or decision in accordance with Section 1: Purpose and Applicability of these Procedures and consistent with 40 CFR 1501.3(a) and 1501.8(w).</P>
                <P>b. Consistent with 40 CFR 1501.3(b), if NEPA is applicable, PHMSA must consider the scope of the action, including whether some aspects are non-discretionary, and its reasonably foreseeable effects to determine the appropriate level of NEPA review. PHMSA must use public and governmental engagement (consistent with 40 CFR 1501.9) and scoping (consistent with 40 CFR 1502.4), when appropriate, to inform this determination. PHMSA must consider potential temporary as well as permanent environmental effects. PHMSA must consider the direct, indirect and cumulative effects including the reasonably foreseeable effects of connected actions when making this determination. The level of NEPA review may not be made on a “net benefit” basis and PHMSA may not offset an action's adverse effects against other beneficial effects when determining the potential for significant effects.</P>
                <P>c. If the proposed action requires the preparation of an EA or EIS, the Agency Environmental Coordinator must notify the Program Manager of the type of environmental document required.</P>
                <P>
                    d. PHMSA must prepare EISs comporting with 40 CFR part 1502. Generally, consideration of reasonably foreseeable effects should include discussion of any reasonably foreseeable greenhouse gas emissions and climate change effects (including effects from climate change on the proposed action), hazardous material releases, effects on communities with environmental justice concerns, and effects on environmentally sensitive resources. Environmentally sensitive resources include, but are not limited to, properties subject to section 4(f) of the U.S. Department of Transportation Act of 1966 (49 U.S.C. 303); historic properties, as defined in the National Historic Preservation Act of 1966 (54 U.S.C. 300101 
                    <E T="03">et seq.</E>
                    ); threatened or endangered species or their habitat, as defined under the Endangered Species Act (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ); farmland protected under the Farmland Protection Policy Act (7 U.S.C. 4201 and 7 CFR ch. VI part 658); and wetlands, as defined in Executive Order 11990, Protection of Wetlands, and DOT Order 5660.1A; floodplains, as defined in Executive Order 11988, Floodplain Management, as amended by Executive Order 13690, and DOT Order 5650.2. Typically, an EIS may be appropriate for a PHMSA regulatory action that requires new construction of transmission pipelines on a national scale.
                </P>
                <P>e. PHMSA must prepare EAs comporting with 40 CFR 1501.5 and must briefly discuss the purpose and need for the proposed action, alternatives, and reasonably foreseeable environmental effects of the proposed action and alternatives. EAs should consider the same types of effects as EISs, as appropriate to the proposed action in question, but should include a more concise discussion, consistent with the reduced risk of significant effects. Typically, an EA would be appropriate for deregulatory rulemaking actions or construction grant projects for existing service lines outside of existing rights-of-way or easements.</P>
                <P>f. PHMSA may apply a CE if such use is consistent with section V.</P>
                <P>v. Categorical Exclusions. CEs are categories of actions that normally do not have a significant effect on the quality of the human environment, individually or in the aggregate, and therefore do not require preparation of an EA or EIS unless extraordinary circumstances exist that make application of the categorical exclusion inappropriate. Consistent with 40 CFR 1507.3(c)(8), appendix 1 of these procedures lists PHMSA's CEs.</P>
                <P>
                    a. The Agency Environmental Coordinator, or their designee, must review the proposed action to determine if a CE covers the proposed action or to identify a CE that potentially covers the proposed action (
                    <E T="03">see</E>
                     Appendix 1). They must also review the proposed action for extraordinary circumstances. If an extraordinary circumstance exists, PHMSA may nevertheless apply the CE if it conducts an analysis and determines that the proposed action does not in fact have the potential to result in significant effects notwithstanding the extraordinary circumstance, or PHMSA modifies the action to avoid the potential to result in significant effects. 40 CFR 1501.4(b)(1).
                </P>
                <P>
                    b. Additional documentation is not required to document that an action has been categorically excluded for those CEs listed in Appendix 1, Paragraph a, unless an extraordinary circumstance exists and PHMSA applies the CE notwithstanding the extraordinary circumstance consistent with 40 CFR 1501.4(b)(1). In instances where PHMSA applies a CE to an action where an extraordinary circumstance exists, PHMSA must publish this determination via PHMSA's 
                    <E T="03">Notices and Rulemaking Documents</E>
                     web page (
                    <E T="03">https://www.phmsa.dot.gov/regulations/federal-register-documents</E>
                    ).
                </P>
                <P>c. CEs listed in Appendix 1, Paragraph b, require documentation, regardless of whether extraordinary circumstances exist. The Agency Environmental Coordinator must prepare documentation of potential environmental impacts.</P>
                <P>d. If no CE covers the proposed action, or if extraordinary circumstances exist that preclude PHMSA from applying a CE, PHMSA must prepare an EA or an EIS before a proposed action may proceed.</P>
                <P>
                    vi. Other Agency CEs. PHMSA may adopt and apply a CE listed in another agency's NEPA procedures for a proposed action or a category of proposed actions consistent with the process outlined in 40 CFR 1501.4(e). PHMSA must publish each application of an adopted CE consistent with § 1501.4(e)(5) via PHMSA's 
                    <E T="03">Notices and Rulemaking Documents</E>
                     web page (
                    <E T="03">https://www.phmsa.dot.gov/regulations/federal-register-documents</E>
                    ). Any adopted categorical exclusion will be available for use by the agency as of 
                    <PRTPAGE P="99332"/>
                    the date of the public notice consistent with 40 CFR 1501.4(e)(3).
                </P>
                <P>vii. Prepare EA. PHMSA must prepare an EA when a proposed action is not categorically excluded and is not expected to result in significant environmental effects, or the significance of the effects of a proposed action is unknown. 40 CFR 1501.5. The decision-making process for the level of NEPA review determination is described in IV.b above. The Agency Environmental Coordinator, or designated representative, must determine the appropriate level of review. Consistent with 40 CFR 1501.5(g), the text of an EA may not exceed 75 pages, not including any citations or appendices.</P>
                <P>
                    viii. Prepare EIS. PHMSA must prepare an EIS for any proposed action that is likely to significantly affect the human environment. The decision-making process for the level of NEPA review determination is described in IV.b above. The Agency Environmental Coordinator, or designated representative, must determine the appropriate level of review. In accordance with 49 U.S.C. 304a, PHMSA must combine FEIS/ROD documents to the extent practicable. 
                    <E T="03">See</E>
                     DOT's 
                    <E T="03">Guidance on the Use of Combined Final Environmental Impact Statements/Records of Decision and Errata Sheets in National Environmental Policy Act Review</E>
                     (2019). Consistent with 40 CFR 1502.7, the text of an FEIS may not exceed 150 pages except for proposals of extraordinary complexity, which may not exceed 300 pages.
                </P>
                <P>ix. As appropriate and where consistent with applicable statutory requirements, PHMSA must combine environmental documents with other Agency documents to facilitate sound and efficient decision making and avoid duplication. 40 CFR 1506.4, 1507.3(c)(5).</P>
                <P>x. Timelines. The Agency Environmental Coordinator, or their designee, must review and approve timelines for EA and EIS documents. PHMSA must complete EAs and EISs within the timeframes outlined in 40 CFR 1501.10. PHMSA may extend EA and EIS deadlines in writing, subject to the Associate Administrator for the Office of Planning and Analytics' approval, consistent with 40 CFR 1501.10(b). If additional time is required, PHMSA may only utilize so much additional time as is necessary to complete the document.</P>
                <P>a. Unless an extension is made, EAs must be completed within 1 year from the date PHMSA determines an EA is required.</P>
                <P>b. Unless an extension is made, EISs must be completed within 2 years of the Notice of Intent to Prepare an Environmental Impact Statement.</P>
                <P>xi. Consistent with 40 CFR 1507.3(c) and (4), the Agency Environmental Coordinator is responsible for ensuring relevant environmental documents, comments, and responses accompany the proposal through PHMSA's decision-making review processes. PHMSA must prepare EAs and EISs to encompass the range of the alternatives to be considered by the decision maker. As appropriate, PHMSA must make available to the public those portions of any additional documents provided to the decision maker in addition to the relevant environmental documents that relate to the comparison of alternatives.</P>
                <P>xii. Prior to final approval of environmental documents, the Agency Environmental Coordinator is responsible for consulting with the Program Manager and PHMSA Office of Chief Counsel for any proposed mitigation commitments required for the proposed action.</P>
                <P>xiii. Supplement. If new information becomes available that is relevant to the environmental process, such as changes in project scope or environmental effects, PHMSA Program Offices must coordinate with the Agency Environmental Coordinator and the PHMSA Office of Chief Counsel to determine if a supplement to or reevaluation of an EA or EIS is necessary, consistent with 40 CFR 1501.5(h) and (i) or 1502.9(d) and (e), respectively.</P>
                <HD SOURCE="HD2">Section 5: Procedures: Extraordinary Circumstances</HD>
                <P>i. Extraordinary circumstances are factors or circumstances that indicate that a normally categorically excluded action may have a significant environmental effect. If an extraordinary circumstance exists, the Agency Environmental Coordinator, or designated representative, must consult the PHMSA Office of Chief Counsel and Program Offices to confirm whether the use of a CE is appropriate, consistent with 40 CFR 1501.4(b). If the Agency Environmental Coordinator or designated representative; the PHMSA Office of Chief Counsel; or Program Offices determines that use of a CE is inappropriate, the level of NEPA review must be an EA or EIS. Consistent with 40 CFR 1507.3(c)(8), PHMSA must consider circumstances including the following when determining whether extraordinary circumstances exist:</P>
                <P>a. The proposed action is greater in scope or size than those normally covered by the category.</P>
                <P>b. The proposed action may increase the likelihood of a reportable release under the Hazardous Materials Regulations (49 CFR parts 171-180) or Pipeline Safety Regulations (49 CFR parts 190-199).</P>
                <P>c. The proposed action may be inconsistent with or cause a violation of a federal, state, local, or Tribal law or requirement.</P>
                <P>d. The proposed action may result in a substantial increase in greenhouse gas emissions.</P>
                <P>e. The proposed action may have disproportionate and adverse effects on communities with environmental justice concerns as defined at 40 CFR 1508.1(f).</P>
                <P>f. The proposed action may have an adverse effect on an environmentally sensitive resource. Environmentally sensitive resources include, but are not limited to:</P>
                <P>1. Wildlife or waterfowl refuges, historic sites, public parks, or other protected properties under section 4(f) of the U.S. Department of Transportation Act (49 U.S.C. 303) or section 6(f) of the Land and Water Conservation Fund Act of 1965 (54 U.S.C. 200305(f)(3)).</P>
                <P>2. Historic, architectural, archeological, or cultural resources subject to section 106 of the National Historic Preservation Act of 1966 (54 U.S.C. 306108) or the Archeological and Historic Preservation Act of 1974 (54 U.S.C. Ch. 3125).</P>
                <P>
                    3. Farmland protected under the Farmland Protection Policy Act (7 U.S.C. 4201 
                    <E T="03">et seq.</E>
                    ). In this context, a potential adverse effect would involve the acquisition and irreversible conversion of non-urban land to non-agricultural uses.
                </P>
                <P>
                    4. Threatened or endangered species or their habitat, as defined under the Endangered Species Act (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <P>5. Wetlands, as defined in Executive Order 11990, Protection of Wetlands, and DOT Order 5660.1A.</P>
                <P>6. Floodplains, as defined in Executive Order 11988, Floodplain Management, as amended by Executive Order 13690, and DOT Order 5650.2. PHMSA's compliance with these Orders will inform its extraordinary circumstances analysis.</P>
                <P>7. State coastal zones, as defined by state coastal zone management programs, or undeveloped coastal barriers along the Atlantic or Gulf Coasts.</P>
                <P>8. Wild and scenic rivers in the National Inventory.</P>
                <P>
                    ii. Compliance with other statutes such as the National Historic Preservation Act of 1966, Archeological and Historic Preservation Act of 1974, 
                    <PRTPAGE P="99333"/>
                    and the Endangered Species Act is separate from, and not displaced by, compliance with NEPA and these procedures. PHMSA will develop Standard Operating Procedures describing the necessary processes to comply with these statutes.
                </P>
                <HD SOURCE="HD2">Section 6: Procedures: Public and Governmental Engagement</HD>
                <P>i. The Agency Environmental Coordinator must ensure that PHMSA provides the appropriate level of public and governmental engagement consistent with 40 CFR 1501.9 and other laws and regulations, regardless of the level of NEPA review. PHMSA must carry out public and governmental engagement in accordance with NEPA and must coordinate these efforts with other PHMSA public involvement opportunities when practicable.</P>
                <P>ii. PHMSA must identify the potentially affected Federal, State, Tribal, and local governments and invite them to serve as cooperating agencies as early as practicable and as appropriate. PHSMA must also ensure that participating agencies have opportunities to provide input on the proposed action and engage in the environmental review process, as appropriate.</P>
                <P>
                    iii. Interested persons may obtain information or status reports on EISs, EAs, and other elements of the NEPA process by contacting PHMSA's Agency Environmental Coordinator (PHMSA Office of Planning and Analytics). 
                    <E T="03">See</E>
                     40 CFR 1507.3(c)(11).
                </P>
                <P>iv. Regulatory Actions. PHMSA promulgates regulations to advance the safe transportation of hazardous materials in all modes, including the Hazardous Materials Regulations (49 CFR parts 171-180) and the Pipeline Safety Regulations (49 CFR parts 190-199). PHMSA does not site, permit, or authorize transportation infrastructure. PHMSA's regulatory standards are intended to reduce the likelihood of a release of hazardous materials into the human environment during transportation. Consistent with 40 CFR 1507.3(c)(2), PHMSA must ensure that relevant environmental documents, comments, and responses will be part of the record in rulemaking proceedings.</P>
                <P>
                    a. PHMSA must notify the public of the availability of Draft EAs and DEISs for regulatory actions subject to public notice and comment, to solicit public comment. PHMSA may publish the Draft EA in the “Regulatory Notices and Analyses” section of a Notice of Proposed Rulemaking or supplemental Notice of Proposed Rulemaking, or as a standalone document in the docket for the rulemaking action, found at 
                    <E T="03">www.regulations.gov</E>
                     (in which case PHMSA must include a citation to the docket in the “Regulatory Notices and Analyses” section). Absent special circumstances, PHMSA must allow at least 30 days for comment on Draft EAs and DEISs. PHMSA may consider longer comment periods for particularly complex proposals or when otherwise appropriate.
                </P>
                <P>b. The Agency Environmental Coordinator may determine public engagement for PHMSA CEs on a case-by-case basis.</P>
                <P>
                    c. If the Agency Environmental Coordinator or their designee determines that a proposed action requires preparation of an EIS, PHMSA must alert the public of its intent to prepare an EIS by publishing a Notice of Intent (NOI) in the 
                    <E T="04">Federal Register</E>
                    . The Associate Administrator for the Office of Planning and Analytics must approve the NOI prior to publication.
                </P>
                <P>d. Consistent with the CEQ Regulations, PHMSA must publish a DEIS for public review for a minimum of 45 days.</P>
                <P>e. PHMSA must consider public comments and address them in the EA and FONSI or the FEIS.</P>
                <P>
                    v. Special Permits. Special permits and associated environmental documents are posted in the 
                    <E T="04">Federal Register</E>
                     and available at 
                    <E T="03">www.Regulations.gov.</E>
                     A special permit, or regulatory waiver, is an order by which PHMSA waives compliance with one or more of the requirements in the hazardous material regulations (49 CFR parts 171-180) or pipeline safety regulations (49 CFR parts 190-199), subject to conditions set forth in the permit.
                </P>
                <P>a. PHMSA must provide the public with a 30-day opportunity to comment on EAs. For particularly complex proposals, PHMSA may extend the minimum comment periods established in these procedures.</P>
                <P>b. PHMSA must make FONSIs publicly available on PHMSA's website.</P>
                <P>c. The Agency Environmental Coordinator must ensure that PHMSA provides the appropriate level of public and governmental engagement consistent with 40 CFR 1501.9 and other laws and regulations, regardless of the level of NEPA review.</P>
                <P>
                    d. If PHMSA determines the action requires an EIS, PHMSA must alert the public of its intent to prepare an EIS by publishing an NOI consistent with 40 CFR 1502.4(e) in the 
                    <E T="04">Federal Register</E>
                    . The Associate Administrator for the Office of Planning and Analytics must approve NOIs prior to publication.
                </P>
                <P>e. Consistent with CEQ regulations, PHMSA must publish a DEIS for public review for a minimum of 45 days.</P>
                <P>f. For these actions, PHMSA must consider public comments and address substantive comments in the EA and FONSIs, or FEIS and RODs.</P>
                <P>vi. Natural Gas Distribution Grants. For pipeline or related site-specific construction projects, PHMSA must notify the public of the availability of EAs and DEISs on PHMSA's website. PHMSA must solicit public comment on Draft EAs and DEISs. PHMSA must also make these documents available in a location that is locally accessible to where the proposed action is located.</P>
                <P>a. PHMSA must evaluate grant projects on a case-by-case basis to determine the appropriate level of outreach, notification, and coordination consistent with 40 CFR 1501.9(c).</P>
                <P>b. PHMSA must provide the public with a 30-day opportunity to comment on draft EAs. For particularly complex proposals, PHMSA may extend the minimum comment periods established in these procedures.</P>
                <P>c. PHMSA must make FONSIs publicly available on PHMSA's website.</P>
                <P>
                    d. If the action requires an EIS, PHMSA must alert the public of its intent to prepare an EIS by publishing an NOI consistent with 40 CFR 1502.4(e) in the 
                    <E T="04">Federal Register</E>
                    . The Associate Administrator for the Office of Planning and Analytics must approve NOIs prior to publication.
                </P>
                <P>e. Consistent with CEQ regulations, PHMSA must publish a DEIS for public review for a minimum of 45 days.</P>
                <P>f. For these actions, PHMSA must consider public comments and address substantive comments in the EA and FONSIs, or FEIS and RODs.</P>
                <HD SOURCE="HD2">Section 7: Procedures: Emergency Circumstances</HD>
                <P>
                    In emergency circumstances (such as life threatening natural or human-caused disasters), where it is necessary to take an action that is likely to have a significant environmental effect, it may not be possible for PHMSA to follow the NEPA implementing procedures outlined in this document. CEQ regulations regarding emergencies permit federal agencies to consult with CEQ to discuss alternative arrangements. 
                    <E T="03">See</E>
                     40 CFR 1506.11.
                </P>
                <P>
                    When the expected environmental effects of the proposed action are unlikely to be significant and the action cannot be categorically excluded, PHMSA must prepare a focused EA in compliance with PHMSA's NEPA implementing procedures and consistent with CEQ regulations as soon as practicable. Requests for alternative 
                    <PRTPAGE P="99334"/>
                    arrangements from PHMSA Program Offices or applicant due to emergency circumstances must be referred to the Agency Environmental Coordinator for evaluation.
                </P>
                <P>Alternative arrangements for such actions should focus on minimizing adverse environmental effects of the PHMSA action and the emergency. To the maximum extent practicable, the alternative arrangements should include the interagency coordination, and public and governmental engagement, that would normally be undertaken for an EA. The alternative arrangements may not alter the requirements of the CEQ regulations regarding EAs, but the level of evidence, analysis, and discussion may be limited to what is practicable under the emergency circumstances. The Agency Environmental Coordinator must approve alternative arrangements. Any alternative arrangements must be documented. The Agency Environmental Coordinator must inform CEQ of the alternative arrangement at the earliest opportunity.</P>
                <P>If significant impacts are likely and an EIS would typically be required, the Agency Environmental Coordinator, in consultation with the Program Office and PHMSA Office of Chief Counsel, must consult with CEQ to request alternative arrangements.</P>
                <HD SOURCE="HD2">Section 8: Review of Environmental Documents Prepared by Other Agencies</HD>
                <P>
                    i. The Agency Environmental Coordinator is PHMSA's receiving official for all requests for comment on environmental documents from other agencies or requests to be a cooperating agency on a NEPA project. If a PHMSA official receives such requests from someone other than the Agency Environmental Coordinator, the request must be forwarded promptly to the Agency Environmental Coordinator. The Agency Environmental Coordinator must review all requests, in consultation with Program Managers and the Office of the Chief Counsel, to determine whether PHMSA can provide useful and constructive comments concerning the action involved. All Associate Administrators and other PHMSA officials must cooperate with the Agency Environmental Coordinator in providing comments on a timely basis so that the Agency Environmental Coordinator may respond in a similar manner (
                    <E T="03">see</E>
                     paragraph 9, DOT Order 5610.1C).
                </P>
                <P>ii. The Agency Environmental Coordinator must assess the comments received from Program Managers and prepare a coordinated PHMSA response to the request. Responses must be forwarded to the PHMSA Office of Chief Counsel, Regulatory Affairs Division, and Program Managers for consultation prior to its being forwarded to the Department.</P>
                <HD SOURCE="HD2">Section 9: Periodic Review</HD>
                <P>PHMSA must continue to review its NEPA implementing policies and procedures and, in consultation with CEQ, revise them as necessary to ensure compliance with NEPA. Consistent with 40 CFR 1507.3(c)(9), this review must also include periodic review of PHMSA's CEs at least every 10 years from approval of these procedures or as otherwise required by applicable law, regulations, and policies/procedures.</P>
                <HD SOURCE="HD1">Appendix 1. Categorical Exclusions Summary</HD>
                <HD SOURCE="HD2">A. Categorical Exclusions Requiring No Further Documentation</HD>
                <P>(1) Equipment acquisition (including purchase or lease) of handheld and mobile methane detection equipment and associated vehicles.</P>
                <HD SOURCE="HD2">B. Categorical Exclusions Requiring Documentation (Documented CEs)</HD>
                <P>(1) Granting, renewing, or denying a special permit related to waiving class location or odorization requirements, following the procedures set forth in 49 CFR 190.341, including the identification of any enforceable conditions, imposed pursuant to 49 CFR 190.341(d)(2), that are required to prevent and address pipeline safety and environmental risk.</P>
                <P>(2) Rulemaking actions by the Office of Hazardous Materials Safety, other than deregulatory rulemaking actions, within one of the following categories:</P>
                <P>(a) policies, directives, regulations, and guidelines that are of an administrative, financial, legal, technical, or procedural nature;</P>
                <P>(b) regulations designating, defining, or classifying regulated materials (hazardous materials, hazardous substances, hazardous wastes, marine pollutants, elevated temperature materials, materials designated as hazardous in the Hazardous Materials Table (49 CFR 172.101), and materials that meet the defining criteria for hazard classes and divisions in 49 CFR part 173);</P>
                <P>(c) regulations imposing requirements on transportation of regulated materials, including shipping papers, marking, labeling, placarding, emergency response information, training, and safety and security plans;</P>
                <P>(d) regulations concerning stowage and segregation of regulated materials in transportation, including rail car, portable tank, and cargo tank placement; loading, unloading, transportation, and storage of regulated materials by mode (rail, aircraft, vessel, and highway); revising standards for bulk and non-bulk packages (cylinders, portable tanks, cargo tanks, radioactive packages, intermediate bulk containers, drums, jerricans, boxes, and composite packagings, etc.); or incident reporting or tracking of regulated movements;</P>
                <P>(e) editorial or technical revisions and clarifications to correct editorial errors and improve clarity; and</P>
                <P>(f) training, testing, and qualification of regulated materials personnel.</P>
                <P>(3) Rulemaking actions by the Office of Pipeline Safety, other than deregulatory rulemaking actions, within one of the following categories:</P>
                <P>(a) policies, directives, regulations, and guidelines that are of an administrative, financial, legal, technical, or procedural nature;</P>
                <P>(b) regulations concerning corrosion control; training, testing, and qualification of operator personnel; or emergency response;</P>
                <P>(c) editorial or technical revisions and clarifications to correct editorial errors and improve clarity; and</P>
                <P>(d) revisions to civil penalty amounts that may be imposed for violations of certain DOT regulations.</P>
                <P>(4) Repair, rehabilitation, or replacement of natural gas distribution pipelines and associated equipment within existing rights-of-way or easements. Associated actions include replacement of service lines, meters, metering stations, valves, taps, abandonment in place or abandonment by removal, minor excavation, replacement of pavement of existing roadway and/or sidewalks, and relocation within existing rights-of-way or easements. Actions will follow the applicable safety standards and requirements described at 49 CFR part 192.</P>
                <SIG>
                    <DATED>Issued in Washington, DC, on December 4, 2024 under authority delegated in 49 CFR 1.81.</DATED>
                    <NAME>Tristan H. Brown,</NAME>
                    <TITLE>Deputy Administrator, Pipeline and Hazardous Materials Safety Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28899 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-60-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="99335"/>
                <AGENCY TYPE="N">DEPARTMENT OF VETERANS AFFAIRS</AGENCY>
                <DEPDOC>[OMB Control No. 2900-0156]</DEPDOC>
                <SUBJECT>Agency Information Collection Activity: Notice of Change in Student Status</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Veterans Benefits Administration, Department of Veterans Affairs.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the 
                        <E T="04">Federal Register</E>
                         concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to the notice. 
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments must be submitted through 
                        <E T="03">www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        <E T="03">Program-Specific information:</E>
                         Nancy Kessinger, 202-632-8924, 
                        <E T="03">nancy.kessinger@va.gov.</E>
                    </P>
                    <P>
                        <E T="03">VA PRA information:</E>
                         Maribel Aponte, 202-461-8900, 
                        <E T="03">vacopaperworkreduact@va.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.</P>
                <P>With respect to the following collection of information, VBA invites comments on:  (1) whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.</P>
                <P>
                    <E T="03">Title:</E>
                     Notice of Change in Student Status, VA Form 22-1999b.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2900-0156. 
                    <E T="03">https://www.reginfo.gov/public/do/PRASearch</E>
                     (Once at this link, you can enter the OMB Control Number to find the historical versions of this Information Collection).
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The VA uses the information collected to determine whether the beneficiaries' educational benefits should be increased, decreased, or terminated, and the effective date of the change, if applicable. Without this information, VA might underpay or overpay benefits. Information technology is being used to reduce the burden. The VA allows schools to submit the information using the new electronic submission portal, Enrollment Manager. This system replaced the previously used VA Online Certification of Enrollment (VA-ONCE). Ninety-five percent of the enrollment certifications received are submitted electronically.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals and Households.
                </P>
                <P>
                    <E T="03">Estimated Annual Burden:</E>
                     132,028 hours.
                </P>
                <P>
                    <E T="03">Estimated Average Burden per Respondent:</E>
                     10 minutes.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     On Occasion.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     792,173.
                </P>
                <AUTH>
                    <HD SOURCE="HED">
                        <E T="03">Authority:</E>
                    </HD>
                    <P>
                         44 U.S.C. 3501 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <NAME>Maribel Aponte,</NAME>
                    <TITLE>VA PRA Clearance Officer, Office of Enterprise and Integration/Data Governance Analytics, Department of Veterans Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28895 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8320-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF VETERANS AFFAIRS</AGENCY>
                <SUBJECT>Privacy Act of 1974; System of Records</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of Veterans Affairs (VA) Veterans Benefits Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of a modified system of records.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Pursuant to the Privacy Act of 1974, notice is hereby given that the Department of Veterans Affairs (VA) is modifying the system of records titled, “Veterans Affairs/Department of Defense Identity Repository (VADIR)-VA” (138VA005Q). This system of records is an electronic repository of military personnel's military history, payroll information and their dependents' data provided to VA by the Department of Defense's Defense Manpower Data Center (DMDC). The VADIR database repository is used in conjunction with other applications across VA business lines to provide an electronic consolidated view of comprehensive eligibility and benefits utilization data from across VA and Department of Defense (DoD). VA applications use the VADIR database to retrieve profile data, military history, and information on benefits, and dependents.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        Comments on this modified system of records must be received no later than January 9, 2025. If no public comment is received during the period allowed for comment or unless otherwise published in the 
                        <E T="04">Federal Register</E>
                         by VA, the modified system of records will become effective a minimum of 30 days after date of publication in the 
                        <E T="04">Federal Register</E>
                        . If VA receives public comments, VA shall review the comments to determine whether any changes to the notice are necessary.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be submitted through 
                        <E T="03">www.Regulations.gov</E>
                         or mailed to VA Privacy Service, 810 Vermont Avenue NW, (005X6F), Washington, DC 20420. Comments should indicate that they are submitted in response to “Veterans Affairs/Department of Defense Identity Repository (VADIR)-VA” (138VA005Q). Comments received will be available at regulations.gov for public viewing, inspection, or copies.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Trisha Dang, Veterans Experience Office, (VEO), Department of Veterans Affairs, 810 Vermont Ave. NW, Building 810, Washington, DC 20420; telephone (202) 461-9898; email 
                        <E T="03">trisha.dang@va.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    VA has updated the System Manager to reflect “Alexander Torres, Project Manager, Department of Veterans Affairs, OIT/Product Engineering/Data&amp;Analytics, 810 Vermont Ave. NW, Building 810, Washington, DC 20420, email: 
                    <E T="03">vavadirsupportteam@va.gov,</E>
                     telephone number (470) 364-4797.”
                </P>
                <P>
                    VA has also updated the Categories of Records to reflect: “The record, or information contained in the record, may include identifying information (
                    <E T="03">e.g.,</E>
                     name, contact information, Social Security number), association to dependents, cross reference to other names used, military service participation and status information (branch of service, rank, enter on duty date, release from active duty date, military occupations, type of duty, character of service, awards), reason and nature of active duty separation (completion of commitment, etc.), combat pay, combat awards, theater location, combat deployments (period of 
                    <PRTPAGE P="99336"/>
                    deployment, location/country), Guard/Reserve activations (period of activation, type of activation), education benefit participation, Transfer of Eligibility (TOE) of educational benefits to dependents, group life insurance participation, survivor pay, disability pay, separation pay, military retirement pay, and medals and awards.”
                </P>
                <HD SOURCE="HD1">Signing Authority</HD>
                <P>The Senior Agency Official for Privacy, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Kurt D. DelBene, Assistant Secretary for Information and Technology and Chief Information Officer, approved this document on October 31, 2024 for publication.</P>
                <SIG>
                    <DATED>Dated: December 5, 2024.</DATED>
                    <NAME>Amy L. Rose,</NAME>
                    <TITLE>Government Information Specialist, VA Privacy Service, Office of Compliance, Risk and Remediation, Office of Information and Technology, Department of Veterans Affairs.</TITLE>
                </SIG>
                <PRIACT>
                    <HD SOURCE="HD2">SYSTEM NAME AND NUMBER:</HD>
                    <P>Veterans Affairs/Department of Defense Identity Repository (VADIR)-VA (138VA005Q).</P>
                    <HD SOURCE="HD2">SECURITY CLASSIFICATION:</HD>
                    <P>Unclassified.</P>
                    <HD SOURCE="HD2">SYSTEM LOCATION:</HD>
                    <P>VADIR is hosted at an OI&amp;T approved VA sponsored data warehouse location via secured cloud storage on a Federal Risk and Authorization Management Program (FedRAMP) certified VA Enterprise Cloud (VAEC).</P>
                    <HD SOURCE="HD2">SYSTEM MANAGER(S):</HD>
                    <P>
                        Alexander Torres, Project Manager, Department of Veterans Affairs, OIT/Product Engineering/Data&amp;Analytics, 810 Vermont Ave. NW, Building 810, Washington, DC 20420, email: 
                        <E T="03">vavadirsupportteam@va.gov,</E>
                         telephone number (470) 364-4797.
                    </P>
                    <HD SOURCE="HD2">AUTHORITY FOR MAINTENANCE OF THE SYSTEM:</HD>
                    <P>38 U.S.C. 5106.</P>
                    <HD SOURCE="HD2">PURPOSE(S) OF THE SYSTEM:</HD>
                    <P>The purpose of VADIR is to receive electronically military personnel and payroll information from the Department of Defense (DoD) in a centralized VA system and then distribute the data to other VA systems and lines of business who require the information for health and benefits eligibility determinations. This information is provided to VADIR by the Defense Manpower Data Center (DMDC). VADIR will also provide veterans information concerning education benefits usage and death, as well as personal and demographic information.</P>
                    <HD SOURCE="HD2">CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:</HD>
                    <P>
                        The category of the individuals covered by the VADIR database encompasses veterans, service members, and their dependents. This would include current service members, separated service members, and their dependents; as well as veterans whose VA military service benefits have been sought by others (
                        <E T="03">e.g.,</E>
                         burial benefits).
                    </P>
                    <HD SOURCE="HD2">CATEGORIES OF RECORDS IN THE SYSTEM:</HD>
                    <P>
                        Records include identifying information (
                        <E T="03">e.g.,</E>
                         name, contact information, Social Security number), association to dependents, cross reference to other names used, military service participation and status information (branch of service, rank, enter on duty date, release from active duty date, military occupations, type of duty, character of service, awards), reason and nature of active duty separation (completion of commitment, etc.), combat pay, combat awards, theater location, combat deployments (period of deployment, location/country), Guard/Reserve activations (period of activation, type of activation), education benefit participation, Transfer of Eligibility (TOE) of educational benefits to dependents, group life insurance participation, survivor pay, disability pay, separation pay, military retirement pay, and medals and awards.
                    </P>
                    <HD SOURCE="HD2">RECORD SOURCE CATEGORIES:</HD>
                    <P>Information in this system of records is provided by components of the Department of Defense.</P>
                    <HD SOURCE="HD2">ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND PURPOSES OF SUCH USES:</HD>
                    <HD SOURCE="HD1">1. Congress</HD>
                    <P>To a Member of Congress or staff acting upon the Member's behalf when the Member or staff requests the information on behalf of, and at the request of, the individual who is the subject of the record.</P>
                    <HD SOURCE="HD1">2. Data Breach Response and Remediation, for VA</HD>
                    <P>To appropriate agencies, entities, and persons when (a) VA suspects or has confirmed that there has been a breach of the system of records, (b) VA has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, VA (including its information systems, programs, and operations), the Federal Government, or national security; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with VA's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.</P>
                    <HD SOURCE="HD1">3. Data Breach Response and Remediation, for Another Federal Agency</HD>
                    <P>To another Federal agency or Federal entity, when VA determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (a) responding to a suspected or confirmed breach or (b) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.</P>
                    <HD SOURCE="HD1">4. Law Enforcement</HD>
                    <P>To a Federal, State, local, territorial, Tribal, or foreign law enforcement authority or other appropriate entity charged with the responsibility of investigating or prosecuting a violation or potential violation of law, whether civil, criminal, or regulatory in nature, or charged with enforcing or implementing such law, provided that the disclosure is limited to information that, either alone or in conjunction with other information, indicates such a violation or potential violation. The disclosure of the names and addresses of veterans and their dependents from VA records under this routine use must also comply with the provisions of 38 U.S.C. 5701.</P>
                    <HD SOURCE="HD1">5. DoJ, Litigation, Administrative Proceeding</HD>
                    <P>To the Department of Justice (DoJ), or in a proceeding before a court, adjudicative body, or other administrative body before which VA is authorized to appear, when:</P>
                    <P>(a) VA or any component thereof;</P>
                    <P>(b) Any VA employee in his or her official capacity;</P>
                    <P>(c) Any VA employee in his or her individual capacity where DoJ has agreed to represent the employee; or</P>
                    <P>
                        (d) The United States, where VA determines that litigation is likely to affect the agency or any of its components is a party to such proceedings or has an interest in such proceedings, and VA determines that use of such records is relevant and necessary to the proceedings.
                        <PRTPAGE P="99337"/>
                    </P>
                    <HD SOURCE="HD1">6. Contractors</HD>
                    <P>To contractors, grantees, experts, consultants, students, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for VA, when reasonably necessary to accomplish an agency function related to the records.</P>
                    <HD SOURCE="HD1">7. NARA</HD>
                    <P>To the National Archives and Records Administration (NARA) in records management inspections conducted under 44 U.S.C. 2904 and 2906, or other functions authorized by laws and policies governing NARA operations and VA records management responsibilities.</P>
                    <HD SOURCE="HD1">8. Department of Defense</HD>
                    <P>To DoD systems or offices for use in connection with matters relating to one of DoD's programs to enable delivery of healthcare or other DoD benefits to eligible beneficiaries.</P>
                    <HD SOURCE="HD1">9. Department of Defense Manpower Data Center (DMDC)</HD>
                    <P>To the Department of Defense Manpower Data Center (DMDC) to reconcile the amount and/or waiver of service, department and retired pay, provided that information disclosed is the name, address, VA file number, service information, date of birth, incarceration status, and social security number of veterans and their surviving spouses</P>
                    <HD SOURCE="HD1">10. Department of Defense Enrollment Eligibility Reporting System (DEERS)</HD>
                    <P>To DoD, to identify retired veterans and dependent members of their families who have entitlement to DoD benefits but who are not identified in the Department of Defense Enrollment Eligibility Reporting System (DEERS) program and to assist in determining eligibility for Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) benefits, provided that information disclosed is the name, address, VA file number, date of birth, date of death, social security number, and service information. This purpose is consistent with 38 U.S.C. 5701.</P>
                    <HD SOURCE="HD1">11. Federal Agencies, for Research</HD>
                    <P>To a Federal agency for the purpose of conducting research and data analysis to perform a statutory purpose of that Federal agency upon the prior written request of that agency.</P>
                    <HD SOURCE="HD1">12. Nonprofits, for RONA</HD>
                    <P>To a nonprofit organization if the release is directly connected with the conduct of programs and the utilization of benefits under title 38, provided that the disclosure is limited the names and addresses of present or former members of the armed services or their beneficiaries, the records will not be used for any purpose other than that stated in the request, and the organization is aware of the penalty provision of 38 U.S.C. 5701(f).</P>
                    <HD SOURCE="HD1">13. Federal Agencies, for Computer Matches</HD>
                    <P>To other Federal agencies in accordance with a computer matching program to determine or verify eligibility of veterans receiving VA benefits or medical care under title 38.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR STORAGE OF RECORDS:</HD>
                    <P>Records are transmitted between DMDC and VA over a dedicated telecommunications circuit using approved encryption technologies. Records (or information contained in records) are maintained in electronic format in the VADIR Oracle database. These records cannot be directly accessed by any VA employee or other users. Information from VADIR is disseminated in three ways: (1) Approved VA systems electronically request and receive data from VADIR, (2) data is replicated via secure link between VADIR and DMDC, and (3) periodic electronic data extracts of subsets of information contained in VADIR are provided to approved VA offices/systems. Backups of VADIR data are created regularly and stored in a secure undisclosed off-site facility.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:</HD>
                    <P>Records are retrieved using various unique identifiers belonging to the individual to whom the information pertains to include such identifiers as name, claim file number, social security number and date of birth.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:</HD>
                    <P>
                        Records in this system are retained indefinitely until a records retention schedule is approved by the Archivist of the United States. The records control for the VDR system hardware and user logs is GRS 4.2: Information Access and Protection Records Item 130 located 
                        <E T="03">www.archives.gov/records-mgmt/grs.html.</E>
                    </P>
                    <HD SOURCE="HD2">ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:</HD>
                    <P>
                        <E T="03">Physical Security:</E>
                         The primary VADIR system is located in an undisclosed location for security purposes. Access to data processing centers is generally restricted to VA employees, VADIR custodial personnel, Federal Protective Service, and other security personnel. Access to computer rooms is restricted AWS staff.
                    </P>
                    <P>
                        <E T="03">System Security:</E>
                         Access to the VA network is protected by the usage of two factor authentication. Once on the VA network, two factor authentication is required to gain access to the VADIR server and/or database. Access to the server and/or database is granted to only a limited number of system administrators and database administrators approved by the System Manager. In addition, VADIR has undergone assessment and authorization based on a risk assessment that followed National Institute of Standards and Technology Vulnerability and Threat Guidelines. The system is considered stable and operational and a final Authority to Operate (ATO) has been granted and is updated annually. The system was found to be operationally secure, with very few exceptions or recommendations for change.
                    </P>
                    <HD SOURCE="HD2">RECORD ACCESS PROCEDURES:</HD>
                    <P>Individuals seeking information on the existence and content of records in this system pertaining to them should contact the VA Privacy Service, 810 Vermont Avenue NW, (005X6F), Washington, DC 20420, in writing as indicated above. The VA Privacy Officer will route the request to the System Manager. A request for access to records must contain the requester's full name, address, telephone number, be signed by the requester, include copy of government issued ID for verification, and describe the records sought in sufficient detail to enable VA personnel to locate them.</P>
                    <HD SOURCE="HD2">CONTESTING RECORD PROCEDURES:</HD>
                    <P>
                        Individuals seeking to contest or amend records in this system pertaining to them should contact the system manager in writing as indicated above. A request to contest or amend records must state clearly and concisely what record is being contested, the reasons for contesting it, and the proposed amendment to the record. Additionally, to the extent that information contested is identified as data provided by DMDC, which is part of the Defense Logistics Agency (DLA), the DLA rules for accessing records, for contesting contents, and appealing initial agency determinations are contained in 32 CFR part 323, or may be obtained from the Privacy Act Officer, Headquarters, Defense Logistics Agency, ATTN: DES-B, 8725 John J. Kingman Road, Stop 6220, Fort Belvoir, VA 22060-6221.
                        <PRTPAGE P="99338"/>
                    </P>
                    <HD SOURCE="HD2">NOTIFICATION PROCEDURES:</HD>
                    <P>Generalized notice is provided by the publication of this notice. For specific notice, see Record Access Procedure, above.</P>
                    <HD SOURCE="HD2">EXEMPTIONS PROMULGATED FOR THE SYSTEM:</HD>
                    <P>None.</P>
                    <HD SOURCE="HD2">HISTORY:</HD>
                    <P>74 FR 37093 (July 27, 2009); 87 FR 79066 (December 23, 2022).</P>
                </PRIACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-28959 Filed 12-9-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8320-01-P</BILCOD>
        </NOTICE>
    </NOTICES>
    <VOL>89</VOL>
    <NO>237</NO>
    <DATE>Tuesday, December 10, 2024</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="99339"/>
            <PARTNO>Part II </PARTNO>
            <AGENCY TYPE="P">Department of Health and Human Services</AGENCY>
            <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
            <HRULE/>
            <CFR>42 CFR Parts 417, 422, et al.</CFR>
            <TITLE>Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly; Proposed Rule</TITLE>
        </PTITLE>
        <PRORULES>
            <PRORULE>
                <PREAMB>
                    <PRTPAGE P="99340"/>
                    <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                    <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
                    <CFR>42 CFR Parts 417, 422, 423, and 460</CFR>
                    <DEPDOC>[CMS-4208-P]</DEPDOC>
                    <RIN>RIN 0938-AV40</RIN>
                    <SUBJECT>Medicare and Medicaid Programs; Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Centers for Medicare &amp; Medicaid Services (CMS), Department of Health and Human Services (HHS).</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Proposed rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicaid, Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, drug coverage, dual eligible special needs plans (D-SNPs), utilization management, network adequacy, and other programmatic areas, including the Medicare Drug Price Negotiation Program. This proposed rule also includes proposals to codify existing subregulatory guidance in the Part C and Part D programs.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Time on January 27, 2025.</P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>In commenting, please refer to file code CMS-4208-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):</P>
                        <P>
                            1. 
                            <E T="03">Electronically.</E>
                             You may submit electronic comments on this regulation to 
                            <E T="03">http://www.regulations.gov.</E>
                             Follow the “Submit a comment” instructions.
                        </P>
                        <P>
                            2. 
                            <E T="03">By regular mail.</E>
                             You may mail written comments to the following address ONLY: Centers for Medicare &amp; Medicaid Services, Department of Health and Human Services, Attention: CMS-4208-P, P.O. Box 8013, Baltimore, MD 21244-8013.
                        </P>
                        <P>Please allow sufficient time for mailed comments to be received before the close of the comment period.</P>
                        <P>
                            3. 
                            <E T="03">By express or overnight mail.</E>
                             You may send written comments to the following address ONLY: Centers for Medicare &amp; Medicaid Services, Department of Health and Human Services, Attention: CMS-4208-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
                        </P>
                        <P>
                            For information on viewing public comments, see the beginning of the 
                            <E T="02">SUPPLEMENTARY INFORMATION</E>
                             section.
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P/>
                        <P>Matthania Volmy, (667) 290-8662—General Questions.</P>
                        <P>Naseem Tarmohamed, (410) 786-0814—Part C and Cost Plan Issues.</P>
                        <P>Matthania Volmy, (667) 290-8662—Part D Issues.</P>
                        <P>Kristy Nishimoto, (206) 615-2367—Beneficiary Enrollment and Appeal Issues.</P>
                        <P>Alissa Stoneking, (410) 786-1120—Parts C and D Payment Issues.</P>
                        <P>Hunter Coohill, (720) 853-2804—Enforcement Issues.</P>
                        <P>Lauren Brandow, (410) 786-9765—PACE Issues.</P>
                        <P>Sara Klotz, (410) 786-1984—D-SNP Issues.</P>
                        <P>
                            <E T="03">PartCandDStarRatings@cms.hhs.gov</E>
                            —Parts C and D Star Ratings Issues.
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <P/>
                    <P>
                        <E T="03">Inspection of Public Comments:</E>
                         All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the search instructions on that website to view public comments. CMS will not post on 
                        <E T="03">Regulations.gov</E>
                         public comments that make threats to individuals or institutions or suggest that the commenter will take actions to harm an individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.
                    </P>
                    <P>
                        <E T="03">Plain Language Summary:</E>
                         In accordance with 5 U.S.C. 553(b)(4), a plain language summary of this proposed rule may be found at 
                        <E T="03">https://www.regulations.gov/.</E>
                    </P>
                    <HD SOURCE="HD1">I. Executive Summary</HD>
                    <HD SOURCE="HD2">A. Purpose</HD>
                    <P>The primary purpose of this proposed rule is to amend the regulations for the Medicare Advantage (Part C) program, Medicare Prescription Drug Benefit (Part D) program, Medicaid program, Medicare cost plan program, and Programs of All-Inclusive Care for the Elderly (PACE). This proposed rule includes a number of new policies that would improve these programs for contract year 2026 as well as codify existing Part C and Part D subregulatory guidance.</P>
                    <P>We note that, as with previous rules, the new marketing and communications policies in this rule are proposed to be applicable for all contract year 2026 marketing and communications, beginning October 1, 2025. However, to operationalize the proposed Format Provider Directories for Medicare Plan Finder provision at § 422.111(m), we anticipate that 2025 plan year directory data will need to be made available online for testing purposes in the summer of 2025, and 2026 plan year data would need to be available online on October 1, 2026. Therefore, we propose an applicability date of July 1, 2025, for this provision.</P>
                    <HD SOURCE="HD2">B. Summary of the Key Provisions</HD>
                    <HD SOURCE="HD3">1. Vaccine Cost Sharing Changes</HD>
                    <P>This proposal would implement section 11401 of the Inflation Reduction Act of 2022 (IRA), which amends section 1860D-2 of the Act to require that, effective for plan years beginning on or after January 1, 2023, the Medicare Part D deductible shall not apply to, and there is no cost-sharing for, an adult vaccine recommended by the Advisory Committee on Immunization Practices (ACIP) covered under Part D.</P>
                    <HD SOURCE="HD3">2. Insulin Cost Sharing Changes</HD>
                    <P>
                        This proposal would implement section 11406 of the IRA, which amends section 1860D-2 of the Act to require that, effective for plan years beginning on or after January 1, 2023, the Medicare Part D deductible shall not apply to covered insulin products, and the Part D cost-sharing amount for a one-month supply of each covered insulin product must not exceed the statutorily defined “applicable copayment amount” for all enrollees. The applicable copayment amount for 2023, 2024, and 2025 is $35. For 2026 and each subsequent year, in accordance with the statute, we are proposing that, with respect to a covered insulin product covered under a prescription drug plan (PDP) or a Medicare Advantage prescription drug 
                        <PRTPAGE P="99341"/>
                        (MA-PD) plan prior to an enrollee reaching the annual out-of-pocket threshold, the “covered insulin product applicable cost-sharing amount” is the lesser of—
                    </P>
                    <P>• $35;</P>
                    <P>• An amount equal to 25 percent of the maximum fair price established for the covered insulin product in accordance with Part E of subchapter XI; or</P>
                    <P>• An amount equal to 25 percent of the negotiated price, as defined in § 423.100, of the covered insulin product under the PDP or MA-PD plan.</P>
                    <HD SOURCE="HD3">3. Medicare Prescription Payment Plan</HD>
                    <P>We propose regulatory changes to codify agency guidance implementing section 11202 of the IRA, which establishes the Medicare Prescription Payment Plan and requires each PDP sponsor offering a prescription drug plan and each MA organization offering an MA-PD plan to provide to any enrollee of such plan, including an enrollee who is subsidy eligible, the option to elect with respect to a plan year to pay cost-sharing under the plan in monthly amounts that are capped. Specifically, we propose to add new § 423.137, add several new Part D required materials and content at § 423.2267, add Medicare Prescription Payment Plan information to the list of required content for Part D sponsor websites at § 423.2265, and add the Medicare Prescription Payment Plan to the list of Part D requirements waived for the Limited Income Newly Eligible Transition (LI NET) program at § 423.2536.</P>
                    <HD SOURCE="HD3">4. Part D Coverage of Anti-Obesity Medications (§ 423.100) and Application to the Medicaid Program</HD>
                    <P>The statutory definition of a covered Part D drug at section 1860D-2(e)(2) of the Social Security Act (the Act) excludes certain drugs and uses—specifically, those that may be excluded by Medicaid under section 1927(d)(2) of the Act. This includes, at section 1927(d)(2)(A) of the Act, “agents when used for anorexia, weight loss, or weight gain.” Historically, drugs used for weight loss have been excluded from the definition of covered Part D drug, regardless of their use for treatment of individuals with obesity, and have been an optional drug benefit for Medicaid programs. Increases in the prevalence of obesity in the United States and changes in the prevailing medical consensus towards recognizing obesity as a disease since the beginning of the Part D program in 2006 have compelled CMS to re-evaluate Part D coverage of anti-obesity medications (AOMs) for Medicare Part D enrollees with obesity where the drug's prescribed use is not for a medically accepted indication (MAI) that is currently covered under Part D. We are proposing to reinterpret the statutory exclusion of agents when used for weight loss to allow Part D coverage of AOMs when used to treat obesity by reducing excess body weight or maintaining weight reduction long-term for individuals with obesity who do not have another condition for which the prescribed use is an MAI that is covered under the current Part D policy. The proposed reinterpretation would also apply to the Medicaid program. Thus, AOMs could not be excluded from Medicaid coverage under this interpretation when used for weight loss or chronic weight management for the treatment of obesity. Coverage of AOMs and drugs that contain the same active ingredient as AOMs that meet the definition of a covered outpatient drug are already subject to section 1927 requirements when used for an indication, other than weight loss, that is an MAI, and Medicaid must cover those products when they are medically necessary. Under our proposed reinterpretation, AOMs approved for weight loss and chronic weight management that are used for weight loss in individuals who do not have obesity or another condition that is an MAI for the AOM would remain excluded from the definition of covered Part D drug and would remain optional benefit for Medicaid programs.</P>
                    <HD SOURCE="HD3">5. Promoting Informed Choice—Format Provider Directories for Medicare Plan Finder</HD>
                    <P>We are proposing to require MA provider directory data, as required under § 422.111(b)(3)(i) be submitted for use to populate Medicare Plan Finder (MPF). In addition, we are proposing to require MA organizations to attest that this information is accurate and consistent with data submitted to comply with CMS's MA network adequacy requirements at § 422.116(a)(1)(i) when it is submitted to CMS for the purpose of incorporating into MPF. The proposed regulatory changes would further promote informed beneficiary choice and transparency found in online resources, empowering people with Medicare to make informed choices about their coverage. In addition, the proposal will help ensure that provider directory information, including the provider's cultural and linguistic capabilities, which are currently required for MA provider directories, and are especially important to underserved communities, will be more readily available when considering an MA plan.</P>
                    <HD SOURCE="HD3">6. Promoting Informed Choice—Expand Agent and Broker Requirements Regarding Medicare Savings Programs, Extra Help, and Medigap</HD>
                    <P>To ensure beneficiaries are well informed about and have an accurate picture of their MA and Part D enrollment options, we are also proposing to add the following topics to the existing list of requirements that agents and brokers must discuss with their customers: the availability of low-income supports including the Part D Low-Income Subsidy (also known as “Extra Help”) and Medicare Savings Programs; for beneficiaries enrolling into MA when first eligible for Medicare or dropping a Medigap plan to enroll in an MA plan for the first time, general information on Medigap Federal guaranteed issue (GI) rights, the practical implications of switching from Medicare Advantage to Traditional Medicare, and, when applicable, provide information on state laws regarding Medigap GI rights for those states where the agent or broker is licensed and appointed to sell; and requiring that agents pause to address remaining questions the beneficiary may have related to enrollment in a plan prior to moving forward with an enrollment. As Medicare enrollees consider their coverage options, it is essential that agents and brokers provide adequate information to ensure beneficiaries can make fully informed choices, both to support enrollees and promote a functioning, competitive marketplace.</P>
                    <HD SOURCE="HD3">7. Promoting Informed Choice—Enhancing Review of Marketing and Communications</HD>
                    <P>
                        We are proposing to broaden the marketing definition in §§ 422.2260 and 423.2260, in order to expand CMS oversight of Medicare Advantage and Part D communications materials and activities and strengthen beneficiary protections against misleading and confusing advertising tactics. Currently, communications materials and activities only fall within the regulatory definition of marketing if they meet certain content and intent standards. To satisfy the content portion of the current regulatory definition of marketing, communications materials and activities must include or address content regarding: (1) the plan's benefits, benefits structure, premiums or cost sharing; (2) measuring or ranking standards (for example, Star Ratings or plan comparisons); or (3), for MA plans only, rewards and incentives as defined 
                        <PRTPAGE P="99342"/>
                        under § 422.134(a). In order to broaden the definition of marketing, CMS is proposing to eliminate this content standard and rely solely on an intent standard to determine whether communications material and activities are considered marketing. Broadening the definition of marketing would expand the scope of materials that must be prospectively submitted to CMS for review, which would allow CMS to better ensure that MA organizations, Part D sponsors, and their downstream entities are not providing misleading, inaccurate, or confusing information to current or potential enrollees, or engaging in activities that could misrepresent the MA organization or Part D sponsor, in accordance with §§ 422.2262 and 423.2262. We are also proposing conforming edits to the definition of “Advertisement (Ad)” in §§ 422.2260 and 423.2260 to align with the proposed updates to the definition of marketing.
                    </P>
                    <HD SOURCE="HD3">8. Promoting Transparency for Pharmacies and Protecting Beneficiaries From Disruptions</HD>
                    <P>We are proposing to require Part D sponsors (or first tier, downstream, or related entities (FDRs), such as pharmacy benefit managers (PBMs), on the sponsors' behalf) to notify network pharmacies which plans the pharmacies will be in-network for in a given plan year by October 1 of the year prior to that plan year and to require sponsors to provide pharmacies a list of these plans to network pharmacies on request after October 1. We are also proposing to require contracts with pharmacies for participation in Part D networks that allow the Part D sponsor or FDR to terminate the contract without cause to also allow pharmacies to terminate the contracts without cause after providing the same notice that the contract requires the sponsor or FDR to provide the pharmacy. We believe these policies will address concerns raised by pharmacies about their ability to provide accurate information to beneficiaries and will help protect beneficiaries from disruptions in care that occur when network pharmacies stop providing services before formally terminating their contracts.</P>
                    <HD SOURCE="HD3">9. Administration of Supplemental Benefits Coverage Through Debit Cards</HD>
                    <P>This provision would codify existing requirements and new protections for supplemental benefits that are administered using debit cards by MA organizations. Specifically, we are proposing to: (1) describe when, how, and in what manner debit cards can be used by an MA organization and enrollee; (2) introduce additional disclosure requirements to increase transparency, including additional disclosure rules around supplemental benefits and plan debit cards (3) further protect access to plan-covered services for MA enrollees by requiring MA organizations to allow an enrollee to receive covered benefits through an alternative process if there is an issue with a plan debit card, (4) ensure debit cards are electronically linked to plan covered items and services through a real-time identification mechanism, and 5) clarify what types of over the counter (OTC) products are acceptable. Finally, we are proposing to prohibit MA organizations from marketing the dollar value of a supplemental benefit or the method by which a supplemental benefit is administered, such as use of a debit card by the enrollee to provide the plan's payment to the provider for the covered item or service.</P>
                    <HD SOURCE="HD3">10. Improving Access—Enhancing Rules on Internal Coverage Criteria</HD>
                    <P>
                        In the final rule titled “Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly,” which appeared in the April 12, 2023, 
                        <E T="04">Federal Register</E>
                         (88 FR 22120) (hereinafter referred to as the “April 2023 final rule”), we codified regulations that clarified the obligations and responsibilities for MA organizations in covering basic benefits and established guardrails for MA organizations to develop and use coverage criteria in a way that aligns with Traditional Medicare. These rules were applicable to coverage for MA organizations beginning January 1, 2024. Through CMS account manager engagement with MA organizations, incoming inquiries from industry stakeholders, and our ongoing 2024 program audits, we have learned a great deal about common misunderstandings related to these new rules. In order to further clarify these rules, we are proposing to build upon and enhance the regulations from the April 2023 final rule, specifically those related to the use of internal coverage criteria, by defining the meaning of “internal coverage criteria,” establishing policy guardrails to ensure access to benefits, and adding more specific rules about publicly posting internal coverage criteria content on MA organization websites.
                    </P>
                    <HD SOURCE="HD3">11. Ensuring Equitable Access to Behavioral Health Benefits Through Section 1876 Cost Plan and MA Cost Sharing Limits (§§ 417.454 and 422.100)</HD>
                    <P>
                        Addressing the nation's behavioral health crisis and ensuring equitable access to behavioral health services are key priorities for CMS.
                        <SU>1</SU>
                        <FTREF/>
                         Beneficiaries with severe mental illness experienced substantial disruptions in care during the COVID-19 pandemic and these disruptions were greater among disadvantaged populations (including historically underserved racial and ethnic groups and low-income populations).
                        <SU>2</SU>
                        <FTREF/>
                         As a result, CMS is pursuing policies to address barriers individuals may face in accessing mental health and substance use disorder care. This includes using the authority under sections 1852(a)(1)(B)(iv), 1856(b)(1), 1857(e)(1), 1876(c)(2)(A), and 1876(i)(3)(D) of the Act to add to the list of Part A and Part B benefits (items and services) for which Medicare Advantage (MA) and Section 1876 Cost Plans' (Cost Plans) in-network cost sharing may not exceed the cost-sharing levels in Traditional Medicare.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             CMS's behavioral health strategy is available at: 
                            <E T="03">https://www.cms.gov/cms-behavioral-health-strategy.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             Busch AB, Huskamp HA, Raja P, Rose S, Mehrotra A. Disruptions in Care for Medicare Beneficiaries with Severe Mental Illness During the COVID-19 Pandemic. JAMA Netw Open. 2022 Jan 4;5(1):e2145677. doi: 10.1001/jamanetworkopen.2021.45677. PMID: 35089352; PMCID: PMC8800078. Retrieved from: 
                            <E T="03">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8800078/.</E>
                        </P>
                    </FTNT>
                    <P>We propose to require MA and Cost Plans' in-network cost sharing for categories of mental health and substance use disorder services (collectively called “behavioral health services”) be no greater than that in Traditional Medicare beginning January 1, 2026.</P>
                    <P>
                        We are proposing behavioral health cost-sharing standards for MA and Cost Plans that strike a balance between: (1) improving the affordability of these services for enrollees in a timely manner; and (2) minimizing disruption to enrollees' access to care and coverage options. We also propose several changes to the cost-sharing regulations for MA and Cost Plans at §§ 417.454 and 422.100. Additionally, we solicit comment on: (1) whether CMS should apply these proposed changes to the behavioral health cost-sharing standards beginning in contract year 2026 or 2027; (2) whether there should be a transition period from the existing contract year 2025 behavioral health cost-sharing standards in current regulations for select service categories (such as, the standards at § 422.100(f)(6)(i), (iii), or 
                        <PRTPAGE P="99343"/>
                        (iv) for MA plans), to the proposed cost-sharing standard; and (3) how long any transition should be. We also solicit comment regarding this behavioral health cost-sharing proposal's potential impact on how MA plans would satisfy existing requirements that cost sharing be actuarially equivalent to Traditional Medicare cost sharing at § 422.100(j)(1) and (2).
                    </P>
                    <HD SOURCE="HD3">12. Improving Experiences for Dually Eligible Enrollees</HD>
                    <P>Dually eligible individuals face fragmentation in many parts of the health care system, including their experiences as enrollees of Medicare and Medicaid managed care plans. One way in which we seek to address such fragmentation is though policies that integrate care for dually eligible individuals. “Integrated care” refers to delivery system and financing approaches that (1) maximize person-centered coordination of Medicare and Medicaid services; (2) mitigate cost-shifting incentives between the two programs; and (3) create a seamless experience for dually eligible individuals. We are proposing to establish new Federal requirements for D-SNPs that are applicable integrated plans to: (1) have integrated member identification (ID) cards that serve as the ID cards for both the Medicare and Medicaid plans in which an enrollee is enrolled; and (2) conduct an integrated health risk assessment (HRA) for Medicare and Medicaid, rather than separate HRAs for each program. We are also proposing to codify timeframes for special needs plans to conduct HRAs and individualized care plans (ICPs) and prioritize the involvement of the enrollee or the enrollee's representative, as applicable, in the development of the ICPs.</P>
                    <HD SOURCE="HD3">13. Medical Loss Ratio (MLR)</HD>
                    <P>To improve medical loss ratio (MLR) reporting and oversight and to better align MA and Part D MLR requirements with commercial MLR and Medicaid MLR requirements, we are proposing to make certain changes to the regulations that govern MLR requirements for MA and Part D. Specifically, we are proposing to establish clinical and quality improvement standards for provider incentives and bonus arrangements included in the MA MLR numerator in order to help align such bonus payments with care outcomes and avoid excess premium transfer to providers. We also propose to prohibit administrative costs from being included in quality improvement activities in both the MA and Part D MLR numerator. Additionally, we propose to adopt additional requirements for the allocation of expenses in the MLR. We also propose to establish new audit and appeals processes for MLR compliance. In addition, we propose to amend the Medicare MLR regulations authorizing the release of Part C and Part D MLR data. We propose to codify the rules we established in the CY 2025 Part D Redesign Program Instructions for the treatment for MLR purposes of Medicare Prescription Payment Plan unsettled balances for 2026 and subsequent years. We also propose to explicitly provide that the Medicare MLR reporting include detailed information regarding provider payment arrangements. In addition to the proposed changes, we are issuing a request for information on potential policies that CMS could adopt regarding how the MA and Part D MLRs are calculated in order to enable policymakers to address concerns surrounding vertical integration in MA and Part D.</P>
                    <HD SOURCE="HD3">14. Medicare Transaction Facilitator Requirements for Network Pharmacy Agreements</HD>
                    <P>We propose to amend § 423.505 by adding paragraph (q) to require that Part D sponsors' network contracts with pharmacies require such pharmacies to be enrolled in the Medicare Drug Price Negotiation Program's (“Negotiation Program”) Medicare Transaction Facilitator Data Module (“MTF DM”). We believe the requirement among Part D sponsors' network pharmacies to be enrolled in the MTF DM that would be added to Part D sponsors' network contracts with pharmacies, if finalized, would facilitate continued beneficiary access to selected drugs that are covered Part D drugs, promote access to negotiated maximum fair prices under the Negotiation Program for both beneficiaries and dispensing entities, and help ensure accurate Part D claims information and payment.</P>
                    <HD SOURCE="HD3">15. Enhancing Health Equity Analyses: Annual Health Equity Analysis of Utilization Management Policies and Procedures</HD>
                    <P>We propose at §  422.137(d)(6)(iii)(A) through (H) to revise the required metrics for the annual health equity analysis of the use of prior authorization to require the metrics be reported by each item or service, rather than aggregated for all items and services.</P>
                    <P>In the April 2024 final rule, CMS added health equity related requirements to §  422.137, including a requirement at §  422.137(d)(6) that the Utilization Management committee must conduct an annual health equity analysis of the use of prior authorization. The analysis must examine the impact of prior authorization at the plan level, on enrollees with one or more of the specified social risk factors (SRF). The analysis must use the outlined metrics, aggregated for all items and services, calculated for enrollees with the specified SRFS, and for enrollees without the specified SRFs, from the prior contract year, to conduct the analysis.</P>
                    <P>During the public comment period, CMS received a significant number of comments on the requirement that the metrics for the health equity analysis be aggregated for all items and services (89 FR 30569). Commenters recommended that CMS require a further level of granularity to ensure that potential disparities could be identified. Specifically, commenters suggested that CMS require disaggregation by item and service to ensure that CMS can identify specific services that may be disproportionately denied. We are proposing to revise the required metrics for the annual health equity analysis of the use of prior authorization to require the metrics be reported by each item or service, rather than aggregated for all items and services.</P>
                    <HD SOURCE="HD3">16. Ensuring Equitable Access to Medicare Advantage Services—Guardrails for Artificial Intelligence (AI)</HD>
                    <P>
                        On October 30, 2023, the Biden-Harris Administration released an Executive Order, “Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence,” directing agencies to ensure that artificial intelligence tools do not impede the advancement of equity and civil rights, and that the use of AI within health care organizations does not deny equal opportunity and justice for the American people.
                        <SU>3</SU>
                        <FTREF/>
                         Given the growing use of AI within the healthcare sector, such as, but not limited to, AI-based patient care decision support tools, vision transformer-based AI methods for lung cancer imaging applications, and AI and machine learning based decision support systems in mental health care settings, we believe it is necessary to ensure that the use of AI does not result in inequitable treatment, bias, or both, within the healthcare system, and instead is used to promote equitable access to care and culturally competent care for all enrollees. As such, we propose to revise 
                        <PRTPAGE P="99344"/>
                        §  422.112(a)(8) to ensure services are provided equitably irrespective of delivery method or origin, whether from human or automated systems. We also clarify that in the event that an MA plan uses AI or automated systems, it must comply with section 1852(b) of the Act and §  422.110(a) and other applicable regulations and requirements and provide equitable access to services and not discriminate on the basis of any factor that is related to the enrollee's health status.
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             
                            <E T="03">https://www.federalregister.gov/documents/2023/11/01/2023-24283/safe-secure-and-trustworthy-development-and-use-of-artificial-intelligence.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">17. Promoting Community-Based Services and Enhancing Transparency of In-Home Service Contractors</HD>
                    <P>CMS has become aware that some entities that provide covered benefits may not be included in an MA organization's provider directory. These concerns relate to safety and a lack of transparency regarding supplemental benefit service providers and their access to an enrollee's home, as well as ensuring individuals know which providers are deeply rooted within the communities they serve. This is particularly of concern when the enrollee may not have information about who may have access to their home, personally identifiable information (PII), or protected health information (PHI). As such, to strengthen beneficiary protections and transparency, we propose to: (1) codify definitions of community-based organizations (CBOs), in-home or at-home supplemental benefit providers and direct furnishing entities; (2) require plans to identify, within the provider directory, which providers and direct furnishing entities meet the proposed definition of a CBO; (3) require plans to identify in-home or at-home supplemental benefit providers and direct furnishing entities, including those that provide a hybrid of services (both in-home or at-home, and in-office services), either through a subset list within the provider directory or through a separate list comprising in-home or at-home supplemental benefit providers and direct furnishing entities; and (4) clarify existing policy by stating that all direct furnishing entities must be included within the provider directory.</P>
                    <HD SOURCE="HD2">C. Conclusion</HD>
                    <P>Finally, we are clarifying and emphasizing our intent that if any provision of this rule, once finalized, is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, or stayed pending further agency action, it shall be severable from this rule and not affect the remainder thereof or the application of the provision to other persons not similarly situated or to other, dissimilar circumstances. Through this rule, we propose provisions that are intended to and will operate independently of each other, even if each serves the same general purpose or policy goal. Where a provision is necessarily dependent on another, the context generally makes that clear (such as by a cross-reference to apply the same standards or requirements).</P>
                    <HD SOURCE="HD2">D. Summary of Costs and Benefits</HD>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99345"/>
                        <GID>EP10DE24.000</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99346"/>
                        <GID>EP10DE24.001</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99347"/>
                        <GID>EP10DE24.002</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99348"/>
                        <GID>EP10DE24.003</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="369">
                        <PRTPAGE P="99349"/>
                        <GID>EP10DE24.004</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD1">II. Implementation of IRA Provisions for the Medicare Prescription Drug Benefit Program</HD>
                    <HD SOURCE="HD2">A. Coverage of Adult Vaccines Recommended by the Advisory Committee on Immunization Practices Under Medicare Part D (§§ 423.100 and 423.120)</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>Section 11401 of the Inflation Reduction Act (IRA) amended section 1860D-2 of the Act by adding new paragraph (8) to subsection (b) and new paragraph (5) to subsection (c) and making other conforming amendments to require that, effective for plan years beginning on or after January 1, 2023, the Medicare Part D deductible shall not apply to, and there is no cost-sharing for, an adult vaccine recommended by the Advisory Committee on Immunization Practices (ACIP) covered under Part D.</P>
                    <P>Section 11401(e) of the IRA directed the Secretary to implement section 11401 of the IRA for 2023, 2024, and 2025 by program instruction or other forms of program guidance. In accordance with the law, CMS issued memoranda via the Health Plan Management System (HPMS) that outlined requirements for Part D sponsors regarding the implementation of section 11401.</P>
                    <P>
                        On September 26, 2022, CMS released an HPMS memorandum titled “Contract Year 2023 Program Guidance Related to Inflation Reduction Act Changes to Part D Coverage of Vaccines and Insulin.” 
                        <SU>4</SU>
                        <FTREF/>
                         In this memorandum, we provided guidance that for any new ACIP-recommended adult vaccine that becomes available during a plan year, Part D sponsors must apply the $0 cost-sharing requirements in section 1860D-2(b)(8) of the Act to applicable claims with dates of service after ACIP's issued recommendation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             
                            <E T="03">https://www.cms.gov/files/document/irainsulinvaccinesmemo09262022.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        On April 4, 2023, CMS issued an HPMS memorandum titled “Final Contract Year (CY) 2024 Part D Bidding Instructions” in which we explained that, in order for a vaccine to be considered ACIP-recommended for adult use, it must be both adopted by the Director of the Centers for Disease Control and Prevention (CDC) and published in the CDC's Morbidity and Mortality Weekly Report (MMWR).
                        <SU>5</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             
                            <E T="03">https://www.cms.gov/files/document/final-cy-2024-part-d-bidding-instructions.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        On July 24, 2023, CMS issued a revision to the April 4, 2023 memorandum in which we clarified that the effective date of the $0 cost-sharing requirement for an ACIP-recommended adult vaccine must be aligned with the date on which the CDC Director adopts the respective ACIP vaccine recommendation, as posted on the CDC's website at 
                        <E T="03">https://www.cdc.gov/vaccines/acip/recommendations.html,</E>
                         not the date on which the recommendation is published in the MMWR.
                        <SU>6</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             
                            <E T="03">https://www.cms.gov/files/document/acip-recommended-vaccines-july-2023.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        In this rule, we propose to codify the requirements related to $0 cost-sharing for adult vaccines recommended by ACIP under Part D for 2026 and each subsequent plan year.
                        <PRTPAGE P="99350"/>
                    </P>
                    <HD SOURCE="HD3">2. Definition of ACIP-Recommended Adult Vaccine</HD>
                    <P>Section 1860D-2(b)(8)(B) of the Act specifies that for purposes of section 1860D-2(b)(8) of the Act, the term “adult vaccine recommended by the Advisory Committee on Immunization Practices” means a covered Part D drug that is a vaccine licensed by the U.S. Food and Drug Administration (FDA) under section 351 of the Public Health Service Act (PHSA) for use by adult populations and administered in accordance with recommendations of the CDC's ACIP as adopted by the CDC Director. We propose to refer to these vaccines as “ACIP-recommended adult vaccines” and to codify this definition at § 423.100. CMS is not proposing to specify a particular age for a vaccine to be considered “adult” for the purposes of determining if a Part D vaccine is subject to $0 cost sharing under section 11401 of the IRA. We defer to how the CDC and ACIP categorize such a recommendation. Part D sponsors must use the information provided by the CDC and ACIP to determine if the vaccine is recommended for, and being administered to, an adult.</P>
                    <P>
                        Consistent with the September 26, 2022 HPMS memorandum, we propose to define an “ACIP-recommended adult vaccine” as a vaccine licensed by the FDA for use in adults and administered in accordance with ACIP recommendations. In some cases, the vaccine may be included on the ACIP “Adult Immunization Schedule” 
                        <SU>7</SU>
                        <FTREF/>
                         and, in other cases, the vaccine may be recommended under a separate ACIP recommendation that is not part of the Adult Immunization Schedule. In alignment with the September 26, 2022 HPMS memorandum, we interpret the term “recommendation” to refer to a recommendation under any one of ACIP's categories of recommendations, including routine, catch-up, risk-based, and shared clinical decision-making immunization recommendations. As described by ACIP, the different categories of recommendations can be distinguished based on the default decision to vaccinate. Routine, catch-up, and risk-based immunization recommendations include a default decision to vaccinate an individual based on their age or other indication, unless contraindicated. For shared clinical decision-making recommendations, the decision of whether or not to vaccinate is determined based on the “best available evidence of who may benefit from vaccination; the individual's characteristics, values, and preferences; the health care provider's clinical discretion; and the characteristics of the vaccine being considered.” 
                        <SU>8</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             
                            <E T="03">https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             
                            <E T="03">https://www.cdc.gov/vaccines/acip/acip-scdm-faqs.html.</E>
                        </P>
                    </FTNT>
                    <P>
                        Some vaccines that are not on the ACIP Adult Immunization Schedule for routine immunization are included on the ACIP Vaccine Recommendations and Guidelines web page.
                        <SU>9</SU>
                        <FTREF/>
                         This web page describes ACIP recommendations for vaccines that are used in limited populations and under limited circumstances. For example, ACIP recommends certain vaccinations for travelers prior to travelling to certain countries. Therefore, consistent with the September 26, 2022 HPMS memorandum, as long as the vaccine is an FDA-licensed vaccine for use by adults that is recommended by ACIP for use by adults, such vaccine would meet our proposed definition of an ACIP-recommended adult vaccine, when provided in accordance with ACIP recommendations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             
                            <E T="03">https://www.cdc.gov/vaccines/hcp/acip-recs/index.html.</E>
                        </P>
                    </FTNT>
                    <P>As described in the September 26, 2022 HPMS memorandum, a Part D vaccine would not meet our proposed definition of an ACIP-recommended adult vaccine and, therefore, would not be subject to the requirements implemented in this proposed rule, if the vaccine is: (1) not licensed by the FDA under section 351 of the PHSA for use by adults; (2) not recommended by ACIP for use by adults; (3) administered to an individual who is not an adult, even if such use in the non-adult is supported by ACIP recommendations (for example, recommendations in the ACIP child and adolescent immunization schedule); or (4) not administered in accordance with ACIP recommendations.</P>
                    <P>In summary, we propose to add at § 423.100 a definition of “ACIP-recommended adult vaccine” that means a covered Part D drug, as defined at § 423.100, that is a vaccine licensed by the FDA under section 351 of the Public Health Service Act for use by adult populations and administered in accordance with recommendations of ACIP of the CDC as adopted by the CDC Director.</P>
                    <HD SOURCE="HD3">3. No Deductible or Cost-Sharing for ACIP-Recommended Adult Vaccines</HD>
                    <P>Section 1860D-2(b)(8)(A) of the Act specifies that the deductible shall not apply and there shall be no coinsurance or other cost-sharing with respect to ACIP-recommended adult vaccines. Generally, Part D vaccines that have ACIP-recommended uses in the adult population and are administered to an adult must be provided with no enrollee cost-sharing. As described in the September 26, 2022 HPMS memorandum, this means that enrollees must not be subject to cost sharing on the ingredient cost of the vaccine submitted on the prescription drug event (PDE) record, or any associated sales tax, dispensing fee, or vaccine administration fee, regardless of the vaccine's formulary tier placement or the benefit phase that the enrollee is in.</P>
                    <P>
                        We are also proposing at § 423.120(g)(3) that enrollees who submit direct member reimbursement (DMR) requests for ACIP-recommended adult vaccines accessed at either out-of-network pharmacies or providers (in accordance with § 423.124(a) and (c)), or at in-network pharmacies or providers, that a Part D sponsor determines are coverable under their benefit must not be subject to cost sharing. While Part D sponsors generally may charge the enrollee for the difference between the cash price and plan allowance for DMRs for covered Part D drugs accessed from both out-of-network and in-network pharmacies, neither § 423.124(b) nor Chapter 14 of the Prescription Drug Benefit Manual directly addresses covered Part D drugs that have statutorily limited cost sharing.
                        <SU>10</SU>
                        <FTREF/>
                         Because there can be no cost sharing for ACIP-recommended adult vaccines accessed at either out-of-network pharmacies or providers (in accordance with § 423.124(a) and (c)), or at in-network pharmacies or providers, that a Part D sponsor determines are coverable under their benefit, the Part D sponsor must reimburse the enrollee for the full cash price paid to the pharmacy or provider for an ACIP-recommended adult vaccine.
                    </P>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             Section 423.124(b) currently states that a Part D sponsor that provides its Part D enrollees with coverage other than defined standard coverage may require its Part D enrollees accessing covered Part D drugs at out-of-network pharmacies to assume financial responsibility for any differential between the out-of-network pharmacy's (or provider's) usual and customary price and the Part D sponsor's plan allowance. Section 50.4.3 of Chapter 14 of the Medicare Prescription Drug Benefit Manual (
                            <E T="03">https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/downloads/chapter-14-coordination-of-benefits-v09-17-2018.pdf</E>
                            ) provides detailed guidance on how Part D sponsors must process DMR requests that are submitted by enrollees who paid cash at an out-of-network (or an in-network) pharmacy (or provider) and where the pharmacy (or provider) did not submit the claim to the Part D plan.
                        </P>
                    </FTNT>
                    <P>
                        The total gross covered drug cost (TGCDC) is usually reported differently on PDEs depending on whether the drug was accessed at an out-of-network or in-
                        <PRTPAGE P="99351"/>
                        network pharmacy or provider. Specifically, Part D sponsors report the cash price that the enrollee paid to the pharmacy or provider as the TGCDC for out-of-network DMRs but only report the negotiated price as the TGCDC for in-network DMRs. However, we are clarifying here that with respect to ACIP-recommended adult vaccines, as an exception to the Chapter 14 guidance, the sponsor should report the cash price paid to the pharmacy or provider as the TGCDC on the PDE for both out-of-network and in-network DMRs. Regardless, there is no true out-of-pocket (TrOOP) cost accumulation for these claims because the beneficiary has no cost sharing for ACIP-recommended adult vaccines under the basic Part D benefit.
                    </P>
                    <P>Under our proposed policy at § 423.120(g), and as described in the September 26, 2022 HPMS memorandum, new Part D vaccines that become available during the plan year and meet the definition of an ACIP-recommended adult vaccine are subject to the cost-sharing requirements of section 1860D-2(b)(8)(A) of the Act. Consistent with the definition of a covered Part D drug at § 423.100, the statutory cost-sharing requirements apply regardless of whether a Part D sponsor adds the vaccine to the formulary midyear, or the enrollee obtains the vaccine via a formulary exception. In addition, we propose at § 423.120(g)(2) that if ACIP issues a new or revised recommendation for a vaccine, related to its use in adults during the plan year, Part D sponsors must apply the cost-sharing requirements of this proposed rule, as applicable, to any ACIP-recommended adult vaccine claims with dates of service after the proposed “Effective date of the ACIP recommendation” discussed later in this proposed rule.</P>
                    <P>Consistent with the April 4, 2023, HPMS memorandum, Part D sponsors may place ACIP-recommended adult vaccines on any tier, including a vaccine tier, and apply utilization management strategies (for example, prior authorization), insofar as such tier placement or utilization management strategy is consistent with the requirements of CMS's formulary review and approval process under § 423.120(b).</P>
                    <P>
                        As described in section 30.2.7 of Chapter 6 of the Medicare Prescription Drug Benefit Manual, Part D sponsors may only use utilization management strategies to assess the necessity of vaccines that are less commonly administered in the Medicare population, facilitate the use of vaccines in line with ACIP recommendations, and evaluate potential reimbursement of vaccines that could be covered under Part B.
                        <SU>11</SU>
                        <FTREF/>
                         For example, utilization management strategies may be used to ensure an enrollee meets the age or clinical requirements recommended by ACIP for a particular vaccine, such as the respiratory syncytial virus (RSV) vaccine which is currently recommended by ACIP for adults aged 75 years of age and older and adults aged 60-74 who are at increased risk for severe RSV disease. However, regardless of an ACIP-recommended adult vaccine's tier placement or applicable utilization management strategies, the statutory zero cost-sharing limits required under this proposed rule would still apply.
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                              
                            <E T="03">https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/downloads/part-d-benefits-manual-chapter-6.pdf</E>
                        </P>
                    </FTNT>
                    <P>In summary, we propose to codify at § 423.120(g)(1) the requirement that Part D sponsors must not apply the deductible or charge cost sharing on ACIP-recommended adult vaccines. We also propose to codify at § 423.120(g)(2) that once a new or revised recommendation is posted on the CDC website, Part D sponsors must provide coverage consistent with § 423.120(g)(1) for dates of service on or after the “Effective date of the ACIP recommendation” as discussed later in this proposed rule. Finally, we propose to codify at § 423.120(g)(3) that these cost-sharing requirements apply for ACIP-recommended adult vaccines obtained from either in-network or out-of-network pharmacies or providers (in accordance with § 423.124(a) and (c)).</P>
                    <HD SOURCE="HD3">4. Effective Date of ACIP Recommendations</HD>
                    <P>In the July 24, 2023, HPMS memorandum, we stated that Part D sponsors must provide $0 cost sharing for an ACIP-recommended adult vaccine as of the date the CDC Director adopts the ACIP's recommendation, and it is posted on the CDC's website. Accordingly, we propose to add at § 423.100 a definition of “Effective date of the ACIP recommendation” that means the date specified on the CDC website noting the date the CDC Director adopted the ACIP recommendation.</P>
                    <P>In the July 24, 2023 HPMS memorandum, we also stated that in the event that the CDC Director's adoption of an ACIP recommendation for an adult vaccine is posted on the CDC's website but an adoption date is not specified, the effective date of the ACIP recommendation is the day after the last day of the ACIP meeting at which the recommendation was approved. However, we are not including this requirement in our proposed definition of “Effective date of the ACIP recommendation” at § 423.100 as it is highly unlikely that an ACIP recommendation will be posted without the date on which it was adopted by the CDC Director. In the event that a recommendation is posted without an effective date, CMS will consult with the CDC to obtain the date the recommendation was adopted by the CDC Director and provide guidance.</P>
                    <P>The ACIP holds three regular meetings annually, generally in February, June, and October, in addition to emergency sessions, for the purpose of reviewing scientific data and voting on vaccine recommendations. We note that the proposed “Effective date of the ACIP recommendation” and the date on which it is published on the CDC's website may not always be the same date (if, for example, the website posting occurs after the date specified as the date the CDC Director adopted the recommendation). Nevertheless, the proposed “Effective date of the ACIP recommendation” determines when the cost-sharing requirements apply. Consequently, if an enrollee paid cost sharing for an ACIP-recommended adult vaccine after the “Effective date of the ACIP recommendation” (for example, the enrollee received the vaccine after the “Effective date of the ACIP recommendation,” but prior to the recommendation being posted on the CDC website), once the recommendation has been posted to the CDC website, the Part D sponsor will need to reimburse the enrollee for any cost sharing they paid for the vaccine.</P>
                    <P>
                        In instances where ACIP expands a previous recommendation, narrows a previous recommendation, or removes a previous recommendation, the “Effective date of the ACIP recommendation” is the date the CDC Director adopted the changed recommendation once the recommendation is posted on the CDC's website. We note that a change to an ACIP recommendation alone does not affect a vaccine's status as a Part D drug. Specifically, a Part D drug is defined at § 423.100, in relevant part, as including a vaccine, if used for a medically accepted indication, as defined in section 1860D-2(e)(4) of the Act. Since an ACIP recommendation does not affect what is considered a medically accepted indication, as defined under section 1860D-2(e)(4) of the Act, for a particular vaccine, an ACIP recommendation alone does not affect a vaccine's status as a Part D drug. However, if the FDA labeling changes to 
                        <PRTPAGE P="99352"/>
                        align with a narrowed ACIP recommendation, this may change what is considered a medically accepted indication and may change what indications are coverable under Part D for a particular vaccine. In other words, if an ACIP recommendation is narrowed or removed, the vaccine may still be coverable under Part D, but an enrollee may be subject to cost-sharing for the vaccine if it is not administered in accordance with the revised ACIP recommendation.
                    </P>
                    <P>When an ACIP recommendation for a particular vaccine is narrowed (for example, additional restrictions are added or the vaccine is recommended for a more limited patient population), Part D sponsors may implement prior authorization (PA) to determine whether the vaccine is being administered in accordance with ACIP recommendations and whether the enrollee should be subject to cost-sharing. For example, if an ACIP recommendation is amended to raise the age for which a vaccine is recommended to be administered, Part D sponsors may implement PA to ensure a beneficiary meets this new age requirement. However, Part D sponsors are not required to implement PA for vaccines to determine if a vaccine is being used for an ACIP-recommended use and is therefore subject to $0 cost-sharing.</P>
                    <P>When an ACIP recommendation is narrowed and a Part D sponsor does not currently have a PA in place for that vaccine, the plan must submit a negative formulary change request to add a PA requirement for that vaccine that aligns with the newly narrowed recommendation, consistent with § 423.120(e)(1). As specified in § 423.120(e)(3)(i), negative change requests for maintenance changes are considered to be approved after 30 days unless the Part D sponsor is notified otherwise. Once the request is approved, Part D sponsors may implement the PA requirement and, if the plan determines that the vaccine is not being used for an ACIP—recommended use, may charge the enrollee the applicable cost-sharing. Part D sponsors are permitted, but not required, to make retroactive determinations for claims that were processed with $0 cost-sharing after the “Effective date of the ACIP recommendation” and before the date on which the PA requirement went into effect.</P>
                    <P>If ACIP withdraws a recommendation for a previously recommended vaccine such that the vaccine no longer meets the definition of an ACIP-recommended adult vaccine, Part D sponsors are not required to submit a negative change request and may immediately apply cost sharing for the vaccine for dates of service after the “Effective date of the ACIP recommendation.”</P>
                    <P>Because the cost-sharing limits for vaccines outlined in this proposal have been in place since 2023 through program instruction authority and we have annually reviewed cost sharing in plan benefit package submissions, we believe the impacts of our proposed codification of these requirements should have minimal impact on Part D sponsors and beneficiaries.</P>
                    <HD SOURCE="HD2">B. Appropriate Cost-Sharing for Covered Insulin Products Under Medicare Part D (§§ 423.100 and 423.120)</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>Section 11406 of the Inflation Reduction Act (IRA) amended section 1860D-2 of the the Act by adding new paragraph (9) to subsection (b) and new paragraph (6) to subsection (c) and making other conforming amendments to require that, effective for plan years beginning on or after January 1, 2023, the Medicare Part D deductible shall not apply to covered insulin products, and the Part D cost-sharing amount for a 1-month supply of each covered insulin product must not exceed the statutorily defined “applicable copayment amount” for all enrollees. For 2023, 2024, and 2025, the applicable copayment amount is $35. For 2026 and each subsequent year, the applicable copayment amount is the lesser of: (1) $35, (2) an amount equal to 25 percent of the maximum fair price (MFP) established for the covered insulin product in accordance with part E of subchapter XI of the Act, or (3) an amount equal to 25 percent of the negotiated price of the covered insulin product under the PDP or MA-PD plan.</P>
                    <P>
                        Section 11406(d) of the IRA directed the Secretary to implement section 11406 of the IRA for 2023, 2024, and 2025 by program instruction or other forms of program guidance. In accordance with the law, CMS issued several memoranda related to cost-sharing for covered insulin products via the Health Plan Management System (HPMS) that outlined expectations for Part D sponsors regarding the implementation of section 11406. On September 26, 2022, CMS released an HPMS memorandum titled “Contract Year 2023 Program Guidance Related to Inflation Reduction Act Changes to Part D Coverage of Vaccines and Insulin,” in which we provided program instructions for the implementation of the requirements in section 11406.
                        <SU>12</SU>
                        <FTREF/>
                         On April 4, 2023, we released additional guidance in the “Final Contract Year (CY) 2024 Part D Bidding Instructions” in which we provided instructions for Part D sponsors as they prepared to submit bids for CY 2024.
                        <SU>13</SU>
                        <FTREF/>
                         Lastly, on April 1, 2024, we released “Final CY 2025 Part D Redesign Program Instructions.” 
                        <SU>14</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                              
                            <E T="03">https://www.cms.gov/files/document/irainsulinvaccinesmemo09262022.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                              
                            <E T="03">https://www.cms.gov/files/document/final-cy-2024-part-d-bidding-instructions.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                              
                            <E T="03">https://www.cms.gov/files/document/final-cy-2025-part-d-redesign-program-instructions.pdf.</E>
                        </P>
                    </FTNT>
                    <P>In this rule, we propose to codify the requirements related to appropriate cost-sharing for covered insulin products under Part D for 2026 and each subsequent plan year.</P>
                    <HD SOURCE="HD3">2. Definition of Covered Insulin Product</HD>
                    <P>Section 1860D-2(b)(9)(C) of the Act defines a covered insulin product as “an insulin product that is a covered Part D drug covered under a PDP or MA-PD plan and that is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FFDCA) or licensed under section 351 of the Public Health Service Act (PHSA) and marketed pursuant to such approval or licensure, including any covered insulin product that has been deemed to be licensed under section 351 of the PHSA pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 and marketed pursuant to such section.”</P>
                    <P>We are proposing to codify the statutory definition of “covered insulin product” at § 423.100 and, in alignment with the guidance in CMS's September 26, 2022 HPMS memorandum, we clarify that a covered insulin product includes drug products that are a combination of more than one type of insulin. We are also proposing, consistent with the September 26, 2022 HPMS memorandum, that the definition of a covered insulin product include drug products that are a combination of both insulin and a non-insulin drug or biological product. Our proposed definition of covered insulin product would not, however, include medical supplies associated with the injection of an insulin product, unless such medical supplies are a device constituent part of a combination product (as defined in 21 CFR 3.2(e)) containing insulin and such combination product is licensed under section 351 of the PHSA.</P>
                    <P>
                        While our proposed definition of “covered insulin product” includes drug products that are a combination of more than one type of insulin or both insulin and non-insulin drug or biological products, the definition would be limited to those drug products 
                        <PRTPAGE P="99353"/>
                        that are FDA-licensed products. Consequently, because a compounded drug product, as described in § 423.120(d), is not FDA-licensed, it would not meet the definition of “covered insulin product”. As such, a compounded drug product would not be subject to the requirements for a “covered insulin product” under our proposed definition at § 423.100.
                    </P>
                    <P>Section 1860D-2(b)(9)(C) of the Act specifies that a “covered insulin product” is an insulin product that is a covered Part D drug covered under a PDP or MA-PD plan. Section 423.100 defines a covered Part D drug to be a Part D drug that is included on a Part D sponsor's formulary, treated as being included in a Part D plan's formulary as a result of a coverage determination or appeal, and obtained at a network pharmacy or an out-of-network pharmacy in accordance with § 423.124(a) and (c). Accordingly, we specify in our proposed definition at § 423.100 that a “covered insulin product” is a covered Part D drug as defined in § 423.100.</P>
                    <P>Additionally, we propose at § 423.100 that a “covered insulin product” is licensed under section 351 of the Public Health Service Act and marketed pursuant to such licensure. We clarify that this proposed definition, in accordance with the statute, includes any covered insulin product that had an approved marketing application that was deemed to be a license for the insulin product (that is, an approved biologics license application) under section 351 of the PHSA pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 and marketed pursuant to such license. We also note that outside of these situations where the insulin had an approved marketing application under section 505 of the Federal Food, Drug, and Cosmetic Act, that was deemed to be a license for the insulin product (that is, an approved biologics license application) under section 351 of the Public Health Service Act pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009, there is no need to reference section 505 of the Federal Food, Drug, and Cosmetic Act since a biological product can no longer be approved under section 505 and must be licensed in a biologics license application under section 351 of the Public Health Service Act. As such, a reference to section 505 is not included in our proposed definition of a “covered insulin product”.</P>
                    <HD SOURCE="HD3">3. Definition of Applicable Cost-Sharing Amount for Covered Insulin Products</HD>
                    <P>Section 1860D-2(b)(9)(D) of the Act defines “applicable copayment amount” with respect to a covered insulin product under a PDP or an MA-PD plan dispensed during plan year 2026, and each subsequent plan year, as the lesser of—</P>
                    <P>• $35;</P>
                    <P>• An amount equal to 25 percent of the maximum fair price established for the covered insulin product in accordance with Part E of subchapter XI, or;</P>
                    <P>• An amount equal to 25 percent of the negotiated price of the covered insulin product under the PDP or MA-PD plan.</P>
                    <P>We interpret the section 1860D-2(b)(9)(D) reference to “applicable copayment amount” as an amount that could be either a fixed copayment or a coinsurance percentage. Therefore, we propose to define this “applicable copayment amount” as an “applicable cost-sharing amount” at § 423.100. In addition, to ensure that the reference to “applicable cost-sharing amount” is specific to the cost-sharing for covered insulin products described under proposed § 423.120(h), and discussed later in this proposed rule, we propose to define the term “covered insulin product applicable cost-sharing amount.”</P>
                    <P>Specifically, we propose to add at § 423.100 a definition of “covered insulin product applicable cost-sharing amount” that means, with respect to a covered insulin product covered under a PDP or an MA-PD plan prior to an enrollee reaching the annual out-of-pocket threshold during plan year 2026 and each subsequent plan year, the lesser of—</P>
                    <P>• $35;</P>
                    <P>• An amount equal to 25 percent of the maximum fair price established for the covered insulin product in accordance with Part E of subchapter XI, or;</P>
                    <P>• An amount equal to 25 percent of the negotiated price, as defined in § 423.100, of the covered insulin product under the PDP or MA-PD plan.</P>
                    <P>
                        For example, the August 15, 2024 publication “Medicare Drug Price Negotiation Program: Negotiated Prices for Initial Price Applicability Year 2026” establishes the maximum fair price for the covered insulin product Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill as $119 for a 30-day supply in CY 2026.
                        <SU>15</SU>
                        <FTREF/>
                         An amount equal to 25 percent of the maximum fair price for this product is $29.75, which is lower than the cost-sharing amount of $35. Therefore, the covered insulin product applicable cost-sharing amount for Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill would be the lesser of: (1) $29.75; or (2) an amount equal to 25 percent of the negotiated price, as defined in § 423.100, of the covered insulin product under the PDP or MA-PD plan.
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                              
                            <E T="03">https://www.cms.gov/files/document/fact-sheet-negotiated-prices-initial-price-applicability-year-2026.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">4. Cost Sharing for Covered Insulin Products</HD>
                    <P>Section 1860D-2(b)(9)(A) of the Act specifies that for plan year 2023 and subsequent plan years, the deductible, as described in section 1860D-2(b)(1) of the Act, shall not apply with respect to any covered insulin product. Section 1860D-2(b)(9)(B)(ii) of the Act further specifies that for 2025 and subsequent plan years, the coverage provides benefits for any covered insulin product, prior to an individual reaching the out-of-pocket threshold, with cost-sharing for a month's supply that does not exceed the applicable copayment amount. We are proposing to codify these requirements at § 423.120(h)(1) and (2).</P>
                    <P>
                        In alignment with the guidance in our September 26, 2022 HPMS memorandum, we propose to interpret the section 1860D-2(b)(9) cost-sharing requirements to apply separately to each prescription fill that is dispensed. For a prescription fill dispensed in an amount up to a 1-month supply, $35 (or a lower amount specified by the sponsor) is considered a copayment for purposes of determining the “covered insulin product applicable cost-sharing amount.” Under our proposal, and consistent with our current policy in the September 26, 2022 HPMS memorandum, Part D sponsors would not be required to prorate the $35 copayment if less than a 1-month supply is dispensed. We believe this proposed policy is supported by section 1860D-2(b)(9)(D) of the Act, which does not explicitly require prorating the applicable copayment amount for less than a 1-month supply. It also aligns with current regulations because insulin is not a solid oral dosage form subject to daily cost-sharing requirements at § 423.153(b)(4). Under our proposal, if the “covered insulin product applicable cost-sharing amount” is a coinsurance, the coinsurance percentage would be 
                        <PRTPAGE P="99354"/>
                        applied to the negotiated price regardless of the days' supply dispensed.
                    </P>
                    <P>With respect to extended-day supplies (that is, greater than a 1-month supply) of covered insulin products, we are proposing that cost sharing must not exceed the cumulative “covered insulin product applicable cost-sharing amount” that would apply if the same days' supply was dispensed in the fewest number of 1-month supply increments necessary. For example, if a covered insulin product is dispensed for greater than a 1-month supply, but less than a two-month supply, the lesser of $70 or 25 percent of MFP or negotiated price, whichever applies, would remain the maximum cost-sharing amount. Similarly, the lesser of $105 or 25 percent of the MFP or negotiated price, whichever applies, would apply for a covered insulin product that is dispensed for greater than a two-month supply up to a three-month supply. If the “covered insulin product applicable cost-sharing amount” is a coinsurance, the coinsurance percentage would be applied to the negotiated price regardless of the days' supply dispensed.</P>
                    <P>While Part D sponsors must not charge cost-sharing that exceeds the “covered insulin product applicable cost-sharing amount,” Part D sponsors may charge cost-sharing that is equal to or less than the “covered insulin product applicable cost-sharing amount.” This means that Part D sponsors have the flexibility to specify cost-sharing that is equal to or lower than the lesser of: a $35 copayment, or 25 percent coinsurance based on the MFP (if established for such product under the Medicare Drug Price Negotiation Program for that year), or 25 percent coinsurance based on the negotiated price. Part D sponsors could meet this cost-sharing requirement by establishing a copayment amount that is equal to or lower than $35 for a 1-month supply, establishing a coinsurance percentage that is equal to or lower than 25 percent of the product's MFP or negotiated price, or establishing both a copayment amount equal to or lower than $35 and a coinsurance percentage equal to or lower than 25 percent of the product's MFP or negotiated price.</P>
                    <P>
                        In the September 26, 2022 HPMS memorandum, we provided guidance on managing out-of-network claims. We are now proposing that enrollees who submit direct member reimbursement (DMR) requests for covered insulin products accessed at either out-of-network pharmacies or providers (in accordance with § 423.124(a) and (c)), or at in-network pharmacies or providers, must not pay more than the “covered insulin product applicable cost-sharing amount.” While Part D sponsors generally may charge the enrollee for the difference between the cash price and plan allowance for DMRs for covered Part D drugs accessed from both out-of-network and in-network pharmacies, neither § 423.124(b) nor Chapter 14 of the Prescription Drug Benefit Manual directly addresses covered Part D drugs that have statutorily limited cost sharing.
                        <SU>16</SU>
                        <FTREF/>
                         Therefore, for covered insulin products accessed at either out-of-network pharmacies or providers (in accordance with § 423.124(a) and (c)), or at in-network pharmacies or providers, we propose at § 423.120(h)(4) that the Part D sponsor must reimburse the enrollee for the full cash price paid to the pharmacy or provider for a covered insulin product minus the “covered insulin product applicable cost-sharing amount.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             Section 423.124(b) currently states that a Part D sponsor that provides its Part D enrollees with coverage other than defined standard coverage may require its Part D enrollees accessing covered Part D drugs at out-of-network pharmacies to assume financial responsibility for any differential between the out-of-network pharmacy's (or provider's) usual and customary price and the Part D sponsor's plan allowance. Section 50.4.3 of Chapter 14 of the Medicare Prescription Drug Benefit Manual (
                            <E T="03">https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/downloads/chapter-14-coordination-of-benefits-v09-17-2018.pdf</E>
                            ) provides detailed guidance on how Part D sponsors must process DMR requests that are submitted by enrollees who paid cash at an out-of-network (or an in-network) pharmacy (or provider) and where the pharmacy (or provider) did not submit claim to Part D plan.
                        </P>
                    </FTNT>
                    <P>The total gross covered drug cost (TGCDC) usually is reported differently on prescription drug events (PDEs) depending on whether the drug was accessed at an out-of-network or in-network pharmacy or provider. Specifically, Part D sponsors report the cash price that the enrollee paid to the pharmacy or provider as the TGCDC for out-of-network DMRs but only report the negotiated price as the TGCDC for in-network DMRs. However, we are clarifying here that with respect to covered insulin products, as an exception to the Chapter 14 guidance, the sponsor should report the cash price paid to the pharmacy or provider as the TGCDC on the PDE for both out-of-network and in-network DMRs. Additionally, true out-of-pocket (TrOOP) cost accumulation for covered insulin products would be limited to the beneficiary's cost-sharing amount, which cannot exceed the “covered insulin product applicable cost-sharing amount.”</P>
                    <P>As described in the April 4, 2023 HPMS memorandum, Part D sponsors may place covered insulin products on any tier, and apply utilization management strategies (for example, prior authorization and step therapy), insofar as such tier placement or utilization management strategy is consistent with the requirements of CMS's formulary review and approval process under § 423.120(b). However, regardless of a covered insulin product's tier placement or applicable utilization management strategy, the statutory cost-sharing limits under this proposed rule still apply.</P>
                    <P>We propose to codify at § 423.120(h)(1) and (2) that with respect to coverage of a covered insulin product, as we propose to define such term at § 423.100, prior to an enrollee reaching the annual out-of-pocket threshold, a Part D sponsor must not apply a deductible and must ensure any enrollee cost-sharing for each prescription fill up to a 1-month supply does not exceed the “covered insulin product applicable cost-sharing amount” as defined at § 423.100. We also propose to codify at § 423.120(h)(3) that Part D sponsors must ensure that any enrollee cost sharing for each prescription fill greater than a 1-month supply does not exceed the cumulative “covered insulin product applicable cost-sharing amount,” that would apply if the same days' supply was dispensed in the fewest number of 1-month supply increments necessary. Finally, we propose to codify at § 423.120(h)(4) that these cost-sharing requirements apply for covered insulin products obtained from either in-network and out-of-network pharmacies and providers.</P>
                    <HD SOURCE="HD2">C. Medicare Prescription Payment Plan (§§ 423.137, 423.2265, 423.2267, and 423.2536)</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>The Inflation Reduction Act of 2022 (IRA) (Pub. L. 117-169) made several additions and amendments to the Social Security Act (the Act) that affect the structure of the defined standard Part D drug benefit. Section 11202 of the IRA (Maximum Monthly Cap on Cost-Sharing Payments under Prescription Drug Plans and MA-PD Plans) added a new section 1860D-2(b)(2)(E) to the Act requiring all Medicare prescription drug plans to offer their Part D enrollees the option to pay out-of-pocket (OOP) Part D drug costs through monthly payments over the course of the plan year instead of at the pharmacy point of sale (POS) beginning January 1, 2025.</P>
                    <P>
                        CMS undertook consumer focus group testing to select a name for the program 
                        <PRTPAGE P="99355"/>
                        established at section 1860D-2(b)(2)(E) of the Act that would resonate with Medicare Part D enrollees. After multiple rounds of consumer testing fieldwork and evaluation of the results, CMS announced the official name of the program as the “Medicare Prescription Payment Plan.” We refer to the program herein using this name.
                    </P>
                    <P>
                        Section 11202(c) of the IRA directs the Secretary to implement the Medicare Prescription Payment Plan for 2025 by program instruction or other forms of program guidance. In accordance with the law, CMS released guidance establishing critical operational, technical, and communication requirements for the Medicare Prescription Payment Plan for 2025. To provide Part D sponsors with sufficient time to implement the program, CMS released the guidance in two parts: the first addressed critical operational and technical requirements and the second addressed communications-related requirements.
                        <SU>17</SU>
                        <FTREF/>
                         In order to solicit the feedback of interested parties, CMS initially published both parts as draft guidance and voluntarily solicited comment. After consideration of the comments, we then released final versions of each part.
                    </P>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             See: Medicare Prescription Payment Plan: Final Part One Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025, and Response to Relevant Comments; Medicare Prescription Payment Plan: Final Part Two Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025, and Response to Relevant Comments.
                        </P>
                    </FTNT>
                    <P>CMS released the draft part one guidance in August 2023, which covered topics such as how incurred OOP pharmacy costs should be re-calculated into monthly billed amounts (“program calculations”); participant billing requirements; pharmacy payment obligations and claims processing; requirements related to Part D enrollee outreach; requirements related to Part D enrollee election; procedures for termination of election; reinstatement and preclusion; participant disputes; and data submission requirements. CMS also provided examples of the program calculations to help Part D sponsors program their claims and billing systems correctly for 2025. After consideration of comments received on the draft part one guidance, CMS released the final part one guidance (hereinafter referred to as “final part one guidance”) in February 2024.</P>
                    <P>CMS released the draft part two guidance in February 2024, which covered topics such as outreach, education, and communications requirements for Part D sponsors; CMS Part D enrollee education and outreach; pharmacy processes; and Part D sponsor operational requirements. After consideration of comments received on the draft part two guidance, CMS released the final part two guidance (hereinafter referred to as “final part two guidance”) in July 2024.</P>
                    <P>In addition to the final part one and final part two guidance, CMS released a technical memorandum in July 2023 providing examples to demonstrate the calculations of the maximum monthly cap on cost sharing payments under the program in different scenarios, a second technical memorandum in April 2024 providing additional examples of calculations that reflect IRA-related changes to the incurred costs that count toward true out-of-pocket costs (TrOOP), and a set of frequently asked questions in October 2024 providing clarifications on the final part one and final part two guidance.</P>
                    <P>CMS also developed model and standardized materials to be used by Part D sponsors in meeting the statutory requirement for Part D sponsors to communicate with enrollees about the program. The materials developed by CMS include a model election request form, a model notice of election approval, a standardized likely to benefit notice, a model notice of voluntary termination, a model notice of failure to pay, and a model notice of involuntary termination. Where possible, CMS based development of the Medicare Prescription Payment Plan model materials on Part D plan enrollment and disenrollment notices to promote consistency across the Part D program. CMS issued the model materials through the Office of Management and Budget's Information Collection Request (ICR) process and released final model materials in July 2024 after consideration of public comments received on the ICR package.</P>
                    <P>CMS does not have authority to implement the Medicare Prescription Payment Plan through program instruction authority beyond 2025. As such, we are pursuing rulemaking to codify the requirements of the program for 2026 and subsequent years.</P>
                    <P>With only a few exceptions, we are proposing to codify, without modification, the requirements established in the final part one and final part two guidance at § 423.137 for 2026 and subsequent years. Because we are codifying existing guidance, these provisions are not expected to impact the baseline.</P>
                    <P>Instances where we are making modifications to the requirements previously finalized for 2025 include—</P>
                    <P>• Proposing to modify the requirements for how Part D sponsors handle adjustments for Part D claims under the Medicare Prescription Payment Plan; and</P>
                    <P>• Proposing to modify the timing requirements for the grace period and initial notice of failure to pay.</P>
                    <P>We are also proposing new requirements for three additional topics:</P>
                    <P>• Requirements related to year-over-year participation for existing participants in the Medicare Prescription Payment Plan and addition of a renewal notice to the required notices related to election into the program;</P>
                    <P>• Requirements for the effective date of voluntary terminations from the program;</P>
                    <P>• Requirements for Part D plans to provide pharmacies with easily accessible information on a Part D enrollee's costs incurred under the program.</P>
                    <P>We are also proposing to modify § 423.2267(e), which lists CMS-required materials and content for Part D sponsors, to include model and standardized materials for the Medicare Prescription Payment Plan, and to modify the list of required content for Part D sponsor websites at § 423.2265 to include Medicare Prescription Payment Plan information. Finally, we are proposing to modify § 423.2536 to waive requirements related to the Medicare Prescription Payment Plan for the Limited Income Newly Eligible Transition (LI NET) program.</P>
                    <HD SOURCE="HD3">2. Provisions of the Proposed Regulation</HD>
                    <HD SOURCE="HD3">(a) Basis, Scope, and General Rule</HD>
                    <P>Section 1860D-2(b)(2)(E)(i) of the Act requires that each PDP sponsor offering a prescription drug plan and each MA organization offering an MA-PD plan must provide to any enrollee of such plan, including an enrollee who is a subsidy eligible individual (as defined in paragraph (3) of section 1860D-14(a) of the Act), the option to elect, with respect to a plan year, to pay cost sharing under the plan in monthly amounts that are capped in accordance with section 1860D-2(b)(2)(E) of the Act.</P>
                    <P>In the final part one guidance, CMS stated that, for calendar year 2025, the provision applies to all Part D sponsors, including both stand-alone PDPs and MA-PDs, as well as Employer Group Waiver Plans (EGWPs), cost plans, and demonstration plans.</P>
                    <P>
                        In the final part two guidance, CMS stated that while the Medicare Prescription Payment Plan is applicable to all Part D plans, it has no practical 
                        <PRTPAGE P="99356"/>
                        application for PACE participants or enrollees in plans that exclusively charge $0 cost sharing for Part D covered drugs. As such, CMS does not expect Part D plans that exclusively charge $0 cost sharing for covered Part D drugs to all plan enrollees to offer enrollees the option to pay their OOP costs through monthly payments over the course of the plan year or otherwise comply with the final part one guidance or the final part two guidance for calendar year 2025. CMS further stated that, if a Part D plan has any enrollees that could pay any cost sharing, even a nominal amount, under the Part D plan at any point during the year, then this clarification would not be applicable to such a plan.
                    </P>
                    <P>For the reasons articulated in the final part two guidance, we intend to continue to not expect such plans to offer enrollees the option to pay their OOP costs through monthly payments over the course of the plan year or otherwise comply with the Medicare Prescription Payment Plan requirements set forth in this proposed rule and in the proposed new regulation at § 423.137.</P>
                    <P>
                        In this proposed rule, we propose to codify at § 423.137(a) the rules we established in the 2025 guidance to apply to plan year 2026 and subsequent years and, in the case of a plan operating on a non-calendar year basis, for the portion of the plan year starting on January 1, 2026. CMS recognizes that implementing the proposed modifications to the requirements established in the final part one and final part two guidance and the new requirements in this proposed rule could be operationally challenging for plans operating on a non-calendar year basis to implement midway through a plan year. As such, we intend to not expect plans operating on a non-calendar year basis to comply with the Medicare Prescription Payment Plan requirements set forth in this proposed rule and in the proposed new regulation at § 423.137 to the extent that those requirements differ from those established in the final part one and final part two guidance during any portion of the non-calendar plan year that starts in 2025 and continues into 2026.
                        <SU>18</SU>
                        <FTREF/>
                         However, such plans would be expected to comply with all requirements set forth in this proposed rule and in the proposed new regulation at § 423.137 for non-calendar plan years beginning in 2026 and subsequent non-calendar plan years.
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             Specifically, during any portion of the non-calendar plan year that starts in 2025 and continues into 2026, we intend to not expect plans operating on a non-calendar year basis to comply with the proposed modifications to the requirements for how Part D sponsors handle adjustments for Part D claims under the Medicare Prescription Payment Plan and the timing requirements for the grace period and initial notice of failure to pay. During any portion of the non-calendar plan year that starts in 2025 and continues into 2026, we also intend to not expect plans operating on a non-calendar year basis to comply with proposed new requirements related to year-over-year participation for existing participants in the Medicare Prescription Payment Plan and addition of a renewal notice to the required notices related to election into the program; for the effective date of voluntary terminations from the program; and for Part D plans to provide pharmacies with easily accessible information on a Part D enrollee's costs incurred under the program.
                        </P>
                    </FTNT>
                    <P>In our final part one guidance, we also established definitions of key terms related to the Medicare Prescription Payment Plan for plan year 2025. We now propose to codify our existing definitions at § 423.137(b) for plan year 2026 and subsequent years with certain clarifications. Specifically, at § 423.137(b)(1), we propose to define “OOP costs for the Medicare Prescription Payment Plan” as the cost sharing amount the Part D enrollee is directly responsible for paying. In the final part one and final part two guidance, we referred to these costs simply as “OOP costs.' ” We propose to codify the more specific definition of “OOP costs for the Medicare Prescription Payment Plan” to avoid confusion with other uses of the term OOP costs, which may be inconsistent with the use of that term in the final part one and final part two guidance.</P>
                    <P>As described in section (b) of this proposed rule, the formula for calculating the maximum monthly cap differs for the first month of participation in the program versus the remaining months of the year. The cap for the first month for which the Part D enrollee has opted into the Medicare Prescription Payment Plan incorporates an enrollee's TrOOP prior to election into the program. However, the subsequent month calculation is determined by calculating the sum of any remaining OOP costs owed by the participant from a previous month that have not yet been billed and any additional OOP costs for the Medicare Prescription Payment Plan in the subsequent month. As such, for the subsequent month calculation of the Part D cost sharing incurred by the Part D enrollee, the term “OOP costs for the Medicare Prescription Payment Plan” includes those Part D cost sharing amounts that the enrollee is responsible for paying after accounting for amounts paid by third-party payers. Specifically, the OOP costs for the Medicare Prescription Payment Plan do not include the covered plan pay amount or other TrOOP-eligible amount(s), such as any amount paid by potential third-party payers, such as State Pharmaceutical Assistance Programs or charities. Additionally, within the definition of OOP costs for the Medicare Prescription Payment Plan, we propose to define “remaining OOP costs owed by the participant” to be the sum of OOP costs for the Medicare Prescription Payment Plan that have not yet been billed to the program participant. For example, if a Medicare Prescription Payment Plan participant incurs $2,000 in January and is billed $166.67, the remaining OOP costs owed by the participant are $2,000 − $166.67 = $1,833.33.</P>
                    <P>
                        Finally, in the final part two guidance, CMS stated that it does not expect the LI NET program to offer enrollees the option to pay their OOP costs through monthly payment over the course of the plan year or to comply with the final part one guidance or final part two guidance for calendar year 2025. CMS clarified that, consistent with the agency's longstanding interpretation and implementation of the LI NET program, participants in the LI NET program are considered to be enrolled in a PDP. However, because the LI NET program is limited to offering Part D-eligible individuals with temporary coverage during a limited, transitional period, CMS stated it does not expect the LI NET program to comply with the requirements of the final part one guidance or the final part two guidance for calendar year 2025 in connection with the offering of such transitional coverage. Pursuant to our authority under section 1860D-14(e)(5)(B) of the Act to waive such requirements of title XI and title XVIII of the Act as may be necessary to carry out the purposes of the LI NET program, we propose to codify in this rule a waiver for the LI NET program with respect to the requirements of the Medicare Prescription Payment Plan for plan year 2026 and subsequent years. The LI NET program is limited to temporary coverage during a limited, transitional period and applying the Medicare Prescription Payment Plan to the LI NET program would be inconsistent with the purposes of such transitional coverage and would raise various operational challenges for the program. Accordingly, we are proposing to revise § 423.2536 to redesignate paragraphs (c) through (k) as paragraphs (d) through (l) and add new paragraph (c) to include the proposed Medicare Prescription Payment Plan requirements at § 423.137 discussed in this section to the list of Part D requirements waived for the LI NET program. In addition, we 
                        <PRTPAGE P="99357"/>
                        are proposing to revise newly redesignated paragraphs § 423.2536(i)(1) and (i)(4) to add the materials proposed at §§ 423.2265(b)(16) and 423.2267(e)(45) through (51) (discussed previously) to the list of communication requirements waived for the LI NET program.
                    </P>
                    <HD SOURCE="HD3">(b) Calculation of the Maximum Monthly Cap on Cost-Sharing Payments</HD>
                    <P>Section 1860D-2(b)(2)(E)(iv) of the Act specifies how the monthly caps on OOP cost sharing payments are to be calculated. The formula for calculating the cap differs for the first month of participation in the program, versus the remaining months of the year. The maximum monthly cap calculations include specifics of a participant's Part D drug costs (previously incurred costs and new OOP costs), as well as the number of months remaining in the plan year; as such, the amount can vary from person-to-person and month-to-month. Assuming a program participant remains in the Medicare Prescription Payment Plan through the end of the plan year, the total amounts billed monthly through the December payment (which would be billed and paid in the following year) will equal the total OOP costs for the Medicare Prescription Payment Plan during the year.</P>
                    <P>Under section 1860D-2(b)(2)(E)(iv)(I) of the Act, for the first month for which the Part D enrollee has opted into the Medicare Prescription Payment Plan, the term “maximum monthly cap” means an amount calculated by taking the annual OOP threshold minus any Part D costs the Part D enrollee incurred during the year before opting into the program, divided by the number of months remaining in the plan year. The number of months remaining in the plan year includes the current reference month (for example, for a calendar year plan, the months remaining in the calculation for the January maximum cap would be 12).</P>
                    <P>
                        Additionally, incurred costs for the Medicare Prescription Payment Plan (as used in the statutory definition of the first month's maximum cap calculation) means the incurred costs, with the meaning set forth at section 1860D-2(b)(4)(C) of the Act and described in section 30 of the Final CY 2025 Part D Redesign Program Instructions (Final 2025 Program Instructions), that were incurred prior to effectuation of an election into the Medicare Prescription Payment Plan, including all TrOOP-eligible costs.
                        <SU>19</SU>
                        <FTREF/>
                         If election into the program occurs mid-month, this would include Part D costs incurred within the calendar month of election but prior to election.
                    </P>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             Final CY 2025 Part D Redesign Program Instructions: 
                            <E T="03">https://www.cms.gov/inflation-reduction-act-and-medicare/part-d-improvements.</E>
                        </P>
                    </FTNT>
                    <P>Under section 1860D-2(b)(2)(E)(iv)(II) of the Act, for each subsequent month for which the Part D enrollee has opted into the program, the maximum monthly cap is determined by calculating the sum of any remaining OOP costs owed by the participant from a previous month that have not yet been billed and any additional OOP costs for the Medicare Prescription Payment Plan in the subsequent month, divided by the number of months remaining in the plan year. The number of months remaining includes the month for which the cap is being calculated. This calculation repeats for each month in which the participant remains in the Medicare Prescription Payment Plan. The resulting maximum monthly cap will change if additional OOP costs for the Medicare Prescription Payment Plan are incurred.</P>
                    <P>Under section 1860D-2(b)(4)(B)(i)(VII) of the Act, the annual OOP cost threshold for 2025 is $2,000. Under section 1860D-2(b)(4)(B)(i)(VII) of the Act, for 2026 and subsequent years, the annual OOP cost threshold is equal to the amount specified for the previous year, increased by the annual percentage increase described in section 1860D-2(b)(6). “Incurred costs” means any costs incurred or treated as incurred under section 1860D-2(b)(4)(C) of the Act.</P>
                    <P>In the final part one guidance, we established standards for calculating the maximum monthly cap for the Medicare Prescription Payment Plan. The participant will not have any monthly bills to pay under this program until opting into the program and incurring OOP costs for covered Part D drugs. Once a participant incurs an OOP Part D drug cost, all their OOP costs for all covered Part D drugs will be billed on a monthly basis as long as the participant remains in the program. Program calculations apply to all OOP costs for the Medicare Prescription Payment Plan, including those in the deductible phase. Part D sponsors must include all covered Part D drugs in the program. However, non-covered drugs are excluded. Part D sponsors are responsible for correctly calculating the monthly caps based on the statutory formulas, determining the amount to be billed (not to exceed the cap), and sending monthly bills to program participants.</P>
                    <P>In the final part one guidance, we also established that opting into the program will not impact how a program participant moves through the Part D benefit or what counts towards their TrOOP costs. Under section 1860D-2(b)(4)(F) of the Act, a participant's TrOOP-eligible costs under the Medicare Prescription Payment Plan will still be treated as incurred based on the date each Part D claim is adjudicated. Opting into the program only provides participants with the ability to spread OOP costs over the year—the total incurred costs and the timing of TrOOP accumulation do not change.</P>
                    <P>In the final part one guidance, we also established standards for how to incorporate extended day supplies of medications in the calculations. For participants who fill prescriptions for an extended day supply, their OOP costs for those prescriptions will be attributed to the month the prescription was filled and will not be pro-rated over the months covered by the prescription. For example, if a participant in the program has $300 in OOP costs for the Medicare Prescription Payment Plan for a 90-day supply dispensed in January, the full $300 will be counted as incurred in January.</P>
                    <P>In addition, we stated that when an individual opts into the Medicare Prescription Payment Plan during the plan year, the individual's incurred costs used to calculate the first month maximum cap are equal to the individual's accumulated TrOOP before opting into the program. If election into the program occurs mid-month, this would include Part D costs incurred within the calendar month of election but prior to election (refer to example B4 in Appendix B of the final part one guidance for an illustration of a mid-month election). The number of months remaining in the plan year includes the month when an individual opts into the program. When an individual opts into the Medicare Prescription Payment Plan prior to the start of the plan year (such as during open enrollment), the first month maximum monthly cap calculation applies to their first month of active coverage within the plan year.</P>
                    <P>
                        The final part one guidance also stated that in scenarios where the OOP costs for the Medicare Prescription Payment Plan in the first month of participation in the program are less than the maximum monthly cap, a Part D sponsor cannot bill the participant more than their actual incurred OOP costs. Specifically, a Part D sponsor must bill the participant the lesser of the participant's OOP costs for the Medicare Prescription Payment Plan or the first month's maximum monthly cap. Section 1860D-2(b)(2)(E)(iv)(I) of the Act clearly states that the first month maximum cap calculation applies to the 
                        <PRTPAGE P="99358"/>
                        first month an enrollee has elected to participate in the Medicare Prescription Payment Plan; in scenarios in which a participant incurs $0 in OOP costs for the Medicare Prescription Payment Plan in the first month, the Part D sponsor must not bill the participant for the first month and would use the subsequent month maximum monthly cap calculation for all succeeding months in the year in which the participant remains in the program.
                    </P>
                    <P>Finally, the final part one guidance established that “OOP costs” (defined as “OOP costs for the Medicare Prescription Payment Plan” for the purposes of this rule) refers only to the patient pay portion for covered Part D drugs that a program participant would have paid at the POS if they had not opted into the Medicare Prescription Payment Plan, not to all incurred costs as defined under section 1860D-2(b)(4)(C) of the Act. For these calculations, the OOP costs for the Medicare Prescription Payment Plan do not include the covered plan paid amount or amounts paid by third parties, such as qualified State Pharmaceutical Assistance Programs (SPAPs) or charities. OOP costs for the Medicare Prescription Payment Plan also do not include any amounts paid by enrollees for monthly premiums.</P>
                    <P>In this proposed rule, we propose to codify the standards we established in the final part one guidance for plan year 2026 and subsequent years at § 423.137(c).</P>
                    <HD SOURCE="HD3">(c) Eligibility and Election</HD>
                    <P>Under section 1860D-2(b)(2)(E)(i) of the Act, Part D sponsors must provide the option to opt into the Medicare Prescription Payment Plan to all Part D enrollees, including enrollees who are eligible for the Low-Income Subsidy (LIS). For 2026 and subsequent years, we propose to codify the statutory requirement that Part D sponsors must offer the program to all Part D enrollees, including those who are LIS eligible, at § 423.137(d).</P>
                    <P>In the final part one guidance, we explained that while the statute requires that an LIS enrollee must have the option to become a Medicare Prescription Payment Plan participant, individuals with low, stable drug costs (such as LIS enrollees) are not likely to benefit from the program. Further, LIS enrollment, for those who qualify, is more advantageous than participation in the Medicare Prescription Payment Plan. We are aware that there may be limited circumstances in which an LIS enrollee would benefit from participation in the Medicare Prescription Payment Plan, but, in general, participation in the Medicare Prescription Payment Plan is unlikely to benefit LIS enrollees. It is important that Part D sponsors inform any individual interested in the Medicare Prescription Payment Plan of potential eligibility for the LIS program. In this rule, for 2026 and subsequent years, we propose to require Part D sponsors to include information on the availability of the LIS program and other financial assistance programs in the election-related materials described at proposed § 423.137(d)(10) with the goal of alerting Part D enrollees to the availability of these programs that can lower costs.</P>
                    <P>In addition, under section 1860D-2(b)(2)(E)(v)(III)(aa) of the Act, Part D sponsors may not restrict the application of the Medicare Prescription Payment Plan benefit to specific covered Part D drugs. To minimize potential confusion and operational challenges, in the final part one guidance, we stated that for 2025, once an individual has opted into the program, OOP cost sharing for all covered Part D drugs must be included in program bills until the participant reaches the OOP threshold, opts out of the Medicare Prescription Payment Plan, or is terminated from the Medicare Prescription Payment Plan due to failure to pay. The program must apply to all of a program participant's prescriptions for covered Part D drugs. We propose to codify this requirement for 2026 and subsequent years at § 423.137(d)(5).</P>
                    <P>Section 1860D-2(b)(2)(E)(v)(II) of the Act states that a Part D enrollee may opt into the Medicare Prescription Payment Plan prior to the beginning of the plan year or in any month during the plan year. In the final part one guidance, we established requirements for a process for enrollees to opt into the Medicare Prescription Payment Plan in 2025, consistent with the statutory requirement cited previously. The final part one guidance set forth the following requirements for 2025:</P>
                    <P>• Part D sponsors must allow Part D enrollees to opt into the Medicare Prescription Payment Plan prior to the plan year (including the Annual Election Period for the subsequent plan year, the Part D initial enrollment period, and Part D special election periods) or at any point during the plan year.</P>
                    <P>• Part D sponsors must allow Part D enrollees to opt into the Medicare Prescription Payment Plan after the conclusion of an enrollment period and before the new plan enrollment effective date (for example, an enrollee could opt into the program for the upcoming plan year after the conclusion of the Annual Election Period and in advance of the January 1 new plan enrollment effective date).</P>
                    <P>In this proposed rule, for 2026 and subsequent years, we propose to codify these requirements at § 423.137(d)(4)(1).</P>
                    <P>In the final part one guidance, we also established requirements for election into the program in 2025, which were designed to reduce administrative burden by aligning with existing requirements and procedures for Part D plan enrollment and to provide a uniform experience for Part D enrollees by reducing potential variation in program administration across Part D plans. We required the Part D enrollee, or their authorized legal representative, to complete an election request, provide the required information to the Part D sponsor, and be approved by the Part D sponsor to opt into the Medicare Prescription Payment Plan. Part D sponsors must have the following mechanisms available to Part D enrollees who wish to opt into the Medicare Prescription Payment Plan:</P>
                    <P>• A paper election request form that can be mailed.</P>
                    <P>• A toll-free telephone number that must provide the individual with evidence the election request was received (for example, a confirmation number).</P>
                    <P>• A website application that must provide the individual with evidence the election request was received (for example, a confirmation number).</P>
                    <P>Part D sponsors must consider Medicare Prescription Payment Plan election requests regardless of the election mechanism or format (for example, a handwritten letter). For an election request to be considered complete, the Part D sponsor must receive the name of the Part D enrollee, their Medicare ID number, and the signature (or verbal attestation, in the case of telephonic requests)</P>
                    <P>of the Part D enrollee or their authorized legal representative validating that the requestor understands and accepts the Part D sponsor's terms and conditions for the program. In this proposed rule, for 2026 and subsequent years, we propose to codify these requirements at §§ 423.137(d)(2) and 423.137(d)(3).</P>
                    <P>
                        We are committed to ensuring that Part D enrollees, once they request to participate, are able to access the benefits of the program as timely as possible and recognize the importance of timely access to prevent enrollees from not filling prescriptions due to affordability challenges. To that end, we requested comment in the draft part one guidance on real-time or POS election approaches that would require Part D sponsors to effectuate election into the 
                        <PRTPAGE P="99359"/>
                        Medicare Prescription Payment Plan without any delay or with only a nominal delay between the election request and effectuation. As we clarified in the final part one guidance, real-time election refers to a process that would enable a Part D enrollee to request election and be effectuated into the program in one instance from any setting (and so is not limited to only the pharmacy POS setting). POS election, rather, is limited to the pharmacy POS setting and would require updates to pharmacies' claims processing systems.
                    </P>
                    <P>In response to the request for comment in the draft part one guidance, many commenters expressed support for real-time election, noting that it would prevent dispensing delays and prescription abandonment. However, due to a number of policy and operational barriers and the restricted lead-up time to the statutory implementation date of January 1, 2025, we did not require real-time or POS election for 2025. In the final part one guidance for 2025, we required a 24-hour effectuation timeframe for election requests made during the plan year, to reduce the likelihood of dispensing delays and prescription abandonment while reducing operational burden for plans and pharmacies. Specifically, we stated that when a Part D sponsor receives a program election request for the next, upcoming plan year (or in advance of a new plan enrollment effective date during a plan year) through either an election request form or through other means, the Part D sponsor must process the request within 10 calendar days of receipt, or the number of calendar days before the plan enrollment starts, whichever is shorter. When a current Part D enrollee requests to opt into the Medicare Prescription Payment Plan during the plan year, Part D sponsors must process the election request within 24 hours.</P>
                    <P>
                        Since publication of the final part one guidance, we have conducted extensive outreach with a variety of stakeholders and conducted in-depth research to assess the feasibility of real-time or POS election options for 2026 or future years. Our research indicates that there is no mechanism for program election information to be passed through the current National Council for Prescription Drug Programs (NCPDP) Telecommunication Standard and easily integrated into Part D sponsor and/or pharmacy benefit manager (PBM) systems; updates to current standards would also be needed to support POS election. These updates would require significant lead time and coordination with industry standards committees that have existing processes and timelines outside of CMS's purview. However, real-time election (facilitated by Part D sponsors outside of the POS) is operationally feasible and need not involve changes to the current Telecommunication Standard; in fact, some Part D sponsors have indicated to CMS that they plan to offer real-time election to their enrollees in 2025. We also note that real-time election facilitated by Part D sponsors could still 
                        <E T="03">take place</E>
                         at the POS; for example, an individual who receives the “Medicare Prescription Payment Plan Likely to Benefit Notice” while picking up a high-cost prescription could step away from the pharmacy counter to call their Part D plan or submit an online election request, and then return to the counter, request that the pharmacist re-process the claim, and pay $0 at POS for the prescription.
                    </P>
                    <P>In this rule, for 2026 and subsequent years, we propose to codify the 24-hour effectuation requirement at § 423.137(d)(4), but request comment on a potential requirement for Part D sponsors to effectuate election requests received via phone or web in real-time for 2026 or future years. In particular, we are interested in the operational feasibility of implementing a real-time election requirement for 2026, what technology and processes would be required to enable a real-time election requirement for 2026, implications for Part D enrollees, and potential burden on interested parties. We are also interested in opportunities for pharmacists to support enrollees in using any future Part D sponsor-adjudicated real-time election mechanisms at the POS.</P>
                    <P>In the final part two guidance, we stated that for 2025, paper election requests are considered received on the date and time—</P>
                    <P>• The Part D sponsor initially stamps a document received by regular mail (that is, U.S. Postal Service); or</P>
                    <P>• A delivery service that has the ability to track when a shipment is delivered (for example, U.S. Postal Service, UPS, FedEx, or DHL) delivers the document.</P>
                    <P>A telephonic election request is considered received on the date and time:</P>
                    <P>• The verbal request is made by telephone with a customer service representative; or</P>
                    <P>• A message is left on the Part D sponsor's voicemail system if the Part D sponsor utilizes a voicemail system to accept requests or supporting statements after normal business hours.</P>
                    <P>An electronic election request is considered received on the date and time a request is received through the Part D sponsor's website and/or portal. This is true regardless of when a Part D sponsor ultimately retrieves or downloads the request. In this rule, for 2026 and subsequent years, we propose to codify these processing time requirements at § 423.137(d)(2).</P>
                    <P>
                        In the final part one guidance, we stated that in 2025, if a Part D sponsor receives an election request that does not have all necessary elements required to consider it complete, the sponsor must not immediately deny the request. For requests received prior to the plan year, the Part D sponsor must contact the individual to request the additional documentation necessary to process the request within 10 calendar days of receipt of the incomplete election request. For requests received during the plan year, the Part D sponsor must contact the individual to request the additional documentation necessary to process the request within 24 hours of receipt of the incomplete election request. Additional documentation to make the program election request complete must be received by the Part D sponsor within 21 calendar days of the request for additional information. The Part D sponsor may deny the election request if the requisite information is not received from the individual in that timeframe. If a Part D enrollee has fulfilled all program election requirements, but the Part D sponsor is unable to process the election into the program in the required amount of time due to no fault of the individual, the Part D sponsor must process a retroactive election back to the original date when the individual should have been admitted into the Medicare Prescription Payment Plan (that is, within 24 hours of the individual providing the requisite information for election into the program). In addition, the Part D sponsor must reimburse the participant for any OOP cost sharing paid on or after that date and include those amounts, as appropriate, in a monthly bill under the program within 45 calendar days. In this rule, for 2026 and subsequent years, we propose to codify these requirements for how Part D sponsors must process program election requests, including timing and notice requirements, procedures for collecting missing information on election requests, and requirements for retroactive election in the event the Part D sponsor fails to process an election within 24 hours at § 423.137(d)(4). Section 423.137(d)(4)(i) includes proposed requirements for processing election requests made prior to the plan year, and § 423.137(d)(4)(ii) includes proposed requirements for processing 
                        <PRTPAGE P="99360"/>
                        election requests made during the plan year.
                    </P>
                    <P>In the final part one guidance, we also included requirements for Part D sponsors to process retroactive election requests in cases where an enrollee cannot have immediate election into the program and believes that any delay in filling a prescription due to the 24-hour timeframe required to process a program election request may seriously jeopardize their life, health, or ability to regain maximum function and so must pay out-of-pocket to the pharmacy. In the final part one guidance, we state that in this situation in 2025, the enrollee must request retroactive election within 72 hours of the date and time when the claim was adjudicated. In this rule, for 2026 and subsequent years, we propose to codify these requirements at § 423.137(d)(6). These requirements ensure that enrollees can participate in the program in cases where they believe that a delay in filling a prescription would seriously jeopardize their life, health, or ability to regain maximum function and can be reimbursed for costs they paid for the prescription before being effectuated in the program.</P>
                    <P>
                        At § 423.137(d)(7), for 2026 and subsequent years, we propose to codify requirements for Part D sponsors to develop standardized procedures for determining and processing reimbursements for excess program payments made by participants who become LIS eligible, consistent with the final part one guidance for 2025. CMS regulations at 42 CFR 423.800(c) apply to all subsidy eligible individuals and require Part D sponsors to reimburse subsidy-eligible individuals, and any organizations paying cost sharing on behalf of such individuals, any excess premium or OOP cost sharing paid by the individual or organization after the effective date of the individual's eligibility for a subsidy. This requirement applies to any OOP cost sharing paid under the Part D benefit, including cost sharing paid by or on behalf of an enrollee who has participated in the Medicare Prescription Payment Plan. Under the timeframes specified at 42 CFR 423.800(e) and 423.466(a), Part D sponsors must process retroactive claims and premium adjustments for LIS-eligible individuals and make any resulting refunds and recoveries within 45 calendar days of the Part D sponsor's receipt of complete information regarding these adjustments.
                        <SU>20</SU>
                        <FTREF/>
                         These same requirements apply to enrollees who have elected into the Medicare Prescription Payment Plan and later become LIS-eligible.
                    </P>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             Refer to Medicare Prescription Drug Benefit Manual; Chapter 13—Premium and Cost-Sharing Subsidies for Low-Income Individuals.
                        </P>
                    </FTNT>
                    <P>Section 1860D-2(b)(2)(E)(v)(II) of the Act requires Part D sponsors to offer the Medicare Prescription Payment Plan to all Part D enrollees in any month during the year. At § 423.137(d)(8), for 2026 and subsequent years, we propose to codify requirements for mid-year plan switches, consistent with the requirements included in the final part one guidance for 2025. If a Part D enrollee who opted into the Medicare Prescription Payment Plan switches plans (Plan Benefit Package (PBP)) during the plan year or is reassigned by CMS, regardless of whether the new plan is offered by the same or a different Part D sponsor, the Part D sponsor of the prior Part D plan must offer the participant the option to repay the full outstanding amount in a lump sum. If the individual chooses to continue paying monthly, the Part D sponsor must continue to bill the participant monthly based on the participant's accrued OOP costs while in the program under that sponsor's Part D plan. The Part D sponsor cannot require full immediate repayment.</P>
                    <P>The Part D sponsor is not permitted to automatically sign up the individual for the Medicare Prescription Payment Plan under the new plan. However, an individual must be able to opt into the program regardless of whether they had participated in the program under the prior plan. If an individual opts into the Medicare Prescription Payment Plan under their new plan after switching plans mid-year, the new Part D sponsor must calculate the individual's monthly cap for the first month of participation under the new plan using the formula for the calculation of the maximum monthly cap in the first month. This is the case even when the first plan and the second plan are administered by the same Part D sponsor.</P>
                    <P>As outlined in section (e) of this proposed rule, preclusion is only permitted in plans that are offered by the same Part D sponsor and may extend beyond the immediately subsequent plan year if a Part D enrollee remains in a plan offered by the same Part D sponsor and continues to owe an overdue balance. If an individual pays off the outstanding balance during a subsequent year, the enrollee is eligible to request to participate in the Medicare Prescription Payment Plan program again.</P>
                    <P>
                        At § 423.137(d)(9), for 2026 and subsequent years, we propose to codify requirements related to participation renewal year-over-year, a topic CMS did not address in the final part one or final part two guidance because the IRA limited CMS program instruction for a single year of the program (CY 2025). To streamline the process for Part D enrollees and Part D sponsors, we propose an automatic election renewal process, wherein program participation continues into the next upcoming year automatically, provided the participant remains in the same PBP in the upcoming year, unless the program participant indicates otherwise. If an enrollee is switching Part D plans, including switching between two PBPs offered by the same Part D sponsor, the automatic election renewal process would not apply. We propose requiring Part D sponsors to send a notice alerting the Part D enrollee that their participation in the program will continue into the next year unless they indicate that they would like to opt out for the upcoming year. This notice would be required to be sent out to program participants by the end of the Annual Election Period (no later than December 7) and must include the Part D sponsor's program terms and conditions for the upcoming year. This proposed automatic renewal process reduces burden for Part D enrollees who would like to remain in the program, as they would not need to complete additional paperwork to renew their election, and it is consistent with automatic renewal of Part D plan enrollment, which provides a seamless experience for Part D enrollees. Automatic renewal also entails less administrative burden for Part D sponsors, as they are not required to process full election request forms again for program participants and would not be required to perform “likely to benefit” analyses (see section (d) of this proposed rule) for the upcoming plan year on program participants. CMS also considered requiring Part D enrollees to actively re-elect into the program each year. Under this approach, Part D sponsors would be required to terminate an enrollee's participation at the end of the contract year and the enrollee would be required to opt back into the program (with the standard election request form or a streamlined renewal form) in order to participate in the following year. CMS opted to propose the automatic election renewal, because the alternative active re-election process places additional burden on both Part D enrollees and Part D sponsors. In addition, this approach is consistent with the existing Part D enrollment process, which automatically renews each year. We request comment on the proposal for automatic election renewal, including the process for enabling 
                        <PRTPAGE P="99361"/>
                        automatic election and associated notification requirements.
                    </P>
                    <P>In the final part two guidance, we addressed program election communications and notice requirements for Part D sponsors, including timing, content, and supplemental information requirements for each required notice in 2025. We required Part D sponsors to make an election request form available throughout the plan year and during the Part D plan enrollment periods.</P>
                    <P>Part D sponsors must send a paper election request form within the same timeframe as the membership ID card mailing specified at 42 CFR 423.2267(e)(32)(i).</P>
                    <P>The election request form may be sent in the membership ID card mailing, or in a separate mailing in the same timeframe. The election request form must include all of the following:</P>
                    <P>• Fields for the Part D enrollees' first and last name, Medicare Number, birth date, phone number, permanent residence street address, and mailing address, if different from permanent residence street address.</P>
                    <P>• A signature field, allowing the enrollee to attest that they understand—</P>
                    <P>++ That the form is a request to participate in the Medicare Prescription Payment Plan, and the Part D sponsor will contact them if more information is needed to complete the request;</P>
                    <P>++ That by signing the form, they have read and understood the form and the Part D sponsor's terms and conditions; and</P>
                    <P>++ That the Part D sponsor will inform the individual when their participation in the program is active, and, until the individual receives that notification, that they are not a participant in the program.</P>
                    <P>• Instructions for how to submit the form to the Part D sponsor.</P>
                    <P>• Instructions for how the Part D enrollee can contact the Part D sponsor for questions or assistance.</P>
                    <P>A Part D sponsor may include the program terms and conditions on the election request form or may include them on a separate attachment. In this rule, we propose to codify these requirements for 2026 and subsequent years at § 423.137(d)(10)(i).</P>
                    <P>Once a program election request is accepted by the Part D sponsor, the Part D sponsor must communicate to the Part D enrollee that the request to participate in the Medicare Prescription Payment Plan has been accepted and effectuated via written notice of election approval, within the timeframes described at § 423.137(d)(10)(ii)(A). For requests received prior to the plan year, Part D sponsors are required to send the written notice of election approval within the timeframe described at § 423.137(d)(10)(ii)(A)(1). For requests received during the plan year, regardless of how the Part D enrollee submitted the election request (paper, telephone, or electronic), the Part D sponsor must deliver the notice of election approval within the timeframe described at § 423.137(d)(10)(ii)(A)(2) first telephonically and then via a written notice. The call must include the required elements for the notice of election approval described at § 423.137(d)(10)(ii)(B). The Part D sponsor must then deliver the written notice of election approval to the program participant either via mail or electronically, depending on the participant's preferred and authorized communication method, within 3 calendar days of delivering the initial telephone notice.</P>
                    <P>If a Part D sponsor is processing an election request over the phone and is able to confirm in that phone call that the election request is approved and the Part D enrollee's participation is active, that same phone call can serve to meet the acceptance of election telephone notification requirement. Similarly, if an electronic election request is approved and effectuated in real time and the Part D sponsor is able to provide a digital confirmation of program participation, the Part D sponsor is not required to also deliver the notice of election approval via phone call. In either case, the Part D sponsor must still deliver the written notice within 3 calendar days.</P>
                    <P>In the final part two guidance, we set forth requirements for Part D plan sponsors related to the contents of the notice of election approval in 2025. The notice of election approval must include—</P>
                    <P>• The effective date of the individual's participation;</P>
                    <P>• A description of how payments for covered Part D drugs under the program will work, including that the individual will pay $0 to the pharmacy for covered Part D drugs and the Part D plan will bill the individual each month;</P>
                    <P>• An overview of how the monthly bill is calculated, including a statement on how monthly bills may change each month, and a statement outlining that under the program, the individual will not pay more for covered Part D drugs than they would have paid without the program or more than the Medicare Part D annual out-of-pocket maximum;</P>
                    <P>• Information about procedures for involuntary termination due to failure to pay and how to submit an inquiry or file a grievance, as well as a statement informing the individual that they can voluntarily leave the program at any time;</P>
                    <P>• A statement describing that leaving the Medicare Prescription Payment Plan, either involuntarily or voluntarily, will not affect the individual's Medicare Part D coverage with the Part D plan;</P>
                    <P>• A description of how if an individual leaves the program, they may still owe a program balance, they can pay the balance all at once or be billed monthly, and they will resume paying the pharmacy directly for their Part D prescriptions after leaving the program; and</P>
                    <P>• An overview of other Medicare programs that can help lower costs, including Extra Help, the Medicare Savings Program, the State Pharmaceutical Assistance Program, and the Manufacturer's Pharmaceutical Assistance Program, and how to learn more about these programs.</P>
                    <P>In this rule, we propose to codify these requirements for 2026 and subsequent years at § 423.137(d)(10)(ii).</P>
                    <P>Part D sponsors are required to send a notice of denial upon denial of an election request. In the final part one guidance, we set forth the following requirements for 2025. For requests received prior to the plan year, the notice of denial must be sent within 10 calendar days of receipt of the election request. For requests received during the plan year, the notice of denial must be sent within 24 hours of receipt of the election request. For incomplete election requests, the notice of denial must be sent within 10 calendar days of the expiration of the timeframe for submission of additional information.</P>
                    <P>Finally, the notice of denial must explain the reason for denial and provide a description of the grievance process available to the individual. In this rule, for 2026 and subsequent years, we propose to codify these requirements at § 423.137(d)(10)(iii).</P>
                    <P>For 2026, we also propose to require Part D sponsors to send a renewal notice alerting the program participant that their participation in the program will continue into the next year unless they indicate that they would like to opt out for the upcoming year. This notice would be required to be sent out to program participants by the end of the AEP (no later than December 7) and must include the Part D sponsor's program terms and conditions for the upcoming year and a reminder that the participant may opt out of the program at any time, including for the upcoming plan year.</P>
                    <P>
                        In this rule, for 2026 and subsequent years, we propose to codify these requirements at § 423.137(d)(10)(iv) and to add the election request form, notice 
                        <PRTPAGE P="99362"/>
                        of election approval, and renewal notice as required materials and content for Part D sponsors at § 423.2267(e)(45), (e)(46) and (e)(51).
                    </P>
                    <P>CMS issued model materials that Part D enrollees can use to fulfill the election request and election approval requirements through the Medicare Advantage and Prescription Drug Programs: Part C and Part D Medicare Prescription Payment Plan Model Documents (CMS-10882; OMB 0938-1475) ICR package. As established in § 423.2267(c), model materials and content are required materials and content created by CMS as an example of how to convey beneficiary information. If Part D sponsors choose to not use a CMS-developed model version of a particular required material or content, they must still accurately convey the vital information in the required material or content to the beneficiary.</P>
                    <P>For the required program election request form that CMS proposes to codify at § 423.2267(e)(45), this means that a Part D sponsor who chooses to develop their own form must include or provide all of the elements outlined at § 423.137(d)(10)(i)(B). For the notice of election approval that CMS proposes to codify at (e)(46), a Part D sponsor who chooses to develop their own notice must include all of the elements outlined at § 423.137(d)(10)(ii)(B). Finally, for the renewal notice that CMS proposes to codify at (e)(51), a Part D sponsor who chooses to develop their own notice must include all of the elements outlined at § 423.137(d)(10)(iv)(B). These notification and content requirements are consistent with the requirements outlined in the final part two guidance for 2025, with the exception of the renewal notice, which was not included in the program instructions.</P>
                    <P>
                        Additionally, Part D sponsors are required to furnish additional educational information on the Medicare Prescription Payment Plan with the election request form and the notice of acceptance. Part D sponsors are encouraged to use the CMS-developed program fact sheet available on 
                        <E T="03">Medicare.gov</E>
                         to satisfy these requirements. If the Part D sponsor develops and uses alternative informational materials in lieu of the CMS-developed fact sheet to satisfy these requirements, they must ensure that these alternative materials accurately convey program information and are compliant with existing Part D requirements specified at 42 CFR part 423 subpart V. In this rule, for 2026 and subsequent years, we propose to codify this requirement at § 423.137(d)(10)(i)(C) and 423.137(d)(10)(ii)(C).
                    </P>
                    <HD SOURCE="HD3">(d) Part D Enrollee Targeted Outreach</HD>
                    <P>The statute establishes that some Part D enrollees will incur OOP costs that make them likely to benefit from election into the Medicare Prescription Payment Plan. As stated in the final part one guidance for 2025, by “likely to benefit,” we generally mean that a participant's monthly costs would be lower under the program compared to any single monthly amount they would have had to pay at the pharmacy without the program. We acknowledge, however, that individuals may consider a number of other factors in determining whether they, personally, would benefit from the program.</P>
                    <P>While this program is open to all Part D enrollees, Part D enrollees incurring high OOP costs earlier in the plan year are generally more likely to benefit. Section 1860D-2(b)(2)(E)(v)(III)(dd) of the Act requires that Part D sponsors have a mechanism in place to notify a pharmacy when a Part D enrollee incurs OOP costs with respect to covered Part D drugs that make it likely the enrollee may benefit from participating in the program.</P>
                    <P>CMS recognizes, however, that notification of Part D enrollees likely to benefit from the Medicare Prescription Payment Plan prior to reaching the pharmacy POS will be a critical component to program success. Early notification will streamline the election process and prevent potential drug dispensing delays. As such, in addition to the statutory requirement for pharmacy POS notification (as outlined in section 1860D-2(b)(2)(E)(v)(III)(dd) of the Act), in the final part two guidance, CMS also established requirements for 2025 for Part D sponsors to undertake targeted outreach, both prior to and during the plan year, directly to Part D enrollees likely to benefit from the program.</P>
                    <P>While the statute requires a likely to benefit notification, it does not outline the specific criteria or define the profile of someone who is likely to benefit under the program. In the final part one guidance, CMS developed a standardized, quantitative framework for assessing “likely to benefit,” which was used to inform targeted outreach requirements both prior to and during the plan year. However as noted previously, CMS recognizes that an individual Part D enrollee may find that they would personally benefit from the program even if they would not be identified as likely to benefit under this particular standardized framework. Those individuals are certainly permitted to opt into the program, as are all Part D enrollees. The definition and framework for “likely to benefit” described in the final part one guidance is specifically for identifying Part D enrollees for targeted outreach and communication in the absence of any information regarding an individual's specific financial circumstances.</P>
                    <P>As described in the final part one guidance, in retrospective modeling of prescription drug event (PDE) data, CMS found that to be “likely to benefit” from the program, the Part D enrollee would have to incur some level of substantial OOP costs; further, the Part D enrollee's highest monthly OOP cost incurred would have to be more than the highest monthly paid amount under the Medicare Prescription Payment Plan (if the program had applied). CMS used this approach to identify “likely to benefit” because it focuses on addressing Part D enrollees' potential cash-flow concerns by lowering their maximum OOP costs in a month (and limiting the potential for participants to be faced with Medicare Prescription Payment Plan monthly payments that may initially provide substantial financial relief but later, due to timing constraints, result in monthly beneficiary payments that are higher than they would have been absent the program). This approach strictly compares the monthly OOP amounts with and without the Medicare Prescription Payment Plan, without any subjective assessments of what amount might be beneficial to an individual Part D enrollee. CMS used the approach described previously to set thresholds for targeted outreach criteria in the first year of the program (2025). In the final part one guidance, we established a 2025 POS notification threshold of $600 for a single prescription. Additional details regarding the POS notification process are described in section (h) of this proposed rule.</P>
                    <P>
                        In the final part two guidance, we established a requirement for Part D sponsors to notify enrollees who were likely to benefit prior to the 2025 plan year. In setting criteria to identify Part D enrollees likely to benefit prior to the plan year, CMS seeks to identify individuals who have persistently high costs for covered Part D prescription drugs. That is balanced, however, by a desire to limit notifications to Part D enrollees who are not likely to benefit from participation in the program (such as Part D enrollees for whom the program would initially provide substantial financial relief but later, due to timing constraints, would result in monthly payments that are higher than they would have been absent the 
                        <PRTPAGE P="99363"/>
                        program). With the goal of assessing the persistence of high OOP costs, and thus, the likelihood of a prior year's OOP costs predicting future OOP burden, CMS analyzed PDE records. CMS first identified Part D enrollees who had incurred total OOP costs of at least $2,000 in the first three quarters of 2021, then examined their total OOP costs in the subsequent year, 2022. CMS's analysis was based on the patient payment amount for covered Part D claims only, reflecting the actual OOP financial burden for Part D enrollees.
                    </P>
                    <P>In the final part two guidance, we established that to fulfill the requirements for prior to the plan year notification, during the fourth quarter of the year, Part D sponsors must review their Part D claims history from the first three quarters of the year to identify Part D enrollees likely to benefit in the upcoming year. For CY 2025, Part D sponsors are required to conduct outreach to Part D enrollees who incurred at least $2,000 in OOP costs for covered drugs through September of 2024. Based on this analysis and any additional analysis Part D sponsors conduct to identify enrollees who may be likely to benefit from this program, the Part D sponsor must send the “Medicare Prescription Payment Plan Likely to Benefit Notice” to identified enrollees no later than the end of the Annual Election Period (open enrollment), which is December 7 of each year. For example, for CY 2025, Part D sponsors assessed claims for covered Part D drugs with dates of services from January through September 2024 and sent the “Medicare Prescription Payment Plan Likely to Benefit Notice” in October, November, or early December 2024 (no later than December 7, 2024). If Part D sponsors develop supplemental strategies for identification of Part D enrollees likely to benefit prior to the plan year, these notifications must be provided during the same timeframe.</P>
                    <P>In the final part two guidance, we established that prior to the plan year, when a Part D sponsor identifies current Part D enrollees as likely to benefit using the methods noted previously, it is then required to notify each such Part D enrollee in writing that they are likely to benefit from the Medicare Prescription Payment Plan, using the standardized “Medicare Prescription Payment Plan Likely to Benefit Notice.” This outreach may be done via mail or electronically (based on the Part D enrollee's preferred and authorized communication methods) and must include a Medicare Prescription Payment Plan election request form. The outreach must also include additional information about the Medicare Prescription Payment Plan; this additional information requirement may be fulfilled by including with the notice the CMS-developed fact sheet about the program. If Part D sponsors develop and use alternative informational materials in lieu of the CMS-developed fact sheet to satisfy this requirement, they must ensure that these alternative materials accurately convey program information and are compliant with existing Part D requirements specified at 42 CFR part 423 subpart V and in the Medicare Communications and Marketing Guidelines (MCMG) Additionally, the initial notice may be provided via telephone, so long as the standardized “Medicare Prescription Payment Plan Likely to Benefit Notice” and additional information are sent within 3 calendar days of the telephone notification.</P>
                    <P>In the final part two guidance, we established that while Part D sponsors are required to notify all Part D enrollees who meet the criteria outlined previously, Part D sponsors should be aware that potential changes to a Part D enrollee's clinical condition, medication status, or cost sharing (for example, discontinuation of therapy or addition of supplemental payers) could affect the likelihood that a Part D enrollee may benefit from the Medicare Prescription Payment Plan. Part D sponsors should be aware of potential status changes when contacted by an enrollee to discuss participation in the program and should counsel enrollees accordingly.</P>
                    <P>
                        In addition to the criteria for identification of Part D enrollees likely to benefit from the program 
                        <E T="03">in advance of</E>
                         an upcoming plan year, in the final part two guidance, CMS established a requirement for 2025 for Part D sponsors to put in place reasonable guidelines for ongoing identification of Part D enrollees likely to benefit 
                        <E T="03">during</E>
                         the plan year. For example, Part D sponsors may undertake targeted outreach to Part D enrollees if they become aware in advance of a new high-cost prescription for a Part D enrollee that would trigger the pharmacy POS notification process. If Part D sponsors have prior authorization or other utilization management edits in place for a drug that, based on their benefit structure, would result in OOP costs above the pharmacy POS notification threshold, then the Part D sponsor could initiate outreach to the Part D enrollee based on approved prior authorization requests, informing them of the Medicare Prescription Payment Plan and of the opportunity to opt into the program.
                    </P>
                    <P>A Part D enrollee is less likely to benefit from opting in during the last quarter of a year (for example, in December, the last month of the plan year, because OOP costs for the Medicare Prescription Payment Plan in that month cannot be spread over more than 1 month). As such, in the final part one and final part two guidance, we established that a Part D enrollee should not be notified that they are likely to benefit in the last month of the plan year for that plan year; however, Part D sponsors may choose to provide them with information on how to opt into the program for the upcoming year. Participants who have already opted into the Medicare Prescription Payment Plan should not be notified about opting into the program while their participation is in effect. Additionally, enrollees who are precluded from opting into the program due to failed monthly payment after conclusion of the required grace period should not be notified that they are likely to benefit from the program during the plan years in which they are precluded from participating in the program. Finally, PDPs that are non-renewing their contracts or individual plan benefit packages are not required to comply with the requirements at § 423.137(e)(3)(i) related to prior to plan year targeted outreach. Non-renewing PDPs must still comply with the requirements at § 423.137(e)(3)(ii) related to during the plan year targeted outreach through the end of the plan year but are not required to identify and outreach to Part D enrollees likely to benefit from the program in the upcoming plan year.</P>
                    <P>In the final part two guidance, we established that Part D sponsors may develop strategies other than the approach outlined previously for identification of additional Part D enrollees likely to benefit during the plan year. However, Part D sponsors must develop standardized processes for implementing their criteria for identification of enrollees likely to benefit from the program during the plan year, including outreach timeframe and mode of communication, and must apply any identification criteria to every Part D enrollee uniformly.</P>
                    <P>
                        In the final part two guidance, we established that during the plan year, when a Part D sponsor identifies current Part D enrollees as likely to benefit from the program, it is required to provide the “Medicare Prescription Payment Plan Likely to Benefit Notice” to the identified Part D enrollee along with a Medicare Prescription Payment Plan election request form and additional information about the Medicare Prescription Payment Plan. This additional information requirement may be fulfilled by including with the notice 
                        <PRTPAGE P="99364"/>
                        the CMS-developed fact sheet about the program. If Part D sponsors develop and use alternative informational materials in lieu of the CMS-developed fact sheet to satisfy this requirement, they must ensure that these alternative materials accurately convey program information and are compliant with existing Part D requirements specified at 42 CFR part 423 subpart V and in the MCMG. This outreach may be done via mail or electronically (based on the Part D enrollee's preferred and authorized communication methods). Additionally, the initial notice may be provided via telephone, so long as the written “Medicare Prescription Payment Plan Likely to Benefit Notice,” election request form, and additional information are sent within 3 calendar days of the telephone notification. Part D sponsors are encouraged to inform the Part D enrollee that they are likely to benefit when contacting the Part D enrollee for other reasons, such as while communicating a prior authorization coverage determination.
                    </P>
                    <P>
                        For the initial years of the program, we propose to maintain the criteria for Part D sponsor outreach prior to the plan year, during the plan year, and at the point of sale that were established in the final part one and final part two guidance for 2025. More specifically, we propose that Part D sponsors must notify a pharmacy when a Part D enrollee incurs OOP costs for a single prescription that equal or exceed the POS threshold of $600. To identify Part D enrollees likely to benefit in advance of the plan year, we propose that Part D sponsors be required to assess their current Part D enrollees' prescription drug costs from the current year and conduct outreach to Part D enrollees who incurred $2,000 in OOP costs for covered Part D drugs through September of that year. We also propose that Part D sponsors will be required to put in place reasonable guidelines for ongoing identification of Part D enrollees likely to benefit 
                        <E T="03">during</E>
                         the plan year. As described in this section, an example of a reasonable guideline for ongoing identification during the plan year would be a standardized approach in which a Part D sponsor undertakes targeted outreach to Part D enrollees when they become aware in advance (such as through the prior authorization process) of a new high-cost prescription that would trigger the pharmacy POS notification process. We remind Part D sponsors that they must develop standardized processes for implementing their criteria for identification of enrollees likely to benefit from the program during the plan year, including outreach timeframe and mode of communication, and must apply any identification criteria to every Part D enrollee uniformly.
                    </P>
                    <P>We plan to revisit these requirements in future rulemaking, as CMS gains program experience and can evaluate program data and operations. In general, we expect to maintain the same overall framework for targeted outreach, which will include a POS notification threshold based on incurred OOP costs, prior to plan year criteria based on incurred OOP costs in the current year, and requirements for Part D sponsors to put in place reasonable guidelines for ongoing identification of Part D enrollees likely to benefit during the plan year. We would assess the targeted outreach requirements for the POS notification threshold and prior to plan year criteria on an annual basis and make modifications, if needed, based on review and analysis of Medicare Prescription Payment Plan data and other Medicare data, including: (1) analysis of program participation levels; (2) analysis of the proportion of participants who met our definition of “likely to benefit,” as established in the final part one guidance and described in this section, based on actual OOP costs incurred and program payments; (3) analysis of the proportion of Part D enrollees who would have met our definition of “likely to benefit” if they had elected into the Medicare Prescription Payment Plan but were not identified based on current targeted outreach criteria; (4) program operations; and (5) level of burden on pharmacies and Part D sponsors. After the assessment and review of the aforementioned factors, CMS would then publish the specific targeted outreach parameters for the upcoming plan year. In this proposed rule, CMS is not codifying an approach to modifying targeted outreach criteria for future years of the program; however, we seek comment on the approach described here and will use feedback from interested parties to support future policy development.</P>
                    <P>In addition to the agency's authorities with respect to the Medicare Prescription Payment Plan under section 11202 of the IRA, CMS also has authority under section 1860D-12(b)(3)(D) of the Act to impose additional contractual terms and conditions on Part D plan sponsors that are necessary and appropriate. Consistent with our authority under section 11202 of the IRA and under section 1860D-12(b)(3)(D) of the Act, in this proposed rule, we propose to codify the targeted outreach framework and thresholds established in the final part one and final part two guidance at § 423.137(e).</P>
                    <P>Specifically, we propose to codify the likely to benefit criteria at paragraph (e)(1), the requirements for the pharmacy POS notification at paragraph (e)(2), and the requirements for Part D sponsor direct outreach to identified likely to benefit enrollees prior to and during the plan year at paragraph (e)(3). Additionally, we propose to codify the targeted outreach notification and education requirements at paragraph (e)(4) and to codify targeted outreach exclusions at paragraph (e)(5). Finally, we propose to add the “Medicare Prescription Payment Plan Likely to Benefit Notice” as a required standardized communication material for Part D sponsors at § 423.2267(e)(47).</P>
                    <P>As stated in the final part two guidance for 2025, the thresholds published by CMS are a minimum requirement. Part D sponsors may develop supplemental strategies for identification of additional Part D enrollees likely to benefit prior to and during the plan year. If supplemental strategies are implemented, then Part D sponsors must apply any additional identification criteria to every enrollee of each plan equally, which we propose to codify at paragraph (e)(1)(ii).</P>
                    <P>We are not scoring any aspects of this provision related to the development and distribution of the “Medicare Prescription Payment Plan Likely to Benefit Notice” in the Collection of Information section of this rule since we believe all information impacts of those provisions have already been accounted for under OMB control number 0938-1475.</P>
                    <HD SOURCE="HD3">(e) Termination of Election, Reinstatement, and Preclusion</HD>
                    <P>Section 1860D-2(b)(2)(E)(v)(IV)(aa) of the Act requires a Part D sponsor to terminate an individual's Medicare Prescription Payment Plan participation if that individual fails to pay their monthly billed amount. In addition, under section 1860D-2(b)(2)(E)(v)(IV)(bb) of the Act, Part D sponsors may preclude an individual from opting into the Medicare Prescription Payment Plan in a subsequent year if the individual fails to pay the amount billed for a month as required under the program.</P>
                    <P>
                        In the final part one guidance, we established standards for termination of election, reinstatement, and preclusion in 2025 consistent with the statutory requirements. CMS established procedures for voluntary termination of election, under which Part D sponsors are required to have a process to allow a participant who has opted into the 
                        <PRTPAGE P="99365"/>
                        Medicare Prescription Payment Plan to opt out during the plan year. In the final part two guidance, we stated that the Part D sponsor must process the participant's voluntary termination request and send the individual a notification confirming the termination within 10 calendar days of receipt of the request but did not specify the effective date of termination. For 2026 and subsequent years, we propose to maintain the requirement for Part D sponsors to send the notice of voluntary termination within 10 calendar days of receipt but require that the effective date of termination must be within 24 hours of receipt of the voluntary termination request. We believe this aligns with the required timeframe for processing election requests during the plan year and ensures timely response to opt out requests during the plan year. We seek comment on this proposal.
                    </P>
                    <P>When a participant opts out of the Medicare Prescription Payment Plan, a Part D sponsor must provide the individual with a notice of termination after the individual notifies the Part D sponsor that they intend to opt out under the Part D sponsor's established process. The notice of voluntary termination must include—</P>
                    <P>• Pertinent dates, including the date on which the individual's participation in the program ends;</P>
                    <P>• An explanation that the individual is receiving the notice either because they requested a voluntary termination or because they changed Part D plans;</P>
                    <P>• A statement clarifying that the notice only applies to participation in the Medicare Prescription Payment Plan, and that the individual's Part D drug coverage will not be impacted;</P>
                    <P>• A statement clarifying that the individual will continue to be billed monthly or can choose to pay the amount owed all at once, and that the individual will not pay interest or fees on the amount owed;</P>
                    <P>• A statement clarifying that the individual can join the Medicare Prescription Payment Plan again and instructions for how to do so, which may differ depending on whether the voluntary termination was requested by the individual or if it was because the individual changed Part D plans; and</P>
                    <P>• An overview of other Medicare programs that can help lower costs, including Extra Help, the Medicare Savings Program, the State Pharmaceutical Assistance Program, and a Manufacturer's Pharmaceutical Assistance Program, and how to learn more about these programs.</P>
                    <P>The Part D sponsor must also offer the participant the option to repay the full outstanding amount in a lump sum. However, the Part D sponsor is prohibited from requiring full immediate repayment from a participant who has been terminated from the Medicare Prescription Payment Plan. If the participant opts not to repay the full outstanding amount in a lump sum, the sponsor must continue to bill amounts owed under the program in monthly amounts not to exceed the maximum monthly cap according to the statutory formula for the duration of the plan year after an individual has been terminated. In this rule, for 2026 and subsequent years, we propose to codify these requirements at § 423.137(f)(2)(i) and to add the voluntary termination notice as a required material and content for Part D sponsors at § 423.2267(e)(50).</P>
                    <P>CMS issued model material that Part D enrollees can use to fulfill the voluntary termination notice requirement through the Medicare Advantage and Prescription Drug Programs: Part C and Part D Medicare Prescription Payment Plan Model Documents (CMS-10882; OMB 0938-1475) ICR package. As established in § 423.2267(c), model materials and content are required materials and content created by CMS as an example of how to convey beneficiary information. If Part D sponsors choose to not use the CMS-developed model notice and develop their own voluntary termination notice, they must include all of the required elements outlined at § 423.137(f)(2)(i)(A)(2)(ii). These notification and content requirements are consistent with the requirements outlined in the final part two guidance for 2025.</P>
                    <P>We also established standards for involuntary termination in 2025, including requirements for the provision of a grace period of at least two months when an individual has failed to pay the billed amount by the payment due date. If an individual fails to pay the billed amount within 15 calendar days of the payment due date, the Part D sponsor must send the individual an initial notice of failure to pay. The notice of failure to pay must include—</P>
                    <P>• Pertinent dates and key pieces of information, including the date the missed monthly payment was due, the amount the individual must pay to remain in the program, and the date by when payment must be received, which is the date of the end of the grace period;</P>
                    <P>• A statement clarifying that the notice only applies to participation in the Medicare Prescription Payment Plan, and that the individual's Part D drug coverage will not be impacted;</P>
                    <P>• Instructions for how to submit payment;</P>
                    <P>• Information about procedures for involuntary termination due to failure to pay, including the date on which the participant would be removed if payment is not received, and how to submit an inquiry or file a grievance;</P>
                    <P>• A statement on how individuals should pay their Part D plan premium first if they cannot afford both their premium and their program balance; and</P>
                    <P>• An overview of other Medicare programs that can help lower costs, including Extra Help, the Medicare Savings Program, the State Pharmaceutical Assistance Program, and the Manufacturer's Pharmaceutical Assistance Program, and how to learn more about these programs.</P>
                    <P>If the individual fails to pay the amount due by the end of the grace period, the Part D sponsor must send the individual an involuntary termination notice explaining that the individual has been terminated from the Medicare Prescription Payment Plan. The involuntary termination notice must be sent within 3 business days following the last day of the end of the grace period, and must include the following:</P>
                    <P>• Pertinent dates, including the date the individual was originally notified of the missed monthly payment and the due date for that payment, as well as the date on which the individual's participation in the program ends, which should be the same date as the notice;</P>
                    <P>• A statement clarifying that the notice only applies to participation in the Medicare Prescription Payment Plan, and that the individual's Part D drug coverage will not be impacted;</P>
                    <P>• Instructions for how to submit payment and the amount owed;</P>
                    <P>• How to submit an inquiry or file a grievance;</P>
                    <P>• A statement clarifying that the individual can join the Medicare Prescription Payment Plan again if they pay the amount owed; and</P>
                    <P>• An overview of other Medicare programs that can help lower costs, including Extra Help, the Medicare Savings Program, the State Pharmaceutical Assistance Program, and the Manufacturer's Pharmaceutical Assistance Program, and how to learn more about these programs.</P>
                    <P>
                        If either the notice of failure to pay or notice of involuntary termination is returned to the Part D sponsor as undeliverable, the Part D sponsor must immediately implement its existing procedure for researching a potential change of address. In this rule, for 2026 
                        <PRTPAGE P="99366"/>
                        and subsequent years, we propose to codify these notice requirement standards at § 423.137(f)(2)(ii) and to add the notice of failure to pay and notice of involuntary termination as required model materials and content for Part D sponsors at § 423.2267(e)(48) and (e)(49).
                    </P>
                    <P>
                        CMS issued model materials that Part D enrollees can use to fulfill the failure to pay and involuntary termination notice requirements through the Medicare Advantage and Prescription Drug Programs: Part C and Part D Medicare Prescription Payment Plan Model Documents (CMS-10882; OMB 0938-1475) ICR package. As established in § 423.2267(c), model materials and content are required materials and content created by CMS as an example of how to convey beneficiary information. If Part D sponsors choose to not use the CMS-developed models and develop their own notice of failure to pay or involuntary termination notice, they must include all of the required elements for each notice outlined at § 423.137(f)(2)(ii)(C)(
                        <E T="03">2</E>
                        ) and (D)(
                        <E T="03">2</E>
                        ), respectively. These notification and content requirements are consistent with the requirements outlined in the final part two guidance for 2025.
                    </P>
                    <P>We also set forth requirements for 2025 related to the grace period and reinstatement. When a program participant fails to pay a program bill, the Part D sponsor must provide individuals with a grace period of at least two months upon notifying the individual of the initial missed payment.</P>
                    <P>We propose to make certain modifications to the timing requirements for the grace period and initial notice of nonpayment established in the final part one guidance. Specifically, in the final part one guidance, we stated that the grace period must begin on the first day of the month for which the balance is unpaid or the first day of the month following the date on which the payment is requested, whichever is later. In this proposed rule, we propose to change the date on which the grace period must begin to the first day of the month following the date on which the initial notice is sent. We believe this would simplify the timing requirements for the notice of nonpayment and the required grace period. We seek comment on whether to adopt this change or continue with the approach described in the final part one guidance.</P>
                    <P>In the final part one guidance for 2025, we also stated that if a participant fails to pay their monthly billed amount with fewer than two full calendar months remaining in the calendar year, the grace period must carry over into the next calendar year. If the program participant is within their grace period from the prior year, the Part D sponsor must allow the participant to opt into the program for the next year, but if the participant fails to pay the amount due from the prior year during the required grace period, the Part D sponsor may terminate the individual's participation in the program in the new year.</P>
                    <P>A participant must be allowed to pay the overdue balance in full during the grace period to remain in the program. Additionally, Part D sponsors must reinstate an individual who has been terminated from the Medicare Prescription Payment Plan within a reasonable timeframe if the individual demonstrates good cause for failure to pay the program billed amount within the grace period and pays all overdue amounts billed. In response to public comments received on the final part one guidance, we clarified that CMS was adopting the same meaning of “good cause” outlined in section 60.2.4 of the Medicare Prescription Drug Benefit Manual, Chapter 3—Eligibility, Enrollment and Disenrollment that applies to reinstatements when an enrollee fails to pay their Part D premiums. CMS also described specific circumstances that constitute good cause, including—</P>
                    <P>• A serious illness, institutionalization and/or hospitalization of the program participant or their authorized representative (that is, the individual responsible for the participant's financial affairs), that lasted for a significant portion of the grace period for Medicare Prescription Payment Plan payment;</P>
                    <P>• Prolonged illness that is not chronic in nature, a serious (unexpected) complication to a chronic condition or rapid deterioration of the health of the participant, a spouse, another person living in the same household, a person providing caregiver services to the participant, or the participant's authorized representative (that is, the individual responsible for the participant's financial affairs) that occurs during the grace period for the Medicare Prescription Payment Plan payment;</P>
                    <P>• Recent death of a spouse, immediate family member, person living in the same household, or person providing caregiver services to the participant, or the participant's authorized representative (that is, the individual responsible for the participant's financial affairs);</P>
                    <P>• Home was severely damaged by a fire, natural disaster or other unexpected event, such that the participant or the participant's authorized representative was prevented from making arrangement for payment during the grace period for the Medicare Prescription Payment Plan;</P>
                    <P>• An extreme weather-related, public safety or other unforeseen event declared as a Federal or state level of emergency prevented premium payment at any point during the Medicare Prescription Payment Plan grace period. For example, the participant's bank or U.S. Post Office closes for a significant portion of the grace period; or</P>
                    <P>• For Part D plan disenrollments effectuated by CMS for failure to pay Part D Income Related Monthly Adjustment Amount (IRMAA), Federal government error (that is, CMS, SSA or the Railroad Retirement Board (RRB)) caused the Medicare Prescription Payment Plan payment to be incorrect or late, and the participant was unaware of the error or unable to take action prior to the disenrollment effective date.</P>
                    <P>In addition, we stated that there may be circumstances other than those listed which meet the definition of good cause, provided these circumstances meet the standard of being outside of the participant's control or are unexpected such that the participant could not have reasonably foreseen their occurrence, and these circumstances are the cause for the non-payment of past due program balances. Finally, we stated that a Part D sponsor may reinstate an individual who has been terminated from the Medicare Prescription Payment Plan and pays all overdue amounts billed in full, at the sponsor's discretion and within a reasonable timeframe, even if the individual does not demonstrate good cause. In this rule, for 2026 and subsequent years, we propose to codify these grace period and reinstatement requirements at § 423.137(f)(3).</P>
                    <P>
                        We also established standards for 2025 for preclusion of election in a subsequent plan year. We clarified that, consistent with the statute, a Part D sponsor may only preclude an individual from participating in the Medicare Prescription Payment Plan in a subsequent year if the individual owes an overdue balance to that plan sponsor. If an individual enrolls in a Part D plan offered by a different Part D sponsor than the Part D sponsor to which the individual owes an overdue balance, that individual cannot be precluded from opting into the Medicare Prescription Payment Plan in a subsequent year by that different Part D sponsor. We also stated that preclusion may extend beyond the immediate subsequent plan year if a Part D enrollee 
                        <PRTPAGE P="99367"/>
                        remains in a plan offered by the same Part D sponsor and continues to owe an overdue balance. While a Part D sponsor that offers more than one Part D plan may have different preclusion policies for its different plans, the Part D sponsor must apply its preclusion policy consistently among all enrollees of the same Part D plan. In this rule, for 2026 and subsequent years, we propose to codify requirements related to preclusion of election in a subsequent plan year at § 423.137(f)(4).
                    </P>
                    <P>For 2025, we established a prohibition on Part D enrollment penalties for failure to pay a Medicare Prescription Payment Plan amount billed. We stated that a Part D plan sponsor is prohibited from disenrolling a Part D enrollee from a Part D plan or declining future enrollment into a Part D plan for failure to pay any amount billed under the Medicare Prescription Payment Plan. In this rule, for 2026 and subsequent years, we propose to codify this requirement at § 423.137(f)(5).</P>
                    <P>Finally, we clarified that, if a participant in the Medicare Prescription Payment Plan is disenrolled voluntarily or involuntarily from their Part D plan under the provisions at 42 CFR 423.44(b), the participant is also terminated from the Medicare Prescription Payment Plan in that plan. In this rule, for 2026 and subsequent years, we propose to codify this requirement at § 423.137(f)(6). We note that nothing in proposed section § 423.137(f) prohibits a Part D sponsor from billing an individual for an outstanding Medicare Prescription Payment Plan amount owed.</P>
                    <P>We are not scoring any aspects of this provision related to the development and distribution of the notice of voluntary termination, the notice of failure to pay, and the notice of involuntary termination in the Collection of Information section of this rule since we believe all information impacts of those provisions have already been accounted for under OMB control number 0938-1475.</P>
                    <HD SOURCE="HD3">(f) Participant Billing Rights</HD>
                    <P>Section 1860D-2(b)(2)(E)(iii) of the Act requires Part D sponsors, on a monthly basis, to bill participants who are in the Medicare Prescription Payment Plan and incur OOP costs for the Medicare Prescription Payment Plan an amount that cannot exceed the applicable maximum monthly cap.</P>
                    <P>In the final part one guidance, we established standards for participant billing rights for 2025 consistent with the statute. Specifically, we established that for each billing period after an individual has opted into the program, a Part D sponsor must not bill a participant who is in the program but has not yet incurred any OOP costs for the Medicare Prescription Payment Plan during the plan year. The Part D sponsor will calculate a monthly amount that takes into account the OOP costs for the Medicare Prescription Payment Plan in that month that were incurred on or after the date on which the individual opted into the program, and that each billing period will be a calendar month. In the final part one guidance, we further explained that the billing period begins either on the effective date of a Part D enrollee's participation in the Medicare Prescription Payment Plan (for the first month a participant elects into the program during the plan year) or the first day of the month (for each subsequent month or for the first month of a participant who elects into the program prior to the start of the plan year). The billing period ends on the last date of that month. Additionally, in the final part one guidance, we established that Part D sponsors must send a bill for the Medicare Prescription Payment Plan that is separate from the bill for the collection of premiums, if applicable, and continue to follow existing regulations and guidance for the collection of premiums as described at 42 CFR 423.293.</P>
                    <P>We clarified that past due balances from prior monthly bills may also be included in a billing statement, which could result in the total amount on the billing statement exceeding the maximum monthly cap. However, the amount billed for the month for which the maximum monthly cap is being calculated cannot be higher than the cap for that month as established in the statute.</P>
                    <P>We also encouraged Part D sponsors to offer multiple means of payment, such as an electronic fund transfer mechanism (including automatic charges of an account at a financial institution or credit or debit card account) and payment by check and to offer participants flexibility around requesting a specific day of the month for program charges and withdrawals from a bank account. We reiterate that encouragement here.</P>
                    <P>In addition, we stated that, because under section 1860D-2(b)(2)(E)(iii) of the Act, Part D sponsors may not bill a participant more than the maximum monthly cap, late fees, interest payments, or other fees, such as for different payment mechanisms, are not permitted under the Medicare Prescription Payment Plan. We also stated that plan sponsors are responsible for ensuring that any third parties they contract with also comply with such requirements.</P>
                    <P>We also reminded Part D sponsors (and any third parties Part D sponsors contract with) that actions to collect unpaid balances related to the Medicare Prescription Payment Plan may be subject to other applicable Federal and state laws and requirements, including those related to payment plans, credit reporting, and debt collection. These requirements also apply in the event of a death of a program participant.</P>
                    <P>We also stated that, while Part D sponsors may create their own billing and payment procedures for the Medicare Prescription Payment Plan, Part D sponsors are required to prioritize payments towards Part D plan premiums to avoid a Part D enrollee losing their Part D coverage when it is unclear whether a payment received from a participant is intended by the participant to cover their outstanding Part D plan premium or Medicare Prescription Payment Plan balance. Specifically, if a Part D enrollee has opted into the program and makes payments directly to the Part D sponsor, and it is unclear whether a payment should go towards the participant's outstanding Part D plan premium or Medicare Prescription Payment Plan balance, the Part D sponsor may contact the enrollee to clarify the purpose of the payment. If the Part D sponsor does not contact the enrollee or is not able to ascertain the purpose of the payment, then the payment must be applied to the Part D premium.</P>
                    <P>Under section 1860D-2(b)(2)(E)(v)(VI) of the Act, Part D sponsors must treat any unsettled balances with respect to amounts owed by participants under the Medicare Prescription Payment Plan as plan losses. In addition, the statute requires that the Secretary shall not be liable for any such balances outside of those assumed as losses estimated in plan bids. In the final part two guidance, we stated that if a Part D sponsor is compensated by or on behalf of the participant for an unsettled balance or sells an unsettled balance as a debt, it cannot treat the amount as a loss and cannot include it in its bid. Only uncompensated unsettled balances can be included in the bid. We also stated that the Part D bid pricing tool (BPT) has been modified to reflect projected losses associated with the Medicare Prescription Payment Plan. Specifically, these losses must be reflected as administrative costs in the Part D BPT.</P>
                    <P>
                        Under section 1860D-2(b)(2)(E)(v)(III)(gg) of the Act, Part D sponsors must have a financial reconciliation process in place to correct 
                        <PRTPAGE P="99368"/>
                        inaccuracies in billing and/or payments. In the final part one guidance, we established standards for Part D sponsors related to financial reconciliation for Medicare Prescription Payment Plan payments. We stated that while a Part D sponsor may not bill a program participant an amount for a month that is more than the maximum monthly cap, a participant may pay more than the maximum monthly cap, up to the annual OOP threshold. However, the participant cannot pay more than their total OOP costs for the Medicare Prescription Payment Plan. If a participant does pay more than their total OOP costs for the Medicare Prescription Payment Plan, the Part D sponsor must reimburse the participant the amount that is paid above the balance owed.
                    </P>
                    <P>In addition, in the final part one guidance, we stated that, for 2025, CMS expects that Part D sponsors will develop standardized procedures for determining and processing reimbursements for excess Medicare Prescription Payment Plan payments made by program participants and that Part D sponsors bear the responsibility for timely financial reconciliation with Part D enrollees. Federal regulations at 42 CFR 423.466(a) require sponsors to process the adjustment and issue refunds or recovery notices within 45 calendar days of receipt of LIS changes, Financial Information Reporting (FIR), or Information Reporting (Nx) transactions necessitating the claims adjustment. As such, Part D sponsors must make the retroactive adjustments and promptly issue refunds or initiate recovery once complete information regarding a claim's adjustment is received. In the final part one guidance, we also stated that the plan must work with the participant to determine if they should either refund the difference directly to the Part D enrollee or apply the overpayment to the remaining OOP costs owed. In addition, Part D sponsors are responsible for appropriately updating TrOOP accumulators and restacking claims.</P>
                    <P>We also stated that when reconciliation results in an increased amount owed by the participant, plans should recalculate the maximum monthly cap for the month(s) in question. As stated in the final part one guidance, under section 1860D-2(b)(2)(E)(iv)(II) of the Act, for each subsequent month for which the Part D enrollee has opted into the program, the maximum monthly cap is determined by calculating the sum of any remaining OOP costs owed by the participant from a previous month that have not yet been billed and any additional OOP costs for the Medicare Prescription Payment Plan in the subsequent month, divided by the number of months remaining in the plan year. When Part D claims adjustments result in increased amounts owed by the participant, and these amounts have not yet been billed to the participant, they should be included in the revised remaining OOP costs owed by the participant and, thus, in the subsequent month maximum cap for the next billing period. Finally, when a covered Part D drug claim adjustment occurs after the end of a plan year, the Part D sponsor should use the general guidance provided earlier in this section to appropriately recalculate the amount owed to or by the participant and issue a final bill or refund, as necessary.</P>
                    <P>In this proposed rule, we propose to codify the requirements established for calendar year 2025 in the final part one guidance discussed in this section for 2026 and subsequent years at § 423.137(g) with an exception. In the final part one guidance, we stated that the plan must work with the participant to determine if they should either refund the difference directly to the Part D enrollee or apply the overpayment to the remaining OOP costs owed by the participant. In this proposed rule, we are proposing to modify that requirement and instead require a plan follow its normal processes for adjustments and issuing refunds. We believe this modification will simplify operational processes on the part of Part D sponsors without negatively impacting Medicare Prescription Payment Plan participants. In addition, in this proposed rule, we are proposing to modify the approach when Part D claims adjustments result in increased amounts owed by the participant; instead of stating that Part D sponsors “should” include the additional costs in the revised remaining OOP costs owed by the participant, we now propose that Part D sponsors “must” include the increased amount in this manner. This is consistent with the requirement established in the final part one guidance and included in section (b) of this proposed rule, which states that once a participant incurs an OOP Part D drug cost, all their OOP costs for all covered Part D drugs will be billed on a monthly basis as long as the participant remains in the program as well as the uniform benefits requirements at § 423.104(b)(2). We seek comment on whether we should finalize these proposed changes or adopt the processes as established in the 2025 final part one guidance for 2026 and subsequent years.</P>
                    <P>We propose to codify the requirement that the Part D sponsor will calculate a monthly amount that takes into account the OOP costs for the Medicare Prescription Payment Plan in that month that were incurred on or after the date on which the individual opted into the program at paragraph (g)(1). We propose to define each billing period as a calendar month at paragraph (g)(2). We propose to establish requirements for the contents of a billing statement at paragraph (g)(3). We propose to establish that unsettled balances with respect to amounts owed under the program will be treated as plan losses at paragraph (g)(4). We propose to establish requirements for prioritization of premium payments at paragraph (g)(5). Finally, we propose to establish general standards for Medicare Prescription Payment Plan financial reconciliation at paragraph (g)(6).</P>
                    <HD SOURCE="HD3">(g) Participant Disputes</HD>
                    <P>
                        In the final part one guidance, we stated that Part D sponsors must apply their established Part D coverage determination and appeals procedures, as required under section 1860D-4(g) and (h) of the Act and § 423.566(a), to any dispute made by a Medicare Prescription Payment Plan participant about the amount of Part D cost sharing owed by that participant for a covered Part D drug. We also stated that Part D sponsors must apply their established Part D grievance procedures, which Part D sponsors are required to have in place under section 1860D-4(f) of the Act and § 423.562, to any dispute made by a Medicare Prescription Payment Plan participant related to any aspect of the Medicare Prescription Payment Plan. This includes election requests, billing requirements, and termination-related issues other than disputes related to the amount of Part D cost sharing owed by a participant for a drug. We also clarified that a decision on the amount of cost sharing for a drug is a coverage determination and directed readers to § 423.566(b)(5) and to the latest Parts C &amp; D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance for requirements related to grievances, coverage determinations, and redeterminations. We stipulated that Part D sponsors must use their existing coverage determination, appeals, and grievance procedures for the Medicare Prescription Payment Plan to ensure that Part D enrollees have the ability to contest copay amounts and any adverse decisions related to participation in the Medicare Prescription Payment Plan. Applying existing procedures required under Part D also reduces the need for Part D sponsors to develop new processes and allows Part D enrollees to use 
                        <PRTPAGE P="99369"/>
                        procedures to which they are accustomed.
                    </P>
                    <P>Consistent with the requirements established in the final part one guidance, at § 423.137(h), we propose to codify requirements for Part D sponsors to apply their existing Part D coverage determination, appeal, and grievance procedures to the Medicare Prescription Payment Plan.</P>
                    <P>We are not scoring this provision in the Collection of Information section of this rule because it codifies existing guidance, and because the filing of an appeal is an information collection associated with an administrative action pertaining to specific individuals or entities and thus is exempt from Paperwork Reduction Act requirements under 5 CFR 1320.4(a)(2) and (c). We seek comment on this assumption.</P>
                    <HD SOURCE="HD3">(h) Pharmacy POS Notification Process</HD>
                    <P>Under section 1860D-2(b)(2)(E)(v)(III)(dd) of the Act and discussed in section (d) of this proposed rule, Part D sponsors must have a mechanism to notify a pharmacy when a Part D enrollee incurs OOP costs with respect to covered Part D drugs that make it likely the Part D enrollee may benefit from participating in the program. Furthermore, section 1860D-2(b)(2)(E)(v)(III)(ee) of the Act requires Part D sponsors to ensure that a pharmacy, after receiving such a notification from the Part D sponsor, informs the Part D enrollee that they are likely to benefit from the Medicare Prescription Payment Plan. The final part one and final part two guidance established standards for 2025 related to pharmacy POS notification processes.</P>
                    <P>In the final part two guidance, we established that all Part D sponsors must use the standard codes developed by NCPDP for communication with network pharmacies about enrollees' Medicare Prescription Payment Plan status, as appropriate. This includes the mechanism to notify the pharmacy that a Part D enrollee has been identified as likely to benefit based on OOP costs at the POS.</P>
                    <P>As established in the final part two guidance, in pharmacy settings in which there is direct contact with enrollees (for example, community pharmacies where enrollees present in person to pick up prescriptions), the Part D sponsor must ensure that a hard copy of the “Medicare Prescription Payment Plan Likely to Benefit Notice” is provided to enrollees identified as likely to benefit (or the person acting on their behalf) at the time the prescription is picked up. This includes pharmacies with a drive-through or curbside pick-up option. Pharmacies should make available the CMS-developed Spanish-language version of the notice, in lieu of the English-language version, to their patients upon request. Identified enrollees who receive the notice from the pharmacy and need the notice in another format or language are instructed to call their Part D sponsor for assistance. The Part D sponsor should ensure compliance with the language access and accessibility requirements at § 423.2267 in the delivery of the “Medicare Prescription Payment Plan Likely to Benefit Notice.” CMS encourages Part D sponsors to provide pharmacies with additional educational material on the Medicare Prescription Payment Plan, such as the CMS-developed fact sheet, which could also be distributed to Part D enrollees along with the notice.</P>
                    <P>The final part two guidance established that the requirement to provide the “Medicare Prescription Payment Plan Likely to Benefit Notice” in no way obligates the pharmacy to provide additional Medicare Prescription Payment Plan counseling or consultation to the Part D enrollee. Pharmacies are encouraged, but not required, to provide educational material related to the Medicare Prescription Payment Plan at the time they provide an enrollee with the notice.</P>
                    <P>In the final part two guidance, CMS established that regardless of the setting, if the pharmacy is in contact with a Part D enrollee identified as likely to benefit and the enrollee declines to complete the prescription purchase, the Part D sponsor must ensure that the pharmacy provides the “Medicare Prescription Payment Plan Likely to Benefit Notice” to the Part D enrollee. For example, if a Part D enrollee visits a retail pharmacy to pick up their prescription but then declines to complete the transaction because of the cost, the Part D sponsor must still ensure that the pharmacy provides the standardized “Medicare Prescription Payment Plan Likely to Benefit Notice” to that Part D enrollee.</P>
                    <P>In the final part two guidance, we also established that when a Part D enrollee opts into the Medicare Prescription Payment Plan after receiving the “Medicare Prescription Payment Plan Likely to Benefit Notice” from the pharmacy, in addition to providing the notice of election approval, as described in section (c) of this proposed rule, the Part D sponsor is responsible for clearly communicating additional necessary next steps to the Part D enrollee. Next steps may include, but are not limited to, how to proceed with filling any outstanding prescriptions.</P>
                    <P>In the final part one and final part two guidance, we established that, in general, all Medicare Prescription Payment Plan requirements are the same for every pharmacy type, including mail order, home infusion, specialty, and long-term care pharmacies. However, CMS is aware that some pharmacy types may not have direct contact with Part D enrollees and/or may lack a practical means for providing the physical standardized “Medicare Prescription Payment Plan Likely to Benefit Notice” directly to the Part D enrollee. Therefore, in the final part one and final part two guidance, we established standards for unique pharmacy scenarios and different pharmacy types.</P>
                    <P>In the final part two guidance, we noted that long-term care pharmacies typically do not have a POS encounter between the pharmacy and the enrollee (long-term care resident). In these cases, the pharmacy may deliver medications that are kept in the custody of long-term care facilities until time of administration. In addition, long-term care pharmacies often use retrospective or post-consumption billing (that is, billing after the drug is dispensed to the facility for an enrollee). As such, when the POS notification is received by a long-term care pharmacy, the Part D sponsor should not require that the long-term care pharmacy provide the “Medicare Prescription Payment Plan Likely to Benefit Notice” prior to dispensing the medication. Instead, the Part D sponsor should require the long-term care pharmacy to provide the notice to the Part D enrollee (or their authorized representative) at the time of its typical enrollee cost-sharing billing process. Given our understanding of the variation in how long-term care pharmacies dispense and bill covered Part D drugs, we are not proposing specific timing requirements for provision of the “Medicare Prescription Payment Plan Likely to Benefit Notice” via long-term care pharmacies. We encourage Part D sponsors to assess the particular circumstances of their network long-term care pharmacies when establishing timing requirements for pharmacy distribution of the notice.</P>
                    <P>
                        The final part two guidance also described special approaches to the POS notification requirements for Indian Health Service (IHS), Tribe and Tribal Organization, and Urban Indian Organization (I/T/U) pharmacies. I/T/U pharmacies provide no-cost prescription drugs to eligible IHS enrollees. When IHS-eligible Part D enrollees fill a prescription at an I/T/U pharmacy, their covered Part D prescription drug cost sharing, as defined by their plan's benefit structure, is not collected at the 
                        <PRTPAGE P="99370"/>
                        POS. As such, if a high-cost prescription drug claim for a Part D enrollee is submitted to a Part D sponsor from an I/T/U pharmacy, the Part D sponsor is not required to return the pharmacy notification indicating the enrollee is likely to benefit from the program. Part D sponsors should also ensure that their customer service representatives are aware of this situation regarding I/T/U pharmacies when receiving inquiries from Part D enrollees regarding program election. In discussing a Part D enrollee's prescription drug costs, customer service representatives may need to review the primary pharmacy type used by the Part D enrollee. Part D enrollees who solely use I/T/U pharmacies, and thus have $0 in OOP costs for covered Part D drugs, may not benefit from participation in the Medicare Prescription Payment Plan.
                    </P>
                    <P>In the final part two guidance, we established that for other pharmacy types without in-person encounters (such as mail order pharmacies), Part D sponsors must require the pharmacy to notify the Part D enrollee via a telephone call or their preferred contact method. This requirement should not, however, be interpreted as a requirement to delay dispensing the medication. Pharmacies are encouraged to utilize existing touchpoints with Part D enrollees, such as outreach to review medication instructions or collect a method of payment, to convey the content of the “Medicare Prescription Payment Plan Likely to Benefit Notice” prior to processing payment for the prescription that triggered the notice. As with retail pharmacies, CMS encourages other pharmacy types to consider providing the “Medicare Prescription Payment Plan Likely to Benefit Notice” via additional modes of communication beyond the requirements in this section, such as through a patient portal or secure email. CMS encourages Part D sponsors to work with pharmacies to establish and maintain reasonable procedures related to the timing and number of attempts for prompt notification of identified Part D enrollees.</P>
                    <P>In addition to the notification mechanisms described in the final part two guidance, we also stated that pharmacies may also choose to develop additional strategies to provide the “Medicare Prescription Payment Plan Likely to Benefit Notice” to enrollees identified as likely to benefit.</P>
                    <P>In the final part two guidance, we established that, given the statutory requirement for notification of enrollees likely to benefit at the pharmacy point of sale, Part D sponsors must ensure that their pharmacy network contracts include a provision requiring pharmacies to provide this notification to Part D enrollees. This provision is sufficient to meet the proposed requirements for Part D sponsors to ensure that a pharmacy, after receiving such a notification from the Part D sponsor, informs the Part D enrollee that they are likely to benefit from the Medicare Prescription Payment Plan. Additional tracking or documentation by the pharmacy or on behalf of the pharmacy by the Part D sponsor that the notice has been delivered to the identified enrollee is not required.</P>
                    <P>In the final part two guidance, CMS acknowledged that a small portion of Part D enrollees will have supplemental coverage, such as through an SPAP, charity, or other health insurance (OHI), that will modify the final OOP amount the enrollee would otherwise owe at the point of sale. The “Medicare Prescription Payment Plan Likely to Benefit Notice” contains language directing enrollees with supplemental coverage to seek advice related to their specific situation prior to opting into the Medicare Prescription Payment Plan. Part D sponsors should ensure that their customer service representatives are aware of this possibility when receiving inquiries from Part D enrollees regarding program election. When discussing a Part D enrollee's prescription drug costs, customer service representatives may need to review records for Information Reporting (Nx) transactions, indicating supplemental coverage or OHI.</P>
                    <P>As specified by section 1860D-2(b)(2)(E)(iv) of the Act, the number of months remaining in the plan year is an important component of the maximum monthly cap calculation. As described in the final part one guidance, the maximum monthly cap in the first month of program participation is determined by calculating the annual OOP threshold minus any Part D costs the Part D enrollee incurred during the year before opting in, divided by the number of months remaining in the plan year. Given that the pharmacy POS threshold is a static amount, this may result in scenarios late in the plan year in which Part D enrollees who receive the “Medicare Prescription Payment Plan Likely to Benefit Notice” at the pharmacy based on their OOP costs, but whose costs are below the maximum monthly cap, are then required to pay the full amount as part of their first month's bill. For example, if a Part D enrollee has not yet opted into the Medicare Prescription Payment Plan and fills a new prescription with an OOP cost of $650 in October 2025, their maximum monthly cap in the first month could be as high as $666.67 (assuming $0 in prior TrOOP accumulation). In this scenario, a Part D enrollee could receive the POS notification based on their OOP costs exceeding the threshold of $600 for 2025, but if they opted into the Medicare Prescription Payment Plan, because their OOP costs are below the maximum monthly cap, the Part D sponsor would bill them for the entire $650 as part of their first month's bill. Part D sponsors should ensure that customer service representatives are aware of this possibility when receiving inquiries from Part D enrollees regarding program election.</P>
                    <P>In this proposed rule, we propose to codify the requirements noted previously that were established in the final part one and final part two guidance for 2026 and subsequent years at § 423.137(i). Specifically, we propose to codify the requirement that the Part D sponsor must use standard NCPDP codes for notifying the pharmacy that an enrollee has been identified as likely to benefit at (i)(1). We propose to codify point of sale requirements for the “Medicare Prescription Payment Plan Likely to Benefit Notice” at paragraph (i)(2). Finally, we propose to codify requirements for Part D sponsors to include a provision in their pharmacy network contracts requiring pharmacies to provide the likely to benefit notification to Part D enrollees at (i)(3).</P>
                    <HD SOURCE="HD3">(i) Pharmacy Claims Processing</HD>
                    <P>In accordance with section 1860D-2(b)(2)(E)(v)(III)(ff) of the Act, Part D sponsors must ensure that enrollee participation in the Medicare Prescription Payment Plan does not affect the amount paid to pharmacies or the timing of such payments. In the final part one guidance, we established that Medicare Prescription Payment Plan participants will pay $0 at the POS instead of the OOP cost sharing they would normally pay at the POS when filling a prescription. Consequently, Part D sponsors must pay the pharmacy the enrollee's cost-sharing amount in addition to the Part D sponsor's portion of the payment. The final part one and final part two guidance established standards for 2025 related to pharmacy claims processing. Additional details related to pharmacy payment obligations are discussed in section (j) of this proposed rule.</P>
                    <P>
                        To ensure a uniform, consistent claims adjudication process and to leverage existing Part D processes to minimize operational burdens, the final part one guidance established that Part D sponsors and pharmacies must use a Bank Identification Number (BIN) and/
                        <PRTPAGE P="99371"/>
                        or Processor Control Number (PCN) electronic claims processing methodology for applicable Medicare Prescription Payment Plan transactions. CMS believes that this standardized approach to processing claims under the Medicare Prescription Payment Plan satisfies the statutory provisions of the Medicare Prescription Payment Plan (such as enabling $0 OOP cost sharing at the POS for all covered Part D drugs) while also having minimal effect on other existing Part D processes (such as COB claims processing with supplemental payers, PDE cost/payment field reporting, or TrOOP accumulation).
                    </P>
                    <P>In addition to the agency's authorities with respect to the Medicare Prescription Payment Plan under section 11202 of the IRA, CMS has authority under section 1860D-12(b)(3)(D) of the Act to impose additional contractual terms and conditions on Part D plan sponsors that are necessary and appropriate. Consistent with our authority under section 11202 of the IRA and under section 1860D-12(b)(3)(D) of the Act, in this proposed rule, we propose to codify the requirement that Part D sponsors use, and ensure that pharmacies use, the Medicare Prescription Payment Plan claims processing methodology outlined herein. Except for certain scenarios discussed in the final part two guidance and in detail in this section, Part D sponsors must utilize, and must ensure that pharmacies utilize, an additional BIN/PCN that is unique to the Medicare Prescription Payment Plan to facilitate electronic processing of supplemental COB transactions for program participants. Part D sponsors must provide the unique Medicare Prescription Payment Plan BIN/PCN and any other pertinent billing information to the pharmacy on paid claim responses when the enrollee is also a Medicare Prescription Payment Plan participant.</P>
                    <P>CMS regulations at 42 CFR 423.120(c)(4) require the Part D sponsor to assign and exclusively use unique routing and beneficiary identifiers for the Medicare Part D program. The intent of the requirement is to ensure that: (1) pharmacies can routinely identify situations in which they are billing a Part D claim, and (2) payers secondary to Part D can properly coordinate benefits on Part D claims. During the bidding process, plans are required to submit BIN/PCN information; CMS periodically extracts and posts the information on the CMS website to assist those involved in the processing of pharmacy claims for beneficiaries enrolled in Part D. The posting of BIN/PCN information would also be of assistance to pharmacies as part of Medicare Prescription Payment Plan transaction processing as it provides the information necessary for a pharmacy to route the claim to the correct processor. We required in final part one guidance that Part D sponsors assign a program-specific PCN that starts with “MPPP.” In addition, Part D sponsors must report the new BIN/PCN to CMS.</P>
                    <P>The method established in the final part one guidance results in two transactions being submitted by the pharmacy to the same Part D sponsor (or their PBM), using two different BIN/PCN combinations. The Part D sponsor's primary unique BIN/PCN (as required by 42 CFR 423.120(c)(4)) is used for the initial Part D claim adjudication; the Part D sponsor then returns the appropriate OOP cost sharing amount in the NCPDP Telecommunication Standard response pricing segment field “Patient Pay Amount” (505-F5). Then, a second Medicare Prescription Payment Plan BIN/PCN is used to process only the final OOP participant liability amount; this process accounts for any other payments made by supplemental coverage to which the participant may be entitled that may reduce the participant's OOP cost. The transaction processed through the Medicare Prescription Payment Plan BIN/PCN must be submitted after processing any applicable other payer transactions in order to capture the final patient responsibility amount after all other payers have paid. This allows the Part D sponsor to pay the pharmacy for the amount the participant would otherwise have paid at the POS to obtain their prescription. This process also allows the “Patient Pay Amount” to be used by Part D sponsors for other downstream reporting requirements, such as PDE records and explanation of benefits (EOB) reporting, which reflect the actual participant liability amounts as incurred.</P>
                    <P>To clarify, Medicare Prescription Payment Plan payments are not considered to be OHI, as the participant's Part D sponsor is the source of both primary and Medicare Prescription Payment Plan payments to the pharmacy. Information Reporting (Nx) transactions will not be generated for Medicare Prescription Payment Plan COB transactions, as the Part D plan is the entity processing both the primary and Medicare Prescription Payment Plan claims and will already be aware of necessary transaction data.</P>
                    <P>The process established in the final part one guidance also allows Part D sponsors to continue to adhere to Medicare Secondary Payer (MSP) laws and any other Federal and state laws establishing payers of last resort (for example, AIDS Drug Assistance Programs (ADAPs)), as discussed in the Medicare Prescription Drug Benefit Manual Chapter 14, Section 30.3.13. As noted earlier in this section, transactions submitted through the Medicare Prescription Payment Plan BIN/PCNs are to be processed after all other payers, including SPAPs, ADAPs, or charities. CMS is aware of concerns that the return of a $0 claim response at the POS may inhibit pharmacies from offering suggestions for their patients to explore other mechanisms to reduce OOP costs, like charitable organizations. CMS recognizes the importance of charitable organizations and other supplemental payers in reducing OOP costs for eligible Part D enrollees; nothing in the final part one or part two guidance prohibits pharmacies from continuing their current practices with regard to recommending charitable support to patients.</P>
                    <P>The final part two guidance also noted that final patient pay amount returned to the pharmacy by a supplemental payer for a covered Part D drug may occasionally be higher than the original Part D patient pay amount. In these cases, for the program participant's portion of the claim (what they would have paid directly to the pharmacy), the Part D sponsor may only include in the Medicare Prescription Payment Plan the participant's original Part D cost sharing, as determined by their plan-specific benefit structure.</P>
                    <P>
                        The final part one guidance stated that Part D sponsors must ensure that there is no impact to PDE cost/payment field reporting as a result of this claims processing methodology. PDE submissions must reflect participant and plan liability amounts as if the Medicare Prescription Payment Plan did not apply. Additionally, this approach should have no impact to prescriber or participant real-time benefit tools, meaning participant liability amounts must be represented as if the Medicare Prescription Payment Plan did not apply. If the individual has opted into the program, Part D sponsors can consider providing patient costs that reflect the program in their participant real-time benefit tool, as long as the total expected cost-sharing is clearly communicated to the individual. If the individual has not opted into the program, the participant real-time benefit tool could be used to alert the individual about the program (either generally or conditionally when the participant real-time benefit tool returns a liability amount over a particular dollar amount).
                        <PRTPAGE P="99372"/>
                    </P>
                    <P>Except as proposed in paragraph § 423.137(d)(6) of this proposed rule, Part D sponsors are not required to include under this program paper claims submitted to the Part D sponsor by a Medicare Prescription Payment Plan participant. “Paper claims” refer to any claims for which the participant requests retroactive reimbursement by the Part D sponsor (whether the request is made via a paper form, telephonically, or electronically), including requests for direct member reimbursement for OON claims.</P>
                    <P>In the final part two guidance, we established requirements for the readjudication of eligible prescription drug claims for new Medicare Prescription Payment Plan participants. When a Part D enrollee receives the “Medicare Prescription Payment Plan Likely to Benefit Notice” from the pharmacy, they may choose to take time to consider opting into the program and leave the pharmacy without the prescription that triggered the notification. As such, when the Part D enrollee returns to the pharmacy to pick up their prescription after successfully opting into the program, the prescription claim that triggered the notification must be readjudicated to allow for appropriate processing by the Part D sponsor and/or PBM. Should a Part D enrollee have other unpaid claims at the same pharmacy for covered Part D drugs from prior dates of service, in addition to the prescription that may have triggered the likely to benefit notification, they may also request that those claims be readjudicated, so as to be included in the Medicare Prescription Payment Plan. CMS encourages Part D sponsors to provide their enrollees with education and information on how to proceed with readjudication of other unpaid claims for covered Part D drugs.</P>
                    <P>For example, a Part D enrollee is prescribed a new medication with an OOP cost that is above the POS notification threshold. The Part D sponsor would notify the pharmacy that the enrollee is likely to benefit from the Medicare Prescription Payment Plan. The pharmacy would then provide the “Medicare Prescription Payment Plan Likely to Benefit Notice” to the Part D enrollee. The enrollee decides to leave the pharmacy without paying for their high-cost prescription, so they can contact their plan and opt into the program. However, the pharmacy also has two other covered Part D prescriptions filled for the Part D enrollee from prior dates of service, for which the Part D enrollee also decided to leave the pharmacy without picking up and paying. When the Part D enrollee returns to the pharmacy after their election into the Medicare Prescription Payment Plan has been effectuated, the Part D sponsor must require the pharmacy to reverse and reprocess the high-cost claim that triggered the likely to benefit notification. The program participant would then pay $0 at the pharmacy for the high-cost claim and pay their typical plan-defined cost sharing for the other claims with prior dates of service. Alternatively, the Part D enrollee could request that the pharmacy reverse and reprocess all three claims, so the program participant pays $0 at the pharmacy for all three drugs.</P>
                    <P>In the case of same-day program effectuation (when the Part D claim date of service is the same as the date of program effectuation), the pharmacy is not required to reverse and resubmit the Part D claim, provided that the pharmacy otherwise obtains the necessary Medicare Prescription Payment Plan BIN/PCN for the program-specific transaction.</P>
                    <P>CMS noted that Part D sponsors are not required to provide that pharmacies reverse and reprocess claims under the Medicare Prescription Payment Plan that have already been paid for by the Part D enrollee. As noted in the final part one guidance and proposed here at § 423.137(d)(6), Part D sponsors must have processes in place to reimburse enrollee cost sharing when an enrollee has met the conditions for a retroactive election into the Medicare Prescription Payment Plan.</P>
                    <P>As noted in section (h) of this proposed rule, in the final part one and final part two guidance, we established that, in general, all Medicare Prescription Payment Plan requirements are the same for every pharmacy type, including mail order, home infusion, specialty, and long-term care pharmacies. However, CMS is aware that different pharmacy types may have slightly different approaches to processing covered Part D claims for Medicare Prescription Payment Plan participants. Therefore, in the final part one and final part two guidance, we established standards for unique pharmacy scenarios and different pharmacy types.</P>
                    <P>The final part two guidance described the processing of covered Part D claims for Medicare Prescription Payment Plan participants in special pharmacy settings. As discussed in that guidance, CMS is aware that there are multiple types of payment arrangements between long-term care pharmacies and long-term care facilities and/or Part D enrollees. In some situations, long-term care pharmacies do not collect Part D cost sharing from the enrollee but instead bill the long-term care facility for the final patient OOP responsibility. When such an arrangement is in place between a long-term care pharmacy and a long-term care facility, and an enrollee in a long-term care facility is participating in the Medicare Prescription Payment Plan, billing the participant's Part D plan's Medicare Prescription Payment Plan BIN/PCN for the participant's OOP costs (when the pharmacy would not have otherwise directly billed the enrollee) may result in additional financial burden on that participant. Given our understanding of the variation in how long-term care pharmacies dispense and bill covered Part D drugs, we are not proposing specific requirements for Part D sponsors related to the use of the Medicare Prescription Payment Plan BIN/PCN with long-term care pharmacies. CMS encourages Part D sponsors to take the participant's particular circumstances into account when considering Medicare Prescription Payment Plan billing practices and to work with the participant, their authorized representative, and the long-term care pharmacy to understand the best billing approach for the participant.</P>
                    <P>
                        Additionally, as noted in section (h) of this proposed rule, I/T/U pharmacies provide no-cost prescription drugs to eligible IHS enrollees. When IHS-eligible Part D enrollees fill a prescription at an I/T/U pharmacy, their covered Part D prescription drug cost sharing, as defined by their plan's benefit structure, is not collected at the POS. Given that, if an IHS-eligible Part D enrollee is also participating in the Medicare Prescription Payment Plan, the Part D plan sponsor must ensure that the I/T/U pharmacy does not bill the Part D plan's Medicare Prescription Payment Plan BIN/PCN. Instead, the Part D plan sponsor must ensure that the I/T/U pharmacy processes the claim as if the IHS-eligible enrollee were not participating in the Medicare Prescription Payment Plan. If a Part D sponsor receives a claim from an I/T/U pharmacy that was submitted to the Medicare Prescription Payment Plan-specific BIN/PCN, the Part D sponsor must reject the claim. To help prevent this situation from occurring, Part D sponsors must also put in place processes to prevent Medicare Prescription Payment Plan BIN/PCNs from being returned on paid claim responses to I/T/U pharmacies. These requirements apply only with respect to I/T/U pharmacies that dispense prescriptions at no cost to the IHS enrollee. The Part D sponsor must 
                        <PRTPAGE P="99373"/>
                        ensure other network pharmacies providing services to Part D enrollees process claims in accordance with the Medicare Prescription Payment Plan requirements, as established in the final part one guidance and final part two guidance.
                    </P>
                    <P>At § 423.137(j)(7), we propose requirements related to transparency around OOP costs for the Medicare Prescription Payment Plan at the pharmacy POS, a topic CMS did not address through program instruction for CY 2025. Once an enrollee is a participant in the Medicare Prescription Payment Plan, they will pay $0 at the pharmacy POS. Part D sponsors then correctly calculate the monthly caps based on the statutory formulas, determine the amount to be billed, and send monthly bills to program participants. CMS has heard concerns about the potential lack of participant visibility into their OOP costs for the Medicare Prescription Payment Plan at the POS, given the $0 final claim response from the Part D sponsor to the pharmacy. As noted in the final part two guidance, CMS strongly encourages Part D sponsors to educate program participants on the options for assessing OOP costs for the Medicare Prescription Payment Plan prior to the pharmacy POS (such as utilizing interactive prescription drug cost tools available on the Part D sponsor's website or calling the plan's customer service line). However, to provide additional support for OOP cost transparency for Medicare Prescription Payment Plan participants, we are proposing requirements for Part D sponsors to ensure that pharmacies can easily access information on a Part D enrollee's OOP costs for the Medicare Prescription Payment Plan for prescriptions processed under the program at the POS. These costs should be provided in the paid claim billing response on the Medicare Prescription Payment Plan COB transaction. In addition, Part D sponsors must ensure that pharmacies are prepared to provide this information to a participant at the POS. We seek comment on the proposal, including suggested processes for how Part D sponsors can provide this information to pharmacies in a manner that conforms with existing standards.</P>
                    <P>In this proposed rule, we propose to codify the requirements established in the final part one and final part two guidance for 2026 and subsequent years and noted previously at § 423.137(j). We propose to codify that Part D sponsors and pharmacies must use a BIN/PCN electronic claims processing methodology for Medicare Prescription Payment Plan transactions at paragraph (j)(1). We propose to codify the requirement for handling of higher final patient pay amounts from supplemental payers at paragraph (j)(2). We propose to codify that the claims processing methodology have no impact on PDE reporting at paragraph (j)(3). We propose to codify that program participation and the associated claims processing methodology have no impact on the cost-sharing information displayed in real-time benefit tools at paragraph (j)(4). We propose to establish standards for exclusion of retroactive or “paper” claims at paragraph (j)(5). We propose to codify requirements for the readjudication of certain covered Part D claims for program participants at (j)(6). Finally, we propose to codify new requirements for Part D sponsors to enhance OOP cost transparency at the POS at (j)(7).</P>
                    <HD SOURCE="HD3">(j) Pharmacy Payment Obligations</HD>
                    <P>Consistent with 1860D-2(b)(2)(E)(v)(III)(ff) of the Act, Part D sponsors must pay the pharmacy the enrollee's cost-sharing amount in addition to the Part D sponsor's portion of the payment. The final part one and final part two guidance established standards for 2025 related to pharmacy payment obligations.</P>
                    <P>Consistent with section 1860D-12(b)(4) of the Act and 42 CFR 423.520, and as stated in the final part one guidance, Part D sponsors must reimburse a network pharmacy the total of a participant's OOP costs for the Medicare Prescription Payment Plan and the Part D sponsor portion of the payment for a covered Part D drug no later than 14 calendar days after the date on which the claim is received for an electronic claim or no later than 30 calendar days after the date on which the claim is received for any other claim. The timing of payment of the total of a participant's OOP costs for the Medicare Prescription Payment Plan and the Part D sponsor portion of the payment for long-term care and home infusion pharmacies should follow current practices for payment of the Part D sponsor portion to be consistent with this requirement.</P>
                    <P>Consistent with section 1860D-11(i) of the Act, CMS may not interfere with the negotiations between Part D sponsors and pharmacies and generally may not institute a price structure for the reimbursement of covered Part D drugs. Further, as stated in the final part one guidance, CMS does not have the statutory authority to directly reimburse Part D sponsors' contracted pharmacies for costs associated with administering the program. That said, CMS recognizes the important role that pharmacies will play in the implementation of this program and strongly encourages Part D sponsors to ensure that pharmacies receive adequate reimbursement for services provided to Part D enrollees related to participation in the Medicare Prescription Payment Plan.</P>
                    <P>As established in the final part one and final part two guidance, any additional transaction fees or other costs pharmacies incur from processing claims under the Medicare Prescription Payment Plan or otherwise related to the program are considered allowable </P>
                    <FP>pharmacy costs associated with the dispensing of a covered Part D drug that may be paid through applicable dispensing fees. Consistent with 42 CFR 423.100 and sections 20.6 and 20.7 of Chapter 5 of the Medicare Prescription Drug Benefit Manual, a drug's negotiated price must include any dispensing fees, and uniform negotiated prices must be available to plan enrollees for a particular covered Part D drug when purchased from the same pharmacy. Should Part D sponsors and pharmacies come to contractual arrangements that reimburse pharmacies for program operations through a non-dispensing fee mechanism (for example, remuneration for administrative services), these arrangements must be reported appropriately via the bid pricing tool and direct and indirect remuneration (DIR) reporting, as necessary.</FP>
                    <P>As established in the final part one guidance and section (f) of this proposed rule, it is not permissible for Part D sponsors to charge program participants fees related to the Medicare Prescription Payment Plan. Additionally, section 1860D-2(b)(2)(E)(v)(III)(ff) of the Act requires Part D sponsors to ensure that enrollee participation in the Medicare Prescription Payment Plan does not affect the amount paid to pharmacies or the timing of such payments. As a result, Part D sponsors cannot impose any fees or costs related to program implementation on pharmacies, as such fees or costs would affect the amount paid to pharmacies in violation of the statute. As established in the final part one guidance, participation in the Medicare Prescription Payment Plan is an arrangement between the Part D sponsor and the Part D enrollee; pharmacies cannot be held responsible for any unsettled balances of a participant or for collecting unpaid balances from the participant on the Part D sponsor's behalf.</P>
                    <P>
                        In this proposed rule, we propose to codify the requirements established in the final part one and final part two guidance for 2026 and subsequent years as noted previously at § 423.137(k). 
                        <PRTPAGE P="99374"/>
                        Specifically, we propose to codify the requirement that the Medicare Prescription Payment Plan does not affect the amount or timing of payment to pharmacies at paragraph (k)(1), including that Part D sponsors cannot impose any fees or costs related to program implementation on pharmacies and that pharmacies cannot be held responsible for any unsettled balances of a participant or for collecting unpaid balances from the participant on the Part D sponsor's behalf.
                    </P>
                    <HD SOURCE="HD3">(k) Monitoring, Compliance and Data Submission Requirements</HD>
                    <P>
                        In the final part one guidance, we clarified that existing requirements in 42 CFR 423.514(a) governing data collection for Part D sponsors apply to the Medicare Prescription Payment Plan. Accordingly, in the final part one guidance, we stated that Part D sponsors must report information related to the Medicare Prescription Payment Plan on PDE records and through new reporting requirements at the beneficiary level and contract-PBP levels. Part D sponsors must report data at the beneficiary-level on election status in the program through the MARx System and contract-level data about the program through HPMS. These data elements were formally issued for public comment in the 
                        <E T="04">Federal Register</E>
                         through the Office of Management and Budget (OMB) Information Collection Request (ICR) process. We are not scoring this provision in the Collection of Information section of this rule since we believe all information impacts of this provision have already been accounted for under OMB control numbers 0938-1468, 0938-0982, and 0938-0992.
                    </P>
                    <P>In the final part two guidance, we stated that CMS will use this data, along with data about plan grievances and beneficiary complaints entered in the Medicare Complaints Tracking Module (CTM), to assess compliance with all Medicare Prescription Payment Plan requirements and ensure program integrity. We stated our expectation that Part D sponsors incorporate the Medicare Prescription Payment Plan into their compliance programs in accordance with 42 CFR 423.504(b)(4)(vi) to ensure they are meeting program requirements. We also noted that, as stated in 42 CFR 422.504(e) and 423.505(e), CMS and/or its contractors may conduct specific audits of Part D sponsors' implementation of the Medicare Prescription Payment Plan and may initiate audit activity that requires additional data collection or site visits.</P>
                    <HD SOURCE="HD3">(l) General Part D Sponsor Outreach and Education Requirements</HD>
                    <P>Under section 1860D-2(b)(2)(E)(v)(III)(bb) of the Act, Part D sponsors must notify prospective Part D enrollees prior to the plan year through promotional materials of the option to participate in the Medicare Prescription Payment Plan. Additionally, under section 1860D-2(b)(2)(E)(v)(III)(cc) of the Act, Part D sponsors must also provide information on such option in educational materials to Part D enrollees.</P>
                    <P>To ensure all prospective and current Part D enrollees are aware of the program, we propose to codify requirements that are consistent with those included in the final part two guidance for Part D sponsors to provide general education on the program via a mailing and through their websites for 2026 and subsequent years at §§ 423.137(m)(1) and 423.137(m)(2), respectively. We propose requiring Part D sponsors to send a program election request form and additional educational information on the program either in the membership ID card mailing, described at § 423.2267(e)(32), or in a separate mailing sent out within the same timeframe. Under § 423.2267(e)(32), membership ID cards must be provided to new enrollees within 10 calendar days from receipt of CMS confirmation of enrollment or by the last day of the month prior to the plan effective date, whichever is later. Part D sponsors may send the Medicare Prescription Payment Plan mailing described at § 423.137(m)(1) to only new plan enrollees who typically receive the membership ID card mailing or to all of their Part D enrollees. Further, for 2026 and subsequent years, we propose to codify requirements at § 423.137(m)(2) for plans to include certain information, as described in more detail later in this section, on their publicly available websites, described at § 423.128(d)(2). As we stated in the final part two guidance, Part D sponsors are encouraged to use the CMS-developed educational fact sheet to satisfy requirements to provide supplemental information on the program.</P>
                    <P>In the final part two guidance, we explained that CMS has updated existing Part D resources that are required to be furnished to Part D enrollees under § 423.2267(e) to include information about the program. These include the Annual Notice of Change (ANOC, described at § 423.2267(e)(3)), the Evidence of Coverage (EOC, described at § 423.2267(e)(1)), and the Explanation of Benefits (EOB, described at § 423.128(e)(7)). Each has been updated to include program information through the OMB ICR process (for the EOB) or through the general annual issuance of Part D model materials (for the ANOC and EOC). In addition to meeting these requirements, we propose to codify at § 423.137(m)(2) for 2026 and subsequent years the following requirements for a Part D sponsor to include on its website:</P>
                    <P>• An election request mechanism, as described at § 423.137(d)(2).</P>
                    <P>• An overview of the Medicare Prescription Payment Plan.</P>
                    <P>• Examples of program calculations and explanations.</P>
                    <P>• A description of Part D enrollees who may be likely to benefit.</P>
                    <P>• The financial implications of program participation.</P>
                    <P>• The implications of missing monthly payments.</P>
                    <P>• Instructions for opting into and out of the program.</P>
                    <P>• A description of the standards for retroactive election when an enrollee believes that a delay in filling a prescription due to the 24-hour effectuation timeframe may seriously jeopardize their life, health, or ability to regain maximum function.</P>
                    <P>• A description of the dispute and grievance procedure, as required under § 423.137(h).</P>
                    <P>• Contact information for Part D enrollees to obtain further information.</P>
                    <P>• General information about the LIS program, including how LIS enrollment for eligible individuals is likely to be more advantageous than participation in the Medicare Prescription Payment Plan.</P>
                    <P>We also propose to amend § 423.2265(b) to add paragraph (b)(16) to include information on the Medicare Prescription Payment Plan as required content for Part D sponsor websites.</P>
                    <P>Additionally, as described in the final part two guidance, Part D sponsors may also include information on the Medicare Prescription Payment Plan in their marketing materials. In developing their materials, Part D sponsors must ensure that the materials accurately convey program information and are compliant with existing Part D requirements specified at 42 CFR part 423 subpart V. Part D sponsors should also refer to the MCMG, which provides guidance and examples regarding what constitutes a marketing material, the rules and processes for sponsor submission of those marketing materials using HPMS, and use of marketing materials.</P>
                    <P>
                        CMS is aware that health care providers and pharmacists play a key role in cost-of-care conversations with their patients that can include 
                        <PRTPAGE P="99375"/>
                        discussions about potential prescription drug costs. As noted in the final part two guidance, CMS encourages Part D sponsors to include information about the Medicare Prescription Payment Plan in their communications with contracted providers and network pharmacies. More specifically for contracted providers, CMS encourages Part D sponsors to target these communications to subgroups of providers based on provider specialty and likelihood of prescribing high cost covered Part D drugs.
                    </P>
                    <P>With regard to network pharmacies, CMS encourages Part D sponsors to provide pharmacies with education and resources related to the Medicare Prescription Payment Plan. While some pharmacies, such as specialty pharmacies, may be more likely to dispense high-cost drugs that trigger the POS notification, all pharmacy types would benefit from program resources and a thorough understanding of how the Medicare Prescription Payment Plan works and how it can benefit participants.</P>
                    <P>The CMS-developed fact sheet may serve as a useful tool for Part D sponsors to communicate information on the Medicare Prescription Payment Plan with both contracted providers and pharmacies.</P>
                    <P>We are not scoring any aspects of this provision related to the inclusion of Medicare Prescription Payment Plan information in the ANOC, EOC, or EOB in the Collection of Information section of this rule since we believe all information impacts of those provisions have already been accounted for under OMB control numbers 0938-1051 and 0938-1228. We are also not scoring the requirement to provide the election request form, as we believe the information impact of that provision has already been accounted for under OMB control number 0938-1475.</P>
                    <HD SOURCE="HD3">(m) Severability</HD>
                    <P>The Medicare Prescription Payment Plan provisions proposed herein are separate and severable from one another. If any of these provisions, once finalized, is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, or stayed pending further agency action, it is our intention that such provision shall be severable from this rule and not affect the remainder thereof, or the application of such provision to other persons not similarly situated or to other, dissimilar circumstances.</P>
                    <HD SOURCE="HD1">III. Strengthening Current Medicare Advantage, Medicare Prescription Drug Benefit, and Medicaid Program Policies</HD>
                    <HD SOURCE="HD2">A. Part D Coverage of Anti-Obesity Medications (AOMs) (§ 423.100) and Application to the Medicaid Program</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>
                        The statutory definition of a covered Part D drug at section 1860D-2(e)(2) of the Social Security Act (the Act) excludes certain drugs and uses—specifically, those that may be excluded by Medicaid under section 1927(d)(2) of the Act. This includes “[a]gents when used for anorexia, weight loss, or weight gain.” Since the drugs, classes of drugs, and medical uses listed in section 1927(d)(2) of the Act “
                        <E T="03">may</E>
                         be excluded from coverage” (emphasis added) under Medicaid, state Medicaid programs have discretion over whether to provide such coverage, whereas Medicare does not. Since the beginning of the Part D program in 2006, CMS has interpreted the statutory exclusion of “[a]gents when used for . . . weight loss . . . ” at section 1927(d)(2)(A) of the Act to mean that a drug when used for weight loss, even when not used for cosmetic purposes, is excluded from the definition of covered Part D drug.
                        <SU>21</SU>
                        <FTREF/>
                         All drugs used for weight loss have been excluded historically from the definition of covered Part D drug and considered to be an optional benefit under the Medicaid program, at the discretion of the state Medicaid program, regardless of their use to treat the disease of obesity. Drugs used for weight loss or chronic weight management can be covered by Part D plans only as a supplemental benefit.
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             73 FR 20489-20490 in “Medicare Program; Policy and Technical Changes to the Medicare Prescription Drug Benefit” published April 15, 2008 (73 FR 20486). However, CMS's longstanding interpretation of the phrase “[a]gents when used for . . . weight 
                            <E T="03">gain</E>
                             . . . ” (emphasis added) in the same section of the Act has not included drugs used to treat acquired immunodeficiency syndrome (AIDS) wasting and cachexia (73 FR 20490).
                        </P>
                    </FTNT>
                    <P>
                        Multiple medical and scientific organizations consider obesity to be a chronic disease.
                        <E T="51">22 23 24 25</E>
                        <FTREF/>
                         In its 2013 resolution to recognize obesity as a disease, the American Medical Association (AMA) noted that although obesity is characterized by increased adiposity (body fat), obesity is a hormonal disease state with impaired functioning of multiple metabolic processes.
                        <SU>26</SU>
                        <FTREF/>
                         Similarly, the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) recognizes obesity as a chronic disease state with adiposity-based complications and pathophysiologic processes resulting from the dysregulated secretion of inflammatory and hormonal factors from fat cells.
                        <SU>27</SU>
                        <FTREF/>
                         Obesity increases the risk of, or exacerbates, hypertension, dyslipidemia, type 2 diabetes, cardiovascular disease, obstructive sleep apnea, nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), and some cancers, among other conditions.
                        <SU>28</SU>
                        <FTREF/>
                         Obesity also is associated with increased risk of all-cause mortality and death due to cardiovascular disease.
                        <SU>29</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             Recognition of Obesity as a Disease H-440.842. Accessed June 28, 2024 from 
                            <E T="03">https://policysearch.ama-assn.org/policyfinder/detail/obesity?uri=%2FAMADoc%2FHOD.xml-0-3858.xml.</E>
                        </P>
                        <P>
                            <SU>23</SU>
                             CDC. Adult Obesity Facts. May 14, 2024. Accessed June 28, 2024 from 
                            <E T="03">https://www.cdc.gov/obesity/php/data-research/adult-obesity-facts.html.</E>
                        </P>
                        <P>
                            <SU>24</SU>
                             Mechanick J.I., Garber A.J., Handelsman Y, Garvey W.T. American Association of Clinical Endocrinologists' position statement on obesity and obesity medicine. Endocr Pract. 2012 Sep-Oct;18(5):642-8. doi: 10.4158/EP12160.PS.
                        </P>
                        <P>
                            <SU>25</SU>
                             World Health Organization. Obesity and Overweight. March 1, 2024. Accessed August 21, 2024 from 
                            <E T="03">https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             American Medical Association House of Delegates. Resolution 420 (A-13). Recognition of Obesity as a Disease. May 15, 2013. Available from: 
                            <E T="03">https://media.npr.org/documents2013/jun/ama-resolution-obesity.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             Mechanick J.I., Hurley D.L., Garvey W.T. Adiposity-Based Chronic Disease As a New Diagnostic Term: The American Association of Clinical Endocrinologists and American College Of Endocrinology Position Statement. Endocr Pract. 2017 Mar;23(3):372-378. doi: 10.4158/EP161688.PS.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             American Association of Clinical Endocrinologists and American College of Endocrinology Comprehensive Clinical Practice Guidelines for Medical Care of Patients with Obesity, Endocrine Practice, Volume 22, Supplement 3, 2016, Pages 1-203, 
                            <E T="03">https://doi.org/10.4158/EP161365.GL.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             Jensen M.D., Ryan D.H., Apovian C.M., et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society [published correction appears in Circulation. 2014 Jun 24;129(25 Suppl 2):S139-40]. 
                            <E T="03">Circulation.</E>
                             2014;129(25 Suppl 2):S102-S138. doi:10.1161/01.cir.0000437739.71477.ee.
                        </P>
                    </FTNT>
                    <P>
                        The prevalence of obesity in both the United States (U.S.) population, and in the Medicare population more specifically, has increased since the beginning of the Part D program. According to the Centers for Disease Control and Prevention (CDC), the prevalence of obesity (defined by CDC as body mass index [BMI] of 30 kg/m
                        <SU>2</SU>
                         or greater) in the U.S. population increased from 30.5 percent in 1999 to 2000 to 41.9 percent from 2017 to March 2020.
                        <SU>30</SU>
                        <FTREF/>
                         The prevalence of obesity from 2017 to March 2020 was 49.9 percent of non-Hispanic Black adults, 45.6 percent 
                        <PRTPAGE P="99376"/>
                        of Hispanic adults, 41.4 percent of non-Hispanic white adults, and 16.1 percent of non-Hispanic Asian adults.
                        <SU>31</SU>
                        <FTREF/>
                         With respect to the Medicare population, CMS data indicate that approximately 22 percent of all Medicare beneficiaries had a diagnosis of obesity in 2022 
                        <SU>32</SU>
                        <FTREF/>
                         compared to 8.7 percent in 2012.
                        <SU>33</SU>
                        <FTREF/>
                         As of 2020, the proportion of Medicare fee-for-service beneficiaries with obesity was 24 percent of the Black/African American population, 19 percent of the White population, 18 percent of the Hispanic population, 17 percent of the American Indian/Alaska Native population, and 7 percent of the Asian/Pacific Islander population.
                        <SU>34</SU>
                        <FTREF/>
                         However, obesity prevalence based on Medicare claims data likely underestimates actual obesity prevalence in the Medicare population since data are dependent on the degree to which obesity was recorded as a diagnosis code on medical claims. This assumption is supported by the fact that available National Health and Nutrition Examination Survey (NHANES) data from 2017 to March 2020 indicate that the prevalence of obesity in the U.S. population age 60 and older was 41.5 percent, which parallels the trend in the general U.S. population described in the CDC statistics and is much higher than the obesity prevalence calculated based on Medicare claims data.
                        <SU>35</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             CDC. Adult Obesity Facts. May 14, 2024. Available from 
                            <E T="03">https://www.cdc.gov/obesity/adult-obesity-facts/index.html.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             Stierman, B., et al. National Health and Nutrition Examination Survey 2017-March 2020 Prepandemic Data Files—Development of Files and Prevalence Estimates for Selected Health Outcomes. 2021. Available from 
                            <E T="03">https://stacks.cdc.gov/view/cdc/106273.</E>
                             Note that race and ethnicity categories reflect the 1997 Standards for the Classification of Federal Data on Race and Ethnicity (62 FR 58782) which have since been updated in 2024 (89 FR 22182).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             Internal analysis of 2022 Chronic Conditions Data.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             Chronic Conditions Data Warehouse. Other Chronic or Disabling Conditions Trends, 2012-2021. April 2023. Available from: 
                            <E T="03">https://www2.ccwdata.org/web/guest/medicare-charts/medicare-other-chronic-and-disabling-condtions/#b2bothertrend.</E>
                             See also: 
                            <E T="03">https://www2.ccwdata.org/documents/10280/19099072/b2b-other-trend.jpg.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             Obesity Disparities in Medicare Fee-For-Service Beneficiaries Data Snapshot. January 2022. Available from: 
                            <E T="03">https://www.cms.gov/files/document/omh-datasnapshot-obesity.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             Stierman, B., et al. National Health and Nutrition Examination Survey 2017-March 2020 Prepandemic Data Files—Development of Files and Prevalence Estimates for Selected Health Outcomes. 2021. Available from 
                            <E T="03">https://stacks.cdc.gov/view/cdc/106273.</E>
                        </P>
                    </FTNT>
                    <P>
                        Data on obesity prevalence across the entire Medicaid population are limited. For example, available state-level data indicate that 43.7 percent of adult Medicaid enrollees in Rhode Island had obesity in 2017 to 2018, which was similar to the rate of obesity in the U.S. adult population at the same time (42.4 percent), but higher than the prevalence of obesity among adults in the state with commercial insurance (36.0 percent).
                        <E T="51">36 37</E>
                        <FTREF/>
                         The prevalence of obesity varies by state; 
                        <SU>38</SU>
                        <FTREF/>
                         therefore, the prevalence of obesity among each state's Medicaid enrollees may be proportional.
                    </P>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             
                            <E T="03">https://www.niddk.nih.gov/health-information/health-statistics/oversight-obesity.</E>
                        </P>
                        <P>
                            <SU>37</SU>
                             Mylona E.K., Benitez G., Shehadeh F., Fleury E., Mylonakis S.C., Kalligeros M., Mylonakis E. The association of obesity with health insurance coverage and demongraphic characteristics: a statewide cross-sectional study. Medicince (Baltimore). 2020 Jul 2;99(27):e21016. doi: 10.1097/MD.0000000000021016.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             
                            <E T="03">https://www.cdc.gov/obesity/php/data-research/adult-obesity-prevalence-maps.html#cdc_data_surveillance_section_4-across-states-and-territories.</E>
                        </P>
                    </FTNT>
                    <P>
                        Given the prevalence and the impact of obesity in the U.S., the Biden-Harris Administration released the National Strategy on Hunger, Nutrition, and Health focused on ending hunger and reducing diet-related diseases such as obesity.
                        <SU>39</SU>
                        <FTREF/>
                         One of the Strategy's pillars is integrating nutrition and health, which recognizes the opportunities within Medicare and Medicaid to support beneficiaries' access to nutritious foods, obesity counseling, and other nutrition-related services. Reinterpreting the statute to provide for coverage for AOMs for individuals who have obesity would build on that National Strategy by offering another tool that can support Medicare and Medicaid beneficiaries in addressing obesity and living healthier lives. Further, CMS believes that excluding AOMs from Part D coverage has created a scenario where Medicare Part D enrollees with obesity have been unable to access drug therapy to treat what is recognized as a chronic disease, potentially exacerbating health disparities in groups disproportionately affected by obesity.
                    </P>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             White-House-National-Strategy-on-Hunger-Nutrition-and-Health-FINAL.pdf.
                        </P>
                    </FTNT>
                    <P>
                        Available AOMs in the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist classes contain the same active ingredients initially approved by the U.S. Food and Drug Administration (FDA) to improve glycemic control in patients with type 2 diabetes, and later approved to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. One AOM in the GLP-1 receptor agonist class has received FDA approval for the reduction of the risk of major adverse cardiovascular events in non-diabetic adults with established cardiovascular disease and either obesity or overweight.
                        <SU>40</SU>
                        <FTREF/>
                         The scientific evidence on AOMs continues to evolve—novel AOMs are in development or new indications for existing AOMs may be approved in the future. A medically accepted indication (MAI), as defined in section 1860D-2(e)(4) of the Act, refers, in part, to the definition of MAI in section 1927(k)(6) of the Act. CMS issued guidance on March 20, 2024 via a Health Plan Management System (HPMS) email clarifying that AOMs that receive FDA approval for an additional indication other than chronic weight management can be considered a Part D drug for that specific use since the use is an MAI that is not a use that is excluded from the definition of a Part D drug.
                        <SU>41</SU>
                        <FTREF/>
                         Therefore, under current policy, AOMs are coverable under Part D for individuals with obesity or overweight only if the drug is being prescribed for another condition (other than weight loss or chronic weight management) for which the drug has an FDA-approved indication or its use is supported by CMS-approved compendia.
                        <SU>42</SU>
                        <FTREF/>
                         Currently, this means that AOMs (or drugs with the same active ingredients) are coverable under Part D for individuals with obesity or overweight for the FDA-approved uses of glycemic control in patients with type 2 diabetes, reduced risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease, reduced risk of major adverse cardiovascular events in non-diabetic adults with established cardiovascular disease. Should our proposed reinterpretation be finalized, Part D enrollees with obesity could receive coverage for AOMs even in cases where the AOM is prescribed for treatment of obesity, and not prescribed for another condition that is an FDA-approved indication or that is supported by CMS-approved compendia.
                    </P>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             Table: GLP-1 and GIP/GLP-1 receptor agonists for chronic weight management. Med Lett Drugs Ther. 2024 Aug 5;66(1708):e1-e2. doi: 10.58347/tml.2024.1708d.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             HPMS email. Part D Coverage of Anti-Obesity Medications with Medically Accepted Indications. March 20, 2024. Available from: 
                            <E T="03">https://www.cms.gov/about-cms/information-systems/hpms/hpms-memos-archive-weekly/hpms-memos-wk-4-march-18-22.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             CMS-approved compendia are described in section 1927(g)(1)(B)(i) of the Act. The recognized compendia are American Hospital Formulary Service Drug Information and DRUGDEX® Information System. See section 10.6 in chapter 6 of the Prescription Drug Benefit Manual. Available from 
                            <E T="03">https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/downloads/part-d-benefits-manual-chapter-6.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        While we refer to AOMs generally throughout the discussion of this proposed reinterpretation and have referred to specific classes of AOMs, this proposal is not limited to particular drugs or drug classes. Currently 
                        <PRTPAGE P="99377"/>
                        available AOMs achieve therapeutic action through a variety of mechanisms including slowed gastric emptying, inhibiting dietary fat absorption, and targeting receptor pathways in the brain that are involved in hunger, cravings, and feelings of fullness. We also acknowledge that “AOM” is a term used pervasively throughout the medical literature but is not a term used by the FDA in reference to drug development. For purposes of this proposal, we use the term “AOM” to refer to products (drugs and biologicals) for the indication of weight management that are intended to be used for medical weight loss, as described in FDA draft guidance 
                        <SU>43</SU>
                        <FTREF/>
                        , consistent with clinical practice guidelines.
                        <SU>44</SU>
                        <FTREF/>
                         We also acknowledge that AOMs, when used for medical weight loss, are generally indicated to reduce excess body weight and maintain weight reduction long-term, and not overtly for “treatment of obesity.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             FDA. Draft Guidance for Industry Developing Products for Weight Management. February 2007. Available from 
                            <E T="03">https://www.fda.gov/media/71252/download.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             American Association of Clinical Endocrinologists and American College of Endocrinology Comprehensive Clinical Practice Guidelines for Medical Care of Patients with Obesity, Endocrine Practice, Volume 22, Supplement 3, 2016, Pages 1-203, 
                            <E T="03">https://doi.org/10.4158/EP161365.GL.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Proposed Reinterpretation</HD>
                    <P>Given the changes in how the medical community has come to regard obesity as a disease since the start of the Part D program, CMS believes that its longstanding interpretation of the reference in section 1927(d)(2) of the Act to “[a]gents when used for . . . weight loss” as including AOMs when used for weight loss or chronic weight management regardless of whether the AOMs were used to treat obesity reflects an outdated medical understanding, and that it would be more consistent with current medical views to propose to reinterpret the phrase “[a]gents when used for . . . weight loss” to exclude AOMs when used for the treatment of obesity. As a result of this proposed reinterpretation, AOMs— when used for weight loss or chronic weight management for the treatment of obesity—would no longer be excluded from Part D coverage based on section 1860D-2(e)(2) of the Act, which prohibits Part D coverage of “drugs or classes of drugs. . .which may be excluded from coverage or otherwise restricted under section 1927(d)(2).” In addition, CMS would no longer consider AOMs when used for weight loss or chronic weight management for the treatment of obesity to be excluded from the definition of Part D drug at § 423.100, which at paragraph (2)(ii) excludes drugs that may be excluded from Medicaid coverage under section 1927(d)(2). Our proposal is not contingent on the underlying etiology of obesity (for example, due to unspecified causes or specified causes such as drug-induced obesity or obesity due to specific genetic variants or syndromes) and would encompass any drugs that are indicated for weight loss or chronic weight management for the treatment of obesity. In table 2., we provide examples to illustrate the effect of our proposal on AOM coverage in Medicare Part D.</P>
                    <P>
                        This proposed reinterpretation would align with our longstanding policy interpreting the phrase “[a]gents when used for. . .weight gain” in section 1927(d)(2)(A) to not include drugs used to treat acquired immunodeficiency syndrome (AIDS) wasting and cachexia (73 FR 20490).
                        <SU>45</SU>
                        <FTREF/>
                         CMS believes that its longstanding interpretation of the phrase “[a]gents when used for . . . weight gain” in section 1927(d)(2)(A) is correct, and by adjusting its interpretation of “[a]gents when used for . . . weight loss,” we would be bringing the interpretation of these two phrases into alignment.
                    </P>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             Since the inception of the Part D program, CMS has aligned Part D with the Medicaid policy that prescription drug products being used to treat AIDS wasting and cachexia are not considered agents used for weight gain, and therefore such products are not excluded under in section 1927(d)(2)(A) of the Act. The Medicaid policy was effective April 5, 1999. See Medicaid Drug Rebate Program Release #88. March 5, 1999. Available from 
                            <E T="03">https://www.medicaid.gov/medicaid-chip-program-information/by-topics/prescription-drugs/downloads/rx-releases/state-releases/state-rel-088.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We are not proposing to reinterpret the statutory exclusion of “[a]gents when used for . . . weight loss” in section 1927(d)(2) of the Act to permit Part D coverage of AOMs when used for weight loss or chronic weight management in individuals with overweight, even if such individuals have weight-related comorbid conditions. We are not proposing such a change in interpretation because, unlike obesity, overweight is not recognized as a disease. The FDA-approved indications for most AOMs used for weight loss or chronic weight management specify that individuals with overweight must also have weight-related conditions, but there is no such requirement for the presence of comorbid conditions in individuals with obesity. We believe this supports recognizing obesity as a distinct disease. Our proposal to limit the reinterpretation to AOMs used for weight loss or weight management for the treatment of obesity is based on the distinction between obesity as a disease and overweight, which is not recognized as a disease, but may occur in combination with other conditions that are weight related. As we have discussed, some AOMs are FDA-approved to improve glycemic control in patients with type 2 diabetes and reduce major cardiovascular events in adults with established cardiovascular disease (in adults with type 2 diabetes, obesity, or overweight), independent of the indication for weight loss or chronic weight management. AOMs that have received FDA approval for these uses have demonstrated effectiveness in these conditions (which are common weight-related conditions) independent of weight loss. Therefore, we believe that for individuals with overweight, the current policy for coverage under Part D should be maintained to permit coverage of an AOM when the AOM is used for a weight-related condition for which the AOM has demonstrated effectiveness independent of weight loss and is an MAI. By contrast, in obesity, we consider weight loss to be the mechanism for reducing excess adiposity and mitigating its accompanying hormonal and metabolic dysregulation. We acknowledge, however, that by limiting our proposed reinterpretation, we could create a perverse incentive for some individuals with overweight to gain additional weight in order to meet criteria for obesity. We solicit comment on our proposed reinterpretation, including our underlying assumptions and the decision not to extend our reinterpretation of the statutory exclusion to provide that individuals with overweight and at least one weight-related comorbidity could receive coverage of AOMs for weight loss or chronic weight management under Part D.</P>
                    <P>
                        We are not proposing a definition of obesity for the purpose of determining eligibility for Part D coverage of AOMs. Obesity is most commonly defined as a BMI of 30 kg/m 
                        <SU>2</SU>
                         or greater, but AACE/ACE has described the limitations of relying on BMI alone to adequately characterize obesity as a chronic disease of excess adiposity.
                        <E T="51">46 47</E>
                        <FTREF/>
                         For purposes of 
                        <PRTPAGE P="99378"/>
                        defining “individuals at risk for diabetes” who may receive diabetes screening tests, section 1861(yy)(2)(C) of the Act defines obesity as a BMI greater than or equal to 30 kg/m 
                        <SU>2</SU>
                        . Some available AOMs specify obesity as a BMI greater than or equal to 30 kg/m 
                        <SU>2</SU>
                         in the FDA-approved indication. The FDA-approved indications for other AOMs initially specified obesity as a BMI greater than or equal to 30 kg/m 
                        <SU>2</SU>
                        , but the indications have since been revised and reference to a specific BMI has been removed. We would permit Part D sponsors to define obesity for the purposes of their prior authorization (PA) criteria as long as the Part D sponsor's PA criteria are not more restrictive than the FDA labeling for the particular AOM. This approach is consistent with other disease states for which CMS does not specify diagnostic criteria, but reviews Part D plan-submitted PA criteria for clinical appropriateness.
                    </P>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             American Association of Clinical Endocrinologists and American College of Endorinology Comprehensive Clinical Practice Guidlines for Medical Care of Patients with Obesity, Endocrine Pratice, Volume 22, Supplement 3, 2016, Pages 1-203, 
                            <E T="03">https://doi.org/10.4158/EP161365.GL.</E>
                        </P>
                        <P>
                            <SU>47</SU>
                             Mechanick J.I., Hurley D.L., Gavery W.T. Adiposity-Based Chronic Disease As a New Diagnostic Term: The American Association of 
                            <PRTPAGE/>
                            Clinical Endocrinologists and American College of Endocrinology Position Statement. Endor Pract. 2017 Mar;23(3):372-378. doi: 10.4158/EP161688.PS.
                        </P>
                    </FTNT>
                    <P>As required under § 423.120(b)(1)(vi), Part D sponsors' Pharmacy and Therapeutics (P&amp;T) committees are required to consider the therapeutic advantages in terms of safety and efficacy of Part D drugs that are included in the plan formulary. This process includes drug-specific safety considerations for the elderly or individuals with disabilities. Further, as required under § 423.120(b)(1)(x), Part D sponsors' P&amp;T committees must review utilization management (UM) criteria for clinical appropriateness. CMS maintains a robust, clinical formulary review process to ensure that all Part D plan formularies comply with statutory and regulatory requirements, including the requirement under section 1860D-11(e)(2)(D)(i) of the Act that CMS may only approve a Part D plan if it “does not find that the design of the plan and its benefits (including any formulary and tiered formulary structure) are likely to substantially discourage enrollment by certain Part D eligible individuals under the plan.” As part of the formulary content review, CMS reviews submitted UM criteria, which include PA criteria and step therapy (ST) requirements, to ensure these criteria are consistent with the FDA labeling and widely used treatment guidelines, as appropriate. Recognizing that obesity is a chronic disease and weight gain is common if drug therapy for obesity is discontinued, we would review Part D sponsors' PA criteria for AOMs in the same manner that we would review the PA criteria for drugs used to treat other chronic conditions that require ongoing drug therapy to maintain successful treatment. PA criteria for AOMs that are overly restrictive may be deemed to be inconsistent with CMS' formulary review requirements if the criteria appear to be likely to substantially discourage enrollment of individuals with obesity in the Part D plan. Similarly, CMS would not approve ST requirements for AOMs that are inconsistent with clinical guidelines.</P>
                    <P>
                        In general, Part D sponsors must cover formulary drugs for all FDA-approved indications that are not excluded from Part D coverage.
                        <SU>48</SU>
                        <FTREF/>
                         Most available AOMs are also indicated for use in individuals with overweight with weight-related comorbid conditions. A weight-related comorbid condition might include, for example, hypertension, type 2 diabetes, dyslipidemia, sleep apnea, or cardiovascular disease. As stated previously, some available AOMs contain the same active ingredients approved by the FDA to improve glycemic control in patients with type 2 diabetes and reduce major cardiovascular events in adults with established cardiovascular disease and type 2 diabetes, and one AOM has received FDA approval to reduce the risk of major adverse cardiovascular events in non-diabetic adults with established cardiovascular disease and either obesity or overweight. Therefore, individuals with type 2 diabetes or established cardiovascular disease (with type 2 diabetes, obesity, or overweight) are already eligible for AOM coverage under current policy because these FDA-approved indications are distinct from the indication of weight loss or chronic weight management. Should our reinterpretation be finalized as proposed, individuals with obesity would be eligible for AOM coverage covered regardless of weight-related comorbid conditions. In comparison, AOMs used for weight loss or chronic weight management in individuals with overweight, who do not have another condition that is an MAI for the AOM, would continue to be excluded from the definition of a Part D drug and would not be coverable under Part D. In other words, Part D sponsors would continue to exclude drugs with FDA-approved indications of weight loss or chronic weight management in individuals with overweight with weight-related comorbidities from Part D coverage, unless the individual has another condition that is an MAI for the AOM. See examples in table 2 illustrating the effect of our proposal as it relates to AOM coverage for individuals with overweight. Consistent with current guidance, CMS expects Part D sponsors to consistently utilize PA for drugs with the highest likelihood of non-Part D covered uses, including when there is a high likelihood that a drug's medical use is excluded from Part D coverage.
                        <SU>49</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             HPMS memorandum. Issuance of the 2010 Call Letter. March 30, 2009. Available from 
                            <E T="03">https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/downloads/2010callletter.pdf.</E>
                             Note, Part D sponsors may limit PA criteria to cover only certain FDA-approved indications if they are implementing indication-based formulary design, consistent with the August 29, 2018 HPMS memorandum, “Indication-Based Formulary Design Beginning in Contract Year (CY) 2020.” Available from: 
                            <E T="03">https://www.cms.gov/research-statistics-data-and-systems/computer-data-and-systems/hpms/hpms-memos-archive-weekly-items/syshpms-memo-2018-aug-29th.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             See section 30.2.2.3 in chapter 6 of the Prescription Drug Benefit Manual. Available from 
                            <E T="03">https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/downloads/part-d-benefits-manual-chapter-6.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Impact on Medicaid Coverage</HD>
                    <P>
                        Our proposal to reinterpret the reference to “[a]gents when used for . . . weight loss” in section 1927(d)(2)(A) of the Act to allow for Medicare Part D coverage of drugs used for the treatment of obesity would also apply to the Medicaid program. Since both Medicaid and Medicare reference the Medicaid definition of covered outpatient drugs in section 1927(k)(2) of the Act and rely on section 1927(d)(2)(A) of the Act for what may constitute “[a]gents when used for . . . weight loss,” it follows that CMS should apply the same interpretation of these provisions for Medicare and Medicaid. Thus, if finalized, our proposed reinterpretation would mean that AOMs, when used for weight loss or chronic weight management for the treatment of obesity, could not be excluded from Medicaid drug coverage. States would continue to have the discretion to utilize preferred drug lists and PA to establish certain limitations on the coverage of these drugs as long as such practices are consistent with the requirements of section 1927(d) of the Act to ensure appropriate utilization. In the case of an individual without obesity seeking coverage for an AOM for weight loss or chronic weight management, a state's coverage determinations and State Plan requirements related to “[a]gents when used for . . . weight loss,” under section 1927(d)(2)(A) of the Act would govern. AOMs and drugs that contain the same active ingredient as AOMs that meet the definition of a covered outpatient drug are already subject to section 1927 requirements, and 
                        <PRTPAGE P="99379"/>
                        Medicaid must cover those products when the prescribed use is an MAI other than weight loss or chronic weight management when they are medically necessary. In table 2, we provide examples to illustrate the effect of our proposal on AOM coverage in Medicaid.
                    </P>
                    <P>We believe that our proposed interpretation for the Medicaid program is consistent with the relevant statutory provisions and with our reinterpretation for the Medicare program and would result in the same benefits and achieve the same goals for the Medicaid program as those articulated for the Medicare program. This proposed policy is intended to facilitate access to these medications for individuals who meet the criteria for obesity whether they are enrolled in Medicaid, Medicare, or both.</P>
                    <P>We seek comments on how this interpretation can best be implemented for state Medicaid programs and Medicaid enrollees. Among other areas, we seek comment on potential interactions with rate setting and coverage standards for Medicaid managed care plans, and ways to ensure adequate notice to beneficiaries and other stakeholders of the changes resulting from this interpretation should this proposal be finalized.</P>
                    <HD SOURCE="HD3">4. Coverage Considerations</HD>
                    <P>CMS is considering what an appropriate applicability date for the reinterpretation in the Part D program would be in light of section 1860D-12(f) of the Act and § 423.516, which provide that CMS may not implement, other than at the beginning of a calendar year, regulations that impose new, significant regulatory requirements on a prescription drug plan (PDP) sponsor or a PDP, and seeks comment on this issue.</P>
                    <P>We have not identified any similar basis for delaying the applicability date for Medicaid to align with a Part D applicability date at the beginning of a calendar year. Accordingly, any reinterpretation of section 1927(d)(2) of the Act would be applicable under the Medicaid program as of the effective date of the rule in which this provision is finalized. Therefore, should this proposal be finalized, state Medicaid programs that provide drug coverage would generally be required to provide coverage of AOMs for weight loss or chronic weight management for treating obesity in Medicaid-enrolled individuals as of the effective date of the final rule, which is generally 60 days after the final rule is published. Should the proposed reinterpretation be applicable to Medicare at the beginning of a calendar year, consistent with section 1860D-12(f) of the Act and § 423.516, there could be a time period during which AOMs used for weight loss or chronic weight management for treatment of obesity would be required to be covered by state Medicaid programs that cover prescription drugs, but would not be covered by Part D. As a result, Medicaid programs that provide drug coverage would be required to cover AOMs used for weight loss or chronic weight management for certain dually eligible individuals until such time as Part D coverage began.</P>
                    <P>We invite commenters to share feedback on the impact of this reinterpretation to Part D sponsors and their enrollees. We also solicit comments on the impact of our proposal on state Medicaid programs and Medicaid enrollees, including dually eligible enrollees. Specifically, we seek comment on the implications of aligning or not aligning the applicability dates for coverage under Medicaid and Medicare. We also seek comments on implementation considerations this proposal might raise under Medicaid, including related to any potential coverage changes, state plan changes, coordination of care, or budget implications, and any implications related to state contracts with Medicaid managed care organizations.</P>
                    <HD SOURCE="HD3">5. Summary</HD>
                    <P>In summary, due to changes in the prevailing medical consensus towards recognizing obesity as a disease, we are re-evaluating Part D coverage of AOMs for Medicare beneficiaries with obesity who do not have another condition for which an AOM is indicated and for whom the prescribed use would be otherwise coverable under Part D. As a result of our proposed reinterpretation of the phrase “[a]gents when used for . . . weight loss” in section 1927(d)(2) of the Act, AOMs that are used for treating obesity and that otherwise meet the definition of Part D drug at § 423.100 would no longer be excluded from Part D coverage pursuant to the exclusion in paragraph (2)(ii) of that definition for drugs that may be excluded from Medicaid coverage under section 1927(d)(2) of the Act. Our proposed reinterpretation would also apply to Medicaid such that state Medicaid programs would no longer have the discretion to exclude AOMs from Medicaid drug coverage as “[a]gents when used for . . . weight loss” when used for weight loss or weight management for the treatment of obesity. If our reinterpretation is finalized as proposed, states that are not already covering AOMs for weight loss or weight management would be required to do so to treat obesity in Medicaid enrollees with obesity. AOMs, when used for weight loss or chronic weight management in individuals who do not have obesity, would continue to be excluded from the definition of Part D drug, and may be excluded at state option from coverage by state Medicaid programs, unless the AOM is being used for a condition other than weight loss or chronic weight management for which such use would be covered as an MAI as defined in section 1927(k)(6) of the Act.</P>
                    <P>We solicit comment on this proposal.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99380"/>
                        <GID>EP10DE24.005</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <PRTPAGE P="99381"/>
                    <HD SOURCE="HD2">B. Network Transparency for Pharmacies</HD>
                    <P>At § 423.505(i), we propose to require Part D sponsors to notify network pharmacies which plans the pharmacies will be in-network for in a given plan year by October 1 of the year prior to that plan year. We also propose to require sponsors to provide pharmacies with such a list of in-network plans on request after October 1. We believe this change is necessary to ensure that pharmacies can provide their customers with accurate information about which plans the pharmacy is participating in.</P>
                    <P>Part D sponsors contract with network pharmacies, either directly or through pharmacy benefit managers (“PBMs”), to provide Part D drugs to their enrollees. Sponsors and PBMs can contract with pharmacies at any time, but they generally perform most of their contracting activities for a plan year in the winter and spring of the prior year (for example, between January and May of 2024 for the 2025 plan year). However, sponsors do not submit bids for their Part D plans until the first Monday in June of the year prior to the plan year (for example, bids for the 2025 plan year were submitted by June 3, 2024) and do not receive final approval of those bids until August. Because sponsors and PBMs typically offer more than one plan in a service area, sometimes under more than one contract and under more than one marketing name, neither they nor the pharmacies they contract with know which plans will be served by the networks the pharmacies agree to join until months after executing network contracts.</P>
                    <P>
                        Pharmacies often do not have the ability to meaningfully negotiate with or demand clear information from PBMs and plans regarding which networks they will participate in. Congress and the Federal Trade Commission (“FTC”) have initiated inquiries into PBM practices, including pharmacy contracting practices, in recent years. The FTC determined that large PBMs employ “lopsided and unfair contracting practices” that prevent pharmacies, particularly smaller pharmacies not affiliated with large chains, from engaging in meaningful negotiations about contracting terms, including monetary and non-monetary terms.
                        <SU>50</SU>
                        <FTREF/>
                         The FTC highlighted PBM's practice of unilaterally amending contracts by requiring pharmacies to opt out of new terms, rather than affirmatively opt in, as making it difficult for pharmacies to understand what terms apply at any given time.
                        <SU>51</SU>
                        <FTREF/>
                         This “passive contracting” often changes the networks pharmacies participate in with little notice or clear communication.
                        <SU>52</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             Federal Trade Commission, “Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies: Interim Staff Report”, July 2024, available at 
                            <E T="03">https://www.ftc.gov/reports/pharmacy-benefit-managers-report,</E>
                             pp. 48-49.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             
                            <E T="03">Id</E>
                            , at p. 50.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>Part D beneficiaries often base their enrollment decisions in part on whether the pharmacies they wish to use are in a plan's network. At the beginning of each plan year, CMS commonly receives complaints from beneficiaries reporting that they enrolled in a plan because they believed their preferred pharmacy was in the network, only to discover that it was not when they attempted to fill a prescription. These beneficiaries often request special enrollment periods (“SEP”) based on this misunderstanding. Beneficiaries may ask their pharmacies which plans the pharmacies are or will be in network for prior to selecting a plan. Pharmacies have reported to CMS that they often do not know which plans they will be in network for in the following plan year unless they check Medicare Plan Finder (“MPF”). While the individuals can use MPF to identify whether a particular pharmacy is in a particular plan for the following plan year during the AEP, MPF does not provide users a comprehensive list of all the plans in a service area that a particular pharmacy is in network for. Rather, a user must select each Part D plan to identify whether the pharmacy is in network. Pharmacies report that this cumbersome process hinders their ability to provide timely and accurate information to their Part D-eligible customers during the AEP in particular.</P>
                    <P>In order to allow pharmacies to provide accurate information to Part D beneficiaries about their network participation, we propose to require sponsors (or first tier, downstream, or related entities (“FDRs”), such as PBMs, on the sponsors' behalf) to provide each network pharmacy a list of the plans the network pharmacy will be participating in for a plan year by October 1 of the year prior to the plan year. We propose to adopt this requirement pursuant to our authority at section 1857(e) of the Act, made applicable to Part D through section 1860D-12(b)(3)(D) of the Act, which authorizes the Secretary to adopt contract terms and conditions as necessary and appropriate, so long as those terms are not inconsistent with the Part D statute. This will allow pharmacies to efficiently provide customers accurate information about their network participation during the AEP that commences on October 15 of each year. We also propose to require that sponsors provide this information on request to network pharmacies after October 1. The information provided must include the contract number, plan ID, and marketing name for each of the sponsor's plans for which the pharmacy is in network. We propose to allow the sponsor to provide the information in hard copy and/or electronically.</P>
                    <P>We solicit comments on this proposal.</P>
                    <HD SOURCE="HD2">C. Part D Medication Therapy Management (MTM) Program Eligibility Criteria (§ 423.153(d)(2))</HD>
                    <P>Section 1860D-4(c)(2) of the Act requires all Part D sponsors to have an MTM program designed to assure, with respect to targeted beneficiaries as described in section 1860D-4(c)(2)(A)(ii) of the Act, Part D drugs are appropriately used to optimize therapeutic outcomes through improved medication use, and to reduce the risk of adverse events, including adverse drug interactions. Section 1860D-4(c)(2)(A)(ii) of the Act requires Part D sponsors to target those Part D eligible individuals who have multiple chronic diseases, are taking multiple covered Part D drugs, and are identified as likely to incur annual costs for covered Part D drugs that exceed a level specified by the Secretary. Since January 1, 2022, Part D sponsors are also required by section 1860D-4(c)(2)(A)(ii)(II) of the Act to target all at-risk beneficiaries (ARBs) in their Part D drug management program (DMP) for MTM. CMS codified the MTM targeting criteria at § 423.153(d)(2).</P>
                    <P>
                        The regulation at § 423.153(d)(2)(i)(A) specifies that to be targeted for MTM, beneficiaries must have multiple chronic diseases, with three chronic diseases being the maximum number a Part D sponsor may require for targeted enrollment. CMS established improved targeting criteria for the Part D MTM program to help ensure more consistent, equitable, and expanded access to MTM services, effective January 1, 2025, in the April 2024 final rule (89 FR 30448). Specifically, CMS finalized the provision at §  423.153(d)(2)(iii) that Part D sponsors must include all core chronic diseases in their targeting criteria for identifying beneficiaries who have multiple chronic diseases, as provided under §  423.153(d)(2)(i)(A). The 10 core chronic diseases are: (1) Alzheimer's disease; (2) Bone disease-arthritis (including osteoporosis, osteoarthritis, and rheumatoid arthritis); (3) Chronic congestive heart failure (CHF); (4) Diabetes; (5) Dyslipidemia; (6) 
                        <PRTPAGE P="99382"/>
                        End-stage renal disease (ESRD); (7) Human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS); (8) Hypertension; (9) Mental health (including depression, schizophrenia, bipolar disorder, and other chronic/disabling mental health conditions); and (10) Respiratory disease (including asthma, chronic obstructive pulmonary disease (COPD), and other chronic lung disorders). Sponsors retain the flexibility to target additional chronic diseases beyond those codified as core chronic diseases.
                    </P>
                    <P>
                        The Affordable Care Act amended the Act by adding section 1860D-4(c)(2)(C)(i), which requires all Part D sponsors to offer all enrollees targeted for MTM an annual comprehensive medication review (CMR). Part D sponsors must offer each beneficiary enrolled in the MTM program an annual CMR with written summaries in CMS' Standardized Format under § 423.153(d)(1)(vii)(B) and (D). We recognize that some MTM enrollees may suffer cognitive impairments and, therefore, may not be able to participate in the CMR. In the April 2024 final rule, CMS codified at § 423.153(d)(1)(vii)(B)(2) its longstanding policy that the pharmacist or qualified provider may perform the CMR with the beneficiary's prescriber, caregiver, or other authorized individual if the beneficiary is offered the CMR and is unable to accept the offer to participate in the CMR due to cognitive impairment. Furthermore, CMS acknowledges that beneficiaries may invite other individuals, such as their caregiver or authorized representative, to join them in the CMR 
                        <SU>53</SU>
                        <FTREF/>
                         under any circumstance. This situation is outside of the policy established under § 423.153(d)(1)(vii)(B)(2) for when the beneficiary is unable to accept the offer to participate due to cognitive impairment. CMS requires Part D sponsors to comply with all Federal and State laws regarding confidentiality and disclosure of medical records or other health and enrollment information per § 423.136. Accordingly, we expect Part D sponsors and MTM providers to comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its implementing regulations and maintain documentation of who participated in the CMR in accordance with § 423.153(d)(1)(vii)(B).
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             May 6, 2024 HPMS memorandum, Contract Year 2025 Part D Medication Therapy Management Program Guidance and Submission Instructions available at: 
                            <E T="03">https://www.cms.gov/files/document/memo-contract-year-2025-medication-therapy-management-mtm-program-submission-v050624.pdf.</E>
                        </P>
                    </FTNT>
                    <P>In response to the December 2022 proposed rule (87 FR 79452), some commenters suggested expanding the inclusion of Alzheimer's disease on the list of core chronic diseases to include other dementias such as Lewy Body disease or frontotemporal lobar degeneration. In our responses to those comments in the April 2024 final rule, we stated that we would continue to analyze chronic diseases that are highly prevalent in the Part D population, align with common targeting practices across sponsors, and are commonly treated with covered Part D drugs, where MTM services could most impact therapeutic clinical outcomes, including those suggested by the commenters, and that we may consider proposing additional core chronic diseases in future rulemaking.</P>
                    <P>
                        We agree that beneficiaries with other dementias may benefit from MTM services. Although Alzheimer's disease is the most common cause of dementia at 60 to 80 percent of dementia cases, the 2024 Alzheimer's Disease Facts and Figures Special Report: Mapping a Better Future for Dementia Care Navigation 
                        <SU>54</SU>
                        <FTREF/>
                         notes that many people with dementia, especially those over the age of 85, have two or more causes of dementia (mixed dementia) including cerebrovascular disease, hippocampal sclerosis, and Parkinson's Disease. The report discusses that it is not possible to definitively distinguish one cause of dementia from another based on symptoms alone. The same report further notes that autopsy and biomarker-based studies have found that 15 to 30 percent of individuals who met the criteria for clinical Alzheimer's dementia based on symptoms did not have the specific brain changes associated with Alzheimer's disease. Since Alzheimer's disease is just one of many possible causes of dementia, changing the core chronic disease from Alzheimer's disease to “Alzheimer's disease and dementia” would allow enrollment of more beneficiaries with other causes of dementia who could potentially benefit from MTM services.
                    </P>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             
                            <E T="03">https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        MTM services are beneficial for people with dementia. One report notes that complex medication regimens for such individuals may lead to polypharmacy and increased adverse drug reactions (ADRs) and interactions, especially if the beneficiary is taking potentially inappropriate medications (PIMs).
                        <SU>55</SU>
                        <FTREF/>
                         The same report states, for instance, that people with dementia are frequently prescribed medications that can impair cognition, such as anticholinergics or sedatives, and that antipsychotics are also often inappropriately prescribed to people with dementia to treat behaviors that can be a symptom of dementia. A CMR with a pharmacist or other trained clinician could help reduce PIM use in this population.
                        <SU>56</SU>
                        <FTREF/>
                         We believe that MTM services such as CMRs empower beneficiaries to speak with their prescribers about preventing any ADRs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             Maidment I.D., Fox C., Boustani M., Katona C. Medication management—the missing link in dementia interventions. Int J Geriatr Psychiatry. 2012 May;27(5):439-42. doi: 10.1002/gps.2745. Epub 2011 Jun 29. PMID: 21714119.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             Rao P., Hung A. Impact of medication therapy management programs on potentially inappropriate medication use in older adults: A systematic review. J Manag Care Spec Pharm. 2024 Jan;30(1):3-14. doi: 10.18553/jmcp.2024.30.1.03. PMID: 38153866; PMCID: PMC10775773.
                        </P>
                    </FTNT>
                    <P>
                        There is also evidence that access to MTM services would improve medication adherence for beneficiaries with dementia. Medication nonadherence is a common problem in people with dementia due to memory loss and cognitive impairment; one article estimated that somewhere from 33 to over 40 percent of such individuals are nonadherent to their oral antidementia medications.
                        <SU>57</SU>
                        <FTREF/>
                         The article stated that Black, Hispanic, and Asian dementia patients were more likely to be nonadherent to antidementia medications than white patients, and that MTM services significantly reduced nonadherence in Black and Hispanic dementia patients. Having a CMR has also been associated with reduced nonadherence to medications for diabetes, hypertension, and hyperlipidemia in people with Alzheimer's disease.
                        <SU>6</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             Dong X., Tsang C., Wan J., Chisolhm-Burns M., et al. Effects of Medicare Part D medication therapy management on racial/ethnic disparities in adherence to antidementia medications among patients with Alzheimer's disease and related dementias: An observational study. Exploratory Research in Clinical and Social Pharmacy. 2024 March; Volume 13, Article 100420:2667-2766. 
                            <E T="03">https://doi.org/10.1016/j.rcsop.2024.100420.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             Dong, X., Tsang, C. C. S., Zhao, S., Browning, J. A., Wan, J. Y., Chisholm-Burns, M. A., . . . Wang, J. (2021). Effects of the Medicare Part D comprehensive medication review on medication adherence among patients with Alzheimer's disease. Current Medical Research and Opinion, 37(9), 1581-1588. 
                            <E T="03">https://doi.org/10.1080/03007995.2021.1935224.</E>
                        </P>
                    </FTNT>
                    <P>
                        Therefore, we have concluded that it would be appropriate to update the list of core chronic diseases used to identify Part D enrollees who have multiple chronic diseases for purposes of determining eligibility for MTM enrollment to include not only 
                        <PRTPAGE P="99383"/>
                        Alzheimer's disease but also all other causes of dementia to improve medication adherence and to reduce the risk of adverse events. Consistent with this proposal, we propose to modify the regulatory text at § 423.153(d)(2)(iii)(A) identifying “Alzheimer's disease” as a core chronic disease to include “Alzheimer's disease and dementia” effective January 1, 2026.
                    </P>
                    <HD SOURCE="HD2">D. Part D Sponsors Must Provide Network Pharmacies Reciprocal Rights To Terminate Contracts Without Cause and Request for Information on Access to Pharmacy Services and Prescription Drugs</HD>
                    <HD SOURCE="HD3">1. Terminate Contracts Without Cause</HD>
                    <P>At § 423.505(i), we propose to require Part D sponsors to allow pharmacies to terminate their network contracts without cause after the same notice period that the sponsor is allowed to terminate network pharmacy contracts without cause. This provision would only apply if the network pharmacy contract allows terminations without cause by the sponsor; if the contract does not allow terminations without cause by the sponsor, it would not be required to allow such terminations by the pharmacy. This change would prohibit the current practice CMS has observed by some sponsors and their FDRs to only allow pharmacies to terminate their network contracts without cause after giving a relatively long period of notice (sometimes exceeding one year), while preserving their right to terminate without cause on much shorter notice. We believe this change to provide greater fairness in contracting terms is necessary to protect beneficiaries from disruptions in receiving Part D benefits that would occur if network pharmacies stop providing services before formally terminating their contracts.</P>
                    <P>Part D sponsors contract with network pharmacies, either directly or through FDRs, to their enrollees. Under § 423.505(b)(18), Part D sponsors must have a standard contract with reasonable and relevant terms and conditions of participation whereby any willing pharmacy may access the standard contract and participate as a network pharmacy. This requirement was adopted pursuant to section 1860D-4(b) of the Act, which requires prescription drug plan sponsors to permit the participation of any pharmacy that meets the terms and conditions under the plan. In addition to the standard terms and conditions that sponsors must offer to any willing pharmacy, sponsors may negotiate non-standard terms and conditions with certain pharmacies that would govern those pharmacies' participation in the sponsor's Part D network.</P>
                    <P>Both the Part D statute and regulations require that all network contracts with pharmacies, including both the standard contract and any non-standard contract a sponsor may use to contract with a network pharmacy, contain certain terms meant to protect beneficiaries and ensure compliance with Part D requirements. For example, section 1860D-4(b)(1)(E) of the Act prohibits sponsors from requiring network pharmacies to accept insurance risk in their network contracts. Section 1860D-4(m) of the Act prohibits sponsors from restricting a pharmacy from informing an enrollee of any differential between the negotiated price of, or copayment or coinsurance for, a drug or biological and a lower price the enrollee would pay for the drug or biological without using health insurance coverage. Finally, § 423.505(i) requires that contracts between sponsors and network pharmacies contain several provisions, including—</P>
                    <P>• Provisions prohibiting pharmacies from holding an enrollee liable for payment of any fees that are the responsibility of the Part D sponsor (§ 423.505(i)(3)(i));</P>
                    <P>• A provision requiring prompt payment of clean claims (§ 423.505(i)(3)(v)); and</P>
                    <P>• A provision requiring disclosure and updating of any drug pricing standards used to determine payment, in accordance with § 423.505(b)(21)(i) (§ 423.505(i)(3)(vii)).</P>
                    <P>Part D sponsors often use FDRs, such as PBMs, to contract with network pharmacies on their behalf. In accordance with § 423.505(i)(3)(iii) and (iv), contracts between sponsors and PBMs must contain the same provisions required for all FDR contracts, including a provision requiring that the PBM perform activities in a manner that complies with all applicable regulations and with the Part D sponsor's contractual obligations to CMS.</P>
                    <P>Therefore, any network pharmacy contracts a PBM enters into as part of its services to the Part D sponsor must contain the same terms that would be required for the contracts if they were directly between the sponsor and the network pharmacy.</P>
                    <P>In recent years, CMS has received an increasing number of complaints from pharmacies about sponsors' and PBMs' Part D network pharmacy contracts. Specifically, pharmacies often report being dissatisfied with reimbursement terms. Many of these pharmacies report that they would like to exit their Part D network contracts, but that they are unable to do so without providing extensive notice. Some of these reports have included copies of the executed contracts in question that include the termination terms. At least one PBM requires 3-years notice for a retail pharmacy in its network to terminate the contract without cause. The notice provisions are often not reciprocal—one PBM network contract requires at least ten months' notice from a pharmacy seeking to exit its network without cause but allows the PBM to terminate the contract without cause on a 90-day notice.</P>
                    <P>CMS has also received reports of pharmacies that are unable to formally terminate their networks contracts simply refusing to fill prescriptions for Part D beneficiaries covered by the plans using those networks. Such ad hoc refusals to fill prescriptions are very disruptive to beneficiaries. The pharmacies that refuse to fill prescriptions for a particular network continue to appear in Medicare Plan Finder and on sponsor websites as network pharmacies until and unless the plan takes action to terminate the pharmacy, which results in beneficiaries receiving misleading information about where they may obtain Part D drugs under the plans they are enrolled in. Because these refusals occur without official terminations, sponsors and PBMs do not receive advance notice of them and cannot perform the transition activities they ordinarily would when a pharmacy leaves a network. These transition activities often include notifying affected beneficiaries and arranging for transfer of prescriptions.</P>
                    <P>
                        We do not believe that pharmacies—particularly small pharmacies unaffiliated with larger chains—have the ability to negotiate such reciprocal termination terms on their own. As described in section III.B. of this proposed rule, pharmacies often do not have the ability to meaningfully negotiate with or demand clear information from PBMs and plans regarding contracting terms. Congress and the FTC have initiated inquiries into PBM practices, including pharmacy contracting practices, in recent years. The FTC determined that large PBMs employ “lopsided and unfair contracting practices” that prevent pharmacies, particularly smaller pharmacies not affiliated with large chains, from engaging in meaningful negotiations about contracting terms, including monetary and non-monetary terms.
                        <SU>58</SU>
                        <FTREF/>
                         The FTC highlighted PBMs' 
                        <PRTPAGE P="99384"/>
                        practice of unilaterally amending contracts by requiring pharmacies to opt out of new terms, rather than affirmatively opt in, making it difficult for pharmacies to understand what terms apply at any given time.
                        <SU>59</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             Federal Trade Commission, “Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug 
                            <PRTPAGE/>
                            Costs and Squeezing Main Street Pharmacies: Interim Staff Report”, July 2024, available at 
                            <E T="03">https://www.ftc.gov/reports/pharmacy-benefit-managers-report,</E>
                             pp. 48-49.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             
                            <E T="03">Id</E>
                            , at 50, 54.
                        </P>
                    </FTNT>
                    <P>To prevent disruptions in care for beneficiaries, CMS proposes to require contracts with pharmacies for participation in Part D networks that allow the sponsor or FDR, such as a PBM, to terminate the contract without cause to allow pharmacies to terminate the contract without cause after providing the same notice that the contract requires the sponsor or FDR to provide the pharmacy. A single network pharmacy contract often governs participation in multiple networks, with some pharmacies participating in all the Part D networks offered by a sponsor or FDR and some only participating in some of the networks. Therefore, we also propose that if the network pharmacy contract allows the sponsor or FDR to terminate the pharmacy's participation in some, but not all, of the networks covered by the contract without cause, that the contract allow the network pharmacy to terminate its participation in some, but not all, networks without cause after providing the same notice the contract requires the sponsor or FDR to provide. We propose to adopt this requirement under our authority at section 1857(e) of the Act, made applicable to Part D through section 1860D-12(b)(3)(D) of the Act, which authorizes the Secretary to adopt contract terms and conditions as necessary and appropriate, so long as those terms are not inconsistent with the Part D statute. This requirement would be consistent with other requirements CMS currently imposes for downstream contracts, including pharmacy contracts, such as the requirement at § 423.505(i)(3)(v) that contracts require sponsors to promptly pay clean claims and at § 423.505(i)(5) that contracts allow Part D sponsors to approve, suspend, or terminate contracts with network pharmacies.</P>
                    <HD SOURCE="HD3">2. Request for Information on Access to Pharmacy Services and Prescription Drugs</HD>
                    <P>
                        As noted in a December 14, 2023 letter from the CMS Office of the Administrator to pPlans and PBMs, pharmacies serve a critical role in Medicare Part D by providing access to medications across the country, including to Part D beneficiaries.
                        <SU>60</SU>
                        <FTREF/>
                         CMS is concerned about the sustainability of these businesses, especially small and independent pharmacies, and their potential closures that may leave Part D beneficiaries without convenient access to pharmacy services—especially in rural and underserved areas. We have also heard that pharmacies may decline to fill certain prescriptions that would result in a net loss in reimbursement.
                    </P>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             
                            <E T="03">https://www.cms.gov/files/document/pharmacy-benefit-manager-insurer-letter.pdf.</E>
                        </P>
                    </FTNT>
                    <P>CMS reminds plans that under section 1860D-4(b)(1)(A) of the Act and § 423.505(b)(18), they must offer a standard contract with reasonable and relevant contract terms whereby any willing pharmacy may participate as a network pharmacy. Additionally, under section 1860D-4(b)(1)(C) of the Act and § 423.120(a), plans must have a contracted pharmacy network that is sufficient to ensure that Part D beneficiaries have convenient access to pharmacy services. CMS seeks comment on what additional data or information to consider—such as reimbursement rates, underlying costs, steering, contracting terms, and other elements which may affect pharmacies' ability to continue providing Part D drugs to beneficiaries—to improve our ability to protect beneficiaries' convenient access to Part D drugs consistent with current access standards at § 423.120.</P>
                    <HD SOURCE="HD2">E. Modifying the Definition of “Service area” § 422.2</HD>
                    <P>In § 422.2, CMS defines service area to include “a geographic area that for local MA plans is a county or multiple counties”. We are proposing to modify the definition to align with our proposal to include a definition of county in § 422.116 that includes “county-equivalents” as recognized by the United States Census Bureau for economic census purposes. To ensure consistency in the use of the term “county” across service area and network adequacy requirements and to codify our longstanding policy of treating county-equivalents the same as counties for these purposes, we are proposing to amend the definition of service area in § 422.2 to refer to “a geographic area that for local MA plans is one or more counties, as defined in § 422.116(a)(1)”.</P>
                    <HD SOURCE="HD2">F. Administration of Supplemental Benefits Coverage Through Debit Cards §§ 422.2, 422.102, 422.102, 422.111, and 422.2263</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>
                        We have made a concerted effort in the past several years to better understand how supplemental benefits are provided by MA plans, how they are being used by enrollees, and how the provision of these benefits can be improved. These most recent efforts began with a request for information (RFI) published in in the August 1, 2022, 
                        <E T="04">Federal Register</E>
                         (87 FR 46918) that solicited feedback on ways to strengthen the MA program, including ways to improve the transparency of supplemental benefits. We received thousands of responses to these requests, and we have used this information to inform our efforts to improve how benefits are administrated within the MA program. A few commenters to the RFI suggested that CMS collect information regarding the usage of Special Supplemental Benefits for the Chronically Ill (SSBCI) so that there would be increased transparency around utilization patterns and costs associated with supplemental benefits, including SSBCI. We finalized a reporting requirement regarding the usage of supplemental benefits in the Paperwork Reduction Act package released on March 14, 2023, and expect to receive this data for the first time in 2025 (88 FR 15726). This data should promote greater transparency regarding the overall utility of these benefits while also helping to inform future decision making. Most recently, in the April 2024 final rule, we added evidentiary standards to SSBCI requirements by requiring MA plans to establish a bibliography of relevant acceptable evidence that an item or service offered as SSBCI has a reasonable expectation of improving or maintaining the health or overall function of a chronically ill enrollee (89 FR 30560). CMS has already begun implementing this requirement and will continue to review these bibliographies to ensure that MA plans are offering SSBCI that are supported by evidence and consistent with statutory and regulatory standards. Overall, through these initiatives, we have focused our efforts on ensuring supplemental benefits improve health outcomes and are continuing this theme in this proposed rule.
                    </P>
                    <P>
                        Section 1852(a)(3)(A) of the Act gives MA organizations the ability to offer supplemental benefits to plan enrollees, subject to the Secretary's approval. CMS has adopted rules—primarily in §§ 422.100(c)(2) and 422.102—to regulate how those supplemental benefits, such as vision, dental, gym membership, and others must be offered. For example, in Medicare Program, Establishment of the Medicare 
                        <PRTPAGE P="99385"/>
                        Advantage Program Final Rule,
                        <SU>61</SU>
                        <FTREF/>
                         which appeared in the 
                        <E T="04">Federal Register</E>
                         on January 28, 2005, we established at § 422.102(a)(4) that an MA organization could offer as a mandatory supplemental benefit a reduction in cost sharing below the actuarial value specified in section 1854(e)(4)(B) of the Act (70 FR 4617). Later, in the Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly Final Rule 
                        <SU>62</SU>
                        <FTREF/>
                         (January 19, 2021; 86 FR 5913) (hereinafter referred to as the January 2021 final rule), we further clarified the scope of supplemental benefits that reduce cost sharing by adding rules at § 422.102(a)(5) and (a)(6)(i) and (ii) to clarify the different circumstances under which an MA plan may reduce cost sharing for covered items and services as a mandatory supplemental benefit and the mechanisms by which an MA plan may make such reductions in cost sharing available to enrollees. Mandatory supplemental benefits are benefits that are included in the plan and are generally available to all enrollees with no additional premiums. As described in § 422.102(b), optional supplemental benefits are benefits that are available to plan enrollees who choose to pay an additional premium in order to receive those services. The majority of supplemental benefits that beneficiaries receive in MA are mandatory supplemental benefits, and we refer to mandatory supplemental benefits in this section unless otherwise specified.
                    </P>
                    <FTNT>
                        <P>
                            <SU>61</SU>
                             
                            <E T="03">https://www.federalregister.gov/documents/2005/12/23/05-24446/medicare-program-establishment-of-the-medicare-advantage-program.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             
                            <E T="03">https://www.govinfo.gov/content/pkg/FR-2021-01-19/pdf/2021-00538.pdf.</E>
                        </P>
                    </FTNT>
                    <P>In the January 2021 final rule, we explained that MA plans may choose to structure mandatory supplemental benefits in a few ways (86 FR 5913). For example, an MA plan may offer, as a mandatory supplemental benefit, the use of a debit card to administer reduced cost sharing for plan-covered services or to provide coverage of 100 percent of the cost of plan-covered items or services. This may include reduced cost sharing for dental and vision services (when offered as a mandatory supplemental benefit, not as an optional benefit) where a claim for additional payment is submitted to the plan, and/or coverage by the plan (through use of the card) of all or part of the cost of OTC items, fitness-related benefits, food and produce, transportation, and utilities support. With respect to a mandatory supplemental benefit in the form of reduced cost sharing, a beneficiary may receive a debit card to use to pay for any applicable cost sharing when receiving a basic benefit or mandatory supplemental benefit, including SSBCI. For example, if the plan provides a transportation service as a covered benefit and provides a debit card to be used to reduce cost sharing for those defined transportation services, the beneficiary could use the debit card to pay for those services. We remind readers that reduced cost sharing is not permitted as an optional supplemental benefit (that is a supplemental benefit that a beneficiary would select in exchange for additional premiums) (see 86 FR 5913). Thus, this mechanism of using debit cards is not permitted to administer optional supplemental benefits (that is, an optional dental or vision service package).</P>
                    <P>We further explained in the January 2021 final rule that MA organizations that choose to use a debit card to administer mandatory supplemental benefits must do so in a manner that ensures the debit card can only be used towards plan-covered items and services. To the extent these items and services are mandatory supplemental benefits, they must also meet all the regulatory supplemental benefit standards at §§ 422.100(c)(2) and 422.102(a) through (f). To summarize, CMS's prior rulemakings provided standards around supplemental benefits, including codifying the definition of a supplemental benefit, identifying the requirements for a benefit to be considered primarily health related, and in regard to Special Supplemental Benefits for the Chronically Ill (SSBCI), requiring plans to establish a bibliography of relevant acceptable evidence that an item or service offered as SSBCI has a reasonable expectation of improving or maintaining the health or overall function of a chronically ill enrollee.</P>
                    <P>The use of debit cards is permitted for administering both mandatory supplemental benefits for all MA enrollees and mandatory supplemental benefits available as Special Supplemental Benefits for the Chronically Ill (SSBCI) as defined at § 422.102(f). We also explained in the January 2021 final rule that debit cards may only be used to administer coverage of items and services that are identified in the MA plan's bid and marketing and communication materials as covered benefits (86 FR 5913). Consistent with guidance in Chapter 4 of the Medicare Managed Care Manual (MCM), § 40.3, we stated that debit cards used for plan-covered benefits must be exclusively linked to only the covered items and drugs specified by the MA organization and that MA organizations are not permitted to offer use of a debit card to enrollees for purchasing items or services that are not plan-covered (86 FR 5913). In addition, the use of the debit card to pay cost sharing or pay for covered items and services must be tied to the period of coverage, that is the specific plan year or part of a plan year during which the enrollee is enrolled with and covered by the MA plan. (MA organizations may include a maximum dollar limit on a per-month basis, per-year basis, or other periodicity within the plan year tied to the benefit maximum.) The debit card itself is not a supplemental benefit; rather, it is a tool used to administer coverage to an enrollee for identified plan-covered items and services at a reduced cost. Plan-covered items and services that are paid for by a debit card must meet the requirements and standards for mandatory supplemental benefits or be basic benefits in the case of reduced cost sharing for a Part A or B covered benefit, as specified in the January 2021 final rule (86 FR 5913).</P>
                    <P>
                        Since the January 2021 final rule, many MA organizations have disclosed the use of debit cards to administer a benefit in their annual bid notes. In reviewing annual bids, we've observed that MA organizations appear to regularly use debit cards to administer several mandatory supplemental benefits, including reductions in cost sharing for dental and vision services and/or payment for OTC items, fitness-related benefits, food and produce, transportation, and utilities support. In recent years, based on questions from stakeholders, including beneficiaries, we have also become aware that there is some confusion around the use of debit cards. For example, we have received many stakeholder questions requesting CMS clarify what these cards are and how they can be used. We have also received complaints from enrollees who tell us that they are confused when trying to use their debit card. Often these individuals do not receive guidance on which plan covered supplemental benefits can be purchased with their debit card or where and how they can use them. Additionally, stakeholders have raised concerns that there are not enough guardrails on how these cards are used and how purchases are tracked, especially at large box stores that carry non-covered items and services (for example, Costco or Walmart) that would be inappropriate 
                        <PRTPAGE P="99386"/>
                        for the MA plan to cover as supplemental benefits. For example, there are concerns that the enrollee may use the plan debit card to purchase items and services that are not covered or that do not meet the requirements for MA supplemental benefits.
                    </P>
                    <P>To provide further clarity to both MA organizations and beneficiaries on the parameters around the appropriate use of plan debit cards, we are proposing requirements on the proper administration of supplemental benefits. Based on our authority under section 1856(b)(1) of the Act to establish standards for MA organizations, along with our authority in section 1857(e)(1) of the Act to adopt additional terms and conditions for MA contracts that are not inconsistent with the Part C statute and that are necessary and appropriate for the MA program, we propose to codify in regulation text the requirements and limitations discussed in the preamble of the 2022 final rule and later in the May 6, 2024, memo titled “Final Contract Year (CY) 2025 Standards for Part C Benefits, Bid Review and Evaluation” regarding the administration of supplemental benefits, including the use of plan debit cards. We believe codifying these standards will also ensure that MA requirements regarding supplemental benefits are applied uniformly across the MA industry and for all supplemental benefits: both standard (that is, primarily health related) supplemental benefits and non-primarily health related SSBCI. We also propose to expand on these requirements by adopting additional disclosure and access guardrails to increase transparency, protect access to plan-covered services for MA enrollees, and ensure that MA plans cover (that is, provide, furnish, and/or pay for) only those items and services that are permissible MA benefits.</P>
                    <P>Specifically, we propose to add a new paragraph (g) at § 422.102 to codify existing guidelines for administering supplemental benefits, including the use of debit cards to administer plan-covered benefits, and add new guardrails to ensure that beneficiaries are fully aware of covered supplemental benefits and how to access those benefits.</P>
                    <HD SOURCE="HD3">2. The Administration of Supplemental Benefits</HD>
                    <P>Our regulations at § 422.100(c)(2) define a mandatory or optional supplemental health care benefit (with the exception of Special Supplemental Benefits for the Chronically Ill (SSBCI) as defined at § 422.102(f)) as an item or service: (1) not covered by original Medicare; (2) that is primarily health related; and (3) for which the plan must incur a non-zero direct medical cost. The 2022 Final Rule further clarified at § 422.100(c)(2)(ii)(A) that to be considered primarily health related, a supplemental benefit must be to diagnose, prevent, or treat an illness or injury; compensate for physical impairments; act to ameliorate the functional/psychological impact of injuries or health conditions; or reduce avoidable emergency and health care utilization. Additionally, we have codified numerous requirements that MA organizations must comply with when delivering supplemental benefits at § 422.102(a) through (e). More recently, we codified standards for SSBCI benefits at § 422.102(f), which include the requirements that SSBCI may only be offered to chronically ill enrollees as defined by section 1852(a)(3)(D) of the Act, must incur a non-zero non-administrative cost, and must have a reasonable expectation of improving or maintaining the health or overall function of the enrollee. SSBCI may include benefits that are not primarily health related per § 422.100(c)(2)(ii)(A) but must have a reasonable expectation of improving or maintaining the health or overall function of the chronically ill enrollee. Additionally, per section 1852(a)(3)(D)(ii)(II) of the Act, CMS has authority to waive the uniformity requirements that usually apply for all MA benefits so that SSBCI can be offered non-uniformly.</P>
                    <P>We are proposing in this rule that MA organizations must have processes for delivering all MA plan covered supplemental benefits to enrollees that ensure compliance with §§ 422.100(c)(2) and 422.102(a) through (f) and appropriate access to suppliers and providers in accordance with § 422.112(a) as applicable. Per § 422.112(a), MA coordinated care plans may specify the networks of providers from whom enrollees may obtain services if the MA organization ensures that all covered services, including supplemental services contracted for by (or on behalf of) the Medicare enrollee, are available and accessible under the plan. The MA organization may therefore contract with providers or vendors to furnish covered services, including supplemental benefits administered via a debit card or otherwise. For example, a plan may contract with a particular vendor to provide their food and produce benefit. In this scenario, that specific vendor is the network provider for furnishing the food and produce benefit. We note that section 1854(a)(6)(B)(iii) of the Act, commonly known as the “non-interference clause,” prohibits CMS from requiring any MA organization to contract with a particular provider to furnish covered items and services. Therefore, CMS does not specify which vendors MA organizations contract with to furnish covered items and services. (Note however that § 422.204(b)(3) requires that providers that furnish covered Part A and B benefits must meet the applicable requirements of Title XVIII of the Act and that certain types of institutional providers must have participation agreements with Medicare.)</P>
                    <P>
                        We also note that all coordinated care plans are required to cover benefits, including supplemental benefits, at in-network cost sharing when an in-network provider or benefit is unavailable or inadequate to meet an enrollee's medical needs in accordance with the standards set forth in our rules and regulations.
                        <SU>63</SU>
                        <FTREF/>
                         This is required for all benefits, regardless of how they are administered.
                    </P>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             § 422.112 (a)(1)(iii); Chapter 4, section 30.2 of the Medicare Managed Care Manual; 88 FR 22200.
                        </P>
                    </FTNT>
                    <P>If an in-network provider is unavailable or inadequate to administer covered plan benefits, whether Parts A and B or supplemental benefits, the MA organization should have a plan or process in place to ensure that the requirements under § 422.112(a)(1)(iii) are met. However, given inconsistencies in how supplemental benefits are provided, we believe it is necessary to clarify this requirement in regulatory text. Therefore, we propose and seek comment on new § 422.102(g)(1) that would require MA organizations to have processes for delivering all MA organization covered supplemental benefits to enrollees that ensure compliance with §§ 422.100(c)(2) and 422.102(a) through (f) and appropriate access to all covered services in accordance with § 422.112(a).</P>
                    <HD SOURCE="HD3">3. New Guardrails for Plan Debit Cards</HD>
                    <P>
                        As described in section III.H.2 of this proposed rule, we are proposing to include a clarification in § 422.102(g)(1) requiring that MA organizations have processes for delivering all MA organization covered supplemental benefits to enrollees that ensure compliance with §§ 422.100(c)(2) and 422.102(a) through (f) and appropriate access to all covered services per § 422.112(a). Thus, we believe it is necessary to specify that this requirement would apply to all plan covered supplemental benefits, including supplemental benefits administered through debit cards. 
                        <PRTPAGE P="99387"/>
                        Under this proposal, plans must have a process in place to maintain enrollee access to these benefits. When plans offer debit cards to assist with the cost sharing for covered benefits or otherwise administer supplemental benefits, the MA organization must ensure that the access requirements at § 422.112(a) are met. This means regardless of the mode of delivery (
                        <E T="03">e.g.,</E>
                         debit card or other means), MA organizations must ensure that all covered services, including supplemental benefits, and SSBCI for eligible enrollees, contracted for by (or on behalf of) enrollees, are available and accessible under the plan.
                    </P>
                    <P>
                        In addition, we require that plan-covered benefits be disclosed in the plan's evidence of coverage (EOC). Section 422.111 requires that MA organizations disclose all benefits offered under an MA plan, including applicable conditions and limitations, and any other conditions associated with receipt or use of benefits. These requirements are applicable to all benefits, including those administered via debit card. We also note that MA organizations are required to send an Explanation of Benefits (EOB) to an enrollee that captures all claims activity that occurs during a reporting period (monthly or quarterly cycle). The EOB must include claims information for all Part C claims processed during the reporting period, including all claims for Part A and Part B covered items and services, mandatory supplemental benefits, optional supplemental benefits, and SSBCI.
                        <SU>64</SU>
                        <FTREF/>
                         The EOB must disclose for each claim a descriptor, billing code and amount billed, total cost approved for reimbursement, share of the total cost paid by the plan, and share of the total cost for which the enrollee is liable. Additionally, the EOB must include certain year-to-date information such as the amount an enrollee has incurred toward the Maximum Out-of-Pocket (MOOP) limit.
                        <SU>65</SU>
                        <FTREF/>
                         These EOB requirements include supplemental benefits that MA plans elect to cover through a debit card.
                    </P>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                              
                            <E T="03">https://www.ecfr.gov/current/title-42/part-422/section-422.111#p-422.111(k).</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                              
                            <E T="03">https://www.ecfr.gov/current/title-42/part-422/section-422.111#p-422.111(k).</E>
                        </P>
                    </FTNT>
                    <P>However, given stakeholder and enrollee feedback, we believe additional clarity and more specific guardrails regarding the use of debit cards are necessary to ensure that enrollees are adequately aware of the benefits that are available to them from their plan through a debit card and how to access them.</P>
                    <P>In the January 2021 final rule, we stated that consistent with current guidance in section 40.3 of Chapter 4 of the Medicare MCM, debit cards may only be used for plan-covered benefits under the condition that the card is exclusively linked to the covered items. We also suggested in the January 2021 final rule (86 FR 5913) that MA organizations may accomplish this by providing a debit card that is linked to an appropriate merchant and item/service codes so that the enrollee may pay the cost sharing at the point of service. We believe such a link is necessary to ensure that the debit card is used for the permissible purpose—to reduce the enrollee's cost sharing for a covered item or service or to pay for an item or service that is covered by the MA plan at up to 100 percent of the cost. Therefore, we propose at § 422.102(g)(2)(i) the following requirements that MA organizations must meet if they choose to administer reductions in cost sharing or provide coverage of 100 percent of the cost of a mandatory supplemental benefit. We are proposing at § 422.102(g)(2)(i) that when administering a mandatory supplemental benefit through plan debit cards, an MA organization must provide debit cards that are electronically linked to plan covered benefits through a real-time identification mechanism to verify eligibility of plan covered benefits at the point of sale. This means that a plan issued debit card must be electronically linked to the covered benefit through a real-time mechanism that ensures the enrollee is only able to receive covered items or services that they are eligible to receive at the point of sale. The debit card must include some sort of mechanism that ensures the enrollee may only use the card to purchase the covered item or service. For example, an MA organization could provide a debit card linked to covered benefits through the use of item/service codes so that the enrollee is only able to pay the cost sharing for those select items at the point of sale. In this scenario, the MA organization would have to ensure that the enrollee is only able to purchase items or services they are specifically eligible to receive. This is necessary to ensure that enrollees only receive benefits they are eligible to receive and to ensure that MA organizations do not inadvertently furnish non-covered benefits. The debit card is intended only to facilitate or administer certain covered benefits and may not be used to pay for non-covered items or services. We are not proposing to prescribe exactly how plans effectuate the proposed requirements at § 422.102(g)(2)(i) because we believe flexibility for plans to innovate around these processes will be beneficial to the industry. However, if an MA organization provides a debit card that is not electronically linked to covered items and services and does not include checks to ensure that the enrollee may only receive covered benefits they are eligible to receive, the MA organization would be in violation of these proposed requirements.</P>
                    <P>Next, we propose at § 422.102(g)(2)(ii) to require MA organizations that use debit cards to administer a supplemental benefit to provide instructions for debit card use and customer service support to enrollees to answer questions or help with issues related to the administration of the card. For example, if an MA organization provides a food and produce benefit that may be accessed via a debit card, the plan must provide eligible enrollees with instructions on how to use the debit card and provide customer support service to beneficiaries who have questions about how to use the debit card. This support service must include instructions to beneficiaries on the process to access these benefits if not accessible by debit card, in accordance with § 422.112(a). We believe this is necessary to ensure that enrollees are fully aware of their benefits and how to properly access those benefits, particularly those living in rural areas with limited access to broadband/internet for communication. Finally, all benefits must be limited to the specific plan year. Therefore, we propose to state at § 422.102(g)(2)(iv) that MA organizations must ensure the use of a debit card to administer a covered benefit is limited to the specific plan year.</P>
                    <P>
                        In the January 2021 final rule, we amended § 422.102(a)(6) to state that an MA organization may offer reduced cost sharing as a mandatory supplemental benefit through the use of reimbursement, through a debit card or other means. In order to further support the proposed requirements at § 422.102(g)(1), we also propose to revise § 422.102(a)(6) by removing “or other means” and adding “manual” before reimbursement to ensure that reductions in cost sharing as a supplemental benefit are clearly limited to either manual reimbursement or to a debit card governed by the proposed rules under § 422.102(g) for covered items and services. We believe this revision ensures that when providing reduced cost sharing through a debit card, that card is governed by the proposed requirements at § 422.102(g)(1)(i). This proposal would 
                        <PRTPAGE P="99388"/>
                        prohibit plans from using other mechanisms not directly described in § 422.102(a)(6)(i).
                    </P>
                    <P>We further believe this revision is necessary because “other means” could be interpreted to allow an unrestricted card or other vague mechanisms, which would conflict with CMS requirements that a debit card be exclusively linked to covered benefits and limited to the plan year or the requirements being proposed at § 422.102(g)(1)(i). Further, MA organizations are required to administer reductions in cost sharing in a manner that ensures the debit card, reimbursement, or allowance can only be used towards plan-covered services and are limited to the specific plan year. The use of an unrestricted card cannot guarantee compliance with these requirements.</P>
                    <P>
                        While we are proposing to remove “or other means,” we solicit comment on what other means, outside of manual reimbursement or a debit card, would be unintentionally removed as options to plans should we finalize this proposed revision. We also solicit comment on how these other means or mechanisms may still guarantee compliance with existing requirements at § 422.102(a)(6) and the requirements proposed at §§ 422.102(g) and 422.111(b)(6) (discussed in section III.H.2 of this proposed rule). For example, it is not our intent that the proposed changes at § 422.102(a)(6) prohibit an organization from using a stored value card,
                        <SU>66</SU>
                        <FTREF/>
                         provided the use of these cards by MA plans complies with the requirements at § 422.102(g). Therefore, we also solicit comment on whether the use of stored value cards meets the requirements at § 422.102(g). Specifically, we solicit comment on whether the mechanisms available and used with stored valued cards are sufficient so that the purchases made through such cards can be electronically linked to plan covered items through a real-time identification mechanism that verifies the eligibility of plan covered benefits at the point of sale, and can restrict the time period allowed for the use of the stored value card to the plan year only. We also solicit comment on whether stored value cards should be explicitly added to § 422.102(a)(6) and § 422.102(g) as an acceptable means of administering reductions in cost sharing and the coverage of supplemental benefits.
                    </P>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             
                            <E T="03">https://www.fiscal.treasury.gov/stored-value-card/.</E>
                        </P>
                    </FTNT>
                    <P>We solicit comment on all aspects of this proposal and may consider finalizing revisions to our policies based on the comments received.</P>
                    <HD SOURCE="HD3">4. Access</HD>
                    <P>While a MA organization may utilize a debit card to administer a benefit, this does not exempt the plan from ensuring access and network adequacy is preserved for the benefit if there is an issue with the vendor or a technical issue with the debit card. As discussed earlier, the regulations at § 422.112(a)(1)(iii) specify that coordinated care plans must arrange for, and cover any, medically necessary (clinically appropriate for non-primarily health related SSBCI) covered benefit outside of the plan provider network, but at in-network cost sharing, when an in-network provider or benefit is unavailable or inadequate to meet an enrollee's medical needs. Additionally, our long-standing guidance under section 40.3.1 of Chapter 4 of the Medicare MCM states, “Every MA plan, independent of the payment method it chooses, must also allow—under circumstances which it describes (for example, when the debit card network is not operating correctly)—for manual reimbursement for the purchase of OTC items based on submitted receipts.” We included this language in the Medicare MCM Chapter 4 to ensure enrollee access by requiring plans to have an alternative method (for example, reimbursement based on submitted receipts) for enrollees to receive their OTC benefits if there was an issue with the contracted vendor or an operational issue with the debit card. We believe that it is important to adopt a similar policy here in order to maintain enrollee access for all benefits administered through a debit card, not just OTC benefits.</P>
                    <P>Therefore, we propose at § 422.102(g)(2)(iii) that a plan must have an alternative process that allows for reimbursement of eligible expenses for plan covered benefits. We believe this proposal would allow enrollees to maintain access to covered benefits that are administered through the offering of a debit card should the real-time identification mechanism fail or otherwise be unavailable. This would allow enrollees to be reimbursed for the purchase of eligible plan covered benefits if they are unable to use their plan debit cards. We believe that requiring plans to allow this alternative will ensure that the enrollee has access to the benefit if there is an issue with the vendor, a technical issue with the debit card, or any other situation in which the use of a debit card is unfeasible for the enrollee. This may include non-technical issues, such as when an enrollee is having trouble understanding how to use the debit card or is otherwise running into non-technical obstacles to its use. This alternative reimbursement process could also apply if there are failures with the electronic processing system used by the provider. This includes situations where a permitted transaction is erroneously declined. In other words, in the case that the debit card is not operating correctly or as intended, there is an issue with the vendor, or any other situation in which the use of a debit card is unfeasible for the enrollee, the MA plan must allow enrollees to be reimbursed for the purchase of the covered benefit based on submitted receipts. This also includes situations in which a contracted vendor is not easily accessible due to an enrollee's transportation constraints. This proposed requirement protects enrollee access to benefits that they are entitled to receive regardless of issues that may arise from a plan's chosen mode of delivery (for example, plan debit card).</P>
                    <P>This alternative process must be in place for both in-network and out-of-network access to the benefit where necessary (for example, in the event that in-network providers and/or vendors are unavailable or inadequate to meet the enrollee's needs). In this scenario, the plan would still be responsible for ensuring out of network access at in network cost sharing. We expect MA organizations to adequately disclose the process by which reimbursement may be made to enrollees and to ensure that the process is accessible to all enrollees. We also encourage MA organizations to be mindful of enrollees in rural areas, especially those who have limited access to broadband or internet communication, when implementing this requirement and when disclosing information about how to effectuate a reimbursement to plan enrollees. This is consistent with and will further ensure compliance by MA coordinated care plans with § 422.112(a).</P>
                    <P>
                        We also note that MA plans that are PPOs are required to provide reimbursement for all covered services, regardless of whether the items are provided within the network of providers under § 422.4(a)(1)(v). Regarding reimbursement, § 422.4(a)(1)(v)(B) requires PPOs to provide for “reimbursement for all covered benefits regardless of whether the benefits are provided within the network of providers.” This applies to all supplemental benefits, including those administered through a debit card (we note that in this scenario, an enrollee may be subject to increased cost sharing). For example, a MA organization may contract with a particular grocery store to furnish their 
                        <PRTPAGE P="99389"/>
                        food and produce benefit. However, in a PPO, enrollees may purchase eligible food and produce at another non-contracted grocer (out of network provider) and be reimbursed for those covered items. We expect MA PPOs to have processes to verify out of network reimbursement is only made for plan-covered services and to indicate to enrollees the process by which reimbursement can be made. As noted above, that process should be mindful of enrollees in rural or remote areas with limited access to providers and internet-based communication methods.
                    </P>
                    <P>Finally, we remind MA plans that our regulations at § 422.112(b)(3) provide for coordinated care MA plans to include community-based services in their plans for coordination and continuity of care for enrollees. In addition, § 422.112(b)(3) specifically states that MA coordinated care plans are required to “coordinate MA benefits with community and social services generally available in the area served by the MA plan.” MA plans may contract with community-based organizations to provide supplemental benefits that are compliant with the statutory and regulatory requirements. We strongly encourage, for example, an MA plan that elects to offer a food and produce supplemental benefit to do so via a community-based organization that is able to process the benefit through a debit card. We understand that in some areas there may be a limited number of community-based providers, including small businesses. However, we strongly encourage plans to partner with community-based providers or other local, smaller businesses when offering supplemental benefits, particularly regarding food and produce benefits that may be offered to chronically ill enrollees under SSBCI regulations at § 422.102(f). We believe that encouraging plans to contract with community-based providers will improve enrollee access to benefits. With covered benefits available in their communities, enrollees will be able to more readily and easily obtain and use covered benefits and thus have the potential to improve their overall health.</P>
                    <HD SOURCE="HD3">5. Additional Disclosure Guardrails</HD>
                    <P>To increase transparency for beneficiaries accessing plan-covered benefits, we also propose to add additional disclosure requirements specific to supplemental benefits under § 422.111. Section 422.111(b) currently requires MA organizations to disclose mandatory and optional supplemental benefits and the premium for those benefits. We propose to amend § 422.111(b)(6) to state that MA organizations must disclose any mandatory supplemental benefits (including reductions in cost sharing) or optional supplemental benefits, the premium for optional supplemental benefits, and any applicable conditions and limitations associated with receipt or use of supplemental benefits. We propose to clarify that this disclosure must include eligible OTC items and, where supplemental benefits are administered through a debit card, must specify which benefits may be accessed using the debit card. We believe that such disclosure is necessary to ensure transparency considering the growth of the scope of supplemental benefits and authorized administrative flexibilities, such as the use of plan-furnished debit cards to administer certain supplemental benefits. This will help ensure that plan enrollees are sufficiently aware of what covered benefits may be accessed through any debit card they receive from their plan.</P>
                    <P>Lastly, regarding OTC items, longstanding CMS guidance (section 40.1 of Chapter 4 of the Medicare MCM) defines OTC items as health-related items and medications that are available without a prescription, and § 422.102(c)(2) provides that permissible supplemental benefits are items and services that are not covered by Medicare Part A, Part B or Part D. Per § 422.100(c)(2), plans may never offer as a supplemental benefit something that is covered under Part B or that is paid for under Part D for the plan's enrollees, including an OTC item or medication. Additionally, while the 2022 Final Rule did include OTC items as an example of permissible primarily health-related supplemental benefits (86 FR 5971), it did not include a non-exhaustive list of acceptable and non-acceptable items. We have also received feedback that a non-exhaustive list could provide further clarity for MA organizations. Therefore, we include a non-exhaustive list here. Examples of permitted primarily health related OTC items that have been reviewed and approved by CMS during the bid review process include, but are not limited to: amplified phones, analgesics, antacids, anti-bacterial grooming products (when recommended by a provider), antihistamines, anti-inflammatories, antiseptics, blood pressure cuffs, callous/wart remover, custom made compression garments (if furnished under circumstances when it would not be covered by the Part B benefit), contact lens solution and cases, over the counter contraceptives (such as condoms and over the counter, non-prescription birth control pills), cotton swabs, COVID-19 tests (over the counter), decongestants, dressing and eating aids, extension grabbers or reaching aids, facial cleaners (including acne wash), feminine hygiene products (such as douche, lubricants, pads, tampons, wipes), fiber supplements, first aid supplies, energy protein bars and power drinks, nutritional drinks/shakes, hand sanitizer, hearing aid batteries, hearing amplifiers, herbal supplements, hip kits, dietary supplements (such as CoQ10, garlic, gingko biloba, melatonin, and saw palmetto,) incontinence supplies (such as adult diapers and under pads), insulin refrigeration units, and lip soothers/balms (non-medicated), low vision aids, magnifying glasses, medicine dispensers, mouth/oral care products (such as toothbrush/paste, floss, mouthwash, denture adhesives/cleaners), naloxone (if furnished under circumstances when it would not be covered by Medicare Part B or Part D), night lights, nicotine replacement therapy (NRT), pain relief products (such as Epsom salt and ice packs), pill bottle openers, pill/tablet boxes, cutters, and crushers, pulse oximeters, probiotics, nonprescription reading glasses, shoe insoles/inserts/arch supports, skin moisturizers for dry skin, skin protectant (such as diaper rash ointment, moleskin, mosquito repellent, petroleum jelly), witch hazel, sleep aids, soap (doctor recommended antibacterial/antimicrobial), sunscreen, supportive items (such as compression hosiery, rib belts, elastic knee support), toilet lights, vitamins and minerals, nonprescription weight loss items, weight scales, and disposable face masks (to protect against respiratory illnesses). Although this is not considered to be an exhaustive list of OTC items, we solicit comment on whether there are additional items that stakeholders believe should be included on this list.</P>
                    <P>
                        CMS has also reviewed items that CMS has determined not to be permissible MA supplemental benefits because they do not meet the requirement that the item or service be primarily health related. Such OTC items that cannot be covered as MA supplemental benefits include air conditioners, baby items, bad breath remedies (gum, breath mints), bagging fees, body scrubs, cannabidiol, cleaning products (Clorox, Lysol), clocks, dehumidifiers, deodorant, grooming/shaving supplies, hair care (shampoo, conditioner, dye, bleach, hair removal and hair growth products), humidifiers, jar openers, paper products (tissue, 
                        <PRTPAGE P="99390"/>
                        toilet paper, paper towels), perfume, pest control, skin moisturizers used for anti-aging, teeth whiteners, water bottles, and personal coolers. We note that items such as air conditioners, cleaning products, dehumidifiers, humidifiers, grooming supplies to assist with hygiene, paper products (tissue, toilet paper, paper towels), and pest control may be permissible as a non-primarily health related SSBCI provided the item has a reasonable expectation of improving or maintaining the health or overall function of the enrollee and meets the standards at § 422.102(f). For example, research indicates that air conditioners may improve the breathing of patients with COPD and asthma.
                        <SU>67</SU>
                        <FTREF/>
                         We solicit comment on these listed items and may revise the list based on feedback received.
                    </P>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             
                            <E T="03">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5291496/.</E>
                        </P>
                    </FTNT>
                    <P>
                        Again, we reiterate that the list of permissible primarily health related OTC items set forth in this proposed rule is non-exhaustive. We've also included a non-exhaustive list of items that are not primarily health related but could be offered as a non-primarily health related SSBCI provided the requirements under § 422.102(f) are met. CMS reviews bids each year to ensure that proposed supplemental benefits meet the applicable regulatory and statutory standards.
                        <SU>68</SU>
                        <FTREF/>
                         For example, MA organizations may propose to offer OTC items not on this list and CMS may come across items in the future, not listed here, that we believe do not meet the definition of a supplemental benefit per § 422.100(c)(2) or are not primarily health related per § 422.100(c)(2)(ii). However, we believe including these lists in this preamble discussion will help MA organizations consistently apply the requirements at §§ 422.100(c)(2) and 422.100(c)(2)(ii) and assist MA organizations when planning and preparing their annual bid packages.
                    </P>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             We strongly encourage MA organizations that are looking to cover new or novel benefits to raise those to CMS well in advance of bid submission to allow ample time for the MA organization to provide, and CMS to review, information explaining how the applicable statutory and regulatory standards are met for the proposed benefits without the time pressures of the bid review process.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">6. Marketing Supplemental Benefits</HD>
                    <P>Another important consideration related to debit cards is MA organizations' marketing tactics. We have become aware of certain advertisements that solely mention debit cards, or marketing terms such as “Medicare flex cards,” with an alluring value attached to them, potentially giving false impressions that the card itself is the benefit, that it can be used to purchase anything and can be used anywhere, and that an individual can receive it automatically by enrolling in the advertised MA plan.</P>
                    <P>CMS has concerns with these advertisements. As discussed previously, the debit card itself is not the supplemental benefit, rather, it is the mechanism through which the MA organization administers and pays for the covered supplemental benefit. There is a risk that a beneficiary might view this type of advertisement and make an enrollment decision based on the belief that, by enrolling in the plan, they will automatically receive a card with “free” money to spend wherever they choose. In reality, that is not the case because debit cards used by MA plans in administering MA supplemental benefits have various restrictions, including restrictions related to eligibility, the timeframe in which the debit card may be used, the providers with whom the debit card may be used, and the covered items and services for which the debit card may be used.</P>
                    <P>To prevent such inaccurate or misleading advertising, we are proposing new parameters for MA organizations' marketing of supplemental benefits. Specifically, we propose to add new paragraph (b)(11) to § 422.2263, prohibiting MA organizations from marketing the dollar value of a supplemental benefit or the method by which a supplemental benefit is administered, such as use of a debit card by the enrollee to provide the plan's payment to the provider for the covered services. We believe that this proposed requirement is necessary to promote informed choice among prospective and current MA enrollees. By prohibiting the dollar value and administration method in marketing materials, it will provide the beneficiary with enough information to inquire further if the supplemental benefit would be helpful to their care, rather than an overly simplified advertisement that does not include the level of information required for an informed enrollment decision. Our proposal would also reduce the number of misleading MA supplemental benefit advertisements.</P>
                    <P>We solicit comment on all aspects of this proposal and may consider revisions based on the comments received.</P>
                    <P>This proposal primarily codifies and clarifies existing guidance and practices and is not expected to have additional impact above current operating expenses. This proposal would not impose any new collection of information requirements.</P>
                    <HD SOURCE="HD2">G. Non-Allowable Supplemental Benefits for the Chronically Ill (SSBCI) (§ 422.102)</HD>
                    <P>
                        Section 1852(a)(3)(D)(ii)(I) of the Act requires that an item or service offered as SSBCI have a reasonable expectation of improving or maintaining the health or overall function of the chronically ill enrollee. The 2024 final rule titled the “Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE)” (the “April 2024 Final Rule”) (89 FR 30448) finalized requirements at § 422.102(f)(3) that, by the date on which it submits its bid to CMS, an MA organization must establish a bibliography of relevant acceptable evidence that an item or service offered as an SSBCI has a reasonable expectation of improving or maintaining the health or overall function of a chronically ill enrollee. In the 2024 Final Rule, we also codified at § 422.102(f)(5) that CMS may decline to approve an MA organization's bid, if CMS determines that the MA organization has not demonstrated, through relevant acceptable evidence, that an SSBCI has a reasonable expectation of improving or maintaining the health or overall function of the chronically ill enrollees that the MA organization is targeting. In addition, in the April 2024 final rule (89 FR 30448), we modified and strengthened the current requirements in § 422.2267(e)(34) for the SSBCI disclaimer that MA organizations offering SSBCI must use whenever SSBCI are mentioned. Specifically, we required that the SSBCI disclaimer list the relevant chronic condition(s) the enrollee must have to be eligible for the SSBCI offered by the MA organization. We also finalized specific font and reading pace parameters for the SSBCI disclaimer in print, television, online, social media, radio, other voice-based ads, and outdoor advertising (including billboards). Finally, we required that MA organizations include the SSBCI disclaimer in all marketing and communications materials that mention SSBCI. These requirements further help to ensure that the marketing of and communication about these benefits was not misleading or potentially confusing 
                        <PRTPAGE P="99391"/>
                        to enrollees who rely on these materials to make enrollment decisions.
                    </P>
                    <P>Section 1852(a)(3)(A) provides CMS the authority to approve supplemental benefits. Supplemental benefits must meet the regulatory and statutory requirements for approval, including that the benefits may not be approved if the agency finds that including such supplemental benefits would substantially discourage enrollment by Medicare+Choice (now Medicare Advantage) eligible individuals with the organization. Further, per section 1854(a)(5)(C) of the Act, CMS is not obligated to accept any or every bid submitted by an MA organization. Based on our experience reviewing, approving, and denying bid proposals throughout the years, we are relying upon these authorities to propose in regulation a non-exhaustive list of non-primarily health related items or services that do not meet the standard of having a reasonable expectation of improving or maintaining the health or overall function of the enrollee standard as described in section 1852(a)(3)(D)(ii)(I) of the Act and at CMS regulations at § 422.102(f)(1)(ii). Therefore, none of these items and services are permissible SSBCI. We believe that codifying this non-exhaustive list of examples of items or services that do not meet these standards provides transparency and greater certainty for MA organizations and enrollees about the rules that govern these benefits, which is necessary and appropriate to ensure that supplemental benefits coverage is properly furnished by all MA organizations that choose to offer these supplemental benefits.</P>
                    <P>
                        SSBCI must meet the regulatory requirements set forth under § 422.102(f). They must also meet the requirements to be a supplemental benefit as described at 422.100(c)(2), with the exceptions that the benefits need not be primarily health related, as described at § 422.100(c)(2)(ii)(A), and the MA organization must incur a non-zero direct non-administrative cost (as opposed to a non-zero medical cost) in covering the benefit. Further, while an SSBCI may be non-primarily health related, there must still be a reasonable expectation that the item or service will improve or maintain the health or overall function of the chronically ill enrollee. For example, an air conditioner is not a primarily health related item or service, but there is acceptable evidence that using an air conditioner may improve the health of patients with asthma, chronic obstructive pulmonary disease (COPD),
                        <SU>69</SU>
                        <FTREF/>
                         or other breathing problems for whom an air conditioner might keep them from being hospitalized during times of excessive heat or wildfires.
                        <SU>70</SU>
                        <FTREF/>
                         A health plan's care coordination team might be able to identify these individuals in advance to provide them access to an air conditioner.
                    </P>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             
                            <E T="03">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5291496/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>70</SU>
                             
                            <E T="03">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2900329/.</E>
                        </P>
                    </FTNT>
                    <P>We propose to codify a non-exhaustive list of non-primarily health related items or services that do not have a reasonable expectation of improving or maintaining the health of a chronically ill enrollee and therefore cannot be offered as SSBCI. Those items include—</P>
                    <P>
                        <E T="03">•</E>
                         Procedures that are solely cosmetic in nature and do not extend upon Traditional Medicare coverage (for example, cosmetic surgery such as facelifts or cosmetic treatment for facial lines, atrophy of collagen and fat, and bone loss due to aging);
                    </P>
                    <P>
                        <E T="03">•</E>
                         Alcohol, tobacco, and cannabis products;
                    </P>
                    <P>
                        <E T="03">•</E>
                         Funeral planning and expenses;
                    </P>
                    <P>
                        <E T="03">•</E>
                         Life insurance;
                    </P>
                    <P>
                        <E T="03">•</E>
                         Hospital indemnity insurance; and
                    </P>
                    <P>
                        <E T="03">•</E>
                         Broad membership-type programs inclusive of multiple unrelated services and discounts.
                    </P>
                    <P>These items and services cannot be offered as SSBCI for the following reasons:</P>
                    <P>Regarding cosmetic services, CMS explained in previous guidance (see HPMS memorandum, “Final Contract Year (CY) 2025 Standards for Part C Benefits, Bid Review and Evaluation,” dated May 6, 2024, pp. 30-31) that coverage for procedures that are cosmetic in nature are not permitted to be offered as SSBCI because these benefits do not meet the statutory requirement of a “reasonable expectation of improving or maintaining the health or overall function of the enrollee.” CMS may decline an MA organization's bid if CMS determines that the MA organization has not demonstrated, through relevant acceptable evidence, that an SSBCI has a reasonable expectation of improving or maintaining the health or overall function of the chronically ill enrollees that the MA organization is targeting. Some plans have proposed to offer cosmetic services for aesthetic purposes only, such as botulinum toxin injections for lines and wrinkles, in their bids. CMS disapproved these proposals during bid review. While MA organizations are permitted to offer non-primarily health related benefits to chronically ill enrollees, these benefits must still have a direct impact on the enrollee's health. Purely cosmetic procedures are not health related and thus cannot be permitted as a supplemental benefit. For these reasons, procedures that are solely cosmetic in nature and do not extend upon Traditional Medicare coverage cannot be offered as SSBCI.</P>
                    <P>
                        We do note however that some cosmetic procedures may be acceptable to be offered as an SSBCI benefit if used to treat medical conditions that affect health or overall function and would not be considered purely cosmetic in nature. For example, the use of botulinum toxin injections is acceptable when treating medical conditions such as an overactive bladder, bladder leakage issues due to neurologic disease, headache prevention in adults with chronic migraine, increased muscle stiffness in adults with limb spasticity, cervical dystonia (CD), strabismus, eyelid spasms or blepharospasm, and hyperhidrosis. There are some circumstances in which Traditional Medicare (
                        <E T="03">i.e.,</E>
                         Medicare Parts A and B) provides coverage for these items. These would be acceptable as a supplemental benefit in situations in which the MA organization is extending upon or providing coverage, beyond that which is provided under Traditional Medicare, related to these procedures. Additionally, coverage for reconstructive medical procedures that extend upon or wrap around Traditional Medicare coverage and are not solely cosmetic in nature (for example, reconstructive surgery for blepharoplasty, subperichondrial hematoma, sebaceous cysts, cleft palate, or trauma related injuries) would also be permitted as a supplemental benefit.
                    </P>
                    <P>
                        In the 2019 HPMS memo titled “Implementing Supplemental Benefits for Chronically Ill Enrollees,” we stated that MA organizations may offer food and produce to assist chronically ill enrollees in meeting nutritional needs assuming all requirements for SSBCI under § 422.102(f) are met, and that such items may include items such as (but not limited to) produce, frozen foods, and canned goods. We noted that tobacco and alcohol are expressly prohibited however, as neither are considered food or nutritional. In addition, CMS has received inquiries from MA organizations about whether they are permitted to offer cannabis-based products as a supplemental benefit. In response to these inquiries, CMS has stated that medical marijuana or derivatives, such as cannabis oil, cannot be covered by MA organizations 
                        <PRTPAGE P="99392"/>
                        as they are illegal substances under Federal law.
                    </P>
                    <P>In the 2019 HPMS memo titled “Implementing Supplemental Benefits for Chronically Ill Enrollees,” we also stated that while MA organizations may provide services to assist in the establishment of decision-making authority for health care needs (for example, power of attorney for health services) and/or may provide education such as financial literacy classes, technology education, and language classes, assuming all requirements for SSBCI under § 422.102(f) are met, but coverage of funeral expenses is not permitted. Funeral services are provided after the death of the beneficiary and, as such, cannot be tied to improving or maintaining that individual's health or overall function. Similarly, life insurance would not be permissible as SSBCI.</P>
                    <P>We also do not consider hospital indemnity insurance to meet the definition of a supplemental benefit. MA organizations offering supplemental benefits must incur a non-zero direct medical cost, except that in the case of an SSBCI that is not primarily health related the MA organization may instead incur a non-zero, direct non-administrative cost (§ 422.100(c)(2)(ii)(B)). Reductions in cost sharing fit into the definition of a supplemental benefit as they are increases in the MA organization's share of the overall payment for the covered health care item or service. However, payment for hospital indemnity insurance premiums would not fit this definition because an MA organization paying for separate, third-party insurance for the enrollee does not incur a direct cost on behalf of the enrollee. Rather, it shifts payment for medical costs to another payer.</P>
                    <P>Additionally, MA organizations are already permitted to reduce cost sharing for inpatient and other covered benefits as part of an SSBCI reduction in cost sharing package. Therefore, MA organizations already have a mechanism to reduce cost sharing under existing rules that do not require offering separate, third-party insurance coverage. Finally, 42 CFR part 422 subpart M appeal and grievance requirements require all covered benefits to be subject to the MA appeal rights. The purchase of a hospital indemnity insurance policy would mean that the actual benefits from the policy to enrollees (that is, payment toward or reimbursement of the costs of health care items and services) would not be covered by subpart M. Having only the payment of premium subject to appeal is inconsistent with how other benefits available through the MA organizations are subject to appeal and potentially creates enrollee confusion or misleads enrollees as to what the MA organization is responsible for furnishing and paying and thus is inappropriate as a supplemental benefit.</P>
                    <P>Finally, CMS has received and declined proposals from MA organizations to offer broad membership programs, inclusive of multiple unrelated services discounts, such as Amazon Prime, Costco, and others, as SSBCI. A generic membership is not permissible as SSBCI because it is not limited to items or services that have a reasonable expectation of improving or maintaining the health or overall function of the enrollee. That is not to say that an MA organization cannot contract with any of these retailers to offer covered benefits in some capacity (for example, benefits administered via a restricted debit card). However, a generic membership that would include items or services that do not have a reasonable expectation of improving or maintaining the health or overall function of the enrollee and no mechanism to ensure that enrollees receive only covered benefits is not compliant with CMS rules regarding supplemental benefits and thus not allowable as a supplemental benefit.</P>
                    <P>
                        Lastly, we reiterate the statutory prohibition against MA organizations offering cash or monetary rebates (section 1851(h)(4)(A) of the Act), and we further reiterate that items or services that are not intended to improve the enrollee's health, such as gambling items (
                        <E T="03">e.g.,</E>
                         online casino games, lottery tickets), firearms and ammunition, would not meet our requirements for supplemental benefits.
                    </P>
                    <P>We propose to codify examples discussed here as items and services that cannot be offered as SSBCI at § 422.102(f)(1)(iii). We solicit comment on all aspects of this proposal and may consider revisions to our proposal based on the comments received. These revisions may include, but are not limited to, a revision to the non-exhaustive list of non-primarily health related items and services that do not have a reasonable expectation of improving or maintaining the health of a chronically ill enrollee and may not be offered as SSBCI.</P>
                    <P>CMS also solicits comment on other items and services not listed here that would be appropriate to include in the list of items that may not be offered as SSBCI.</P>
                    <P>We ask that commenters include in their comments explanations and why they believe suggested items do not meet the statutory requirement of having a reasonable expectation of improving or maintaining the health or overall function of the enrollee and include any relevant information and research for CMS to consider. Based on the comments received, we may consider finalizing revisions to this proposed policy.</P>
                    <P>Finally, we note that just because we are proposing to codify a non-exhaustive list of benefits and services that may not be offered as an SSBCI, this does not mean that all items not included on this list are allowable. All benefits must be proposed in a plan's annual bid and are subject to review by CMS. Further, all SSBCI must meet the requirements under § 422.102(f), including the requirement of a written bibliography of relevant acceptable evidence that demonstrates the impact of a service on the health or overall function of its recipient (§ 422.102(f)(3)), and the requirement that any enrollees targeted with an SSBCI service or benefit must meet all the eligibility requirements under § 422.102(f).</P>
                    <P>This proposal primarily codifies and clarifies existing guidance and practices and is not expected to have additional impact above current operating expenses for MA organizations. This proposal would not impose any new collection of information requirements.</P>
                    <P>We seek comment on all aspects of this proposal and may consider revisions to the final policy based on the comments received.</P>
                    <HD SOURCE="HD2">H. Eligibility for Supplemental Benefits for the Chronically Ill (SSBCI) and Technical Changes to the Definition of Chronically Ill Enrollee (§ 422.102)</HD>
                    <HD SOURCE="HD3">1. Eligibility for Supplemental Benefits for the Chronically Ill (SSBCI)</HD>
                    <P>The Balanced Budget Act (BBA) of 2018 (Pub. L. 115-123) provided new authorities concerning supplemental benefits that may be offered to chronically ill enrollees in Medicare Advantage (MA) plans. We addressed these new supplemental benefits extensively in the Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program (hereafter referred to as “June 2020 final rule”) (85 FR 33800 through 33805), where we referred to them as Special Supplemental Benefits for the Chronically Ill (SSBCI).</P>
                    <P>
                        Supplemental benefits, including SSBCI, are generally funded using MA plan rebate dollars. The MA rebate dollars may be used for mandatory, but not optional, supplemental benefits 
                        <PRTPAGE P="99393"/>
                        offered by the plan (§ 422.266(b)(1)).
                        <SU>71</SU>
                        <FTREF/>
                         When submitting an annual bid to participate in the MA program, an MA organization includes in its bid a Plan Benefit Package (PBP) and Bid Pricing Tool (BPT) for each of its plans, where the MA organization provides information to CMS on the premiums, cost sharing, and supplemental benefits (including SSBCI) it proposes to offer. Since the statutory amendment authorizing SSBCI and our subsequent guidance in a Health Plan Management System (HPMS) memorandum dated April 24, 2019 (“2019 HPMS memo” hereafter),
                        <SU>72</SU>
                        <FTREF/>
                         the number of MA plans that offer SSBCI—and the number and scope of SSBCI offered by an individual plan—has significantly increased. We have observed these trends in reviewing PBPs from MA plans submitted over the last 5 years.
                    </P>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             Rebates can also be used to buy down Part B and D premiums under § 422.266(b)(2) and (b)(3).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             
                            <E T="03">https://www.cms.gov/medicare/health-plans/healthplansgeninfo/downloads/supplemental_benefits_chronically_ill_hpms_042419.pdf.</E>
                        </P>
                    </FTNT>
                    <P>As we described in Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE) (hereafter referred to as the “April 2024 final rule”) (89 FR 30551), to offer an item or service as an SSBCI to an enrollee, an MA plan must make at least two separate determinations with respect to that enrollee in order to satisfy the statutory and regulatory requirements for these benefits. First, the MA plan must determine that an enrollee is eligible for the SSBCI by meeting the statutory definition of “chronically ill enrollee.” Section 1852(a)(3)(D)(iii) of the Act defines “chronically ill enrollee” as an individual enrolled in the MA plan who meets all of the following: (I) has one or more comorbid and medically complex chronic conditions that is life-threatening or significantly limits the overall health or function of the enrollee; (II) has a high risk of hospitalization or other adverse health outcomes; and (III) requires intensive care coordination. Per § 422.102(f)(1)(i)(B), CMS may publish a non-exhaustive list of conditions that are medically complex chronic conditions that are life-threatening or significantly limit the overall health or function of an individual. This list of chronic conditions is the same as the list for which MA organizations may offer chronic condition special needs plans (C-SNPs), which can be found in the definition of “severe or disabling chronic condition” within § 422.2.</P>
                    <P>
                        Section 422.102(f)(4)(i) and (ii) requires that the MA plans have written policies for making SSBCI enrollment determinations, document that each enrollee eligible for SSBCI is a chronically ill enrollee and provide this documentation to CMS upon request.
                        <SU>73</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             89 FR 30551.
                        </P>
                    </FTNT>
                    <P>Second, the MA plan must determine that the SSBCI has a reasonable expectation of improving or maintaining the health or overall function of the enrollee.</P>
                    <P>Section 422.102(f)(4)(iii)(A) requires MA plans must have and apply written policies based on objective criteria for determining a chronically ill enrollee's eligibility to receive a particular SSBCI. Section 422.102(f)(4)(v) further requires that MA plans maintain without modification, as it relates to an SSBCI, evidentiary standards for a specific enrollee to be determined eligible for a particular SSBCI, or the specific objective criteria used by a plan as part of SSBCI eligibility determinations for the full coverage year.</P>
                    <P>In the June 2020 final rule, we stated that it is our expectation that plans communicate to enrollees information in a clear manner about the scope of SSBCI that the MA plan covers and who is eligible for those benefits (85 FR 33803). We made further changes to our regulations in our April 2024 final rule, where we modified the disclaimer requirements at § 422.2267(e)(34) to require plans to include clear information about SSBCI eligibility criteria in marketing and communications materials that mention SSBCI, including by listing the chronic conditions an enrollee must have in order to be eligible for the SSBCI. Taken together, these previous actions and the proposed changes to the regulation here demonstrate our broader concern about the importance of transparency as it applies to SSBCI eligibility.</P>
                    <P>
                        Currently, as permitted by § 422.504(f)(2), CMS may review SSBCI eligibility criteria by requesting it from plans. This is currently done on a case-by-case basis. Since there is no public posting of a plan's criteria for determining how an enrollee may or may not qualify for an SSBCI, enrollees are left to speculate whether a particular benefit, which may be attractive to an enrollee and spur them to enroll in a plan, is even available to them. This lack of transparency limits a potential enrollee's ability to review and determine whether they may be eligible for SSBCI based on the plan's eligibility criteria. Additionally, we received several comments in response to the Medicare Program; Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications proposed rule (herein after referred to as the “November 2023 proposed rule”) requesting that plans post their objective eligibility criteria for SSBCI on a public-facing website to increase transparency for potential enrollees. In response to these comments, we noted that CMS would consider taking this action in future rulemaking (89 FR 30558).
                        <SU>74</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             
                            <E T="03">https://www.federalregister.gov/d/2024-07105/p-1069.</E>
                        </P>
                    </FTNT>
                    <P>
                        Further, when reviewing SSBCI eligibility criteria, we have discovered that several plans offering SSBCI benefits do not determine eligibility in an objective manner, as required at § 422.102(f)(4)(iii)(A).
                        <SU>75</SU>
                        <FTREF/>
                         For example, an enrollee may self-attest that they are eligible for SSBCI without additional criteria or any verification from the plan of this eligibility status. This would not meet our requirements. Additionally, we have noted in our reviews that some plans determine what SSBCI to cover and pay for without consultation with a doctor or other medical professional to determine the clinical appropriateness of the items and services offered under the SSBCI benefit. CMS has also identified instances where plans, when determining eligibility, are not properly evaluating enrollees using all three components of the definition for “chronically ill enrollee” as defined in section 1852(a)(3)(D)(iii) of the Act. One of the three requirements in the statutory definition of “chronically ill enrollee” is that the individual requires intensive care coordination. As we noted in the June 2020 Final Rule, we did not define “intensive care coordination” or establish standards for when an MA enrollee requires such services.
                        <SU>76</SU>
                        <FTREF/>
                         We wished to allow plans flexibility in determining what the phrase meant to best serve their enrollees. However, we noted some examples of methods through which 
                        <PRTPAGE P="99394"/>
                        plans may determine an enrollee required intensive care coordination, such as conducting a health risk assessment, performing a retrospective claims review for an enrollee, or by other means the plan deems necessary. CMS reaffirms its position stated in the June 2020 final rule, that objective criteria which utilize the above mechanisms for meeting the three-pronged definition are present in the medical community and may be readily accessible to the plan.
                    </P>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             Prior to the effective date the April 2024 final rule, this requirement was codified at 42 CFR. 422.102(f)(3)(iii). The April 2024 final rule slightly reorganized § 422.102(f) as part of amendments to adopt new requirements.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             
                            <E T="03">https://www.federalregister.gov/d/2020-11342/p-59.</E>
                        </P>
                    </FTNT>
                    <P>We have identified that the current regulation text (§ 422.102(f)(1)(i)(A)) may need further clarification for plans. It was never our intention to imply that the presence of a chronic illness or chronic condition alone is sufficient to satisfy all three of the statutory criteria to qualify as a chronically ill enrollee. Therefore, we are clarifying that having a medically complex chronic condition or comorbidity by itself is insufficient to satisfy the requirements in § 422.102(f)(1)(i)(A)(1), (f)(1)(i)(A)(2), and (f)(1)(i)(A)(3), and are proposing a technical edit to clarify this requirement. We propose to amend § 422.102(f)(1)(i)(A) and (f)(1)(i)(A)(1) through (3) to specify that ” a chronically ill enrollee is an individual enrolled in the MA plan who meets all of the following:</P>
                    <P>• Has one or more comorbid and medically complex chronic conditions that is life threatening or significantly limits the overall health or function of the enrollee.</P>
                    <P>• Has a high risk of hospitalization or other adverse health outcomes. (3) Requires intensive care coordination. This is consistent with the statute, which defines a “chronically ill enrollee” at section 1852(a)(3)(D)(iii) of the Act as an enrollee who: (1) has one or more comorbid and medically complex chronic conditions that is life threatening or significantly limits the overall health or function of the enrollee; (2) has a high risk of hospitalization or other adverse health outcomes; and (3) requires intensive care coordination. This clarification would allow the definition of a chronically ill enrollee at § 422.102(f)(1)(i)(A)(1) through (3) to mirror the statutory language at section 1852(a)(3)(D)(iii) of the Act as intended in the 2020 final rule.</P>
                    <P>Additionally, we propose that plans must demonstrate that an enrollee has met all three of the criteria set forth in § 422.102(f)(1)(i)(A) through the use an objective process (for example, either a health risk assessment, a claims review, or other similar means). We wish to continue to allow plans flexibility in the methods they use to determine that enrollees have met all three criteria.</P>
                    <P>
                        By way of example, a plan could establish that in order to be eligible for certain SSBCI, an enrollee must have a confirmed diagnosis of diabetes by their primary care physician, and must also have been admitted to the hospital in the last 90 days. Under this example, the diagnosis of a chronic illness is sufficient to satisfy the first criterion (as proposed), that the enrollee, “has one or more comorbid and medically complex chronic conditions that is life threatening or significantly limits the overall health or function of the enrollee 
                        <SU>77</SU>
                        <FTREF/>
                        .” However, the plan must also determine that the enrollee has met the second and third criteria: (2) has a high risk of hospitalization or other adverse health outcomes; and (3) requires intensive care coordination. The plan may determine that an enrollee meets the second requirement by being hospitalized in the last 90 days. The plan may reason that enrollees who have been hospitalized in the last 90 days are at high risk of readmission and so meet the second statutory requirement of having a high risk of hospitalization. The plan may further decide that the enrollee would require intensive care coordination to prevent further hospitalization, and thus would satisfy the third regulatory requirement. In this hypothetical scenario, the plan has determined through an objective process that the chronically ill enrollee meets all three requirements at § 422.102(f)(1)(i)(A). Given the variability, inconsistency and subjective eligibility determinations by plans that we have observed or been notified about as part of our routine monitoring, we are proposing three additional amendments to the regulation text. First, we propose to codify at a new paragraph at § 422.102(f)(1)(i)(C) a provision prohibiting MA plans from using the presence of a chronic illness as the sole basis for determining eligibility for SSBCI, in accordance with statute and the minimum requirements for an MA plan to determine that an individual meets the statutory definition of “chronically ill enrollee.” As described previously, it has become evident through our routine monitoring that some plans are not abiding by the statutory requirements to determine eligibility for SSBCI. CMS has proceeded with compliance actions in these cases, and while we noted in the June 2020 final rule that we wished to allow flexibility for plans to identify needs within their unique plan population, some plans have inappropriately determined eligibility for SSBCI when the enrollee does not meet the three-pronged criteria set forth at section 1852(a)(3)(D)(iii) of the Act to receive SSBCI. As we make the technical edit to clarify our regulation, we also propose to add regulation text to § 422.102(f)(1)(i)(C) which provides that having one or more comorbidities and medically complex chronic conditions alone is not sufficient to demonstrate that an enrollee meets all three criteria set forth in paragraph (f)(1)(i)(A) and that MA plans must, through health risk assessments, review of claims data, or other similar means, demonstrate that enrollees meet all three criteria set forth in paragraph (f)(1)(i)(A). Our proposal to make a technical correction would clarify our policy as it regards SSBCI eligibility and would not impose any new collection of information requirements.
                    </P>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             As previously noted, the list of chronic conditions that qualify as comorbid and medically complex chronic conditions that are life threatening or significantly limit the overall health or function of an enrollee for purposes of SSBCI eligibility can be found within the definition of “severe or disabling chronic condition” in CMS's regulations at § 422.2.
                        </P>
                    </FTNT>
                    <P>
                        We further propose that plans must publish on their public-facing website the objective criteria developed and used by the MA plan as required in § 422.102(f)(4)(i) and (iii)(A) to determine whether an enrollee is eligible to receive any, and which particular, SSBCI benefits the plan offers. These objective criteria must set forth how the plan evaluates each enrollee and determines whether the enrollee meets the three-pronged definition of a chronically ill enrollee as set forth in the statute. Specifically, we are proposing that plans must post on their public-facing website their objective criteria for determining that an enrollee is a chronically ill enrollee within the statutory and regulatory definition and is eligible to receive SSBCI offered by the plan. Plans must make this information available to all persons on their public-facing website. We remind MA plans of their digital accessibility obligations as recipients of Federal assistance under section 504 of the Rehabilitation Act.
                        <SU>78</SU>
                        <FTREF/>
                         We propose this requirement be codified in the regulation text at § 422.102(f)(4)(iii)(C). In addition, we propose minor reorganization of paragraph (f)(4)(iii) by adding the words, “Have objective criteria for SSBCI. Specifically, the plan must” and then listing the requirements in paragraphs (f)(4)(iii)(A) through (C).
                    </P>
                    <FTNT>
                        <P>
                            <SU>78</SU>
                             29 U.S.C. 794; 45 CFR pt. 84.
                        </P>
                    </FTNT>
                    <P>
                        We believe this proposal would provide greater transparency and 
                        <PRTPAGE P="99395"/>
                        consistency to the eligibility determination process for potential enrollees and will enhance the enrollees' ability to make informed decisions about their enrollment and the benefits. We remind plans that § 422.102(f)(4)(v) requires that plans maintain their evidentiary standards or objective criteria for enrollee eligibility for the entire coverage year.
                    </P>
                    <P>In addition, we remind plans that under § 422.2262, general communications materials and activities requirements, MA organizations may not mislead, confuse, or provide materially inaccurate information to current or potential enrollees. Consistent with these existing requirements, we expect that MA organizations, as well as the agents and brokers that are operating on behalf of such organizations, will provide appropriate information on how the plan evaluates each enrollee and determines whether the enrollee meets the three-pronged definition of a chronically ill enrollee when discussing SSBCI benefits with a current or potential enrollee, to ensure that information about SSBCI provided in such discussions is accurate and not misleading.</P>
                    <P>Additionally, while there is not currently a consistent manner by which plans publicly report this information or submit the information directly to CMS, we believe these proposals will provide an increased level of compliance oversight, increase good governance and oversight of the Medicare Trust Fund, and improve patient participation in their care and awareness of their eligibility for benefits, by making this information publicly available rather than only available upon request by CMS.</P>
                    <P>We seek public comment on both proposals and may, based on the comments received, consider finalizing revisions to this final policy.</P>
                    <HD SOURCE="HD2">I. Risk Adjustment Data Updates</HD>
                    <HD SOURCE="HD3">1. Update Hierarchical Condition Categories (HCC) Definition (§ 422.2)</HD>
                    <P>
                        The current definition of Hierarchical Condition Categories (HCC) at 42 CFR 422.2 references the 
                        <E T="03">International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM),</E>
                         which was the standard medical data code set HHS adopted for health conditions from October 16, 2002, to September 30, 2015 (45 CFR 162.1002(a)(1) and 45 CFR 162.1002(b)(1)). For the period starting on October 1, 2015, HHS adopted an updated version of the ICD, 
                        <E T="03">ICD-10-CM,</E>
                         as the standard medical data code set for health conditions (45 CFR 162.1002(c)(2)). The ICD diagnosis codes—referred to as disease codes in the current HCC definition—that are grouped in an HCC for risk score calculation are only those valid codes that are from the ICD version that is in place during a respective year. For example, for dates of service starting on October 1, 2015, only valid 
                        <E T="03">ICD-10-CM</E>
                         codes would have been included in HCCs, since 
                        <E T="03">ICD-9-CM</E>
                         codes were no longer in use.
                    </P>
                    <P>
                        We are proposing to remove the reference to a specific version of the ICD from the definition of HCC in § 422.2, while maintaining a reference to the ICD in general. The ICD is updated as advances are made in healthcare, and as new editions are issued, the code set standard adopted by HHS may change to use the most current edition. See section 1173(c) of the Act for the Secretary's authority to adopt code sets, as well as 45 CFR part 162 (specifically, §§ 162.1000 through 162.1011) for the diagnosis code sets adopted for HIPAA transactions. The current HCC definition in § 422.2 states that disease groupings consist of “disease codes (currently 
                        <E T="03">ICD-9-CM</E>
                         codes) that predict average healthcare spending.” Amending the HCC definition to remove reference to a specific version of the ICD would keep the definition in § 422.2 current as updates are made to the HCCs in model calibrations and newer versions of the ICD are created and adopted by the Secretary. We are also proposing to substitute the terms “disease codes” with “diagnosis codes” and “disease groupings” with “diagnosis groupings” to be consistent with ICD terminology.
                    </P>
                    <P>The proposed update at § 422.2 is a technical change to the longstanding definition of HCC. The proposal to remove the reference to a specific version of the ICD from the HCC definition does not change the meaning of HCC or how it is used in § 422.311, which has been defined and used in MA regulations since 2010 (75 FR 19803) as part of describing risk adjustment data validation audit reports and the voluntary dispute resolution process available for MA organizations to dispute errors identified during those audits. For this reason, we do not expect the proposed change to result in additional costs or savings and are not scoring this provision in the Regulatory Impact Analysis section. Further, as we are not imposing any new reporting requirements, we do not believe that our proposal will result in additional paperwork burden and have not incorporated a burden increase in the Collection of Information section.</P>
                    <HD SOURCE="HD3">2. Clarifying the Obligation of PACE Regulations To Submit Data (§ 460.180(b))</HD>
                    <P>CMS is authorized under section 1894(d)(1) of the Act to make payments to PACE organizations in the same manner as MA organizations. Consistent with that, PACE organizations must submit data in accordance with the risk adjustment data requirements for MA organizations at § 422.310. Codified at 42 CFR 460.200, PACE organizations are required to collect data, maintain records, and submit reports as required by CMS to establish payments rates. We are proposing to codify our longstanding practice of requiring the collection and mandatory submission of risk adjustment data by PACE organizations by adding a new paragraph at 42 CFR 460.180(b)(3) that requires the data they submit is in accordance with risk adjustment data submission requirements in § 422.310. By codifying this longstanding requirement of PACE organizations, the proposed provision does not create any new requirements or make changes to payment for PACE organizations. See, for example, 64 FR 66234, 66266 (Nov. 24, 1999) (“We will subsequently require PACE organizations to submit additional encounter data consistent with the encounter data requirements for [MAOs] set forth in 42 CFR 422.257 [the precursor to § 422.310] . . . .”); see also the system of record notice (SORN) for the CMS Encounter Data System (EDS), System No. 09-70-0506, at 79 FR 34539 (July 17, 2014) and the CMS Risk Adjustment Suite of Systems (RASS), System No. 09-70-0508, at 80 FR 49237 (August 17, 2015).</P>
                    <P>
                        We are proposing to add a new paragraph at § 460.180(b)(3) to codify existing longstanding practice for the collection and mandatory submission of risk adjustment data, as specified in § 422.310, for PACE organizations. The proposed provision does not create any new requirements or make any changes to payment for PACE organizations. The proposed regulatory changes will not result in additional costs, nor do we expect the impact of these changes to result in savings. For this reason, we do not expect the proposed change to result in additional costs or savings and are not scoring this provision in the Regulatory Impact Analysis section. Further, as we are not imposing any new reporting requirements, we do not believe that our proposal will result in additional paperwork burden and have not incorporated a burden increase in the Collection of Information section.
                        <PRTPAGE P="99396"/>
                    </P>
                    <HD SOURCE="HD3">3. Clarifying the Obligation of Cost Plans To Submit Certain Data (§ 417.486(a))</HD>
                    <P>Currently, we require the submission of risk adjustment data from organizations that operate cost plans under section 1876 of the Act in the same manner as MA organizations. Codified at 42 CFR 417.486(a), the contract of Section 1876 Cost plans must provide that the plan agrees to submit to CMS: (1) all financial information required under subpart O of this part and for final settlement; and (2) any other information necessary for the administration or evaluation of the Medicare program.</P>
                    <P>In this proposed rule, we propose to amend § 417.486(a) to add a new § 417.486(a)(3) to codify existing longstanding practice of requiring the collection and mandatory submission of risk adjustment data as specified in 42 CFR 422.310 by 1876 Cost plans. As stated in the 2012 Advance Notice, we have required the submission of encounter data for Cost plans under our authority in sections 1876(h)(3), 1833(a)(1)(A), and 1861(v) to determine “reasonable costs.” Also see 42 CFR 417.568 (requiring Cost plans to “provide adequate cost and statistical data . . . that can be verified by qualified auditors”) and § 417.576(b)(2)(iii) (requiring Cost plans to submit “[a]ny other information required by CMS”). These proposed regulatory changes will not result in additional costs, nor do we expect the impact of these changes to result in savings. For this reason, we do not expect the proposed change to result in additional costs or savings and are not scoring this provision in the Regulatory Impact Analysis section. Further, as we are not imposing any new reporting requirements, we do not believe that our proposal will result in additional paperwork burden and have not incorporated a burden increase in the Collection of Information section.</P>
                    <HD SOURCE="HD2">J. Ensuring Equitable Access to Medicare Advantage (MA) Services—Guardrails for Artificial Intelligence (§ 422.112)</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>
                        On January 25, 2021, the Biden-Harris Administration released an Executive Order, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government” (
                        <E T="03">E.O. 13985</E>
                        ), directing agencies to embed equity principles, policies, and approaches across Federal Government programs. In October 2022, the White House Office of Science and Technology Policy (OSTP) released the Blueprint for an AI Bill of Rights,
                        <SU>79</SU>
                        <FTREF/>
                         identifying five principles to protect the public from the misuse of artificial intelligence, including eliminating discriminatory practices by algorithms and systems. On October 30, 2023, the Biden-Harris Administration also released an Executive Order, “Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence,” directing agencies to ensure that artificial intelligence tools do not impede the advancement of equity and civil rights, and that the use of AI within health care organizations does not deny equal opportunity and justice for the American people.
                        <SU>80</SU>
                        <FTREF/>
                         On January 30, 2024, CMS published “Medicare Program; Request for Information on Medicare Advantage Data” which received several comments related to the use and regulation of AI and requests for CMS ensure that MA plans' use of AI complies with existing CMS rules without negatively impacting health disparities.
                        <SU>81</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>79</SU>
                             
                            <E T="03">https://www.whitehouse.gov/ostp/ai-bill-of-rights/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>80</SU>
                             
                            <E T="03">https://www.federalregister.gov/documents/2023/11/01/2023-24283/safe-secure-and-trustworthy-development-and-use-of-artificial-intelligence.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>81</SU>
                             
                            <E T="03">https://www.federalregister.gov/documents/2024/01/30/2024-01832/medicare-program-request-for-information-on-medicare-advantage-data.</E>
                        </P>
                    </FTNT>
                    <P>15 U.S.C. 9401(3) defines “artificial intelligence” or “AI” as “a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments. Artificial intelligence systems use machine- and human-based inputs to—(A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.”</P>
                    <P>
                        The health care industry has seen the adoption of AI in multiple capacities, such as, but not limited to, AI-based patient care decision support tools, vision transformer-based AI methods for lung cancer imaging applications, and AI and machine learning based decision support systems in mental health care settings.
                        <SU>82</SU>
                        <FTREF/>
                         In some instances, automation has created efficiencies, cost savings, and time management improvements for health providers and support staff.
                    </P>
                    <FTNT>
                        <P>
                            <SU>82</SU>
                             Khosravi M., Zare Z., Mojtabaeian S.M., Izadi R., Artificial Intelligence and Decision-Making in Healthcare: A Thematic Analysis of a Systematic Review of Reviews. Health Serv Res Manag Epidemiol. 2024 Mar 5;11:23333928241234863. doi: 10.1177/23333928241234863. PMID: 38449840; PMCID: PMC10916499.
                        </P>
                    </FTNT>
                    <P>
                        However, there have been many instances of algorithmic discrimination, where the use of AI has resulted in deepening bias and discrimination, exacerbating existing inequities within the health care system.
                        <SU>83</SU>
                        <FTREF/>
                         Often, these individual patients are members of historically underserved and marginalized groups, which, increases the risk of automated bias and discrimination for these populations when AI tools are used within their health care.
                        <SU>84</SU>
                        <FTREF/>
                         A study in the Journal of Biomedical Informatics determined that people of color or individuals with lower socioeconomic status typically have less complete electronic health records (EHRs). The study demonstrates that as advances in AI are incorporated into the clinic, patients of lower socioeconomic status and patients of color, can receive differential treatment in early disease detection and risk prediction.” 
                        <SU>85</SU>
                        <FTREF/>
                         Also, AI and related tools rely on large data sets which can have missing or incorrect information. The massive volume of data needed to train an AI model amplifies bias and may result in low quality AI recommendations without complete and substantial data. It is not uncommon for individual patients to have incorrect or missing data in their medical records, which produces flawed AI recommendations.
                        <SU>86</SU>
                        <FTREF/>
                         In addition, CMS has received concerns from external stakeholders through various formats about beneficiary harm potentially resulting from MA organizations' use of AI.
                    </P>
                    <FTNT>
                        <P>
                            <SU>83</SU>
                             Executive Office of the President, May 2016, “Big Data: A Report on Algorithmic Systems, Opportunity, and Civil Rights.” 
                            <E T="03">https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/2016_0504_data_discrimination.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>84</SU>
                             Hoffman and Podgurski, “Artificial Intelligence and Discrimination in Health Care, Yale Journal of Health Policy, Law, and Ethics,” Vol. 19 [2020], Iss. 3, Art. 1. 
                            <E T="03">https://yaleconnect.yale.edu/get_file?pid=bbaf6b35fe2b49fd1f4c39fbb91951db5b92a42618d4fd2a6724813f4cf64872.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>85</SU>
                             Getzen, Emily et al. “Mining for equitable health: Assessing the impact of missing data in electronic health records.” 
                            <E T="03">Journal of biomedical informatics</E>
                             vol. 139 (2023): 104269. doi:10.1016/j.jbi.2022.104269.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>86</SU>
                             Hoffman and Podgurski, “Artificial Intelligence and Discrimination in Health Care, Yale Journal of Health Policy, Law, and Ethics,” Vol. 19 [2020], Iss. 3, Art. 1.
                        </P>
                    </FTNT>
                    <P>
                        One example of algorithmic discrimination involves the use of AI to predict which patients are most likely to miss their medical appointments. The AI often uses data, such as prior no-show history, to advise providers to double-book certain patients. In this instance, lower-income patients were more likely to miss their medical appointments due to challenges around transportation, childcare, and work schedules. As a result of using this data 
                        <PRTPAGE P="99397"/>
                        within the AI tool, providers double-booked lower-income patients, causing longer wait times for lower-income patients and perpetuating the cycle of additional missed appointments for vulnerable patients.
                        <SU>87</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>87</SU>
                             Hoffman and Podgurski, “Artificial Intelligence and Discrimination in Health Care, Yale Journal of Health Policy, Law, and Ethics,” Vol. 19 [2020], Iss. 3, Art. 1. 
                            <E T="03">https://yaleconnect.yale.edu/get_file?pid=bbaf6b35fe2b49fd1f4c39fbb91951db5b92a42618d4fd2a6724813f4cf64872.</E>
                        </P>
                    </FTNT>
                    <P>Our proposed policy intends to make clear that MA organizations must provide all enrollees, without exception, equitable access to services, including when MA organizations use AI or other automated systems to aid their decision-making.</P>
                    <HD SOURCE="HD3">2. Proposed Policy</HD>
                    <P>On June 29, 2000 (65 FR 40170), we issued a final rule titled, Medicare Program; Medicare+Choice Program (the June 2000 final rule), which described the requirement that MA plans must provide services in a culturally competent manner that addresses unique racial and ethnically related health care concerns. We stated that these services should accommodate the unique health-related beliefs, attitudes, practices, and communication patterns of beneficiaries and their caregivers to improve services, strengthen programs, increase community participation and eliminate disparities in health status among diverse population groups (65 FR 40217). Furthermore, we required that MA organizations ensure that all covered benefits are “available and accessible to all enrollees.” As such, § 422.112(a)(8) requires MA organizations that offer coordinated care plans to ensure that services are provided in a culturally competent manner to all enrollees, including those with limited English proficiency or reading skills, and diverse cultural and ethnic backgrounds.</P>
                    <P>
                        In the April 2023 final rule (88 FR 22120), CMS revised the paragraph heading at § 422.112(a)(8), from “
                        <E T="03">Cultural considerations”</E>
                         to “
                        <E T="03">Ensuring Equitable Access to Medicare Advantage (MA) Services.”</E>
                         Additionally, in the April 2023 final rule (88 FR 22120), at § 422.112(a)(8), CMS replaced the phrase, “those with limited English proficiency or reading skills, and diverse cultural and ethnic backgrounds” after the word “including” and added in its place paragraphs (i) through (vii), listing more examples of underserved populations to whom an MA organization must ensure that services are provided in a culturally competent manner and promote equitable access to services in order to satisfy the existing requirement. CMS noted specifically in the April 2023 final rule that, “MA organizations must provide all enrollees, without exception, accommodations to equitably access services according to applicable statutory, regulatory, and other guidance.” 
                        <SU>88</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>88</SU>
                             
                            <E T="03">https://www.federalregister.gov/d/2023-07115/p-361.</E>
                        </P>
                    </FTNT>
                    <P>
                        Given the growing use of AI within the health care sector, we believe it is necessary to ensure that the use of AI does not result in inequitable treatment, bias, or both, within the health care system, and instead is used to promote equitable access to care and culturally competent care for all enrollees. As such, we propose to revise § 422.112(a)(8), 
                        <E T="03">Ensuring equitable access to Medicare Advantage (MA) Services,</E>
                         by moving the examples listed in paragraphs (i) through (vii) under a new paragraph (i)(A) through (G), and creating a new paragraph (ii) that requires MA organizations to ensure services are provided equitably irrespective of delivery method or origin, whether from human or automated systems. We specify that artificial intelligence or automated systems, if utilized, must be used in a manner that preserves equitable access to MA services.
                    </P>
                    <P>
                        In the same way that MA organizations, “must provide all enrollees, without exception, accommodations to equitably access services according to applicable statutory, regulatory, and other guidance,” 
                        <SU>89</SU>
                        <FTREF/>
                         MA organizations must provide enrollees with equitable access to services under the MA plan design or benefits or both regardless of the tools or methods utilized to make care decisions or to provide that care. Section 1852(b) of the Act and § 422.110(a) prohibit an MA organization from denying, limiting, or conditioning the coverage or furnishing of benefits to individuals eligible to enroll in an MA plan offered by the organization on the basis of any factor that is related to health status. Additionally, § 422.100(f)(2) provides that plan designs and benefits may not discriminate against beneficiaries, promote discrimination, discourage enrollment, encourage disenrollment, steer subsets of Medicare beneficiaries to particular MA plans, or inhibit access to services. We are not proposing any regulatory modifications to these requirements, as these existing requirements already apply to MA plans if they use AI or automated systems. Instead, we reiterate that in the event that an MA plan uses AI or automated systems, they must comply with section 1852(b) of the Act, § 422.110(a) and other applicable regulations and requirements, provide equitable access to services, and not discriminate on the basis of any factor that is related to the enrollee's health status. Regarding enforcement and oversight of MA organizations, CMS has a well-established, robust, and successful process for ensuring organizations that offer MA plans are complying with our regulations and program guidance. As a result of CMS's authority under 42 CFR part 422, subparts K and O, CMS may conduct program audits and compliance activities as well as issue compliance and enforcement actions to MA organizations who fail to comply with our regulations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>89</SU>
                             
                            <E T="03">https://www.federalregister.gov/d/2023-07115/p-361.</E>
                        </P>
                    </FTNT>
                    <P>As the health care system evolves and utilizes new and emerging AI tools, we feel the need to clarify that these tools, including but not limited to, machine learning, patient care decision support tools, and/or other algorithmic tools, must not violate CMS rules. If MA organizations use these AI tools or automated systems in any manner, it is their responsibility to ensure that the usage of such tools complies with all existing Medicare policies, including, but not limited to, providing culturally competent care to all enrollees in a non-discriminatory manner. In the event that an MA organization licenses an AI or automated system, or contracts with a third party for services that are furnished using one of these tools, the MA organization will be held responsible in accordance with §§  422.110(a) and 422.504(i)(1), which provides that an MA organization is ultimately responsible even if it uses an First Tier, Downstream, and Related Entity (FDR) to fulfill obligations and responsibilities under the MA regulations and MA contract with CMS. We also note that MA organizations are responsible for ensuring that usage of AI tools complies with internal coverage criteria rules. This provision addresses the equitable coverage of Medicare-covered benefits and therefore applies equally to Cost plans. Because this is a clarification of existing policy, we do not anticipate any new burden associated with this proposal. Further, at this time, this proposal is specific to MA plans. We note that CMS's formulary review process of Medicare Part D plans includes a comprehensive check to ensure enrollees are not facing discrimination or bias or both.</P>
                    <P>
                        We recognize that technology in this space is quickly evolving. As such, we want to ensure that these proposed 
                        <PRTPAGE P="99398"/>
                        revisions and clarifications take into consideration the fast-paced nature of this industry and the evolving application of these tools within the health care industry. As such, we have provided examples for how MA organizations could ensure they remain in compliance with this proposal. MA organizations could maintain compliance by: (1) ensuring that they understand, recognize, and limit the impact of biased data inputs within any AI and/or automated system they utilize; (2) that they create and follow a process to regularly review any automated system they utilize to ensure that the use of the automated system is non-discriminatory; and (3) that outputs with a known discriminatory bias (such as expected utilization or predictability of payment or both) are not used within a MA organization's automated system in a manner that discriminates in the delivery of services in violation of section 1852(b) of the Act or § 422.110(a).
                    </P>
                    <HD SOURCE="HD3">3. Definitions</HD>
                    <P>
                        For purposes of this policy, we propose to adopt the following definition of “automated system” in § 422.2 based on the Blueprint for an AI Bill of Rights. We propose to define “automated system” as “any system, software, or process that uses computation as whole or part of a system to determine outcomes, make or aid decisions, inform policy implementation, collect data or observations, or otherwise interact with individuals or communities or both. Automated systems include, but are not limited to, systems derived from machine learning, statistics, or other data processing or artificial intelligence techniques, and exclude passive computing infrastructure. `Passive computing infrastructure' is any intermediary technology that does not influence or determine the outcome of decision, make or aid in decisions, inform policy implementation, or collect data or observations, including web hosting, domain registration, networking, caching, data storage, or cybersecurity. As used in this part, automated systems that are within the scope of this definition are only those that have the potential to meaningfully impact individuals' or communities' rights, opportunities, or access.” 
                        <SU>90</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>90</SU>
                             
                            <E T="03">https://www.whitehouse.gov/ostp/ai-bill-of-rights/.</E>
                        </P>
                    </FTNT>
                    <P>We also propose to define “Patient care decision support tool,” consistent with the definition at 45 CFR 92.4, as any automated or non-automated tool, mechanism, method, technology, or combination thereof used by an MA organization to support clinical decision-making in its health programs or activities. We recognize that this industry is fast-evolving and ever-changing, and therefore the following uses are examples, but not an exhaustive list. Patient care decision support tools are tools used to guide health care decision-making and can range in form from flowcharts and clinical guidelines to complex computer algorithms, decision support interventions, and models. MA organizations may use these systems to assist with decision-making for various purposes. Patient care decision support tools are used for screening, risk prediction, diagnosis, prognosis, clinical decision-making, treatment planning, health care operations, and allocation of resources, all of which affect the care that individuals receive. Patient care decision support tools may create or contribute to discrimination and their use may lead to poorer health outcomes among members of historically marginalized communities.</P>
                    <P>We reiterate that “artificial intelligence” or “AI” is defined in 15 U.S.C. 9401(3) as “a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments. Artificial intelligence systems use machine and human-based inputs to—(A) perceive real and virtual environments; (B) abstract such perceptions into models through analysis in an automated manner; and (C) use model inference to formulate options for information or action.”</P>
                    <P>We seek comment on this proposal and may consider finalizing revisions based on the comments received.</P>
                    <HD SOURCE="HD2">K. Promoting Community-Based Services and Enhancing Transparency of In-Home Service Contractors (§ 422.2, 422.111)</HD>
                    <P>Section 1852(c)(1) of the Act requires an MA organization to disclose, among other things, the number, mix, and distribution of plan providers in a clear, accurate, and standardized form to each enrollee in an MA plan offered by the MA organization at the time of enrollment and at least annually thereafter. CMS implemented this requirement in a regulation at § 422.111(a) and (b)(3)(i), requiring that an MA organization must disclose the number, mix, and distribution (addresses) of providers from whom enrollees may reasonably be expected to obtain services, in the manner specified by CMS, to each enrollee electing an MA plan it offers; in a clear, accurate, and standardized form; and at the time of enrollment and at least annually thereafter, by the first day of the annual coordinated election period. In addition, under § 417.427, the MA disclosure requirements at § 422.111 also apply to section 1876 cost plans. The regulatory proposals herein apply to all organizations offering network-based plans as defined at § 422.2, including MA plans and section 1876 cost plans. We refer to these entities generally as “plans” throughout this proposal.</P>
                    <P>
                        CMS has historically interpreted the disclosure requirement at § 422.111(b)(3)(i)—“the number, mix, and distribution (addresses) of providers from whom enrollees may reasonably be expected to obtain services”—as referring to the provider directory. CMS developed the MA and Section 1876 Cost Plan Provider Directory Model and Instructions document,
                        <SU>91</SU>
                        <FTREF/>
                         a model material created as an example of how to convey the required information to enrollees. In accordance with § 422.2267(c), when drafting their provider directories based on CMS's model, plans must accurately convey the vital information in the required material and follow the order of content when specified by CMS.
                    </P>
                    <FTNT>
                        <P>
                            <SU>91</SU>
                             The current MA and Section 1876 Cost Plan Provider Directory Model and Instructions document is located at: 
                            <E T="03">https://www.cms.gov/medicare/health-drug-plans/managed-care-marketing/models-standard-documents-educational-materials.</E>
                        </P>
                    </FTNT>
                    <P>
                        The current provider directory model contains an array of specific required information based on § 422.111(b)(3)(i) but also provides some flexibility to plans. For example, plans that offer supplemental benefits must furnish a provider directory for those benefits, but plans may choose to include these network providers that offer supplemental benefits in a directory combined with health care providers or in an entirely separate provider directory. The provider directory model also requires that plans include in the directory any providers or entities providing covered benefits or services, which may be reasonably contacted by an enrollee for the purposes of making an appointment (for example, dentist appointment). However, this means that some entities which provide covered benefits to enrollees may be currently excluded from the directory as they do not have a phone number for appointments, or because they take appointments by booking through a third party. Due to these and other possible scenarios, CMS has become aware that some entities that provide covered benefits, especially those that provide covered supplemental benefits, 
                        <PRTPAGE P="99399"/>
                        including non-primarily health related benefits, may not be included in the provider directory (such as, but not limited to, adult day care entities, transportation services, pest control services, contractors or other building services which construct ramps for homes, etc.). While our intent was to require plans to include all entities that furnish covered benefits to enrollees, CMS has become aware that some plans do not include all such entities (while still complying with regulations and acting consistent with current guidance).
                    </P>
                    <P>We therefore propose to add at § 422.2 a definition for a “direct furnishing entity” which means any individual or entity that delivers or furnishes covered benefits to the enrollee. This includes Medicare Part A and B covered benefits, as well as all types of supplemental benefits. A direct furnishing entity may include entities like transportation services or adult day care facilities. We also note that direct furnishing entities may include first tier, downstream, or related entities (FDRs), but we wish to define a new term to clarify that with this definition, we mean entities from whom enrollees may expect to receive directly furnished services, regardless of their status as an FDR. We further note the distinction between services administered to enrollees and plan-covered services. Agents and brokers, for example, fall under the definition of an FDR, but would not meet the proposed definitions of a direct furnishing entity as they do not cover, furnish or directly provide Medicare Part A or B benefits or services, nor any supplemental benefits.</P>
                    <P>We solicit feedback on the proposed definition for a direct furnishing entity. Specifically, we are interested in: (1) whether this definition is sufficient to encompass individuals or entities who may reasonably provide covered supplemental benefits to the enrollee and should therefore be included in the provider directory, or (2) whether the definition should be further refined to include a more tailored subset of individuals or entities. We may consider finalizing changes to this definition based on comments received.</P>
                    <P>Our intent in requiring a provider directory and further specifying parameters for required provider directory data elements was to include entities that meet the above proposed definition of a direct furnishing entity in the provider directory under § 422.111(b)(3)(i) because enrollees may reasonably be expected to obtain services from them. However, as we noted previously, it is possible that in certain instances, a plan may have contracted with a direct furnishing entity to provide some covered benefits, but reasonably believed that § 422.111(b)(3)(i) did not require that particular direct furnishing entity to be included in the provider directory because there is no phone number the enrollee can call to request an appointment with that entity at a specific address (as required per the current provider directory model).</P>
                    <P>
                        CMS has also been alerted to concerns related to the possible exclusion of these direct furnishing entities from provider directories. These concerns relate to safety and a lack of transparency regarding supplemental benefit service providers and their access to an enrollee's home. Since many supplemental benefits include interaction with an enrollee at the enrollee's home (for example, in-home support services, meal delivery, home modifications, individuals providing adult day care services), a greater safety risk exists for enrollees who use these services. This is particularly of concern when the enrollee may not have information about who may have access to their home, personally identifiable information (PII), or protected health information (PHI). In 2023, CMS became aware of news reports that an FDR contracted with several MA organizations to provide in-home support services had over 1,200 complaint reports logged against the FDR's employees, including several allegations of sexual harassment and assault that occurred in the enrollees' home that were referred to law enforcement for further investigation.
                        <SU>2</SU>
                        <FTREF/>
                         It has been further reported that other FDRs that furnished covered benefits in an enrollee's home may have jeopardized enrollees' safety and caused harm. In these instances, enrollees and their caregivers may have benefited from increased transparency from the MA plan regarding the specific FDRs that the MA organization utilizes to furnish services, including those that may likely enter the enrollee's home to furnish covered items and services.
                    </P>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             
                            <E T="03">https://www.bloomberg.com/news/features/2023-05-30/papa-eldercare-startup-faces-abuse-claims-by-seniors-caregivers?embedded-checkout=true&amp;leadSource=uverify%20wall.</E>
                        </P>
                    </FTNT>
                    <P>CMS also strongly encourages plans to do business with organizations deeply rooted within the community they serve and may be best suited to serve. As explained in the Calendar Year 2023 Physician Fee Schedule proposed rule (87 FR 46102), community-based organizations (CBOs) are defined as public or private not-for-profit entities that provide specific services to the community, or targeted populations in the community, to address the health and social needs of those populations. They may include community-action agencies, housing agencies, area agencies on aging, centers for independent living, aging and disability resource centers, or other non-profits that apply for grants to perform social services. While we currently require at § 422.112(b)(3) that coordinated care plans' arrangements with contracted providers include programs for the coordination of plan services with community and social services generally available in the area served by the MA plan, we note that there is currently no way for enrollees to determine through the provider directory, or other means set forth in regulation, which contracted providers are CBOs located in or near the community in which the enrollee lives.</P>
                    <P>In an effort to allow enrollees more access to information regarding their service providers, and further encourage MA plans' use of community-based providers, CMS is proposing to codify new requirements in the regulation. We propose to add new language to clarify that plans must include in their provider directory all direct furnishing entities. We propose to clarify our policy by amending § 422.111(b)(3) to explicitly state the requirement to include direct furnishing entities. We propose that § 422.111(b)(3)(i)(A) and (B) would be revised to specify the following:</P>
                    <P>• All direct furnishing entities as defined in § 422.2, from whom enrollees may reasonably be expected to obtain services.</P>
                    <P>• Each provider's cultural and linguistic capabilities, including languages (including American Sign Language) offered by the provider or a skilled medical interpreter at the provider's office.</P>
                    <P>Section 422.111(b)(3)(i)(C) and (D) are described later in this section. Section 422.111(b)(3)(i)(E) and (F) would be revised to specify the following:</P>
                    <P>• Any out-of-network coverage; any point-of-service option, including the supplemental premium for that option.</P>
                    <P>• How the MA organization meets the requirements of §§ 422.112 and 422.114 for access to services offered under the plan.</P>
                    <P>
                        While it has been CMS's expectation that plans include the information at proposed § 422.111(b)(3)(i)(A) already in their provider directories (to the extent that there is a reasonable expectation that enrollees may obtain services from these direct furnishing entities), we believe that adjusting our regulation text to codify this policy explicitly will 
                        <PRTPAGE P="99400"/>
                        prevent any confusion or misunderstanding regarding CMS's MA provider directory requirements.
                    </P>
                    <P>Further, we propose that plans must clearly identify all direct furnishing entities that provide in-home or at-home supplemental benefits or services, or a hybrid of these benefits or services (both in-home or at-home, and in-office benefits or services) at § 422.111(b)(3)(i)(D). We propose that § 422.111(b)(3)(i)(D) would require easily identifiable notations, filters, or other distinguishing features to indicate in-home or at-home supplemental benefit providers (as defined in § 422.2). For the purposes of this requirement, we are proposing to define an in-home or at-home supplemental benefit provider as any direct furnishing entity in which the direct furnishing entity or an employee of the direct furnishing entity is given an enrollee's physical address in order to provide in-person supplemental benefits or SSBCI items or services to that enrollee. We also propose that this definition state that an in-home or at-home supplemental benefit provider may include direct furnishing entities who offer both in-office as well as in-home or at-home supplemental benefits. We propose that this definition be added to the regulation at § 422.2. We solicit comment on this definition and whether it should be expanded to include any entity that may enter an individual's home for purposes beyond providing supplemental benefits, items, or services to enrollees. We are particularly interested in whether additional transparency and further safety assurances are necessary for individuals who may receive covered benefits including Medicare Parts A and B benefits at their physical address. We may consider finalizing changes to this definition based on the comments received.</P>
                    <P>We also seek comment on the manner plans would be required to identify these in-home or at-home supplemental benefit providers. We note that currently the provider directory model requires plans to include a notation next to any provider listings where the providers only offer home visits and do not see patients at a physical office location. Because the provider directory model currently requires that supplemental benefit providers only offering in-home or at-home services be easily identified, it excludes providers and suppliers who may provide in-home or at-home services in addition to in-office services. Therefore, any enrollees wishing to find in-home or at-home supplemental benefit providers may refer to this notation in the provider directory but may not be aware of other providers and suppliers that provide a hybrid of services (both in-home or at-home, and in-office services). Additionally, we note that some provider directories may include a large volume of providers, both PCPs as well as supplemental benefit providers, making some lists prohibitively large. We propose that plans would be required to create a subset of the provider directory through which plans identify in-home or at-home supplemental benefit service providers, including those that may provide a hybrid of services (both in-home or at-home, and in-office services). An example of how a plan may identify this subset list is a designated section for these types of providers under section 2 (List of Network Providers) of their provider directory, as shown in the model document, alongside the plan's other listed provider types (for example, PCPs, specialists, hospitals, etc.). Another example specific to a plan's online provider directory is a filter function for this provider type, which would result in a filtered list of the in-home or at-home supplemental benefit providers. Such a subset list of in-home or at-home service providers, including those that may provide a hybrid of services (both in-home or at-home, and in-office supplemental benefit services), would allow the enrollee to clearly identify and differentiate which direct furnishing entities may be entering their home. We propose that, by including such a list, plans must continue to adhere to the current provider directory requirements set forth at §§ 422.111(a)(2), 422.111(b)(3)(i), 422.111(h)(2)(i) and (ii), 422.120, 422.2262, 422.2265(b)(3) and (4), 422.2265(c)(1)(iv), 422.2267(a), 422.2267(c), 422.2267(d), and 422.2267(e)(11) regarding what information must be included, and all other relevant provider directory requirements. We seek comment on this proposed requirement and may consider revisions to a final policy based on the comments received.</P>
                    <P>As an alternative to this subset list, which would be found within the provider directory, we propose and seek comment on requiring plans to create a list that is entirely separate from the currently required provider directory that identifies the in-home or at-home supplemental benefit providers including those that may provide a hybrid of services (both in-home or at-home, and in-office services) under the plan. This alternative proposal may reduce enrollee burden in identifying such providers and increase transparency for the enrollee, as they would not have to filter a provider directory or scroll through a potentially large directory to locate a specific designation for these types of providers in order to find the relevant information. We similarly propose, as an alternative, that the list required by this alternative would have to be easily available through the plan's public-facing website, and plans must continue to adhere to the current provider directory requirements set forth at §§ 422.111(a)(2), 422.111(b)(3)(i), 422.120, 422.2262, and 422.2267(e)(11) regarding what information must be included, and other relevant provider directory requirements. We seek comment on this alternative and may consider finalizing it or making revisions based on comments received.</P>
                    <P>
                        We further propose to define community-based organizations (CBOs) in regulation, as there currently exists no definition in MA regulations. We propose to add this definition to § 422.2. This definition would provide clarity to plans when adding the new proposed CBO notation to their provider directories regarding which direct furnishing entities are CBOs. This proposed definition is taken from the Calendar Year 2023 Medicare Physician Fee Schedule proposed rule (87 FR 46102) cited previously. We propose to define CBOs as “public or private not-for-profit entities that provide specific services to the community or targeted populations in the community to address the health and social needs of those populations.” We noted in the Calendar Year 2023 Medicare Physician Fee Schedule proposed rule that these CBOs may include community-action agencies, housing agencies, area agencies on aging, centers for independent living, aging and disability resource centers or other non-profits that apply for grants or contract with health care entities to perform social services. They may receive grants from other agencies in the U.S. Department of Health and Human Services, including Federal grants administered by the Administration for Children and Families (ACF), Administration for Community Living (ACL), the Centers for Disease Control and Prevention (CDC), the Substance Abuse and Mental Health Services Administration (SAMHSA), or state-funded grants to provide social services. We solicit comment on this proposed definition, and whether this definition would be sufficiently broad enough to include all locally based organizations with whom an enrollee may wish to engage. We may consider finalizing revisions to this 
                        <PRTPAGE P="99401"/>
                        definition based on the comments received.
                    </P>
                    <P>We also propose to include new regulation text at § 422.111(b)(3)(i)(C) requiring plans to include in their provider directory easily identifiable notations indicating direct furnishing entities that are CBOs. We propose to codify this requirement in § 422.111(b)(3)(i)(C) that plans must include in their provider directories easily identifiable notations, filters, or other distinguishing features to indicate providers and direct furnishing entities that are community-based organizations (CBOs) (as defined in § 422.2).</P>
                    <P>
                        We are interested in encouraging more engagement from both plans and enrollees with organizations invested in the community and local economy and wish to provide enrollees the ability to more easily identify and engage with CBOs. We also wish to encourage plans, to the extent possible, to engage with local businesses and vendors when determining which entities to contract with. As we noted in the Calendar Year 2025 Medicare Physician Fee Schedule proposed rule (89 FR 61875), local businesses and CBOs, “know the populations they serve and their communities and may have the infrastructure or systems in place to help coordinate supportive services that address social determinants of health or serve as a source from which ACOs can receive information regarding community needs.” While CMS is prohibited from requiring plans to contract with specific providers under section 1854(a)(6)(B)(iii) of the Act and § 422.256(a)(2)(i), we strongly encourage plans to engage with CBOs given evidence indicating that providers who coordinate care with CBOs to address health related social needs (HRSNs) (for example, housing, transportation, care management, etc.) can positively influence health outcomes.
                        <SU>92</SU>
                        <FTREF/>
                         Therefore, we wish to strongly encourage collaboration of this kind. We further note that this complies with our regulation at § 422.112(b)(3) requiring coordinated care plans to coordinate MA plan services with community and social services generally available in the area served by the MA plan. Plans may contract with CBOs to provide benefits—including supplemental benefits—that are compliant with the statutory and regulatory requirements. For example, a plan could elect to offer a meal or food and produce supplemental benefit (so long as the benefit meets the requirements of § 422.100(c)(2) and other requirements for supplemental benefits) and pay a CBO for furnishing the covered benefit. We understand that in some areas there may be a limited number of CBO providers, and so we encourage plans to continue engaging with CBOs. Plans including a notation within the provider directory identifying an entity that is a CBO would increase enrollee awareness of these types of entities. This could lead to more enrollees choosing to receive items and services from CBOs that are more familiar with their community, can better coordinate supportive services, and can further address their community needs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>92</SU>
                             McCarthy, D., Lewis, C., Horstman, C., Bryan, A., &amp; Shah, T. (2022). “Guide to Evidence for Health-Related Social Needs Interventions: 2022 Update” [ROI Calculator for Partnerships to Address the Social Determinants of Health]. The Commonwealth Fund. 
                            <E T="03">https://www.commonwealthfund.org/sites/default/files/202209/ROI_calculator_evidence_review_2022_update_Sept_2022.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We believe the burden associated with these proposed requirements would be minimal. First, the proposed addition of the CBO notation in the provider directory would likely involve minimal burden given that plans must also include a notation or filter for other types of entities. With our proposed CBO definition, it should take little time for plans to identify their contracted CBOs and websites to add a notation to the listings for these entities in their provider directory. The proposed addition of direct furnishing entity listings should also create minimal burden since this is a clarification of existing policy and plans may already include all direct furnishing entities in their provider directories currently. There should therefore be few plans that need to make adjustments to their current provider directory due to the new proposed regulation text clarifying this requirement. We also expect if commenters believe that a subset list of in-home or at-home supplemental benefit providers is a satisfactory method to identify these providers, then there would be minimal burden associated as plans already must maintain an updated provider list as required by regulation. However, should commenters believe that the creation of a separate list for in-home and at-home supplemental benefit providers be prudent, we would likewise expect a low associated burden. As discussed, this list would be a subgroup of the current provider directory and include only in-home or at-home supplemental benefit providers, and, as previously noted, plans should already have information regarding which organizations fall under the proposed definition for an in-home or at-home supplemental benefit provider.</P>
                    <P>In summary, we propose to: (1) codify definitions of CBOs and in-home or at-home supplemental benefit providers and direct furnishing entities; (2) require plans to identify, within the provider directory, which providers and direct furnishing entities meet the proposed definition of a CBO; (3) require plans to identify in-home or at-home supplemental benefit providers and direct furnishing entities, including those that provide a hybrid of services (both in-home or at-home, and in-office services), either through a subset list within the provider directory or through a separate list comprising in-home or at-home supplemental benefit providers and direct furnishing entities; and (4) clarify existing policy by stating that all direct furnishing entities must be included within the provider directory.</P>
                    <P>We solicit comment on these proposals and may consider finalizing revisions based on the comments received.</P>
                    <HD SOURCE="HD2">L. Ensuring Equitable Access to Behavioral Health Benefits Through Section 1876 Cost Plan and MA Cost Sharing Limits (§§ 417.454 and 422.100)</HD>
                    <P>
                        Traditional Medicare benefits (that is, Medicare Parts A and B) include a wide range of mental health and substance use disorder services (collectively called “behavioral health services”).
                        <SU>93</SU>
                        <FTREF/>
                         Per section 1876(c)(2)(A) of the Act and §§ 417.416 and 417.440(b)(1) and section 1852(a)(1) of the Act and §§ 422.100 and 422.101, respectively, Section 1876 Cost Plans (Cost Plans) and Medicare Advantage (MA) plans (including employer group waiver plans (EGWPs)) must cover these Medicare Parts A and B services, subject to limited exclusions.
                        <SU>94</SU>
                        <FTREF/>
                         As part of CMS's behavioral health strategy, we aim to ensure equitable access to behavioral health services across all of Medicare, including for MA and Cost Plan enrollees, and to effectively expand access to these services in both programs.
                        <E T="51">95 96</E>
                        <FTREF/>
                         We believe improving 
                        <PRTPAGE P="99402"/>
                        equitable access to behavioral health services is especially crucial for MA enrollees because: (1) beneficiaries in Traditional Medicare pay 20 percent coinsurance (with zero cost sharing for opioid treatment program services) while MA enrollees may be charged up to 50 percent coinsurance (or actuarially equivalent copayment) for the same behavioral health services, (2) lower-income beneﬁciaries are more likely to be diagnosed with mental health conditions and may not receive the behavioral health services they need, suggesting potential affordability concerns,
                        <E T="51">97 98</E>
                        <FTREF/>
                         and (3) based on contract year 2024 plan data: 
                        <SU>99</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>93</SU>
                             McGinty, Beth. “Medicare's Mental Health Coverage: What's Included, What's Changed, and What Gaps Remain,” Commonwealth Fund, Mar. 2, 2023. Retrieved from: 
                            <E T="03">https://www.commonwealthfund.org/publications/explainer/2023/mar/medicare-mental-health-coverage-included-changed-gaps-remain.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>94</SU>
                             For example, MA plans are not required to provide hospice services—a service covered in Traditional Medicare.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>95</SU>
                             CMS's behavioral health strategy is available at: 
                            <E T="03">https://www.cms.gov/cms-behavioral-health-strategy.</E>
                        </P>
                        <P>
                            <SU>96</SU>
                             Fleet, Alexa. Improving Behavioral Health Care For Older Americans: If Not Now, When? June 2022. Retrieved from: 
                            <E T="03">https://www.healthaffairs.org/content/forefront/improving-behavioral-health-care-older-americans-if-not-now.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>97</SU>
                             American Counseling Association. More Than 30 Years of Mental Health Care Inequity: Restricted Access to Providers for Medicare Beneficiaries. August 2021. Retrieved from: 
                            <E T="03">https://www.counseling.org/docs/default-source/government-affairs/medicare-issue-brief.pdf.</E>
                        </P>
                        <P>
                            <SU>98</SU>
                             Carter, Julie; Medicare Rights Center. “Coverage Gaps Keep Medicare Beneficiaries from Needed Care.” June 2024. Retrieved from: 
                            <E T="03">https://www.medicarerights.org/medicare-watch/2024/06/13/coverage-gaps-keep-medicare-beneficiaries-from-needed-care.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>99</SU>
                             This is based on March 1, 2024, contract year 2024 plan data (excludes employer, D-SNPs, and MSAs) of the plan's maximum cost sharing (including no cost sharing) and reflects plans with coinsurance and copayment amounts.
                        </P>
                    </FTNT>
                    <P>• Between 23 percent and 25 percent of all MA plans charge in-network cost-sharing amounts that are greater than cost sharing in Traditional Medicare for: mental health specialty services, psychiatric services, and partial hospitalization (as shown in table 8).</P>
                    <P>• Between 42 percent and 71 percent of all MA plans charge in-network cost-sharing amounts that are greater than cost sharing in Traditional Medicare for: outpatient substance use disorder services and opioid treatment program services (as shown in table 8).</P>
                    <P>• MA enrollees in plans charging cost-sharing amounts greater than cost sharing in Traditional Medicare can expect to pay between $7 and $21 more on average in cost sharing per visit for those services received in-network for: mental health specialty services, psychiatric services, and partial hospitalization in comparison to beneficiaries in Traditional Medicare (as shown in table 10).</P>
                    <P>• MA enrollees in plans charging cost-sharing amounts greater than cost sharing in Traditional Medicare can expect to pay between $30 and $47 more on average in cost sharing per visit for those services received in-network for: mental health specialty services, psychiatric services, and partial hospitalization in comparison to beneficiaries in Traditional Medicare (as shown in table 10).</P>
                    <P>
                        Improving equitable access to behavioral health services by providing in-network cost sharing for MA and Cost Plan enrollees that is in line with Traditional Medicare cost sharing for these services would positively impact a significant proportion of Medicare-eligible beneficiaries. We believe this would have this positive impact because: (1) about 25 percent of Medicare beneficiaries live with a mental illness and roughly half of Medicare beneficiaries are enrolled in an MA plan; 
                        <E T="51">100 101</E>
                        <FTREF/>
                         (2) the number of MA enrollees with a need for behavioral health services will likely continue to grow alongside increasing Medicare enrollment trends; 
                        <SU>102</SU>
                        <FTREF/>
                         and (3) improved access to and compliance with behavioral health treatment may improve beneficiaries' overall cost of care over time.
                        <E T="51">103 104</E>
                        <FTREF/>
                         While enrollment in Cost Plans represents a small proportion of all Medicare-eligible beneficiaries (approximately 169,000 as of July 2024,) 
                        <SU>105</SU>
                        <FTREF/>
                         we believe extending this proposal to Cost Plan enrollees is appropriate because (1) CMS wants to improve equitable access to behavioral health services across all Medicare program choices; and (2) we expect the positive effects from improved access to behavioral health services for MA enrollees will extend to Cost Plan enrollees as current in-network cost sharing for these services may be as high as 50 percent coinsurance in these plans. Based on contract year 2024 Cost Plan data: 
                        <SU>106</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>100</SU>
                             Kaiser Family Foundation: Wyatt Koma et. al. One in Four Older Adults Report Anxiety or Depression Amid the COVID-19 Pandemic. October 2020. Retrieved from: 
                            <E T="03">https://www.kff.org/mental-health/issue-brief/one-in-four-older-adults-report-anxiety-or-depression-amid-the-covid-19-pandemic/.</E>
                        </P>
                        <P>
                            <SU>101</SU>
                             McGinty, Beth. “Medicare's Mental Health Coverage: What's Included, What's Changed, and What Gaps Remain,” Commonwealth Fund, Mar. 2, 2023. As of February 5, 2024: 
                            <E T="03">https://www.commonwealthfund.org/publications/explainer/2023/mar/medicare-mental-health-coverage-included-changed-gaps-remain.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>102</SU>
                             Kaiser Family Foundation: Freed, Meredith; Sroczynski, Nolan; and Neuman, Tricia. Mental Health and Substance Use Disorder Coverage in Medicare Advantage Plans. April 2023. Retrieved from: 
                            <E T="03">https://www.kff.org/mental-health/issue-brief/mental-health-and-substance-use-disorder-coverage-in-medicare-advantage-plans/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>103</SU>
                             American Counseling Association. More Than 30 Years of Mental Health Care Inequity: Restricted Access to Providers for Medicare Beneficiaries. August 2021. Retrieved from: 
                            <E T="03">https://www.counseling.org/docs/default-source/government-affairs/medicare-issue-brief.pdf.</E>
                        </P>
                        <P>
                            <SU>104</SU>
                             Milliman. Potential economic impact of integrated medical-behavioral healthcare: Updated projections for 2017. February 2018. Retrieved from: 
                            <E T="03">https://www.milliman.com/en/insight/potential-economic-impact-of-integrated-medical-behavioral-healthcare-updated-projections.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>105</SU>
                             CMS. Contract Summary 2024. Data as of July 2024. Retrieved from: 
                            <E T="03">https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/mcradvpartdenroldata/monthly/contract-summary-2024-07.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>106</SU>
                             This is based on March 1, 2024, contract year 2024 plan data of the plan's maximum cost sharing (including no cost sharing) and reflects plans with coinsurance and copayment amounts. It does not consider inpatient hospital cost sharing as Cost Plans are not required to report information for all services, including Part A inpatient hospital psychiatric services.
                        </P>
                    </FTNT>
                    <P>• Between 5 percent and 50 percent of all Cost Plans charge in-network cost sharing amounts that are greater than cost sharing in Traditional Medicare for one or more professional behavioral health service categories (as shown in table 9).</P>
                    <P>• Cost Plan enrollees in those plans can expect to pay between $5 and $20 more on average in cost sharing per visit for those services received in-network (depending on the service category) in comparison to beneficiaries in Traditional Medicare (as shown in table 11).</P>
                    <P>
                        We propose, beginning in contract year 2026, to require that in-network 
                        <SU>107</SU>
                        <FTREF/>
                         cost sharing for behavioral health service categories be no greater than that of Traditional Medicare for MA and Cost Plans (including EGWPs). The authorities for this proposal are discussed in detail in the following section of this proposed rule. Specifically, CMS proposes to amend the existing requirements at §§ 417.454(e) and 422.100(j) (that cost sharing for certain benefits not exceed cost sharing in Original Medicare) to add the behavioral health service categories: mental health specialty services, psychiatric services, partial hospitalization, intensive outpatient services, inpatient hospital psychiatric services (all length of stay scenarios), outpatient substance use disorder services, and opioid treatment program services.
                        <SU>108</SU>
                        <FTREF/>
                         To this end, CMS is proposing behavioral health cost-sharing standards in MA and Cost Plans that strike a balance between: (1) improving the affordability of behavioral health services for enrollees in a timely manner and (2) minimizing disruption to MA enrollees access to care and coverage options.
                    </P>
                    <FTNT>
                        <P>
                            <SU>107</SU>
                             This proposal would also apply to out-of-network cost sharing standards for D-SNP PPOs per § 422.100(o).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>108</SU>
                             In this proposal behavioral health services are generally considered to be any service furnished for the diagnosis, evaluation, or treatment of a mental health disorder, including substance use disorders.
                        </P>
                    </FTNT>
                    <P>
                        As discussed in sections III.L.X.e.(4). and VII.E.3. of this proposed rule, we solicit comment on: (1) whether CMS should apply these proposed changes beginning in contract year 2026 or 2027, (2) whether there should be a transition period from the existing contract year 
                        <PRTPAGE P="99403"/>
                        2025 behavioral health cost-sharing standards (in current regulations at § 422.100(f)(6)(i), (f)(6)(iii), and (f)(6)(iv)) to the proposed cost-sharing standard for select behavioral health service categories, and (3) how long any transition should be. We also solicit comment regarding this proposal's potential impact on the ability of MA plans to satisfy the existing actuarial equivalence requirements for the entire Part A and B benefits package (that is, the package of basic benefits) at section 1852(a)(1)(B) of the Act and § 422.100(j)(1) and (2) in section III.L.X.e.(4). of this proposed rule. Under this proposal, the requirements at § 422.100(f)(7)(iii), requiring CMS to communicate and provide a public comment period on how we apply the proposed cost-sharing standards each year prior to bid submission, such as through Health Plan Management System (HPMS) memoranda prior to bid submission, will apply to the proposed new behavioral health cost-sharing limits.
                    </P>
                    <HD SOURCE="HD3">a. Legal Authority</HD>
                    <P>Section 1852 of the Act imposes requirements that apply to the cost sharing and benefit design of MA plans. Section 1852(a)(1)(B)(iv)(VIII) of the Act explicitly authorizes the Secretary to identify services that the Secretary determines appropriate (including services that the Secretary determines require a high level of predictability and transparency for beneficiaries) to be subject to a cost-sharing limit that is tied to the cost sharing imposed for those services under original Medicare. Section 1852(b) of the Act also prohibits MA plan designs that have the effect of discriminating against or discouraging enrollment by beneficiaries based on their health needs. Sections 1856(b) and 1857(e) of the Act authorize CMS to set implementing standards for Part C and adopt additional requirements as necessary, appropriate and not inconsistent with Part C. Under this authority, we propose to revise § 422.100(j)(1)(i) and add new paragraphs (j)(1)(i)(G) and (j)(1)(i)(H) to limit MA plan in-network cost sharing for the following service categories as defined in the plan benefit package: intensive outpatient services, mental health specialty services, outpatient substance use disorder services, partial hospitalization, psychiatric services, and inpatient hospital psychiatric services (all length of stay scenarios currently specified in paragraph (f)(6)(iv)) to that charged under Traditional Medicare. This necessarily includes revising § 422.100(f)(6)(iii), (f)(6)(iv), and (j)(1)(i). First, at § 422.100(f)(6)(iii)(A) we propose to replace the reference to partial hospitalization with rehabilitation services to serve as an example of a category subject to the range of cost-sharing standards in paragraph (f)(6)(iii). </P>
                    <P>Second, at § 422.100(f)(6)(iv) we propose to: (1) add a reference to § 422.100(j)(1)(i)(H) in paragraph (f)(6)(iv)(A) to reflect the proposed cost-sharing standard for inpatient hospital psychiatric services and (2) revise paragraphs (f)(6)(iv)(B) and (f)(6)(iv)(D) to remove references to inpatient hospital psychiatric services because cost sharing for inpatient hospital psychiatric services will be addressed as specified in proposed new paragraph (j)(1)(i)(H). Third, at § 422.100(j)(1)(i) we propose to clarify that the proposed behavioral health cost-sharing standards would not apply until contract year 2026.</P>
                    <P>Similarly, we propose to add new paragraphs § 417.454(e)(5) and (e)(6) to limit in-network behavioral health cost sharing of Cost Plans in the same manner as for MA plans. This necessarily includes clarifying at § 417.454(e): (1) when the proposed cost sharing limit (that cost sharing may not be greater than cost sharing in Traditional Medicare (original Medicare) for that benefit) will apply for the additional categories of services and (2) the methods Cost Plan organizations may use for coinsurance or copayment structures to abide by the proposed behavioral health cost-sharing requirements for these basic benefits. We also make a technical change to § 417.454(e) to clarify that the cost sharing limits apply to all Cost Plans by adding references to Competitive Medical Plans (CMPs). These proposals reflect CMS's authority to interpret and implement the requirement, at section 1876(c)(2) of the Act, that Cost Plans cover Part A and B benefits and, at section 1876(i)(3)(D) of the Act, to add new contract terms and conditions for Cost Plans that are not inconsistent with section 1876 as the Secretary may find necessary and appropriate.</P>
                    <P>In addition, in proposing to apply Traditional Medicare cost-sharing amounts to opioid treatment program services or any other service with zero cost sharing, we rely on our authority in section 1856(b)(1) and 1857(e)(1) of the Act. Section 1856(b)(1) of the Act provides CMS authority to establish MA standards by regulation and section 1857(e)(1) of the Act provides authority to impose additional “terms and conditions” found “necessary and appropriate.” Under these authorities, we propose to add opioid treatment program services in proposed new §§ 417.454(e)(5) and 422.100(j)(1)(i)(G) to limit MA and Cost Plan cost sharing for these services to that charged under Traditional Medicare, meaning that no cost sharing could be imposed for these services.</P>
                    <P>
                        We also propose the following revisions to the cost-sharing regulations at §§ 417.454 and 422.100(f) and (j): (1) revise language at § 417.454(e)(1) to match terminology of chemotherapy administration services with language at § 422.100(j)(1)(i)(A), (2) remove language at § 422.100(f)(6)(iv)(D) that the total inpatient benefit cost sharing must not exceed the MA plan's MOOP amount to reflect how CMS has not applied this requirement, (3) remove paragraphs (j)(1)(i)(C)
                        <E T="03">(1)</E>
                         and (j)(1)(i)(C)
                        <E T="03">(2)</E>
                         to consolidate the skilled nursing facility cost-sharing standard information at § 422.100(j)(1)(i)(C), and (4) clarify that the skilled nursing facility per-day cost sharing for days 21 through 100 must not be greater than one-eighth of the projected (or actual) Part A deductible amount for the year at paragraph (j)(1)(i)(C). As such, this proposal codifies our current practice with some revisions (such as, annually updating the copayment limits for Cost Plans to remain actuarially equivalent to 50 percent coinsurance). Primarily, we propose these changes to increase the level of transparency for these policies and provide more stability and predictability for MA and Cost Plan organizations.
                    </P>
                    <P>At new § 417.454(f), we propose to codify the policy of a 50 percent coinsurance (or actuarially equivalent copayment) limit on in-network basic benefits as applicable to Cost Plans as we believe payment of less than 50 percent of total Cost Plan financial liability discriminates against enrollees who need those services. For example, setting limits on cost sharing for covered services and ensuring Cost Plan organizations comply with these limits are important ways to ensure that the cost sharing aspect of a plan design does not discriminate against or discourage enrollment in a Cost Plan by beneficiaries who have high health care needs. In addition, this 50 percent coinsurance (or actuarially equivalent copayment) limit on in-network basic benefits is necessary and appropriate to apply to Cost Plans pursuant to how these plans must, under section 1876(c)(2) of the Act, furnish Part A and Part B services (with limited exceptions such as for the hospice benefit) to their enrollees.</P>
                    <P>
                        In making these revisions to clarify how the actuarially equivalent copayment limits will be set for basic benefits, we expect Cost Plan 
                        <PRTPAGE P="99404"/>
                        organizations should have: (1) greater knowledge about how cost-sharing limits are set; and (2) a better ability to anticipate where the copayment limits will be in future years. These additional proposals reflect CMS's authority under sections 1856(b), 1857(e), 1876(c)(2), and 1876(i)(3)(D) of the Act.
                    </P>
                    <HD SOURCE="HD3">b. Behavioral Health Crisis</HD>
                    <P>
                        A Kaiser Family Foundation (KFF)/CNN Mental Health in America survey found that 90 percent of Americans believe our nation is experiencing a mental health crisis.
                        <SU>109</SU>
                        <FTREF/>
                         This crisis grew more challenging because of the COVID-19 pandemic. For example, beneficiaries with severe mental illness experienced substantial disruptions in care during the COVID-19 pandemic and these disruptions were greater among certain populations, including historically underserved racial and ethnic groups and low-income populations.
                        <SU>110</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>109</SU>
                             Kaiser Family Foundation: Lopes, Lunna et al. KFF/CNN Mental Health In America Survey. October 2022. Retrieved from: 
                            <E T="03">https://www.kff.org/report-section/kff-cnn-mental-health-in-america-survey-findings/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>110</SU>
                             Busch AB, Huskamp HA, Raja P, Rose S, Mehrotra A. Disruptions in Care for Medicare Beneficiaries With Severe Mental Illness During the COVID-19 Pandemic. JAMA Netw Open. 2022 Jan 4;5(1):e2145677. doi: 10.1001/jamanetworkopen.2021.45677. PMID: 35089352; PMCID: PMC8800078. Retrieved from: 
                            <E T="03">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8800078/</E>
                            .
                        </P>
                    </FTNT>
                    <P>Poor behavioral health outcomes are especially detrimental to older adults. Addressing the behavioral health needs of beneficiaries during this crisis is a key priority for CMS as illustrated by study findings that:</P>
                    <P>
                        • Older adults have higher rates of suicide compared to those under 55 years old and, between 2001 and 2021, suicide rates significantly increased for men ages 55-74 (25 percent increase, from 21.2 to 26.6 per 100,000 population) and women ages 55-84 (44 percent increase, from 3.9 to 5.6 per 100,000 population).
                        <SU>111</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>111</SU>
                             Garnett MF, Spencer MR, Weeks JD. Suicide Among Adults Age 55 and Older, 2021. NCHS Data Brief. 2023 Nov;(483):1-8. PMID: 38051033. Retrieved from: 
                            <E T="03">https://www.cdc.gov/nchs//data/databriefs/db483.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        • Lower income Medicare beneficiaries (with household incomes under $25,000) are more likely to have mental health conditions than those with higher household incomes.
                        <E T="51">112 113 114</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>112</SU>
                             Friedman C. The mental health of Medicare beneficiaries with disabilities during the COVID-19 pandemic. Rehabil Psychol. 2022 Feb;67(1):20-27. doi: 10.1037/rep0000427. Epub 2021 Nov 8. PMID: 34748364. Retrieved from: 
                            <E T="03">https://psycnet.apa.org/record/2022-02246-001</E>
                            .
                        </P>
                        <P>
                            <SU>113</SU>
                             American Counseling Association. More Than 30 Years of Mental Health Care Inequity: Restricted Access to Providers for Medicare Beneficiaries. August 2021. Retrieved from: 
                            <E T="03">https://www.counseling.org/docs/default-source/government-affairs/medicare-issue-brief.pdf.</E>
                        </P>
                        <P>
                            <SU>114</SU>
                             Kaiser Family Foundation: Wyatt Koma et. al. One in Four Older Adults Report Anxiety or Depression Amid the COVID-19 Pandemic. October 2020. Retrieved from: 
                            <E T="03">https://www.kff.org/mental-health/issue-brief/one-in-four-older-adults-report-anxiety-or-depression-amid-the-covid-19-pandemic/</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        • Older adults face significant barriers to access behavioral health services including workforce shortages, issues of affordability, and a shortage of services in the home and community settings.
                        <E T="51">115 116</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>115</SU>
                             Fleet, Alexa. Improving Behavioral Health Care For Older Americans: If Not Now, When? June 2022. Retrieved from: 
                            <E T="03">https://www.healthaffairs.org/content/forefront/improving-behavioral-health-care-older-americans-if-not-now.</E>
                        </P>
                        <P>
                            <SU>116</SU>
                             HHS Office of Inspector General. “A Lack of Behavioral Health Providers in Medicare and Medicaid Impedes Enrollees' Access to Care” April 2024. Retrieved from: 
                            <E T="03">https://oig.hhs.gov/reports-and-publications/all-reports-and-publications/a-lack-of-behavioral-health-providers-in-medicare-and-medicaid-impedes-enrollees-access-to-care/.</E>
                        </P>
                    </FTNT>
                    <P>In addition, studies on behavioral health needs of MA enrollees find:</P>
                    <P>
                        • About 13 percent to 28 percent of MA enrollees live with mental illness.
                        <SU>117</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>117</SU>
                             McGinty, Beth. Medicare's Mental Health Coverage: What's Included, What's Changed, and What Gaps Remain. March 2023. Retrieved from: 
                            <E T="03">https://www.commonwealthfund.org/publications/explainer/2023/mar/medicare-mental-health-coverage-included-changed-gaps-remain#:~:text=How%20prevalent%20are%20mental%20health,to%2050%20percent%20receive%20treatment</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        • On average, only 3 percent of MA enrollees received treatment from a behavioral health provider in 2023.
                        <SU>118</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>118</SU>
                             HHS Office of Inspector General. “A Lack of Behavioral Health Providers in Medicare and Medicaid Impedes Enrollees' Access to Care” April 2024. Retrieved from: 
                            <E T="03">https://oig.hhs.gov/reports-and-publications/all-reports-and-publications/a-lack-of-behavioral-health-providers-in-medicare-and-medicaid-impedes-enrollees-access-to-care/</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        • MA enrollees paid about $9 more on average for in-network mental health services than for comparable physical-health services.
                        <SU>119</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>119</SU>
                             Pelech, Daria and Hayford, Tamara. Health Affairs. Medicare Advantage and Commercial Prices for Mental Health Services. February 2019. DOI: 10.1377/hlthaff.2018.05226. Retrieved from: 
                            <E T="03">https://www.healthaffairs.org/doi/10.1377/hlthaff.2018.05226?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub%20%200pubmed</E>
                            .
                        </P>
                    </FTNT>
                    <P>• MA enrollees who receive behavioral health services typically see their provider five times a year while beneficiaries in Traditional Medicare saw their behavioral health provider eight times a year.</P>
                    <P>
                        Other research emphasizes the negative impact high-cost sharing can have on beneficiary utilization of high-value health services, clinical outcomes, and total costs of care.
                        <E T="51">120 121 122</E>
                        <FTREF/>
                         These findings are more striking for beneficiaries with disabilities or those with an income just above the threshold Medicaid uses to determine eligibility for additional coverage.
                        <SU>123</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>120</SU>
                             Fusco N, Sils B, Graff JS, Kistler K, Ruiz K. Cost-sharing and adherence, clinical outcomes, health care utilization, and costs: A systematic literature review. J Manag Care Spec Pharm. 2023 Jan;29(1):4-16. doi: 10.18553/jmcp.2022.21270. Epub 2022 Apr 7. PMID: 35389285; PMCID: PMC10394195. Retrieved from: 
                            <E T="03">https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC10394195/.</E>
                        </P>
                        <P>
                            <SU>121</SU>
                             Health Affairs: Shivani, A. et. al. Fine-Tuning Cost Sharing As Part Of Health Reform December 3, 2021. DOI: 10.1377/hblog20211130.358084. Retrieved from: 
                            <E T="03">https://www.healthaffairs.org/content/forefront/fine-tuning-cost-sharing-part-health-reform</E>
                            .
                        </P>
                        <P>
                            <SU>122</SU>
                             Parish WJ, Mark TL, Weber EM, Steinberg DG. Substance Use Disorders Among Medicare Beneficiaries: Prevalence, Mental and Physical Comorbidities, and Treatment Barriers. Am J Prev Med. 2022 Aug;63(2):225-232. doi: 10.1016/j.amepre.2022.01.021. Epub 2022 Mar 21. PMID: 35331570. Retrieved from: 
                            <E T="03">https://www.sciencedirect.com/science/article/pii/S0749379722001040?via%3Dihub</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>123</SU>
                             Nelson, Hannah. Cost-Sharing Burden Limits Access to Care for Medicare Members. April 2021. Retrieved from: 
                            <E T="03">https://healthpayerintelligence.com/news/cost-sharing-burden-limits-access-to-care-for-medicare-members</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        Considering these findings, HHS and CMS are pursuing policies that can address barriers individuals may face in accessing mental health and substance use disorder care.
                        <E T="51">124 125 126</E>
                        <FTREF/>
                         Some of the policies CMS is pursuing to address these behavioral health access concerns are summarized in the following section.
                    </P>
                    <FTNT>
                        <P>
                            <SU>124</SU>
                             Office of the Assistant Secretary for Planning and Evaluation (ASPE). Issue Brief: HHS Roadmap for Behavioral Health Integration. September 2022. Retrieved from: 
                            <E T="03">https://aspe.hhs.gov/sites/default/files/documents/4e2fff45d3f5706d35326b320ed842b3/roadmap-behavioral-health-integration.pdf</E>
                            .
                        </P>
                        <P>
                            <SU>125</SU>
                             CMS. CMS Action Plan to Enhance Prevention and Treatment for Opioid Use Disorder. June 2021. Retrieved from: 
                            <E T="03">https:/;www.cms.gov/files/document/action-plan-behavioral-health-strategy.pdf</E>
                            .
                        </P>
                        <P>
                            <SU>126</SU>
                             Kaiser Family Foundation: Meredith Freed, Juliette Cubanski, and Tricia Neuman. FAQs on Mental Health and Substance Use Disorder Coverage in Medicare. January 2023. Retrieved from: 
                            <E T="03">https://www.kff.org/mental-health/issue-brief/faqs-on-mental-health-and-substance-use-disorder-coverage-in-medicare/</E>
                            .
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">c. CMS's Behavioral Health Strategy</HD>
                    <P>
                        CMS's vision is that beneficiaries and consumers with behavioral health needs have access to person-centered, timely, affordable care that enables optimal health and wellness.
                        <SU>127</SU>
                        <FTREF/>
                         For example, in the Calendar Year 2023 Physician Fee Schedule (87 FR 69404) 
                        <SU>128</SU>
                        <FTREF/>
                         and the 
                        <PRTPAGE P="99405"/>
                        Calendar Year 2024 Physician Fee Schedule (88 FR 81540),
                        <SU>129</SU>
                        <FTREF/>
                         CMS finalized provisions effectively expanding access to the following behavioral health services in Traditional Medicare:
                    </P>
                    <FTNT>
                        <P>
                            <SU>127</SU>
                             CMS's behavioral health strategy is available at: 
                            <E T="03">https://www.cms.gov/cms-behavioral-health-strategy</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>128</SU>
                             “Medicare and Medicaid Programs; CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Implementing Requirements for Manufacturers of Certain Single-dose Container or 
                            <PRTPAGE/>
                            Single-use Package Drugs To Provide Refunds With Respect to Discarded Amounts; and COVID-19 Interim Final Rules.” Available at: 
                            <E T="03">https://www.federalregister.gov/documents/2022/11/18/2022-23873/medicare-and-medicaid-programs-cy-2023-payment-policies-under-the-physician-fee-schedule-and-other</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>129</SU>
                             “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction” final rule with comment period. Available at: 
                            <E T="03">https://www.federalregister.gov/documents/2023/11/22/2023-24293/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        • Counseling and cognitive behavioral therapy—this was done by codifying new benefit categories for mental health counselors, marriage and family therapists.
                        <SU>130</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>130</SU>
                             The November 2022 final rule is available at: 
                            <E T="03">https://www.federalregister.gov/documents/2022/11/18/2022-23873/medicare-and-medicaid-programs-cy-2023-payment-policies-under-the-physician-fee-schedule-and-other</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        • Buprenorphine treatment for beneficiaries with opioid use disorder (OUD)—this was done by permitting the use of audio-only communication technology to initiate treatment in cases where audio-video technology is not available to the beneficiary, and all other applicable requirements are met.
                        <SU>131</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>131</SU>
                             The November 2022 final rule is available at: 
                            <E T="03">https://www.federalregister.gov/documents/2022/11/18/2022-23873/medicare-and-medicaid-programs-cy-2023-payment-policies-under-the-physician-fee-schedule-and-other</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        • Behavioral health care—this was done by paying for an “Intensive Outpatient Program” (IOP), which can be performed by hospital outpatient departments, community mental health clinics, Federally Qualified Health Centers (FQHCs), Opioid Treatment Providers (OTPs), or Rural Health Clinics (RHCs).
                        <SU>132</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>132</SU>
                             The November 2023 final rule is available at: 
                            <E T="03">https://www.federalregister.gov/documents/2023/11/22/2023-24293/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        In addition, in the April 2024 final rule,
                        <SU>133</SU>
                        <FTREF/>
                         CMS finalized expanding beneficiaries' access to additional behavioral health providers in MA by requiring Marriage and Family Therapists (MFTs), Mental Health Counselors (MHCs), Opioid Treatment Program (OTP) providers, Community Mental Health Centers or other behavioral health and addiction medicine specialists and facilities to meet MA network adequacy standards under a new facility-specialty type, “Outpatient Behavioral Health.” We also recently announced the Innovation in Behavioral Health Model to improve quality of care for Medicare and Medicaid enrollees with mental health and substance use disorders.
                        <SU>134</SU>
                        <FTREF/>
                         Through this model, CMS will support innovative approaches to connect people with the physical, behavioral, and social supports needed to manage these conditions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>133</SU>
                             “Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024—Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE)” final rule. Available at: 
                            <E T="03">https://www.federalregister.gov/public-inspection/2024-07105/medicare-program-medicare-advantage-and-the-medicare-prescription-drug-benefit-program-for-contract</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>134</SU>
                             Centers for Medicare &amp; Medicaid Services, 2024. “CMS Announces New Model to Advance Integration in Behavioral Health.” Available at: 
                            <E T="03">https://www.cms.gov/newsroom/press-releases/cms-announces-new-model-advance-integration-behavioral-health</E>
                            .
                        </P>
                    </FTNT>
                    <P>This proposal continues to advance CMS's behavioral health strategy through changes to our MA and Cost Plan cost-sharing standards that we believe would improve enrollee access to behavioral health services. A brief history of the MA behavioral health cost-sharing standards follows.</P>
                    <HD SOURCE="HD3">d. Regulatory History of Behavioral Health Cost-Sharing Standards</HD>
                    <P>Section 422.100(f)(6) provides that cost sharing for basic benefits offered through a MA plan must not exceed levels annually determined by CMS to be discriminatory for such services, which CMS determines using specific standards adopted through previous rulemakings. (All MA organizations and Cost Plan organizations must also comply with applicable Federal civil rights laws that prohibit discrimination, including those that prohibit discrimination on the basis of race, color, national origin, sex, age, and disability, such as section 1557 of the Affordable Care Act, Title VI of the Civil Rights Act of 1964, section 504 of the Rehabilitation Act of 1973, and the Age Discrimination Act of 1975.)</P>
                    <P>CMS imposes cost-sharing limits to ensure that the cost sharing aspect of a plan's design does not discriminate against or discourage enrollment of beneficiaries who have high health care needs and who need specific services. CMS issued cost-sharing limits for covered services and guidance addressing discriminatory cost sharing, as applied to specific benefits and to categories of benefits, in the annual Call Letter (prior to 2020) and in annual bidding instructions. Prior to contract year 2023, the behavioral health service category cost-sharing limits CMS set for MA plans were based on the following limits:</P>
                    <P>• Opioid treatment program services, outpatient substance use disorder services, mental health specialty services, psychiatric services, and partial hospitalization: 50 percent coinsurance for all plans.</P>
                    <P>• Inpatient hospital psychiatric services: 100 percent of Medicare FFS cost sharing for plans with a mandatory MOOP type and 125 percent of Medicare FFS cost sharing for plans with a lower (voluntary) MOOP type.</P>
                    <P>For contract year 2025 and prior years, CMS typically utilized behavioral health professional and inpatient hospital cost-sharing data validations of 50 percent coinsurance to guard against potentially discriminatory benefit designs for Cost Plans.</P>
                    <P>
                        CMS also set professional behavioral health service category copayment limits that were in place without change for many years for MA plans until contract year 2022. These copayment limits were originally set to strike a balance between limiting beneficiary out-of-pocket costs and the potential impact to plan design and costs. The overarching goal of these copayment limits was to ensure beneficiary access to affordable and sustainable benefit packages rather than to be precisely tied to actuarially equivalent values to the coinsurance limit each year. For MA plans, CMS began to annually update these behavioral health cost-sharing limits for contract year 2023 through contract year 2025 using the methodology in § 422.100(f)(6) through (f)(8) that was established in the April 2022 final rule. We also solicited comment on potential future rulemaking to further limit MA behavioral health service category cost-sharing standards in that final rule.
                        <SU>135</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>135</SU>
                             “Contract Year (CY) 2023 Medicare Advantage (MA) Maximum Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing Standards Final Rule with Comment Period.” Available at: 
                            <E T="03">https://www.federalregister.gov/documents/2022/04/14/2022-07642/medicare-program-maximum-out-of-pocket-moop-limits-and-service-category-cost-sharing-standards</E>
                            .
                        </P>
                    </FTNT>
                    <PRTPAGE P="99406"/>
                    <HD SOURCE="HD3">(1) April 2022 Final Rule</HD>
                    <P>
                        The April 2022 final rule amended §§ 422.100 and 422.113 to establish the methodologies CMS uses to set annual cost-sharing limits for MA plans 
                        <SU>136</SU>
                        <FTREF/>
                         for contract year 2023 and future years. As a general matter, these MA cost sharing limitations do not apply to Cost Plans. In the April 2022 final rule, CMS finalized a four-year transition for professional service category MA cost-sharing limits, beginning in contract year 2023, from 50 percent coinsurance to a range of cost-sharing limits (30 to 50 percent coinsurance and actuarially equivalent copayment amounts) based on MOOP type. This requirement provides lower MOOP types the most cost sharing flexibility to incentivize MA plans to establish lower MOOP amounts. The range of MA cost-sharing limits established by the April 2022 final rule (30 to 50 percent coinsurance and actuarially equivalent copayments for contract year 2026 and future years) apply to the following professional behavioral health service categories: mental health specialty services, psychiatric services, partial hospitalization, and intensive outpatient program services. The April 2022 final rule also codified MA cost-sharing limits for contract year 2023 and future years generally based on the following for the other behavioral health service categories:
                    </P>
                    <FTNT>
                        <P>
                            <SU>136</SU>
                             The April 2022 final rule did not change Cost Plan cost-sharing standards.
                        </P>
                    </FTNT>
                    <P>• 50 percent coinsurance and actuarially equivalent copayment amounts for the opioid treatment program services and outpatient substance use disorder services categories.</P>
                    <P>• 100 percent of Medicare FFS cost sharing and actuarially equivalent copayment amounts for plans with a mandatory MOOP type and 125 percent of Medicare FFS cost sharing and actuarially equivalent copayment amounts up to the MOOP limit for plans with a lower (voluntary) MOOP type for inpatient hospital psychiatric services.</P>
                    <P>In addition, the April 2022 final rule finalized the addition of a third, intermediate MOOP type and MA cost-sharing standards specific to this MOOP type. The MA cost-sharing standards for the intermediate MOOP type are, in most cases, primarily based on the numeric midpoint between the cost-sharing limits CMS sets for the mandatory and lower MOOP types. Specifically, the behavioral health service category contract year 2026 MA cost-sharing limits at § 422.100(f)(6)(i), (iii), and (iv) for the intermediate MOOP type are as follows:</P>
                    <P>• 40 percent coinsurance or an actuarially equivalent copayment for mental health specialty services, psychiatric services, partial hospitalization, and intensive outpatient program services.</P>
                    <P>• 50 percent coinsurance or an actuarially equivalent copayment for the opioid treatment program services and outpatient substance use disorder services categories.</P>
                    <P>
                        • A dollar value that reflects approximately 112.5 percent of estimated Medicare FFS cost sharing for inpatient hospital psychiatric services.
                        <SU>137</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>137</SU>
                             If the inpatient hospital psychiatric services dollar limit for particular length of stay scenario(s) is set at the MOOP limit for the other MOOP type(s), the percentage of estimated Medicare FFS cost sharing that approximately represents the dollar limit for the intermediate MOOP type in that length of stay scenario may be less than 112.5%. This is because the dollar limit for the intermediate MOOP type reflects the numeric midpoint of the actual cost-sharing limits applied to the other MOOP types (before rounding rules are applied).
                        </P>
                    </FTNT>
                    <P>Per § 422.100(f)(6)(ii), CMS also applies specific rounding rules in calculating MA behavioral health service category copayment limits for all MOOP types.</P>
                    <P>In the April 2022 final rule, we noted that CMS may pursue future rulemaking to alter the methodology for calculating the MA MOOP and cost-sharing limits finalized in that rule if: (1) there are significant unforeseen impacts or negative consequences that need to be addressed; or (2) additional changes outweigh the interests of maintaining a settled methodology and sufficiently protect enrollees from changes in cost sharing and benefits from one year to the next. Related to this, CMS included a comment solicitation in the April 2022 final rule that is discussed in the following section.</P>
                    <HD SOURCE="HD3">(2) Behavioral Health Cost-Sharing Limits Comment Solicitation</HD>
                    <P>CMS included a comment solicitation in the April 2022 final rule to do all of the following:</P>
                    <P>• Highlight the importance of in-network behavioral health cost sharing.</P>
                    <P>• Inform stakeholders that CMS may pursue future rulemaking to further limit MA behavioral health service category cost-sharing standards (compared to the standards set through the April 2022 final rule).</P>
                    <P>• Receive feedback to consider before pursuing potential future rulemaking on this topic.</P>
                    <P>
                        We shared that CMS was considering whether MA cost-sharing limits for mental health care (such as mental health specialty services, psychiatric services, partial hospitalization, opioid treatment program services, and treatment for substance use disorders) should be subject to additional cost-sharing limits, such as a requirement that cost sharing for those services not exceed cost sharing in Traditional Medicare. In response to the April 2022 final rule comment solicitation on this topic, CMS received a few timely comments.
                        <SU>138</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>138</SU>
                             Public comments for this solicitation that were received before the close of the comment period are posted at: 
                            <E T="03">https://www.regulations.gov/document/CMS-2020-0010-0667</E>
                            .
                        </P>
                    </FTNT>
                    <P>A couple of commenters were supportive of lowering MA cost-sharing limits for mental health services and treatment for substance use disorders or setting limits that had parity with the cost sharing for medical services. These commenters stated that changing the cost-sharing limits for these services would: (1) prevent MA organizations from discriminating against beneficiaries that use these services; (2) improve health care treatment by making the mental health treatment affordable for beneficiaries; and (3) align with the President's FY 2023 Budget and Unity Agenda that direct more resources to improving access to mental health and substance use disorder treatment.</P>
                    <P>A commenter stated that CMS should ensure MA beneficiary cost sharing for mental health and substance use disorder treatments are not subject to additional non-quantitative treatment limits (NQTLs) (like prior authorization and step therapy) in comparison to medical services. This commenter also requested CMS:</P>
                    <P>• Remove or reduce cost sharing for primary care services overall and specifically for behavioral health services that are provided in a primary care physician (PCP) setting to defined patient populations (such as those living in mental health professional shortage areas and underserved Black and Hispanic individuals); and</P>
                    <P>• Ensure MA plans provide coverage and adequate payment for integrated behavioral health services by PCPs and other licensed behavioral health professionals in PCP settings.</P>
                    <P>This commenter stated these requests would: (1) provide cost savings to patients and payers; (2) improve access to care and health equity; (3) align with CMS' goal to have 100 percent of Medicare beneficiaries in an accountable relationship by 2030; (4) increase utilization of preventive services; and (5) improve beneficiary health outcomes.</P>
                    <P>
                        A couple of commenters were opposed to lowering MA cost-sharing 
                        <PRTPAGE P="99407"/>
                        limits generally or specifically for mental health services. A commenter stated that current anti-discriminatory measures (including the non-discriminatory limits set by the April 2022 final rule, CMS's discrimination reviews of each plan's benefit design, and the risk adjustment aspect of the MA program designed to protect against discrimination) are sufficient and mentioned MA plans produce better beneficiary outcomes than Medicare FFS.
                    </P>
                    <P>CMS considered these comments when developing this proposal and we thank the commenters for their feedback.</P>
                    <HD SOURCE="HD3">e. Proposed Behavioral Health Cost-Sharing Standard: Cost Sharing No Greater Than Original Medicare (§ 422.100(j)(1))</HD>
                    <P>After considering: (1) the comments received on the April 2022 final rule comment solicitation related to behavioral health cost-sharing limits; and (2) behavioral health-related research conducted since the April 2022 final rule publication (discussed in section III.L.b. of this proposed rule), CMS developed and considered changes to in-network cost-sharing standards to propose for behavioral health services (versus the standards for contract year 2026 and future years in existing regulations). Our goal in choosing between these different standards was to strike a balance between: (1) improving the affordability of behavioral health services for enrollees in a timely manner; and (2) minimizing disruption to enrollees' access to care and coverage options. These different behavioral health cost-sharing standards are described and evaluated in detail in section VII.E.3. of this proposed rule. In brief, for MA plans, CMS evaluated each approach through analyses primarily focused on the following:</P>
                    <P>• Calculating the difference between the proposed and existing MA behavioral health service category cost-sharing standards for contract year 2026 and future years using illustrative actuarially equivalent dollar values based on contract year 2025 Medicare FFS data projections.</P>
                    <P>• Estimating: (1) the number of MA plans that may reduce their behavioral health service category cost sharing to comply with the standard posed by the alternative; and (2) how much MA plan cost sharing may be lowered for each service category on a weighted average basis based on contract year 2024 MA plans with cost-sharing amounts above the limits posed by each alternative.</P>
                    <P>Similar analyses were completed for cost plans.</P>
                    <P>Based on the analyses summarized in section VII.E.3. of this proposed rule, CMS has determined that applying cost sharing no greater than Traditional Medicare to the behavioral health service categories (identified in the introduction of this section) beginning in contract year 2026 would strike an appropriate balance between beneficiary affordability and minimizing disruption to enrollees' access to care and coverage options. As a result, CMS is proposing here to set the professional MA behavioral health service category cost-sharing limits beginning contract year 2026 (as discussed in the April 2022 final rule, contract year 2026 is the last year of the range of cost-sharing limits transition at § 422.100(f)(6)(iii) and (f)(8) for MA) because this proposal's intended outcome aligns with our behavioral health strategy and outweighs the potential benefits of maintaining the current, settled methodology.</P>
                    <P>
                        We note this proposal would affect D-SNP PPOs because § 422.100(o)(1) requires that, starting in 2026, an MA organization offering a local PPO plan or regional PPO plan that is a D-SNP limit cost sharing for out-of-network services to the cost-sharing limits applicable to specific in-network services for all MA plans, as described in § 422.100(f)(6). Section 422.100(o)(2) also limits D-SNP PPO out-of-network cost sharing to the cost-sharing limits for such services established at § 422.100(j)(1) when such services are delivered in-network. These requirements were finalized in the April 2024 final rule.
                        <SU>139</SU>
                        <FTREF/>
                         We propose to revise the last phrase of § 422.100(o)(2) regarding regional PPO D-SNPs to align the cross-references with the language that we have proposed to update in this rulemaking. Specifically, we are proposing to update the cross-reference in § 422.100(o)(2) from “excluding paragraph (j)(1)(i)(C)(
                        <E T="03">2</E>
                        )” to “excluding the last sentence of paragraph (j)(1)(i)(C).”
                    </P>
                    <FTNT>
                        <P>
                            <SU>139</SU>
                             “Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024—Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE)” published in the 
                            <E T="04">Federal Register</E>
                             April 23, 2024; Available at: 
                            <E T="03">https://www.federalregister.gov/documents/2024/08/06/2024-17024/medicare-program-changes-to-the-medicare-advantage-and-the-medicare-prescription-drug-benefit.</E>
                        </P>
                    </FTNT>
                    <P>We propose to update the cost sharing standards for several categories of benefits, including behavioral health and non-behavioral health related benefit categories, for Cost Plans to match the standards for MA plans. The following sections describe the: (1) proposed in-network behavioral health service category cost-sharing limits and (2) potential impacts this proposal may have on contract year 2026 plan cost-sharing amounts by service category. If this proposal is finalized, CMS will continue to examine the affordability and availability of behavioral health services for MA enrollees. This may include monitoring the utilization of behavioral health services by MA enrollees through encounter data (as discussed in section III.L.e.(4). of this proposed rule) which may inform CMS's understanding of the utilization of certain categories of services and future rulemaking.</P>
                    <HD SOURCE="HD3">(1) Proposed In-Network Service Category Cost-Sharing Limits</HD>
                    <P>
                        Table 3 (MA plans) and table 4 (Cost Plans) compare existing and proposed behavioral health in-network service category cost-sharing standards for contract year 2026 and future years. In effect, these tables summarize this proposal's impact to behavioral health service category cost-sharing limits if finalized (based on contract year 2025 Medicare FFS data projections, the most recent data available at the time of developing this proposal). Specifically, table 3 reflects this proposal's impact to MA coinsurance limits and its potential impact to the dollar limits (based on actuarially equivalent values to the specified coinsurance limits or percentages of estimated Traditional Medicare FFS cost sharing for inpatient hospital psychiatric services). We note the illustrative dollar limits for the behavioral health service categories in table 3 are similar to cost sharing for these services in qualified health plans (QHPs) in the marketplace. For example, QHPs are required to offer standardized options for 2024 with set copayments for mental health and substance use disorder outpatient office visits that range between $0 and $50 based on the plan level (for example, bronze or silver).
                        <SU>140</SU>
                        <FTREF/>
                         In comparison, based on the information in table 3, the partial hospitalization copayment limit for an MA plan with a lower MOOP type in contract year 2026 could decrease from 50 percent coinsurance or $150 copayment to 20 percent coinsurance or $60 copayment if this proposal is finalized (a $90 difference in the 
                        <PRTPAGE P="99408"/>
                        copayment limit). Similarly, table 4 reflects this proposal's impact to Cost Plan in-network cost-sharing limits.
                    </P>
                    <FTNT>
                        <P>
                            <SU>140</SU>
                             See table 9 and 10 on page 25850 and 25851 from, “Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2024” final rule published April 27, 2023. Retrieved from: 
                            <E T="03">https://www.federalregister.gov/documents/2023/04/27/2023-08368/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2024.</E>
                        </P>
                    </FTNT>
                    <P>
                        We note that the dollar limits included in table 4 under the existing cost sharing validations column do not reflect actuarially equivalent values to the coinsurance percentage listed. This is because Cost Plan cost sharing validations have been maintained for many years at these amounts. As part of this proposal, copayment limits 
                        <SU>141</SU>
                        <FTREF/>
                         for Cost Plans would be updated annually following the rules at § 422.100(f)(7), including the subregulatory process specified at § 422.100(f)(7)(iii) to reflect actuarially equivalent values to the coinsurance limits based on the most recent Medicare FFS data projections available and application of the rounding rules in paragraph (f)(6)(ii). As a result, comparing the difference in copayment limits between the existing and proposed standards in table 4 reflect the impacts from: (1) using updated Medicare FFS data projections to set actuarially equivalent copayment limits and (2) basing copayment limits on revised coinsurance limits specified in Medicare FFS for these benefits. For example, in comparison to the $150 actuarially equivalent copayment value to 50 percent coinsurance in table 3 for partial hospitalization services, table 4 reflects a $55 copayment limit in the existing cost sharing validations column for this service category. This illustrates how this proposal will have different levels of impact for Cost Plans than for MA plans in some cases. Specifically for this example, based on the information in table 4, the partial hospitalization copayment limit for a Cost Plan in contract year 2026 could change from 50 percent coinsurance or $55 copayment to 20 percent coinsurance or $60 copayment if this proposal is finalized (a $5 increase in the copayment limit). We also note that Cost Plan enrollees may continue to receive basic benefits at cost sharing in Traditional Medicare by going out-of-network. Ensuring that Cost Plan cost sharing does not exceed Traditional Medicare cost sharing for these services avoids an incentive for Cost Plan enrollees to go out-of-network, which might mean foregoing any coordination services or efforts by the Cost Plan that come with using the Cost Plan's network providers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>141</SU>
                             As discussed in more detail subsequently in this section of the proposed rule, this annual process to update the copayment limits for Cost Plans would apply to all basic benefits.
                        </P>
                    </FTNT>
                    <P>We emphasize that the dollar values in table 3 and the proposed dollar limits in table 4 are illustrative (based on contract year 2025 Medicare FFS data projections). As a result, CMS expects the proposed copayment and dollar limits illustrated in tables 3 and 4 would be different in contract year 2026 and future years based on using updated data to develop the actuarially equivalent values for the coinsurance cost sharing limits that we are proposing. This may also include, as discussed in the April 2022 Final Rule, changes to the approach to calculate actuarially equivalent copayments in future years. For example, CMS may change the calculation to consider a different list of provider specialties, services, or facilities based on generally accepted actuarial principles and practices outlined in § 422.100(f)(7)(i). We would generally describe such changes in the annual guidance described in § 422.100(f)(7)(iii).</P>
                    <GPH SPAN="3" DEEP="637">
                        <PRTPAGE P="99409"/>
                        <GID>EP10DE24.006</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="91">
                        <PRTPAGE P="99410"/>
                        <GID>EP10DE24.007</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="237">
                        <GID>EP10DE24.008</GID>
                    </GPH>
                    <P>
                        Under this proposal, the requirement that cost-sharing limits applicable for any service category cannot exceed the associated MOOP limit would continue to apply for MA plans, including for the inpatient hospital psychiatric length of stay scenarios at § 422.100(f)(6)(iv). For example, in table 3, the illustrative MA inpatient hospital psychiatric services dollar limits for each length of stay scenario are all less than the contract year 2025 MOOP limits (for example, the contract year 2025 lower MOOP limit is $4,150).
                        <SU>142</SU>
                        <FTREF/>
                         However, if 100 percent of estimated Medicare FFS cost sharing for an inpatient hospital psychiatric length of stay scenario resulted in a dollar limit that exceeded the MOOP limit, CMS would set the MA dollar limit for that scenario and MOOP type at the MOOP limit for that contract year under this proposal. In essence, our proposal could result in MA inpatient hospital psychiatric dollar limits that vary by MOOP type if dollar limit calculations result in values that exceed MOOP limit(s).
                    </P>
                    <FTNT>
                        <P>
                            <SU>142</SU>
                             “Final Contract Year (CY) 2025 Standards for Part C Benefits, Bid Review and Evaluation” issued May 6, 2024. Available at: 
                            <E T="03">https://www.cms.gov/about-cms/information-systems/hpms/hpms-memos-archive-weekly.</E>
                        </P>
                    </FTNT>
                    <P>In conjunction with proposing these behavioral health cost-sharing standards, we propose to: (1) revise § 417.454(e) to apply a limit for cost sharing for certain benefit categories, similar to the MA cost sharing standards, of cost sharing no greater than Traditional Medicare, to Cost Plans; and (2) add new § 417.454(f) to codify and clarify our longstanding policy for Cost Plans that in-network cost sharing be no greater than the 50 percent coinsurance (or actuarially equivalent copayment) standard at § 422.100(f)(6)(i) for which Cost Plans have historically been subject as part of our PBP data validations. We believe that these proposals will protect enrollees of Cost Plans and create consistent flexibility in cost sharing standards between MA and Cost Plans for the following non-behavioral service categories: inpatient hospital acute services, home health, certain categories of DME, and Part B drugs other than chemotherapy drugs. Specifically, at § 417.454(e) we propose to add paragraphs (5) through (9) which reference those service categories and behavioral health service categories. In addition, CMS proposes to add new paragraph § 417.454(f) which references the cost sharing standard at § 422.100(f)(6)(i) (the 50 percent coinsurance or actuarially equivalent copayment cost sharing standard) as applicable as the in-network basic benefit cost sharing standard for Cost Plans, excluding benefits addressed at § 417.454(e). Under these proposals, the Cost Plan must use cost sharing that does not exceed specific coinsurance thresholds. This may be achieved by the Cost Plan using coinsurance that does not exceed the coinsurance limit or copayments that do not exceed dollar values that are actuarially equivalent to the coinsurance limit.</P>
                    <P>
                        Under these proposals, CMS may annually update the copayment limits for service categories subject to § 417.454(e) or (f) to retain actuarially equivalent values to the applicable coinsurance standard for each service category. In annually setting these copayment limits, we intend to not disincentivize Cost Plans from using copayments in their plan designs. Specifically, CMS proposes to revise § 417.454(e) to specify that when Cost 
                        <PRTPAGE P="99411"/>
                        Plans use: (1) coinsurance, the coinsurance must not exceed the coinsurance charged in original Medicare; or (2) copayments, the copayment must not exceed the actuarially equivalent value calculated for that benefit using the Medicare Advantage rules at § 422.100(j)(1)(ii) and Medicare FFS data projections as defined in § 422.100(f)(4)(i). Per § 422.100(j)(1)(ii), CMS calculates copayment limits using the rules specified in § 422.100(f)(7) and (f)(8). If CMS does not calculate a specific copayment limit, the plan would have to establish a copayment that does not exceed an actuarially equivalent value to the coinsurance required under original Medicare; such actuarially equivalent value must be established in accordance with § 422.100(f)(7)(i) (which requires compliance with generally accepted actuarial principles and practices) and based on the average Medicare FFS allowed amount in the plan's service area or the estimated total MA plan financial liability for that benefit for that contract year. Under this proposal, the Cost Plan would have to comply with the MA requirements specified in the cross-referenced regulations. Cross-referencing the MA regulations would ensure consistency across the programs for Medicare beneficiaries that elect Part A and B coverage through one of these Medicare health plans and avoid repetitive and lengthy regulation text being added to § 417.454(e). This proposal would therefore result in consistently updated actuarially equivalent copayment limits for the applicable service categories across the MA and Cost Plan programs.
                    </P>
                    <P>The subregulatory process for how the actuarially equivalent copayment limits are calculated and established is addressed at § 422.100(f)(7) and would utilize the most recent Medicare FFS data projections available (as defined in § 422.100(f)(4)(i)) and application of the rounding rules in paragraph (f)(6)(ii). This includes the subregulatory notice and comment process outlined in § 422.100(f)(7)(iii). Section 422.100(j)(1)(ii) also requires compliance with paragraph (f)(8), the requirements for copayment limits during the actuarially equivalent copayment transition from 2023 through 2025. However, as the actuarially equivalent copayment transition concludes before this proposal would be applicable, paragraph (f)(8) is not relevant for Cost Plans. Table 5 shows the potential impact of these proposals for Cost Plans based on the most recent Medicare FFS data projections available for non-behavioral health related service categories.</P>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99412"/>
                        <GID>EP10DE24.009</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="167">
                        <PRTPAGE P="99413"/>
                        <GID>EP10DE24.010</GID>
                    </GPH>
                    <HD SOURCE="HD3">(2) Potential Impacts To Plan Behavioral Health Cost Sharing Amounts</HD>
                    <P>CMS considered the potential impact this proposal, if finalized, may have on plans and enrollees related to their behavioral health service category cost-sharing amounts. Tables 6 through 11 use contract year 2024 MA and Cost Plan data and contract year 2025 Medicare FFS data projections to roughly estimate these potential plan and enrollee impacts. We excluded D-SNPs from this data as states cover Medicare cost sharing for many dually eligible enrollees. However, we believe our proposal will have a beneficial effect on access to care for dually eligible individuals by increasing revenue for behavioral health providers in any instances in which states do not cover the full cost sharing amounts on their behalf. There could be state savings directly attributable to behavioral health benefits as well if utilization remains stable, which we expect given state coverage of dually eligible beneficiary cost sharing.</P>
                    <P>Organizations establish plan copayment amounts based on many variables that may change annually (including provider contracting arrangements, managed care practices, and scope of supplemental benefit offerings). As a result, CMS expects the values in tables 6 through 11 would be different in future years based on updated data (for example, contract year 2025 MA plan data). In addition, CMS cannot fully predict plan behavior and the MA organizations' reactions to the new behavioral health cost sharing limits. Due to these inherent uncertainties, we emphasize the potential plan and enrollee impacts discussed in this section are rough estimates and solicit comment on the scope of changes MA plans may make in response to this proposal if finalized.</P>
                    <P>Table 6 identifies the average MA plan cost sharing (weighted by enrollment) by behavioral health service category of all contract year 2024 plans. CMS considered the difference between the MA plan cost sharing values in table 6 and the proposed cost-sharing standards in table 3 as an initial estimate of how likely this proposal would be to require significant cost sharing changes by most MA plans for each category. For example, all of the weighted average MA plan cost sharing amounts for the three length-of-stay scenarios for the inpatient hospital psychiatric service category are less than the proposed and illustrative dollar limits in table 3. In contrast, as shown in table 6, the weighted average MA plan cost-sharing amount (25 percent coinsurance or $36 copayment) for the “outpatient substance use disorder services” service category exceeds the proposed 20 percent coinsurance or $30 copayment limit in table 3. As a result, we consider these comparisons as supportive evidence that this proposal would directly result in most MA plans: (1) lowering their cost sharing for the “outpatient substance use disorder services” category; and (2) making nominal or no changes to their cost sharing for inpatient hospital psychiatric services. We make additional comparisons and interpretations based on contract year 2024 MA plan cost sharing values in tables 8 and 10 to better understand the scope of changes certain MA plans may make in response to this proposal for each category.</P>
                    <GPH SPAN="3" DEEP="252">
                        <PRTPAGE P="99414"/>
                        <GID>EP10DE24.011</GID>
                    </GPH>
                    <P>
                        Table 7 provides the same information as table 6 but for Cost Plans. CMS considered the difference between the Cost Plan cost sharing values in table 7 and the proposed cost-sharing standards in table 4 as an initial estimate of the likelihood this proposal would require significant cost sharing changes by most Cost Plans for each applicable category.
                        <SU>143</SU>
                        <FTREF/>
                         For example, as shown in table 7, the weighted average Cost Plan cost sharing amount for the “opioid treatment program services” service category exceeds the proposed zero cost sharing standard in table 4. In contrast, as shown in table 7, the weighted average Cost Plan cost sharing amount for the “mental health specialty services” service category is lower than the proposed cost-sharing standard in table 4. As a result, we consider these comparisons as supportive evidence that this proposal would directly result in most Cost Plans: (1) lowering their cost sharing for the “opioid treatment program services” category; and (2) making nominal or no changes to their cost sharing for mental health specialty services. We make additional comparisons and interpretations based on contract year 2024 Cost Plan cost sharing values in tables 9 and 11 to better understand the scope of changes certain Cost Plans may make in response to this proposal for each applicable category.
                    </P>
                    <FTNT>
                        <P>
                            <SU>143</SU>
                             Cost Plans are not required to report information for all Medicare and non-Medicare services, including Part A inpatient hospital psychiatric services. Due to this lack of data, in comparing the information in tables 4 and 7 we are only able to evaluate potential professional behavioral health service category cost sharing impacts for Cost Plans.
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="246">
                        <PRTPAGE P="99415"/>
                        <GID>EP10DE24.012</GID>
                    </GPH>
                    <P>Table 8 identifies the number and percent of contract year 2024 MA plans and enrollees with cost sharing greater than the proposal by behavioral health service category. As shown in table 8, the behavioral health service category with the most contract year 2024 MA plans that have cost sharing greater than cost sharing in Traditional Medicare is opioid treatment program services. CMS considers the information in table 8 to be a rough estimate of the proportion of continuing MA plans and enrollees that may experience lower behavioral health cost sharing (by service category) if this proposal is finalized. For example, based on information in table 8, we estimate that about 42 percent of MA plans (and 41 percent of MA enrollees) may experience lower cost sharing for outpatient substance use disorder services in contract year 2026 if this proposal is finalized. In contrast, we expect a greater proportion of MA plans and enrollees would experience lower professional behavioral health cost sharing if this proposal is finalized. For example, based on table 8, we estimate that about 42 percent of MA plans (and 41 percent of MA enrollees) may experience lower cost sharing for outpatient substance use disorder services in contract year 2026 if this proposal is finalized. The information in table 8 aligns with our general expectation that the greater the decrease to existing cost-sharing standards from this proposal, the more plans, enrollees, and provider contracts that will be directly affected. The prior examples fit with this expectation as this proposal would lower MA cost-sharing standards for—</P>
                    <P>• Inpatient hospital psychiatric services from 125 percent to 100 percent of estimated Medicare FFS cost sharing (only for MA plans with the lower MOOP type); and</P>
                    <P>• Outpatient substance use disorder services from 50 percent coinsurance to 20 percent coinsurance (or an actuarially equivalent copayment) for all MA plans (regardless of MOOP type).</P>
                    <GPH SPAN="3" DEEP="147">
                        <GID>EP10DE24.013</GID>
                    </GPH>
                    <P>
                        Table 9 provides the same information as table 8 but for Cost Plans. In comparison to the findings from table 8, table 9 shows that substantially fewer Cost Plans and enrollees would be impacted by this proposal. For example, based on information in table 9, we estimate that 5 percent of Cost Plans (and about 1 percent of their enrollees) may experience lower outpatient substance use disorder services cost sharing in contract year 2026 (compared to the cost sharing they experience in contract year 2024) if this proposal is finalized. In contrast, this is 
                        <PRTPAGE P="99416"/>
                        substantially less than the 42 percent of MA plans that may lower cost sharing for this service category (as shown in table 8). As a result, based on the findings in table 9, we believe Cost Plans would not be substantially incentivized to leave the market if this proposal is finalized given the likely limited breadth of impact.
                    </P>
                    <GPH SPAN="3" DEEP="111">
                        <GID>EP10DE24.014</GID>
                    </GPH>
                    <P>Column D in table 10 reflects the difference between: (1) the weighted average MA plan cost sharing by behavioral health service category of the plans identified in table 8; and (2) the proposed cost-sharing limit for each category. Table 11 shows the same information as table 10 but for Cost Plans. If this proposal is finalized, CMS considers the values in Column D of tables 10 and 11 as a rough estimate of how much, on a weighted average basis, enrollee cost sharing may decrease for each behavioral health service category in continuing plans that did not previously establish cost sharing amounts equal to or less than Traditional Medicare. For example, as shown in table 10, $30.38 is the estimated average difference in cost sharing for the “outpatient substance use disorder services” service category between: (1) the $60.38 weighted average cost sharing for this service category of contract year 2024 MA plans with cost sharing amounts greater than the proposed standard; and (2) this proposal's $30 illustrative copayment limit for that category (which reflects the actuarially equivalent copayment value to the 20 percent coinsurance standard in Traditional Medicare for this benefit, based on contract year 2025 Medicare FFS data projections). In comparison for this same service category, table 11 reflects a $10.00 difference in cost sharing between Cost Plan cost sharing amounts (those above the proposed limit identified in table 9) and the $30 illustrative copayment limit for the “outpatient substance use disorder services” service category (based on contract year 2025 Medicare FFS data projections). Comparing tables 10 and 11 in this manner supports our belief that Cost Plans will be less impacted by this proposal if finalized compared to MA plans.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99417"/>
                        <GID>EP10DE24.015</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99418"/>
                        <GID>EP10DE24.016</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        Based on tables 6, 8, and 10, CMS expects this proposal (if finalized) may result in a large proportion of continuing MA plans making significant 
                        <PRTPAGE P="99419"/>
                        changes to their cost sharing for the “opioid treatment program services” service category in comparison to the other behavioral health service categories (on average). This is because, as shown in tables 6, 8, and 10, the “opioid treatment program services” service category has the:
                    </P>
                    <P>• Highest percent of contract year 2024 MA plans and enrollees with cost sharing above the proposed standard (coinsurance percentage and illustrative actuarially equivalent copayment or dollar limit).</P>
                    <P>• Of the professional behavioral health service categories, largest cost sharing difference between the weighted average MA plan cost sharing and the proposed limit for that category for: (1) all MA plans; and (2) MA plans with cost sharing above the proposed cost-sharing standard.</P>
                    <P>
                        Similar findings may be made for this service category for Cost Plans based on the information in tables 7, 9, and 11. As a result, this proposal (if finalized) has the potential to meaningfully improve access to opioid treatment programs as a significant proportion of MA and Cost Plan enrollees would likely experience substantively lower cost sharing for these services. While a decrease of $47 on average may be substantial for some MA plans (or $20 on average for Cost Plans), research finds that patients with severe alcohol and other drug problems report completing only two serious recovery attempts (median) before remission.
                        <SU>144</SU>
                        <FTREF/>
                         As a result, we expect lower cost sharing will increase utilization of opioid treatment program services and thus provide more beneficiaries with the services they need to achieve remission. In addition, a study shows that every dollar spent on substance use disorder treatment saves $4 in health care costs.
                        <SU>145</SU>
                        <FTREF/>
                         Finally, we note that over the past two decades, the number of overdose deaths in the older adult population has quadrupled.
                        <SU>146</SU>
                        <FTREF/>
                         As a result, applying the Traditional Medicare limit of zero cost sharing could have a significant positive impact on enrollees' ability to access those services and address the opioid use disorder crisis. We acknowledge this proposal of zero cost sharing also increases the cost liability for MA and Cost Plan organizations to cover opioid treatment program services. However, we believe this increase in cost liability is not as much of a concern as it otherwise would be for a highly utilized service (such as physical therapy). In other words, we find the increase in cost liability for MA and Cost Plan organizations to cover opioid treatment program services as outweighed by the potential positive enrollee outcomes described previously in this section. Given the expected positive impacts of applying the Traditional Medicare limit of zero cost sharing to opioid treatment program services, this proposed limit reflects an additional term or condition necessary and appropriate for the MA program, and not inconsistent with the Part C statute, which CMS has the authority to impose under section 1857(e)(1) of the Act.
                    </P>
                    <FTNT>
                        <P>
                            <SU>144</SU>
                             Kelly JF, Greene MC, Bergman BG, White WL, Hoeppner BB. How Many Recovery Attempts Does it Take to Successfully Resolve an Alcohol or Drug Problem? Estimates and Correlates From a National Study of Recovering U.S. Adults. Alcohol Clin Exp Res. 2019 Jul;43(7):1533-1544. doi: 10.1111/acer.14067. Epub 2019 May 15. PMID: 31090945; PMCID: PMC6602820.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>145</SU>
                             Substance Abuse and Mental Health Services Administration (US); Office of the Surgeon General (US). Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health [internet]. Washington (DC): US Department of Health and Human Services; 2016 Nov. CHAPTER 7, VISION FOR THE FUTURE: A PUBLIC HEALTH APPROACH. Available from: 
                            <E T="03">https://www.ncbi.nlm.nih.gov/books/NBK424861/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>146</SU>
                             Chatterjee, Rhitu. “Mental health care is hard to find, especially for people with Medicare or Medicaid.” April 2024. Retrieved from: 
                            <E T="03">https://www.npr.org/sections/health-shots/2024/04/03/1242383051/mental-health-care-shortage-medicare-medicaid-hhs-inspector-general.</E>
                        </P>
                    </FTNT>
                    <P>We also believe tables 6 through 11 support the proposed MA and Cost Plan cost-sharing standard changes for the other behavioral health service categories. For instance, the MA data suggests that this proposal would result in either: (1) somewhat nominal reductions to plan cost sharing amounts for several behavioral health service categories across a substantive proportion of plans and enrollees or (2) substantive reductions to plan cost sharing amounts for certain inpatient hospital psychiatric length of stay scenarios for a small proportion of plans and enrollees. Similarly, for Cost Plans, we find that the data in tables 7, 9, and 11 suggest that this proposal would result in either: (1) moderate reductions to plan cost sharing amounts for opioid treatment program services across a substantive proportion of plans and enrollees or (2) nominal reductions to plan cost-sharing amounts for most of the other behavioral health service categories for a small proportion of plans and enrollees. For example, based on tables 8 and 10, approximately 24 percent of MA plans (or 4.5 million or 21 percent of MA enrollees) could have a reduction in cost sharing by about $7 per visit on average for mental health specialty services based on this proposal and contract year 2024 plan data. In comparison, based on tables 9 and 11, approximately 8 percent of Cost Plans (or 5,070 or 3 percent of Cost Plan enrollees) could have a reduction in cost sharing by about $5 per visit on average for this service category. CMS finds either of these consequences for mental health specialty services plan cost sharing amounts would further our progress towards improving access to behavioral health services across MA and Cost Plans. As a result, we find the burdens or costs that this proposal would impose on MA and Cost Plans are outweighed by the potential positive beneficiary outcomes.</P>
                    <P>
                        By reducing costs for mental health specialty services by nominal amounts for each visit, we expect an increase in utilization of these services. This service category includes costs from social workers and psychologists, which are the behavioral health providers most utilized by enrollees in 2023.
                        <SU>147</SU>
                        <FTREF/>
                         Considering the combined effects of lower MA and Cost Plan cost sharing amounts across the behavioral health service categories, we also expect positive health outcome effects and improved enrollee access to these services.
                    </P>
                    <FTNT>
                        <P>
                            <SU>147</SU>
                             HHS Office of Inspector General. “A Lack of Behavioral Health Providers in Medicare and Medicaid Impedes Enrollees' Access to Care” April 2024. Retrieved from: 
                            <E T="03">https://oig.hhs.gov/reports-and-publications/all-reports-and-publications/a-lack-of-behavioral-health-providers-in-medicare-and-medicaid-impedes-enrollees-access-to-care/.</E>
                        </P>
                    </FTNT>
                    <P>We reiterate that the information in tables 6 through 11 reflects an estimate of this proposal's potential impact to MA and Cost Plans and enrollees in contract year 2026 based on the most recent data available at the time of developing this proposal. If this proposal is finalized, plans may make changes to their plan designs within the limits of applicable statutes and regulatory requirements discussed in the following section.</P>
                    <HD SOURCE="HD3">(3) Statutory and Regulatory Limitations on Benefit Design Changes</HD>
                    <P>
                        In the annual MA bids or for a new contract year for Cost Plans, plan benefit design changes may be made in response to multiple factors, including new cost-sharing requirements. If this proposal is finalized, MA and Cost Plan organizations have the flexibility to offset any potential cost changes related to providing behavioral health services (if they were not already establishing cost-sharing amounts at or below cost sharing in Traditional Medicare). For example, MA and Cost Plan organizations may choose to change aspects of their benefit designs in a manner that would distribute the impact across all enrollees such as changing 
                        <PRTPAGE P="99420"/>
                        premium, supplemental benefits, and MOOP amount, as applicable, or make cost-sharing changes to other service categories. However, it is also possible that market forces will play a role in the organization deciding among potential plan benefit design changes. In addition, these organizations may choose to adjust profit margins rather than change benefits and/or premiums.
                    </P>
                    <P>MA organizations may make changes to their plan benefit design that comply with existing statutory and regulatory requirements. This includes sections 1852(a)(1)(B)(i) and 1852(b)(1) of the Act. Section 1852(a)(1)(B)(i) of the Act provides that the MA organization must cover, subject to limited exclusions, the benefits under Parts A and B (that is, basic benefits as defined at § 422.100(c)) with cost sharing that does not exceed or is at least actuarially equivalent to cost sharing in original Medicare in the aggregate; this is repeated in a bid requirement under section 1854(e)(4) of the Act. We have addressed and implemented this requirement in several regulations, including §§ 422.100(j)(2), 422.102(a)(4), and 422.254(b)(4).</P>
                    <P>Section 1852(b)(1) of the Act prohibits discrimination by MA organizations on the basis of health status-related factors and directs that CMS may not approve an MA plan if CMS determines that the design of the plan and its benefits are likely to substantially discourage enrollment by certain MA eligible individuals. We have relied on this to establish certain minimum standards for MA plans, including cost sharing standards, designed to ensure that MA cost sharing designs and structures are not established in a way that discourages enrollment by Medicare beneficiaries with high health needs (whether overall or for specific categories of covered benefits).</P>
                    <P>In addition, section 1854(a)(5) and (6) of the Act provide that CMS is not obligated to accept every bid submitted and may negotiate with MA organizations regarding the bid, including benefits. Under section 1854(a)(5)(C)(ii) of the Act, CMS is also authorized to deny a plan bid if the bid proposes too significant an increase in enrollee costs or a decrease in benefits from one plan year to the next. While this proposal does not limit our negotiation authority with respect to MA organizations' bid submissions (§ 422.256), it would provide cost-sharing standards for an acceptable benefit design for CMS to apply in reviewing and evaluating bids.</P>
                    <P>MA and Cost Plan organizations must also comply with applicable Federal civil rights laws that prohibit discrimination, including those that prohibit discrimination on the basis of race, color, national origin, sex, age, and disability, such as section 1557 of the Affordable Care Act, Title VI of the Civil Rights Act of 1964, section 504 of the Rehabilitation Act of 1973, and the Age Discrimination Act of 1975.</P>
                    <P>None of the proposals in this proposed rule limit application of such anti-discrimination requirements. As a result, CMS believes these existing statutory antidiscrimination requirements, regulatory actuarial equivalence requirements for MA plans, and the competitive nature of the MA and Cost Plan programs will prevent potentially concerning changes organizations could otherwise make in response if this proposal is finalized. However, as discussed in the following section, we solicit comment on whether implementing this proposal beginning in contract year 2026 would sufficiently protect enrollees from potentially disruptive changes in access to care (including cost sharing and benefits) and coverage options from one year to the next.</P>
                    <HD SOURCE="HD3">(4) Comment Solicitations</HD>
                    <P>As discussed in sections III.L.e.(2). and (3). and VII.E.3. of this proposed rule, CMS believes applying cost sharing no greater than Traditional Medicare as the cost-sharing standard for the behavioral health service categories will not result in significant negative disruption to many enrollees or MA and Cost Plan organizations. This is in part because as shown in:</P>
                    <P>
                        • 
                        <E T="03">Table 6:</E>
                         The weighted average behavioral health cost sharing—of all contract year 2024 MA plans—reflects amounts that are less than the proposed standards for the behavioral health service categories, with two exceptions for the “opioid treatment program services” and “outpatient substance use disorder services” service categories.
                    </P>
                    <P>
                        • 
                        <E T="03">Table 7:</E>
                         The weighted average behavioral health cost sharing—of all contract year 2024 Cost Plans—reflects amounts that are less than the proposed standards for the behavioral health service categories, with one exception for “opioid treatment program services” service category.
                    </P>
                    <P>
                        • 
                        <E T="03">Table 10:</E>
                         The weighted average behavioral health cost sharing of contract year 2024 MA plans for only plans with cost sharing above the proposed standard is not significantly greater than our proposal for most of the professional service categories.
                    </P>
                    <P>
                        • 
                        <E T="03">Table 11:</E>
                         The weighted average behavioral health cost sharing of contract year 2024 Cost Plans for only plans with cost sharing above the proposed standard is not significantly greater than our proposal for most of the professional service categories.
                    </P>
                    <P>As shown in table 6, the weighted average contract year 2024 MA plan cost sharing is about 9.5 percent coinsurance or $29 copayment for the “opioid treatment program services” and about 25 percent coinsurance or $36 copayment for “outpatient substance use disorder services” service categories. In comparison, as shown in table 10, the proposed behavioral health cost-sharing standards for these categories would eliminate cost sharing for “opioid treatment program services” and establish 20 percent coinsurance or a $35 copayment limit (illustrative dollar value that is actuarially equivalent to 20 percent coinsurance based on contract year 2025 Medicare FFS data projections) for the “outpatient substance use disorder services” categories. As a result, if the proposed behavioral health cost-sharing standards are finalized, we expect most continuing MA plans will not have to significantly adjust their benefit designs to come into compliance. In addition, based on our findings from tables 7 and 11 we also expect most continuing Cost Plans will not be significantly impacted by this proposal as most plans are currently in compliance with the proposed requirements.</P>
                    <P>Conversely, there are a subset of plans that established cost sharing amounts significantly above the weighted average values in table 6. Specifically, 3 percent of MA plans (impacting 3 percent of enrollees) established cost sharing greater than 30 percent coinsurance (or approximately $92 copayment) for partial hospitalization. In these cases, this proposal may have a more significant impact by lowering the cost sharing limit for this service category to 20 percent coinsurance or $60 copayment. Given the potential for this proposal to impact some MA and Cost Plans more significantly, we considered whether CMS should apply—</P>
                    <P>• These proposed changes beginning in contract year 2026 or 2027; or</P>
                    <P>• A transition period from the existing contract year 2025 behavioral health cost-sharing limits to the proposed cost-sharing standard for select behavioral health service categories, and if so, how long the transition should be.</P>
                    <P>
                        For example, CMS considered whether a potential transition period is warranted for service categories with substantial changes to the cost sharing standard so MA and Cost Plans have sufficient time to address potential changes in bidding that stem from this proposal (if finalized) and other, 
                        <PRTPAGE P="99421"/>
                        unrelated policy changes occurring at the same time (such as, new changes stemming from IRA Part D requirements and CMS's annual updates to the risk adjustment model and plan payments). In making this consideration, CMS evaluated MA encounter data to determine the potential impact this proposal may have on enrollee utilization of these behavioral health services. This data was not available for Cost Plans. Specifically, we compared the average length of stay and the percent of enrollees with any utilization of the various behavioral health service categories based on whether the MA enrollee's plan had cost sharing amounts for those services equal to, or less than, cost sharing in Traditional Medicare. The results of this analysis are provided in tables 12 and 13 for the most recent year of MA encounter data available at the time of developing this proposal, contract year 2023.
                    </P>
                    <GPH SPAN="3" DEEP="183">
                        <GID>EP10DE24.017</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="195">
                        <GID>EP10DE24.018</GID>
                    </GPH>
                    <P>Based on the information in tables 12 and 13, CMS finds that the data suggests that this proposal may result in small increases to per-enrollee utilization of certain behavioral health services but could also decrease the average duration or length of stay of these services. For example, table 12 shows that the percent of MA enrollees with any utilization of mental health specialty services, psychiatric services, and outpatient substance abuse services increased nominally if the enrollee was in a plan with cost sharing equal to or less than Traditional Medicare in comparison to plans with cost sharing greater than Traditional Medicare. For these same service categories, table 13 shows that enrollees in plans with cost sharing equal to or less than Traditional Medicare had shorter average length of stays or number of visits in comparison to enrollees in plans with cost sharing greater than Traditional Medicare for these services. As a result, we believe this proposal will not produce an immediate drastic change in utilization of the behavioral health service categories to the extent that a transition period is warranted. However, we solicit comment on this assumption.</P>
                    <HD SOURCE="HD3">f. Proposed Regulation Changes</HD>
                    <P>Thus, we propose the following changes to §§ 417.454 and 422.100:</P>
                    <P>
                        • Revise language at § 417.454(e) to clarify: (1) when the proposed new cost sharing limits—that is, the additional categories of basic benefits for which cost sharing may not be greater than cost sharing in original Medicare for that benefit—would apply and (2) the methods by which Cost Plan organizations (HMO or CMP) may abide by the requirements in this paragraph when they use coinsurance or copayment structures for these basic benefits.
                        <PRTPAGE P="99422"/>
                    </P>
                    <P>• Revise language at § 417.454(e)(1) to match terminology of chemotherapy administration services with language at § 422.100(j)(1)(i)(A) applying the same cost sharing limit to MA plans.</P>
                    <P>• Add § 417.454(e)(5) to reflect proposed cost-sharing standard that Cost Plans may not establish cost sharing that exceeds cost sharing in Traditional Medicare for the following behavioral health service categories: intensive outpatient services, mental health specialty services, opioid treatment program services, outpatient substance use disorder services, partial hospitalization, and psychiatric services.</P>
                    <P>• Add § 417.454(e)(6) to reflect proposed cost-sharing standard that Cost Plans may not establish cost sharing for inpatient hospital acute and psychiatric services (all length of stay scenarios) that exceeds cost sharing for these services in Traditional Medicare.</P>
                    <P>• Add § 417.454(e)(7) through (e)(9) to reflect proposed cost-sharing standard that Cost Plans may not establish cost sharing for home health services, certain categories of DME, and drugs covered under Part B other than chemotherapy drugs that exceeds cost sharing for these services in Traditional Medicare.</P>
                    <P>• Add § 417.454(f) to codify and clarify our longstanding policy for Cost Plans that in-network cost sharing be no greater than the 50 percent coinsurance (or actuarially equivalent copayment) standard applied to MA plans for basic benefits without otherwise specified cost-sharing standards.</P>
                    <P>• Replace the partial hospitalization example with occupational therapy at § 422.100(f)(6)(iii)(A) to reflect the proposed cost-sharing standard of cost sharing no greater than original Medicare for the partial hospitalization service category.</P>
                    <P>• Add a regulation reference to paragraph (j)(1)(i)(H) at § 422.100(f)(6)(iv)(A) to reflect the proposed new paragraph which would apply cost sharing no greater than original Medicare to inpatient hospital psychiatric services.</P>
                    <P>• Remove language specific to inpatient hospital psychiatric services and associated lengths of stay scenarios at § 422.100(f)(6)(iv)(B) and (D) to reflect the proposed cost-sharing standard.</P>
                    <P>• Remove language at § 422.100(f)(6)(iv)(D) that the total inpatient benefit cost sharing must not exceed the MA plan's MOOP amount for clarity.</P>
                    <P>• Add language to § 422.100(j)(1)(i) that the requirement for cost sharing to not exceed cost sharing under original Medicare applies on different dates for different benefits categories as proposed in paragraphs under paragraph (j)(1)(i).</P>
                    <P>• Add language to § 422.100(j)(1)(i)(C) that the Part A deductible amount referred to is for the year.</P>
                    <P>
                        • Remove § 422.100(j)(1)(i)(C)
                        <E T="03">(2)</E>
                         and move language from paragraph (j)(1)(i)(C)
                        <E T="03">(1)</E>
                         to paragraph (j)(1)(i)(C) to consolidate skilled nursing facility cost-sharing standard information.
                    </P>
                    <P>• Add § 422.100(j)(1)(i)(G) to reflect proposed cost-sharing standard of cost sharing no greater than original Medicare for the following behavioral health service categories: intensive outpatient services, mental health specialty services, opioid treatment program services, outpatient substance use disorder services, partial hospitalization, and psychiatric services for contract year 2026 and subsequent years.</P>
                    <P>• Add § 422.100(j)(1)(i)(H) to reflect proposed cost-sharing standard of cost sharing no greater than original Medicare for inpatient hospital psychiatric services (all length of stay scenarios) for contract year 2026 and subsequent years.</P>
                    <P>
                        • Revise language at § 422.100(o)(2) that references paragraph (j)(1)(i)(C)
                        <E T="03">(2)</E>
                         to reference paragraph (j)(1)(i)(C) in relation to regional PPO dual eligible special needs plans.
                    </P>
                    <P>We solicit comment on these proposals.</P>
                    <HD SOURCE="HD2">M. Ensuring Equitable Access—Enhancing Health Equity Analyses: Annual Health Equity Analysis of Utilization Management Policies and Procedures (§ 422.137)</HD>
                    <P>
                        On January 20, 2021, President Biden issued Executive Order 13985: “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” (E.O. 13985).
                        <SU>148</SU>
                        <FTREF/>
                         E.O. 13985 describes the Administration's policy goals to advance equity across Federal programs and directs Federal agencies to pursue a comprehensive approach to advancing equity for all, including those who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality. Consistent with this Executive Order, in 2022, CMS announced “Advance Equity” as the first pillar of its Strategic Plan.
                        <SU>149</SU>
                        <FTREF/>
                         This pillar emphasizes the importance of advancing health equity by addressing the health disparities that impact our health care system. CMS defines health equity as “the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.” 
                        <SU>150</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>148</SU>
                             
                            <E T="03">https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>149</SU>
                             
                            <E T="03">https://www.federalregister.gov/d/2022-26956/p-228</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>150</SU>
                             
                            <E T="03">https://www.cms.gov/pillar/health-equity</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        In April 2024, CMS published the “Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE)” 
                        <SU>151</SU>
                        <FTREF/>
                         final rule (89 FR 30448) (hereinafter referred to as the April 2024 final rule). In the April 2024 final rule,
                        <FTREF/>
                         CMS explained that we have received feedback from interested parties, including people with Medicare, patient groups, consumer advocates, and providers that utilization management (UM) practices in Medicare Advantage (MA), including the use of prior authorization, can sometimes create a barrier for patients in accessing medically necessary care. Further, as explained in detail in the April 2024 final rule, some research indicated that the use of prior authorization may disproportionately impact individuals who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality (89 FR 30566).
                        <E T="51">152 153</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>151</SU>
                             
                            <E T="03">https://www.federalregister.gov/documents/2024/04/23/2024-07105/medicare-program-changes-to-the-medicare-advantage-and-the-medicare-prescription-drug-benefit</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>152</SU>
                             
                            <E T="03">https://www.hmpgloballearningnetwork.com/site/frmc/commentary/addressing-health-inequities-prior-authorization</E>
                            ; and 
                            <E T="03">https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC10024078/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>153</SU>
                             
                            <E T="03">https://www.federalregister.gov/d/2023-24118/p-600</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        Under section 1852 of the Act, MA organizations are generally allowed to use utilization management tools, such as prior authorization.
                        <SU>154</SU>
                        <FTREF/>
                         Authority for 
                        <PRTPAGE P="99423"/>
                        MA organizations to use utilization management policies and procedures regarding basic benefits is subject to the mandate in section 1852(a)(1) of the Act that MA plans cover Medicare Part A and Part B benefits (subject to specific, limited statutory exclusions) and, thus, to CMS's authority under section 1856(b) of the Act to adopt standards to carry out the MA statutory provisions. In addition, the MA statute and MA contracts cover both the basic and supplemental benefits covered under MA plans, so additional contract terms added by CMS pursuant to section 1857(e)(1) of the Act may also address supplemental benefits. Additionally, per section 1852(b) of the Act and §  422.100(f)(2), plan designs and benefits may not discriminate against beneficiaries, promote discrimination, discourage enrollment, encourage disenrollment, steer subsets of Medicare beneficiaries to particular MA plans, or inhibit access to services. These requirements apply to both basic and supplemental benefits. We consider utilization management policies and procedures to be part of the plan benefit design, and therefore they cannot be used to discriminate or direct enrollees away from certain types of services.
                    </P>
                    <FTNT>
                        <P>
                            <SU>154</SU>
                             Sections 1852(c)(1)(G) and (c)(2)(B) of the Social Security Act, and the MA regulations at 42 CFR 422.4(a)(1)(ii) and 422.138, expressly reference a MA plan's application of utilization management tools, like prior authorization and other “procedures used by the organization to control utilization of services and expenditures.” MA plans may require prior authorization on medical items and services, except for certain services, including emergency services, urgent care, and stabilization services. For preferred provider organization (PPO) plans, prior authorization is prohibited on plan-covered services from out-of-network providers (see § 422.4(a)(1)(v)(D)).
                        </P>
                    </FTNT>
                    <P>
                        In the April 2024 final rule, CMS added two health equity related requirements to §  422.137. First, at §  422.137(c)(5), to require that beginning January 1, 2025, the UM committee must include at least one member with expertise in health equity. Second, at §  422.137(d)(6), we finalized that the UM committee must conduct an annual health equity analysis of the use of prior authorization. The analysis must examine the impact of prior authorization at the plan level, on enrollees with one or more of the specified social risk factors (SRF).
                        <SU>155</SU>
                        <FTREF/>
                         The analysis must compare metrics related to the use of prior authorization for enrollees with the specified SRFs to enrollees without the specified SRFs. Further, the analysis must use the outlined metrics, aggregated for all items and services, calculated for enrollees with the specified SRFS, and for enrollees without the specified SRFs, from the prior contract year, to conduct the analysis. Finally, by July 1, 2025, and annually thereafter, the health equity analysis must be posted on the plan's publicly available website in a prominent manner and clearly identified in the footer of the website.
                    </P>
                    <FTNT>
                        <P>
                            <SU>155</SU>
                             Section 422.137(d)(6)(ii): (1) receipt of the low-income subsidy or being dually eligible for Medicare and Medicaid (LIS/DE); or (2) having a disability.
                        </P>
                    </FTNT>
                    <P>During the public comment period, CMS received a significant number of comments on the requirement that the metrics for the health equity analysis be aggregated for all items and services (89 FR 30569). Some commenters expressed concern that because the proposed analysis would consist of prior authorization metrics aggregated for all items and services, it would not provide enough detail for true accountability and could allow plans to hide disparities. For that reason, commenters recommended that CMS require a further level of granularity to ensure that potential disparities could be identified. Specifically, commenters suggested that CMS require disaggregation by item and service to ensure that CMS can identify specific services that may be disproportionately denied. At the time, we believed that there was significant value in establishing baseline data because we recognized that there was little publicly available information regarding the use of prior authorization and its potential impact on specific populations.</P>
                    <P>
                        In the April 2024 final rule, we signaled our intent to propose reporting and posting of disaggregated (that is, more granular) data on these topics in the future. Furthermore, we stated that we agree that disaggregation of the reported metrics for all items and services could assist in increasing transparency and ensuring the most accurate data regarding prior authorization is available.
                        <SU>156</SU>
                        <FTREF/>
                         By proposing to require the data to be disaggregated, CMS and MA organizations may more readily identify trends related to the use of prior authorization and, therefore, be able to more fully identify and address the impact of prior authorization on enrollees with the specified SRFs. This disaggregated data also will help inform future policymaking.
                    </P>
                    <FTNT>
                        <P>
                            <SU>156</SU>
                             
                            <E T="03">https://www.federalregister.gov/d/2024-07105/p-1232</E>
                            .
                        </P>
                    </FTNT>
                    <P>For these reasons, we propose at §  422.137(d)(6)(iii)(A) through (H) to revise the required metrics for the annual health equity analysis of the use of prior authorization to require the following:</P>
                    <P>• The percentage of standard prior authorization requests that were approved, reported by each covered item and service.</P>
                    <P>• The percentage of standard prior authorization requests that were denied, reported by each covered item and service.</P>
                    <P>• The percentage of standard prior authorization requests that were approved after appeal, reported by each covered item and service.</P>
                    <P>• The percentage of prior authorization requests for which the timeframe for review was extended, and the request was approved, reported by each covered item and service.</P>
                    <P>• The percentage of expedited prior authorization requests that were approved, reported by each covered item and service.</P>
                    <P>• The percentage of expedited prior authorization requests that were denied, reported by each covered item and service.</P>
                    <P>• The average and median time that elapsed between the submission of a request and a determination by the MA plan, for standard prior authorizations, reported by each covered item and service.</P>
                    <P>• The average and median time that elapsed between the submission of a request and a decision by the MA plan for expedited prior authorizations, reported by each covered item and service.</P>
                    <P>We also seek comment on alternative ways to group items and services for the purpose of reporting on these metrics, while still allowing for meaningful disaggregation to increase transparency, identify trends, and address the impact of prior authorization on enrollees with the specified SRFs.</P>
                    <P>Because the required metrics are to be reported based on percentage of prior authorization requests, and average and median time elapsed, CMS does not believe the health equity analysis and accompanying report will result in potential enrollee privacy issues. However, out of an abundance of caution, CMS is considering whether to include a provision to allow suppression of certain data points should disaggregation present an issue regarding enrollee privacy. For example, if reporting by each covered item and service would result in such a small data set that it could put enrollee privacy at risk, an MA plan would be permitted to suppress that data set. CMS solicits feedback on whether cell suppression is necessary in order to ensure that enrollee privacy is protected and on how to ensure that this suppression would be done in a uniform manner. Based on feedback received during the public comment period, we may consider revising any potential final policy to account for these potential privacy concerns.</P>
                    <P>
                        We also received comments on the April 2024 final rule stating concerns that the analysis would be challenging for enrollees and the public to navigate and understand. At the time, we determined that this would not present 
                        <PRTPAGE P="99424"/>
                        a significant issue because the data was required to be aggregated for all items and services. However, because we are now proposing that MA organizations report the metrics by each covered item and service, we believe an executive summary of the results of the analysis is necessary to ensure that the public and plan enrollees can navigate and understand the data more fully. Therefore, we propose at §  422.137(d)(7)(v) that the results of the health equity analysis include an executive summary. The executive summary must include the following elements: additional context that may be necessary or helpful for understanding the results of the analysis; clarifying information that is relevant to the results of the analysis, or that could help the public understand the analysis more fully; and an overview of the information produced by the analysis, including key statistics and results. We propose that MA plans must also ensure that accompanying language is not misleading or misrepresentative of the findings of the analysis. We solicit comment on additional requirements to be included in the executive summary, including, but not limited to, how this information could be formatted and presented in a uniform manner across all MA plans, adherence to plain language principals and accessibility standards, and consumer centered design standards. We also solicit comment on how the data produced by the analysis could be formatted to ensure consistency and uniformity across MA plans, and to ensure usability by enrollees and the public.
                    </P>
                    <P>CMS is considering adding “having a mental health or substance use disorder diagnosis” to the list of social risk factors that MA plans must use to conduct the annual health equity analysis. We solicit comment on this addition and whether this appropriately addresses a gap in the existing social risk factors. We also solicit comment on whether this is something that MA plans would be able to operationalize, any potential barriers or challenges CMS should consider in policy development and reporting, and how MA plans might overcome these barriers.</P>
                    <P>We welcome comment on the proposal and may revise the final policy based on comments received.</P>
                    <HD SOURCE="HD2">N. Medicare Advantage Network Adequacy (§ 422.116)</HD>
                    <P>Section 1852(d)(1)(A) of the Social Security Act allows MA organizations to select the providers from which an enrollee may receive covered benefits, provided that the MA organization, in addition to meeting other requirements, makes such benefits available and accessible in the service area with promptness and in a manner that assures continuity in the provision of benefits. 1852(d)(1)(D) of the Act requires MA organizations to provide access to appropriate providers for medically necessary treatment and services. In § 422.116, CMS codified a means of compliance with these statutory requirements by requiring network-based MA plans to demonstrate that they have an adequate contracted provider network that is sufficient to provide access to covered services in accordance with access standards described in 1852(d)(1) and in §§  422.112(a)(10) and § 422.114 and by meeting the network adequacy standards at § 422.116(a)(2). MA organizations must maintain an adequate contracted network of providers regardless of whether a provider or facility type is included in the network adequacy standards at §  422.116.</P>
                    <HD SOURCE="HD3">1. Defining County</HD>
                    <P>Network adequacy is assessed at the county level, including county-equivalents, across all geographic areas in the United States and its territories. CMS uses the county level for purposes of determining the number and type of providers and facilities, based on time and distance, that an MA organization must contract with to ensure there is adequate access to Part A and B services for beneficiaries. The minimum number, specialty type, and time and distance requirements are codified at § 422.116(d) and (e). CMS's longstanding policy and interpretation of existing network adequacy regulations uses the term “county” to mean the areas designated by the Census Bureau as the primary political and administrative division of States. The Census Bureau also considers certain geographic areas as county-equivalents. County-equivalents include, but are not limited to, boroughs, certain designated cities, parishes, municipalities and the District of Columbia. CMS uses the Census Bureau's designation of counties and county-equivalents in establishing network adequacy standards to ensure consistency in the application of CMS' network adequacy requirements across the country.</P>
                    <P>For purposes of network adequacy, CMS is proposing to codify its longstanding policy of treating county equivalents the same as counties for network adequacy purposes by defining “county” in § 422.116. In § 422.116, we propose to create a new (a)(1) and redesignate the current (a)(1) through (a)(4) as (a)(2) through (a)(5). We further propose to define “county” in new (a)(1) as “the primary political and administrative division of most States and includes functionally equivalent divisions called “county equivalents” as recognized by the United States Census Bureau (for economic census purposes)”. Note that we have also proposed to modify the definition of service area in § 422.2 in C-E of this section to incorporate the proposed definition of “county” in § 422.116(a)(1).</P>
                    <HD SOURCE="HD3">2. Limiting Exception Request Rationales</HD>
                    <P>
                        Under its authority to set standards to implement and carry out the MA statute (in section 1856(b)(1) of the Act), CMS codified network adequacy standards at § 422.116 under the final rule, Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program, which appeared in the 
                        <E T="04">Federal Register</E>
                         on June 2, 2020 (85 FR 33796), hereinafter referred to as the June 2020 final rule. CMS has also adopted specific access requirements in §§ 422.100(b), 422.112, 422.113 and 422.114 to ensure that MA enrollees in various types of MA plans have access to covered services.
                    </P>
                    <P>In the June 2020 final rule, we codified regulations allowing MA organizations to submit exceptions to the network adequacy standards in §  422.116, including, the circumstances under which an MA organization may request an exception (§ 422.116(f)(1)) and the factors that CMS considers when evaluating an MA organization's request for an exception (§ 422.116(f)(2)), including examples of how it would be applied. We indicated that we would interpret the regulation such that the MA plan would have to contract with telehealth providers, mobile providers, or providers outside the time and distance standards, but accessible to most enrollees (or consistent with the local pattern of care), in order for the MA plan to request an exception by CMS (85 FR 33858).</P>
                    <P>
                        Currently, subregulatory guidance, the Medicare Advantage and Section 1876 Cost Plan Network Adequacy Guidance,
                        <SU>157</SU>
                        <FTREF/>
                         indicates that organizations may request exceptions utilizing the following valid rationales:
                    </P>
                    <FTNT>
                        <P>
                            <SU>157</SU>
                             
                            <E T="03">https://www.cms.gov/files/document/medicare-advantage-and-section-1876-cost-plan-network-adequacy-guidance12-12-2023.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        • Provider is no longer practicing (for example, deceased, retired).
                        <PRTPAGE P="99425"/>
                    </P>
                    <P>• Provider does not provide services at the office/facility address listed in the supply file.</P>
                    <P>• Provider does not provide services in the specialty type listed in the supply file, and for which this exception is being requested.</P>
                    <P>• Provider has opted out of Medicare.</P>
                    <P>• Provider does not contract with any organizations or contracts exclusively with another organization.</P>
                    <P>• Sanctioned provider on List of Excluded Individuals and Entities.</P>
                    <P>• Provider is at capacity and is not accepting new patients.</P>
                    <P>• Other: Use of Original Medicare telehealth providers, mobile providers, specific patterns of care in a community</P>
                    <P>We have explained in our Medicare Advantage and Section 1876 Cost Plan Network Adequacy Guidance, that while the time and distance standards vary by county and specialty type, and are generally attainable across the country, there are unique instances where a given county's supply of providers/facilities is such that an organization would not be able to meet the network adequacy criteria. The exceptions process allows MA organizations to provide evidence to CMS when the health care market landscape has changed or is not reflected in the current CMS network adequacy criteria. The organization must include conclusive evidence in its exception request that the CMS network adequacy criteria cannot be met because of changes to the availability of providers/facilities, resulting in insufficient supply.</P>
                    <P>Per § 422.116(f)(1)(i), an MA plan may request an exception to network adequacy criteria when both of the following occur: (A) certain providers or facilities listed in the Provider Supply file are not available for the MA plan to meet the network adequacy criteria for a given county and specialty type; and (B) the MA plan has contracted with other providers and facilities who are located beyond the limits in the time and distance criteria, but are available and accessible to most enrollees, consistent with the local pattern of care.</P>
                    <P>As part of CMS's evaluation of MA networks using § 422.116, MA organizations must first submit their Health Service Delivery (HSD) tables, containing all their network providers, to CMS. CMS processes and reviews the network submissions against our established regulatory standards through use of an automated system located in the Health Plan Management Systems (HPMS) network management module. This automated module within HPMS evaluates the networks based on CMS' current network time and distance standards. Once the evaluation is complete, CMS, through HPMS, provides MA organizations with an Automated Criteria Check (ACC) report. The ACC report contains CMS's determination of whether the standards in § 422.116 have been met or not met, and the report displays where the MA organization's specific county/specialty combinations, within the given service area, are passing and failing those standards. MA organizations may decide to submit an exception request for those parts of their network submission that were found to be failing our standards by using the exception request template found in the HPMS in accordance with CMS procedural instructions.</P>
                    <P>After submission, CMS evaluates exception requests based on the criteria noted in § 422.116(f)(2), including whether the current access to providers and facilities is different than that in the HSD reference and provider supply files for the year (see § 422.116(a)(4)(ii)), whether the organization demonstrates that the network access is consistent with or better than the original Medicare pattern of care, and whether approval is in the best interest of the beneficiaries. The exception request is then either approved or denied. Once the CMS exception request review is complete, the results of CMS's determination are uploaded into HPMS with an approval or denial status for MA organizations to view. If an exception request is denied, CMS will provide feedback with the exception disposition, including, as applicable, a sampling of the providers that CMS lists in the Provider Supply File that are available for the MA organization to contract with that would allow the organization to meet the time and distance standards for the specific county/specialty type. MA organizations must resubmit all previously approved exception requests whenever CMS requests an organization to upload its HSD tables to review an MA organization's network(s).</P>
                    <P>To continue to strengthen our network adequacy process and the rules related to exception requests to our network adequacy standards, CMS is proposing to codify our long-standing network adequacy exception request rationales, with one change. We propose to eliminate the rationale that the “provider does not contract with any organization or contracts exclusively with another organization” (meaning MA organization) as a basis for an exception. It is important for CMS to ensure consistent and equitable access to healthcare services for all Medicare Advantage enrollees. In removing this rationale, CMS aims to limit the reasons that an organization could be able to by-pass the established network adequacy criteria for a given specialty/county and provide greater incentives for MA organizations to establish contracts with providers that are located within our established time and distance standards.</P>
                    <P>Therefore, CMS is proposing to codify the following as valid rationales when an MA plan submits substantial and credible evidence, in the form and manner requested by CMS, to demonstrate that an exception request under §  422.116(f)(1)(i) should be considered:</P>
                    <P>• Provider is no longer practicing (for example, deceased, retired).</P>
                    <P>• Provider does not provide services at the office or facility address listed in the Provider Supply file in paragraph (a)(4)(ii) of this section.</P>
                    <P>• Provider does not provide services for the specialty type listed in the Provider Supply file in paragraph (a)(4)(ii) of this section.</P>
                    <P>• Provider has opted out of Medicare (in compliance with § 422.204(b)(4)).</P>
                    <P>• Provider is a sanctioned provider on the List of Excluded Individuals and Entities (in compliance with § 422.204); or provider is on the CMS preclusion list (in compliance with § 422.222);</P>
                    <P>• Provider is at capacity and is not accepting new patients.</P>
                    <P>One of the listed rationales may be used to explain the reason that an MA plan has failed to demonstrate that its network meets the minimum requirements of § 422.116(a) through (e) but MA organizations should provide CMS with as fulsome of an explanation as possible, including supporting documentation, regarding why an exception should be granted under the standards in § 422.116(f).</P>
                    <P>
                        Our current subregulatory guidance states that CMS considers certain exception rationales under an “other” category. Currently, the “other” category permits organizations to request an exception for “provider does not contract with any organization”, “the provider has the potential to cause beneficiary harm”, and “the provider is inappropriately credentialed.” CMS is proposing to eliminate the “other” category and eliminate the exception rationale of “provider does not contract with any organization,” as described above. CMS is also eliminating “provider has the potential to cause beneficiary harm” because this exception rationale is already covered under CMS' evaluation of any exception, which includes ensuring the exception is in the best interest of the beneficiary as noted in §  422.116(f)(2)(iii). Finally, CMS is retaining the last exception currently 
                        <PRTPAGE P="99426"/>
                        under “other” in guidance. This exception “the provider is not properly credentialed” is being incorporated under the proposed exception rationale of provider does not provide services for the specialty type listed in the Provider Supply file.
                    </P>
                    <P>Our current subregulatory guidance also describes as exception rationales factors such as use of Original Medicare telehealth providers, mobile providers, and specific patterns of care in a community. When CMS evaluates these exception rationales, we consider whether network access is consistent with or better than the Traditional Medicare pattern of care and whether approval of an exception is in the best interest of beneficiaries, under §  422.116(f)(2). These factors may be relevant to demonstrate that network access is consistent with or better than the Traditional Medicare pattern of care (§  422.116(f)(2)(ii)) or that approval of the exception is in the best interests of beneficiaries (§  422.116(f)(2)(iii)). Our guidance states that for organizations using Traditional Medicare telehealth providers, services must meet the requirements for “telehealth services” under section 1834(m) of the Act (for example, provider types, eligible originating sites, geography, and currently approved list of Medicare telehealth services), as well as the requirements for “communication technology-based services” not subject to the section 1834(m) limitations (brief communication technology-based service/virtual check-in, remote evaluation of pre-recorded patient information, and inter-professional internet consultation). The MA organization must demonstrate that it meets all applicable requirements. Our guidance also states that if an MA organization uses mobile providers (for example, mobile x-ray suppliers, orthotics and prosthetics mobile units), they must be qualified and furnish services through scheduled appointments. In addition, organizations requesting an exception using the “pattern of care” rationale described in § 422.116(f)(2)(ii) are required to providesubstantial and credible evidence that shows that the supply of providers/facilities is insufficient, as well as the reason that the MA organization does not contract with the available providers/facilities within the time and distance. The MA organization must show that the pattern of care in the area is unique and can demonstrate their contracted network is consistent with or better than the Original Medicare pattern of care. CMS will consider an MA organization's reason for not contracting with an available provider/facility if such a contract is not in the best interest of the beneficiaries in the applicable service area.</P>
                    <P>We note that, as we have indicated in our subregulatory guidance, CMS will not accept an organization's assertion that it cannot meet current CMS network adequacy criteria because of an “inability to contract,” meaning they could not successfully negotiate and establish a contract with a provider/facility. The non-interference provision at section 1854(a)(6)(B)(iii) of the Act states that the Secretary may not require any MA organization to contract with a particular hospital, physician, or other entity or individual to furnish items and services or require a particular price structure for payment under such a contract. As such, we are not assuming the role of arbitrator or judge regarding the bona fides of contract negotiations between an MA organization and available providers or facilities.</P>
                    <P>CMS notes that with these proposals we are codifying long-standing rules related to network adequacy exception request rationales, with one change to eliminate the rationale that a “provider does not contract with any organization or contracts exclusively with another organization”; therefore, we do not believe there is any additional paperwork burden to be considered. We welcome comment on these proposals, including the exhaustive list of exception request rationales proposed here, and whether there are additional rationales to consider that are in the best interest of beneficiaries. In addition, we are soliciting comment on potential unintended consequences from this proposal, including potential changes in the provider landscape, that could limit plan choice and/or availability in certain areas of the country.</P>
                    <HD SOURCE="HD3">3. Plan Benefit Package Level Reviews</HD>
                    <P>Finally, CMS is considering whether conducting network adequacy reviews at the MA plan benefit package level would provide greater assurances regarding the adequacy of an MA organization's network at the more discrete, plan level service area. Our current practice is to conduct network adequacy reviews of an MA organization's network at the contract level, by county type. Reviewing the plan-level network may result in a more accurate portrayal of an enrollee's experience since, for example, while an MA organization's contract may exceed CMS's minimum provider number requirements some providers and facilities that participate in a contract's network may not be available to enrollees in a particular plan under that contract. This situation could therefore result in some MA contracts satisfying current network adequacy requirements, but an individual plan not satisfying current network adequacy requirements, resulting in a beneficiary having access to an inadequate number of providers in a given plan. We note that the CMS network adequacy time and distance standards in § 422.116 would not change but would instead be applied at the plan benefit package level.</P>
                    <P>In the June 2020 final rule, CMS indicated in preamble that we conduct network adequacy reviews at the contract level, meaning we evaluate the adequacy of the MA organization's network across all the plan benefit packages within the contract for the plan types as defined in § 422.2 offered for that contract; we do not separately or singularly evaluate the network of a specific plan benefit package. We indicated at the time that conducting network reviews at the contract level allowed us to consider the broadest availability of contracted providers and facilities for an MA organization while also providing administrative efficiency for both MA organizations and CMS. While this is still our current practice, we are considering whether network evaluations at the plan benefit package level, for active contracts only, would be more appropriate to help CMS ensure more consistent and thorough oversight of MA provider networks.</P>
                    <P>
                        We point out that CMS already has the authority to conduct plan benefit package level reviews based on our current regulatory language. Section 422.116(a)(1)(i) requires that a network-based MA plan as described in § 422.2, but not including MSA plans, must demonstrate that it has an adequate contracted provider network that is sufficient to provide access to covered services in accordance with access standards. We solicit comment on this potential change in methodology and the impact on the counties served by MA organizations, including any considerations for rural counties, and whether there could be additional ways for CMS to strengthen our evaluation of an adequate network for MA organizations, specifically individual plans within a contract. We also solicit comment on the effort required by MA organizations to submit network data at the individual plan benefit package level. In addition, we solicit comment on whether SNP PBPs, as part of product offerings within a contract, offer limited network options that meet our standards or contract with the same provider network as non-SNP PBPs under the same contract. If CMS chooses 
                        <PRTPAGE P="99427"/>
                        to review active contracts at the plan benefit package level, we will indicate that change by updating the associated Paperwork Reduction Act (PRA) CMS-10636 forms, where we can seek public comment on proposed collections of information.
                    </P>
                    <HD SOURCE="HD2">O. Promoting Informed Choice—Expand Agent and Broker Requirements Regarding Medicare Savings Programs, Extra Help, and Medigap (§§  422.2274 and 423.2274)</HD>
                    <P>Sections 1852(c) and 1860D-4(a) of the Act require MA organizations and Part D sponsors to provide certain information to current MA and Part D plan (PDP) enrollees concerning MA plan and PDP benefits, coverage, plan rules, and other information that could inform potential enrollment changes. Additionally, section 1851(h)(4) requires MA organizations to conform to fair marketing standards in relation to marketing activities for MA plans, including standards that CMS may establish pursuant to section 1856. Likewise, section 1860D-1(b)(1)(B)(vi) of the Act extends these fair marketing standard requirements to Part D sponsors. These statutory provisions provide CMS the authority to implement regulatory requirements on MA organizations and Part D sponsors to ensure plan benefits and cost sharing information are discussed with beneficiaries to ensure they have an accurate picture of their enrollment options and help them make informed decisions when considering their health care coverage. We note that such requirements are also consistent with CMS's own statutory obligation, at section 1851(d) of the Act, to disseminate information to current and prospective Medicare beneficiaries on coverage options, including information comparing MA plans' premiums and cost sharing, to promote informed decision-making. Section 1860D-1(c) of the Act specifies corresponding dissemination requirements for current and prospective Part D eligible individuals regarding PDP comparisons.</P>
                    <P>As described in the Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly final rule (88 FR 22120), hereinafter referred to as the April 2023 final rule, CMS listened to a considerable number of marketing and enrollment audio calls between agents and brokers and beneficiaries (both current and prospective beneficiaries). Many of these calls indicated that agents and brokers failed to ask pertinent questions to help a beneficiary enroll in a plan that best fits their health care needs. During our review, we repeatedly heard instances in which agents only reviewed the beneficiary's health care providers and prescription drugs with them, which likely is not sufficient information for a beneficiary to consider when determining which health care option might best fit their needs. Other examples we heard included agents failing to ask the beneficiary if they had a preferred primary care provider or specialist, failing to confirm whether or not the preferred provider was in the plan's network, failing to discuss what pharmacies are in-network, as well as failing to ask if the beneficiary preferred copays or coinsurance, or preferred lower monthly premiums, or slightly higher monthly premiums as a trade-off for lower out of pocket costs for appointments, as an example. Before enrolling a beneficiary in an MA, MA-PD, or Part D plan, in addition to discussing topics like the beneficiary's health care providers, prescription drugs, copays, coinsurance, monthly premiums, and out of pocket costs prior to enrolling a beneficiary in an MA, MA-PD, or Part D plan, agents and brokers should also discuss costs of other healthcare services, plan benefits, and the beneficiary's specific health needs. Covering these topics with each beneficiary prior to their enrollment in a new plan, as discussed in the April 2023 final rule, helps ensure the beneficiary is enrolling into a plan that best meets their needs.</P>
                    <P>
                        Based on these considerations, CMS finalized a new paragraph (c)(12) of §§ 422.2274 and 423.2274 in the April 2023 final rule, which defined a CMS-developed list of topics that MA organizations and Part D sponsors must ensure agents and brokers of first tier, downstream, and related entities (FDRs) that represent the MA organizations and Part D sponsors discuss with beneficiaries during the marketing and sale of an MA or MA-PD plan or PDP and prior to their enrollment in a new plan. Since the finalization of §§ 422.2274(c)(12) and 423.2274(c)(12), as part of our monitoring and oversight of the MA program, we have listened to and evaluated marketing and enrollment audio calls to understand the effectiveness of the new rule's implementation. As part of our monitoring and review efforts, we proactively evaluate the issues we uncover and consider appropriate revisions to our rules that may help improve the beneficiary experience so they have a more accurate picture of their enrollment options as they pertain to making an MA or Part D enrollment decision and can make more informed health care choices. For instance, after reviewing audio calls, we noticed gaps in information provided to beneficiaries surrounding low-income subsidy (LIS) eligibility and Medicare Savings Programs (MSPs) that would be beneficial to make an informed enrollment choice. We have also received feedback during meetings with State Health Insurance Assistance Program (SHIP) counselors who expressed concerns with beneficiaries not fully understanding how enrollment into an MA or MA-PD plan can impact future availability of Medicare Supplement Insurance (Medigap) coverage. In addition, a Commonwealth Fund study involving agents and brokers found that beneficiaries who work with agents and brokers are often unaware of their guaranteed issue (GI) rights or the rules around underwriting with Medigap when switching from an MA plan to traditional Medicare, which can lead to significant confusion.
                        <SU>158</SU>
                        <FTREF/>
                         We believe expanding upon the CMS-developed lists provided at §§ 422.2274(c)(12) and 423.2274(c)(12) to require this additional information will help beneficiaries better understand how their health care choice will address their individual needs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>158</SU>
                             
                            <E T="03">https://www.commonwealthfund.org/publications/2023/feb/challenges-choosing-medicare-coverage-views-insurance-brokers-agents.</E>
                        </P>
                    </FTNT>
                    <P>Sections 422.2274(c)(12) and 423.2274(c)(12) require that MA organizations and Part D sponsors, as part of their oversight of their FDRs, ensure that agents and brokers operating on their behalf discuss a specified list of questions and topics with a potential beneficiary prior to completing an enrollment. In the following paragraphs, we propose adding three topics, LIS, MSP, and Medigap, to that list. In addition, we are proposing to update §§ 422.2274(c)(12) and 423.2274(c)(12) to also provide that agents and brokers pause to ask whether a beneficiary has any outstanding questions prior to an enrollment decision being made. And finally, we are proposing corresponding technical changes to §§ 422.2274(c)(12) and 423.2274(c)(12) to put the newly proposed and existing requirements into a more organized and reader-friendly format.</P>
                    <HD SOURCE="HD3">1. Low-Income Subsidy (LIS)</HD>
                    <P>
                        CMS regulations at §  423.773 define the requirements for full and partial LIS Part D eligible individuals in accordance with section 1860D-14 of the Act as amended by section 11404 of 
                        <PRTPAGE P="99428"/>
                        the Inflation Reduction Act of 2022 (IRA). This recent statutory change provided the full LIS for those who only qualified for the partial LIS prior to 2024, which means an increased number of beneficiaries are eligible to receive “Extra Help” paying their monthly premium, yearly deductible, and prescription drug cost sharing. In the April 2023 final rule, in accordance with the IRA of 2022, CMS amended §  423.773(b)(1) to require that, to be eligible for the full LIS for plan years beginning on or after January 1, 2024, an individual must have an income below 150 percent of the Federal poverty line (FPL). To coordinate with this change, CMS also amended §  423.773(d) to specify that the requirement that an individual have an income below 150 percent of the FPL to be eligible for the partial LIS applies only to plan years beginning before January 1, 2024, effectively sunsetting the partial LIS after 2023 and significantly increasing the number of beneficiaries who can get full help paying for their prescription drugs.
                    </P>
                    <P>
                        Since the new requirements at §  423.773 went into effect, as of January 1, 2024, LIS eligibility criteria have increased the number of beneficiaries who can get full extra help paying for their premium, deductible, and prescription drugs costs. We believe that agents and brokers have a responsibility to inform a beneficiary of the new LIS eligibility criteria prior to their enrollment in an MA, MA-PD or Part D plan because being LIS eligible may impact a beneficiary's premium, coinsurance, deductibles, and other costs. Therefore, we are proposing to modify §§  422.2274(c)(12) and 423.2274(c)(12) to include LIS eligibility criteria as an additional topic that agents and brokers must address before enrolling a beneficiary in an MA, MA-PD or Part D plan, so that all eligible beneficiaries can make fully informed enrollment decisions including decisions about applying to receive extra help in paying for this important coverage. Specifically, at §  422.2274(c)(12), we propose to add the phrase “low-income subsidy eligibility (that is, at a minimum, explaining the eligibility requirements as defined at § 423.773 and the effect on drug costs if eligible, and identifying resources where they can get more information on applying)” to the existing list of required topics, before the phrase “costs of health care services.” At § 423.2274(c)(12), we propose to add the phrase “low-income subsidy eligibility (that is, at a minimum, explaining the eligibility as defined at § 423.773 and the effect on drug costs if eligible, and providing resources to the beneficiary about where they can go for more information on applying)” to the existing list of required topics, before the term “premiums.” We believe that agents and brokers should provide this additional information since it may impact a beneficiary's enrollment decision. As part of this proposed requirement, agents and brokers would be required to identify resources to the beneficiary about where the beneficiary can obtain more information regarding their potential eligibility for LIS or get help applying for LIS. For example, agents and brokers could offer existing CMS links and resources that provide guidance on eligibility on LIS and how a beneficiary can apply for LIS.
                        <SU>159</SU>
                        <FTREF/>
                         This information may be an essential factor in a beneficiary's decision to enroll in an MA, MA-PD or Part D plan, or Medicare Savings Programs (MSP).
                    </P>
                    <FTNT>
                        <P>
                            <SU>159</SU>
                             
                            <E T="03">https://www.cms.gov/medicare/enrollment-renewal/part-d-plans/low-income-subsidy/eligibility-low-income-subsidy.</E>
                        </P>
                    </FTNT>
                    <P>
                        We also are proposing to add a requirement that agents and brokers review, prior to a beneficiary's enrollment in an MA, MA-PD, or Part D plan, existing resources for state programs, including MSPs, that can help with health care costs. MSPs are Medicaid eligibility groups through which states cover Medicare premiums and, in many cases, cost sharing for eligible beneficiaries. This proposed requirement to discuss resources for state programs is a relevant addition alongside the proposed LIS eligibility requirement because most LIS-eligible beneficiaries may find other information about additional help with health care costs useful for making an informed decision about their health care coverage and enrollment options. Most beneficiaries eligible for LIS are also eligible for MSPs. With this new requirement, we would not expect agents and brokers to provide all necessary details for a beneficiary to make a final decision about applying for help from a state program.
                        <SU>160</SU>
                        <FTREF/>
                         However, we would expect agents and brokers to explain that state programs that can help with premiums and cost sharing costs exist, and additionally expect agents and brokers would be equipped to offer contact information for the state as a resource for a beneficiary to receive more information about their options and eligibility for those states where the agent is licensed and appointed to sell, as required under §§ 422.2274(b)(1) and 423.2274(b)(1). We would encourage agents and brokers to use CMS-developed materials to communicate important information to beneficiaries about relevant state programs. For instance, the CMS MSP web page describes Federal limits for each MSP and contains a link to easily contact state representatives.
                        <SU>161</SU>
                        <FTREF/>
                         Specifically, we propose to create §§  422.2274(c)(12)(v) and 423.2274(c)(12)(iv) to add the phrase “resources for state programs, including Medicare Savings Programs,” to the existing list of required topics.
                    </P>
                    <FTNT>
                        <P>
                            <SU>160</SU>
                             See section 1144(c)(3) of the SSA. Under Federal law, when an individual applies for LIS benefits and consents, their information is transmitted to the state to initiate an application of the individual for MSP benefits.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>161</SU>
                             United States Centers for Medicare &amp; Medicaid Services, 
                            <E T="03">Medicare Savings Programs, https://www.medicare.gov/basics/costs/help/medicare-savings-programs.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Medicare Supplemental Insurance (Medigap)</HD>
                    <P>
                        In addition to LIS eligibility and resources for state programs, to further promote informed decision-making for beneficiaries, we are proposing that agents and brokers be required to discuss with beneficiaries the potential impact enrolling into a MA plan can have on Medigap Federal guaranteed issue rights. If a beneficiary chooses to enroll in Traditional Medicare with a Medigap plan during their Medigap Open Enrollment Period OEP) or in certain limited situations outside of their Medigap OEP, they have Medigap protections or Medigap Federal GI rights. In situations where the Medigap Federal GI rights apply, the Medigap insurance company must sell the beneficiary a Medigap policy, must cover all of the beneficiary's preexisting health conditions, and cannot charge more for a Medigap policy because of the beneficiary's past or present health problems.
                        <SU>162</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>162</SU>
                             See section 1882(s)(3)(A) of the SSA.
                        </P>
                    </FTNT>
                    <P>
                        Over the years, CMS has received feedback from congressional offices, SHIPs and Medicare beneficiary advocacy organizations from or on behalf of Medicare beneficiaries who have enrolled into an MA plan without understanding the impact doing so can have on selecting a Medigap plan in the future. For example, we have heard about beneficiaries who, based on personal preference, have decided to enroll into Traditional Medicare with a Medigap plan after having previously enrolled in an MA plan, only to find that they are unable to do so, or that the cost outside of the MA “trial right” periods, which are some of the situations where the Medigap Federal GI rights apply,
                        <SU>163</SU>
                        <FTREF/>
                         is not affordable. To 
                        <PRTPAGE P="99429"/>
                        better ensure that beneficiaries are equipped with pertinent information on the impact on their Medigap Federal GI rights when making an MA plan enrollment decision, at § 422.2274(c)(12)(vi), we are proposing to require than an agent or broker convey information regarding Medigap Federal GI rights to beneficiaries who are enrolling into an MA plan when first eligible for Medicare, or those who are dropping a Medigap plan to enroll into an MA plan for the first time. Specifically, at § 422.2274(c)(12)(vi)(A)(1), we are proposing to require that an agent or broker convey that the beneficiary generally has a 12-month period under Federal law in which they can disenroll from the MA plan and switch back to Traditional Medicare and purchase a Medigap plan with Medigap Federal GI rights.
                        <SU>164</SU>
                        <FTREF/>
                         For purposes of this discussion and proposal, we refer to both of these situations that trigger Medigap Federal GI rights as “MA `trial right' periods.” As noted previously, when seeking to purchase a Medigap plan in a situation where the Medigap Federal GI rights apply, the insurance company selling it must cover all preexisting health conditions and can't charge a beneficiary more for a Medigap policy because of past or present health problems. It is therefore important that beneficiaries have information about the impact on their Medigap Federal GI rights when making an MA plan enrollment decision.
                    </P>
                    <FTNT>
                        <P>
                            <SU>163</SU>
                             The MA “trial right” period and other Federal Medigap GI rights are described in CMS' Choosing 
                            <PRTPAGE/>
                            a Medigap Policy: A Guide to Health Insurance for People with Medicare. 
                            <E T="03">See</E>
                             section 3 of the Centers for Medicare &amp; Medicaid Services, 
                            <E T="03">Choosing a Medigap Policy: A Guide to Health Insurance for People with Medicare, https://www.medicare.gov/publications/02110-medigap-guide-health-insurance.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>164</SU>
                             See sections 1882(s)(3)(b)(v) and (vi) of the SSA. Under Federal law, this trial right period may be extended for up to 2 years in certain circumstances involving involuntary termination of the beneficiary's MA plan coverage within the first 12 months of enrollment. See section 1882(s)(3)(F) of the SSA.
                        </P>
                    </FTNT>
                    <P>
                        Under this proposal, at § 422.2274(c)(12)(vi)(A)(
                        <E T="03">2</E>
                        ), the agent or broker would also be required to explain that, in general, if a beneficiary enrolled in an MA plan decided to switch back to Traditional Medicare outside of their MA “trial right” period, they are not guaranteed the right under Federal law to purchase a Medigap plan and if they do, the insurance company can take all previous and preexisting health conditions into consideration, resulting in the beneficiary likely paying more. In addition, under this proposal, we would encourage agents and brokers to use and refer a beneficiary to beneficiary-focused CMS materials, like the annual Choosing a Medigap Policy: A Guide to Health Insurance for People with Medicare, which includes information on MA “trial right” periods and Federal Medigap GI rights.
                        <SU>165</SU>
                        <FTREF/>
                         We note that while this proposal focuses on the Medigap Federal GI rights for beneficiaries in their MA “trial right” periods, agents and brokers would be encouraged to also provide information on state laws regarding Medigap GI rights for those states where the agent or broker is licensed and appointed to sell, as proposed under § 422.2274(c)(12)(vi)(B), as states can, and many do, offer additional GI rights. We note that, unlike the first two proposed topics discussed (LIS and MSP), the proposed requirement for agents and brokers to discuss the Medigap Federal GI rights for beneficiaries in their MA “trial right” periods would only be applicable to the sale an MA or MA-PD plan and would not be applicable to PDP sales.
                    </P>
                    <FTNT>
                        <P>
                            <SU>165</SU>
                             Centers for Medicare &amp; Medicaid Services and National Association of Insurance Commissioners, 
                            <E T="03">Choosing a Medigap Policy: A Guide to Health Insurance for People with Medicare, https://www.medicare.gov/publications/02110-medigap-guide-health-insurance.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Pausing for Additional Questions</HD>
                    <P>
                        We are also proposing to add a requirement that agents and brokers pause to ask the beneficiary, prior to finalizing the enrollment, whether the beneficiary has any remaining questions related to the beneficiary's enrollment in a plan. During our review of audio calls between agents and brokers and beneficiaries, CMS has learned that agents and brokers do not always ask beneficiaries if they have any questions about the topics discussed or other related questions that may not have been mentioned. Agents and brokers are required to cover a number of different topics prior to enrolling a beneficiary into an MA, MA-PD or Part D plan. The required topics are designed to ensure the beneficiary is fully informed about the choice they are making. The breadth of information that is presented during enrollment appointments may be intimidating to a beneficiary, and CMS has observed indications of this in our review of audio calls. We noticed some beneficiaries were confused regarding whether their current coverage would be ending, which was not addressed by the agent prior to the enrollment being completed. In other calls, some beneficiaries appear to be confused about plan networks and if their provider is part of a plan's network. We observed that a beneficiary may not feel comfortable or empowered to ask questions of an agent and broker unprompted. Additionally, mirroring what we heard in our review of audio calls, a recent United States Senate Committee on Finance report found that beneficiaries were sometimes confused because they enrolled into a new plan but were unaware that their provider was not in the plan's network until they started using the new plan.
                        <SU>166</SU>
                        <FTREF/>
                         In addition, a Commonwealth Fund study reported that one significant complexity for beneficiaries when choosing a plan is that they “make decisions that result in trade-offs they are not likely to fully understand.” 
                        <SU>167</SU>
                        <FTREF/>
                         Therefore, we believe that requiring agents and brokers to pause to proactively ask beneficiaries about whether they have questions about the topics the agent and broker has discussed, or other questions related to enrollment in an MA, MA-PD or Part D plan will further promote informed decision-making among beneficiaries. We understand that many agents and brokers may do this already as a routine part of sales calls with beneficiaries. However, through our observations, we have seen enough instances where this does not happen effectively or at all, with a detrimental impact to the beneficiary who is then enrolled in a plan that does not best fit their health needs in part because they did not have a clear opportunity to ask questions, that we believe this proposed regulation is appropriate. Specifically, at § 422.2274(c)(12), we propose to delete the “and” that comes before “specific health care needs” and create § 422.2274(c)(12)(xi) to say, “conclude by pausing to ask if the beneficiary has any questions about the topics discussed in paragraph (c)(12) of this section or others, including those related to enrollment.” At § 423.2274(c)(12), we propose to delete the “and” that comes before “services and incentives” and create § 423.2274(c)(12)(vii) to say, “conclude by pausing to ask if the beneficiary has any questions about the topics discussed in paragraph (c)(12) of this section or others, including those related to enrollment.” Similar to the rationale described in the April 2023 
                        <PRTPAGE P="99430"/>
                        final rule regarding §§ 422.2274(c)(12) and 423.2274(c)(12), if agents and brokers are required to cover the topics described in this proposal with beneficiaries prior to their enrollment, we expect that beneficiaries will be more knowledgeable about their Medicare options as well as the MA, MA-PD or Part D plans that are available to them together with the associated costs, and thus better prepared to make an informed choice. Agents and brokers are uniquely positioned to help beneficiaries select and enroll in a Medicare option that best fits their health care needs. Given the complex nature of Traditional Medicare, and the Parts C and D programs, we believe our proposed additional topics to discuss with a beneficiary, together with the proposed requirement to pause to ask if the beneficiary has any additional questions is critical to ensuring beneficiaries make fully informed enrollment decisions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>166</SU>
                             United States Senate Committee on Finance, 
                            <E T="03">Deceptive Marketing Practice Flourish in Medicare Advantage,</E>
                             page 9. [
                            <E T="03">https://www.finance.senate.gov/imo/media/doc/Deceptive%20Marketing%20Practices%20Flourish%20in%20Medicare%20Advantage.pdf</E>
                            ] (November 2, 2022).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>167</SU>
                             Riaz Ali, Aimee Cicchiello, Morgan Hanger, Lesley Hellow, Ken Williams, Gretchen Jacobson, 
                            <E T="03">How Agents Influence Medicare Beneficiaries' Plan Choices,</E>
                             (Commonwealth Fund, [April 21, 2021]) [
                            <E T="03">https://www.commonwealthfund.org/publications/fund-reports/2021/apr/how-agents-influence-medicare-beneficiaries-plan-choices</E>
                            ] (August 21, 2024).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">4. Technical Changes</HD>
                    <P>We are also proposing technical changes to §§ 422.2274(c)(12) and 423.2274(c)(12) to put the newly proposed and existing requirements into a more organized and reader-friendly format. Specifically, we are proposing to create §§ 422.2274(c)(12)(i) through (iii) and (vii) through (x) and 423.2274(c)(12)(i) and (ii) and (vi) and (vii) to list the requirements individually instead of in paragraph form. We are then proposing to include those three new topics (LIS, MSP, Medigap), as discussed in this proposal, to be included as new §§ 422.2274(c)(12)(iv) through (vi), respectively. The two newly proposed topics (LIS, MSP) under § 423.2274(c)(12) will be included as new §§ 423.2274(c)(12)(iii) and 423.2274(c)(12)(iv), respectively. Finally, the newly proposed requirement that an agent pause to ask the beneficiary if they have any questions would be included as new paragraphs § 422.2274(c)(12)(xi) and 423.2274(c)(12)(vii).</P>
                    <P>In addition, we are also proposing a minor technical correction to § 422.2274(c)(12) to delete the redundant word “regarding” before “pharmacies.”</P>
                    <P>We expect these proposed changes to impose a negligible amount of additional information collection requirements (that is, reporting, recordkeeping, or third-party disclosure requirements) on impacted organizations in terms of the updating of their existing processes related to their oversight of FDRs to ensure agents and brokers communicate information about LIS, MSPs, and Medigap to beneficiaries and discuss the beneficiary's enrollment-related questions before they enroll in a new plan. Including these proposed requirements under §§ 422.2274(c)(12) and 423.2274(c)(12) requires four additional items for agents and brokers to cover, but they can be covered during calls or appointments they already have prior to a beneficiary's enrollment in an MA, MA-PD or Part D plan. We are not proposing that agents and brokers use standardized language to review LIS eligibility, resources for state programs, or Medigap, nor that they must schedule a separate appointment to meet this requirement. We do not expect these proposed requirements to require significant additional training for agents and brokers or MA organizations. Also, adding beneficiary questions as a required topic further clarifies the purpose of paragraph (c)(12), which is that FDRs that represent the MA organization must fully discuss a beneficiary's needs in a health plan prior to enrollment.</P>
                    <P>
                        Furthermore, we believe this burden does not need to be submitted to the Office of Management and Budget (OMB) based on the currently approved control number 0938-0753 (CMS-R-267), which states the following in relation to § 422.2274: “The time, effort, and financial resources necessary to comply with the following collection of information requirements would be incurred by persons during the normal course of their activities and, therefore, should be considered usual and customary business practices. Consequently, the information collection requirements and burden are exempt (5 CFR 1320.3(b)(2)) from the requirements of the PRA.” Consequently, there is no need for review by OMB under the authority of the PRA of 1995 (44 U.S.C. 3501 
                        <E T="03">et seq.</E>
                        ). In addition, this provision is not expected to have any economic impact on the Medicare Trust Fund.
                    </P>
                    <P>We welcome comment on our proposed amendments to §§ 422.2274(c)(12) and 423.2274(c)(12), and we thank commenters in advance for their feedback.</P>
                    <HD SOURCE="HD2">P. Format Medicare Advantage (MA) Organizations' Provider Directories for Medicare Plan Finder (§§ 422.111 and 422.2265)</HD>
                    <P>
                        CMS continues to take steps to improve the usability of Medicare Plan Finder, strengthen oversight of plan marketing materials, and require agents and programs share information intended to ensure enrollees are able to make informed choices about their Medicare, Medicare Advantage, and Part D coverage. Policymakers, MedPAC, and other researchers have raised concerns about the increase in the number of plans having a detrimental impact on choice and competition, leading to confusion and difficulty for beneficiaries as they compare plans and choose an option.
                        <E T="51">168 169 170 171</E>
                        <FTREF/>
                         Plans differ on multiple dimensions, including covered services, premiums, service-specific cost-sharing, and provider networks, and evidence shows that too much choice complexity, particularly on financial dimensions, hinders beneficiaries' ability choose a plan that best meets their needs.
                        <E T="51">172 173 174 175 176</E>
                        <FTREF/>
                         Moreover, even modest increases in the number of options can further impair consumer choice,
                        <SU>177</SU>
                        <FTREF/>
                         reduce enrollment,
                        <SU>178</SU>
                        <FTREF/>
                         and can lead to premium increases.
                        <SU>179</SU>
                        <FTREF/>
                         On 
                        <PRTPAGE P="99431"/>
                        the other hand, facilitating plan comparison shopping through reduced complexity can lead to improved plan selection and more effective competition. CMS continues to consider opportunities to support consumer choice as part of broader efforts to strengthen the MA program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>168</SU>
                             MedPAC (2023). “Report to Congress: Medicare and the Health Care Delivery System” June 2023.
                        </P>
                        <P>
                            <SU>169</SU>
                             Rollins, Eric (2023). “Standardized benefits in Medicare Advantage plans” MedPAC presentation, September 7, 2023. Downloaded from 
                            <E T="03">https://www.medpac.gov/document/standardized-benefits-in-medicare-advantage-plans/</E>
                             on September 11, 2024.
                        </P>
                        <P>
                            <SU>170</SU>
                             Lieberman, Steven M., Loren Adler, Erin Trish, Joseph Antos, John Bertko, Paul Ginsburg (2018). “A Proposal to Enhance Competition and Reform Bidding in the Medicare Advantage Program.”
                        </P>
                        <P>
                            <SU>171</SU>
                             Pearson, Joshua and Rayna Stoycheva (2023). “Medicare vs. Medicare Advantage: Trends and Challenges for Older Adults in Navigating Medicare Enrollment Decisions” Harkin Institute Report, October 2023, Number 23-2.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>172</SU>
                             Taylor, Erin Audrey, Katherine Grace Carman, Andrea Lopez, Ashley N. Muchow, Parisa Roshan, Christine Eibner (2016). “Consumer Decisionmaking in the Health Care Marketplace.” Rand Research Report.
                        </P>
                        <P>
                            <SU>173</SU>
                             Johnson. Eric, Ran Hassin, Tom Baker, Allison T. Bajger, Galen Treuer (2013). “Can Consumers Make Affordable Care Affordable? The Value of Choice Architecture.” 
                            <E T="03">PLoS ONE</E>
                             8(12): e81521.
                        </P>
                        <P>
                            <SU>174</SU>
                             Abaluck, Jason and Jonathan Gruber (2011). “Choice Inconsistencies among the Elderly: Evidence from Plan Choice in the Medicare Part D Program.” 
                            <E T="03">American Economic Review</E>
                             101 (June 2011): 1180-1210.
                        </P>
                        <P>
                            <SU>175</SU>
                             Kling, Jeffrey, Sendhil Mullainathan, Eldar Shafir, Lee Vermeulen, Marian Wrobel (2012). “Comparison Friction: Experimental Evidence from Medicare Drug Plans” 
                            <E T="03">The Quarterly Journal of Economics,</E>
                             Volume 127, Issue 1, February 2012, Pages 199-235.
                        </P>
                        <P>
                            <SU>176</SU>
                             Bhargava, S., Loewenstein, G. &amp; Sydnor, J. (2017). Choose to lose: Health plan choices from a menu with dominated options. Quarterly Journal of Economics, 132(3), 1319-1372.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>177</SU>
                             Bundorf, M. Kate, and Helena Szrek, “Choice Set Size and Decision Making: The Case of Medicare Part D Prescription Drug Plans,” 
                            <E T="03">Medical Decision Making,</E>
                             Vol. 30, No. 5, September-October 2010, pp. 582-593.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>178</SU>
                             McWilliams JM, Afendulis CC, McGuire TG, Landon BE (2011). Complex Medicare advantage choices may overwhelm seniors—especially those with impaired decision making. 
                            <E T="03">Health Affairs</E>
                             Sep;30(9):1786-94.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>179</SU>
                             Ericson, Keith (2014). “Consumer Inertia and Firm Pricing in the Medicare Part D Prescription 
                            <PRTPAGE/>
                            Drug Insurance Exchange.” 
                            <E T="03">American Economic Journal: Economic Policy,</E>
                             February 2014, 6(1): 38-64.
                        </P>
                    </FTNT>
                    <P>To reiterate, it is important that, when Medicare beneficiaries are exploring their options, they have the information they need to make the best choice for their needs. When deciding between Traditional Medicare and MA, one key factor is that CMS requires MA plans to have a provider network. Provider directories allow beneficiaries and their caregivers to weigh Medicare options and decide if a certain provider network meets their needs, such as to check if their existing physicians are in the network, what other contracted providers are available to deliver other medical care, amongst a myriad of other factors. As the landscape of MA has evolved, CMS has implemented rules, and made modifications to those rules, to ensure that people with Medicare and the trusted individuals they rely on to aid in their decision making, have the information necessary to make decisions about their Medicare options, including many of the required materials and disclaimers found under § 422.2267(e), as well as the requirements under § 422.2265(b) and (c) that certain content and materials are made available on the MA organization's website.</P>
                    <P>
                        We believe that additional regulatory changes are now required to allow the agency to ensure that CMS is leveraging technological methods to streamline the beneficiary experience so that beneficiaries have the information they need to make the best choice for their needs, including MA provider directories. CMS proposes to make changes that will allow MA provider directories to be viewable on Medicare Plan Finder (MPF) for the 2026 Annual Enrollment Period (AEP). In addition, to ensure the accuracy of the data being submitted, we propose to require MA organizations to attest to the accuracy of the provider directory data being submitted. In total, we believe these proposed changes will result in an advancement of informed beneficiary choice and transparency benefitting people with Medicare, while also promoting robust competition within the Medicare market, aligned with the President's July 2021 Executive Order on Promoting Competition in the American Economy.
                        <SU>180</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>180</SU>
                             
                            <E T="03">https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/.</E>
                        </P>
                    </FTNT>
                    <P>Section 1851(d)(1) of the Act states that the Secretary shall provide for activities to broadly disseminate information to current and prospective Medicare beneficiaries on MA plan coverage options to promote an active, informed selection among such options. Specifically, per section 1851(d)(2)(A)(ii) of the Act, at least 15 days before the beginning of each annual, coordinated election period, the Secretary shall provide MA-eligible individuals with a list identifying the MA plans that are (or will be) available to residents of the areas in which they reside, including certain information concerning such MA plans, presented in a comparative form. This information is described in section 1851(d)(4) of the Act and includes plan benefits, premiums, service area, quality and performance indicators, and supplemental benefits. Section 1851(d)(4)(A)(vii) of the Act, also sets forth that information comparing MA plan options must specifically include the extent to which an enrollee may select among in-network providers and the types of providers participating in the plan's network. In addition, section 1851(d)(7) of the Act provides that MA organizations shall provide CMS with such information about the MA organization and each MA plan that it offers, as may be required for the preparation of the information described in section 1851(d)(2)(A) of the Act.</P>
                    <P>Section 1852(d)(1) of the Act requires access to services and states that MA organizations offering an MA plan may select the providers from whom the benefits under the plan are provided if the MA organization complies with several conditions including access to appropriate providers (section 1852(d)(1)(D) of the Act). Regulations at § 422.116(a)(1) further clarify this obligation by providing network adequacy access requirements for MA plans. Specifically, network-based MA plans must demonstrate an adequate contracted provider network that is sufficient to provide access to covered services in accordance with access standards at section 1852(d)(1) of the Act. Additionally, MA organizations must attest that they have an adequate network for access and availability of a specific provider or facility type that CMS does not independently evaluate in a given year (§ 422.116(a)(1)(i)).</P>
                    <P>Section 1852(c)(1)(C) of the Act further requires MA plans to disclose the number, mix, and distribution of plan providers. Based on this statutory requirement, CMS has implemented regulations at § 422.111(b)(3)(i) that require MA plans disclose the number, mix, and distribution (addresses) of providers from whom enrollees may reasonably be expected to obtain services; each provider's cultural and linguistic capabilities, including languages (including American Sign Language) offered by the provider or a skilled medical interpreter at the provider's office. Together, these regulations establish the overarching requirements for the MA provider directory content.</P>
                    <P>The Interoperability and Patient Access final rule (85 FR 25633) became effective on June 30, 2020, and requires MA organizations, beginning on January 1, 2021, to make standardized information about their provider networks accessible through a Provider Directory Application Programming Interface (API) that conforms with CMS/HHS technical standards at § 422.119(c). The Interoperability and Patient Access final rule, also included in § 422.120 that the Provider Directory API must be accessible via a public-facing digital endpoint on the MA organization's website to ensure that this information is viewable and accessible to prospective and current enrollees as well as third-party application developers, who can create services to help patients find providers for care and treatment. Requirements at § 422.120 further specify that the MA plan's directory of contracted providers must be complete and accurate and include names, addresses, phone number, specialties and (as applicable for MA-PDs) the number of pharmacies in the network and mix of pharmacy types. MA organizations must ensure this information is updated within 30 calendar days of receiving provider directory information or updates. Provider Directory API technical standards were also modified for more specificity in the Interoperability and Patient Access final rule (89 FR 8974) which was effective on February 8, 2024.</P>
                    <P>
                        To comply with the previously referenced statutory and regulatory requirements, CMS has taken a two-prong approach. CMS implemented MPF as an online resource where current and prospective beneficiaries and their caregivers can explore their Medicare coverage options. On MPF, individuals can look for Medicare Advantage and Part D plans and make informed choices based on the 
                        <PRTPAGE P="99432"/>
                        information provided, such as plan benefits, premiums, deductibles, and star ratings to name a few. While CMS has implemented improvements to MPF over the years to incorporate more data, MPF does not currently include information on MA plans' contracted provider networks, such as the specific providers with which a plan contracts and from which an enrollee may receive health care services. In addition to creating MPF, CMS has implemented regulations that require each MA organization to disclose or otherwise make available certain required information, including hardcopy and electronic provider directory requirements under § 422.2267(e)(11), as well as a searchable online directory as required under § 422.2265(b)(4). Through these requirements, the provider directory information is made available to prospective and existing MA plan enrollees so they may view MA plans' in-network providers and other relevant information as required under § 422.111(b)(3)(i), such as the provider's specialty, location, and cultural and linguistic capabilities in the MA organization's online PDF or printable version (§ 422.2265(b)(3)). While this schema meets the statutory requirements using plan websites and MPF, in their current form to make enrollment decisions, is cumbersome. When prospective and current MA plan enrollees use provider directories and MPF today to help them make enrollment decisions, they must toggle between different MA plan websites and MPF to find and review the plans' provider directories to determine if the providers they currently see are in the various plans' networks, as well as review the information provided by MPF.
                    </P>
                    <P>In order to simplify and streamline the Medicare beneficiary experience when shopping for an MA plan, we are proposing to expand on the existing requirements applicable to MA organizations regarding their provider directories at a newly established § 422.111(m) to include a new provision to require MA organizations to submit or otherwise make available their plan provider directory data, that is the requirements found under § 422.111(b)(3)(i), available to CMS/HHS in a format, manner, and timeframe that CMS/HHS determines in order for the MA organization's provider directory data to be integrated online by CMS/HHS for display on MPF. In addition, we are proposing to include a requirement that MA organization update the provider directory data that is submitted or otherwise make available to CMS for this purpose within 30 days of receiving information from providers of a change, which mirrors the current standard for updating provider directory data found under § 422.2267(e)(11).</P>
                    <P>As previously noted, CMS has adopted regulations to implement requirements applicable to MA organizations for publicly accessible, accurate, and timely provider directory information through the Interoperability and Patient Access final rule. The provider directory requirements of the Interoperability and Patient Access final rule aide in establishing the groundwork for MA plan provider directory information to be readily accessible for MA organizations to submit to CMS for inclusion on MPF.</P>
                    <P>While publishing MA plan provider directory information on MPF is an important step, doing so in a way that ensures that beneficiaries are accessing accurate information, is a critical part of improving the Medicare beneficiary experience while using MPF. In order to enhance the accuracy of the information that will be published online by CMS/HHS on MPF, we are also proposing to add new subparagraph § 422.111(m)(4), which would require an MA organization attest that the information being submitted to CMS/HHS under this new requirement is accurate and consistent with data submitted to comply with CMS's MA network adequacy requirements at § 422.116(a)(1)(i). Given the significance of the choice that a beneficiary is making based on the information provided by the MA organization, it is critical to include this attestation requirement to ensure that the information being submitted by MA organizations is accurate and consistent with data submitted to comply with CMS's MA network adequacy criteria when it is submitted to CMS for the purpose of incorporating it into MPF. It is imperative that MA organizations' provider directory data remains consistent with the contracted provider network data submitted to CMS in order to provide sufficient access to covered services.</P>
                    <P>Furthermore, with regard to the attestation, because provider directory data changes so frequently, we understand that it may be impractical to require an attestation with each update. CMS is considering how to best balance the need for accountability of accurate data with the burden of the attestation. If this proposed rule is finalized, we will operationalize it by publishing a provider directory data submissions guide that would include operational guidance, which will explain how the attestation process will be implemented. We currently envision an attestation when the data is first made available to CMS, and then a yearly attestation thereafter. We ask commenters for feedback on the attestation process, including the intervals for the attestation.</P>
                    <P>
                        It is important to highlight that our proposals at new proposed § 422.111(m) would closely mirror the provider directory submission requirements at 45 CFR 156.230(c) for Qualified Health Plan (QHP) issuers on the federally facilitated Exchange (FFE). Currently, 45 CFR 156.230(c) requires issuers seeking certification to offer QHPs on the FFE to submit provider and formulary information in a format and manner and at times determined by HHS/CMS to HHS/CMS. This information is then used to feed 
                        <E T="03">HealthCare.gov</E>
                         and its Direct Enrollment partner websites to allow consumers to filter available QHPs based on the providers and drugs covered by those QHPs. As discussed previously, we are proposing to take a substantially similar approach for MA organizations. Given that many health insurance carriers offer both MA plans an QHPs, we believe this is a reasonable approach. We note that these proposals apply only to MA organizations (not Part D sponsors). Additionally, to operationalize the proposed Format Provider Directories for Medicare Plan Finder provision at § 422.111(m), we anticipate that 2025 plan year directory data will need to be made available online for testing purposes in the summer of 2025, and 2026 plan year data would need to be available online on October 1, 2026. We therefore propose an applicability date of July 1, 2025, for this provision.
                    </P>
                    <P>Additionally, this proposed rule fits within one of the important pillars of CMS's Strategic Plan to “Advance Equity” as it will help ensure that provider directory information, including a provider's cultural and linguistic capabilities (as CMS currently requires for MA provider directories), which are especially important to underserved communities, will be more readily available to people with Medicare when considering their Medicare choices. Ultimately, we believe our proposal would streamline the MPF online platform and promote informed beneficiary choice and market competition.</P>
                    <P>
                        We welcome comment on our proposed creation of § 422.111(m) and we thank commenters in advance for their feedback.
                        <PRTPAGE P="99433"/>
                    </P>
                    <HD SOURCE="HD2">Q. Promoting Informed Choice—Enhancing Review of Marketing &amp; Communications (§§ 422.2260 and 423.2260)</HD>
                    <P>Over the past decade and a half, as the MA and Part D marketing and communications landscape has changed and evolved, CMS has modified our regulations, including our marketing and communications standards, definitions, and submission requirements, to strengthen and enhance CMS' ability to monitor and oversee MA organizations and Part D sponsors, including the different modalities and distribution channels used by the MA and Part D industry to market and communicate information about product offerings. However, additional regulatory changes are required for CMS to keep pace with the ever-changing MA and Part D marketing and communications landscape.</P>
                    <P>Section 1851(h)(1) of the Act prohibits MA organizations from distributing marketing materials and application forms to (or for the use of) MA eligible individuals unless the document has been submitted to the Secretary at least 45 days (10 days for certain materials) prior to use and the document has not been disapproved. Additionally, section 1851(h)(4) requires MA organizations to conform to fair marketing standards in relation to marketing activities for MA plans, including standards that CMS may establish pursuant to section 1856. While the Act requires the submission and review of the marketing materials and applications, it does not provide a definition of what materials fall under the term marketing. Section 1856(b)(1) of the Act authorizes CMS to adopt, through rulemaking, standards that are consistent with, implement and carry out the Medicare Advantage statutory provisions. Section 1860D-1(b)(1)(B)(vi) of the Act directs that the Secretary use rules similar to and coordinated with the MA rules at section 1851(h) for approval of marketing material and application forms for Part D plan sponsors. Section 1860D-4(l) of the Act applies certain prohibitions under section 1851(h) to Part D sponsors in the same manner as such provisions apply to MA organizations.</P>
                    <P>With regard to 1876 cost plans, similar to section 1851(h) of the Act, section 1876(c)(3)(C) of the Act focuses on CMS's review and approval process for marketing materials rather than providing an exhaustive list of the types of materials that are considered marketing or promotional information and materials. Specifically, section 1876(c)(3)(C) of the Act states that no brochures, application forms, or other promotional or informational material may be distributed by cost plans to (or for the use of) individuals eligible to enroll with the organization under this section unless (i) at least 45 days before its distribution, the organization has submitted the material to the Secretary for review; and (ii) the Secretary has not disapproved the distribution of the material. Consistent with these statutory requirements, CMS reviews all such materials submitted by section 1876 cost plans and disapproves such materials upon determination that the material is materially inaccurate or misleading or otherwise makes a material misrepresentation. As part of the implementation of section 1876(c)(3)(C) of the Act, the regulation governing marketing activities for cost plans at 42 CFR 417.428(a) refers to the MA marketing procedures and requirements set forth in 42 CFR part 422, subpart V. Consequently, pursuant to CMS's authority in section 1876(c)(3)(C) to regulate section 1876 cost plan marketing, as well as the authority in section 1876(i)(3)(D) to specify new section 1876 contract terms, and as established in §  417.428, the proposed changes regarding MA and Part D marketing discussed in this section would also apply to section 1876 cost plans.</P>
                    <P>Under current regulations at §§ 422.2260 and 423.2260, communications “means activities and use of materials created or administered by the MA Organization or Part D sponsor or any downstream entity to provide information to current and prospective enrollees. Marketing is a subset of communications.” In regulations at §§ 422.2260 and 423.2260, marketing “means communications materials and activities that meet both the following standards for intent and content.” The intent standard, as defined under §§ 422.2260(1)(i) and 423.2260(1)(i), are communications materials and activities that intend, “as determined under paragraph (1)(ii) of this definition, to do any of the following” to “(A) draw a beneficiary's attention to a MA or Part D plan or plans, (B) influence a beneficiary's decision-making process when making a MA or Part D plan selection, (C) influence a beneficiary's decision to stay enrolled in a plan (that is, retention-based marketing).” In addition, §§ 422.2260(1)(ii) and 423.2260(1)(ii) state that, “In evaluating the intent of an activity or material, CMS will consider objective information including, but not limited to, the audience of the activity or material, other information communicated by the activity or material, timing, and other context of the activity or material and is not limited to the MA organization's or Part D sponsor's stated intent.”</P>
                    <P>The current content standards, as defined under §§ 422.2260(2) and 423.2260(2), provide that to meet the regulatory definition of marketing, communications materials and activities must also include or address content regarding (i) the plan's benefits, benefits structure, premiums or cost sharing, (ii) measuring or ranking standards (for example, Star Ratings or plan comparisons), or (iii), for MA plans only, rewards and incentives as defined under § 422.134(a). Communications that do not meet both of these regulatory intent and content standards do not fall within the current regulatory definition of marketing, and as a result, such materials are not subject to the specific submission, review, and distribution requirements for marketing materials provided in §§ 422.2261(b) and 423.2261(b).</P>
                    <P>
                        Prior to 2018, for over two decades, CMS had a broad regulatory definition of marketing at §§ 422.2260 and 423.2260 which stated that marketing materials include any informational materials targeted to Medicare beneficiaries which: promote the MA organization or Part D plan, or any MA plan offered by the MA organization, inform Medicare beneficiaries that they may enroll, or remain enrolled in, an MA or Part D plan offered by the MA or Part D organization, explain the benefits of enrollment in an MA or Part D plan, or rules that apply to enrollees, explain how Medicare services are covered under an MA or Part D plan, including conditions that apply to such coverage and may include, but are not limited to a broad list of materials defined in the regulation (from general audience materials such as general circulation brochures, newspapers, magazines, television, radio, billboards, yellow pages, or the internet to letters to members about contractual changes; changes in providers, premiums, benefits, plan procedures etc.). The marketing materials definition excluded certain ad hoc enrollee communications materials that were targeted to current enrollees, were customized or limited to a subset of enrollees or apply to a specific situation, did not include information about the plan's benefit structure; and applied to a specific situation or cover claims processing or other operational issues. This broad definition of marketing meant that MA organizations and Part D sponsors prospectively submitted to CMS for review the majority of beneficiary-facing materials they used.
                        <PRTPAGE P="99434"/>
                    </P>
                    <P>
                        In the “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program” final rule, published in the 
                        <E T="04">Federal Register</E>
                         on April 16, 2018, (83 FR 16440), hereinafter referred to as the “April 2018 final rule,” CMS included and defined “communication requirements” in the scope of part 422, subpart V, and part 423, subpart V, and amended §§ 422.2260 and 423.2260 to add a new definition of “marketing” alongside the original definition of “marketing materials.” With this change, marketing became a subset of communications and was defined as “activities and use of materials that meet the following: conducted by the MA organization or downstream entities, intended to draw a beneficiary's attention to a MA plan or plans, intended to influence a beneficiary's decision-making process when selecting a MA plan for enrollment or deciding to stay enrolled in a plan (that is, retention-based marketing).” CMS also revised the list of marketing materials excluded from submission to CMS and subject to review, to encompass all materials that “do not include information about the plan's benefit structure or cost sharing or do not include information about measuring or ranking standards (for example, star ratings).” 
                        <SU>181</SU>
                        <FTREF/>
                         In creating this delineation, only those communications that met the new definition of marketing and marketing materials were subject to more stringent requirements, including the need for submission to and review by CMS.
                    </P>
                    <FTNT>
                        <P>
                            <SU>181</SU>
                             83 FR 16627.
                        </P>
                    </FTNT>
                    <P>
                        To better focus CMS's review of such marketing materials, the April 2018 final rule aimed to narrow the scope of materials that fell under the marketing definition to those that had the highest likelihood of misleading or confusing beneficiaries into making an adverse enrollment decision. Such materials were subject to the more stringent marketing requirements, including submission requirements, hence allowing CMS the ability to focus on materials most likely to negatively impact a beneficiary's enrollment experience. In this April 2018 final rule, CMS reasoned that certain materials in existence at the time, that fell within the definition of marketing materials, “pose[d] little to no threat of a detrimental enrollment decision,” 
                        <SU>182</SU>
                        <FTREF/>
                         and would be unlikely to lead a beneficiary to request additional information or make an enrollment decision, such as those that did not mention certain types of content such as benefit structure, cost sharing, measuring or ranking standards.
                        <SU>183</SU>
                        <FTREF/>
                         Thus, CMS excluded from the new definition of marketing materials those materials that did not contain such information and aimed to focus the material submission requirements “on materials and activities that aim to influence enrollment decisions” 
                        <SU>184</SU>
                        <FTREF/>
                         and “that present the greatest likelihood for a negative beneficiary experience.” 
                        <SU>185</SU>
                        <FTREF/>
                         In addition, the April 2018 final rule said that materials that included certain content tied to the updated definition of marketing, such as information about the plan's benefit structure or cost sharing or information about measuring or ranking standards (for example, star ratings), but did not otherwise meet the marketing definition, would not be considered marketing.
                        <SU>186</SU>
                        <FTREF/>
                         As the final rule explained, “the goal of this proposal is to exclude member communications that convey important factual information that is not intended to influence the enrollee's decision to make a plan selection or to stay enrolled in their current plan.” 
                        <SU>187</SU>
                        <FTREF/>
                         An example of this in practice would be a postcard mailed to current enrollees letting them know that they can obtain a flu shot at zero cost sharing, which prior to the April 2018 final rule, would have been considered a marketing material and submitted to CMS for review even though it was likely to have had little impact on an enrollment decision.
                    </P>
                    <FTNT>
                        <P>
                            <SU>182</SU>
                             83 FR 16626.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>183</SU>
                             83 FR 16626-83 FR 16627.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>184</SU>
                             83 FR 16626.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>185</SU>
                             83 FR 16626.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>186</SU>
                             83 FR 16627.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>187</SU>
                             83 FR 16627.
                        </P>
                    </FTNT>
                    <P>
                        In September 2018, CMS further clarified these definitions, in section 20.1 of the Medicare Communications &amp; Marketing Guidelines (MCMG). The MCMG provided examples to distinguish between marketing and communications and explained that CMS would evaluate the intent and content of all marketing activities and materials to ensure they met the definition of marketing. The MCMG clarified that marketing activities and materials are distinguished from communications activities and materials based on these standards.
                        <SU>188</SU>
                        <FTREF/>
                         These standards were subsequently codified in the “Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly” final rule, published in the 
                        <E T="04">Federal Register</E>
                         on January 19, 2021 (86 FR 5864), hereinafter known as the “January 2021 final rule.” In addition to codifying the guidance from the MCMG, CMS further revised and streamlined the communications and marketing definitions and the intent and content standards. At that time, our objective in updating the intent and content standards of the marketing definition, and the stricter submission and review requirements associated with these new, revised standards, was to enable CMS to more effectively focus CMS's review on the materials that were most likely to impact a beneficiary's enrollment decision.
                    </P>
                    <FTNT>
                        <P>
                            <SU>188</SU>
                              
                            <E T="03">https://www.cms.gov/Medicare/Health-Plans/ManagedCareMarketing/Downloads/CY2019-Medicare-Communications-and-Marketing-Guidelines_Updated-090518.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        In 2023, CMS continued to pursue rulemaking to further strengthen beneficiary protections to address the growth of misleading advertising practices, including by those entities that circumvent our rules by carefully crafting advertisements with messaging that by design, allowed these entities to avoid our requirements for submission to and approval by CMS prior to their use in the marketplace. In the “Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly” final rule, which appeared in the 
                        <E T="04">Federal Register</E>
                         on April 12, 2023 (88 FR 22120), hereinafter referred to as the “April 2023 final rule,” CMS codified provisions that prohibit marketing ads from including the mention of benefits not available in a service area 
                        <SU>189</SU>
                        <FTREF/>
                         and requiring third-party marketing organizations (TPMOs) to state the number of organizations and plans they represent in the service area in which they are marketing.
                        <SU>190</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>189</SU>
                             88 FR 22240.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>190</SU>
                             88 FR 22253.
                        </P>
                    </FTNT>
                    <P>
                        Yet, even with these changes, CMS continues to see, through CMS monitoring efforts, marketing misrepresentation complaints from beneficiaries and outreach from stakeholders that we consider to be related to advertisements on television, mail, and the internet. For example, CMS has observed television ads that instill a sense of urgency combined with a narrative that leads the beneficiary to believe they are not receiving important benefits they are entitled to by touting the availability of information about Medicare options if the viewer calls a 
                        <PRTPAGE P="99435"/>
                        phone number. Yet, the information about Medicare options in such advertisements is described in such a broad, generic and non-specific manner that these advertisements are arguably considered communications rather than marketing under our current rules. These broad, generic and non-specific advertisements can potentially mislead and confuse beneficiaries. For example, advertisements positioned as an opportunity to review a beneficiary's options, or their current plan benefits or possible changes to their current plan, may pull potential enrollees into the “chain of enrollment,” even though the materials or the language used in the television advertisement are not considered to be marketing under our rules. Because these advertisements are so general and do not meet our current marketing definition, these are able to effectively circumvent CMS's more stringent marketing requirements under which the materials would be subject to CMS's review and approval prior to their use, or in the case of File and Use, as defined under §§ 422.2261(b)(3) and 423.2261(b)(3), not be used until 5 days following their submission.
                    </P>
                    <P>As stated above, CMS is concerned that the current narrow definition of marketing has created a loophole that has been used by MA organizations, Part D sponsors and their downstream entities and resulted in the proliferation of misleading and confusing marketing practices that currently fall outside our scope of review. Specifically, since the time these rules that narrowed the definition of marketing were finalized, CMS has observed a shifting landscape of misleading marketing practices in MA and Part D, including television, web-based and direct mail advertisements that clearly attempt to draw a beneficiary's attention to a plan or plans, or influence a beneficiary's enrollment decisions, such as by alluding to potential plan or benefit changes, or touting “new” benefits or non-specific “Medicare options.” A common factor for such ads is that they encourage a beneficiary to call a 1-800 number. As noted earlier, these ads, that do not mention or address any of the subjects listed in the content standard within CMS's marketing regulations in §§ 422.2260 and 423.2260, such as plan benefits or ranking standards, do not technically meet the definition of marketing because these advertising practices use generic messaging that do not mention specific benefits and therefore do not require submission to CMS. However, such materials still include a call to attention, as described in the “Advertisement (Ad)” definition at §§ 422.2260 and 423.2260, like calling a 1-800 number for more information. Moreover, the ads initiate an enrollment trajectory by setting beneficiary expectations that the beneficiary will call a number and be presented with Medicare choice options, which invariably means Medicare Advantage plan choices since the TPMO that receives the calls may only be selling a select number of MA plans, which can then lead to a beneficiary making a Medicare Advantage plan enrollment decision. CMS has reviewed marketing misrepresentation complaints and listened to agent sales calls where a beneficiary contacts a 1-800 number to learn more information from an advertisement, only to be led to an enrollment into a plan that does not best meet their health care needs, ultimately resulting in a complaint to CMS.</P>
                    <P>To further illustrate this type of communication ad, CMS has seen TPMO television ads which, without mentioning an MA plan by name, ask the viewer to call a toll-free number to find out whether the viewer's Medicare plans will be changing and whether that change might include potential rising costs or changes to the provider networks. The ad will list a 1-800 number and encourage the viewer to call to find out the answers to whether there have been any changes to their Medicare plan. Similarly, CMS has seen TPMO websites that appear and purport to be educational, providing information on what MA or Part D is and how it works, while not mentioning any particular benefits and thus, not falling into the narrower definition of marketing. Yet, the website will also include an opportunity to collect and share a beneficiary's information with a third-party, in order to market MA or Part D plans to the beneficiary which leads to a beneficiary providing their consent to be contacted and likely marketed to. Unlike advertisements that meet the definition of marketing, these more generic advertisements do not mention specific plans or benefits, yet through tactics that can be misleading or confusing, encourage a beneficiary to contact a 1-800 number where they unknowingly step into a chain of enrollment they were likely not expecting.</P>
                    <P>
                        Coinciding with these concerning trends, CMS has seen a sharp increase in beneficiary complaints of marketing misrepresentation since the issuance of the April 2018 final rule that made changes to and narrowed the marketing definition. These complaints corroborate the concerns with the marketing practices described in the previous paragraphs. Marketing misrepresentation complaints rose from approximately 9,000 complaints in 2018 to approximately 41,000 by 2021, a four-fold increase since 2018. While the volume of marketing misrepresentation complaints declined in 2022 to roughly 36,000, the number of complaints was still over three times greater, at approximately 32,000 in 2023, than in 2018.
                        <SU>191</SU>
                        <FTREF/>
                         As noted earlier, many of these complaints detail beneficiaries' negative enrollment experience after calling a 1-800 number based on an ad. In fact, through CMS monitoring efforts of agent sales beginning in 2022, CMS has reviewed a representative sample of over 400 agent sales calls and associated marketing misrepresentation complaints in the CTM. Of the calls CMS has reviewed to date, approximately 33% of the agent sales calls include beneficiaries mentioning that they saw an ad on television or received something in the mail which prompted them to call. Complaints by beneficiaries who called or were contacted by 1-800 numbers seen through an ad often detail the beneficiary having a negative enrollment experience and opting to change the enrollment that was transacted on the phone call. As examples, there are some beneficiary complaints where a beneficiary describes being unwittingly enrolled into a plan without their consent when they called for more information. Other beneficiaries describe receiving inaccurate information regarding the plan they were being switched into and later learning their providers were out of network. Yet, when CMS conducted further investigations into these ads, we found that many of the ads in question were not submitted to CMS as marketing materials, and generally would be considered to be communications that did not require submission to CMS under our narrower definition of marketing.
                    </P>
                    <FTNT>
                        <P>
                            <SU>191</SU>
                             Complaints Tracking Module (CTM) Marketing Misrepresentation Reports from 2018 to 2024.
                        </P>
                    </FTNT>
                    <P>
                        As previously mentioned, because the ads in question were not submitted to CMS, it hampers our ability to determine an ad's origin, and in the case of TPMO ads, what MA organizations or Part D sponsors are associated with the TPMO. Additionally, since these advertisements are not submitted to CMS, CMS is unable to review to confirm whether the advertisement contains any misleading information. CMS believes stronger oversight and collection of materials that can influence a beneficiary's decision making will ensure that CMS can better 
                        <PRTPAGE P="99436"/>
                        protect beneficiaries against misleading, inaccurate or confusing marketing tactics, in addition to expediting our ability to more quickly act on non-compliant ads associated with beneficiary complaints.
                    </P>
                    <P>When CMS created the content and intent standards beginning with the April 2018 final rule, we did not foresee advertisements that did not, as an example, contain a plan's benefits, benefits structure, premiums, or cost sharing, leading to negative enrollment experiences. At the time, the bulk of advertisements were being created by a single plan, rather than a TPMO representing multiple plans. As stated earlier, the statutory requirements under section 1851(h)(1) of the Act provide CMS with the authority to review and approve materials most likely to mislead or confuse beneficiaries and lead to a negative enrollment experience. However, since the April 2018 final rule, CMS has observed a shifting MA and Part D marketing landscape, which alongside growing marketing misrepresentation complaints and changing marketing trends and tactics, requires an updated marketing definition that can better target the materials that mislead or confuse beneficiaries into making an adverse enrollment decision. This includes advertisements which encourage a beneficiary to call to review their plan changes or gather information, and sets a trajectory that ultimately leads to beneficiaries being unwittingly enrolled in a new plan with negative consequences. To date, CMS continues to receive concerning complaints related to misleading and confusing advertisements and marketing tactics, which are resulting in negative beneficiary enrollment experience.</P>
                    <P>
                        To further emphasize the need to expand our oversight, in 2023, CMS disapproved roughly half of all television ads that were submitted by TPMOs to CMS for prospective review.
                        <SU>192</SU>
                        <FTREF/>
                         This begs the question, if this is true for materials that are being submitted to and reviewed by CMS under the current regulatory definition of marketing, what is the state of those materials that are not being submitted because of the limitations on the scope of our existing regulation? As noted earlier, CMS has received many complaints where a beneficiary calls a 1-800 number after viewing a TV ad and ends up being enrolled in a plan that results in adverse effects. According to a KFF report on the state of TV marketing activities, during the 2023 open enrollment period (10/1/2022 to 12/7/2022), English language Medicare ad airings totaled 643,852 with 86% or 556,068 of these television ads advertising MA plans.
                        <SU>193</SU>
                        <FTREF/>
                         The report cited that viewers of programs across the top 20 markets saw an average of between 4 to 6 ads per day, depending on the network affiliation, and regular viewers of specific TV programs could expect to see 6-8 ads per day.
                        <SU>194</SU>
                        <FTREF/>
                         It is clear from this report that beneficiaries are inundated with TV ads.
                    </P>
                    <FTNT>
                        <P>
                            <SU>192</SU>
                             HPMS Marketing Review Module Reports.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>193</SU>
                             Jeannie Fuglesten Biniek, Alex Cottrill, Nolan Sroczynski, Meredith Freed, Tricia Neuman, Breeze Floyd, Laura Baum, and Erika Franklin Fowler, 
                            <E T="03">How Health Insurers and Brokers Are Marketing Medicare,</E>
                             (KFF, [September 20, 2023]) [
                            <E T="03">https://www.kff.org/report-section/how-health-insurers-and-brokers-are-marketing-medicare-report/#flooded-with-ads</E>
                            ] (August 6th, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>194</SU>
                             
                            <E T="03">How Health Insurers and Brokers Are Marketing Medicare,</E>
                             (KFF, [September 20, 2023]) [
                            <E T="03">https://www.kff.org/report-section/how-health-insurers-and-brokers-are-marketing-medicare-report/#flooded-with-ads</E>
                            ] (August 6th, 2024).
                        </P>
                    </FTNT>
                    <P>As previously mentioned, when CMS has investigated TV ads based on complaints or concerns expressed by advocacy organizations, the ads could not be found in the HPMS marketing module, the system used to collect and review marketing materials. The takeaway from this investigative work is that a number of TV ads, intended to draw a beneficiary's attention to MA or Part D plans and to ultimately influence a beneficiary's decision-making process when making a MA or Part D plan selection, were not submitted to CMS by the creator and MA and Part D plans associated with these ads determined that the ads were not marketing as defined under §§ 422.2260 and 423.2260. CMS believes broader oversight of the ads beneficiaries are confronted with, even if the ads do not contain content on specific topics such as benefits, co-pays or star ratings, will provide additional protections against misleading marketing practices. In these proposals, CMS is seeking to expand oversight over the materials that plans, and their downstream entities, use in their marketing activities that intend to draw a beneficiary to a plan or influence a beneficiary's enrollment decisions. CMS expects that this approach, if finalized, would provide CMS with greater insight into the shifting landscape of MA and Part D advertising and the materials that are outside of the scope of the materials currently submitted to CMS for review.</P>
                    <P>
                        Similar trends were also reported by State oversight agencies, as detailed in a 2022 report from the United States Senate Committee of Finance titled 
                        <E T="03">Deceptive Marketing Practices Flourish in Medicare Advantage.</E>
                         The report shares data from State insurance commissioners and State Health Insurance Assistance Programs (SHIPs), with most of these entities reporting a similar increase in complaints from 2020 to 2021,
                        <SU>195</SU>
                        <FTREF/>
                         the same timeframe wherein CMS first reported that beneficiary complaints had doubled. In the report, which included data from 14 states, “ten states reported that mail advertisements were a source for complaints, nine states reported that robocalls and telemarketers were a source for complaints, and eight states reported that television advertisements were a source for complaints.” 
                        <SU>196</SU>
                        <FTREF/>
                         As one of many examples that illustrate the misleading marketing beneficiaries experience, states reported complaints about mailers that would appear to be official Medicare notices and “serve the explicitly misleading purpose of prompting beneficiaries to “initiate contact,” so that MA marketing prohibitions can be circumvented.” 
                        <SU>197</SU>
                        <FTREF/>
                         Based on these reports, alongside beneficiary complaints and CMS marketing oversight and review of agent sales calls, it appears that various entities, including TPMOs, have exploited the current content requirements of our marketing definition as a means of skirting CMS oversight, with detrimental effects for beneficiaries and the marketplace. CMS's existing regulations at §§ 422.2261(c)(2) and 423.2261(c)(2) provide that CMS may collect certain non-marketing communications materials. However, these mechanisms appear to be insufficient to provide appropriate oversight of MA and Part D marketing activities under the circumstances outlined above because without the requirement for these materials to be submitted, CMS is typically only able to address concerning materials of this nature after a complaint or concern has been received. In order to proactively monitor these materials and more efficiently review potentially misleading marketing materials before they are seen by beneficiaries, we believe that amending CMS's marketing regulations to allow 
                        <PRTPAGE P="99437"/>
                        for a more comprehensive review of the materials used by MA organizations, Part D sponsors, and their TPMOs, to market MA and Part D plans is appropriate to ensure beneficiaries are protected.
                    </P>
                    <FTNT>
                        <P>
                            <SU>195</SU>
                             United States Senate Committee of Finance, 
                            <E T="03">Deceptive Marketing Practices Flourish in Medicare Advantage,</E>
                             page 6. 
                            <E T="03">https://www.finance.senate.gov/imo/media/doc/Deceptive%20Marketing%20Practices%20Flourish%20in%20Medicare%20Advantage.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>196</SU>
                             
                            <E T="03">Deceptive Marketing Practices Flourish in Medicare Advantage, https://www.finance.senate.gov/imo/media/doc/Deceptive%20Marketing%20Practices%20Flourish%20in%20Medicare%20Advantage.pdf,</E>
                             page 11.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>197</SU>
                             
                            <E T="03">Deceptive Marketing Practices Flourish in Medicare Advantage, https://www.finance.senate.gov/imo/media/doc/Deceptive%20Marketing%20Practices%20Flourish%20in%20Medicare%20Advantage.pdf,</E>
                             page 11.
                        </P>
                    </FTNT>
                    <P>In light of the facts and circumstances set forth above, and in accordance with our statutory authority to review marketing materials and application forms, and to develop marketing standards under these sections, we are proposing to eliminate the content standard, as described in §§ 422.2260(2) and 423.2260(2) of the marketing definition, so that all communications materials and activities that meet the existing intent standard are considered marketing for purposes of CMS's MA and Part D marketing and communications regulations. This proposed change would improve CMS oversight over the full scope of materials and activities that are intended to draw a beneficiary's attention to one or more specific MA plans, Part D plans or other plans, influence a beneficiary's decision-making process when making a MA or Part D plan selection or influence a beneficiary's decision to stay enrolled in a plan. CMS expects that this broader level of oversight will further strengthen beneficiary protections against misleading or confusing marketing tactics so that CMS can better ensure that MA organizations, Part D sponsors and their downstream entities are not providing misleading, inaccurate, or confusing information to current or potential enrollees, or engaging in activities that could misrepresent the MA organization or Part D sponsor, in accordance with §§ 422.2262 and 423.2262. By expanding CMS's oversight of these materials, CMS can more readily review ads related to marketing misrepresentation complaints and quickly act on them, without concern over whether the material has been submitted. Additionally, submission of all materials that are intended to draw a beneficiary's attention to a plan or influence a beneficiary's decisions will also enable CMS to more readily address materials that are attempting evade CMS submission requirements while attempting to influence beneficiary enrollment decision making. Further, by ensuring these materials are included in CMS submission and review processes, CMS can more effectively, speedily and reliably detect problematic materials that seem to be designed to circumvent CMS's existing submission requirements and may negatively impact a beneficiary's enrollment experience.</P>
                    <P>
                        The MCMG provides a few scenarios to illustrate distinctions between communications or marketing materials under CMS's current regulatory definitions of those two terms. One scenario provided in the MCMG discussed a flyer that reads, “Swell Health is now offering Medicare Advantage coverage in Nowhere County. Call us at 1-800-BE-SWELL for more information.” As the MCMG explains, under the current marketing definition, this flyer would not be considered a marketing material because it does not include specific plan benefits, benefits structure, ranking standards or any other element of the current content standard within the marketing definition.
                        <SU>198</SU>
                        <FTREF/>
                         However, under the proposed update to the marketing definition, this material would be considered marketing because of its intent to draw a beneficiary's attention to a plan or plans. Alternatively, the MCMG discusses a scenario where a letter is sent to current enrollees reminding them to get their flu shot. In the letter, it says that “Swell Health enrollees can get their flu shot for $0 copay at a network pharmacy . . .” 
                        <SU>199</SU>
                        <FTREF/>
                         Under the current definition of marketing, this material is not considered marketing as it does not meet the intent standard to “draw a beneficiary's attention to a MA plan or plans, influence a beneficiary's decision-making process when making a MA plan selection, or influence a beneficiary's decision to stay enrolled in a plan (that is, retention-based marketing).” Instead, the material is solely intended to encourage current enrollees to get the flu shot. Therefore, under the proposed changes to the marketing definition, this material would remain a communications material. If the plan were to be advertising this, say through a flyer, this would change the intent and hence be considered a marketing material as the intent would be to draw a beneficiary's attention to an MA plan through advertising their access to certain benefits. However, a material that is solely explaining benefits to a current enrollee for educational purposes would not be considered marketing under our proposed definition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>198</SU>
                             
                            <E T="03">https://www.cms.gov/files/document/medicare-communications-marketing-guidelines-2-9-2022.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>199</SU>
                             
                            <E T="03">https://www.cms.gov/files/document/medicare-communications-marketing-guidelines-2-9-2022.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        In the April 2018 final rule, when updating the marketing and communications definitions, we finalized “an exclusion from marketing materials that provides that unless CMS provides otherwise, materials required under §§ 422.111 and 423.128 are not marketing materials.” 
                        <SU>200</SU>
                        <FTREF/>
                         While CMS is proposing to expand the materials defined as marketing, CMS intends to retain the material designations for required materials listed under §§ 422.2267(e) and 423.2267(e) and continue excluding those materials required under §§ 422.111 and 423.128, that are defined as communications, from requirements to submit for CMS review, unless otherwise noted in our regulation. Where relevant, all required materials listed under §§ 422.2267(e) and 423.2267(e), CMS required materials and content, have been defined as either marketing or communications. Since these materials are required, CMS has a clear understanding of the intent behind each material and whether it should be designated as communications or marketing. Therefore, we are also proposing to reference in the marketing definition the exception for required materials specified in §§ 422.2267(e) and 423.2267(e), which will maintain the material designation as provided by CMS. Those materials that are currently identified as communications will continue to be defined as communications and will continue to follow the same submission and review process as prior to this proposed rule. As an example, in §§ 422.2267(e)(4) and 423.2267(e)(4), the Pre-Enrollment checklist (PECL) is defined as a standardized communications material and is not currently required to be submitted to CMS for review. CMS wants to make it clear that even with the proposed changes to the marketing definition in this rule, the PECL would continue to be considered a communications material and not be required to be submitted to CMS for review. Separately, there are certain communications materials that CMS indicates in §§ 422.2267(e) and 423.2267(e) as required to be submitted for review (such as the Evidence of Coverage). This proposed rule will not include any changes to this process or to the non-marketing communications materials that are required to be submitted for review.
                    </P>
                    <FTNT>
                        <P>
                            <SU>200</SU>
                             83 FR 16629.
                        </P>
                    </FTNT>
                    <P>
                        We are proposing conforming edits to the definition of “Advertisement (Ad)” in §§ 422.2260 and 423.2260 to align with the proposed updates to the definition of marketing. Specifically, we are proposing to remove the second sentence from the advertisement definition, as the content standard will be eliminated from the marketing definition. Advertisements, as with all other materials and activities, will be subject to the considerations set forth in 
                        <PRTPAGE P="99438"/>
                        the proposed revised definition of marketing. With that said, considering the nature of advertisements pertaining to MA and Part D, CMS believes that most, if not all, advertisements pertaining to MA and Part D created or administered by an MA organization or Part D sponsor or any downstream entity operating on their behalf, will fall under the proposed updated marketing definition. However, even though these materials will now need to be submitted to CMS, the overall burden will be tempered by the fact that we anticipate the majority of them will be accepted as File and Use per §§ 422.2261(b)(3) and 423.2261(b)(3) where plans may distribute or make available certain types of marketing materials, designated by CMS based on the material's content, audience, and intended use, as they apply to potential risk to the beneficiary, 5 days following the submission. Additionally, we are proposing to consolidate the remaining definition of marketing to exclude extraneous numbering, which is no longer needed, as a result of the elimination of the content standard. Under §§ 422.2260 and 423.2260, we will consolidate the remaining portion of the definition currently under sections (1)(i) and (1)(ii) to simply be a two-sentence definition in line with the rest of this section.
                    </P>
                    <P>Finally, to combat any ambiguity with the intent standard of the marketing definition, we emphasize that in evaluating the intent of an activity or material, CMS may look beyond and broadly consider the MA organization's or Part D sponsor's “stated intent,” as described under current §§ 422.2260(1)(ii) and 423.2260(1)(ii), which will be consolidated through the proposed update to the marketing definition. This means that, under this proposed rule, the activities or materials of an MA organization or Part D sponsor may meet the regulatory definition of marketing even if it is not immediately apparent to the recipient of such materials or activities that they are intended to be influencing a beneficiary's decision-making process when making a plan selection, influencing a beneficiary's decision to stay enrolled in a plan or drawing a beneficiary's attention to a plan or plans. In evaluating such activities and materials, CMS will continue to consider the corollary result of any call to attention that aims to “draw a beneficiary's attention to a MA or Part D plan or plans, influence a beneficiary's decision-making process when making a MA or Part D plan selection, or influence a beneficiary's decision to stay enrolled in a plan (that is, retention-based marketing).” As an example, if a television advertisement says, “Questions about Medicare, call 1-800-LEARN-MORE,” and the call results in MA or Part D plans being discussed as an option, the advertisement would fall under §§ 422.2260 and 423.2260 and be considered marketing under this proposed rule because the intent of the advertisement is ultimately to draw a beneficiary's attention to an MA or Part D plan or to encourage a beneficiary to call the number and speak to someone about enrollment and plan choice options.</P>
                    <P>In summary, this proposal would enhance CMS's oversight of the marketing and communications materials and activities most likely to influence a beneficiary's enrollment decision. CMS believes that the content standard within the marketing definition is limiting CMS's ability to review and target materials that are negatively influencing a beneficiary's enrollment experience. By removing the content standard from the marketing definition at §§ 422.2260 and 423.2260, CMS can better ensure that communications activities and materials that are intended to “draw a beneficiary's attention to a MA plan or plans or Part D plans, influence a beneficiary's decision-making process when making a MA plan or Part D plan selection, or influence a beneficiary's decision to stay enrolled in a plan (that is, retention-based marketing)” will fall under the definition of marketing, and that materials are submitted to CMS and subject to review under §§ 422.2261 and 423.2261. Our goal is to ensure that beneficiaries are protected from misleading marketing so that they receive the best information to enroll in a plan that best meets their health care needs. We solicit comments on our proposed amendments to update the marketing definition at §§ 422.2260 and 423.2260, and we thank commenters in advance for their feedback. We are also soliciting specific comment on the potential or alternative financial impacts of this proposal.</P>
                    <HD SOURCE="HD2">R. Timely Submission Requirements for Prescription Drug Event (PDE) Records (§ 423.325)</HD>
                    <P>
                        CMS requires that Part D sponsors submit certain prescription drug claims information to CMS for specified Medicare Part D-related purposes as described in the Social Security Act (the Act). In accordance with the authority under sections 1860D-15(c)(1)(C), 1860D-15(d)(2) and 1860D-15(f) of the Act, CMS conditions Medicare Part D program payments to Medicare Part D plans upon the disclosure and provision of information needed to carry out payment. In addition, section 1860D-15(f)(2)(A) of the Act allows CMS to utilize information collected under section 1860D-15(f) of the Act for the purposes of, and to the extent necessary in, conducting oversight, evaluation, and enforcement under Title XVIII of the Act and carrying out section 1860D-15 of the Act or the Medicare Drug Price Negotiation Program (“Negotiation Program”) under Part E of Title XI of the Act. Under sections 1860D-14A(c)(1)(C) and 1860D-14C(c)(3) of the Act, CMS collects information from Part D sponsors that allows for discounts under the Coverage Gap Discount Program and Manufacturer Discount Program, respectively, to be provided to applicable beneficiaries for applicable drugs. Part D sponsors submit this prescription drug claims information to CMS on prescription drug event (PDE) records through the CMS Drug Data Processing System (DDPS).
                        <SU>201</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>201</SU>
                             OMB 0938-0982, CMS-10174, expiration February 28, 2025 (available at 
                            <E T="03">https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=202403-0938-002</E>
                            ).
                        </P>
                    </FTNT>
                    <P>
                        A PDE record is data summarizing the final adjudication of a Part D dispensing event that is reported to CMS by the Part D sponsor using a CMS-defined file layout.
                        <SU>202</SU>
                        <FTREF/>
                         CMS requires that PDE records are accurate, complete, and truthful since they are used for the purposes of obtaining Federal reimbursement.
                        <SU>203</SU>
                        <FTREF/>
                         These records are critical not only for accurate payment, but also for a wide range of sponsor compliance assessment activities, and other Part D program integrity audits. To that end, CMS performs checks (or edits) on the PDE data to validate and help ensure its accuracy.
                        <SU>204</SU>
                        <FTREF/>
                         This process results in the PDE records being accepted or rejected by CMS. Accepted PDE records may be subsequently adjusted or deleted by the Part D sponsor by submitting adjustment PDE records or deletion PDE records to CMS.
                        <SU>205</SU>
                        <FTREF/>
                         Rejected PDE records must be reviewed, resolved, and, if appropriate, 
                        <PRTPAGE P="99439"/>
                        resubmitted by the plan to CMS. The resubmitted PDE record goes through the same editing process and results in CMS accepting or rejecting the resubmitted PDE record.
                    </P>
                    <FTNT>
                        <P>
                            <SU>202</SU>
                             The PDE file layouts are available at 
                            <E T="03">https://www.csscoperations.com/internet/csscw3.nsf/DID/M7XCJKG0JI.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>203</SU>
                             42 CFR 423.505(k)(3).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>204</SU>
                             For PDE edits, see generally, DDPS Edit Lookup, available at 
                            <E T="03">https://www.csscoperations.com/internet/csscw3.nsf/DIDC/FGSMOX8LWK~Prescription%20Drug%20Program%20(Part%20D)~References</E>
                             (click Download).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>205</SU>
                             For additional information and examples that result in adjustment and deletion PDE records, see HPMS memorandum, PDE Guidance for Post Point-of-Sale Claim Adjustments, July 3, 2013, available at 
                            <E T="03">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/post%20pos%20adjustments_247.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        CMS uses accepted PDE records in the Part D payment reconciliation described at § 423.336 and 423.343(c) and (d), reopenings of Part D payment reconciliations described at § 423.346, the Coverage Gap Discount Program invoicing process described generally at § 423.2315, and the Manufacturer Discount Program invoicing process.
                        <SU>206</SU>
                        <FTREF/>
                         PDE records for selected drugs (as described at section 1192(c) of the Act) will also be used to administer the Negotiation Program.
                        <E T="51">207 208</E>
                        <FTREF/>
                         In order for CMS to make payments, conduct oversight, administer the various programs under Medicare Part D and the Negotiation Program, as well as perform other statutory obligations, the PDE records must be received from Part D sponsors in a timely manner. Part D sponsors that do not submit PDE data in a timely manner (as explained in the following Background and Requirements sections) may be determined to be out of compliance consistent with § 423.505(n)(1)(i) and may be subject to compliance actions described at § 423.505(n)(3).
                    </P>
                    <FTNT>
                        <P>
                            <SU>206</SU>
                             HPMS memorandum, Medicare Part D Manufacturer Discount Program Final Guidance, November 17, 2023 (available at 
                            <E T="03">https://www.cms.gov/files/document/manufacturer-discount-program-final-guidance.pdf</E>
                            ).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>207</SU>
                             Medicare Drug Price Negotiation Program: Revised Guidance, Implementation of Sections 1191—1198 of the Social Security Act for Initial Price Applicability Year 2026 
                            <E T="03">https://www.cms.gov/files/document/revised-medicare-drug-price-negotiation-program-guidance-june-2023.pdf.</E>
                        </P>
                        <P>
                            <SU>208</SU>
                             Medicare Drug Price Negotiation Program: Final Guidance, Implementation of Sections 1191—1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027 
                            <E T="03">https://www.cms.gov/files/document/medicare-drug-price-negotiation-final-guidance-ipay-2027-and-manufacturer-effectuation-mfp-2026-2027.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        In this rule, we propose to codify the general PDE submission timeliness guidance that currently applies and that addresses three types of PDE submissions: initial PDE records submitted after a pharmacy claim is received by the Part D sponsor (hereinafter referred to as “initial PDE records”), adjustment and deletion PDE records that update previously submitted records that have been accepted by CMS, and records to resolve PDE records that were rejected by CMS.
                        <SU>209</SU>
                        <FTREF/>
                         Further, we propose to codify a specific PDE submission timeliness requirement for initial PDE records when those PDE records are for selected drugs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>209</SU>
                             HPMS memorandum, Revision to Previous Guidance Titled “Timely Submission of Prescription Drug Event (PDE) Records and Resolution of Rejected PDEs”, October 6, 2011, available at 
                            <E T="03">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/hpms_memo_pde_timeliness_clarification_240.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. Background—General PDE Submission Timeliness</HD>
                    <P>CMS has always required that Part D sponsors submit their PDE data to CMS in a timely manner. Timely PDE submissions assist in the effective quality review of PDE data prior to CMS using the data in payment reconciliations and invoicing to manufacturers for the Coverage Gap Discount Program and Manufacturer Discount Program (hereinafter referred to collectively as the discount programs). We conduct analysis and validation of PDE data on an ongoing basis and identify data quality issues for Part D sponsors' review and action. This pre-reconciliation data quality review initiative promotes accuracy in the plan-reported financial data used in the Part D payment reconciliation and the invoice and reconciliation processes for the discount programs.</P>
                    <P>
                        Accordingly, in 2011, we released guidance on the timely submission of PDE records. On May 16, 2011, CMS released a memorandum “Timely Submission of Prescription Drug Event (PDE) Records and Resolution of Rejected PDEs.” 
                        <SU>210</SU>
                        <FTREF/>
                         The guidance described the PDE submission timeframes for initial PDE records, adjustment and deletion records, and records to resolve PDE records that CMS rejected through the PDE editing process. After consideration of industry comments, CMS modified the PDE submission timeframes and released revised PDE submission timeliness guidance on October 6, 2011.
                        <SU>211</SU>
                        <FTREF/>
                         As described in that guidance, initial PDE records are due within 30 days following the date the claim is received by the Part D sponsor or the date of service, whichever is greater. Adjustment and deletion PDE records are due within 90 days following discovery of the issue requiring a change to the PDE. Resolution of rejected PDE records are due within 90 days following the receipt of rejected record status from CMS. We propose to codify PDE submission timeframes similar to those timeframes described in the October 2011 guidance and refer to those timeframes as the 
                        <E T="03">General PDE Submission Timeliness Requirements.</E>
                    </P>
                    <FTNT>
                        <P>
                            <SU>210</SU>
                             HPMS memorandum, Timely Submission of Prescription Drug Event (PDE) Records and Resolution of Rejected PDEs, May 16, 2011, available at 
                            <E T="03">https://www.cms.gov/httpseditcmsgovresearch-statistics-data-and-systemscomputer-data-and-systemshpmshpms-memos-archive/hpms-memo-qtr1-4.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>211</SU>
                             HPMS memorandum, Revision to Previous Guidance Titled “Timely Submission of Prescription Drug Event (PDE) Records and Resolution of Rejected PDEs”, October 6, 2011, available at 
                            <E T="03">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/hpms_memo_pde_timeliness_clarification_240.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Background—Selected Drugs PDE Submission Timeliness</HD>
                    <P>
                        On August 16, 2022, the Inflation Reduction Act of 2022 (IRA) (Pub. L. 117-169) was signed into law. It established the Negotiation Program to negotiate maximum fair prices (MFPs) for certain high expenditure, single source drugs and biological products (
                        <E T="03">i.e.,</E>
                         selected drugs). The requirements for this program are described in sections 1191 through 1198 of the Act, as added by sections 11001 and 11002 of the IRA.
                    </P>
                    <P>
                        Under section 1193(a) of the Act, participating manufacturers must not only provide access to the MFP for a selected drug to MFP-eligible individuals (as defined in section 1191(c)(2) of the Act), but they must also provide access to the MFP to pharmacies, mail order services, and other dispensing entities with respect to such MFP-eligible individuals who are dispensed the selected drug during a price applicability period (as defined in section 1191(b)(2) of the Act). This distinguishes the Negotiation Program from Part D programs such as the Coverage Gap Discount Program and the Manufacturer Discount Program where there is no such statutory requirement for the manufacturer to provide a specified price to a pharmacy or other dispensing entity. CMS stated in section 40.4 of the Medicare Drug Price Negotiation Program: Final Guidance, Implementation of Section 1191—1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027 (hereinafter referred to as the final guidance) that a Primary Manufacturer (as defined in section 40 of the final guidance) must provide access to the MFP in one of two ways: (1) prospectively ensuring that the price paid by the dispensing entity when acquiring the drug is no greater than the MFP; or (2) retrospectively providing reimbursement for the difference between the dispensing entity's acquisition cost and the MFP.
                        <SU>212</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>212</SU>
                             Medicare Drug Price Negotiation Program: Final Guidance, Implementation of Sections 1191—1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027 
                            <E T="03">
                                https://www.cms.gov/files/document/
                                <PRTPAGE/>
                                medicare-drug-price-negotiation-final-guidance-ipay-2027-and-manufacturer-effectuation-mfp-2026-2027.pdf.
                            </E>
                        </P>
                    </FTNT>
                    <PRTPAGE P="99440"/>
                    <P>
                        To help operationalize dispensing entity access to the MFP, in section 40.4 of the final guidance, CMS stated it will engage with a Medicare Transaction Facilitator (MTF) to facilitate the exchange of data and payment between Primary Manufacturers and dispensing entities and to support the verification that the selected drug was dispensed to an MFP-eligible individual. The MTF will use the PDE records submitted by Part D sponsors to CMS through DDPS to verify that the selected drug was dispensed to an MFP-eligible individual. Additionally, the MTF will furnish Primary Manufacturers with certain claim-level data elements, including from PDE records, confirming that a selected drug was dispensed to an MFP-eligible individual and identifying which dispensing entity dispensed the selected drug to the MFP-eligible individual. In the final guidance, unless the dispensing entity's acquisition cost for the selected drug is equal to or less than the MFP, or, as detailed in section 40.4.5 of the final guidance, the Primary Manufacturer establishes that section 1193(d)(1) of the Act (related to 340B discounts) applies, CMS requires that the Primary Manufacturer transmit payment of an amount that provides access to the MFP within 14 calendar days of when the MTF sends the claim-level data elements that verify the selected drug was dispensed to an MFP-eligible individual to the Primary Manufacturer (“14-day prompt MFP payment window”). CMS notes that the 14-day prompt MFP payment window aligns with the timing requirement in the longstanding prompt pay rules in Part D for plan sponsors.
                        <SU>213</SU>
                        <FTREF/>
                         However, dispensing entities should be aware that they may not receive payment from a Part D plan sponsor for the Part D claim on the same date that the Primary Manufacturer provides a retrospective MFP refund to the dispensing entity. Due to operational differences between the Part D program and the Negotiation Program, the respective prompt payment windows for a particular dispensed prescription may start on different dates for the Part D sponsor and the Primary Manufacturer.
                    </P>
                    <FTNT>
                        <P>
                            <SU>213</SU>
                             See 42 CFR 423.520, Prompt Payment by Part D Sponsors, which requires Part D sponsor to transmit payment to pharmacies within 14 days after receiving an electronic Part D claim that is a clean claim.
                        </P>
                    </FTNT>
                    <P>
                        To help ensure prompt payments by Primary Manufacturers to dispensing entities to provide access to the MFP, initial PDE records for selected drugs under the Negotiation Program necessitate a PDE submission timeliness requirement that is different from the general PDE submission timeliness requirement for initial PDE records. Under the current general PDE submission timeliness requirements, dispensing entities could wait up to approximately six weeks to receive access to the MFP (
                        <E T="03">e.g.,</E>
                         30 calendar days for the Part D sponsor to submit PDE data to the DDPS, plus approximately one to three days for the PDE data to move from DDPS to the MTF to the Primary Manufacturer, plus up to an additional 14 days for the Primary Manufacturer to transmit an MFP refund payment). If the Primary Manufacturer does not prospectively make the MFP available to the dispensing entity, then the lag between when the dispensing entity receives payment from the Part D plan and when the dispensing entity receives the MFP refund payment from the Primary Manufacturer could impose a financial strain on dispensing entities given that anticipated MFP refunds could be a material percent of the dispensing entity's purchase price. To mitigate potential financial hardship on dispensing entities such as pharmacies, which could impact Part D beneficiary access to selected drugs, and more closely align MFP refund payments with the timing requirements in the longstanding prompt pay rules in the Part D program, CMS believes it is necessary to create a specific new requirement for PDE submission timeliness requirements for selected drugs. Therefore, CMS is proposing to shorten the PDE submission timeliness requirements for selected drugs to reduce the maximum amount of time a dispensing entity could wait to receive access to the MFP.
                    </P>
                    <P>
                        On May 3, 2024, when CMS released draft guidance describing the implementation of the Negotiation Program for initial price applicability year 2027 and manufacturer effectuation of the MFP in 2026 and 2027 (draft guidance), CMS noted that it was evaluating a PDE submission timeliness requirement for PDE records that is different from the general PDE submission timeliness requirement for initial PDE records.
                        <SU>214</SU>
                        <FTREF/>
                         To ensure that dispensing entities receive timely payment of MTF refunds, CMS stated that it was evaluating whether the 30-day window for Part D sponsors to submit PDE records should be shortened to 7 days of receipt of the claim to help ensure dispensing entities receive timely payment of MFP refunds.
                    </P>
                    <FTNT>
                        <P>
                            <SU>214</SU>
                             Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191-1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027 
                            <E T="03">https://www.cms.gov/files/document/medicare-drug-price-negotiation-draft-guidance-ipay-2027-and-manufacturer-effectuation-mfp-2026-2027.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        CMS received and reviewed comments from interested parties on the draft guidance related to the consideration of a shorter PDE submission timeliness requirement for selected drugs and addressed those comments on page 53 of the final guidance.
                        <SU>215</SU>
                        <FTREF/>
                         To inform policy development for this rulemaking, CMS re-reviewed all comments received on the topic of PDE submission timeliness requirements. Many commenters supported CMS shortening the PDE submission window and agreed with the 7-day timeliness requirement or recommended other timeliness requirements shorter than 30 calendar days. Some commenters recommended CMS not change the PDE reporting general timeliness requirement and keep the 30-day window for selected drugs. Many commenters noted that shortening the PDE submission window could increase the volume of claim adjustments and reversals during and after the 14-day prompt MFP payment window. These commenters noted that it typically takes pharmacies up to 14 days to reverse a claim when a beneficiary does not pick up a prescription and asked CMS to provide more detail on how the MTF will address claim reversals and adjustments. One commenter noted that if CMS shortens the PDE submission window, plan sponsors would need additional implementation time to revise agreements and internal processes. While CMS addressed these comments in final guidance by stating that it intends to propose to shorten the current 30-day window for plans to submit PDE records for selected drugs to 7 calendar days, CMS also received several comments posing technical questions on the PDE reporting process and DDPS operations, and offering input on other PDE operational matters, which CMS considered out of scope for final guidance. However, CMS recognizes the importance of public feedback on potential operational concerns surrounding a shorter PDE submission window for selected drugs. CMS is soliciting comments in this proposed rule on the operational considerations of shortening the timeframe for initial PDE records for selected drugs to 7 calendar days, including potential challenges 
                        <PRTPAGE P="99441"/>
                        Part D sponsors may face in implementing the proposed timeframe.
                    </P>
                    <FTNT>
                        <P>
                            <SU>215</SU>
                             Insert link to final guidance when it is available.
                        </P>
                    </FTNT>
                    <P>CMS is also soliciting comments on whether it should shorten the submission timeline for selected drugs for adjustment and deletion PDE records, and for records to resolve PDE records that were rejected by CMS. CMS is particularly interested in comments on operational feasibility, as well as comments that address whether a shorter submission timeline would help facilitate timely payments by Primary Manufacturers to dispensing entities, or whether the 90-calendar day submission timeframe for adjustments and deletions and/or for the resolution of rejected records is sufficient for the purpose of the Negotiation Program.</P>
                    <P>
                        We propose to codify this 7-calendar day timeframe for initial PDE records for selected drugs and refer to this timeframe as the 
                        <E T="03">Selected Drugs PDE Submission Timeliness Requirement.</E>
                    </P>
                    <HD SOURCE="HD3">3. Requirements—General PDE Submission Timeliness</HD>
                    <P>We propose to codify the existing 30-day and 90-day general PDE submission timeframes, with two slight modifications. First, we propose that the 30-day and 90-day requirements refer to calendar days, as opposed to business days. Second, we propose to modify the timing of the initial PDE records submission, which currently begins from the date the claim is received by the Part D sponsor or the date of service, whichever is greater. Given that the claim cannot be received by the Part D sponsor (or its contracted first tier, downstream, or related entity (for example, pharmacy benefit manager (PBM))) until on or after the date of service, we propose to clarify that initial PDE records must be submitted within 30 calendar days of when the Part D sponsor (or its contracted first tier, downstream, or related entity) receives the claim.</P>
                    <P>Based on our experience with the Part D program, these proposed 30-calendar day and 90-calendar day PDE submission timeframes are appropriate, striking a balance between allowing sufficient time for the Part D sponsors to submit PDE records while providing sufficient time for CMS to review and flag data quality issues that may require action from the Part D sponsor prior to the PDE record being used in the invoicing and reconciliation processes for the discount programs and the Part D payment reconciliations. These proposed timeframes, which CMS developed with industry feedback, have been in subregulatory guidance since 2011 and have worked well for Part D sponsors and CMS.</P>
                    <P>Therefore, we propose the following general PDE submission timeliness requirements. We propose that the Part D sponsor must submit an initial PDE record within 30 calendar days from the date the Part D sponsor receives the claim. We propose that the Part D sponsor must submit adjustment or deletion PDE records within 90 calendar days of the discovery or notification of an issue requiring a change to the previously submitted PDE records. We propose that the Part D sponsor must resolve rejected PDE records within 90 calendar days of the rejection. We propose that these general PDE submission timeliness requirements apply unless, for the initial PDE records submissions, the proposed selected drugs PDE submission timeliness requirement applies.</P>
                    <HD SOURCE="HD3">4. Requirement—Selected Drugs PDE Submission Timeliness</HD>
                    <P>
                        We propose to establish a selected drugs PDE submission timeliness requirement, in which CMS requires that a Part D sponsor must submit initial PDE records for selected drugs (as described at section 1192(c) of the Act) within 7 calendar days from the date the Part D sponsor (or its contracted first tier, downstream, or related entity) receives the claim. The proposed PDE submission timeliness requirement is consistent with CMS' authority under section 1860D-15(f) of the Act, which authorizes CMS to collect PDE data for the purposes of, and to the extent necessary in, carrying out both section 1860D-15 of the Act and part E of title XI of the Act (
                        <E T="03">i.e.,</E>
                         the Negotiation Program).
                    </P>
                    <P>Figure 1 illustrates the general and selected drugs PDE submission timeline requirements.</P>
                    <GPH SPAN="3" DEEP="103">
                        <GID>EP10DE24.019</GID>
                    </GPH>
                    <P>CMS believes Part D sponsors are compliant with the longstanding guidance pertaining to 30- and 90-day PDE submission timelines, and thus, CMS does not expect the proposed change to result in additional costs or savings and are not scoring these requirements in the Regulatory Impact Analysis section. We are not imposing any new reporting requirements for drugs other than selected drugs. We do not believe that our proposal pertaining to 7-, 30-, and 90-day PDE submission timeline will result in additional paperwork burden and have not incorporated a burden increase in the Collection of Information section.</P>
                    <HD SOURCE="HD3">5. Severability</HD>
                    <P>The general PDE submission timeliness requirements and the selected drugs PDE submission timeliness requirement provisions proposed herein are separate and severable from one another. If either provision, once finalized, is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, or stayed pending further agency action, it is our intention that such provision shall be severable from this rule and not affect the remainder thereof, or the application of such provision to other persons not similarly situated or to other, dissimilar circumstances.</P>
                    <HD SOURCE="HD2">S. Medicare Transaction Facilitator Requirements for Network Pharmacy Agreements</HD>
                    <P>
                        The Inflation Reduction Act of 2022 (IRA) (Pub. L. 117-169), enacted August 16, 2022, established the Medicare Drug Price Negotiation Program (hereinafter the “Negotiation Program”) to negotiate maximum fair prices (MFPs) for certain high expenditure, single source drugs 
                        <PRTPAGE P="99442"/>
                        and biological products. The requirements for the Negotiation Program are described in sections 1191 through 1198 of the Social Security Act (hereinafter “the Act”), as added by sections 11001 and 11002 of the IRA. Sections 11001(c) and 11002(c) of the IRA direct the Secretary of the United States Department of Health and Human Services (hereinafter “the Secretary”) to implement the Negotiation Program provisions in sections 11001 and 11002 of the IRA, including amendments made by such sections, for 2026, 2027, and 2028 by program instruction or other forms of program guidance. In accordance with the law, CMS issued the Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191-1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027 on May 3, 2024 (hereinafter “draft guidance”), and the Medicare Drug Price Negotiation Program: Final Guidance, Implementation of Sections 1191-1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027 on October 2, 2024 (hereinafter “final guidance”).
                        <SU>216</SU>
                        <FTREF/>
                         In the final guidance, CMS noted that it also planned to engage in rulemaking to propose certain policies under Medicare Part D that relate to or have implications for the Negotiation Program but involve exercising authorities under the Act that are not subject to the IRA's program instruction requirement. Accordingly, as discussed in more detail below, in this rule, CMS proposes at § 423.505(q) to require that Part D sponsors' network contracts with pharmacies require such pharmacies to be enrolled in the Negotiation Program's Medicare Transaction Facilitator (MTF) Data Module (DM) (hereinafter “MTF DM”).
                    </P>
                    <FTNT>
                        <P>
                            <SU>216</SU>
                             Medicare Drug Price Negotiation Program: Final Guidance, Implementation of Sections 1191-1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price in 2026 and 2027 
                            <E T="03">https://www.cms.gov/files/document/medicare-drug-price-negotiation-final-guidance-ipay-2027-and-manufacturer-effectuation-mfp-2026-2027.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. Background on the Medicare Transaction Facilitator</HD>
                    <P>
                        Section 1193(a) of the Act instructs CMS to enter into agreements (a “Medicare Drug Price Negotiation Program Agreement,” hereinafter referred to as a “Negotiation Program Agreement”) with willing manufacturers of selected drugs (as described in section 1192(c) of the Act) for a price applicability period (as defined in section 1191(b)(2) of the Act). After entering into a Negotiation Program Agreement with CMS and in accordance with section 1193(a) of the Act, any “Primary Manufacturer” (as defined in section 40 of the final guidance) of a selected drug that continues to participate in the Negotiation Program and reaches agreement upon an MFP must provide access to the MFP to MFP-eligible individuals (defined in section 1191(c)(2)(A) of the Act) and to pharmacies, mail order services, and other dispensing entities that dispense drugs covered under Medicare Part D (hereinafter “dispensing entities”) with respect to such MFP-eligible individuals. In section 40.4 of the final guidance, CMS stated that a Primary Manufacturer must provide access to the MFP in one of two ways: (1) prospectively ensuring that the price paid by the dispensing entity when acquiring the drug is no greater than the MFP, or (2) retrospectively providing reimbursement for the difference between the dispensing entity's acquisition cost and the MFP. Consistent with longstanding Part D prompt pay rules regarding payment by plan sponsors to network pharmacies,
                        <SU>217</SU>
                        <FTREF/>
                         CMS will require that a Primary Manufacturer transmit payment of an amount that provides access to the MFP within 14 calendar days of when certain claim-level data elements are sent to the Primary Manufacturer by the MTF DM.
                    </P>
                    <FTNT>
                        <P>
                            <SU>217</SU>
                             See 42 CFR 423.520, Prompt Payment by Part D Sponsors, which requires the Part D sponsor to transmit payment to network pharmacies within 14 days after receiving an electronic Part D claim that is a clean claim.
                        </P>
                    </FTNT>
                    <P>In section 40.4 of the final guidance, CMS stated, based on CMS' continuous engagement with and extensive feedback from interested parties, for 2026 and 2027, CMS will engage with MTF contractors to facilitate the exchange of data and payment between pharmaceutical supply chain entities for the purposes of the Negotiation Program. The MTF will have two distinct modules, the MTF DM and the MTF Payment Module (hereinafter “MTF PM”), a voluntary option to pass payment for MFP refunds from Primary Manufacturers to dispensing entities. The combined data and payment facilitation functionalities present in the MTF DM and the MTF PM will attempt to address the interests expressed by dispensing entities and manufacturers in a single platform for transmitting the data necessary for program administration and supporting MFP refund payments to create greater efficiency, standardization, and predictability in the execution of a high volume of continuous payments.</P>
                    <P>
                        The MTF DM will facilitate the exchange of certain claim-level data elements and claim-level payment elements for selected drugs to support the verification that the selected drug was dispensed to an MFP-eligible individual, as described in section 40.4.2 of the final guidance. The data supplied by the MTF DM to Primary Manufacturers will have been verified by both the Part D sponsor and CMS' Drug Data Processing System (DDPS) resulting in dual verification of both an individual's eligibility for Part D, and Part D coverage of the selected drug for each claim being transmitted. For context, when a Part D plan sponsor receives a claim for a selected drug from a dispensing entity, the Part D plan sponsor verifies that the beneficiary listed on the claim paid by the Part D plan sponsor is enrolled in Medicare Part D and coverage is provided under Part D for the dispensed drug. After the Part D plan sponsor verifies Medicare eligibility and coverage of the selected drug, the plan pays the dispensing entity no more than the MFP plus any dispensing fees for the selected drug. Then, the Part D plan sponsor sends the data on the Part D claim as a Prescription Drug Event (PDE) record (
                        <E T="03">i.e.,</E>
                         claim summary records submitted by Medicare Part D plan sponsors to CMS for every prescription filled by a dispensing entity for a Medicare Part D beneficiary) to DDPS. CMS uses DDPS to perform verification steps to validate that the individual was an eligible Part D enrollee at the time of the claim, as described in section 40.4.2.1 of the final guidance. After CMS verifies MFP eligibility for the individual related to the claim, DDPS will transmit the PDE record for the Part D claim for the selected drug to the MTF DM. Therefore, because MFP eligibility status has been twice validated before the data elements are sent from the MTF DM to the Primary Manufacturer, the data elements will have been verified as involving a selected drug that was dispensed to an MFP-eligible individual.
                    </P>
                    <P>
                        As stated in section 40.4.2.1 of the final guidance, enrollment in the MTF DM will be mandatory for Primary Manufacturers. CMS will require all Primary Manufacturers to register with the MTF DM by a deadline to be specified by CMS and to maintain the functionality necessary to receive certain claim-level data elements from the MTF DM and return certain claim-
                        <PRTPAGE P="99443"/>
                        level payment elements to the MTF DM. Each Primary Manufacturer will be required to sign data use, privacy, and security agreements with CMS and comply with data use, privacy, and security requirements to protect the data elements received from and transmitted to the MTF.
                    </P>
                    <P>As discussed in section 40.4.2.2 of the final guidance and in more detail below, dispensing entity enrollment in the MTF DM is also needed for necessary operations related to administration of the Negotiation Program and the Part D program. Dispensing entity enrollment in the MTF DM allows for several key functionalities that help ensure accurate Part D claims information and payment and continued access for beneficiaries and dispensing entities to selected drugs. These functionalities include the collecting and sharing of banking information from dispensing entities to Primary Manufacturers; creating and sending of Electronic Remittance Advice that uses the X12 835 standard adopted under the Health Insurance Portability and Accountability Act of 1996 (hereinafter “ERAs”) (for electronic transfer of funds) or remittances (for paper checks) to dispensing entities; a streamlined ability to submit complaints and disputes regarding selected drugs dispensed; and an opportunity for dispensing entities to identify themselves as anticipating material cashflow concerns at the start of a price applicability period with respect to selected drugs as a result of potential delays created by reliance on retrospective MFP refunds within the 14-day prompt MFP payment window. Accordingly, CMS proposes to require Part D plan sponsors to include in their network pharmacy agreements provisions requiring dispensing entities to be enrolled in the MTF DM.</P>
                    <P>If a Primary Manufacturer elects to utilize the MTF PM, then the MTF PM will complement the data-related activities of the MTF DM and facilitate payment of an MFP retrospective refund on MFP-eligible claims of selected drugs from the participating Primary Manufacturer to the dispensing entity. Specifically, as discussed in section 40.4.3 of the final guidance, the MTF PM will (1) provide Primary Manufacturers with a mechanism for electronic transfer of funds or payment by paper check to facilitate MFP refund payments from Primary Manufacturers to dispensing entities; and (2) provide Primary Manufacturers with a credit/debit ledger system to track the flow of MFP refunds and to handle reversals, adjustments, and other claim revisions inevitable in a dynamic claim payment system. Participation in the MTF PM will be voluntary for Primary Manufacturers, which will have the option of passing MFP refund payments to dispensing entities through the MTF PM or using their own processes outside of the MTF PM to effectuate the MFP. Primary Manufacturers that elect to use the MTF PM to pass through payments will be required to execute MTF agreements with the MTF PM outlining each party's rights, responsibilities, and potential liabilities associated with the transfer and receipt of funds through the MTF PM.</P>
                    <HD SOURCE="HD3">2. Network Pharmacy Contracts With Part D Plan Sponsors</HD>
                    <P>
                        CMS has broad contracting authority with respect to Part D plan sponsors under section 1860D-12 of the Act. As applied to the Part D program through section 1860D-12(b)(3)(D) of the Act, section 1857(e)(1) of the Act authorizes the Secretary to adopt contract terms and conditions as necessary and appropriate and not inconsistent with the Part D statute. Additionally, section 1860D-12(b)(3)(D)(i) of the Act specifies that information provided to the Secretary under the application of section 1857(e)(1) of the Act may be used (in relevant part) for the purposes of carrying out the Part D program or Part E of Title XI of the Act (
                        <E T="03">i.e.,</E>
                         the Negotiation Program). Pursuant to these authorities, CMS proposes to require plan sponsors (or first tier, downstream, or related entities, such as PBMs, on the sponsors' behalf) to include in their network participation agreements with contracting pharmacies a provision that requires the pharmacy to be enrolled in the MTF DM (or any successor to the MTF DM) in a form and manner to be determined by CMS. CMS emphasizes that under the proposed regulation, such provision must require the pharmacy “to be enrolled” in the MTF DM, as opposed to merely requiring the pharmacy “to enroll” in the MTF DM, to establish an ongoing obligation that the pharmacy maintain its enrollment in the MTF DM. CMS also proposes that such provision must require the pharmacy to maintain and certify to CMS that the enrollment information provided in the MTF DM is accurate, complete, and up to date, pursuant to applicable terms and conditions of participation with the MTF DM, in a form and manner to be determined by CMS. CMS proposes amending § 423.505 by adding paragraph (q) to codify this requirement.
                    </P>
                    <P>Consistent with section 1860D-12(b)(3)(D) of the Act, such a requirement would be necessary and appropriate and not inconsistent with the Part D statute. As previously mentioned, the MTF DM will contain several key functionalities that are necessary and appropriate for operations related to administration of the Negotiation Program and the Part D program. Through each of the functionalities outlined below, dispensing entity enrollment in the MTF DM would help ensure continued access to selected drugs that are covered under Part D for beneficiaries and dispensing entities and help maintain the accuracy of Part D claims information and payment.</P>
                    <P>First, the MTF DM will provide dispensing entities enrolled in the MTF DM with remittances or ERAs to reconcile MFP refund payments when a Primary Manufacturer chooses to pass payment to the dispensing entity through the MTF PM. Interested parties strongly requested that electronic MFP refunds be accompanied by an ERA or remittance. To meet standards in the creation of an accurate ERA or remittance, up-to-date banking information for a dispensing entity will be needed. Dispensing entities will be asked to provide up-to-date banking information during MTF DM enrollment. For Primary Manufacturers that make payments outside of the MTF PM, CMS plans to make available through the MTF DM dispensing entities' bank account information and designated destination for ERAs or remittances, as applicable.</P>
                    <P>These ERAs or remittances will assist dispensing entities in closing out their open accounts receivable, thereby minimizing cashflow interruptions. Specifically, the information contained in the ERA or remittance will connect claims payment determination and amount with how the payment was made, including the electronic funds transfer information, if applicable. Consistent with each dispensing entity's own standard business practices, CMS expects dispensing entities to review their accounts receivables for each claim for which a Primary Manufacturer owes an MFP refund and determine whether a Primary Manufacturer has paid all the claims the dispensing entity believes are MFP-eligible claims, in the amounts the dispensing entity believes are sufficient to effectuate the MFP. Moreover, CMS has consistently heard from interested parties that without an ERA or remittance, MFP refund payments may be rejected, and, in these scenarios, dispensing entities would not have means to reconcile received payments against outstanding MFP-eligible claims.</P>
                    <P>
                        Second, there will be streamlined access for dispensing entities enrolled in the MTF DM to submit complaints and disputes within the MTF DM to 
                        <PRTPAGE P="99444"/>
                        help identify issues with timely MFP refund payment, supporting dispensing entities to continue efficient operations and prevent undue financial hardship, while maintaining accuracy of Part D claims information and payment. Allowing dispensing entities streamlined access to this system will support the administration of the Negotiation Program and Part D program. Through the MTF DM, a dispensing entity can submit a complaint concerning claims for selected drugs that potentially require an MFP refund, which CMS will review. Additionally, all Primary Manufacturers will be required to utilize the MTF DM to report to the MTF DM information (claim-level payment elements) about how the Primary Manufacturer has made the MFP available for each claim for which the Primary Manufacturer received data from the MTF DM or indicate why no MFP refund payment has been made on a claim. While dispensing entities are encouraged to remediate with the manufacturer directly if they believe that they have not received a retrospective refund payment that effectuates the MFP, dispensing entities may use the complaints process within the complaint and dispute system in the MTF DM to alert CMS.
                    </P>
                    <P>
                        Third, the MTF DM will serve as a central repository for information about dispensing entities enrolled in the MTF DM that anticipate material cashflow concerns due to the reliance on retrospective MFP refunds within the 14-day prompt MFP payment window. Interested parties have noted that small pharmacies that rely primarily on prescription revenue to maintain business operations would face material cashflow pressures due to the shift from payment by the Part D plan sponsor to a combination of Part D plan sponsor payment plus a potentially lagged MFP refund. Based on this input, CMS is concerned that this challenge will be most acute in the transition period when MFPs for selected drugs first become effective in January 2026 and at the start of each subsequent initial price applicability year when MFPs for new selected drugs first become effective (
                        <E T="03">i.e.,</E>
                         at the start of a price applicability period with respect to a selected drug). CMS does not anticipate this challenge to continue with respect to a selected drug once MFP refunds for that selected drug are flowing and dispensing entities become accustomed to the 14-day prompt MFP payment window. Consider a scenario in which the dispensing entity purchases a selected drug at a price discounted from the wholesale acquisition cost (WAC), for example, at WAC minus four percent, for ten units. Initially, this expenditure creates a temporary cashflow gap. However, upon receiving the MFP refund payment, the dispensing entity's upfront cost is offset, effectively restoring its financial position. Assuming a consistent utilization rate for the drug, any temporary negative cashflow should be balanced by the subsequent MFP refund payment. The timing and consistency of this pattern should lead to stable cashflow and avoid a long-term cash deficit over time. During MTF DM enrollment, CMS will ask dispensing entities to self-identify whether they are a dispensing entity that anticipates having material cashflow concerns. CMS expects dispensing entities of the types that have raised material concerns about cashflow related to the effectuation of MFP—such as sole proprietor rural and urban pharmacies with high volume of Medicare Part D prescriptions dispensed, pharmacies who predominantly rely on prescription revenue to maintain business operations, long-term care pharmacies, 340B covered entities with in-house pharmacies, and I/T/U pharmacies—may self-identify through this process. This information will be provided to Primary Manufacturers to assist in the development of their MFP effectuation plans, which must include a process for mitigating material cashflow concerns for dispensing entities. The MTF DM will also be available to dispensing entities enrolled in the MTF that need to update their self-identification with respect to material cashflow concerns, as CMS anticipates that indication could change over time.
                    </P>
                    <P>Fourth, CMS intends that dispensing entities will be able to view the status of MFP refunds from Primary Manufacturers through the MTF DM. The ability to track MFP refunds could also help dispensing entities better manage their cashflow or aid their financial planning to meet other administrative burdens or operational costs.</P>
                    <P>Fifth, the MTF DM will collect and share bank account information belonging to dispensing entities enrolled in the MTF DM with Primary Manufacturers that pay MFP refunds to dispensing entities outside the MTF PM. Through CMS' engagement with interested parties, both manufacturers and dispensing entities have expressed the concern that they typically do not have direct financial relationships with one another, increasing dispensing entities' risk of experiencing payment delays. As such, during MTF DM enrollment, CMS will ask dispensing entities to provide their bank account information. CMS believes that the collecting and sharing of dispensing entities' bank account information with Primary Manufacturers will address interested parties' concerns related to the lack of an established channel to support MFP refund payments made outside the MTF PM, and help dispensing entities to continue efficient operations.</P>
                    <P>In sum, CMS believes that enrollment in the MTF DM by dispensing entities would facilitate continued beneficiary and dispensing entity access to selected drugs that are covered Part D drugs. Manufacturers and dispensing entities have asked the agency to undertake a role in assuring that MFP refund payments to dispensing entities can be made efficiently, and the development of an MTF DM has an important role in that process. With less financial uncertainty, dispensing entities are better positioned to keep dispensing selected drugs covered under Part D. Given the wide number and scope of dispensing entities that dispense drugs to Part D beneficiaries—which is currently approximately 60,000-plus community pharmacies and 80,000-plus dispensing entities in total—this proposed requirement will help reach the maximum number of entities that serve Medicare beneficiaries. Requiring network pharmacy agreements to require enrollment by pharmacies in the MTF DM will help promote successful MFP effectuation under the Negotiation Program and facilitate continued access to selected drugs covered under Part D for Medicare beneficiaries.</P>
                    <P>
                        For the reasons stated above, CMS proposes to require plan sponsors (or first tier, downstream, or related entities, such as PBMs, on the sponsors' behalf) to include in their network participation agreements with contracting pharmacies a provision that requires the pharmacy to be enrolled in the MTF DM (or any successor to the MTF DM), which would entail an ongoing obligation that the pharmacy maintain its enrollment in the MTF DM, in a form and manner to be determined by CMS. CMS also proposes that such provision must require the pharmacy to maintain and certify to CMS that the enrollment information provided in the MTF DM is accurate, complete, and up to date, pursuant to applicable terms and conditions of participation with the MTF DM, in a form and manner to be determined by CMS. CMS seeks comment on this proposal.
                        <PRTPAGE P="99445"/>
                    </P>
                    <HD SOURCE="HD3">3. Overview for Dispensing Entity Enrollment in the MTF DM</HD>
                    <P>
                        As of the date of the publication of this proposal in the 
                        <E T="04">Federal Register</E>
                        , CMS is still determining the exact process for enrollment of dispensing entities in the MTF DM and welcomes feedback on factors CMS should incorporate into this process. Currently, for 2026 and 2027, CMS may use existing databases to identify contact information for dispensing entities that dispense prescription drugs to Medicare beneficiaries or participate in one or more parts of the Medicare program. CMS may use that information to facilitate the process for dispensing entities to enroll in the MTF DM. CMS may also use that information to conduct outreach activities to dispensing entities such that they are aware of the MTF, including the benefits, functions, and process for enrollment, and, if finalized, this proposed contractual requirement to be enrolled in the MTF DM. Regardless of whether CMS conducts any outreach to dispensing entities, under this proposal, the plan sponsor would remain responsible for ensuring that its network agreements with pharmacies include a provision that requires the pharmacy to be enrolled in the MTF DM in a form and manner to be determined by CMS.
                    </P>
                    <P>When enrolling in the MTF DM, the dispensing entity would enter, certify, and maintain its enrollment information, including but not limited to: (1) legal business name and address; (2) Tax Identification Number (TIN) and/or NPI; (3) financial institution details, including address and contact information; (4) financial institution routing number; (5) deposit or account number with financial institution; (6) type of registered financial account; and (7) secure location for making available the ERA or remittance, as applicable. During MTF DM enrollment, CMS would allow dispensing entities to identify themselves as anticipating material cashflow concerns at the start of a price applicability period with respect to selected drugs as a result of potential delays created by reliance on retrospective MFP refunds within the 14-day prompt MFP payment window. The dispensing entity's (and, as applicable, their third-party support entity's) banking information would be shared with Primary Manufacturers to establish accurate ERA for electronic MFP refund payments (or remittance advice for paper checks) made outside of the MTF PM.</P>
                    <P>
                        CMS would require each dispensing entity to execute an agreement package during the MTF enrollment process, which, for example, may include an MTF agreement with CMS and a participation agreement with CMS' MTF DM contractor. Under the terms and conditions of participation in the MTF DM, the dispensing entity would be responsible for maintaining MTF enrollment information in the MTF DM and be subject to audits conducted by CMS or its agents. If any of the dispensing entity's enrollment information in the MTF DM changes, the dispensing entity would also be required to update and recertify the information in the MTF DM. CMS intends to publish copies of draft MTF terms and conditions of the agreement package on the CMS IRA website.
                        <SU>218</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>218</SU>
                             See: 
                            <E T="03">https://www.cms.gov/inflation-reduction-act-and-medicare.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">T. Proposed Regulatory Changes to Medicare Advantage (MA) and Part D Medical Loss Ratio (MLR) Standards (§§ 422.2401, 422.2420, 422.2430, 422.2450, 422.2452, 422.2454, 422.2460, 422.2480, 422.2490, 423.2401, 423.2420, 423.2430, 423.2450, 423.2452, 423.2454, 423.2480, 423.2490)</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>
                        Section 1103 of Title I, Subpart B of the Health Care and Education Reconciliation Act (Pub. L. 111-152) amended section 1857(e) of the Act to add a medical loss ratio (MLR) requirement to Medicare Part C (MA program). An MLR is expressed as a percentage, generally representing the percentage of revenue used for patient care rather than for such other items as administrative expenses or profit. Because section 1860D-12(b)(3)(D) of the Act incorporates by reference the requirements of section 1857(e) of the Act, these MLR requirements also apply to the Medicare Part D program. In the May 23, 2013, 
                        <E T="04">Federal Register</E>
                        , we published a final rule titled “Medicare Program; Medical Loss Ratio Requirements for the Medicare Advantage and the Medicare Prescription Drug Benefit Programs” (78 FR 31284) (hereinafter referred to as the May 2013 Medicare MLR final rule), in which we codified the MLR requirements for MA organizations and Part D prescription drug plan sponsors (“Part D sponsors”) (including organizations offering cost plans that offer the Part D benefit) in the regulations at 42 CFR part 422, subpart X, and part 423, subpart X.
                    </P>
                    <P>
                        Generally, the MLR for each MA and Part D contract reflects the ratio of costs (numerator) to revenues (denominator) for all enrollees under the contract. For an MA contract, the MLR reflects the percentage of revenue received under the contract spent on the following categories of expenditures: incurred claims for all enrollees, prescription drug costs for those enrollees in MA plans under the contract offering the Part D benefit, quality initiatives that meet the requirements at §  422.2430, and amounts used to reduce Part B premiums. The MLR for a Part D contract reflects the percentage of revenue received under the contract spent on incurred claims for all enrollees for Part D prescription drugs and on quality initiatives that meet the requirements at §  423.2430. The percentage of revenue that is used for other items such as administration, marketing, and profit is excluded from the numerator of the MLR for MA and Part D (
                        <E T="03">see</E>
                         §§  422.2401 and 423.2401; 422.2420(b)(4) and 423.2420(b)(4); 422.2430(b) and 423.2430(b)).
                    </P>
                    <P>The MLR calculation, prior to any credibility adjustment, can be depicted as the following general formula:</P>
                    <FP SOURCE="FP-2">
                        <E T="03">MRL = (Incurred Claims + Quality Improving Activities) ÷ (Revenue − Certain Taxes and Fees)</E>
                    </FP>
                    <P>
                        In the May 2013 Medicare MLR final rule, we codified at §§ 422.2410 and 423.2410 the requirements for 2014 and subsequent years that MA organizations and Part D sponsors are subject to financial and other sanctions for failure to meet the requirement that they have an MLR of at least 85 percent. Specifically, CMS set forth that, if we determine that a contract of an MA organization or Part D sponsor has an MLR that is less than 0.85 for a contract year, the contract has not met the MLR requirement and the MA organization or Part D sponsor must remit to CMS an amount equal to the product of (1) the total revenue of the MA or Part D contract for the contract year multiplied by (2) the difference between 0.85 and the MLR for the contract year (
                        <E T="03">see</E>
                         §§  422.2410 and 423.2410). We also established at §§  422.2460 and 423.2460 that, for each contract year, each MA organization and Part D sponsor must submit an MLR Report to CMS that included the data needed from the MA organization or Part D sponsor to calculate and verify the MLR and remittance amount, if any, for each contract such as the amount of incurred claims, expenditures on quality improving activities, non-claims costs, taxes, licensing and regulatory fees, total revenue, and any remittance owed to CMS under §  422.2410 or §  423.2410.
                    </P>
                    <P>
                        To facilitate the submission of MLR data, CMS developed a standardized MLR Report template that MA organizations and Part D sponsors are 
                        <PRTPAGE P="99446"/>
                        required to populate with their data and upload to the Health Plan Management System (HPMS), starting with contract year (CY) 2014 MLR reporting. For any given reporting year (calendar year), MA organizations and Part D sponsors must submit their MLR Reports in December of the year following the reporting year, or another time as determined by CMS. Based on the data entered by the MA organization or Part D sponsor for each component of the MLR numerator and denominator, the MLR reporting software would calculate an unadjusted MLR for each contract. The MLR reporting software would also calculate and apply a credibility adjustment provided for in §§  422.2440 and 423.2440, based on the number of member months entered into the MLR Report, in order to calculate the contract's adjusted MLR and remittance amount (if any). The credibility adjustment takes into account the specific circumstances of contracts with lower enrollment and reduces the probability that an MA organization or Part D sponsor with relatively smaller enrollment has to pay a remittance in a given year due to the propensity for random fluctuations in claims each year. In addition to the numerical fields used to calculate the MLR and remittance amount, the MLR Report template included narrative fields in which MA organizations and Part D sponsors provided detailed descriptions of the methods used to allocate expenses, including how each specific expense met the criteria for the expense category to which it was assigned.
                    </P>
                    <P>
                        In the final rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program” (83 FR 16440), which appeared in the April 16, 2018, 
                        <E T="04">Federal Register</E>
                         (hereinafter referred to as the April 2018 final rule), we finalized a proposal to modify the MLR reporting requirements by significantly reducing the amount of MLR data that MA organizations and Part D sponsors submit to CMS on an annual basis, starting with contract year 2018. Specifically, the reporting requirement was changed to collect the minimum amount of information needed for Medicare MLR reporting: the organization name, contract number, adjusted MLR, and the remittance amount.
                    </P>
                    <P>
                        In light of subsequent experience overseeing the administration of the Medicare MLR program while relying on the simplified MLR reporting requirements, and after further consideration of the potential impacts on beneficiaries and costs to the government and taxpayers when CMS has limited access to detailed MLR data, we proposed to reinstate the detailed MLR reporting requirements that were in effect for contract years 2014 through 2017. This detailed reporting required the submission of the underlying data used to calculate and verify the MLR and any remittance amount, such as incurred claims, total revenue, expenditures on quality improving activities, non-claims costs, taxes, and regulatory fees. We also proposed some modifications to the reinstated reporting requirements. These modifications included three types of changes to the MLR Reporting Tool. First, the MLR Reporting Tool's formulas were revised to incorporate changes to the MLR calculation such as adding categories for fraud reduction expenses in the section for Activities that Improve Healthcare Quality. Second, CMS separated out certain items that were consolidated, for example, the low-income cost-sharing subsidy amounts were added as an information-only line in the MLR Reporting Tool. Third, CMS included expenditures related to supplemental benefits in the MLR Reporting Tool. These modifications were proposed in the rule titled “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs” (87 FR 1842), which appeared in the March 7, 2022, 
                        <E T="04">Federal Register</E>
                         (hereinafter referred to as the March 2022 proposed rule) and finalized in the final rule titled “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” (87 FR 27704), which appeared in the May 9, 2022, 
                        <E T="04">Federal Register</E>
                         (hereinafter referred to as the May 2022 final Medicare rule).
                    </P>
                    <P>
                        The factors that led us to make these changes included the growth of the MA and Part D programs, the related growth in MLR remittances, and the growth in the number of contracts that failed to meet the MLR requirement during the period when MA organizations and Part D sponsors had reduced reporting requirements. When the proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program” (82 FR 56336), which appeared in the November 28, 2017, 
                        <E T="04">Federal Register</E>
                         (hereinafter referred to as the November 2017 proposed rule), to eliminate the detailed Medicare MLR reporting requirements was released, MA organizations and Part D sponsors had submitted MLR data for CYs 2014 and 2015. Total remittances for all contracts for the two years averaged $29.6 million, and an average of 16 contracts failed to meet the minimum Medicare MLR requirement. By the time CMS issued the April 2018 final rule, annual average remittances for CYs 2014 through 2016 totaled $91.8 million, and an annual average of 21 contracts failed to meet the MLR requirement. Thereafter, for CYs 2017 through 2019, the average amount of annual remittances more than doubled to $204.9 million, and the average number of contracts that failed to meet the MLR requirement nearly doubled to 40 contracts per year.
                    </P>
                    <P>In the May 2013 Medicare MLR final rule, we also codified sanctions at §§ 422.2410 and 423.2410 as set forth in statute. Specifically, the statute imposes several levels of sanctions for failure to meet the 85 percent minimum MLR requirement, including remittance of funds, a prohibition on enrolling new members, and ultimately, contract termination. The minimum MLR requirement creates incentives for MA organizations and Part D sponsors to reduce administrative costs, such as marketing costs, profits, and other uses of the revenue received by plan sponsors and helps ensure that taxpayers and enrolled beneficiaries receive value from Medicare health and drug plans.</P>
                    <P>Section 1001(5) of the 2010 Patient Protection and Affordable Care Act (Pub. L. 111-148), as amended by section 10101(f) of the 2010 Health Care and Education Reconciliation Act (Pub. L. 111-152), also established new MLR reporting and rebate requirement under section 2718 of the Public Health Service Act that applies to health insurance issuers (issuers) of private health insurance coverage in the employer group and individual markets as of CY 2011. We will refer to the MLR requirements that apply to issuers of private insurance as the “commercial MLR rules.” Regulations implementing the commercial MLR rules are published at 45 CFR part 158.</P>
                    <P>
                        In a 2016 rule titled “Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party 
                        <PRTPAGE P="99447"/>
                        Liability” (81 FR 27853), which appeared in the May 6, 2016, 
                        <E T="04">Federal Register</E>
                        , we also established Medicaid and CHIP managed care regulations at §§ 438.8(k) and 457.1203(f) respectively, that require managed care plans to annually submit reports of their MLR to States, and, at §§ 438.74 and 457.1203(e) respectively, we require States to submit annually a summary of those reports to CMS based on our authority under sections 1903(m)(2)(A)(iii), 1902(a)(4), and 2101(a) of the Act.
                    </P>
                    <P>
                        In the May 2013 Medicare MLR final rule, we stated that we would use the commercial MLR rules as a reference point for developing the Medicare MLR requirements because the intent of the provisions is comparable. We observed that maintaining consistency between the commercial MLR rules and Medicare MLR rules serves to limit burden on organizations that participate in both markets and makes commercial and Medicare MLRs as comparable as possible for comparison and evaluation purposes. In the March 2022 proposed rule, we reiterated our longstanding policy of attempting to align the Medicare MLR requirements with the commercial MLR requirements to limit burden on organizations that participate in both markets.
                        <SU>219</SU>
                        <FTREF/>
                         We also cited this policy when we amended our regulations to authorize the public release of the Part C and Part D MLR data that we collect for a contract year under §§ 422.2460 and 423.2460 in the rule titled “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements” (81 FR 80170), which appeared in the November 15, 2016, 
                        <E T="04">Federal Register</E>
                        . At the same time, in developing the Medicare MLR regulations, we have recognized that some aspects of the regulation for commercial plans needed to be tailored to fit the unique characteristics of the MA and Prescription Drug plan (PDP) markets. For example, Medicare MLRs are reported on a contract basis, rather than by state and market.
                    </P>
                    <FTNT>
                        <P>
                            <SU>219</SU>
                              
                            <E T="03">https://www.federalregister.gov/d/2022-00117/p-656.</E>
                        </P>
                    </FTNT>
                    <P>In this proposed rule, we propose to make certain modifications to the MLR reporting requirements and to add requirements based upon MLR audit examinations in the Medicare Part C and Part D programs. The overall goal of the modifications is to do all of the following:</P>
                    <P>• Further align the Medicare MLR program with the commercial and Medicaid MLR programs.</P>
                    <P>• Improve the accuracy of MA and Part D MLR reporting.</P>
                    <P>• Safeguard the integrity of the Medicare program.</P>
                    <P>• Ensure beneficiaries receive value from the MA and Part D programs.</P>
                    <P>Specifically, we propose to amend § 422.2420(b)(2)(xi) to establish clinical or quality improvement standards for provider incentives and bonus arrangements included in the MA MLR numerator. We propose to amend §§ 422.2430(a) and 423.2430(a) to prohibit administrative costs from being included in quality improving activities in the MA and Part D MLR numerators. We also propose to amend §§ 422.2420(d)(2)(i) and 423.2420(d)(2)(i)) to impose additional requirements for the allocation of expenses in the MLR. Additionally, we propose to add new paragraphs §§ 422.2450, 422.2452, 422.2454, 423.2450, 423.2452, and 423.2454 to establish new audit and appeals processes for MLR compliance. We also propose to add §§ 422.2490(b)(6) and 423.2490(b)(6), to add an exclusion to the data release, to exclude from release the DIR information reported within the MLR data as part of incurred claims. Furthermore, we propose to exclude unsettled balances from the Medicare Prescription Payment Plan from the MLR numerator at § 423.2420(b)(4)(iii). We are issuing a request for information on whether CMS could and should adopt policies regarding how the MA and Part D MLRs are calculated to help enable policymakers to address concerns surrounding vertical integration in MA and Part D. Finally, we are proposing to amend §§ 422.2460(a) and 422.2490(b) to explicitly provide that the MLR reporting includes detailed information regarding provider payment arrangements. These proposals are described in detail below.</P>
                    <HD SOURCE="HD3">2. Proposal To Require Clinical or Quality Improvement Standards for Provider Incentive and Bonus Arrangements To Be Included in the MA MLR Numerator (§ 422.2420)</HD>
                    <P>Section 1857(e)(4) of the Act requires the Secretary to determine for a contract year whether an MA organization has failed to have an MLR of at least 85 percent. Because section 1860D-12(b)(3)(D) of the Act incorporates by reference the requirements of section 1857(e) of the Act, these MLR requirements also apply to the Medicare Part D program. However, the statute does not specify how the Secretary must calculate the MLR. Accordingly, in the May 2013 Medicare MLR final rule, we established regulations specifying how we calculate the MLR for MA and Part D contracts.</P>
                    <P>For MA and Part D contracts, we identify the elements that are required to be included in the MLR numerator for a contract at §§ 422.2420(b) and 423.2420(b). Specifically, under §§  422.2420(b)(1) and 423.2420(b)(1), MA organizations and Part D sponsors must include in the MLR numerator incurred claims (as defined in paragraphs (b)(2) through (b)(4) for both programs); expenditures under the contract for activities that improve health care quality, which are referenced at paragraph (b)(1)(iii), and described in detail at §§ 422.2430 and 423.2430; and, under § 422.2420(b)(1)(ii), for the MA program, the amount to reduce the Part B premium, if any, for all MA plans under the contract for the contract year.</P>
                    <P>For the MA program, incurred claims include direct claims that the MA organization pays to providers (including under capitation contracts) for covered services that are provided to all enrollees under the contract. Under § 422.2420(b)(2)(xi), incurred claims for clinical services and prescription drug costs must include “the amount of incentive and bonus payments made to providers,” which includes paid and accrued medical incentives and bonuses. Currently, incentive and bonus payments made to providers are included as incurred claims in the MLR numerator regardless of whether they are tied to clinical or quality improvement standards for providers.</P>
                    <P>
                        While many types of provider incentives and bonuses can reward higher-quality care to enrollees, MLR examinations in other markets have found some incentive or bonus payments to providers are not based on quality or performance metrics. For example, as noted in the final rule titled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2023” (87 FR 27208), which appeared in the May 6, 2022, 
                        <E T="04">Federal Register</E>
                         (hereinafter referred to as the May 2022 commercial final rule), commercial examinations have found issuers reporting incentive or bonus payments to affiliated providers that are not based on quality or performance metrics, but rather, involve transferring excess premium revenue to providers to circumvent MLR rebate requirements. In addition, as discussed in the final rule titled “Medicaid Program; Medicaid and 
                        <PRTPAGE P="99448"/>
                        Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality” (89 FR 41002), which appeared in the May, 10, 2024, 
                        <E T="04">Federal Register</E>
                         (hereinafter referred to as the May 2024 Medicaid final rule), Medicaid reviews of States' oversight of managed care plan MLR reporting found many managed care plans' contracts with network providers did not base incentive payments on a requirement for the provider to meet quantitative clinical or quality improvement standards or metrics.
                    </P>
                    <P>
                        Given these findings, we revised the commercial MLR regulations at 45 CFR 158.140(b)(2)(iii) to only permit issuers to include provider incentive and bonus payments in their MLR numerator if they are tied to clearly defined, objectively measurable, and well-documented clinical or quality improvement standards for these costs to qualify as expenditures in the MLR numerator in the May 2022 commercial final rule.
                        <SU>220</SU>
                        <FTREF/>
                         Similarly, effective July 9, 2024, we revised the Medicaid and CHIP regulations at 42 CFR 438.3(i), 438.8(e)(2), 457.1201, and 457.1203 to specify that only those provider incentives and bonuses tied to clearly defined, objectively measurable, and well-documented clinical or quality improvement standards that apply to providers may be included in incurred claims for MLR reporting in the May 2024 Medicaid final rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>220</SU>
                              
                            <E T="03">https://www.govinfo.gov/content/pkg/FR-2022-05-06/pdf/2022-09438.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Given the similarities between the commercial MLR regulations when these findings were made and current MA MLR regulations, we believe that the concerns identified about incentive or bonus payments to providers not being based on quality or performance metrics in the commercial market are also applicable to the MA market. If MA organizations or Part D sponsors use incentive or bonus payments to providers to inflate their MLRs by including such payments for the sole purpose of meeting the MLR and not for clinical or quality improvement purposes, that would conflict with the purpose of the MLR requirement. Generally, the purpose of the MLR requirement is to create incentives for MA organizations and Part D sponsors to reduce administrative costs, as well as reduce funding for activities such as marketing, profits, and other business functions and thereby ensure that taxpayers and enrolled beneficiaries receive maximum value from Medicare health plans. If incentive and bonus payments are not tied to clinical or quality improvement purposes, taxpayers and enrolled beneficiaries would not receive any value from such payments.</P>
                    <P>Furthermore, we believe that aligning our regulations with the commercial and Medicaid regulations would be consistent with our longstanding policy of modeling Medicare MLR rules on commercial MLR rules and would limit the burden on organizations that participate in multiple markets and promote comparability of commercial, Medicaid, and Medicare MLRs for comparison and evaluation purposes.</P>
                    <P>As such, we propose to amend § 422.2420(b)(2)(xi) such that only those provider incentives and bonuses made, or expected to be made, that are tied to clearly defined, objectively measurable, and well documented clinical or quality improvement standards that apply to providers may be included in incurred claims in the numerator for MA MLR reporting and remittance purposes.</P>
                    <P>While we believe that concerns about incentive or bonus payments to providers not based on quality or performance metrics in the MA market and our longstanding policy of alignment with the commercial MLR rules support amending the MA MLR rules to reflect the commercial MLR rules for provider incentive and bonus payments, we believe that certain unique characteristics of the Part D program may counsel against a similar change for that program at this time. Specifically, under § 423.2420(b)(2)(i), for MA contracts that include MA-PD plans and for PDP contracts, incurred claims include only drug costs that are “actually paid” by the Part D sponsor. The concept of “actually paid” is defined at § 423.308 and refers to Part D costs that must be actually incurred by the Part D sponsor, net of any direct or indirect remuneration (DIR) from any source. Therefore, the amount reported in the MLR numerator as direct drug costs incurred by the sponsor must be net of all DIR (including discounts, charge backs or rebates, cash discounts, free goods contingent on a purchase agreement, up-front payments, coupons, goods in kind, free or reduced-price services, grants, or other price concessions or similar benefits offered to some or all purchasers) from any source (including manufacturers, pharmacies, enrollees, or any other person) that would serve to decrease the costs incurred by the Part D sponsor.</P>
                    <P>
                        DIR that serves to increase the costs incurred by the Part D sponsor—referred to as 
                        <E T="03">negative DIR</E>
                        —is included in the MLR numerator when it meets the requirements at § 423.308 for amounts that are actually paid.
                        <SU>221</SU>
                        <FTREF/>
                         Negative DIR includes incentive and bonus payments made to pharmacies and other Part D providers. Because incentive and bonus payments made under the Part D program are already accounted for as DIR, Part D sponsors are not subject to a separate requirement to include such payments in the MLR numerator. Revising the Part D MLR regulations to require that incentive and bonus payments be tied to clinical or quality improvement standards could potentially require changes to the definition of drug costs that are “actually paid,” which, in turn, could affect other processes outside of the MLR that rely on that definition which is out of the scope of this provision. Furthermore, CMS believes that incentive and bonus payments made under the Part D program are generally tied to pharmacy performance metrics. Accordingly, we do not believe that it is necessary to amend the Part D MLR regulations at this time. However, we seek comments on whether interested parties believe there are additional considerations that should motivate CMS to consider adding § 423.2420(b)(2)(x) to mirror the proposed change to § 422.2420(b)(2)(xi).
                    </P>
                    <FTNT>
                        <P>
                            <SU>221</SU>
                             For additional discussion of negative DIR, please review the Final Medicare Part D DIR Reporting Guidance, which is released by CMS annually.
                        </P>
                    </FTNT>
                    <P>We seek comment on these proposals, including whether any modifications to the credibility adjustment may be necessary.</P>
                    <HD SOURCE="HD3">3. Proposal To Prohibit Administrative Costs From Being Included in Quality Improving Activities in the MA and Part D MLR Numerator (§§ 422.2430 and 423.2430)</HD>
                    <P>
                        Under §§ 422.2420(b)(1)(iii) and 423.2420(b)(1)(ii), MA organizations and Part D sponsors must include expenditures under the contract for activities that improve health care quality, also known as quality improvement activities (QIAs), in the numerator for MA and Part D contract MLRs. QIAs are described in detail for both programs at §§ 422.2430 and 423.2430, respectively. As specified at paragraph (a)(2) of §§ 422.2430 and 423.2430, a QIA must be designed to improve health outcomes, implement activities to prevent hospital readmissions, implement activities to improve patient safety, implement wellness and health promotion activities, or enhance the use of health care data to improve quality, transparency, and outcomes.
                        <PRTPAGE P="99449"/>
                    </P>
                    <P>As specified at paragraph (a)(3) of §§ 422.2430 and 423.2430, a non-claims expense incurred by an MA organization or Part D sponsor may be accounted for as a quality improvement activity only if the activity falls into one of the categories described previously and meets all of the following requirements:</P>
                    <P>• It must be designed to improve health quality.</P>
                    <P>• It must be designed to increase the likelihood of desired health outcomes in ways that are capable of being objectively measured and of producing verifiable results and achievements.</P>
                    <P>• It must be directed toward individual enrollees or incurred for the benefit of specified segments of enrollees or provide health improvements to the population beyond those enrolled in coverage as long as no additional costs are incurred due to the non-enrollees.</P>
                    <P>• It must be grounded in evidence-based medicine, widely accepted best clinical practice, or criteria issued by recognized professional medical associations, accreditation bodies, government agencies or other nationally recognized health care quality organizations.</P>
                    <P>In addition, under paragraph (a)(4) of §§ 422.2430 and 423.2430, QIAs include Medication Therapy Management Programs that meet the requirements of § 423.153(d), as well as fraud reduction activities, including fraud prevention, fraud detection, and fraud recovery.</P>
                    <P>Sections 1857(e)(4) and 1860D-12(b)(3)(D) of the Act require MA organizations and Part D sponsors to report to CMS the MLR for each contract for each contract year and meet a minimum MLR requirement of 85 percent. Under §§ 422.2460(a) and 423.2460(a), the MLR report to CMS must include the data needed by the MA organization or Part D sponsor to calculate and verify the MLR, including the incurred claims, quality improving activity expenditures, non-claims costs, taxes, licensing and regulatory fees, total revenue, and any remittance owed to CMS. However, §§ 422.2430 and 423.2430 do not specify the types of expenses that may be reported as a QIA expense or the extent to which the expenses must relate to a QIA.</P>
                    <P>
                        The commercial MLR audit examinations have found QIA expenses to be a high-risk reporting area with “wide discrepancies in the types of expenses that issuers include in QIA expenses and creates an unequal playing field among issuers.” 
                        <SU>222</SU>
                        <FTREF/>
                         The commercial MLR examinations found some issuers were including only direct expenses such as salaries of the staff performing the quality improving functions in QIA expenses, while other issuers were including indirect expenses such as overhead, the full salaries of employees who were conducting QIA only part of the time, IT infrastructure that supports regular business functions such as billing, office space, marketing, lobbying, third-party vendor profits, and company parties and retreats, including catering and travel.
                        <SU>223</SU>
                        <FTREF/>
                         These examinations also found that some issuers allocated indirect expenses such as overhead, marketing, lobbying, and third-party vendor profits to count as QIA expenses. In addition, many issuers did not have an accurate method to quantify the actual cost attributable to each QIA expense category and were often arbitrarily reporting or apportioning indirect expenses without adequate documentation or support. As discussed in the May 2024 Medicaid final rule, including such indirect expenses not directly related to activities that improve health care quality inflates the MLR numerator, and inconsistent MLR reporting undermines the integrity of the MLR programs.
                        <SU>224</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>222</SU>
                              
                            <E T="03">https://www.federalregister.gov/d/2022-09438/p-1778.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>223</SU>
                              
                            <E T="03">https://www.federalregister.gov/d/2022-09438/p-1779.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>224</SU>
                              
                            <E T="03">https://www.federalregister.gov/d/2024-08085/p-1255.</E>
                        </P>
                    </FTNT>
                    <P>
                        To clarify the types of QIA costs that may be included in MLR calculations, in the May 2022 commercial final rule, we amended the commercial regulations for QIA expenditures in 45 CFR 158.150(a), effective July 1, 2022, to provide that “only expenditures directly related to activities that improve health care quality may be included in QIA expenses.” In addition, we updated the Medicaid and CHIP MLR QIA reporting requirements in the May 2024 Medicaid final rule to add a reference to the same commercial regulation that prohibits the inclusion of overhead or indirect expenses that are not directly related to health care quality improvement activity expenditures. As stated in the May 2024 Medicaid final rule, the difference in standards could have posed a potential administrative burden for managed care plans that participate in Medicaid, CHIP, and the commercial markets because managed care plans and issuers may include different types of expenses in reporting QIA.
                        <SU>225</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>225</SU>
                              
                            <E T="03">https://www.federalregister.gov/d/2024-08085/p-1297.</E>
                        </P>
                    </FTNT>
                    <P>Given the similarities between current Medicare MLR rules and the commercial and Medicaid MLR rules in place when we identified discrepancies in the types of expenses issuers of commercial plans and Medicaid managed care plans reported in QIA, we believe that the concerns identified are also applicable to the MA and Part D markets. Furthermore, we believe that aligning our regulations with the commercial and Medicaid requirements would be consistent with our longstanding policy of modeling Medicare MLR rules on commercial MLR rules and would limit the burden on organizations that participate in multiple markets and promote comparability of commercial, Medicaid, and Medicare MLRs for comparison and evaluation purposes. For these reasons, we propose to amend §§ 422.2430(a) and 423.2430(a) to specify that only expenditures directly related to activities that improve health care quality may be included as quality improving activity expenses for purposes of MA and Part D MLR reporting.</P>
                    <P>We seek comment on these proposals.</P>
                    <HD SOURCE="HD3">4. Proposal To Codify Current Requirements That MA and Part D MLR Reports Include a Description of How Expenses Are Allocated Across Lines of Business (§§ 422.2420 and 423.2420)</HD>
                    <P>Under §§ 422.2420(d) and 423.2420(d), MA organizations and Part D sponsors, respectively, must allocate each MLR expense under one category and allocation to each category must be based on generally accepted accounting methods. MA organizations and Part D sponsors must also report expenditures that benefit multiple contracts on a pro rata or proportional share basis.</P>
                    <P>
                        Current Medicare MLR reporting instructions require MA organizations and Part D sponsors to include descriptions of the methodologies used to allocate expenses included in the calculation of the MLR. More specifically, as described in the MA and Part D MLR reporting instructions, the MLR Report workbook should be “used by organizations to describe the methods used to allocate expenses, as reported on the MLR Report, including incurred claims, health care quality improvement expenses, Federal and state taxes and licensing or regulatory fees, and non-claims costs.” 
                        <SU>226</SU>
                        <FTREF/>
                         The MLR reporting instructions further state that “a detailed description of each expense element should be provided, including how each specific expense meets the criteria for the type of expense in which it is categorized.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>226</SU>
                              
                            <E T="03">https://www.cms.gov/medicare/health-drug-plans/medical-loss-ratio.</E>
                        </P>
                    </FTNT>
                    <P>
                        Commercial regulations at 45 CFR 158.170(b) and Medicaid and CHIP 
                        <PRTPAGE P="99450"/>
                        regulations at 42 CFR 438.8(k)(1)(vii) and 457.1203(f) similarly require details on expense allocation in MLR reporting around the types of expenditures that were allocated, how the expenses met the criteria for inclusion in the MLR, and the methods used to allocate expenses. Like the Medicare MLR regulations, the commercial and Medicaid and CHIP regulations further require that issuers and managed care plans that operate multiple lines of business must submit information on the types of expenditures allocated to each line of business.
                    </P>
                    <P>As noted in the April 2018 final rule (82 FR 56459), consistent with our general approach when developing the original Medicare MLR requirements of aligning those requirements with the commercial MLR requirements to the greatest extent possible, we attempted to model the Medicare MLR reporting format on the tools used to report commercial MLR data in order to limit the burden on organizations that participate in both markets. As a result, the fields in the MA and Part D MLR Report workbook are similar to the fields on the commercial MLR reporting form, including fields for descriptions of the methodologies used to allocate expenses included in the calculation of the MLR.</P>
                    <P>We are proposing to align the Medicare MLR regulations with the commercial and Medicaid MLR requirements related to information on allocation of expenses and with current Medicare MLR reporting practices. Specifically, we propose to codify requirements that MA organizations and Part D sponsors report a detailed description of the methods used to allocate expenses, including incurred claims, expenditures on QIA, licensing and regulatory fees, and State and Federal taxes and assessments. Furthermore, we propose that the detailed description of each expense element must include how each specific expense meets the criteria for the type of expense in which it is categorized as well as the method by which it was aggregated and allocated. We propose adding this requirement to the Medicare MLR regulations at §§ 422.2420(d)(2)(i) and 423.2420(d)(2)(i).</P>
                    <P>We seek comment on these proposals.</P>
                    <P>As proposed, this provision is consistent with our current Medicare MLR reporting guidance and the requirements that were in place for CYs 2014 through 2017. This provision codifies an existing requirement in the reporting instructions and makes a clarification that is not expected to place additional requirements on MA organizations and Part D sponsors. As such, the proposed regulations §§ 422.2420(d)(2)(i) and 423.2420(d)(2)(i) do not create any additional burden for MA organizations or Part D sponsors. MA organizations' and Part D sponsors' compliance with the MLR reporting requirements is already evaluated through the current MLR desk review process described at §§ 422.2480 and 423.2480. In addition, the burden associated with the submission of MLR data is already approved under the OMB control number 0938-1232 (Medical Loss Ratio Annual Reports, MLR Notices, and Recordkeeping Requirements (CMS-10476)). We have not incorporated this provision in the Collection of Information section of this proposed rule, nor are we are scoring this provision in the Regulatory Impact Analysis section because MA organizations and Part D sponsors are already complying with the proposed regulations.</P>
                    <HD SOURCE="HD3">5. Proposal To Establish Standards for MA and Part D MLR Audit Examinations (§§ 422.2401, 422.2450, 422.2452, 422.2454, 422.2480, 423.2401, 423.2450, 423.2452, 423.2454, and 423.2480)</HD>
                    <P>As stated in 42 CFR 422.503(d), 422.504(d)-(e), 422.2480, 423.504(d), 423.505(d), and 423.2480, MA organizations' and Part D sponsors' MLR reports are subject to review and audit by CMS or by any person or organization that CMS designates. As part of the review and audit process, CMS or its representative may request additional documentation supporting the information contained in the MLR report. MA organizations and Part D sponsors must provide this information in a timely manner.</P>
                    <P>Currently, as described at §§ 422.2480 and 423.2480, CMS conducts desk reviews and analyses of the reported MLR data to identify omissions or suspected inaccuracies and communicate findings to MA organizations and Part D sponsors in order to resolve potential compliance issues. If an issue is identified during desk review, the MLR report may be corrected and resubmitted in order to resolve the identified issue, or the inquiry may be resolved by the MA organization or Part D sponsor providing additional explanation or supporting information sufficient to satisfy the inquiry and complete the desk review.</P>
                    <P>With the growth of the MA and Part D programs, greater scrutiny to ensure that MA organizations and Part D sponsors are appropriately spending funds to provide care to enrollees is increasingly important. Given the findings from the commercial and Medicaid MLR audit examinations, such as for QIA reporting, as discussed previously, we expect there may be similar reporting issues in the Medicare MLR program. In addition to ensuring compliance with the applicable requirements for calculating and reporting MLR information, we believe that audit examinations could help identify areas where submitters might be able to reduce reporting errors. MLR audits will improve the accuracy of MA organizations' and Part D sponsors' annual MLR submissions, safeguard the integrity of the Medicare program, and ensure beneficiaries receive value from the MA and Part D programs.</P>
                    <P>We propose new regulations and amendments to existing regulations to establish standards for the MA and Part D MLR audit examinations. These changes would more fully align the Medicare MLR regulations with longstanding operational practices of commercial and Medicaid MLR oversight, which consists of audit examinations, an appeal process for remittances determined to be owed as the result of an audit, and compliance actions when necessary.</P>
                    <P>
                        More specifically, we propose specifications for how CMS will conduct MA and Part D MLR audit examinations in addition to the MLR desk review process discussed previously and in regulations §§ 422.2480 and 423.2480. Under our existing authority, we propose requiring MA organizations and Part D sponsors selected for MLR audit examinations to provide detailed MLR data and underlying records that can be used to substantiate amounts included in the calculation of each contract's MLR. We also propose calling audit examinations for only those contracts with an MLR greater than 85 percent. Currently, CMS provides MA organizations and Part D sponsors with opportunities to correct MLR data through the MLR desk review process or through other self-reporting mechanisms, such as contacting CMS directly. Following the completion of the desk review process, consistent with the MLR regulations at §§ 422.2460(d) and 423.2460(d), the MLR is considered to have been reported once and is not reopened as a result of any payment reconciliation process. In addition, as stated in the May 2013 Medicare MLR final rule, if an MA organization or Part D sponsor reports that a contract's MLR for a contract year does not meet the 85 percent standard, a remittance amount is collected and that MLR is considered final. As such, the MLR audit examinations would not include 
                        <PRTPAGE P="99451"/>
                        contracts that previously paid remittances as the result of an MLR below 85 percent. As described further in this proposed rule, if through the audit process, it is determined that a contract did not meet the 85 percent threshold, we would recalculate the MLR based on audit examination findings to determine appropriate remittances and would not reopen MLR reports for submission of corrections. CMS may conduct Medicare MLR audit examinations in 2025 and the compliance actions that result from the audits and provisions in this rule would take effect in 2026.
                    </P>
                    <P>The following sections outline our proposal to establish regulations for an MA and Part D MLR audit process, an MLR audit remittance calculation and payment process if an MLR audit remittance is determined to be owed, and an appeal process for MA organizations and Part D sponsors to dispute the MLR audit remittance if requested. The last section outlines the compliance actions CMS may take as the result of MLR audit findings and proposed modifications to existing regulations to allow for future flexibility to pursue additional compliance actions if necessary.</P>
                    <HD SOURCE="HD3">a. MA and Part D MLR Audit Process</HD>
                    <P>We propose to add §§ 422.2450 and 423.2450 to regulations to establish the audit process to validate MA organization and Part D sponsors' MLR compliance. At §§ 422.2450(a) and 423.2450(a) we propose that CMS will provide at least 15 calendar days advance notice of its intent to conduct an audit of an MA organization or Part D sponsor. At §§ 422.2450(b) and 423.2450(b), we propose that all audits would include an entrance conference during which the scope of the audit would be presented and an exit conference during which the initial audit findings would be discussed. At §§ 422.2450(c) and 423.2450(c), we propose that all requested audit documentation would be provided by MA organizations or Part D sponsors to CMS within 30 calendar days of the audit entrance conference. CMS may extend, at CMS's discretion, the time for an MA organization or Part D sponsor to provide the documentation requested.</P>
                    <P>At §§ 422.2450(d) and 423.2450(d), we propose that CMS would share its preliminary audit findings with the MA organization or Part D sponsor, and the MA organization or Part D sponsor would then have 30 calendar days to respond to such findings. CMS may extend, at CMS's discretion, the time for an MA organization or Part D sponsor to submit such a response. At §§ 422.2450(e) and 423.2450(e), we propose that if the MA organization or Part D sponsor does not dispute the preliminary findings within the 30-day timeframe proposed at §§ 422.2450(d) and 423.2450(d), then the audit report becomes final. However, if the MA organization or Part D sponsor disputes the preliminary findings within the 30-day timeframe proposed at §§ 422.2450(d) and 423.2450(d), CMS would review and consider such response before finalizing the audit findings. At §§ 422.2450(f) and 423.2450(f), we propose that CMS would send a copy of the final audit report to the MA organization or Part D sponsor as well as issue corrective actions that the MA organization or Part D sponsor must undertake as a result of the audit findings. At §§ 422.2450(g) and 423.2450(g), we propose that if CMS determines as the result of an audit that an MA organization or Part D sponsor has failed to pay remittances it is obligated to pay pursuant to §§ 422.2470 and 423.2470, CMS may order the MA organization or Part D sponsor to pay those remittances in a manner consistent with new regulations §§ 422.2452 and 423.2452 described in the subsequent section of this proposed rule.</P>
                    <P>We seek comment on these proposals.</P>
                    <HD SOURCE="HD3">b. MLR Audit Remittance Process and Payment of MLR Audit Remittance</HD>
                    <P>We propose to add §§ 422.2452 and 423.2452 to establish the process for notifying MA organizations and Part D sponsors of the MLR audit remittance and how the MLR audit remittance would be collected in association with MLR audit examinations.</P>
                    <P>To support these new regulations, we propose to amend §§ 422.2401 and 423.2401 to add two definitions relevant for the establishment of the MLR audit remittance process.</P>
                    <P>
                        We propose to add a definition for the term 
                        <E T="03">MLR audit remittance process,</E>
                         which is the process by which CMS would calculate the MLR audit remittance for a contract that has failed to meet the 85 percent minimum MLR requirement as the result of an MLR audit examination and notify the MA organization or Part D sponsor about the remittance. The process includes collecting the MLR audit remittance indicated in the final audit report issued by CMS, receiving responses from MA organizations or Part D sponsors requesting an appeal of the MLR audit remittance, and taking actions to adjudicate an appeal (if requested) and receive MLR remittances from MA organizations and Part D sponsors.
                    </P>
                    <P>Per these definitions, CMS would calculate and notify MA organizations and Part D sponsors of the MLR audit remittance associated with the MLR audit examination findings. In the new regulations, at paragraph (a) of §§ 422.2452 and 423.2452, we propose that CMS would send the final audit report to MA organizations and Part D sponsors with the MLR audit remittance, if applicable. Specifically, proposed paragraphs (a)(1), (a)(2), (a)(3), and (a)(4) state that, if applicable, the notice would contain the following information: a MLR audit remittance; relevant banking and financial mailing instructions for MA organizations and Part D sponsors that owe CMS an MLR audit remittance that would be transferred to the Treasury General Fund; relevant CMS contact information; and a description of the steps for the MA organizations or Part D sponsor to request an appeal of the MLR audit remittance calculation.</P>
                    <P>At paragraph (b) of §§ 422.2452 and 423.2452, we propose to establish that MA organizations and Part D sponsors would have 15 calendar days from the date of issuance of the final audit report to request an appeal. We propose at paragraphs (b)(1) and (b)(2) of these new sections that, if an MA organization or Part D sponsor agrees with the MLR audit remittance, no response from the MA organization and Part D sponsor for that part of the audit report would be required, and that, if an MA organization or Part D sponsor does not request an appeal within 15 calendar days, CMS would not consider any subsequent requests for appeal of the MLR audit remittance.</P>
                    <P>At paragraph (c) of §§ 422.2452 and 423.2452, we propose to establish the actions that would take place if an MA organization or Part D sponsor does not appeal the MLR audit remittance. At paragraph (c)(1), we propose that an MA organization or Part D sponsor that owes money and does not appeal would have to remit payment in full within 120 calendar days from issuance of the final audit report. We further specify that an MA organization or Part D sponsor that does not appeal and does not remit payment within 120 calendar days of issuance of the final audit report would be subject to having any debts owed to CMS referred to the Department of the Treasury for collection.</P>
                    <P>If an MA organization or Part D sponsor does not appeal the MLR audit remittance indicated in the final audit report within 15 calendar days of the issuance of the final audit report, no subsequent requests for appeal would be considered.</P>
                    <P>
                        We seek comment on these proposals.
                        <PRTPAGE P="99452"/>
                    </P>
                    <HD SOURCE="HD3">c. Process for Appealing the MLR Audit Remittance</HD>
                    <P>We propose to add §§ 422.2454 and 423.2454 to regulations to establish that an MA organization or Part D sponsor may request an appeal of the calculation of the MLR audit remittance amount and the process and requirements for making such a request associated with MLR audit examination findings.</P>
                    <P>At paragraph (a) of §§ 422.2454 and 423.2454, we propose to establish requirements that would apply to MA organizations' and Part D sponsors' requests for appeal of the MLR audit remittance calculation.</P>
                    <P>Specifically, at paragraph (a)(1), we propose to establish the process under which an MA organization or Part D sponsor could request reconsideration of the MLR audit remittance. We propose to specify that the 15 calendar day period for filing the request would begin on the date the final audit report from CMS is issued. We believe that would provide organizations with sufficient time to request an appeal, as MA organizations and Part D sponsors would be aware of the amounts that factor into the MLR audit remittance at the time the final audit report is issued. Requiring a request for appeal within this timeframe would help ensure accurate and timely payment of the MLR audit remittance.</P>
                    <P>CMS would not accept requests for appeal that are submitted more than 15 calendar days after the date of issuance of the final audit report. As noted previously, if an MA organization or Part D sponsor does not reply within 15 calendar days, they would be deemed to accept the MLR audit remittance indicated in the final audit report.</P>
                    <P>If an MA organization or Part D sponsor agrees with the MLR audit remittance, no response to that part of the audit exam report would be required. Failure to request an appeal within 15 calendar days of the date of issuance of the final audit report would indicate acceptance of the MLR audit remittance.</P>
                    <P>We also propose that MA organizations and Part D sponsors would have to include in their request: (1) the calculation with which they disagree and (2) evidence supporting the assertion that the CMS calculation of the MLR audit remittance is incorrect. We further specify that CMS would not consider, and MA organizations and Part D sponsors should not submit, new data or data that was submitted to CMS after the final audit report was issued, unless requested by CMS.</P>
                    <P>In addition, to establish a review process under which MA organizations and Part D sponsors may request a reconsideration of CMS's MLR audit remittance calculation, we propose to add two additional levels of appeal: (1) an informal hearing conducted by the CMS Office of Hearings to review CMS's determination, following a request for appeal of the reconsideration of CMS's determination, and (2) a review by the CMS Administrator of the hearing officer's determination if there is an appeal of the CMS hearing officer's determination. We believe that these levels of appeal would afford MA organizations and Part D sponsors sufficient opportunities to present objections to the calculation of the MLR audit remittance in MLR audit examinations.</P>
                    <P>At paragraph (a)(1)(iii), we propose to establish that the CMS reconsideration official would review the MLR audit remittance calculation and evidence timely submitted by the MA organization or Part D sponsor supporting the assertion that the CMS calculation of the MLR audit remittance is incorrect. We further propose to establish that the CMS reconsideration official would inform the MA organization or Part D sponsor of their decision on the reconsideration in writing and that their decision would be final and binding unless the MA organization or Part D sponsor requests a hearing officer review.</P>
                    <P>At paragraph (a)(2), we propose to establish that MA organizations and Part D sponsors that disagree with CMS's reconsideration decision under paragraph (a)(1) of this section would be able to request an informal hearing by a CMS hearing officer.</P>
                    <P>Specifically, at paragraph (a)(2)(i), we propose that MA organizations and Part D sponsors would have to submit their requests for an informal hearing within 15 calendar days from the date of issuance of the reconsideration decision. At paragraph (a)(2)(ii), we propose that MA organizations and Part D sponsors would have to include in their request a copy of CMS's reconsideration decision, the specific findings or issues with which they disagree, and the reasons for which they disagree. At paragraph (a)(2)(iii), we propose to establish the informal hearing procedures. Specifically, we propose that the CMS hearing officer would provide written notice of the time and place of the informal hearing at least 30 calendar days before the scheduled date and the CMS reconsideration official would provide a copy of the record of the reconsideration decision to the hearing officer. We further propose that the hearing would be conducted by a hearing officer who would neither receive testimony nor accept new evidence. We finally propose that the hearing officer would be limited to the review of the record that the CMS reconsideration official had when making the reconsideration decision. At paragraph (a)(2)(iv), we propose that the CMS hearing officer would send a written decision to the MA organization or Part D sponsor explaining the basis for the decision. At paragraph (a)(2)(v), we propose to establish that the hearing officer's decision would be final and binding, unless the decision is reversed or modified by the CMS Administrator.</P>
                    <P>We further propose to establish at paragraph (a)(3) that MA organizations and Part D sponsors that disagree with the hearing officer's decision would be able to request a review by the CMS Administrator.</P>
                    <P>At paragraph (a)(3)(i), we propose that MA organizations and Part D sponsors would have to submit their requests for a review by the Administrator within 15 calendar days of the date of the decision and may submit written arguments to the Administrator for review but would not be able to submit evidence in addition to the evidence submitted during CMS's reconsideration. At paragraph (a)(3)(ii), we propose that the CMS Administrator would have the discretion to elect or decline to review the hearing officer's decision within 30 calendar days of receiving the request for review. We further propose that if the Administrator declines to review the hearing officer's decision, the hearing officer's decision would be final and binding.</P>
                    <P>We propose at paragraph (a)(3)(iii) that, if the Administrator elects to review the hearing officer's decision within 30 calendar days of receiving the request, the Administrator would review the hearing officer's decision, as well as any information included in the record of the hearing officer's decision and any written arguments submitted by the MA organization or Part D sponsor, and determine whether to uphold, reverse, or modify the decision. At paragraph (a)(3)(iv), we propose that the Administrator's determination would be final and binding and no other requests for review would be considered.</P>
                    <P>
                        At paragraph (b), we propose to establish the matters subject to appeal and that an MA organization or Part D sponsor bears the burden of proof. At paragraph (b)(1), we propose to establish that the MA organization or Part D sponsor appeal would be limited to CMS's calculation of the MLR audit remittance. At paragraph (b)(2), we propose that the MA organization or Part D sponsor would bear the burden 
                        <PRTPAGE P="99453"/>
                        of proof by providing evidence demonstrating that CMS's audit examination findings for the MLR audit remittance are incorrect.
                    </P>
                    <P>At paragraph (b), we propose to establish the matters subject to appeal and that an MA organization or Part D sponsor bears the burden of proof. At paragraph (b)(1), we propose to establish that the MA organization or Part D sponsor appeal would be limited to CMS's calculation of the MLR audit remittance. At paragraph (b)(2), we propose that the MA organization or Part D sponsor would bear the burden of proof by providing evidence demonstrating that CMS's audit examination results for the MLR audit remittance require further review. The MA organizations and Part D sponsors may not challenge the underlying methodology for the MLR audit remittance calculation.</P>
                    <P>Proposed paragraph (d) would clarify that nothing in this section would limit an MA organization or Part D sponsor's responsibility to comply with any other applicable statute or regulation.</P>
                    <P>We seek comment on these proposals.</P>
                    <HD SOURCE="HD3">d. MLR Audit Compliance Actions</HD>
                    <P>To address issues of noncompliance as identified through an MLR audit, CMS would pursue certain actions depending on the audit results. If an audit examination finds inaccurate MLR data was reported and that the recalculated MLR (based on the audit finding(s)) is less than 85 percent, CMS proposes to determine remittances owed, send a remittance notice, issue a Corrective Action Plan (CAP) consistent with regulations §§ 422.504 and 423.505, and require a detailed response from the MA organization or Part D sponsor outlining how the plan would address the audit finding(s).</P>
                    <P>If an audit examination finds inaccurate MLR data was reported but the MLR remains greater than 85 percent when recalculated based on the audit finding(s), CMS proposes to issue progressive noncompliance actions consistent with the regulations at §§ 422.504(m) and 423.505(n), depending on the plan's previous record of compliance and the gravity of the violation (for example, violation frequency, level of financial impact). CMS also proposes to require the MA organization or Part D sponsor to address the audit finding(s) and explain the corrective actions they have taken or plan to take. CMS reserves the right to review the actual implementation of the MA organization's or Part D sponsor's plan to provide correct MLR data in future MLR annual reporting forms, examinations, or as otherwise may be appropriate, to ensure noncompliance issues are being or have been addressed.</P>
                    <P>Finally, we propose to amend §§ 422.2480(d) and 423.2480(d) to establish that if CMS finds MLR data to be reported in an untimely and inaccurate manner, we may pursue intermediate sanctions in accordance with 42 CFR part 422, subpart O and 42 CFR part 423, subpart O. This amendment will provide us with flexibility in the future to take additional actions if audit examinations uncover instances where MLR data is not reported in a timely and accurate manner in compliance with 42 CFR part 422, subpart X and part 423, subpart X. It will also encourage MA organizations and Part D sponsors to approach their MLR calculations with greater precision. We seek comment on this proposal.</P>
                    <HD SOURCE="HD3">6. Proposal To Change Medicare MLR Regulations Authorizing Release of Part C and Part D MLR Data (§§ 422.2490 and 423.2490)</HD>
                    <P>Part C MLR data defined at § 422.2490(a) and Part D MLR data defined at § 423.2490(a) refers to the data the MA organizations and Part D sponsors submit to CMS in their annual MLR Reports, as required under existing §§ 422.2460 and 423.2460. For the purpose of the data release under §§ 422.2490 and 423.2490, we currently exclude certain categories of information from the release of Part C and Part D MLR data, as described at §§ 422.2490(b) and 423.2490(b). Specifically, CMS excludes four categories of information from the release of Part C and Part D MLR data. First, at §§ 422.2490(b)(1) and 423.2490(b)(1), we exclude from release any narrative information that MA organizations and Part D sponsors submit to support the amounts that they include in their MLR Reports, such as descriptions of the methods used to allocate expenses. Second, at §§ 422.2490(b)(2) and 423.2490(b)(2), we exclude from release any plan-level information that MA organizations and Part D sponsors submit in their MLR Reports. Third, at §§ 422.2490(b)(3) and 423.2490(b)(3), we exclude from release any information that could be used to identify Medicare beneficiaries or other individuals. Fourth, at §§ 422.2490(b)(4) and 423.2490(b)(4), we exclude from release any MLR review correspondence.</P>
                    <P>At §§ 422.2490(b)(6) and 423.2490(b)(6), we propose to add an exclusion to the data release, to exclude from release the DIR information reported within the MLR data as part of incurred claims. We are proposing this exclusion to align with the disclosure requirements regarding DIR data as required by section 1860D-15(f) of the Act.</P>
                    <HD SOURCE="HD3">7. Proposal To Exclude Medicare Prescription Payment Plan Unsettled Balances From the MLR (§§ 422.2420 and 423.2420)</HD>
                    <P>The Inflation Reduction Act of 2022 (IRA) (Pub. L. 117-169) made several additions and amendments to the Act that affect the structure of the defined standard Part D drug benefit. Section 11202 of the IRA (Maximum Monthly Cap on Cost-Sharing Payments under Prescription Drug Plans and MA-PD Plans) added a new section 1860D-2(b)(2)(E) to the Act requiring all Medicare prescription drug plans to offer their Part D enrollees the option to pay out-of-pocket (OOP) Part D drug costs through monthly payments over the course of the plan year instead of at the pharmacy point of sale (POS) beginning January 1, 2025. Section 1860D-2(b)(2)(E)(v)(VI) of the Act specifies that any unsettled balances with respect to amounts owed under the Medicare Prescription Payment Plan “shall be treated as plan losses and the Secretary shall not be liable for any such balances outside of those assumed as losses estimated in plan bids.”</P>
                    <P>Section 11202(c) of the IRA directs the Secretary to implement the Medicare Prescription Payment Plan for 2025 by program instruction or other forms of program guidance. In accordance with the law, CMS released guidance establishing critical operational and technical, and communication requirements for the Medicare Prescription Payment Plan for 2025. In the Medicare Prescription Payment Plan: Final Part Two Guidance on Select Topics, Implementation of section 1860D-2 of the Social Security Act for 2025, and Response to Relevant Comments, CMS established that, consistent with the inclusion of plan losses in the administrative expense portion of the Part D bid, unsettled balances from the Medicare Prescription Payment Plan will be considered administrative costs for purposes of the MLR calculation and therefore be excluded from the MLR numerator.</P>
                    <P>
                        CMS does not have program instruction authority to implement the Medicare Prescription Payment Plan beyond 2025, so we are pursuing rulemaking to codify the requirements of the program for 2026 and subsequent years. In this proposed rule, with respect to the treatment of unsettled balances from the Medicare Prescription Payment Plan, we propose to exclude unsettled balances from the Medicare Prescription Payment Plan from the 
                        <PRTPAGE P="99454"/>
                        MLR numerator at §§ 422.2420(b)(4)(i)(D) and 423.2420(b)(4)(i)(D).
                    </P>
                    <HD SOURCE="HD3">8. Request for Information on MLR and Vertical Integration</HD>
                    <P>
                        MLR reporting may be less transparent for integrated medical systems where the MA organization or Part D sponsor is a subsidiary, owner, or affiliate in such a system. In these situations, there may be reduced transparency when an MA organization or Part D sponsor reports an MLR based only on their own direct expenditures due to the relationships between these related entities and the potential that payments made to related parties may, in some cases, be inflated to ensure the MA organization or Part D sponsor meets its MLR reporting requirements, obscuring the actual MA and Part D-related profits made by the integrated system as a whole. Policymakers, MedPAC, and other researchers have raised concerns that large MA organizations are becoming more vertically integrated by acquiring hospitals, physician practices, pharmacy benefit managers, specialty pharmacies, and other related health care businesses.
                        <E T="51">227 228</E>
                        <FTREF/>
                         Furthermore, there is evidence that this vertical integration is associated with higher health and prescription drug expenditures.
                        <E T="51">229 230</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>227</SU>
                              
                            <E T="03">https://www.cms.gov/newsroom/fact-sheets/cms-letter-plans-and-pharmacy-benefit-managers.</E>
                        </P>
                        <P>
                            <SU>228</SU>
                              
                            <E T="03">www.ftc.gov/system/files/ftc_gov/pdf/pharmacy-benefit-managers-staff-report.pdf,</E>
                             page 45.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>229</SU>
                              
                            <E T="03">https://www.medpac.gov/wp-content/uploads/2023/06/Jun23_MedPAC_Report_To_Congress_SEC.pdf,</E>
                             page 17.
                        </P>
                        <P>
                            <SU>230</SU>
                              
                            <E T="03">https://www.medpac.gov/wp-content/uploads/2024/03/Mar24_MedPAC_Report_To_Congress_SEC.pdf,</E>
                             page 365.
                        </P>
                    </FTNT>
                    <P>In addition to the proposed regulatory changes, we are issuing a request for information seeking comment from the public on whether CMS could and should adopt policies, and if so, what potential policies it could or should adopt, regarding how the MA and Part D MLRs are calculated to help enable policymakers to address concerns surrounding vertical integration in MA and Part D. Based on the information we receive, CMS will consider additional rulemaking or guidance for future contract year rulemaking. Specifically, we are requesting comment, data, and examples regarding the following potential policies:</P>
                    <P>• Establish parameters in MLR reporting that limit the amount of transfer payments that are incurred between related parties that can be included in the numerator, such as by limiting the amount for any service included in the numerator to be under a relative benchmark.</P>
                    <P>• Revise definition of incurred claims to include profits earned by related parties as indirect remuneration to a Part D sponsor or MA organization and not allowable for inclusion in the MLR numerator.</P>
                    <P>• Revise definition of incurred claims to include payments that are net of direct or indirect remuneration by or to the Parent Organization, in addition to the Part D sponsor.</P>
                    <P>• Establish a framework for assessing transfer payments made to or by related parties by expanding related-party reporting requirements in the MLR. CMS specifically invites comment on the kind of information CMS could collect about transfer payments to be able to assess what portions of such payments should be reported in the MLR numerator.</P>
                    <P>• We also request comment on the type of information we could collect to better define types of vertical integration or related party relationships that exist in the health insurance market.</P>
                    <P>• Other frameworks or policies not enumerated here.</P>
                    <P>Please note that this is a request for information only and is issued solely for information and planning purposes.</P>
                    <HD SOURCE="HD3">9. Technical Correction (§ 422.2420)</HD>
                    <P>In the course of this rulemaking, we noticed the need for a technical correction at regulation § 422.2420(c)(2)(iv), which specifies that Federal income tax-exempt MA organization community benefit expenditure payments may be deducted up to a specific limit when calculating the MLR. The regulation text currently refers to Part D sponsors in two places when it should refer to MA organizations, and thus we propose to make the correction.</P>
                    <HD SOURCE="HD3">10. Proposal To Add Provider Payment Arrangement Reporting in the Medicare MLR Reporting Regulations (§§ 422.2460 and 422.2490)</HD>
                    <P>
                        Alternative payment models (APMs) have become increasingly prevalent in the health care system.
                        <SU>231</SU>
                        <FTREF/>
                         In addition, CMS continues to test different value-based programs to pay providers based on quality, rather than quantity of care.
                        <E T="51">232 233 234</E>
                        <FTREF/>
                         APMs are arrangements under which providers have added incentives to provide high-quality and cost-effective care, which can apply to a clinical condition, episode of care, or patient population.
                        <SU>235</SU>
                        <FTREF/>
                         Researchers and stakeholders, through the Request for Information on MA data, have raised concerns that there is limited public information available about APMs outside of Traditional Medicare.
                        <E T="51">236 237</E>
                        <FTREF/>
                         In addition, researchers have raised concerns that these payment arrangements may not be transparent and could lead to increases in reported claims spending in the Medicare MLR, particularly when the insurer and provider are the same business entity or very closely tied together.
                        <SU>238</SU>
                        <FTREF/>
                         Furthermore, stakeholders have called on CMS to collect more data on value-based payment arrangements between providers and plans. 
                        <SU>239</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>231</SU>
                              
                            <E T="03">https://www.techtarget.com/revcyclemanagement/answer/Value-Based-Reimbursement-Grows-as-Providers-Take-on-More-Risk.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>232</SU>
                              
                            <E T="03">https://hcp-lan.org/workproducts/apm-methodology-2023.pdf.</E>
                        </P>
                        <P>
                            <SU>233</SU>
                              
                            <E T="03">https://www.cms.gov/medicare/quality/value-based-programs.</E>
                        </P>
                        <P>
                            <SU>234</SU>
                             
                            <E T="03">https://www.cms.gov/priorities/innovation/about#:~:text=The%20CMS%20Innovation%20Center's%20models,Advantage%20or%20Medicare%20Part%20D.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>235</SU>
                              
                            <E T="03">https://qpp.cms.gov/apms/overview.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>236</SU>
                              
                            <E T="03">https://www.ajmc.com/view/all-payer-value-based-contracting-in-organizations-with-medicare-acos.</E>
                        </P>
                        <P>
                            <SU>237</SU>
                              
                            <E T="03">https://www.regulations.gov/document/CMS-2024-0008-0001/comment.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>238</SU>
                              
                            <E T="03">https://www.brookings.edu/articles/medicare-advantage-spending-medical-loss-ratios-and-related-businesses-an-initial-investigation/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>239</SU>
                              
                            <E T="03">https://www.govinfo.gov/content/pkg/FR-2024-01-30/pdf/2024-01832.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        Therefore, to improve transparency and oversight of the use of Medicare Trust Fund dollars, we are proposing to collect additional details regarding plan expenditures categorized by different provider payment arrangements.
                        <SU>240</SU>
                        <FTREF/>
                         Building on the existing Medicare Part C reporting requirements, we propose simplified provider payment arrangement categories for ease of reporting as we believe the streamlined categories will provide sufficient information to help inform the accuracy of MLR submissions, and value of services provided to MA enrollees.
                        <SU>241</SU>
                        <FTREF/>
                         Specifically, we propose to amend § 422.2460(a) so the regulation text explicitly provides that the MLR report submitted to CMS includes aggregate expenditures by provider payment arrangement type in MA. Under our proposed amendment, paragraph (a) of § 422.2460 would state that, except as provided in paragraph (b), for each contract year, each MA organization must submit to CMS, in a timeframe and manner we specify, a report that includes the data needed to calculate and verify the MLR and remittance amount, if any, for each contract, 
                        <PRTPAGE P="99455"/>
                        including the amount of incurred claims for Medicare-covered benefits, supplemental benefits, provider payment arrangements, and prescription drugs; expenditures on quality improving activities; non-claims costs; taxes; licensing and regulatory fees; total revenue; and any remittance owed to CMS under § 422.2410.
                    </P>
                    <FTNT>
                        <P>
                            <SU>240</SU>
                              
                            <E T="03">https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-422/subpart-X/section-422.2420.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>241</SU>
                              
                            <E T="03">https://www.cms.gov/files/document/cy2024-part-c-reporting-requirements.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        If our proposal to amend our regulations to require additional MLR data is finalized, we intend to make changes to the MLR Reporting Tool. We will revise the MLR Reporting Tool to add separate fields to capture various categories of expenditures for provider payment arrangements. Specifically, we propose to collect the following sample list of three categories of provider payment arrangements ordered from lowest to highest financial accountability for providers: FFS, APMs, and population-based payments. These proposed categories of provider payment arrangements are based on the Health Care Payment Learning &amp; Action Network (HCPLAN) APM framework and ongoing measurement effort in order to reduce the reporting burden on stakeholders.
                        <SU>242</SU>
                        <FTREF/>
                         FFS payment arrangements are typically based on FFS payments in which providers are paid for each service that is billed by the patient's insurer and may or may not be linked to pay-for-performance or quality payments to improve quality performance such as care coordination fees or bonuses for reporting data. APMs may include upside and/or downside risk such as shared-savings linked to utilization, a clinical episode, or procedure-based bundled payments. Providers who meet quality, and cost or utilization targets may receive shared savings, and/or be held financially accountable for missing performance measures designed to deliver care to patients at the right time, place, and level of intensity. Finally, in population based payments providers are paid through capitated payments for comprehensive treatment of specific conditions, bundled services such as oncology care, or a global budget that is not condition specific, but is linked to quality. These comprehensive payment arrangements are designed to pay providers a percentage of, or the full premium. Providers are then fully financially accountable for the delivery of person-centered care through coordinated preventive health, health improvement, acute and chronic care services.
                        <E T="51">243 244</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>242</SU>
                              
                            <E T="03">https://www.cms.gov/priorities/innovation/innovation-models/health-care-payment-learning-and-action-network.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>243</SU>
                              
                            <E T="03">https://hcp-lan.org/workproducts/apm-methodology-2023.pdf.</E>
                        </P>
                        <P>
                            <SU>244</SU>
                              
                            <E T="03">https://hcp-lan.org/workproducts/apm-refresh-whitepaper-final.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We believe it is appropriate for CMS to retain flexibility to modify the scope of the data fields and the specific list of provider payment arrangements required to be reported on the MLR Reporting Template. Maintaining this flexibility will allow CMS to collect data that is sufficiently detailed to enable us to understand benefit expenditures and verify and increase accountability for the accuracy of MLR calculation. We believe the proposed amendment to § 422.2460(a) will provide us with the flexibility to modify the scope of data fields and categories required for expenditures under various provider payment arrangements. The intent of this proposed rule is not to create a static MLR report; rather this rule is intended to enable reporting requirements that support the program needs, such as supporting MLR calculation, verifying data reporting accuracy, gaining insight into expenditures under various provider payment arrangements, and providing transparency into program expenditures.</P>
                    <P>
                        Modifications to the MLR data requirements for expenditures under provider payment arrangements will be set forth in a revision to the MLR Paperwork Reduction Act package (CMS-10476, OMB 0938-1232) and made available to the public for review and comment under the standard PRA process which includes the publication of 60- and 30- day 
                        <E T="04">Federal Register</E>
                         notices and the posting of the collection of information documents on our PRA website. The sample list of provider payment arrangements in the proposed rule should be viewed as examples of the types of categories CMS is interested in collecting based on the APM framework described above. We will set forth data reporting requirements in a revised package as required by the PRA. This package will be published in the 
                        <E T="04">Federal Register</E>
                         and be available for public comment.
                    </P>
                    <P>We solicit comment on whether the sample list of categories of provider payment arrangements include the appropriate breakouts for separating out incurred claims in the MLR Reporting Tool. We are interested in feedback that addresses whether we should increase or decrease the number of categories, as well as suggestions for clarifications, alternative categories, or for consolidating categories. Given the differences in provider payment arrangements between MA and Part D, CMS is not proposing to add these requirements to the Medicare MLR reporting for the Part D portion of MA-PD plans or standalone Part D plans at this time at § 423.2460(a). We are interested in the extent to which the proposed payment arrangement reporting in the Medicare MLR report applies to Part D and potential provider payment arrangements for Part D.</P>
                    <P>Finally, we do not intend to release the provider payment arrangements data we collect publicly unless it is deidentified and reported as aggregate totals. Specifically, we propose to add an exclusion to the data release at § 422.2490(b)(7) to exclude any provider payment arrangement data that is not reported on a deidentified basis and that is not reported on an aggregate total basis. We solicit comment on whether there is additional sensitivity around expenditures under provider payment arrangements, such that public release of data concerning those expenditures would be harmful.</P>
                    <HD SOURCE="HD1">U. Enhancing Rules on Internal Coverage Criteria § 422.101</HD>
                    <P>
                        In the final rule titled “Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly,” which appeared in the 
                        <E T="04">Federal Register</E>
                         on April 12, 2023 (88 FR 22120) (hereinafter referred to as the “April 2023 final rule”), we codified regulations that clarified the obligations and responsibilities for MA organizations in covering basic benefits and established guardrails for when MA organizations may develop and use coverage criteria to achieve better alignment with Traditional Medicare.
                        <SU>245</SU>
                        <FTREF/>
                         We clarified at § 422.101(b)(2) that statutes and regulations that set the scope of coverage in the Traditional Medicare program are applicable to MA organizations in setting the scope of basic benefits that must be covered by MA plans.
                        <SU>246</SU>
                        <FTREF/>
                         We codified requirements for making medical necessity determinations at § 422.101(c)(1), which includes using applicable coverage criteria in Traditional Medicare laws, CMS's national coverage determinations (NCDs), applicable local coverage determinations (LCDs), and—when Traditional Medicare coverage criteria are not fully established—internal coverage criteria. We also codified 
                        <PRTPAGE P="99456"/>
                        specific requirements at § 422.101(b)(6) that determine when MA organizations may use internal coverage criteria, what the criteria must be based on, and rules for making the internal coverage criteria publicly accessible. Finally, we codified enrollee protections related to the use of prior authorization (at § 422.112(b)(8)) and required MA organizations to establish a utilization management committee that reviews and approves all plan utilization management policies (at § 422.137). These rules were applicable to coverage for MA organizations beginning January 1, 2024.
                    </P>
                    <FTNT>
                        <P>
                            <SU>245</SU>
                             88 FR 22189.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>246</SU>
                             88 FR 22187.
                        </P>
                    </FTNT>
                    <P>Since the issuance of the April 2023 final rule, CMS has received numerous questions about the application of these rules. As a result, we issued a memo titled “Frequently Asked Questions related to Coverage Criteria and Utilization Management Requirements in CMS Final Rule (CMS-4201-F),” on February 6, 2024 (hereinafter referred to as the “February 2024 HPMS memo”) to provide answers to commonly asked questions and provide additional clarifying information to MA organizations about how these new rules apply to basic benefits. Additionally, through CMS account manager engagement with MA organizations, incoming inquiries from industry stakeholders, and our ongoing 2024 program audits, we have learned a great deal about common misunderstandings related to these new rules and where these new policies could be further clarified with additional rulemaking to achieve the intended goal of ensuring access to medically necessary care for MA enrollees. Therefore, we are proposing here to build upon and enhance the regulations from the April 2023 final rule, specifically those related to the use of internal coverage criteria, by defining the phrase “internal coverage criteria,” establishing policy guardrails to preserve access to basic benefits, and adding more specific rules about publicly posting internal coverage criteria content on MA organization websites. MA organizations' coverage of and responsibility to provide basic benefits is subject to the mandate in section 1852(a)(1) of the Act that MA plans cover Medicare Part A and Part B benefits (subject to specific, limited statutory exclusions) and, thus, to CMS's authority under section 1856(b) of the Act to adopt standards to carry out the MA provisions. These proposals will further implement the requirements set forth in section 1852 of the Act and §§ 422.100 and 422.101, which require MA organizations to furnish all reasonable and necessary Part A and B benefits and are therefore proposed pursuant to CMS's authority under section 1856(b) of the Act.</P>
                    <HD SOURCE="HD3">1. Using Internal Coverage Criteria To Interpret or Supplement General Provisions</HD>
                    <P>
                        In the April 2023 final rule, we codified at § 422.101(b)(6)(i) that MA organizations may apply internal coverage criteria when coverage criteria under Traditional Medicare are not fully established in three specific circumstances. In § 422.101(b)(6)(i)(A), we explained that one circumstance when it is appropriate to use internal coverage criteria is when additional, unspecified criteria are needed to interpret or supplement general provisions in order to determine medical necessity consistently. We required that MA organizations must demonstrate that the additional criteria the MA organizations apply provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services. The NCDs and LCDs that MA plans must follow are developed through rigorous evidence review processes 
                        <SU>247</SU>
                        <FTREF/>
                         with public input to identify gaps or lack of clarity in a proposed policy; as a result, the evidence-based coverage criteria are as specific as possible upon finalization. It is only in the rare instance when an NCD or LCD is lacking in specificity or clarity, that we would consider internal coverage criteria to be permissible to interpret or supplement general provisions under 422.101(b)(6)(i)(A). Our intent with this requirement was to allow MA organizations to interpret or supplement the 
                        <E T="03">plain language</E>
                         of existing and applicable Medicare coverage and benefit criteria (as stated in applicable Medicare statutes, regulations, NCDs, or applicable LCDs) when needed, but also only when the additional criteria protect patient safety and outweigh any risks of harm or decreased access to the items or services. However, we believe this regulatory text needs to be refined to more clearly state our intent about interpreting existing policies and to achieve our goal of protecting patients without decreasing access to medically necessary care.
                    </P>
                    <FTNT>
                        <P>
                            <SU>247</SU>
                             CMS National Coverage Analysis Evidence Review Guidance Document (August 7, 2024) 
                            <E T="03">available at https://www.cms.gov/files/document/cms-evidence-review2024pdf.pdf;</E>
                            ; Revised Process for Making National Coverage Determinations 78 FR 48164 (August 7, 2013) 
                            <E T="03">available at https://www.cms.gov/medicare/coverage/determinationprocess/downloads/fr08072013.pdf;</E>
                             and Medicare Program Integrity Manual Chapter 13-Local Coverage Determinations (February 2, 2019) 
                            <E T="03">available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c13.pdf.</E>
                              
                        </P>
                    </FTNT>
                    <P>
                        First, we propose to replace the term “general provisions” at § 422.101(b)(6)(i)(A) with “the plain language of applicable Medicare coverage and benefit criteria.” The term “general provisions” was meant to encapsulate all forms of applicable Medicare coverage and benefit rules that exist in statute, regulation, NCD, or applicable LCD. These general provisions already exist as Medicare coverage policies at the time that the MA organization is required to apply them to make a determination about coverage. We propose to add the term “plain language” in regulation text to make it explicitly evident that internal coverage criteria may only be used to supplement or interpret already existing content within these Medicare coverage and benefit rules. In other words, internal coverage criteria cannot be used to add new, unrelated (that is, without supplementary or interpretive value) coverage criteria for an item or service that already has existing, but not fully established, coverage policies. This also supports the current requirement at § 422.101(b)(6)(ii)(C) that MA organizations must “identify the general provisions that are being supplemented or interpreted” in the publicly accessible material. It was our intent that the MA organization identify the 
                        <E T="03">plain language</E>
                         of the applicable Medicare coverage and benefit criteria that they are interpreting or supplementing in the publicly available material and provide an explanation of the rationale that supports the adoption and application of the internal coverage criteria. Therefore, we also propose to make conforming edits to the “publicly accessible” requirements at § 422.101(b)(6)(ii)(C) to replace the term “general provisions” with “the plain language of applicable Medicare coverage and benefit criteria.”
                    </P>
                    <P>
                        Second, we propose to remove the existing requirement at § 422.101(b)(6)(i)(A) that the MA organization must demonstrate that the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services. In our examination of publicly available internal coverage criteria since the rule became effective on January 1, 2024, we have found that an assessment about whether the criteria provide clinical benefits that are 
                        <E T="03">highly likely to outweigh</E>
                         any clinical harms is difficult to definitively prove through evidence and, as a result, enforce as a policy. We have observed numerous instances of MA organizations simply 
                        <PRTPAGE P="99457"/>
                        and baldly stating that their internal coverage criteria provide clinical benefits that are highly likely to outweigh any clinical harms, but we have not seen much in the way of evidence in the information provided by the MA organizations that definitively proves this to be true. Often, the clinical benefits that are cited by the MA organizations are simply the avoidance of potential risks or harms associated with the relevant healthcare item or service at issue. We have found that it is difficult to measure the probability that the criteria cited and applied by the MA organizations will (or may) have a net positive effect over the potential risks of not applying the criteria. Further, the qualitative explanations that the MA organizations have asserted as to why the benefits of the criteria used are highly likely to outweigh any harms are not often supported with reliable evidence. For these reasons, we propose to remove the “clinical benefits that are highly likely to outweigh any clinical harms” requirement in both § 422.101(b)(6)(i)(A) and (ii)(C), and replace it with two important policy guardrails in new paragraph (iv) that will apply to all internal coverage criteria adopted under paragraph (b)(6)(i)—not just internal coverage criteria that are authorized under § 422.101(b)(6)(i)(A).
                    </P>
                    <P>As a possible alternative, we solicit comment on replacing the existing requirement at § 422.101(b)(6)(i)(A) that the MA organization must demonstrate that the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms with a requirement that the MA organization must demonstrate through evidence that the additional criteria explicitly support patient safety. We solicit comment on whether this approach is clearer than the current standard and how we could define patient safety in a way that MA organizations understand how to comply with the rule.</P>
                    <P>
                        Finally, unrelated to our policy proposal to modify paragraph (A), we propose to make a minor change at § 422.101(b)(6)(i)(B) to state that NCDs or applicable LCDs include flexibility that explicitly allows for 
                        <E T="03">discretionary</E>
                         coverage by the MA organization in circumstances beyond the specific indications that are listed in an NCD or applicable LCD. The addition of the word “discretionary” is meant to make clear that when an NCD or applicable LCD provides flexibility for the Medicare Administrative Contractor (MAC) to cover or not cover the item or service beyond the specific indications listed, the coverage or non-coverage of the item or service by the MA organization is purely discretionary and is not guaranteed.
                    </P>
                    <HD SOURCE="HD3">2. Definition of Internal Coverage Criteria</HD>
                    <P>In the April 2023 final rule, we codified at § 422.101(b)(6) that MA organizations may create publicly accessible internal coverage criteria that are based on current evidence in widely used treatment guidelines or clinical literature when coverage criteria are not fully established in applicable Medicare statutes, regulations, NCDs or LCDs. We further defined what we meant by “coverage criteria are not fully established” and “publicly accessible” at § 422.101(b)(6)(i) and (ii), respectively, but we did not provide a definition of “internal coverage criteria.” Over the past year, through engagements with stakeholders, we have found that various MA organizations have interpreted the meaning of “internal coverage criteria” differently. For example, some MA organizations are not aware that coverage criteria from third parties (entities other than CMS or the MA organization) can be considered internal coverage criteria of the MA organization when the organization adopts the criteria (or criterion) that contain policies or measures that cannot be found in Medicare laws, NCDs, or LCDs. Another MA organization believed that evidence found in articles or studies cited in the bibliography section of an LCD, but not discussed or listed in the coverage guidance section, could be applied as part of the LCD and not considered internal coverage criteria of the MA plan. A different MA organization wondered whether criteria and policies found in CMS manual guidance should be considered internal coverage criteria. Finally, some organizations are just not aware that their long-established coverage policies contain internal coverage criteria because they have been supplementing existing Traditional Medicare policies for years to fill in gaps where coverage criteria do not specify all possible circumstances where coverage of a Part A or Part B item or service may be available for a beneficiary. These are just some of the examples that we have been made aware of, and we believe there are other misunderstandings throughout the plan community. Therefore, we are proposing additional rules to define the term and clarify what CMS considers “internal coverage criteria.”</P>
                    <P>We propose new regulatory text at § 422.101(b)(6)(iii) to provide clarity on these topics for MA organizations and to further protect beneficiaries by ensuring equal access to these basic benefits. More specifically, we propose to define internal coverage criteria as any policies, measures, tools, or guidelines, whether developed by an MA organization or a third party, that are not expressly stated in applicable statutes, regulations, NCDs, LCDs, or CMS manuals and are adopted or relied upon by an MA organization for purposes of making a medical necessity determination at § 422.101(c)(1). We explain in regulation text that this includes any coverage criteria that restrict access to, or payment for, medically necessary Part A or Part B items or services based on the duration or frequency, setting or level of care, or clinical effectiveness of the care.</P>
                    <P>First and foremost, we find it important to reiterate that internal coverage criteria are inherently “internal” to the MA plan that utilizes them because they are a policy, measure, tool, or guideline that does not exist in applicable Medicare coverage or benefit rules. Further, other MA plans are not required to use the criteria and therefore it would be an element of coverage specific to the MA plan. This includes criteria used to further interpret or supplement the plain language of applicable Medicare coverage and benefit criteria because any coverage criteria or guidelines that are not contained in the actual statutes, regulations, NCDs, or applicable LCDs, or addressed in CMS manual guidance interpreting or explaining such criteria or guidelines would be considered non-Medicare criteria. For example, using information or evidence to form coverage criteria not found in the plain language of an LCD, but found in an article or study cited in the bibliography of an LCD, would be an example of an MA plan using internal coverage criteria. Only coverage criteria and policies found in the NCD, applicable LCD, related statutes or regulations, or addressed in CMS manual guidance interpreting related statutes or regulations, are not subject to the rules at § 422.101(b)(6); all other coverage criteria applied by an MA organization would be considered internal coverage criteria.</P>
                    <P>
                        Based on this proposed definition, we do not consider content and information found in CMS published manuals (
                        <E T="03">e.g.,</E>
                         Medicare Managed Care Manual, Medicare Program Integrity Manual, Medicare Benefit Policy Manual) to be internal coverage criteria under § 422.101(b)(6). As we explained in the April 2023 final rule, these manuals contain significant explanations and interpretations of Traditional Medicare laws governing Part A and Part B benefits, most of it longstanding, to 
                        <PRTPAGE P="99458"/>
                        provide instructions and procedures for day-to-day operations for those responsible for administering the Medicare program and making coverage decisions on individual claims. We expect that MA plans will consult these manuals without the burden of having to justify their clinical or evidentiary value as required for internal coverage criteria under § 422.101(b)(6) (both currently and under the revisions we are proposing).
                    </P>
                    <P>We have also received questions from MA organizations about whether information in Referenced Local Coverage Determination articles are considered internal coverage criteria when used to make coverage decisions. Referenced Local Coverage Determination articles are issued by Medicare Administrative Contractors (MACs) to provide coding/billing guidelines and instructions for a particular LCD and do not contain coverage criteria; that is the role of the LCD. We have observed that MA organizations sometimes use these articles to see if specific item or service codes are contained in the article, and when the code is not listed, use the article as a basis to deny coverage. This is inappropriate because the LCD provides the criteria that must be satisfied for Medicare coverage; not the Referenced Local Coverage Determination article. Simply because an item or service code is not listed in the Referenced Local Coverage Determination article does not mean the item or service is not covered by the LCD. Additionally, Referenced Local Coverage Determination articles do not meet the standard of “current evidence in widely used treatment guidelines or clinical literature” because they do not exist to provide any clinical value. As a result, we clarify here that information contained in Referenced Local Coverage Determination articles may not be used as internal coverage criteria when making coverage decisions on basic benefits.</P>
                    <P>We clarify in the proposed regulation text at § 422.101(b)(6)(iii) that criteria developed by a third-party may be considered internal coverage criteria when used by an MA organization in making medical necessity determinations. If the third-party coverage criteria contain additional policies, measures, tools or guidelines that do not exist in Medicare statute, regulation, manual, NCD or LCD, it would be internal coverage criteria of the MA organization when used or relied upon for the purpose of making a medical necessity decision regardless of who developed or created the coverage criteria. We note that many third-party developers of coverage criteria have synthesized existing Medicare coverage criteria found in statute, regulation, or NCD/LCD into proprietary workflows or tools and have filled in gaps or supplemented the Medicare coverage policies with additional measures, parameters, or policies in an attempt to more clearly identify and specify when the item or services should be covered. We clarify in this proposal that the application of additional measures or policies or more specific parameters that further define Medicare coverage policies are the application of internal coverage criteria under § 422.101(b)(6)(i)(A) and, therefore, must meet all regulatory requirements at § 422.101(b)(6). In some circumstances, there may be multiple parts of an NCD or applicable LCD that are being supplemented or interpreted with internal coverage criteria by an MA plan. Every instance where the plain language of a Medicare coverage rule is interpreted or supplemented is considered internal coverage criteria, and each instance must be based on current evidence in widely used treatment guidelines or clinical literature and must be publicly accessible. Therefore, we expect MA organizations to work closely with these third parties to understand whether the proprietary third-party criteria contain any standards or requirements that go beyond what is found in existing Medicare coverage criteria. Later in this preamble, we will discuss proposed requirements for how MA organizations should identify items and services that contain internal coverage criteria by listing them on their internal websites.</P>
                    <P>
                        One of the ways that internal coverage criteria can go undetected, and therefore would fail to be made publicly available by the MA organization as required by § 422.101(b)(6), is when the criteria are built into an algorithm or software tool that generates a decision without an explicit understanding by the MA organization of the underlying factors that were considered by that algorithm or software tool in the making of the decision. As mentioned in the February 2024 HPMS memo, an algorithm, artificial intelligence, or software tool can be used to assist MA plans in making coverage determinations, but it is the responsibility of the MA organization to ensure that the algorithm or artificial intelligence complies with all applicable rules for how coverage determinations by MA organizations are made.
                        <SU>248</SU>
                        <FTREF/>
                         In section K of this proposed rule, we propose to define “automated system” as any system, software, or process that uses computation as whole or part of a system to determine outcomes, make or aid decisions, inform policy implementation, collect data or observations, or otherwise interact with individuals or communities or both. Automated systems include, but are not limited to, systems derived from machine learning, statistics, or other data processing or artificial intelligence techniques, and exclude passive computing infrastructure. Considering this definition of automated system in the context of the February 2024 HPMS memo, the MA organization must understand whether any internal coverage criteria have been built into an automated system, and if so, the specific details of the criteria that are built into the tool must be publicly accessible and meet our evidentiary standards at § 422.101(b)(6). Furthermore, we are concerned that many automated systems can exacerbate discrimination and bias. An MA organization cannot avoid or evade responsibility for compliance with MA regulations and the MA contract by using these automated systems and the MA organization maintains ultimate responsibility for adhering to and otherwise fully complying with all regulations and terms and conditions of the MA organization's contract with CMS.
                    </P>
                    <FTNT>
                        <P>
                            <SU>248</SU>
                             February 2024 HPMS memo, page 2.
                        </P>
                    </FTNT>
                    <P>
                        In the proposed definition of internal coverage criteria to be added at § 422.101(b)(6)(iii), we use a non-exhaustive list of types of internal coverage criteria—called policies, measures, tools, or guidelines—that we have seen MA organizations use when making medical necessity determinations. Use of other terms to describe the internal coverage criteria would not change their underlying function and how they are used by MA organizations. Under the proposed definition at § 422.101(b)(6)(iii), internal coverage criteria include any coverage policies that restrict access to, or payment for, medically necessary Part A or Part B items or services based on the duration or frequency, setting or level of care, or clinical effectiveness of the care. Again, these types of policies are only considered internal when they are not articulated in applicable Medicare coverage and benefit criteria. It is common that MA organizations have policies such as these for health care items or services that are not covered by applicable Medicare statutes, regulations, NCDs, or LCDs. These types of policies are often used to comply with section 1862(a)(1)(A) of the Act, which requires that Part A and Part B benefits be reasonable and necessary for 
                        <PRTPAGE P="99459"/>
                        the diagnosis or treatment of illness, or injury, or to improve the functioning of a malformed body member. Additionally, MA organizations are required to have measures that prevent, detect, and correct fraud, waste, and abuse.
                        <SU>249</SU>
                        <FTREF/>
                         Since internal coverage criteria may be used to assess the appropriateness of the health care service and could result in the denial of a medical necessity decision, it is important that they be based on current evidence in widely used treatment guidelines or clinical literature and made publicly available.
                    </P>
                    <FTNT>
                        <P>
                            <SU>249</SU>
                             42 CFR 422.503(b)(4)(vi).
                        </P>
                    </FTNT>
                    <P>
                        It is important that we distinguish aspects of MA plan coverage that do not qualify as internal coverage criteria under the proposed definition. Utilization management processes and procedures are interventions that take place before, during, and after the clinical encounter 
                        <SU>250</SU>
                        <FTREF/>
                         and include prior authorization (or pre-authorization), concurrent review, retrospective review, and claim review. MA organizations are required by section 1852(g)(1)(a) of the Act to have procedures for making determinations regarding whether an individual enrolled in the plan is entitled to receive a health service. Unless expressly prohibited by statute or regulation (for example, prior authorization for emergency services), MA organizations can decide which utilization management processes they wish to employ and are not required to follow or practice the same utilization management processes conducted by MACs in Traditional Medicare. These types of utilization management decisions about when to apply these interventions are not considered internal coverage criteria under § 422.101(b)(6); but internal coverage criteria applied during one of these interventions (
                        <E T="03">i.e.,</E>
                         prior authorization) are subject to the rules at § 422.101(b)(6). For example, Traditional Medicare may not require prior authorization for a specific healthcare service, but an MA organization may require prior authorization to confirm the presence of diagnoses and ensure the service is medically necessary. (See § 422.138.) In this case, any internal coverage criteria applied as part of the prior authorization process will be subject to rules related to internal coverage criteria, but the ability of the MA organization to decide which items and services are subject to prior authorization is not subject to rules on internal coverage criteria at § 422.101(b)(6). Utilization management programs are necessary for MA organizations to manage the utilization of covered item and services and ensure that benefits are medically necessary in accordance with the statute and applicable regulations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>250</SU>
                             
                            <E T="03">https://www.ncbi.nlm.nih.gov/books/NBK560806/.</E>
                        </P>
                    </FTNT>
                    <P>Another example of coverage policies that fall outside the scope of internal coverage criteria are coverage requirements that are based on whether a provider is in-network or out-of-network. An MA organization that offers an MA coordinated care plan may specify the networks of providers from whom enrollees may obtain services if the MA organization ensures that all covered services, including supplemental services, are available and accessible under the plan. In other words, network-based MA plans may limit access to Medicare-covered items and services via networks, as long as those networks provide adequate enrollee access (see for example, §§  422.112(a)(1) and 422.114(a)) to services consistent with standards required by section 1852 of the Act (and other applicable laws) and established by CMS. Therefore, if an enrollee obtains a health care service outside of the plan's specified network, it may be subject to non-coverage depending on the type of plan being offered (that is, Health Maintenance Organization, Preferred Provider Organization) and the MA plan's written policies on provider network coverage. Coverage limitations based on network status are not internal coverage criteria under the proposed definition.</P>
                    <HD SOURCE="HD3">3. Prohibitions</HD>
                    <P>CMS understands that MA organizations need to have coverage policies to make consistent medical necessity decisions and that appropriate limitations on the use of these policies is necessary, so we are relying on our authority under sections 1856(b) and 1857(e)(1) of the Act to adopt regulatory limitations designed to implement and carry out the obligations of MA plans to cover benefits while protecting beneficiaries and ensuring their access to medically necessary covered benefits. Section 1852(a) of the Act requires MA plans to cover basic benefits and authorizes coverage of supplemental benefits. Ensuring access to covered benefits is an important policy goal for CMS in administering the MA program and we have concluded that it is necessary and appropriate to adopt specific requirements for how basic benefits are covered to ensure that MA enrollees receive the items and services for which benefits are available under Parts A and B. Therefore, based on these authorities, we are proposing two requirements that prohibit the use of all internal coverage criteria.</P>
                    <P>First, we propose at § 422.101(b)(6)(iv)(A) that a coverage criterion is prohibited when it does not have any clinical benefit, and therefore, exists to reduce utilization of the item or service. Section 1862(a)(1)(A) of the Act requires Traditional Medicare benefits to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. In the absence of an NCD or LCD, these decisions are made on a case-by-case basis after considering the individual's particular factual situation. MA plans must consider clinical circumstances in making a decision as to whether Part A and Part B items and services are reasonable and necessary as well. Under this proposed requirement that the criterion must have a clinical benefit, the internal criterion must have a value that contributes to a determination of whether the benefit is reasonable and necessary under the statute. For example, if the evidence supporting use of an internal coverage criterion is rooted in managing care to reduce utilization of an item or service to a less costly alternative without any clinical value to the patient, the internal coverage criterion would be a violation of this proposed rule.</P>
                    <P>
                        Secondly, we propose at § 422.101(b)(6)(iv)(B) that internal coverage criterion is prohibited when the criterion is used to automatically deny coverage of basic benefits without the MA organization making an individual medical necessity determination as required at § 422.101(c)(1)(i). Internal coverage criteria that neither considers the individual medical necessity of the patient nor the clinical effectiveness of the care would be inconsistent with sections 1862 and 1852(g)(1)(A) of the Act. For instance, a coverage criterion that establishes a blanket policy to automatically deny access to a covered benefit in every circumstance without consideration of the enrollee's medical history, physician's recommendations, clinical notes, and when appropriate, involvement of the organization's medical director would be a violation of this rule. Unless there is current evidence as described at § 422.101(b)(6) that the health care item or service is experimental or investigational, we would view this blanket policy as being designed to reduce the utilization of the item or service, establishing a barrier to potentially medically necessary care without the MA organization making an individual medical necessity 
                        <PRTPAGE P="99460"/>
                        determination as required by law. This proposed rule is intended to ensure that MA enrollees have equal access to Part A and Part B benefits as other Medicare beneficiaries and that any coverage criteria used by the MA plan is done so in accordance with principles that support the reasonable and necessary standard under the Act.
                    </P>
                    <P>Both prohibitions being proposed herein at 422.101(b)(6)(iv), which apply to all internal coverage criteria used by an MA organization, provide important guardrails to ensure appropriate access to benefits in a way that CMS can objectively measure with evidence. We solicit comment on whether there are other prohibitions on internal coverage criteria that CMS should consider that support and promote access to medically necessary care in the MA program. We remind MA organizations that section 1852(b) of the Act and § 422.110(a) prohibit an MA organization from denying, limiting, or conditioning the coverage or furnishing of benefits to individuals eligible to enroll in an MA plan offered by the organization on the basis of any factor that is related to health status. Additionally, § 422.100(f)(2) provides that plan designs and benefits may not discriminate against beneficiaries, promote discrimination, discourage enrollment, encourage disenrollment, steer subsets of Medicare beneficiaries to particular MA plans, or inhibit access to services. As a result, an MA organization that uses internal coverage criteria must comply with section 1852(b) of the Act, § 422.110(a), and § 422.100(f)(2) and may not discriminate on the basis of any factor that is related to the enrollee's health status. CMS will continue to conduct routine monitoring and auditing of MA organizations, and through these processes, may discover that internal coverage criteria are being used that do not comply with rules at § 422.101(b)(6) or the anti-discrimination rules mentioned herein. In these circumstances, CMS will utilize its current compliance and enforcement processes to determine if any action should be taken for the non-compliance and to remediate the issue. We have strengthened our audit processes and will consider new compliance and reporting activities to examine MA organization's compliance with these proposed rules.</P>
                    <HD SOURCE="HD3">4. Public Availability</HD>
                    <P>In the April 2023 final rule, we codified at § 422.101(b)(6)(ii) that when MA organizations use internal coverage policies, they must provide the internal coverage criteria in use, a summary of evidence that was considered during the development of the criteria, a list of sources of such evidence, and an explanation of the rationale that supports the adoption of the coverage criteria in a publicly accessible way. We did not require specific mechanisms for how the information must be made publicly accessible in an effort to provide MA organizations flexibility in complying with these new requirements. We further explained in the February 2024 HPMS memo that MA organizations are required to have a website under § 422.111(h)(2) and that use of that website for purposes of posting this information is appropriate. We further elaborated in the memo that publicly accessible means generally accessible to CMS, enrollees, providers, researchers, and other stakeholders without undue burden. Transparency in this area provides a measure of protection for enrollees and assurances that the coverage criteria are rational and supportable by current, widely used treatment guidelines and clinical literature.</P>
                    <P>With the importance of this protection in mind, we propose to add more structure and detail to the public accessibility requirements to ensure that MA organizations are making this information available in a manner that is routinized and easy to follow. However, before we discuss the details of newly proposed requirements, first we propose to make an update to the terminology used in § 422.101(b)(6) to change the term “accessible” to “available.” We understand that “accessible” has other meanings and there are specific requirements for accessibility of online materials under section 504 that could make the term particularly confusing in this context. We believe that “available” more accurately describes our intent, which is that the information is publicly available to the people who need it. Therefore, we propose to update § 422.101(b)(6) and § 422.101(b)(6)(ii) by replacing the word “accessible” with “available.” This change does not negate or alter the obligations of MA organizations to ensure accessibility of online materials in accordance with section 504 or other laws.</P>
                    <P>Over the course of the past year, we have reviewed numerous MA organization websites to observe how they are posting the currently required content. We have seen a variety of different approaches; some with dedicated web pages that organize the Medicare item or service by vendor, and others that build the required content into very detailed coverage policy documents. Both approaches often include hyperlinks to vendor criteria that contain the content required under § 422.101(b)(6)(ii). In total, we have found that the average person faces difficulty accessing an MA organization's website for the purpose of determining whether or not the MA plan applies internal coverage criteria to the particular Medicare item or service. Therefore, we are proposing requirements to make this required information more understandable, readable, and easier to locate.</P>
                    <P>
                        First, for consistency in terminology, we propose to update § 422.101(b)(6)(ii) which currently states, “For internal coverage policies . . .” to read “For internal coverage 
                        <E T="03">criteria.”</E>
                         Second, we are proposing to update the requirements in paragraphs (b)(6)(ii)(A)-(C) to be more specific about the information that must be publicly accessible. In paragraph (A), which requires posting each internal coverage criterion in use, we are adding that each internal coverage criterion used by the MA organization in making medical necessity decisions on Part A and Part B benefits must be clearly identified and marked as internal coverage criterion of the MA plan within coverage policies. We often see internal coverage criteria that are intertwined with, or that expand upon, NCD or applicable LCD coverage policies without any acknowledgement that the MA plan is applying additional criteria beyond what is found in the applicable NCD or LCD. Therefore, we are requiring that MA organizations examine and identify each internal coverage criterion being used and mark or label it as such within their policy documents for readers to understand that the specific internal criterion noted is being applied and may be specific to the MA plan. We are updating the word “criteria” to “criterion” to make it clear that we expect each single coverage criterion used to be listed and identified, noting that there may be more than one criterion that is applied to a given regulation, NCD, or applicable LCD. In paragraph (B), we are proposing to add to the list of evidence that supports the coverage criterion by requiring that the evidence be connected to the internal coverage criterion with a corresponding footnote. This will allow readers to understand which evidence supports the use of which internal coverage criterion within the coverage policies. In paragraph (C), we are making corresponding edits to mirror the proposed changes previously discussed in § 422.101(b)(6)(i)(A) by replacing “general provisions” with “the plain language of applicable Medicare coverage and benefit criteria” and 
                        <PRTPAGE P="99461"/>
                        removing the “clinical benefits that are highly likely to outweigh any clinical harms” requirement. Additionally, we are changing “criteria” to “criterion” in § 422.101(b)(6)(ii)(C) to make it clear that we require an explanation of the rationale that supports adoption of each individual internal coverage criterion in use.
                    </P>
                    <P>
                        In new paragraph (D), we are proposing that by January 1, 2026, MA organizations must publicly display on the MA organization's website a list of all items and services for which there are benefits available under Part A or Part B where the MA organization uses internal coverage criteria when making medical necessity decisions. The list of items and services on the website must include the information in paragraph (b)(6)(ii)(A) through (C) (explicitly or by connecting directly to that information through a hyperlink) and include the vendor's name when using a third-party vendor's criteria. The MA organization's internal coverage criteria web page must be displayed in a prominent manner and clearly identified in the footer of the website. The web page must be easily available to the public, without barriers, including but not limited to ensuring the information is available free of charge, without having to establish a user account or password, without having to submit personal identifying information, in a machine-readable format with the data contained within that file being digitally searchable and downloadable, and include a txt file in the root directory of the website domain that includes a direct link to the machine-readable file to establish and maintain automated access. We believe that by making this information more easily available to automated searches and data pulls, it will help third-parties and researchers conduct studies to examine the clinical value of the internal coverage criteria being used by MA plans.
                        <SU>251</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>251</SU>
                             We also note that the requirements for accessibility of online materials under Section 504 of the Rehabilitation Act apply to this information as well. See 29 U.S.C. 794; 45 CFR pt. 84.
                        </P>
                    </FTNT>
                    <P>In addition to the public posting of this content, we are considering an annual reporting to CMS of the information in § 422.101(b)(6)(ii)(A)-(D) under our reporting requirements listed at § 422.516(a). We believe this information is critical to ensuring appropriate access to Part A and Part B benefits in the MA program and there is value in comparing use of internal coverage criteria across all MA organizations. CMS would specify the format and collection of this information through the normal Paperwork Reduction Act (PRA) process. Further, we solicit comment on whether CMS should require a specific format for the information posted on the MA organization website and whether a standard template for the posted information would be helpful.</P>
                    <P>Finally, we do not expect that any of the regulatory changes proposed in this section will have an impact on the Medicare Trust Fund. Use of internal coverage criteria by MA organizations is optional, and when used, helps MA organizations make consistent medical necessity decisions that are aligned with coverage rules in Traditional Medicare. We believe that most MA organizations are using internal coverage criteria that are supported by current evidence in widely used treatment guidelines or clinical literature, and therefore we do not believe that these regulatory proposals will significantly change utilization patterns of Part A or Part B items or services. These changes and protections promote transparency across MA organizations so enrollees can make informed choices on plan selection and know when to appeal an adverse coverage decision, and providers can be informed about the criteria they must satisfy when seeking coverage of items and services on behalf of their patients.</P>
                    <P>If finalized, these proposed rules would be applicable beginning January 1, 2026. We solicit comments on all aspects of these proposals.</P>
                    <HD SOURCE="HD2">V. Clarifying MA Organization Determinations To Enhance Enrollee Protections in Inpatient Settings (§§ 422.138, 422.562, 422.566, 422.568, 422.572, 422.616, and 422.631)</HD>
                    <P>We are proposing four modifications to existing regulations at 42 CFR part 422, subpart M, to clarify and strengthen existing rules related to organization determinations. First, we are proposing to clarify the rule that if an enrollee has no further liability to pay for services furnished by a Medicare Advantage (MA) organization, a determination regarding these services is not subject to appeal. Specifically, we are clarifying that an enrollee's further liability to pay for services cannot be determined until an MA organization has made a determination on a request for payment. Second, we are proposing to modify the definition of an organization determination to clarify that a coverage decision made by an MA organization contemporaneously to when an enrollee is receiving such services, including level of care decisions (such as inpatient or outpatient coverage), is an organization determination subject to appeal and other existing requirements. Third, we are proposing to strengthen the notice requirements to ensure that a provider who has made a standard organization determination or integrated organization determination request on an enrollee's behalf, or when it is otherwise appropriate, receives notice of the MA organization's decision. Finally, we are proposing a change to the reopening rules to curtail an MA organization's authority to reopen and modify an approved authorization for an inpatient hospital admission on the basis of good cause for new and material evidence. We address each of these proposals in detail below.</P>
                    <HD SOURCE="HD3">1. Clarifying When a Determination Results in No Further Financial Liability for the Enrollee (§ 422.562)</HD>
                    <P>Section 1852(g)(1)(A) of the Social Security Act (the Act) requires an MA organization to have a procedure for making determinations regarding whether an enrollee is entitled to receive a health service and the amount (if any) that the individual is required to pay with respect to such service. Under section 1852(g)(2) of the Act, an MA organization must provide for reconsideration of an adverse determination upon an enrollee's request. The existing regulations at part 422, subpart M set forth the administrative appeals process available to enrollees who wish to dispute an organization determination made by an MA organization. Section 422.562(c) describes limits on the applicability of the administrative appeals process in part 422, subpart M. The limitation in § 422.562(c)(1) states that if an enrollee receives immediate QIO review (as provided in § 422.622) of a determination of noncoverage of inpatient hospital care, then the enrollee is not entitled to review of that issue by the MA organization. The second limitation at § 422.562(c)(2) states that if an enrollee has no further liability to pay for services that were furnished by an MA organization, a determination regarding these services is not subject to appeal.</P>
                    <P>
                        The organization determination and reconsideration regulations of part 422, subpart M broadly distinguish between two categories of decisions: coverage decisions (that is, a decision on whether the MA organization will furnish, authorize, or arrange for an item, service, or Part B drug) and payment decisions (that is, a decision whether to pay or deny payment for services furnished to an enrollee). These divergent categories of organization determinations have distinct requirements related to processing timeframes (including the applicability of processing timeframe extensions), the 
                        <PRTPAGE P="99462"/>
                        parties eligible to submit an organization determination or reconsideration request, notice requirements, and whether an MA organization must expeditiously process an organization determination or reconsideration request upon receiving a valid request.
                    </P>
                    <P>
                        When a coverage request is received, or when the MA organization issues an unsolicited coverage decision related to ongoing services, the MA organization will apply applicable coverage criteria and either approve, furnish, arrange for, or deny coverage for the services at issue. An approved coverage decision should result in the enrollee receiving the services at issue and the MA organization making payment to the treating provider when a request for payment is eventually submitted. When a request for payment for furnished services is received without a previously approved coverage decision, the MA organization will apply coverage criteria and must either make payment or deny the request within the timeframes specified in the “prompt payment” provisions of § 422.520. In addition, the MA organization must calculate the enrollee's applicable cost-sharing and/or financial liability for the furnished service (when issuing a partially or fully adverse decision) including considering applicable beneficiary protections related to plan-directed care. “Plan-directed care” occurs when a contracted provider furnishes a service or refers an enrollee for a service that an enrollee reasonably believes is a plan-covered service. Upon receiving plan-directed care, an enrollee cannot be financially liable for more than the applicable cost-sharing for that service (see § 422.105). Accordingly, under existing § 422.562(c)(2), if a payment determination related to services furnished by a MA organization results in no remaining financial liability for the enrollee, including adverse decisions that fall within the plan-directed care beneficiary protections, the decision is not subject to the appeal requirements of part 422, subpart M.
                        <SU>252</SU>
                        <FTREF/>
                         This means that neither the enrollee nor any other party may appeal an adverse payment decision under subpart M after an MA organization determines the enrollee is not financially liable for more than the applicable cost-sharing of the services for which payment was requested.
                        <SU>253</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>252</SU>
                             We note that a state Medicaid agency has a specific right to appeal an adverse payment decision for a qualified Medicare beneficiary (QMB) or other full-benefit dually eligible individual for services in which the state Medicaid agency has made payment or may be liable, pursuant to § 405.908 and incorporated into part 422, subpart M through § 422.562(d)(1). The right for a state Medicaid agency to appeal an adverse payment decision may exist even when § 422.562(c)(2) would otherwise preclude the right to appeal.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>253</SU>
                             We note that the provision at § 422.562(c)(2) only applies to services “furnished by an MA organization” which, as we have explained, generally occurs when a contracted provider, as an agent of the MA organization, renders covered services to an MA organization's enrollee. Section 422.562(c)(2) does not limit the right for parties to appeal adverse payment determinations related to services provided by a non-contracted provider as non-contracted providers are not considered agents of an MA organization due to the lack of a mutual contractual relationship. Instead, non-contracted providers may become assignees of an enrollee by formally agreeing to waive any right to payment from the enrollee, in accordance with § 422.574(b), and then may utilize the administrative appeals process established at §§ 422.578 through 422.616 to appeal adverse payment determinations in their capacity as an assignee of the enrollee.
                        </P>
                    </FTNT>
                    <P>CMS has historically interpreted the limitations of § 422.562(c)(2) to apply to payment determinations, not coverage decisions (that is, those addressed under § 422.566(b)(3) and (4)). From a practical perspective, a coverage decision will affect the care an enrollee is to receive or is receiving in addition to the enrollee's cost-sharing liability. Nevertheless, we have identified that some MA organizations misapply the appeal limitation provision of § 422.562(c)(2) to certain coverage decisions, specifically those related to an enrollee's inpatient admission or level of care. These MA organizations often improperly label these adverse coverage decisions as “contractual denials” or “payment decisions” even though no request for payment has been submitted and, oftentimes, the services are still being rendered at the time of the MA organization's decision. We have seen instances, for example, where an MA organization will deny an enrollee coverage for ongoing inpatient services being received in a contracted hospital and take the position that because MA beneficiary protection policies on plan-directed care prevent the enrollee from being financially liable for more than their applicable cost-sharing, when a request for payment is ultimately submitted, § 422.562(c)(2) prevents the enrollee from appealing the coverage denial. Consequently, these enrollees are left without an avenue to appeal decisions that directly affect their immediate medical care and may also alter the amount of their applicable cost-sharing if the enrollee's level of care is changed from inpatient to outpatient during their hospital stay. Further, the application of § 422.562(c)(2) in this manner may also contravene section 1852(g)(2) of the Act which requires MA organizations provide reconsideration of denials of enrollee coverage, in whole or in part, upon request by the enrollee involved.</P>
                    <P>To eliminate potential confusion related to identifying when organization determinations may not be appealable due to the lack of enrollee financial liability, we propose modifying § 422.562(c)(2) to clarify that the provision is only applicable to contracted provider payment disputes arising from a claim payment decision in which the enrollee has no additional financial liability. The reference to “no further liability to pay” in 422.562(c)(2) means the enrollee's financial liability will not be affected by whether the payment determination is upheld or overturned. In scenarios where an enrollee may still have a balance due for their cost sharing amount, this amount would not be considered “further liability to pay” if this amount would not be affected by resolution of the payment dispute.</P>
                    <P>Specifically, we are proposing to modify this paragraph to state that, based on an MA organization's determination on a request for payment, if an enrollee has no further liability to pay for services that were furnished by an MA organization, a determination regarding these services is not subject to appeal. In other words, we are proposing to clarify that this limitation is only applicable if there's been a claim payment determination, which necessarily requires a submission of a claim or other request for payment from a contracted provider or enrollee. Coverage decisions, whether approved or denied, will continue to be subject to the subpart M appeals process. Under our proposal, an enrollee would be considered potentially liable to pay for a service until the MA organization makes a determination in response to a request for payment, including the submission of a provider's claim for the furnished service.</P>
                    <P>
                        We believe the proposed clarification to § 422.562(c)(2) properly reestablishes the intent to exclude contracted provider payment appeals from the subpart M administrative appeals process when the enrollee no longer has any interest in the dispute because the enrollee has received the services in question and has no further liability to pay for those services. In addition, the proposed clarification would safeguard enrollees' right to appeal adverse coverage decisions that may affect the type, duration, or level of services to be, or being, furnished. However, simply because a payment decision does not implicate the subpart M administrative appeals process, an MA organization is not discharged of its obligation to pay its contracted providers for services 
                        <PRTPAGE P="99463"/>
                        rendered. Section 1852(a)(1) of the Act and CMS regulations at § 422.101(a) and (b) require all MA organizations to provide coverage of, by furnishing, arranging for, or 
                        <E T="03">making payment for</E>
                         (emphasis added), all items and services that are covered by Part A and Part B of Medicare and that are available to beneficiaries residing in the plan's service area. We expect MA organizations to establish networks of providers to deliver plan-covered benefits and pay them in accordance with terms of the contracts established. Failure to abide by contract terms and contract disputes can have a negative impact on providers, their ability to properly deliver benefits, and ultimately adversely impact patients in the health care system.
                    </P>
                    <HD SOURCE="HD3">2. Clarifying the Definition of an Organization Determination To Enhance Enrollee Protections in Inpatient Settings (§§ 422.138 and 422.566)</HD>
                    <P>Section 1852(g)(1)(A) of the Act requires MA organizations to have a procedure for making determinations regarding whether an enrollee is entitled to receive health services or payment under the program. In accordance with section 1852(g)(1)(A) of the Act, §§ 422.566 through 422.572 establish the requirements related to organization determinations. Existing § 422.566(b) defines an organization determination as any determination made by an MA organization that falls within a prescribed set of discrete actions. These include, at subsection (b)(3), an “MA organization's refusal to provide or pay for services, in whole or in part, including the type or level of services, that the enrollee believes should be furnished or arranged for by the MA organization” and, at subsection (b)(4), the “[r]eduction, or premature discontinuation, of a previously authorized ongoing course of treatment.” Taken collectively, this means an organization determination may be made prior to the receipt of services (for example, prior authorization), after the receipt of services (for example, payment requests), or during receipt of services (for example, continuation or termination of services) the enrollee receives from either contracted or non-contracted providers.</P>
                    <P>An “organization determination,” as defined by § 422.566, is a decision “regarding the benefits an enrollee is entitled to receive under an MA plan . . . and the amount, if any, that the enrollee is required to pay for a health services” to include, among other actions, “the MA organization's refusal to provide or pay for services, in whole or in part, including the type or level of services, that the enrollee believes should be furnished or arranged for by the MA organization.” When an MA organization makes an adverse organization determination (for example, denying coverage for a service), it must adhere to certain requirements that include providing notice of the decision to the enrollee in a format prescribed by CMS (see § 422.568(e)), within designated timeframes (see §§ 422.568 and 422.572), and, if the adverse decision was based on medical necessity, ensuring the decision was reviewed by a physician or other appropriate heath care professional with expertise in the field of medicine appropriate for the services at issue (see § 422.566(d)). In accordance with § 422.576, an “organization determination is binding on all parties unless it is reconsidered under §§ 422.578 through 422.596 or is reopened and revised under § 422.616.” An enrollee or physician who is acting on behalf of the enrollee (regardless of their affiliation with an MA organization) may request an expedited reconsideration of an adverse organization determination concerning the type or level of services that the enrollee believes they should receive (see §§ 422.578 and 422.584(a)). However, pursuant to § 422.562(c)(2), if an “enrollee has no further liability to pay for services that were furnished by the MAO, a determination regarding these services is not subject to appeal.”</P>
                    <P>Historically, we have interpreted the definition of an organization determination to include when an MA organization makes a coverage decision on the appropriateness of an inpatient admission, or the appropriateness of inpatient services (that is, a level of care determination), contemporaneously with an enrollee's receipt of the services at issue. This would be true whether the MA organization ultimately approved the enrollee's admission to a facility, determined that the enrollee's level of care in the same facility should be reduced, or determined that the enrollee should be discharged (see §§ 422.620 through 422.624). Accordingly, these decisions would have to comply with all applicable notice and appeal requirements for organization determinations and would be binding on all parties unless they are reconsidered under §§ 422.578 through 422.596 or are reopened and revised under § 422.616.</P>
                    <P>We acknowledge that many MA organizations understand these decisions are organization determinations subject to the existing rules in subpart M including, but not limited to, timely notice of the decision. However, through routine audits, feedback from the provider community, and discussions with MA organizations, CMS has identified circumstances where some MA organizations have misinterpreted the organization determination provisions to exclude decisions that rescind a previously authorized inpatient admission, deny coverage for inpatient services, or downgrade an enrollee's hospital coverage from inpatient to outpatient (often either simultaneously denying inpatient coverage while approving coverage for outpatient observation services or instructing the provider to only bill for outpatient services when submitting a subsequent claim), when the decision is made concurrently to the enrollee receiving such services. These types of decisions most often occur while enrollees are receiving inpatient services in an in-network hospital and are at times referred to as “concurrent review decisions,” “level of care determinations,” “clinical utilization review decisions,” or “inpatient authorization denials.” For the sake of clarity and consistency in describing these types of decisions, we will use the term “concurrent review” for purposes of this rulemaking.</P>
                    <P>We understand MA organizations conduct concurrent review on hospitalizations and other services that require review for continued care, such as long-term care stays in SNFs, LTACHs, or IRFs, HHA services, partial hospitalizations, or intensive outpatient programs. Such review includes utilization management activities that occur during inpatient level care, post-acute care, or an ongoing outpatient course of treatment. In general, the concurrent review process includes obtaining necessary clinical information from the treating physician and other providers to determine medical necessity based on the clinical status of the enrollee and applicable Medicare coverage criteria. Concurrent review involves the evaluation of the appropriateness of the ongoing level of care, including decisions related to the extension of previously approved care.</P>
                    <P>
                        We offer the following example to illustrate a common scenario we have seen, although we note that certain details may vary depending on the MA organization making the decision. An enrollee will present to an in-network hospital and the treating physician will order the enrollee admitted to an inpatient status. During the admission process, the hospital will provide the enrollee's MA organization with a Notice of Admission, in accordance with the contract between the hospital 
                        <PRTPAGE P="99464"/>
                        and MA organization, that alerts the MA organization of the admission but (in most circumstances) does not request approval for the admission. After receiving the Notice of Admission, the MA organization will monitor the enrollee's condition by reviewing the medical documentation on its own accord and, when applicable, will notify the hospital that it has made an adverse concurrent review decision related to the enrollee's inpatient admission or receipt of inpatient services on the basis that the enrollee's condition does not meet certain inpatient coverage criteria. Accordingly, if the hospital submits an inpatient claim for the services, whenever it ultimately submits a request for payment, the MA organization will automatically deny payment for inpatient services based on the concurrent review decision. In its concurrent review decision, the MA organization may either approve outpatient observation services for the enrollee or suggest that the hospital bill the entire hospital stay as outpatient services. If the treating physician disagrees with the decision, the physician may engage the MA organization in a peer-to-peer discussion with a plan physician or may appeal using the plan's internal dispute resolution processes.
                        <SU>254</SU>
                        <FTREF/>
                         It is important to note that in many circumstances the MA organization does not inform the enrollee of the concurrent review determination and the enrollee is not afforded the opportunity to appeal the decision (or have an appeal submitted on their behalf) as required. The result of the concurrent review is the hospital may either continue to provide non-covered inpatient services or it may reclassify the enrollee's hospital status from inpatient to outpatient. Many times, the enrollee does not know a change in status has occurred until they are required to pay the outpatient deductible and applicable cost-sharing.
                        <SU>255</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>254</SU>
                             We have received conflicting information on the nature of peer-to-peer discussions from MA organizations. Some describe the process as solely educational in nature and that it has no bearing on the prior decision. Other MA organizations appear to use the discussion either to supplement or as a part of a contracted provider's appeal.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>255</SU>
                             We note that because an adverse concurrent review decision is a denial of inpatient hospital coverage, such a decision could also affect an enrollee's eligibility for covered post-hospital extended care services furnished in a skilled nursing facility (SNF). Section 1861(i) of the Act requires Medicare beneficiaries receive at least 3 consecutive days in a covered inpatient hospital stay within the preceding 30 calendar days in order to qualify for covered skilled SNF care. While we understand that most, if not all, MA organizations currently waive this coverage requirement, they are not required to continue to do so in future plan years. Therefore, if an MA organization that does not waive the 3-day inpatient hospital stay requirement makes an adverse concurrent review decision, the enrollee may not accrue the 3-day inpatient hospital stay necessary to receive covered skilled SNF care they otherwise could receive. A similar impediment to covered skilled SNF care could occur for enrollees that have opted into Traditional Medicare for the following year when an adverse concurrent review is made in the last 30 days of the plan year.
                        </P>
                    </FTNT>
                    <P>We have seen several different justifications for why an MA organization may not process a determination to deny an enrollee's inpatient admission, or deny coverage for inpatient services, made concurrently to the provision of such services under the requirements for other organization determinations. Some MA organizations have posited that these concurrent reviews are outside the definition of an organization determination because the timing of the decision is made during an ongoing course of treatment. These MA organizations appear to mistakenly believe that the existing definition of an organization determination is limited to decisions made before services begin and payment decisions that are made after a claim is submitted, and thus, a decision on inpatient coverage made concurrent to the services being rendered does not meet the definition of an organization determination or need to comply with the applicable organization determination notice and appeal right requirements.</P>
                    <P>We have also seen other situations where an MA organization appropriately considers the downgrading of an enrollee from receiving inpatient to outpatient services as an organization determination and yet will still fail to provide proper notice of the decision to the enrollee, process a timely appeal request, or both. We have received many complaints from the provider community that when the enrollee's treating physician requests an expedited reconsideration of an adverse concurrent review decision, pursuant to § 422.578, the MA organization will not process the appeal for a myriad of reasons. Some MA organizations have concluded that a level of care denial is not an appealable subject matter, while others believe reconsideration requests may not be processed while an enrollee is receiving the services at issue. The most common reason cited by plans for not processing appeals of adverse concurrent review decisions is the erroneous view that concurrent reviews made while an enrollee is being treated in an in-network hospital are “contractual denials” that are ineligible for review under the administrative appeals process of part 422, subpart M. This line of reasoning relates to the provision at § 422.562(c)(2) which states that “[i]f an enrollee has no further liability to pay for services that were furnished by an MA organization, a determination regarding these services is not subject to appeal.” MA organizations reason that because contracted providers are contractually restricted from billing the enrollee for denied services and must accept the contractual payment as “payment in full,” coupled with the enrollee protections against financial liability at §§ 422.504(g) and 422.562(c)(2), a concurrent review decision will ultimately result in the enrollee having no further financial liability for the inpatient services being rendered so there is no right to appeal the decision. As we have explained in section III.W.1. of this proposed rule, this interpretation overlooks the fact that the MA organization has made an adverse decision on the authorization or provision of inpatient services which not only impacts the type of care the enrollee receives but also directly impacts the amount of deductible and cost-sharing for which the enrollee is liable, when a request for payment is eventually submitted.</P>
                    <P>
                        CMS does not agree with the above interpretations of the existing organization determination and appeal regulations of part 422, subpart M. In the past, we have addressed these types of misinterpretations and non-compliance by MA organizations on a case-by-case basis as those issues were presented to us. However, we realize that the inconsistent application or misapplication of MA policies governing concurrent review is becoming increasingly varied and widespread across the industry, creating substantial confusion to MA organizations and, at times, variable outcomes to providers and enrollees. In addition, we recognize that the direct consequence of the misapplication of MA policies is that many enrollees do not receive notice of a decision to downgrade their level of care from inpatient to outpatient, nor are they given opportunity to appeal such decisions as provided under § 422.562(b)(4) (the right to a reconsideration of an adverse organization determination by an MAO). After considering other options available to CMS to clarify this matter, including increasing outreach and updating non-regulatory guidance, we decided the most appropriate and effective manner to address this issue is to clarify and strengthen the existing 
                        <PRTPAGE P="99465"/>
                        requirements related to organization determinations.
                    </P>
                    <P>We, therefore, propose to clarify that decisions made based on the review of an enrollee's need for continued care, commonly known as concurrent review, are organization determinations under the rules at § 422.566(b). Specifically, we are proposing to revise § 422.566(b)(3) to clarify that a decision by an MA organization made pre-service, post-service, or concurrent with the enrollee's receipt of services in an inpatient or outpatient setting is an organization determination subject to the rules in part 422, subpart M which includes providing the enrollee (and the provider, as appropriate) with timely notice and applicable appeal rights. We note that while the primary focus of the above discussion relates to the denial of inpatient hospital coverage as a result of an MA organization's concurrent review, our proposed clarification to the definition of an organization determination is inclusive of all other types of services.</P>
                    <P>
                        In addition to adding a reference to decisions made concurrently to the enrollee's receipt of services, we are also proposing to add to § 422.566(b)(3) a reference regarding applicable decisions made prior to the enrollee's receipt of services and after the services have been completed. Similar to our previous discussion related to concurrent review, we propose these additions to clarify that the subject-matter of an MA organization decision dictates whether it has made an organization determination, regardless of when in the continuum of an enrollee seeking and receiving covered medical care the decision is made. We use the term pre-service in proposed § 422.566(b)(3) to refer to a request for an MA organization to approve coverage for a service before the service is received by the enrollee. An enrollee, enrollee's representative, or a provider on behalf of an enrollee, has the right to request the enrollee's MA organization approve an item, service, or Part B drug in circumstances where there is a question whether the item, service, or Part B drug will be covered. This right to receive prior approval applies to services for which an MA organization may require prior authorization as a condition for coverage as well as services for which there is no prior authorization requirement. When an MA organization receives a request for an item, service, or Part B drug, it must process the request according to the timeframes at § 422.568(b) or § 422.572(a).
                        <SU>256</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>256</SU>
                             Beginning January 1, 2026, a request for a service or item that is subject to an MA organization's prior authorization requirement must be processed within 7 calendar days. The timeframe for processing requests for items and services not subject to an MA organization's prior authorization requirement remains 14 calendar days. See CMS-0057-F (89 FR 8976).
                        </P>
                    </FTNT>
                    <P>The reference to post-service in our proposed addition to § 422.566(b)(3) refers to applicable decisions that have been requested (or made by an MA organization in the absence of an organization determination request) after the enrollee has finished receiving the services at issue. The vast majority of post-service organization determinations are made in response to receiving a claim or other request for payment from an enrollee or provider. We are, however, aware that some MA organizations are denying payment for services before receiving a claim or other request for payment. More specifically, we have seen MA organizations decide on the appropriateness of an enrollee's inpatient admission, or the appropriateness of inpatient services, after an enrollee has been discharged from the hospital but before a request for payment has been received. These decisions have been referred to as “retrospective reviews” and, similar to our previous discussion on concurrent review decisions, many MA organizations making these decisions fail to comply with all applicable organization determination requirements, including providing appropriate notice and appeal rights to enrollees.</P>
                    <P>
                        As a point of clarity, we regularly observe MA organizations making retrospective organization determinations when performing a post-payment review (a review that occurs after payment is made on the selected claim in order to determine whether the initial determination for payment was appropriate (see definition at § 405.902)).
                        <SU>257</SU>
                        <FTREF/>
                         The retrospective review decisions we are discussing here, however, are not reviews of an MA organization's prior payment decisions but are initial determinations impacting payment for inpatient hospital services that are made after the enrollee has been released from a hospitalization, but before a request for payment is received.
                    </P>
                    <FTNT>
                        <P>
                            <SU>257</SU>
                             Post-payment reviews are performed under the reopening rules at §§ 405.980-405.986 and 422.616 (see § 405.929). Pursuant to § 422.616(d), when a payment determination is revised on reopening (including through post-payment review), any party may file an appeal of the revised determination. However, similar to initial payment determinations, when an MA organization revises a contracted provider payment determination that results in no additional financial liability or cost-sharing for the enrollee, § 422.562(c)(2) precludes any party from appealing the revised payment determination under the administrative appeals processes of part 422, subpart M. Contracted providers may appeal adverse payment determination revisions under the terms of the contract between the provider and the MA organization.
                        </P>
                    </FTNT>
                    <P>We have primarily observed MA organizations make retrospective review decisions on inpatient hospital services in a similar fashion as concurrent review. For example, an enrollee may be admitted as an inpatient in a hospital contracted with the enrollee's MA organization. During the hospital stay (or shortly thereafter), the MA organization will become aware of the inpatient admission, generally upon the hospital sending the MA organization a Notice of Admission. The hospital will finish providing services and discharge the enrollee in accordance with §§ 422.620-422.622. At some point after discharge, but before a claim for payment is submitted, the MA organization will notify the hospital that it is denying payment for all inpatient services and will instruct the hospital to submit an outpatient claim, while sometimes simultaneously approving the provider to bill for observation services. The MA organization does not send a notice of the denial to the enrollee. The hospital receives an opportunity to dispute the decision under the MA organization's internal dispute resolution processes, but the enrollee has no opportunity to dispute the decision under the rules of part 422 subpart M.</P>
                    <P>
                        We find that retrospective reviews are conducted very similarly to concurrent reviews in that both reviews involve obtaining necessary clinical information from the treating physician or other providers to determine medical necessity for the services rendered, using the clinical status of the enrollee and applicable Medicare coverage criteria. In addition, both concurrent and retrospective review decisions are often made without the MA organization first receiving a request for coverage or payment. The primary difference between the two review types is that concurrent review occurs while the services are being rendered while retrospective review occurs after the services at issue are fully furnished. This means that a concurrent review decision concerns the delivery of care being received by the enrollee, while a retrospective review decision concerns whether the MA organization will make payment for the services the enrollee received. Put simply, a concurrent review decision (whether made unsolicited or in response to a request) is a coverage decision while a retrospective review decision (whether made unsolicited or in response to a request) is a payment decision.
                        <PRTPAGE P="99466"/>
                    </P>
                    <P>
                        An MA organization's refusal to pay for services, in whole or in part, including the type or level of services, the enrollee believes should be furnished or arranged for by the MA organization is an organization determination under the rules at existing § 422.566(b)(3). As we mentioned above, we have proposed adding references to § 422.566(b)(3) to clarify that the definition of an organization determination includes decisions made before, during, and after the enrollee's receipt of the services at issue. Under our proposed clarifications to what actions constitute an organization determination, a post-service payment decision, even if made without the MA organization first receiving a payment request, is subject to the rules in subpart M. In addition, as we explained in section III.W.1. of this proposed rule, the regulations of part 422, subpart M treat organization determinations related to coverage for services to be or contemporaneously being rendered (coverage decisions) differently from determinations related to payment for services already furnished (payment decisions). As such, a retrospective review decision would be subject to all applicable subpart M requirements related to payment organization determinations, including those related to notice and appeal rights. 
                        <SU>258</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>258</SU>
                             While the focus of this discussion is on unsolicited retrospective reviews, we acknowledge that enrollees or providers may, at times, submit a request for “authorization” for services which have already been fully rendered. Indeed, we understand that some MA organizations currently permit the submission of late “authorization” requests for certain services subject to prior authorization requirements within designated timeframes after a service has been rendered and, if approved, would consider the applicable prior authorization requirements met when separately considering payment. However, as we have explained above, once a service has been fully furnished, the only matter for an MA organization to decide is whether to make payment and any resulting enrollee financial liability or cost-sharing. Thus, similar to unsolicited retrospective review decisions, post-service authorization requests, whether permitted by MA organizations or not, must be processed as payment requests, under the applicable payment timeframes and policies. We note that our proposed policies do not prevent MA organizations from waiving prior authorization requirements on a case-by-case basis, based on good cause or any other consideration, during the claim adjudication or subsequent appeal processes when such processes are described in their EOC.
                        </P>
                    </FTNT>
                    <P>
                        In accordance with § 422.568(d)(1), an MA organization must give the enrollee written notice when denying payment in whole or in part. The payment denial notice must use approved language in a readable and understandable form (§ 422.568(e)(1)), state the specific reasons for the denial (§ 422.568(e)(2)), inform the enrollee of their right to appeal (§ 422.568(e)(3)), describe the standard reconsideration process and the rest of the appeal process (§ 42.568(e)(4)(ii)), and comply with any other notice requirements specified by CMS (§ 422.568(e)(5)). CMS created the Notice of Denial of Medical Coverage or Payment (form CMS-10003-NDMCP), more commonly known as the Integrated Denial Notice (IDN), as a standardized notice for MA organizations to use when making adverse coverage or payment decisions. Alternatively, an MA organization may use the model Explanation of Benefits (EOB), when making an adverse payment decision as long as it includes the approved standard language from the IDN.
                        <SU>259</SU>
                        <FTREF/>
                         We explain in subregulatory guidance that an MA organization must provide notice of an adverse payment decision to an enrollee using the IDN or EOB when the enrollee submitted the request or through an EOB when the payment request was submitted by a provider (the provider would receive a corresponding remittance notice or similar notice).
                        <SU>260</SU>
                        <FTREF/>
                         We have not previously considered the proper notice for MA organizations to use when making payment decisions without first receiving a request for payment.
                    </P>
                    <FTNT>
                        <P>
                            <SU>259</SU>
                             An EOB is a model communication material which must also contain the information required under § 422.111(k).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>260</SU>
                             See section 40.12.1 of the Parts C &amp; D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance available at 
                            <E T="03">https://www.cms.gov/Medicare/Appeals-and-Grievances/MMCAG/Downloads/Parts-C-and-D-Enrollee-Grievances-Organization-Coverage-Determinations-and-Appeals-Guidance.pdf.</E>
                        </P>
                    </FTNT>
                    <P>As we previously discussed, it is our understanding that retrospective review decisions are most often, if not exclusively, made on inpatient services performed by hospitals that are contracted with the MA organization. In most instances (excluding those which fall outside the plan-directed care beneficiary protection), when an MA organization makes a payment decision on contracted provider services, existing § 422.562(c)(2) would preclude a party's appeal of a decision as the enrollee would generally have no additional financial liability under the terms of the contract between the MA organization and the provider. However, as we discussed in section III.W.1. of this proposed rule, proposed § 422.562(c)(2) would not be applicable until an MA organization makes a decision on an enrollee's financial liability in response to a request for payment. Under proposed § 422.562(c)(2), an enrollee would not be precluded from appealing an adverse retrospective review decision as the MA organization would not yet have received a request for payment when the retrospective review decision is made. We believe this would be an appropriate outcome as an adverse retrospective review decision on inpatient hospital services typically results in the MA organization instructing the hospital to submit an outpatient claim (at times including an approval for observation services), thereby changing the cost-sharing amount for which the enrollee would be responsible. Cost-sharing, which may include deductibles, co-payments, and co-insurance, varies across the MA program, but most often has different requirements for inpatient and outpatient hospital services. Therefore, whether a hospitalization is billed as an inpatient or an outpatient stay would likely result in different out-of-pocket costs for the enrollee. We note that the difference in cost-sharing liability could be higher or lower for an enrollee after an adverse retrospective review decision on inpatient hospital services. The exact difference in amounts would depend on the enrollee's cost-sharing requirements of their particular plan, the length of their hospitalization, and, potentially, the amount and types of services which were rendered. We believe that ensuring an enrollee has adequate notice of an adverse MA organization payment decision, which may negatively affect their out-of-pocket expenses for a hospitalization, is paramount for providing a meaningful opportunity to appeal. However, because we have not previously considered which existing notice type (that is, the IDN or an EOB) would be most appropriate for MA organizations to use when making a retrospective review decision without first receiving a request, we are requesting comments on the type of notice MA organizations should utilize to ensure enrollees have adequate notice of the organization determination and its implications on the enrollee's cost-sharing responsibilities. Based on this feedback, CMS may consider clarifying in future guidance how MA organizations can ensure compliance with existing notice requirements when issuing retrospective review decisions prior to receiving a request for payment.</P>
                    <P>
                        Finally, we also propose to make a corresponding change at § 422.138(c), to include concurrent reviews as a type of determination subject to the rules at § 422.138(c). Per CMS regulations at § 422.138(c), if the MA organization approved the furnishing of a covered item or service through a prior authorization or pre-service determination of coverage or payment, it may not deny coverage later on the basis 
                        <PRTPAGE P="99467"/>
                        of lack of medical necessity and may not reopen such a decision for any reason except for good cause (as provided at § 405.986 of this chapter) or if there is reliable evidence of fraud or similar fault per the reopening provisions at § 422.616. We propose to add concurrent review decisions to § 422.138(c) as subject to this requirement. In the same way that a provider and patient reasonably rely upon an MA organization's approval of a prior authorization before services are rendered, an approval of inpatient or outpatient services during a concurrent review is an organization determination that is relied upon by the patient and provider to continue delivering medically necessary services that they expect to be covered and paid for by the MA organization. As a result, an MA organization should not be able to later deny the services based on a lack of medical necessity if the continued treatment had already been approved during a concurrent review.
                    </P>
                    <HD SOURCE="HD3">3. Strengthening Requirements Related to Notice to Providers (§§ 422.568, 422.572, and 422.631)</HD>
                    <P>Section 1852(g)(1)(B) of the Act requires MA organizations to provide an explanation of determinations regarding whether an individual enrolled with a plan is entitled to receive a health service under this section and the amount (if any) that the individual is required to pay with respect to such service. In accordance with section 1852(g)(1)(B) of the Act, § 422.568 establishes the timeframe and notice requirements for standard organization determinations. Section 422.568(e)(5) establishes an additional framework for promulgating expanded notice requirements. Under § 422.568(f), if a MA organization fails to timely meet applicable notice requirements, the failure constitutes an appealable adverse organization determination.</P>
                    <P>
                        Existing § 422.568(d) requires MA organizations to provide enrollees written notice if an MA organization decides to deny coverage for a service or an item, Part B drug, or payment in whole or in part, or decides to reduce or prematurely discontinue the level of care for a previously authorized ongoing course of treatment. Section 422.568(e) specifies that an MA organization's written notice of a coverage denial must use approved notice language, state the specific reasons for the denial, inform the enrollee of their right to request and the procedures for requesting a standard or expedited reconsideration, and must also comply with other notice requirements specified by CMS.
                        <SU>261</SU>
                        <FTREF/>
                         CMS created the Notice of Denial of Medical Coverage or Payment (
                        <E T="03">Form 10003-NDMCP</E>
                        ), also known as the Integrated Denial Notice (IDN) as a standardized denial notice that MA organizations may use to comply with the written notice requirements of § 422.568(e). This notice is approved by the Office of Management and Budget, subject to Paperwork Reduction Act procedures and is posted on the CMS website.
                        <SU>262</SU>
                        <FTREF/>
                         While MA organizations are required to provide timely notice of an approved organization determination, written notice is not required. This means that MA organizations may provide oral notice of approved coverage decisions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>261</SU>
                             Section 422.568(e) also regulates the notice requirements for payment denials, which are largely the same, with the exception that payment denial notices do not need to include information on expedited reconsideration processes.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>262</SU>
                              
                            <E T="03">https://www.cms.gov/medicare/forms-notices/beneficiary-notices-initiative/ma-denial-notice.</E>
                        </P>
                    </FTNT>
                    <P>The existing notice requirements for standard organization determinations at § 422.568(b)(1) only specify that MA organizations must provide the enrollee with notice of its decisions. This is a notable difference from the requirements related to expedited organization determinations at existing § 422.572(a) and (b) that require MA organizations to provide timely notice of any expedited organization determination to the enrollee and the physician or prescriber involved, as appropriate. Likewise, for Part B drug requests, regulations at § 422.568(b)(3) require notice to the prescribing physician or other prescriber involved, as appropriate.</P>
                    <P>
                        However, existing CMS guidance instructs MA organizations to notify the provider, as well as the enrollee, whenever a provider submits an organization determination on behalf of the enrollee (see section 40.12.1 of the Parts C &amp; D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance.
                        <SU>263</SU>
                        <FTREF/>
                        ) Similar references are also made in the text of the IDN, as CMS explains to enrollees that “If your doctor requested coverage on your behalf, [the MA organization has] sent a copy of this decision to your doctor.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>263</SU>
                              
                            <E T="03">https://www.cms.gov/medicare/appeals-and-grievances/mmcag/downloads/parts-c-and-d-enrollee-grievances-organization-coverage-determinations-and-appeals-guidance.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We do not find a compelling reason that a provider should not receive notice of a standard organization determination when the provider submitted a request on behalf of an enrollee or when it is otherwise appropriate for the provider to receive notice of the determination. Indeed, under existing regulations at § 422.566(c)(1)(ii), a provider is already permitted to request an organization determination on an enrollee's behalf. This longstanding policy is premised on a reasonable belief that an enrollee will welcome and be informed of their provider or physician's willingness to pursue an organization determination on their behalf. We see no reason that a provider or physician to whom an enrollee has already entrusted their care or has sought to request coverage for their care, should not receive notice of an organization determination that directly affects such care. In fact, we believe an enrollee's provider is often in the best position to receive, explain, and timely act upon the MA organization decision for an enrollee.</P>
                    <P>
                        Similar requirements for integrated organization determinations apply to applicable integrated plans at § 422.631. Under § 422.631(d)(1)(i), applicable integrated plans are required to send an enrollee a written notice of any adverse decision on an integrated organization determination (including a determination to authorize a service or item in an amount, duration, or scope that is less than the amount previously requested or authorized for an ongoing course of treatment) within the timeframes set forth in § 422.631(d)(2). Existing § 422.631(d)(1)(ii) states that an integrated organization determination not reached within the timeframes specified constitutes a denial and thus is an adverse decision. Section 422.631(d)(1)(iii) specifies the integrated organization determination notice requirements for applicable integrated plans must be written in plain language, available in a language and format accessible to the enrollee, include the date the determination was made and will take effect, the reason for the determination, the enrollee's right to an integrated reconsideration and to have someone file an appeal on their behalf, procedures for an integrated reconsideration, circumstances for an expedited resolution and enrollee's rights to continue benefits while their appeal is pending. CMS created the coverage decision letter (CDL) (
                        <E T="03">Form CMS-10716</E>
                        ), an OMB approved notice, for use by applicable integrated plans to comply with the written notice requirements at § 422.631(d)(1)(iii). The existing notice requirements at § 422.631(d)(1)(i) only specify that an applicable integrated plan must provide the enrollee with notice of its decisions. However, integrated organization determinations for Part B drug requests are governed by the provisions at § 422.568(b)(3) that require notice to the 
                        <PRTPAGE P="99468"/>
                        prescribing physician or other prescriber involved, as appropriate. Likewise, existing CMS guidance instructs applicable integrated plans to notify the provider, as well as the enrollee.
                    </P>
                    <P>We, therefore, propose strengthening requirements related to notice of a standard organization determination at § 422.568 in paragraph (b)(1) and the introductory text for paragraph (d) and integrated organization determinations at § 422.631(d)(1)(i) to require MA plans and applicable integrated plans to notify an enrollee's physician or provider, as appropriate, of an organization determination or integrated organization determination on a request for a non-drug item or service (in addition to the existing requirement related to notifying an enrollee). Note that “as appropriate” means, as with similar requirements in §§ 422.568(b)(3) and 422.572(a), that notice should be given to the provider or prescriber who submitted an organization determination request on behalf of an enrollee or in other circumstances where it would be in the enrollee's best interest for their provider or prescriber to receive notice of a decision related to an enrollee-submitted request.</P>
                    <P>We are also proposing corresponding amendments to §§ 422.568(f), 422.572(f), and 422.631(d)(1)(ii) to state that if the MA organization or applicable integrated plan fails to provide the enrollee, physician, or provider involved, as appropriate, with timely notice of an organization determination or integrated organization determination as specified in this section, this failure itself constitutes an adverse organization determination and may be appealed. We note that the proposed change at § 422.572(f) is a technical change to expedited organization determination requirements. Under existing rules at § 422.572(a), MA organizations are required to provide notice of an expedited organization determination to the physician or prescriber, as appropriate. However, existing § 422.572(f), which establishes that a MA organization's failure to timely meet expedited organization determination notice requirements constitutes an adverse decision, only refers to the MA organization's responsibility to provide timely notice to the enrollee. We, therefore, propose a technical change to § 422.572(f) to clarify that the failure to provide timely notice of an expedited organization to the enrollee and the physician or prescriber, when appropriate, would itself constitute an appealable adverse organization determination.</P>
                    <P>
                        In addition, we are proposing a technical change at § 422.631(a) to reference the correct Part B drug regulation at § 422.568(b)(3) rather than the current reference to § 422.568(b)(2) to govern the timeframes and notice requirements for integrated organization determinations for Part B drugs. The final rule titled the “Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program,” which appeared in the February 8, 2024, 
                        <E T="04">Federal Register</E>
                        , redesignated § 422.568(b)(2) as § 422.568(b)(3).
                    </P>
                    <P>We do not believe this proposal will have a substantial impact on the practices of MA organizations or applicable integrated plans as we are codifying longstanding guidance that we believe the majority of plans already implement this practice based on the relatively few complaints from providers and enrollees. In addition, we also understand that due to the contractual relationship MA organizations have with their providers, most contracted providers should already receive notice of relevant organization determinations, including those that the provider submitted on behalf of the enrollee. However, we note that the few complaints that we do receive on this issue reinforce how disruptive the lack of provider notice can be for enrollees attempting to promptly receive covered medical services. When an enrollee is the only party to receive written notice of a decision, not only can this result in a delay in their receipt of approved medical care but could also delay the submission of a valid appeal when coverage is denied.</P>
                    <P>We also believe this proposal will positively support our proposed modification of the definition of an organization determination at § 422.566(b) by ensuring providers will always receive notice of a decision notwithstanding when in the continuum of care the decision is made. As discussed in section III.W.2. of this proposed rule, CMS has identified that some MA organizations routinely misinterpret existing organization determination provisions related to decisions that rescind prior authorization of an inpatient admission, deny coverage for inpatient services, or downgrade an enrollee's hospital coverage, from inpatient to outpatient, when the decision is made concurrently to the enrollee receiving such services. In these cases, the MA organizations are not providing enrollees or their providers proper notice of the adverse organization determination or providing appeal rights. Our proposed clarifications to the definition of an organization determination at § 422.566(b)(3) seek to clarify that applicable decisions made before, during, or after the enrollee's receipt of services are organization determinations and thus are subject to notice requirements pursuant to §§ 422.568, 422.572 and 422.631. Our proposal at §§ 422.568 and 422.631 would, therefore, require the MA organization or applicable integrated plan to provide notice to the enrollee and physician or provider that must comply with the standard organization determination or integrated organization determination requirements. We note, however, that in the case of an MA organization conducting pre-service or concurrent review for inpatient services, our expectation is that the facts and circumstances around that type of review will often satisfy the medical exigency standard. Therefore, we expect in most circumstances an MA organization must provide an expedited determination because applying the standard timeframe for making a determination could seriously jeopardize the life or health of the enrollee or the enrollee's ability to regain maximum function, consistent with the provisions at §§ 422.570(c)(2) and 422.631(c)(3).</P>
                    <HD SOURCE="HD3">4. Modifying Reopening Rules Related to Decisions on an Approved Hospital Inpatient Admission (§§ 422.138 and 422.616)</HD>
                    <P>
                        Under the regulations at § 422.576, an organization determination is binding on all parties unless it is reconsidered under the rules at §§ 422.578 through 422.596 or is reopened and revised under § 422.616. The reopening rules at § 422.616 permit an organization or reconsidered determination made by an MA organization that is otherwise final and binding to be reopened and revised by the MA organization under the applicable rules in part 405, subpart I at §§ 405.980 through 405.986. The reopening rules in part 405, subpart I are based on § 1869(b)(1)(G) of the Act which states that the Secretary may reopen or revise any initial 
                        <PRTPAGE P="99469"/>
                        determination or reconsidered determination described in this subsection under guidelines established in regulations. While the reopening rules in §§ 405.980 through 405.986 are applicable to the Traditional Medicare program, the regulatory provisions at 42 CFR part 405 historically have been cross-referenced in the managed care regulations and have been applied to the MA program consistent with the provisions at §§ 422.562(d) and 422.616 since the inception of the MA program (and to MA's predecessor, the Medicare+Choice program). Thus, the ability of an MA organization to reopen and revise an organization determination for the reasons set forth in regulation is well established in the MA program. For purposes of this proposal, the discussion is specific to the application of the reopening rules to organization determinations made by an MA organization that involve inpatient hospital admission decisions.
                    </P>
                    <P>
                        Section 422.616(b) permits a reopening at the instigation of any party and, in accordance with § 422.616(d), once an adjudicator issues a revised determination, any party may file an appeal. Pursuant to the applicable reopening regulations at § 405.980(b), an organization determination or reconsideration may be reopened by an MA organization within 1 year from the date of the initial determination or redetermination for any reason. However, in recently promulgated prior authorization rules at § 422.138(c), if an MA organization approved the furnishing of a covered item or service through a prior authorization or pre-service determination of coverage or payment, it may not deny coverage later on the basis of lack of medical necessity and may not reopen such a decision for any reason except for good cause (as provided at § 405.986) or if there is reliable evidence of fraud or similar fault per the reopening provisions at § 422.616.
                        <SU>264</SU>
                        <FTREF/>
                         Under § 422.138(c), in the case of an approved organization determination for the furnishing of a covered item or service made through prior authorization or a pre-service determination, an MA organization is not permitted to reopen that decision within 1 year from the date of determination for any reason as is otherwise permitted at § 405.980(b)(1). While the rules at § 422.138(c) currently allow for reopening of a favorable prior authorization decision within 4 years from the date of the initial determination or redetermination for good cause, as defined in § 405.986, we believe a proposed modification to the MA reopening rules at § 422.616 is necessary with respect to favorable organization determinations on inpatient hospital admissions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>264</SU>
                             See 88 FR 22120, 22185-22217.
                        </P>
                    </FTNT>
                    <P>We are aware that some MA organizations are reopening and revising or otherwise rescinding a prior approval for an inpatient hospital admission based on a medical necessity determination during the enrollee's receipt of the previously authorized services or during the adjudication of the subsequent inpatient claim for payment. For example, when deciding to admit an enrollee, the hospital requests and receives approval for the admission from the enrollee's MA organization. Later, however, the MA organization obtains and reviews additional medical documentation and determines that the enrollee does not meet the necessary criteria to support payment for inpatient hospital services and rescinds or overrides its prior approval. As discussed in the context of our proposal to strengthen the notice requirements in § 422.568, some MA organizations are not consistently providing notice or appeal rights to the enrollee for these decisions.</P>
                    <P>The rules at § 405.980(b) permit reopening of a decision if there is a finding of good cause as defined in § 405.986. If good cause is found, an organization determination may be reopened within 4 years from the date of the determination. Under the rules at § 405.986, good cause may be established when (1) there is new and material evidence that was not available or known at the time of the determination and that may result in a different conclusion; or (2) the evidence that was considered in making the determination or decision clearly shows on its face that an obvious error was made at the time of the determination or decision. New and material evidence is evidence that was not readily available or known to the person or entity requesting or initiating the reopening at the time the initial determination was made by the MA organization and may result in a different conclusion than reached in the initial determination. Such evidence may include any record used in the furnishing of care and supporting the medical necessity of such care. This includes, but is not necessarily limited to, medical records, progress notes, and physician orders. Under the reopening rules, a change of legal interpretation or policy by CMS in a regulation, ruling, or general instruction is not a basis for reopening an organization determination.</P>
                    <P>Under existing rules at § 422.138(c), in cases where an enrollee's inpatient admission into the facility is approved prior to admission, this decision is binding and may not be reopened and revised by the MA organization unless there is good cause for a reopening pursuant to the rules at § 405.986. The inpatient hospital admission rules at § 412.3(d)(1) and (3) are clear that the coverage criteria set forth therein are based on the admitting physician's expectation at the time of admission about whether the hospital care will cross two-midnights or is otherwise appropriate, as supported by the medical record. Since the physician's expectation at the time of admission is based on the clinical information known at that time as well as the documented medical record at the time of admission, any subsequent clinical information obtained after an MA organization has made its initial organization determination would not have the effect of creating a good cause reopening on the basis of new and material evidence that was not available or known at the time of the determination or decision and that may result in a different conclusion. As part of the organization determination process, it is incumbent on the MA organization to obtain and review all relevant clinical information to make an organization determination on a request for inpatient hospital admission and to comply with requirements for basic benefits as described in § 422.101(b)(2).</P>
                    <P>Due to the ongoing issues we have seen with previously approved inpatient hospital admissions later being inappropriately revised or rescinded, and to augment the rules at § 422.138(c), we propose to amend § 422.616(a) to state that the reopening provisions are subject to the rules at § 422.138(c) and propose a new paragraph (e) of § 422.616 that would place a limitation on reopening determinations related to favorable inpatient hospital admissions. Specifically, proposed § 422.616(e) would state that if an MA organization approved an inpatient hospital admission under the rules at § 412.3(d)(1) or (3), any additional clinical information obtained after the initial organization determination cannot be used as new and material evidence to establish good cause for reopening the determination.</P>
                    <P>
                        We believe these proposed amendments to the reopening rules at § 422.616 present a reasonable approach to curtailing the reopening of approved hospital admission decisions and are consistent with the rules on inpatient admission decision-making. Decisions on inpatient admissions under § 412.3(d)(1) or (d)(3) are based on whether the complex medical factors documented in the clinical record 
                        <PRTPAGE P="99470"/>
                        support the admitting physician's clinical expectation or judgment. Section 412.3(d)(1) states that, except as specified in paragraphs (d)(2) and (3) of § 412.3, an inpatient admission is generally appropriate for payment under Medicare Part A when the admitting physician expects the patient to require hospital care that crosses two midnights. Section 412.3(d)(1)(i) states that the expectation of the physician should be based on such complex medical factors as patient history and comorbidities, the severity of signs and symptoms, current medical needs, and the risk of an adverse event. The factors that lead to a particular clinical expectation must be documented in the medical record to be granted consideration (with respect to determining the appropriateness of payment for an inpatient stay). Section 412.3(d)(1)(ii) states that if an unforeseen circumstance, such as a beneficiary's death or transfer, results in a shorter beneficiary stay than the physician's expectation of at least two midnights, the patient may be considered to be appropriately treated on an inpatient basis, and payment for an inpatient hospital stay may be made under Medicare Part A. The exception in § 412.3(d)(2) relates to inpatient admission for a surgical procedure specified by Medicare as inpatient only under § 419.22(n). The exception in § 412.3(d)(3) states that where the admitting physician expects a patient to require hospital care for only a limited period of time that does not cross two midnights, an inpatient admission may be appropriate for payment under Medicare Part A based on the clinical judgment of the admitting physician and medical record support for that determination. The physician's decision is based on such complex medical factors as patient history and comorbidities, the severity of signs and symptoms, current medical needs, and the risk of an adverse event. In these cases, the factors that lead to the decision to admit the patient as an inpatient must be supported by the medical record in order to be granted consideration.
                    </P>
                    <P>Based on these rules, we believe it is appropriate to limit reopening of a decision involving inpatient hospital admission by prohibiting reopening for good cause based on new and material evidence. Any additional clinical information obtained after the initial organization determination cannot have the effect of creating a good cause reopening because the determination was made based on what was known by the physician and documented in the medical record at the time of admission. Under the rules at § 405.986(a)(2), good cause for reopening may also be established if the evidence that was considered in making the determination clearly shows on its face that an obvious error was made at the time of the determination or decision. This proposed rule does not seek to modify or limit the applicability of reopening for obvious error per the rules at § 405.986(a)(2) with respect to favorable inpatient hospital admission decisions. For example, there could be a situation where the admitting physician documents something related to the enrollee's condition incorrectly into the clinical record that the plan relied upon when making the favorable decision and the facts and circumstances of such a mistake, including the significance and materiality of the error, may support a reopening of the favorable decision on the basis of obvious error. We believe the need for a plan to reopen a favorable inpatient hospital admission decision on the basis of obvious error under the rules at § 405.986(a)(2) should be a rare occurrence given the breadth of clinical documentation that is considered when making a decision on an inpatient hospital admission.</P>
                    <P>We acknowledge that our proposed limitation on the type of clinical information that may be considered new and material evidence to form the basis to reopen a favorable determination related to an inpatient hospital admission is a departure from corresponding Traditional Medicare reopening policies and would, at times, restrict certain clinical information from forming the basis of new and material evidence to reopen that would otherwise be available in Traditional Medicare. While we strive to create and apply policies consistently between the MA program and Traditional Medicare, the programs' inherent differences require a tailored approach in this scenario. In particular, under Traditional Medicare, an initial determination related to an inpatient admission would only be made after a beneficiary had received the service and a claim for payment has been submitted (see § 405.920) and, therefore, generally after a beneficiary's medical record supporting that service has been fully developed. In contrast, MA enrollees may receive a favorable determination related to an inpatient hospital admission before or contemporaneously to the enrollee's receipt of services (see § 422.566(b)(3)). This means the enrollee's medical records are continuing to be updated to reflect the changing medical circumstances. Thus, it is more likely that clinical information obtained after an initial organization determination could lead to an MA organization reopening a decision for an enrollee than a beneficiary in Traditional Medicare, even though the inpatient admissions criteria in § 412.3 apply in the same manner to both programs. MA enrollees should be able to rely upon an approved inpatient admission made in advance of the receipt of services, or concurrently with the receipt of services, despite changing medical circumstances. They should not be concerned that an MA organization may revise or rescind an approved admission due to clinical information that was not available or in existence when the provider determined the need for admission and the MA organization approved the admission.</P>
                    <P>Finally, for clarity in the applicability of the reopening rules to prior authorization and pre-service determinations, we are proposing a technical amendment to the parenthetical text in paragraph (c) of § 422.138 to add a cross reference to the rules at § 422.616, including proposed new paragraph (e) related to decisions to approve an inpatient hospital admission.</P>
                    <P>We are soliciting comments on the above proposals and will consider the need to revise one or more of these approaches based on relevant stakeholder feedback. With respect to the proposal to clarify that an organization determination includes decisions made by an MA plan concurrent with an enrollee's receipt of services and on a retrospective basis after services have ended, we are specifically soliciting comments on whether a notice other than the existing EOB may be needed to convey written information to an enrollee on the anticipated impact of the decision on the enrollee's financial liability and the right to appeal.</P>
                    <HD SOURCE="HD2">W. Formulary Inclusion and Placement of Generics and Biosimilars</HD>
                    <P>
                        Multiple recent reports, actions, and findings published or taken by entities outside CMS have raised concerns that Part D sponsors and their PBMs engage in practices that favor, intentionally or unintentionally, more expensive brand drugs and reference products over generics, biosimilars, and other lower cost drugs in terms of formulary placement or non-placement. For example, a March 2022 HHS OIG report titled, “Medicare Part D and Beneficiaries Could Realize Significant Spending Reductions with Increased Biosimilar Use,” found that, since biosimilars were introduced in 2015, 
                        <PRTPAGE P="99471"/>
                        use of and spending on these drugs in Part D has steadily increased. However, the report also found that biosimilars are still used far less frequently than their higher-cost reference product alternatives, and that Part D spending on biologics with available biosimilars could have decreased by $84 million in 2019, if all biosimilars had been used as frequently as the most-used biosimilars. The report asserted that a lack of biosimilar coverage on Part D formularies could limit the potential for these drugs to reduce costs for Part D and beneficiaries. The report noted that, in 2019, not all plan formularies covered available biosimilars, and those formularies that did cover biosimilars rarely encouraged their use over reference products through preferential formulary tier placement and utilization management (UM) tools.
                        <SU>265</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>265</SU>
                             
                            <E T="03">https://oig.hhs.gov/reports/all/2022/ medicare-part-d-and-beneficiaries-could-realize-significant-spending-reductions-with-increased-biosimilar-use/.</E>
                        </P>
                    </FTNT>
                    <P>
                        In addition, a July 2024 Federal Trade Commission (FTC) report titled, “Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies” stated that an FTC review of a number of contracts, including both commercial and Part D contracts, and internal documents summarizing such contracts, revealed “that some rebate contracts explicitly premise high rebates on the exclusion of AB-rated generics. These generic exclusions can be accomplished through `NDC blocks' of generic equivalents—that is, a contractual prohibition on payments for generic drugs, as identified by their National Drug Code or `NDC' number. These findings are consistent with public comments that identify the practice of PBMs preferring higher point-of-sale price branded products over generics, which may raise out-of-pocket costs for patients.” 
                        <SU>266</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>266</SU>
                             
                            <E T="03">https://www.ftc.gov/system/files/ftc_gov/pdf/pharmacy-benefit-managers-staff-report.pdf (page 68).</E>
                        </P>
                    </FTNT>
                    <P>
                        Furthermore, in September 2024, the FTC filed an Administrative Complaint against certain PBMs and related entities asserting violations of the FTC Act based upon formulary and manufacturer rebate practices relating to disfavoring certain lower cost insulin products (some of which are biosimilars).
                        <SU>267</SU>
                        <FTREF/>
                         Among other things, the complaint alleges that these PBMs “systematically prefer high list price insulin products, with high rebates and fees, over similar low list price products, with low rebates and fees, on formularies to inflate the perceived value of their commercial drug formularies and offer higher rebate guarantees.” 
                        <SU>268</SU>
                        <FTREF/>
                         While this complaint did not involve the Medicare Part D program, it is instructive as to PBM practices generally, since the respondents also operate in the Part D space as contractors to Part D sponsors.
                    </P>
                    <FTNT>
                        <P>
                            <SU>267</SU>
                             Compl., 
                            <E T="03">In re Caremark Rx, LLC et al.,</E>
                             FTC Dkt. No. 9437, 
                            <E T="03">https://www.ftc.gov/system/files/ftc_gov/pdf/d9437_caremark_rx_zinc_health_services_et_al_part_3_complaint_public_redacted.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>268</SU>
                             
                            <E T="03">Id.</E>
                             at ¶ 256.
                        </P>
                    </FTNT>
                    <P>
                        In addition to external organizations highlighting this issue, CMS has previously stated that it had identified instances when Part D sponsors did not include on their formularies generic alternatives when available and issued guidance to address this issue. In the final CY 2020 Call Letter,
                        <SU>269</SU>
                        <FTREF/>
                         in the section “Improving Access to Generic and Biosimilar Medicines” that discussed tier composition policy, CMS stated, “The use of cost-effective therapeutic alternatives like generic and biosimilar medicines is critical to the current and long-term success of Medicare Part D. . . .CMS will continue to encourage Part D sponsors to prioritize formulary placement for generics and biosimilars through favorable tier placement relative to branded products. . . . [W]hile CMS analysis of CY 2019 formularies shows robust access to cost-effective generic medications and that Part D sponsors have been achieving very high generic dispensing and substitution rates, we do note that there are limited instances when Part D sponsors are not including generic alternatives when available. Instead, sponsors are only covering the brand drugs, which decreases generic substitution and increases beneficiary costs.” 
                        <SU>270</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>269</SU>
                             
                            <E T="03">https://www.cms.gov/medicare/health-plans/medicareadvtgspecratestats/downloads/announcement2020.pdf</E>
                             (
                            <E T="03">pages 210-211</E>
                            ).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>270</SU>
                             With respect to generic substitution, CMS noted that a significant number of states have passed legislation requiring pharmacies to substitute lower cost generic drug products for brand name drug products where available, and that there are laws to encourage generic and biosimilar uptake, including the Hatch-Waxman Act and state generic substitution laws.
                        </P>
                    </FTNT>
                    <P>
                        In the final CY 2020 Call Letter, CMS also stated that we would continue to monitor beneficiary access to generic alternatives, utilization of multi-source brand drugs when generics are available, and situations where the brand drug is situated more favorably in comparison to the generic with regards to tiering and UM, and that we would consider future policy changes should this trend continue.
                        <SU>271</SU>
                        <FTREF/>
                         As part of such monitoring, CMS has identified cases when an equivalent generic or biosimilar is not included on the formulary when it is available. There are also occasions when the generic is included on the same or higher formulary tier as the brand drug, and occasions when a biosimilar is included on the same or higher formulary tier as the reference product.
                    </P>
                    <FTNT>
                        <P>
                            <SU>271</SU>
                             Id.
                        </P>
                    </FTNT>
                    <P>These reports, actions, and findings continue to be concerning because of the potential for higher out-of-pocket prescription drug costs for Medicare beneficiaries when lower cost generics and biosimilars are excluded from formularies or are placed on the same or higher formulary tiers as the more expensive brand-name drug or reference product. Furthermore, the patterns described in the reports, actions, and findings may exist for other lower cost drugs. Because such formulary decisions risk increasing out-of-pocket costs for enrollees, CMS believes these reports, actions, and findings may be indicative of UM programs that are not cost-effective and therefore out of compliance with Part D requirements.</P>
                    <P>We remind sponsors that section 1860D-4(c)(1)(A) of the Act requires a Part D sponsor to have in place, directly or through appropriate arrangements, with respect to covered Part D drugs, “[a] cost-effective drug utilization management program, including incentives to reduce costs when medically appropriate, such as through the use of multiple source drugs (as defined in section 1927(k)(7)(A)(i) of the Act).” This statutory requirement is codified at § 423.153(b), which states that Part D sponsors must have established “a reasonable and appropriate drug utilization management program” that, among other requirements, “[i]ncludes incentives to reduce costs when medically appropriate.”</P>
                    <P>
                        Given the concerns highlighted by the preceding reports, actions, and findings, CMS finds it necessary to clarify that, to be compliant with Part D requirements, Part D plan formularies must provide beneficiaries with broad access to generics, biosimilars, and other lower cost drugs. We view such access as a necessary component of a reasonable and appropriate drug UM program that is cost-effective and that includes incentives to reduce costs when medically appropriate. In other words, the plain language in section 1860D-4(c)(1)(A) of the Act and current § 423.153(b) makes clear that a UM program cannot be considered cost-effective or inclusive of incentives to reduce costs if it broadly excludes or restricts access to generics, biosimilars, and other lower cost drugs that can reduce costs in a medically appropriate manner and improve the cost efficiency 
                        <PRTPAGE P="99472"/>
                        of drug utilization. This does not mean that a sponsor is required to include all generics and biosimilars associated with a brand drug or reference product on the formulary, or if they are included, that they all be placed on a more preferred formulary tier relative to the brand drug or reference product. Nor do we require that a sponsor forego UM edits (for example, prior authorization (PA) and step therapy (ST)) on generics and biosimilars. Instead, we are making it a point of emphasis that broad access to generics, biosimilars, and other lower cost drugs is a necessary component of having a reasonable, appropriate, and cost-effective UM program.
                    </P>
                    <P>
                        Broad access to generics, biosimilars, and other lower cost drugs, refers not only to formulary inclusion, but also tier placement and UM practices such as PA, ST, and quantity limits (QL). This is because a drug UM program may not be cost-effective even if the plan broadly includes generics, biosimilars, and other lower cost drugs on the formulary, if tier placement and other UM restrictions effectively limit access to these drugs compared to their more expensive branded versions and reference products. The idea that a cost-effective UM program includes formulary placement and tiering, and UM practices (including PA, ST, and QL), is consistent with the plain text of section 1860D-4(c)(1)(A) of the Act. For example, a plan that generally includes on formulary higher cost drugs and biologicals, while broadly excluding their lower cost generics and biosimilar alternatives, cannot reasonably claim to have a “cost-effective” UM program that incentivizes reduced costs, when medically appropriate, including through the use of multiple source drugs. The concept of the UM program encompassing formulary inclusion, tier placement, and various UM practices has been a fundamental component of the Part D program since its inception. The January 2005 final rule establishing the Part D program stated, “While drug utilization management is common practice, plans appropriately employ a number of different approaches (for example, formularies, step therapy, tiered cost sharing, prior authorization) and different combinations of those approaches. . .” 70 FR 4277-4278. Also, the Prescription Drug Benefit Manual, Chapter 7, Section 60.1—General Rule (Effective 9-1-2008), states that “Common utilization management tools include formularies, prior authorization requirements, and promotion of lower cost generics.” 
                        <SU>272</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>272</SU>
                             
                            <E T="03">https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/downloads/dwnlds/chapter7pdf</E>
                             (page 28).
                        </P>
                    </FTNT>
                    <P>CMS currently conducts an extensive formulary review process to ensure Part D sponsors provide an adequate formulary consistent with § 423.120(b)(2). Although we have been monitoring beneficiary access to generics and biosimilars, we now plan to include an additional step in the formulary review process to check that Part D sponsors provide broad access to generics, biosimilars, and other lower cost drugs. Specifically, CMS will holistically review whether a plan's formulary and UM practices with respect to these drugs constitute a drug UM program that is “cost-effective,” “reasonable and appropriate,” and inclusive of “incentives to reduce costs.” This review would encompass an evaluation of whether the formulary includes generics, biosimilars, and other lower cost drugs, when available, for brand drugs and reference products, and whether the generics, biosimilars, and other lower cost drugs are placed on a lower formulary tier than the brand drugs or reference products. In addition, CMS would review whether a formulary incorporates fewer utilization controls on brand drugs and reference products than on lower cost alternatives. CMS would use its authority to negotiate the terms and conditions of submitted Part D sponsors' bids under section 1860D-11(d)(2) of the Act if a plan's proposed formulary does not appear to provide broad access to generics, biosimilars, and other lower cost drugs in order to ensure such access for Part D beneficiaries and compliance with Part D requirements in section 1860D-4(c)(1)(A) of the Act and § 423.153(b)(1).</P>
                    <P>In conjunction with our formulary review process, CMS intends to continue to monitor and analyze plan sponsors' inclusion of generics, biosimilars and other lower cost drugs on formularies. CMS seeks comments on: (1) the prevalence of manufacturer rebates and the extent to which such rebates influence formulary decisions that reduce Part D beneficiaries' access to generics, biosimilars, and other lower cost drugs; and (2) whether further programmatic actions within CMS's current statutory authority are necessary to prevent Part D formularies from excluding or disfavoring coverage of generics, biosimilars, and other lower cost drugs. Based on this feedback, CMS may consider further steps in future rulemaking or guidance to promote broad access to generics, biosimilars, and other lower cost drugs for Part D beneficiaries.</P>
                    <HD SOURCE="HD1">IV. Medicare Advantage/Part C and Part D Prescription Drug Plan Quality Rating System (§§ 422.166 and 423.186)</HD>
                    <HD SOURCE="HD2">A. Introduction</HD>
                    <P>
                        CMS develops and publicly posts a 5-star rating system for Part C,
                        <SU>273</SU>
                        <FTREF/>
                         more commonly referred to as Medicare Advantage (MA), and Part D plans as part of its responsibility to disseminate comparative information, including information about quality, to beneficiaries under sections 1851(d) and 1860D-1(c) of the Act. The Part C and Part D Star Ratings system is used to determine quality bonus payment (QBP) ratings for MA plans under section 1853(o) of the Act and the amount of MA beneficiary rebates under section 1854(b) of the Act. We use multiple data sources based on the collection of different types of quality data under section 1852(e) of the Act to measure quality and performance of contracts, such as CMS administrative data, surveys of enrollees, and information provided directly from health and drug plans. CMS regulations, including §§ 417.472(j) and (k), 422.152(b), 423.153(c), and 423.156, require plans to report on quality improvement and quality assurance and to provide data which help beneficiaries compare plans. The methodology for the Star Ratings system for the MA/Part C and Part D programs is codified at §§ 422.160 through 422.166 and 423.180 through 423.186, respectively, and we have specified the measures used in setting Star Ratings through rulemaking. In addition, the cost plan regulation at § 417.472(k) requires cost contracts to be subject to the Parts 422 and 423 Medicare Advantage and Part D Prescription Drug Program Quality Rating System. (83 FR 16526 and 16527). As a result, the policies and regulatory changes proposed here will apply to the quality ratings for MA plans, cost plans, and Part D plans.
                    </P>
                    <FTNT>
                        <P>
                            <SU>273</SU>
                             We generally use “Part C” to refer to the quality measures and ratings system that apply to MA plans and cost plans.
                        </P>
                    </FTNT>
                    <P>
                        We have continued to identify enhancements to the Star Ratings program to ensure it is aligned with the CMS Quality Strategy as that Strategy 
                        <SU>274</SU>
                        <FTREF/>
                         evolves over time. To support the CMS National Quality Strategy, CMS is moving towards a building-block approach to streamline quality measures across CMS quality and value-based care programs. Across our programs, 
                        <PRTPAGE P="99473"/>
                        where applicable, we are considering including the Universal Foundation 
                        <SU>275</SU>
                        <FTREF/>
                         of quality measures, which is a core set of measures that are aligned across CMS programs. CMS is committed to aligning a core set of measures across all our quality and value-based care programs and ensuring we measure quality across the entire care continuum in a way that promotes the best, safest, and most equitable care for all individuals. Improving alignment of measures across Federal programs and with private payers would reduce provider burden while also improving the effectiveness and comparability of measures. Using the Universal Foundation of quality measures would focus provider attention, reduce burden, identify disparities in care, prioritize development of interoperable, digital quality measures, allow for cross-comparisons across programs, and help identify measurement gaps. The Universal Foundation is a building block to which programs would add additional aligned or program-specific measures. This core set of measures would evolve over time to meet the needs of individuals served across CMS programs. We submitted the following Part C measures to the 2024 Measures under Consideration list as part of the Pre-Rulemaking Measure Review process as a step toward proposing use of these Universal Foundation measures in the Star Ratings system through future rulemaking: Adult Immunization Status, Depression Screening and Follow-Up for Adolescents and Adults, and Social Need Screening and Intervention.
                        <SU>276</SU>
                        <FTREF/>
                         We have previously solicited feedback regarding potentially proposing these measures as Star Ratings measures in the future through both the Advance Notice of Methodological Changes for Calendar Year (CY) 2023 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies and the Advance Notice of Methodological Changes for Calendar Year (CY) 2024 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies. CMS is continuing to consider ways to streamline the measurement set for the Part C and D Star Ratings program. We currently plan to solicit comments through the 2026 Advance Notice and Rate Announcement process on ways to focus the measurement set to improve the impact of the Star Ratings program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>274</SU>
                             
                            <E T="03">https://www.cms.gov/medicare/quality/meaningful-measures-initiative/cms-quality-strategy.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>275</SU>
                             
                            <E T="03">https://www.nejm.org/doi/full/10.1056/NEJMp2215539</E>
                             and 
                            <E T="03">https://www.cms.gov/medicare/quality/cms-national-quality-strategy/aligning-quality-measures-across-cms-universal-foundation.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>276</SU>
                             Information on the Measures Under Consideration list for 2024 will be available here: 
                            <E T="03">https://mmshub.cms.gov/measure-lifecycle/measure-implementation/pre-rulemaking/lists-and-reports.</E>
                        </P>
                    </FTNT>
                    <P>In this proposed rule, we are proposing to add or update the following measures:</P>
                    <P>• Initiation and Engagement of Substance Use Disorder Treatment (IET) (Part C)</P>
                    <P>• Initial Opioid Prescribing for Long Duration (IOP-LD) (Part D)</P>
                    <P>• Breast Cancer Screening (Part C)</P>
                    <P>• Plan Makes Timely Decisions about Appeals (Part C) and Reviewing Appeals Decisions (Part C)</P>
                    <P>We are also proposing how the health equity index (HEI) reward will be calculated for contracts that are required by a state Medicaid agency to move one or more D-SNP plan benefit packages from an existing MA contract to an MA contract that only includes one or more D-SNPs with a service area limited to that state, consistent with § 422.107(e), beginning with the 2029 Star Ratings. Additionally, we are proposing to clarify at §§ 422.166(f)(3)(vi) and 423.186(f)(3)(vi) that in order for Institutional Special Needs Plan (I-SNP)-only contracts to have the rating-specific HEI calculated, these contracts must have data for at least half the measures included in the rating-specific HEI for the subset of measures that I-SNP-only contracts are required to report.</P>
                    <P>We are also proposing a couple of technical clarifications of the existing rules related to how the HEI reward enrollment thresholds described at §§ 422.166(f)(3)(viii) and 423.186(f)(3)(viii) are assessed in the case of contract consolidations for the second year following the consolidation and changes to how the HEI score would be calculated for contracts that have data discrepancies between their submitted patient-level detail and summary-level data for HEDIS measures included in the HEI. We are also proposing a clarification of how the improvement measure hold harmless for the highest rating is determined based on the rounded rating before the addition of the HEI reward, if applicable, at §§ 422.166(g) and 423.186(g), as well as proposing a technical clarification at §§ 422.162(b)(3)(iv)(A)(2) and (B)(2) and §§ 423.182(b)(3)(iv)(A)(2) and (B)(2) to provide details about how the enrollment-weighted measure score is calculated when a consumed or surviving contract is missing data for a measure.</P>
                    <P>In the proposed rule titled “Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable Care Act and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications,” which appeared in the December 27, 2022, Federal Register (hereinafter referred to as the December 2022 proposed rule), we proposed to remove guardrails (that is, bi-directional caps that restrict upward and downward movement of a measure's cut points for the current year's measure-level Star Ratings compared to the prior year's measure-threshold specific cut points) when determining measure-specific thresholds for non-Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures (87 FR 79625-79626). We are considering finalizing this proposal, in this rulemaking, to apply beginning with the 2026 measurement year and 2028 Star Ratings because with the implementation of Tukey outer fence outlier deletion, extreme outliers are removed before the clustering algorithm is applied, which minimizes the need for guardrails to achieve predictability and stability of cut points. Additionally, the removal of guardrails would allow cut points to adjust when there are unanticipated changes in performance across the industry. We intend to address comments received regarding the removal of guardrails to the December 2022 proposed rule in the final rule.</P>
                    <HD SOURCE="HD2">B. Adding, Updating, and Removing Measures (§§ 422.164 and 423.184)</HD>
                    <P>
                        The regulations at §§ 422.164 and 423.184 specify the criteria and procedures for adding, updating, and removing measures for the Part C and D Star Ratings program. In the “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program” final rule which appeared in the 
                        <E T="04">Federal Register</E>
                         on April 16, 2018 (83 FR 16532) hereinafter referred to as the April 2018 final rule, we stated we are committed to continuing to improve the Part C and Part D Star Ratings system and anticipated that over time measures would be added, updated, and removed. We also specified at §§ 422.164(d) and 423.184(d) rules for measure updates based on whether they are substantive or non-substantive. The regulations, at paragraph (d)(1), list examples of non-
                        <PRTPAGE P="99474"/>
                        substantive updates. See also 83 FR 16534-16537. Due to the regular updates and revisions made to measures, CMS does not codify a list in regulation text of the measures (and their specifications) adopted for the Part C and Part D Star Ratings program. CMS lists the measures used for the Star Ratings each year in the Medicare Part C &amp; D Star Ratings Technical Notes or similar guidance issued with publication of the Star Ratings. In this rule, CMS is proposing to add the Initiation and Engagement of Substance Use Disorder Treatment (Part C) and Initial Opioid Prescribing for Long Duration (Part D) measures to the Star Ratings program and to update the Breast Cancer Screening (Part C), Plan Makes Timely Decisions about Appeals (Part C), and Reviewing Appeals Decisions (Part C) measures for performance periods beginning on or after January 1, 2026.
                    </P>
                    <P>We are committed to continuing to improve the Part C and Part D Star Ratings system by focusing on improving clinical and other health outcomes. Consistent with §§ 422.164(c)(1) and 423.184(c)(1), we continue to review measures that are nationally endorsed and in alignment with the private sector. For example, we regularly review measures developed by the National Committee for Quality Assurance (NCQA) and Pharmacy Quality Alliance (PQA).</P>
                    <HD SOURCE="HD3">1. Adding Measures</HD>
                    <HD SOURCE="HD3">a. Initiation and Engagement of Substance Use Disorder Treatment (IET) (Part C)</HD>
                    <P>
                        We propose to add the Initiation and Engagement of Substance Use Disorder Treatment (IET) measure beginning with the 2028 Star Ratings covering the 2026 measurement year. Adding the IET measure to the Part C Star Ratings would further align the Part C Star Ratings with the Universal Foundation as discussed in the CY 2024 and CY 2025 Rate Announcements.
                        <SU>277</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>277</SU>
                             See Announcement of Calendar Year (CY) 2024 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (
                            <E T="03">cms.gov</E>
                            ) pages 162-163 and Announcement of Calendar Year (CY) 2025 Medicare Advantage (MA) Capitation Rates and Part C and D Payment Policies (
                            <E T="03">cms.gov</E>
                            ) page 137. 
                        </P>
                    </FTNT>
                    <P>The IET measure is a composite measure that averages two separate rates: Initiation of Substance Use Disorder Treatment and Engagement of Substance Use Disorder Treatment. Prior to measurement year 2022, this measure was called Initiation and Engagement for Alcohol and Other Drug Abuse or Dependence Treatment and the individual rates have been reported on the Part C and Part D Star Ratings display page beginning with the 2012 performance period (2014 display page). For measurement year 2022, NCQA made several updates to the IET measure, including updating its name. Since many individuals with substance use disorder (SUD) attempt treatment multiple times before they are able to successfully engage, the measure was changed from “member-based” to “episode-based” to allow for each recovery attempt to count independently, which should result in a more valid representation of engagement with SUD treatment for health plan populations. The length of the negative SUD history period was increased from 60 days to 194 days to limit the number of members receiving ongoing treatment who fall into the denominator. Emergency department visits and medically managed withdrawal services were removed from the negative SUD history period because emergency department visits and withdrawal services alone are not suggestive of ongoing or planned treatment for individuals with SUD and thus do not signal that a member is already engaged in comprehensive care. The requirement that psychosocial treatment accompany pharmacotherapy was also removed to align with the most current clinical practice guidelines (for example, allowing for patients who may not accept concomitant psychosocial treatment). Finally, the adult age stratification was split between 18-64 years and 65+ years to better highlight any gaps in care between different age groups.</P>
                    <P>CMS began reporting the two indicators or rates included in the historical IET measure on the display page for the 2014 Star Ratings. However, starting with the display page for the 2024 Star Ratings covering the 2022 measurement year, we began reporting the updated measure being proposed here, including the separate rates for initiation and engagement that are part of the HEDIS measure and an average of the two rates. As provided at §§ 422.164(c)(3) and (4) and 423.184(c)(3) and (4), as new performance measures are developed and adopted, they are initially posted on the display page for at least 2 years. We intend to use the period that the updated IET measure was on the display page to meet this requirement.</P>
                    <P>
                        To lessen the complexity in the Star Ratings program by minimizing the number of new Star Rating measures, CMS is proposing to average the initiation and engagement rates into one measure for reporting in the Star Ratings program. A contract must have scores on both rates to receive a score for this measure as we propose to use it in the Star Ratings program. This is similar to how the data are reported for the IET measure in the Quality Rating System for the Qualified Health Plans on the Exchanges.
                        <SU>278</SU>
                        <FTREF/>
                         The two rates of this composite measure will continue to be reported as separate measures on the display page so as to be available to plans for use in their quality improvement projects after the composite IET measure is added to the Star Ratings pending rulemaking.
                    </P>
                    <FTNT>
                        <P>
                            <SU>278</SU>
                             The Quality Rating System public use file shows the averaged rate of initiation and engagement: 
                            <E T="03">https://www.cms.gov/files/zip/qrs-nationwide-puf-py2023.zip.</E>
                        </P>
                    </FTNT>
                    <P>
                        We submitted the IET measure for inclusion in the 2023 Pre-rulemaking Measure Review (PRMR) process, required under 
                        <E T="03">section 1890A</E>
                         of the Act. The Consensus-Based Entity (CBE), which is currently Battelle, convenes interested parties that participate in committees to review measures as part of the PRMR process. Battelle utilized the Novel Hybrid Delphi and Nominal Group multi-step process, which is an iterative consensus-building approach aimed at a minimum of 75% agreement among voting members, rather than a simple majority vote. The final result from the committee's vote can be: Recommend, Recommend with conditions, Do not recommend, or Consensus not reached. Consensus not reached signals continued disagreement amongst the committee despite being presented with perspectives from public comment, committee member feedback, and discussion, and highlights the multi-faceted assessments of quality measures. More details regarding the CBE PRMR voting procedures may be found in Chapter 4 of the Guidebook of Policies and Procedures for Pre-Rulemaking Measure Review and Measure Set Review.
                        <SU>279</SU>
                        <FTREF/>
                         Although the committee did support the IET measure overall, there were diverging perspectives related to data collection burden, the effect of patients refusing treatment on measure performance, and exclusions. Approximately 29 percent (4 of the 14 voting members) 
                        <SU>280</SU>
                        <FTREF/>
                         did not recommend this measure resulting in the committee not reaching consensus. Some members of the committee cited data collection burden as a challenge to the feasibility of the measure given interoperability barriers with electronic health record (EHR) systems across 
                        <PRTPAGE P="99475"/>
                        providers and specialties; however, this concern was not shared by all committee members and some members noted that there was nothing specific related to this measure that would result in data collection issues. CMS has taken the CBE's input into consideration, but since MA contracts have been collecting and reporting this measure for over 10 years, we do not anticipate that data collection burden will be an issue with moving this measure from the display page to the Star Ratings. Additionally, the issue of members refusing treatment is not unique to this measure. Only one committee member, a patient representative, mentioned that some patients may choose not to initiate treatment and that this should not be counted against the plan; however, for this measure there are not significant clinical reasons for refusing treatment that would need to be accounted for in the measure specification. Having considered the CBE's input, we are proposing moving this measure from the display page to the Star Ratings beginning with the 2028 Star Ratings covering the 2026 measurement year.
                    </P>
                    <FTNT>
                        <P>
                            <SU>279</SU>
                             
                            <E T="03">https://p4qm.org/sites/default/files/2023-09/Guidebook-of-Policies-and-Procedures-for-Pre-Rulemaking-Measure-Review-%28PRMR%29-and-Measure-Set-Review-%28MSR%29-Final_0.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>280</SU>
                             
                            <E T="03">PRMR-2023-MUC-Recommendations-Report-Final-.pdf (p4qm.org).</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Initial Opioid Prescribing for Long Duration (IOP-LD) (Part D)</HD>
                    <P>As part of CMS' ongoing efforts to address the national opioid crisis, we have implemented balanced drug utilization review (DUR) policies and quality measurement strategies to help reduce prescription opioid misuse in the Medicare Part D population while maintaining medically necessary access. To support this goal, CMS proposes to add the IOP-LD measure for the 2028 Star Ratings (2026 measurement year) in accordance with § 423.184(c) because it is an important measure to promote safer prescription opioid use. The IOP-LD measure will be an additional tool for Part D sponsors to monitor initial opioid prescription exposure to reduce the risk for long-term opioid use and opioid use disorder. Adequate management of pain and assessment after opioid initiation is vital to minimize the risk of long-term opioid use, opioid misuse, and overdose.</P>
                    <P>
                        CMS began reporting the IOP-LD measure to Part D sponsors through the Patient Safety reports starting in measurement year 2020 and has publicly reported the measure on the Part D display page 
                        <SU>281</SU>
                        <FTREF/>
                         since 2023 (2021 performance data) in accordance with § 423.184(c)(3). Consistent with § 423.184(c)(2), we announced in the Announcement of Calendar Year (CY) 2021 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies,
                        <SU>282</SU>
                        <FTREF/>
                         as well as in subsequent Rate Announcements, that the IOP-LD measure would be considered in the future for addition to the Star Ratings. The IOP-LD measure underwent further review and evaluation during the 2023 PRMR process by the CBE to provide recommendations for selecting quality and efficiency measures for use in CMS programs as required by section 1890A of the Act. A consensus for inclusion in the Part D Star Ratings was not reached during the PRMR process for the IOP-LD measure. Approximately 36 percent (5 of the 14 voting members) did not recommend this measure, resulting in the committee not reaching the 75 percent consensus threshold as summarized in the PRMR 2023 Recommendations Report.
                        <SU>283</SU>
                        <FTREF/>
                         As noted in the Report, committee members acknowledged the importance of having a measure that assesses opioid prescriptions as a method of harm reduction and that the measure may fill a gap in opioid safety in the Star Ratings program. Committee members sought clarification on the specifications and consideration of measure exclusions for patients with complex medical needs. Some members of the committee expressed concern for the adequacy of evidence and alignment with current clinical guidelines for opioid prescribing. The committee also discussed potential unintended consequences of measure implementation on prescriber hesitancy, the quality of pain management, and harm for patients who need long-term opioids. CMS discussed that the measure is not intended to guide clinical decision-making for individual patients and does not represent a prescribing limit.
                    </P>
                    <FTNT>
                        <P>
                            <SU>281</SU>
                             Display Page Technical Notes and Measure Data available at: 
                            <E T="03">https://www.cms.gov/medicare/health-drug-plans/part-c-d-performance-data.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>282</SU>
                             
                            <E T="03">https://www.cms.gov/files/document/2021-announcement.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>283</SU>
                             Pre-Rulemaking Measure Review Measures Under Consideration 2023 Recommendations Report: 
                            <E T="03">https://p4qm.org/sites/default/files/2024-02/PRMR-2023-MUC-Recommendations-Report-Final-.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We seek comments from a broad range of interested parties on the proposal to add the IOP-LD measure to the Part D Star Ratings. The IOP-LD measure is an important area of focus for the Medicare Part D program and is supported by evidence-based literature and national guidelines. The measure specifications are designed to reduce unintended consequences and complement Medicare Part D opioid-related policies.</P>
                    <P>
                        <E T="03">Measure Specifications:</E>
                         The PQA is the measure steward. The IOP-LD measure was endorsed by the PQA's membership and included a review by the PQA's Patient and Caregiver Advisory Panel in 2018, with 100% voting members in favor of the measure as important to patients and caregivers.
                        <SU>284</SU>
                        <FTREF/>
                         The National Quality Forum (NQF) Patient Safety Standing Committee (NQF #3558) 
                        <SU>285</SU>
                        <FTREF/>
                         also endorsed the measure in 2019, demonstrating that it meets high standards of evidence to impact healthcare quality. The NQF Patient Safety Standing Committee unanimously deemed the IOP-LD measure to meet the importance criterion, with zero votes for “low” on any importance-related sub-criteria.
                    </P>
                    <FTNT>
                        <P>
                            <SU>284</SU>
                             The Pharmacy Quality Alliance Patient &amp; Caregiver Advisory Panel Meeting Minutes. 
                            <E T="03">https://www.pqaalliance.org/assets/docs/PQA_2018_PCAP_Excerpt.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>285</SU>
                             The Patient Safety Final Technical Report—Spring 2020 Cycle. 
                            <E T="03">https://www.qualityforum.org/Publications/2021/03/Patient_Safety_Final_Technical_Report_-Spring_2020_Cycle.aspx.</E>
                        </P>
                    </FTNT>
                    <P>
                        CMS will use the PQA Measure Manual specifications and Value Sets.
                        <SU>286</SU>
                        <FTREF/>
                         The IOP-LD measure evaluates the percentage of Part D beneficiaries, 18 years or older with at least one initial opioid prescription for more than 7 cumulative days' supply. To prevent misapplication, the following beneficiaries are excluded: (i) those with cancer or sickle cell disease diagnoses and (ii) those who elected to receive hospice care or are in palliative care at any time during the measurement period or the 90 days prior to the index prescription start date, which is the earliest date of service (DOS) for an opioid medication during the measurement year. The IOP-LD period has a lookback period, which is 90 days prior to each opioid prescription claim. Therefore, beneficiaries with no opioid prescription claims in the lookback period are defined as having a negative medication history for opioids.
                    </P>
                    <FTNT>
                        <P>
                            <SU>286</SU>
                             Licensing and Using PQA Measures. 
                            <E T="03">https://www.pqaalliance.org/measure-licensing-use.</E>
                        </P>
                    </FTNT>
                    <P>
                        The initial opioid prescription is the earliest DOS for an opioid prescription claim during the measurement year following a negative medication history. The opioid initiation period is the 3-day period when the numerator is assessed and ensures a comprehensive view of initial opioid prescribing. The opioid initiation period includes the date of the initial opioid prescription plus 2 days. All prescription claims during the opioid initiation period are counted cumulatively towards the days' supply total to avoid situations where a patient is prescribed a long duration of opioids following a very brief initial duration (that is, 1-3 days).
                        <PRTPAGE P="99476"/>
                    </P>
                    <P>The IOP-LD measure is intended for retrospective population-level performance measurement of Part D plan sponsors (at the contract-level) and not to guide clinical decision-making for individual patients. The measure does not address opioid dosage, only the duration of an initial opioid prescription. Medications used for opioid use disorder (MOUD) are not included in the IOP-LD measure; for methadone, only use for pain is included.</P>
                    <P>
                        The measure is not intended to impact current long-term opioid use. Because this measure only captures initial opioid prescriptions in individuals with no opioid history in the preceding 90 days, it is not anticipated to result in unintended consequences related to discontinuation or abrupt tapering of opioid use in current, long-term users. We recognize that some beneficiaries may require a longer duration for their initial opioid prescription based on the acute pain condition being treated (for example, major surgery or injury). Subsequent fills for opioids after the initial opioid prescription are not factored into the measure. However, by design, the measure does encourage re-evaluation of the benefits and risks for continued opioid therapy, which is a recommendation in the updated Centers for Disease Control and Prevention (CDC) Clinical Practice Guideline for Prescribing Opioids for Pain, 2022 
                        <SU>287</SU>
                        <FTREF/>
                         (“2022 CDC Guideline”). Based on Recommendation 6 of the 2022 CDC Guideline, when opioids are used to treat acute pain, no greater quantity of opioids should be prescribed than needed for the expected duration of pain that is severe enough to require opioids. However, when acute pain does continue longer than the expected duration, prescribers, practices, and clinicians “should have mechanisms in place for the subset of patients who experience severe acute pain that continues longer than the expected duration. These mechanisms should allow for timely reevaluation to confirm or revise the initial diagnosis and adjust pain management accordingly.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>287</SU>
                             
                            <E T="03">https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm?s_cid=rr7103a1_w</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Evidence for Measure:</E>
                         The duration of initial opioid exposure is associated with a higher likelihood of long-term opioid use. There is a consistent body of empirical evidence that a greater days' supply for initial opioid prescriptions is associated with significant risks, including increased risk of long-term opioid use, opioid misuse, and overdose. In the 2022 CDC Guideline, the CDC reaffirmed their recommendation on initial opioid prescription duration that “when opioids are needed for acute pain, clinicians should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids.” In the associated implementation consideration text, the updated CDC Guideline notes that “when the diagnosis and severity of acute pain warrant use of opioids, clinicians should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids” and “for many common causes of nontraumatic, nonsurgical pain, when opioids are needed, a few days or less are often sufficient.” Furthermore, the 2022 CDC Guideline references an analysis conducted in 2014 
                        <SU>288</SU>
                        <FTREF/>
                         that found that the median durations of initial opioid analgesic prescriptions for acute pain indications in primary care settings were 4 to 7 days, suggesting that in most cases, clinicians considered an initial opioid prescription of 4 to 7 days' duration sufficient. In April 2023, the Food and Drug Administration (FDA) announced that it was requiring updates to the prescribing information of opioid pain medicines to provide additional guidance on the use of opioids. In this Drug Safety Communication,
                        <SU>289</SU>
                        <FTREF/>
                         the FDA stated, “Data also suggest that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine, although the dose and duration of treatment needed to adequately manage pain will vary based on the underlying cause and individual patient factors.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>288</SU>
                             Mundkur ML, Franklin JM, Abdia Y, et al. Days' supply of initial opioid analgesic prescriptions and additional fills for acute pain conditions treated in the primary care setting—United States, 2014. MMWR Morb Mortal Wkly Rep 2019;68:140-3. 
                            <E T="03">https://doi.org/10.15585/mmwr.mm6806a3.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>289</SU>
                             
                            <E T="03">https://www.fda.gov/media/167058/download</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        Existing evidence-based literature reinforces the CDC's recommendations regarding the duration of initial opioid prescriptions. A retrospective cohort study by Shah et al., found that the probability of long-term opioid use increased with each additional day supplied when initiating opioid therapy, following the third day supplied.
                        <SU>290</SU>
                        <FTREF/>
                         The study examined 1,294,247 patients aged 18 years or older who met the inclusion criteria and received initial opioid prescriptions, defined as those with no opioid prescriptions in the preceding 6 months of continuous enrollment. The study found that the probability of long-term use was more than twice as high for individuals who received greater than 7 days' supply, when compared to those with at least one day's supply (13.5 percent vs. 6.0 percent).
                    </P>
                    <FTNT>
                        <P>
                            <SU>290</SU>
                             Shah A, Hayes CJ, Martin BC. Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use—United States, 2006-2015. 
                            <E T="03">MMWR Morb Mortal Wkly Rep.</E>
                             Mar 17 2017;66(10):265-269.
                        </P>
                    </FTNT>
                    <P>
                        A different retrospective study published by Shah et al., provided further evidence that a greater days' supply for initial opioid prescriptions was associated with a decreased likelihood of opioid discontinuation.
                        <SU>291</SU>
                        <FTREF/>
                         The study followed a total of 1,353,902 opioid naïve individuals who had at least one opioid prescription between June 1, 2006, and December 31, 2014 and at least six months of continuous pharmacy and medical enrollment without an opioid prescription before their first opioid prescription. Among the 1.3 million study participants, 993,935 were enrolled for at least 1 year. Out of the 993,935 study participants, 33,019 individuals (3.32 percent) continued opioid use for 365 days or longer. After controlling for patient factors and underlying pain etiologies, the authors' results suggested a dose-response relationship between days' supply and likelihood of discontinuation. The hazard ratios for discontinuation of opioids were 0.70 (95 percent confidence interval (CI) 0.70-0.71) for a 3-4 days' supply, 0.48 (95 percent CI 0.47-0.48) for a 5-7 days' supply, 0.37 (95 percent CI 0.37-0.38) for an 8-10 days' supply, 0.32 (95 percent CI 0.31-33) for an 11-14 days' supply, 0.29 (95 percent CI 0.28-0.29) for 15-21 days' supply, and 0.20 (95 percent CI 0.19-0.20) for 22 or more days' supply of opioids, where a 1-2 days' supply is the reference group. This study also narrowed the sample by further evaluating opioid-naïve individuals to only those individuals who were opioid naïve for 12 months. This decreased the sample to 955,371 individuals and the results found the relationship between the first opioid prescription and the likelihood of discontinuation from opioids showed similar trends to the original study population.
                    </P>
                    <FTNT>
                        <P>
                            <SU>291</SU>
                             Shah A, Hayes CJ, Martin BC. Factors Influencing Long-Term Opioid Use Among Opioid Naive Patients: An Examination of Initial Prescription Characteristics and Pain Etiologies. J Pain. Nov 2017;18(11):1374-1383. doi:10.1016/j.jpain2017.06.010 at 
                            <E T="03">https://www.jpain.org/article/S1526-5900(17)30635-1/pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        Another study by Hadlandsmyth replicated Shah et al.'s methodology and researched the relationship between initial opioid exposure and long-term 
                        <PRTPAGE P="99477"/>
                        use.
                        <SU>292</SU>
                        <FTREF/>
                         There were 19,600 Veteran's Health Administration patients who received an initial opioid prescription (defined as the first prescription with no opioid prescriptions in the preceding year) and subsequently met the criteria for long-term opioid use within one year of follow-up. The authors of this study compared their 2011 and 2016 data. Their results corroborated Shah's study that an association exists between initial opioid exposure and the rate of long-term use. This long-term opioid use appeared to persist even though the overall rate of long-term opioid use may have decreased, therefore concluding that cumulative days' supply was a strong predictor of long-term use and limiting initial opioid use can potentially decrease the risk of long-term opioid use. The study results found that in 2016, the overall rate of continued opioid use 1 year after initial opioid exposure was 16.8 percent and in 2011 was 29.2 percent.
                    </P>
                    <FTNT>
                        <P>
                            <SU>292</SU>
                             Hadlandsmyth K, Lund BC, Mosher HJ. Associations between initial opioid exposure and the likelihood for long-term use. 
                            <E T="03">J Am Pharm Assoc (2003).</E>
                             Jan-Feb 2019;59(1):17-22. doi:10.1016/j.japh.2018.09.005 at 
                            <E T="03">https://www.sciencedirect.com/science/article/pii/S1544319118304059?via%3Dihub.</E>
                        </P>
                    </FTNT>
                    <P>
                        Additionally, a study by Mojtabai analyzed trends in prescription opioid use among adults in the United States from 1999-2000 to 2013-2014.
                        <SU>293</SU>
                        <FTREF/>
                         The study found a significant increase in the prevalence of prescription opioid use, driven by an increase in long-term use.
                        <SU>21</SU>
                         By 2013-2014, nearly 80 percent of opioid users were classified as long-term users.
                        <SU>21</SU>
                         Long-term opioid use was linked to poorer physical health status, concurrent use of benzodiazepines, and a history of heroin use.
                        <SU>21</SU>
                         These findings emphasize the growing prevalence and implications of long-term opioid use in the U.S.
                        <SU>21</SU>
                    </P>
                    <FTNT>
                        <P>
                            <SU>293</SU>
                             Mojtabai, R. (2018). National trends in long‐term use of prescription opioids. 
                            <E T="03">Pharmacoepidemiology and drug safety, 27</E>
                            (5), 526-534 at 
                            <E T="03">https://pubmed.ncbi.nlm.nih.gov/28879660/.</E>
                            P&gt;
                            <SU>21</SU>
                             73 FR 20489-20490 in “Medicare Program; Policy and Technical Changes to the Medicare Prescription Drug Benefit” published April 15, 2008 (73 FR 20486). However, CMS's longstanding interpretation of the phrase “[a]gents when used for. . .weight 
                            <E T="03">gain</E>
                             . . .” (emphasis added) in the same section of the Act has not included drugs used to treat acquired immunodeficiency syndrome (AIDS) wasting and cachexia (73 FR 20490).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Medicare Part D Opioid-Related Policy Alignment:</E>
                         Medicare Part D sponsors must have concurrent DUR systems, policies, and procedures designed to ensure that a review of the prescribed drug therapy is performed before each prescription is dispensed to an enrollee in a sponsor's Part D plan, typically at the point-of-sale (POS) (that is, the pharmacy) or point of distribution as described in § 423.153(c)(2). To help prevent and combat prescription opioid overuse through improved concurrent DUR, sponsors are expected to implement real-time opioid safety edits at the POS, including an edit to limit initial opioid prescription fills for opioid naïve beneficiaries to no more than a 7 days' supply. Sponsors should 
                        <E T="03">not</E>
                         implement these edits so that beneficiaries' access to MOUD, such as buprenorphine, is impacted; sponsors should not include MOUD in this edit.
                    </P>
                    <P>
                        Sponsors should have procedures in place to allow the edit to be overridden at POS if an enrollee is already taking opioids or is exempt.
                        <SU>294</SU>
                         
                        <SU>295</SU>
                        <FTREF/>
                         For example, sponsors may not have opioid claims history for new enrollees, especially at the start of a new contract year, and they may experience a claim rejection due to the opioid naïve edit with their first opioid prescription over 7 days' supply. Furthermore, beneficiaries who are residents of a long-term care facility, are in hospice care or receiving palliative or end-of-life care or have cancer or sickle cell disease should be excluded from these reviews. A pharmacist can override a POS edit for an exemption or for the enrollee not being opioid naïve. A beneficiary or their prescriber may also request a coverage determination from the plan for a longer duration for their initial fill, including the right to request an expedited or standard coverage determination in advance of prescribing. Subsequent prescriptions filled within the plan's look back window are not subject to the 7 days' supply limit, as the enrollee will no longer be considered opioid naïve.
                        <SU>296</SU>
                        <FTREF/>
                         While the opioid safety edit may help plan sponsors reduce prescription opioid overuse across their enrollment population, it should not be implemented by Part D plans as a one-size-fits-all prescribing limit or as a substitute for individual clinical judgment. Implementation of opioid safety edits, including the opioid naïve edit, by Part D sponsors, is monitored through the CMS Part D Reporting Requirements (OMB 0938-0992), beneficiary complaints, and other sources of CMS administrative data.
                    </P>
                    <FTNT>
                        <P>
                            <SU>294</SU>
                             HPMS memorandum, dated December 19, 2022, Medicare Part D Opioid Safety Edit Reminders and Recommendations and Frequently Asked Questions (FAQs) available at: 
                            <E T="03">https://www.cms.gov/files/document/cy-2023-opioid-safety-edit-reminders-and-recommendations.pdf.</E>
                        </P>
                        <P>
                            <SU>295</SU>
                             HPMS memorandum, dated July 5, 2024, Contract Year (CY) 2025 Medicare Part D Opioid Safety Edits—Submission Instructions, Recommendations, and Reminders available at: 
                            <E T="03">https://www.cms.gov/files/document/cy-2025-opioid-safety-edit-submission-instructions.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>296</SU>
                             Medicare Part D Opioid Policies: Information for Prescribers available at: 
                            <E T="03">https://www.cms.gov/medicare/coverage/prescription-drug-coverage-contracting/improving-drug-utilization-review-controls-part-d.</E>
                        </P>
                    </FTNT>
                    <P>The IOP-LD measure complements the opioid naïve safety edit because it is similarly focused on the duration of initial opioid prescriptions to reduce risks, but the IOP-LD measure is retrospective. Sponsors are also required to establish a drug management program (DMP) for beneficiaries at-risk for misuse or abuse of frequently abused drugs, and beneficiaries with potential patterns of opioid misuse or with a history of opioid-related overdose are to be included in DMPs per the established retrospective criteria. DMP requirements are codified at § 423.153(f). Under such programs, Part D sponsors engage in case management of such beneficiaries by contacting their prescribers to determine if a beneficiary is at risk.</P>
                    <P>The Medicare Part D opioid-related policies were carefully developed to balance the need to address opioid misuse with the need to maintain a positive patient-doctor relationship, to preserve access to medically necessary drug regimens, and to reduce the potential for unintended consequences. The IOP-LD measure is an additional tool for sponsors to assess the effectiveness of Medicare Part D opioid-related strategies to reduce the risk of long-term opioid use, opioid misuse, or overdose.</P>
                    <P>
                        <E T="03">Data-Driven Need:</E>
                         CMS routinely monitors the impact of the Medicare Part D opioid-related policies. We have observed positive trends in our population, especially after the opioid DUR—safety edit and DMP—policies were enhanced beginning in 2019, but we must continue to use available tools to proactively address potential misuse and overdose, including quality measures.
                    </P>
                    <P>The IOP-LD rates for Part D contracts can be improved. The average IOP-LD rate across all contracts was about 16 percent for the 2021 measurement year (2023 display page) and 2022 measurement year (2024 display page). The average rates were 17 percent for MA-PDs and 13 percent for PDPs in the 2021 measurement year and 17 percent and 14 percent for MA-PDs and PDPs, respectively, in 2022. There was a range of IOP-LD rates among contracts; some of the highest rates for this measure by contract are 43 percent, 53 percent, and 64 percent.</P>
                    <P>
                        Furthermore, based on the internal analysis of Part D prescription drug event (PDE) data from 2018 to 2023 (extracted January 17, 2024), the percentage of non-MOUD opioid Part D claims with 7 days' supply or less positively increased from 18.4 percent in 2018 to 27.7 percent in 2023 after the implementation of enhanced opioid safety edits at POS in 2019, but the 
                        <PRTPAGE P="99478"/>
                        number of claims were 10 million (2018), 12 million (2019), 11.5 million (2020), 12 million (2021), 12 million (2022), and 9.4 million (2023).
                    </P>
                    <P>
                        The percentage of Part D enrollees who had at least one opioid Part D claim in the year in PDE data decreased from 28.6 percent in 2018 to 20.6 percent in 2023 (not including MOUD).
                        <SU>297</SU>
                        <FTREF/>
                         Similarly, the percentage of non-MOUD opioid Part D claims (out of all covered Part D claims) after exclusions decreased from 4.7 percent to 3.6 percent. However, the number of users and claims remains a concern. The number of non-MOUD opioid Part D users from 2018 to 2023 were 10.4 million (2018), 9.8 million (2019), 9.1 million (2020), 9.3 million (2021), 9.3 million (2022), and 9.4 million (2023). The number of non-MOUD opioid Part D claims from 2018 to 2023 were 55 million (2018), 51.3 million (2019), 49.3 million (2020), 47.5 million (2021), 45.9 million (2022), and 44.7 million (2023).
                    </P>
                    <FTNT>
                        <P>
                            <SU>297</SU>
                             CMS internal analysis excluded beneficiaries who elected to receive hospice care, are in palliative care, who have cancer or sickle cell disease, or who are in a long-term care setting.
                        </P>
                    </FTNT>
                    <P>
                        The PQA has developed other measures to address opioid misuse, including the Use of Opioids at High Dosage in Persons without Cancer (OHD), Use of Opioids from Multiple Providers in Persons without Cancer (OMP), and Use of Opioids at High Dosage and from Multiple Providers in Persons without Cancer (OHDMP) measures, which CMS has used for quality and performance oversight. In 2019, the PQA updated these three measures and CMS implemented the measure revisions in the Patient Safety reports to Part D sponsors for the 2019 measurement year. These three measures were added to the display page beginning in 2021 (then using 2019 data).
                        <SU>298</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>298</SU>
                             See Announcement of Calendar Year (CY) 2020 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter available at: 
                            <E T="03">https://www.cms.gov/medicare/health-plans/medicareadvtgspecratestats/downloads/announcement2020.pdf.</E>
                             The ODHMP measure was retired from the 2022 display page as announced in the Announcement of Calendar Year (CY) 2022 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies available at: 
                            <E T="03">https://www.cms.gov/files/document/2022-announcement.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        These three measures share the same denominator criteria, based on the number of member-years (MYs) of enrolled Part D beneficiaries with two or more prescription claims for opioids, filled on at least two unique dates of service, for at least 15 total cumulative opioid days' supply over a period of 90 days or longer during the measurement period.
                        <SU>299</SU>
                        <FTREF/>
                         CMS currently adjusts Part D enrollment based on MYs 
                        <SU>300</SU>
                        <FTREF/>
                         to account for enrolled beneficiaries for only part of the contract year. Upon reviewing the denominator data, there has been an increase in the number of MYs of enrolled beneficiaries from almost 35.6 million to about 42.7 million from 2017 to 2022 measurement years (respectively, from 2019 to 2024 display page). However, the proportion of MYs of enrolled beneficiaries receiving at least two fills of prescription opioids and at least 15 days of supply of opioids over a period of 90 days or longer has decreased from 17 percent in 2017 to 9 percent in 2022. Even with this reduction, roughly four million MYs of enrolled beneficiaries still demonstrate long-term use of opioid prescriptions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>299</SU>
                             Refer to 2024 Medicare part C &amp; D Display Measure Technical Notes available at: 
                            <E T="03">https://www.cms.gov/medicare/health-drug-plans/part-c-d-performance-data.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>300</SU>
                             These measures will use continuous enrollment beginning in measurement year 2025 (2027 display page) as announced in the Announcement of Calendar Year (CY) 2025 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies available at: 
                            <E T="03">https://www.cms.gov/files/document/2025-announcement.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        There is also continued concern for long-term opioid and illicit opioid use leading to overdose and death. According to the CDC, there are widening disparities among various population groups for overdose death rates, which have recently been driven by illicitly manufactured fentanyl use.
                        <SU>301</SU>
                        <FTREF/>
                         In 2020, the overdose death rates per 100,000 people increased by 44 percent for the Black population and 39 percent for American Indian and Alaska Native (AI/AN) population compared to 2019. Additionally, among Black males 65 years and older, the overdose death rate was nearly seven times more than their White male counterparts of the same age group.
                    </P>
                    <FTNT>
                        <P>
                            <SU>301</SU>
                             CDC Newsroom Release. Overdose death rates increased significantly for Black, American Indian/Alaska Native people in 2020: 
                            <E T="03">https://www.cdc.gov/media/releases/2022/s0719-overdose-rates-vs.html.</E>
                        </P>
                    </FTNT>
                    <P>
                        Additionally, officials from the Substance Abuse and Mental Health Services Administration (SAMHSA), CDC, and the National Institute on Drug Abuse published a study that followed a cohort of 136,762 Medicare beneficiaries who experienced an index nonfatal drug overdose in 2020.
                        <SU>302</SU>
                        <FTREF/>
                         This population consisted primarily of Hispanic (5.8 percent), non-Hispanic Black (10.9 percent), and non-Hispanic White (78.8 percent) beneficiaries. The researchers followed the beneficiaries 12 months after the initial index nonfatal drug overdose and found that 23,815 beneficiaries (17.4 percent) had at least one more nonfatal drug overdose and 1,323 beneficiaries (1.0 percent) died of a fatal overdose. The study found that opioids were involved in 72.2 percent of these fatal drug overdoses.
                    </P>
                    <FTNT>
                        <P>
                            <SU>302</SU>
                             JAMA Internal Medicine: Overdose, Behavioral Health Services, and Medications for Opioid Use Disorder After a Nonfatal Overdose at 
                            <E T="03">https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2820177.</E>
                        </P>
                    </FTNT>
                    <P>Differences are seen in the Medicare Part D population based on internal analysis of PDE and administrative claims data by CMS. In 2023, the percentages of non-MOUD opioid Part D users were 24 percent for Black beneficiaries, 24 percent for AI/AN beneficiaries, and 22 percent for White beneficiaries. We found that overall, the number of Part D beneficiaries with a primary opioid overdose claim decreased from 32,120 in 2018 to 28,365 in 2023 (0.83 per 1,000 to 0.62 per 1,000 Part D beneficiaries). The opioid overdose rates varied among the Part D population in 2023 (January 1, 2023 to December 31, 2023): 1.52 per 1,000 AI/AN Part D beneficiaries, 1.35 per 1,000 Black Part D beneficiaries, and 0.57 per 1,000 White Part D beneficiaries. The disparities in opioid overdose rates existing among different population groups, as highlighted by CMS's internal data analysis, underscore the urgency to address the widening gap in health outcomes. As discussed in this preamble section, there is room for improvement and variations in IOP-LD rates among Part D sponsors.</P>
                    <P>The IOP-LD measure is a preventative-focused quality measure that addresses initial prescription opioid exposure to reduce the likelihood of long-term opioid use and reduce the risk of opioid overdose. We propose to add the Part D IOP-LD measure to the Star Ratings for the 2028 Star Ratings (2026 measurement year) and solicit comments on this proposal.</P>
                    <HD SOURCE="HD3">2. Updating Measures</HD>
                    <HD SOURCE="HD3">a. Breast Cancer Screening (Part C)</HD>
                    <P>
                        CMS is proposing a substantive update to the existing Breast Cancer Screening measure because the measure steward, NCQA, is updating the measure as a result of changes in the applicable clinical guidance. In April 2024, the U.S. Preventive Services Task Force (USPSTF) issued final updated guidance for the age at which breast cancer screenings should begin.
                        <SU>303</SU>
                        <FTREF/>
                         Subsequently, NCQA announced their intention to update their breast cancer 
                        <PRTPAGE P="99479"/>
                        screening measure for measurement year 2025 to include biennial mammography screening for women aged 40-74 years at average risk of breast cancer (see 
                        <E T="03">https://www.ncqa.org/blog/updates-to-breast-cancer-screening-age-range-for-hedis-my-2025/</E>
                        ). As discussed in the CY 2025 Rate Announcement, CMS is proposing to expand the age range for the Breast Cancer Screening measure to women aged 40-49, for an updated age range of 40-74, for the 2027 and subsequent measurement years.
                        <SU>304</SU>
                        <FTREF/>
                         The expanded age range for this screening measure significantly increases the size of the population covered by this measure and is therefore a substantive measure specification change within the scope of § 422.164(d)(2). The legacy measure with the narrower age range of 50-74 years will remain available and used in Star Ratings until the updated measure has been on the display page for two years and has been adopted through rulemaking. For measures such as this, NCQA requires plans to submit the data as the total rate and rates for each age stratification so data will be available to calculate the legacy measure rate until the expanded rate is adopted through rulemaking for the Star Ratings. The updated measure will be on the display page for the 2027 and 2028 Star Ratings and will be included in the 2029 Star Ratings if finalized through rulemaking.
                    </P>
                    <FTNT>
                        <P>
                            <SU>303</SU>
                             
                            <E T="03">https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening#bcei-recommendation-title-area</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>304</SU>
                             See Announcement of Calendar Year (CY) 2025 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (
                            <E T="03">cms.gov</E>
                            ) page 138.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Plan Makes Timely Decisions About Appeals (Part C) and Reviewing Appeals Decisions (Part C)</HD>
                    <P>
                        CMS is proposing substantive updates to the Plan Makes Timely Decisions about Appeals (Part C) measure that evaluates the percent of appeals timely processed by the plan (numerator) out of all the plan's appeals decided by the Independent Review Entity (IRE) (includes upheld, overturned, partially overturned, and appeals not evaluated by the IRE because the plan agreed to cover) (denominator). Given the extent to which cases are now submitted electronically (via the portal) to the IRE, CMS has updated the Maximus Medicare Health Plan Reconsideration Process Manual Medicare Managed Care Reconsideration Project (that is, the IRE Manual) effective January 1, 2025 
                        <SU>305</SU>
                        <FTREF/>
                         to better align when submission of a case file to the IRE is considered timely with the existing regulations. First, CMS is eliminating the additional days the IRE allows for appeal files that are submitted electronically. Currently, the IRE includes additional days to make allowances for any mail delays. Because the IRE now receives over 99 percent of case files electronically via the portal, CMS has updated the language in the IRE Manual to use a deadline for timely portal (that is, electronic) submission that aligns with the timeliness requirements in § 422.590 for submission of standard, expedited, and Part B drug cases. Section 422.590(a)(2) requires Medicare health plans to submit an unfavorable standard service reconsideration to the IRE as expeditiously as the enrollee's health condition requires, or not later than 30 calendar days after the receipt of a valid reconsideration request, subject to an additional 14-calendar day extension if requested by the enrollee or otherwise justified and in the enrollee's interest as set forth in § 422.590(f). These timeframes apply as well to Medicare cost plans under § 417.600.
                    </P>
                    <FTNT>
                        <P>
                            <SU>305</SU>
                             
                            <E T="03">https://www.medicareappeal.com/sites/default/files/New%20Manual%20with%20Timefram%20Updates%2010%207%2024.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>The regulations do not provide any additional time for mail delays and Medicare health plans are not required to use overnight delivery for non-expedited cases. For purposes of defining and calculating timeliness, the IRE currently adds five calendar days to the timeframes listed above for all appeal file submissions. For example, the IRE currently considers a standard service case, without an extension, to be submitted timely if it is received within 35 calendar days of the valid request for reconsideration; this means that for electronic submissions by the plan, the plan has an extra five days to submit the file to the IRE beyond the deadline established in the applicable regulation. Since CMS is eliminating this 5-day period for all cases submitted electronically starting on January 1, 2025, we are proposing to make this update to the Plan Makes Timely Decisions about Appeals measure to align the measure with the timeframe used by the IRE in processing appeal files submitted to it. CMS believes this change is justified due to the overwhelming majority of cases being submitted electronically; further, eliminating the 5-day grace period for electronic submissions aligns this measure with the regulation text, which does not provide for or require any grace period for submission of files to the IRE. Per § 422.590(a)(2), (b)(2), (c)(2) and (e)(5), submission of the written explanation of an adverse reconsideration decision and associated documentation to the IRE is required within the same timeframe as notice to the enrollee (that is, 30, 60, or 7 days or 24 hours, depending on the specific item or service under appeal). Please note these changes are only in effect for electronic submissions. The timeliness of case files submitted by mail would continue to be subject to the 5-day grace period.</P>
                    <P>
                        The second update CMS is implementing starting January 1, 2025, is to use the electronic system receipt date and time as the date the appeal was received by the IRE, regardless of whether it is during the IRE's business hours, for electronic submissions through the IRE's secure web portal. Currently, the IRE uses the system receipt date as the date the appeal was received if it is during the IRE's normal business hours. If the system receipt time or date is outside of the IRE's normal business hours, the following business day is currently used as the receipt date. For example, if the appeal is received on a Sunday when the IRE offices are closed, the appeal would be considered received on Monday when the offices are open. With this change the receipt date would be Sunday rather than Monday. CMS has updated the IRE Manual and process to allow case files submitted via the electronic portal to be considered received on the date and time of portal submission, even if it is outside of normal business hours, starting January 1, 2025. This means that cases received up to 11:59 p.m. (Eastern Time) each day via the portal would be considered received on that day. (However, the processing timeframe for the IRE-level review would not commence until the following business day.) This update more closely reflects the process of the submission of electronic files than current practice; because the electronic submission is available to the IRE at the time the electronic submission process is complete and the portal system has the functionality to track the minute of submission and record that as part of the submission record, using that date and time will better reflect when the IRE has possession and the ability to use the submitted materials to perform its work. These proposed specification changes would only affect electronic submissions. If hard copies are delivered outside of the IRE's normal business hours, the following business day is used as the receipt date. We are proposing to incorporate this change as part of the Plan Makes Timely Decisions about Appeals measure. We are proposing to incorporate this change also in the Reviewing Appeals Decisions measure since the appeals used in this measure are based on the date in the 
                        <PRTPAGE P="99480"/>
                        calendar year the appeals were received by the IRE, and this proposed update could affect the received date.
                    </P>
                    <P>We are proposing to adopt these measure updates as defined at § 422.164(d)(2) for the Plan Makes Timely Decisions about Appeals and the Reviewing Appeals Decisions measures for the 2026 measurement year. The legacy appeals measures would remain in the Star Ratings until the updated measures have been on the display page for at least 2 years. Then, the legacy measures would be retired, and the respecified appeals measures would move into the Star Ratings beginning with the 2029 Star Ratings.</P>
                    <HD SOURCE="HD3">3. Summary of Measure Changes for the Part C and D Star Ratings</HD>
                    <P>
                        Table 14 summarizes the additional and updated measures addressed in this proposed rule, beginning with the 2028 Star Ratings. The measure descriptions listed in this table are high-level descriptions. The annual Star Ratings measure specifications supporting document, the 
                        <E T="03">Medicare Part C &amp; D Star Ratings Technical Notes,</E>
                         provides detailed specifications for each measure. Detailed specifications include, where appropriate, more specific identification of a measure's: (1) numerator, (2) denominator, (3) calculation, (4) timeframe, (5) case-mix adjustment, and (6) exclusions. The Technical Notes document is updated annually. The annual Star Ratings are produced in the fall of the prior year. For example, Star Ratings for the year 2028 are produced in the fall of 2027. If a measurement period is listed as “the calendar year 2 years prior to the Star Ratings year” and the Star Ratings year is 2028, the measurement period is referencing the January 1, 2026 to December 31, 2026 period. As noted earlier in section IV.B. of this proposed rule, CMS does not codify the specific measures for the Part C and Part D Quality Rating System in regulation; doing so would be unnecessarily lengthy and cumbersome due to the relative regularity with which measure specifications are updated.
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99481"/>
                        <GID>EP10DE24.020</GID>
                    </GPH>
                    <PRTPAGE P="99482"/>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">C. Health Equity Index Reward (§§ 422.166(f)(3) and 423.186(f)(3))</HD>
                    <P>The Health Equity Index (HEI) reward will be implemented beginning with the 2027 Star Ratings (measurement years 2024 and 2025) that will be released in October 2026. The HEI reward is an upside only reward for obtaining high measure-level scores for the subset of enrollees with the specified social risk factors (SRFs). The current SRFs include receipt of the low income subsidy or being dually eligible for Medicare and Medicaid (LIS/DE), or having a disability as defined by the original reason for Medicare entitlement. Additional SRFs may be added over time through rulemaking. The goal of the HEI reward is to improve health equity by incentivizing MA, 1876 cost, and PDP contracts to perform well among enrollees with specified SRFs.</P>
                    <P>The methodology for the HEI reward is codified at §§ 422.166(f)(3) and 423.186(f)(3). The calculation of the HEI reward includes an assessment of contract enrollment against two enrollment thresholds as described at §§ 422.166(f)(3)(vii) and 423.186(f)(3)(vii). To qualify for the full HEI reward (which ranges from 0.0 to 0.4 on a linear scale), contracts must have percentages of enrollees with the specified SRFs combined greater than or equal to the contract-level median in the most recent year of data used to calculate the HEI. To qualify for one-half of the HEI reward (which ranges from 0.0 to 0.2 on a linear scale), contracts must have percentages of enrollees with SRFs greater than or equal to one-half of the contract-level median up to, but not including the contract-level median percentage of enrollees with SRFs in the most recent year of data used to calculate the HEI. Paragraph (f)(3)(viii) describes how the HEI reward is calculated, with paragraphs (f)(3)(viii)(A) and (B) addressing calculation of the HEI reward in cases of contract consolidation.</P>
                    <P>We propose to revise §§ 422.166(f)(3)(viii)(B) and 423.186(f)(3)(viii)(B) to clarify how the HEI reward enrollment thresholds are assessed beginning with the 2027 Star Ratings in the case of calculating the HEI reward for contract consolidations for the second year following the consolidation. We also propose changes at §§ 422.166(f)(3)(viii)(C) and 423.186(f)(3)(viii)(C) to how the HEI reward will be calculated beginning with the 2029 Star Ratings for contracts that are required by a state Medicaid agency to move one or more D-SNP plan benefit packages from an existing MA contract to an MA contract that only includes one or more D-SNPs with a service area limited to that state, consistent with § 422.107(e). Finally, we propose to revise §§ 422.166(f)(3)(vi) and 423.186(f)(3)(vi) to clarify that in order for I-SNP-only contracts to have the rating-specific HEI calculated, these contracts must have data for at least half the measures included in the rating-specific HEI for the subset of measures that I-SNP-only contracts are required to report.</P>
                    <P>
                        In calculating the HEI reward for the surviving contract of a consolidation, we want to avoid masking the scores of contracts with low performance among enrollees with the specified SRFs under higher performing contracts. We also want to avoid rewarding contracts that serve relatively few enrollees with the specified SRFs as they consolidate with contracts serving relatively more of these enrollees, because we want to focus the HEI reward on contracts serving larger percentages of enrollees with the specified SRFs where improvement is most needed. Starting with the 2027 Star Ratings, for the second year following a consolidation, we propose at §§ 422.166(f)(3)(viii)(B) and 423.186(f)(3)(viii)(B) to clarify that the combined enrollment from the consumed and surviving contracts from the most recent year of data used in calculating the HEI will be used to assess whether the surviving contract meets one of the enrollment thresholds as described at §§ 422.166(f)(3)(vii) and 423.186(f)(3)(vii). When two or more contracts consolidate, the enrollment data used for the second year following the consolidation are from prior to the consolidation since the HEI is measuring performance prior to the contracts combining. For example, if two contracts consolidate as of January 1, 2026, we would combine the enrollment of the surviving and consumed contracts when calculating the 2027 Star Ratings based on enrollment in the surviving and consumed contracts in 2025. This is similar to how enrollment is combined for the calculation of enrollment for the second year following a consolidation for the categorical adjustment index at §§ 422.166(f)(2)(i)(B)(
                        <E T="03">1</E>
                        ) and 423.186(f)(2)(i)(B)(
                        <E T="03">1</E>
                        ).
                    </P>
                    <P>
                        In the final rule titled “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency,” which appeared in the 
                        <E T="04">Federal Register</E>
                         on May 9, 2022 (87 FR 27704), we codified at § 422.107(e) a provision allowing D-SNPs with exclusively aligned enrollment to apply for and maintain MA contracts that only include one or more D-SNPs with a service area limited to a specific state. If states require such D-SNP-only contracts along with integrated materials described at § 422.107(e)(ii) through their state Medicaid agency contracts, CMS will facilitate operationalization of additional opportunities for integration. As we described in the May 2022 final rule (87 FR 27763), D-SNP-only contracts established under § 422.107(e) result in several benefits for states and dually eligible individuals, including greater transparency on the MA organizations' performance in serving dually eligible enrollees by establishing Star Ratings specific to D-SNPs. As of plan year 2025, five states have taken advantage of the opportunity at § 422.107(e) to require D-SNP-only contracts. We anticipate the number of states with D-SNP-only contract requirements to increase by another eight or nine states in 2026, with the majority of these new states a result of the transition of those participating in the capitated financial alignment model demonstrations. We expect a limited number of additional states may move in this direction over time.
                    </P>
                    <P>
                        As a result of these state requirements, some MA organizations have had to, or will have to, move D-SNP plan benefit packages from existing MA contracts (hereafter referred to as “legacy MA contracts”) to D-SNP-only contracts established under § 422.107(e). These changes may make it more difficult for a legacy MA contract to meet either of the enrollment thresholds for the percentages of enrollees with the specified SRFs for the HEI reward as defined at §§ 422.166(f)(3)(vii) and 423.186(f)(3)(vii) while the specified SRFs included in the HEI are LIS/DE or having a disability as currently defined at §§ 422.166(f)(3)(i)(A) and 423.186(f)(3)(i)(A). As such, MA organizations operating in states that elected § 422.107(e) may not be eligible for the HEI reward if fewer enrollees with SRFs remain following the establishment of separate D-SNP-only contracts, potentially creating an incentive for these organizations to promote enrollment of individuals with the specified SRFs in the legacy MA contracts as opposed to the D-SNPs. This incentive runs counter to our goal of encouraging enrollment in high-quality integrated products that better 
                        <PRTPAGE P="99483"/>
                        suit the dually eligible population. To address this, we propose at §§ 422.166(f)(3)(viii)(C) and 423.186(f)(3)(viii)(C) to modify the way eligibility for an HEI reward and the size of the HEI reward are determined for legacy MA contracts that no longer meet either of the percentage SRF enrollment thresholds due to state contracting requirements under § 422.107(e). As additional SRFs are added to the HEI reward through rulemaking, we anticipate that the need for this adjustment will no longer be necessary. Thus, we propose at §§ 422.166(f)(3)(viii)(C) and 423.186(f)(3)(viii)(C) that this change would be implemented every year after the D-SNP-only contract established under § 422.107(e) is required to be created until the Star Ratings year when additional SRFs are added to the HEI reward, after which time, legacy MA contracts will have the potential HEI reward calculated based on their own enrollment and performance following the methodology at §§ 422.166(f)(3)(viii) and 423.186(f)(3)(viii). There are no changes to how eligibility for, or the size of, the HEI reward are calculated for D-SNP-only contracts established under § 422.107(e).
                    </P>
                    <P>
                        We propose a series of rules that would be applied in order to determine whether the legacy MA contract would qualify for an HEI reward and the size of the reward if applicable. First, we propose at §§ 422.166(f)(3)(viii)(C)(
                        <E T="03">1</E>
                        ) and 423.186(f)(3)(viii)(C)(
                        <E T="03">1</E>
                        ) to follow the methodology for calculating the HEI reward at paragraphs §§ 422.166(f)(3)(viii) and 423.186(f)(3)(viii) for legacy MA contracts that continue to meet either of the percentage SRF enrollment thresholds (
                        <E T="03">i.e.,</E>
                         the contract-level median threshold or one-half of the contract-level median threshold) based on their own enrollment. For legacy MA contracts that do not meet either of the percentage SRF enrollment thresholds (
                        <E T="03">i.e.,</E>
                         the contract-level median threshold or one-half of the contract-level median threshold) based on their own enrollment, we propose at §§ 422.166(f)(3)(viii)(C)(
                        <E T="03">2</E>
                        ) and 423.186(f)(3)(viii)(C)(
                        <E T="03">2</E>
                        ) to first determine whether the legacy MA contract can reliably have the rating-specific HEI score calculated based on its own enrollment as described at §§ 422.166(f)(3)(iv) and (vi) and 423.186(f)(3)(iv) and (vi). If the legacy MA contract cannot reliably have the rating-specific HEI score calculated based on its own enrollment, then the legacy MA contract would not qualify for an HEI reward for the given rating. We propose this to ensure that legacy MA contracts are not rewarded unless they are still providing relatively high quality care for their remaining enrollees with SRFs, and we cannot ensure this if the rating-specific HEI score cannot be reliably calculated.
                    </P>
                    <P>
                        Additionally, we propose at §§ 422.166(f)(3)(viii)(C)(
                        <E T="03">2</E>
                        ) and 423.186(f)(3)(viii)(C)(
                        <E T="03">2</E>
                        ) that if the D-SNP-only contract established under § 422.107(e) that received the D-SNP(s) from the legacy MA contract cannot have the rating-specific HEI score reliably calculated, then the legacy MA contract would not qualify for an HEI reward for the given rating. We propose this because without the HEI score from the D-SNP-only contract established under § 422.107(e), the potential HEI reward for the legacy contract would be based solely on its own performance among a relatively small percentage of enrollees with the specified SRFs. This would be inconsistent with our policy goals for the HEI reward, one of which is to focus the HEI reward on contracts serving larger percentages of enrollees with the specified SRFs, as this is where improvement is most needed. For example, the D-SNP-only contract established under § 422.107(e) that received the D-SNP(s) from the legacy MA contract would not be able to have a rating-specific HEI score reliably calculated if the D-SNP contract is too new or does not have enough data, and therefore the legacy MA contract in this instance also would not qualify for an HEI reward. To further illustrate this point using example measurement years, a D-SNP-only contract established under § 422.107(e) that begins operating in 2027 would first be eligible for a Star Rating as of the 2029 Star Ratings (measurement year 2027) and an HEI reward as of the 2030 Star Ratings (measurement years 2027 and 2028). For the 2027 and 2028 Star Ratings, the calculation of the enrollment thresholds and the HEI for the legacy MA contract would be based on measurement periods that were prior to the D-SNP-only contract transition. The 2029 Star Ratings are based on a measurement period following the D-SNP-only contract transition, and since the D-SNP-only contract cannot have an HEI reward calculated that rating year, the legacy MA contract would not be eligible for the HEI reward unless it qualifies solely based on its own enrollment.
                    </P>
                    <P>
                        We propose at §§ 422.166(f)(3)(viii)(C)(
                        <E T="03">3</E>
                        ) and 423.186(f)(3)(viii)(C)(
                        <E T="03">3</E>
                        ) that the legacy MA contract would not qualify for a rating-specific HEI reward if the legacy MA contract's performance on the rating-specific HEI based on its own enrollment does not meet the minimum index score of greater than zero defined at §§ 422.166(f)(3)(vii) and 423.186(f)(3)(vii) or if the legacy MA contract's performance on the rating-specific HEI based on its own enrollment is less than the performance on the rating-specific HEI of the D-SNP-only contract established under § 422.107(e).
                    </P>
                    <P>
                        If both the legacy MA contract and the D-SNP-only contract established under § 422.107(e) can reliably have the rating-specific HEI scores calculated as defined at §§ 422.166(f)(3)(iv) and (vi) and §§ 423.186(f)(3)(iv) and (vi) based on their own enrollment, and the legacy MA contract does not meet an enrollment threshold on its own, then we propose at §§ 422.166(f)(3)(viii)(C)(
                        <E T="03">4</E>
                        ) and 423.186(f)(3)(viii)(C)(
                        <E T="03">4</E>
                        ) the methodology to determine the potential HEI reward for the legacy MA contract for the given rating. Specifically, we propose at §§ 422.166(f)(3)(viii)(C)(
                        <E T="03">4</E>
                        )(
                        <E T="03">i</E>
                        ) and 423.186(f)(3)(viii)(C)(
                        <E T="03">4</E>
                        )(
                        <E T="03">i</E>
                        ) to base the enrollment threshold at §§ 422.166(f)(3)(vii) and 423.186(f)(3)(vii) on the combined enrollment from the legacy MA contract and the D-SNP-only contract established under § 422.107(e) from the most recent measurement year used in calculating the HEI. Additionally, we propose at §§ 422.166(f)(3)(viii)(C)(
                        <E T="03">4</E>
                        )(
                        <E T="03">i</E>
                        ) and 423.186(f)(3)(viii)(C)(
                        <E T="03">4</E>
                        )(
                        <E T="03">i</E>
                        ) that if the legacy MA contract's rating-specific HEI score based on its own enrollment meets the minimum index score of greater than zero defined at §§ 422.166(f)(3)(vii) and 423.186(f)(3)(vii), and the legacy MA contract's rating-specific HEI score based on its own enrollment is greater than or equal to the rating-specific HEI score for the D-SNP-only contract established under § 422.107(e), then the legacy MA contract would qualify for an HEI reward for the given rating. This potential rating-specific HEI reward would be calculated following §§ 422.166(f)(3)(viii) and 423.186(f)(3)(viii) and would be based on the enrollment threshold using the combined enrollment from the legacy MA contract and the D-SNP-only contract established under § 422.107(e) as defined at §§ 422.166(f)(3)(viii)(C)(
                        <E T="03">4</E>
                        )(
                        <E T="03">i</E>
                        ) and 423.186(f)(3)(viii)(C)(
                        <E T="03">4</E>
                        )(
                        <E T="03">i</E>
                        ), and using the HEI score for the D-SNP-only contract established under § 422.107(e). We propose this because we want to avoid overly rewarding legacy MA contracts that are serving a smaller percentage of enrollees with SRFs and therefore may find it easier to perform well on the HEI.
                    </P>
                    <P>
                        We also propose at §§ 422.166(f)(3)(viii)(C)(
                        <E T="03">5</E>
                        ) and 
                        <PRTPAGE P="99484"/>
                        423.186(f)(3)(viii)(C)(
                        <E T="03">5</E>
                        ) that when multiple legacy MA contracts move their D-SNP plan benefit packages to the same D-SNP-only contract established under § 422.107(e), the combined enrollment from the multiple legacy MA contracts and the D-SNP-only contract would be used to determine if a percentage SRF enrollment threshold is met for legacy MA contracts that do not meet an enrollment threshold based on their own enrollment.
                    </P>
                    <P>Further, in calculating the rating-specific HEI, we require at §§ 422.166(f)(3)(vi) and 423.186(f)(3)(vi) that contracts must have at least 500 enrollees and meet the criteria specified at §§ 422.166(f)(3)(iv) and 423.186(f)(3)(iv) for at least half of the measures included in the rating- specific HEI. Since I-SNP-only contracts are not required to report CAHPS, HOS, and certain HEDIS measures, there may be situations depending on the set of measures included in the HEI each year where I-SNP-only contracts cannot meet this half of measures requirement based on not being required to report some of the measures included in the HEI. To address this, we propose to revise §§ 422.166(f)(3)(vi) and 423.186(f)(3)(vi) to clarify that starting with the 2027 Star Ratings, contracts that are I-SNP-only contracts in the rating year must meet the criteria specified at §§ 422.166(f)(3)(iv) and 423.186(f)(3)(iv) for at least half of the measures included in the rating-specific HEI for the subset of measures that I-SNP-only contracts are required to report. For example if there were 20 measures included in a rating-specific HEI but only 16 of the measures were required to be reported by I-SNP-only contracts, then I-SNP-only contracts would need to meet the criteria specified at §§ 422.166(f)(3)(iv) and 423.186(f)(3)(iv) for at least half of the 16 measures or for 8 measures. We propose this to avoid situations where I-SNP-only contracts are not able to meet the half of measures requirement at §§ 422.166(f)(3)(vi) and 423.186(f)(3)(vi) based solely on reporting requirements. We are not proposing changes for other contract types, because we do not anticipate scenarios for other contract types where it is not possible to meet the half of measures requirement based solely on reporting requirements. We also propose at §§ 422.166(f)(3)(iv)(C) and 423.186(f)(3)(iv)(C) that for a measure to be included in the calculation of the HEI for a contract that is an I-SNP-only contract in the ratings year, the measure must be required to be reported by I-SNP-only contracts. We propose this to address situations where a contract may not have been an I-SNP-only contract in one of the measurement years and therefore has data on measures that are not required to be reported by I-SNP-only contracts and are not reflective of the population served by I-SNP-only contracts.</P>
                    <P>Finally, we propose changes at §§ 422.166(f)(3)(v)(A) and 423.186(f)(3)(v)(A) to how the HEI score would be calculated for contracts that have data discrepancies between their submitted patient-level detail and summary-level data for HEDIS measures included in the HEI beginning with the 2026 and 2027 measurement years used for the 2029 Star Ratings. For HEDIS measures included in the HEI we rely on the patient-level detail data that contracts submit to CMS. It is critical that these data are complete so we can accurately calculate performance for the subset of enrollees with the specified SRFs. We propose that for measures included in the HEI, if a contract's HEDIS measure score across all enrollees for a measure that is calculated by CMS using the contract's submitted patient-level detail HEDIS data does not match the contract's summary-level HEDIS score submitted to NCQA for either of the two measurement years used to construct the HEI as defined at §§ 422.166(f)(3)(i)(B) and 423.186(f)(3)(i)(B), the contract would receive −1 points for that measure (the same number of points assigned to the bottom third of the distribution of contract performance) in the calculation of the HEI as described at §§ 422.166(f)(3)(v) and 423.186(f)(3)(v). We also propose at §§ 422.166(f)(3)(v)(A) and 423.186(f)(3)(v)(A) that a contract that does not provide patient-level HEDIS data for a measure included in the HEI for which it has provided summary-level HEDIS data to NCQA would receive −1 points for that measure in the calculation of a contract's HEI score at §§ 422.166(f)(3)(v) and 423.186(f)(3)(v). For example, if the HEI is based on the 2026 and 2027 measurement years and a contract does not provide HEDIS patient-level data for a measure for either the 2026 or 2027 measurement years, the contract would receive −1 points for that measure in the calculation of its HEI score.</P>
                    <P>We solicit comments on these proposals, including whether these rules for calculating the HEI reward when an MA organization is required by a state, consistent with § 422.107(e), to establish and maintain a D-SNP-only contract that is limited to only D-SNPs offered by the MA organization in that state should apply for one year, multiple years, or every year after the D-SNP-only contract is required to be established by the state or until additional SRFs are added to the HEI.</P>
                    <HD SOURCE="HD2">D. Applying the Improvement Measure Scores (§§ 422.166(g) and 423.186(g))</HD>
                    <P>We propose to clarify at §§ 422.166(g)(1)(i) and (ii) and §§ 423.186(g)(1)(i) and (ii) that the improvement measure hold harmless for the highest rating is determined based on the rounded rating before the addition of the HEI reward, if applicable. This is consistent with how the improvement measure hold harmless rules have historically been applied based on the rounded rating, and §§ 422.166(f)(3)(ix) and 423.186(f)(3)(ix) require that the HEI reward be added after the application of the improvement measures and before rounding to the nearest half star.</P>
                    <P>To operationalize this, CMS would determine the application of the improvement measures for the highest rating using the rating rounded to the nearest half star before the addition of the HEI reward, if applicable. Then when adding the HEI reward if applicable for the highest rating, CMS would go back to the unrounded rating either with or without the improvement measures as determined using the steps described at §§ 422.166(g) and 423.186(g), add the HEI reward, and then round to the nearest half star. This is our current (and historical) process and how the proposed regulatory clarification would be applied.</P>
                    <HD SOURCE="HD2">E. Contract Consolidations (§ 422.162(b)(3) and § 423.182(b)(3))</HD>
                    <P>
                        We are proposing a technical clarification of existing policy at §§ 422.162(b)(3)(iv)(A)(2) and (B)(2) and §§ 423.182(b)(3)(ii)(A)(2) and (B)(2) to provide details about how the enrollment-weighted measure score is calculated when a consumed or surviving contract is missing data for a measure. In the first year of the consolidation when a measure score for a consumed or surviving contract is missing as a result of not having enough data to meet the measure technical specification or for a CAHPS measure having reliability less than 0.6, CMS proposes to treat this measure score as missing in the calculation of the enrollment-weighted measure score. Similarly, in the second year of the consolidation for all measures, except HEDIS, HOS, CAHPS, and call center measures, when a measure score for a consumed or surviving contract is missing as a result of not having enough 
                        <PRTPAGE P="99485"/>
                        data to meet the measure technical specification, CMS proposes to treat this measure score as missing in the calculation of the enrollment-weighted measure score. For § 423.182(b)(3)(ii)(A)(2) and (B)(2) we also removed reference to § 423.184(g)(1)(ii) since it was reserved in the Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024—Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE) final rule (pages 30639-30642).
                    </P>
                    <HD SOURCE="HD2">F. Burden</HD>
                    <P>As described in this section of this proposed rule, we are proposing adding and updating certain measures. The proposed measure additions and updates are calculated from administrative data or entail moving existing measures from the display page to Star Ratings, which would have no impact on plan burden. We are also proposing a series of technical clarifications related to applying the improvement measure scores and calculating the health equity index, as well as proposing how the health equity index reward would be calculated for contracts that are required by a state Medicaid agency to move one or more D-SNP plan benefit packages from an existing MA contract to an MA contract that only includes one or more D-SNPs with a service area limited to that state, consistent with § 422.107(e). The proposed provisions would not change any respondent requirements or burden pertaining to any of CMS's Star Ratings related PRA packages.</P>
                    <HD SOURCE="HD1">V. Improving Experiences for Dually Eligible Enrollees</HD>
                    <HD SOURCE="HD2">A. Member ID Cards, Health Risk Assessments, and Individualized Care Plans (§§ 422.101, 422.107, 422.2267, 423.2267)</HD>
                    <P>Dually eligible individuals face fragmentation in many parts of the health care system, including their experiences as enrollees of Medicare and Medicaid managed care plans. One way in which we seek to address such fragmentation is through policies that integrate care for dually eligible individuals. “Integrated care” refers to delivery system and financing approaches that (1) maximize person-centered coordination of Medicare and Medicaid services; (2) mitigate cost-shifting incentives between the two programs; and (3) create a seamless experience for dually eligible individuals.</P>
                    <P>In recent years, we have advanced integrated care by:</P>
                    <P>• Incorporating features of the Medicare-Medicaid Financial Alignment Initiative's (FAI) Medicare-Medicaid Plans (MMPs) into dual eligible special needs plan (D-SNP) requirements, including enrollee participation in plan governance, screening for social risk factors in health risk assessments (HRAs) (which applies to all SNPs), integrated enrollee materials, and mechanisms for joint Federal-State oversight;</P>
                    <P>• Implementing provisions of the Bipartisan Budget Act of 2018 to unify appeals and grievance processes across Medicare and Medicaid; and</P>
                    <P>• Increasing opportunities for enrollment in D-SNPs with aligned Medicaid managed care plans operated by the same parent organization.</P>
                    <P>However, there remain aspects of care for dually eligible individuals that can be misaligned, confusing, or duplicative even when a dually eligible individual is enrolled in Medicare and Medicaid managed care plans operated by the same parent organization.</P>
                    <P>In this section we describe proposals to establish new Federal requirements for D-SNPs that are applicable integrated plans (AIPs) to: (1) have integrated member identification (ID) cards that serve as the ID cards for both the Medicare and Medicaid plans in which an enrollee is enrolled; and (2) conduct an integrated health risk assessment for Medicare and Medicaid, rather than separate HRAs for each program. These proposals continue our work to advance integrated care by applying MMP features into D-SNP requirements. More importantly, our proposals would improve and simplify experiences for dually eligible enrollees in AIP D-SNPs. We are also proposing to amend the requirements related to HRAs and individualized care plans (ICPs) for all SNPs (that is, D-SNPs, chronic condition SNPs, and institutional SNPs). Under this third proposal, we would codify timeframes for SNPs to conduct HRAs and develop ICPs and prioritize the involvement of the enrollee or the enrollee's representative, as applicable, in the development of the ICPs. Finally, we propose a related addition to requirements for D-SNP enrollee advisory committees. We describe each proposal in greater detail in the following sections.</P>
                    <HD SOURCE="HD3">a. Integrating Member ID Cards for Dually Eligible Enrollees in Certain Integrated D-SNPs</HD>
                    <P>
                        Sections 422.2267(e)(30) and 423.2267(e)(32) require MA and Part D plans, including D-SNPs, to provide member ID cards to enrollees. Medicaid managed care plans, which include managed care organizations (MCOs), prepaid inpatient health plans (PIHPs), and prepaid ambulatory health plans (PAHPs) also send member ID cards to enrollees which they use to access the items and services provided under that plan. However, when a dually eligible individual is enrolled in both a Medicare Advantage (MA) plan and a Medicaid managed care plan, the plans usually issue the enrollee separate member ID cards—one for their MA plan and one for their Medicaid managed care plan—to access services for each program. This is administratively confusing, as providers may not always know which insurance to charge for which services, and confusing for enrollees, who may not always be aware of when to present which card.
                        <SU>306</SU>
                        <FTREF/>
                         Through studies and conversations with dually eligible enrollees, we have learned that individuals dually eligible for Medicare and Medicaid view having one insurance card instead of two as a benefit of integrated care.
                        <SU>307</SU>
                        <FTREF/>
                         As such, we are proposing to continue our effort to integrate materials for dually eligible enrollees by requiring that certain D-SNPs provide one integrated member ID card to serve as the ID card for both the Medicare and Medicaid plans in which the enrollee is enrolled.
                    </P>
                    <FTNT>
                        <P>
                            <SU>306</SU>
                             CMS commissioned studies on experiences and terms pertaining to integrated care and solicited feedback from States and plans on integrated member ID cards.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>307</SU>
                             Rachelle Brill, Listening to Dually Eligible Individuals: Person-Centered Enrollment Strategies for Integrated Care. Center for Consumer Engagement in Health Innovation, June 2021. Online at 
                            <E T="03">https://communitycatalyst.org/wp-content/uploads/2023/06/Person-Centered-Enrollment-Strategies-for-Integrated-Care.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        In the past several years, we have partnered with States to make integrated materials more broadly available, with the goal of streamlining the managed care enrollee experience and reducing burden and confusion for dually eligible individuals. As of January 2024, approximately 846,000 dual eligible individuals were enrolled in integrated care plans that used integrated materials. That includes all MMPs in the FAI, which use integrated Medicare and Medicaid materials including the member ID card, annual notice of change, evidence of coverage (Member Handbook), Formulary (List of Covered 
                        <PRTPAGE P="99486"/>
                        Drugs), Summary of Benefits, and Provider and Pharmacy Directory.
                    </P>
                    <P>
                        In the final rule titled “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” which appeared in the May 9, 2022, 
                        <E T="04">Federal Register</E>
                         (hereinafter referred to as the May 2022 final rule), we finalized a pathway at § 422.107(e) by which States can require D-SNPs with exclusively aligned enrollment (EAE) to use integrated Medicare and Medicaid materials including the Summary of Benefits, Formulary, and combined Provider and Pharmacy Directory—essential information for dually eligible enrollees to be able to understand and utilize their managed care benefits. Eleven States currently require D-SNPs that are AIPs, as defined at § 422.561, to use at least some integrated materials for CY 2025, as shown in table 15.  
                    </P>
                    <GPH SPAN="3" DEEP="101">
                          
                        <GID>EP10DE24.021</GID>
                    </GPH>
                      
                    <P>In addition, in some cases, dually eligible enrollees in D-SNPs and an affiliated Medicaid managed care plan with EAE receive a single ID card that serves as the ID card for both health plans. According to State Medicaid agency contracts (SMACs) for contract year 2024, nine States (California, Florida, Hawaii, Idaho, Massachusetts, Minnesota, New Jersey, Tennessee, and Wisconsin) currently require D-SNPs to use a single integrated member ID card for both Medicare and Medicaid benefits.</P>
                    <P>
                        Establishing a Federal requirement for integrated member ID cards for AIP D-SNPs would improve experiences for dually eligible individuals (in such plans not already deploying an integrated ID card) and build on our past work to integrate Medicare and Medicaid. Therefore, under our authority to interpret, implement and carry out the Part C and D programs under sections 1851(h), 1852(c), 1860D-1(b)(1)(B)(vi), 1860D-4(a), and 1860D-4(
                        <E T="03">l</E>
                        ) of the Social Security Act (the Act), we are proposing to add a requirement at §§ 422.2267(e)(30) and 423.2267(e)(32) that AIPs provide enrollees one integrated member ID card that serves as the ID card for both the Medicare and Medicaid plans in which they are enrolled.
                    </P>
                    <P>We are not proposing substantive changes to the Medicare or Medicaid requirements for the content of the ID cards. Therefore, the integrated ID cards would need to comply with the applicable Medicare requirements at §§ 422.2267(e)(30) and 423.2267(e)(32) and as further described in the Medicare Communications and Marketing Guidelines as well as applicable Medicaid requirements.</P>
                    <P>
                        For example, we finalized a provision at § 438.3(s)(7) in the final rule titled “Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program,” which appeared in the September 26, 2024, 
                        <E T="04">Federal Register</E>
                         (hereinafter referred to as the September 2024 Medicaid final rule), requiring States that contract with MCOs, PIHPs, or PAHPs that provide coverage of Medicaid outpatient drugs to require those managed care plans to assign and exclusively use unique Medicaid-specific Bank Identification Number (BIN) and Processor Control Number (PCN) combination, and group number identifiers for all Medicaid managed care enrollee identification cards for pharmacy benefits to make the Medicaid drug program run more efficiently and improve the level of pharmacy services provided to Medicaid enrollees. Although Medicaid managed care plans are not Federally required to issue member ID cards, it is a standard business practice for the MCOs, PIHPs, and PAHPs to routinely issue identification cards for pharmacy benefits for Medicaid enrollees. To the extent AIPs cover outpatient drugs for which Medicaid (not Medicare) would be the primary payer, § 438.3(s)(7) would still apply to the AIP.
                    </P>
                    <P>We note that the September 2024 Medicaid final rule states that § 438.3(s)(7) is effective for Medicaid managed care contracts (which would require compliance by MCOs, PIHPs, and PAHPs) no later than the first rating period for contracts with managed care plans beginning on or after 1 year following the effective date of the September 2024 Medicaid final rule, which is November 19, 2024. While our proposed updates to §§ 422.2267 and 423.2267 are applicable for contract year 2027, beginning October 1, 2026, the requirements at § 438.3(s)(7) would be applicable as is described in the September 2024 Medicaid final rule.</P>
                    <P>
                        Our proposal would not add new requirements in the nine States that currently require integrated member ID cards in their SMACs. Similarly, we expect—independent of this proposal—several additional States will require integrated member ID cards when MMPs transition to D-SNPs in 2026 (because these States already require integrated member ID cards for the MMPs). If finalized, this proposal would require current AIPs in three additional States and Territories (District of Columbia, New York, and Puerto Rico) to implement integrated member ID cards, and if more plans become AIPs, this requirement would apply to any such plans as well. However, we do not believe that this proposed requirement to integrate member ID cards would create additional burden in these States and Territories as the issuance of member ID cards is a normal and customary practice throughout the insurance industry. Since we will be working with several States to update an array of integrated materials as we transition MMPs to become integrated D-SNPs in 2026, and to give AIPs time needed to implement such updates as appropriate during the annual material creation cycle, we propose to require the use of the integrated member ID card for enrollments effective January 1, 2027. Thus, our proposed updates to marketing and communication provisions at §§ 422.2267(e)(30) and 423.2267(e)(32) would be applicable for all contract year 2027 marketing and 
                        <PRTPAGE P="99487"/>
                        communications beginning October 1, 2026.
                    </P>
                    <P>
                        We believe requiring that AIPs use integrated member ID cards is an important step to further integration and make enrollees' experience with Medicaid and Medicare less confusing, less burdensome, and more accessible. To our knowledge, this proposal represents the first time we have proposed a Federal requirement for any integrated materials for any type of D-SNP. We chose to focus on ID cards because having one ID card is important to dually eligible individuals 
                        <SU>308</SU>
                        <FTREF/>
                         and—relative to integrating other materials—is operationally manageable for integrated plans and requires the least of State Medicaid agencies. We solicit comment on this proposal and feedback on successes, challenges, and other experiences to date with integrated member ID cards.
                    </P>
                    <FTNT>
                        <P>
                            <SU>308</SU>
                             Rachelle Brill, Listening to Dually Eligible Individuals: Person-Centered Enrollment Strategies for Integrated Care. Center for Consumer Engagement in Health Innovation, June 2021. Online at 
                            <E T="03">https://communitycatalyst.org/wp-content/uploads/2023/06/Person-Centered-Enrollment-Strategies-for-Integrated-Care.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        We are considering, and invite comment on, whether the final rule should provide that any requirement for integrated ID cards should apply to AIPs and 
                        <E T="03">all</E>
                         HIDE SNPs, including those that do not also qualify as AIPs. However, in this proposed rule, we chose to limit our proposal to AIPs because we assume that integrated member ID cards would be more complex to administer in situations where some D-SNP enrollees have aligned enrollment but others are enrolled in a Medicaid plan operated by a different organization or fee-for-service Medicaid. In contrast to an AIP, where all of the D-SNP's enrollees would receive the integrated ID card, a non-AIP would need a reliable and timely mechanism for differentiating among enrollees within the plan to determine which ID card to send. We are unaware of any D-SNPs or other MA plans that currently deploy the types of integrated ID cards envisioned in our proposal for plans that do not have exclusively aligned enrollment. We solicit comment on the accuracy of these assumptions and, as noted above, whether in the final rule to apply the proposed requirement to AIPs and 
                        <E T="03">all</E>
                         HIDE SNPs. We also welcome comments on different situations in which commenters believe that integrated member ID cards could be helpful to include in potential future rulemaking.
                    </P>
                    <P>Finally, we welcome comment on other considerations for future rulemaking on ID cards, including ways to prevent stigma and ensure their security and utility for dually eligible enrollees.</P>
                    <HD SOURCE="HD3">b. Integrating Health Risk Assessments for Dually Eligible Enrollees in Certain Integrated D-SNPs</HD>
                    <P>Medicare requirements at § 422.101(f)(1) require D-SNPs to conduct a comprehensive HRA for each enrollee, both at the time of enrollment and annually thereafter. Separately, Medicaid managed care regulations at § 438.208(b)(3) require Medicaid managed care plans to make a best effort to conduct an initial screening of enrollee needs within 90 days of their effective enrollment date, and States may require additional assessments such as long-term services and supports (LTSS) and home and community-based services eligibility screenings.</P>
                    <P>In the FAI, MMP enrollees complete a single integrated HRA, encompassing both Medicare and Medicaid requirements. In contrast, dually eligible individuals enrolled in both a D-SNP and a Medicaid managed care plan may end up completing multiple assessments during the year, some of which may be duplicative, as managed care plans aim to meet all applicable enrollee assessment requirements across both programs, and to gather information about enrollee needs and preferences and create individualized care plans. Completing two separate, but potentially overlapping, assessments creates unnecessary burden for enrollees, who may have to answer the same detailed personal questions more than once.</P>
                    <P>
                        In the final rule titled “Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly” which appeared in the January 19, 2021, 
                        <E T="04">Federal Register</E>
                         (hereinafter referred to as the January 2021 final rule), we clarified that D-SNPs receiving capitation for Medicaid services may combine their Medicare-required HRA with a State Medicaid-required assessment to reduce burden for enrollees, as long as the assessment meets all applicable requirements (86 FR 5879). We also noted that, to the extent there is overlap and the HRA required by § 422.101(f)(1)(i) can be aligned with other assessments conducted by a SNP, the model of care (MOC) should describe that alignment, consistent with the standards in MOC 2, Element B in Chapter 5, section 20.2.2 of the Medicare Managed Care Manual. We explained that the factors outlined in the MOC guidelines allow SNPs the flexibility to align the HRA required by § 422.101(f)(1)(i) with other assessment tools. In addition, the contract year (CY) 2024 Medicare Part C Reporting Requirements, in which MA plans must report on HRA completion, allow D-SNPs to count a Medicaid HRA that is performed within 90 days before or after the effective date of Medicare enrollment as meeting the Part C obligation to perform an HRA, so long as the requirements in § 422.102(f) regarding the HRA are met.
                        <SU>309</SU>
                        <FTREF/>
                         As outlined in both the January 2021 rule and the most recent Part C Reporting Requirements, we have allowed a certain degree of flexibility for SNPs to streamline their Medicare and Medicaid assessments. However, we have not previously required that D-SNPs integrate Medicare and Medicaid enrollee HRAs into a single HRA for dually eligible individuals.
                    </P>
                    <FTNT>
                        <P>
                            <SU>309</SU>
                             2024 Part C Reporting Technical Specifications: 
                            <E T="03">https://www.cms.gov/files/document/cy2024-part-c-technical-specifications-02222024.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        States have implemented their own requirements, through SMACs, to reduce burden and duplication. For example, Arizona requires D-SNPs to perform an integrated HRA for both Medicare and Medicaid. California requires D-SNPs with exclusively aligned enrollment to make their best effort to create a single unified HRA for enrollees, and New Jersey's SMAC includes requirements related to minimizing duplication of assessments.
                        <SU>310</SU>
                        <FTREF/>
                         Other States, while not explicitly requiring integrated HRAs, have implemented requirements to improve integration and coordination across Medicare and Medicaid HRAs and services. A 2019 Health Management Associates (HMA) report commissioned by the Medicaid and CHIP Payment and Access Commission (MACPAC) noted one State requires its D-SNPs to request a representative from an enrollee's Medicaid plan to participate in all needs assessments, and that another State requires integrating Medicaid LTSS assessments within the HRA.
                        <SU>311</SU>
                        <FTREF/>
                         We have also heard from a few D-SNP parent organizations that are actively working to reduce duplication between their Medicare and Medicaid HRAs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>310</SU>
                             CMS review and analysis of State SMACs.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>311</SU>
                             
                            <E T="03">https://www.macpac.gov/wp-content/uploads/2019/03/Care-Coordination-in-Integrated-Care-Programs-Serving-Dually-Eligible-Beneficiaries.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        Under our authority at section 1856(b) of the Act to establish standards for MA plans by regulation, we propose to adopt specific standards to implement the requirement at section 
                        <PRTPAGE P="99488"/>
                        1859(f)(5)(A)(ii)(I) of the Act that all MA SNPs conduct an initial assessment and an annual reassessment of the individual's physical, psychosocial, and functional needs. We propose to add a new paragraph at § 422.101(f)(1)(v) that would require D-SNPs that are AIPs (as defined in § 422.561) to conduct a comprehensive HRA that meets all requirements at § 422.101(f)(1)(i) through (v) as well as any applicable Medicaid requirements, including those at § 438.208, such that enrollees in the AIP complete a single integrated HRA for Medicare and Medicaid. If this proposal is finalized, we believe it would meaningfully reduce assessment burden for dually eligible individuals and improve their experience as managed care enrollees (where States aren't already requiring something similar). It may also improve integration of care within D-SNP AIPs and their affiliated Medicaid managed care plans by collecting all enrollee assessment information in one place, potentially facilitating better care coordination across Medicare and Medicaid services. This proposal would also continue our efforts to incorporate MMP features into D-SNP requirements. Finally, we believe this proposal for a new Federal requirement would not create a significant burden for health plans because similar State requirements to integrate Medicare and Medicaid HRAs are already in place in some States, and at least a few health plans have taken on these efforts themselves.
                    </P>
                    <P>
                        We are proposing only to require D-SNPs that are AIPs to meet this new requirement because we believe it is most feasible for D-SNPs whose enrollees are exclusively aligned with an affiliated Medicaid MCO to implement a fully integrated HRA. Because all FIDE SNPs are AIPs beginning in 2025, the proposal encompasses all FIDE SNPs. Numerous HIDE SNPs and some coordination-only D-SNPs with exclusively aligned enrollment are also AIPs. We are considering whether we should apply this new requirement to 
                        <E T="03">all</E>
                         HIDE SNPs or all D-SNPs, even those without exclusively aligned enrollment. However, in a scenario where some D-SNP enrollees receive their Medicaid benefits from a different organization or through fee-for-service, it could be challenging for the D-SNP to assess aligned enrollees with an integrated HRA and to assess non-aligned enrollees with a different, Medicare-only assessment. We welcome comment on whether, in the final rule, this requirement should be applied to all HIDE SNPs or suggestions as to whether application to a different subset of D-SNPs should be proposed in future rulemaking.
                    </P>
                    <P>This proposal would not change any specific Medicare or Medicaid requirements for the timing of or elements included in an HRA (although we address an issue related to the timing of required HRAs elsewhere in this proposed rule). Nor would this proposal preclude deployment of assessments that are modular (such as a base level assessment that meets all Medicare and Medicaid requirements with optional additional sections that are specific to people for substance use or other factors) or include additional elements for people with special needs. For example, some States may require more expansive assessment questions to develop a service plan for 1915(c) waiver services, or plans may conduct additional assessment for people who screen positive for substance use disorder or other conditions. Our proposal would not require that all enrollees complete such an assessment, nor would it preclude plans from conducting such additional assessments separately from the HRA. Rather, our proposal simply requires that the base HRA and screening applies across both programs, such that enrollees are not asked to complete independent HRAs for Medicare and Medicaid. We welcome comment on potential challenges that health plans and other stakeholders foresee, or have already experienced, in implementing HRAs that integrate LTSS assessments. We also welcome comment on any potential conflicts with State Medicaid assessment requirements our proposal may create.</P>
                    <P>
                        In addition to separate Medicare and Medicaid managed care assessment requirements, different Medicare and Medicaid enrollment timeframes and effective dates can be a barrier to D-SNP AIPs administering a single, integrated HRA. In the final rule titled “Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024—Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly” which appeared in the April 23, 2024, 
                        <E T="04">Federal Register</E>
                         (hereinafter referred to as the April 2024 final rule), we noted at 89 FR 30704 that Medicare and Medicaid managed care enrollment start and end dates can be misaligned. Sections 1851(f)(2) and 1860D-1(b)(1)(B)(iv) of the Social Security Act, and regulations codified at §§ 422.68 and 423.40 respectively, generally require that Medicare enrollments become effective on the first day of the first calendar month following the date on which the election or change is made, although section 1851(f)(4) of the Act and §§ 422.68(d) and 423.40(c) allow CMS flexibility to determine the effective dates for enrollments that occur in the context of special enrollment periods.
                    </P>
                    <P>Medicaid managed care regulations at § 438.54 do not specify the timelines or deadlines by which any enrollment must be effective. Some States have cut-off dates after which enrollment in a Medicaid managed care plan is not effectuated until the first day of the next month after the following month. In this scenario, a dually eligible individual requesting to enroll in an AIP D-SNP with an aligned Medicaid MCO on March 28 might be enrolled in the D-SNP effective April 1, but in the aligned Medicaid MCO effective May 1, leaving a month-long gap. We believe it would still be feasible to assess an enrollee using an integrated HRA in this scenario, given that the enrollee's Medicaid eligibility would already be verified. However, we are interested in hearing from stakeholders about whether this would present operational challenges to implementing an integrated HRA for AIP D-SNP enrollees.</P>
                    <P>
                        We believe our proposal would reduce confusion, assessment burden, and fragmentation for dually eligible individuals enrolled in AIP D-SNPs and potentially lead to more effective coordination of care. We also believe our proposal would not be overly burdensome for AIP D-SNPs to implement, given there are existing requirements in eight States 
                        <SU>312</SU>
                        <FTREF/>
                         either to use a single, integrated HRA or take action to reduce duplication in HRAs. We welcome comment on our proposal.
                    </P>
                    <FTNT>
                        <P>
                            <SU>312</SU>
                             Based on CMS review of 2024 SMACs.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">c. Promoting Person-Centeredness in SNP ICPs and Timeliness of HRAs and ICPs</HD>
                    <HD SOURCE="HD3">(1) Medicare Context</HD>
                    <P>
                        Section 1859(f)(5)(A) of the Act requires SNPs to conduct an initial assessment and an annual reassessment of each enrollee's physical, psychosocial, and functional needs and ensure that the results are addressed in each enrollee's ICP. We codified this requirement at § 422.101(f)(1)(i), using the term “health risk assessment,” as a required component of the SNP MOC. Specifically, § 422.101(f)(1)(i) requires 
                        <PRTPAGE P="99489"/>
                        that MA organizations offering SNPs conduct a comprehensive initial HRA of the individual's physical, psychosocial, and functional needs as well as annual HRA, using a comprehensive risk assessment tool that CMS may review during oversight activities, and ensure that the results from the initial assessment and annual reassessment conducted for each individual enrolled in the plan are addressed in the individuals' individualized care plan.
                    </P>
                    <P>
                        In addition, § 422.112(b)(4)(i) requires that MA organizations offering coordinated care plans make a “best effort” attempt to conduct an initial assessment of each enrollee's health care needs, including following up on unsuccessful attempts to contact an enrollee, within 90 days of the effective date of enrollment. In the CY 2024 Medicare Part C Reporting Requirements, as further defined by the Medicare Part C Technical Specifications Document Contract Year 2024,
                        <SU>313</SU>
                        <FTREF/>
                         CMS specifies that SNPs must provide CMS with the number of initial HRAs completed within 90 days of (before or after) the effective date of enrollment and annual HRAs performed within 365 days of the last HRA. As described in the Medicare Part C Technical Specification Document Contract Year 2024, SNPs may report an enrollee as unable to be reached if: the enrollee did not respond to at least three “non-automated” phone calls and a follow-up letter from the SNP where all the efforts were to solicit participation in the HRA, none of the efforts to solicit participation were automated calls (“robo” or “blast” calls), and documentation of the enrollee's refusal and/or the SNP's inability to reach the enrollee is available at any time to CMS. The technical specifications include additional details regarding how to interpret the CY 2024 Medicare Part C Reporting Requirements.
                    </P>
                    <FTNT>
                        <P>
                            <SU>313</SU>
                             
                            <E T="03">https://www.cms.gov/medicare/enrollment-renewal/health-plans/part-c.</E>
                        </P>
                    </FTNT>
                    <P>In addition, § 422.101(f)(1)(ii) requires SNPs to develop and implement a comprehensive ICP through an interdisciplinary team in consultation with the beneficiary, as feasible, identifying goals and objectives including measurable outcomes as well as specific services and benefits to be provided. There are no timeframe requirements for developing ICPs in § 422.101(f). Chapter 5 of the Medicare Managed Care Manual, section 20.2.2, MOC 2, Element C notes that SNPs must describe the process for developing the ICP, including specifying how often the ICP is modified as beneficiaries' health care needs change, in the SNPs' MOC, which are subject to review and approval by NCQA and subsequent CMS audits.</P>
                    <HD SOURCE="HD3">(2) Medicaid Context</HD>
                    <P>Many D-SNPs have affiliated Medicaid managed care plans that deliver Medicaid services to D-SNP enrollees through their parent organization or another entity that is owned and controlled by the D-SNP's parent organization. For Medicaid managed care, § 438.208(b)(3) requires that MCOs, PIHPs, or PAHPs make a best effort to conduct an initial screening of each enrollee's needs, within 90 days of the effective date of enrollment for all new enrollees, including subsequent attempts if the initial attempt to contact the enrollee is unsuccessful.</P>
                    <P>For individuals enrolled in certain Medicaid home and community-based services (HCBS) programs, we have adopted requirements for a person-centered care planning process. For section 1915(c) Medicaid HCBS waiver programs, these requirements are set forth at § 441.301(c)(1) through (3); for section 1915(k) Medicaid HCBS State plan amendments, these requirements are set forth at § 441.540; and for section 1915(i) Medicaid State plan HCBS benefits, these requirements are set forth at § 441.725. We refer readers to these regulations for more details.</P>
                    <P>Generally, these regulations require the State administering these Medicaid HCBS programs to ensure an individualized person-centered services plan, meeting certain minimum requirements, is developed for each individual beneficiary enrolled in a Medicaid HCBS program. This plan must reflect the services and supports that are important for the individual to meet their needs identified through an assessment of functional need, as well as what is important to the individual with regard to their preferences for the delivery of such services and supports (§§ 441.301(c)(2); 441.540(b); 441.725(b)). The process by which the person-centered service plan is developed must be led or driven by the individual. The individual's authorized representative should play a participatory role, as needed and as defined by the individual. If State law confers decision-making authority to the legal representative, the individual should still lead the person-centered service plan process to the extent possible. The plan must also meet other person-centered requirements, including: ensuring people chosen by the individual are included in the process; providing necessary information and support to ensure that the individual directs the process to the maximum extent possible; reflecting cultural considerations of the individual; and offering choices to the individual regarding the services and supports they receive and from whom (§§ 441.301(c)(1); 441.540(a); 441.725(a)). The resulting person-centered service plan must be tailored and individualized, and the approach must consider personal preferences and goals. Additionally, the State must ensure that the person-centered service plan for every individual is reviewed, and revised as appropriate, based upon reassessment of functional need at least every 12 months, when the individual's circumstances change significantly, or at the individual's request (§§ 441.301(c)(3)(i); 441.540(c); 441.725(c)).</P>
                    <HD SOURCE="HD3">(3) Medicare-Medicaid Plan (MMP) Context</HD>
                    <P>Like Medicaid managed care plans, MMPs are subject to more requirements than SNPs on person-centeredness and timeliness of HRAs and ICPs. The MMP care coordination requirements for HRAs and ICPs for the FAI are included in the three-way contracts between CMS, State Medicaid agencies, and MMPs. In several States, the three-way contracts apply requirements on the person-centeredness of ICPs beyond what is required for SNPs and specific requirements for the timing of HRAs and ICPs. Most States participating in the FAI (Illinois, Massachusetts, Michigan, Ohio, South Carolina, and Texas) require MMPs to develop HRAs and ICPs within 90 days or less of enrollment and include enrollees in the development of the ICPs.</P>
                    <HD SOURCE="HD3">d. Opportunities for Improvement</HD>
                    <P>
                        Over the years, we have identified opportunities to improve person-centeredness in care planning and the need to codify the timeline for development of HRAs and ICPs. For example, we have learned of instances in which SNPs did not complete initial or annual HRAs timely, or it took several months to develop an ICP for enrollees after an HRA. In addition, we have reviewed ICPs that were only loosely related to the needs and preferences of enrollees or did not contain measurable outcomes. We have identified some similarities in our review of MMP care plans, such as care plans that do not include goals that are meaningful to enrollees. Through this proposed rule, we are seeking to address these opportunities for improvement, better align requirements across Medicare and Medicaid, and build on 
                        <PRTPAGE P="99490"/>
                        our experiences in other programs and demonstrations.
                    </P>
                    <P>We propose amendments to § 422.101(f)(1) to codify timeliness standards, improve the organization of the various HRA and ICP requirements, and strengthen these requirements. First, in § 422.101(f)(1)(i), we propose to specify that SNPs conduct the comprehensive initial HRA within 90 days (before or after) of the effective date of enrollment for all new enrollees. This would better align with the Medicaid requirement at § 438.208(b)(3) and, for Medicare, conform to § 422.112(b)(4)(i) and the standard currently described for reporting HRA completion in the Part C Reporting Requirements. We also note that, as described in the Medicare Part C Technical Specifications, when a person enrolls, disenrolls, and re-enrolls into any SNP under the same contract number, the previous HRA is still considered valid and can continue to be used as long as it is not more than 365 days old. CMS will continue to provide guidance on these types of issues through the Medicare Part C Technical Specifications.</P>
                    <P>Second, we propose to move the requirement for a comprehensive annual HRA from § 422.101(f)(1)(i) to § 422.101(f)(1)(ii) based on the updates and to improve the flow of the rule.</P>
                    <P>Third, we propose to relocate the requirement for SNPs to use a comprehensive risk assessment tool that CMS may review during oversight activities that assesses the enrollee's physical, psychosocial, and functional needs and includes one or more questions from a list of screening instruments specified by CMS in subregulatory guidance on housing stability, food security, and access to transportation from § 422.101(f)(1)(i) to § 422.101(f)(1)(iii). This is a technical change to improve the organization of the rule.</P>
                    <P>Fourth, we propose a new § 422.101(f)(1)(iv)(A) through (C) to establish specific requirements for all SNPs related to outreach to enrollees regarding completion of the HRA. Consistent with the Medicare Part C Technical Specifications, we propose to require that the SNP must make at least three non-automated phone call attempts, unless an enrollee agrees or declines to participate in the HRA before three attempts are made. We propose to newly require that these attempts be made on different days at different times of day. Also consistent with the Medicare Part C Technical Specifications, we propose to require that, if the enrollee has not responded to these attempts, the SNP send a follow-up letter to conduct the initial or annual risk assessments. We also propose that, for any enrollees who are unable to be reached or decline to participate in the HRA, the SNP must document the attempts to contact the enrollee and, if applicable, the enrollee's choice not to participate.</P>
                    <P>Fifth, in § 422.101(f)(1)(v), as discussed earlier in this proposed rulemaking in section III.E.b. of this proposed rule, we propose to require D-SNPs that are AIPs conduct a comprehensive HRA that meets all requirements at paragraphs (f)(1)(i) through (iv) of this section as well as any applicable Medicaid requirements, including those at § 438.208, such that enrollees complete a single integrated assessment for Medicare and Medicaid.</P>
                    <P>Sixth, we propose to relocate the requirement to ensure that the results from the comprehensive initial and annual HRA conducted for each individual enrolled in the plan are addressed in the enrollee's ICP to § 422.101(f)(1)(vi).</P>
                    <P>Seventh, we propose to add a new § 422.101(f)(1)(vii) that would require that SNPs within 30 days of conducting a comprehensive initial HRA or 30 days after the effective date of enrollment, whichever is later, develop and implement a comprehensive ICP that—</P>
                    <P>• Is person-centered and based on the enrollee's preferences, including for delivery of services and benefits, and needs identified in the HRA;</P>
                    <P>• Is developed through an interdisciplinary care team with the active participation of the enrollee (or the enrollee's representative, as applicable), as feasible;</P>
                    <P>• Identifies person-centered goals and objectives (as prioritized by the enrollee), including measurable outcomes as well as specific services and benefits to be provided; and</P>
                    <P>• Is updated as warranted by changes in the health status or care transitions of enrollees.</P>
                    <P>While section 1859(f)(5)(A) of the Act uses the term individual throughout, we have used the term enrollee to make it clear that the proposed requirements are for individuals who are enrolled in the SNP, consistent with how we have generally used the term enrollee in other recent rulemaking.</P>
                    <P>
                        The Resources for Integrated Care (RIC) Tip Sheet on Using Person-Centered Language provides context for what we intend the proposed requirements for a person-centered ICP to mean and include.
                        <SU>314</SU>
                        <FTREF/>
                         It notes that person-centered language acknowledges the person first and foremost and places any diagnosis, condition, or disability in the context of the whole person and describes person-centered language as an essential component of a person-centered MOC (see The Medical Model versus Person-Centered Model callout box). As also described in the RIC tip sheet, the traditional medical model of health care focuses mainly on diagnosis and treatment of disease, and individuals receiving services under this model are typically expected to take a passive role. In a person-centered model, people are empowered to participate as active partners in discussions and decisions about their care. The person-centered model considers diagnosis, condition, and disability in the context of the whole person. This model focuses on supporting and communicating with people by emphasizing their strengths, capabilities, and opportunities to reach their chosen goals. We also note that an IT system-generated ICP that simply suggests understanding the importance of keeping appointments with providers or taking medications as prescribed is not what we intend to meet the proposed requirement. We believe that, for the ICP to be an effective tool in promoting health, the ICP should be tailored to the specific needs of the enrollee based on the enrollee's chosen goals.
                    </P>
                    <FTNT>
                        <P>
                            <SU>314</SU>
                             
                            <E T="03">https://www.resourcesforintegratedcare.com/wp-content/uploads/2020/04/Using_Person_Centered_Language_Tip_Sheet.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We intend for ICPs to engage and motivate enrollees by including goals that are meaningful to each enrollee. These may include goals that are not specific to a medical diagnosis, such as attending a child's graduation, pursuing higher education, or being able to attend religious services each week. The ICP should outline steps for managing conditions, such as diabetes or high blood pressure, that may have been identified in the HRA and impact the enrollee's ability to meet their goals. The steps should also take account of the enrollee's preferences for delivery of any needed services or benefits. For example, an enrollee may have a goal of attending a child's graduation, but weight and mobility limitations are current barriers identified in the HRA. The care plan would include specific steps to help the enrollee lose weight and improve mobility, which would support the enrollee's efforts to attend the graduation. This personalized approach allows enrollees to take control of their health and work toward achieving meaningful life goals and aspirations.</P>
                    <P>
                        As part of a person-centered care plan, we also remind SNPs that § 422.2267(a)(3) requires that ICPs be 
                        <PRTPAGE P="99491"/>
                        provided to enrollees on a standing basis in any non-English language identified in paragraphs (a)(2) and (a)(4) of § 422.2267 or accessible format upon receiving a request for any required materials (including the ICP) or otherwise learning of the enrollee's primary language or need for an accessible format. The HHS website Think Cultural Health 
                        <SU>315</SU>
                        <FTREF/>
                         has a suite of resources that SNPs can use to ensure their case managers/care coordinators are developing person-centered plans that consider the language access and disability access needs of enrollees. In particular, the Guide to Providing Effective Communication and Language Assistance Services 
                        <SU>316</SU>
                        <FTREF/>
                         may be useful to SNP front-line employees working with enrollees as well as D-SNP management. Another resource that SNPs may find helpful to ensure the development of culturally and linguistically appropriate care plans is the CMS OMH Guide to Developing a Language Access Plan.
                        <SU>317</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>315</SU>
                             
                            <E T="03">https://thinkculturalhealth.hhs.gov/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>316</SU>
                             
                            <E T="03">https://thinkculturalhealth.hhs.gov/education/communication-guide.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>317</SU>
                             
                            <E T="03">https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Language-Access-Plan.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Proposed § 422.101(f)(1)(vii)(D) would codify that SNPs must update ICPs as warranted when there are changes in an enrollee's health status or the enrollee has a care transition. While not a complete list, examples of the types of changes that would necessitate a review of the ICP could include hospitalization, being diagnosed with a new chronic condition such as diabetes, admission to a long-term care facility when such admission is likely to result in long-term institutionalization, or return home from a long-term care facility.</P>
                    <P>
                        Finally, we propose to add § 422.101(f)(1)(viii) to require that, for any enrollees who are unable to be reached or decline to participate in the development or updates to the comprehensive ICP, the SNP must document the attempts to contact the enrollee or the enrollee's refusal to participate. While our goal is for SNPs to develop person-centered ICPs, if a SNP is unable to reach an enrollee (after the SNP has fulfilled its obligations as previously described to contact the enrollee for the HRA) or an enrollee declines to participate, then at a minimum the SNP should base the ICP on enrollee encounter data or other available data. We strongly encourage SNPs to continue to try to reach the enrollee even after satisfying the proposed regulatory requirement. We note that RIC has developed a brief on Locating and Engaging Members: Key Considerations for Plans Serving Members Dually Eligible for Medicare and Medicaid, which SNPs may find helpful in bolstering their efforts to engage enrollees.
                        <SU>318</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>318</SU>
                             
                            <E T="03">https://www.resourcesforintegratedcare.com/wp-content/uploads/2022/11/Locating-and-Engaging-Members-Key-Considerations-for-Plans-Serving-Members-Dually-Eligible-for-Medicare-and-Medicaid-Brief.pdf?csrt=17807429552740464906.</E>
                        </P>
                    </FTNT>
                    <P>In addition, as a result of these updates, we propose to redesignate § 422.101(f)(1)(iii) as § 422.101(f)(1)(ix) and redesignate § 422.101(f)(1)(iv) as § 422.101(f)(1)(x) and change the term “individual's” to “enrollee's”.</P>
                    <P>
                        Collectively, our proposals would promote more timely and person-centered HRAs and ICPs for SNP enrollees. Our proposals at §§ 422.101(f)(1)(i) through (iv), 422.101(f)(1)(vi), and 422.101(f)(1)(viii) through (x) would codify elements of the CY 2024 Part C Reporting Requirements and Technical Specifications and restructure the current section for better flow. Our proposal at § 422.101(f)(1)(vii) would require that SNPs create and implement the ICP within 30 days of conducting an initial HRA or 30 days after the effective date of enrollment, whichever is later, although many SNPs already complete ICPs within such timeframes. We believe that the benefit gained by the ability for enrollees to quickly have an ICP in place which will assist with coordinating their care in a person-centered manner outweighs this burden. These enrollees often have limited financial resources and health care needs that are more wide-ranging and complex than the average Medicare enrollee.
                        <SU>319</SU>
                        <FTREF/>
                         We are considering whether to instead adopt alternative timelines for development and implementation of the ICP. We note that the three-way contracts for MMPs participating in several of the FAI States require that HRAs and ICPs be conducted within 90 days of enrollment. Alternatively, we are considering allowing additional time for the development of the ICP, such as within 60 or 90 days of completion of the HRA. We are also considering that the ICP not be required when the enrollee is unable to be reached or declines to participate. Some States participating in the FAI—including Illinois, Michigan, South Carolina, and Texas—do not require the ICP in these circumstances. We are considering whether text messaging could be useful for contacting enrollees to conduct HRAs in addition to phone calls and how follow-up to conduct the HRA would occur following the contact by text messages.
                    </P>
                    <FTNT>
                        <P>
                            <SU>319</SU>
                             
                            <E T="03">https://www.kff.org/medicare/issue-brief/10-things-to-know-about-medicare-advantage-dual-eligible-special-needs-plans-d-snps/.</E>
                        </P>
                    </FTNT>
                    <P>Finally, for § 422.101(f)(vii) where we use the term “person-centered,” we are considering whether to cross-reference the elements of the person-centered planning process at § 441.540(a) as written, a subset of those elements, or a different definition. Cross-referencing the person-centered planning process at § 441.540(a) would promote consistency in the language across Medicare and Medicaid, which is helpful for the purpose of integrated Medicare and Medicaid. However, we are not sure that all the components of the description at § 441.540(a) fully apply to SNP enrollees.</P>
                    <P>We solicit comments on these alternatives. We also seek feedback on potential challenges to our proposals and alternatives under consideration.</P>
                    <HD SOURCE="HD3">e. Assuring Enrollee Advisory Committee Input on MOC Updates</HD>
                    <P>In the May 2022 final rule, we codified the requirement at § 422.107(f) that D-SNPs establish or maintain one or more enrollee advisory committees (EACs) that serve the D-SNPs offered by the MA organization in a State. We believe that it is important for enrollees to have a voice in the development of the D-SNPs' MOC, which includes details regarding how a D-SNP conducts HRAs and ICPs. Enrollee feedback on the MOC should improve how D-SNPs and other SNPs engage enrollees in conducting HRA and ICPs, the quality of information obtained from these enrollees, and the usefulness of the HRAs and ICPs as tools in supporting enrollees' health care. Therefore, we propose adding language to D-SNP EAC requirements at § 422.107(f) to include updates to MOCs as described at § 422.101(f) among the minimum required EAC discussion topics. While MA organizations can already include MOCs among their D-SNP EAC topics, adding these topics to the D-SNP EAC conversations would ensure MA organizations solicit feedback directly from enrollees to improve the care coordination process including HRAs and ICPs as described in the MOC.</P>
                    <P>
                        We are not proposing to require that D-SNP EACs review or approve the MOC, 
                        <E T="03">per se,</E>
                         because they are often lengthy and technical documents. However, we believe the D-SNP EAC's perspectives should inform updates to the MOC over time. We do not anticipate additional burden from this proposal. We welcome comments on our proposal and underlying assumptions.
                        <PRTPAGE P="99492"/>
                    </P>
                    <HD SOURCE="HD3">f. Comment Solicitation—Making State Medicaid Agency Contracts Public</HD>
                    <P>Section 164 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275) amended section 1859(f) of the Act to require that a D-SNP contract with the State Medicaid agency in each State in which the D-SNP operates. We refer to such contracts as SMACs. As we have emphasized in rulemaking over the last several years, SMACs are important vehicles for integrating the delivery of Medicare and Medicaid services and improving experiences for dually eligible individuals. In many States, the provisions in the SMAC are of significant public policy interest, affecting the ways that many people experience the Medicare and Medicaid programs.</P>
                    <P>Some States, including Indiana, New Jersey, and Washington, have posted SMACs and any SMAC amendments—usually as a single model agreement, rather than the individual signed copies with each D-SNP—on their websites. We encourage all States to post the content of the SMACs online. However, we have never done so on a CMS website.</P>
                    <P>Posting SMACs would improve public transparency on the important requirements included in these agreements. This, in turn, would promote accountability in implementing the terms of the SMAC and make it easier for States, advocates, researchers, and others to identify promising practices or opportunities for improvement across States. However, while we review all SMACs for compliance with the requirements of § 422.107, CMS is not a signatory to the SMACs. And we have never systematically analyzed the extent to which SMACs may include confidential commercial or financial information that should not be shared publicly.</P>
                    <P>We solicit comments on whether and how CMS should post SMACs online.</P>
                    <HD SOURCE="HD2">B. Clarifying Highly Integrated Dual Eligible Special Needs Plan Definition Relative to Oregon's Coordinated Care Organization Structure (§ 422.2)</HD>
                    <P>
                        The definition of HIDE SNPs is codified at § 422.2. According to this definition, a HIDE SNP, in addition to meeting other requirements, is a D-SNP offered by an MA organization that provides coverage of Medicaid benefits under a capitated contract between the State Medicaid agency and the MA organization itself, the MA organization's parent organization, or another entity that is owned and controlled by its parent organization. CMS defined this term in the final rule titled “Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021” which appeared in the April 16, 2019, 
                        <E T="04">Federal Register</E>
                         (hereinafter referred to as the April 2019 final rule) (84 FR 15705), and further refined it in the final rule titled “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” which appeared in the May 9, 2022, 
                        <E T="04">Federal Register</E>
                         (hereinafter referred to as the May 2022 final rule) (87 FR 27755).
                    </P>
                    <P>The May 2022 final rule revised the HIDE SNP definition to outline more clearly the services HIDE SNPs must cover in their contracts with State Medicaid agencies to include LTSS or behavioral health services to the extent Medicaid coverage of those benefits is available to individuals eligible to enroll in a HIDE SNP, and required the capitated contract with the State Medicaid agency to cover the entire service area of the D-SNP beginning in 2025. The revisions facilitate HIDE SNP enrollees having access to both Medicare and Medicaid benefits from a single parent organization.</P>
                    <P>
                        However, the definition of HIDE SNP at § 422.2 does not explicitly account for certain ownership arrangements of Medicaid managed care organizations that operate Medicaid health plans affiliated with D-SNPs that we believe should meet the definition of and be treated as a HIDE SNP. In Oregon, the State Medicaid managed care program utilizes community-governed organizations called coordinated care organizations (CCOs) to provide comprehensive Medicaid benefits, including physical, behavioral, and dental services.
                        <SU>320</SU>
                        <FTREF/>
                         These nonprofit community-governed organizations are locally based (rather than national organizations), and may be single corporate structures or networks of providers with contractual relationships, per Oregon law.
                        <SU>321</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>320</SU>
                             
                            <E T="03">https://www.oregon.gov/oha/HPA/Pages/CCOs-Oregon.aspx.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>321</SU>
                             
                            <E T="03">https://oregon.public.law/statutes/ors_414.572.</E>
                        </P>
                    </FTNT>
                    <P>In the Portland metro area that includes Clackamas, Multnomah, and Washington counties, one of the CCOs delivering Medicaid benefits to eligible residents is Health Share, a nonprofit public benefit corporation with 11 founding members that include providers, health systems, and county governments. A subset of these founding members includes organizations with which Health Share contracts to provide covered Medicaid physical, behavioral, and dental health services to beneficiaries assigned to them on a fully capitated basis through agreements called Integrated Delivery System (IDS) Participation Contracts. These founding members with IDS Participation Contracts administer Medicaid benefits on Health Share's behalf and assume full risk for their assigned beneficiaries' services.</P>
                    <P>
                        Three of these Health Share founding members are organizations that also operate a D-SNP with a service area that includes the three-county Portland metro area. Dually eligible individuals in that three-county service area who are enrolled in one of these D-SNPs can therefore receive their Medicaid benefits from the same organization from which they receive their Medicare benefits, through the organization's IDS Participation Contract with Health Share to provide Medicaid benefits. Oregon estimates that between 80 and 91 percent of the Health Share enrollees who receive Medicare benefits through a D-SNP are assigned to the same organization for their Medicaid benefits, depending on which of the three organizations in which they are enrolled. We believe this arrangement is functionally similar to and should be treated as meeting the HIDE SNP definition because dually eligible individuals are receiving their Medicare and Medicaid benefits from the same organization or the parent organization of the entities that operate the D-SNP and the Medicaid managed care plan. While that organization does not 
                        <E T="03">directly</E>
                         hold a contract with the State Medicaid agency for Medicaid managed care services, it is responsible for the full obligations of the CCO contract with the State Medicaid agency through its IDS Participation Contract with Health Share. Furthermore, the current HIDE SNP definition requires the capitated contract to be between the State Medicaid agency and either the MA organization itself, the MA organization's parent organization, or another entity that is owned and controlled by its parent organization. While the founding members of Health Share do not meet the CMS definition 
                        <PRTPAGE P="99493"/>
                        of a parent organization,
                        <SU>322</SU>
                        <FTREF/>
                         founding members appoint representatives to Health Share's board of directors, vote on key leadership decisions, serve on standing committees of the board (including committees that oversee Health Share's contractual obligations), and financially support Health Share. We believe this is functionally an entity that is owned and controlled by the MA organization's parent organization as included in paragraph (1)(ii) of the HIDE SNP definition. For these reasons, we categorized these D-SNPs in the three-county Portland area as HIDE SNPs for CY 2025 as part of our review of Oregon's SMAC agreements with D-SNPs operating in the State. Nonetheless, given the foregoing ambiguity about the applicability of the existing HIDE SNP definition, we are proposing to modify the HIDE definition at § 422.2 to make clear that it applies to this type of arrangement, whether in Oregon or elsewhere.
                    </P>
                    <FTNT>
                        <P>
                            <SU>322</SU>
                             CMS considers a parent organization to be the legal entity that owns a controlling interest in a contracting organization.
                        </P>
                    </FTNT>
                    <P>Under our authority at section 1859(f)(8)(D) of the Act to require that all D-SNPs meet certain minimum criteria for Medicare and Medicaid integration, and under section 1856(b) to establish requirements by regulation, we are proposing to amend the definition of a HIDE SNP at § 422.2 to make minor edits to paragraph (1) and add a new paragraph (1)(iii) to the definition to explicitly describe a scenario in which there is a capitated contract between the State Medicaid agency and a local nonprofit public benefit corporation of which the MA organization is a founding member. The proposed change would clarify that D-SNPs with this ownership arrangement meet the HIDE SNP definition. (We are not proposing any changes to paragraphs (2) or (3) of the HIDE SNP definition.)</P>
                    <P>In developing this proposal, we considered other scenarios that have arisen related to the HIDE SNP definition. For example, in the April 2019 final rule (84 FR 15705) we discussed a scenario in which an entity with a managed care contract with the State Medicaid agency subsequently subcontracts certain aspects of the managed care contract to another entity under § 438.230. We noted that in such situations where that subcontractor also is a D-SNP, we recognized that there may be a level of integration for enrollees that is greater than that of a D-SNP that has no contract—directly or indirectly—with a State to provide LTSS, behavioral health services, or both. However, we stated we do not believe that the subcontractor in that situation should be treated as a HIDE SNP.</P>
                    <P>We believe that the situation we addressed in the April 2019 final rule is fundamentally different from the arrangement in Oregon, in which the founding members with IDS Participation Contracts with Health Share have an ownership and leadership role within Health Share, as noted previously, participating financially and in key decision-making. In other more common delegation scenarios, like the one described in the April 2019 final rule, the delegated organization does not have such a role in the organization that is delegating its responsibilities. We believe this is an essential difference that sets these two situations apart. With our proposal, we do not aim to allow scenarios where the delegated organization does not have a meaningful ownership role in the delegating organization to meet the HIDE SNP definition. We therefore include the term “local nonprofit benefit corporation” in our proposal to be specific to the structure of CCOs and to clarify that such an arrangement does not include certain delegation situations in which an MCO—including a for-profit MCO—capitates an unrelated organization with no ownership stake in the MCO to administer Medicaid benefits on the MCO's behalf, as is currently common in California. We also include the term “founding member” because we have experience with this ownership arrangement in Oregon. In contrast, we have not fully analyzed how the arrangement may differ if an organization newly became a member through acquisition or otherwise. We chose to include this language to keep this narrowly applicable to a scenario we understand and limit any possible gaming until we have more experience. However, we welcome comments on our proposed use of the term “founding member.”</P>
                    <P>We welcome comment on our proposed clarifications to the HIDE SNP definition. We also welcome comment on whether the language we propose here is sufficiently narrow such that it does not unintentionally encompass additional delegation situations that are contrary to our goals of increasing the level of integration between D-SNPs and affiliated Medicaid managed care plans and facilitating D-SNP enrollees having access to Medicare and Medicaid benefits provided by the same parent organization. Additionally, we welcome comment on whether there are existing scenarios like Health Share we may want to consider as we revise the HIDE SNP definition.</P>
                    <P>We do not believe that this provision would add any additional burden to the three D-SNPs in Oregon with affiliated Medicaid CCOs, which we have already classified as HIDE SNPs in recent years. We do not believe that any additional work from the three D-SNPs would amount to burden above and beyond what is routine, and as such, this work has already been accounted for in other burden estimates under OMB control number 0938-1410 (CMS-10796).</P>
                    <HD SOURCE="HD2">C. Technical Changes</HD>
                    <HD SOURCE="HD3">1. Technical Change to the Specific Rights to Which a PACE Participant Is Entitled (§ 460.112)</HD>
                    <P>In the Medicare Program: Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Program for Contract Year 2024—Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE) (hereinafter referred to as the April 2024 final rule), we finalized changes to the regulations impacting the specific rights to which a participant is entitled (89 FR 30756). Specifically, we added a new paragraph (a) which was entitled “right to treatment,” and redesignated existing paragraphs § 460.112 (a) through (c) as (b) through (d). In the new paragraph (a), we finalized that each participant has the right to appropriate and timely treatment for their health conditions.</P>
                    <P>
                        On May 6, 2024, we issued the Nondiscrimination in Health Programs and Activities final rule (hereinafter referred to as the Nondiscrimination 2024 final rule), with the intention of adding language to the respect and nondiscrimination paragraph regarding sexual orientation and gender identity. Because the respect and nondiscrimination paragraph had only been redesignated a few weeks prior to the issuance of the Nondiscrimination 2024 final rule, the updated language was added in error to paragraph (a) instead of the redesignated paragraph (b); thereby replacing the right to treatment language provision added to paragraph (a) through the April 2024 final rule. As a result of this error, the current regulation text has two identically titled subsections (§§ 460.112(a) and 460.112(b)). To avoid any further confusion and for the reasons explained in the April 2024 final rule at 89 FR 30756, we propose to make a technical change to reinstate 
                        <PRTPAGE P="99494"/>
                        the language that each participant has the right to appropriate and timely treatment for their health conditions in § 460.112(b) instead of in § 460.112(a).
                    </P>
                    <P>We also finalized two paragraphs under § 460.112(a) in the April 2024 final rule. Paragraph (a)(1) related to the right to receive all care and services needed to improve or maintain the participant's health condition and attain the highest practicable physical, emotional, and social well-being. Paragraph (a)(2) related to the participants' rights to access emergency health care services when and where the need arises without prior authorization by the PACE interdisciplinary team. Since the two paragraphs under § 460.112(a), (a)(1) and (a)(2), more appropriately align with the requirement in the “right to treatment” paragraph, we propose to redesignate § 460.112(a)(1) and (a)(2) as § 460.112(b)(1) and (b)(2). The subparagraphs under § 460.112(b) more appropriately align with the “respect and nondiscrimination” paragraph. Therefore, we propose to redesignate the paragraphs under § 460.112(b)(1) through (b)(8) as § 460.112(a)(1) through (a)(8).</P>
                    <P>
                        Finally, we note that two courts, in 
                        <E T="03">Tennessee</E>
                         v. 
                        <E T="03">Becerra,</E>
                         No. 1:24-cv-161-LG-BWR (S.D. Miss.), and 
                        <E T="03">Texas</E>
                         v. 
                        <E T="03">Becerra,</E>
                         6:24-cv-211-JDK (E.D. Tex.), have issued orders that, in relevant part, stay nationwide the effective date of, respectively, § 460.112 to the extent it “extend[s] discrimination on the basis of sex to include discrimination on the basis of gender identity” and § 460.112(a). Nothing in this technical change is intended to affect the scope of those stay orders or CMS's compliance with those orders as long as they remain in effect.
                        <SU>323</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>323</SU>
                             For updated information about court orders impacting the Nondiscrimination in Health Programs and Activities 2024 Final Rule, please see 
                            <E T="03">hhs.gov/1557.</E>
                        </P>
                    </FTNT>
                    <P>This provision is technical and is therefore not expected to have economic impact beyond current operating expenses.</P>
                    <HD SOURCE="HD3">2. Technical Change to PACE Contracted Services (§ 460.70(e)(2))</HD>
                    <P>In the April 2024 final rule, we finalized changes to the PACE service delivery requirements at § 460.98. Specifically, we removed paragraph (b)(4), added a new paragraph at § 460.98(c), and redesignated paragraphs (b)(5) and (c) through (e) as paragraphs (b)(4) and (d) through (f), respectively (89 FR 30845). As part of these changes, the paragraph titled “Minimum services furnished at each PACE center” was redesignated from § 460.98(c) to § 460.98(d). However, the April 2024 final rule did not include a correction to the cross-reference at § 460.70(e)(2) to reflect the redesignation of “Minimum services furnished at each PACE center” requirements from § 460.98(c) to § 460.98(d).</P>
                    <P>Therefore, we are proposing a technical change at § 460.70(e)(2) to update the cross-reference from § 460.98(c) to § 460.98(d), which would affirm the connection between § 460.70(e)(2) and the “Minimum services furnished at each PACE center” requirements at the redesignated § 460.98(d).</P>
                    <P>The proposed technical change would not impose any new requirements or burden on PACE organizations. Additionally, we expect no cost impact to the Medicare Trust Fund.</P>
                    <P>We solicit comment on the proposed technical change.</P>
                    <HD SOURCE="HD3">3. Technical Change to Notice of Availability of Language Assistance Services and Auxiliary Aids and Services (§ 423.2267(e)(33))</HD>
                    <P>In the April 2024 final rule, we finalized changes at § 422.2267(e)(31) and (e)(33) to—(1) update multi-language insert (MLI) references to notice of availability of language assistance services and auxiliary aids and services (Notice of Availability); (2) allow plans to utilize the updated MLI during contract year 2025; and (3) require the Notice of Availability be provided in English and at least the 15 languages most commonly spoken by individuals with limited English proficiency of the relevant State or States associated with the plan's service area and be provided in alternate formats for individuals with disabilities who require auxiliary aids and services to ensure effective communication.</P>
                    <P>When amending the regulation at § 423.2267(e)(33)(i), we neglected to denote that the MLI is a notice for Part D sponsors. Similarly, when we amended the regulation at § 423.2267(e)(33)(ii), we neglected to note the Notice of Availability is a notice for Part D sponsors.</P>
                    <P>Therefore, we are proposing technical changes in § 423.2267(e)(33)(i) and (ii) to denote the MLI and notice of availability are notices for Part D sponsors.</P>
                    <P>The proposed technical changes would not impose any new requirements or burden on Part D sponsors.</P>
                    <HD SOURCE="HD1">VI. Collection of Information Requirements</HD>
                    <P>
                        Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 
                        <E T="03">et seq.</E>
                        ), we are required to provide 60-day notice in the 
                        <E T="04">Federal Register</E>
                         and solicit public comment before a “collection of information,” as defined under 5 CFR 1320.3(c) of the PRA's implementing regulations, is submitted to the Office of Management and Budget (OMB) for review and approval. To fairly evaluate whether an information collection requirement should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues:
                    </P>
                    <P>• The need for the information collection and its usefulness in carrying out the proper functions of our agency.</P>
                    <P>• The accuracy of our estimate of the information collection burden.</P>
                    <P>• The quality, utility, and clarity of the information to be collected.</P>
                    <P>• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.</P>
                    <P>We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements. Comments, if received, will be responded to within the subsequent final rule (CMS-4208-F, RIN 0938-AV40).</P>
                    <HD SOURCE="HD2">A. Wage Data</HD>
                    <HD SOURCE="HD3">1. Private Sector</HD>
                    <P>
                        To derive average (mean) costs, we are using data from the most current U.S. Bureau of Labor Statistics' (BLS's) National Occupational Employment and Wage Estimates for all salary estimates (
                        <E T="03">https://www.bls.gov/oes/2023/may/oes_nat.htm</E>
                        ), which, at the time of publication of this proposed rule, provides May 2023 wages. In this regard, table 16 presents BLS's mean hourly wage, our estimated cost of fringe benefits and other indirect costs (calculated at 100 percent of salary), and our adjusted hourly wage.
                    </P>
                    <GPH SPAN="3" DEEP="240">
                        <PRTPAGE P="99495"/>
                        <GID>EP10DE24.022</GID>
                    </GPH>
                    <P>Adjusting our employee hourly wage estimates by a factor of 100 percent is a rough adjustment that is being used since fringe benefits and other indirect costs vary significantly from employer to employer and because methods of estimating these costs vary widely from study to study. In this regard, we believe that doubling the hourly wage to estimate costs is a reasonably accurate estimation method.</P>
                    <HD SOURCE="HD3">2. Beneficiaries</HD>
                    <P>We believe that the cost for beneficiaries undertaking administrative and other tasks on their own time is a post-tax wage of $20.71/hr. The Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices identifies the approach for valuing time when individuals undertake activities on their own time. To derive the costs for beneficiaries, a measurement of the usual weekly earnings of wage and salary workers of $998, divided by 40 hours to calculate an hourly pre-tax wage rate of $24.95/hr. This rate is adjusted downwards by an estimate of the effective tax rate for median income households of about 17 percent, resulting in the post-tax hourly wage rate of $20.71/hr. Unlike our private sector wage adjustments, we are not adjusting beneficiary wages for fringe benefits and other indirect costs since the individuals' activities, if any, would occur outside the scope of their employment.</P>
                    <P>For valuing time spent outside of work, there is logic to this approach but also to using a fully loaded wage. In the past we have used occupational code 00-0000, the average of all occupational codes, which currently is $29.76/hr. Thus, we propose a range for enrollees of $20.71/hr to $29.76/hr. Nevertheless, the upper limit is based on an average over all occupations while the lower limit reflects a detailed analysis by ASPE targeted at enrollees many of whom are over 65 and unemployed; consequently, in our primary estimates we will use the lower limit as we consider it more accurate. The effect of this range will be footnoted in table J5 and the summary table (table F11). Since the impact to beneficiaries is approximately $54,000, increasing the wage by 50 percent would result in a roughly $24,000 increase.</P>
                    <HD SOURCE="HD2">B. Proposed Information Collection Requirements (ICRs)</HD>
                    <P>The following ICRs are listed in the order of appearance within the preamble of this proposed rule.</P>
                    <HD SOURCE="HD3">1. ICRs Regarding Medicare Prescription Payment Plan Calculation of the Maximum Monthly Cap on Cost-Sharing Payments (§ 423.137(c))</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1475 (CMS-10882).</P>
                    <P>This rule proposes to implement the requirements in section 1860D-2(b)(2)(E)(iv) of the Act related to the calculation of the monthly caps on OOP cost sharing payments. The burden related to these new requirements for Part D sponsors reflects the time and effort needed to correctly calculate the monthly caps based on the statutory formulas, determine the amount to be billed, and send monthly bills to program participants.</P>
                    <P>We estimate a one-time burden for Part D sponsors to update their payment systems to process data from their PBMs and contracted pharmacies, calculate monthly caps, and determine the amount to be billed. The average number of Part D contracts per year is 807 (based on 2021, 2022, and 2023 data). This average number of Part D contracts per year excludes contracts with Program of All-Inclusive Care for the Elderly (PACE) organizations and D-SNPs and Medicare-Medicaid Plans (MMP) that exclusively charge $0 cost sharing, which we do not expect to offer enrollees the option to pay their OOP costs through monthly payments over the course of the plan year or otherwise comply with the Medicare Prescription Payment Plan requirements set forth in this proposed rule and in the proposed new regulation at § 423.137. On average, we expect each Part D contract to have a team that consists of one software developer at $132.80/hr, one web developer at $91.90/hr, and one business operations specialist at $85.70/hr who will each spend 125 hours to implement these system changes. This team will also include a software quality assurance analyst and tester who will spend 10 hours at $104.30/hr performing assurance and testing. Thus, a total of 385 hours is spent per contract with a weighted average wage of $103.49/hr (see table 17).</P>
                    <GPH SPAN="3" DEEP="125">
                        <PRTPAGE P="99496"/>
                        <GID>EP10DE24.023</GID>
                    </GPH>
                    <P>In aggregate, we estimate a one-time burden of 310,695 hours (385 hr/contract * 807 Part D contracts) at a cost of $32,153,826 (310,695 hr * $103.49/hr).</P>
                    <P>After an enrollee elects to participate in the Medicare Prescription Payment Plan, the Part D sponsor will pay the pharmacy for any amounts that would have been due as OOP costs, calculate the enrollee's monthly payment based on the statutory formula and any prior prescription drug expenditures, and send a separate bill to the enrollee for those amounts every month.</P>
                    <P>
                        The burden associated with sending monthly bills to program participants is a function of the number of enrollees likely to enroll in the program. CMS conducted internal analyses of CY 2021 Prescription Drug Event (PDE) data to identify the number of enrollees likely to be identified as likely to benefit from the program and estimates that between 435,000 and 3,200,000 individuals will elect to participate in the Medicare Prescription Payment Plan. Because of the prior to plan year and during the plan year targeted outreach required for individuals identified as likely to benefit, we assume that the majority of enrollees who participate will pick up a high-cost prescription early in the year, for which they will be billed over all 12 months of the plan year. Assuming 3,200,000 enrollees participate, and they all incur drug costs in January for which they are billed over the course of 12 months, the projected number of bills sent per year is 38,400,000 (3,200,000 * 12). Billing statements may be provided via mail or electronically; consistent with existing estimates for other required Part D materials, we estimate that approximately one-third or 12,800,000 (
                        <FR>1/3</FR>
                         * 38,400,000) will be sent electronically since we estimate that one third of enrollees will opt to receive billing statements electronically while the remaining two-thirds or 25,600,000 (
                        <FR>2/3</FR>
                         * 38,400,000) will receive hard copy billing statements.
                    </P>
                    <P>We assume the following costs include paper, toner, and postage (envelope weight is normally considered negligible when citing these rates and is not included), and envelope (supplies) for hard-copy mailings:</P>
                    <P>
                        • 
                        <E T="03">Paper:</E>
                         $3.50 for a ream of 500 sheets. The cost for one page is $0.007 ($3.50/500 sheets).
                    </P>
                    <P>
                        • 
                        <E T="03">Toner:</E>
                         $70 for 10,000 pages. The toner cost per page is $0.007 ($70/10,000 pages).
                    </P>
                    <P>
                        • 
                        <E T="03">Postage:</E>
                         The cost of first-class metered mail is $0.73 per letter up to 1 ounce. We estimate that a sheet of paper weighs 0.16 ounces, and do not anticipate additional postage for mailings in excess of 1 ounce.
                    </P>
                    <P>
                        • 
                        <E T="03">Envelope:</E>
                         Bulk envelope costs are $440 for 10,000 envelopes or $0.044 per envelope.
                    </P>
                    <P>We estimate the aggregate cost per mailed billing statement is $0.802 ([$0.007 for paper * 2 pages] + [$0.007 for toner * 2 pages] + $0.73 for postage + $0.044 per envelope). We assume a maximum of 4 single sided pages will be needed for a billing statement, based on the required content for billing statements. Billing statements are assumed to be printed double-sided to save on printing costs, yielding 2 pages of double-sided print, generally weighing less than 1 ounce. Because preparing and generating a hard-copy billing statement is automated once the systems have been developed, we do not estimate any labor costs. Therefore, we estimate a total annual mailing cost by sponsors to enrollees of $20,531,200 (25,600,000 mailings * $0.802/mailing).</P>
                    <P>Part D sponsors will also need to process payments received from Medicare Prescription Payment Plan participants. This may require the development of new systems since Part D premium payment often occurs through automatic deduction from Social Security. On average, we expect that for each Part D contract a two-person team consisting of one web developer at $91.90/hr and one business operations specialist at $85.70/hr will each spend 50 hours to these system changes. To make the necessary systems changes, we estimate a total one-time burden of 80,700 hours (807 Part D contracts * 100 hr/contract) at a cost of $7,166,160 (807 contracts × [($91.90/hr × 50 hr) + ($85.70/hr × 50 hr)]).</P>
                    <P>We also estimate annual burden associated with maintenance of associated systems. On average, we expect that for each Part D contract, a two-person team consisting of one database administrator at $100.78/hr and one computer systems analyst at $106.54/hr will each spend 50 hours per year performing system maintenance. In aggregate, we estimate an annual burden of 80,700 hours (807 Part D contracts * 100 hr/contract) at a cost of $8,365,362 (807 contracts × [($100.78/hr × 50 hr) + ($106.54/hr × 50 hr)]).</P>
                    <P>Therefore, the total burden for all Part D contracts associated with the aforementioned provisions is 472,095 hours at a first-year cost of $68,216,548 and an annual subsequent year cost of $28,896,562 (see table 18).</P>
                    <GPH SPAN="3" DEEP="137">
                        <PRTPAGE P="99497"/>
                        <GID>EP10DE24.024</GID>
                    </GPH>
                    <HD SOURCE="HD3">2. ICRs Regarding Medicare Prescription Payment Plan Eligibility and Election Requirements (§ 423.137(d))</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1475 (CMS-10882).</P>
                    <P>This rule's proposed amendments to § 423.137(d) would require that Part D sponsors offer the Medicare Prescription Payment Program to all Part D enrollees. It also proposes requirements for how Part D sponsors must process program election requests, including timing and notice requirements and procedures for collecting missing information on election requests.</P>
                    <P>The proposed amendments to § 423.137(d) require Part D sponsors to have a process to effectuate retroactive election into the Medicare Prescription Payment Plan when an enrollee believes that a delay in filling a prescription would seriously jeopardize their life, health, or ability to regain maximum function and has paid the associated cost sharing before their participation was effective. Sponsors are also required to develop standardized procedures for determining and processing reimbursements for excess program payments made by participants who become LIS eligible. Finally, we propose to require Part D sponsors to send a notice alerting the Part D enrollee that their participation in the Medicare Prescription Payment Plan will continue into the next year unless they indicate that they choose to opt out. In developing these requirements, we referred to existing requirements and procedures for Part D plan enrollment, to minimize the updates and new systems necessary to implement and administer the Medicare Prescription Payment Plan.</P>
                    <P>We estimate a one-time burden for Part D sponsors to set up systems to process election requests and develop procedures to effectuate retroactive election into the program and process reimbursements for participants who become LIS eligible. We expect that for each Part D contract, a four-member team will be used consisting of one software developer at $132.80/hr, one web developer at $91.90/hr, and one business operations specialist at $85.70/hr will each work 40 hours while a software quality assurance analyst and tester will spend 10 hours at $104.30/hr to implement these system changes.</P>
                    <P>The total time spent per contract is 130 hours at a weighted average wage of $103.54/hr (see table 19).</P>
                    <GPH SPAN="3" DEEP="117">
                        <GID>EP10DE24.025</GID>
                    </GPH>
                    <P>In aggregate, we estimate a one-time burden of 104,910 hours (130 hr/plan * 807 Part D contracts) at a cost $10,862,381 (104,910 hr * $103.54/hr).</P>
                    <P>We estimate a one-time burden for Part D sponsors to develop a standard notice of request for additional information to provide to any enrollees who provide an incomplete election request form. On average, we expect that for each Part D contract, a team of one medical and health services manager who will spend 2 hours at $129.28/hr and one business operations specialist who will spend 10 hours at $85.70/hr will be needed to implement this proposal. In aggregate, we estimate a one-time burden of 9,684 hr (12 hr/contract * 807 Part D contracts) at a cost of $900,257 (807 contracts × [($129.28/hr × 2 hr) + ($85.70/hr × 10 hr)]).</P>
                    <P>
                        We also estimate annual burden for Part D sponsors providing these requests for additional information to Part D enrollees. We estimate that 3,200,000 individuals will elect to participate in the Medicare Prescription Payment Plan, representing 3,200,000 election request forms. We estimate that approximately 10 percent of election request forms will be incomplete, requiring 320,000 requests for additional information. We assume that one-third or 106,667 (320,000 * 
                        <FR>1/3</FR>
                        ) enrollees will receive this request electronically or via telephone; and the remaining two-thirds of enrollees or 213,333 (320,000 * 
                        <FR>2/3</FR>
                        ) will receive hard copy notices.
                    </P>
                    <P>
                        We estimate the aggregate cost per mailed request for additional information to be $0.802 ([$0.007 for paper * 2 pages] + [$0.007 for toner * 2 pages] + $0.73 for postage + $0.044/envelope). We assume a maximum of 2 
                        <PRTPAGE P="99498"/>
                        pages will be needed for this notice. Notices are assumed to be printed double-sided to save on paper costs, yielding 2 pages of double-sided print, generally weighing less than 1 ounce. Because preparing and generating hard copy notices is automated once the systems have been developed, we do not estimate associated labor costs. Therefore, we estimate total annual mailing costs to sponsors of $171,093 (213,333 hard copy notices * $0.802/notice).
                    </P>
                    <P>To estimate the information collection burden for beneficiaries, we estimate that it would take approximately 15 minutes (0.25 hr) to complete the requests for additional information. We estimate the cost for beneficiaries undertaking administrative and other tasks on their own time is a post-tax wage of $20.71/hr. We estimate a total one-time burden of 80,000 hours (320,000 enrollees * 0.25 hr) at a cost of $1,656,800 ($20.71/hr * 80,000 hr) across 320,000 enrollees.</P>
                    <P>Finally, we estimate a one-time burden for Part D sponsors to develop a standard auto-renewal notice alerting the Part D enrollee that their participation in the Medicare Prescription Payment Plan will continue into the next year unless they indicate that they choose to optout. On average, we expect that for each Part D contract, a team of one medical and health services manager who will spend 2 hours at $129.28/hr and one business operations specialist who will spend 10 hours at $85.70/hr will be needed to implement this proposal. In aggregate, we estimate a one-time burden of 9,684 hours (12 hr/contract * 807 Part D contracts) at a cost of $900,257 (807 contracts × [($129.28/hr × 2 hr) + ($85.70/hr × 10 hr)]).</P>
                    <P>To estimate the information collection burden for beneficiaries, we estimate that approximately 160,000 enrollees will voluntarily terminate their participation in the program in CY2026. We estimate that 99,200 will opt out of the program electronically, and the remaining 60,800 will opt out via telephone. We estimate that it would take approximately 5 minutes (0.083 hr) to voluntarily terminate participation in the Medicare Prescription Payment Program. We estimate the cost for beneficiaries undertaking administrative and other tasks on their own time is a post-tax wage of $20.71/hr. We estimate a total one-time burden of 13,280 hours (160,000 enrollees * 0.083 hr) at a cost of $275,029 ($20.71/hr * 13,280 hr).</P>
                    <P>
                        We estimate annual burden for Part D sponsors to provide these auto-renewal notices to all enrollees participating in the Medicare Prescription Payment Plan at the end of the plan year. Assuming 3,200,000 individuals participating in the Medicare Prescription Payment Plan, we estimate a total of 3,200,000 auto-renewal notices sent each year. We assume that one-third or 1,065,600 enrollees (3,200,000 * 
                        <FR>1/3</FR>
                        ) will receive this notice electronically and the remaining two-thirds or 2,133,333 enrollees (3,200,000 * 
                        <FR>2/3</FR>
                        ) will receive hard copy notices.
                    </P>
                    <P>We estimate the aggregate cost per mailed request for additional information to be $0.802 ([$0.007 for paper * 2 pages] + [$0.007 for toner * 2 pages] + $0.73 for postage + $0.044/envelope). We assume a maximum of 2 pages will be needed for this notice. Notices are assumed to be printed double-sided to save on paper costs, yielding 2 pages of double-sided print, generally weighing less than 1 ounce. Because preparing and generating hard copy notices is automated once the systems have been developed, we do not estimate associated labor costs. Therefore, we estimate total annual mailing costs to sponsors of $1,710,933 (2,133,333 hard copy notices * $0.802/notice).</P>
                    <P>The total burden for all Part D contracts associated with the aforementioned requirements is 124,278 hours with one-time first year cost of $14,544,921 and subsequent year costs of $1,882,026 (see table 20). The total burden for Part D beneficiaries with the aforementioned requirements is 93,280 hours with an on-going annual cost of $1,931,829 (see table 20).</P>
                    <GPH SPAN="3" DEEP="274">
                        <GID>EP10DE24.026</GID>
                    </GPH>
                    <PRTPAGE P="99499"/>
                    <HD SOURCE="HD3">3. ICRs Regarding Medicare Prescription Payment Plan Part D Enrollee Targeted Outreach (§ 423.137(e))</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1475 (CMS-10882).</P>
                    <P>This rule proposes to require Part D sponsors to undertake targeted outreach to enrollees who are likely to benefit from making an election into the Medicare Prescription Payment Plan, including notifying a pharmacy when a Part D enrollee incurs OOP costs with respect to covered Part D drugs that make it likely the enrollee may benefit from participating in the program, and directly outreaching to enrollees likely to benefit prior to the plan year and on an ongoing basis during the plan year.</P>
                    <P>We estimate one-time burden for Part D sponsors to develop systems to identify “likely to benefit” enrollees prior to the plan year and during the plan year. On average, we expect that for each Part D contract, a three-person team consisting of one business operations specialist at $85.70/hr, one web developer at $91.90/hr, and one software developer at $132.80/hr who will each spend 20 hours to develop and program these systems. In aggregate, we estimate a one-time burden of 48,420 hours (807 Part D contracts * 60 hr/contract) at a cost of $5,009,856 (807 contracts x [($85.70/hr × 20 hr) + ($91.90/hr × 20 hr) + ($132.80/hr × 20 hr)]).</P>
                    <P>We estimate annual burden for Part D sponsors to review annual updates to the “likely to benefit” identification criteria and update their systems accordingly. On average, we expect that for each Part D contract, one business operations specialist will spend 2 hours at $85.70/hr (see table 16) to review annual updates and make corresponding systems changes. In aggregate, we estimate an annual burden of 1,614 hours (807 Part D contracts * 2 hr/contract) at a cost of $138,320 (1,614 hr * $85.70/hr).</P>
                    <P>The total burden for all Part D contracts associated with the aforementioned requirements is 50,034 hours with a first-year cost of $5,148,176 and a subsequent year cost of $138,320 (see table 21).</P>
                    <GPH SPAN="3" DEEP="103">
                        <GID>EP10DE24.027</GID>
                    </GPH>
                    <HD SOURCE="HD3">4. ICRs Regarding Medicare Prescription Payment Plan Termination of Election, Reinstatement, and Preclusion (§ 423.137(f))</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1475 (CMS-10882).</P>
                    <P>This rule proposes to require Part D sponsors to have a process to allow a participant who has opted into the Medicare Prescription Payment Plan to opt out during the plan year. Part D sponsors are also required to terminate an individual's Medicare Prescription Payment Plan participation if that individual fails to pay their monthly billed amount.</P>
                    <P>We estimate a one-time burden for Part D sponsors to develop an opt-out process for enrollees who have elected into the program. On average, we expect that each Part D contract will build a 3-person team consisting of one business operations specialist at $85.70/hr, one web developer at $91.90/hr, and one software developer at $132.80/hr who will each spend 10 hours to develop and program these systems, for a per contract burden of 30 hours for the team. In aggregate, we estimate a one-time burden of 24,210 hours (807 Part D contracts * 30 hr) at a cost of $2,504,928 (807 contracts × [($85.70/hr × 10 hr) + ($91.90/hr × 10 hr) + ($132.80/hr × 10 hr)]).</P>
                    <P>We also estimate a one-time burden for Part D sponsors to develop processes to reinstate individual terminated for good cause. We note that because this provision mirrors existing requirements for reinstatements when an enrollee fails to pay their Part D premiums, this should be a minor systems change. On average, we expect that for each Part D contract a two-person team consisting of one business operations specialist at $85.70/hr and one software developer at $132.80/hr who will each spend 2 hours developing these processes and updating plan systems. In aggregate, we estimate a one-time burden of 3,228 hours (807 Part D contracts * 4 hr) at a cost of $352,659 (807 contracts × [($85.70/hr × 2 hr) + ($132.80/hr × 2 hr)]).</P>
                    <P>Finally, we estimate a one-time burden for Part D sponsors to develop systems to track individuals with outstanding balances who are precluded from program participation in subsequent plan years. On average, we expect that for each Part D contract a three-person team consisting of one business operations specialist at $85.70/hr, one web developer at $91.90/hr, and one software developer at $132.80/hr who will each spend 10 hours developing these processes and updating plan systems for a total of 30 hours per contract. In aggregate, we estimate a one-time burden of 24,210 hours (807 Part D contracts * 30 hr) at a cost of $2,504,928 (807 contracts × [($85.70/hr × 10 hr) + ($91.90/hr × 10 hr) + ($132.80/hr × 10 hr)]).</P>
                    <P>The total burden for all Part D contracts associated with the aforementioned requirements is 51,648 hours with a one-time first year cost of $5,362,515.</P>
                    <GPH SPAN="3" DEEP="130">
                        <PRTPAGE P="99500"/>
                        <GID>EP10DE24.028</GID>
                    </GPH>
                    <HD SOURCE="HD3">5. ICRs Regarding Medicare Prescription Payment Plan Pharmacy POS Notification Process (§ 423.137(i))</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1475 (CMS-10882).</P>
                    <P>This rule proposes to require Part D sponsors to ensure that a pharmacy, after receiving such a notification from the Part D sponsor, informs the Part D enrollee that they are likely to benefit from the Medicare Prescription Payment Plan. The provision also outlines the required claims processing methodology for applicable Medicare Prescription Payment Plan transactions.</P>
                    <P>The burden related to these new requirements for pharmacies reflects the time and effort needed to process the notifications provided by the Part D sponsor and include the “Medicare Prescription Payment Plan Likely to Benefit Notice” with the enrollee's prescription collateral. We estimate a one-time burden for pharmacies to update their systems for this change, which will require 10 hours of time for each member of a two-person team consisting of one software developer at $132.80/hr and one web developer at $91.90/hr for a total of 20 hours per contract. Assuming approximately 73,397 pharmacies bill Part D based on monthly 2024 pharmacy network information, the total burden estimate across all pharmacies is 1,467,940 hours (73,397 pharmacies × 20 hr) at a cost of $164,923,059 (73,397 pharmacies × [($91.90/hr × 10 hr) + ($132.80/hr × 10 hr)]).</P>
                    <P>We do not estimate any additional burden for pharmacists to print and provide the “Medicare Prescription Payment Plan Likely to Benefit Notice” because we expect this to be integrated into the other prescription collateral provided to the enrollee under existing practices, such as those approved by OMB under control number 0938-0975 (CMS-10147).</P>
                    <HD SOURCE="HD3">6. ICRs Regarding Medicare Prescription Payment Plan Pharmacy Claims Processing (§ 423.137(j))</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1475 (CMS-10882).</P>
                    <P>The electronic claims processing methodology outlined in this proposed rule is utilized today by Part D sponsors and pharmacies and therefore the addition of the BIN/PCN that is unique to the Medicare Prescription Payment Plan does not represent new burden that is not approved by OMB. However, CMS is requiring that Part D sponsors report their program-specific PCN starting with “MPPP” to CMS. We estimate that this will require 1 hour at $85.70/hr for a business operations specialist to report their identifier to CMS. In aggregate, we estimate a one-time burden of 807 hours (807 Part D contracts * 1 hr/response) at a cost of $69,160 (807 hr * $85.70/hr).</P>
                    <HD SOURCE="HD3">7. ICRs Regarding Part D Coverage of Anti-Obesity Medications (§ 423.100) and Application to the Medicaid Program</HD>
                    <P>As indicated later in this section, we will submit proposed changes to OMB under control number 0938-0659 (CMS-R-153) regarding the modification of policies and criteria. We will also submit proposed changes to OMB under control number 0938-0193 (CMS-179) regarding the preparation and submission of State Plan Amendments.</P>
                    <P>We are proposing to reinterpret the phrase “[a]gents when used for . . . weight loss” in section 1927(d)(2) of the Act such that AOMs that are used for weight reduction or chronic weight management for the treatment of obesity and otherwise meet the definition of Part D drug at § 423.100 would no longer be excluded from Part D coverage pursuant to the exclusion in paragraph (2)(ii) of the definition, for drugs that may be excluded from Medicaid coverage under section 1927(d)(2) of the Act. Our proposed reinterpretation would also apply to Medicaid such that state Medicaid programs would no longer have the discretion to exclude these drugs pursuant to section 1927(d)(2) of the Act from Medicaid coverage when used for weight reduction or chronic weight management for the treatment of obesity. States that are not already covering AOMs for weight reduction or chronic weight management would be required to do so to treat obesity in Medicaid enrollees.</P>
                    <P>Except as indicated later in this section, there is no new or revised information collection burden for Part D plans associated with this proposal to allow for Part D coverage of AOMs. The Part D plan's activities related to the decision to include AOMs on their Part D formularies would be the same as for any new drug that comes on the market. This burden is currently approved by OMB under control number 0938-0964 (CMS-10141) under the requirement that the Pharmacy and Therapeutics committee documents its decisions regarding formulary development and revision.</P>
                    <P>
                        The following proposed changes will be submitted to OMB for review under control number 0938-0659 (CMS-R-153) using the standard non-rule PRA process which includes the publication of 60- and 30-day 
                        <E T="04">Federal Register</E>
                         notices. 
                    </P>
                    <P>
                        As Medicaid is an operationally different program from Medicare Part D, there will be a burden for the state Medicaid programs that do not already cover AOMs when used for weight reduction or chronic weight management for Medicaid enrollees with obesity to modify their existing coverage and reimbursement policies and criteria to remove such exclusion of AOMs. This burden may include the time and cost for administrative processes and requirements, including changes to utilization management criteria, claims processing to allow coverage of these products for this indication, review of stakeholder input, change to provider and beneficiary 
                        <PRTPAGE P="99501"/>
                        documents to reflect this change in policy, and state internal operational implementation procedures. We believe that it will take a business operations specialist 40 hours at $85.70/hr to modify the state's policies and criteria. In aggregate, we estimate a one-time burden of 1,560 hours (39 states × 40 hr) at a cost of $133,692 (1,560 hr × $85.70/hr). Once the modifications are developed, there should be no additional burden.
                    </P>
                    <P>
                        The following proposed changes will be submitted for OMB review and approval under control number 0938-0193 (CMS-179) using the standard non-rule PRA process which includes the publication of 60- and 30-day 
                        <E T="04">Federal Register</E>
                         notices.
                    </P>
                    <P>This new provision may also require the submission of a State Plan Amendment (SPA) for formal review and approval. In such instances, we estimate that it would take a Business Operations Specialist 20 hours at $85.70/hr. In aggregate, we estimate a one-time burden of 780 hours (39 states × 20 hr) at a cost of $66,846 (780 hr × $85.70/hr).</P>
                    <HD SOURCE="HD3">8. ICRs Regarding Part D Medication Therapy Management (MTM) Program Eligibility Criteria (§ 423.153(d))</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1154 (CMS-10396).</P>
                    <P>Based on comments we received from the December 2022 proposed rule (87 FR 79452), CMS proposes to revise § 423.153(d)(2)(iii)(A) identifying “Alzheimer's disease” as a core chronic disease to “Alzheimer's disease and dementia,” to include all other dementias in the core chronic diseases for targeting beneficiaries for MTM program eligibility. We are also revising our burden estimates to reflect updated data, including up-to-date postage rates and using 2023 data. We estimate that the proposed change to add dementia to the core chronic diseases will increase the number (and percentage) of Part D enrollees eligible for MTM services by 71,210 beneficiaries, from 7,882,987 (14.5 percent × 54,503,892 Part D enrollees based on internal data from 2023) to 7,954,197 (14.6 percent × 54,503,892 Part D enrollees based on internal data from 2023) among 866 Part D contracts with an approved MTM program in 2023.</P>
                    <P>
                        Under § 423.153(d)(1)(vii)(B) and (C), all MTM enrollees must be offered a comprehensive medication review (CMR) at least annually and targeted medication reviews (TMRs) no less than quarterly. A CMR is an interactive consultation, performed by a pharmacist or other qualified provider, that is either in person or performed via synchronous telehealth, that includes a review of the individual's medications and may result in the creation of a recommended medication action plan as required in § 423.153(d)(1)(vii)(B)(
                        <E T="03">1</E>
                        ). An individualized, written summary in CMS's Standardized Format must be provided following each CMR. For ongoing monitoring, sponsors are required to perform TMRs for all beneficiaries enrolled in the MTM program with follow-up interventions when necessary. The TMRs must occur at least quarterly beginning immediately upon enrollment in the MTM program and may address specific or potential medication-related problems. TMRs may be performed to assess medication use, to monitor whether any unresolved issues need attention, to determine if new drug therapy problems have arisen, or assess if the beneficiary has experienced a transition in care. Under § 423.153(d)(1)(vii)(E), plans are also required to provide all enrollees targeted for MTM services with information about safe disposal of prescription medications that are controlled substances. Plans may mail this information as part of the CMR summary, a TMR, or other MTM correspondence or service. The proposed changes do not impact the requirements for MTM services.
                    </P>
                    <P>In this section, we estimate the additional burden on plan sponsors to conduct CMRs (labor cost) and mail the written CMR summaries (non-labor cost) to the additional beneficiaries that will be targeted for MTM enrollment based on our proposal to include dementia within the required core chronic diseases for identifying beneficiaries who have multiple chronic diseases. We also estimate the cost of sending safe disposal information to the beneficiaries who will be newly targeted under these revised criteria, but do not receive a CMR.</P>
                    <P>To obtain aggregate burden we separately estimate: (1) the burden for pharmacists to complete the CMR; (2) the mailing costs of the CMRs; and (3) the cost of mailing of safe disposal instructions to those targeted beneficiaries who do not accept the offer of a CMR.</P>
                    <P>
                        • 
                        <E T="03">The burden for pharmacists to complete the additional CMRs:</E>
                         Based on plan-reported data, we found that 70.9 percent of MTM program enrollees accepted the offer of a CMR in 2023. To estimate the cost of conducting the additional CMRs, we multiply the expected number of additional MTM program enrollees (71,210) by 0.709 to obtain the number of additional CMRs we estimate will actually be conducted (50,488). We estimate a pharmacist would take 40 minutes (0.6667 hr) at $129.62/hr (see table 16) to complete a CMR. Thus, the total burden is 33,660 hours (0.6667 hr/CMR * 50,488 enrollees who accept the CMR offer) at a cost of $4,363,009 (33,660 hr * $129.62/hr).
                    </P>
                    <P>
                        • 
                        <E T="03">Mailing Costs of CMRs:</E>
                         To estimate the cost of sending the CMR summaries, we assume that the average length of a CMR is 7 pages double-sided (including 1 page for information regarding safe disposal). The cost of mailing one CMR summary is the cost of postage plus the cost of printing one CMR summary. First-class postage costs $0.64 per metered mailing. Paper costs are $0.007 per sheet ($3.50 per ream/500 sheets per ream), and toner costs $70.00 per cartridge and lasts for 10,000 sheets (at $0.007 per sheet = $70.00/10,000 sheets). Bulk envelope costs are $440 for 10,000 envelopes or $0.044 per envelope. Therefore, the cost of printing and mailing the average CMR summary is $1.022 ([$0.64 postage for the first ounce + $0.24 for the second ounce + $0.044/envelope] * [7 sheets * ($0.007 for paper + $0.007 for toner)]). And taken as a whole, the annual cost of mailing CMRs to the additional 50,488 beneficiaries expected to accept the CMR offer is $51,599 (50,488 enrollees × $1.022/mailing).
                    </P>
                    <P>
                        • 
                        <E T="03">Mailing costs for Safe Disposal Information:</E>
                         Out of the 71,210 additional beneficiaries expected to be targeted for MTM based on the revised criteria, we expect that 29.1 percent or 20,722 (71,210 * 0.291) beneficiaries will decline a CMR. These beneficiaries will still need to receive information regarding the safe disposal of prescription drugs that are controlled substances. For purposes of calculating the burden, we assume that any safe disposal information that is not included in a CMR is either (1) being mailed in a TMR, which may be as short as one page and may contain private health information; or (2) is mailed as a standalone document which does not contain any private health information. For purposes of impact, (1) if one additional page is included in the TMR, then there is no additional postage; and (2) if the safe disposal information is mailed separately, there would be no private health information, and the burden would be the cost of one page plus bulk postage. Due to a lack of data with regard to what percentage of safe disposal information will be mailed as part of a TMR or other MTM correspondence or service, we are assuming that all safe disposal information not sent with a CMR will be 
                        <PRTPAGE P="99502"/>
                        one page that is mailed separately using bulk postage in order to project the maximum cost of such mailing. If the letter does not contain private health information and thus bulk mailing (which include the envelope, typically a fold over paper) is used, the cost to mail one page of safe disposal information is $0.01495 per enrollee [(1 page * $0.007/sheet) + (1 page * $0.007 toner) + ($0.19/200 items for bulk postage).] Therefore, we estimate that the cost of mailing safe disposal information to those beneficiaries targeted for MTM who do not receive it in a CMR summary is $310 ($0.01495 * 20,722).
                    </P>
                    <P>Therefore, the total burden associated with the proposed revisions to the MTM targeting criteria is 33,660 hours and $4,414,918 ($4,363,009 for a pharmacist to perform the CMRs for beneficiaries newly targeted for MTM under the revised criteria + $51,599 to mail the CMR written summary in the CMS Standardized Format with safe disposal information + $310 for mailing information regarding safe disposal to beneficiaries newly targeted for MTM who do not receive a CMR).</P>
                    <HD SOURCE="HD3">9. ICRs Regarding Eligibility for Supplemental Benefits for the Chronically Ill (SSBCI) (§ 422.102(f)(4)(iii)(C))</HD>
                    <P>
                        The following proposed changes will be submitted to OMB for review under control number 0938-TBD (CMS-10915). At this time the OMB control number has yet to be determined (TBD) but will be issued by OMB upon their clearance of this proposed collection of information request. CMS will include that number in the subsequent CMS-4208-F final rule. OMB will issue the control number's expiration date upon their approval of the final rule's collection of information request. The issuance of that date can be monitored at 
                        <E T="03">www.Reginfo.gov.</E>
                    </P>
                    <P>
                        As explained in section III.H. of the proposed rule, for each SSBCI, the plan must list all the written policies and objective criteria on which the policies are based as noted in § 422.102(f)(4)(iii)(C) on a public facing website. For web developers and programmers to annually post the required information on the plan website we estimate it would take 2 hours at $125.48/hr (see table 16). We estimate 761 plans including local and regional CCPs, MSA, and PFFS and reflects the publicly available CMS counts of these plans as of July 2024 accessible at 
                        <E T="03">https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/mcradvpartdenroldata/monthly/contract-summary-2024-07.</E>
                         In aggregate we estimate an annual burden of 1,522 hours (761 plans * 2 hr/plan) at a cost of $190,981 (1,522 hr * $125.48/hr). Medicare Cost plans are excluded from the count since they are not permitted to offer SSBCI.
                    </P>
                    <HD SOURCE="HD3">10. ICRs Regarding Ensuring Equitable Access to Behavioral Health Benefits Through Section 1876 Cost Plan and MA Cost Sharing Limits (§§ 417.454 and 422.100)</HD>
                    <P>As discussed in section III.M. of this proposed rule, we propose to amend the existing requirements at §§ 417.454 and 422.100(j) (that cost sharing for certain benefits not exceed cost sharing for the same benefits in Original Medicare) to add categories of mental health and substance use disorder services (collectively called “behavioral health services”). The service categories include mental health specialty services, psychiatric services, partial hospitalization, intensive outpatient services, inpatient hospital psychiatric services (all length of stay scenarios), outpatient substance use disorder services, and opioid treatment program services. This proposal requires Section 1876 Cost Plans (Cost Plans) and Medicare Advantage (MA) plans (including employer group waiver plans (EGWPs)) in-network cost sharing for these behavioral health services to be no greater than that in Traditional Medicare, beginning in contract year 2026. Specifically, this proposal: (1) modifies the way that in-network service category cost-sharing limits for behavioral health services have been set by adopting a new cost-sharing standard and (2) updates current guidance governing organization bid requirements about how benefits must be provided by plans, which are currently approved by OMB under control number 0938-0763 (CMS-R-262).</P>
                    <P>
                        Plans comply with our current practice because CMS annually reviews bids and organizations have submitted supporting documentation (for contract year 2024 and prior years) to demonstrate compliance with § 422.254(b)(5), (c)(5), and (c)(6), which require that MA organization bid submissions 
                        <SU>324</SU>
                        <FTREF/>
                         must be prepared in accordance with CMS actuarial guidelines. Following these guidelines requires use of generally accepted actuarial principles, the actuarial bases of the bid, a description of cost sharing applicable under the plan,
                        <SU>325</SU>
                        <FTREF/>
                         and the actuarial value of the cost sharing. CMS relies on our oversight and monitoring authority and our longstanding bid review policy (and the compliance program, recordkeeping, audit and access requirements at §§ 422.503 and 422.504) to request any additional information and necessary documentation from organizations to investigate plan compliance with the program and benefit requirements.
                    </P>
                    <FTNT>
                        <P>
                            <SU>324</SU>
                             Bid submissions from coordinated care plans, including regional MA plans and specialized MA plans for special needs beneficiaries (described at § 422.4(a)(1)(iv)), and MA private fee-for-service plans are subject to these actuarial guidelines.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>325</SU>
                             Cost Plans are not required to report information for all services in their plan benefit package.
                        </P>
                    </FTNT>
                    <P>Consequently, CMS asserts that that this proposal does not impose any new or revised collection of information requirements and/or burden and is not subject to the requirements of the PRA because: (1) this proposal does not change how CMS evaluates compliance with cost-sharing limits as part of bid review; (2) plans comply with our current practice; and (3) this proposal does not change any bid documentation requirements in the CMS issued, annual bid instructions.</P>
                    <HD SOURCE="HD3">11. ICRs Regarding Improving Equitable Access—Enhancing the Health Equity Analysis (§  422.137(d))</HD>
                    <P>
                        The following proposed changes will be submitted to OMB for review under control number 0938-0964 (CMS-10141) using the standard non-rule PRA process which includes the publication of 60- and 30-day 
                        <E T="04">Federal Register</E>
                         notices.
                    </P>
                    <P>
                        Currently, under §  422.137(d), all MA organization utilization management committees must conduct an annual health equity analysis of the use of prior authorization at the plan-level, based on specified metrics, aggregated for all items and services. The MA organizations must make the results of the analysis publicly available on their plan's website in a manner that is easily accessible and without barriers. As explained in section III.N. of this proposed rule, CMS is proposing to amend the regulation to require that the metrics for the health equity analysis be reported for each covered item and service (in other words, the data in the analysis must be presented in a disaggregated form). The information relevant to this analysis and corresponding report is routinely collected in plan systems for each covered item and service, and therefore the data required for the analysis should be readily available for plans. Therefore, we do not believe there is a burden associated with this requirement. We estimate an annual burden for the requirement that the data must be 
                        <PRTPAGE P="99503"/>
                        compiled into a report and posted publicly. For web developers and programmers of any plan to annually post the required information on the plan website would require 8 hours at $125.48/hr) (see table 16). We estimate 767 plans including local and regional CCP, MSA, PFFS plans and Medicare Cost plans and is based on the publicly available CMS data on plan type counts accessible at: 
                        <E T="03">https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/mcradvpartdenroldata/monthly/contract-summary-2024-07. In</E>
                         aggregate we estimate an annual burden of 6,136 hours (8 hr * 767 contracts) at a cost of $769,945 (6,136 hr * $125.48/hr) to fulfil the requirement that the plans publicly post the analysis to their website.
                    </P>
                    <HD SOURCE="HD3">12. ICRs Regarding Formatting Medicare Advantage (MA) Organizations' Provider Directories for Medicare Plan Finder (§ 422.120(c))</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-TBD (CMS-10906).</P>
                    <P>As indicated in section III.Q. of this proposed rule we propose adding new requirements at § 422.111(m) for MA organizations' provider directory formats. Under this proposal, MA organizations would be required to provide provider directory data that are formatted per CMS/HHS specifications to CMS/HHS and attest to the accuracy and consistency of their provider directory data. The purpose of this proposal is to allow for MA organizations' provider directory data to be populated into Medicare Plan Finder (MPF) so that current and prospective MA enrollees would have the ability to search for a provider or facility and determine whether the provider or facility has a contractual relationship with the MA plans displayed in MPF. We believe this would further CMS's objective to promote informed beneficiary choice, efficiency, and transparency through online resources while advancing health equity.</P>
                    <P>
                        Since the production of provider directories are part of an automated process, the burden associated with this provision is a one-time burden for a computer programmer for each plan to create the proposed functionality within their system. We estimate that for each plan a computer programmer would spend 8 hours at $103.60/hr (see table 16). In aggregate, we estimate a one-time burden of 6,088 hours (761 plans * 8 hr/plan) at a cost of $630,717 (6,088 hr * $103.60/hr). The 761 plans include local and regional CCP, MSA, and PFFS plans and is based on the publicly available CMS data on plan type counts accessible at 
                        <E T="03">https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/mcradvpartdenroldata/monthly/contract-summary-2024-07.</E>
                         Medicare Cost plans have been excluded from the count since the ultimate goal of the provision is a display in Medicare Plan Founder, and Medicare Cost plans are not currently listed there.
                    </P>
                    <HD SOURCE="HD3">13. ICRs Regarding Enhancing Review of Marketing and Communications (Part 422, Subpart V, and Part 423, Subpart V)</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1051 (CMS-10260).</P>
                    <P>As discussed in section III.R. of this proposed rule, in the April 2018 final rule, we narrowed the definition of “marketing materials” under §§  422.2260 and 423.2260 to only include materials and activities that aim to influence enrollment decisions. As noted in section III.R. of this proposed rule, these definitions were further updated in the January 2021 final rule, with the net result of narrowing the types of materials CMS required to be submitted, to those materials that CMS considered, at the time of the January 2021 final rule, to be the most likely to influence a beneficiary's decision to enroll in a plan. However, as indicated in this proposed rule, since the time these rules were finalized, CMS has observed a shifting landscape of misleading marketing practices in MA and Part D, including television and mail ads that, despite not meeting the definition of marketing, seemingly draw a beneficiary's attention to a plan or influence a beneficiary's enrollment decision. Moreover, CMS has seen a steady increase in marketing misrepresentation complaints beginning after the issuance of the April 2018 final rule. Therefore, we believe many communications materials excluded from the current regulatory definition of marketing and, consequently, from the submission and review requirements for marketing materials in §§ 422.2261(b) and 423.2261(b), should in fact be collected, as they are likely influencing a beneficiary's enrollment decision even when they do not meet the content standards of the current regulatory definition of marketing.</P>
                    <P>The burden of this provision is the time and money incurred by plans and TPMOs submitting more materials. To estimate this burden, we refer to table 16 of April 2018 final rule (83 FR 16696 and 16697). This table is based on a year of marketing data, from July 2015—June 2016. We illustrate the effects of the current proposal by reviewing what was then called (in the April 2018 final rule), category 4000 material, which dealt with advertisements. Table 16 indicates that in 2015-2016, we received roughly 44,000 advertisements of which 11,000 (44,000 * 25%) would no longer be submitted once the April 2018 final rule was finalized as they did not meet the updated definition of marketing, so that we would continue to receive 33,000 (44,000 * 75%) advertisements that were still to be considered marketing. We assume these proportions are stable. If so, in each year from 2019-2025, 25 percent of MA and Part D plan advertisements were no longer submitted while 75% of advertisements are still considered marketing and continue to be submitted to CMS. If the rule is finalized, then effective 2026, besides the 75 percent of materials that would have been collected, we will also collect the 25 percent of materials that were not required to be submitted from 2019 through 2025. Thus, relative to what was submitted in 2019 through 2025, that is, relative to 75 percent of the advertisements that are potential marketing materials, we are adding 25 percent more advertisements that were not collected in 2019-2025. That means we are increasing the current 75 percent by 33.3 percent resulting in the 25 percent of the materials (33.3% * 75% = 25%) being added. A similar analysis applies to all categories of marketing affected by this proposal.</P>
                    <P>However, we now use a different classification system, rather than the classification system based on the categories mentioned in the April 2018 final rule. Since we currently only collect marketing materials, unless directly specified in our regulations, we classify most materials by material type and whether the material is marketing or CMS required material. To illustrate this, we point out, that we duplicated the sampling of data from July 2015 to June 2016 by reviewing marketing materials collected from July 2023 to June 2024. With this background we can illustrate some subtleties associated with the comparison of the 2015 to 2016 and the 2023 to 2024 data.</P>
                    <P>
                        To properly compare the two samples, we must identify the categories of materials in each of them at the time, category 1100 (relevant to the 2015 and 2016 data) included the Annual Notice of Change (ANOC) and Evidence of Coverage (EOC) documents. After the April 2018 final rule, the EOC was no longer considered a marketing material and was no longer required to be submitted to CMS. However, as of today, the EOC has been updated to be 
                        <PRTPAGE P="99504"/>
                        required for submission to CMS, as per §§ 422.2261(c)(1) and 423.2261(c)(1), even though it was defined as a communications material. The ANOC is still a marketing material and continues to be collected, and therefore neither category will be affected by the update to the marketing definition, even though one material is marketing and one material is communications. Due to the differing classification system from the April 2018 final rule, and since there will be no burden impacts associated with the submission of the ANOC or EOC, the 1100 category is not relevant to the differences between the 2016 to 2017 data and the 2023 to 2024 data. Similarly, category 3000 (from the categories of the 2015-2016 data) refers to grievance forms, but for the 2023 to 2024 data, we no longer collect grievances forms as they are not considered marketing and therefore are not included in the data. Additionally, under the current proposal, grievance forms would not meet the definition of marketing and therefore does not have any associated burden. Table 23 contains all categories from the 2015 to 2016 sample and indicates which ones are still relevant to the current proposal.
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="353">
                        <GID>EP10DE24.029</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>The sample of marketing data from July 2023-June 2024 had 76,170 items. These 76,170 items include items corresponding to the 2015-2016 categories with category IDs listed in table 23 of 1000 (enrollment and related documents), 4000 (advertisements), and 6000 (Presentations/Scripts/Surveys). Table 16 of the April 2018 final rule (83 FR 16697) indicates the total number of marketing items in these categories as well as how many were not required to be submitted for 2019-2025. This allows us to accurately calculate how much the 76,170 materials from 2023-2024 data should be increased. Table 24 summarizes the numerical details.</P>
                    <P>We now make two observations. First, the 76,170 items in the 2023-2024 collection correspond to categories 1000, 4000, and 6000. Based on the April 2018 final rule, only 35,124 materials would have been collected in 2015-2016 had the provisions of the April 2018 final rule been in effect. Additionally, 28,172 items would not have been collected. Thus, 80.21% of the 35,124 materials (28,172) were not collected in 2019-2025; if the current proposal is finalized, we would be increasing marketing materials by 80.21%.</P>
                    <P>
                        Secondly, the 35,124 materials that would have been collected in the 2015-2016 sample had the April 2018 final rule applied to them correspond to the categories of item in the 2023-2024 data which had 76,170 items. This indicates an annual trend in growth of marketing materials of 10.15% (that is, 35,124 * 1.1015 
                        <SU>8</SU>
                         = 76,170). We expect this trend to continue in the near future.
                    </P>
                    <P>Based on these observations, we can calculate the burden of this provision if finalized in 2026. The results are presented in table 25.</P>
                    <GPH SPAN="3" DEEP="162">
                        <PRTPAGE P="99505"/>
                        <GID>EP10DE24.030</GID>
                    </GPH>
                    <P>
                        To clarify the meaning of table 25, we illustrate the calculation for 2026. For 2023-2024, we had 76,170 marketing materials. That number must be trended by a compound increase of 10.15 percent annually resulting in 101,797.6 (76,170 * 1.1015
                        <SU>3</SU>
                        ) marketing materials expected in 2026 if the provision is not finalized. If the provision is finalized, we must increase this by 81,652 materials (80.21% * 101,797.6) to a total of 183,449.5. The burden of processing the first 101,797.6 materials is included in the current burden, while the proposed provision would add the burden of processing an additional 81,651.9 materials. We estimate 767 plans will be impacted by these changes, including local and regional CCP, MSA, PFFS plans and Medicare Cost plans and is based on the publicly available CMS data on plan type counts accessible at: 
                        <E T="03">https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/mcradvpartdenroldata/monthly/contract-summary-2024-07.we.</E>
                    </P>
                    <P>To calculate the burden, as in the April 2018 final rule, we assume it would take an average of 30 minutes (0.5 hr) to process each material resulting in a burden of 40,826 hours (81,651.9 additional materials * 0.5 hr) in the first year. We also estimate a cost of $3,498,788 (40,826 hr * $85.70/hr for a business operations specialist) in the first year.</P>
                    <P>CMS received 76,170 materials in the base year of 2023, and that the applied trend increase of 10.15 percent would have applied in each year between 2023 and the proposed implementation date for this provision in 2026.</P>
                    <GPH SPAN="3" DEEP="137">
                        <GID>EP10DE24.031</GID>
                    </GPH>
                    <P>Given the annual increase, we have annualized our burden estimates over 3 years. In this regard, we estimate an annual burden of 45,110 hours at a cost of $3,865,927. We are also soliciting specific comment on the potential or alternative financial impacts of this proposal.</P>
                    <HD SOURCE="HD3">14. ICRs Related To Require Clinical or Quality Improvement Standards for Provider Incentive and Bonus Arrangements To Be Included in the MA MLR Numerator (§ 422.2420(b)(2))</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1232 (CMS-10476).</P>
                    <P>We propose to amend § 422.2420(b)(2) to clarify that only provider incentives and bonuses tied to clearly defined, objectively measurable, and well-documented clinical or quality improvement standards may be included in incurred claims for MA MLR reporting and remittance calculation purposes. We anticipate that implementing this provision would require minor changes to the MLR Annual Reporting Form Instructions and would not significantly increase the associated reporting burden of 61.1 hours per response.</P>
                    <P>
                        We estimate that approximately 700 MA organizations contracts must comply with the updated reporting requirements based on 2021 reported MLR data (the most recent data available). We further estimate that it would take each MA organization a one-time effort of 1 hour at $85.70/hr (see table 16) for a business operations specialist to update the financial data needed for MLR calculations. In aggregate, we estimate a one-time burden of 700 hours (700 MA organization contracts * 1 hr/response) at a cost of $59,990 (700 hr * $85.70/hr).
                        <SU>326</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>326</SU>
                             
                            <E T="03">https://www.cms.gov/medicare/health-drug-plans/medical-loss-ratio.</E>
                        </P>
                    </FTNT>
                    <PRTPAGE P="99506"/>
                    <HD SOURCE="HD3">15. ICRs Related to Proposal To Add Provider Payment Arrangement Reporting in the Medicare MLR Report Regulations (§§ 422.2460 and 422.2490)</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1232 (CMS-10476).</P>
                    <P>We propose to amend §§ 422.2460 and 422.2490 to require MA organizations to submit data on provider payment arrangements through the MLR Reporting Tool. This additional reporting will not be made public unless the data is deidentified and reported as aggregate totals. We anticipate that implementing this provision would require minor changes to the MLR Annual Reporting Form and Instructions and would not significantly increase the associated reporting burden of 61.1 hours per response.</P>
                    <P>
                        We estimate that approximately 700 MA organizations contracts must comply with the updated reporting requirements based on CY 2021 reported MLR data (the most recent data available). We further estimate that it would take each MA organization an annual effort of 3 hours at $85.70/hr (see table 16) for a business operations specialist to update the financial data needed for MLR calculations given that CMS is proposing to use a widely agreed upon HCPLAN APM framework. In aggregate, we estimate an annual burden of 2,100 hours (700 MA organizations contracts * 3 hr/response) at a cost of $179,970 (2,100 hr * $85.70/hr).
                        <SU>327</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>327</SU>
                              
                            <E T="03">https://www.cms.gov/medicare/health-drug-plans/medical-loss-ratio.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">16. ICRs Related To Prohibit Administrative Costs From Being Included in Quality Improving Activities in the MA and Part D MLR Numerator (§§ 422.2430(a) and 423.2430(a))</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1232 (CMS-10476). </P>
                    <P>
                        We propose to amend §§ 422.2430(a) and 423.2430(a) to specify that only expenditures directly related to activities that improve health care quality may be included as quality improving activity expenses for MLR reporting. We anticipate that implementing these provisions would require minor changes to the MLR Annual Reporting Form Instructions and would not significantly increase the associated reporting burden of 61.1 hours per response. We estimate that approximately 764 MA organizations and Part D sponsors contracts must comply with the updated reporting requirements based on 2021 reported MLR data (the most recent data available). We further estimate that it would take a business operations specialist at each MA organization and Part D sponsor a one-time effort of 1 hour at $85.70/hr (see table 16) to update the financial data needed for MLR calculations. In aggregate, we estimate a one-time burden of 764 hours (764 plans * 1 hr/response) at a cost of $65,475 (764 hr * $85.70/hr).
                        <SU>328</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>328</SU>
                             
                            <E T="03">https://www.cms.gov/medicare/health-drug-plans/medical-loss-ratio.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">17. ICRs Related to Establish Standards for MA and Part D MLR Audit Examinations (§§ 422.2480(d), 423.2480(d), 422.2401, 423.2401, 422.2450, 423.2450, 422.2452, 423.2452, 422.2454, and 423.2454)</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1232 (CMS-10476).</P>
                    <P>Our proposed amendments would establish a process for MLR audit examinations and a collection and appeals process for MLR audit remittances based on MLR audit findings. We expect MA organizations and Part D sponsors would have to retain detailed MLR information for auditing purposes. We anticipate that implementing this provision would require minor changes to the MLR Annual Reporting Form Instructions and would not significantly increase the associated reporting burden of 61.1 hours per response.</P>
                    <P>
                        MA organizations' and Part D sponsors' current record retention practices should already support future audits, however, there may be some burden associated with confirming compliance with record retention requirements. We estimate that approximately 764 MA organizations and Part D sponsors contracts must confirm compliance with the record retention requirements. We further estimate that it would take 1 hour at $85.70/hr (see table 16) for a business operations specialist to confirm the data needed for potential MLR auditing has been retained on an annual basis. Therefore, we expect approximately 764 hours (764 plans * 1 hr/year) at a cost of $65,475 ($764 hr * $85.70/hr).
                        <SU>329</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>329</SU>
                              
                            <E T="03">https://www.cms.gov/medicare/health-drug-plans/medical-loss-ratio.</E>
                        </P>
                    </FTNT>
                    <P>
                        In addition, CMS may conduct up to 9 MLR audit examinations annually, and the compliance actions that result from the audits and provisions in this rule would take effect in 2026. The annual burden would be higher for audited contracts, although MA organizations and Part D sponsors should have all of the materials requested by auditors consistent with current record retention practices. We estimate the burden to be 80 hours for the contracts selected for audit. Therefore, if 9 audits are conducted in a given year we expect the burden to be approximately 720 hours (9 contracts * 80 hr/year) at a cost of $61,704 (720 hr * $85.70/hr).
                        <SU>330</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>330</SU>
                              
                            <E T="03">https://www.cms.gov/medicare/health-drug-plans/medical-loss-ratio.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">18. ICRs Regarding Improving Access—Enhancing Rules on Internal Coverage Criteria (§ 422.101(b)(6))</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number (0938-0753) (CMS-R-267).</P>
                    <P>This rule proposes that by January 1, 2026, MA organizations must publicly display on the organization's website a list of all Medicare items and services where the MA organization uses internal coverage criteria when making medical necessity decisions. The list of items and services on the website must include the information in § 422.101(b)(6)(ii)(A) through (C) (or connect directly to that information through a hyperlink) and include the vendor's name when using a third-party vendor's criteria.</P>
                    <P>The MA organization's internal coverage criteria web page must be displayed in a prominent manner and clearly identified in the footer of the website. The web page must be easily available to the public, without barriers, including but not limited to ensuring the information is available free of charge, without having to establish a user account or password, without having to submit personal identifying information, in a machine-readable format with the data contained within that file being digitally searchable and downloadable, and include a txt file in the root directory of the website domain that includes a direct link to the machine-readable file to establish and maintain automated access.</P>
                    <P>
                        In § 422.101(b)(6)(ii)(A), which requires posting the internal coverage criteria in use, we are adding that any internal coverage criterion used by the MA organization in making medical necessity decisions on Part A and Part B benefits must be clearly identified and marked as internal coverage criteria of the MA plan within their coverage policies. In paragraph (B), we are proposing to add that the evidence supporting the internal coverage criteria must be connected with a corresponding footnote. In paragraph (C), we are 
                        <PRTPAGE P="99507"/>
                        changing “criteria” to “criterion” to make it clear that we require an explanation of the rationale that supports adoption of each individual internal coverage criterion in use.
                    </P>
                    <P>
                        We believe that for a business operations specialist to make the public posting of the new information described previously would require on average 1.5 hours a month at $85.70/hr (see table 16). In aggregate, we estimate an annual burden of 13,806 hr (767 plans * 1.5 hr/month * 12 months) at a cost of $1,183,174 (13,806 hr * $85.70/hr). The 767 plans include local and regional CCP, MSA, PFFS plans and Medicare Cost plans and is based on the publicly available CMS data on plan type counts accessible at 
                        <E T="03">https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/mcradvpartdenroldata/monthly/contract-summary-2024-07.</E>
                    </P>
                    <HD SOURCE="HD3">19. ICRs Regarding Clarifying MA Organization Determinations To Enhance Enrollee Protections in Inpatient Settings (§§ 422.138, 422.562, 422.566, 422.568, and 422.616)</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-0753 (CMS-R-267).</P>
                    <P>The proposal to clarify the definition of an organization determination is intended to enhance enrollee protections in inpatient settings. This would be accomplished by proposing to clarify that an MA organization's refusal, pre- or post-service or in connection with a decision made concurrently with an enrollee's receipt of services, to provide or pay for services, in whole or in part, including the type or level of services, that the enrollee believes should be furnished or arranged for by the MA organization is an organization determination subject to part 422, subpart M.</P>
                    <P>When making an organization determination, the plan must issue a coverage determination notice. The proposed clarification to the definition of an organization determination would mean that when an MA organization downgrades an enrollee from receiving inpatient to outpatient services or when an MA organization denies payment for services after such services were rendered but before a request for payment is submitted, the MA organization would be required to provide proper notice of the decision to the enrollee. The proposal also includes strengthening requirements related to notifying providers. The existing notice requirements for standard organization determinations at § 422.568 specify that MA organizations must provide the enrollee with notice of its decisions. Under existing rules, MA organizations are required to use an OMB-approved standardized denial notice (CMS Form 10003-NDMCP/OMB 0938-0829) to notify enrollees of adverse decisions. We propose to amend requirements related to notice of a standard organization determination at § 422.568(b)(1) to notify an enrollee's physician or provider, as appropriate, as well. As stated in section III.V.3. of this proposed rule, we do not believe the proposal to strengthen notice requirements will have a substantial impact on the practices of MA organizations as we are codifying longstanding requirements and guidance that we believe the majority of plans already implement based on the few complaints we receive on this issue from providers and enrollees. In addition, we also understand that due to the contractual relationship MA organizations have with their providers, most contracted providers should already receive notice of relevant organization determinations, including those that the provider submitted on behalf of the enrollee.</P>
                    <P>However, while we acknowledge that some plans are complying with the existing rules in a manner that is consistent with our proposed clarification, we do not have the data on the number of plans that are complying with this requirement. We estimate that annually 60,000 inpatient approvals are downgraded to observation status. We are estimating that of those 60,000 cases, approximately 10 percent of those cases are being handled appropriately (that is, plans are complying with the existing regulations). We do not have definitive data sources that indicate the number of plans that may not be in compliance and, therefore, invite stakeholder comment on our assumptions.</P>
                    <P>The burden associated with the proposed provisions are due to: (1) additional notices to enrollees and providers not currently receiving them; and (2) an increase in the number of appeals received. Due to lack of data, we cannot fully quantify all burden; however, we can quantify some and perform qualitative estimates. We discuss each burden source separately.</P>
                    <HD SOURCE="HD3">a. Additional Notices</HD>
                    <P>Under our proposal, there would be an increase in the number of notices to providers and enrollees regarding downgrading inpatient stays to observation status. The associated burden with this proposal would be the increase in costs related to the issuance of these notices. Because the issuance of these notices is typically automated, there could be a one-time first year cost to update systems in addition to a potential annual mailing cost. We estimate that, per plan, it may take a programmer 4 to 8 hours to update systems. In aggregate we estimate a one-time, first year burden of 5,816 hours (8 hr/plan * 727 plans) at a cost of $602,538 (5,816 hr * $103.60/hr).</P>
                    <P>We are basing our estimate for the cost of notices on the projected cost of postage (the major cost) and the number of notices. By examining risk-adjustment data for MA plan use of Condition Code 44, the code used in Traditional Medicare for a downgrade of an inpatient stay to observation, we estimate there are 60,000 downgrades annually. This approach has some assumptions, for example, that MA plans are using Condition Code 44 to indicate downgrades, and that most downgrades are being captured. Since the information in the notice is confidential, they must be mailed via first class at a postage rate of $0.73/notice. In addition, we believe that the majority of plans are currently not complying with our requirements and are estimating that there will be a new burden for approximately 90% of plans. This assumption is based on complaints, correspondence with plans, and other anecdotal evidence, but we acknowledge that it is speculative since we do not collect related data. Based on our assumptions, the cost of mailing notices would be a non-labor cost of $39,420 annually (60,000 downgrades * 90 percent that are not currently complying * $0.73/notice).</P>
                    <P>We note that besides the other assumptions detailed previously, this estimate is an over-estimate since some enrollees will receive their Integrated Denial Notice (IDN) in the hospital and hence incur no mailing costs. Because it is an over-estimate, we focused on the main drivers of cost and did not include the cost of paper, toner, and envelopes. Had we included toner and paper costs, the estimate would increase by a maximum of $756 (60,000 maximum notices * 90 percent * (0.007 cost of paper + 0.007 cost of toner). The inclusion of bulk envelopes could raise the cost by a maximum of $2,160 (60,000 maximum notices * 90 percent * $0.04 bulk envelope cost).</P>
                    <HD SOURCE="HD3">b. Increased Appeals</HD>
                    <P>
                        While we expect an increase in the number of organization determinations reported, as well as the number of appeals received, we do not have data to confirm this assumption. Appeals data available to CMS is not currently broken out by the type of service; therefore, we do not know how many 
                        <PRTPAGE P="99508"/>
                        MA organizations fail to provide proper notification and how many inpatient approvals being downgraded to outpatient are appealed. There are no current appeals going to the Independent Review Entity (IRE) level. We are unable to estimate (1) how many cases of the 60,000 will now receive notices (2) how many appeals would arise, (3) how many are overturned, and (4) how many will go to the IRE. Thus, we cannot quantify this, but we can qualitatively identify this as a cost.
                    </P>
                    <P>We also note that our proposal to amend the reopening rules at § 422.616 will not add to existing plan processes or requirements, so we believe any overall burden associated with processing a reopening of an organization determination related to inpatient hospital admissions will remain unchanged or will possibly be reduced (given that we are proposing to eliminate the discretion of an MA organization to reopen an approved authorization for an inpatient hospital admission based on new and material evidence). The decision to reopen an organization determination is at the discretion of an MA organization. Our proposal to curtail an MA organization's authority to reopen and modify an approved authorization for an inpatient hospital admission on the basis of good cause for new and material evidence does not impose any new burden in the decision-making process related to prior authorization for inpatient hospital admissions. Consequently, this provision will not have added impact. We do not believe the proposed changes will adversely impact enrollees or MA organizations. Similarly, we do not believe the proposed changes would have any impact to the Medicare Trust Funds.</P>
                    <P>Likewise, our proposed clarification to § 422.562(c)(2) will not add to existing plan processes or requirements, so we believe the overall estimated burden on MA organizations associated with processing organization determinations and appeals will be unchanged and this provision will not have added impact. We do not believe the proposed change will adversely impact enrollees or MA organizations and, further, believe that most MA organizations are properly excluding provider payment appeals from the subpart M administrative appeals process when a dispute no longer involves enrollee financial liability for furnished services. Similarly, we do not believe the proposed changes would have any impact to the Medicare Trust Funds.</P>
                    <P>We invite stakeholder comment on our approaches to determine the potential burden and our estimates.</P>
                    <HD SOURCE="HD3">20. ICRs Regarding Promoting Person-Centeredness in SNP ICPs and Timeliness of HRAs and ICPs (§§ 422.101(f) and 422.107(e))</HD>
                    <P>In section V.A. of this proposed rule, we propose amendments to § 422.101(f)(1) to codify timeliness standards, improve the organization of the various HRA and ICP requirements, and strengthen these requirements. These proposals would require that—</P>
                    <P>• SNPs conduct the comprehensive initial HRA within 90 days (before or after) of the effective date of enrollment for all new enrollees. This would better align with the Medicaid requirement at § 438.208(b)(3) and conform to the standard currently described for reporting HRA completion in the Part C reporting requirements.</P>
                    <P>• SNPs make at least three non-automated phone call attempts, unless an enrollee agrees or declines to participate in the HRA before three attempts are made, on different days at different times of day. We also propose that for any enrollees that are unable to be reached or decline to participate in the HRA, the SNP must document the attempts to contact the enrollee or the enrollee's choice not to participate. These updates would better conform to the standard currently described for reporting HRA completion in the Part C reporting requirements.</P>
                    <P>• Within 30 days of conducting a comprehensive initial HRA or 30 days after the effective date of enrollment, whichever is later, SNPs to develop and implement a comprehensive ICP that—</P>
                    <P>++ Is person-centered and based on the enrollee's preferences, including for delivery of services and benefits, and needs identified in the HRA;</P>
                    <P>++ Is developed through an interdisciplinary care team with the active participation of the enrollee (or the enrollee's representative, as applicable) as feasible;</P>
                    <P>++ Identifies person-centered goals and objectives (as prioritized by the enrollee), including measurable outcomes as well as specific services and benefits to be provided; and</P>
                    <P>++ Is updated as warranted by changes in the health status or care transitions of enrollees.</P>
                    <P>Since SNPs are already required to conduct HRAs and ICPs, we do not anticipate that the proposed changes to § 422.101(f) would impose any new burden on MA organizations offering SNPs. However, we would need to revise language on timeframes and related narrative in the Model of Care Matrix that is currently approved by OMB under control number 0938-1296 (CMS-10565).</P>
                    <P>In section V.A. of this proposed rule, we also propose to add language to the D-SNP EAC requirements at § 422.107(f) to include updates to MOCs as described at § 422.101(f) among required EAC discussion topics. While MA organizations can already include MOCs among their D-SNP EAC topics, adding these topics to the D-SNP EAC conversations would ensure MA organizations solicit feedback directly from enrollees to improve the care coordination process including HRAs and ICPs as described in the MOC.</P>
                    <P>We do not anticipate new or additional burden from this proposal since MA organizations are already convening EACs per the existing requirements at § 422.107(f) and can solicit feedback on MOCs as part of their existing convenings. Thus, we would not need to revise any of the currently approved requirements and/or burden under OMB control number 0938-1422 (CMS-10799).</P>
                    <P>We welcome comments on our assumptions.</P>
                    <HD SOURCE="HD3">21. ICRs Regarding Integrating Member ID Cards for Dually Eligible Enrollees in Certain Integrated D-SNPs (§§ 422.2267(e)(30) and 423.2267(e)(32))</HD>
                    <P>
                        Our May 2022 final rule noted that the Member Identification Card burden is exempt from the requirements of the PRA since the issuance of Medicare Identification Cards is a normal and customary practice throughout the insurance industry, citing the fact that health plans, whether commercial, through Medicare or Medicaid, or Original Fee-for-Service issue cards that inform providers of the enrollee's insurance. The MA requirements were previously described in the May 2022 final rule, and we are simply combining these requirements with Medicaid requirements for one ID card. Sections 422.2267(e)(30) and 423.2267(e)(32) require D-SNPs to provide member ID cards to enrollees. Medicaid managed care plans also send member ID cards to enrollees. However, when a dually eligible individual is enrolled in both an MA plan and a Medicaid managed care plan, the plans may issue the enrollee separate member ID cards—one for their MA plan and one for their Medicaid managed care plan—to access services for each program. Our proposal would require that applicable integrated plans (AIPs), as defined in § 422.561, provide one integrated member ID card to serve as the ID card for both the Medicare and Medicaid plans in which the enrollee is enrolled. Given that issuance of member 
                        <PRTPAGE P="99509"/>
                        ID cards is a normal and customary practice throughout the insurance industry and most States with AIPs currently require integrated member ID cards in their SMACs, we do not estimate any PRA-related burden for the proposed requirement. We welcome comments on our assumptions.
                    </P>
                    <HD SOURCE="HD3">22. ICRs Regarding Integrating Health Risk Assessments for Dually Eligible Enrollees in Certain Integrated D-SNPs (§ 422.101(f)(1)(v))</HD>
                    <P>The following proposed changes will be submitted to OMB for review under control number 0938-1446 (CMS-10825).</P>
                    <P>Medicare requirements at § 422.101(f)(1) require D-SNPs to conduct a comprehensive HRA for each enrollee, both at the time of enrollment and annually thereafter. Separately, Medicaid managed care regulations at § 438.208(b)(3) require Medicaid managed care plans to make a best effort to conduct an initial screening of enrollee needs within 90 days of their effective enrollment date, and State requirements may include additional assessments such as long-term services and supports (LTSS) and home and community-based services eligibility screenings. While some States have implemented their own requirements, through SMACs, to reduce burden and duplication, not all States have done so. In this rule, we propose to require D-SNPs that are AIPs to conduct a comprehensive HRA that meets all Medicare and Medicaid requirements, rather than two separate HRAs.</P>
                    <P>
                        If this provision is finalized, AIPs in seven states (DC, FL, ID, NJ, PR, VA, and WI) that do not currently combine their HRAs would be required to adhere to this new provision. We believe that in plan year 2026, a business operation specialist associated with each contract that has an AIP in these seven states would spend an average of 2 hours to determine whether the HRA tool currently in use meets State requirements and make any necessary system updates in preparation for implementation in plan year 2027. With 26 unique contracts in the seven States that would be required to meet this provision, we estimate that half of the contracts or 13 contracts (26 contracts * 
                        <FR>1/2</FR>
                        ) will only need to make minor administrative changes to comply with this provision. This would be a one-time burden of 26 hours (13 contracts * 2 hr) at a cost of $2,228 (26 hr * $85.70/hr (see table 26). We estimate that the other half of the contracts (13 contracts) would require more extensive updating and merging of two separate HRAs (at 40 hr/response) to comply with this provision. We estimate such MA organizations would need to merge two separate HRAs and implement systems updates to operationalize the integrated HRA. We estimate that these activities would take 40 hours per contract. This would be a one-time burden of 520 hours (13 contracts * 40 hr) at a cost of $44,564 (520 hr * $85.70/hr).
                    </P>
                    <P>After initial implementation, this proposed requirement would reduce burden for AIPs in the seven states listed earlier with HRAs that are not already integrated, as plans would be conducting one integrated HRA instead of two. As discussed in the prior paragraph, we estimate that half of the contracts that would be affected by our proposal currently administer some form of a consolidated HRA. Conversely, we estimate that the other half of the contracts are currently conducting two HRAs. Based on this assumption, we are estimating that half of the contracts that would be required to adhere to this provision if it is finalized would see a reduction of burden by half. We expect some long-term burden reduction from the 13 contracts that currently administer two HRAs for their enrollees but would only administer one HRA under this proposal. We welcome comments on our assumptions.</P>
                    <HD SOURCE="HD2">C. Summary of Proposed Information Collection Requirements and Associated Burden</HD>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99510"/>
                        <GID>EP10DE24.032</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99511"/>
                        <GID>EP10DE24.033</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99512"/>
                        <GID>EP10DE24.034</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <PRTPAGE P="99513"/>
                    <HD SOURCE="HD2">D. Submission of PRA-Related Comments</HD>
                    <P>We have submitted a copy of this proposed rule to OMB for its review of the rule's information collection requirements. The requirements are not effective until they have been approved by OMB.</P>
                    <P>
                        To obtain copies of the supporting statement and any related forms for the proposed collections discussed previously, please visit the CMS website at 
                        <E T="03">https://www.cms.gov/regulations-and-guidance/legislation/paperworkreductionactof1995/pra-listing,</E>
                         or call the Reports Clearance Office at 410-786-1326.
                    </P>
                    <P>
                        We invite public comments on these potential information collection requirements. If you wish to comment, please submit your comments electronically as specified in the 
                        <E T="02">DATES</E>
                         and 
                        <E T="02">ADDRESSES</E>
                         sections of this proposed rule and identify the rule (CMS-4208-P), the ICR's CFR citation, and the OMB control number.
                    </P>
                    <HD SOURCE="HD1">VII. Regulatory Impact Analysis</HD>
                    <HD SOURCE="HD2">A. Statement of Need</HD>
                    <P>The primary purpose of this proposed rule is to amend the regulations for the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) programs, and Programs of All-Inclusive Care for the Elderly (PACE). It is necessary to codify our implementation of policies laid out in acts of Congress and to improve access, transparency, and equity for beneficiaries enrolled in MA and Part D plans. The rule includes a number of new policies from the Bipartisan Budget Act of 2018 (BBA) and the IRA, as well as policies instituted by those acts that have operated under program instruction to this point. Further explanation of the purpose, methods, and expected outcomes of those provisions believed to have an economic impact on beneficiaries, plans, providers, or other entities is provided in the Anticipated Effects section of this RIA.</P>
                    <P>Rulemaking is required for CMS to amend its longstanding interpretation of the reference in section 1927(d)(2) of the Act to “[a]gents when used for . . . weight loss” under which coverage for anti-obesity medications (AOMs) has been excluded from Part D, and is subject to state discretion under Medicaid, even for treating individuals with obesity.</P>
                    <P>We believe it would be more consistent with current medical views of obesity as a disease to propose to reinterpret the phrase “[a]gents when used for . . . weight loss” to exclude AOMs when used for weight loss or chronic weight management for the treatment of obesity.</P>
                    <HD SOURCE="HD2">B. Overall Impact Analysis</HD>
                    <P>We have examined the impacts of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), Executive Order 14094, entitled “Modernizing Regulatory Review” (April 6, 2023), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).</P>
                    <P>Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 14094 amends section 3(f) of Executive Order 12866 (Regulatory Planning and Review). The amended section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) having an annual effect on the economy of $200 million or more in any 1 year, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or Tribal governments or communities; (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising legal or policy issues for which centralized review would meaningfully further the President's priorities.</P>
                    <P>A regulatory impact analysis (RIA) must be prepared for a regulatory action that is significant under section 3(f)(1). Based on our estimates of the combined impact of the provisions in this proposed rule, OIRA has determined this rulemaking is significant under section 3(f)(1) of E.O. 12866. Accordingly, we have prepared a Regulatory Impact Analysis that presents the costs and benefits of the rulemaking to the best of our ability. Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act), OIRA has determined that this rule meets the criteria set forth in 5 U.S.C. 804(2). Therefore, OMB has reviewed this proposed regulation, and the Department has provided the following assessment of its impact.</P>
                    <P>Section 202 of UMRA also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2024, that threshold is approximately $183 million. This proposed rule is not anticipated to have an unfunded effect on State, local, or Tribal governments, in the aggregate, or on the private sector of $183 million or more.</P>
                    <P>Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. Since this proposed rule does not impose any substantial costs on State or local governments, preempt State law or have federalism implications, the requirements of Executive Order 13132 are not applicable.</P>
                    <P>If regulations impose administrative costs on reviewers, such as the time needed to read and interpret this proposed rule, then we should estimate the cost associated with regulatory review. There are currently fewer than 1,000 contracts (which includes MA, MA-PD, and PDP contracts) and 500 Medicaid MCOs, prepaid inpatient health plans (PIHP), and prepaid ambulatory health plans (PAHPs), as well as 55 State Medicaid Agencies. We also expect a variety of other organizations to review (for example, consumer advocacy groups, major PBMs). We expect that each organization will designate one person to review the rule. A reasonable maximal number is 2,000 total reviewers. We note that other assumptions are possible.</P>
                    <P>
                        Using the BLS wage information for medical and health service managers (code 11-9111), we estimate that the cost of reviewing this proposed rule is $106.42 per hour, including fringe benefits, overhead, and other indirect costs (
                        <E T="03">http://www.bls.gov/oes/current/oes_nat.htm</E>
                        ). Assuming an average reading speed, we estimate that it will take approximately 19 hours for each person to review this proposed rule. For each entity that reviews the rule, the 
                        <PRTPAGE P="99514"/>
                        estimated cost is therefore $2,022 (19 hours × $106.42). Therefore, we estimate that the maximum total cost of reviewing this proposed rule is $4.04 million ($2,022 × 2,000 reviewers). However, we expect that many reviewers, for example pharmaceutical companies and PBMs, will not review the entire rule but just the sections that are relevant to them. We expect that on average (with fluctuations) 10 percent of the rule will be reviewed by an individual reviewer; we therefore estimate the total cost of reviewing to be $0.4 million.
                    </P>
                    <P>Note that this analysis assumes one reader per contract. Some alternatives include assuming one reader per parent organization. Using parent organizations instead of contracts would reduce the number of reviewers. However, we believe it is likely that review will be performed by contract. The argument for this is that a parent organization might have local reviewers assessing potential region-specific effects from this proposed rule.</P>
                    <HD SOURCE="HD2">C. Impact on Small Businesses—Regulatory Flexibility Analysis (RFA)</HD>
                    <P>The RFA, as amended, requires agencies to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions.</P>
                    <P>We proposed a wide range of policies in the proposed rule. These policies would codify, modify, and update current guidance governing MA organization bid requirements.</P>
                    <P>This rule has several affected stakeholders. They include: (1) MA organizations such as HMOs, local and regional PPOs, MSAs, PFFS and Part D sponsors, PACE plans, and Stand-Alone Part D plans (PDP) (2) providers, including institutional providers, outpatient providers, clinical laboratories, and pharmacies; and (3) enrollees. Some descriptive data on these stakeholders are as follows:</P>
                    <P>• Pharmacies and Drug Stores, NAICS 456110, have a $37.5 million threshold for “small size” with 88 percent of pharmacies, those with under 20 employees, considered small.</P>
                    <P>• Direct Health and Medical Insurance Carriers, NAICS 524114, have a $47 million threshold for “small size,” with 75 percent of insurers having under 500 employees meeting the definition of small business. Several Medicare Advantage plans (about 30 to -40 percent) are not-for-profit resulting in a “small entity” status.</P>
                    <P>• Ambulatory Health Care Services, NAICS 621, including about 2 dozen subspecialties, including Physician Offices, Dentists, Optometrists, Dialysis Centers, Medical Laboratories, Diagnostic Imaging Centers, have a threshold ranging from $8 to $35 million (Dialysis Centers, NAICS 621492, have a $47 million threshold). Almost all firms are big, and this also applies to sub-specialties. For example, for Physician Offices, NAICS 621111, receipts for offices with under 9 employees typically exceed $34 million.</P>
                    <P>• Hospitals, NAICS 622, including General Medical and Surgical Hospitals (NAICS 622110), Psychiatric and Substance Abuse Hospitals (NAICS 622210), and Specialty Hospitals (NAICS 622310) have a $47 million threshold for small size, with half of the hospitals (those with between 20-500 employees) considered small.</P>
                    <P>• Skilled Nursing Facilities (SNFs), NAICS 623110, have a $34 million threshold for small size, with half of the SNFs (those with under 100 employees) considered small.</P>
                    <P>We are certifying that this rule will not have a significant economic impact on a substantial number of small entities. The RFA does not define the terms “significant economic impact” or “substantial number.” The Small Business Administration (SBA) advises that this absence of statutory specificity allows what is “significant” or “substantial” to vary, depending on the problem that is to be addressed in the rulemaking, the rule's requirements, and the preliminary assessment of the rule's impact. Nevertheless, HHS typically considers a “significant” impact to be 3 to 5 percent or more of the affected entities' costs or revenues. To explain our position, we explain certain operational aspects of the Medicare program.</P>
                    <P>Each year, MA organizations, submit a bid for each plan for furnishing Part A and B (and sometimes D) benefits and the entire bid amount is paid by the government through the Medicare Trust Fund to the plan if the plan's bid is below an administratively set benchmark. If the plan's bid exceeds that benchmark, the beneficiary pays the difference in the form of a basic premium (note that a small percentage of plans bid above the benchmark, whereby enrollees pay a basic premium, thus this percentage of plans is not “significant” as defined by the RFA and as justified in this section of this rule). Part D sponsors also submit a bid for each plan, and the payments made to stand-alone Part D plans (PDPs) are covered by the Supplementary Medical Insurance Medicare Trust Fund. PACE organizations are paid a capitation amount that is funded by both the Medicare Trust Funds (the Hospital Insurance and Supplementary Medical Insurance trust funds) as well as the State Medicaid programs they negotiate with.</P>
                    <P>MA plans can also offer enhanced benefits, that is, benefits not covered under Traditional Medicare. These enhanced benefits are paid for through enrollee premiums, rebates or a combination. Under the statutory payment formula, if the plan bid submitted by an MA organization for furnishing Part A and B benefits is lower than the administratively set benchmark, the government pays a portion of the difference to the plan in the form of a rebate. The rebate must be used to provide supplemental benefits (that is, benefits not covered under Traditional Medicare) and/or to lower beneficiary Part B or Part D premiums. Some examples of these supplemental benefits include vision, dental, and hearing, fitness and worldwide coverage of emergency and urgently needed services.</P>
                    <P>Part D sponsors submit bids and plans are paid through a combination of Medicare funds and beneficiary premiums. In addition, for enrolled low-income beneficiaries, Part D plans receive special government payments to cover most of premium and cost sharing amounts those beneficiaries would otherwise pay.</P>
                    <P>Thus, the cost of providing services by these insurers is funded by a variety of government funding and in some cases by enrollee premiums. As a result, MA plans, Part D plans, Prescription Drug Plans, and PACE plans are not expected to incur burden or losses since the private companies' costs are being supported by the government and enrolled beneficiaries. This lack of expected burden applies to both large and small health plans.</P>
                    <P>Small entities that must comply with MA regulations, such as those in this proposed rule, are expected to include the costs of compliance in their bids, thus avoiding additional burden, since the cost of complying with any proposed rule is funded by payments from the government and, if applicable, enrollee premiums.</P>
                    <P>
                        For Direct Health and Medical Insurance Carriers, NAICS 524114, plans estimate their costs for the upcoming year and submit bids and proposed plan benefit packages. Upon approval, the plan commits to providing the proposed benefits, and CMS commits to paying the plan either (1) the full amount of the bid, if the bid is below the benchmark, which is a ceiling 
                        <PRTPAGE P="99515"/>
                        on bid payments annually calculated from Traditional Medicare data; or (2) the benchmark, if the bid amount is greater than the benchmark.
                    </P>
                    <P>Theoretically, there is additional burden if plans bid above the benchmark. However, consistent with the RFA, the number of these plans is not substantial. Historically, only 2 percent of plans bid above the benchmark, and they contain roughly 1 percent of all plan enrollees. Since the HHS criterion for a “substantial” number of small entities is 3 to 5 percent, the number of plans bidding above the benchmark is not substantial.</P>
                    <P>The preceding analysis shows that meeting the direct cost of this proposed rule does not have a significant economic impact on a substantial number of small entities, as required by the RFA. Besides the direct costs, discussed above, are certain indirect consequences of these provisions which also create impact. We have already explained that 98 percent of MA plans (including MA-PD plans) bid below the benchmark. Thus, their estimated costs for the coming year are fully paid by the Federal Government, given that as previously noted, under the statutory payment formula, if a bid submitted by a Medicare Advantage plan for furnishing Part A and B benefits is lower than the administratively set benchmark, the government pays a portion of the difference to the plan in the form of a beneficiary rebate, which must be used to provide supplemental and/or lower beneficiary Part B or Part D premiums. If the plan's bid exceeds the administratively set benchmark, the beneficiary pays the difference in the form of a basic premium. However, as also noted previously, the number of MA plans bidding above the benchmark to whom this burden applies does not meet the RFA criteria of a significant number of plans. If the provisions of this proposed rule were to cause bids to increase and if the benchmark remains unchanged or increases by less than the bid does, the result could be a reduced rebate. Plans have different ways to address this in the short-term, such as reducing administrative costs, modifying benefit structures, and/or adjusting profit margins. These decisions may be driven by market forces. Part of the challenge in pinpointing the indirect effects is that there are many other factors combining with the effects of this proposed rule, making it effectively impossible to determine whether a particular policy had a long-term effect on bids, administrative costs, margins, or supplemental benefits. Notwithstanding the foregoing, we have requested comment on the assessment of this outcome in association with this proposed rule.</P>
                    <P>We next examine in detail each of the other stakeholders and explain how they can bear cost. Each of the following are providers (inpatient, outpatient, or pharmacy) that furnish plan-covered services to plan enrollees for: (1) Pharmacies and Drug Stores, NAICS 446110; (2) Ambulatory Health Care Services, NAICS 621, including about 2 dozen sub-specialties, including Physician Offices, Dentists, Optometrists, Dialysis Centers, Medical Laboratories, Diagnostic Imaging Centers, and Dialysis Centers, NAICD 621492; (3) Hospitals, NAICS 622, including General Medical and Surgical Hospitals, Psychiatric and Substance Abuse Hospitals, and Specialty Hospitals; and (4) SNFs, NAICS 623110.</P>
                    <P>If these providers are contracted with the plan, their aggregate payment for services is the sum of the enrollee cost sharing and plan payments.</P>
                    <P>The rules for non-contracted providers servicing plan enrollees depends on the plan type involved. Non-contracted providers in both MA and MA PD plans are not expected to incur burden from a final rule because the regulations (42 CFR 422.214 and sections 1852(k)(1) and 1866(a)(1)(O) of the Act) require they be paid at least the FFS Rate. PACE must provide only contracted providers to its participants (42 CFR 460.70(a)). Similarly non-contracted pharmacies are a sporadic issue in stand-alone drug plans which are encouraged to limit out of network access to those situations when it is required (42 CFR 423.124). PACE plan participants must obtain services from the PACE organization or its contracted providers (42 CFR 460.70(a)). Consequently, non-contracted providers have no additional cost burden above the already existing burden in Traditional Medicare.</P>
                    <HD SOURCE="HD2">D. Anticipated Effects</HD>
                    <P>
                        Many provisions of this proposed rule have negligible impact either because they are technical provisions, clarifications, or provisions that codify existing guidance. Other provisions have an impact that cannot be quantified.
                        <SU>331</SU>
                        <FTREF/>
                         Throughout the preamble we have noted when we estimated that provisions have no impact. Additionally, this Regulatory Impact Analysis discusses several provisions with either zero impact or impact that cannot be quantified. The remaining provisions' effects are estimated in section VI. of this proposed rule and in this RIA. Where appropriate, when a group of provisions have both paperwork and non-paperwork impact, this RIA cross-references impacts from section VI. of this proposed rule in order to arrive at the total impact. The following table 27 provides a summary of the estimated transfers and costs associated with the various provisions in this proposed rule over a 10-year period. Further detail is provided in later in this RIA.
                    </P>
                    <FTNT>
                        <P>
                            <SU>331</SU>
                             We request comment—especially data or other quantitative evidence—on costs, benefits and transfers attributable to the provisions of this proposed rule.
                        </P>
                    </FTNT>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99516"/>
                        <GID>EP10DE24.035</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <PRTPAGE P="99517"/>
                    <HD SOURCE="HD3">1. Effects of Coverage of Adult Vaccines Recommended by the Advisory Committee on Immunization Practices under Medicare Part D (§§ 423.100 and 423.120)</HD>
                    <P>This proposal would implement section 11401 of the IRA which amends section 1860D-2 of the Act to require that, effective for plan years beginning on or after January 1, 2023, the Medicare Part D deductible shall not apply to, and there is no cost-sharing for, an adult vaccine recommended by the Advisory Committee on Immunization Practices (ACIP) covered under Part D.</P>
                    <P>The cost-sharing limits for ACIP-recommended adult vaccines outlined in this proposed rule have been in place since CMS implemented the limits in 2023 through program instruction authority. We have annually reviewed cost-sharing in plan benefit package submissions and believe our proposed codification of these requirements should have minimal impact on Part D sponsors and beneficiaries. All Part D enrollees have had zero cost sharing for ACIP-recommended adult vaccines since 2023.</P>
                    <P>
                        Shortly after the IRA was enacted, CBO scored the $0 cost-sharing requirement for ACIP-recommended adult vaccines as a Federal cost of $4.4 billion from FY 2022 to FY 2031 and, therefore, the estimates are not a result of this rule.
                        <SU>332</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>332</SU>
                             
                            <E T="03">https://www.cbo.gov/system/files/2022-09/PL117-169_9-7-22.pdf</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Effects of Appropriate Cost-Sharing for Covered Insulin Products under Medicare Part D (§§ 423.100 and 423.120)</HD>
                    <P>This proposal would implement section 11406 of the IRA, which amends section 1860D-2 of the Act to require that, effective for plan years beginning on or after January 1, 2023, the Medicare Part D deductible shall not apply to covered insulin products, and the Part D cost-sharing amount for a 1-month supply of each covered insulin product must not exceed the statutorily defined “applicable copayment amount” for all enrollees. The applicable copayment amount for 2023, 2024, and 2025 was $35. For 2026 and each subsequent year, in accordance with the statute, we are proposing that, with respect to a covered insulin product covered under a PDP or an MA-PD plan prior to an enrollee reaching the annual out-of-pocket threshold, the “covered insulin product applicable cost-sharing amount” is the lesser of—</P>
                    <P>• $35;</P>
                    <P>• An amount equal to 25 percent of the maximum fair price established for the covered insulin product in accordance with Part E of subchapter XI; or</P>
                    <P>• An amount equal to 25 percent of the negotiated price, as defined in § 423.100, of the covered insulin product under the PDP or MA-PD plan.</P>
                    <P>
                        The requirement to provide enrollees with an applicable copayment amount equal to the lesser of $35, 25 percent of the MFP, or 25 percent of the negotiated price, has not yet been implemented. As described in Part E of subchapter XI of the Act, the Secretary must establish a Drug Price Negotiation Program and negotiate MFPs for selected drugs that will go into effect beginning in initial price applicability year (IPAY) 2026. The selected drug list for IPAY 2026 includes insulin products that will be subject to the cost-sharing requirements outlined in this proposal.
                        <SU>333</SU>
                        <FTREF/>
                         The selected drug list under the Drug Price Negotiation Program in future years may also include additional insulin products. As defined in § 423.100, the negotiated price is the price for a covered Part D drug that the Part D sponsor (or other intermediary contracting organization) and the network dispensing pharmacy or other network dispensing provider have negotiated as the lowest possible reimbursement such network entity will receive, in total, for a particular drug. A negotiated price must meet all of the following: (1) includes all price concessions from network pharmacies or other network providers; (2) includes any dispensing fees; and (3) excludes additional contingent amounts, such as incentive fees, if these amounts increase prices. Finally, a negotiated price is reduced by non-pharmacy price concessions and other direct or indirect remuneration that the Part D sponsor passes through to Part D enrollees at the point of sale.
                    </P>
                    <FTNT>
                        <P>
                            <SU>333</SU>
                             
                            <E T="03">https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation.</E>
                        </P>
                    </FTNT>
                    <P>Beginning in 2026, the applicable copayment amount for a 1-month supply of a covered insulin product will depend on which of the following is the lowest amount: $35, an amount equal to 25 percent of the insulin product's MFP (if the insulin product is a selected drug), or an amount equal to 25 percent of the negotiated price of the insulin product. If 25 percent of the MFP or 25 percent of the negotiated price is not less than $35, the impact on Part D sponsors will be minimal as this $35 applicable copayment amount has been in place since 2023. However, if either 25 percent of the MFP or 25 percent of the negotiated price is less than $35, the impact on Part D sponsors will depend on (1) the magnitude of difference between 25 percent of the MFP or 25 percent of the negotiated price and $35 and (2) the number of beneficiaries affected. In other words, the greater the difference in 25 percent of the MFP or 25 percent of the negotiated price and $35, the greater the impact on Part D sponsors.</P>
                    <P>We estimated the impact of the change in Part D insulin coverage for years 2026 through 2035 using a claim-level simulation model under the defined standard benefit before and after the application of the change. As the beneficiary cost-sharing is reduced, the net effect is an increase in benefit costs. Additionally, because of the premium stabilization provisions of the IRA, beneficiary premiums are not impacted until 2031. In 2031 and subsequent years, we expect beneficiaries will see small increase in premiums to account for the richer benefit structure. Overall, we expect Federal costs to increase by approximately $1.2 billion from 2026 to 2035.</P>
                    <GPH SPAN="3" DEEP="102">
                        <PRTPAGE P="99518"/>
                        <GID>EP10DE24.036</GID>
                    </GPH>
                    <HD SOURCE="HD3">3. Effects of Part D Coverage of Anti-Obesity Medications (AOMs) (§ 423.100) and Application to the Medicaid Program</HD>
                    <P>We are proposing to reinterpret the reference to “[a]gents when used for . . . weight loss” in section 1927(d)(2)(A) of the Act to not include drugs used for weight loss or chronic weight management for the treatment of obesity to reflect changes in the prevailing medical consensus towards recognizing obesity as a disease. As a result of this proposed reinterpretation, AOMs used for weight loss or chronic weight management for the treatment of obesity would not be excluded from the definition of Part D drug at § 423.100, and state Medicaid programs would likewise not be permitted to exclude AOMs used for weight loss or chronic weight management for the treatment of obesity from Medicaid coverage pursuant to section 1927(d)(2)(A) of the Act.</P>
                    <P>As we stated in section III.A.1. of this proposed rule, while we refer to AOMs generally throughout our proposal and have included discussion on specific classes of AOMs, this proposal is not limited to particular drugs or drug classes. Older AOMs are significantly less costly than newer AOMs in the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist classes. AOMs in the GLP-1 and GIP/GLP-1 receptor agonist classes have emerged as preferred therapies over older AOMs and are therefore likely to be the driver of overall costs related to this proposal.</P>
                    <P>The impact of our proposed reinterpretation must be considered in the context of newly approved indications for AOMs that are medically accepted indications (MAIs) that are coverable under current policy, which will increase their coverage under Part D regardless of our proposal. Additionally, there is a robust pipeline for these drugs, which may impact pricing and utilization in the future.</P>
                    <P>It is also possible that the changes in Part D and Medicaid coverage of AOMs as a result of our proposal could prompt changes in private health plan coverage outside of Medicare and Medicaid. This could impact premiums for those plans, including Affordable Care Act marketplace plans, but these impacts are not quantifiable without data on changes for the private health insurance market in response to this proposal. We request comment on the potential impact of our proposal on the private employer insurance market and the ACA marketplace.</P>
                    <P>Furthermore, for the purposes of this impact analysis, when we refer to AOMs and their respective FDA-approved indications, we are generally referring to a drug's active ingredient(s) and not particular formulations or brands. Therefore, for the purposes of our estimates, if a beneficiary with obesity has type 2 diabetes, we assume that under current policy the beneficiary could obtain coverage for an AOM that is FDA-approved for glycemic control in type 2 diabetes, but not an AOM that is FDA-approved only for weight loss or chronic weight management. If the two drugs have the same active ingredient, then the beneficiary with obesity and type 2 diabetes is able to obtain coverage for the AOM because under current policy they can obtain coverage for the drug that is approved for glycemic control in type 2 diabetes.</P>
                    <HD SOURCE="HD3">a. Medicare Impacts</HD>
                    <P>
                        Currently, Part D enrollees can obtain coverage for AOMs only when prescribed for an FDA-approved indication or for a use that is supported by CMS-approved compendia for a condition other than weight loss. For example, some AOMs are FDA-approved for use in type 2 diabetes and cardiovascular risk reduction in individuals with established cardiovascular disease and either obesity or overweight. Existing AOMs may potentially receive FDA approval for new indications in the future. At least one manufacturer has conducted a study on sleep apnea that was published and met its primary endpoint of reducing the severity of sleep apnea for the treatment of obesity and is seeking regulatory approval.
                        <SU>334</SU>
                        <FTREF/>
                         Therefore, for the purposes of these estimates, we consider AOMs to be already coverable under current Part D policy for individuals with obesity and type 2 diabetes, established cardiovascular disease, or sleep apnea. Our proposal would extend AOM coverage to Medicare beneficiaries with obesity who do not have a condition that is coverable by Part D under the current policy.
                    </P>
                    <FTNT>
                        <P>
                            <SU>334</SU>
                             Lilly. Lilly's tirzepatide reduced obstructive sleep apnea (OSA) severity, with up to 51.5% of participants meeting the criteria for disease resolution. June 21, 2024. Available from: 
                            <E T="03">https://investor.lilly.com/news-releases/news-release-details/lillys-tirzepatide-reduced-obstructive-sleep-apnea-osa-severity.</E>
                        </P>
                    </FTNT>
                    <P>We used Medicare claims data from 2022 to identify Part D enrollees with obesity. This was narrowed from those with obesity to those with obesity but without other conditions (specifically, type 2 diabetes, cardiovascular disease, or sleep apnea) for which we considered AOMs to be coverable under current Part D policy for the purposes of these estimates. We estimate that approximately 7 percent of the Part D population would become newly able to obtain coverage for these drugs if this proposal is finalized. We assumed a 1 percent annual growth rate. As shown in table 29, the majority of Medicare beneficiaries with obesity have a comorbid condition that we consider coverable under current Part D policy for the purposes of our estimates.</P>
                    <GPH SPAN="3" DEEP="128">
                        <PRTPAGE P="99519"/>
                        <GID>EP10DE24.037</GID>
                    </GPH>
                    <P>
                        Next, we estimated the proportion of this population expected to utilize AOMs annually. This included the effect of treatment discontinuation to refine the estimated duration of treatment per year. Taking into account published discontinuation rates of AOMs in the GLP-1 agonist class,
                        <SU>335</SU>
                        <FTREF/>
                         our estimates assume that 52.5 percent of those who start treatment with an AOM will discontinue treatment after 2 months. This was combined with an assumption that 10 percent of the population newly able to obtain AOM coverage would initiate treatment with an AOM, growing by 0.3 percent each year, to determine the total amount of Part D utilization per year. We assumed a 10 percent rate of initiation of therapy in the population newly able to obtain AOM coverage since this was an approximate mean of the range used in a published modeling study.
                        <SU>336</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>335</SU>
                             Rodriguez PJ, Goodwin Cartwright BM, Gratzl S, et al. Semaglutide vs Tirzepatide for Weight Loss in Adults With Overweight or Obesity. 
                            <E T="03">JAMA Intern Med.</E>
                             2024;184(9):1056-1064. doi:10.1001/jamainternmed.2024.2525.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>336</SU>
                             Ippolito B, Levy JF. Expanding Medicare Coverage Of Anti-Obesity Medicines Could Increase Annual Spending By $3.1 Billion To $6.1 Billion. Health Aff (Millwood). 2024 Sep;43(9):1254-1262. doi: 10.1377/hlthaff.2024.00356.
                        </P>
                    </FTNT>
                    <P>The cost per utilization was based on 2024 prescription drug event (PDE) data for the drugs in question. These costs were trended forward to each projection year and adjusted for estimated manufacturer rebates. To account for changes in the AOM drug development pipeline, the estimates assumed that there would be a gradual shift from older to newer products.</P>
                    <P>The resulting estimated utilization cost was used to modify the model for projecting Part D benefit costs to determine net Federal costs per year. As shown in table 30., we estimate an increase of $24.8 billion in trust fund expenditures over a 10-year period. As discussed in section III.A.4. of this proposed rule we are soliciting comment on an appropriate applicability date of the new interpretation should our proposal be finalized. Therefore, for the purposes of this analysis, we report annual costs with a placeholder for each year starting with the first year the reinterpretation is applicable in Medicare Part D. This analysis would be updated in any final rule for this policy to reflect the determined effective date of a final rule and the applicability date for Part D plans. There is no expected premium impact until 2031 due to the premium stabilization provisions in section 11201 of the IRA, so the premium offsets shown in table 30. reflect the earliest such offsets would be factored into the analysis (assuming 2026 notionally as year 1 of implementation). The estimates do not include medical cost savings for this proposal, as the magnitude and timing of any potential savings is highly uncertain. While we expect that there could be offsetting medical savings due to treatment of obesity, those savings will be much slower to emerge, such that in the near-term, the costs will have a larger impact on the overall picture of the estimated financial impact of this proposal. These estimates also assume that beneficiaries for whom these drugs are prescribed for a coverable indication under current Part D policy will continue to have access regardless of whether this provision is finalized as proposed; therefore, the costs associated with such use are not included in our estimates for this proposal. Our financial estimates include the population dually eligible for Medicare and Medicaid. As discussed in section III.A.3. of this proposed rule, should the proposal be finalized, AOM costs for these individuals would be borne by Medicare when the reinterpretation of section 1927(d)(2) to no longer exclude AOMs from the definition of Part D drug when used for weight loss or chronic weight management for the treatment of obesity becomes applicable under Part D. For dually eligible individuals, Medicaid provides drug coverage for covered outpatient drugs that are Part D excluded drugs. As such, state Medicaid programs would bear the costs of AOMs for dually eligible individuals if the applicable date of coverage under the Medicaid program is earlier than the applicable date of coverage under the Medicare program.</P>
                    <GPH SPAN="3" DEEP="84">
                        <GID>EP10DE24.038</GID>
                    </GPH>
                    <P>
                        It is possible that our estimates significantly underestimate the impact of our proposal. These estimates are sensitive to the utilization rate, which has a high degree of uncertainty. We factored in an estimated discontinuation 
                        <PRTPAGE P="99520"/>
                        rate based on published literature, but discontinuation rates and duration of therapy before treatment is discontinued vary in the literature.
                        <SU>337</SU>
                        <FTREF/>
                         Our assumption may not fully reflect patients who discontinue but subsequently resume treatment with AOMs. Discontinuation rates vary across studies and are influenced by a variety of factors including cost, adverse effects, or successful weight loss.
                        <E T="51">338 339</E>
                        <FTREF/>
                         Some factors contributing to discontinuation may be mitigated, for example, if AOMs approved in the future have more favorable tolerability profiles. Our estimates rely on available claims data and therefore a limitation in our estimates is whether a diagnosis of obesity was reliably reported. Available National Health and Nutrition Examination Survey (NHANES) data from 2017 to March 2020 indicates that the prevalence of obesity in the U.S. population age 60 and older was 41.5 percent,
                        <SU>340</SU>
                        <FTREF/>
                         which is much higher than the 25 percent prevalence observed in Medicare claims data. Additionally, the definition of cardiovascular disease that we applied to perform the analysis was based on CMS's pre-determined chronic condition algorithms for Ischemic Heart Disease, Stroke/Transient Ischemic Attack, and Peripheral Vascular Disease (PVD).
                        <SU>341</SU>
                        <FTREF/>
                         This definition is broader than the definition of cardiovascular disease in a recent clinical trial investigating major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight, in which established cardiovascular disease was defined as prior myocardial infarction, prior stroke, or peripheral arterial disease.
                        <SU>342</SU>
                        <FTREF/>
                         Therefore, our calculation may overestimate the proportion of beneficiaries with cardiovascular disease for whom AOMs are already coverable under current policy and, correspondingly, underestimates the number of beneficiaries who will be newly able to obtain AOM coverage under the proposed policy. Finally, for the purposes of our financial estimates, we included sleep apnea as a coverable indication under current policy since this new indication for an approved AOM has been submitted to FDA for approval. This assumption increases the number of Part D enrollees who we considered to already have a coverable indication under current policy. Part D enrollees with obesity and sleep apnea only (that is, enrollees with sleep apnea who do not have type 2 diabetes or cardiovascular disease as a coverable indication) would be considered part of the population newly able to obtain AOM coverage until sleep apnea meets the definition of an MAI coverable under current Part D policy.
                    </P>
                    <FTNT>
                        <P>
                            <SU>337</SU>
                             Gleason PP, Urick BY, Marshall LZ, Friedlander N, Qiu Y, Leslie RS. Real-world persistence and adherence to glucagon-like peptide-1 receptor agonists among obese commercially insured adults without diabetes. J Manag Care Spec Pharm. 2024 Aug;30(8):860-867. doi: 10.18553/jmcp.2024.23332.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>338</SU>
                             Cohen, JP. Study Shows 85% Of Patients Discontinue GLP-1s For Weight loss After 2 Years. Forbes. July 11, 2024. Available from: 
                            <E T="03">https://www.forbes.com/sites/joshuacohen/2024/07/11/study-shows-85-of-patients-discontinue-glp-1s-for-weight-loss-after-2-years/.</E>
                        </P>
                        <P>
                            <SU>339</SU>
                             Do D, Lee T, Peasah SK, Good CB, Inneh A, Patel U. GLP-1 Receptor Agonist Discontinuation Among Patients With Obesity and/or Type 2 Diabetes. JAMA Netw Open. 2024 May 1;7(5):e2413172. doi: 10.1001/jamanetworkopen.2024.13172.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>340</SU>
                             Stierman, B., et al. National Health and Nutrition Examination Survey 2017—March 2020 Prepandemic Data Files—Development of Files and Prevalence Estimates for Selected Health Outcomes. 2021. Available from 
                            <E T="03">https://stacks.cdc.gov/view/cdc/106273.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>341</SU>
                             
                            <E T="03">https://www2.ccwdata.org/web/guest/condition-categories-chronic</E>
                             and 
                            <E T="03">https://www2.ccwdata.org/web/guest/condition-categories-other.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>342</SU>
                             Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023 Dec 14;389(24):2221-2232. doi: 10.1056/NEJMoa2307563.
                        </P>
                    </FTNT>
                    <P>We analyzed the population of Part D enrollees with obesity to determine if there were disparities between the population with comorbid conditions that are coverable MAIs under the current Part D policy and the population without such comorbid conditions for whom AOMs would become coverable under Part D if our proposal is finalized. We examined beneficiary characteristics to determine if our proposal would disproportionately affect underserved racial and ethnic minority groups, rural communities, individuals with lower incomes, or other disadvantaged groups. The population of Medicare beneficiaries with obesity but without type 2 diabetes, cardiovascular disease, or sleep apnea was more likely to be female (68 percent vs. 57 percent, respectively) or have a disability (22 percent vs. 18 percent, respectively) than the population of Medicare beneficiaries with obesity who had one or more of those conditions.</P>
                    <HD SOURCE="HD3">b. Medicaid Impacts</HD>
                    <P>
                        Currently, state Medicaid programs have discretion to cover the drugs or classes of drugs listed in section 1927(d)(2) of the Act, including “agents used for . . . weight loss . . .” As discussed in section III.A.3. of this proposed rule, should our proposal be finalized as proposed, state Medicaid programs providing coverage of drugs 
                        <SU>343</SU>
                        <FTREF/>
                         would be required to provide coverage of AOMs under Medicaid when used for weight loss or chronic weight management for treatment of obesity. That is, state Medicaid programs would no longer be permitted to consider AOMs to be excludable agents under section 1927(d)(2)(A) of the Act when they are used for weight loss or chronic weight management for treatment of obesity. States do have the discretion to utilize preferred drug lists and implement prior authorization processes to establish certain limitations on the coverage of these drugs as long as such practices are consistent with the requirements of section 1927(d) of the Act to ensure appropriate utilization. We estimate financial impact to the Federal Government and state Medicaid programs if this proposal is finalized.
                    </P>
                    <FTNT>
                        <P>
                            <SU>343</SU>
                             Under the Medicaid program, section 1902(a)(54) of the Act provides states with the option of providing coverage of prescribed drugs as described in section 1902(a)(12) of the Act. All states have elected to do so.
                        </P>
                    </FTNT>
                    <P>
                        For Medicaid, estimates were developed first by determining the current amount of spending and claims on AOMs, including GLP-1 and GIP/GLP-1 agonists used for the treatment of other indications (for example, type 2 diabetes or cardiovascular disease). Gross spending on these drugs in Medicaid was $7.5 billion in 2023 based on analysis of Transformed Medicaid Statistical Information System (T-MSIS) data. According to Medicaid Drug Rebate Program data, net spending was significantly less, $2.5 billion in 2023, due to the significant rebates Medicaid collects on these drugs.
                        <SU>344</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>344</SU>
                             Section 1927 of the Act governs the Medicaid Drug Rebate Program and payment for covered outpatient drugs. In general, for payment to be made available for covered outpatient drugs, manufacturers must enter into a national drug rebate agreement as set forth in Section 1927(a) of the Act. Pursuant to that agreement, manufacturers must pay rebates to states which are determined according to a formula set forth in section 1927(c) of the Act. In addition, states may have authority to enter into supplemental rebate agreements with the manufacturers through which states may obtain additional rebates.
                        </P>
                    </FTNT>
                    <P>
                        There is limited data on the number of Medicaid enrollees with obesity. One study found that 44 percent of adult Medicaid enrollees in Rhode Island, for example, had obesity in 2017 to 2018.
                        <SU>345</SU>
                        <FTREF/>
                         According to data from the NHANES, 42.4 percent of all adults in the United States had obesity in 2017 to 2018.
                        <SU>346</SU>
                        <FTREF/>
                         For the purposes of our financial 
                        <PRTPAGE P="99521"/>
                        estimates, we assumed that 45 percent of adult Medicaid enrollees have obesity. We also assumed the Medicaid population with obesity had the same proportion of other conditions which, for the purposes of our estimates, we considered AOMs to be already coverable (type 2 diabetes, cardiovascular disease, or sleep apnea), as the Medicare population. Therefore, should our proposal be finalized, approximately 12 percent of the adult Medicaid population would be newly able to obtain coverage for AOMs. Twelve percent was derived by taking 26 percent (Medicaid enrollees with obesity and at least one coverable condition) of 45 percent (proportion of Medicaid enrollees with obesity).
                    </P>
                    <FTNT>
                        <P>
                            <SU>345</SU>
                             Mylona EK, Benitez G, Shehadeh F, Fleury E, Mylonakis SC, Kalligeros M, Mylonakis E. The association of obesity with health insurance coverage and demographic characteristics: a statewide cross-sectional study. Medicine (Baltimore). 2020 Jul 2;99(27):e21016. doi: 10.1097/MD.0000000000021016.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>346</SU>
                              
                            <E T="03">https://www.niddk.nih.gov/health-information/health-statistics/overweight-obesity.</E>
                        </P>
                    </FTNT>
                    <P>To estimate the financial impact of our proposal, we developed assumptions on how much expanding coverage of these drugs would increase usage and spending. Fifteen states already cover AOMs for weight loss (in addition to other indications). We compared the number of AOM claims per enrollee in states covering AOMs for weight loss to the number in states that do not and found that the number of AOM claims per enrollee was 18 percent higher in states that cover AOMs for weight loss. Since some AOMs are FDA-approved for use in pediatric populations, these claims include current pediatric use. We also assumed that expanding AOM coverage to the 12 percent of Medicaid enrollees with obesity and no other conditions would also expand coverage to the 33 percent of Medicaid enrollees with obesity and at least one other condition (45 percent of Medicaid enrollees with obesity minus 12 percent of Medicaid enrollees with obesity and no coverable conditions) due to general increased awareness of AOM coverage in the Medicaid program. That is, we anticipated that there could be an increase in prescribing of these drugs for weight loss in Medicaid enrollees with obesity and other coverable conditions when a prescriber may not have otherwise prescribed the drugs for these individuals, despite coverage already being available. We assumed that use of these drugs would increase 30 percent because of the proposal—this could also include expanded access among Medicaid enrollees in states already covering these drugs for weight loss.</P>
                    <P>Medicaid costs are typically split between the Federal Government and the states. The Federal Medical Assistance Percentage (FMAP) can vary by state, by enrollment group, and by service. We arrived at an estimated the Federal share of 72 percent based on the average Federal share for prescription drugs and rebates. This Federal share is higher than the regular average FMAP in large part because this includes adults enrolled in Medicaid due to the Medicaid expansion under the Affordable Care Act, for whom the Federal share is 90 percent. As shown in table 31, we estimate that spending net of rebates on these drugs would increase by $14.8 billion over 10 years, with the Federal Government paying $11.0 billion and states paying $3.8 billion. As discussed in section III.A.4. of this proposed rule we are soliciting comment on an appropriate applicability date of the new interpretation should our proposal be finalized. Therefore, for the purposes of this analysis, we report annual costs with a placeholder for each year starting with the first year the new interpretation is applicable in Medicaid. This analysis would be updated in any final rule for this policy to reflect the determined effective date of a final rule and the applicability date for state Medicaid programs.</P>
                    <GPH SPAN="3" DEEP="89">
                        <GID>EP10DE24.039</GID>
                    </GPH>
                    <P>Costs may be significantly higher or lower than projected. Our estimates relied on assumptions about rates of obesity and other conditions in the Medicaid population since T-MSIS does not contain complete diagnosis-level data. It is possible that a larger proportion of the Medicaid population has obesity without other conditions since the Medicaid population is younger than the Medicare population and therefore may not yet have developed other conditions that are coverable under the current policy. The AOM utilization in states already covering AOMs for weight loss may include some utilization by Medicaid enrollees with overweight with weight-related comorbidities, if states permit such coverage. We were unable to determine if a claim was used for weight loss for treatment of obesity or in individuals with overweight with weight-related comorbidities. Using AOM utilization data from states that have not expanded AOM coverage approximates the baseline level of AOM coverage for conditions other than obesity. There is some additional uncertainty in the baseline costs under current policy given the limited data on the current state-by-state coverage rules and utilization of AOMs for other conditions. Spending on AOMs is already increasing significantly due to use for treatment of other conditions, and it is difficult to predict how many people may use these drugs in the future. States may take steps to limit use of these drugs even if they are covered by imposing utilization management restrictions or seek to lower the net price of these drugs by negotiating supplemental rebates by using preferred drug lists. We have not considered the impact of the use of AOMs on other medical costs.</P>
                    <HD SOURCE="HD3">4. Part D Medication Therapy Management (MTM) Program Targeting Requirements (§ 423.153)</HD>
                    <P>We propose modifying the regulatory text at § 423.153(d)(2)(iii)(A) identifying “Alzheimer's disease” as a core chronic disease to “Alzheimer's disease and dementia,” which would expand the targeting criteria to include Alzheimer's disease and all other causes of dementias. We anticipate that this change would allow beneficiaries with other causes of dementia who could potentially benefit from MTM services to be targeted for MTM enrollment.</P>
                    <P>
                        We estimate that this proposal would increase the number and percentage of Part D enrollees eligible for MTM services from 7.9 million (14.5 percent) to 8 million (14.6 percent). Although the increase in MTM program enrollment is 
                        <PRTPAGE P="99522"/>
                        estimated to cost $4,414,918 for the provision of required MTM services to beneficiaries with dementia who become eligible for MTM enrollment under this proposal, there is uncertainty in the estimates of effects of this proposal because there may be other administrative costs attributable to MTM, and MTM program costs are not a specific line item that can be easily extracted from the bid. Additionally, published studies have found that MTM services may generate overall medical savings, for example, through reduced adverse outcomes including reduced hospitalizations and readmissions, outpatient encounters, or nursing home admissions. CMS is unable to generate reliable savings estimates from the published studies due to limitations in potential study design, including the lack of a control group and numerous intervening variables. The burden associated with these proposed changes is addressed in section VI. of this proposed rule (in the ICR section for MTM targeting criteria.
                    </P>
                    <HD SOURCE="HD3">5. Effects of Ensuring Equitable Access to Behavioral Health Benefits Through Section 1876 Cost Plan and MA Cost-Sharing Limits (§§ 417.454 and 422.100)</HD>
                    <P>
                        Traditional Medicare benefits under Parts A and B include a wide range of mental health and substance use disorder services (collectively called “behavioral health services”).
                        <SU>347</SU>
                        <FTREF/>
                         Per section 1876(c)(2)(A) of the Act and §§ 422.100 and 422.101, respectively, section 1876 Cost Plans (Cost Plans) and Medicare Advantage (MA) plans must cover the same set of services, subject to limited exclusions.
                        <SU>348</SU>
                        <FTREF/>
                         As discussed in section III.M. of this proposed rule, CMS believes the affordability of behavioral health services is especially crucial for MA enrollees as they (1) represent a significant proportion of Medicare-eligible beneficiaries and (2) pay between $7 and $47 more on average in in-network cost sharing per visit for one or more professional behavioral health service categories in comparison to beneficiaries in Traditional Medicare (as shown in table 32). In addition, while enrollment in Cost Plans represents a small proportion of all Medicare-eligible beneficiaries (approximately 169,000 as of July 2024) 
                        <SU>349</SU>
                        <FTREF/>
                         we believe extending this proposal to Cost Plan enrollees is appropriate because: (1) CMS wants to improve equitable access to behavioral health services across all Medicare program choices and (2) enrollees in these plans pay between $5 and $13 more on average in in-network cost sharing per visit for one or more professional behavioral health service categories in comparison to beneficiaries in Traditional Medicare (as shown in table 32).
                        <SU>350</SU>
                        <FTREF/>
                         To this end, CMS is proposing behavioral health cost-sharing standards in MA and Cost Plans that strike a balance between: (1) improving the affordability of behavioral health services for enrollees in a timely manner and (2) minimizing disruption to enrollees' access to care and coverage options.
                    </P>
                    <FTNT>
                        <P>
                            <SU>347</SU>
                             McGinty, Beth. “Medicare's Mental Health Coverage: What's Included, What's Changed, and What Gaps Remain,” Commonwealth Fund, Mar. 2, 2023. Retrieved from: 
                            <E T="03">https://www.commonwealthfund.org/publications/explainer/2023/mar/medicare-mental-health-coverage-included-changed-gaps-remain</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>348</SU>
                             For example, MA plans are not required to provide hospice services—a service covered in Traditional Medicare.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>349</SU>
                             CMS. Contract Summary 2024. Data as of July 2024. Retrieved from: 
                            <E T="03">https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/mcradvpartdenroldata/monthly/contract-summary-2024-07</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>350</SU>
                             We note that enrollees in Cost Plans can access basic benefits out-of-network at cost sharing in Traditional Medicare.
                        </P>
                    </FTNT>
                    <P>As part of CMS's behavioral health strategy and to improve the affordability of behavioral health services, we propose to require—beginning in contract year 2026—that in-network cost sharing for behavioral health service categories be no greater than that in Traditional Medicare for Cost Plans and MA plans (including employer group waiver plans (EGWPs)). The behavioral health service categories subject to this proposal include mental health specialty services, psychiatric services, partial hospitalization, intensive outpatient program services, inpatient hospital psychiatric services (all length of stay scenarios), outpatient substance use disorder services, and opioid treatment program services. We also propose some clarifying amendments at §§ 417.454 and 422.100, including the applicability of the 50% coinsurance (or actuarially equivalent copayment) standard for Cost Plans. These proposed amendments primarily continue current policy with minor updates (such as, to annually update copayment limits CMS sets for Cost Plans based on the most recent Medicare FFS data projections).</P>
                    <P>If this proposal is finalized, CMS would not experience additional burden as we could, as needs arise, adjust the plan benefit package as part of normal business operations. In addition, CMS expects this proposal would prompt some—</P>
                    <P>
                        • Organizations to adjust their plan benefit designs,
                        <SU>351</SU>
                        <FTREF/>
                         primarily to come into compliance with this proposal, if: (1) any of their contract year 2025 plan benefits are not compliant with the proposed behavioral health cost-sharing standard for contract year 2026 and (2) they submit a bid to continue that plan offering for contract year 2026; and
                    </P>
                    <FTNT>
                        <P>
                            <SU>351</SU>
                             Cost Plans may not have to adjust their benefit designs for all behavioral health service categories as these plans are not required to report information for all services in the plan benefit package, including for inpatient hospital psychiatric services.
                        </P>
                    </FTNT>
                    <P>• Enrollees who remain in those continuing plans to experience changes in cost that will change over time based on their health status and service utilization (such as, behavioral health services or other service categories).</P>
                    <P>These potential impacts to organizations and enrollees are discussed in greater detail in the following section. In brief, CMS expects that this proposal to make in-network cost sharing for behavioral health services no greater than that in Traditional Medicare will increase utilization of these services and thus reduce: (1) enrollee disparities in health outcomes and health care costs formerly arising because of affordability issues related to behavioral health care; and (2) program costs due to better behavioral health disease management, health outcomes, and fewer high-cost services (such as, emergency room visits for life-threatening behavioral health condition complications).</P>
                    <HD SOURCE="HD3">a. Potential Impacts From Behavioral Health Cost-Sharing Limits No Greater Than Traditional Medicare to Organizations and Enrollees</HD>
                    <P>
                        From an aggregate perspective, CMS assumes that this proposal will not result in: (1) additional out of pocket costs for MA enrollees compared to beneficiaries in Traditional Medicare; or (2) significant losses for MA organizations. This is because there is a statutory requirement for MA organizations to submit bids that are at least actuarially equivalent to coverage in Traditional Medicare. This statutory requirement is operationalized through an actuarial equivalence test based on a projection of MA cost sharing under each plan. At the time that the actuarially equivalent cost sharing amounts are calculated, the expectation is that there will be no costs or savings for the policy year in question. As a result, the plan will cover—and MA enrollees would receive—the same level of total benefits on average in each contract year prior to and after implementation. However, CMS also expects lower behavioral health cost-sharing limits will pose varying 
                        <PRTPAGE P="99523"/>
                        individual impacts to MA organizations and enrollees that change over time.
                    </P>
                    <P>Cost Plans are not required to submit a bid that is at least actuarially equivalent to coverage in traditional Medicare. As a result, if this proposal is finalized enrollees in these plans could receive a different level of total benefits on average after its implementation. However, CMS expects this proposal will not result in significant additional out of pocket costs for Cost Plan enrollees because our analysis of cost sharing for the applicable professional behavioral health service categories demonstrates that: (1) most of these plans already established cost sharing for these services that is equal to or less than cost sharing in Traditional Medicare (as shown in table 32; and (2) plans with cost sharing greater than cost sharing in Traditional Medicare should not have to vastly change their cost sharing designs to come into compliance (as shown in table 33). For example, as shown in table 33, only 5 percent of Cost Plans have cost sharing greater than Traditional Medicare for the “outpatient substance abuse services” service category. Of those plans, as shown in table 34, the average in-network cost sharing is $40, or $10 more than cost sharing in Traditional Medicare. Finally, we also note that Cost Plan enrollees may continue to receive basic benefits at cost sharing in Traditional Medicare by going out-of-network. As such, beneficiary choice will continue to act as an incentive for Cost Plan organizations to offer favorable benefit designs. As a result, we believe Cost Plans should not be incentivized to either drastically increase overall costs for their enrollees or leave the market as a direct result of this proposal.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="139">
                        <GID>EP10DE24.040</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="343">
                        <GID>EP10DE24.041</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="307">
                        <PRTPAGE P="99524"/>
                        <GID>EP10DE24.042</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>CMS expects in the first applicable contract year when lower behavioral health cost-sharing limits would apply (contract year 2026), MA and Cost Plan organizations may or may not have increased costs to provide behavioral health services. This is because, as discussed in section III.M. of this proposed rule, plans incorporate varying cost sharing arrangements for behavioral health services—with amounts less than, greater than, or equal to cost sharing in Traditional Medicare for these services. As a result, continuing plans that previously established cost sharing for behavioral health services at amounts that are equal to or less than Traditional Medicare may not have any cost impacts as a direct result of this proposal. In contrast, for organizations that do reduce plan cost sharing for one or more behavioral health service categories in response to this proposal, CMS expects they will initially have increased costs to provide those behavioral health services. However, plan bids must: (1) remain at least actuarially equivalent to Traditional Medicare if it is an MA plan; and (2) satisfy Traditional Medicare coverage requirements for both MA and Cost Plans. As a result, CMS expects that the reduction in cost sharing for behavioral health services in contract year 2026 will lead organizations to—</P>
                    <P>• Predict the impacts that lower cost sharing will have on their cost to provide behavioral health benefits and profit margins (primarily based on plan-level total financial liability to provide behavioral health services and actuarial expectations of changes in enrollee utilization of behavioral health services based on the population served) and;</P>
                    <P>• Potentially adjust aspects of their bid design and allocation of rebate dollars (such as changes to cost sharing amounts for other service categories, premiums, deductibles, or supplemental benefits).</P>
                    <P>In contract year 2027 and subsequent years, organizations may become better aware of the cost impact of this proposal as potential cost savings from improved enrollee behavioral health outcomes become more apparent. As a result, as part of normal business operations, organizations may make additional adjustments based on their initial experience of actual changes to their cost of providing behavioral health benefits and profit margins. For example, each year organizations may adjust case management strategies and behavioral health provider contracting (and thus their total plan financial liability for behavioral health services). MA plans have significant plan design flexibility and multiple levers they can use to inform how they make these adjustments and develop bids that continue to remain actuarially equivalent to Traditional Medicare in contract year 2026 and subsequent years. CMS expects these types of adjustments and implementation timeframe would vary between organizations and influence how an organization chooses to design their plan bid(s) in subsequent contract years.</P>
                    <P>The specific adjustments organizations make in response to this proposal would in turn determine the varying short- and long-term individual financial impacts enrollees would experience. Specifically, CMS expects enrollees would experience different out-of-pocket impacts that change annually based on: (1) how organizations evolve their plan benefit designs; (2) their health conditions and utilization of services; and (3) enrollment switching patterns, if applicable. As an illustrative example, in response to this proposal, a continuing MA plan for contract year 2026 may have: (1) reduced cost sharing for behavioral health services; and (2) increased cost sharing for a few non-behavioral health benefits. In this scenario, enrollees that continue enrollment in this plan and utilize (to the same extent) the following:</P>
                    <P>
                        • Behavioral health services—may experience cost savings.
                        <PRTPAGE P="99525"/>
                    </P>
                    <P>• Non-behavioral health services that have increased cost sharing—may experience an increase in costs.</P>
                    <P>• Behavioral and non-behavioral health services with and without changes in cost sharing—may experience cost savings, increases, or neutral effects depending on how they allocate their utilization of these services.</P>
                    <P>However, the extent to which organizations may shift costs to services utilized by certain groups of enrollees is limited to ensure that beneficiaries—regardless of their health condition—can access needed health services. Consistent with statutory requirements, CMS would do the following:</P>
                    <P>• Not approve a plan bid if its proposed benefit design substantially discourages enrollment in that plan for certain Medicare-eligible individuals.</P>
                    <P>• Continue evaluations and enforcement of its current authority prohibiting plans from misleading beneficiaries in their marketing and communication materials and continue efforts to improve plan offerings and plan comparison tools and resources (for example, Medicare &amp; You and 1-800-MEDICARE).</P>
                    <P>Over time, as plans continue to evolve their plan benefit designs and the long-term effects of lower behavioral health cost sharing begin to show, the out-of-pocket impacts individual enrollees experience may change. For example, potential long-term impacts for enrollees with behavioral health conditions may include the following:</P>
                    <P>• Improved aggregate health outcomes and health care costs from increased utilization of high-value behavioral health services (such as, regular check-ins with a behavioral health provider).</P>
                    <P>• Decreased utilization of high-cost services related to poor behavioral health management (such as, emergency psychiatric admissions).</P>
                    <P>Given the breadth of potential impacts to enrollees from changes organizations may make to their plan benefit designs in response to this proposal, changing the behavioral health cost-sharing standards could create savings or losses for certain organizations or groups of enrollees at different times after its implementation. For this reason, there is a possibility that this proposal may be of substantial magnitude. A discussion of possible quantification of these potential effects follows.</P>
                    <HD SOURCE="HD3">b. Impact Analysis: Behavioral Health Cost-Sharing Limits No Greater Than Traditional Medicare</HD>
                    <P>Ideally, we would justify this proposal quantitatively but lack sufficient data. To accurately quantify this proposal's potential impacts to similarly situated organizations (such as those that lower behavioral health service category cost sharing amounts by a substantive or nominal amount as a direct result of this proposal) or by certain groups of enrollees (such as those with or without behavioral health conditions) the Office of the Actuary (OACT) would need sufficient data for the following:</P>
                    <P>• Contract year 2026—MA and Cost Plan organization and enrollee cost impacts based on: (1) expected decrease in behavioral health service category cost sharing amounts; (2) estimates of potential cost impacts to other non-behavioral health benefits to meet actuarial equivalence requirements for MA plans; (3) estimates of plans' total financial liability to provide services with a change in cost directly related to this proposal; and (4) the expected change in frequency of enrollee utilization of the impacted benefits (behavioral health services and non-behavioral health service categories or benefits).</P>
                    <P>• Contract year 2027 and subsequent years—annual MA and Cost Plan organization and enrollee cost impacts based on: (1) estimate of changes to plans' total financial liabilities to provide impacted behavioral health and non-behavioral health benefits; (2) revised estimates of potential cost impacts to other non-behavioral health benefits to continue meeting actuarial equivalence requirements for MA plans; (3) expected change in frequency of enrollee utilization of impacted benefits; (4) estimate of cost savings per enrollee from better behavioral health outcomes; and (5) enrollee migration patterns between plans.</P>
                    <P>OACT lacks sufficient data on these topics and as a result, cannot quantitatively project the financial impacts for certain organizations or groups of enrollees if this proposal is finalized. As noted previously, the aggregate, short term impact to MA organizations should be minimal due to the statutory requirement that plans remain actuarially equivalent to Traditional Medicare. While there are possible impacts due to the redistribution of cost sharing to compensate for the proposed limits on behavioral health cost sharing, these impacts would depend on which other services had corresponding changes in cost sharing. The affected service categories are unknown until bid submission, so the impacts are not currently quantifiable.</P>
                    <P>
                        While there is uncertainty in the impact analysis of this proposal to lower behavioral health cost-sharing standards is not currently possible, existing studies clarify potential implications from this proposal for organizations and enrollees with and without a need for behavioral health services. For example, a study 
                        <SU>352</SU>
                        <FTREF/>
                         comparing the rate of beneficiary follow-up within 30 days after a psychiatric hospitalization between plans with equivalent mental and physical health cost sharing amounts and plans with mental health cost sharing amounts that were greater than their primary and specialty care cost sharing found that beneficiaries in plans with equivalent cost sharing—
                    </P>
                    <FTNT>
                        <P>
                            <SU>352</SU>
                             Trivedi AN, Swaminathan S, Mor V. Insurance parity and the use of outpatient mental health care following a psychiatric hospitalization. JAMA. 2008 Dec 24;300(24):2879-85. doi: 10.1001/jama.2008.888. PMID: 19109116; PMCID: PMC4757896.
                        </P>
                    </FTNT>
                    <P>• Were significantly more likely to have follow-up visits after a psychiatric hospitalization; and</P>
                    <P>• This important service primarily benefited affected enrollees with lower education and in rural areas.</P>
                    <P>
                        Another study 
                        <SU>353</SU>
                        <FTREF/>
                         assessed the impact of the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008 (which lowered beneficiaries' coinsurance from 50 percent to 20 percent for mental health visits) on changes to specialty and primary care outpatient mental care visits and psychotropic medication fills. They found that Medicare beneficiaries' use of psychotropic medication increased after the implementation of cost-sharing parity, without a detected change in visits. The greater use of psychotropic medications was primarily among people with probable serious mental illness and among Medicare beneficiaries who did not report having supplemental coverage. The article concluded that—
                    </P>
                    <FTNT>
                        <P>
                            <SU>353</SU>
                             Cook, Benjamin &amp; Flores, Michael &amp; Zuvekas, Samuel &amp; Newhouse, Joseph &amp; Hsu, John &amp; Sonik, Rajan &amp; Lee, Esther &amp; Fung, Vicki. (2020). The Impact Of Medicare's Mental Health Cost-Sharing Parity On Use Of Mental Health Care Services: An assessment of whether Medicare cost-sharing reductions for outpatient mental health services was associated with changes in mental care visits to physicians and psychotropic medication fills. Health Affairs. 39. 819-827. 10.1377/hlthaff.2019.01008.
                        </P>
                    </FTNT>
                    <P>• Increased psychotropic medication fills could signal improvements in mental health care access among Medicare beneficiaries, especially among the subgroups most likely to benefit from the policy change; and</P>
                    <P>
                        • A lack of changes to mental care visits may suggest other, nonfinancial barriers are impacting beneficiaries from receiving mental health treatment (for example, barriers related to transportation, the availability of 
                        <PRTPAGE P="99526"/>
                        providers, or community- or person-level stigma).
                    </P>
                    <P>As a result, CMS believes this proposal (which would also reduce the coinsurance limit for several professional behavioral health standards from 50 to 20 percent coinsurance) in conjunction with other provisions focused on addressing nonfinancial barriers for enrollees to receive behavioral health services described in section III.M. of this proposed rule would work together to improve access to, and utilization of, behavioral health services in MA and Cost Plans.</P>
                    <P>
                        Another intended consequence of this proposal is a higher level of integration for medical and behavioral health services. Integrating medical and behavioral healthcare is one method some payers use to improve enrollee health outcomes while reducing the growth rate of healthcare claim expenditures. As lower behavioral health cost sharing limits may increase utilization of these services, we expect this proposal may provide additional financial incentive for MA plans to integrate these services. Specifically, there should be incentive through capitated payments to the MA organization to ensure beneficiaries receive efficient and effective care despite changes in cost sharing and utilization patterns. Medical and behavioral healthcare integration has been studied both qualitatively and quantitatively in several contexts. One such study 
                        <SU>354</SU>
                        <FTREF/>
                         reviewed relevant literature, conducted interviews, and held a workshop to develop a human-centered vision for the mental health ecosystem, reinforced by the experiences of those with mental illness, behavioral health providers, and efforts already underway by state, local, and Federal health leaders. This vision hinges upon five major shifts for better mental health care access, with one major shift being reform of payment systems. This study cites numerous attempts to improve mental health both in the U.S. and in the United Kingdom. Several of the attempts cited had significant reductions in hospitalizations, emergency room visits, and overall costs. Milliman,
                        <SU>355</SU>
                        <FTREF/>
                         in a 2018 update to a report originally made to the American Psychiatric Association in 2014 on the efficiencies of integrating behavioral and medical health, estimated savings to Medicare of $6 to $12 billion, for calendar year 2017, if behavioral health services were integrated into lower cost medical services.
                    </P>
                    <FTNT>
                        <P>
                            <SU>354</SU>
                             Egizi, Alison Muckle; Blasco, Gwen; Collins, Helen. A human-centered vision for improving the mental health care ecosystem. July 2022. Retrieved from: 
                            <E T="03">https://www2.deloitte.com/us/en/insights/industry/public-sector/mental-health-equity-and-creating-an-accessible-system.html.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>355</SU>
                             Milliman. Potential economic impact of integrated medical-behavioral healthcare: Updated projections for 2017. February 2018. Retrieved from: 
                            <E T="03">https://www.milliman.com/en/insight/potential-economic-impact-of-integrated-medical-behavioral-healthcare-updated-projections.</E>
                        </P>
                    </FTNT>
                    <P>Based on these existing studies we believe that lowering cost sharing for behavioral health services could lead to significant savings for MA and Cost Plan organizations, enrollees, and Medicare over time.</P>
                    <HD SOURCE="HD3">c. Comment Solicitation: Behavioral Health Cost-Sharing Limits No Greater Than Traditional Medicare</HD>
                    <P>
                        CMS also considered how the proposed cost-sharing standard may impact the flexibility MA organizations have in preparing a plan bid that meets the existing actuarial equivalence requirements at § 422.100(j)(1) and (2).
                        <SU>356</SU>
                        <FTREF/>
                         To assess this, the Office of the Actuary (OACT) first estimated what percentage of total 2023 Medicare FFS cost sharing is represented by the MA service categories currently subject to cost sharing no greater than Traditional Medicare (2023 was the most recently available data at the time of developing this proposal). The OACT then estimated the percentage representing the additional behavioral health MA service categories subject to this proposal. We note that this approach is from the perspective of an MA plan having to meet the Traditional Medicare cost-sharing standards for all the service categories listed in paragraph (j)(1) even though only a subset MA plans with certain MOOP types are subject to that standard for certain service categories. This approach is intended to assess the minimum level of flexibility MA organizations would have to structure cost sharing differently from Traditional Medicare, regardless of their MOOP type (that is, most plans would have more flexibility). The OACT's analysis found that—
                    </P>
                    <FTNT>
                        <P>
                            <SU>356</SU>
                             These actuarial requirements do not apply to Cost Plans.
                        </P>
                    </FTNT>
                    <P>• Existing MA cost-sharing standards with limits above cost sharing in Traditional Medicare represent about 51 percent of total 2023 Medicare FFS cost sharing; and</P>
                    <P>• The proposed addition of behavioral health service categories to the list of services for which cost sharing must be no greater than Traditional Medicare would nominally increase the percentage of total 2023 Medicare FFS cost sharing that MA cost-sharing standards represent from 49 to 51 percent.</P>
                    <P>In assessing the results of this analysis, there are several limitations. First, these percentages are only estimates based on how Traditional Medicare pays by service and not differently by provider. Second, the OACT does not have a statistical method to determine how high a percent threshold would result in insufficient flexibility for MA organizations to design cost sharing that is different from Traditional Medicare while fulfilling the actuarial equivalence requirements in § 422.100(j)(1) and (2). However, the OACT generally expects an approximate 2 percent decrease to the proportion of total cost sharing that can be raised above what Traditional Medicare requires (from 51 to 49 percent) is not likely to result in insufficient flexibility for MA organizations when designing their plan benefits. As a result, we believe that this proposal, if finalized, will not require MA organizations to make disruptive changes to their plan benefit designs so their plans meet the existing actuarial equivalence requirements to Traditional Medicare while complying with the proposed behavioral health cost-sharing limits. Nevertheless, we solicit comment on this supposition.</P>
                    <P>In summary, we expect this proposal to make in-network behavioral health service category cost-sharing limits no greater than Traditional Medicare will result in both increased savings and higher quality of health care in the MA and Cost Plan program over time. A detailed analysis of these effects would require additional data that are not available at this time. We solicit public comment on the economic cost and benefits of this proposal, which may include comments on data sources and available analyses of behavioral health service utilization impacts on health care savings and costs that could offer additional insight into the likely impacts of this proposal.</P>
                    <HD SOURCE="HD3">6. Proposal To Enhance Review of Marketing and Communications (§§ 422.2260 and 423.2260)</HD>
                    <P>
                        CMS is proposing to expand the definition of marketing under §§ 422.2260 and 423.2260 to broaden CMS oversight of certain categories of MA and Part D communications materials and activities in order to strengthen beneficiary protections. The updated definition would ensure all communications materials and activities that intend to draw a beneficiary's attention to an MA plan, Part D Plan or other plan, influence a beneficiary's decision-making process when making a MA or Part D plan selection or influence 
                        <PRTPAGE P="99527"/>
                        a beneficiary's decision to stay enrolled in a plan (as described in the current intent standard of the marketing definition in §§ 422.2260(1) and 423.2260(1)) are submitted to CMS and subject to review under the more comprehensive marketing material review requirements. While CMS does expect this proposed change will result in an increase in the volume of materials submitted to CMS, most of those materials are, and will continue to be, designated as File &amp; Use per §§ 422.2261(b) and 423.2261(b) and therefore, only those materials which are prospectively reviewed will directly impact CMS time and cost burden.
                    </P>
                    <P>Under this provision, CMS estimates that if this provision is finalized based on the trend estimates in the COI, CMS will receive 80.21 percent more marketing materials. Of those submitted marketing materials, CMS estimates that 10 percent of those materials will be prospectively reviewed by health insurance specialists. Therefore, we take the hour burden of a single review (0.5 hour) and multiply that by the number of materials that we expect to be reviewed (10 percent of submitted materials as estimated in table F10) and the hourly wage of a health insurance specialist ($64.06). For CY 2026, the estimated cost burden for CMS would be $261,531.36 (0.5*8165.20*64.06). For CY 2027, the estimated cost burden for CMS would be $288,077.82 (0.5*8994*64.06). For CY 2028, the estimated cost burden for CMS would be $317,314.80 (0.5*9906.80*64.06).</P>
                    <P>CMS notes that it has not collected the materials currently categorized as communications since prior to the April 2018 final rule, and therefore these estimates could vary depending on how the advertising landscape has changed and how frequently plans and TPMOs have been utilizing communications materials which are not currently required to be submitted for CMS review. In addition, it is possible that, based on concerns brought to CMS' attention through data such as complaints, surveillance activities, or retrospective reviews, CMS could increase the percentage of materials that are prospectively reviewed.</P>
                    <HD SOURCE="HD3">7. Proposal To Require Clinical or Quality Improvement Standards for Provider Incentive and Bonus Arrangements To Be Included in the MA MLR Numerator (§ 422.2420(b)(2))</HD>
                    <P>
                        We propose to amend § 422.2420(b)(2) to clarify that only provider incentives and bonuses tied to clearly defined, objectively measurable, and well-documented clinical or quality improvement standards may be included in incurred claims for MA MLR reporting. Due to the proposed change, if MA organizations report fewer provider incentives and bonuses in the MLR numerator and their MLR percent decreases, remittances paid could increase. While we do not know exactly how many incentives and bonuses would be impacted by this change, using information from prior Marketplace and Medicaid Regulatory Impact Analyses,
                        <E T="51">357 358</E>
                        <FTREF/>
                         we estimate that with a 1 percent decrease in incurred medical incentive pools and bonuses in the Medicare MLR numerator based on the Medicare MLR data for contract year 2017 (when detailed incentive and bonus data were last reported), the proposed clarification would have almost no impact on remittances paid by MA organizations, an estimated approximately $4 million per year. To arrive at this estimate, we calculated updated Medicare MLR remittances based on the assumptions outlined previously, subtracted those amounts from the actual Medicare MLR remittances and estimate a 1.8 percent increase per year in remittances paid by MA organizations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>357</SU>
                             
                            <E T="03">https://www.govinfo.gov/content/pkg/FR-2022-01-05/pdf/2021-28317.pdf,</E>
                             page 133.
                        </P>
                        <P>
                            <SU>358</SU>
                             
                            <E T="03">https://www.govinfo.gov/content/pkg/FR-2023-05-03/pdf/2023-08961.pdf,</E>
                             page 139.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">8. Proposal To Prohibit Administrative Costs From Being Included in Quality Improving Activities in the MA and Part D MLR Numerator (§§ 422.2430(a) and 423.2430(a))</HD>
                    <P>We also propose to amend §§ 422.2430(a) and 423.2430(a) to specify that only expenses directly related to activities that improve health care quality may be included in quality improving activity expenses for MA and Part D MLR reporting. We expect this proposed change could result in an increase in remittances from MA organizations and Part D sponsors that currently include indirect expenses in quality improving activities. Although we do not know how many MA organizations and Part D sponsors include indirect expenses in quality improving activities, we estimate the impact of the proposed change by assuming that indirect expenses inflate quality improving activities by 41.5 percent (the midpoint of the 33 percent to 50 percent range we have observed during commercial and Medicaid MLR audit examinations) for half of the organizations that report quality improving activity expenses (sorted based on lowest to highest and highest to lowest MA organization and Part D sponsor revenue). To determine the amount in remittances that we expect based on the proposed change, we reviewed the MLR data for contract year 2017 (when detailed health care quality improvement expenses were last reported). Using the assumption that indirect expenses improve the quality improving activities by 41.5 percent, we multiplied the quality improving activity expenses for each plan contract by 41.5 percent and subtracted these expenses from the numerator. Next, we updated the MLR for each contract and determined the change in remittances for contracts that fell below the 85 percent threshold. Using these calculations and steps, we determined the proposed clarification would increase remittances paid by MA organizations and Part D sponsors by a range of approximately $13 million to $189 million per year (sorted lowest to highest). Extrapolating the estimated transfers to the Treasury General Fund over 10 years, we expect the policy change to transfer an average of approximately $101 million per year, and $1.01 billion between 2026 and 2035.</P>
                    <HD SOURCE="HD3">9. Proposal To Establish Standards for MA and Part D MLR Audit Examinations (§§ 422.2480(d), 423.2480(d), 422.2401, 423.2401, 422.2450, 423.2450, 422.2452, 423.2452, 422.2454, and 423.2454)</HD>
                    <P>Our proposed amendments to the MA and Part D MLR regulations, including the addition of or modification to §§ 422.2401, 423.2401, 422.2450, 423.2450, 422.2452, 423.2452, 422.2454, and 423.2454, would increase the MLR reporting burden by requiring that MA organizations and Part D sponsors to provide auditors with detailed MLR data and any underlying records that can be used to substantiate amounts included in the calculation of each contract's MLR and any remittance determined to be owed. We anticipate the level of effort related to record retention, responding to record requests, and preparing and mailing MLR audit remittances would vary by MA organization and Part D sponsor and their potential audit findings and is therefore difficult to quantify.</P>
                    <P>
                        The proposed update would primarily impose additional costs on the Federal government. To conduct MLR audit examinations in Medicare we would pay a contractor to perform the audits to identify suspected inaccuracies and communicate findings to the MA organizations and Part D sponsors. We anticipate that we would pay a contractor to perform audits approximately equal to the number we are currently paying them to perform 
                        <PRTPAGE P="99528"/>
                        pilot MLR audit examinations, which is consistent with commercial MLR audits previously conducted (approximately $1 million to $1.5 million per year).
                    </P>
                    <P>
                        MA organizations and Part D sponsor MLR audits are expected to lead to more MLR remittances to the Treasury General Fund. These additional payments are transfers since no goods or services are being created. The impact to the Medicare Trust Funds is $0. To estimate the potential total increase in MLR remittances because of MA and Part D MLR audit examinations, first we accessed the total remittances paid for the most recent contract years available. Based on Medicare Part C and D MLR data, the average of total remittances paid for CYs 2017-2021, excluding 2020, which was significantly impacted by the COVID-19 pandemic with unusually large remittances collected, was $194,032,540.30.
                        <SU>359</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>359</SU>
                             
                            <E T="03">https://www.cms.gov/medicare/health-drug-plans/medical-loss-ratio.</E>
                        </P>
                    </FTNT>
                    <P>
                        Then we reviewed the results of eight commercial MLR audit examination reports, which approximates the annual number of MA and Part D MLR examinations CMS expects to conduct. The commercial MLR audit examination reports from CYs 2015 to 2019, the most recent publicly available reports, reported $11,691,450 in rebates were distributed back to policyholders.
                        <SU>360</SU>
                        <FTREF/>
                         To compare MLR remittance amounts we determined that the MA and Part D programs are 2.7 times larger than the enrollment size of the commercial Marketplace. As of January 2024, 21.3 million consumers signed up for coverage through the commercial Marketplaces.
                        <SU>361</SU>
                        <FTREF/>
                         As of August 2024, 57.2 million people were enrolled in Medicare Part C and D, excluding PACE organizations, which do not report MLR.
                        <SU>362</SU>
                        <FTREF/>
                         Therefore, we multiplied the $11,691,450 in commercial MLR audit rebates by 2.7 to estimate MA and Part D MLR audit remittances, which would total approximately $31,566,915. Extrapolating the estimated transfers to the Treasury General Fund over 10 years, we expect the MLR audit examinations to transfer an average of approximately $32 million per year, and $320 million between 2026 and 2035.
                    </P>
                    <FTNT>
                        <P>
                            <SU>360</SU>
                             
                            <E T="03">https://www.cms.gov/CCIIO/Programs-and-Initiatives/Health-Insurance-Market-Reforms/MLR_examinations_reports.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>361</SU>
                             
                            <E T="03">https://www.cms.gov/data-research/statistics-trends-reports/marketplace-products/2024-marketplace-open-enrollment-period-public-use-files.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>362</SU>
                             
                            <E T="03">https://www.cms.gov/data-research/statistics-trends-and-reports/medicare-advantagepart-d-contract-and-enrollment-data/monthly-contract-and-enrollment-summary-report.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">10. Proposal To Add Provider Payment Arrangement Reporting in the Medicare MLR Reporting Regulations (§§ 422.2460 and 422.2490)</HD>
                    <P>
                        Our proposal to require separate reporting amounts for provider payment arrangements would increase the Medicare MLR reporting burden by requiring MA organizations to compile additional information in the MLR Reporting Tool. We anticipate the level of effort to compile this information would vary based on the size of the MA organization, how they submit the existing Medicare Part C reporting requirements to report payments to providers, and whether they have ever responded to the HCPLAN APM measurement survey. The 2023 APM Measurement Methodology and Results report stated a total of 64 health plans, four FFS Medicaid states, and Traditional Medicare participated in the 2023 LAN Measurement Effort representing almost 264 million or 86.7% of people covered by an insurance plan in the Commercial, Medicare Advantage, Medicaid, or Traditional Medicare markets.
                        <SU>363</SU>
                        <FTREF/>
                         While the level of effort is difficult to quantify, in the COI we estimate an annual burden of 2,100 hours (700 MA organizations * 3 hr/response) at a cost of $179,970 (2,100 hours * $85.70/hr).
                    </P>
                    <FTNT>
                        <P>
                            <SU>363</SU>
                             
                            <E T="03">https://hcp-lan.org/workproducts/apm-methodology-2023.pdf.</E>
                        </P>
                    </FTNT>
                    <P>The proposed update would also impose additional costs on the Federal government related to analyzing the additional data. However, given that the additional reporting will not change the Medicare MLR calculation we do not expect the proposal to increase MLR remittances or create significant additional costs for the Federal government.</P>
                    <HD SOURCE="HD3">11. Clarifying MA Organization Determinations To Enhance Enrollee Protections in Inpatient Settings (§§ 422.138, 422.562, 422.566, 422.568, and 422.616)</HD>
                    <P>We are proposing modifications to existing regulations at 42 CFR part 422, subpart M, to clarify and strengthen existing rules related to organization determinations. The intent of this proposal is to clarify the definition of an organization determination to enhance enrollee protection in inpatient settings. We want to ensure enrollees and providers acting on their behalf receive notice of an inpatient/outpatient downgrade and are aware of their appeal rights. The intent of this provision is also to increase awareness when inpatient stays are downgraded with the expectation that there would be more appeals and some overturns. Thus, qualitatively, we expect this proposal to generate increased costs to the MA organizations and ultimately to the Medicare Trust Fund since inpatient stays are more expensive than observations.</P>
                    <P>In section VI.B.18. of this proposed rule, we estimated that there are annually 60,000 downgrades of inpatient to observation. Although we can estimate 60,000 affected enrollees, we do not have any way to estimate the following: (1) what percent of the enrollees are already receiving required written notification and what percent of them will receive a notice due to change in the provision; (2) of those receiving the notice, what percent will appeal; (3) of those appealing the downgrade, what percent will be overturned by the plan; (4) of those appeals upheld by the plan what percent will be overturned by the Independent Review Entity (IRE) (given that 100 percent of upheld plan decisions are forwarded to IRE). If this data was available, we could obtain average costs of inpatient stays and observation days and estimate the cost to the trust fund. In the absence of this data, we are estimating this as a non-quantified cost to the plans that is passed on to the Trust Fund.</P>
                    <HD SOURCE="HD2">E. Alternatives Considered</HD>
                    <P>In this section, CMS includes discussions of alternatives considered. Several provisions of this proposed rule reflect a codification of existing policy where we have evidence, as discussed in the appropriate preamble sections, that the codification of this existing policy would not affect compliance. In such cases, the preamble typically discusses the effectiveness metrics of these provisions for public health.</P>
                    <HD SOURCE="HD3">1. Proposal for Medicare Prescription Payment Plan (§§ 423.137(e), 423.137 (d), 423.137(f), 423.137(i), and 423.137(j))</HD>
                    <HD SOURCE="HD3">a. Auto Renewal</HD>
                    <P>As Medicare Prescription Payment Plan participation is tied to drug expenditures in a given plan year, CMS considered how to address year-over-year program participation.</P>
                    <P>
                        • 
                        <E T="03">Option #1:</E>
                         Implement an automatic election renewal process that requires a Part D sponsor to automatically renew a Part D enrollee's participation in the Medicare Prescription Payment Plan, provided the participant remains in the same Plan Benefit Package (PBP) in the upcoming year, unless the program participant indicates otherwise. This option would minimize burden for Part D enrollees, who would not need to 
                        <PRTPAGE P="99529"/>
                        complete additional paperwork to remain in the program, and Part D sponsors, which would not be required to process new election forms for active program participants or conduct “likely to benefit” analyses for the upcoming plan year for those participants. The primary impact of this approach is the burden and cost on Part D sponsors associated with annual notifications alerting participants that their participation in the program is continuing into the next year.
                    </P>
                    <P>
                        • 
                        <E T="03">Option #2:</E>
                         Require Part D enrollees to re-elect into the program each plan year. This option would allow Part D enrollees to actively choose to participate in the program each year but would place additional burden on both enrollees and Part D sponsors. In addition to requiring Part D sponsors to send annual notifications alerting participants that their participation in the program is ending and that participation renewal is required, this option would also require enrollees to complete a new election request form annually and require plan sponsors to review election requests from the same enrollee each year and send new notices of election approval following the renewal request.
                    </P>
                    <P>As noted in the earlier in this rule, CMS proposed an automatic election renewal process requiring Part D sponsors to alert program participants no later than December 7 that their participation in the program will continue into the next year unless they indicate they would like to opt out. We believe this approach minimizes burden for both enrollees and plan sponsors.</P>
                    <HD SOURCE="HD3">b. Point-of-Sale Enrollment</HD>
                    <P>Timely effectuation of election requests is important to prevent dispensing delays and potential prescription abandonment. For enrollees who trigger the likely to benefit threshold with a new high-cost prescription and receive the “Medicare Prescription Payment Plan Likely to Benefit Notice” informing them about the Medicare Prescription Payment Plan at the point of sale, a real-time or point of sale election mechanism could allow them to pay $0 at the point of sale and still leave the pharmacy with their medication. We considered the following three options for point-of-sale enrollment:</P>
                    <P>
                        • 
                        <E T="03">Option #1:</E>
                         Permit point of sale enrollment by establishing a new value in an existing NCPDP data field for the Medicare Prescription Payment Plan. If a Part D enrollee indicates to the pharmacist that they would like to opt into the program, the pharmacist would reverse the claim and resubmit it with a specific clarification code indicating that the individual has agreed to opt into the program. The PBM would then accept the clarification code value, add the individual to the relevant eligibility file, and return a message to the pharmacy providing the plan-specific BIN/PCN. The pharmacist would process the claim like a COB claim, bill any other applicable OHI, and bill the plan-specific BIN/PCN for the Medicare Prescription Payment Plan. The new program participant would be able to collect their prescription without paying any OOP cost sharing at the POS. The PBM would then communicate to the Part D sponsor that the individual has opted into the program.
                    </P>
                    <P>
                        • 
                        <E T="03">Option #2:</E>
                         Permit real-time enrollment by telephone or mobile or web-based application. If a Part D enrollee wanted to elect into the Medicare Prescription Payment Plan, they could call their plan's telephone number or submit a web-based application. The Part D sponsor would manually effectuate the individual's election into the program and communicate the election to the PBM in real time. The PBM would then add the individual to the relevant eligibility file. Once the individual's election is effectuated, the pharmacist would either reverse and resubmit the claim to receive the plan-specific Medicare Prescription Payment Plan BIN/PCN, or the new program participant would receive a verbal confirmation via the phone call with the Part D sponsor providing the plan-specific BIN/PCN.
                    </P>
                    <P>
                        • 
                        <E T="03">Option #3:</E>
                         Require Part D sponsors to process election requests within 24 hours. If a Part D enrollee wishes to elect into the Medicare Prescription Payment Plan, they may use any of the plan's election mechanisms. During the plan year, Part D sponsors must process the election request within 24 hours. The Part D sponsor would then communicate the effectuation to the enrollee and to the PBM.
                    </P>
                    <P>As noted earlier in this rule, CMS proposed to codify the 24-hour timeframe for election requests made during the plan year, as required in 2025, and requested comment on real-time election. We believe that the 24-hour timeframe, paired with the required process to retroactively apply the program to those meeting criteria for a retroactive election, reduces the likelihood of dispensing delays and prescription abandonment while avoiding the operational burden that would be required for Part D sponsors, PBMs, and pharmacies to develop and implement mechanisms to support real-time or POS election. We are continuing to explore the operational feasibility of a real-time election mechanism for 2026 and subsequent years.</P>
                    <HD SOURCE="HD3">b. Pharmacy Processes</HD>
                    <P>Section 1860D-2(b)(2)(E)(v)(III)(ff) of the Act states that an individual's participation in the Medicare Prescription Payment Plan does not affect the amount paid (or the timing of such payments) to pharmacies. Accordingly, we proposed that the Part D sponsor must pay the pharmacy for the final amount the individual would have otherwise paid at the POS. Because an individual's OOP costs are net of any contributions made by supplemental payers to Part D to which the individual may be entitled and that reduce the OOP amount due, this requires the Medicare Prescription Payment Plan to be integrated into current COB transactions for program participants.</P>
                    <P>We proposed to require pharmacies and Part D sponsors to utilize an additional BIN/PCN that is unique to the Medicare Prescription Payment Plan to facilitate electronic processing of supplemental COB transactions for program participants.</P>
                    <P>We also considered the use of a pre-funded card, which would keep the pharmacy whole and could allow for COB with other payers supplemental to Part D; however, we are concerned this approach does not provide the same level of Part D sponsor oversight to ensure that payments are only made for covered Part D drugs for the participant cardholder. Additionally, there are other concerns surrounding timeliness of issuing payment cards and participants needing to present a physical card at the POS, which could be forgotten, lost, or stolen, potentially causing delays in obtaining prescription drugs, elevated risk of fraud, additional costs to the Part D program, and potential card processing fees for pharmacies. We are also aware that not all organizations have the financial capabilities established to enable a prefunded payment card system. Moreover, interested parties have also expressed a desire to have a single, uniform method of adjudicating and managing the patient liability for the Medicare Prescription Payment Plan at the POS; we determined the use of unique BIN/PCNs for the final transaction to the Medicare Prescription Payment Plan best accomplishes that objective.</P>
                    <HD SOURCE="HD3">2. Part D Coverage of Anti-Obesity Medications (AOMs) (§ 423.100) and Application to the Medicaid Program</HD>
                    <P>
                        In this section, we discuss the alternative considered when developing our proposal to reinterpret section 1927(d)(2)(A) of the Act such that drugs 
                        <PRTPAGE P="99530"/>
                        used for weight loss or chronic weight management for treatment of obesity would no longer be excluded from the definition of Part D drug to reflect changes in the prevailing medical consensus towards recognizing obesity as a disease. FDA-approved indications for available AOMs generally include weight loss or chronic weight management in both individuals with obesity and individuals with overweight and at least one weight-related comorbid condition. We considered an alternative proposal to extend our reinterpretation of the statutory exclusion to no longer consider drugs used for weight loss or chronic weight management for individuals with overweight and at least one weight-related comorbidity as excluded from the definition of Part D drug. This alternative proposal would expand Part D coverage of AOMs to Medicare beneficiaries with overweight and a weight-related comorbidity other than type 2 diabetes or cardiovascular disease, since those conditions are already coverable MAIs under current policy. See section III.A.2. of this proposed rule for further discussion regarding our rationale not to extend our reinterpretation of the statutory exclusion such that individuals with overweight and at least one weight-related comorbidity could receive coverage of AOMs under Part D.
                    </P>
                    <P>These estimates follow a similar methodology to the estimates of our proposal to permit AOM coverage for weight loss or chronic weight management for treatment of obesity as described in section VII.D.6. of this proposed rule. For Medicare, the estimates expanded the population newly able to obtain AOM coverage from 7 percent to approximately 9 percent of total Part D enrollees based on 2022 data, which includes the number of Part D enrollees with obesity (7 percent) and with overweight and weight-related comorbidities (2 percent). As shown in table 35, the alternative proposal would result in expenditures of $35 billion over a 10-year period for the Part D trust fund (increased from $24.8 billion for the proposal discussed in section VII.D.1.a. to provide coverage for obesity only). For the purposes of this alternative analysis, we report annual costs with a placeholder for each year starting with the first year the reinterpretation would be applicable in Medicare Part D. Premium offsets reflect the earliest such offsets would be factored into the analysis due to premium stabilization provisions in section 11201 of the IRA (assuming 2026 notionally as year 1 of implementation).</P>
                    <GPH SPAN="3" DEEP="101">
                        <GID>EP10DE24.043</GID>
                    </GPH>
                    <P>
                        It is possible that our estimates significantly underestimate the impact of our alternative proposal. Our estimates rely on available claims data and therefore a major limitation in our estimates is whether a diagnosis of overweight was reliably reported. Available NHANES data from 2017 to 2018 indicates that the prevalence of overweight in the U.S. adult population was 30.7 percent 
                        <SU>364</SU>
                        <FTREF/>
                         which is more than triple the prevalence observed in Medicare claims data (8.1 percent). NHANES data did not report the proportion of overweight in adults age 60 and older, but the prevalence of obesity in the overall U.S. adult population is similar to the prevalence in adults age 60 and older; therefore, we think it is reasonable to assume that the proportion of overweight in the Medicare population should be similar to the proportion of overweight in the overall U.S. adult population.
                    </P>
                    <FTNT>
                        <P>
                            <SU>364</SU>
                             
                            <E T="03">https://www.niddk.nih.gov/health-information/health-statistics/overweight-obesity.</E>
                        </P>
                    </FTNT>
                    <P>We were unable to estimate the financial impact of the alternative proposal on the Medicaid program due to lack of available data on the proportion of Medicaid enrollees with overweight and weight-related comorbidities.</P>
                    <HD SOURCE="HD3">3. Ensuring Equitable Access to Behavioral Health Benefits Through Section 1876 Cost Plan and MA Cost-Sharing Limits (§§ 417.454 and 422.100)</HD>
                    <P>In this section, CMS discusses alternatives we considered when developing our proposal to add behavioral health service categories to the list of services for which MA and Section 1876 Cost Plan (Cost Plan) in-network cost sharing must be no greater than that in Traditional Medicare, beginning in contract year 2026. We do not include alternatives for the proposal to clarify the applicability of the 50 percent coinsurance (or actuarially equivalent copayment) standard for Cost Plans and other proposals that primarily continue current policy with minor updates. For example, this includes our proposed revision to § 417.454(a)(1) which would allow for CMS to annually update copayment limits for basic benefits that apply to Cost Plans based on the most recent Medicare FFS data projections.</P>
                    <HD SOURCE="HD3">a. Cost Estimation</HD>
                    <P>
                        As noted in section VII.D.4. of this proposed rule, because of multiple factors affecting bids and our longstanding actuarially equivalent MA plan bid requirements, we have not estimated a cost for this proposal and acknowledge a possible combination of savings and costs for individual organizations and enrollees. Similarly, we would not be able to quantify potential impacts from these alternative behavioral health cost-sharing standards considered for MA and Cost Plans. However, potential impacts from the alternatives on average MA and Cost Plan cost-sharing amounts for these services are noted in section VII.E.3.d. of this proposed rule. In addition, as the actuarial equivalence tests are applied to MA plans for each alternative presented in this section, the implication is that—in aggregate—the expected enrollee cost-sharing expenses will remain the same for those enrollees in MA and for beneficiaries in Traditional Medicare. This actuarial requirement does not apply to Cost Plans; however, we do not expect major effects from this proposal on these plans, primarily because: (1) only a 
                        <PRTPAGE P="99531"/>
                        small proportion of these plans (20% or fewer) have established cost sharing greater than the alternatives considered; (2) in most cases plans with cost sharing greater than the alternatives considered should not have to vastly change their cost sharing designs to come into compliance (less than $20.00 per service category in most cases); and (3) Cost Plans represent a small proportion of all Medicare-eligible beneficiaries (approximately 169,000 as of July 2024 
                        <SU>365</SU>
                        <FTREF/>
                        ). In addition, we expect beneficiary choice will continue to act as an incentive for Cost Plan organizations to offer favorable benefit designs. Consequently, we expect no material changes to the Medicare Trust Fund expenditures since aggregate enrollee cost sharing remains unchanged or minimally affected under the proposed or alternative scenarios discussed in section VII.E.3.d. of this proposed rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>365</SU>
                             CMS. Contract Summary 2024. Data as of July 2024. Retrieved from: 
                            <E T="03">https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/mcradvpartdenroldata/monthly/contract-summary-2024-07.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Applicability Date</HD>
                    <P>All alternatives in section VII.E.3.d. of this proposed rule consider specific behavioral health cost-sharing standards that would apply beginning in contract year 2026. If this proposal is finalized and issued within an expected timeframe, we believe changes to the behavioral health cost-sharing standards should be applicable beginning no earlier than contract year 2026 to provide sufficient time between the publication of the final rule and the behavioral health cost-sharing compliance date (operationally this would be the bid deadline for the first contract year in which the cost-sharing limits would apply). Specifically, sufficient time between these dates is necessary for: (1) CMS to implement the finalized policy (which may include creating validations in the PBP functionality and issuing subregulatory operational guidance for MA organizations); and (2) organizations to ensure their benefit designs align with the finalized behavioral health cost-sharing policies and any operational guidance issued by CMS. However, as discussed in section III.M. of this proposed rule, we solicit comments on aspects of our proposal including whether a transition period from the existing contract year 2026 behavioral health cost-sharing standards in current regulations to the proposed cost-sharing standard (alternative 3) is necessary and if so, how long the transition should be.</P>
                    <HD SOURCE="HD3">c. Evaluation Approach of Alternatives Considered</HD>
                    <P>In section VII.E.3.d. of this proposed rule, we evaluate which alternative may best strike a balance between: (1) improving the affordability of behavioral health services for enrollees in a timely manner; and (2) minimizing disruption to enrollees' access to care and coverage options. This evaluation is supported by narratives and tables that indicate how each alternative may impact future contract year: (1) behavioral health service category cost-sharing (copayment and coinsurance) limits set by CMS; and (2) behavioral health cost sharing amounts established by MA and Cost Plans. Specifically, we evaluate these potential consequences for the following behavioral health service categories that are subject to this proposal:</P>
                    <P>
                        • Inpatient hospital psychiatric services 
                        <SU>366</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>366</SU>
                             Cost Plans are not required to report information for all services, including Part A inpatient hospital psychiatric services. Due to this lack of data, from a Cost Plan perspective we are only able to evaluate potential impacts to inpatient hospital psychiatric services cost-sharing limits (for all length of stay scenarios) and not to plan cost sharing amounts. In contrast, for MA plans we are able to evaluate potential impacts to both cost-sharing limits and plan amounts for this service category.
                        </P>
                    </FTNT>
                    <P>
                        • Mental health specialty services 
                        <SU>367</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>367</SU>
                             Beginning January 1, 2024, Medicare started allowing marriage, family, and mental health counselors to bill independently for their professional services and made changes to payment for certain mental health specialty services including services involving community health workers and outpatient psychotherapy for crisis services. At the time of drafting this proposed rule, the OACT did not have sufficient utilization data available for these services to incorporate their costs into the projected weighted average allowed amount that we use to calculate illustrative “mental health specialty services” service category copayment limits that could result from the alternatives discussed in this section. As a result, the illustrative “mental health specialty services” service category copayment limits in this section are based on a projected weighted average allowed amount calculated using the same provider specialties that were used to calculate the copayment limits for this service category for contract year 2025, including: clinical psychologist, licensed clinical social worker, and psychiatry. Regardless of whether this proposal is finalized or not, CMS plans to update the Medicare FFS data used to inform the calculation of copayment limits for the “mental health specialty services” service category for contract year 2026 and future years to include covered services from marriage, family, and mental health counselors and new payment rates for certain mental health specialty services. As a result, CMS expects actual “mental health specialty services” service category copayment limits that would result from each alternative discussed in this section would be different from the illustrative copayment limits provided in this section.
                        </P>
                    </FTNT>
                    <P>• Psychiatric services</P>
                    <P>
                        • Partial hospitalization 
                        <SU>368</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>368</SU>
                             Beginning January 1, 2024, Medicare started covering Intensive Outpatient Program services. This benefit provides the same services as the partial hospitalization program benefit but requires fewer hours of therapy per week (a minimum of 9 hours versus over 20 hours). At the time of drafting this proposed rule, the OACT did not have sufficient utilization data available for this service type to project an allowed amount for these Intensive Outpatient Program services that is separate from partial hospitalization program services. As a result, in evaluating the alternatives discussed in this section, CMS considered that the illustrative partial hospitalization copayment limits in this section would also apply to the Intensive Outpatient Program services. Regardless of whether this proposal is finalized or not, CMS plans to set cost-sharing limits specific to Intensive Outpatient Program services for contract year 2026 and future years that are separate from the cost-sharing limits applicable to partial hospitalization program services and establish separate data entry for this benefit in the PBP bid tool. As a result, CMS expects actual copayment limits that would result from each alternative discussed in this section for Intensive Outpatient Program services would be different from the illustrative partial hospitalization program services copayment limits provided in this section.
                        </P>
                    </FTNT>
                    <P>• Outpatient substance use disorder services</P>
                    <P>• Opioid treatment program services</P>
                    <P>
                        Tables indicating potential consequences to the cost-sharing limits and plan cost-sharing amounts for these service categories are included in section VII.E.3.e. of this proposed rule. To develop the illustrative dollar values in these tables, we used: (1) analyses of the most recent and relevant data sources CMS had at the time of developing this proposal: contract year 2025 Medicare FFS data projections (based on 2019-2023 Medicare FFS data, respectively) and contract year 2024 MA and Cost Plan data 
                        <SU>369</SU>
                        <FTREF/>
                         and (2) application of the existing rounding rules in current regulation (§ 422.100(f)(6)(ii)) that apply to MA copayment limits and are proposed to apply to Cost Plan copayment limits per § 417.454(e). Additional detail about the specific Traditional Medicare FFS data projections used in the calculations to develop these amounts are available in the footnotes of tables 3 and 4 in section III.L. of this proposed rule. For example, this includes the provider specialties that informed the projected total weighted average allowed amount per visit for mental health specialty services.
                    </P>
                    <FTNT>
                        <P>
                            <SU>369</SU>
                             Excludes employer, D-SNPs, and MSAs.
                        </P>
                    </FTNT>
                    <P>• The consequences discussed and shown in the tables in sections VII.E.3.d. and e. of this proposed rule are uncertain because:</P>
                    <P>
                        • Final behavioral health copayment and dollar limits set in future contract years (under the existing cost-sharing standards in current regulations, the proposed cost-sharing standard, or the other alternative cost-sharing standards considered) would likely be different than the illustrative behavioral health copayment and dollar limits in this 
                        <PRTPAGE P="99532"/>
                        proposed rule based on using updated Traditional Medicare FFS data projections and coverage rules to calculate the limits.
                    </P>
                    <P>• Plan behavioral health cost-sharing amounts established by organizations in future contract years cannot be precisely predicted because: (1) organizations may establish plan cost sharing amounts up to the applicable final limit set by CMS, regardless of any prior trend in establishing cost sharing for that service category; (2) organizations establish plan cost sharing amounts based on many variables that may change annually (including provider contracting arrangements, managed care practices, and scope of supplemental benefit offerings); (3) if CMS does not set a copayment limit for a behavioral health service category, the plan's copayment amount may be actuarially equivalent to, or less than, the applicable cost-sharing standard based on data specified in the regulation which may include their total financial liability for that benefit (which may be greater or less than the illustrative copayment limits in this section); and (4) Cost Plans are not required to report information for all services.</P>
                    <P>However, the consequences each alternative poses to the behavioral health coinsurance limits and percent of estimated Traditional Medicare FFS cost sharing (which determine dollar cost- sharing limits for inpatient hospital psychiatric services) are characterized by a relatively high degree of certainty because these values are not subject to the influencing factors discussed previously.</P>
                    <P>CMS considered both the consequences discussed in this section to guide our decision making among the alternative behavioral health cost-sharing standards considered. We believe the data used to develop the potential consequences to future year behavioral health copayment limits and plan cost sharing amounts is sufficiently accurate for this purpose. Tables 32 to 34 and 36 to 55 indicate these consequences of each alternative. Next, we provide an overview of tables 32 to 34 and 36 to 55 to avoid repetitive text in the discussion of specific alternatives.</P>
                    <P>Tables 36 to 40 specify contract year 2026 and future year MA behavioral health cost-sharing standards that would apply to specific service categories based on: (1) the current (or baseline) cost-sharing standard from § 422.100(f)(6) and (j)(1); (2) the cost-sharing standard posed by each alternative (percent coinsurance or percent of estimated Medicare FFS cost sharing); and (3) illustrative dollar limits that reflect actuarially equivalent values to the baseline and alternative cost-sharing standards, based on contract year 2025 Traditional Medicare FFS data projections and application of the regulatory rounding rules. These comparisons are completed for categories from each group of behavioral health services that have different cost-sharing standards in current regulations. Specifically, tables 36 to 40 present information for the following MA behavioral health service categories:</P>
                    <P>• Mental health specialty services (table 36) and partial hospitalization program services (table 37) currently subject to a range of cost-sharing limits for professional services in paragraph (f)(6)(iii)).</P>
                    <P>• Inpatient hospital psychiatric services for the 15-day length of stay scenario (table 38) currently subject to dollar limits based on specific percentages of Medicare FFS cost sharing in paragraph (f)(6)(iv).</P>
                    <P>• Opioid treatment program services (table 39) and outpatient substance use disorder services (table 40) currently subject to the 50 percent coinsurance (or actuarially equivalent copayment) cap on cost sharing in paragraph (f)(6)(i).</P>
                    <P>CMS uses the information in tables 36 to 40 to assess each alternative's potential impact to MA behavioral health cost-sharing limits on an overall and service category specific basis. Tables 41 to 45 use similar data for Cost Plans for this same purpose. Substantive differences in table 41 to 45 from tables 36 to 40 include the following:</P>
                    <P>• A lack of a range of cost-sharing limits considered under Alternative 1 for Cost Plans (as they are not subject to setting one of three MOOP types as MA plans are) instead, the lowest cost-sharing limit under Alternative 1 is considered for all Cost Plans (as shown in tables 41 and 42).</P>
                    <P>• The illustrative dollar limits only reflect actuarially equivalent values to the alternative cost-sharing standards, not the baseline standards. This is because the current (baseline) standards derive from § 417.454 and longstanding dollar limits applied to Cost Plans for behavioral health services (as shown in tables 41 to 45).</P>
                    <P>
                        Tables 46 and 47 specify—by service category—the number and percent of contract year 2023 and 2024 MA plans that: (1) established cost sharing amount(s) exceeding the cost-sharing limit applied to plans with a mandatory MOOP type for that contract year and service category; and (2) switched to a lower or intermediate MOOP type from a mandatory MOOP type in the prior contract year. CMS developed these tables to assess how each alternative may impact the number of MA plans that offer lower MOOP amounts in future contract years. We make this assessment for each alternative based on our evaluation in the narratives of how and to what extent tables 41 and 42 suggest that differentiated behavioral health cost-sharing limits (beginning in contract year 2023 
                        <SU>370</SU>
                        <FTREF/>
                        ) may have incentivized MA plans to adopt lower MOOP amounts for contract year 2023 and 2024. Corresponding tables for Cost Plans are not applicable under this proposal.
                    </P>
                    <FTNT>
                        <P>
                            <SU>370</SU>
                             As discussed in the April 2022 final rule, most professional cost-sharing standards were the same for all MOOP types before contract year 2023. The cost-sharing standards established by the April 2022 final rule created differentiated professional and inpatient hospital cost-sharing limits (including for some behavioral health service categories) by MOOP type beginning in contract year 2023 to encourage plans to adopt lower MOOP amounts.
                        </P>
                    </FTNT>
                    <P>
                        Tables 33, 48, 49, 52 A through C, and 53 (MA plans and enrollees) and tables 34, 50, 51, 54, and 55 (Cost Plans and enrollees) evaluate contract year 2024 plan and enrollee data 
                        <SU>371</SU>
                        <FTREF/>
                         by behavioral health service category. Specifically—
                    </P>
                    <FTNT>
                        <P>
                            <SU>371</SU>
                             Contract year 2024 plan weighted average cost sharing values reflect maximum cost sharing for each behavioral health service category (including plans with copayment and coinsurance percentages). Specifically, plan coinsurance values were converted into equivalent copayment dollar amounts and vice versa to calculate a weighted average coinsurance and copayment value for each category that reflects all cost sharing designs. These plan cost sharing conversions were based on the OACT's contract year 2025 projected total Medicare FFS allowed amount for each professional service category. This approach allows for a consistent comparison between plan cost sharing amounts and the potential cost-sharing standard that could apply if a particular alternative was finalized. As a result, contract year 2024 plan weighted average cost sharing values consistently reflect dollar values that are normalized based on the same and most recent data available, contract year 2025 Medicare FFS projections. The OACT developed the contract year 2025 projected total Medicare FFS allowed amounts using 2022 Medicare FFS cost and utilization data and their projections of cost changes between 2022 to 2025. The OACT employed generally accepted actuarial principles and practices in calculating these projected amounts (per § 422.100(f)(7)).
                        </P>
                    </FTNT>
                    <P>• Tables 48 and 49 (MA) and tables 50 and 51 (Cost Plans) identify the percent of plans and enrollees with cost sharing amounts that are greater than the cost-sharing limits considered by each alternative.</P>
                    <P>• Tables 33, 52A through C, and 53 (MA) and tables 34, 54, and 55 (Cost Plans) specify: (1) the weighted average plan cost sharing amount for the plans identified with cost-sharing amounts that are greater than the cost-sharing limits considered by each alternative; and (2) the difference between those weighted average plan cost sharing amounts and the cost-sharing standards posed by each alternative.</P>
                    <P>
                        In essence, tables 33, 47,48, 52A through C, and 53 (MA plans and 
                        <PRTPAGE P="99533"/>
                        enrollees) and tables 34, 50, 51, 54, and 55 (Cost Plans and enrollees) approximate the: (1) proportion of plans that may lower cost sharing; (2) proportion of enrollees that may be in those plans and experience that lower cost sharing; and (3) weighted average reduction in plan cost sharing that may occur for each behavioral health service category (as possible) and alternative. As a result, in the narratives in section VII.E.3.d. of this proposed rule, we consider the information in these tables to reflect an estimate of each alternative's potential impact on MA and Cost Plans and enrollees based on the most recent Medicare FFS and plan data available.
                    </P>
                    <HD SOURCE="HD3">d. Alternatives Considered for Behavioral Health Service Category Cost-Sharing Limits</HD>
                    <P>In this section CMS summarizes the MA and Cost Plan cost-sharing standards considered by each alternative, evaluates the potential and definitive consequences of each alternative in comparison to the other alternatives, and provides rationale for our decision to propose the behavioral health cost-sharing standards considered under Alternative 3.</P>
                    <HD SOURCE="HD3">(1) Alternative 1</HD>
                    <P>In this alternative, CMS considered MA behavioral health service category cost-sharing standards for contract year 2026 and future years that would: (1) maintain or increase the amount of cost-sharing incentive MA plans have to offer lower MOOP types; and (2) result in lower behavioral health cost-sharing limits for all MOOP types in comparison to the limits that would apply based on the existing cost-sharing standards in current regulations. As discussed in the April 2022 final rule, CMS set a transition to a range of cost-sharing limits for professional services proportionate to each MOOP type by contract year 2026 to incentivize MA organizations to offer plans with lower MOOP amounts. This alternative takes a similar approach by applying behavioral health service category cost-sharing standards that are unique to each MOOP type, with the lower MOOP types retaining the most cost-sharing flexibilities. To apply this alternative to Cost Plans (which lack MOOP types), we considered applying the lowest cost-sharing standard that was considered for MA plans (those with a mandatory MOOP type).</P>
                    <HD SOURCE="HD3">(a) Specific Cost-Sharing Standards Considered</HD>
                    <P>This alternative considers the following MA cost-sharing standards for the professional behavioral health service categories (mental health specialty services, psychiatric services, partial hospitalization, outpatient substance use disorder services, and opioid treatment program services):</P>
                    <P>
                        • 
                        <E T="03">Lower MOOP Type:</E>
                         Cost sharing no greater than Traditional Medicare (which is 20 percent coinsurance or an actuarially equivalent copayment, except for the “opioid treatment program services” service category which has no cost sharing in Traditional Medicare).
                    </P>
                    <P>
                        • 
                        <E T="03">Intermediate MOOP Type:</E>
                         15 percent coinsurance (or an actuarially equivalent copayment).
                    </P>
                    <P>
                        • 
                        <E T="03">Mandatory MOOP Type:</E>
                         10 percent coinsurance (or an actuarially equivalent copayment).
                    </P>
                    <P>The 10 percent coinsurance (or an actuarially equivalent copayment) would apply to all Cost Plans for the same professional behavioral health service categories under this alternative. In addition, this alternative considers setting the “inpatient hospital psychiatric services” service category dollar limits (all length of stay scenarios) for MA plans based on the following:</P>
                    <P>
                        • 
                        <E T="03">Lower MOOP Type:</E>
                         Cost sharing no greater than Traditional Medicare (100 percent of estimated Medicare FFS cost sharing).
                    </P>
                    <P>
                        • 
                        <E T="03">Intermediate MOOP Type:</E>
                         the numeric midpoint between the cost-sharing limits set for the lower and mandatory MOOP types (continuing current policy 
                        <SU>372</SU>
                        <FTREF/>
                        ).
                    </P>
                    <FTNT>
                        <P>
                            <SU>372</SU>
                             While this alternative continues current policy to set the “inpatient hospital psychiatric services” service category cost-sharing limits for the intermediate MOOP type, this approach effectively lowers the cost-sharing limits for this MOOP type because the numeric midpoint would reflect a lower value from the changes considered to the cost-sharing standards for the mandatory and lower MOOP types.
                        </P>
                    </FTNT>
                    <P>
                        • 
                        <E T="03">Mandatory MOOP Type:</E>
                         50% of estimated Medicare FFS cost sharing.
                    </P>
                    <P>The 50 percent estimated Medicare FFS cost sharing amount for MA plans with a mandatory MOOP type would also apply to all Cost Plans for the same “inpatient hospital psychiatric services” service categories under this alternative.</P>
                    <P>As a result, this alternative results in: (1) proportionate cost-sharing limits for each MOOP type for MA plans; and (2) meaningful decreases to the existing behavioral health cost-sharing standards in current regulations for contract year 2026 and future years (which in some cases go up to 50 percent coinsurance or an actuarially equivalent copayment) for MA and Cost Plans. For example, the professional behavioral health MA cost-sharing standards consistently decrease by a coinsurance increment of 5 percent between MOOP types (with the mandatory MOOP type receiving the least cost-sharing flexibility) under this alternative.</P>
                    <HD SOURCE="HD3">(b) Evaluation</HD>
                    <P>In comparison to the existing cost-sharing standards in current regulations and the other alternatives in this section, this alternative considers the lowest behavioral health cost-sharing limits for MA and Cost Plans (with one exception for the opioid treatment program service category where alternative 3 results in a lower, zero-dollar cost-sharing requirement as shown in tables 39 and G18). For example, as shown in table 36 for MA plans, this alternative results in a $25 copayment limit for the “mental health specialty services” service category. This is $10 to $45 less than the copayment limits that would result for that service category and MOOP type if the existing MA cost-sharing standards or other alternatives were used. As another example, as shown in table 38 for MA plans, this alternative decreases the dollar limit for the 15-day length of stay scenario of the “inpatient hospital psychiatric services” service category and intermediate MOOP type by $826 in comparison to the current regulatory MA cost-sharing standard. This is the most significant decrease because alternatives 2 and 3 reflect decreases from the current regulatory MA cost-sharing standard of only $55 and $275, respectively—for the same service category, length of stay, and MOOP type. Tables 37, 39, and 40 (MA plans) and tables 41 to 43, and 45 (Cost Plans) reflect similar findings for additional behavioral health service categories.</P>
                    <P>This alternative improves upon the existing cost-sharing incentives for MA plans to offer lower MOOP types because it considers—</P>
                    <P>• Adding two service categories that have differentiated cost-sharing limits by MOOP type (opioid treatment program services and outpatient hospital substance use disorder services),</P>
                    <P>• Increasing the value of each inpatient hospital psychiatric services cost-sharing incentive by: (1) lowering all the cost-sharing limits; and (2) increasing the cost-sharing limit differentiation between the MOOP types from a coinsurance increment of 25 to 50 percent; and</P>
                    <P>
                        • Nominal reductions to the cost-sharing limit differentiation between the MOOP types for the professional service categories from a coinsurance increment of 10 to 5 percent.
                        <PRTPAGE P="99534"/>
                    </P>
                    <P>In contrast, the other alternatives consider cost-sharing standards that apply to all MOOP types equally and thus do not retain or improve the existing behavioral health cost-sharing incentives for MA plans to establish lower MOOP amounts.</P>
                    <P>
                        Despite these improvements to the cost-sharing incentives, CMS believes this alternative would not result in substantially more MA plans choosing to establish lower MOOP amounts in future contract years in comparison to the effects that alternative 2 and 3 might pose. This is because, as supported by tables 41 and 42, the driving force for MA plans to switch to lower MOOP types in contract year 2023 and 2024 seems to be the ability to utilize cost-sharing flexibilities for emergency services. For example, as shown in table 41, of the MA plans that switched from a mandatory MOOP type to a lower or intermediate MOOP type in contract year 2024, the percent of plans that utilized 
                        <SU>373</SU>
                        <FTREF/>
                         cost-sharing flexibilities was about—:
                    </P>
                    <FTNT>
                        <P>
                            <SU>373</SU>
                             As discussed in section VII.E.3.c. of this proposed rule, in this context utilizing a cost sharing flexibility means the plan established a cost sharing amount for a service category that is greater than the applicable cost-sharing limit set for the mandatory MOOP type.
                        </P>
                    </FTNT>
                    <P>
                        • 
                        <E T="03">86 percent:</E>
                         emergency services;
                    </P>
                    <P>
                        • 
                        <E T="03">39 percent:</E>
                         partial hospitalization;
                    </P>
                    <P>
                        • 
                        <E T="03">20 percent:</E>
                         skilled nursing facility—first 20 days;
                    </P>
                    <P>
                        • 
                        <E T="03">19 percent:</E>
                         inpatient hospital psychiatric—8-day length of stay scenario;
                    </P>
                    <P>
                        • 
                        <E T="03">12 percent:</E>
                         urgently needed services; and
                    </P>
                    <P>• Less than percent for all other service categories.</P>
                    <P>
                        CMS takes these percentages 
                        <SU>374</SU>
                        <FTREF/>
                         of utilization as evidence that the cost-sharing flexibilities for emergency services and other non-behavioral health service categories may, by themselves, offer sufficient incentive for a similar proportion of MA plans to offer lower MOOP types in future years.
                    </P>
                    <FTNT>
                        <P>
                            <SU>374</SU>
                             The number and percentage of plans that utilized each service category cost sharing flexibility do not total to 100% as most plans that switched utilized cost-sharing flexibilities from multiple service categories.
                        </P>
                    </FTNT>
                    <P>Based on tables 33, 48, 49, 52, and 53, CMS expects this alternative, in comparison to the potential effects from the other alternatives, would result in: (1) the most MA plans and enrollees experiencing lower behavioral health cost sharing than prior contract years; and (2) the greatest decreases in plan cost sharing for most behavioral health service categories. For example, based on contract year 2024 MA plan data and the cost-sharing standards posed by this alternative, we estimate that—for the “psychiatric services” service category—of MA plans that continue in contract year 2026 and maintain a mandatory MOOP type are as follows:</P>
                    <P>• About 48 percent of plans would have to reduce their cost sharing (as shown in table 48).</P>
                    <P>• About 45 percent of enrollees could experience this reduction in cost sharing (as shown in table 49).</P>
                    <P>• The enrollees in those plans could experience a reduction in cost sharing—on average—of about $19 per visit (as shown in table 52C, from about $34 to $15 per visit).</P>
                    <P>In comparison, as shown in tables 33, 48, 49, and 53, the cost-sharing limits considered in alternatives 2 and 3 for this service category may impact fewer MA plans and enrollees and require less significant cost sharing decreases based on contract year 2024 plan data. Specifically, for the “psychiatric services” service category, we estimate that in response to alternative 2 and 3 that of MA plans that continue in contract year 2026:</P>
                    <P>• Less than 1 percent and about 25 percent of plans would have to reduce their cost sharing, respectively (as shown in table 48).</P>
                    <P>• About 1 percent and 22 percent of enrollees could experience this reduction in cost sharing, respectively (as shown in table 49).</P>
                    <P>• The enrollees in those plans could experience a reduction in cost sharing—on average—of about $10 per visit for alternative 2 (as shown in table 53) or about $7 per visit for alternative 3 (as shown in table 33).</P>
                    <P>Based on tables 34, 50, 51, 54, and 55, CMS also expects this alternative, in comparison to the potential effects from the other alternatives, would result in the most Cost Plans and enrollees experiencing: (1) lower behavioral health cost sharing than prior contract years; and (2) greater decreases in plan cost sharing for most behavioral health service categories. For example, based on contract year 2024 Cost Plan data and the cost-sharing standards posed by this alternative, we estimate that—for the “mental health specialty services” service category—of Cost Plans that continue in contract year 2026:</P>
                    <P>• About 20 percent of plans would have to reduce their cost sharing (as shown in table 50).</P>
                    <P>• About 13 percent of enrollees could experience this reduction in cost sharing (as shown in table 51).</P>
                    <P>• The enrollees in those plans could experience a reduction in cost sharing—on average—of about $17 per visit (as shown in table 54, from about $32 to $15 per visit).</P>
                    <P>In comparison, as shown in tables 34, 50, 51, and 55, the cost-sharing limits considered in alternatives 2 and 3 for this service category may impact fewer Cost Plans and enrollees and require less significant cost sharing decreases based on contract year 2024 plan data. Specifically, for the “mental health specialty services” service category, we estimate that in response to alternative 2 and 3 that of Cost Plans that continue in contract year 2026:</P>
                    <P>• 0 percent and about 8 percent of plans would have to reduce their cost sharing, respectively (as shown in table 50).</P>
                    <P>• 0 percent and about 3 percent of enrollees could experience this reduction in cost sharing, respectively (as shown in table 51).</P>
                    <P>• The enrollees in those plans could experience a reduction in cost sharing—on average—of about $0 per visit for alternative 2 (as shown in table 55) or about $5 per visit for alternative 3 (as shown in table 34).</P>
                    <P>Given the information in tables 33, 48, 49, 52, and 53 (MA plans) and tables 34, 50, 51, 54, and 55 (Cost Plans), this alternative (in comparison to the other alternatives in this section) has the most potential to improve the affordability of behavioral health services for enrollees. However, CMS believes this potential could pose significant disruption to MA plans' bidding process. This is because, the contract year 2024 plan data findings in these tables suggest that most continuing plans would have to significantly change their benefit designs to come into compliance with the cost-sharing standards posed by this alternative. We are also concerned that setting behavioral health service category cost-sharing limits for multiple MOOP types at amounts that are less than the cost sharing in Traditional Medicare for those benefits would impact an MA plan's ability to meet all other cost-sharing requirements (including overall bid actuarial equivalence to Traditional Medicare, as discussed in section III.L. of this proposed rule). In combination, this alternative could result in a proportion of MA and Cost Plans leaving the market.</P>
                    <HD SOURCE="HD3">(c) CMS Decision</HD>
                    <P>We reject this alternative because CMS has concerns about whether this alternative would pose disruption significant enough to possibly cause MA and Cost Plan exits to the detriment of the overall market.</P>
                    <HD SOURCE="HD3">(2) Alternative 2</HD>
                    <P>
                        In this alternative, CMS considered proposing behavioral health cost-
                        <PRTPAGE P="99535"/>
                        sharing standards that would: (1) be less likely to result in MA and Cost Plans exiting the market in comparison to alternative 1 (by considering limits greater than those considered by alternative 1); and (2) still represent a decrease in comparison to the existing contract year 2026 and future year behavioral health cost-sharing standards in current regulations.
                    </P>
                    <HD SOURCE="HD3">(a) Specific Cost-Sharing Standards Considered</HD>
                    <P>Specifically, CMS considered the following behavioral health service category cost sharing limits for all MA and Cost Plans under this alternative:</P>
                    <P>• 30 percent coinsurance or actuarially equivalent copayment for mental health specialty services, psychiatric services, partial hospitalization, opioid treatment program services, and outpatient hospital substance use disorder services.</P>
                    <P>• 110 percent of estimated Medicare FFS cost sharing, including the projected Part A deductible and related Part B costs, to set the cost sharing dollar limits for each inpatient hospital psychiatric length of stay scenario.</P>
                    <P>
                        These values (30 percent coinsurance and 110 percent of estimated Medicare FFS cost sharing) are lower than the existing contract year 2026 and future year behavioral health cost-sharing regulatory requirements for both MA plans (with lower and intermediate MOOP types) and Cost Plans.
                        <SU>375</SU>
                        <FTREF/>
                         However, for MA plans with a mandatory MOOP type compared to current regulations this alternative results in: (1) increases to the inpatient hospital psychiatric dollar limits (all length of stay scenarios); (2) a reduction in cost sharing from 50 percent coinsurance to 30 percent coinsurance for opioid treatment program services and outpatient hospital substance use disorder services; and (3) no change to the cost-sharing standards for the other three service categories.
                        <SU>376</SU>
                        <FTREF/>
                         This is because this alternative considers cost-sharing standards that are greater than alternative 1 (which went up to 100 percent of estimated Medicare FFS cost sharing to set the inpatient hospital psychiatric service category dollar limits and up to 20 percent for the other behavioral health service categories for the lower MOOP type).
                    </P>
                    <FTNT>
                        <P>
                            <SU>375</SU>
                             The existing contract year 2026 and future years inpatient hospital psychiatric cost-sharing limit for MA plans with an intermediate MOOP type in current regulations is based on the numeric midpoint of the dollar limits set for the lower and mandatory MOOP types for each length of stay scenario. In assessing the midpoint of the methodology to set the dollar limits for the lower and mandatory MOOP types we note this is approximately 112.5% of estimated Medicare FFS cost sharing and above the 110% value posed under this alternative.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>376</SU>
                             The existing contract year 2026 and future years inpatient hospital psychiatric cost-sharing limit for the mandatory MOOP type in current regulations is based on 100% of estimated Medicare FFS cost sharing while this alternative calculates dollar limits for all MOOP types using 110% of estimated Medicare FFS cost sharing.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(b) Evaluation</HD>
                    <P>In most cases, this alternative considers the smallest decreases from the behavioral health service category cost-sharing limits that exist in the current regulations for MA and Cost Plans. For example, as shown in table 37 for MA plans, this alternative results in a $90 copayment limit for the partial hospitalization service category (all MOOP types) which is $0 to $60 less than the copayment limits that would result for that service category (depending on MOOP type) if the existing cost-sharing standards were used. In comparison, alternative 1 would result in copayment limits ranging from $30 to $60 depending on MOOP type and alternative 3 would result in a $60 copayment limit for the same service category (all MOOP types). Using another example from table 40 (for MA plans), the $45 copayment limit for the “outpatient substance use disorder services” service category posed by this alternative reflects a decrease of $30 from the current regulatory cost-sharing standard ($75, all MOOP types). In comparison, the copayment limits resulting from alternatives 1 and 3 ($15 to $30, depending on MOOP type and $30 all MOOP types, respectively) reflect more significant decreases from the current regulatory cost-sharing standard for the same service category (decreases between $60 to $45, depending on MOOP type and $45 all MOOP types, respectively). Tables 36 and 39 (MA plans) and tables 43 to 45 (Cost Plans) reflect similar findings for additional service categories.</P>
                    <P>In contrast, table 38 highlights a case where this alternative would result in an increase to the existing inpatient hospital psychiatric cost-sharing standards in current regulations for MA plans. For example, as shown in table 38, this alternative would increase the percent of estimated Medicare FFS cost sharing that determines the dollar limits for the 15-day length of stay scenario of the “inpatient hospital psychiatric services” service category for an MA plan that establishes a mandatory MOOP amount from 100 percent (or a $2,204 dollar limit based on the current regulations at § 422.100(f)(6)(iv)) to 110 percent or $2,424. As shown in table 38 for the same length of stay scenario and MOOP type, alternative 1 would lower the percent of estimated Medicare FFS cost sharing to 50 percent or $1,102 and alternative 3 would retain the current regulatory standard of 100 percent estimated Medicare FFS cost sharing or $2,204. As a result, tables 36 to 40 show that this alternative would create some decreases and increases to the behavioral health service category cost-sharing limits (depending on the MA plan's MOOP type) in comparison to the existing contract year 2026 and future year MA cost-sharing standards in current regulations.</P>
                    <P>While this alternative applies cost-sharing limits consistently across all MOOP types, we expect this alternative would not substantially impact the number of MA plans switching to lower MOOP types in future years for multiple reasons. First, as discussed in relation to alternative 1 in this section, tables 46 and 47 show that most MA plans that switched from a mandatory MOOP type to lower MOOP types in contract year 2023 and 2024 did not utilize the behavioral health cost-sharing flexibilities available to them. Second, the most utilized cost-sharing flexibility by the plans that switched to lower MOOP types in those contract years—emergency services—would not be impacted by this alternative and increasing flexibility in the dollar limits for this category in future years are memorialized in § 422.113(b)(2)(v). As a result, we expect the emergency services cost-sharing flexibility will continue to be a significant incentive for MA plans to consider switching to lower MOOP types. Thirdly, we believe other factors such as principles and incentives inherent in managed care, effective negotiations between MA organizations and providers, and competition are considered by MA organizations when making determinations for their plan's design, including MOOP type. As a result, we do not believe the potential concern about this alternative adversely impacting the number of plans offering lower MOOP amounts in future years is as significant as it might otherwise be.</P>
                    <P>
                        Tables 48 and 49 show that less than 5 percent of MA plans and enrollees would have lower cost sharing for the majority of the behavioral health service categories if this alternative was selected based on the cost sharing amounts plans established for contract year 2024. For example, based on contract year 2024 MA plan data and the cost-sharing standards posed by this alternative, we estimate that—for the partial hospitalization service category—of MA plans that continue in contract year 2026:
                        <PRTPAGE P="99536"/>
                    </P>
                    <P>• About 3 percent of plans would have to reduce their cost sharing (as shown in table 48).</P>
                    <P>• About 3 percent of enrollees could experience this reduction in cost sharing (as shown in table 49).</P>
                    <P>• The enrollees in those plans could experience a reduction in cost sharing—on average—of about $10 per day (as shown in table 53, from $100 to $90).</P>
                    <P>As shown in tables 33, 48, 49, and 52, the cost-sharing limits considered in alternatives 1 and 3 for this service category may impact substantially more MA plans and enrollees and require more substantive cost sharing decreases based on contract year 2024 MA plan data. Specifically, for the partial hospitalization service category, we estimate that in response to alternative 1 and 3 that of MA plans that continue in contract year 2026 are as follows:</P>
                    <P>• About 59 percent and 23 percent of plans would have to reduce their cost sharing, respectively (as shown in table 48).</P>
                    <P>• About 50 percent and 16 percent of enrollees could experience this reduction in cost sharing, respectively (as shown in table 49).</P>
                    <P>• The enrollees in those plans could experience a reduction in cost sharing—on average—between $17 and $35 (depending on their plan's MOOP type for alternative 1 as shown in tables 52A through 52C) or $21 for alternative 3 (as shown in table 33).</P>
                    <P>A similar comparison can be made for Cost Plans. Tables 41 and 42 show that 0 percent of Cost Plans and enrollees would have lower cost sharing for all of the behavioral health service categories if this alternative was selected based on the cost sharing amounts plans established for contract year 2024. In contrast, as shown in tables 34, 50, 51, and 54, the cost-sharing limits considered in alternatives 1 and 3 for this service category may impact substantially more Cost Plans and enrollees and require more substantive cost sharing decreases based on contract year 2024 Cost Plan data. For example, for the “outpatient substance use disorder services” service category, we estimate that in response to alternative 1 and 3 that of Cost Plans that continue in contract year 2026 are as follows:</P>
                    <P>• About 20 percent and 5 percent of plans would have to reduce their cost sharing, respectively (as shown in table 50).</P>
                    <P>• About 13 percent and 1 percent of enrollees could experience this reduction in cost sharing, respectively (as shown in table 51).</P>
                    <P>• The enrollees in those plans could experience a reduction in cost sharing—on average—of $15 (for alternative 1 as shown in table 54) or $10 for alternative 3 (as shown in table 34). Based on our evaluation of tables 33, 48, 49, 52, and 53 (MA plans) and tables 34, 50, -51, 54, and -55 (Cost Plans), CMS expects this alternative: (1) would result in nominal decreases to plan cost sharing for most behavioral health cost sharing services for a small proportion of plans and enrollees; and (2) has the least potential to improve the affordability of behavioral health services for enrollees in comparison to the other alternatives.</P>
                    <HD SOURCE="HD3">(c) CMS Decision</HD>
                    <P>We reject this alternative to apply another approach that would better address the potential financial barriers enrollees may face to access equitable and high-quality behavioral health services while still minimizing the potential for MA plans' exits to the overall detriment of the market.</P>
                    <HD SOURCE="HD3">(3) Alternative 3 (Proposed)</HD>
                    <P>In this alternative and proposed approach, CMS considered behavioral health cost-sharing standards that would—</P>
                    <P>• Be more likely to result in a greater proportion of enrollees experiencing lower behavioral health cost sharing than alternative 2 (based on contract year 2024 plan data); and</P>
                    <P>• Not be as significantly different as alternative 1 in comparison to: (1) the existing cost-sharing standards in current regulations for contract year 2026 and future years; and (2) plan cost sharing amounts based on the contract year 2024 weighted average plan cost sharing of plans with cost sharing amounts above the standards considered for the behavioral health service categories.</P>
                    <P>In essence, this proposed alternative aims to strike a better balance in comparison to alternative 1 and 2 between: (1) improving the affordability of behavioral health services for enrollees in a timely manner; and (2) minimizing disruption to MA and Cost Plan enrollees' access to care and coverage options.</P>
                    <HD SOURCE="HD3">(a) Specific Cost-Sharing Standards Considered</HD>
                    <P>This alternative (proposal) considers adding categories of behavioral health services to the list of services at §§ 417.454(e) and § 422.100(j)(1) for which Cost Plans and MA plans (including EGWPs) in-network cost sharing must be no greater than that in Traditional Medicare. Specifically, the following Traditional Medicare cost sharing amounts would apply as a cost-sharing limit to all MA and Cost Plans under this alternative:</P>
                    <P>• 20 percent coinsurance or actuarially equivalent copayment for mental health specialty services, psychiatric services, partial hospitalization, opioid treatment program services, and outpatient hospital substance use disorder services.</P>
                    <P>• 100 percent of estimated Medicare FFS cost sharing, including the projected Part A deductible and related Part B costs, to set the cost-sharing dollar limits for each inpatient hospital psychiatric length of stay scenario.</P>
                    <P>• Zero cost sharing for the “opioid treatment program services” service category.</P>
                    <P>This proposed alternative results in cost-sharing limits that are lower than the existing cost-sharing limits for contract year 2026 and future years in the current regulations for all service categories and MA MOOP types (with one exception). The exception is that continuing MA plans with a mandatory MOOP type would retain a cost-sharing limit equal to cost sharing under Traditional Medicare for inpatient hospital psychiatric services (all length of stay scenarios) and experience no changes if this proposed alternative is finalized. However, if this proposal is finalized and Traditional Medicare changes the cost sharing amount for one of the behavioral health service categories subject to § 417.454(e) or § 422.100(j)(1), the new Traditional Medicare cost sharing amount would apply as the limit for that category.</P>
                    <HD SOURCE="HD3">(b) Evaluation</HD>
                    <P>
                        This alternative considers—with a few exceptions—behavioral health cost-sharing limits that are: (1) less than the existing cost-sharing standards for contract year 2026 and future years and the standards considered by alternative 2; and (2) greater than the standards considered by alternative 1. Specifically, applying either this alternative or alternative 1 result in the same cost-sharing limits for MA plans with the lower MOOP type in the “mental health specialty services”, partial hospitalization, “inpatient hospital psychiatric services”, and “outpatient substance use disorder services” service categories. However, as shown in tables 27 to 31, the differences between this alternative and alternative 1 are substantive for MA plans with one of the other MOOP types. For example, as shown in table 36 (MA plans), this alternative results in a $35 copayment limit for the “mental health specialty services” service category—a decrease of $15 to $50 (depending on the MA plan's MOOP type) in comparison to the copayment limits that would result for that service 
                        <PRTPAGE P="99537"/>
                        category if the existing cost-sharing standards were used ($85 to $50). In contrast, the copayment limits for this service category resulting from alternatives 1 and 2 are $35 to $15 (depending on the MA plan's MOOP type) and $50, respectively. As a result, this alternative results in a copayment limit for the “mental health specialty services service category” that is: (1) less than the existing cost-sharing standards in current regulations and the standards considered by alternative 2 for all MA MOOP types; and (2) greater than the standards considered by alternative 1—excluding the lower MOOP type (where the standards are equivalent). In addition, as shown in tables 41 to 45, this alternative results in cost-sharing standards for Cost Plans that are greater than the standards considered by alternative 1 for all behavioral health service categories—excluding opioid treatment program services.
                    </P>
                    <P>As shown in tables 38 and 43, this alternative results in a dollar limit of $2,204 for the 15-day length of stay scenario of the “inpatient hospital psychiatric services” service category (for MA and Cost Plans). In comparison, the dollar limits that would result for this service category and length of stay scenario using the existing cost-sharing standards or alternative 1 or 2 are: $2,204 to $2,755 (depending on MOOP type or $2,204 for Cost Plans), $1,102 to $2,204 (depending on MOOP type or $1,102 for Cost Plans), and $2,424 (MA and Cost Plans), respectively. As a result, this alternative results in a dollar limit for the 15-day length of stay scenario of the “inpatient hospital psychiatric services” service category that is: (1) less than the existing MA cost-sharing standards in current regulations—excluding the mandatory MOOP type (where the standards are equivalent); (2) different from the longstanding 50 percent coinsurance (or actuarially equivalent copayment) standard applied to Cost Plans; (3) less than the standard considered by alternative 2 for MA and Cost Plans; and (4) greater than the standards considered by alternative 1—excluding the lower MOOP type (where the standards are equivalent).</P>
                    <P>Based on tables 36 through 38 and 40 (MA plans) and tables 41 through 43 and 45, this alternative does not pose as significant a decrease from the existing contract year 2026 and future year behavioral health cost-sharing regulatory requirements as alternative 1 (which considered, at the lowest, cost-sharing limits of 10 percent coinsurance for the professional behavioral health service categories and 50 percent of estimated Medicare FFS cost sharing for inpatient hospital psychiatric services for the mandatory MOOP type). The exception to this finding is for the “opioid treatment program services” service category. As shown in tables 39 and 44, this alternative presents the most substantial decrease from the existing cost-sharing standards for the “opioid treatment program services” service category cost-sharing limit in comparison to the other alternatives. Specifically, based on the current regulations for contract year 2026 and future years, this alternative would lower the “opioid treatment program services” service category cost-sharing limit from 50 percent coinsurance (or a $155 actuarially equivalent copayment limit for all MA plans) to zero cost sharing. In contrast, for the same service category, the other alternatives would result in the following:</P>
                    <P>
                        • 
                        <E T="03">MA plans:</E>
                         alternative 1 would lower the cost-sharing limit to 20 percent coinsurance (or $60) to 10 percent coinsurance (or $30), depending on MOOP type, and alternative 2 would lower it to 30 percent coinsurance or $95.
                    </P>
                    <P>
                        • 
                        <E T="03">Cost Plans:</E>
                         alternative 1 would lower the cost-sharing limit to 10 percent coinsurance (or $30) and alternative 2 would lower it to 30% coinsurance or $95.
                    </P>
                    <P>
                        While this decrease is substantial in comparison to the other alternatives, research finds that patients with severe alcohol and other drug problems report completing only two serious recovery attempts (median) before remission.
                        <SU>377</SU>
                        <FTREF/>
                         In addition, a study shows that every dollar spent on substance use disorder treatment saves $4 in health care costs.
                        <SU>378</SU>
                        <FTREF/>
                         As a result, CMS believes that the cost liability to cover opioid treatment program services with zero cost sharing is not as much of a concern as it otherwise would be for a highly utilized service (such as physical therapy) and applying zero cost sharing could have a significant positive impact on enrollees' ability to access those services. We also note the illustrative dollar limits for the behavioral health service categories in tables 36 to 45 are similar to cost sharing for these services in qualified health plans (QHPs) in the marketplace. For example, QHPs are required to offer standardized options for 2024 with set copayments for mental health and substance use disorder outpatient office visits that range between $0 and $50 based on the plan level (for example, bronze or silver).
                        <SU>379</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>377</SU>
                             Kelly JF, Greene MC, Bergman BG, White WL, Hoeppner BB. How Many Recovery Attempts Does it Take to Successfully Resolve an Alcohol or Drug Problem? Estimates and Correlates From a National Study of Recovering U.S. Adults. Alcohol Clin Exp Res. 2019 Jul;43(7):1533-1544. doi: 10.1111/acer.14067. Epub 2019 May 15. PMID: 31090945; PMCID: PMC6602820.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>378</SU>
                             Substance Abuse and Mental Health Services Administration (US); Office of the Surgeon General (US). Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health [internet]. Washington (DC): US Department of Health and Human Services; 2016 Nov. CHAPTER 7, VISION FOR THE FUTURE: A PUBLIC HEALTH APPROACH. Available from: 
                            <E T="03">https://www.ncbi.nlm.nih.gov/books/NBK424861/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>379</SU>
                             See table 9 and 10 on page 25850 and 25851 from, “Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2024” final rule published April 27, 2023. Retrieved from: 
                            <E T="03">https://www.federalregister.gov/documents/2023/04/27/2023-08368/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2024.</E>
                        </P>
                    </FTNT>
                    <P>Similar to alternative 2, this alternative does not retain or improve the existing cost-sharing incentives for MA plans to establish lower MOOP amounts because the proposed behavioral health cost-sharing standards would apply equally to all MOOP types. However, as discussed in detail in section VII.E.3.d.(2). of this proposed rule, we believe the cost-sharing standards considered by alternative 2 or this proposal will not significantly affect the number of plans choosing to offer lower MOOP amounts in future years. Our primary rationale for this belief is because, as supported by tables 46 and 47, the driving factor for contract year 2023 and 2024 plans to switch to lower MOOP types seems to focus on the ability to access cost-sharing flexibilities for emergency services more so than any other service category.</P>
                    <P>The percent of contract year 2024 MA plans and enrollees that have higher behavioral health service category cost sharing compared to this alternative is shown in tables 48 and 49. In summary, we note the following:</P>
                    <P>• Less than 5 percent of MA plans and enrollees have cost sharing that is greater than this proposal for the inpatient hospital psychiatric service category (including all length of stay scenarios).</P>
                    <P>• About a quarter of MA plans (23 to 25 percent), representing between 16 and 22 percent of enrollees, have cost sharing greater than this alternative for most of the professional health service categories (mental health specialty services, psychiatric services, partial hospitalization), depending on the specific service category.</P>
                    <P>• About half of MA plans and enrollees (42 and 41 percent, respectively), have cost sharing greater than this proposal for outpatient substance use disorder services.</P>
                    <P>
                        • Most MA plans (71 percent), representing approximately 62 percent 
                        <PRTPAGE P="99538"/>
                        of enrollees, have cost sharing that is greater than this alternative for the “opioid treatment program services” service category.
                    </P>
                    <P>In comparison, as shown in tables 48 and 49—for most behavioral health service categories—over 40 percent of MA plans and enrollees have cost sharing amounts greater than alternative 1 and less than 5 percent of MA plans and enrollees have cost sharing amounts greater than alternative 2.</P>
                    <P>The percent of contract year 2024 Cost Plans and enrollees that have higher behavioral health service category cost sharing compared to this alternative (proposal) is shown in tables 50 and 51. In summary, we note the following:</P>
                    <P>• No Cost Plans have cost sharing greater than this alternative for partial hospitalization.</P>
                    <P>• Approximately 8 percent of plans, representing about 3 percent of enrollees, have cost sharing greater than this alternative for mental health specialty services.</P>
                    <P>• About 13 percent of plans and enrollees, have cost sharing greater than this proposal for psychiatric services.</P>
                    <P>• Fifty percent of plans, representing approximately 61percent of enrollees, have cost sharing that is greater than this alternative for the “opioid treatment program services” service category.</P>
                    <P>In comparison, as shown in tables 50 and 51—for most behavioral health service categories—over 12 percent of plans and enrollees have cost sharing amounts greater than alternative 1 and no plans or enrollees have cost sharing amounts greater than alternative 2.</P>
                    <P>Table 33 demonstrates that this alternative may require plans to reduce cost sharing by nominal and more substantive amounts based on the service category, with one exception. This exception is that CMS does not expect MA plans would have to reduce cost sharing for the inpatient hospital psychiatric 60-day length of stay scenario because, as shown in table 39, no contract year 2024 plans established cost sharing for this category that is greater than this alternative's limit. For example, based on contract year 2024 MA plan data and the cost-sharing standards posed by this alternative, we estimate that—for the “outpatient substance use disorder services” service category—of MA plans that continue in contract year 2026:</P>
                    <P>• About 42 percent of plans would have to reduce their cost sharing (as shown in table 48).</P>
                    <P>• About 41 percent of enrollees could experience this reduction in cost sharing (as shown in table 49).</P>
                    <P>• The enrollees in those plans could experience a reduction in cost sharing—on average—of about $30 per day (as shown in table 33, from $60 to $30).</P>
                    <P>In comparison, as shown in tables 48, 49, 52A through 52C, and 53 for the same service category, we estimate that in response to alternative 1 and 2 that of MA plans that continue in contract year 2026:</P>
                    <P>• About 68 percent and 13 percent of plans would have to reduce their cost sharing, respectively (table 48).</P>
                    <P>• About 64 percent and 17 percent of enrollees could experience this reduction in cost sharing, respectively (table 49).</P>
                    <P>• The enrollees in those plans could experience a reduction in cost sharing—on average—between $22 and $38 per day (depending on their plan's MOOP type for alternative 1 as shown in tables 52A through 52C) or $44 per day for alternative 2 (as shown in table 53).</P>
                    <P>Based on our evaluation of tables 33 through 34 and tables 48 through 55, this alternative results in a more substantial proportion of MA and Cost Plan enrollees likely having lower behavioral health cost sharing in comparison to alternative 2 while not proposing such significant changes as to be more likely to disrupt coverage options in comparison to alternative 1. For example, CMS does not expect a majority of MA or Cost Plans would have to decrease their cost sharing amounts by a significant amount for most of the behavioral health service categories if this alternative/proposal is finalized. As a result, we expect these cost sharing changes would not directly result in a significant number of plans leaving the market and reducing coverage options for Medicare-eligible beneficiaries.</P>
                    <HD SOURCE="HD3">(c) CMS Decision</HD>
                    <P>After considering alternatives 1 through 3, we chose to propose applying cost sharing no greater than Traditional Medicare for the behavioral health service categories (alternative 3) as the cost-sharing standard for MA and Cost Plans beginning in contract year 2026. CMS's goal, as indicated in the introduction of this section, is to propose a cost-sharing standard that strikes a balance between: (1) improving the affordability of behavioral health services for enrollees in a timely manner; and (2) minimizing disruption to MA enrollees access to care and coverage options. For the reasons discussed in this section and section III.L. of this proposed rule, we believe this alternative best strikes this balance.</P>
                    <HD SOURCE="HD3">e. Summary Tables</HD>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="166">
                        <GID>EP10DE24.044</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="170">
                        <PRTPAGE P="99539"/>
                        <GID>EP10DE24.045</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="374">
                        <GID>EP10DE24.046</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="233">
                        <PRTPAGE P="99540"/>
                        <GID>EP10DE24.047</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="225">
                        <GID>EP10DE24.048</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="217">
                        <PRTPAGE P="99541"/>
                        <GID>EP10DE24.049</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="217">
                        <GID>EP10DE24.050</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="235">
                        <PRTPAGE P="99542"/>
                        <GID>EP10DE24.051</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="211">
                        <GID>EP10DE24.052</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="215">
                        <PRTPAGE P="99543"/>
                        <GID>EP10DE24.053</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="356">
                        <GID>EP10DE24.054</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="254">
                        <PRTPAGE P="99544"/>
                        <GID>EP10DE24.055</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="245">
                        <GID>EP10DE24.056</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="258">
                        <PRTPAGE P="99545"/>
                        <GID>EP10DE24.057</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="240">
                        <GID>EP10DE24.058</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="210">
                        <PRTPAGE P="99546"/>
                        <GID>EP10DE24.059</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99547"/>
                        <GID>EP10DE24.060</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99548"/>
                        <GID>EP10DE24.061</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99549"/>
                        <GID>EP10DE24.062</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99550"/>
                        <GID>EP10DE24.063</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99551"/>
                        <GID>EP10DE24.064</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="99552"/>
                        <GID>EP10DE24.065</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <PRTPAGE P="99553"/>
                    <HD SOURCE="HD3">4. Proposal To Require Clinical or Quality Improvement Standards for Provider Incentive and Bonus Arrangements To Be Included in the MA MLR Numerator (§ 422.2420(b)(2))</HD>
                    <P>For our proposal to require clinical or quality improvement standards for provider incentive and bonus arrangements to be included in the MA MLR numerator, we considered two alternatives.</P>
                    <P>First, we considered requiring MA organizations to submit documentation with their annual MLR Report demonstrating how bonuses and incentives included in the MLR numerator were tied directly to improved care quality. This approach would result in at least as many additional hours as our proposal, using the assumptions previously discussed, to produce the documentation necessary to justify the bonuses and incentives included in the MLR numerator. We estimate that it would take double the number of hours to prepare and submit such documentation, which would result in $105,672 ($52,836 × 2) additional aggregate burden for MA organizations.</P>
                    <P>Second, we considered auditing bonuses and incentives included in the annual MLR Report for select MA organizations to confirm these expenses were tied directly to improved care quality. This approach would result in at least as many additional hours as our proposal, using the assumptions previously discussed, to prepare for and undergo an audit for these expenses. We estimate that it would take four times the number of hours to prepare and submit such documentation and work with auditors to validate the information provided in the MLR Report, which would result in $211,344 ($52,836 × 4) additional aggregate burden for MA organizations. This approach would also involve hiring additional staff or securing a contractor to complete this work on an annual basis. We estimate that it would take approximately one tenth the audit budget for a single MA organization ($1,500,000 total budget/9 MA organizations budgeted = $166,666.67 for a single audit) to audit these specific expenses, which would result in $16,666.67 additional aggregate burden for CMS per MA organization per year.</P>
                    <P>We are not proposing the first alternative because we do not believe adding a requirement to our current MLR reporting process is beneficial. This additional step of preparing and submitting documentation on bonuses and incentives would create additional burden for MA organizations to generate and for CMS to review. MA organizations already attest to the accuracy of their MLR report, and the desk review process provides oversight of submissions on an annual basis that may or may not use this additional documentation depending on issues identified and addressed through the desk review process.</P>
                    <P>CMS has the authority to conduct audits of MA organizations' MLR reports. However, we are not proposing the second alternative because we believe conducting full audits of select MA organizations' MLR reports would provide more information than auditing specific data elements alone. Smaller, more focused audits of bonuses and incentives would create additional burden for MA organizations to generate and for CMS to conduct, and this additional burden could outweigh the potential significance of findings and impact to MLR calculations reported.</P>
                    <HD SOURCE="HD3">5. Proposal To Prohibit Administrative Costs From Being Included in Quality Improving Activities in the MA and Part D MLR Numerator (§§ 422.2430(a) and 423.2430(a))</HD>
                    <P>For our proposal to prohibit administrative costs from being included in quality improving activities in the MA and Part D MLR numerator, we considered two alternatives.</P>
                    <P>First, we considered requiring MA organizations to submit documentation with their annual MLR Report describing all quality improving activity costs included in the MLR numerator. This approach would result in at least as many additional hours as our proposal, using the assumptions previously discussed, to produce the documentation necessary to describe all costs spent on quality improving activities included in the MLR numerator. We estimate that it would take double the number of hours to prepare and submit such documentation, which would result in $105,672 ($52,836 × 2) additional aggregate burden for MA organizations and Part D sponsors.</P>
                    <P>Second, we considered auditing quality improving activity costs included in the annual MLR Report for select MA organizations and Part D sponsors to confirm these costs were not administrative in nature. This approach would result in at least as many additional hours as our proposal, using the assumptions previously discussed, to prepare for and undergo an audit for these costs. We estimate that it would take four times the number of hours to prepare and submit such documentation and work with auditors to validate the information provided in the MLR Report, which would result in $211,344 ($52,836  ×  4) additional aggregate burden for MA organizations and Part D sponsors. This approach would also involve hiring additional staff or securing a contractor to complete this work on an annual basis. We estimate that it would take approximately one tenth the audit budget for a single MA organization or Part D sponsor ($1,500,000 total budget/9 MA organizations and Part D sponsors budgeted = $166,666.67 for a single audit) to audit these specific costs, which would result in $16,666.67 additional aggregate burden for CMS per MA organization or Part D sponsor per year.</P>
                    <P>We are not proposing the first alternative because we do not believe adding a requirement to our current MLR reporting process is beneficial. This additional step of preparing and submitting documentation on quality improving activities would create additional burden for MA organizations and Part D sponsors to generate and for CMS to review. MA organizations and Part D sponsors already attest to the accuracy of their MLR report, and the desk review process provides oversight of submissions on an annual basis that may or may not use this additional documentation depending on issues identified and addressed through the desk review process.</P>
                    <P>CMS has the authority to audit MA organizations and Part D sponsor's MLR reports. However, we are not proposing the second alternative because we believe conducting full audits of select MA organizations and Part D sponsors' MLR reports would provide more information than auditing specific data elements alone. Smaller, more focused audits of quality improving activities would create additional burden for MA organizations to generate and for CMS to conduct, and this additional burden could outweigh the potential significance of findings and impact to MLR calculations reported.</P>
                    <HD SOURCE="HD3">6. Proposal To Establish Standards for MA and Part D MLR Audit Examinations (§§ 422.2480(d), 423.2480(d), 422.2401, 423.2401, 422.2450, 423.2450, 422.2452, 423.2452, 423.2454, and 423.2454)</HD>
                    <P>For our proposal to establish standards for MA and Part D MLR audit examinations, we considered two alternatives.</P>
                    <P>
                        First, we considered requiring MA organizations and Part D sponsors to submit with the MLR Report documentation that details how the MLR calculation and remittances owed were determined each year. This 
                        <PRTPAGE P="99554"/>
                        approach would result in at least as many additional hours as our proposal, using the assumptions previously discussed, to produce the documentation necessary to outline the entire MLR calculation. We estimate that it would take four times the number of hours to prepare and submit such documentation, which would result in $211,344 ($52,836  ×  4) additional aggregate burden for MA organizations and Part D sponsors.
                    </P>
                    <P>Second, we considered auditing all MLR Reports for MA organizations and Part D sponsors that owed remittances for the previous reporting year. This approach would result in at least as many additional hours as our proposal, using the assumptions previously discussed, to prepare for and undergo an MLR audit. We estimate that it would take four times the number of hours to prepare and submit such documentation and work with auditors to validate the information provided in the MLR Report, which would result in $211,344 ($52,836  ×  4) additional aggregate burden for MA organizations and Part D sponsors. This approach would also involve hiring additional staff or securing a contractor to complete this work on an annual basis. We estimate that it would take approximately three to four times the full audit budget ($1,500,000 total budget) to audit all MA organizations and Part D sponsors that owed remittances for the previous reporting year, since 60 MA organizations and Part D sponsors owed remittances in contract year 2022 (about six times the number of MA organizations and Part D sponsors budgeted), which would result in $9,000,000 additional aggregate burden for CMS per year.</P>
                    <P>We are not proposing the first alternative because we do not believe adding a requirement to our current MLR reporting process is beneficial. This additional step of preparing and submitting documentation on all MLR data elements would create additional burden for MA organizations and Part D sponsors to generate and for CMS to review. MA organizations and Part D sponsors already attest to the accuracy of their MLR report, and the desk review process provides oversight of submissions on an annual basis that may or may not use this additional documentation depending on issues identified and addressed through the desk review process.</P>
                    <P>We are not proposing the second alternative because this approach would require significant funding and effort on behalf of MA organizations, Part D sponsors, and CMS. Our option to audit up to 9 MA organizations' and Part D sponsors' MLR reports contracts would take approximately 9 months to 1 year to complete. Auditing up to 60 MA organizations and Part D sponsors' MLR reports would take, given the estimates above, at least 6 years to complete for a single contract year's reporting. The number of MA organizations and Part D sponsors that ultimately owe remittances for failing to meet the 85 percent threshold also changes year to year, making the ability to plan and conduct audits difficult.</P>
                    <HD SOURCE="HD3">7. Proposal To Add Provider Payment Arrangement Reporting in the Medicare MLR Reporting Regulations (§§ 422.2460 and 422.2490)</HD>
                    <P>For our proposal to require separate reporting amounts for provider payment arrangements, we considered three alternatives. First, we considered keeping the status quo in reporting so MA organizations do not have to submit any detail on their provider payment arrangements.</P>
                    <P>Second, we considered requiring MA organizations to submit documentation with their annual MLR Report describing each of their provider payment arrangements in detail. We estimate that it would take double the number of hours to prepare and submit such documentation, which would result in $359,940 ($179,970 * 2) additional aggregate burden for MA organizations.</P>
                    <P>Third, we considered asking what provider payment arrangement information MA organizations may be able to share through the vertical integration request for information. This approach would have provided CMS with more information before proposing a policy change. However, we obtained recommendations from several stakeholders through the MA data request for information that CMS collect similar data that is reported through the HCPLAN survey to support access to additional data on APM adoption.</P>
                    <P>We are not proposing the first alternative because CMS and stakeholders will benefit from increased transparency in provider payment arrangement types. Such reporting will help policymakers understand more about the prevalence of different provider payment arrangements and consider whether and how MLR reports might vary based on different patterns in provider payment arrangements.</P>
                    <P>In addition, we are not proposing the second alternative because we were concerned about the additional reporting burden associated with requiring MA organizations to submit documentation with their annual MLR Report describing each of their provider payment arrangements in detail. CMS is proposing provider payment arrangement reporting in aggregate dollar amounts and limited categories to enable MA organizations to operationalize additional provider payment arrangement reporting and to see if we obtain enough data to better understand the different types of APM arrangements in MA.</P>
                    <P>Finally, we are not proposing the third alternative to ask what kind of provider payment arrangement information we should collect from MA organizations because the HCPLAN survey has standardized definitions widely agreed upon by industry stakeholders. In addition, through the MA data request for information CMS has already received feedback from many stakeholders advocating for the collection of more APM information. CMS is also asking for feedback on proposed provider payment arrangement categories in the proposed policy, which enables stakeholders to propose alternative data collection methods.</P>
                    <HD SOURCE="HD2">F. Accounting Statement and Table</HD>
                    <P>
                        The following table summarizes costs, savings, and transfers by provision. As required by OMB Circular A-4 (available at 
                        <E T="03">https://obamawhitehouse.archives.gov/omb/circulars_a004_a-4/</E>
                        ), in table 56, we have prepared an accounting statement showing the transfers and costs associated with the provisions of this proposed rule over a 10-year period or for contract years 2026 through 2035.
                    </P>
                    <GPH SPAN="3" DEEP="270">
                        <PRTPAGE P="99555"/>
                        <GID>EP10DE24.066</GID>
                    </GPH>
                    <HD SOURCE="HD2">G. Conclusion</HD>
                    <P>This proposed rule would result in net annualized costs of $72 million. These costs are primarily attributable to provisions pertaining to the information collection requirements of the Medicare Prescription payment plan. This provision implements requirements created by the IRA and is expected to increase costs in the first year by over $264. million, dropping to $36.7 million annually in subsequent years. The proposed rule would also result in significant outlays from the Medicare Trust Fund. There are anticipated savings to the Trust Fund, notably coming from proposed adjustments in MLR calculations and audits, which may result in transfers of $1010 and $320 million over a 10-year period. However, the rule also includes transfers from the Medicare Trust Fund and other entities to cover AOMs. Coverage of AOMs are anticipated to result in annualized monetized Federal transfers amounting to $2,502 million from the Medicare Trust Fund, $ $1,084 million in Federal Medicaid transfers, and $374 million in State Medicaid transfers.</P>
                    <HD SOURCE="HD1">VIII. Response to Comments</HD>
                    <P>
                        Because of the large number of public comments we normally receive on 
                        <E T="04">Federal Register</E>
                         documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the “DATES” section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.
                    </P>
                    <P>Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &amp; Medicaid Services, approved this document on November 8, 2024.</P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects</HD>
                        <CFR>42 CFR Part 417</CFR>
                        <P>Administrative practice and procedure, Grant programs-health, Health care, Health Insurance, Health maintenance organizations (HMO), Loan programs-health Medicare, and Reporting and recordkeeping requirements.</P>
                        <CFR>42 CFR Part 422</CFR>
                        <P>Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.</P>
                        <CFR>42 CFR Part 423</CFR>
                        <P>Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.</P>
                        <CFR>42 CFR Part 460</CFR>
                        <P>Aged, Citizenship and naturalization, Civil rights, Health, Health care, Health records, Individuals with disabilities, Medicaid, Medicare, Religious discrimination, Reporting and recordkeeping requirements, Sex discrimination.</P>
                    </LSTSUB>
                    <P>For the reasons set forth in the preamble, the Centers for Medicare &amp; Medicaid Services proposes to amend 42 CFR Chapter IV as set forth below:</P>
                    <PART>
                        <HD SOURCE="HED">PART 417—HEALTH MAINTENANCE ORGANIZATIONS, COMPETITIVE MEDICAL PLANS, AND HEALTH CARE PREPAYMENT PLANS</HD>
                    </PART>
                    <AMDPAR>1. The authority for part 417 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>42 U.S.C. 1302 and 1395hh, and 300e, 300e-5, and 300e-9, and 31 U.S.C. 9701.</P>
                    </AUTH>
                    <AMDPAR>2. Section 417.454 is amended by revising paragraph (e) and adding paragraph (f) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 417.454 </SECTNO>
                        <SUBJECT>Charges to Medicare enrollees.</SUBJECT>
                        <STARS/>
                        <P>
                            (e) 
                            <E T="03">Services for which cost sharing may not exceed cost sharing under original Medicare.</E>
                             For each year beginning on or after January 1, 2026, in-network cost sharing established by an HMO or CMP for the basic benefits listed in this paragraph may not exceed the cost sharing required under original Medicare. When an HMO or CMP uses coinsurance, the coinsurance must not exceed the coinsurance charged in original Medicare. When an HMO or CMP uses copayments, the copayment must not exceed the actuarially equivalent value calculated for that 
                            <PRTPAGE P="99556"/>
                            benefit using the Medicare Advantage rules at § 422.100(j)(1)(ii) of this chapter and Medicare FFS data projections as defined in § 422.100(f)(4)(i). The benefits listed in this paragraph are as follows:
                        </P>
                        <P>(1) Chemotherapy administration services to include chemotherapy/radiation drugs and radiation therapy integral to the treatment regimen.</P>
                        <P>(2) Renal dialysis services as defined at section 1881(b)(14)(B) of the Act.</P>
                        <P>(3) Skilled nursing care defined as services provided during a covered stay in a skilled nursing facility during the period for which cost sharing would apply under Original Medicare.</P>
                        <P>(4) A COVID-19 vaccine and its administration described in section 1861(s)(10)(A) of the Act.</P>
                        <P>(5) Behavioral health service categories including all of the following:</P>
                        <P>(i) Intensive outpatient services.</P>
                        <P>(ii) Mental health specialty services.</P>
                        <P>(iii) Opioid treatment program services.</P>
                        <P>(iv) Outpatient substance use disorder services.</P>
                        <P>(v) Partial hospitalization.</P>
                        <P>(vi) Psychiatric services.</P>
                        <P>(6) Inpatient hospital acute and psychiatric services cost sharing must not exceed 100 percent of estimated Medicare FFS cost sharing, including the projected Part A deductible and related Part B costs, for the following length-of-stay scenarios for a period for which cost sharing would apply under original Medicare:</P>
                        <P>(i) For acute services as follows:</P>
                        <P>(A) 3 days.</P>
                        <P>(B) 6 days.</P>
                        <P>(C) 10 days.</P>
                        <P>(D) 60 days.</P>
                        <P>(ii) For psychiatric services as follows:</P>
                        <P>(A) 8 days</P>
                        <P>(B) 15 days.</P>
                        <P>(C) 60 days.</P>
                        <P>(7) Home health services (as defined in section 1861(m) of the Act).</P>
                        <P>(8) The following specific service categories of durable medical equipment (DME):</P>
                        <P>(i) Equipment.</P>
                        <P>(ii) Prosthetics.</P>
                        <P>(iii) Medical supplies.</P>
                        <P>(iv) Diabetes monitoring supplies.</P>
                        <P>(v) Diabetic shoes or inserts.</P>
                        <P>(9) Other drugs covered under Part B of original Medicare (that is, Part B drugs not included in paragraph (e)(1) of this section).</P>
                        <P>
                            (f) 
                            <E T="03">Cost sharing for other Medicare Part A and B benefits.</E>
                             For Medicare Part A and Part B services furnished in-network for which a cost sharing limit is not established by other regulation or statute, the HMO or CMP must not establish a cost sharing amount that exceeds 50 percent coinsurance or an actuarially equivalent copayment value (calculated by CMS following the requirements in § 422.100(f)(7) of this chapter or, if CMS does not calculate a copayment limit, based on the average Medicare FFS allowable amount for the plan service area or the estimated total HMO or CMP plan financial liability for the service category or for a reasonable group of benefits in the PBP for that contract year).
                        </P>
                    </SECTION>
                    <AMDPAR>3. Section 417.486 is amended by adding paragraph (a)(3) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 417.486 </SECTNO>
                        <SUBJECT>Disclosure of information and confidentiality.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(3) Risk adjustment data as specified in section 422.310 of this chapter for the purposes of determining an individual's health status. In applying this provision, references to MA organizations in § 422.310 shall be read to mean HMOs and CMPs.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 422—MEDICARE ADVANTAGE PROGRAM</HD>
                    </PART>
                    <AMDPAR>4. The authority for part 422 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.</P>
                    </AUTH>
                    <AMDPAR>5. Section 422.2 is amended by—</AMDPAR>
                    <AMDPAR>a. Adding in alphabetical order definitions for “Automated system”, “Community-based organizations”, and “Direct furnishing entity”;</AMDPAR>
                    <AMDPAR>b. Revising the definition of “Hierarchical condition categories (HCC)” and paragraph (1) of the definition of “Highly integrated dual eligible special needs plan”;</AMDPAR>
                    <AMDPAR>c. Adding in alphabetical order a definition for “In-home or at-home supplemental benefit provider”; and</AMDPAR>
                    <AMDPAR>d. Revising the definition of “Service area”.</AMDPAR>
                    <P>The additions and revisions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 422.2 </SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Automated system</E>
                             means any system, software, or process that uses computation as whole or part of a system to determine outcomes, make or aid decisions, inform policy implementation, collect data or observations, or otherwise interact with individuals or communities or both. Automated systems include, but are not limited to, systems derived from machine learning, statistics, or other data processing or artificial intelligence techniques, and exclude passive computing infrastructure. `Passive computing infrastructure' is any intermediary technology that does not influence or determine the outcome of decision, make or aid in decisions, inform policy implementation, or collect data or observations, including web hosting, domain registration, networking, caching, data storage, or cybersecurity. As used in this part, automated systems that are considered in scope are only those that have the potential to meaningfully impact individuals' or communities' rights, opportunities, or access.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Community-based organizations (CBOs)</E>
                             mean public or private not-for-profit entities that provide specific services to the community or targeted populations in the community, to address the health and social needs of those populations.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Direct furnishing entity</E>
                             means any individual or entity that delivers or furnishes covered benefits to the enrollee. This includes Medicare Part A and B covered benefits, as well as supplemental benefits.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Hierarchical condition categories (HCC)</E>
                             mean diagnosis groupings that predict average healthcare spending. HCCs consist of International Classification of Diseases, Clinical Modification (ICD-CM) diagnosis codes and represent the disease component of the enrollee risk score that are applied to MA payments.
                        </P>
                        <P>
                            <E T="03">Highly integrated dual eligible special needs plan</E>
                             * * *
                        </P>
                        <P>(1) The capitated contract is between the State Medicaid agency and one of the following:</P>
                        <P>(i) The MA organization.</P>
                        <P>(ii) The MA organization's parent organization, or another entity that is owned and controlled by its parent organization.</P>
                        <P>(iii) A local nonprofit public benefit corporation of which the MA organization, MA organization's parent organization, or another entity that is owned and controlled by its parent organization is a founding member where the local nonprofit public benefit corporation is responsible for the delivery of physical, behavioral, and dental health services.</P>
                        <STARS/>
                        <P>
                            <E T="03">In-home or at-home supplemental benefit provider</E>
                             means any direct furnishing entity in which the direct furnishing entity or an employee of the direct furnishing entity is given an enrollee's physical address in order to provide supplemental benefits or special supplemental benefits for the 
                            <PRTPAGE P="99557"/>
                            chronically ill (SSBCI) items or services to that enrollee. An in-home or at-home supplemental benefit provider may include direct furnishing entities who offer both in-office as well as in-home or at-home supplemental benefits.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Service area</E>
                             means a geographic area that for local MA plans is one or more counties, as defined in § 422.116 of this chapter, and for MA regional plans is a region approved by CMS within which an MA-eligible individual may enroll in a particular MA plan offered by an MA organization. Facilities in which individuals are incarcerated are not included in the service area of an MA plan. Each MA plan must be available to all MA-eligible individuals within the plan's service area. In deciding whether to approve an MA plan's proposed service area, CMS considers the following criteria:
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>6. Section 422.100 is amended by:</AMDPAR>
                    <AMDPAR>a. Removing the phrase “services, partial hospitalization, and” and adding in its place the phrase “services, occupational therapy, and” in paragraph (f)(6)(iii)(A);</AMDPAR>
                    <AMDPAR>b. Removing the phrase “under paragraph (f)(6)(iv) of this section” and adding in its place the phrase “under paragraphs (f)(6)(iv) and (j)(1)(i)(H) of this section” in paragraph (f)(6)(iv)(A);</AMDPAR>
                    <AMDPAR>c. Revising paragraphs (f)(6)(iv)(B) and (f)(6)(iv)(D) introductory text;</AMDPAR>
                    <AMDPAR>d. Removing the phrase “January 1, 2023, in-network” and adding in its place the phrase “January 1, 2023, unless otherwise specified in this section, in-network” in paragraph (j)(1)(i) introductory text;</AMDPAR>
                    <AMDPAR>e. Revising paragraph (j)(1)(i)(C);</AMDPAR>
                    <AMDPAR>f. Adding paragraphs (j)(1)(i)(G) and (H); and</AMDPAR>
                    <AMDPAR>g. Revising paragraph (o)(2).</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 422.100 </SECTNO>
                        <SUBJECT>General requirements.</SUBJECT>
                        <STARS/>
                        <P>(f) * * *</P>
                        <P>(6) * * *</P>
                        <P>(iv) * * *</P>
                        <P>(B) Cost sharing limits for inpatient hospital acute service categories are calculated for the following length-of-stay scenarios for a period for which cost sharing would apply under original Medicare:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) 3 days.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) 6 days.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) 10 days.
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) 60 days.
                        </P>
                        <STARS/>
                        <P>(D) Provided that the total cost sharing for the inpatient benefit does not exceed overall cost sharing for inpatient benefits in original Medicare on a per member per month actuarially equivalent basis, MA plan cost sharing applicable to inpatient hospital acute service categories is permitted up to the following limits (based on original Medicare cost sharing for a new benefit period):</P>
                        <STARS/>
                        <P>(j) * * *</P>
                        <P>(1) * * *</P>
                        <P>(i) * * *</P>
                        <P>(C) Skilled nursing care, defined as services provided during a covered stay in a skilled nursing facility during the period for which cost sharing would apply under original Medicare, when the MA plan establishes the mandatory MOOP type; when the MA plan establishes the lower MOOP type, the cost sharing must not be greater than $20 per day for the first 20 days of a SNF stay; when the MA plan establishes the intermediate MOOP type, the cost sharing must not be greater than $10 per day for the first 20 days of a SNF stay. For all MOOP types, the per-day cost sharing for days 21 through 100 must not be greater than one-eighth of the projected (or actual) Part A deductible amount for the year. Total cost sharing for the overall SNF benefit must not be greater than the per member per month actuarially equivalent cost sharing for the SNF benefit in original Medicare.</P>
                        <STARS/>
                        <P>(G) Behavioral health service categories for contract year 2026 and subsequent contract years including all of the following:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Intensive outpatient services.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Mental health specialty services.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) Opioid treatment program services.
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) Outpatient substance use disorder services.
                        </P>
                        <P>
                            (
                            <E T="03">5</E>
                            ) Partial hospitalization.
                        </P>
                        <P>
                            (
                            <E T="03">6</E>
                            ) Psychiatric services.
                        </P>
                        <P>(H) Inpatient hospital psychiatric services cost sharing must not exceed 100 percent of estimated Medicare FFS cost sharing, including the projected Part A deductible and related Part B costs, for the following length-of-stay scenarios for a period for which cost sharing would apply under original Medicare for contract year 2026 and subsequent years:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) 8 days.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) 15 days.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) 60 days.
                        </P>
                        <STARS/>
                        <P>(o) * * *</P>
                        <P>(2) Complies with the limits described in paragraph (j)(1) of this section with the exception that references to the MOOP amounts refer to the total catastrophic limits under § 422.101(d)(3) for local PPOs and MA regional plans and, for regional PPO dual eligible special needs plans, excluding the last sentence of paragraph (j)(1)(i)(C) and the last sentence of paragraph (j)(1)(i)(E) of this section.</P>
                    </SECTION>
                    <AMDPAR>7. Section 422.101 is amended by revising paragraphs (b)(6) and (f)(1)(i) through (iv) and adding paragraphs (f)(1)(v) through (x) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.101 </SECTNO>
                        <SUBJECT>Requirements relating to basic benefits.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(6) MA organizations may create publicly available internal coverage criteria that are based on current evidence in widely used treatment guidelines or clinical literature when coverage criteria are not fully established in applicable Medicare statutes, regulations, NCDs or LCDs. Current, widely used treatment guidelines are those developed by organizations representing clinical medical specialties and refers to guidelines for the treatment of specific diseases or conditions. Acceptable clinical literature includes large, randomized controlled trials or prospective cohort studies with clear results, published in a peer-reviewed journal, and specifically designed to answer the relevant clinical question, or large systematic reviews or meta-analyses summarizing the literature of the specific clinical question.</P>
                        <P>
                            (i) 
                            <E T="03">Coverage criteria not fully established.</E>
                             Coverage criteria are not fully established if any of the following occur:
                        </P>
                        <P>(A) Additional, unspecified criteria are needed to interpret or supplement the plain language of applicable Medicare coverage and benefit criteria in order to determine medical necessity consistently.</P>
                        <P>(B) NCDs or applicable LCDs include flexibility that explicitly allows for discretionary coverage in circumstances beyond the specific indications that are listed in an NCD or LCD.</P>
                        <P>(C) There is an absence of any applicable Medicare statutes, regulations, NCDs or LCDs setting forth coverage criteria.</P>
                        <P>
                            (ii) 
                            <E T="03">Publicly available.</E>
                             For internal coverage criteria, the MA organization must provide in a publicly available way all of the following:
                        </P>
                        <P>
                            (A) Each internal coverage criterion in use and a summary of evidence that was considered during the development of each internal coverage criterion used to make medical necessity determinations. Any internal coverage criterion used by the MA organization must be clearly 
                            <PRTPAGE P="99558"/>
                            identified and marked as internal coverage criteria in the coverage policies of the MA plan.
                        </P>
                        <P>(B) A list of the sources of such evidence that are connected by footnote to the applicable coverage criterion.</P>
                        <P>(C) An explanation of the rationale that supports the adoption of each coverage criterion used to make a medical necessity determination. When coverage criteria are not fully established as described in paragraph (b)(6)(i)(A) of this section, the MA organization must identify the plain language of applicable Medicare coverage and benefit criteria that are being supplemented or interpreted.</P>
                        <P>(D) By January 1, 2026, MA organizations must publicly display on the MA organization's website a list of all items and services for which there are benefits available under Part A or Part B where the MA organization uses internal coverage criteria when making medical necessity decisions. The list of items and services on the website must include the information in paragraphs (b)(6)(ii)(A) through (C) of this section (explicitly or by connecting directly to that information through a hyperlink) and include the vendor's name when using a third-party vendor's criteria. Additionally, the web page that lists the items and services that contain internal coverage criteria must meet the following requirements:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Displayed in a prominent manner and clearly identified in the footer of the website.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Easily available to the public, without barriers, including but not limited to ensuring the information is available:
                        </P>
                        <P>
                            (
                            <E T="03">i</E>
                            ) Free of charge.
                        </P>
                        <P>
                            (
                            <E T="03">ii</E>
                            ) Without having to establish a user account or password.
                        </P>
                        <P>
                            (
                            <E T="03">iii</E>
                            ) Without having to submit personal identifying information.
                        </P>
                        <P>
                            (
                            <E T="03">iv</E>
                            ) In a machine-readable format with the data contained within that file being digitally searchable and downloadable.
                        </P>
                        <P>
                            (
                            <E T="03">v</E>
                            ) Include a txt file in the root directory of the website domain that includes a direct link to the machine-readable file to establish and maintain automated access.
                        </P>
                        <P>
                            (iii) 
                            <E T="03">Internal coverage criteria defined.</E>
                             Internal coverage criteria are any policies, measures, tools, or guidelines, whether developed by an MA organization or a third party, that are not expressly stated in applicable Medicare statutes, regulations, NCDs, LCDs, or CMS manuals and are adopted or relied upon by an MA organization for purposes of making a medical necessity determination at § 422.101(c)(1). This includes any coverage policies that restrict access to or payment for medically necessary Part A or Part B items or services based on the duration or frequency, setting or level of care, or clinical effectiveness.
                        </P>
                        <P>
                            (iv) 
                            <E T="03">Prohibited.</E>
                             Use of an internal coverage criterion is prohibited when either of the following occur:
                        </P>
                        <P>(A) The criterion does not have any clinical benefit.</P>
                        <P>(B) The criterion is used to automatically deny coverage of basic benefits without the MA organization making an individual medical necessity determination as required at § 422.101(c)(1)(i).</P>
                        <STARS/>
                        <P>(f) * * *</P>
                        <P>(1) * * *</P>
                        <P>(i) Within 90 days (before or after) of the effective date of enrollment for all new enrollees, conduct a comprehensive initial health risk assessment (HRA).</P>
                        <P>(ii) Conduct a comprehensive annual HRA.</P>
                        <P>(iii) Use a comprehensive risk assessment tool that CMS may review during oversight activities that meet both of the following:</P>
                        <P>(A) Assesses the enrollee's physical, psychosocial, and functional needs.</P>
                        <P>(B) Includes one or more questions from a list of screening instruments specified by CMS in subregulatory guidance on each of the following domains:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Housing stability.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Food security.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) Access to transportation.
                        </P>
                        <P>(iv) Must do all of the following:</P>
                        <P>(A) Make at least three non-automated phone call attempts, unless an enrollee agrees or declines to participate in the HRA before three attempts are made, on different days at different times of day to reach the enrollee to schedule the comprehensive initial or annual HRA.</P>
                        <P>(B) If the enrollee has not responded, send a follow-up letter to conduct the initial or annual HRA.</P>
                        <P>(C) For any enrollees who are unable to be reached or decline to participate in the HRA, document the attempts to contact the enrollee and, if applicable, the enrollee's choice not to participate.</P>
                        <P>(v) For D-SNPs that are applicable integrated plans (as defined in § 422.561), conduct a comprehensive HRA that meets all requirements at paragraphs (f)(1)(i) through (iv) of this section as well as any applicable Medicaid requirements, including those at § 438.208, such that enrollees complete a single integrated assessment for Medicare and Medicaid.</P>
                        <P>(vi) Ensure that the results from the comprehensive initial and annual HRA conducted for each enrollee are addressed in the enrollee's individualized care plan as required under paragraph (f)(1)(vii) of this section.</P>
                        <P>(vii) Within 30 days of conducting a comprehensive initial HRA or 30 days after the effective date of enrollment, whichever is later, develop a comprehensive individualized plan of care that meets all of the following:</P>
                        <P>(A) Is person-centered and based on the enrollee's preferences, including for delivery of services and benefits, and their needs identified in the HRA.</P>
                        <P>(B) Is developed through an interdisciplinary care team with the active participation of the enrollee (or the enrollee's representative, as applicable), as feasible.</P>
                        <P>(C) Identifies person-centered goals and objectives (as prioritized by the enrollee), including measurable outcomes as well as specific services and benefits to be provided.</P>
                        <P>(D) Is updated as warranted by changes in the health status or care transitions of enrollees.</P>
                        <P>(viii) For any enrollees who are unable to be reached or decline to participate in the development or updates to the comprehensive individualized plan of care, document the attempts to contact the enrollee or the enrollee's refusal to participate.</P>
                        <P>(ix) In the management of care, use an interdisciplinary team that includes a team of providers with demonstrated expertise and training, and, as applicable, training in a defined role appropriate to their licensure in treating individuals similar to the targeted population of the plan.</P>
                        <P>(x) Provide, on at least an annual basis, beginning within the first 12 months of enrollment, as feasible and with the enrollee's consent, for face-to-face encounters for the delivery of health care or care management or care coordination services and be between each enrollee and a member of the enrollee's interdisciplinary team or the plan's case management and coordination staff, or contracted plan healthcare providers. A face-for-face encounter must be either in person or through a visual, real-time, interactive telehealth encounter.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>8. Section § 422.102 is amended by—</AMDPAR>
                    <AMDPAR>a. Revising paragraphs (a)(6)(i) and (f)(1)(i)(A);</AMDPAR>
                    <AMDPAR>b. Adding paragraphs (f)(1)(i)(C) and (f)(1)(iii);</AMDPAR>
                    <AMDPAR>c. Revising paragraph (f)(4)(iii); and</AMDPAR>
                    <AMDPAR>d. Adding paragraph (g).</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <PRTPAGE P="99559"/>
                        <SECTNO>§ 422.102 </SECTNO>
                        <SUBJECT>Supplemental benefits.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(6) * * *</P>
                        <P>(i) Reductions in cost sharing through the use of manual reimbursement or through a debit card for cost sharing paid for covered benefits. Reimbursements must be limited to the specific plan year.</P>
                        <STARS/>
                        <P>(f) * * *</P>
                        <P>(1) * * *</P>
                        <P>(i) * * *</P>
                        <P>(A) A chronically ill enrollee is an individual enrolled in the MA plan who meets all of the following:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Has one or more comorbid and medically complex chronic conditions that is life threatening or significantly limits the overall health or function of the enrollee.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Has a high risk of hospitalization or other adverse health outcomes.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) Requires intensive care coordination.
                        </P>
                        <STARS/>
                        <P>(C) An enrollee who has one or more comorbidities and medically complex chronic conditions alone is not sufficient to demonstrate that an enrollee meets all 3 criteria set forth in paragraph (f)(1)(i)(A) of this section. MA plans must, through health risk assessments, review of claims data, or other similar means, demonstrate that enrollees meet all 3 criteria set forth in paragraph (f)(1)(i)(A) of this section.</P>
                        <STARS/>
                        <P>(iii) Examples of items or services that may not be offered as SSBCI include all of the following:</P>
                        <P>(A) Procedures that are solely cosmetic in nature and do not extend upon Traditional Medicare coverage (for example, cosmetic surgery, such as facelifts, or cosmetic treatments for facial lines, atrophy of collagen and fat, and bone loss due to aging).</P>
                        <P>(B) Hospital indemnity insurance.</P>
                        <P>(C) Funeral planning and expenses.</P>
                        <P>(D) Life insurance.</P>
                        <P>(E) Alcohol.</P>
                        <P>(F) Tobacco.</P>
                        <P>(G) Cannabis products.</P>
                        <P>(H) Broad membership programs inclusive of multiple unrelated services and discounts.</P>
                        <STARS/>
                        <P>(4) * * *</P>
                        <P>(iii) Have objective criteria for SSBCI. Specifically, the plan must:</P>
                        <P>(A) Have and apply written policies based on objective criteria for determining a chronically ill enrollee's eligibility to receive a particular SSBCI.</P>
                        <P>(B) Document the written policies specified in paragraph (f)(4)(iii)(A) of this section and the objective criteria on which the written policies are based.</P>
                        <P>(C) For each SSBCI, the MA plan must list all the written policies and objective criteria on which the policies are based as noted in paragraph (f)(4)(i) of this section on their public facing website.</P>
                        <STARS/>
                        <P>
                            (g) 
                            <E T="03">Administration of supplemental benefits</E>
                            —(1) 
                            <E T="03">General rule.</E>
                             MA organizations must have processes for delivering supplemental benefits to enrollees that ensure compliance with §§ 422.100(c)(2) and 422.102(a) through (f) and appropriate access to all covered items and services, in accordance with § 422.112(a).
                        </P>
                        <P>
                            (2) 
                            <E T="03">Provision of benefits through debit card.</E>
                             MA organizations that administer reductions in cost sharing or provide coverage of 100 percent of the cost of a mandatory supplemental benefit through use of a debit card must do all of the following:
                        </P>
                        <P>(i) Provide debit cards that are electronically linked to plan covered items and services through a real-time identification mechanism to verify eligibility of plan covered benefits at the point of sale.</P>
                        <P>(ii) Provide instructions for debit card use and customer service support to enrollees.</P>
                        <P>(iii) Have an alternative process that allows for reimbursement of eligible expenses for plan covered benefits.</P>
                        <P>(iv) Ensure debit cards are limited to the specific plan year.</P>
                    </SECTION>
                    <AMDPAR>9. Section 422.107 is amended by revising paragraph (f)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.107 </SECTNO>
                        <SUBJECT>Requirements for dual eligible special needs plans.</SUBJECT>
                        <STARS/>
                        <P>(f) * * *</P>
                        <P>(1) The enrollee advisory committee must include at least a reasonably representative sample of the population enrolled in the dual eligible special needs plan or plans, or other individuals representing those enrollees, and solicit input on, among other topics, ways to improve access to covered services, coordination of services, updates to the model of care described in § 422.101(f), and health equity for underserved populations.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>10. Section 422.111 is amended by revising paragraphs (b)(3)(i) and (b)(6) and adding paragraph (m) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.111 </SECTNO>
                        <SUBJECT>Disclosure requirements.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(3) * * *</P>
                        <P>(i) The number, mix, and distribution (addresses) of providers and direct furnishing entities from whom enrollees may reasonably be expected to obtain services, including all of the following:</P>
                        <P>(A) All direct furnishing entities, as defined in § 422.2, from whom enrollees may reasonably be expected to obtain services.</P>
                        <P>(B) Each provider's cultural and linguistic capabilities, including languages (including American Sign Language) offered by the provider or a skilled medical interpreter at the provider's office.</P>
                        <P>(C) Easily identifiable notations, filters, or other distinguishing features to indicate providers and direct furnishing entities that are community-based organizations (CBOs) (as defined in § 422.2).</P>
                        <P>(D) Easily identifiable notations, filters, or other distinguishing features to indicate in-home or at-home supplemental benefit providers (as defined in § 422.2).</P>
                        <P>(E) Any out-of-network coverage; any point-of-service option, including the supplemental premium for that option.</P>
                        <P>(F) How the MA organization meets the requirements of §§ 422.112 and 422.114 for access to services offered under the plan.</P>
                        <STARS/>
                        <P>
                            (6) 
                            <E T="03">Supplemental benefits.</E>
                             Any mandatory supplemental benefits (including reductions in cost sharing) or optional supplemental benefits, the premium for optional supplemental benefits, and the applicable conditions and limitations associated with receipt or use of supplemental benefits. This includes both of the following:
                        </P>
                        <P>(i) Disclosure of eligible over-the-counter items.</P>
                        <P>(ii) If providing supplemental benefits through a debit card, specifying which benefits may be accessed using the debit card.</P>
                        <STARS/>
                        <P>
                            (m) 
                            <E T="03">Increasing consumer transparency.</E>
                             For plan years beginning on or after January 1, 2026, MA organizations must do all of the following:
                        </P>
                        <P>(1) Make the information described in paragraph (b)(3)(i) of this section available to CMS/HHS for publication online in accordance with guidance from CMS/HHS.</P>
                        <P>(2) Submit, or otherwise make available, the information described in paragraph (b)(3)(i) of this section to CMS/HHS in a format and manner and at times determined by CMS/HHS.</P>
                        <P>(3) Update the information subject to this paragraph (m) within 30 days of the date an MA organization becomes aware of a change.</P>
                        <P>
                            (4) Attest, in a format and manner and at times determined by CMS/HHS, that 
                            <PRTPAGE P="99560"/>
                            all information submitted or otherwise made available to CMS/HHS under this paragraph (m) is accurate and consistent with data submitted to comply with CMS's MA network adequacy requirements at § 422.116(a)(1)(i).
                        </P>
                    </SECTION>
                    <AMDPAR>11. Section 422.112 is amended by revising paragraph (a)(8) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.112 </SECTNO>
                        <SUBJECT>Access to services.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>
                            (8) 
                            <E T="03">Ensuring equitable access to Medicare Advantage (MA) services.</E>
                             Ensure that services are provided as follows:
                        </P>
                        <P>(i) In a culturally competent manner by including all of the following:</P>
                        <P>(A) People with limited English proficiency or reading skills.</P>
                        <P>(B) People of ethnic, cultural, racial, or religious minorities.</P>
                        <P>(C) People with disabilities.</P>
                        <P>(D) People who identify as lesbian, gay, bisexual, or other diverse sexual orientations.</P>
                        <P>(E) People who identify as transgender, nonbinary, and other diverse gender identities, or people who were born intersex.</P>
                        <P>(F) People living in rural areas and other areas with high levels of deprivation.</P>
                        <P>(G) People otherwise adversely affected by persistent poverty or inequality.</P>
                        <P>(ii) Equitably irrespective of delivery method or origin, whether from human or automated systems. Artificial intelligence or automated systems, if utilized, must be used in a manner that preserves equitable access to MA services.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>12. Section 422.116 is amended by—</AMDPAR>
                    <AMDPAR>a. Redesignating paragraphs (a)(1) through (4) as paragraphs (a)(2) through (5);</AMDPAR>
                    <AMDPAR>b. Adding a new paragraph (a)(1) and</AMDPAR>
                    <AMDPAR>c. Revising paragraph (f)(1)(i)(A).</AMDPAR>
                    <P>The addition and revision read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 422.116</SECTNO>
                        <SUBJECT> Network adequacy.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(1) County, for purposes of this section, is defined as the primary political and administrative division of most States and includes functionally equivalent divisions called “county equivalents” as recognized by the United States Census Bureau (for economic census purposes).</P>
                        <STARS/>
                        <P>(f) * * *</P>
                        <P>(1) * * *</P>
                        <P>(i) * * *</P>
                        <P>(A) Certain providers or facilities are not available for the MA plan to meet the network adequacy criteria as shown in the Provider Supply file for the year for a given county and specialty type based on substantial and credible evidence, in the form and manner requested by CMS, regarding the following valid rationales:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Provider is no longer practicing (for example, deceased, retired).
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Provider does not provide services at the office or facility address listed in the Provider Supply file (§ 422.116(a)(4)(ii)).
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) Provider does not provide services for the specialty type listed in the Provider Supply file (§ 422.116(a)(4)(ii)).
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) Provider has opted out of Medicare (in compliance with § 422.204(b)(4)).
                        </P>
                        <P>
                            (
                            <E T="03">5</E>
                            ) Provider is a sanctioned provider on the List of Excluded Individuals and Entities (in compliance with § 422.204); or provider is on the CMS preclusion list (in compliance with § 422.222).
                        </P>
                        <P>
                            (
                            <E T="03">6</E>
                            ) Provider is at capacity and is not accepting new patients; and
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>13. Section §  422.137 is amended by revising paragraphs (d)(6)(iii)(A) through (H) and adding paragraph (d)(7)(v) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§  422.137 </SECTNO>
                        <SUBJECT>Medicare Advantage Utilization Management Committee.</SUBJECT>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>(6) * * *</P>
                        <P>(iii) * * *</P>
                        <P>(A) The percentage of standard prior authorization requests that were approved, reported by each covered item and service.</P>
                        <P>(B) The percentage of standard prior authorization requests that were denied, reported by each covered item and service.</P>
                        <P>(C) The percentage of standard prior authorization requests that were approved after appeal, reported by each covered item and service.</P>
                        <P>(D) The percentage of prior authorization requests for which the timeframe for review was extended, and the request was approved, reported by each covered item and service.</P>
                        <P>(E) The percentage of expedited prior authorization requests that were approved, reported by each covered item and service.</P>
                        <P>(F) The percentage of expedited prior authorization requests that were denied, reported by each covered item and service.</P>
                        <P>(G) The average and median time that elapsed between the submission of a request and a determination by the MA plan, for standard prior authorizations, reported by each covered item and service.</P>
                        <P>(H) The average and median time that elapsed between the submission of a request and a decision by the MA plan for expedited prior authorizations, reported by each covered item and service.</P>
                        <P>(7) * * *</P>
                        <P>(v) Include an executive summary of the results of the analysis. The executive summary must provide additional context for the results of the analysis. The executive summary must provide clarifying information for the report, including an overview of the information produced by the analysis. Accompanying language must not be misleading or misrepresent the findings that result from the analysis.</P>
                    </SECTION>
                    <AMDPAR>14. Section 422.138 is amended by revising paragraph (c) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.138 </SECTNO>
                        <SUBJECT>Prior authorization.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Effect of prior authorization, pre-service, or concurrent approval.</E>
                             If the MA organization approved the furnishing of a covered item or service through a prior authorization pre-service determination of coverage or payment, or a concurrent determination made during the enrollee's receipt of inpatient or outpatient services, it may not deny coverage later on the basis of lack of medical necessity and may not reopen such a decision for any reason except for good cause (as provided at §§ 405.986 and 422.616 of this chapter) or if there is reliable evidence of fraud or similar fault per the reopening provisions at § 422.616. The definitions of the terms “reliable evidence” and “similar fault” in § 405.902 of this chapter apply to this provision.
                        </P>
                    </SECTION>
                    <AMDPAR>
                        15. Section 422.162 is amended by revising paragraphs (b)(3)(iv)(A)(
                        <E T="03">2</E>
                        ) and (b)(3)(iv)(B)(
                        <E T="03">2</E>
                        ) to read as follows:
                    </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.162</SECTNO>
                        <SUBJECT> Medicare Advantage Quality Rating System.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(3) * * *</P>
                        <P>(iv) * * *</P>
                        <P>(A) * * *</P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) For contract consolidations approved on or after January 1, 2022, if a measure score for a consumed or surviving contract is missing due to a data integrity issue as described in § 422.164(g)(1)(i) and (ii), CMS assigns a score of zero for the missing measure score in the calculation of the enrollment-weighted measure score. If a measure score for a consumed or surviving contract is missing due to not having enough data to meet the measure technical specification or the reliability is less than 0.6 for a CAHPS measure, CMS treats this measure score as missing in the calculation of the enrollment-weighted measure score.
                            <PRTPAGE P="99561"/>
                        </P>
                        <P>(B) * * *</P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) For contract consolidations approved on or after January 1, 2022, for all measures except HEDIS, CAHPS, and HOS, if a measure score for a consumed or surviving contract is missing due to a data integrity issue as described in § 422.164(g)(1)(i) and (ii), CMS assigns a score of zero for the missing measure score in the calculation of the enrollment-weighted measure score. For all measures except HEDIS, CAHPS, HOS, and call center measures, if a measure score for a consumed or surviving contract is missing due to not having enough data to meet the measure technical specification, CMS treats this measure score as missing in the calculation of the enrollment-weighted measure score.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>16. Section 422.166 is amended by:</AMDPAR>
                    <AMDPAR>a. Revising paragraph (f)(3)(iv) introductory text;</AMDPAR>
                    <AMDPAR>b. Adding paragraphs (f)(3)(iv)(C), (f)(3)(v)(A), and reserved paragraph (f)(3)(v)(B);</AMDPAR>
                    <AMDPAR>c. Revising paragraphs (f)(3)(vi) and (f)(3)(viii)(B);</AMDPAR>
                    <AMDPAR>d. Adding paragraph (f)(3)(viii)(C); and</AMDPAR>
                    <AMDPAR>e. Revising paragraphs (g)(1)(i) and (ii).</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 422.166 </SECTNO>
                        <SUBJECT>Calculation of Star Ratings.</SUBJECT>
                        <STARS/>
                        <P>(f) * * *</P>
                        <P>(3) * * *</P>
                        <P>(iv) For a measure to be included in the calculation of a contract's HEI score, the measure must meet all of the following criteria:</P>
                        <STARS/>
                        <P>(C) Beginning with the 2027 Star Ratings, for contracts that are Institutional Special Needs Plan (I-SNP) only contracts in the ratings year, the measure must be required to be reported for I-SNP-only contracts.</P>
                        <P>(v) * * *</P>
                        <P>(A) Starting with the 2029 Star Ratings if a contract's HEDIS measure score across all enrollees for a HEDIS measure included in the HEI calculated from the patient-level data submitted by the contract does not match the summary-level score submitted by the contract to NCQA for either of the measurement years used to construct the HEI, the contract will receive -1 points for the HEDIS measure in the calculation of the HEI. If a contract does not submit HEDIS patient-level data for a measure for which it submitted contract-level data for either of the measurement years used to construct the HEI, the contract will receive -1 points for the HEDIS measure in the calculation of the HEI.</P>
                        <P>(B) [Reserved]</P>
                        <P>(vi) Starting with the 2027 Star Ratings, to have the HEI calculated, contracts that are I-SNP-only contracts in the ratings year must have at least 500 enrollees in the most recent measurement year used in the HEI and have at least half of the measures included in the HEI meet the criteria specified under paragraph (f)(3)(iv) of this section for the subset of measures that I-SNP-only contracts are required to report. To have the HEI calculated, all other contracts must have at least 500 enrollees in the most recent measurement year used in the HEI and have at least half of the measures included in the HEI meet the criteria specified under paragraph (f)(3)(iv) of this section.</P>
                        <STARS/>
                        <P>(viii) * * *</P>
                        <P>(B) Starting with the 2027 Star Ratings, for the second year following a consolidation when calculating the HEI score for the surviving contract, the patient-level data used in calculating the HEI score is combined across the consumed and surviving contracts in the consolidation and used in calculating the HEI score. The enrollment used in assessing whether the surviving contract meets an enrollment threshold under paragraph (f)(3)(vii) of this section will be the combined enrollment from the consumed and surviving contracts from the most recent year of data used to calculate the HEI.</P>
                        <P>(C) Starting with the 2029 Star Ratings, in states where, consistent with § 422.107(e), one or more MA contracts that only include one or more dual eligible special needs plans (D-SNPs) with a service area limited to that state are required to be established and maintained, the original MA contract(s) from which the D-SNP plan benefit package or packages were moved (hereafter referred to as the “legacy MA contract(s)”) into the MA contract established under § 422.107(e) will have the HEI reward calculated as follows every year after the D-SNP-only contract is required to be created until the Star Ratings year in which additional SRFs beyond receipt of LIS, dual-eligibility, and disability are added to the HEI:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) If the legacy MA contract, based on its own enrollment, meets an enrollment threshold under paragraph (f)(3)(vii) of this section, the methodology for calculating the HEI reward in paragraph (f)(3)(viii) of this section is followed.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) If the legacy MA contract, based on its own enrollment, does not meet an enrollment threshold as defined in paragraph (f)(3)(vii) of this section, and either one of the legacy MA contract or the MA contract established under § 422.107(e) cannot have the HEI reliably calculated as described in paragraphs (f)(3)(iv) and (vi) of this section, then the legacy MA contract does not qualify for an HEI reward.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) If the legacy MA contract, based on its own enrollment, does not meet an enrollment threshold as defined in paragraph (f)(3)(vii) of this section, and the legacy MA contract's performance on the HEI based on its own enrollment is less than—
                        </P>
                        <P>
                            (
                            <E T="03">i</E>
                            ) The minimum index score defined at paragraph (f)(3)(vii) of this section; or
                        </P>
                        <P>
                            (
                            <E T="03">ii</E>
                            ) The performance on the HEI of the MA contract established under § 422.107(e)
                        </P>
                        <P>Then, the legacy MA contract does not qualify for an HEI reward.</P>
                        <P>
                            (
                            <E T="03">4</E>
                            )(
                            <E T="03">i</E>
                            ) If the legacy MA contract, based on its own enrollment, does not meet an enrollment threshold as defined in paragraph (f)(3)(vii) of this section, and both the legacy MA contract and the MA contract established under § 422.107(e) can have the HEI score reliably calculated following paragraphs (f)(3)(iv) and (vi) of this section, then the enrollment combined across the legacy MA contract and the MA contract established under § 422.107(e) for the most recent measurement year used in calculating the HEI is used in assessing the enrollment threshold in paragraph (f)(3)(vii) of this section.
                        </P>
                        <P>
                            (
                            <E T="03">ii</E>
                            ) If an enrollment threshold is met using the combined enrollment described in paragraph (f)(3)(viii)(C)(
                            <E T="03">4</E>
                            )(
                            <E T="03">i</E>
                            ) of this section, the legacy MA contract's rating-specific HEI score meets the minimum index score of greater than zero defined at paragraph (f)(3)(vii) of this section, and the legacy MA contract's rating-specific HEI score is greater than or equal to the rating-specific HEI score of the MA contract established under § 422.107(e), then the HEI reward for the legacy MA contract is calculated following paragraph (f)(3)(viii) of this section based on the enrollment threshold using the combined enrollment from the legacy MA contract and the MA contract established under § 422.107(e), and using the HEI score for the MA contract established under § 422.107(e).
                        </P>
                        <P>
                            (
                            <E T="03">5</E>
                            ) When multiple legacy MA contracts move their D-SNP plan benefit package(s) to the same MA contract established under § 422.107(e) and any of the legacy MA contracts do not meet an enrollment threshold as defined in paragraph (f)(3)(vii) of this 
                            <PRTPAGE P="99562"/>
                            section, and both the legacy MA contracts and the MA contract established under § 422.107(e) can have the HEI score reliably calculated following paragraphs (f)(3)(iv) and (vi) of this section, then the combined enrollment from the legacy MA contracts and the MA contract established under § 422.107(e) for the most recent measurement year used in calculating the HEI is used in assessing the enrollment threshold in paragraph (f)(3)(vii) of this section for any of the legacy MA contracts that do not meet an enrollment threshold on their own. If an enrollment threshold is met using the combined enrollment in this paragraph, the steps in paragraph (f)(3)(viii)(C)(
                            <E T="03">4</E>
                            )(
                            <E T="03">ii</E>
                            ) of this section are followed separately for each of the legacy MA contracts. If a legacy MA contract meets the enrollment thresholds on its own or if it cannot have the HEI score reliably calculated following paragraphs (f)(3)(iv) and (vi) of this section, the legacy MA contract would not be included in the calculation of the combined enrollment.
                        </P>
                        <STARS/>
                        <P>(g) * * *</P>
                        <P>(1) * * *</P>
                        <P>(i) If the highest rating rounded to the half star before the addition of the HEI reward, if applicable, for each contract-type is 4 stars or more without the use of the improvement measure(s) and with all applicable adjustments (CAI and the reward factor), a comparison of the highest rating with and without the improvement measure(s) is done. The higher rating is used for the rating.</P>
                        <P>(ii) If the highest rating rounded to the half star before the addition of the HEI reward, if applicable, is less than 4 stars without the use of the improvement measure(s) and with all applicable adjustments (CAI and the reward factor), the rating will be calculated with the improvement measure(s).</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>17. Section 422.562 is amended by revising paragraph (c)(2) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.562 </SECTNO>
                        <SUBJECT>General provisions.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(2) Based on an MA organization's determination on a request for payment, if an enrollee has no further liability to pay for services that were furnished by an MA organization, a determination regarding these services is not subject to appeal.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>18. Section 422.566 is amended by revising paragraph (b)(3) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.566</SECTNO>
                        <SUBJECT> Organization determinations.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(3) The MA organization's refusal, pre- or post-service or in connection with a decision made concurrently with an enrollee's receipt of services, to provide or pay for services, in whole or in part, including the type or level of services, that the enrollee believes should be furnished or arranged for by the MA organization.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>19. Section 422.568 is amended by revising paragraphs (b)(1) introductory text, (d) introductory text, and (f) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.568 </SECTNO>
                        <SUBJECT>Standard timeframes and notice requirements for organization determinations.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>
                            (1) 
                            <E T="03">Requests for service or item.</E>
                             Except as provided in paragraph (b)(2) of this section, when a party has made a request for an item or service, the MA organization must notify the enrollee (and the physician or provider involved, as appropriate) of its determination as expeditiously as the enrollee's health condition requires but no later than either of the following:
                        </P>
                        <STARS/>
                        <P>
                            (d) 
                            <E T="03">Written notice for MA organization denials.</E>
                             The MA organization must give the enrollee and the physician or provider involved, as appropriate, a written notice if—
                        </P>
                        <STARS/>
                        <P>
                            (f) 
                            <E T="03">Effect of failure to provide timely notice.</E>
                             If the MA organization fails to provide the enrollee and the physician or provider involved, as appropriate, with timely notice of an organization determination as specified in this section, this failure itself constitutes an adverse organization determination and may be appealed.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>20. Section 422.572 is amended by revising paragraph (f) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.572 </SECTNO>
                        <SUBJECT>Timeframes and notice requirements for expedited organization determinations.</SUBJECT>
                        <STARS/>
                        <P>
                            (f) 
                            <E T="03">Effect of failure to provide a timely notice.</E>
                             If the MA organization fails to provide the enrollee and the physician or prescriber involved, as appropriate, with timely notice of an expedited organization determination as specified in this section, this failure itself constitutes an adverse organization determination and may be appealed.
                        </P>
                    </SECTION>
                    <AMDPAR>21. Section 422.616 is amended by revising paragraph (a) and adding paragraph (e) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.616 </SECTNO>
                        <SUBJECT>Reopening and revising determinations and decisions.</SUBJECT>
                        <P>(a) Subject to paragraph (e) of this section and the rules at § 422.138(c) of this part, an organization or reconsidered determination made by an MA organization, a reconsidered determination made by the independent entity described in § 422.592, or the decision of an ALJ or attorney adjudicator or the Council that is otherwise final and binding may be reopened and revised by the entity that made the determination or decision, under the rules in part 405 of this chapter.</P>
                        <STARS/>
                        <P>(e) Limitation on reopening a determination related to an approved inpatient hospital admission: If the MA organization approved an inpatient hospital admission under the rules at § 412.3(d)(1) and (3), any additional clinical information obtained after the initial organization determination cannot be used as new and material evidence to establish good cause for reopening the determination.</P>
                    </SECTION>
                    <AMDPAR>22. Section 422.631 is amended by revising paragraphs (a) and (d)(1)(i) and (ii) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.631 </SECTNO>
                        <SUBJECT>Integrated organization determinations.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">General rule.</E>
                             An applicable integrated plan must adopt and implement a process for enrollees to request that the plan make an integrated organization determination. The process for requesting that the applicable integrated plan make an integrated organization determination must be the same for all covered benefits. Timeframes and notice requirements for integrated organization determinations for Part B drugs are governed by the provisions for Part B drugs in §§ 422.568(b)(3), 422.570(d)(2), and 422.572(a)(2).
                        </P>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>(1) * * *</P>
                        <P>(i) The applicable integrated plan must send an enrollee a written notice (and notify the physician or provider involved, as appropriate) of any adverse decision on an integrated organization determination (including a determination to authorize a service or item in an amount, duration, or scope that is less than the amount previously requested or authorized for an ongoing course of treatment) within the timeframes set forth in this section.</P>
                        <P>
                            (ii) For an integrated organization determination not reached within the timeframes specified in this section (which constitutes a denial and is thus an adverse decision), the applicable 
                            <PRTPAGE P="99563"/>
                            integrated plan must send a notice to the enrollee (and notify the physician or provider involved, as appropriate) on the date that the timeframes expire. Such notice must describe all applicable Medicare and Medicaid appeal rights.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>23. Section 422.2260 is amended by revising the definitions of “Advertisement (Ad)” and “Marketing” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.2260 </SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Advertisement (Ad)</E>
                             means a read, written, visual, oral, watched, or heard bid for, or call to attention.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Marketing</E>
                             means communications materials and activities that are intended to draw a beneficiary's attention to a MA plan or plans, influence a beneficiary's decision-making process when making a MA plan selection, or influence a beneficiary's decision to stay enrolled in a plan (that is, retention-based marketing), except those required materials specified in § 422.2267(e) of this chapter, which will maintain the material designation as provided by CMS. In evaluating the intent of an activity or material, CMS considers objective information including, but not limited to, the audience of the activity or material, other information communicated by the activity or material, timing, and other context of the activity or material and is not limited to the MA organization's stated intent.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>24. Section 422.2263 is amended by adding paragraph (b)(11) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.2263 </SECTNO>
                        <SUBJECT>General marketing requirements.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(11) Market the dollar value of a supplemental benefit or the method by which a supplemental benefit is administered, such as use of a debit card by the enrollee to provide the plan's payment to the provider for the covered services.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>25. Section 422.2267 is amended:</AMDPAR>
                    <AMDPAR>a. In paragraph (e)(30)(vi) by removing the word “and”;</AMDPAR>
                    <AMDPAR>b. In paragraph (e)(30)(vii) by removing the phrase “of this section.” and adding in its place the phrase “of this section; and”; and</AMDPAR>
                    <AMDPAR>c. By adding paragraph (e)(30)(viii).</AMDPAR>
                    <P>The addition reads as follows:</P>
                    <SECTION>
                        <SECTNO>§ 422.2267 </SECTNO>
                        <SUBJECT>Required materials and content.</SUBJECT>
                        <STARS/>
                        <P>(e) * * *</P>
                        <P>(30) * * *</P>
                        <P>(viii) For dual eligible special needs plans that are applicable integrated plans, as defined in § 422.561, must be an integrated member ID card that serves as the ID card for both the Medicare and Medicaid plans in which the enrollee is enrolled, beginning no later than contract year 2027.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>26. Section 422.2274 is amended by revising paragraph (c)(12) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.2274 </SECTNO>
                        <SUBJECT>Agent, broker, and other third-party requirements.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(12) Ensure that, prior to an enrollment, CMS' required questions and topics regarding beneficiary needs in a health plan choice are fully discussed. Topics to be discussed include all the following:</P>
                        <P>(i) Primary care providers and specialists (that is, whether or not the beneficiary's current providers are in the plan's network).</P>
                        <P>(ii) Pharmacies (that is, whether or not the beneficiary's current pharmacy is in the plan's network).</P>
                        <P>(iii) Prescription drug coverage and costs (including whether or not the beneficiary's current prescriptions are covered).</P>
                        <P>(iv) Low-income subsidy eligibility (that is, at a minimum, explaining the eligibility requirements as defined at § 423.773, and the effect on drug costs if eligible, and identifying resources where they can get more information on applying).</P>
                        <P>(v) Resources for state programs, including Medicare Savings Programs</P>
                        <P>(vi) For beneficiaries who are enrolling into a MA plan when first eligible for Medicare, or those who are dropping a Medigap plan to enroll into an MA plan for the first time.</P>
                        <P>(A) The agent must explain all of the following:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) That there is a 12-month period under Federal law in which they are permitted to disenroll from the MA plan and switch back to Traditional Medicare and purchase a Medigap plan with guaranteed issue rights.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) If the beneficiary enrolls into Traditional Medicare and decides to purchase a Medigap plan outside of the 12-month window, that they are not guaranteed the right under Federal law to purchase a Medigap plan in the future, and if they do, the insurance company selling the Medigap plan may not cover all preexisting health conditions and may charge more based on past or present health problems.
                        </P>
                        <P>(B) The agent may do either of the following:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Provide additional state-based guaranteed issue rights information.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Supplement state-based guaranteed issue rights information with the information provided under 422.2274(c)(12)(vi)(A) of this section, when it offers additional protections or flexibility.
                        </P>
                        <P>(vii) Costs of health care services.</P>
                        <P>(viii) Premiums.</P>
                        <P>(ix) Benefits.</P>
                        <P>(x) Specific health care needs.</P>
                        <P>(xi) Conclude by pausing to ask if the beneficiary has any questions about the topics discussed in paragraph (c)(12) of this section or others, including those related to enrollment.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>27. Section 422.2401 is amended by adding in alphabetical order definitions for “MLR audit remittance” and “MLR audit remittance process” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.2401 </SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <P>
                            <E T="03">MLR audit remittance</E>
                             means the amount CMS calculates and an MA organization pays for an MA contract that has failed to meet the 85 percent minimum MLR requirement as the result of an MLR audit examination.
                        </P>
                        <P>
                            <E T="03">MLR audit remittance process</E>
                             means the process by which CMS calculates the MLR audit remittance for a contract that is determined to have failed to meet the 85 percent minimum MLR requirement as the result of an MLR audit examination and notify the MA organization about the remittance. The process includes all of the following:
                        </P>
                        <P>(1) Collecting the MLR audit remittance indicated in the final audit report issued by CMS.</P>
                        <P>(2) Receiving responses from MA organizations requesting an appeal of the MLR audit remittance.</P>
                        <P>(3) Taking actions to adjudicate an appeal (if requested).</P>
                        <P>(4) Receiving MLR remittances from MA organizations.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>28. Section 422.2420 is amended by—</AMDPAR>
                    <AMDPAR>a. Revising paragraph (b)(2)(xi);</AMDPAR>
                    <AMDPAR>b. Adding paragraph (b)(4)(i)(D);</AMDPAR>
                    <AMDPAR>c. Revising paragraph (c)(2)(iv)(B);</AMDPAR>
                    <AMDPAR>d. Redesignating paragraphs (d)(2)(i) through (iii) as paragraphs (d)(2)(ii) through (iv); and</AMDPAR>
                    <AMDPAR>e. Adding new paragraph (d)(2)(i).</AMDPAR>
                    <P>The additions and revisions read as follows:</P>
                    <SECTION>
                        <PRTPAGE P="99564"/>
                        <SECTNO>§ 422.2420 </SECTNO>
                        <SUBJECT>Calculation of medical loss ratio.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(2) * * *</P>
                        <P>(xi) The amount of incentive and bonus payments made, or expected to be made, to providers that are tied to clearly defined, objectively measurable, and well-documented clinical or quality improvement standards that apply to providers.</P>
                        <P>(3) * * *</P>
                        <P>(4) * * *</P>
                        <P>(i) * * *</P>
                        <P>(D) Unsettled balances from the Medicare Prescription Payment Plan</P>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(2) * * *</P>
                        <P>(iv) * * *</P>
                        <P>(B) Such payment may be deducted up to the limit of either 3 percent of total revenue under this part or the highest premium tax rate in the State for which the MA organization is licensed, multiplied by the MA organization's earned premium for the contract.</P>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>(2) * * *</P>
                        <P>(i) The report required in § 422.2460 must include a detailed description of the methods used to allocate expenses, including incurred claims, expenditures on quality improving activities, licensing and regulatory fees, and State and Federal taxes and assessments. A detailed description of each expense element must be provided, including how each specific expense meets the criteria for the type of expense in which it is categorized, as well as the method by which it was aggregated.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>29. Section 422.2430 is amended by redesignating paragraphs (a) and (b) as paragraphs (b) and (c) and adding a new paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.2430 </SECTNO>
                        <SUBJECT>Activities that improve health care quality.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">General requirements.</E>
                             The report required in § 422.2460 must include expenditures directly related to activities that improve health care quality, as such activities are described in this section.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>30. Section 422.2450 is added to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.2450 </SECTNO>
                        <SUBJECT>MLR audit process.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Notice of audit.</E>
                             CMS provides at least 15 calendar days advance notice of its intent to conduct an audit of an MA organization.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Conferences.</E>
                             All audits include an entrance conference during which the scope of the audit is presented and an exit conference during which the initial audit findings are discussed.
                        </P>
                        <P>
                            (c) 
                            <E T="03">Audit documentation.</E>
                             All requested audit documentation must be provided by the MA organization to CMS within 30 calendar days of the audit entrance conference. CMS may extend, at CMS's discretion, the time for an MA organization to provide the documentation requested.
                        </P>
                        <P>
                            (d) 
                            <E T="03">Preliminary audit findings.</E>
                             CMS shares its preliminary audit findings with the MA organization, which then has 30 calendar days to respond to such findings. CMS may extend, for good cause, the time for an MA organization to submit such a response.
                        </P>
                        <P>
                            (e) 
                            <E T="03">Final audit findings.</E>
                             If the MA organization does not dispute the preliminary findings within the 30-day timeframe per paragraph (d) of this section, then the audit report becomes final. Alternatively, if the MA organization disputes the preliminary findings, CMS reviews and considers such response before finalizing the audit findings.
                        </P>
                        <P>
                            (f) 
                            <E T="03">Corrective actions.</E>
                             CMS sends a copy of the final audit report to the MA organization as well as issues corrective actions that the MA organization must undertake as a result of the audit findings.
                        </P>
                        <P>
                            (g) 
                            <E T="03">Order to pay remittances.</E>
                             If CMS determines as the result of an audit that an MA organization has failed to pay remittances it is obligated to pay under § 422.2480, it may order the MA organization to pay those remittances consistent with § 422.2452.
                        </P>
                    </SECTION>
                    <AMDPAR>31. Section 422.2452 is added to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.2452 </SECTNO>
                        <SUBJECT>MLR audit remittance and payment process.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Notice of MLR audit remittance.</E>
                             After the calculation of the MLR audit remittance, CMS sends the MA organization the final audit report with the MLR audit remittance amount. The final audit report contains the following information:
                        </P>
                        <P>(1) A MLR audit remittance for the contract that has failed to meet the 85 percent MLR minimum requirement based on audit findings, which may be one of the following:</P>
                        <P>(ii) An amount due from the MA organization.</P>
                        <P>(iii) $0 if nothing is due from the MA organization.</P>
                        <P>(2) Relevant banking and financial mailing instructions for MA organizations that owe a MLR audit remittance.</P>
                        <P>(3) Relevant CMS contact information.</P>
                        <P>(4) A description of the steps for requesting an appeal of the MLR audit remittance calculation, in accordance with the requirements specified in § 422.2454.</P>
                        <P>
                            (b) 
                            <E T="03">Request for an appeal.</E>
                             A MA organization that disagrees with the MLR audit remittance has 15 calendar days from the date of issuance of the final audit report, as described in paragraph (a) of this section, to request an appeal of the MLR audit remittance under the process described in § 422.2454.
                        </P>
                        <P>(1) If an MA organization agrees with the MLR audit remittance, no response is required.</P>
                        <P>(2) If an MA organization disagrees with the MLR audit remittance, it must request an appeal within 15 calendar days from the date of issuance of the final audit report. CMS will not consider any requests for appeal after this 15-day period.</P>
                        <P>
                            (c) 
                            <E T="03">Actions if a MA organization does not request an appeal.</E>
                             (1) The MA organization is required to remit payment to CMS within 120 calendar days from the date of issuance of the final audit report.
                        </P>
                        <P>(2) If the MA organization fails to remit payment within that 120-calendar-day period, CMS refers the debt owed to CMS to the Department of the Treasury for collection.</P>
                        <P>
                            (d) 
                            <E T="03">Actions following a request for appeal.</E>
                             If an MA organization responds to the final audit report disagreeing with the MLR audit remittance and requesting appeal, CMS conducts a review process under the process described at § 422.2454.
                        </P>
                    </SECTION>
                    <AMDPAR>32. Section 422.2454 is added to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.2454 </SECTNO>
                        <SUBJECT>MLR audit remittance appeals process.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Appeals process.</E>
                             If an MA organization does not agree with the MLR audit remittance described in § 422.2452(a), it may appeal under the following three-level appeal process:
                        </P>
                        <P>
                            (1) 
                            <E T="03">Reconsideration.</E>
                             An MA organization may request reconsideration of the MLR audit remittance described in § 422.2452(a) according to the following process:
                        </P>
                        <P>
                            (i) 
                            <E T="03">Manner and timing of request.</E>
                             A written request for reconsideration must be filed within 15 days from the date of issuance of the final audit report to the MA organization.
                        </P>
                        <P>
                            (ii) 
                            <E T="03">Content of request.</E>
                             The written request for reconsideration must do all of the following:
                        </P>
                        <P>(A) Specify the calculation with which the MA organization disagrees and the reasons for its disagreement.</P>
                        <P>
                            (B) Include evidence supporting the assertion that CMS's calculation of the MLR audit remittance is incorrect.
                            <PRTPAGE P="99565"/>
                        </P>
                        <P>(C) Not include new data or data that was submitted to CMS after the final audit report was issued.</P>
                        <P>
                            (iii) 
                            <E T="03">Conduct of reconsideration.</E>
                             In conducting the reconsideration, the CMS reconsideration official reviews the calculations that were used to determine the MLR audit remittance and any additional evidence timely submitted by the MA organization.
                        </P>
                        <P>
                            (iv) 
                            <E T="03">Reconsideration decision.</E>
                             The CMS reconsideration official informs the MA organization of its decision on the reconsideration in writing.
                        </P>
                        <P>
                            (v) 
                            <E T="03">Effect of reconsideration decision.</E>
                             The decision of the CMS reconsideration official is final and binding unless a timely request for an informal hearing is filed in accordance with paragraph (a)(2) of this section.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Informal hearing.</E>
                             An MA organization dissatisfied with CMS's reconsideration decision made under paragraph (a)(1) of this section is entitled to an informal hearing as provided for under paragraphs (a)(2)(i) through (iv) of this section.
                        </P>
                        <P>
                            (i) 
                            <E T="03">Manner and timing of request.</E>
                             A request for an informal hearing must be made in writing and filed with the CMS hearing officer within 15 calendar days from the date of issuance of the reconsideration decision.
                        </P>
                        <P>
                            (ii) 
                            <E T="03">Content of request.</E>
                             The request for an informal hearing must include a copy of the reconsideration decision and must specify the findings or issues in the decision with which the MA organization disagrees and the reasons for its disagreement.
                        </P>
                        <P>
                            (iii) 
                            <E T="03">Informal hearing procedures.</E>
                             The informal hearing is conducted in accordance with the following:
                        </P>
                        <P>(A) The CMS Hearing Officer provides written notice of the time and place of the informal hearing at least 30 calendar days before the scheduled date.</P>
                        <P>(B) The CMS reconsideration official provides, within 10 calendar days of the hearing officer receiving an informal hearing request, a copy of the record that was before the reconsideration official.</P>
                        <P>(C) The hearing officer review is conducted by a CMS hearing officer who neither receives testimony nor accepts any new evidence. The CMS hearing officer is limited to the review of the record that was before CMS reconsideration official had when making the reconsideration decision.</P>
                        <P>
                            (iv) 
                            <E T="03">Decision of the CMS hearing officer.</E>
                             The CMS hearing officer decides whether to uphold or overturn the reconsideration official's decision and sends a written decision to the MA organization explaining the basis for the decision.
                        </P>
                        <P>
                            (v) 
                            <E T="03">Effect of hearing officer's decision.</E>
                             The hearing officer's decision is final and binding, unless the decision is reversed or modified by the CMS Administrator in accordance with paragraph (a)(3) of this section.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Review by the Administrator.</E>
                             The Administrator's review is conducted in the following manner:
                        </P>
                        <P>
                            (i) 
                            <E T="03">Manner and timing of request.</E>
                             An MA organization that has received a hearing officer's decision may request review by the Administrator within 15 calendar days of the date of issuance of the hearing officer's decision under paragraph (a)(2)(iv) of this section. The MA organization may submit written arguments to the Administrator for review.
                        </P>
                        <P>
                            (ii) 
                            <E T="03">Discretionary review.</E>
                             (A) After receiving a request for review, the Administrator has the discretion to elect to review the hearing officer's determination in accordance with paragraph (a)(3)(iii) of this section or to decline to review the hearing officer's decision within 30 calendar days of receiving the request for review.
                        </P>
                        <P>(B) If the Administrator declines to review the hearing officer's decision, the hearing officer's decision is final and binding.</P>
                        <P>
                            (iii) 
                            <E T="03">Electing to review.</E>
                             If the Administrator elects to review the hearing officer's decision, the Administrator reviews the hearing officer's decision, as well as any information included in the record of the hearing officer's decision and any written argument submitted by the MA organization, and determine whether to uphold, reverse, or modify the hearing officer's decision.
                        </P>
                        <P>
                            (iv) 
                            <E T="03">Effect of Administrator's decision.</E>
                             The Administrator's decision is final and binding.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Matters subject to appeal and burden of proof.</E>
                             (1) The MA organization's appeal is limited to CMS's calculation of the MLR audit remittance.
                        </P>
                        <P>(2) The MA organization bears the burden of proof for providing evidence demonstrating that CMS's audit examination results for the MLR audit remittance require further review. The MA organization may not challenge the underlying methodology for the MLR audit remittance calculation.</P>
                        <P>
                            (c) 
                            <E T="03">Stay of financial transaction until appeals are exhausted.</E>
                             If an MA organization requests review of the MLR audit remittance, the financial transaction associated with the payment of the MLR audit remittance is stayed until all appeals are exhausted. Once all levels of appeal are exhausted or the MA organization fails to request further review within the applicable 15-calendar-day timeframe, CMS communicates with the MA organization to complete the financial transaction associated with the payment of the MLR audit remittance.
                        </P>
                        <P>
                            (d) 
                            <E T="03">Continued compliance with other law required.</E>
                             Nothing in this section limits a MA organization's responsibility to comply with any other statute or regulation.
                        </P>
                    </SECTION>
                    <AMDPAR>33. Section 422.2460 is amended by revising paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.2460 </SECTNO>
                        <SUBJECT>Reporting requirements.</SUBJECT>
                        <P>(a) Except as provided in paragraph (b) of this section, for each contract year, each MA organization must submit to CMS, in a timeframe and manner specified by CMS, a report that includes the data needed by the MA organization to calculate and verify the medical loss ratio (MLR) and remittance amount, if any, for each contract under this part, including the amount of incurred claims for original Medicare covered benefits, supplemental benefits, provider payment arrangements, and prescription drugs; total revenue; expenditures on quality improving activities; non-claims costs; taxes; licensing and regulatory fees; and any remittance owed to CMS under § 422.2410.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>34. Section 422.2480 is amended by revising paragraph (d) introductory text to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.2480 </SECTNO>
                        <SUBJECT>MLR review and non-compliance.</SUBJECT>
                        <STARS/>
                        <P>(d) Data submitted under § 422.2460, calculations, or any other MLR submission required by this subpart which have not been reported in a timely and accurate manner or have been found to be materially incorrect or fraudulent—</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>35. Section 422.2490 is amended by adding paragraphs (b)(6) and (7) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 422.2490 </SECTNO>
                        <SUBJECT>Release of Part C MLR data.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(6) DIR information reported within the MLR data as part of incurred claims.</P>
                        <P>(7) Provider payment arrangement data that is not reported on a deidentified basis and provider payment arrangement data that is not reported on an aggregate total basis.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT</HD>
                    </PART>
                    <AMDPAR>36. The authority for part 423 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <PRTPAGE P="99566"/>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.</P>
                    </AUTH>
                    <AMDPAR>37. Section 423.100 is amended by adding in alphabetical order definitions for “ACIP-recommended adult vaccine,” “Covered insulin product,” “Covered insulin product applicable cost-sharing amount,” and “Effective date of the ACIP recommendation” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.100 </SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <P>
                            <E T="03">ACIP-recommended adult vaccine</E>
                             means a covered Part D drug, as defined at § 423.100, that is a vaccine licensed by the U.S. Food and Drug Administration (FDA) under section 351 of the Public Health Service Act for use by adult populations and administered in accordance with recommendations of the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) as adopted by the CDC Director.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Covered insulin product</E>
                             means, for purposes of § 423.120(h), an insulin product, including a product that is a combination of more than one type of insulin or a product that is a combination of both insulin and a non-insulin drug or biological product, that—
                        </P>
                        <P>(1) Is a covered Part D drug covered under a PDP or MA-PD plan—</P>
                        <P>(i) Is licensed under section 351 of the Public Health Service Act; and</P>
                        <P>(ii) Is marketed under the license described in paragraph (1)(i) of this definition.</P>
                        <P>(2) Is not a compounded drug product that contains insulin (as described in § 423.120(d)).</P>
                        <P>
                            <E T="03">Covered insulin product applicable cost-sharing amount</E>
                             means, with respect to a covered insulin product, as defined in this section, covered under a PDP or an MA-PD plan prior to an enrollee reaching the annual out-of-pocket threshold during plan year 2026 and each subsequent plan year, the lesser of the following:
                        </P>
                        <P>(1) $35.</P>
                        <P>(2) An amount equal to 25 percent of the maximum fair price established for the covered insulin product in accordance with part E of subchapter XI.</P>
                        <P>(3) An amount equal to 25 percent of the negotiated price (as defined in § 423.100) of the covered insulin product under the PDP or MA-PD plan.</P>
                        <STARS/>
                        <P>
                            <E T="03">Effective date of the ACIP recommendation</E>
                             means the date specified on the CDC website noting the date the CDC Director adopted the ACIP recommendation.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>38. Section 423.120 is amended by adding paragraphs (g) and (h) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.120 </SECTNO>
                        <SUBJECT>Access to covered Part D drugs</SUBJECT>
                        <STARS/>
                        <P>
                            (g) 
                            <E T="03">Coverage of ACIP-recommended adult vaccines.</E>
                             With respect to an ACIP-recommended adult vaccine, a Part D sponsor must—
                        </P>
                        <P>(1) Not apply any deductible nor charge any cost-sharing; and</P>
                        <P>(2) Once a new or revised recommendation is posted on the CDC website, provide coverage consistent with paragraph (g)(1) of this section for dates of service on or after the effective date of the ACIP recommendation, as defined at § 423.100.</P>
                        <P>(3) Apply the requirements in paragraphs (g)(1) and (2) of this section to ACIP-recommended adult vaccines obtained from either an in-network or out-of-network pharmacy or provider in accordance with § 423.124(a) and (c).</P>
                        <P>
                            (h) 
                            <E T="03">Appropriate cost-sharing for covered insulin products.</E>
                             With respect to a covered insulin product, as defined at § 423.100, covered under a PDP or an MA-PD plan prior to an enrollee reaching the annual out-of-pocket threshold, a Part D sponsor must do all of the following:
                        </P>
                        <P>(1) Not apply a deductible.</P>
                        <P>(2) Ensure any enrollee cost sharing for each prescription fill up to a one-month supply does not exceed the covered insulin product applicable cost-sharing amount defined at § 423.100.</P>
                        <P>(3) Ensure any enrollee cost sharing for each prescription fill greater than a 1-month supply does not exceed the cumulative covered insulin product applicable cost-sharing amount (as defined in § 423.100) that would apply if the same days' supply was dispensed in the fewest number of 1-month supply increments necessary.</P>
                        <P>(4) Apply the requirements in paragraphs (h)(1) through (3) of this section to covered insulin products obtained from either an in-network or out-of-network pharmacy or provider.</P>
                    </SECTION>
                    <AMDPAR>39. Section 423.137 is added to subpart C to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.137 </SECTNO>
                        <SUBJECT>Medicare Prescription Payment Plan.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">General.</E>
                             For plan years beginning on or after January 1, 2026, or, in the case of a plan operating on a non-calendar year basis, for the portion of the plan year starting on January 1, 2026, each PDP sponsor offering a prescription drug plan and each MA organization offering an MA-PD plan must provide to any enrollee of such plan, including an enrollee who is a subsidy eligible individual (as defined at § 423.4), the option to elect with respect to a plan year to pay $0 cost sharing at the point of sale and pay cost sharing under the plan in monthly amounts that are capped in accordance with this section.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Definitions.</E>
                             For the purposes of this section, the following definitions apply:
                        </P>
                        <P>
                            (1) 
                            <E T="03">OOP costs for the Medicare Prescription Payment Plan</E>
                             means the out-of-pocket cost sharing amount the Part D enrollee is directly responsible for paying.
                        </P>
                        <P>(i) For the subsequent month calculation of the Part D cost sharing incurred by the Part D enrollee, it includes those Part D cost sharing amounts that the enrollee is responsible for paying after taking into account amounts paid by third-party payers.</P>
                        <P>(ii) It does not include the covered plan pay amount or other costs defined under section 1860D-2(b)(4)(C) of the Act.</P>
                        <P>
                            (2) 
                            <E T="03">Remaining OOP costs owed by the participant</E>
                             means the sum of out-of-pocket costs for the Medicare Prescription Payment Plan that have not yet billed to the program participant. For example, if a Medicare Prescription Payment Plan participant incurs $2,000 in January 2025 and is billed $166.67, the remaining OOP costs for the Medicare Prescription Payment Plan are $2,000−$166.67 = $1,833.33.
                        </P>
                        <P>
                            (c) 
                            <E T="03">Calculation of the maximum monthly cap on cost-sharing payments.</E>
                             For each month in the plan year for which an enrollee in a PDP or an MA-PD plan has made an election to participate in the Medicare Prescription Payment Plan, the PDP sponsor or MA organization must determine a maximum monthly cap (as defined in paragraph (c)(1) of this section) for such enrollee.
                        </P>
                        <P>
                            (1) 
                            <E T="03">Enrollee monthly payments.</E>
                             For each month an enrollee is participating in the Medicare Prescription Payment Plan, the PDP sponsor or MA organization shall bill such enrollee an amount (not to exceed the maximum monthly cap) for the out-of-pocket costs of such enrollee in such month.
                        </P>
                        <P>
                            (i) 
                            <E T="03">First month maximum monthly cap calculation.</E>
                             For the first month for which the enrollee has made an election to participate in the Medicare Prescription Payment Plan, the maximum monthly cap is an amount determined by calculating the annual out-of-pocket threshold specified in section 1860D-2(b)(4)(B) of the Act minus the incurred costs of the enrollee as described in section 1860D-2(b)(4)(C) of the Act; divided by the number of months remaining in the plan year.
                            <PRTPAGE P="99567"/>
                        </P>
                        <P>(A) When the out-of-pocket costs incurred in the first month of program participation are less than the maximum monthly cap defined in paragraph (c)(1)(i) of this section, the PDP sponsor or MA organization must bill the participant the lesser of the participant's actual out-of-pocket costs or the first month's maximum monthly cap.</P>
                        <P>(B) When an enrollee opts into the Medicare Prescription Payment Plan prior to the start of the plan year, the calculation described in (c)(1)(i) applies to their first month of active coverage within the plan year.</P>
                        <P>
                            (ii) 
                            <E T="03">Calculation of maximum monthly cap in subsequent months.</E>
                             For subsequent months in the plan year, the maximum monthly cap is an amount determined by calculating the sum of any remaining out-of-pocket costs owed by the enrollee from a previous month that have not yet been billed to the enrollee and any additional out-of-pocket costs incurred by the enrollee; divided by the number of months remaining in the plan year.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Eligible out-of-pocket costs.</E>
                             The calculations described in paragraphs (c)(1)(i) and (ii) of this section apply only to covered Part D drugs, as defined at § 423.100.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Months remaining in the plan year.</E>
                             For the calculations described in paragraphs (c)(1)(i) and (ii) of this section, the number of months remaining in the plan year includes the month for which the cap is being calculated.
                        </P>
                        <P>
                            (4) 
                            <E T="03">Impact on true out-of-pocket cost accumulation.</E>
                             Participation in the Medicare Prescription Payment Plan must have no impact on true out-of-pocket cost accumulation. Costs defined under section 1860D-2(b)(4)(C) of the Act incurred under the Medicare Prescription Payment Plan must still be treated as incurred based on the date each Part D claim is adjudicated.
                        </P>
                        <P>
                            (5) 
                            <E T="03">Prescriptions for an extended day supply.</E>
                             For participants who fill prescriptions for an extended day supply, their OOP costs for the Medicare Prescription Payment Plan for those prescriptions must be attributed to the month the prescription was filled and not be pro-rated over the months covered by the prescription.
                        </P>
                        <P>
                            (6) 
                            <E T="03">Mid-year plan switching.</E>
                             When an individual opts into the Medicare Prescription Payment Plan after switching plans midyear, the new Part D sponsor must calculate the individual's monthly cap for the first month of participation under the new plan using the formula for the calculation of the maximum monthly cap in the first month.
                        </P>
                        <P>
                            (d) 
                            <E T="03">Eligibility and election.</E>
                             An individual is eligible for the Medicare Prescription Payment Plan if they are enrolled in a Part D plan and have not been precluded from participation due to failure to pay, as described in paragraphs (f)(2)(ii) and (f)(5) of this section. LIS-eligible Part D enrollees are eligible to participate in the program.
                        </P>
                        <P>
                            (1) 
                            <E T="03">Election.</E>
                             A Part D sponsor must allow any Part D enrollee, including those who are LIS-eligible, to opt into the program prior to the beginning of the plan year or at any point during the plan year. A Part D enrollee must also be allowed to opt into the program in advance of a new plan enrollment effective date, including during any of the following:
                        </P>
                        <P>(i) The annual election period for the subsequent plan year.</P>
                        <P>(ii) The Part D initial enrollment period.</P>
                        <P>(iii) Part D special election periods.</P>
                        <P>
                            (2) 
                            <E T="03">Format of election requests.</E>
                             A Part D sponsor must allow any Part D enrollee or a Part D enrollee's authorized legal representative acting on behalf of the enrollee to opt into the program using a paper or electronic election request form or through a telephone call. Part D sponsors must process any election request regardless of format.
                        </P>
                        <P>
                            (i) 
                            <E T="03">Paper election requests.</E>
                             Paper election requests are considered received on the date and time:
                        </P>
                        <P>(A) The Part D sponsor initially stamps a document received by regular mail (that is, U.S. Postal Service); or</P>
                        <P>(B) A delivery service that has the ability to track when a shipment is delivered (for example, U.S. Postal Service, UPS, FedEx, or DHL) delivers the document.</P>
                        <P>
                            (ii) 
                            <E T="03">Telephonic election requests.</E>
                             Telephonic election requests are considered received on the date and time that either of the following occurs:
                        </P>
                        <P>(A) The verbal request is made by telephone with a customer service representative.</P>
                        <P>(B) A message is left on the Part D sponsor's voicemail system if the Part D sponsor utilizes a voicemail system to accept requests or supporting statements after normal business hours.</P>
                        <P>
                            (iii) 
                            <E T="03">Electronic election requests.</E>
                             An electronic election request is considered received on the date and time a request is received through the Part D sponsor's website. This is true regardless of when a Part D sponsor ultimately retrieves or downloads the request.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Completion of election request.</E>
                             For an election request to be considered complete, the Part D sponsor must receive all of the following:
                        </P>
                        <P>(i) The name of the Part D enrollee.</P>
                        <P>(ii) The Medicare ID number of the Part D enrollee.</P>
                        <P>(iii) The Part D enrollee's or their authorized legal representative's agreement to the Part D sponsor's terms and conditions for the program (signature or, in the case of telephonic requests, verbal attestation).</P>
                        <P>
                            (4) 
                            <E T="03">Processing an election request—</E>
                            (i) 
                            <E T="03">Prior to plan year.</E>
                             Part D sponsors must process election requests received prior to the plan year within the following timeframes:
                        </P>
                        <P>(A) Within 10 calendar days of receipt, process a complete election request as specified in § 423.137(d)(3).</P>
                        <P>(B) Within 10 calendar days of receipt of an incomplete election request, contact the Part D enrollee to request the necessary information to process the request as specified in § 423.137(d)(3).</P>
                        <P>(C) If information necessary to consider the request complete, as required at § 423.137(d)(3), is not received within 21 calendar days of the request for information, the Part D sponsor may deny the request.</P>
                        <P>
                            (ii) 
                            <E T="03">During a plan year.</E>
                             Part D sponsors must process election requests received during a plan year within the following timeframes:
                        </P>
                        <P>(A) Within 24 hours of receipt, process a complete election request, as specified in § 423.137(d)(3).</P>
                        <P>(B) Within 24 hours of receipt of an incomplete election request, contact the Part D enrollee to request the necessary information to process the request, as required in § 423.137(d)(3).</P>
                        <P>(C) If information necessary to consider the request complete, as required at § 423.137(d)(3), is not received within 21 calendar days of the request for information, the Part D sponsor may deny the request.</P>
                        <P>(D) In the event a Part D sponsor fails to process the request within 24 hours due to no fault of the Part D enrollee, the Part D sponsor must—</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Process a retroactive election effective on the date on which the enrollee should have been admitted into the program; and
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Reimburse the enrollee for any cost-sharing paid on or after that date within 45 calendar days and include those amounts, as appropriate, in the program calculations.
                        </P>
                        <P>
                            (5) 
                            <E T="03">Inclusion of all covered Part D drugs once in the program.</E>
                             Once a participant has opted into the program, cost sharing for all covered Part D drugs must be included in the program.
                        </P>
                        <P>
                            (6) 
                            <E T="03">Retroactive election.</E>
                             (i) A Part D sponsor must have in place a process to effectuate a retroactive election into the Medicare Prescription Payment Plan if both of the following conditions are met:
                            <PRTPAGE P="99568"/>
                        </P>
                        <P>(A) The Part D enrollee believes that any delay in filling the prescription(s) due to the 24-hour timeframe required to process their request to opt in may seriously jeopardize their life, health, or ability to regain maximum function.</P>
                        <P>(B) The Part D enrollee requests retroactive election within 72 hours of the date and time the claim(s) were adjudicated.</P>
                        <P>(ii) The Part D sponsor must process the reimbursement for all cost sharing paid by the enrollee for the prescription and any covered Part D prescription filled between the date of adjudication of the claim and the date that the enrollee's election is effectuated within 45 calendar days of the election date.</P>
                        <P>(iii) If the Part D sponsor determines that an enrollee failed to request retroactive election within the required timeframe, it must promptly notify the individual of its determination and provide instructions on how the individual may file a grievance, as required under § 423.137(h)(2).</P>
                        <P>
                            (7) 
                            <E T="03">Retroactive LIS eligibility.</E>
                             A Part D sponsor must develop standardized procedures for determining and processing reimbursements for excess Medicare Prescription Payment Plan payments made by program participants who become LIS eligible and that meet requirements specified at §§ 423.800(c) and (e) and 423.466(a).
                        </P>
                        <P>
                            (8) 
                            <E T="03">Mid-year plan switching.</E>
                             When a Part D enrollee switches Part D plans, whether offered by the same or a different Part D sponsor, during the plan year or is reassigned by CMS, the Part D sponsor of the new Part D plan is not permitted to automatically sign up the individual for the Medicare Prescription Payment Plan under the new plan but must allow the individual to opt into the program. Part D plan has the definition established at § 423.4.
                        </P>
                        <P>(i) The Part D sponsor of the prior Part D plan must offer the participant the option to repay the full outstanding amount in a lump sum. If the individual chooses to continue paying monthly, the Part D sponsor must continue to bill the participant monthly based on the participant's accrued OOP costs for the Medicare Prescription Payment Plan while in the program under that sponsor's Part D plan. The Part D sponsor cannot require full immediate repayment.</P>
                        <P>(ii) Part D enrollees may only be precluded from opting into the program under a new Part D plan if both of the following conditions are met:</P>
                        <P>(A) Both the former and new plans are offered by the same Part D sponsor.</P>
                        <P>(B) The enrollee was involuntarily terminated from the program under the former plan, as described in paragraph (f)(2)(ii) of this section, for failure to pay and still owes an overdue balance.</P>
                        <P>
                            (9) 
                            <E T="03">Automatic renewal.</E>
                             A Part D sponsor is required to automatically renew a Part D enrollee's participation in the Medicare Prescription Payment Plan for subsequent plan years. The Part D sponsor must notify the enrollee of the renewal and remind enrollees that they may opt out of the program at any time, in accordance with paragraph (f)(2)(i) of this section.
                        </P>
                        <P>
                            (10) 
                            <E T="03">Election communications</E>
                            —(i) 
                            <E T="03">Election request form.</E>
                             A Part D sponsor must make available throughout the plan year and during the Part D plan enrollment periods described at paragraph (d)(4)(i)(A) of this section an election request form in the formats specified in paragraph (d)(2) of this section.
                        </P>
                        <P>
                            (A) 
                            <E T="03">Timing.</E>
                             A Part D sponsor must send a paper election request form within the same timeframe as the membership ID card mailing specified at § 423.2267(e)(32)(i). The election form may be sent in the membership ID card mailing itself or in a separate mailing.
                        </P>
                        <P>
                            (B) 
                            <E T="03">Contents.</E>
                             The election request form must include or provide all of the following:
                        </P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Fields for all of the following Part D enrollee information:
                        </P>
                        <P>
                            (
                            <E T="03">i</E>
                            ) First and last name.
                        </P>
                        <P>
                            (
                            <E T="03">ii</E>
                            ) Medicare Number.
                        </P>
                        <P>
                            (
                            <E T="03">iii</E>
                            ) Birth date.
                        </P>
                        <P>
                            (
                            <E T="03">iv</E>
                            ) Phone number.
                        </P>
                        <P>
                            (
                            <E T="03">v</E>
                            ) Permanent residence street address, and mailing address, if different from permanent residence street address.
                        </P>
                        <P>
                            (
                            <E T="03">vi</E>
                            ) Signature field, allowing the enrollee to attest that they understand that form is a request to participate in the Medicare Prescription Payment Plan and the Part D sponsor will contact them if more information is needed to complete the request; (their signature indicates they have read and understood the Part D sponsor's terms and conditions; and the Part D sponsor will inform the individual when their participation in the program is active, and, until the individual receives that notification, they are not a participant in the program. 
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Instructions for how to submit the form to the Part D sponsor.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) Instructions for how the Part D enrollee can contact the Part D sponsor for questions or assistance.
                        </P>
                        <P>
                            (C) 
                            <E T="03">Additional information.</E>
                             Additional educational information about the Medicare Prescription Payment Plan must accompany the election request form when provided in hard copy or on the web. The additional information requirement may be fulfilled by including with the election request form the CMS-developed fact sheet about the program. If the Part D sponsor develops and uses alternative informational materials in lieu of the CMS-developed fact sheet to satisfy this requirement, they must ensure that these alternative materials accurately convey program information and are compliant with existing Part D requirements specified at subpart V of this part.
                        </P>
                        <P>
                            (D) 
                            <E T="03">Terms and conditions.</E>
                             A Part D sponsor may include their program terms and conditions on the election request form or may include them on a separate attachment.
                        </P>
                        <P>
                            (ii) 
                            <E T="03">Notice of election approval.</E>
                             Upon accepting an election request, the Part D sponsor must send a notice of election approval.
                        </P>
                        <P>
                            (A) 
                            <E T="03">Timing.</E>
                             (
                            <E T="03">1</E>
                            ) For requests received prior to the plan year, the notice of election approval must be sent within 10 calendar days of receipt of the election request.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) For requests received during the plan year, the notice of election approval must be sent within 24 hours of receipt of the election request.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) The initial notice must be delivered via telephone, to be followed by a written notice delivered to the participant within three calendar days of delivering the initial telephone notice.
                        </P>
                        <P>
                            (B) 
                            <E T="03">Contents.</E>
                             The notice of election approval must include all of the following:
                        </P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) The effective date of the individual's participation.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) A description of how payments for covered Part D drugs under the program will work.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) An overview of how the monthly bill is calculated.
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) Information about procedures for involuntary termination due to failure to pay and how to submit an inquiry or file a grievance.
                        </P>
                        <P>
                            (
                            <E T="03">5</E>
                            ) A statement that leaving the program will not affect the individual's Part D plan enrollment.
                        </P>
                        <P>
                            (
                            <E T="03">6</E>
                            ) A description of how individuals may still owe a program balance if they leave the program, and they can choose to pay their balance all at once or be billed monthly.
                        </P>
                        <P>
                            (
                            <E T="03">7</E>
                            ) An overview of other Medicare programs that can help lower costs and how to learn more about these programs. These programs include all of the following:
                        </P>
                        <P>
                            (
                            <E T="03">i</E>
                            ) Extra Help.
                        </P>
                        <P>
                            (
                            <E T="03">ii</E>
                            ) The Medicare Savings Program.
                        </P>
                        <P>
                            (
                            <E T="03">iii</E>
                            ) The State Pharmaceutical Assistance Program.
                        </P>
                        <P>
                            (
                            <E T="03">iv</E>
                            ) A manufacturer's Pharmaceutical Assistance Program.
                        </P>
                        <P>
                            (C) 
                            <E T="03">Additional information.</E>
                             Additional educational information 
                            <PRTPAGE P="99569"/>
                            about the Medicare Prescription Payment Plan must accompany the notice of election approval. The additional information requirement may be fulfilled by including with the notice the CMS-developed fact sheet about the program. If the Part D sponsor develops and uses alternative informational materials in lieu of the CMS-developed fact sheet to satisfy this requirement, they must ensure that these alternative materials accurately convey program information and are compliant with existing Part D requirements specified at subpart V of this part.
                        </P>
                        <P>
                            (iii) 
                            <E T="03">Notification of denial.</E>
                             Upon denial of an election request, the Part D sponsor must send a notice of denial.
                        </P>
                        <P>
                            (A) 
                            <E T="03">Timing.</E>
                             (
                            <E T="03">1</E>
                            ) For requests received prior to the plan year, the notice of denial must be sent within 10 calendar days of receipt of the election request.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) For requests received during the plan year, the notice of denial must be sent within 24 hours of receipt of the election request.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) For incomplete election requests, within 10 calendar days of the expiration of the timeframe for submission of additional information.
                        </P>
                        <P>
                            (B) 
                            <E T="03">Contents.</E>
                             The notice of denial must explain the reason for denial and a description of the grievance process available to the individual.
                        </P>
                        <P>
                            (iv) 
                            <E T="03">Renewal notice.</E>
                             A Part D sponsor must send a notice alerting program participants that their participation in the program will automatically renew for the subsequent plan year.
                        </P>
                        <P>
                            (A) 
                            <E T="03">Timing.</E>
                             The notice must be sent no later than the end of the annual coordinated election period, as described at § 422.62(a)(2).
                        </P>
                        <P>
                            (B) 
                            <E T="03">Contents.</E>
                             The notice must include all of the following:
                        </P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Notification to the participant that their participation will automatically renew for the upcoming year.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Reminder that the participant may opt out of the program at any time, including for the upcoming plan year.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) The Part D sponsor's program terms and conditions for the upcoming plan year.
                        </P>
                        <P>
                            (e) 
                            <E T="03">Part D enrollee targeted outreach.</E>
                             A Part D sponsor must undertake targeted outreach to enrollees who are likely to benefit from making an election into the Medicare Prescription Payment Plan.
                        </P>
                        <P>
                            (1) 
                            <E T="03">Identification criteria.</E>
                             An enrollee deemed to be “likely to benefit” from the Medicare Prescription Payment Plan is identified by the Part D sponsor based on the following criteria.
                        </P>
                        <P>(i) For 2026 and subsequent years, the targeted outreach criteria are as follows:</P>
                        <P>(A) A Part D enrollee is likely to benefit from participating in the program if the enrollee incurs $600 or more in out-of-pocket costs for a single covered Part D drug.</P>
                        <P>(B) A Part D enrollee is likely to benefit from participating in the program if the enrollee incurred $2,000 in out-of-pocket costs for covered Part D drugs in the first nine months of the year prior to the upcoming plan year.</P>
                        <P>(ii) A Part D sponsor may develop supplemental strategies for identification of additional Part D enrollees likely to benefit. If supplemental strategies are implemented, then the Part D sponsor must apply any additional identification criteria to every enrollee of each plan equally.</P>
                        <P>
                            (2) 
                            <E T="03">Point of sale notification.</E>
                             (i) A Part D sponsor must have a mechanism to notify a pharmacy when a Part D enrollee incurs out-of-pocket costs with respect to covered Part D drugs that make it likely the enrollee may benefit from participating in the program using the identification criteria set forth in paragraphs (e)(1)(i)(A) and (e)(1)(ii) of this section.
                        </P>
                        <P>(ii) A Part D sponsor must ensure that a pharmacy, after receiving such a notification from the Part D sponsor, informs the Part D enrollee that it is likely that the Part D enrollee may benefit from the Medicare Prescription Payment Plan.</P>
                        <P>
                            (3) 
                            <E T="03">Part D sponsor notification.</E>
                             A Part D sponsor must directly outreach to enrollees identified as likely to benefit from the program during either of the following timeframes:
                        </P>
                        <P>
                            (i) 
                            <E T="03">Prior to the plan year.</E>
                             Prior to the plan year, a Part D sponsor must notify current enrollees that they are likely to benefit from the program during the fourth quarter of the year, and no later than the end of the annual coordinated election period, as described at § 422.62(a)(2), using the identification criteria set forth in paragraphs (e)(1)(i)(B) and (e)(1)(ii) of this section.
                        </P>
                        <P>
                            (ii) 
                            <E T="03">On an ongoing basis during the plan year.</E>
                             Part D sponsors must put in place reasonable guidelines for ongoing identification and notification of enrollees that are likely to benefit from the program on an ongoing basis during the plan year.
                        </P>
                        <P>
                            (4) 
                            <E T="03">Targeted outreach notification requirements.</E>
                             When an enrollee is identified as likely to benefit from the program, using the identification criteria set forth in paragraphs (e)(1)(i) and (ii) of this section or based on Part D sponsor-developed guidelines set forth at paragraph (e)(3)(ii) of this section, the Part D sponsor must provide to the enrollee the standardized Medicare Prescription Payment Plan Likely to Benefit Notice consistent with the requirements at § 423.2267(b).
                        </P>
                        <P>(i) When the enrollee is identified as likely to benefit directly by the Part D sponsor, either prior to or during the plan year, the notification may be done via mail or electronically (based on the Part D enrollee's preferred and authorized communication methods).</P>
                        <P>(A) The outreach must include a program election request form and additional information about the Medicare Prescription Payment Plan. The additional information requirement may be fulfilled by including with the notice the CMS-developed fact sheet about the program. If the Part D sponsor develops and uses alternative informational materials in lieu of the CMS-developed fact sheet to satisfy this requirement, they must ensure that these alternative materials accurately convey program information and are compliant with existing Part D requirements specified at 42 CFR part 423 subpart V.</P>
                        <P>(B) During the plan year, the initial notice may be provided via telephone, so long as the written “Medicare Prescription Payment Plan Likely to Benefit Notice,” election request form, and additional information are sent within three calendar days of the telephone notification.</P>
                        <P>(ii) When the enrollee is identified as likely to benefit during the plan year at the pharmacy point of sale, the notice must be provided as described in paragraph (i)(2) of this section.</P>
                        <P>
                            (5) 
                            <E T="03">Targeted outreach exclusions.</E>
                             A Part D sponsor does not have to notify enrollees that they are likely to benefit from the program under any of the following circumstances:
                        </P>
                        <P>(i) For the current year during the final month of the plan year (December).</P>
                        <P>(ii) When the enrollee is currently participating in the program, including—</P>
                        <P>(A) For the current year; and</P>
                        <P>(B) For the upcoming year.</P>
                        <P>(iii) When the enrollee is precluded from opting into the program.</P>
                        <P>(iv) When the PDP is non-renewing its contract or individual plan benefit package. This exclusion only applies to the requirements at paragraph (e)(3)(i) of this section related to prior to plan year targeted outreach.</P>
                        <P>
                            (f) 
                            <E T="03">Termination of election, reinstatement, and preclusion—</E>
                            (1) 
                            <E T="03">General rule.</E>
                             Except as provided in paragraph (f)(2) of this section, a Part D sponsor may not do any of the following:
                        </P>
                        <P>
                            (i) Terminate an individual from the Medicare Prescription Payment Plan.
                            <PRTPAGE P="99570"/>
                        </P>
                        <P>(ii) Orally or in writing, or by any action or inaction, request or encourage an individual to disenroll.</P>
                        <P>
                            (2) 
                            <E T="03">Basis for termination</E>
                            —(i) 
                            <E T="03">Voluntary terminations.</E>
                             A Part D sponsor must have a process to allow participants who have opted into the Medicare Prescription Payment Plan to opt out during the plan year.
                        </P>
                        <P>(A) When a participant opts out of the Medicare Prescription Payment Plan, a Part D sponsor must—</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Process the termination with an effective date within 24 hours of receipt of the request for termination.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Provide the individual with a notice of termination after the individual notifies the Part D sponsor that they intend to opt out under the Part D sponsor's established process.
                        </P>
                        <P>
                            (
                            <E T="03">i</E>
                            ) 
                            <E T="03">Timing.</E>
                             The Part D sponsor must send the notice of termination within ten calendar days of receipt of the request for termination.
                        </P>
                        <P>
                            (
                            <E T="03">ii</E>
                            ) 
                            <E T="03">Contents.</E>
                             The notice of voluntary termination must include all of the following. The date on which the individual's participation in the program ends. An explanation of why the individual is receiving the notice. A statement clarifying that the notice only applies to participation in the Medicare Prescription Payment Plan. A statement clarifying that the individual will continue to be billed monthly or can choose to pay the amount owed all at once, and that the individual will not pay interest or fees on the amount owed. A statement clarifying that the individual can join the Medicare Prescription Payment Plan again and instructions for how to do so. An overview of other Medicare programs that can help lower costs and how to learn more about these programs, including Extra Help, the Medicare Savings Program, the State Pharmaceutical Assistance Program, and a manufacturer's Pharmaceutical Assistance Program.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) Offer the participant the option to repay the full outstanding amount in a lump sum. A Part D sponsor is prohibited from requiring full immediate repayment from a participant who has been terminated from the Medicare Prescription Payment Plan.
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) If the participant opts not to repay the full outstanding amount in a lump sum, continue to bill amounts owed under the program in monthly amounts not to exceed the maximum monthly cap according to the statutory formula for the duration of the plan year after an individual has been terminated.
                        </P>
                        <P>
                            (
                            <E T="03">5</E>
                            ) Maintain appropriate records of the termination once the termination is processed.
                        </P>
                        <P>
                            (ii) 
                            <E T="03">Involuntary termination.</E>
                             If a participant fails to pay their monthly billed amount under the program, a Part D sponsor is required to terminate that individual's Medicare Prescription Payment Plan participation.
                        </P>
                        <P>(A) A participant will be considered to have failed to pay their monthly billed amount only after the conclusion of the required grace period as specified at paragraph (f)(4) of this section.</P>
                        <P>(B) When a Part D sponsor involuntarily terminates a participant, the sponsor must do all of the following:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Provide the individual with a notice of termination consistent with the requirements of paragraphs (f)(C) and (f)(D) of this section.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Offer the participant the option to repay the full outstanding amount in a lump sum. A Part D sponsor is prohibited from requiring full immediate repayment from a participant who has been terminated from the Medicare Prescription Payment Plan.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) If the participant opts not to repay the full outstanding amount in a lump sum, continue to bill amounts owed under the program in monthly amounts not to exceed the maximum monthly cap according to the statutory formula for the duration of the plan year after an individual has been terminated.
                        </P>
                        <P>
                            (C) 
                            <E T="03">Notice of failure to pay.</E>
                             If a Part D sponsor involuntarily terminates a participant under paragraph (f)(2)(ii) of this section, the Part D sponsor must send the individual an initial notice explaining that the individual has failed to pay the billed amount.
                        </P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) 
                            <E T="03">Timing.</E>
                             The notice of failure to pay must be sent within 15 calendar days of the payment due date.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) 
                            <E T="03">Contents.</E>
                             The notice of failure to pay must include all of the following:
                        </P>
                        <P>
                            (
                            <E T="03">i</E>
                            ) Pertinent dates, including the date the missed monthly payment was due, the amount the individual must pay to remain in the program, and the date by when payment must be received, which is the date of the end of the grace period.
                        </P>
                        <P>
                            (
                            <E T="03">ii</E>
                            ) A statement clarifying that the notice only applies to participation in the Medicare Prescription Payment Plan.
                        </P>
                        <P>
                            (
                            <E T="03">iii</E>
                            ) Instructions for how to submit payment.
                        </P>
                        <P>
                            (
                            <E T="03">iv</E>
                            ) Information about procedures for involuntary termination due to failure to pay, including the date on which the participant would be removed if payment is not received, and how to submit an inquiry or file a grievance.
                        </P>
                        <P>
                            (
                            <E T="03">v</E>
                            ) A statement describing how individuals should pay their Part D plan premium first if they cannot afford both their premium and their program balance.
                        </P>
                        <P>
                            (
                            <E T="03">vi</E>
                            ) An overview of other Medicare programs that can help lower costs and how to learn more about these programs, including Extra Help, the Medicare Savings Program, the State Pharmaceutical Assistance Program, and a manufacturer's Pharmaceutical Assistance Program.
                        </P>
                        <P>
                            (D) 
                            <E T="03">Involuntary termination notice.</E>
                             If the individual has failed to pay the amount due by the end of the grace period described at paragraph (f)(4) of this section, the Part D sponsor must send the individual a termination notice explaining that the individual has been terminated from the Medicare Prescription Payment Plan.
                        </P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) 
                            <E T="03">Timing.</E>
                             The involuntary termination notice must be sent within 3 business days following the last day of the end of the grace period.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) 
                            <E T="03">Contents.</E>
                             The involuntary termination notice must include all of the following:
                        </P>
                        <P>
                            (
                            <E T="03">i</E>
                            ) Pertinent dates, including the date the individual was originally notified of the missed monthly payment and the due date for that payment, as well as the date on which the individual's participation in the program ends, which should be the same date as the notice.
                        </P>
                        <P>
                            (
                            <E T="03">ii</E>
                            ) A statement clarifying that the notice only applies to participation in the Medicare Prescription Payment Plan, and that the individual's Part D drug coverage will not be impacted.
                        </P>
                        <P>
                            (
                            <E T="03">iii</E>
                            ) Instructions for how to submit payment and the amount owed.
                        </P>
                        <P>
                            (
                            <E T="03">iv</E>
                            ) Instructions for how to submit an inquiry or file a grievance.
                        </P>
                        <P>
                            (
                            <E T="03">v</E>
                            ) A statement clarifying that the individual can join the Medicare Prescription Payment Plan again if they pay the amount owed.
                        </P>
                        <P>
                            (
                            <E T="03">vi</E>
                            ) An overview of other Medicare programs that can help lower costs and how to learn more about these programs, including Extra Help, the Medicare Savings Program, the State Pharmaceutical Assistance Program, and a manufacturer's Pharmaceutical Assistance Program.
                        </P>
                        <P>(E) If either notice is returned to the Part D sponsor as undeliverable, the Part D sponsor must immediately implement its existing procedure for researching a potential change of address.</P>
                        <P>
                            (3) 
                            <E T="03">Required grace period and reinstatement.</E>
                             When a program participant fails to pay a program bill, the Part D sponsor must provide individuals with a grace period of at least 2 months upon notifying the individual of the initial missed payment.
                        </P>
                        <P>
                            (i) The grace period must begin on the first day of the month following the date 
                            <PRTPAGE P="99571"/>
                            on which the initial notice described in paragraph (f)(3) of this section is sent.
                        </P>
                        <P>(ii) A participant must be allowed to pay the overdue balance in full during the grace period to remain in the program.</P>
                        <P>(iii) If a participant fails to pay their monthly billed amount under the program with fewer than 2 full calendar months remaining in the calendar year, the grace period must carry over into the next calendar year.</P>
                        <P>(A) If the program participant is within their grace period from the prior year, the Part D sponsor must allow the participant to opt into the program for the next year.</P>
                        <P>(B) If that participant fails to pay the amount due from the prior year during the required grace period, the Part D sponsor may terminate the individual's participation in the program in the new year following the procedures outlined in paragraph (f)(2)(ii).</P>
                        <P>(iv) If an individual who has been terminated from the Medicare Prescription Payment Plan demonstrates good cause for failure to pay the program billed amount within the grace period and pays all overdue amounts billed, a Part D sponsor must reinstate that individual into the Medicare Prescription Payment Plan.</P>
                        <P>(A) A Part D sponsor is expected to reinstate an individual into the program within a reasonable timeframe after the individual has repaid their past due Medicare Prescription Payment Plan balance in full.</P>
                        <P>(B) To demonstrate good cause, the individual must establish by a credible statement that failure to pay the monthly amount billed within the grace period was due to circumstances for which the individual had no control, or which the individual could not reasonably have been expected to foresee.</P>
                        <P>(v) If an individual who has been terminated from the Medicare Prescription Payment Plan pays all overdue amounts billed in full, a Part D sponsor may also reinstate that individual, at the sponsor's discretion and within a reasonable timeframe, even if the individual does not demonstrate good cause.</P>
                        <P>
                            (4) 
                            <E T="03">Preclusion of election in a subsequent plan year.</E>
                             If an individual fails to pay the amount billed for a month as required under the Medicare Prescription Payment Plan, a Part D sponsor may preclude that individual from opting into the Medicare Prescription Payment Plan in a subsequent year.
                        </P>
                        <P>(i) A Part D sponsor may only preclude an individual from opting into the Medicare Prescription Payment Plan in a subsequent year if the individual owes an overdue balance to that Part D sponsor.</P>
                        <P>(ii) If an individual enrolls in a Part D plan offered by a different Part D sponsor than the Part D sponsor to which the individual owes an overdue balance, that individual cannot be precluded from opting into the Medicare Prescription Payment Plan in a subsequent year by that different Part D sponsor.</P>
                        <P>(iii) If a Part D enrollee remains in a plan offered by the same Part D sponsor and continues to owe an overdue balance, preclusion may extend beyond the immediately subsequent plan year.</P>
                        <P>(A) If an individual pays off the outstanding balance under the Medicare Prescription Payment Plan during a subsequent year, the Part D sponsor must promptly permit them to opt into the Medicare Prescription Payment Plan after the balance is paid.</P>
                        <P>(B) [Reserved]</P>
                        <P>(iv) A Part D sponsor that offers more than one Part D plan may have different preclusion policies for its different plans. However, the Part D sponsor must apply its preclusion policy consistently among all enrollees of the same Part D plan.</P>
                        <P>
                            (5) 
                            <E T="03">Prohibition on Part D enrollment penalties.</E>
                             A Part D plan sponsor is prohibited from doing any of the following:
                        </P>
                        <P>(i) Disenrolling a Part D enrollee from a Part D plan for failure to pay any amount billed under the Medicare Prescription Payment Plan.</P>
                        <P>(ii) Declining future enrollment into a Part D plan based on an individual's failure to pay a monthly amount billed under the Medicare Prescription Payment Plan.</P>
                        <P>
                            (6) 
                            <E T="03">Disenrollment.</E>
                             (i) If a participant in the Medicare Prescription Payment Plan is disenrolled voluntarily or involuntarily from their Part D plan under the provisions in § 423.44(b), the participant is also terminated from the Medicare Prescription Payment Plan in that plan.
                        </P>
                        <P>(ii) If the participant enrolls in a different plan, they may opt into the Medicare Prescription Payment Plan under their new plan.</P>
                        <P>
                            (7) 
                            <E T="03">Billing for amounts owed.</E>
                             Nothing in this section prohibits a Part D sponsor from billing an individual for an outstanding Medicare Prescription Payment Plan amount owed.
                        </P>
                        <P>
                            (g) 
                            <E T="03">Participant billing rights—</E>
                            (1) 
                            <E T="03">General rule.</E>
                             For each billing period after an individual has opted into the program and incurred out-of-pocket costs, a Part D sponsor must calculate a monthly amount that takes into account the out-of-pocket costs in that month that were incurred on or after the date on which the individual opted into the program.
                        </P>
                        <P>(i) A Part D sponsor must not bill a participant who is in the program but has not yet incurred any out-of-pocket costs during the plan year.</P>
                        <P>(ii) While past due balances from prior monthly bills may also be included in a billing statement, which could result in the total amount on the billing statement exceeding the maximum monthly cap, the amount billed for the month for which the maximum monthly cap is being calculated cannot be higher than the cap for that month.</P>
                        <P>(iii) A Part D sponsor must not charge late fees, interest payments, or other fees, such as for different payment mechanisms.</P>
                        <P>(A) A Part D sponsor must ensure that—</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Any third party it contracts with complies with such requirements.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Participants do not incur any charges or fees as a result of overbilling or overpayment errors made by the Part D sponsor.
                        </P>
                        <P>(iv) A Part D sponsor must send a bill for the Medicare Prescription Payment Plan that is separate from the bill for collection of premiums, if applicable.</P>
                        <P>
                            (2) 
                            <E T="03">Billing period.</E>
                             Each billing period will be a calendar month.
                        </P>
                        <P>(i) The billing period begins on either of the following:</P>
                        <P>(A) The effective date of a Part D enrollee's participation in the Medicare Prescription Payment Plan (for the first month a participant elects into the program during the plan year).</P>
                        <P>(B) The first day of the month (for each subsequent month or for the first month of a participant who elects into the program prior to the start of the plan year).</P>
                        <P>(ii) The billing period ends on the last date of that month.</P>
                        <P>
                            (3) 
                            <E T="03">Billing statement.</E>
                             Billing statements must include all of the following information:
                        </P>
                        <P>(i) A statement that the bill is for the Medicare Prescription Payment Plan;</P>
                        <P>(ii) A brief description of the program; and</P>
                        <P>(iii) A reference to where additional information about the program can be found.</P>
                        <P>(iv) The effective date of program participation.</P>
                        <P>(v) The last payment received, showing the date, amount of the last payment, and the means of payment made by the participant.</P>
                        <P>(vi) Any balance carried over from the prior month, including any missed payments.</P>
                        <P>
                            (vii) Itemized out-of-pocket costs by prescription for the month being billed.
                            <PRTPAGE P="99572"/>
                        </P>
                        <P>(viii) The amount due from the participant for the month being billed (that is, the amount based on the application of the monthly cap calculation).</P>
                        <P>(ix) The remaining total out-of-pocket cost sharing balance.</P>
                        <P>(x) Information on the next steps if the participant fails to pay by the stated due date.</P>
                        <P>(xi) Information on how to voluntarily opt out of the program and balances due if participation is terminated.</P>
                        <P>(xii) Information on the dispute processes available if the individual disputes their bill.</P>
                        <P>(xiii) LIS program information, including:</P>
                        <P>(A) General information about how to enroll in the LIS program (as an additional or alternative avenue for addressing prescription drug costs).</P>
                        <P>(B) A statement that LIS enrollment, for those who qualify, is likely to be more advantageous than participation in the Medicare Prescription Payment Plan.</P>
                        <P>(xiv) Plan contact information for participant questions about the billing statement.</P>
                        <P>
                            (4) 
                            <E T="03">Treatment of unsettled balances.</E>
                             Any unsettled balances with respect to amounts owed under the program will be treated as plan losses.
                        </P>
                        <P>(i) The Secretary is not liable for any such balances outside of those assumed as losses estimated in a Part D sponsor's plan bid.</P>
                        <P>(ii) If a Part D sponsor is compensated by or on behalf of the participant for an unsettled balance or sells an unsettled balance as a debt, that Part D sponsor cannot treat the amount as a loss and cannot include it in its bid.</P>
                        <P>
                            (5) 
                            <E T="03">Prioritization of premium payments.</E>
                             If a Part D enrollee has opted into the program and makes payments directly to the Part D sponsor, and it is unclear whether a payment should go towards the participant's outstanding Part D plan premium or Medicare Prescription Payment Plan balance, then the payment must be applied to the Part D premium.
                        </P>
                        <P>
                            (6) 
                            <E T="03">Financial reconciliation.</E>
                             A Part D sponsor must have a financial reconciliation process in place to correct inaccuracies in billing or payments or both.
                        </P>
                        <P>
                            (i) 
                            <E T="03">Participant payment.</E>
                             (A) A participant may pay more than the maximum monthly cap, up to the annual out-of-pocket threshold.
                        </P>
                        <P>(B) The participant cannot pay more than their total OOP costs for the Medicare Prescription Payment Plan.</P>
                        <P>(C) If a participant does pay more than their total OOP costs for the Medicare Prescription Payment Plan, then the Part D sponsor must reimburse the participant the amount that is paid above the balance owed.</P>
                        <P>
                            (ii) 
                            <E T="03">Reimbursements for excess participant payments.</E>
                             A Part D sponsor must develop standardized procedures for determining and processing reimbursements for excess Medicare Prescription Payment Plan payments made by program participants.
                        </P>
                        <P>
                            (iii) 
                            <E T="03">Claims adjustments resulting in increased amounts owed.</E>
                             When Part D claims adjustments result in increased amounts owed by the participant, and these amounts have not yet been billed to the participant, they must be included in the revised remaining OOP costs owed by the participant (as defined at § 423.137(b)(1)) and, thus, in the subsequent month maximum cap for the next billing period.
                        </P>
                        <P>
                            (h) 
                            <E T="03">Participant disputes—</E>
                            (1) 
                            <E T="03">Coverage determination and appeals procedures.</E>
                             A Part D sponsor must apply the Part D coverage determination and appeals procedures specified at § 423.566(a) to any disputes made by program participants concerning the cost sharing amount of a covered Part D drug.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Grievance procedures.</E>
                             A Part D sponsor must apply the Part D grievance procedure specified at § 423.562 to any dispute made by a program participant related to any aspect of the Medicare Prescription Payment Plan.
                        </P>
                        <P>
                            (i) 
                            <E T="03">Pharmacy point of sale notification process.</E>
                             (1) When a Part D sponsor is notifying a pharmacy that a Part D enrollee has incurred out-of-pocket costs with respect to covered Part D drugs that make it likely the enrollee may benefit from participating in the program, as required at paragraph (e)(2) of this section, the Part D sponsor must use standard codes for notifying the pharmacy that an enrollee has been identified as likely to benefit, as outlined by the National Council for Prescription Drug Programs.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Point of sale notification requirements.</E>
                             A Part D sponsor must ensure that the Medicare Prescription Payment Plan Likely to Benefit Notice is provided to enrollees identified as likely to benefit (or the person acting on their behalf) through the pharmacy point of sale notification process.
                        </P>
                        <P>(i) In pharmacy settings in which there is direct contact with enrollees (for example, community pharmacies where enrollees present in person to pick up prescriptions), the Part D sponsor must ensure that a hard copy of the “Medicare Prescription Payment Plan Likely to Benefit Notice” is provided to enrollees identified as likely to benefit (or the person acting on their behalf) at the time the prescription is picked up.</P>
                        <P>(ii) For non-retail pharmacy settings without in-person encounters (such as mail order pharmacies), a Part D sponsor must require the pharmacy to notify the Part D enrollee via a telephone call or their preferred contact method.</P>
                        <P>(iii) If the pharmacy is in contact with a Part D enrollee identified as likely to benefit and the enrollee declines to complete the prescription filling process, the Part D sponsor must ensure that the pharmacy provides the “Medicare Prescription Payment Plan Likely to Benefit Notice” to the Part D enrollee.</P>
                        <P>(3) A Part D sponsor must ensure that any contract between the Part D sponsor and a pharmacy (or between a first tier, downstream, or related entity and a pharmacy on the Part D sponsor's behalf) for participation in one or more of the Part D sponsor's networks includes a provision requiring pharmacies to provide this notification to Part D enrollees.</P>
                        <P>
                            (j) 
                            <E T="03">Pharmacy claims processing—</E>
                            (1) 
                            <E T="03">Electronic claims processing methodology.</E>
                             Part D sponsors must use, and must ensure pharmacies use, a bank identification number (BIN) or processor control number (PCN) electronic claims processing methodology for applicable Medicare Prescription Payment Plan transactions.
                        </P>
                        <P>(i) Part D sponsors must utilize, and ensure pharmacies utilize, an additional BIN/PCN that is unique to the Medicare Prescription Payment Plan to facilitate electronic processing of supplemental COB transactions for program participants.</P>
                        <P>(ii) A Part D sponsor must provide the unique Medicare Prescription Payment Plan BIN/PCN and any other pertinent billing information to the pharmacy on paid claim responses when the enrollee is also a Medicare Prescription Payment Plan participant.</P>
                        <P>(iii) A Part D sponsor must assign a program-specific PCN that starts with “MPPP” and report the new BIN/PCN to CMS.</P>
                        <P>(iv) The transaction processed through the Medicare Prescription Payment Plan BIN/PCN will be submitted after processing any applicable other payer transactions in order to capture the final patient responsibility amount after all other payers have paid.</P>
                        <P>
                            (2) 
                            <E T="03">Supplemental coverage that increases final patient pay amount.</E>
                             When a Part D enrollee has supplemental coverage that modifies their final out-of-pocket responsibility for covered Part D drugs:
                        </P>
                        <P>
                            (i) When the final patient pay amount returned to the pharmacy by a 
                            <PRTPAGE P="99573"/>
                            supplemental payer for a covered Part D drug is higher than the original Part D patient pay amount, the Part D sponsor may only include in the Medicare Prescription Payment Plan the participant's original Part D cost sharing, as determined by their plan-specific benefit structure.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Prescription drug event reporting.</E>
                             A Part D sponsor must ensure that the claims processing methodology described in paragraph (j)(1) of this section has no impact on prescription drug event (PDE) cost/payment field reporting, meaning PDE records must reflect participant and plan liability amounts as if the Medicare Prescription Payment Plan did not apply.
                        </P>
                        <P>
                            (4) 
                            <E T="03">Real-time benefit tools.</E>
                             A Part D sponsor must ensure that participation in the Medicare Prescription Payment Plan or the associated claims processing methodology described in paragraph (j)(1) of this section or both has no impact on the cost-sharing information displayed in real-time benefit tools.
                        </P>
                        <P>
                            (5) 
                            <E T="03">Inclusion of retroactive claims.</E>
                             A Part D sponsor is not required to retroactively include under this program claims submitted to the Part D sponsor by a Medicare Prescription Payment Plan participant (whether the request is made via paper form, telephonically, or electronically) except as provided in 423.137(d)(6).
                        </P>
                        <P>
                            (6) 
                            <E T="03">Re-adjudication of prescription drug claims for new program participants.</E>
                             (i) When a Part D enrollee receives the “Medicare Prescription Payment Plan Likely to Benefit Notice” from the pharmacy, they may choose to take time to consider opting into the program and leave the pharmacy without the prescription that triggered the notification.
                        </P>
                        <P>(ii) When the Part D enrollee returns to the pharmacy after their election into the Medicare Prescription Payment Plan has been effectuated, the plan sponsor must require the pharmacy to reverse and reprocess the high-cost claim that triggered the likely to benefit notification.</P>
                        <P>(A) Should a Part D enrollee have other unpaid claims at the same pharmacy for covered Part D drugs from prior dates of service, in addition to the prescription that may have triggered the likely to benefit notification, they may also request that those claims be readjudicated.</P>
                        <P>(iii) When the Part D claim date of service is the same as the date of program effectuation), the Part D sponsor is not required to ensure the pharmacy reverse and resubmit the Part D claim, provided that they otherwise obtain the necessary Medicare Prescription Payment Plan BIN/PCN for the program-specific transaction.</P>
                        <P>
                            (7) 
                            <E T="03">Obtaining and providing OOP costs for the Medicare Prescription Payment Plan.</E>
                             Part D sponsors must ensure that pharmacies—
                        </P>
                        <P>(i) Can easily access a Part D enrollee's OOP costs for the Medicare Prescription Payment Plan at the point of sale; and</P>
                        <P>(ii) Are prepared to provide OOP costs for the Medicare Prescription Payment Plan to a participant at the point of sale.</P>
                        <P>
                            (k) 
                            <E T="03">Pharmacy payment obligations.</E>
                             (1) A Part D sponsor must ensure that enrollee participation in the Medicare Prescription Payment Plan does not affect the amount paid to pharmacies or the timing of such payments, consistent with § 423.520. A Part D sponsor must not do either of the following:
                        </P>
                        <P>(i) Impose any fees or costs related to program implementation on pharmacies.</P>
                        <P>(ii) Hold pharmacies responsible for any unsettled balances of a participant or for collecting unpaid balances from the participant on the Part D sponsor's behalf.</P>
                        <P>(l) [Reserved].</P>
                        <P>
                            (m) 
                            <E T="03">General Part D sponsor outreach and education requirements—</E>
                            (1) 
                            <E T="03">Mailing.</E>
                             A Part D sponsor must provide a Medicare Prescription Payment Plan election request form, described at paragraph (d)(10)(i) of this section, and additional educational information on the program in a hard copy mailing.
                        </P>
                        <P>(i) The mailing must be sent by the later of—</P>
                        <P>(A) Within 10 calendar days from receipt of CMS confirmation of enrollment in the Part D plan; or</P>
                        <P>(B) The last day of the month prior to the plan effective date.</P>
                        <P>(ii) The election request form and supplemental information may be sent—</P>
                        <P>(A) With the membership ID card mailing described at § 423.2267(e)(32); or</P>
                        <P>(B) In its own envelope.</P>
                        <P>(iii) The mailing may be sent only to a Part D enrollee who is receiving a new membership ID card or to all Part D enrollees.</P>
                        <P>(iv) The additional information requirement may be fulfilled by including in the mailing the CMS-developed fact sheet about the program. If the Part D sponsor develops and uses alternative informational materials in lieu of the CMS-developed fact sheet to satisfy this requirement, they must ensure that these alternative materials accurately convey program information and are compliant with existing Part D requirements specified at 42 CFR part 423 subpart V.</P>
                        <P>
                            (2) 
                            <E T="03">Websites.</E>
                             In addition to meeting requirements described at §§ 423.128(d)(2) and 423.2265(b), a Part D sponsor is required to include all of the following on its website:
                        </P>
                        <P>(i) An election request mechanism, as described at § 423.137(d)(2).</P>
                        <P>(ii) An overview of the Medicare Prescription Payment Plan.</P>
                        <P>(iii) Examples of the program calculation and explanations.</P>
                        <P>(iv) A description of Part D enrollees who may be likely to benefit from the program.</P>
                        <P>(v) The financial implications of participation.</P>
                        <P>(vi) The implications of not paying monthly bills.</P>
                        <P>(vii) Instructions for how to opt into and out of the program, including timing requirements around election effectuation.</P>
                        <P>(viii) A description of the standards for retroactive election in cases where an enrollee believes that a delay in filling a prescription may seriously jeopardize their life, health, or ability to regain maximum function.</P>
                        <P>(ix) A description of the dispute and grievance procedure, as required under § 423.137(h).</P>
                        <P>(x) Contact information Part D enrollees can use to obtain further information</P>
                        <P>(xi) General information about the LIS program, including an overview of how LIS enrollment, for those who qualify, is likely to be more advantageous than program participation.</P>
                    </SECTION>
                    <AMDPAR>40. Section 423.153 is amended revising paragraph (d)(2)(iii)(A) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.153 </SECTNO>
                        <SUBJECT>Drug utilization management, quality assurance, medication therapy management (MTM) programs, drug management programs, and access to Medicare Parts A and B claims data extracts.</SUBJECT>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>(2) * * *</P>
                        <P>(iii) * * *</P>
                        <P>(A) Alzheimer's disease and dementia.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>
                        41. Section 423.182 is amended by revising paragraphs (b)(3)(ii)(A)(
                        <E T="03">2</E>
                        ) and (b)(3)(ii)(B)(
                        <E T="03">2</E>
                        ) to read as follows:
                    </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.182 </SECTNO>
                        <SUBJECT>Part D Prescription Drug Plan Quality Rating System.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(3) * * *</P>
                        <P>(ii) * * *</P>
                        <P>(A) * * *</P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) For contract consolidations approved on or after January 1, 2022, if 
                            <PRTPAGE P="99574"/>
                            a measure score for a consumed or surviving contract is missing due to a data integrity issue as described in § 423.184(g)(1)(i), CMS assigns a score of zero for the missing measure score in the calculation of the enrollment-weighted measure score. If a measure score for a consumed or surviving contract is missing due to not having enough data to meet the measure technical specification or the reliability is less than 0.6 for a CAHPS measure, CMS treats this measure score as missing in the calculation of the enrollment-weighted measure score.
                        </P>
                        <P>(B) * * *</P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) For contract consolidations approved on or after January 1, 2022, for all measures except CAHPS, if a measure score for a consumed or surviving contract is missing due to a data integrity issue as described in § 423.184(g)(1)(i), CMS assigns a score of zero for the missing measure score in the calculation of the enrollment-weighted measure score. For all measures except CAHPS and call center measures, if a measure score for a consumed or surviving contract is missing due to not having enough data to meet the measure technical specification, CMS treats this measure score as missing in the calculation of the enrollment-weighted measure score.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>42. Section 423.186 is amended by:</AMDPAR>
                    <AMDPAR>a. Revising paragraph (f)(3)(iv) introductory text;</AMDPAR>
                    <AMDPAR>b. Adding paragraphs (f)(3)(iv)(C), (f)(3)(v)(A), and reserved paragraph (f)(3)(v)(B);</AMDPAR>
                    <AMDPAR>c. Revising paragraph (f)(3)(vi) and (f)(3)(viii)(B);</AMDPAR>
                    <AMDPAR>d. Adding paragraph (f)(3)(viii)(C); and</AMDPAR>
                    <AMDPAR>e. Revising paragraphs (g)(1)(i) and (ii).</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 423.186 </SECTNO>
                        <SUBJECT>Calculation of Star Ratings.</SUBJECT>
                        <STARS/>
                        <P>(f) * * *</P>
                        <P>(3) * * *</P>
                        <P>(iv) For a measure to be included in the calculation of a contract's HEI score, the measure must meet all of the following criteria:</P>
                        <STARS/>
                        <P>(C) Beginning with the 2027 Star Ratings, for contracts that are Institutional Special Needs Plan (I-SNP) only contracts in the ratings year, the measure must be required to be reported for I-SNP-only contracts.</P>
                        <P>(v) * * *</P>
                        <P>(A) Starting with the 2029 Star Ratings if a contract's HEDIS measure score across all enrollees for a HEDIS measure included in the HEI calculated from the patient-level data submitted by the contract does not match the summary-level score submitted by the contract to NCQA for either of the measurement years used to construct the HEI, the contract will receive −1 points for the HEDIS measure in the calculation of the HEI. If a contract does not submit HEDIS patient-level data for a measure for which it submitted contract-level data for either of the measurement years used to construct the HEI, the contract will receive −1 points for the HEDIS measure in the calculation of the HEI.</P>
                        <P>(B) [Reserved]</P>
                        <P>(vi) Starting with the 2027 Star Ratings, to have the HEI calculated, contracts that are ISNP-only contracts in the ratings year must have at least 500 enrollees in the most recent measurement year used in the HEI and have at least half of the measures included in the HEI meet the criteria specified under paragraph (f)(3)(iv) of this section for the subset of measures that I-SNP-only contracts are required to report. To have the HEI calculated, all other contracts must have at least 500 enrollees in the most recent measurement year used in the HEI and have at least half of the measures included in the HEI meet the criteria specified under paragraph (f)(3)(iv) of this section.</P>
                        <STARS/>
                        <P>(viii) * * *</P>
                        <P>(B) Starting with the 2027 Star Ratings, for the second year following a consolidation when calculating the HEI score for the surviving contract, the patient-level data used in calculating the HEI score is combined across the consumed and surviving contracts in the consolidation and used in calculating the HEI score. The enrollment used in assessing whether the surviving contract meets an enrollment threshold under paragraph (f)(3)(vii) of this section will be the combined enrollment from the consumed and surviving contracts from the most recent year of data used to calculate the HEI.</P>
                        <P>(C) Starting with the 2029 Star Ratings, in states where, consistent with § 422.107(e), one or more MA contracts that only include one or more dual eligible special needs plans (D-SNPs) with a service area limited to that state are required to be established and maintained, the original MA contract(s) from which the D-SNP plan benefit package or packages were moved (hereafter referred to as the “legacy MA contract(s)”) into the MA contract established under § 422.107(e) will have the HEI reward calculated as follows every year after the D-SNP-only contract is required to be created until the Star Ratings year in which additional SRFs beyond receipt of LIS, dual-eligibility, and disability are added to the HEI:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) If the legacy MA contract, based on its own enrollment, meets an enrollment threshold under paragraph (f)(3)(vii) of this section, the methodology for calculating the HEI reward in paragraph (f)(3)(viii) of this section is followed.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) If the legacy MA contract, based on its own enrollment, does not meet an enrollment threshold as defined in paragraph (f)(3)(vii) of this section, and either one of the legacy MA contract or the MA contract established under § 422.107(e) cannot have the HEI reliably calculated as described in paragraphs (f)(3)(iv) and (vi) of this section, then the legacy MA contract does not qualify for an HEI reward.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) If the legacy MA contract, based on its own enrollment, does not meet an enrollment threshold as defined in paragraph (f)(3)(vii) of this section, and the legacy MA contract's performance on the HEI based on its own enrollment is less than—
                        </P>
                        <P>
                            (
                            <E T="03">i</E>
                            ) The minimum index score defined at paragraph (f)(3)(vii) of this section; or
                        </P>
                        <P>
                            (
                            <E T="03">ii</E>
                            ) The performance on the HEI of the MA contract established under § 422.107(e) Then, the legacy MA contract does not qualify for an HEI reward.
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            )(
                            <E T="03">i</E>
                            ) If the legacy MA contract, based on its own enrollment, does not meet an enrollment threshold as defined in paragraph (f)(3)(vii) of this section, and both the legacy MA contract and the MA contract established under § 422.107(e) can have the HEI score reliably calculated following paragraphs (f)(3)(iv) and (vi) of this section, then the enrollment combined across the legacy MA contract and the MA contract established under § 422.107(e) for the most recent measurement year used in calculating the HEI is used in assessing the enrollment threshold in paragraph (f)(3)(vii) of this section.
                        </P>
                        <P>
                            (
                            <E T="03">ii</E>
                            ) If an enrollment threshold is met using the combined enrollment described in paragraph (4)(
                            <E T="03">i</E>
                            ) of this paragraph, the legacy MA contract's rating-specific HEI score meets the minimum index score of greater than zero defined at paragraph (f)(3)(vii) of this section, and the legacy MA contract's rating-specific HEI score is greater than or equal to the rating-specific HEI score of the MA contract established under § 422.107(e), then the HEI reward for the legacy MA contract is calculated following paragraph 
                            <PRTPAGE P="99575"/>
                            (f)(3)(viii) of this section based on the enrollment threshold using the combined enrollment from the legacy MA contract and the MA contract established under § 422.107(e), and using the HEI score for the MA contract established under § 422.107(e).
                        </P>
                        <P>
                            (
                            <E T="03">5</E>
                            ) When multiple legacy MA contracts move their D-SNP plan benefit package(s) to the same MA contract established under § 422.107(e) and any of the legacy MA contracts do not meet an enrollment threshold as defined in paragraph (f)(3)(vii) of this section, and both the legacy MA contracts and the MA contract established under § 422.107(e) can have the HEI score reliably calculated following paragraphs (f)(3)(iv) and (vi) of this section, then the combined enrollment from the legacy MA contracts and the MA contract established under § 422.107(e) for the most recent measurement year used in calculating the HEI is used in assessing the enrollment threshold in paragraph (f)(3)(vii) of this section for any of the legacy MA contracts that do not meet an enrollment threshold on their own. If an enrollment threshold is met using the combined enrollment in this paragraph, the steps in paragraph (f)(3)(viii)(C)(
                            <E T="03">4</E>
                            )(
                            <E T="03">ii</E>
                            ) of this section are followed separately for each of the legacy MA contracts. If a legacy MA contract meets the enrollment thresholds on its own or if it cannot have the HEI score reliably calculated following paragraphs (f)(3)(iv) and (vi), the legacy MA contract would not be included in the calculation of the combined enrollment.
                        </P>
                        <STARS/>
                        <P>(g) * * *</P>
                        <P>(1) * * *</P>
                        <P>(i) If the highest rating rounded to the half star before the addition of the HEI reward, if applicable, for each contract-type is 4 stars or more without the use of the improvement measure(s) and with all applicable adjustments (CAI and the reward factor), a comparison of the highest rating with and without the improvement measure(s) is done. The higher rating is used for the rating.</P>
                        <P>(ii) If the highest rating rounded to the half star before the addition of the HEI reward, if applicable, is less than 4 stars without the use of the improvement measure(s) and with all applicable adjustments (CAI and the reward factor), the rating will be calculated with the improvement measure(s).</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>43. Section 423.325 is added to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.325 </SECTNO>
                        <SUBJECT>PDE submission timeliness requirements.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">General PDE submission timeliness requirements.</E>
                             Unless paragraph (b) of this section applies, a Part D sponsor must submit PDE records to CMS as follows:
                        </P>
                        <P>(1) Initial PDE records within 30 calendar days from the date the Part D sponsor (or its contracted first tier, downstream, or related entity) receives the claim.</P>
                        <P>(2) Adjustment or deletion PDE records within 90 calendar days of the Part D sponsor (or its contracted first tier, downstream, or related entity) discovering or receiving notification of an issue that requires a change to the previously submitted PDE record.</P>
                        <P>(3) Revised PDE records to resolve CMS rejected records within 90 calendar days of the rejection.</P>
                        <P>
                            (b) 
                            <E T="03">Selected Drugs PDE submission timeliness requirement.</E>
                             A Part D sponsor must submit initial PDE records for selected drugs (as described at section 1192(c) of the Act) within 7 calendar days from the date the Part D sponsor (or its contracted first tier, downstream, or related entity) receives the claim.
                        </P>
                    </SECTION>
                    <AMDPAR>44. Section 423.505 is amended by adding paragraphs (i)(7) and (8) and (q) to read as follows.</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.505 </SECTNO>
                        <SUBJECT>Contract provisions.</SUBJECT>
                        <STARS/>
                        <P>(i) * * *</P>
                        <P>(7) Any contract between the sponsor and a pharmacy, or between a first tier, downstream, or related entity and a pharmacy on the sponsor's behalf, for participation in one or more of the Part D sponsor's networks must include a provision requiring the sponsor or the first tier, downstream, or related entity to provide the pharmacy a list of the Part D PBPs that the pharmacy participates in pursuant to the contract.</P>
                        <P>(i) For every Part D PBP that the pharmacy participates in pursuant to the contract, the list must include all of the following:</P>
                        <P>(A) The Part D contract number assigned by CMS.</P>
                        <P>(B) The plan ID assigned by CMS for the PBP.</P>
                        <P>(C) The marketing name of the PBP.</P>
                        <P>(ii) The contract must require the sponsor or the first tier, downstream, or related entity to provide this list to the pharmacy by October 1 of the year prior to the plan year and at the pharmacy's request thereafter.</P>
                        <P>(iii) The sponsor or the first tier, downstream, or related entity can meet its obligations under this paragraph by either of the following:</P>
                        <P>(A) Providing a hard copy of the list to the pharmacy.</P>
                        <P>(B) Providing the list electronically by—</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Sending an electronic file to the pharmacy; or
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Providing the pharmacy instructions on how to access the list electronically.
                        </P>
                        <P>(8) Any contract between the sponsor and a pharmacy, or between a first tier, downstream, or related entity and a pharmacy on the sponsor's behalf, for participation in one or more of the Part D sponsor's networks that allows the sponsor or the first tier, downstream, or related entity to terminate the contract or the pharmacy's participation in a particular network without cause must allow the pharmacy to terminate the contract or its participation in a particular network without cause after providing the same notice that the contract requires the Part D sponsor or the first tier, downstream, or related entity to provide for a termination without cause.</P>
                        <STARS/>
                        <P>
                            (q) 
                            <E T="03">Enrollment in the Medicare Transaction Facilitator Data Module for the Medicare Drug Price Negotiation Program.</E>
                             For contract year 2026 and all subsequent years, any contract between the sponsor and a pharmacy, or between a first tier, downstream, or related entity and a pharmacy on the sponsor's behalf, for participation in one or more of the Part D sponsor's networks must include a provision requiring the pharmacy to be enrolled in the Medicare Transaction Facilitator Data Module (MTF DM) (or any successor to the MTF DM) in a form and manner determined by CMS. Such provision must also require the pharmacy to maintain and certify up-to-date, complete, and accurate enrollment information with the MTF DM, pursuant to applicable terms and conditions of participation with the MTF DM, including but not limited to contact, third-party support entity or entities, and banking information, in a form and manner determined by CMS.
                        </P>
                    </SECTION>
                    <AMDPAR>45. Section 423.2265 is amended by adding paragraph (b)(16) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.2265 </SECTNO>
                        <SUBJECT>Websites.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(16) Information about the Medicare Prescription Payment Plan as described in § 423.137(m)(2).</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>46. Section 423.2260 is amended by revising the definitions of “Advertisement” and “Marketing” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.2260 </SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <STARS/>
                        <PRTPAGE P="99576"/>
                        <P>
                            <E T="03">Advertisement (Ad)</E>
                             means a read, written, visual, oral, watched, or heard bid for, or call to attention.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Marketing</E>
                             means communications materials and activities that are intended to draw a beneficiary's attention to a Part D plan or plans, influence a beneficiary's decision-making process when making a Part D plan selection, or influence a beneficiary's decision to stay enrolled in a Part D plan (that is, retention-based marketing), except those required materials specified in § 423.2267(e) of this chapter, which will maintain the material designation as provided by CMS. In evaluating the intent of an activity or material, CMS will consider objective information including, but not limited to, the audience of the activity or material, other information communicated by the activity or material, timing, and other context of the activity or material and is not limited to the Part D sponsor's stated intent.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>47. Section 423.2267 is amended by—</AMDPAR>
                    <AMDPAR>a. Removing the word “and” at the end of paragraph (e)(32)(vi);</AMDPAR>
                    <AMDPAR>b. Removing the period and adding in its place “; and” at the end of paragraph (e)(32)(vii);</AMDPAR>
                    <AMDPAR>c. Adding paragraphs (e)(32)(viii);</AMDPAR>
                    <AMDPAR>d. Revising paragraphs (e)(33)(i) introductory text and (e)(33)(ii) introductory text; and</AMDPAR>
                    <AMDPAR>e. Adding paragraphs (e)(45) through (51).</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 423.2267 </SECTNO>
                        <SUBJECT>Required materials and content.</SUBJECT>
                        <STARS/>
                        <P>(e) * * *</P>
                        <P>(32) * * *</P>
                        <P>(viii) For dual eligible special needs plans that are applicable integrated plans, as defined in § 422.561, must be an integrated member ID card that serves as the ID card for both the Medicare and Medicaid plans in which the enrollee is enrolled, beginning no later than contract year 2027.</P>
                        <STARS/>
                        <P>(33) * * *</P>
                        <P>(i) Prior to contract year 2026 marketing on September 30, 2025, the notice for Part D sponsors is referred to as the Multi-language insert (MLI). This is a standardized communications material which states, “We have free interpreter services to answer any questions you may have about our health or drug plan. To get an interpreter, just call us at [1-xxx-xxx-xxxx]. Someone who speaks [language] can help you. This is a free service.” in the following languages: Spanish, Chinese, Tagalog, French, Vietnamese, German, Korean, Russian, Arabic, Italian, Portuguese, French Creole, Polish, Hindi, and Japanese.</P>
                        <STARS/>
                        <P>(ii) For CY 2026 marketing and communications beginning September 30, 2025, the required notice for Part D sponsors is referred to as the Notice of availability of language assistance services and auxiliary aids and services (Notice of Availability). This is a model communications material through which Part D sponsors must provide a notice of availability of language assistance services and auxiliary aids and services that, at a minimum, states that the Part D sponsors provide language assistance services and appropriate auxiliary aids and services free of charge.</P>
                        <STARS/>
                        <P>
                            (45) 
                            <E T="03">Election request form.</E>
                             This is a model communications material that Part D sponsors must provide to allow enrollees to request to opt into the Medicare Prescription Payment Plan, as required under § 423.137(d)(10)(i).
                        </P>
                        <P>
                            (46) 
                            <E T="03">Notice of election approval.</E>
                             This is a model communications material that Part D sponsors must provide upon accepting a Medicare Prescription Payment Plan election request, as required under § 423.137(d)(10)(ii).
                        </P>
                        <P>
                            (47) 
                            <E T="03">Medicare Prescription Payment Plan Likely to Benefit Notice.</E>
                             This is a standardized communications material that Part D sponsors must provide to enrollees identified as being likely to benefit from opting into the Medicare Prescription Payment Plan, as required under § 423.137(e)(4).
                        </P>
                        <P>
                            (48) 
                            <E T="03">Notice of failure to pay.</E>
                             This is a model communications material that Part D sponsors must provide to Medicare Prescription Payment Plan participants who fail to pay a program bill, as required under § 423.137(f)(2)(C).
                        </P>
                        <P>
                            (49) 
                            <E T="03">Involuntary termination notice.</E>
                             This is a model communications material that Part D sponsors must provide to Medicare Prescription Payment Plan participants who are being involuntarily terminated from the program due to failure to pay, as required under § 423.137(f)(2)(D).
                        </P>
                        <P>
                            (50) 
                            <E T="03">Voluntary termination notice.</E>
                             This is a model communications material that Part D sponsors must provide to Medicare Prescription Payment Plan participants who request to voluntarily leave the program, as required under § 423.137(f)(2)(i)(A)(
                            <E T="03">2</E>
                            ).
                        </P>
                        <P>
                            (51) 
                            <E T="03">Renewal notice.</E>
                             This is a model communications material that Part D sponsors must send to Medicare Prescription Payment Plan participants alerting them that their participation in the program will automatically renew for the subsequent plan year, as required under § 423.137(d)(10)(iv).
                        </P>
                    </SECTION>
                    <AMDPAR>48. Section 423.2274 is amended by revising paragraph (c)(12) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.2274 </SECTNO>
                        <SUBJECT>Agent, broker, and other third-party requirements.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(12) Ensure that, prior to an enrollment CMS' required questions and topics regarding beneficiary needs in a health plan choice are fully discussed. Topics to be discussed include all the following:</P>
                        <P>(i) Pharmacies (that is, whether or not the beneficiary's current pharmacy is in the plan's network).</P>
                        <P>(ii) Prescription drug coverage and costs (including whether or not the beneficiary's current prescriptions are covered).</P>
                        <P>(iii) Low-income subsidy eligibility (that is, at a minimum, explaining the eligibility requirements as defined at § 423.773 and the effect on drug costs if eligible, and identifying resources where they can get for more information on applying).</P>
                        <P>(iv) Resources for state programs, including Medicare Savings Programs</P>
                        <P>(v) Premiums</P>
                        <P>(vi) Other services or incentives</P>
                        <P>(vii) Conclude by pausing to ask if the beneficiary has any questions about the topics discussed in paragraph (c)(12) of this section or others, including those related to enrollment.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>49. Section 423.2401 is amended by adding in alphabetical order definitions for “MLR audit remittance” and “MLR audit remittance process” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.2401 </SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <P>
                            <E T="03">MLR audit remittance</E>
                             means the amount CMS calculates and a Part D sponsor pays for a Part D contract that has failed to meet the 85 percent minimum MLR requirement as the result of an MLR audit examination.
                        </P>
                        <P>
                            <E T="03">MLR audit remittance process</E>
                             means the process by which CMS calculates the MLR audit remittance for a contract that is determined to have failed to meet the 85 percent minimum MLR requirement as the result of an MLR audit examination and notify the Part D sponsor about the remittance. The process includes all of the following:
                        </P>
                        <P>
                            (1) Collecting the MLR audit remittance indicated in the final audit report issued by CMS.
                            <PRTPAGE P="99577"/>
                        </P>
                        <P>(2) Receiving responses from Part D sponsors requesting an appeal of the MLR audit remittance.</P>
                        <P>(3) Taking actions to adjudicate an appeal (if requested).</P>
                        <P>(4) Receiving MLR remittances from Part D sponsors.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>50. Section 423.2420 is amended by—</AMDPAR>
                    <AMDPAR>a. Adding paragraph (b)(4)(i)(D);</AMDPAR>
                    <AMDPAR>b. Redesignating paragraphs (d)(2)(i) through (iii) as paragraphs (d)(2)(ii) through (d)(2)(iv); and</AMDPAR>
                    <AMDPAR>c. Adding new paragraph (d)(2)(i).</AMDPAR>
                    <P>The additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 423.2420 </SECTNO>
                        <SUBJECT>Calculation of medical loss ratio.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(4) * * *</P>
                        <P>(i) * * *</P>
                        <P>(D) Unsettled balances from the Medicare Prescription Payment Plan.</P>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>(2) * * *</P>
                        <P>(i) The report required in § 423.2460 must include a detailed description of the methods used to allocate expenses, including incurred claims, expenditures on quality improving activities, licensing and regulatory fees, and State and Federal taxes and assessments. A detailed description of each expense element must be provided, including how each specific expense meets the criteria for the type of expense in which it is categorized, as well as the method by which it was aggregated.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>51. Section 423.2430 is amended by redesignating paragraphs (a) and (b) as paragraphs (b) and (c) and adding a new paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.2430 </SECTNO>
                        <SUBJECT>Activities that improve health care quality.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">General requirements.</E>
                             The report required in § 423.2460 must include expenditures directly related to activities that improve health care quality, as such activities are described in this section.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>52. Section 423.2450 is added to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.2450 </SECTNO>
                        <SUBJECT>MLR audit process.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Notice of audit.</E>
                             CMS provides at least 15 days advance notice of its intent to conduct an audit of a Part D sponsor.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Conferences.</E>
                             All audits include an entrance conference during which the scope of the audit is presented and an exit conference during which the initial audit findings are discussed.
                        </P>
                        <P>
                            (c) 
                            <E T="03">Audit documentation.</E>
                             All requested audit documentation must be provided by the Part D sponsor to CMS within 30 calendar days of the audit entrance conference. CMS may extend, at CMS's discretion, the time for a Part D sponsor to provide the documentation requested.
                        </P>
                        <P>
                            (d) 
                            <E T="03">Preliminary audit findings.</E>
                             CMS shares its preliminary audit findings with the Part D sponsor, which then has 30 calendar days to respond to such findings. CMS may extend, for good cause, the time for a Part D sponsor to submit such a response.
                        </P>
                        <P>
                            (e) 
                            <E T="03">Final audit findings.</E>
                             If the Part D sponsor does not dispute the preliminary findings within the 30-day timeframe per paragraph (d) of this section, then the audit report becomes final. Alternatively, if the Part D sponsor disputes the preliminary findings, CMS reviews and considers such response before finalizing the audit findings.
                        </P>
                        <P>
                            (f) 
                            <E T="03">Corrective actions.</E>
                             CMS sends a copy of the final audit report to the Part D sponsor as well as issues corrective actions that the Part D sponsor must undertake as a result of the audit findings.
                        </P>
                        <P>
                            (g) 
                            <E T="03">Order to pay remittances.</E>
                             If CMS determines as the result of an audit that a Part D sponsor has failed to pay remittances it is obligated to pay under § 423.2480, it may order the Part D sponsor to pay those remittances consistent with § 423.2452.
                        </P>
                    </SECTION>
                    <AMDPAR>53. Section 423.2452 is added to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.2452 </SECTNO>
                        <SUBJECT>MLR audit remittance and payment process.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Notice of MLR audit remittance.</E>
                             After the calculation of the MLR audit remittance, CMS sends the Part D sponsor the final audit report with the MLR audit remittance amount. The final audit report contains the following information:
                        </P>
                        <P>(1) A MLR audit remittance for the contract that has failed to meet the 85 percent MLR minimum requirement based on audit findings, which may be one of the following:</P>
                        <P>(ii) An amount due from the Part D sponsor.</P>
                        <P>(iii) $0 if nothing is due from the Part D sponsor.</P>
                        <P>(2) Relevant banking and financial mailing instructions for Part D sponsors that owe a MLR audit remittance.</P>
                        <P>(3) Relevant CMS contact information.</P>
                        <P>(4) A description of the steps for requesting an appeal of the MLR audit remittance calculation, in accordance with the requirements specified in § 423.2454.</P>
                        <P>
                            (b) 
                            <E T="03">Request for an appeal.</E>
                             A Part D sponsor that disagrees with the MLR audit remittance has 15 calendar days from the date of issuance of the final audit report, as described in paragraph (a) of this section, to request an appeal of the MLR audit remittance under the process described in § 423.2454.
                        </P>
                        <P>(1) If a Part D sponsor agrees with the MLR audit remittance, no response is required.</P>
                        <P>(2) If a Part D sponsor disagrees with the MLR audit remittance, it must request an appeal within 15 calendar days from the date of issuance of the final audit report. CMS will not consider any requests for appeal after this 15-day period.</P>
                        <P>
                            (c) 
                            <E T="03">Actions if a Part D sponsor does not request an appeal.</E>
                             (1) The Part D sponsor is required to remit payment to CMS within 120 calendar days from the date of issuance of the final audit report.
                        </P>
                        <P>(2) If the Part D sponsor fails to remit payment within that 120-calendar-day period, CMS refers the debt owed to CMS to the Department of the Treasury for collection.</P>
                        <P>
                            (d) 
                            <E T="03">Actions following a request for appeal.</E>
                             If a Part D sponsor responds to the final audit report disagreeing with the MLR audit remittance and requesting appeal, CMS conducts a review process under the process described at § 423.2454.
                        </P>
                    </SECTION>
                    <AMDPAR>54. Section 423.2454 is added to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.2454 </SECTNO>
                        <SUBJECT>MLR audit remittance appeals process.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Appeals process.</E>
                             If a Part D sponsor does not agree with the MLR audit remittance described in § 423.2452(a), it may appeal under the following three-level appeal process:
                        </P>
                        <P>
                            (1) 
                            <E T="03">Reconsideration.</E>
                             A Part D sponsor may request reconsideration of the MLR audit remittance described in § 423.2452(a) according to the following process:
                        </P>
                        <P>
                            (i) 
                            <E T="03">Manner and timing of request.</E>
                             A written request for reconsideration must be filed within 15 days from the date of issuance of the final audit report to the Part D sponsor.
                        </P>
                        <P>
                            (ii) 
                            <E T="03">Content of request.</E>
                             The written request for reconsideration must do all of the following:
                        </P>
                        <P>(A) Specify the calculation with which the Part D sponsor disagrees and the reasons for its disagreement.</P>
                        <P>(B) Include evidence supporting the assertion that CMS's calculation of the MLR audit remittance is incorrect.</P>
                        <P>(C) Not include new data or data that was submitted to CMS after the final audit report was issued.</P>
                        <P>
                            (iii) 
                            <E T="03">Conduct of reconsideration.</E>
                             In conducting the reconsideration, the CMS reconsideration official reviews the calculations that were used to determine the MLR audit remittance and any additional evidence timely submitted by the Part D sponsor.
                            <PRTPAGE P="99578"/>
                        </P>
                        <P>
                            (iv) 
                            <E T="03">Reconsideration decision.</E>
                             The CMS reconsideration official informs the Part D sponsor of its decision on the reconsideration in writing.
                        </P>
                        <P>
                            (v) 
                            <E T="03">Effect of reconsideration decision.</E>
                             The decision of the CMS reconsideration official is final and binding unless a timely request for an informal hearing is filed in accordance with paragraph (a)(2) of this section.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Informal hearing.</E>
                             A Part D sponsor dissatisfied with CMS's reconsideration decision made under paragraph (a)(1) of this section is entitled to an informal hearing as provided for under paragraphs (a)(2)(i) through (a)(2)(iv) of this section.
                        </P>
                        <P>
                            (i) 
                            <E T="03">Manner and timing of request.</E>
                             A request for an informal hearing must be made in writing and filed with the CMS hearing officer within 15 calendar days from the date of issuance of the reconsideration decision.
                        </P>
                        <P>
                            (ii) 
                            <E T="03">Content of request.</E>
                             The request for an informal hearing must include a copy of the reconsideration decision and must specify the findings or issues in the decision with which the Part D sponsor disagrees and the reasons for its disagreement.
                        </P>
                        <P>
                            (iii) 
                            <E T="03">Informal hearing procedures.</E>
                             The informal hearing is conducted in accordance with the following:
                        </P>
                        <P>(A) The CMS Hearing Officer provides written notice of the time and place of the informal hearing at least 30 calendar days before the scheduled date.</P>
                        <P>(B) The CMS reconsideration official provides, within 10 calendar days of the hearing officer receiving an informal hearing request, a copy of the record that was before the reconsideration official.</P>
                        <P>(C) The hearing officer review is conducted by a CMS hearing officer who neither receives testimony nor accepts any new evidence. The CMS hearing officer is limited to the review of the record that was before CMS reconsideration official had when making the reconsideration decision.</P>
                        <P>
                            (iv) 
                            <E T="03">Decision of the CMS hearing officer.</E>
                             The CMS hearing officer decides whether to uphold or overturn the reconsideration official's decision and sends a written decision to the Part D sponsor explaining the basis for the decision.
                        </P>
                        <P>
                            (v) 
                            <E T="03">Effect of hearing officer's decision.</E>
                             The hearing officer's decision is final and binding, unless the decision is reversed or modified by the CMS Administrator in accordance with paragraph (a)(3) of this section.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Review by the Administrator.</E>
                             The Administrator's review is conducted in the following manner:
                        </P>
                        <P>
                            (i) 
                            <E T="03">Manner and timing of request.</E>
                             A Part D sponsor that has received a hearing officer's decision may request review by the Administrator within 15 calendar days of the date of issuance of the hearing officer's decision under paragraph (a)(2)(iv) of this section. The Part D sponsor may submit written arguments to the Administrator for review.
                        </P>
                        <P>
                            (ii) 
                            <E T="03">Discretionary review.</E>
                             (A) After receiving a request for review, the Administrator has the discretion to elect to review the hearing officer's determination in accordance with paragraph (a)(3)(iii) of this section or to decline to review the hearing officer's decision within 30 calendar days of receiving the request for review.
                        </P>
                        <P>(B) If the Administrator declines to review the hearing officer's decision, the hearing officer's decision is final and binding.</P>
                        <P>
                            (iii) 
                            <E T="03">Electing to review.</E>
                             If the Administrator elects to review the hearing officer's decision, the Administrator reviews the hearing officer's decision, as well as any information included in the record of the hearing officer's decision and any written argument submitted by the Part D sponsor, and determine whether to uphold, reverse, or modify the hearing officer's decision.
                        </P>
                        <P>
                            (iv) 
                            <E T="03">Effect of Administrator's decision.</E>
                             The Administrator's decision is final and binding.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Matters subject to appeal and burden of proof.</E>
                             (1) The Part D sponsor's appeal is limited to CMS's calculation of the MLR audit remittance.
                        </P>
                        <P>(2) The Part D sponsor bears the burden of proof for providing evidence demonstrating that CMS's audit examination results for the MLR audit remittance require further review. The Part D sponsor may not challenge the underlying methodology for the MLR audit remittance calculation.</P>
                        <P>
                            (c) 
                            <E T="03">Stay of financial transaction until appeals are exhausted.</E>
                             If a Part D sponsor requests review of the MLR audit remittance, the financial transaction associated with the payment of the MLR audit remittance is stayed until all appeals are exhausted. Once all levels of appeal are exhausted or the Part D sponsor fails to request further review within the applicable 15-calendar-day timeframe, CMS communicates with the Part D sponsor to complete the financial transaction associated with the payment of the MLR audit remittance.
                        </P>
                        <P>
                            (d) 
                            <E T="03">Continued compliance with other law required.</E>
                             Nothing in this section limits a Part D sponsor's responsibility to comply with any other statute or regulation.
                        </P>
                    </SECTION>
                    <AMDPAR>55. Section 423.2480 is amended by revising paragraph (d) introductory text to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.2480</SECTNO>
                        <SUBJECT> MLR review and non-compliance.</SUBJECT>
                        <STARS/>
                        <P>(d) Data submitted under § 423.2460, calculations, or any other MLR submission required by this subpart which have not been reported in a timely and accurate manner or have been found to be materially incorrect or fraudulent—</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>56. Section 423.2490 is amended by adding paragraph (b)(6) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.2490</SECTNO>
                        <SUBJECT> Release of Part D MLR data.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(6) DIR information reported within the MLR data as part of incurred claims.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>57. Section 423.2536 is amended by—</AMDPAR>
                    <AMDPAR>a. Redesignating paragraphs (c) through (k) as paragraphs (d) through (l);</AMDPAR>
                    <AMDPAR>b. Adding a new paragraph (c); and</AMDPAR>
                    <AMDPAR>c. Revising newly redesignated paragraphs (i)(1) and (4).</AMDPAR>
                    <P>The addition and revisions to read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 423.2536 </SECTNO>
                        <SUBJECT>Waiver of Part D program requirements.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Medicare Prescription Payment Plan.</E>
                             Section 423.137.
                        </P>
                        <STARS/>
                        <P>(i) * * *</P>
                        <P>(1) Section 423.2265(b)(4), (5), (11), (13), and (16);</P>
                        <STARS/>
                        <P>(4) Section 423.2267(e)(3) through (5), (9) through (12), (14) through (17), (25), (29), (33), and (45) through (51); and</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 460—PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)</HD>
                    </PART>
                    <AMDPAR>58. The authority for part 460 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f).</P>
                    </AUTH>
                    <SECTION>
                        <SECTNO>§ 460.70 </SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>59. Section 460.70 is amended in paragraph (e)(2) by removing the reference “§ 460.98(c)” and adding in its place the reference “§ 460.98(d)”.</AMDPAR>
                    <AMDPAR>60. Section 460.112 is amended by revising paragraphs (a)(1) and (2), adding paragraphs (a)(3) through (8), and revising paragraph (b) to read as follows</AMDPAR>
                    <SECTION>
                        <PRTPAGE P="99579"/>
                        <SECTNO>§ 460.112 </SECTNO>
                        <SUBJECT>Specific rights to which a participant is entitled.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(1) To receive comprehensive health care in a safe and clean environment and in an accessible manner.</P>
                        <P>(2) To be treated with dignity and respect, be afforded privacy and confidentiality in all aspects of care, and be provided humane care.</P>
                        <P>(3) Not to be required to perform services for the PACE organization.</P>
                        <P>(4) To have reasonable access to a telephone.</P>
                        <P>(5) To be free from harm, including physical or mental abuse, neglect, corporal punishment, involuntary seclusion, excessive medication, and any physical or chemical restraint imposed for purposes of discipline or convenience and not required to treat the participant's medical symptoms.</P>
                        <P>(6) To be encouraged and assisted to exercise rights as a participant, including the Medicare and Medicaid appeals processes as well as civil and other legal rights.</P>
                        <P>(7) To be encouraged and assisted to recommend changes in policies and services to PACE staff.</P>
                        <P>(8) To have all information regarding PACE services and treatment options explained in a culturally competent manner.</P>
                        <P>
                            (b) 
                            <E T="03">Right to treatment.</E>
                             Each participant has the right to appropriate and timely treatment for their health conditions, including the right to both of the following:
                        </P>
                        <P>(1) Receive all care and services needed to improve or maintain the participant's health condition and attain the highest practicable physical, emotional, and social well-being.</P>
                        <P>(2) Access emergency health care services when and where the need arises without prior authorization by the PACE interdisciplinary team.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>61. Section 460.180 is amended by revising paragraph (b)(3) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 460.180 </SECTNO>
                        <SUBJECT>Medicare payment to PACE organizations.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(3) CMS adjusts the monthly capitation payment amount derived under paragraph (b)(2) of this section based on a risk adjustment that reflects the individual's health status. The provisions of § 422.310 of this chapter apply to PACE organizations and risk adjustment data submitted by PACE organizations to CMS. In applying § 422.310 to PACE organizations and risk adjustment of payments to PACE organizations, references to MA organizations are read as references to PACE organizations. CMS ensures that payments take into account the comparative frailty of PACE enrollees relative to the general Medicare population.</P>
                        <STARS/>
                    </SECTION>
                    <SIG>
                        <NAME>Xavier Becerra,</NAME>
                        <TITLE>Secretary, Department of Health and Human Services.</TITLE>
                    </SIG>
                </SUPLINF>
                <FRDOC>[FR Doc. 2024-27939 Filed 11-26-24; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 4120-01-P</BILCOD>
            </PRORULE>
        </PRORULES>
    </NEWPART>
    <VOL>89</VOL>
    <NO>237</NO>
    <DATE>Tuesday, December 10, 2024</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="99581"/>
            <PARTNO>Part III </PARTNO>
            <AGENCY TYPE="P">Consumer Financial Protection Bureau</AGENCY>
            <CFR>12 CFR Part 1090</CFR>
            <TITLE>Defining Larger Participants of a Market for General-Use Digital Consumer Payment Applications; Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="99582"/>
                    <AGENCY TYPE="S">CONSUMER FINANCIAL PROTECTION BUREAU</AGENCY>
                    <CFR>12 CFR Part 1090</CFR>
                    <DEPDOC>[Docket No. CFPB-2023-0053]</DEPDOC>
                    <RIN>RIN 3170-AB17</RIN>
                    <SUBJECT>Defining Larger Participants of a Market for General-Use Digital Consumer Payment Applications</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Consumer Financial Protection Bureau.</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>The Consumer Financial Protection Bureau (CFPB) issues this rule to define larger participants of a market for general-use digital consumer payment applications. Larger participants of this market will be subject to the CFPB's supervisory authority under the Consumer Financial Protection Act (CFPA). A nonbank covered person qualifies as a larger participant if it facilitates an annual covered consumer payment transaction volume of at least 50 million transactions as defined in the rule, and it is not a small business concern.</P>
                    </SUM>
                    <DATES>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>This rule is effective January 9, 2025.</P>
                    </DATES>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            George Karithanom, Regulatory Implementation and Guidance Program Analyst, Office of Regulations, at 202-435-770. If you require this document in an alternative electronic format, please contact 
                            <E T="03">CFPB_Accessibility@cfpb.gov.</E>
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">I. Overview</HD>
                    <P>
                        Section 1024 of the CFPA,
                        <SU>1</SU>
                        <FTREF/>
                         codified at 12 U.S.C. 5514, gives the CFPB supervisory authority over all nonbank covered persons 
                        <SU>2</SU>
                        <FTREF/>
                         offering or providing three enumerated types of consumer financial products or services: (1) Origination, brokerage, or servicing of consumer loans secured by real estate and related mortgage loan modification or foreclosure relief services; (2) private education loans; and (3) payday loans.
                        <SU>3</SU>
                        <FTREF/>
                         The CFPB also has supervisory authority over “larger participant[s] of a market for other consumer financial products or services, as defined by rule[s]” the CFPB issues.
                        <SU>4</SU>
                        <FTREF/>
                         In addition, the CFPB has the authority to supervise any nonbank covered person that it “has reasonable cause to determine by order, after notice to the covered person and a reasonable opportunity . . . to respond . . . is engaging, or has engaged, in conduct that poses risks to consumers with regard to the offering or provision of consumer financial products or services.” 
                        <SU>5</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Consumer Financial Protection Act of 2010, title X of the Dodd-Frank Wall Street Reform and Consumer Protection Act, Public Law 111-203, 124 Stat. 1376, 1955 (2010) (hereinafter, “CFPA”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             The provisions of 12 U.S.C. 5514 apply to certain categories of covered persons, described in section (a)(1), and expressly excludes from coverage persons described in 12 U.S.C. 5515(a) (very large insured depository institutions and credit unions and their affiliates) or 5516(a) (other insured depository institutions and credit unions). The term “covered person” means “(A) any person that engages in offering or providing a consumer financial product or service; and (B) any affiliate of a person described [in (A)] if such affiliate acts as a service provider to such person.” 12 U.S.C. 5481(6).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             12 U.S.C. 5514(a)(1)(A), (D), (E).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             12 U.S.C. 5514(a)(1)(B), (a)(2); 
                            <E T="03">see also</E>
                             12 U.S.C. 5481(5) (defining “consumer financial product or service”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             12 U.S.C. 5514(a)(1)(C); 
                            <E T="03">see also</E>
                             12 CFR part 1091 (prescribing procedures for making determinations under 12 U.S.C. 5514(a)(1)(C)). In addition, the CFPB has supervisory authority over very large depository institutions and credit unions and their affiliates. 12 U.S.C. 5515(a). Furthermore, the CFPB has certain authorities relating to the supervision of other depository institutions and credit unions. 12 U.S.C. 5516(c)(1). One of the CFPB's objectives under the CFPA is to ensure that “Federal consumer financial law is enforced consistently, without regard to the status of a person as a depository institution, in order to promote fair competition[.]” 12 U.S.C. 5511(b)(4).
                        </P>
                    </FTNT>
                    <P>
                        This rule (the Final Rule) is the sixth in a series of CFPB rulemakings to define larger participants of markets for consumer financial products and services for purposes of CFPA section 1024(a)(1)(B).
                        <SU>6</SU>
                        <FTREF/>
                         The Final Rule establishes the CFPB's supervisory authority over nonbank covered persons that are larger participants in a market for “general-use digital consumer payment applications.” In establishing the CFPB's supervisory authority over such persons, the Final Rule does not impose new substantive consumer protection requirements. In addition, some nonbank covered persons that would be subject to the CFPB's supervisory authority under the Final Rule also may be subject to other CFPB supervisory authorities, including for example under CFPA section 1024 as a larger participant in another market defined by a previous CFPB larger participant rule. Finally, regardless of whether they are subject to the CFPB's supervisory authority, nonbank covered persons generally are subject to the CFPB's regulatory and enforcement authority and to applicable Federal consumer financial law.
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             The first five rules defined larger participants of markets for consumer reporting, 77 FR 42874 (July 20, 2012) (Consumer Reporting Rule), consumer debt collection, 77 FR 65775 (Oct. 31, 2012) (Consumer Debt Collection Rule), student loan servicing, 78 FR 73383 (Dec. 6, 2013) (Student Loan Servicing Rule), international money transfers, 79 FR 56631 (Sept. 23, 2014) (International Money Transfer Rule), and automobile financing, 80 FR 37496 (June 30, 2015) (Automobile Financing Rule).
                        </P>
                    </FTNT>
                    <P>The market described in the Final Rule includes providers of funds transfer and payment wallet functionalities through digital payment applications for consumers' general use in making payments to other persons for personal, family, or household purposes. Examples include consumer financial products and services that are commonly described as “digital wallets,” “payment apps,” “funds transfer apps,” “peer-to-peer payment apps,” “person-to-person payment apps,” “P2P apps,” and the like. Providers of consumer financial products and services delivered through these digital applications help consumers to make a wide variety of consumer payment transactions, including payments to friends and family and payments for purchases of nonfinancial goods and services.</P>
                    <P>
                        The CFPB is authorized to supervise nonbank covered persons that are subject to CFPA section 1024(a) for purposes of (1) assessing compliance with Federal consumer financial law; (2) obtaining information about such persons' activities and compliance systems or procedures; and (3) detecting and assessing risks to consumers and consumer financial markets.
                        <SU>7</SU>
                        <FTREF/>
                         The CFPB conducts examinations of various scopes of supervised entities. In addition, the CFPB may, as appropriate, request information from supervised entities prior to or without conducting examinations.
                        <SU>8</SU>
                        <FTREF/>
                         Section 1090.103(d) of the CFPB's existing larger participant regulations also provides that the CFPB may require submission of certain records, documents, and other information for purposes of assessing whether a person qualifies as a larger participant of a market as defined by a CFPB larger participant rule.
                        <SU>9</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             12 U.S.C. 5514(b)(1). The CFPB's supervisory authority also extends to service providers of those covered persons that are subject to supervision under 12 U.S.C. 5514(a)(1). 12 U.S.C. 5514(e); 
                            <E T="03">see also</E>
                             12 U.S.C. 5481(26) (defining “service provider”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             
                            <E T="03">See, e.g.,</E>
                             12 U.S.C. 5514(b)(1) (authorizing the CFPB both to “require reports and conduct examinations on a periodic basis” of nonbank covered persons subject to supervision).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             12 CFR 1090.103(d).
                        </P>
                    </FTNT>
                    <P>
                        Consistent with CFPA section 1024(b)(2), the CFPB has established and implemented a risk-based supervisory program that is designed to prioritize supervisory activity among nonbank covered persons subject to CFPA section 1024(a) on the basis of risk.
                        <SU>10</SU>
                        <FTREF/>
                         The CFPB's prioritization process 
                        <PRTPAGE P="99583"/>
                        takes into account, among other factors, the size of each entity, the volume of its transactions involving consumer financial products or services, the size and risk presented by the market in which it is a participant, the extent of relevant State oversight, and any field and market information that the CFPB has on the entity. Specifically, as the CFPB Supervision and Examination Manual explains in greater detail, the CFPB evaluates risks to consumers at market-wide and the institution product line levels. At the market-wide level, the CFPB considers and compares risks to consumers across different types of products (
                        <E T="03">e.g.,</E>
                         mortgage loans or debt collectors) along with the relative product market size in the overall consumer finance marketplace. At the institution product line level, the CFPB evaluates and compares risks across entities that, regardless of status as a nonbank or an insured depository institution or credit union, offer the same or similar products (
                        <E T="03">e.g.,</E>
                         providers of mortgage loans). When evaluating risks across entities in an institution product line, the CFPB considers which entities have business models and market shares that pose greater risk of harm to consumers. The CFPB also places significant weight on “field and market intelligence,” which includes findings from prior examinations and other information about the strength of compliance management systems, metrics gathered from public reports, and the number and severity of consumer complaints the CFPB receives.
                        <SU>11</SU>
                        <FTREF/>
                         Taken together, this approach of assessing risks at the market-wide level and at the institutional level allows the CFPB to focus on areas where consumers have the greatest potential to be harmed, specifically, on relatively higher-risk institution product lines within relatively higher-risk markets. Finally, as described in CFPA section 1024(b)(3), the CFPB also coordinates its supervisory activities at nonbank covered persons with the supervisory activities conducted by Federal prudential regulators and State regulatory authorities.
                        <SU>12</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             12 U.S.C. 5514(b)(2). The CFPB notes that its prioritization process is not the subject of this rulemaking.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             
                            <E T="03">See id.</E>
                             For further description of the CFPB's supervisory prioritization process, see 
                            <E T="03">CFPB Supervision and Examination Manual</E>
                             (updated Sept. 2023), part I.A (pages 11-12 of Overview section), 
                            <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_supervision-and-examination-manual_2023-09.pdf</E>
                             (last visited Nov. 10, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             12 U.S.C. 5514(b)(3). The Final Rule further describes this coordination in response to general comments about existing oversight of the market below. As discussed there, the CFPB also coordinates its supervisory activity with the Federal Trade Commission. The CFPB notes that its coordination process is not the subject of this rulemaking.
                        </P>
                    </FTNT>
                    <P>
                        The specifics of how an examination takes place vary by market and entity. However, the examination process generally proceeds as follows.
                        <SU>13</SU>
                        <FTREF/>
                         CFPB examiners contact the entity for an initial conference with management and often request records and other information. CFPB examiners may review the components of the supervised entity's compliance management system. Based on these discussions and a preliminary review of the information received, examiners determine the scope of an on-site or remote examination and coordinate with the entity to initiate this portion of the examination. While on-site or working remotely, examiners discuss with management the entity's compliance policies, processes, and procedures; review documents and records; test transactions and accounts for compliance; and evaluate the entity's compliance management system. At the conclusion of that stage of an examination, examiners may review preliminary examination findings at a closing meeting. After the closing meeting, if examiners have identified potential violations of Federal consumer financial law, they also may provide the entity an opportunity to respond in writing to those potential findings.
                        <SU>14</SU>
                        <FTREF/>
                         Finally, examinations may involve issuing confidential examination reports, supervisory letters, and compliance ratings. In addition to the process described above, the CFPB also may conduct other supervisory activities, such as periodic monitoring.
                        <SU>15</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             For further description of the CFPB's examination process, see 
                            <E T="03">CFPB Supervision and Examination Manual,</E>
                             part I.A.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             
                            <E T="03">See, e.g.,</E>
                             CFPB, 
                            <E T="03">Supervisory Highlights Issue 8, Summer 2015,</E>
                             sec. 3.1.3 (describing supervision process of sending a Potential Action and Request for Response (PARR) letter to a supervised entity), 
                            <E T="03">https://files.consumerfinance.gov/f/201506_cfpb_supervisory-highlights.pdf</E>
                             (last visited Nov. 5, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             
                            <E T="03">CFPB Supervision and Examination Manual,</E>
                             part I.A (page 12 of Overview section describing supervisory monitoring).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">II. Background</HD>
                    <P>
                        On November 17, 2023, the CFPB published a notice of proposed rulemaking to define larger participants of a market for general-use digital consumer payment applications (Proposed Rule).
                        <SU>16</SU>
                        <FTREF/>
                         As described in part V below, the Proposed Rule would have defined a larger participant as any nonbank covered person that, in the previous calendar year, both facilitated at least five million consumer payment transactions by providing general-use digital consumer payment applications and was not a small business concern as defined in the Proposed Rule. The CFPB requested comment on the Proposed Rule. The CFPB received 59 comments from consumer advocate organizations (consumer groups), nonprofits, companies, industry associations, State attorneys general, Members of Congress, and other individuals. The comments are discussed in more detail below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             88 FR 80197 (Nov. 17, 2023).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">III. Summary of the Final Rule</HD>
                    <P>
                        The CFPB is authorized to issue rules to define larger participants in markets for consumer financial products or services. Subpart A of the CFPB's existing larger-participant regulation, 12 CFR part 1090, prescribed procedures, definitions, standards, and protocols that apply to the CFPB's supervision of larger participants.
                        <SU>17</SU>
                        <FTREF/>
                         Those generally-applicable provisions will apply to the CFPB's supervision of larger participants in the general-use digital consumer payment application market described by the Final Rule. The definitions in § 1090.101 should be used to interpret terms in the Final Rule unless otherwise specified.
                    </P>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             12 CFR 1090.100 through 103.
                        </P>
                    </FTNT>
                    <P>
                        The CFPB includes relevant market descriptions and associated larger-participant tests, as it develops them, in subpart B.
                        <SU>18</SU>
                        <FTREF/>
                         Accordingly, the Final Rule defining larger participants of a market for general-use digital consumer payment applications is codified in § 1090.109 in subpart B.
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             12 CFR 1090.104 (consumer reporting market); 12 CFR 1090.105 (consumer debt collection market); 12 CFR 1090.106 (student loan servicing market); 12 CFR 1090.107 (international money transfer market); 12 CFR 1090.108 (automobile financing market).
                        </P>
                    </FTNT>
                    <P>The CFPB is finalizing the Proposed Rule largely as proposed, with certain changes described below, including changes to increase the transaction threshold that the CFPB will use as part of the test to assess when a nonbank covered person is a larger participant of a market for general-use digital consumer payment applications.</P>
                    <P>
                        The Final Rule defines larger participants of a market for general-use digital consumer payment applications. That market encompasses specific activities. The market definition generally includes nonbank covered persons that provide funds transfer or payment wallet functionalities through a digital payment application for consumers' general use in making consumer payments transactions as defined in the Final Rule. The Final Rule defines “consumer payment transactions” to include payments to 
                        <PRTPAGE P="99584"/>
                        other persons for personal, household, or family purposes, excluding certain transactions as described in more detail in the section-by-section analysis in part V below. The Final Rule also identifies a limited set of digital payment applications that do not fall within the proposed market definition because they do not have general use for purposes of the Final Rule.
                    </P>
                    <P>
                        The Final Rule sets forth a test to determine whether a nonbank covered person is a larger participant of the general-use digital consumer payment applications market. As further explained below, a nonbank covered person is a larger participant if it satisfies two criteria. First, the nonbank covered person (together with its affiliated companies) must provide general-use digital consumer payment applications with an annual volume of at least 50 million consumer payment transactions denominated in U.S. dollars. Second, the nonbank covered person must not be a small business concern based on the applicable Small Business Administration (SBA) size standard. As prescribed by subpart A of the CFPB's general larger participant regulation, any nonbank covered person that qualifies as a larger participant would remain a larger participant until two years from the first day of the tax year in which the person last met the larger-participant test.
                        <SU>19</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             12 CFR 1090.102.
                        </P>
                    </FTNT>
                    <P>
                        As noted above, § 1090.103(d) of the CFPB's existing larger participant regulation provides that the CFPB may require submission of certain records, documents, and other information for purposes of assessing whether a person is a larger participant of a market as defined by a CFPB larger participant rule.
                        <SU>20</SU>
                        <FTREF/>
                         As with the CFPB's other larger participant rules codified in subpart B, this authority will be available to facilitate the CFPB's identification of larger participants of the general-use digital consumer payment applications market. In addition, pursuant to existing § 1090.103(a), a person will be able to dispute whether it qualifies as a larger participant in the general-use digital payment applications market. The CFPB will notify an entity when the CFPB intends to undertake supervisory activity; if the entity claims not to be a larger participant, it will then have an opportunity to submit documentary evidence and written arguments in support of its claim.
                        <SU>21</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             12 CFR 1090.103(d).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             12 CFR 1090.103(a).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">IV. Legal Authority and Procedural Matters</HD>
                    <HD SOURCE="HD2">A. Rulemaking Authority</HD>
                    <P>
                        The CFPB is issuing the Final Rule pursuant to its authority under the CFPA, as follows: (1) sections 1024(a)(1)(B) and (a)(2), which authorize the CFPB to supervise nonbanks that are larger participants of markets for consumers financial products or services, as the CFPB defines by rule; 
                        <SU>22</SU>
                        <FTREF/>
                         (2) section 1024(b)(7), which, among other things, authorizes the CFPB to prescribe rules to facilitate the supervision of covered persons under section 1024; 
                        <SU>23</SU>
                        <FTREF/>
                         and (3) section 1022(b)(1), which grants the CFPB the authority to prescribe rules as may be necessary or appropriate to enable the CFPB to administer and carry out the purposes and objectives of Federal consumer financial law, and to prevent evasions of such law.
                        <SU>24</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             12 U.S.C. 5514(a)(1)(B), (a)(2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             12 U.S.C. 5514(b)(7).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             12 U.S.C. 5512(b)(1).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Consultation With Other Agencies</HD>
                    <P>
                        In developing the Final Rule and the Proposed Rule, the CFPB consulted with the Federal Trade Commission (FTC), as well as with the Board of Governors of the Federal Reserve System, the Commodity Futures Trading Commission (CFTC), the Federal Deposit Insurance Corporation (FDIC), the Financial Crimes Enforcement Network, the National Credit Union Administration (NCUA), the Office of the Comptroller of the Currency (OCC), and the Securities and Exchange Commission (SEC), on, among other things, consistency with any prudential, market, or systemic objectives administered by such agencies.
                        <SU>25</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             Specifically, 12 U.S.C. 5514(a)(2) directs that the CFPB consult with the FTC prior to issuing a final rule to define larger participants of a market pursuant to CFPA section 1024(a)(1)(B). In addition, 12 U.S.C. 5512(b)(2)(B) directs the CFPB to consult, before and during the rulemaking, with appropriate prudential regulators or other Federal agencies, regarding consistency with objectives those agencies administer. The manner and extent to which provisions of 12 U.S.C. 5512(b)(2) apply to a rulemaking of this kind that does not establish standards of conduct are unclear. Nevertheless, to inform this rulemaking more fully, the CFPB performed the consultations described in that provision of the CFPA.
                        </P>
                        <P>Some commenters questioned whether the CFPB met its consultation obligations based on the statement in the proposal that it “consulted with or provided an opportunity for consultation and input to” the FTC and certain other agencies. 88 FR 80197 at 80199. The CFPB clarifies that it did meet during the rulemaking process with the FTC and other agencies listed above to consult about the rule. Some commenters also suggested that the CFPB is specifically required to consult with the FTC's Bureau of Competition, in line with those commenters' view that the CFPB must apply antitrust principles when defining a market for a larger participant rule. However, the relevant statutory provision, 12 U.S.C. 5514(a)(2), by its terms requires the CFPB to consult with the FTC, and not with specific divisions of the FTC. The CFPB addresses comments regarding the applicability of antitrust principles in discussion of general comments in part V further below.</P>
                    </FTNT>
                    <HD SOURCE="HD1">V. Section-by-Section Analysis</HD>
                    <HD SOURCE="HD2">Part 1090</HD>
                    <HD SOURCE="HD2">Subpart B—Markets</HD>
                    <HD SOURCE="HD2">Section 1090.109 General-Use Digital Consumer Payment Applications Market</HD>
                    <HD SOURCE="HD3">Proposed Rule</HD>
                    <P>As described further below, the CFPB proposed to establish CFPB authority to supervise nonbank covered persons that are larger participants in this market because: (1) the market has grown dramatically and become increasingly important to the everyday financial lives of consumers; (2) CFPB supervisory authority over its larger participants would help the CFPB to promote compliance with Federal consumer financial law; (3) that authority would help the CPFB to detect and assess risks to consumers and the market, including emerging risks; and (4) that authority would help the CFPB to ensure consistent enforcement of Federal consumer financial law between nonbanks and insured banks and credit unions.</P>
                    <P>
                        To accomplish these goals, the Proposed Rule would have added to existing subpart B of part 1090 of the CFPB's rules a new § 1090.109 establishing CFPB supervisory authority over nonbank covered persons who are larger participants in a market for general-use digital consumer payment applications.
                        <SU>26</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             As explained in the Proposed Rule and discussed further below, the general-use digital payment applications described in this Final Rule are “financial products or services” under the CFPA. 12 U.S.C. 5481(15)(A)(iv), (vii). Nonbanks that offer or provide such financial products or services to consumers primarily for personal, family, or household purposes are “covered persons” under the CFPA. 12 U.S.C. 5481(5)(A), (6).
                        </P>
                    </FTNT>
                    <P>
                        As the Proposed Rule explained, many nonbanks provide consumer financial products and services that allow consumers to use digital applications accessible through personal computing devices, such as mobile phones, tablets, smart watches, or computers, to transfer funds to other persons. Some nonbanks also provide consumer financial products and services that allow consumers to use digital applications on their personal computing devices to store payment credentials they can then use to purchase goods or services at a variety of stores, whether by communicating with a checkout register or a self-
                        <PRTPAGE P="99585"/>
                        checkout machine, or by selecting the payment credential through a checkout process at ecommerce websites. Subject to the definitions, exclusions, limitations, and clarifications discussed in the Proposed Rule, the proposed market definition generally would have covered these consumer financial products and services.
                    </P>
                    <P>
                        The Proposed Rule explained that the CFPB proposed to establish supervisory authority over nonbank covered persons who are larger participants in this market because this market has large and increasing significance to the everyday financial lives of consumers.
                        <SU>27</SU>
                        <FTREF/>
                         Consumers are growing increasingly reliant on general-use digital consumer payment applications to initiate payments.
                        <SU>28</SU>
                        <FTREF/>
                         Recent market research indicates that 76 percent of Americans have used at least one of four well-known P2P payment apps, representing substantial growth since the first of the four was established in 1998.
                        <SU>29</SU>
                        <FTREF/>
                         Even among consumers with annual incomes lower than $30,000 who have more limited access to digital technology,
                        <SU>30</SU>
                        <FTREF/>
                         61 percent reported using P2P payment apps.
                        <SU>31</SU>
                        <FTREF/>
                         And higher rates of use by U.S. adults in lower age brackets may drive further growth well into the future.
                        <SU>32</SU>
                        <FTREF/>
                         Across the United States, merchant acceptance of general-use digital consumer payment applications also has rapidly expanded as businesses seek to make it as easy as possible for consumers to make purchases through whatever is their preferred payment method.
                        <SU>33</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             The Proposed Rule explained that, in proposing a larger participant rule for this market, the CFPB was not proposing to determine the relative risk posed by this market as compared to other markets. It noted that, as explained in its previous larger participant rulemakings, “[t]he Bureau need not conclude before issuing a [larger participant rule] that the market identified in the rule has a higher rate of non-compliance, poses a greater risk to consumers, or is in some other sense more important to supervise than other markets.” 88 FR 80197 at 80200 (citing Consumer Debt Collection Larger Participant Rule, 77 FR 65775 at 65779).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             
                            <E T="03">See</E>
                             CFPB, 
                            <E T="03">Issue Spotlight: Analysis of Deposit Insurance Coverage Through Payment Apps</E>
                             (June 1, 2023) (CFPB Deposit Insurance Spotlight), 
                            <E T="03">https://www.consumerfinance.gov/data-research/research-reports/issue-spotlight-analysis-of-deposit-insurance-coverage-on-funds-stored-through-payment-apps/full-report/</E>
                             (last visited Oct. 23, 2023); 
                            <E T="03">see also</E>
                             McKinsey &amp; Company, 
                            <E T="03">Consumer digital payments: Already mainstream, increasingly embedded, still evolving</E>
                             (Oct. 20, 2023) (describing results of consulting firm's annual survey reporting that for the first time, more than 90 percent of U.S. consumers surveyed in August 2023 reported using some form of digital payment over the course of a year), 
                            <E T="03">https://www.mckinsey.com/industries/financial-services/our-insights/banking-matters/consumer-digital-payments-already-mainstream-increasingly-embedded-still-evolving</E>
                             (last visited Oct. 30, 2023); J.D. Power, 
                            <E T="03">Banking and Payments Intelligence Report</E>
                             (Jan. 2023) (reporting results of a survey of Americans that found that from the first quarter of 2021 to the third quarter of 2022, the number of respondents who had used a mobile wallet in the past three months rose from 38 percent to 49 percent), 
                            <E T="03">https://www.jdpower.com/business/resources/mobile-wallets-gain-popularity-growing-number-americans-still-prefer-convenience</E>
                             (last visited Oct. 23, 2023); PULSE, 
                            <E T="03">PULSE Study Finds Debit Issuers Focused on Digital Payments, Mobile Self-Service, Fraud Mitigation</E>
                             (Aug. 17, 2023) (reporting that nearly 80 percent of debit card issuers reported increases in consumers' use of mobile wallets in 2022), 
                            <E T="03">https://www.pulsenetwork.com/public/insights-and-news/news-release-2023-debit-issuer-study/</E>
                             (last visited Oct. 30, 2023); FIS, 
                            <E T="03">The Global Payments Report</E>
                             (2023) (FIS 2023 Global Payments Report) at 175 (industry study reporting that in 2022 digital wallets became the leading payment preference of U.S. consumers shopping online), 
                            <E T="03">https://www.fisglobal.com/-/media/fisglobal/files/campaigns/global-payments%20report/FIS_TheGlobalPaymentsReport_2023.pdf</E>
                             (last visited Nov. 5, 2024)
                            <E T="03">; Digital Payment Industry in 2023: Payment methods, trends, and tech processing payments electronically, eMarketer (formerly known as Insider Intelligence)</E>
                             (Jan. 9, 2023) (projecting 2023 transaction volume by U.S. P2P mobile payment app providers to reach over $1.1 trillion), 
                            <E T="03">https://www.emarketer.com/insights/digital-payment-services/</E>
                             (last visited Nov. 5, 2024); Consumer Reports Survey Group, 
                            <E T="03">Peer-to-Peer Payment Services</E>
                             (Jan. 10, 2023) (Consumer Reports P2P Survey) at 1 (reporting results from a survey finding that four in ten Americans use P2P services at least once a month), 
                            <E T="03">https://advocacy.consumerreports.org/wp-content/uploads/2023/01/P2P-Report-4-Surveys-2022.pdf</E>
                             (last visited Oct. 23, 2023); Kevin Foster, Claire Greene, and Joanna Stavins, 
                            <E T="03">2022 Survey and Diary of Consumer Payment Choice: Summary Results</E>
                             (Sept. 17, 2022) at 8 (reporting results of survey conducted by Federal Reserve System staff finding that, as of 2022, two thirds of consumers reported adopting one or more online payment accounts in the previous 12 months—a share that was nearly 20 percent higher than five years earlier), 
                            <E T="03">https://www.atlantafed.org/-/media/documents/banking/consumer-payments/survey-diary-consumer-payment-choice/2022/sdcpc_2022_report.pdf</E>
                             (last visited Oct. 30, 2023); FDIC, 
                            <E T="03">FDIC National Survey of Unbanked and Underbanked Households</E>
                             (2021) at 33 (Table 6.4 reporting finding that nearly half of all households (46.4 percent) used a nonbank app in 2021), 
                            <E T="03">https://www.fdic.gov/analysis/household-survey/2021report.pdf</E>
                             (last visited Oct. 23, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Monica Anderson, Pew Research Center, 
                            <E T="03">Payment apps like Venmo and Cash App bring convenience—and security concerns—to some users</E>
                             (Sept. 8, 2022) (Pew 2022 Payment App Article), 
                            <E T="03">https://www.pewresearch.org/short-reads/2022/09/08/payment-apps-like-venmo-and-cash-app-bring-convenience-and-security-concerns-to-some-users/</E>
                             (last visited Oct. 23, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             Emily A. Vogels, Pew Research Center, 
                            <E T="03">Digital divide persists even as Americans with lower incomes make gains in tech adoption</E>
                             (June 22, 2021) (reporting results of early 2021 survey by Pew Research Center, finding 76 percent of adults with annual household incomes less than $30,000 have a smartphone and 59 percent have a desktop or laptop computer, compared with 87 percent and 84 percent respectively of adults with household incomes between $30,000 and $99,999, and 97 percent and 92 percent respectively of adults with household incomes of $100,000 or more), 
                            <E T="03">https://www.pewresearch.org/short-reads/2021/06/22/digital-divide-persists-even-as-americans-with-lower-incomes-make-gains-in-tech-adoption/</E>
                             (last visited Oct. 23, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             
                            <E T="03">Consumer Reports P2P Survey</E>
                             at 2 (55 percent reported ongoing use and six percent stated they used to use this kind of service).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             
                            <E T="03">See id.</E>
                             (85 percent of surveyed consumers aged 18 to 29 and 85 percent of surveyed consumers aged 30 to 44 reported using a digital payment application, compared with 67 percent of consumers aged 45 to 59 and 46 percent of consumers aged 60 and over); 
                            <E T="03">see also</E>
                             Ariana-Michele Moore, 
                            <E T="03">The U.S. P2P Payments Market: Surprising Data Reveals Banks are Missing the Mark</E>
                             (AiteNovarica 2023 Impact Report) at 6, 24 (Figure 13 reporting 94 percent and 86 percent adoption of P2P accounts and digital wallets among the youngest adult cohort born between 1996 and 2002, compared with 57 percent and 40 percent among the oldest cohort born before 1995), 
                            <E T="03">https://aite-novarica.com/report/us-p2p-payments-market-surprising-data-reveals-banks-are-missing-mark</E>
                             (last visited Oct. 23, 2023) and 
                            <E T="03">https://datos-insights.com/reports/us-p2p-payments-market-surprising-data-reveals-banks-are-missing-mark/</E>
                             (last visited Nov. 5, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             
                            <E T="03">See</E>
                             Geoff Williams, 
                            <E T="03">Retailers are embracing alternative payment methods, though cards are still king</E>
                             (Dec. 1, 2022) (National Retail Federation article citing its 2022 report describing a Forrester survey indicating that 80 percent of merchants accept Apple Pay or plan to do so in the next 18 months, 65 percent of merchants accept Google Pay or plan to do so in the next 18 months, and, online, 74 percent accept PayPal or plan to do so), 
                            <E T="03">https://nrf.com/blog/retailers-are-embracing-alternative-payment-methods-though-cards-are-still-king</E>
                             (last visited Oct. 23, 2023); 
                            <E T="03">see also</E>
                             The Strawhecker Group (TSG), 
                            <E T="03">Merchants respond to Consumer Demand by Offering P2P Payments</E>
                             (June 8, 2022) (TSG: Merchants Offering P2P Payments) (reporting results of TSG and Electronic Transactions Association survey of over 500 small businesses merchants finding that 82 percent accept payment through at least one digital P2P option), 
                            <E T="03">https://thestrawgroup.com/merchants-respond-to-consumer-demand-by-offering-p2p-payments/</E>
                             (last visited Oct. 23, 2023).
                        </P>
                    </FTNT>
                    <P>
                        The Proposed Rule described how consumers rely on general-use digital consumer payment applications for many aspects of their everyday lives. In general, consumers make payments to other individuals for a variety of reasons, including sending gifts or making informal loans to friends and family and purchasing goods and services, among many others.
                        <SU>34</SU>
                        <FTREF/>
                         Consumers can use digital applications to make payments to individuals for these purposes, as well as to make payments to businesses, charities, and other organizations. According to one recent market report, nonbank digital payment apps have rapidly grown in the past few years to become the most popular way to send money to other individuals other than cash,
                        <SU>35</SU>
                        <FTREF/>
                         and are 
                        <PRTPAGE P="99586"/>
                        used for a higher number of such transactions than cash.
                        <SU>36</SU>
                        <FTREF/>
                         For many consumers, general-use digital consumer payment applications offer an alternative, technological replacement for non-digital payment methods.
                        <SU>37</SU>
                        <FTREF/>
                         Consumers increasingly have adopted general-use digital consumer payment applications 
                        <SU>38</SU>
                        <FTREF/>
                         as part of a broader movement toward noncash payments.
                        <SU>39</SU>
                        <FTREF/>
                         Amid growing merchant acceptance of general-use digital consumer payment applications, consumers with middle and lower incomes use digital consumer payment applications for a share of their overall retail spending that rivals or exceeds their use of cash.
                        <SU>40</SU>
                        <FTREF/>
                         Such applications now have a share of ecommerce payments volume that is similar to or greater than other traditional payment methods such as credit cards and debit cards used outside of such applications.
                        <SU>41</SU>
                        <FTREF/>
                         Such applications also have been gaining an increasing share of in-person retail spending.
                        <SU>42</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             
                            <E T="03">AiteNovarica 2023 Impact Report</E>
                             at 8-9 (Figure 1 reporting 66 percent of 5,895 consumers surveyed reported making at least one domestic P2P payment in 2022 whether via digital means or not, and Figure 2 reporting that, of consumers who made P2P payments in 2022, among other purposes, 70 percent did so for birthday gifts, 64 percent for holiday gifts, 49 percent for other gift occasions, 46 percent to lend money, 41 percent to make a charitable contribution, 39 percent paid for services, 39 percent purchased items, 31 percent provided funds in an emergency situation, and 18 percent provided financial support).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             
                            <E T="03">Id.</E>
                             at 25 (Figure 14 reporting that, among other payment methods or sources, 74 percent of consumers made P2P payments in cash, 69 percent used alternative digital P2P payment services, defined as services offered by nonbank providers 
                            <PRTPAGE/>
                            via mobile app, web service, or digital wallet, and 27 percent used Zelle through a bank's mobile application).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             
                            <E T="03">Id.</E>
                             at 27-28 (Figure 15 reporting that, compared with 20 percent of P2P transactions made in cash, 37 percent of P2P transactions made through alternative P2P payment services).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             
                            <E T="03">See</E>
                             Marqueta, 
                            <E T="03">2022 State of Consumer Money Movement Report</E>
                             (May 26, 2022) at 1 (summary of report describing results of industry survey finding that 56 percent of US consumers felt comfortable leaving their non-digital wallet at home and taking their phone with them to make payments), 
                            <E T="03">https://www.marqeta.com/resources/2022-state-of-consumer-money-movement</E>
                             (last visited Oct. 23, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             
                            <E T="03">AiteNovarica 2023 Impact Report</E>
                             at 24 (Figure 13 reporting 81 percent of U.S. adults surveyed held one or more P2P accounts and 69 percent had one or more digital wallets).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             
                            <E T="03">The Federal Reserve Payments Study: 2022 Triennial Initial Data Release</E>
                             (indicating a rapid increase in core non-cash payments between 2018 and 2021 and a rapid decline in ATM cash withdrawals during the same period), 
                            <E T="03">https://www.federalreserve.gov/paymentsystems/fr-payments-study.htm</E>
                             (last visited Nov. 19, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             PYMNTS, 
                            <E T="03">Digital Economy Payments: The Ascent of Digital Wallets</E>
                             (Feb. 2023) at 16-17 (December 2022 survey finding 6.1 percent of overall consumer spending by consumers with lower incomes made using digital consumer payment applications, compared with 9.9 percent of consumer spending by consumers with middle-level incomes), 
                            <E T="03">https://www.pymnts.com/study/digital-economy-payments-ecommerce-shopping-retail-consumer-spending/</E>
                             (last visited Oct. 23, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             
                            <E T="03">See FIS 2023 Global Payments Report</E>
                             at 176 (reporting 32 percent share of ecommerce transactions, by value, made using a digital wallet, compared with 30 percent by credit card and 20 percent by debit card).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             
                            <E T="03">See, e.g., 2023 Pulse Debit Issuer Study</E>
                             (Aug. 17, 2023) at 11 (reporting that mobile wallet use at point of sale nearly doubled in 2022, representing nearly 10 percent of total debit card purchase transactions in 2022), 
                            <E T="03">https://content.pulsenetwork.com/2023-debit-issuer-study/2023-pulse-debit-issuer-study-white-paper</E>
                             (last visited Nov. 5, 2024); 
                            <E T="03">Digital Economy Payments: The Ascent of Digital Wallets</E>
                             at 12 (December 2022 survey finding 7.5 percent of in-person consumer purchase volume made with a digital consumer payment application). 
                            <E T="03">See also</E>
                             CFPB Issue Spotlight, 
                            <E T="03">Big Tech's Role in Contactless Payments: Analysis of Mobile Devices Operating Systems and Tap-to-Pay Practices</E>
                             (Sept. 7, 2023) (CFPB Contactless Payments Spotlight) (describing market report by Juniper Research forecasting that the value of digital wallet tap-to-pay transactions will grow by over 150 percent by 2028), 
                            <E T="03">https://www.consumerfinance.gov/data-research/research-reports/big-techs-role-in-contactless-payments-analysis-of-mobile-device-operating-systems-and-tap-to-pay-practices/full-report/</E>
                             (last visited Oct. 23, 2023).
                        </P>
                    </FTNT>
                    <P>
                        The Proposed Rule would have brought nonbanks that qualified as larger participants in a market for general-use digital consumer payment applications under the CFPB's supervisory jurisdiction.
                        <SU>43</SU>
                        <FTREF/>
                         The Proposed Rule explained that supervision of larger participants, who engage in a substantial portion of the overall activity in this market, would help to ensure that they are complying with applicable requirements of Federal consumer financial law, such as the CFPA's prohibition against unfair, deceptive, and abusive acts and practices, the privacy provisions of the Gramm-Leach-Bliley Act (GLBA) and its implementing Regulation P,
                        <SU>44</SU>
                        <FTREF/>
                         and the Electronic Fund Transfer Act (EFTA) and its implementing Regulation E.
                        <SU>45</SU>
                        <FTREF/>
                         The Proposed Rule also explained that, as firms increasingly offer funds transfer and wallet functionalities through general-use digital consumer payment applications, the rule would enable the CFPB to detect and assess new risks to both consumers and the market.
                        <SU>46</SU>
                        <FTREF/>
                         As stated in the Proposed Rule, the CFPB's ability to detect and assess emerging risks is critical as new product offerings blur the traditional lines of banking and commerce.
                        <SU>47</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             12 U.S.C. 5514(a)(1)(B).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             
                            <E T="03">See generally</E>
                             12 CFR part 1016—Privacy of Consumer Financial Information (CFPB's Regulation P implementing 15 U.S.C. 6804).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             15 U.S.C. 1693 
                            <E T="03">et seq.,</E>
                             implemented by Regulation E, 12 CFR part 1005. 
                            <E T="03">See, e.g.,</E>
                             12 CFR 1005.11 (Procedures for financial institutions to resolve errors).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             88 FR 80197 at 80201 &amp; n.43 (citing CFPB, 
                            <E T="03">The Convergence of Payments and Commerce: Implications for Consumers</E>
                             (Aug. 2022) (CFPB Report on Convergence of Payments and Commerce) at sec. 4.1 (highlighting the potential that consumer financial data and behavioral data are used together in increasingly novel ways), 
                            <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_convergence-payments-commerce-implications-consumers_report_2022-08.pdf</E>
                             (last visited Oct. 27, 2023)).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             
                            <E T="03">See generally id.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Proposed Rule explained that the CFPB regularly supervises depository institutions that provide general-use digital consumer payment applications.
                        <SU>48</SU>
                        <FTREF/>
                         As the Proposed Rule noted, greater supervision of nonbanks in this market therefore would further the CFPB's statutory objective of ensuring that Federal consumer financial law is enforced consistently between nonbanks and depository institutions in order to promote fair competition.
                        <SU>49</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             For example, as the Proposed Rule noted, some depository institutions and credit unions provide general bill-payment services and other types of electronic fund transfers through digital applications for consumer deposit accounts. 
                            <E T="03">Id.</E>
                             at n.45.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             12 U.S.C. 5511(b)(4).
                        </P>
                    </FTNT>
                    <P>
                        The Proposed Rule also recognized that States have been active in regulation of money transmission by money services businesses and that many States actively examine money transmitters.
                        <SU>50</SU>
                        <FTREF/>
                         The Proposed Rule stated that the CFPB would coordinate with appropriate State regulatory authorities in examining larger participants.
                    </P>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             88 FR 80197 at 80198 n.12, 80214 n.108 (citing CSBS, 
                            <E T="03">Reengineering Nonbank Supervision, Ch. 4: Overview of Money Services Businesses</E>
                             (Oct. 2019) (CSBS Reengineering Nonbank Supervision MSB Chapter), 
                            <E T="03">https://www.csbs.org/sites/default/files/other-files/Chapter%204%20-%20MSB%20Final%20FINAL_updated_0.pdf</E>
                             (last visited Nov. 5, 2024)).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">
                        General Comments Received 
                        <SU>51</SU>
                        <FTREF/>
                    </HD>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             Some commenters provided additional recommendations that are outside the scope of this rulemaking, such as increasing education of consumers who use general-use digital consumer payment applications, promulgating new consumer protections for these consumers, or imposing information collection requirements such as collecting the legal entity identifier (LEI) of larger participants. The Final Rule does not address these comments, which are outside the scope of a rulemaking under CFPA section 1024(a)(1)(B) to define and establish supervisory authority over larger participants in a market for consumer financial products and services. In addition, a consumer group suggested that the CFPB the CFPB expressly clarify that meeting the definition of a larger participant does not automatically cause application of exclusions in State privacy laws for GLBA compliance and that the CFPB coordinate with States to avoid risk of preempting State privacy laws when the CFPB supervises for compliance with the GLBA and its implementing Regulation P. This rulemaking does not establish or interpret substantive consumer protection requirements and thus does not interpret Regulation P (including its provision describing its relationship with State laws in 12 CFR 1016.17); it also does not itself govern State coordination, which occurs separately when the CFPB carries out nonbank supervision.
                        </P>
                    </FTNT>
                    <P>In this part of the section-by-section analysis, the Final Rule summarizes and responds to comments about general aspects of the proposal, including the rulemaking process, the CFPB's general reasons for issuing the proposal, and certain other general topics.</P>
                    <HD SOURCE="HD3">Comments on Rulemaking Process</HD>
                    <P>
                        Some comments addressed the rulemaking process. First, some commenters suggested that the CFPB should not have issued, and should not finalize, the Proposed Rule during the 
                        <PRTPAGE P="99587"/>
                        pendency of a Supreme Court case concerning the constitutionality of the CFPB's funding structure under the Appropriations Clause.
                        <SU>52</SU>
                        <FTREF/>
                         Second, some industry commenters, a nonprofit commenter, an individual commenter, and some Members of Congress asked the CFPB to extend the comment period, such as by an additional 30 or 45 days. These commenters cited various reasons for their request, including the number of holidays during the comment period, the complexity of the proposed market including coverage of digital assets, the complexity of the proposed larger-participant test that included multiple steps, a need for more specifics regarding which products and services were encompassed in the market and the risks the CPFB believed they pose that justify the need for the Proposed Rule, and overlap between the comment period for the Proposed Rule, the comment period for the CFPB's proposal regarding personal financial data rights, and the CFPB's new market-monitoring orders covering some of the same entities. One industry commenter added that the decision not to extend the comment period formed part of the basis for their view that the CFPB should withdraw the Proposed Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             
                            <E T="03">See CFPB</E>
                             v. 
                            <E T="03">Cmty. Fin. Servs. Ass'n of Am., Ltd.,</E>
                             601 U.S. 416 (2024) (U.S. argued Oct. 3, 2023).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Comments on the Large and Growing Market</HD>
                    <P>
                        Commenters agreed that the market for general-use digital consumer payment applications has grown substantially in recent years. For example, consumer groups, several nonprofits, a payment network, an industry association, two banking industry associations, and a credit union association agreed (and an industry provider acknowledged 
                        <SU>53</SU>
                        <FTREF/>
                        ) that there has been rapid growth and widespread consumer adoption of general-use digital consumer payment applications. In support of their view, these commenters cited data in the Proposed Rule as well as other public information. An industry association stated that digital consumer payment applications have helped millions of U.S. consumers to send money to friends and family and make retail payments more efficient. A group of State attorneys general noted that a significant portion of consumers with lower incomes frequently rely upon general-use digital consumer payment applications. Two nonprofit commenters also agreed that adoption by younger individuals may drive further growth.
                        <SU>54</SU>
                        <FTREF/>
                         An industry association observed that the proposed market has experienced rapid increases in consumer adoption that likely will continue. As a consequence, this commenter described this market as still in what industry lifecycle literature describes as a stage of market growth as opposed to market maturity.
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             As discussed further below, this commenter stated that growth alone was insufficient to justify the Proposed Rule, and that the CFPB must make certain specific findings regarding market risk. The Final Rule responds to those comments further below in the discussion of general comments about the relevance of risks to consumers to the rulemaking.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             While not disputing the rapid growth in the market, some other industry commenters suggested that the broader consumer payments sector should be considered, including when defining the market and setting the threshold for the larger-participant test, as discussed in the section-by-section analysis of those provisions further below.
                        </P>
                    </FTNT>
                    <P>
                        Several of these commenters stated that these general-use digital consumer payment applications increasingly are accepted by retailers and embedded into in-person and online commerce, which is itself growing. They pointed to this as one trend driving existing growth and future growth in the market. A comment from several consumer groups stated that as merchants seek to avoid interchange fees, they will increasingly rely upon digital payment applications as a payment method at the point of sale. A banking association and consumer group stated that they also expected the lines between banking, commerce, and technology to further converge and blur.
                        <SU>55</SU>
                        <FTREF/>
                         A comment from several consumer groups stated that nonbank providers of consumer financial products and services have greater latitude under U.S. law to integrate those products into commercial platforms, and that large technology firms' business models depend on data collection.
                        <SU>56</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             One of these commenters pointed to an industry white paper describing a trend in the market toward “embedding financial services into nonfinancial apps and other digital experiences.” Google LLC White Paper, 
                            <E T="03">Embedded finance: The new gold rush in financial services</E>
                             (2021) (Google LLC Embedded Finance White Paper) at 4 (“These embedded experiences will soon permeate all aspects of our lives that involve money—and they'll feel so frictionless that users won't be aware of the underlying work financial institutions are doing to support these transactions.”), at 6 (“Embedded finance means, simply, embedding your financial services in the non-financial products, services or technologies consumers already use and love. Since they spend much of their time in non-financial applications in their everyday lives—but only a fractional amount of time in financial applications—the growth opportunity for financial services companies is considerable.”), 
                            <E T="03">https://cloud.google.com/resources/financial-services-embedded-finance-whitepaper</E>
                             (last visited Nov. 5, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             One consumer group commenter added that in its view, Big Tech firms have a business model that seeks to maximize data collection based on different goals from publicly-chartered and regulated financial institutions.
                        </P>
                    </FTNT>
                    <P>Another nonprofit commenter suggested in general terms that CFPB supervision of larger participants in the general-use digital consumer payment applications market could help the CFPB to detect and assess risks to the U.S. financial system. It stated that the market may present such risk, given how general-use digital consumer payment applications facilitate a high volume of transactions, including flows of funds through stored value accounts that are not FDIC-insured.</P>
                    <P>
                        However, some industry and nonprofit commenters stated that the rapid growth in the market and widespread consumer adoption merely indicates that the market is successful and popular among consumers. In their view, as discussed further below, the fact that the market is large and growing market is not an adequate basis for subjecting its larger participants to supervision, absent findings of risks to consumers or markets or market failures.
                        <SU>57</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             The Final Rule further summarizes and responds to those comments in the discussion below of general comments on detecting and assessing risks (including emerging risks) to consumers and markets.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Comments on Promoting Compliance With Federal Consumer Financial Law</HD>
                    <P>
                        The Proposed Rule stated that CFPB supervision of larger participants would promote compliance with applicable requirements of Federal consumer financial law. A group of State attorneys general, consumer groups, some nonprofit and individual commenters, a banking association, and a comment from a payment network and an industry association generally agreed that the proposal would serve this purpose, as described below. However, as described further below, some industry and nonprofit and other commenters disagreed or stated that the proposal did not provide sufficient support for the claim that it would serve this purpose.
                        <SU>58</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             Some commenters also suggested that existing State and Federal oversight of some market activities, including for compliance with Federal consumer financial law, was adequate. The Final Rule separately addresses comments on those general topics further below.
                        </P>
                    </FTNT>
                    <P>
                        Several commenters expressed concern that larger participants may be violating or inadequately incentivized to comply with one or more of the Federal consumer financial laws cited in the Proposed Rule. A joint comment from consumer groups stated that consumers are exposed to unfair, deceptive and abusive practices in the payments area, and stated that oversight of this market is needed to ensure market participants comply with the prohibition against 
                        <PRTPAGE P="99588"/>
                        unfair, deceptive, and abusive acts and practices.
                        <SU>59</SU>
                        <FTREF/>
                         This comment assessed the risk of abusive practices as high due to what the comment described as lack of competition and consumer choice with respect to the larger participants defined in the Proposed Rule. A comment from a group of State attorneys general stated that the Proposed Rule, coupled with existing State consumer protection statutes, would allow the Federal and State governments to work together to prevent and abate unfair, deceptive, and abusive acts and practices in the market. A consumer group and a nonprofit commenter stated that the Proposed Rule would be especially useful in promoting compliance with the prohibition against unfair, deceptive, and abusive acts and practices by companies that provide financial services to incarcerated and recently incarcerated persons. And a consumer group and nonprofit commenter stated that it was common sense that unfair, deceptive, and abusive acts and practices protections be applied to new entrants and technologies like those described in the Proposed Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5531, 5536 (prohibiting unfair, deceptive, and abusive acts and practices in connection with the offering or provision of consumer financial products and services).
                        </P>
                    </FTNT>
                    <P>
                        As an example of how supervision of larger participants would promote compliance, a banking association noted that the CFPB's publication 
                        <E T="03">Supervisory Highlights</E>
                         
                        <SU>60</SU>
                        <FTREF/>
                         communicates CFPB expectations of compliance to the overall market and encouraged its use in this market, and stated that the proposal should enable the CFPB to publish 
                        <E T="03">Supervisory Highlights</E>
                         identifying problematic conduct in this market. A comment from several consumer groups pointed to findings in 
                        <E T="03">Supervisory Highlights</E>
                         related to violations of Regulation E and other provisions of Federal consumer financial law violations at banks. The comment stated that the CFPB also should supervise larger nonbank companies handling consumer payments, including payment apps, because such violations at nonbanks are just as likely if not more so.
                    </P>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             The CFPB periodically publishes 
                            <E T="03">Supervisory Highlights</E>
                             to share key examination findings in order to help industry limit risks to consumers and comply with Federal consumer financial law. Each 
                            <E T="03">Supervisory Highlights</E>
                             publication shares recent examination findings, including information about recent enforcement actions that resulted, at least in part, from the CFPB's supervisory activities. These reports also communicate operational changes to the CFPB's supervision program and provide a convenient and easily-accessible resource for information on the CFPB's recent guidance documents. 
                            <E T="03">Supervisory Highlights</E>
                             does not refer to any specific institution in order to maintain the confidentiality of supervised entities. 
                            <E T="03">See https://www.consumerfinance.gov/compliance/supervisory-highlights/</E>
                             (last visited Nov. 5, 2024).
                        </P>
                    </FTNT>
                    <P>
                        Regarding EFTA and Regulation E, a comment from consumer groups stated that oversight is needed to ensure payment app and digital wallet providers comply with the EFTA's consumer protections for electronic fund transfers, highlighted payment fraud as a significant risk, and stated that violations of the EFTA related to digital payments are extremely common, even among banks that are closely supervised by regulators. The commenter cited to several findings of EFTA violations from CFPB examinations in this area that the CFPB has published in 
                        <E T="03">Supervisory Highlights.</E>
                         A credit union association commenter stated that nonbanks that offer consumer payment services have error resolution responsibilities under Regulation E which the CFPB cannot effectively assess without exercising supervisory authority.
                    </P>
                    <P>
                        Commenters also addressed risks posed to consumers associated with potential violations of the GLBA and Regulation P.
                        <SU>61</SU>
                        <FTREF/>
                         A comment from a group of State attorneys general supported the Proposed Rule in part because it would allow the CFPB to examine digital payment applications for compliance with the privacy provisions of the GLBA. The comment stated the Proposed Rule would permit the CFPB to address the critical data privacy issues posed by digital payment applications by allowing the CFPB to assess how applications are storing, using, and sharing their collections of sensitive consumer data as well as changes to larger participants' privacy policies. A consumer group commenter stated that its review had identified multiple risks associated with peer-to-peer payment application companies. The commenter stated that more than 25,000 consumers had signed a petition urging the CFPB to take action with respect to various risks posed by payments applications, including risks associated with fraud and collection and storage of consumer information.
                        <SU>62</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>61</SU>
                             Title V, subtitle A of the GLBA and its implementing regulation, Regulation P, govern the treatment of nonpublic personal information about consumers by financial institutions.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             Similarly, other commenters emphasized potential risks with respect to use of consumer data and risks to consumer privacy that may be associated with payment application and digital wallet providers, including the risk of losing money through fraud or mistakes or having personal data collected and shared.
                        </P>
                    </FTNT>
                    <P>
                        Other commenters such as a company, nonprofits, and an industry association stated that the Proposed Rule did not adequately assess the degree of existing compliance or otherwise explain how it would promote compliance. For example, one commenter criticized the statement in the proposal that CFPB supervision would incentivize compliance as circular, given what it viewed as inadequate discussion in the Proposed Rule of the level of existing non-compliance or risks of non-compliance.
                        <SU>63</SU>
                        <FTREF/>
                         In addition, several industry comments suggested that EFTA/Regulation E, GLBA/Regulation P, or both do not apply to certain market participants, which they viewed as undermining the notion that the Proposed Rule would promote compliance with Federal consumer financial law. A company commenter added that the proposal did not explain how the prohibition against unfair, deceptive, or abusive acts or practices applied to market participants, or why supervision is the appropriate mechanism to identify and prevent any anticipated violations of Federal consumer financial law more broadly. Further, an industry commenter stated that State supervision by itself is more effective and better at enforcing the law than CFPB supervision.
                    </P>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             Further below, the Final Rule summarizes and responds to comments more broadly addressing the general topic of risks to consumers in the market.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Comments on Detecting and Assessing Risks to Consumers and Markets, Including Emerging Risks</HD>
                    <P>
                        Comments from a group of State attorneys general, a payment network, a banking association, consumer groups, and nonprofits agreed that CFPB supervision of larger participants in this market would help the CFPB to detect and assess risks to consumers and markets, including emerging risks, in this rapidly growing and evolving market. For example, an industry association generally described the potential for CFPB supervision to promote maturity in the market, which it described as immature and rapidly evolving.
                        <SU>64</SU>
                        <FTREF/>
                         In addition, these comments pointed to several reasons why the CFPB supervision and examination process is well suited to this goal. A consumer group stated that supervisory authority is one of the most basic tools regulators have to identify new risks in the market as early as possible, before market failures with wide-ranging implications occur. Several consumer groups added that CFPB should not rely only on third-party sources of 
                        <PRTPAGE P="99589"/>
                        information to assess market activity, which would lead to delayed responses to problems, compared with supervision.
                        <SU>65</SU>
                        <FTREF/>
                         A nonprofit commenter stated that because supervision occurs outside of the adversarial legal process, it is an especially effective tool for rapidly gathering information that can prevent dubious practices before they develop.
                    </P>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                             In its view, the Proposed Rule may result in development of a robust, consumer-protected market, given how previous larger participant rules had helped to ensure consumer protection remains a prominent concern among participants in those markets.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             These commenters also stated supervision of larger participants would allow the CFPB to respond more quickly to emerging problems affecting servicemembers who are especially vulnerable to identity theft and fraud in the market.
                        </P>
                    </FTNT>
                    <P>Several comments also identified various existing and emerging risks in the market that the commenters believed the CFPB would be able to effectively detect and assess though supervision, including risks with respect to consumers' loss of funds and loss and misuse or abuse of data. The Final Rule summarizes these comments below. In addition, a group of State attorneys general stated that the rule will allow the CFPB to detect and assess risks that emerge not only from the existing products and services, but also as a result of future technological advancements in the market.</P>
                    <P>
                        With respect to the potential for consumers to lose funds or access to funds, a group of State attorneys general noted that research cited in the proposal indicated that almost a third of digital payment application users with lower incomes reported one or more problems related to funds being sent to the wrong person or not receiving funds that were sent to them.
                        <SU>66</SU>
                        <FTREF/>
                         These commenters stated that a lack of regulatory oversight has significantly contributed to those problems. A nonprofit commenter stated that larger participants pose unique risks to consumers related to what the commenter characterized as the lack of consumer protections associated with these applications, as well as the possible systemic risks they may present to the financial markets. The commenter raised specific concerns about the risk of consumer loss of funds from uninsured entities and lack of consumer awareness of such matters. The commenter also stated that CFPB supervision of these nonbank payment applications would, among other things, help to identify and mitigate systemic financial risk and enhance consumer protection. An individual commenter stated that the market had diverse participants but that there are common areas of risk with payment apps linked to a stored value product, including a risk of losing access to funds to pay for food or bills due to a technical glitch. Additional commenters raised various concerns about what they often described as fraud in the market and lack of related consumer protections, and a nonprofit commenter cited complaints submitted to the FTC regarding peer-to-peer payment fraud. At the same time, several industry commenters suggested that certain consumer protections such as EFTA/Regulation E or GLBA/Regulation P do not apply to some market participants, as described further above, and that consumers often are adequately protected by other parties to the transaction such as banks and credit unions, as described in the discussion of general comments about existing oversight of the market further below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             
                            <E T="03">Consumer Reports P2P Survey</E>
                             at 7 (also indicating that of all respondents who have used a P2P service, 22 percent reported one or more such problems). 
                            <E T="03">See also</E>
                             88 FR 80197 at 80200 n.25 (proposal's discussion of other data in this report, noted above).
                        </P>
                    </FTNT>
                    <P>
                        With regard to uses of consumer payments data, a banking association, a payment network, a nonprofit commenter, and several consumer groups stated that the way in which nonbanks can exploit the convergence of payments and commerce poses risk to consumers with respect to this market, such as through aggregation and monetization of consumer financial data. A group of State attorneys general added that supervision of larger participants would help the CFPB to detect and assess emerging risks in the use of consumer financial data as technology continues to evolve. And an individual commenter and several industry comments stated that consumer payments data is often used for purposes beyond initiation of the consumer payment transaction.
                        <SU>67</SU>
                        <FTREF/>
                         Several consumer groups described the level and use of consumer data collected by large technology firms as unreasonable and potentially dangerous. Several other commenters including individuals noted that the collection of such data also raises data security risks, including what a nonprofit commenter described as novel security risks raised by digital wallets. At the same time, other comments from industry suggested that data security risks to consumers were particularly low given the security and anti-fraud enhancements from market participants' reliance on features such as tokenization.
                        <SU>68</SU>
                        <FTREF/>
                         And a nonprofit commenter stated that government regulators generally are not effective at preventing data breaches as some of the largest have occurred at heavily-regulated institutions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             The Final Rule discusses and responds to these comments in more detail in the section-by-section analysis of the exclusion for certain marketplace activities described further below.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             In addition, digital assets industry comments described what they viewed as additional security that digital assets provide. As discussed in the section-by-section analysis of the larger-participant test further below, the Final Rule does not count those transactions toward the larger-participant test.
                        </P>
                    </FTNT>
                    <P>
                        Some commenters disagreed that the goal of detecting and assessing risks including emerging risks warrants the proposed expansion of CFPB's supervisory authority in this market. For example, two nonprofit commenters stated that the rationale of detecting and assessing emerging risks was not supported by evidence, and instead only by the theoretical possibility of harm in an innovative, successfully-growing and popular market. Another nonprofit commenter stated that the proposal did not examine the nature of the emerging risks, whether by mentioning novel security risks posed by digital wallets or other harms. Another nonprofit commenter stated its belief that market participants' responses to the CFPB's previous market-monitoring orders generated adequate information for the CFPB to determine the level of risks posed by this emerging market.
                        <SU>69</SU>
                        <FTREF/>
                         Two industry associations stated that they agreed in principle that regulation needed to evolve along with new technology, but they stated that the CFPB first must identify harms it perceives in the market before proposing to supervise its larger participants. Another industry association agreed, stating that the Proposed Rule merely described the possibility of “new risks” from “new product offerings” and did not state what the “new risks” might be. It pointed to market reports that, in its view, indicated that nonbanks' multi-sided business models in the digital economy provide new benefits to consumers and promote competition.
                        <SU>70</SU>
                        <FTREF/>
                         A nonprofit commenter characterized the proposal as referring to hypothetical risks that may occur in the future, and described this reference as a mere pretext to support an agenda to target large technology firms. An industry commenter added that the goal of detecting and assessing new and emerging risks is inadequate as a 
                        <PRTPAGE P="99590"/>
                        foundation for a larger participant rule. In its view, the CFPB can only engage in larger participant rulemakings when it identifies risks that supervision would mitigate. The commenter also asserted that, because the CFPB must consider risks to consumers in exercising its supervisory authority under section 1024(b)(2), the CFPA also requires that the CFPB establish the existence of specific risks to consumers that would be mitigated by supervision when issuing a larger participant rule under section 1024(a)(1)(B) and (2). The industry commenter also claimed that principles of administrative law likewise require the rule to target identified risks.
                        <SU>71</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             However, this commenter also recommended that the CFPB continue to gather information on the market before expanding its supervisory authority as proposed.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>70</SU>
                             Separately, this commenter observed that the financial technology sector that encompasses the proposed market often uses advanced technologies including artificial intelligence, block chain technology, and data mapping to create new financial products and services that are beneficial in various ways. This commenter did not state that such products posed any risk or could pose any emerging or new risks.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             The commenter also stated in a footnote that if the rule does not need to identify meaningful risks to consumers then the CFPA would violate the non-delegation doctrine in constitutional law. The commenter did not explain the basis for that view, and the CFPB disagrees with that view. Through the CFPA, Congress has provided guidance to the CFPB on how to exercise its rulemaking authority under 12 U.S.C. 5514(a)(1)(B) and has imposed limits on that authority, including rules of construction for defining larger participants and policy considerations, which the CFPB has addressed in this Final Rule.
                        </P>
                    </FTNT>
                    <P>
                        More broadly, many of the industry commenters and other commenters stated that the Proposed Rule did not adequately consider whether market activity currently poses risks to consumers and if so how and to what degree. Other commenters similarly stated that the proposal failed to establish that certain provisions of Federal consumer financial law apply to market participants; that the proposal failed to identify potential violations of law or other specific harms that the Proposed Rule would seek to address, or any relevant market failures; and that the CFPB should first issue a report articulating the risks it sees in the proposed market or otherwise identify such risks prior to issuing a final rule.
                        <SU>72</SU>
                        <FTREF/>
                         Certain commenters also stated that the CFPB should evaluate risk separately with respect to various subcomponents of the market described in the Proposed Rule, and argued for the exclusion of various market participants, as discussed in more detail in the section-by-section analysis of the corresponding component of the market definition further below.
                        <SU>73</SU>
                        <FTREF/>
                         Finally, a nonprofit commenter stated that the CFPB should provide greater clarity to market participants as to how the CFPB would assess risk in its prioritization process in this market, including what risks it would consider.
                    </P>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             A nonprofit commenter stated that the unique data security risks that digital wallets pose should be addressed through public education rather than regulation. As noted above, consumer education is outside the scope of this rule and, for the reasons explained in the response to general comments, education is not a substitute for supervision.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             Some commenters suggested that CFPB supervision itself would increase risk such as by reducing examinees' resources available for fraud prevention, or exposing the supervised entity's data to breaches. For the reasons explained in the impacts analysis in part VII, the CFPB has not determined the Final Rule will reduce fraud prevention. With regard to the risk of data breaches, the CFPB's information security system mitigates those risks as further discussed in part VII.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Comments on Ensuring Consistent Enforcement of Federal Consumer Financial Law Between Banks and Nonbanks</HD>
                    <P>
                        Some comments addressed the Proposed Rule's statement that the rule would further the CFPB's statutory mandate to ensure consistent enforcement of Federal consumer financial law between nonbanks and banks and credit unions, in order to promote fair competition. Several consumer groups, banking and credit union industry associations, a payment network, some nonprofits, and an industry provider generally agreed that the Proposed Rule would have that benefit. For example, a community banking association stated that community banks have long expressed concerns that financial technology and large technology firms are offering financial products and services traditionally provided by banks, without the same level of regulatory oversight. A banking association stated that consumers are best protected when banks and nonbanks offering similar financial products and services are subject to the same oversight, which mitigates the potential for consumer harm and improves consumer trust and confidence. This commenter and another banking association added that establishing parity in supervision will help to ensure that nonbanks provide the same consumer protections when they provide the same services as banks. A payment network and a nonprofit commenter agreed that the proposal would help to ensure that entities engaged in the same functional activities are subject to the same functional regulation. Some comments described nonbanks as deriving a competitive advantage due to their lesser supervisory oversight, and banks and credit unions as disadvantaged. For example, the credit union industry association commenter stated that the lesser supervisory oversight of nonbank peer-to-peer payment apps increases burdens on credit unions responding to consumer disputes of transactions conducted in those apps due to the app providers' underinvestment in compliance and customer service and consumer preferences for contacting the credit union. The community banking association also stated that this gap in oversight erodes consumer trust. One of the banking industry associations agreed, noting that its 2022 survey found that an overwhelming majority of consumers were concerned about a gap in regulatory oversight between fintech firms (including cryptocurrency firms) and banks, and believed that the CFPB and Congress should do more to protect consumers from harm and abuse in these areas.
                        <SU>74</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             Consumer Bankers Ass'n, Press Release, 
                            <E T="03">NEW POLL: Nearly Ninety Percent Of Americans Concerned That Fintech &amp; Crypto Firms Do Not Have Appropriate Level of Federal Regulation</E>
                             (Dec. 12, 2022) (describing 56 percent of respondents that want greater oversight compared to 24 percent who are satisfied with existing oversight), 
                            <E T="03">https://consumerbankers.com/press-release/new-poll-nearly-ninety-percent-of-americans-concerned-that-fintech-crypto-firms-do-not-have-appropriate-level-of-federal-regulations/</E>
                             (last visited Nov. 18, 2024).
                        </P>
                    </FTNT>
                    <P>
                        At the same time, some industry and nonprofit commenters challenged the potential for Proposed Rule to promote consistent enforcement of Federal consumer financial law as between nonbanks and depository institutions, and thereby promote fair competition, as well as the appropriateness of that consideration in the rulemaking. For example, some of these commenters described the proposed objective as an illegitimate form of “mission creep . . . outside of [the CFPB's] core jurisdiction” or further suggested that the Proposed Rule would place the CFPB in the role of market gatekeeper for nonbanks, which would frustrate competition and innovation (which one of these commenters described as the effect that banking regulation already has on banks). Some industry commenters also suggested the objective failed to account for the structure of nonbank market activity vis-à-vis banks and credit unions. For example, an industry association stated that many nonbank market participants either complement banks and credit unions by making it easier for consumers to use payment methods provided by those financial institutions, or partner directly with the banks and credit unions. Some banking associations also expressed concern that the rule would increase indirect burden on banks and may create confusion about differences between banks and nonbanks. As another example, an industry provider stated that banks provide deposit accounts (and associated funds transfer functionalities), not pass-through payment wallets allowing consumers to access payment methods issued by 
                        <PRTPAGE P="99591"/>
                        third-party financial institutions.
                        <SU>75</SU>
                        <FTREF/>
                         And for that reason, in its view, increased oversight of those activities would not serve the CFPB's stated purpose. However, another industry association stated that banks have been introducing their own digital wallets, both directly and through affiliates, in an effort to compete with nonbank incumbents that have embedded their digital wallets into merchant checkout processes.
                    </P>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             As discussed below in the section-by-section analysis of the definition of “covered payment functionality,” the preamble uses the phrase pass-through payment wallet to describe this type of functionality discussed by commenters.
                        </P>
                    </FTNT>
                    <P>
                        Finally, an industry association also suggested that in some ways the Final Rule may not promote consistent enforcement of Federal consumer financial law. It stated that the CFPB should explain why larger participants in the proposed market should be subject to what it viewed as significantly more CFPB supervisory authority than exists over other persons that facilitate consumer payment transactions, such as banks and credit unions providing physical payment cards and providers of payment applications that do not have “general use” as defined in the Proposed Rule such as automobile purchase applications and food delivery applications.
                        <SU>76</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             The commenter also stated the Proposed Rule excluded from “general use” bill-payment applications and applications used to purchase financial assets including securities. However, the Proposed Rule specifically acknowledged the existence in the market of “a general-use bill-payment function.” 88 FR 80197 at 80206. In addition, the Proposed Rule did not list applications for purchase of securities among the examples of activities that do not have “general use” because it already excluded those transaction from the proposed definition of “consumer payment transaction” as discussed in the section-by-section analysis of that term further below.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Comments on Other Regulators' Existing Oversight Authority</HD>
                    <P>Some commenters suggested the rule would help existing regulatory oversight efforts in the market, while others stated that the Proposed Rule did not adequately consider whether the CFPB supervisory authority was needed in light of existing regulatory oversight mechanisms of other regulators.</P>
                    <P>A group of State attorneys general stated that the Proposed Rule would allow Federal and State authorities to coordinate to prevent and abate unfair, deceptive, and abusive acts and practices in the market. They indicated that violations of Federal law detected through CFPB's supervisory examinations could assist State enforcement, including in States such as California, New Jersey, and New York, where a commercial practice that violates Federal law is deemed or presumed to violate the State's consumer protection laws.</P>
                    <P>
                        On the other hand, some other commenters stated that the Proposed Rule did not adequately consider the degree to which the market already is overseen by other regulators, including State oversight of nonbank market participants that are money transmitters, Federal prudential regulators' oversight with respect to banks and credit unions that provide accounts, hold funds, and process payments facilitated by nonbank market participants, and FTC enforcement of consumer protection laws including competition laws.
                        <SU>77</SU>
                        <FTREF/>
                         Several industry associations stated that the rulemaking generally must better account for the potential for CFPB supervision to duplicate the oversight by those other regulators, and the unnecessary burdens and diverging regulatory expectations that such duplicative supervision can create.
                        <SU>78</SU>
                        <FTREF/>
                         One of these commenters stated that the CFPB should clarify the scope and requirements of the rule to prevent these outcomes, and stated that close coordination by the CFPB with other regulators is needed before the CFPB pursues oversight of larger participants.
                    </P>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             A few industry comments also mentioned Federal oversight of money transmitters by FinCEN in the U.S. Treasury. These commenters did not describe any nexus between that oversight and compliance with Federal consumer financial law, or otherwise suggest that supervisory activity by FinCEN and the CFPB would have overlapping subject matter related to compliance with Federal consumer financial law.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>78</SU>
                             Some commenters also discussed Federal prudential regulators' existing oversight of banks and credit unions as relevant due to the inclusion in the market of nonbanks that partner with banks and credit unions, and of pass-through payment wallets that facilitate the use of accounts provided by banks and credit unions. The Final Rule summarizes and responds to those comments in more detail in the section-by-section analysis of “covered payment functionality” below.
                        </P>
                    </FTNT>
                    <P>
                        With respect to existing State oversight, an industry association stated that State financial regulators supervise various aspects of the market and the CFPA requires the CFPB to account for oversight by State authority when exercising its supervisory authority. Two other industry associations indicated that in their view the Proposed Rule did not consider how the CFPB would address overlap in scope with State examinations on the same subject matter particularly at money transmitters. A nonprofit commenter suggested that State oversight is sufficient because States are better at enforcing the law because they have a better understanding of local conditions.
                        <SU>79</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>79</SU>
                             This commenter also stated that States generally occupy the field of consumer protection law, that Federal supervisory oversight by the CFPB would “preempt” State law, and that the proposal did not provide compelling evidence for doing so. The CFPB disagrees that a larger participant rule, which establishes CFPB supervisory authority and does not impose substantive consumer protection obligations, preempts such State consumer protection laws.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Comments on CFPB Enforcement and Market-Monitoring Authorities</HD>
                    <P>An industry association stated that the Proposed Rule did not explain how supervisory authority would promote additional compliance with Federal consumer financial law beyond compliance the CFPB ensures through its enforcement function and aided by its market-monitoring function. A nonprofit suggested that CFPB enforcement is sufficient to address risks to consumers, and that supervision would only impose unnecessary burden.</P>
                    <HD SOURCE="HD3">Comments Raising “Major Questions” Doctrine</HD>
                    <P>
                        Another area of comment related to the “major questions doctrine.” Those commenters who addressed the doctrine generally were critical of the Proposed Rule and took an expansive view of the circumstances in which the doctrine applies. First, one nonprofit commenter stated that the major question doctrine precludes the CFPB from defining larger participants in a digital wallet market generally. This commenter stated that, despite the existence of digital wallets at the time of adoption of the CFPA, Congress did not expressly include them within the scope of CFPB supervisory authority and therefore chose to foster innovation free from the CFPB's supervisory oversight. Further, in its view, the market has vast economic and political significance given both the aggregate dollar value of transactions on digital wallets (nearly $1 trillion) and references by the CFPB to payment systems as “critical infrastructure” and to “Big Tech” companies.
                        <SU>80</SU>
                        <FTREF/>
                         Second, some commenters stated that the CFPB's interpretation of the merchant payment processing exclusion in CFPA section 1002(15)(A)(vii)(I) also is impermissible under the major questions doctrine.
                        <FTREF/>
                        <SU>81</SU>
                          
                        <PRTPAGE P="99592"/>
                        Third, some commenters stated that the major questions doctrine voids the CFPB's interpretation of CFPA section 1024(b) as authorizing supervision of all consumer financial products and services provided by a larger participant for compliance with Federal consumer financial law and related risks.
                        <SU>82</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>80</SU>
                             CFPB Press Release (Nov. 7, 2023) (announcing Proposed Rule), 
                            <E T="03">https://www.consumerfinance.gov/about-us/newsroom/cfpb-proposes-new-federal-oversight-of-big-tech-companies-and-other-providers-of-digital-wallets-and-payment-apps/</E>
                             (last visited Nov. 8, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>81</SU>
                             In addition, some commenters stated that the inclusion of certain digital assets transfers in the proposed definition of consumer payment transactions raised a “major question.” As 
                            <PRTPAGE/>
                            discussed further below, the CFPB has decided, for purposes of this Final Rule, not to define larger participants in the general-use digital consumer payment applications market by reference to activity involving digital assets. This Final Rule therefore does not address these major questions comments further.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>82</SU>
                             As discussed further above in the general comments on how the rule would enable the CFPB through its supervisory activity to detect and assess risks to consumers and markets, a nonbank commenter claimed that the larger participant rule itself must identify meaningful risk, or it would violate the major questions doctrine. For the reasons described below in the response to these general comments above, the CFPB disagrees with both claims. The CFPB also disagrees that this rule implicates the major questions doctrine for reasons discussed below.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Comments on Potential Scope of CFPB Examinations of Larger Participants</HD>
                    <P>
                        Relatedly, the CFPB received several other comments on the proposal's statement that the CFPB's supervisory authority is not limited to the products or services that qualified a person for supervision, but also includes other activities of such a person that involve other consumer financial products or services or are subject to Federal consumer financial law.
                        <SU>83</SU>
                        <FTREF/>
                         Four commenters (representing the banking industry) expressed agreement with the CFPB's description of its supervisory authority over larger participants. They stated that the CFPB's position is consistent with how the CFPB supervises large banks, where every consumer financial activity that the bank engages in is subject to CFPB jurisdiction. Several other commenters (several industry trade groups, an individual company, and a law firm) disagreed with the CFPB's description of its supervisory authority. These commenters generally interpreted CFPA section 1024 to limit the scope of nonbank supervisory authority over larger participants to specific consumer financial products and services included in the market covered by the corresponding larger participant rule. One of these commenters asserted that the rule could not be used by the CFPB to scrutinize the digital assets business lines of entities, including those already subject to supervision. One commenter also suggested that even if the CFPA's view of its authority is correct, it would be unreasonable for the CFPB to actually exercise that authority because the costs of such supervision would exceed the benefits. Another said the exercise of such authority would discourage innovation and competition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>83</SU>
                             88 FR 80197 at 80198 n.7 (quoting 77 FR 42874 at 42880).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Response to General Comments Received</HD>
                    <P>After first responding to comments on rulemaking process issues, the Final Rule provides a response below to other general comments. For the reasons described below, the CFPB continues to believe that issuance of this larger participant rule is warranted because: (1) the market has grown dramatically and become increasingly important to the everyday financial lives of consumers; (2) CFPB supervisory authority over its larger participants would help the CFPB to promote compliance with Federal consumer financial law; (3) that authority would help the CPFB to detect and assess risks to consumers and the market, including emerging risks; and (4) that authority would help the CFPB to ensure consistent enforcement of Federal consumer financial law between banks and nonbanks.</P>
                    <HD SOURCE="HD3">Rulemaking Process</HD>
                    <P>
                        While the CFPB was considering comments on the Proposed Rule, the Supreme Court issued a decision ruling that the CFPB funding mechanism is constitutional under the Appropriations Clause.
                        <SU>84</SU>
                        <FTREF/>
                         The CFPB disagrees with commenters' suggestion that it should have forgone larger participant rulemaking activity during such a challenge.
                    </P>
                    <FTNT>
                        <P>
                            <SU>84</SU>
                             
                            <E T="03">CFPB</E>
                             v. 
                            <E T="03">Cmty. Fin. Servs. Ass'n of Am., Ltd.,</E>
                             601 U.S. 416 (2024).
                        </P>
                    </FTNT>
                    <P>
                        The CFPB also disagrees with those commenters suggesting that an extension of the comment period was necessary to allow for meaningful input on the Proposed Rule. The Proposed Rule would have a narrow impact, establishing CFPB supervisory authority over a group of nonbank covered persons who already are subject to CFPB enforcement and market-monitoring authority, and at least some of whom already are subject to CFPB supervisory authority on other grounds. Despite this, the CFPB received timely comments from a wide array of commenters, as described above, and all but one of the commenters described here filed timely comments after requesting more time. The CFPB disagrees that an extension of the comment period is warranted based on the proposal of a market definition that commenters viewed as complex or a larger-participant test with more than one criterion. As discussed below, commenters provided numerous useful comments about the proposed market definition and the CFPB is making several adjustments to the market definition in the Final Rule in response including to improve clarity. With regard to the larger-participant test, the CFPB proposed a test that was based on two criteria (consumer payment transaction volume and the entity's size by reference to SBA size standards) that were explained in the proposal and are not especially complicated. Proposed rules often include small entity exclusions, and many commenters provided substantive comments on the proposed exclusion, as discussed further below.
                        <SU>85</SU>
                        <FTREF/>
                         Further, it was unnecessary to extend the comment period with an accompanying notice of the risks the CFPB believes market participants pose to consumers because, as explained in the Proposed Rule and discussed below, the CFPB is not required to make findings about relative risks in a market to justify issuing (or proposing) a larger participant rule. Finally, the CFPB notes that the Proposed Rule set a January 8, 2024, deadline for filing of comments, about two months after the rule was issued on November 7, 2023, and 52 calendar days after its November 17, 2023, publication in the 
                        <E T="04">Federal Register</E>
                        . Commenters had well over 30 days to prepare comments even accounting for the end-of-year holiday season.
                        <SU>86</SU>
                        <FTREF/>
                         Indeed, several of the requests for an extension cited their own substantive comments on the Proposed Rule as the reasons for requesting an extension. For these reasons, the CFPB also disagrees with the industry comment suggesting that the lack of extension of the comment period supports a conclusion that the CFPB should withdraw the Proposed Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>85</SU>
                             With respect to the proposed coverage of digital assets, commenters from the digital asset sector provided extensive and detailed comments, demonstrating that those commenters were able to provide meaningful input on the Proposed Rule during the comment period. In any event, as discussed below, the CFPB has decided, for purposes of this Final Rule, not to define larger participants in the general-use digital consumer payment applications market by reference to activity involving digital assets.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>86</SU>
                             The extensive comments in the rulemaking record demonstrate that the presence of Federal holidays (Veteran's Day after issuance of the proposal and Thanksgiving, Christmas, and New Years after publication in the 
                            <E T="04">Federal Register</E>
                            ) and a concurrent proposal and ongoing market monitoring in this market did not preclude commenters from offering detailed substantive comments. In any event, the CFPB sent the market-monitoring inquiries to a limited number of firms and issued the parallel proposal (which, unlike this rulemaking, proposed substantive consumer protections) almost three weeks earlier with a 60-day comment period.
                        </P>
                    </FTNT>
                    <PRTPAGE P="99593"/>
                    <HD SOURCE="HD3">Establishing CFPB Supervisory Authority Over the Large and Growing Market</HD>
                    <P>
                        As described above, commenters agreed with the findings in the Proposed Rule that the market has grown rapidly to achieve a significant size with high levels of adoption and broad reliance by consumers on general-use digital consumer payment applications. As the proposal explained in detail, the market for general-use digital consumer payment applications has large and increasing significance to the everyday financial lives of consumers, who are growing increasingly reliant on such applications to initiate payments.
                        <SU>87</SU>
                        <FTREF/>
                         Further growth can be anticipated.
                        <SU>88</SU>
                        <FTREF/>
                         For example, as the proposal stated, nonbank digital payment applications have rapidly grown in the past few years to become the most popular way to send money to other individuals other than cash, and are used for a higher number of such transactions than cash.
                        <SU>89</SU>
                        <FTREF/>
                         The proposal also cited various market research publications indicating that most merchants in the United States accept general-use digital consumer payment applications as a means or method of payment. Given the extent of consumer adoption and reliance, the extent of the consumer payment transaction volume (approximately 13.5 billion annually) and value (approximately $1.2 trillion annually), and the breadth of associated consumer data collected, it is important for the CFPB to establish Federal supervisory oversight of larger participants.
                    </P>
                    <FTNT>
                        <P>
                            <SU>87</SU>
                             
                            <E T="03">See</E>
                             88 FR 80197 at 80200-80201.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>88</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>89</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        The CFPB also has considered the industry association commenter's observation that the market for general-use digital consumer payment applications as defined in the Proposed Rule may not have reached the maturity stage in the industry lifecycle. The CFPB acknowledges that, compared to the markets covered by previous larger participant rulemakings,
                        <SU>90</SU>
                        <FTREF/>
                         this market has developed more recently, fueled by technological change. In the years after a large nonbank financial technology firm developed the first well-known digital payment app in the late 1990s,
                        <SU>91</SU>
                        <FTREF/>
                         other large fintech firms including BigTech firms 
                        <SU>92</SU>
                        <FTREF/>
                         entered and expanded the market by leveraging new digital consumer technologies, such as smartphones that support digital applications (which proliferated starting in the late 2000s) 
                        <SU>93</SU>
                        <FTREF/>
                         and smartphone near-field communication (NFC) technologies that support in-store payments (which proliferated in the 2010s).
                        <SU>94</SU>
                        <FTREF/>
                         More recently, well-known market participants have been bundling consumer financial products and services to help consumers to make payments to friends and family and payments to merchants together in the same digital application. Although the market is newer than some other consumer finance markets, consumer adoption for these types of consumer payment transactions already has reached very high levels. As described in the Proposed Rule and explained above, general-use digital consumer payment applications already play a fundamental role in facilitating the payments that many consumers in the United States make every day. Therefore, the CFPB believes it is an appropriate time for it to issue a rule to establish the authority of the CFPB to supervise larger participants in this market. The CFPB reaches that conclusion in the Final Rule not solely due to the size of the market and its growth, but in conjunction with its goals described below of promoting compliance with Federal consumer financial law, detecting and assessing risks to consumers and markets, and ensuring consistent enforcement of Federal consumer financial law.
                    </P>
                    <FTNT>
                        <P>
                            <SU>90</SU>
                             Following significant growth in the 1980s, by 1990, personal remittances from the United States had reached over US$10 billion. 
                            <E T="03">See</E>
                             World Bank Group, 
                            <E T="03">Personal remittances, paid (current US$)—United States, https://data.worldbank.org/indicator/BM.TRF.PWKR.CD.DT?locations=US</E>
                             (last visited Nov. 5, 2024). Nearly two decades earlier, consumer reporting agencies and consumer debt collection markets had already grown to the point that Congress adopted substantive consumer protection legislation to regulate them. 
                            <E T="03">See</E>
                             Public Law 91-508 (Oct. 26, 1970) (title VI adopting Fair Credit Reporting Act); Public Law 95-109 (Sept. 20, 1977) (Title VIII adopting Fair Debt Collection Practices Act). By that time, following adoption of the Higher Education Act of 1965, Public Law 89-329 (Nov. 8, 1965), student lending and student loan servicing had already been expanding. And largescale consumer automobile financing dates back to at least the 1920s. 
                            <E T="03">See Buy Now Pay Later: A History of Personal Credit,</E>
                             Harv. Bus. School Library (section titled “Cards on time” noting that “[i]n the 1920s, auto financing took a giant leap forward when the car manufacturers entered the game”), 
                            <E T="03">https://www.library.hbs.edu/hc/credit/credit4d.html</E>
                             (last visited Nov. 5, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>91</SU>
                             PayPal Editorial Staff, 
                            <E T="03">Alternative and digital payment methods: Shaping the payment industry and preparing for the future</E>
                             (Dec. 18, 2023) (stating that “[t]he first digital solution in the alternative payment industry was PayPal, developed in 1998 to enable people to make payments via an email address”), 
                            <E T="03">https://www.paypal.com/us/brc/article/alternative-payment-method-trends</E>
                             (last visited Nov. 5, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>92</SU>
                             Consistent with its use by the Financial Stability Board, the Final Rule uses the term “BigTech” to refer to large technology companies with extensive customer networks. 
                            <E T="03">See, e.g.,</E>
                             Financial Stability Board Report P091219-1, 
                            <E T="03">BigTech in finance—Market developments and potential financial stability implications</E>
                             (Dec. 9, 2019) at 3 (“BigTech firms are large technology companies with extensive established customer networks. Some BigTech firms use their platforms to facilitate provision of financial services. Those that do so can be seen as a subset of FinTech firms—a broader class of technology firms (many of which are smaller than BigTech firms) that offer financial services.”), 
                            <E T="03">https://www.fsb.org/wp-content/uploads/P091219-1.pdf</E>
                             (last visited Nov. 5, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>93</SU>
                             Apple Press Release, 
                            <E T="03">Apple Reinvents the Phone with iPhone</E>
                             (Jan. 9, 2007), 
                            <E T="03">https://www.apple.com/newsroom/2007/01/09Apple-Reinvents-the-Phone-with-iPhone/</E>
                             (last visited Nov. 5, 2024); Michael DeGusta, 
                            <E T="03">Are Smart Phones Spreading Faster than Any Technology in Human History?</E>
                             MIT Technology Review (May 9, 2012) (citing data that smart phones, which represented only six percent of U.S. mobile phone sales as of 2006, had grown to a two-thirds share as of 2012, with use by nearly 40 percent of the U.S. population), 
                            <E T="03">https://www.technologyreview.com/2012/05/09/186160/are-smart-phones-spreading-faster-than-any-technology-in-human-history/</E>
                             (last visited Nov. 5, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>94</SU>
                             
                            <E T="03">CFPB Contactless Payments Spotlight, supra.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Promoting Compliance With Federal Consumer Financial Law</HD>
                    <P>
                        As described in the proposal, supervision of larger participants in a market for general-use digital consumer payment applications will help ensure those companies are complying with applicable requirements of Federal consumer financial law.
                        <SU>95</SU>
                        <FTREF/>
                         One of the primary purposes of supervision under CFPA section 1024(b)(1) is “assessing compliance with the requirements of Federal consumer financial law,” and the Final Rule will further the CFPB's ability to assess compliance by larger participants with the requirements of those laws.
                        <SU>96</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>95</SU>
                             88 FR 80197 at 80201, 80212.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>96</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5514(b)(1)(A).
                        </P>
                    </FTNT>
                    <P>
                        As identified by several commenters and described further above, the larger participants defined in the Rule engage in activities that are subject to applicable Federal consumer financial law such as the prohibition against unfair, deceptive, and abusive acts and practices set forth in the CFPA; the EFTA and its implementing Regulation E; and the data privacy protections of the GLBA and its implementing Regulation P. The CFPB disagrees with the comments suggesting that certain larger participants would not be subject to any Federal consumer financial laws.
                        <SU>97</SU>
                        <FTREF/>
                         The larger participants defined by the rule are covered persons under the CFPA and would at a minimum be subject to the CFPA's prohibition against unfair, deceptive, and abusive acts and practices.
                        <SU>98</SU>
                        <FTREF/>
                         Assessing 
                        <PRTPAGE P="99594"/>
                        compliance with the prohibition against unfair, deceptive, and abusive acts and practices is itself important, because such practices can cause significant harm to consumers.
                        <SU>99</SU>
                        <FTREF/>
                         Many of these commenters also acknowledged that some of the other Federal consumer financial laws would apply to at least a subset of the larger participants defined by the Proposed Rule.
                        <SU>100</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>97</SU>
                             As discussed further below, the CFPB disagrees with industry commenter suggestions that pass-through payment wallets are excluded from the scope of the CFPA as “electronic conduit services.”
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>98</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5481(5) (defining the term “covered person”), 5531 (applying prohibition against unfair, deceptive, and abusive acts and 
                            <PRTPAGE/>
                            practices to all “covered persons” as well as other persons), 5536 (same). The CFPB also can supervise larger participants for other Federal consumer financial laws that apply, including laws that take effect or for which compliance is mandatory in the future. For example, the CFPB recently finalized a personal financial data rights rule under its CFPA authority that is part of Federal consumer financial law and that generally applies to market participants. CFPB, Final Rule, Required Rulemaking on Personal Financial Data Rights, 89 FR 90838 (Nov. 18, 2024) (CFPB Personal Financial Data Rights Rule). As another example, the CFPB's nonbank registration regulation imposes requirements on covered nonbanks related to the registration of covered orders including, for covered nonbanks that are supervised registered entities, written-statement requirements. 
                            <E T="03">See</E>
                             12 CFR 1092.201(q), 1092.204.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>99</SU>
                             For example, under the CFPA, an unfair act or practice must cause or be likely to cause “substantial injury” to consumers. 12 U.S.C. 5531(c)(1); 
                            <E T="03">see also, e.g., Supervisory Highlights Issue 18, Winter 2019</E>
                             at 13-14 sec. 3.1.2, 
                            <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_supervisory-highlights_issue-18_032019.pdf</E>
                             (last visited Nov. 13, 2024) (noting that CFPB supervisory activities resulted in or supported the public enforcement action resolved in 2019 by consent order 
                            <E T="03">In re: Enova International, Inc.,</E>
                             Admin. Proc. File No. 2019-BCFP-0003 (Jan. 25, 2019) ¶¶ 9-33 (describing unfair acts and practices including repeat debiting of consumer accounts without valid authorization), 
                            <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_enova-international_consent-order_2019-01.pdf</E>
                             (last visited Nov. 13, 2024); 
                            <E T="03">Supervisory Highlights Issue 21, Winter 2020</E>
                             at 16 sec. 4.1 (noting that CFPB supervisory activities resulted in or supported the public enforcement action resolved in 2019 against Maxitransfers Corporation including deceptive acts and practices in statements in terms and conditions regarding company's responsibility for errors by their agents), 
                            <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_supervisory-highlights_issue-21_2020-02.pdf</E>
                             (last visited Nov. 13, 2024); 
                            <E T="03">Issue 32, Spring 2024, supra,</E>
                             at 14 sec. 4.1 (noting that CFPB supervisory activities resulted in or supported the public enforcement action resolved in 2023 against Toyota Motor Credit Corporation finding several unfair acts and practices).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>100</SU>
                             For a discussion of comments suggesting that the market should be confined to entities that receive or hold the funds being transferred in consumer payment transactions, or that the market should cover consumer payment transactions that transfer funds from nonbank accounts but not from bank accounts, see the section-by-section discussion below of Final Rule § 1090.109(a)(2) regarding the term “consumer payment functionality.”
                        </P>
                    </FTNT>
                    <P>
                        The CFPB agrees with the commenters that stated that this rule will help the CFPB to ensure compliance with Federal consumer financial laws, and disagrees with those that stated that it would not. The CFPB's supervisory authority will promote compliance with applicable legal requirements in multiple ways. As described in the proposal, under the CFPA, the CFPB shall use its supervisory authority to “assess[ ] compliance with the requirements” of Federal consumer financial laws 
                        <SU>101</SU>
                        <FTREF/>
                         and to “obtain[ ] information about the activities and compliance systems of procedures” of market participants.
                        <SU>102</SU>
                        <FTREF/>
                         The CFPB may review the entity's activities and compliance systems or procedures and issue supervisory findings or criticisms as appropriate.
                        <SU>103</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>101</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5514(b)(1)(A).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>102</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5514(b)(1)(B).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>103</SU>
                             See also discussion below regarding 12 U.S.C. 5514(b)(1)(C) in connection with the use of CFPB supervisory authority for the purpose of “detecting and assessing risks to consumers and markets for consumer financial products and services,” including the CFPB's use of its authority under the Final Rule to better understand how the Federal consumer financial laws apply to larger participants defined by the rule and the products and services they offer and to review and mitigate risks related to noncompliance.
                        </P>
                    </FTNT>
                    <P>
                        Supervision is one of the CFPB's most important and powerful tools to protect consumers by promoting compliance with Federal consumer financial law. As discussed in the proposal and as a nonprofit commenter emphasized, the prospect of the CFPB exercising supervisory authority over such firms may cause them to allocate additional resources and attention to compliance and to take steps to mitigate any noncompliance.
                        <SU>104</SU>
                        <FTREF/>
                         In addition, based on the CFPB's supervisory experience in other markets, the CFPB's supervisory activities authorized under the Final Rule are likely to help entities to identify issues before they become systemic or cause significant harm. Through its supervisory activity, the CFPB detects and addresses legal violations. In some instances, the CFPB uses enforcement actions to address violations that it originally identified through supervision. The CFPB also uses supervision to help ensure that supervised entities develop and maintain systems and procedures to prevent and remedy violations. CFPB supervisory reviews and related compliance ratings promote the development of compliance risk management practices designed to manage consumer compliance risk, support compliance, and prevent consumer harm.
                        <SU>105</SU>
                        <FTREF/>
                         Through supervision, CFPB examiners may articulate supervisory expectations to supervised larger participants in connection with supervisory events.
                        <SU>106</SU>
                        <FTREF/>
                         The CFPB also notes that, following the issuance of its five prior larger participant rules, it has successfully used its supervisory authority to detect violations and promote compliance in each of the markets covered by those rules, as the CFPB has documented in its periodic publication 
                        <E T="03">Supervisory Highlights.</E>
                        <SU>107</SU>
                        <FTREF/>
                         Thus, the CFPB disagrees with comments criticizing the proposal's statement that CFPB supervision will help to ensure that larger participants are complying with applicable requirements of Federal consumer financial law.
                        <SU>108</SU>
                        <FTREF/>
                         Moreover, by authorizing the CFPB to supervise larger participants, the Rule will promote strong compliance risk management practices in this market.
                        <SU>109</SU>
                        <FTREF/>
                         The CFPB also disagrees with commenters stating that CFPB supervision generally harms 
                        <PRTPAGE P="99595"/>
                        consumers by reducing the resources available to those companies. Instead, CFPB supervision as provided under the rule will, as intended by Congress, promote compliance with Federal consumer financial law and otherwise facilitate the CFPB's statutory objectives. For the reasons discussed above, the CFPB concludes that the rule will help the CFPB to promote compliance with Federal consumer financial law in the market. That, in turn, will reduce risks of harm to consumers, as also discussed in the impacts analysis in part VII below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>104</SU>
                             
                            <E T="03">See</E>
                             88 FR 80197 at 80211-12.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>105</SU>
                             
                            <E T="03">See, e.g., Federal Financial Institutions Examination Council, Uniform Interagency Consumer Compliance Rating System,</E>
                             81 FR 79473, 79474 (Nov. 14, 2016) (discussing assessment by agency examiners of consumer compliance), 
                            <E T="03">https://www.ffiec.gov/press/pr110716.htm</E>
                             (last visited Nov. 5, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>106</SU>
                             
                            <E T="03">See</E>
                             CFPB, 
                            <E T="03">Bulletin 2021-01: Changes to Types of Supervisory Communications</E>
                             (Mar. 31, 2021), 
                            <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_bulletin_2021-01_changes-to-types-of-supervisory-communications_2021-03.pdf</E>
                             (last visited Nov. 5, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>107</SU>
                             The CFPB publishes 
                            <E T="03">Supervisory Highlights</E>
                             on its website several times each year at 
                            <E T="03">https://www.consumerfinance.gov/compliance/supervisory-highlights/</E>
                             (last visited Nov. 5, 2024). Since its first larger participant rules took effect in late 2012 and early 2013, these publications have highlighted findings of violations of Federal consumer financial law and compliance management weaknesses from examinations in markets subject to its larger participant rules. 
                            <E T="03">See, e.g., Issue 4, Spring 2014</E>
                             at 8-10 (consumer reporting market), at 11-14 (consumer debt collection market); 
                            <E T="03">Issue 10, Winter 2016</E>
                             at 11-14 (international money transfer market). For the most recent examples, 
                            <E T="03">see, e.g., Issue 35, Fall 2024</E>
                             (automobile finance market); 
                            <E T="03">Issue 34, Summer 2024</E>
                             (consumer debt collection market); 
                            <E T="03">Issue 32, Spring 2024</E>
                             at 4-7 (consumer reporting market); 
                            <E T="03">Issue 31, Fall 2023</E>
                             at 13-14 (international money transfer market); 
                            <E T="03">Issue 30, Summer 2023</E>
                             at 4-8 (automobile financing market), at 8-9 (consumer reporting market), at 12-13 (consumer debt collection market), at 29-30 (international money transfer market); 
                            <E T="03">Issue 29, Winter 2023</E>
                             at 14-15 (student loan servicing market); 
                            <E T="03">Issue 28, Fall 2022</E>
                             at 4-7 (automobile financing market), at 7-8 (consumer reporting market), at 16-17 (consumer debt collection market); 
                            <E T="03">Issue 27, Fall 2022</E>
                             at 14-25 (student loan servicing market); 
                            <E T="03">Issue 26, Spring 2022</E>
                             at 5-11 (consumer reporting market), at 14-16 (consumer debt collection market), at 22-25 (international money transfer market), at 25-27 (student loan servicing market).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>108</SU>
                             
                            <E T="03">See</E>
                             88 FR 80197 at 80201. Further, the CFPB disagrees that it is required to make findings of noncompliance in the market in order to issue this rule, for generally the same reasons (discussed below) that it is not required to make findings regarding the level of risk in the market or market failure.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>109</SU>
                             For example, as discussed in the impacts analysis further below in part VII, entities may improve their compliance management either in response to the possibility of an examination or in response to an examination finding regarding compliance management weaknesses. 
                            <E T="03">See also CFPB Supervision and Examination Manual,</E>
                             part II.A (describing how CFPB examinations conduct compliance management reviews).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Detecting and Assessing Risks to Consumers and Markets, Including Emerging Risks</HD>
                    <P>The CFPB concludes that this rule will help the CFPB to detect and assess risks to consumers and markets from the provision of general-use digital consumer payment applications. As explained in the Proposed Rule and for the reasons elaborated further below, the CFPB agrees with comments suggesting that CFPB supervision of larger participants in this rapidly-growing and evolving market will be especially useful to the detection and assessment of emerging risks. As discussed below, the CFPB disagrees with the commenters that stated that the CFPB must first make a risk determination before establishing supervisory authority over larger participants by rule.</P>
                    <P>The CFPB concludes that establishing its supervisory authority over larger participants in this market would help it to detect and assess emerging risks for several reasons.</P>
                    <P>
                        First, the CFPB shares the view of the group of State attorneys general and other commenters that this highly-concentrated market will continue to grow and evolve rapidly as the technology that has fueled its rapid growth also continues to evolve. As with other markets the CFPB now supervises, it is important for the CFPB to be able to closely assess whether pressure to sustain high growth in this market will drive nonbank firms to develop new and increasingly risky products.
                        <SU>110</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>110</SU>
                             
                            <E T="03">Cf.</E>
                             Financial Crisis Inquiry Commission Report (Feb. 25, 2011) at 104 (“The refinancing boom was over, but originators still needed mortgages to sell to the Street. They needed new products that, as prices kept rising, could make expensive homes more affordable to still-eager borrowers. The solution was risker, more aggressive, mortgage products that brought higher yields for investors but correspondingly greater risks for borrowers.”), at 414 (also noting that “high-risk, nontraditional mortgage lending by nonbank lenders flourished in the 2000s and did tremendous damage in an ineffectively regulated environment, contributing to the financial crisis”), 
                            <E T="03">https://www.govinfo.gov/content/pkg/GPO-FCIC/pdf/GPO-FCIC.pdf</E>
                             (last visited Nov. 6, 2024).
                        </P>
                    </FTNT>
                    <P>
                        In addition, the CFPB agrees with the comments expecting that the market will continue to grow, including by expanding how general-use digital consumer payment applications help consumers to make payments in other ways. As the proposal explained, it is critical for the CFPB to be able to detect and assess emerging risks as new product offerings blur the traditional lines of banking and commerce.
                        <SU>111</SU>
                        <FTREF/>
                         This blurring was noted by several commenters that described a trend toward “embedded finance” described above and is illustrated in industry comments discussed below describing various ways that nonbanks' general-use digital payment applications serve as intermediaries between consumers and merchants.
                        <SU>112</SU>
                        <FTREF/>
                         Such applications also can facilitate payments from many different types of accounts consumers hold across multiple financial institutions. Supervision can detect and assess risks that may arise from a single application establishing connections that can cause payments to be made from many different consumer accounts.
                        <SU>113</SU>
                        <FTREF/>
                         In addition, as noted in the industry report cited by a consumer group commenter, consumers also can use payment functionalities embedded in digital applications, such as text messages, to make payments, including peer-to-peer payments.
                        <SU>114</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>111</SU>
                             For example, the proposal noted how in its 2022 market-monitoring report on the convergence of payments and commerce, the CFPB described the potential for consumer financial data and behavioral data to be used together in increasingly novel ways. 88 FR 80197 at 80201 and n.43.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>112</SU>
                             
                            <E T="03">See</E>
                             section-by-section analysis of § 1090.109(a)(1) and of “covered payment functionality” in 1090.109(a)(2). 
                            <E T="03">See also Google LLC Embedded Finance White Paper</E>
                             at 7 (“Embedded finance also offers a bonus for financial services companies: The data you collect from each transaction can help enhance customer service experience and innovate new products and experiences. The possibilities are endless for these kinds of partnerships, with high revenue and business growth potential. Before embarking on the embedded finance journey, however, you'll need to prepare” by, among other steps, “[p]lan[ning] to manage and analyze the vast trove of data you'll be collecting.”); CFPB 
                            <E T="03">Report on Convergence of Payments and Commerce, supra,</E>
                             at sec. 3.3 (“Embedded commerce”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>113</SU>
                             Today, a general-use digital consumer payment application can initiate payments from multiple credit cards, prepaid accounts, and checking accounts. A general-use digital consumer payment application can facilitate payments from accounts that the provider offers through depository institution partners, or from linked accounts issued by other institutions (sometimes referred to as pass-through payments).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>114</SU>
                             
                            <E T="03">Google LLC Embedded Finance White Paper</E>
                             at 3; Apple Cash website (“Send and Receive Money in Messages. With Apple Cash, you can send and receive money with just a text, in Messages. So it's easy to tip your dog walker, request funds from your roommate, or chip in for a coworker's gift.”), 
                            <E T="03">https://www.apple.com/apple-cash/</E>
                             (last visited Nov. 6, 2024).
                        </P>
                    </FTNT>
                    <P>
                        The CFPB also agrees with the group of State attorneys general that new risks may emerge as the relevant technologies in this market evolve. In this market, by using its supervisory activity as general-use digital consumer payment applications incorporate new technology, the CFPB can inform its assessment of risks to consumers and to markets.
                        <SU>115</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>115</SU>
                             In the CFPB's experience, for some financial institutions, even the rollout of relatively conventional digital technologies can pose significant risks to consumers, including in the area of digital payments. 
                            <E T="03">Cf.</E>
                             CFPB, 
                            <E T="03">In re: VyStar Credit Union,</E>
                             Admin Proc. File No. 2024-CFPB-0013 (Oct. 31, 2024), ¶ 20 (describing how outage in the establishment of a new online banking platform of large credit union left consumers unable to engage in certain banking activities, and that “[s]ome members' previously scheduled recurring payments were delayed or even deleted.”), 
                            <E T="03">https://files.consumerfinance.gov/f/documents/cfpb-vystar-credit-union-consent-order_2024-10.pdf</E>
                             (last visited Nov. 16, 2024).
                        </P>
                    </FTNT>
                    <P>
                        Supervision can be effective at detecting and assessing such risks. As a nonprofit commenter noted, supervision allows for rapid exchange of information outside of the adversarial legal process. The supervisory process also generally is confidential, which also facilitates the exchange of information.
                        <SU>116</SU>
                        <FTREF/>
                         For example, when examiners conduct a compliance management review, they can assess the strength of larger participants' compliance management as applied to the development and marketing of new products.
                        <SU>117</SU>
                        <FTREF/>
                         In addition, as illustrated by its work during the COVID-19 pandemic, examiners who are familiar with supervised entities can review activities across a market to identify emerging risks of consumer harm in a time of macroeconomic stress or 
                        <PRTPAGE P="99596"/>
                        shock.
                        <SU>118</SU>
                        <FTREF/>
                         As another example, through its supervisory tool, the CFPB can respond rapidly to reports of any widespread outages at larger participants by gathering information through an established supervisory relationship.
                        <SU>119</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>116</SU>
                             The CFPB treats CFPB confidential supervisory information consistent with applicable regulation; see 12 CFR part 1070. As noted above, even when Supervision highlights its findings to the public through 
                            <E T="03">Supervisory Highlights,</E>
                             it generally does not identify individual firms (outside of highlighting any associated enforcement actions).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>117</SU>
                             
                            <E T="03">See, e.g., CFPB Supervision and Examination Manual,</E>
                             part I.A (page 6 of compliance management review section explaining how examiners' compliance management review includes a review of the “processes for development and implementation of new consumer financial products or services and distribution channels or strategies, to determine degree of compliance function participation.”); 
                            <E T="03">see also id.</E>
                             at 4-5 (describing how examiners review product development as a component of the review of board and management oversight of compliance); 
                            <E T="03">id.</E>
                             at 9 (review of training of staff responsible for product development); 
                            <E T="03">id.</E>
                             at UDAAP Examination Procedures at 2 (review of product development documentation in connection with examiner's assessment of compliance with the prohibition against unfair, deceptive, and abusive practices).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>118</SU>
                             
                            <E T="03">See, e.g.,</E>
                             CFPB, 
                            <E T="03">Prioritized Assessment FAQs</E>
                             (July 20, 2020) at 1 (“The Bureau is adapting its supervision program to meet the needs of the current national emergency . . . . Through Prioritized Assessments, the Bureau will expand its supervisory oversight to cover a greater number of institutions than our typical examination schedule allows, gain a greater understanding of industry responses to pandemic-related challenges, and help ensure that entities are attentive to practices that may result in consumer harm.”), 
                            <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_prioritized-assessment_frequently-asked-questions.pdf</E>
                             (last visited Nov. 7, 2024); 
                            <E T="03">Supervisory Highlights Issue 23, Jan. 2021</E>
                             (secs. 3.3, 3.5, and 3.6 of COVID-19 special edition describing supervisory observations in prioritized assessments in student loan servicing, consumer reporting, and consumer debt collection markets subject to larger participant rules), 
                            <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_supervisory-highlights_issue-23_2021-01.pdf</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>119</SU>
                             
                            <E T="03">See</E>
                             CFPB, 
                            <E T="03">What happens if my payment app has an outage and I can't access my account?</E>
                             (Dec. 21, 2023) (describing consumer complaints as one way the CFPB collects information about outages at payment apps), 
                            <E T="03">https://www.consumerfinance.gov/ask-cfpb/what-happens-if-my-payment-app-has-an-outage-and-i-cant-access-my-account-en-2145/</E>
                             (last visited Nov. 8, 2024); FEDS Notes, 
                            <E T="03">Offline Payments: Implications for Reliability and Resiliency in Digital Payment Systems</E>
                             (Aug. 16, 2024) (describing how “several recent high-profile outages have highlighted the need for building more reliability and resiliency in digital payment systems”), 
                            <E T="03">https://www.federalreserve.gov/econres/notes/feds-notes/offline-payments-implications-for-reliability-and-resiliency-in-digital-payment-systems-20240816.html</E>
                             (last visited Nov. 8, 2024).
                        </P>
                    </FTNT>
                    <P>
                        Supervision of larger participants in this market also can identify new and emerging risks to consumers relating to the applicability of existing requirements of Federal consumer financial law to new products. For example, comments from consumer groups and State attorneys general suggested that non-compliance with EFTA/Regulation E and GLBA/Regulation P is common in this market, while some industry commenters stated that neither EFTA/Regulation E nor GLBA/Regulation P apply to at least some market participants. Other commenters described how some consumers may be confused about the legal protections afforded through certain payment apps. The CFPB does not define the application of those laws in this rulemaking. Through its supervisory activity, the CFPB can gather information to assess the applicability of those laws to the specific consumer financial products and services that a larger participant provides. Where the law applies and is violated, examiners can address the situation through supervisory action and where appropriate the CFPB can consider enforcement activity. In addition, such findings can help to inform what the CFPB communicates to the broader market, including through its 
                        <E T="03">Supervisory Highlights</E>
                         publication.
                    </P>
                    <P>
                        The CFPB disagrees with certain comments, summarized further above, that suggested that in a larger participant rule the CFPB is required to assess the degree or prevalence of risks to consumers, potential violations of law, or other specific harms occurring in the described market. The relevant provisions of the CFPA do not impose such requirements. While some comments did not identify any legal basis for this alleged obligation, others asserted that the obligation arises from section 1024(b)(2), which concerns the CFPB's operation of a “risk-based supervision program.” The CFPB believes that these comments misinterpret the scope and purpose of section 1024(b)(2). As the CFPB has previously explained,
                        <SU>120</SU>
                        <FTREF/>
                         that provision describes the manner in which the CFPB must “exercise its authority under paragraph [(b)](1)” 
                        <SU>121</SU>
                        <FTREF/>
                         which in turn authorizes the CFPB to supervise “persons described in subsection (a)(1).” The Final Rule does not exercise authority provided by section 1024(b)(1). Rather, it “describe[s],” in part, a set of persons falling within section 1024(a)(1), by defining a category of “larger participant[s].” The CFPB only exercises the authority set forth in section 1024(b)(1) when it actually requires reports or conducts examinations of such persons. In exercising authority under section 1024(b)(1), the CFPB considers (and for larger participants under this Final Rule will consider) the factors set forth in section 1024(b)(2), including risks to consumers, as further described above in part I's discussion of the CFPB's prioritization process. However, the CFPA does not mandate consideration of those factors when issuing a rule that defines a category of larger participants under paragraph (a)(1).
                        <SU>122</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>120</SU>
                             
                            <E T="03">See</E>
                             77 FR 42874 at 42883; 77 FR 65775 at 65779.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>121</SU>
                             12 U.S.C. 5514(b)(2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>122</SU>
                             This conclusion is reinforced by the immediately following subsection of the CFPA, 1024(a)(1)(C), which expressly references the consideration of risk. Under that provision, the CFPB has the authority to supervise any nonbank covered person that the CFPB “has reasonable cause to determine, by order, after notice . . . and a reasonable opportunity . . . to respond . . . is engaging, or has engaged, in conduct that poses 
                            <E T="03">risks to consumers</E>
                             with regard to the offering or provision of consumer financial products or services.” 12 U.S.C. 5514(a)(1)(C) (emphasis added).
                        </P>
                    </FTNT>
                    <P>
                        As noted above, one industry comment further argued that general principles of administrative law require the CFPB to identify concrete risks to consumers that will be mitigated by supervision in order to issue this rule. The commenter suggested that the Proposed Rule should have specified in detail what kind of compliance improvements the CFPB envisions, what activities of particular entities are currently non-compliant, why compliance will prevent particular risks to consumers, the likelihood of such risks occurring, the resulting harm to consumers, and how all of these issues compare to related markets. Elsewhere this Final Rule discusses the CFPB's statutory authority, reasons, and supporting evidence for issuing this Final Rule and explains how this Final Rule will help the CFPB to effectuate the statutory purposes of the CFPA. The CFPB disagrees that it was additionally required to consider in this rulemaking the kinds of detailed information about mitigation of concrete risks contemplated by the commenter. As explained above, there is no indication in the text of the CFPA that the CFPB is required to consider such information in issuing a larger participant rule.
                        <SU>123</SU>
                        <FTREF/>
                         Because the CFPB's risk-based prioritization process considers the type of information about risks described in part I above, the CFPB's supervision of larger participants ultimately may assist the CFPB in detecting and assessing risks to consumers and to markets.
                        <SU>124</SU>
                        <FTREF/>
                         But sections 1024(a)(1)(B) and (2) do not require the CFPB to reach conclusions regarding such matters before it can even initiate risk-based prioritization for a category of larger participants.
                    </P>
                    <FTNT>
                        <P>
                            <SU>123</SU>
                             With respect to cross-market comparisons of risk, as explained in the Proposed Rule and in its previous larger participant rulemakings, “[t]he Bureau need not conclude before issuing a [larger participant rule] that the market identified in the rule has a higher rate of non-compliance, poses a greater risk to consumers, or is in some other sense more important to supervise than other markets.” 88 FR 80197 at 80200 n.24; 77 FR 65775 at 65779.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>124</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5514(b)(1)(C).
                        </P>
                    </FTNT>
                    <P>
                        To the extent the industry commenter suggests the CFPB should consider such information because it asserts its own type of digital wallet product is “low risk” and should therefore be excluded from the market and ineligible for CFPB supervision, the CFPB does not believe that it is required to categorically exempt allegedly “low-risk” products within a market when issuing a rule to define larger participants of a market.
                        <FTREF/>
                        <SU>125</SU>
                          
                        <PRTPAGE P="99597"/>
                        The CFPB likewise disagrees with other commenters who suggested that the CFPB is obligated to undertake a separate risk assessment of various subcomponents or sectors of the described market, or to include only the riskiest subcomponents or sectors within the larger participant definition. CFPA section 1024(a)(1)(B) provides for the issuance of rules defining “larger participant[s] of a market” for consumer financial products or services, and contains no language requiring exemptions for allegedly “low-risk” subcomponents of a market. Consistent with CFPA section 1024(b)(2), the CFPB considers whether products are lower risk, and thus less of a priority for supervisory attention, when choosing particular entities and consumer financial products and services for supervisory examinations as part of its operation of its risk-based supervision program.
                        <SU>126</SU>
                        <FTREF/>
                         The CFPB's operation of that risk-based supervision program is designed to prevent CFPB's supervision program from placing undue burdens on larger participants whose activities are genuinely lower risk. The CFPB also provides below further justification for the scope of the market described in this Final Rule, including regarding the inclusion of pass-through payment wallets in the market.
                        <SU>127</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>125</SU>
                             Nor has the CFPB determined in this rulemaking exercising CFPA section 1024(a)(1)(B) authority that any specific market participant or larger participant poses any particular type or level of risk, low or otherwise, to consumers. Thus, 
                            <PRTPAGE/>
                            although this commenter made claims regarding its product having low risk including low risk of violation of the prohibition against unfair, deceptive, and abusive acts and practices, the CFPB does not adjudicate such claims in this legislative rulemaking, for the reasons described above. In any event, the CFPB disagrees that the commenter was prevented from presenting evidence regarding the risks posed by its products. It had notice of the CFPB's reasons for the proposal and commented on them.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>126</SU>
                             As described above, the CFPB Supervision and Examination Manual describes the CFPB's established process for conducting risk-based prioritization of nonbank covered persons subject to its supervisory authority under CFPA section 1024(a).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>127</SU>
                             
                            <E T="03">See</E>
                             section-by-section analysis of § 1090.109(a)(2) (definition of “wallet functionality”).
                        </P>
                    </FTNT>
                    <P>
                        The CFPB disagrees with the industry commenter suggesting that the CFPB may issue a rule to define larger participants of a market for consumer products or services only in cases of “market failure.” There is no support for this view in the text or legislative history of the CFPA. Moreover, while concerns about market failure often underlie laws and regulations imposing substantive consumer protection requirements,
                        <SU>128</SU>
                        <FTREF/>
                         this Final Rule does not impose substantive requirements and instead concerns the scope of the CFPB's supervisory authority, which is an authority designed to accomplish the statutory purposes established under CFPA section 1024(b)(1)(A)-(C). In that context, there is little reason to read section 1024(a)(1)(B) to impliedly bar the issuance of a larger participant rule in the absence of a demonstrated market failure.
                    </P>
                    <FTNT>
                        <P>
                            <SU>128</SU>
                             
                            <E T="03">See, e.g.,</E>
                             12 U.S.C. 4301(a) (Congressional finding in Truth in Savings Act that “competition between depository institutions would be improved . . . if there was uniformity in the disclosure of terms and conditions on which interest is paid and fees are assessed in connection with such accounts.”); 15 U.S.C. 1601(a) (Congressional finding in Truth in Lending Act that “competition among the various financial institutions and other firms engaged in the extension of consumer credit would be strengthened by the informed use of credit.”).
                        </P>
                    </FTNT>
                    <P>
                        Although the CFPB disagrees with the comments suggesting that it must make findings regarding risk to issue this larger participant rule and it does not do so here, as discussed above other commenters described various existing and emerging risks to consumers that may be associated with products and services provided by larger participants. Those comments raise legitimate concerns regarding potential risks to consumers in the market and thus provide further support for the CFPB's conclusion that this rule will help the CFPB to use its supervisory tool to detect and assess risks to consumers and the market. It is not necessary for this rule to adjudicate the nature, extent, or source of such risks, or for the CFPB to publish market-wide findings about such risks as a predicate for larger participant rulemakings. As discussed above, the CFPB incorporates information available to it about such risks (including from its market-monitoring function, among others) when prioritizing which nonbank covered persons subject to CFPA section 1024(a) it will examine.
                        <SU>129</SU>
                        <FTREF/>
                         In response to the nonprofit calling on the CFPB to describe in more detail the risks it would consider in prioritizing larger participants for examination in this market, part I of the Final Rule above explains in further detail the CFPB's prioritization process and the factors the CFPB considers as part of that process, consistent with the CFPA and as described in its Supervision and Examination Manual. The CFPB also expects that it will continue to periodically publish 
                        <E T="03">Supervisory Highlights</E>
                         to communicate key examination findings and risks identified over time on a market-by-market basis.
                    </P>
                    <FTNT>
                        <P>
                            <SU>129</SU>
                             The CFPB also provides additional responses further below to the comments suggesting it must publish the results of its market monitoring, or establish why its supervisory tool is superior to its market-monitoring tool. In any event, the CFPB has used data from its market-monitoring orders to inform the estimates published in this Final Rule, as discussed in the section-by-section analysis of the larger-participant test further below.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Ensuring Consistent Enforcement of Federal Consumer Financial Law</HD>
                    <P>
                        With regard to comments on whether the Proposed Rule would further the CFPB's statutory objective of ensuring that Federal consumer financial law is enforced consistently between nonbanks and depository institutions in order to promote fair competition,
                        <SU>130</SU>
                        <FTREF/>
                         the CFPB agrees with commenters who stated that the Proposed Rule would further that objective by permitting the CFPB to supervise both banks and nonbanks operating in the general-use digital consumer payment application market and by reducing the competitive advantage nonbanks may derive from being subject to less supervisory oversight. The CFPB disagrees with the commenter that characterized the Proposed Rule as a form of “mission creep . . . outside [the CFPB's] core jurisdiction.” The commenter did not address the CFPA's statutory objective of consistent enforcement of Federal consumer financial law without regard to an entity's status as a depository institution. In addition, the CFPB already has enforcement and rulemaking authority with respect to participants in the market; thus, those entities already fall within the CFPB's “jurisdiction” in significant ways.
                        <SU>131</SU>
                        <FTREF/>
                         The CFPB also disagrees with a related comment that described the larger participant rule as placing the CFPB in a market gatekeeper role. That comment appeared to misunderstand the function of larger participant rules, which do not regulate who enters a market but instead identify “larger participants” for purposes of section 1024(a)(1)(B). In addition, the CFPB disagrees with some commenters' suggestion that the rule should not be issued because of their concerns about the rule potentially making nonbanks less competitive and frustrating their innovation. As discussed below, the Final Rule adopts a significantly higher threshold, resulting in fewer market participants qualifying as larger participants. Even 
                        <PRTPAGE P="99598"/>
                        with respect to larger participants, the CFPB does not have evidence to indicate that the Final Rule is likely to significantly affect innovation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>130</SU>
                             12 U.S.C. 5511(b)(4).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>131</SU>
                             The CFPB also disagrees with the industry comment suggesting that the Proposed Rule failed to account for the role of the FTC in promoting competition. As the Proposed Rule explained, it is focused on the statutory objective (codified in 12 U.S.C. 5511(b)(4)) of ensuring Federal consumer financial law “is enforced consistently, without regard to the status of a person as a depository institution, in order to promote fair competition[.]” 88 FR 80197 at 80198 n.5. The CFPB can promote consistent enforcement of Federal consumer financial law without impeding the FTC's mission; the two are compatible, and the CFPB coordinates with the FTC regarding its supervision activities more broadly.
                        </P>
                    </FTNT>
                    <P>
                        The CFPB also disagrees with those industry comments stating that the Proposed Rule would not promote consistent enforcement of Federal consumer financial law and fair competition because the proposed market definition included pass-through payment wallets that banks do not provide. Banks and credit unions can and do provide payment wallet functionalities. For example, very large depository institutions offer payment wallet functionalities that facilitate consumers' payments from accounts at the depository institution to make purchases online and in stores.
                        <SU>132</SU>
                        <FTREF/>
                         In addition, these comments appear to presuppose that the CFPB can only further the statutory objective of consistent enforcement in this rule if banks and nonbanks compete to offer precisely the same products in precisely the same manner to consumers. But the objective of consistent enforcement can also be furthered where the CFPB has the ability to supervise both nonbanks and depository institutions that play complementary roles in payment transactions. For example, when a depository institution subject to the CFPB's supervisory authority makes its accounts accessible to the consumer through a general-use digital consumer payment application provided by an unaffiliated nonbank, supervision of both the depository institution and the nonbank serves the statutory objective described above. Nonbanks may initiate payments from consumer accounts held at banks and credit unions and engage in a number of related activities that can implicate Federal consumer financial law compliance obligations.
                        <SU>133</SU>
                        <FTREF/>
                         In addition, the CFPB agrees with the credit union association commenter that unaffiliated payment applications can cause burdens on credit unions related to error resolution and customer service. Where the CFPB can supervise both a nonbank pass-through payment wallet and a depository institution involved in payments transactions, it is better positioned to consistently enforce applicable legal obligations with respect to the two entities. Below in the section-by-section analysis of “wallet functionality,” this Final Rule further discusses the reasons why pass-through payment wallets are appropriately included in the market definition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>132</SU>
                             For example, an industry association commenter pointed to a new digital wallet called Paze and a click-to-pay product offered by banks. 
                            <E T="03">See also, e,g.,</E>
                             Early Warning Services, LLC, Press Release, 
                            <E T="03">Paze Hits Major Milestone: 125 million Credit and Debit Cardholders Can Check out Online</E>
                             (Oct. 1, 2024) (describing “Paze, a reimagined digital wallet offered by banks and credit unions,” as available for use with 125 million payment card accounts issued by seven very large banks), 
                            <E T="03">https://www.paze.com/paze-hits-major-milestone-125-million-credit-and-debit-cardholders-can-check-out-online</E>
                             (last visited Nov. 7, 2024); 
                            <E T="03">Click to Pay with American Express</E>
                             (describing how depository institution offers an ecommerce payment wallet), 
                            <E T="03">https://network.americanexpress.com/globalnetwork/v4/products/click-to-pay-with-american-express</E>
                             (last visited Nov. 7, 2024). 
                            <E T="03">See also CFPB Contactless Payments Spotlight, supra</E>
                             (n.59 describing how JPMorgan previously provided the Chase Pay app to facilitate consumer payments for retail purchases).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>133</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Board of Gov. of Fed. Rsv. System, FDIC, OCC, 
                            <E T="03">Joint Statement on Banks' Arrangements with Third Parties to Deliver Bank Deposit Products and Services</E>
                             (July 25, 2024) at 1 (noting how under certain bank/fintech arrangements, “banks rely on one or multiple third parties to . . . process payments (sometimes with the ability to directly submit payment instructions to payment networks); perform regulatory compliance functions; provide end-user facing technology applications; service accounts; perform customer service; and perform complaint and dispute resolution functions”), 
                            <E T="03">https://www.occ.gov/news-issuances/news-releases/2024/nr-ia-2024-85a.pdf</E>
                             (last visited Nov. 7, 2024). 
                            <E T="03">See id.</E>
                             at 1-3 (describing how deployment of new digital payment technologies create a potential for insufficient risk management to meet consumer protection obligations such as requirements under Regulation E to investigate and resolve certain payment disputes within required timeframes).
                        </P>
                    </FTNT>
                    <P>
                        Finally, the CFPB disagrees with the industry association commenter to the extent it was suggesting that larger participant rules cannot promote fair competition between banks and nonbanks unless they apply antitrust principles to define the market. For the reasons discussed below in the section-by-section analysis of the market definition in § 1090.109(a)(1), the purpose of antitrust law is different from the purpose of larger participant rules and the CFPB does not apply antitrust law in this rule. Nonetheless, as explained above, banks, credit unions, and their affiliates can offer and provide covered payment functionalities with general use through digital applications. In this rulemaking, the CFPB shares the goals expressed by the banking association and payment network commenters of applying consistent functional oversight to similar functional activities in this market. And as explained below in the section-by-section analysis of the market definition, the activities encompassed by the market definition are similar in how they support, digitally, a common set of payment activities that consumers engage in, such as making everyday payments to friends and family and for purchases. Relatedly, the CFPB disagrees with the industry association commenter to the extent it was suggesting that, by not including physical payment cards in the market, the Final Rule will not promote consistent enforcement of Federal consumer financial law. For the reasons discussed in the section-by-section analysis further below, the CFPB concludes the “digital application” component of the market definition is appropriate. The CFPB already has broad supervisory oversight of the use of physical payment cards issued by the very large banks and credit unions that it supervises. However, there is a supervisory gap over the significant role that nonbank larger participants play in facilitating the use of payment cards through general-use digital consumer payment applications. As described above, consumer adoption of general-use digital consumer payment applications is very high, indicating that consumers often prefer them to physical cards. Indeed, in some cases, such as at the time of origination or card replacement, a nonbank's general-use digital consumer payment application may be the only way for the consumer to use the payment card.
                        <SU>134</SU>
                        <FTREF/>
                         The Final Rule will fill this gap, which will promote consistent enforcement of Federal consumer financial law.
                        <SU>135</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>134</SU>
                             PULSE, 
                            <E T="03">PULSE Debit Issuer Study</E>
                             (Aug. 8, 2024) at 9-10 (reporting that all surveyed issuers report provisioning debit cards to digital wallets, that 38 percent of debit cards are loaded into digital wallets, and that digital issuance of debit cards directly to such wallets is the top new capability that debit card issuers plan to introduce with 50 percent of issuers planning to add this service), 
                            <E T="03">https://content.pulsenetwork.com/2024-debit-issuer-study/2024-pulse-debit-issuer-study</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>135</SU>
                             With respect to what the commenter referred to as food delivery applications and automobile purchase applications, for the reasons discussed in the section-by-section analysis of the exclusion for certain merchant and marketplace payment activities in paragraph (C) of the definition of “consumer payment transaction,” the CFPB believes those are part of a distinct market.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Other Regulators' Existing Oversight Authority</HD>
                    <P>
                        With regard to comments on existing oversight of market participants, the CFPB agrees with the comment from the group of State attorneys general that stated that the rule would help existing regulatory oversight efforts in the market and would allow for increased coordination between Federal and State authorities to prevent unlawful conduct. The Bureau agrees that the existing regulatory oversight framework governing general-use digital consumer payment applications is important, but the Bureau believes that establishing its supervisory authority as part of this framework would better promote compliance with and consistent enforcement of Federal consumer 
                        <PRTPAGE P="99599"/>
                        financial law and help it to detect risks to consumers and the market. The CFPB disagrees with the industry association comment suggesting that the CFPB must determine whether the market covered by the rule is inadequately supervised before issuing a larger participant rule; no such requirement appears in the text of the CFPA.
                        <SU>136</SU>
                        <FTREF/>
                         The CFPB accounts for existing oversight when evaluating how to exercise its supervisory authority pursuant to CFPA section 1024(b)(2). Specifically, the CFPB takes seriously its inter-governmental coordination obligations, described below, and believes that they will promote coordination and minimize regulatory burden in connection with the CFPB's exercise of its supervisory authority over larger participants in this market and the existing regulatory oversight structure at the Federal and State levels.
                    </P>
                    <FTNT>
                        <P>
                            <SU>136</SU>
                             
                            <E T="03">See, e.g.,</E>
                             12 U.S.C. 5514(a)(1)(B), (a)(2).
                        </P>
                    </FTNT>
                    <P>
                        For example, as required by the CFPA and explained in the Proposed Rule, the CFPB coordinates its examination activity, including at nonbanks, with State regulators.
                        <SU>137</SU>
                        <FTREF/>
                         One purpose of this coordination is to prevent duplication and unnecessary regulatory burden. That coordination will address commenter concerns regarding CFPB oversight of larger participants that may engage in market activity that is subject to State money transmitter laws. In addition, industry comments often recognized that providers of pass-through payment wallets that do not hold or receive funds generally are not engaged in money transmission under State laws, and thus are not subject to State-level supervision.
                    </P>
                    <FTNT>
                        <P>
                            <SU>137</SU>
                             88 FR 80197 at 80198 n.12. 
                            <E T="03">See also</E>
                             12 U.S.C. 5514(b)(2)(D) (CFPB shall exercise its supervisory authority under 12 U.S.C. 5514(b)(1) in a manner designed to ensure that such exercise takes into consideration, among other things, the extent to which supervised nonbanks are subject to oversight by State authorities for consumer protection); 12 U.S.C. 5514(b)(3) (CFPB coordination of supervisory activities with States); Int'l Money Transfer Larger Participant Rule, 79 FR 56631 at 56632, 56638, 56643 (explaining how the Bureau will coordinate with appropriate State regulatory authorities and will consider the extent of State supervisory activity when prioritizing individual examinations.); 2013 CFPB-State Supervisory Coordination Framework (May 7, 2013) (describing process for CFPB-State coordination under information-sharing memorandum of understanding), 
                            <E T="03">https://files.consumerfinance.gov/f/201305_cfpb_state-supervisory-coordination-framework.pdf</E>
                             (last visited Nov. 8, 2024).
                        </P>
                    </FTNT>
                    <P>
                        The CFPB also disagrees with industry comments suggesting that this rule establishing CFPB authority to supervise larger participants in this market will create CFPB supervisory activities that are unnecessarily duplicative or burdensome vis-à-vis oversight activities by the FTC and prudential regulators. Congress has adopted mechanisms to prevent unnecessarily duplicative or burdensome CFPB supervisory activities in cases where the FTC may exercise enforcement authority or prudential regulators may exercise supervisory authority over larger participants.
                        <SU>138</SU>
                        <FTREF/>
                         Among other things, the CFPB coordinates across its functions with the FTC, which does not have a supervisory tool.
                        <SU>139</SU>
                        <FTREF/>
                         In addition, the CFPA provides that the CFPB has exclusive authority with respect to the prudential regulators to supervise larger participants for purposes of assuring compliance with Federal consumer financial law.
                        <SU>140</SU>
                        <FTREF/>
                         Also, consistent with the requirements of CFPA section 1024(b)(3), the CFPB coordinates with prudential regulators to minimize the duplication and regulatory burden of supervisory activity pursuant to memoranda of understanding, including where appropriate at nonbank larger participants.
                        <SU>141</SU>
                        <FTREF/>
                         Moreover, as discussed above, nonbank larger participants engage in substantial volumes of market activity with interconnection across the U.S. financial system. CFPB supervision of nonbank larger participants can assess compliance with the requirements of Federal consumer financial law across their various market activities, which involve interactions with banks and credit unions overseen by various Federal prudential regulators. Thus, CFPB oversight of larger participants can ensure consistent enforcement of Federal consumer financial law and complement the oversight of the Federal prudential regulators.
                    </P>
                    <FTNT>
                        <P>
                            <SU>138</SU>
                             Such supervisory authority may exist, for example, where (as noted by the industry commenter) prudential regulators may examine certain nonbank service providers to banks under authorities such as the Bank Service Company Act. 
                            <E T="03">See generally</E>
                             12 U.S.C. 1861-67.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>139</SU>
                             The CFPB coordinates with the FTC consistent with its obligations under the CFPA, including 12 U.S.C. 5514(c)(3) and 5581(b)(5). 
                            <E T="03">See</E>
                             CFPB-FTC Memorandum of Understanding (Feb. 25, 2019) (section VII describing how CFPB coordinates its supervision and examination activities with the FTC), 
                            <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_ftc_memo-of-understanding_2019-02.pdf</E>
                             (last visited Nov. 8, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>140</SU>
                             12 U.S.C. 5514(c), (d) (describing the extent to which CFPB supervisory and enforcement authorities are exclusive with respect to nonbank covered persons described in CFPA section 1024(a)(1)). 
                            <E T="03">See also</E>
                             CFPA section 1025(b)(1) (similarly providing that the CFPB has exclusive authority to supervise very large depository institutions and their affiliates for the purposes listed therein, including assessing compliance with the requirements of Federal consumer financial laws).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>141</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5514(b)(3) (“To minimize regulatory burden, the Bureau shall coordinate its supervisory activities with the supervisory activities conducted by prudential regulators . . . including establishing their respective schedules for examining persons described in subsection (a)(1) [of CFPA section 1024] and requirements regarding reports to be submitted by such persons.”). 
                            <E T="03">See, e.g.,</E>
                             CFPB, Board of Gov. of Fed. Rsv. System, FDIC, NCUA, and OCC Memorandum of Understanding (MOU) on Supervisory Coordination (May 16, 2012) at 2 (noting how CFPA sections 1024(b)(3)-(4) and 1025(b)(2) require the CFPB to “coordinate its supervisory activities with the supervisory activities conducted by the Prudential Regulators, including consultation regarding their respective schedules for examining Covered Institutions and requirements regarding reports to be submitted by Covered Institutions.”), 
                            <E T="03">https://files.consumerfinance.gov/f/201206_CFPB_MOU_Supervisory_Coordination.pdf</E>
                             (last visited Nov. 7, 2024); 
                            <E T="03">see also id.</E>
                             (listing objectives of the MOU, including “[a]void[ing] unnecessary duplication of effort” and “[m]inimiz[ing] unnecessary regulatory burden”); 
                            <E T="03">id.</E>
                             at 8 (“The CFPB and Prudential Regulators will coordinate in connection with examinations that relate to Covered Supervisory Activities of Covered Institutions' Service providers”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">CFPB's Existing Enforcement and Market-Monitoring Authorities</HD>
                    <P>
                        The CFPB disagrees with those industry commenters suggesting that it cannot use its larger participant rulemaking authority to establish supervisory authority in this market due to the existence of the CFPB's enforcement and market-monitoring authorities. The CFPA identifies supervision of nonbank covered persons under CFPA section 1024 as a primary function of the CFPB.
                        <SU>142</SU>
                        <FTREF/>
                         Sections 1024(a)(1)(B) and (2) of the CFPA specifically empower the CFPB to prescribe larger participant rules for the purpose of authorizing CFPB supervision, and those provisions contain no requirement that a larger participant rule consider the adequacy of the CFPB's other authorities or functions.
                        <SU>143</SU>
                        <FTREF/>
                         Given the statutory scheme in the CFPA, any larger participant rule will generally apply to nonbank covered persons that also are subject to the CFPB's market-monitoring and enforcement authorities. These comments thus appear to reflect, in large part, a policy disagreement with Congress's decision to give the CFPB the ability to supervise nonbank larger participants of markets for consumer financial products and services it defines by rule in addition to its other authorities.
                    </P>
                    <FTNT>
                        <P>
                            <SU>142</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5511(c)(4) (listing supervision of covered persons, including nonbank covered persons, as one of the CFPB's “primary functions”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>143</SU>
                             By contrast, in allocating its supervisory resources under CFPA section 1024(b)(2) the CFPB considers, among other things, “the extent to which such institutions are subject to oversight by State authorities for consumer protection.” 12 U.S.C. 5514(b)(2)(D).
                        </P>
                    </FTNT>
                    <P>
                        Further, as the Proposed Rule noted and as also discussed above, supervision can serve an important function that is distinct from and complementary to enforcement and 
                        <PRTPAGE P="99600"/>
                        market monitoring.
                        <SU>144</SU>
                        <FTREF/>
                         For example, supervision can benefit consumers and providers by detecting compliance problems early, at a point when correcting the problems would be relatively inexpensive and before many (or many more) consumers have been harmed.
                        <SU>145</SU>
                        <FTREF/>
                         In addition, the CFPB conducts its supervisory activities not only for the purposes of assessing compliance with the requirements of Federal consumer financial law, but also for purposes of obtaining information about the person's activities and compliance systems or procedures and detecting and assessing risks to consumers and markets. These latter two purposes of its supervisory activities generally are distinct from its enforcement activities, which focus on addressing violations of Federal consumer financial law.
                        <SU>146</SU>
                        <FTREF/>
                         In addition to promoting compliance in their own right, those activities also help to inform CFPB decisions regarding when to initiate enforcement activity. Similarly, CFPB supervisory and examination activity at individual firms can inform how the CFPB conducts market-wide monitoring. The CFPB's market monitoring function also can support decisions about when to initiate supervisory activity. For example, under CFPA section 1022(c)(1), the CFPB may use its market monitoring to support its functions, including to inform its prioritization of its nonbank supervision examination activities at larger participants.
                        <SU>147</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>144</SU>
                             88 FR 80197 at 80212-13.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>145</SU>
                             
                            <E T="03">See also</E>
                             CFPB Supervision Director, 
                            <E T="03">What new supervised institutions need to know about working with the CFPB</E>
                             (Jan. 9, 2023) (“Supervisory activities may help entities identify issues before they become systemic or cause significant harm.”), 
                            <E T="03">https://www.consumerfinance.gov/about-us/blog/what-new-supervised-institutions-need-to-know-about-working-with-the-cfpb/</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>146</SU>
                             12 U.S.C. 5511(c)(4).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>147</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5512(c)(1).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">The Final Rule Does Not Implicate the “Major Questions” Doctrine</HD>
                    <P>
                        The CFPB disagrees with comments stating that the Rule implicates the “major questions” doctrine, which is reserved for “extraordinary cases” in which the “history and the breadth of the authority that the agency has asserted” and the vast “economic and political significance” of the assertion of authority by the agency “provide a reason to hesitate before concluding that Congress meant to confer such authority.” 
                        <SU>148</SU>
                        <FTREF/>
                         As noted above, the Final Rule does not impose any new substantive consumer protection requirements on larger participants. Because general-use digital consumer payment applications are consumer financial products and services as defined in the CFPA,
                        <SU>149</SU>
                        <FTREF/>
                         the CFPB already has enforcement authority, market-monitoring authority, and rulemaking authority with respect to nonbank covered persons participating in the market for general-use digital consumer payment applications. Whether or not the CFPB may exercise one additional form of authority—supervision—over a group of larger participants in that market is not a question of vast economic and political significance in the sense recognized by courts.
                        <SU>150</SU>
                        <FTREF/>
                         In this regard, the CFPB notes that one nonprofit commenter confuses the overall dollar value of transactions through digital wallets (which the commentator estimates at almost $1 trillion) with the economic impact of this larger participant rulemaking, which is of course vastly smaller.
                        <SU>151</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>148</SU>
                             
                            <E T="03">W. Virginia</E>
                             v. 
                            <E T="03">EPA,</E>
                             597 U.S. 697, 721 (2022) (cleaned up).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>149</SU>
                             
                            <E T="03">See</E>
                             nn.241-42 
                            <E T="03">infra</E>
                             (noting explanation in Proposed Rule, 88 FR 80197 at 80205 nn.64-65).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>150</SU>
                             
                            <E T="03">Cf., e.g., Biden</E>
                             v. 
                            <E T="03">Nebraska,</E>
                             143 S. Ct. 2355, 2373-74 (2023) (citing an estimate that the agency's action would “cost taxpayers between `$469 billion and $519 billion' ” and that it implicated a “matter of earnest and profound debate across the country”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>151</SU>
                             Similarly, the CFPB's statements in press materials cited by the commenter do not suggest that this rulemaking would have a vast economic impact. The costs and benefits of this rulemaking are further discussed below. The CFPB also disagrees with the commenter that section 1024(a)(1)(B) would need to refer specifically to “digital wallets” to authorize this rulemaking. By that logic, there could be no larger participant rulemakings because section 1024(a)(1)(B) refers to markets for “other consumer financial products or services” without expressly identifying particular consumer financial products and services.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">CFPB Examinations of Larger Participants</HD>
                    <P>
                        With respect to comments on the statement in the Proposed Rule noting that the CFPB's supervisory authority is not limited to the consumer financial products or services that qualified a person for supervision, the CFPB clarifies it is not relying on that position as a rationale for the Final Rule or as authority for issuing the Final Rule, and that the CFPB would finalize the market definition, market-related definitions, and larger-participant test as currently formulated in this Final Rule irrespective of the existence of that position.
                        <SU>152</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>152</SU>
                             Nonetheless, the CFPB notes that it explained the basis for this interpretation in its first larger participant rulemaking, for the consumer reporting market, where it noted that the “Dodd-Frank Act authorizes the Bureau to supervise `covered person[s]' described in 12 U.S.C. 5514(a)(1)(A) through (E)[ ]” and that supervision of certain other activities of such persons “is consistent with the purposes that the Dodd-Frank Act sets out for the Bureau's supervisory activities” set forth in 12 U.S.C. 5514(b)(1). 
                            <E T="03">See</E>
                             77 FR 42874 at 42880; 
                            <E T="03">see also</E>
                             12 U.S.C. 5514(a)(1)(B) (providing that “this section shall apply to any covered person” that is a nonbank “larger participant of a market for other consumer financial products or services” as defined by rule); 12 U.S.C. 5514(b)(1) (providing that “[t]he Bureau shall require reports and conduct examinations on a periodic basis of persons described in [12 U.S.C. 5514(a)(1)] for” certain listed purposes). The CFPB disagrees with certain commenters' suggestion that the reference to “relevant product markets and geographic markets” in the provision describing the operation of the CFPB's risk-based supervision program (12 U.S.C. 5514(b)(2)) was intended to impliedly limit the scope of the CFPB's supervisory authority under 12 U.S.C. 5514(a)(1) and (b)(1) to only the consumer financial products and services described in the larger participant rule. The CFPB also disagrees that this interpretation implicates the major questions doctrine for reasons discussed above in the CFPB's response to other comments about that doctrine.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">109(a)(1) Market Definition—Providing a General-Use Digital Consumer Payment Application</HD>
                    <HD SOURCE="HD3">Proposed Rule</HD>
                    <P>
                        Proposed § 1090.109(a)(1) would have described the market for consumer financial products or services covered by the Proposed Rule as encompassing “providing a general-use digital consumer payment application.” The term would have been defined as providing a covered payment functionality through a digital application for consumers' general use in making consumer payment transaction(s). This term incorporated other terms defined in proposed § 1090.109(a)(2): “consumer payment transaction(s),” “covered payment functionality,” “digital application,” and “general use.” The term “covered payment functionality” would have included a “funds transfer functionality” and a “wallet functionality,” terms which proposed § 1090.109(a)(2) also would have defined.
                        <SU>153</SU>
                        <FTREF/>
                         The Proposed Rule sought comment on all aspects of the proposed market definition, including whether the market definition in proposed § 1090.109(a)(1) or the market-related definitions in proposed § 1090.109(a)(2), discussed in the section-by-section analysis below, should be expanded, narrowed, or otherwise modified.
                    </P>
                    <FTNT>
                        <P>
                            <SU>153</SU>
                             The term “consumer payment transaction(s)” also would have incorporated another term—“State,” which proposed § 1090.109(a)(2) would have defined.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Comments Received</HD>
                    <P>
                        Several commenters addressed the proposed market definition overall. The Final Rule summarizes those comments in this section-by-section analysis of the market definition in § 1090.109(a)(1). In addition, some comments addressed certain specific defined terms used in the market definition or called for 
                        <PRTPAGE P="99601"/>
                        certain exclusions or additions to the market by modifying those defined terms. The Final Rule summarizes and responds to those comments in the section-by-section analysis of the market-related definitions in § 1090.109(a)(2) below.
                    </P>
                    <P>As discussed above, some commenters expressed support for the Proposed Rule to establish supervisory authority over the market that includes funds transfer apps and wallet functionalities with general use that nonbank covered persons provide to consumers through digital applications. For example, as described above, a group of State attorneys general stated that the CFPB's supervisory oversight of larger participants in this market would help to promote compliance with Federal consumer financial law and to detect and assess risks posed by this emerging financial market and market participants. Banking and credit union associations, as well as a payment network and nonprofit, also supported CFPB supervisory oversight of larger participants in the proposed market, as described in the summary of general comments above. As also described above, consumer group comments also were supportive of the scope of the market activities defined in the Proposed Rule, while calling for certain scope expansions, as discussed further below. In addition, an industry association expressed general support for the proposal to define a market that allows the CFPB to oversee entities with varied business models.</P>
                    <P>
                        Other commenters disagreed with the approach to market definition in the Proposed Rule. For example, some industry commenters stated that larger participant rules must apply antitrust law market definition principles because, in their view, the statutory provision in CFPA section 1024(a)(1)(B) authorizing CFPB rules to define larger participants of “a market” incorporates those principles. Some of these commenters did not provide a legal basis for this view. Others, such as three industry trade associations, cited Congress' use of the phrase “relevant product markets” in an adjacent provision, CFPA section 1024(b)(2), and suggested that the term “market” in section 1024(a)(1)(B) is implicitly limited by the phrase “relevant product market.” 
                        <SU>154</SU>
                        <FTREF/>
                         They further suggested that the terms “market” and “relevant product market” should be understood to incorporate antitrust case law discussing the boundaries of a market for purposes of evaluating the viability of an antitrust claim, including cases holding that a group of products are in the same market under antitrust law if they are reasonably interchangeable by consumers for the same purposes.
                        <SU>155</SU>
                        <FTREF/>
                         Two of these industry associations also stated that Congress included the requirement in CFPA section 1024(a)(2) that the CFPB consult with the FTC prior to issuing a larger participant rule because of the FTC's role in enforcing Federal antitrust laws.
                        <SU>156</SU>
                        <FTREF/>
                         These commenters therefore concluded that a larger participant rule must define “a market” that qualifies as a “relevant product market” within the meaning of antitrust law.
                        <SU>157</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>154</SU>
                             Section 1024(b)(2) calls for the CFPB to exercise its authority in CFPA section 1024(b)(1) to require reports and examinations of nonbank covered persons described in CFPA section 1024(a)(1) “in a manner designed to ensure that such exercise . . . is based on the assessment by the Bureau of the risks posed to consumers in the relevant product markets and geographic markets,” and taking into consideration certain factors further specified in CFPA section 1024(b)(2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>155</SU>
                             
                            <E T="03">See, e.g., United States</E>
                             v. 
                            <E T="03">E.I. du Pont de Nemours &amp; Co.,</E>
                             351 U.S. 377, 395 (1956). One commenter also cited a European regulation in support of its position.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>156</SU>
                             The summary and response to comments regarding the FTC consultation process is included in part IV above.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>157</SU>
                             Two of the industry associations also indicated that the Proposed Rule did not do so because antitrust law market definition requires examining the factors that influence consumer choices, and the Proposed Rule did not discuss those factors.
                        </P>
                    </FTNT>
                    <P>
                        Those commenters and several other comments from industry, nonprofits, and Members of Congress also disagreed with the proposed market on the grounds that it was overbroad, conflating several markets into one. For example, a comment from Members of Congress stated that in their view, the proposal sought to cover different markets such as peer-to-peer services, stored value accounts, neobanking, merchant payment processing, and payment credential management.
                        <SU>158</SU>
                        <FTREF/>
                         In addition, some industry associations stated that the proposed market would not qualify as a valid market because it groups together four different types of activities that, in their view, are not economic substitutes. They stated that these activities function in different ways and meet different needs and use cases. They described four of these activities as follows: (1) drawing from a stored balance held by the company; (2) routing funds held in a third-party bank account for transmission to a recipient; (3) charging or offering a payment method for consumer purchases in a manner that is excluded from State money transmitter regulations; 
                        <SU>159</SU>
                        <FTREF/>
                         and (4) storing and transmitting payment credentials without participating in the flow of funds from the consumer to the recipient. They also stated that digital applications for person-to-person transfers and digital applications for processing payments for merchants are different and present different risks of consumer harm. Because these activities in their view constitute separate markets, they stated that the Proposed Rule deviated without justification from previous larger participant rules that did not encompass multiple markets.
                        <SU>160</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>158</SU>
                             However, as discussed above, the market is not based on providing a stored value account. And as discussed below under “covered payment functionality,” the market definition generally does not apply to merchant payment processors.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>159</SU>
                             They added that State money transmitter regulation excludes this activity because, in their view, the activity poses low risks.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>160</SU>
                             As an example, they cited the international money transfer larger participant rule in which the CFPB declined to include the domestic money transfer market.
                        </P>
                    </FTNT>
                    <P>
                        More broadly, an industry association also stated that the market includes “P2P” and digital wallet functionalities that, in their view, are not reasonably interchangeable because they provide “similar” but “differentiated” services to consumers. Another industry association stated that consumers rely on funds transfer functionalities and wallet functionalities in different ways, and that these functionalities sometimes, but not always, may be interrelated. They stated that the CFPB should do a “piecewise analysis” of these functionalities, separately analyzing how consumers rely upon them. They stated that wallet functionalities initiate funds transfers but are subject to Regulation E only when they store funds. They suggested that the Proposed Rule did not establish a purpose for including wallet functionalities in the market when they do not store funds. An industry firm and two nonprofits suggested that wallet functionalities that do not store funds instead facilitate consumers' payments for purchases from merchants by storing and transmitting payment credentials for accounts held at third-party financial institutions the CFPB already supervises. They described that activity as part of a separate market from the other payment functionalities included in the proposed market. They stated that the CFPB's proposal to include such wallet functionalities in the proposed market does not reflect the sensitivity the CFPB has shown to differences among other consumer financial products and services, such as consumer reporting, consumer debt collection, and student loan servicing, by covering them in separate larger 
                        <PRTPAGE P="99602"/>
                        participant rulemakings defining separate markets.
                        <SU>161</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>161</SU>
                             This commenter and another industry association suggested this approach was inconsistent with how a previous larger participant rule engaged in “tailor[ing]” of the rule. 78 FR 73383 at 73397. However, the quoted portion of the previous rule addressed the tailoring of the larger-participant test to the market at hand, which was not the subject of the comments described here.
                        </P>
                    </FTNT>
                    <P>A nonprofit commenter described the proposed market as being composed of multiple sectors, including the first three groups of activities listed by the industry association comments described above, as well as what they described as fully online fintech firms such as “neobanks” and money transmitters. In its view, consumers interact with these products differently and rely on them for different purposes, and each presents different consumer harms.</P>
                    <HD SOURCE="HD3">Response to Comments Received</HD>
                    <P>
                        As an initial matter, the CFPB disagrees with some industry commenters' novel suggestion that larger participant rules must define a market that would qualify as a market under antitrust law. In the CFPB's international money transfer larger participant rulemaking, large providers of international money transfers urged the CFPB to take the opposite position—
                        <E T="03">i.e.,</E>
                         to state that larger participant rules do not define “markets” for purposes of antitrust law. In response, the CFPB so clarified.
                        <SU>162</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>162</SU>
                             
                            <E T="03">See</E>
                             Comment on proposed international money transfer larger participant rule by Dolex Dollar Express, Inc., MoneyGram Payment Systems, Inc., RIA Financial Services, Sigue Corporation, and Western Union Financial Services, Inc. (April 1, 2014) (2014 Industry Comment Letter) at 5 (“[T]he term `market' for purposes of defining a larger participant should not be used in the absence of cautionary language to make clear that the term is not reflective of a Bureau determination of `market' for antitrust purposes.”), 
                            <E T="03">https://www.regulations.gov/comment/CFPB-2014-0003-0014</E>
                             (last visited Nov. 7, 2024); CFPB, Final International Money Transfer Larger Participant Rule, 79 FR 56631 at 56635 n.43 (stating in response to comment that in its larger participant rulemakings “[t]he Bureau neither defines markets for purposes of antitrust law, nor intends the market definition in this Final Rule to be used for any purpose other than determining larger-participant status”).
                        </P>
                    </FTNT>
                    <P>
                        Having carefully considered commenters' arguments, the Final Rule maintains the position announced in the international money transfer larger participant rule for several reasons. As explained below, the market definition in the Final Rule fits within a more general understanding of the term “market” reflected in CFPA section 1024(a), which does not require application of antitrust law. First, commenters have not identified any language in CFPA section 1024, or any legislative history, that expressly refers to antitrust statutes, antitrust caselaw, or antitrust concepts of a market such as substitutability and reasonable interchangeability. Instead, the commenters' argument depends on an attenuated and unpersuasive argument that (1) reads the term “market” in section 1024(a)(1)(B) as being implicitly limited by the phrase “relevant product market” in a separate provision, section 1024(b)(2); and then (2) further suggests that the phrase “relevant product market” in section 1024(b)(2) was meant to implicitly import antitrust concepts of substitutability and reasonable interchangeability into the CFPB's larger participant rulemakings under section 1024(a)(1)(B). Second, section 1024(a)(1)(B) gives authority to the CFPB to define by rule a larger participant of “a market for 
                        <E T="03">other</E>
                         consumer financial products or services[.]” 
                        <SU>163</SU>
                        <FTREF/>
                         That phrasing is meaningful because CFPA section 1024(a) enumerates, in paragraphs (A), (D), and (E) three categories of consumer financial products and services over which the CFPB has supervisory authority. Legislative history suggests that Congress understood each to be a separate “market” in a general sense.
                        <SU>164</SU>
                        <FTREF/>
                         The first category encompasses an array of different services that broadly relate to mortgage loans (the “origination, brokerage, or servicing of [mortgage] loans” and also “loan modification and foreclosures relief services in connection with such loans”).
                        <SU>165</SU>
                        <FTREF/>
                         Another category is “private education loans,” which are generally understood to be part of a broader market for educational financing that also includes Federal student loans.
                        <SU>166</SU>
                        <FTREF/>
                         The third category is “payday loans,” which are understood to compete with other types of higher-cost credit such as title loans and installment loans.
                        <SU>167</SU>
                        <FTREF/>
                         These categories thus do not describe consumer financial products and services that correspond to the strict antitrust conception of a market, which undercuts the suggestion that the term “market” in section 1024(a)(1)(B) should be understood to implicitly incorporate antitrust concepts.
                        <SU>168</SU>
                        <FTREF/>
                         Third, the purpose of defining a “relevant product market” under antitrust law is to determine whether a firm can exert monopoly power in a market and thereby profit from supra-competitive pricing.
                        <SU>169</SU>
                        <FTREF/>
                         Market power and the analysis of it generally is the domain of antitrust law, not the Federal consumer financial law over which the CFPB has authority. Commenters have not presented any persuasive reason why Congress would have wanted the terms 
                        <PRTPAGE P="99603"/>
                        “market” and “relevant product market” in section 1024 to be limited by reference to antitrust laws that the CFPB does not enforce and that do not concern the CFPB's supervisory function.
                    </P>
                    <FTNT>
                        <P>
                            <SU>163</SU>
                             12 U.S.C. 5514(a)(1)(B).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>164</SU>
                             The Senate Report to the CFPA describes the “mortgage market” that is the subject of CFPA section 1024(a)(1)(A) as “consist[ing] of more than 25,000 lenders, servicers, brokers, and loan modification firms that would be subject to Bureau supervision and enforcement.” S. Rep. 111-176 (Apr. 30, 2010) at 163.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>165</SU>
                             12 U.S.C. 5514(a)(1)(A); 
                            <E T="03">see, e.g.,</E>
                             CPFB, Final Rule, Mortgage Servicing Rules Under the Real Estate Settlement Procedures Act (Regulation X), 78 FR 10696, 10699 (Feb. 14, 2013) (providing an overview of the “mortgage servicing market” within the context of the “mortgage market” that is “broader”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>166</SU>
                             12 U.S.C. 5514(a)(1)(D); 
                            <E T="03">see, e.g.,</E>
                             CFPB, Final Rule, Defining Larger Participants of the Student Loan Servicing Market, 78 FR 73383, 73385 (Dec. 6, 2013) (“[t]he student loan servicing market is comprised of entities that service Federal and private student loans that have been disbursed to pay for post-secondary education expenses”); Kelly D. Edmiston, Lara Brooks, and Steven Shepelwich, Fed. Rsv. Bk. of Kansas City Research Working Paper 12-05, “Student Loans: Overview and Issues (Update)” (Aug. 2012 rv. Apr. 2013) at 4 (“The student loan market is made up of federal and `private' student loans. Federal student loans are those that are listed under Title IV of the Higher Education Act. Private student loans are those made by depository and non-depository financial institutions (banks) and non-profit lenders (states).”), 
                            <E T="03">https://www.kansascityfed.org/documents/5428/rwp12-05edmistonbrooksshepelwich.pdf</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>167</SU>
                             12 U.S.C. 5514(a)(1)(E); 
                            <E T="03">see, e.g.,</E>
                             CFPB, Final Rule, Payday, Vehicle Title, and Certain High-Cost Installment Loans, 82 FR 54472, 54475 (Nov. 17, 2017) (referring to payday loans as part of a “broader set of liquidity loan products that also includes certain higher-cost longer-term installment loans” that are sometimes referred to as “payday installment loans”); NCUA, Final Rule, Payday Alternative Loans, 84 FR 51942 (Oct. 1, 2019) (authorizing credit unions to originate certain higher-cost installment loans with a term of up to 12 months to compete with payday loans).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>168</SU>
                             Similarly, larger participant rulemakings only apply to nonbank covered persons, and not to insured depository institutions, insured credit unions, and certain of their affiliates that may compete with nonbanks (and that may be subject to CFPB supervision under section 1025 or certain CFPB supervisory activities described under section 1026). 
                            <E T="03">See</E>
                             12 U.S.C. 5514(a)(3)(A). If Congress had intended larger participant rulemakings to define a market for antitrust purposes, it presumably would have expressly accounted for how insured depository institutions, insured credit unions, and certain of their affiliates participate in such markets too.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>169</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Thomas G. Krattenmaker, Robert H. Lande, Steven C. Salop, 
                            <E T="03">Monopoly Power and Market Power in Antitrust Law,</E>
                             76 Geo. L.J. 241, 255 (1987) (noting that “antitrust law now requires proof of actual or likely market power or monopoly power to establish most types of antitrust violations” and “market power and market definition are closely related, because a relevant market is that group of firms that significantly constrains each other's pricing and output decisions.”), 
                            <E T="03">https://www.justice.gov/archives/atr/monopoly-power-and-market-power-antitrust-law</E>
                             (last visited Nov. 7, 2024); Louis Kaplow, 
                            <E T="03">On the Relevance of Market Power,</E>
                             130 Harv. L. Rev. 1303, 1304 n.1 &amp; 1366 (2017) (noting that “[i]t is familiar that market power is a prerequisite for most types of competition law violations[,]” listing different violations that depend on establishing market power, and noting how the “relevant market” is the frame of reference for assessing whether a firm has monopoly power for purposes of a Sherman Act violation).
                        </P>
                    </FTNT>
                    <P>
                        In addition, the CFPB disagrees with comments suggesting that the FTC consultation requirement in section 1024(a)(2) compels the conclusion that the term “market” should be interpreted by reference to antitrust law.
                        <SU>170</SU>
                        <FTREF/>
                         The commenters cite no legislative history or other evidence supporting their position, and the provision itself does not reference the FTC's competition mission or its Bureau of Competition. The FTC also has a consumer protection mission 
                        <SU>171</SU>
                        <FTREF/>
                         and it has certain overlapping authority with the CFPB over nonbanks that provide consumer financial products and services, which generally would include nonbanks that qualify for supervision as a larger participant.
                        <SU>172</SU>
                        <FTREF/>
                         Given that overlap, the CFPA includes various provisions requiring the CFPB to coordinate or consult with the FTC.
                        <SU>173</SU>
                        <FTREF/>
                         In that context, there is little reason to interpret the consultation requirement in section 1024(a)(2) as reflecting an unstated Congressional intention that the term “market” be interpreted by reference to antitrust law.
                        <SU>174</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>170</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5514(a)(2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>171</SU>
                             
                            <E T="03">See, e.g., What the FTC Does,</E>
                              
                            <E T="03">https://www.ftc.gov/news-events/media-resources/what-ftc-does</E>
                             (last visited Nov. 7, 2024) (noting “the Agency's two primary missions: protecting competition and protecting consumers”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>172</SU>
                             12 U.S.C. 5581(b)(5)(A) (transferring FTC's authority to prescribe rules under an enumerated consumer law to the CFPB, but not its enforcement authority).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>173</SU>
                             
                            <E T="03">See, e.g.,</E>
                             12 U.S.C. 5514(c)(3) (requiring CFPB and FTC agreement for coordinating on enforcement actions regarding nonbanks subject to its supervisory authority); 12 U.S.C. 5581(b)(5)(D) (requiring coordination between CFPB and FTC in certain rulemakings “that apply to a covered person or service provider with respect to the offering or provision of consumer financial products and services[.]”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>174</SU>
                             In addition, it is not necessary to define an antitrust market for the rule to help the CFPB to ensure consistent enforcement of Federal consumer financial law between nonbanks and depository institutions in order to promote fair competition. For the reasons discussed in the response to general comments above, the CFPB concludes the Final Rule would serve that purpose based on the market it defines.
                        </P>
                    </FTNT>
                    <P>More generally, the CFPB agrees with the comments that expressed support for the proposed market definition as describing a set of activities that most consumers in the United States regularly rely upon to conduct a significant portion of their everyday payments. These everyday financial transactions involve making payments to multiple unaffiliated persons, as described further below in the section-by-section analysis of the revised definition of “general use” adopted in the Final Rule. The universe of potential recipients for consumer payment transactions can vary from one general-use digital consumer payment application to another. Some peer-to-peer payment applications facilitate payments to multiple consumers. Others facilitate payments to multiple unaffiliated merchants. As discussed further below, the general trend in the market is to facilitate payments to some combination of both. That is, many of the well-known market participants bundle together different payment methods for consumers to make payments to friends, family, and merchants.</P>
                    <P>
                        Depending on the market participant and which payment method the consumer selects, the general-use digital consumer payment application provider may hold the funds used to make a payment or they may be held by a third-party financial institution. Regardless of who holds the funds used for a payment, market participants share the common activity of facilitating consumer payments transactions by providing payments data processing products and services to consumers through digital applications.
                        <SU>175</SU>
                        <FTREF/>
                         In light of these considerations, and as further discussed below, the Final Rule reasonably defines a market that comfortably fits within the parameters Congress set for markets in CFPA section 1024(a)(a)(1)(B).
                        <SU>176</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>175</SU>
                             
                            <E T="03">See also</E>
                             discussion under “covered payment functionality” of comments seeking exclusion of nonbanks providing payment services in partnership with banks. Some market activity such as that of P2P payment apps often consists of consumer financial products and services that rely upon both funds transmitting and payments data processing, while other types of market activity, such as pass-through payment wallets, may be more limited to payments data processing. As the CFPB recently explained in another rulemaking, CFPA section 1002(15)(A)(vii) encompasses activity that “extends beyond payment processing to broadly include other forms of financial data processing, including where the financial data are processed in connection with other financial or non-financial products and services.” 88 FR 74796, 74842 (Oct. 31, 2023) (proposed rule); 
                            <E T="03">see also</E>
                             89 FR 90838 at 90955 (same point in final rule). Providing payments data processing in connection with funds transmitting is simply one example of this. 
                            <E T="03">See also</E>
                             CFPA section 1002(5)(A) (defining a “consumer financial product or service” as including a financial product or service that is described in “one or more categories under” CFPA section 1002(15)).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>176</SU>
                             Contrary to the suggestion of some commenters, grouping activities that are in some ways different into a single market is not a departure from previous larger participant rulemakings. 
                            <E T="03">See</E>
                             77 FR 42874 at 42886 (consumer reporting larger participant rule concluding that “resellers, national credit repositories, specialty consumer reporting agencies, analyzers, and others engaged in consumer reporting activities as defined in the final rule are properly included in a single market” because “[t]hese different types of firms all participate in the process of preparing consumer financial information for use in decisions regarding consumer financial products or services”); 77 FR 9592 at 9598 (Feb. 17, 2012) (discussing difficulty separating business models of third-party debt collectors, debt buyers, and collection attorneys because “[s]ome third-party debt collectors also buy debt, and debt buyers may utilize in-house or third-party collectors. Similarly, collection attorneys and law firms may, in addition to representing debt owners, buy debt and collect on their own behalf.”).
                        </P>
                    </FTNT>
                    <P>
                        The CFPB disagrees with the conclusions by some industry and nonprofit commenters that the proposed market does not describe a valid “market” for purposes of CFPA section 1024(a)(1)(B).
                        <SU>177</SU>
                        <FTREF/>
                         That includes industry comments suggesting that the CFPB cannot reasonably define a single market that encompasses consumer financial products and services that facilitate digital payments with different purposes, such as payments to friends and family and payments for purchases. Similarly, the CFPB disagrees with comments suggesting that it cannot reasonably define a market that encompasses the facilitation of consumer payments using different payment methods or accounts, such as stored value accounts held with the market participant, third-party banak accounts, and payment cards issued by third party financial institutions such as debit cards and credit cards. These comments appear to rely on an unduly narrow view of the meaning of the term “market” in the CFPA, which as discussed above in response to antitrust-related comments Congress used in a more general sense. To that end, the Final Rule reasonably defines a market that comports with the range of “markets” in subsections (A), (D), and (E) of section 1024(a)(1) that Congress appears to have referenced in using the term “other markets” in section 1024(a)(1)(B).
                    </P>
                    <FTNT>
                        <P>
                            <SU>177</SU>
                             To the extent commenters criticized the proposed market as invalid based on its limitation to payment functionalities provided through “digital applications” with “general use,” the Final Rule discusses those comments in the section-by-section analysis of those defined terms below.
                        </P>
                    </FTNT>
                    <P>
                        In addition, these comments ignored or did not adequately account for how often companies provide a single general-use digital payment application with covered payment functionalities that facilitate consumer payment transactions with either purpose (to pay friends and family and to make purchases), often offering multiple payment methods for transactions with either purpose. In the CFPB's experience and expertise, informed by its market monitoring and other activities, well-known market participants increasingly provide 
                        <PRTPAGE P="99604"/>
                        general-use digital consumer payment applications that bundle together options to make payments for these different purposes and payment methods, often in a manner that appears seamless to the consumer as described below. This assessment, focusing on the commonality across market participants' activities, also is consistent with market research described in the Proposed Rule and discussed further below, and even some industry associations' own presentation of these activities in other settings.
                        <SU>178</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>178</SU>
                             This trend predates 2024. 
                            <E T="03">See, e.g.,</E>
                             Testimony of Scott Talbott, Sr. Vice President of Government Affairs, Electronic Transactions Association (ETA), House Cmttee. on Fin. Servs, Serial No. 117-82 (Apr. 28, 2022) at 52 (“Digital wallets can be defined broadly to include mobile and other online applications that allow users to process payments, access account information, and pay for services. Digital wallets provide users with access to stored payment credentials, which may include a credit or debit card, bank account, or, less commonly, a prepaid or gift card linked to the phone or app. This technology has gained popularity with consumers as a safe and convenient way to transmit funds in multiple settings, including for online purchases, payments at brick-and-mortar retailers, and person-to-business (
                            <E T="03">i.e.,</E>
                             bill pay) and P2P transfers. The concept of the digital wallet has been swiftly embraced by the public due to its ease of use. The user just has to download and register a mobile wallet on his or her phone.”), 
                            <E T="03">https://www.congress.gov/117/chrg/CHRG-117hhrg47649/CHRG-117hhrg47649.pdf</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <P>
                        Many well-known market participants bundle offerings of both peer-to-peer (P2P) and payments for purchases—sometimes in a formal and explicit manner, other times less so. Comments from several Members of Congress highlighted the degree to which sole proprietors and other small businesses rely on market participants to accept payments. While larger merchants may accept these payments by entering into formal merchant acceptance agreements, small businesses such as sole proprietors may simply enroll their bank account in a P2P payment service to receive funds from consumers.
                        <SU>179</SU>
                        <FTREF/>
                         As the Proposed Rule noted, by 2022, an industry report found that 82 percent of small business merchants surveyed accepted at least one P2P payment option.
                        <SU>180</SU>
                        <FTREF/>
                         Research by a major payment network similarly describes how small and medium businesses are paid not only through “mobile wallets” but also through “mobile payment apps.” 
                        <SU>181</SU>
                        <FTREF/>
                         Moreover, recent market research found that nearly half of U.S. consumers surveyed reported using a P2P app for purposes such as making purchases with payment cards and bill pay functions. The report concluded that “P2P apps are at an inflection point, transitioning from single-purpose apps to additional, more robust, and often-bundled product features.” 
                        <SU>182</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>179</SU>
                             One government report estimated that in tax year 2017, three P2P apps alone filed U.S. tax reports (at a reporting threshold of $20,000) disclosing nearly $200 billion in payments to businesses through those platforms. Treasury Inspector General For Tax Administration, 
                            <E T="03">The Internal Revenue Service Faces Challenges in Addressing the Growth of Peer-to-Peer Payment Application Use,</E>
                             Report No. 2021-30-022 (Apr. 22, 2021) at 6 (Figure 3), 
                            <E T="03">https://www.tigta.gov/sites/default/files/reports/2022-07/202130022fr_4.pdf</E>
                             (last visited Nov. 7, 2024). In some contexts, the bundling of the two types of payments has been so seamless that the payment apps themselves have not been able to effectively disentangle personal payments from purchases. 
                            <E T="03">See</E>
                             26 U.S.C. 6050W (“Returns relating to payments made in settlement of payment card and third party network transactions”); IR-2023-221 (Nov. 21, 2023) (describing phase-in transition years where reporting not required unless payees receive over $20,000 for more than 200 transactions in tax year 2023, and more than $5,000 for tax year 2024), 
                            <E T="03">https://www.irs.gov/newsroom/irs-announces-delay-in-form-1099-k-reporting-threshold-for-third-party-platform-payments-in-2023-plans-for-a-threshold-of-5000-for-2024-to-phase-in-implementation</E>
                             (last visited Oct. 24, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>180</SU>
                             
                            <E T="03">TSG: Merchants Offering P2P Payments</E>
                             (reporting results of TSG and Electronic Transactions Association survey of over 500 small businesses merchants), 
                            <E T="03">cited in</E>
                             Proposed Rule at n.30. For example, some of these apps began by offering only P2P payments focused on paying friends and family, but then leveraged that feature to gain formal merchant acceptance. 
                            <E T="03">See, e.g.,</E>
                             eBay, 
                            <E T="03">eBay Launches Venmo as a Payment Option, a Continued Push to Expand Ways to Pay and Invest in Digital Natives</E>
                             (June 13, 2024), 
                            <E T="03">https://www.ebayinc.com/stories/news/ebay-launches-venmo-as-a-payment-option-a-continued-push-to-expand-ways-to-pay-and-invest-in-digital-natives</E>
                             (last visited Nov. 7, 2024); James Pothen, 
                            <E T="03">Cash App exec hints at Square integration</E>
                             (June 3, 2024), 
                            <E T="03">https://www.paymentsdive.com/news/square-cash-app-pos-p2p-block-jack-dorsey-retail-point-of-sale-strategy/717753/</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>181</SU>
                             VISA Global Back to Business Study (7th ed. 2023) (describing multinational survey of plans for digital payment option acceptance by small and micro businesses (SMBs) including in the United States indicating 55 percent of SMBs planned to accept “mobile payment apps” in 2023 and 50 percent planned to accept “mobile wallets”), 
                            <E T="03">https://usa.visa.com/content/dam/VCOM/blogs/visa-back-to-business-7-one-pager-september-2023.pdf</E>
                             (last visited Nov. 7, 2024). A recent Forbes survey similarly described how both “digital wallet apps” and “[p]eer-to-peer apps” are popular ways for consumers to make retail purchases. Amanda Claypool, 
                            <E T="03">53% Of Americans Use Digital Wallets More Than Traditional Payment Methods: Poll</E>
                             (updated Aug. 25, 2023), 
                            <E T="03">https://www.forbes.com/advisor/banking/digital-wallets-payment-apps/</E>
                             (last visited Nov. 7, 2024). For example, Amazon, which provides Amazon Pay, also had a brief partnership with Venmo. 
                            <E T="03">See</E>
                             PYMNTS.COM, 
                            <E T="03">Venmo No Longer Accepted on Amazon in January</E>
                             (Dec. 7, 2023), 
                            <E T="03">https://www.pymnts.com/amazon-payments/2023/amazon-will-discontinue-venmo-payments-in-january/</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>182</SU>
                             Marqueta, 2024 State of Payments Report at 39, 
                            <E T="03">https://www.marqeta.com/state-of-payments</E>
                             (last visited Aug. 1, 2024). 
                            <E T="03">See also</E>
                             Press Release, 
                            <E T="03">Venmo Introduces the Ability to Schedule Payment Requests</E>
                             (Oct. 9, 2024) (reporting that “more than 84% of consumers have used a peer-to-peer service with common payments including monthly rent, utilities, and other regular living expenses[]” as found in a 2022 survey by Lending Tree at 
                            <E T="03">https://www.lendingtree.com/personal/peer-to-peer-services-survey/</E>
                             (last visited Nov. 7, 2024)), 
                            <E T="03">https://newsroom.paypal-corp.com/2024-10-09-Venmo-Introduces-the-Ability-to-Schedule-Payments-and-Requests</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <P>
                        Meanwhile, as suggested by comments from consumer groups, other digital wallets gained market share by offering formal merchant acceptance but then began to promote a P2P payment feature.
                        <SU>183</SU>
                        <FTREF/>
                         For example, as consumer group commenters pointed out, PayPal, which initially grew as a payment functionality for merchants selling goods and services through an affiliated company's online marketplace, has long since graduated to offering a broader range of services including peer-to-peer payments.
                        <SU>184</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>183</SU>
                             Apple, 
                            <E T="03">New features come to Apple services this fall</E>
                             (June 11, 2024) (describing new “Tap to Cash” feature that can be used with existing Apple Cash stored value product), 
                            <E T="03">https://www.apple.com/newsroom/2024/06/new-features-come-to-apple-services-this-fall/</E>
                             (last visited Nov. 7, 2024); Business Wire, 
                            <E T="03">VISA Reinvents the Card, Unveils New Products for Digital Age</E>
                             (May 15, 2024) (provider of Click-to-Pay ecommerce wallet describing new mobile device app-based feature for VISA cards “Tap to P2P (person-to-person): Allows money to be sent between family and friends”), 
                            <E T="03">https://www.businesswire.com/news/home/20240515563838/en/</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>184</SU>
                             
                            <E T="03">Compare</E>
                             PayPal, Inc. Form S-1 (Sept. 28, 2001) at 5 (“We depend on online auction transactions for a significant percentage of our payment volume.”), 
                            <E T="03">https://www.sec.gov/Archives/edgar/data/1103415/000091205701533855/a2059025zs-1.htm, with</E>
                             eBay Press Release, 
                            <E T="03">eBay Inc. Board Approves Completion of eBay and PayPal Separation</E>
                             (June 26, 2015), 
                            <E T="03">https://www.ebayinc.com/stories/news/ebay-inc-board-approves-completion-of-ebay-and-paypal-separation/</E>
                             (last visited Nov. 7, 2024) &amp; PayPal, 
                            <E T="03">Send money to just about anyone, anywhere</E>
                             (website FAQ describing how consumers can use the PayPal app to “[s]end money online to friends and family in the US”), 
                            <E T="03">https://www.paypal.com/us/digital-wallet/send-receive-money/send-money</E>
                             (last visited Nov. 7, 2024). 
                            <E T="03">See also</E>
                             PayPal Holdings, Inc. Form 10-K (Feb. 2, 2024) (PayPal 2023 10-K) at 8 (“Our Venmo digital wallet in the U.S. is a leading mobile application used to move money between our customers and to make purchases at select merchants.”), 
                            <E T="03">https://www.sec.gov/Archives/edgar/data/1633917/000163391724000024/pypl-20231231.htm.</E>
                        </P>
                    </FTNT>
                    <P>
                        In addition, the most recent Federal Government diary and survey on consumer payment choice results continue to illustrate how mobile app/online payment accounts generally are understood as supporting both “purchases and person-to-person payments[.]” 
                        <SU>185</SU>
                        <FTREF/>
                         That project groups together nonbank payment apps such as PayPal, Venmo, Apple Pay, Google Pay, Cash App, and Samsung Pay under the 
                        <PRTPAGE P="99605"/>
                        common heading “online payment accounts.” 
                        <SU>186</SU>
                        <FTREF/>
                         Other surveys, market research, and even a foreign regulator similarly refer collectively to both uses—payments to other consumers and payments for purchases.
                        <SU>187</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>185</SU>
                             Berhan Bayeh, Emily Cubides &amp; Shaun O'Brien, Fed. Rsv. Fin. Svcs. FedCash Services, 
                            <E T="03">2024 Findings from the Diary of Consumer Payment Choice</E>
                             (May 2024) (2024 Diary Findings) at 5-6 (Figure 3 grouping together “purchases and P2P payments” and describing growth in proportion made “online or remotely” versus “in-person”), 
                            <E T="03">https://www.frbservices.org/binaries/content/assets/crsocms/news/research/2024-diary-of-consumer-payment-choice.pdf</E>
                             (last visited Nov. 7, 2024). The Proposed Rule noted how the Federal Government publishes the results of an annual diary and survey on consumer payment choice. 88 FR 80197 at 80200 n.25 (citing report on 2022 diary and survey by Federal Reserve System staff).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>186</SU>
                             
                            <E T="03">2023 Survey and Diary of Consumer Payment Choice Tables</E>
                             (table 1 reporting survey results indicating that 71.8 percent of U.S. consumers adopted online payment accounts as of 2023), 
                            <E T="03">https://www.atlantafed.org/-/media/documents/banking/consumer-payments/survey-diary-consumer-payment-choice/2023/tables_dcpc2023.pdf</E>
                             (last visited Nov. 7, 2024). That survey also reported that “[s]even in 10 consumers made at least one payment using a phone or tablet in the 12 months ending October 2023.” Kevin Foster, Claire Greene &amp; Joanna Stavins, Fed. Rsv. Bk. of Atlanta Research Data Report No. 24-1, 
                            <E T="03">2023 Survey and Diary of Consumer Payment Choice: Summary Results</E>
                             (June 3, 2024) at 16-17 (“On average, 13 mobile payments per consumer were reported” for October 2023, of which “10 were for purchases, two for bills, and one to pay another person”), 
                            <E T="03">https://www.atlantafed.org/-/media/documents/banking/consumer-payments/survey-diary-consumer-payment-choice/2023/sdcpc_2023_report.pdf</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>187</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Claire Greene, Fumiko Hayashi, Alicia Lloro, Oz Shy, Joanna Stavins &amp; Ying Lei Toh, 
                            <E T="03">Defining Households That Are Underserved in Digital Payment Services,</E>
                             Fed. Rsv. Bk. of Atlanta Research Data Report No. 24-3 (Sept. 9, 2024), sec. 3.1 (describing a “(sub)component of financial inclusion relating to digital payments (a subset of payments), which we term digital payments inclusion. Digital payments are payments made through a digital device or channel, such as electronic fund transfer (for example, automated clearing house [ACH] and instant payments); debit, prepaid, or credit card; closed-loop online payment services offered by online payment service providers (for example, PayPal and Cash App); and cryptocurrency transfer.”), table 1 (describing examples of digital payments with wide acceptance by merchants, billers, and individuals), 
                            <E T="03">https://www.atlantafed.org/-/media/documents/banking/consumer-payments/research-data-reports/2024/10/10/03--defining-households-that-are-underserved-in-digital-payment-services.pdf</E>
                             (last visited Nov. 7, 2024); Pengfei Han &amp; Zhu Wang, 
                            <E T="03">Technology Adoption and Leapfrogging: Racing for Mobile Payments,</E>
                             Fed. Rsv. Bk. of Richmond Working Paper No. 21-05R (Mar. 2021 rev. May 1, 2024) (Racing for Mobile Payments) at 6 (“Following Crowe et al. (2010), we define a mobile payment to be a money payment made for a product or service through a mobile phone, regardless of whether the phone actually accesses the mobile network to make the payment. Mobile payment technology can also be used to send money from person to person.”), 
                            <E T="03">https://www.richmondfed.org/-/media/RichmondFedOrg/publications/research/working_papers/2021/wp21-05r.pdf</E>
                             (last visited Nov. 7, 2024); U.S. Dept. of Treasury, 
                            <E T="03">Assessing the Impact of New Entrant Non-bank Firms on Competition in Consumer Finance Markets</E>
                             (Nov. 2022) at 13 (“New entrant non-bank firms offer digital applications to make payments online and through mobile devices that have expanded accessibility for consumers. These payments firms generally provide a front-end digital user interface for consumers to make payments to other parties (other consumers or, increasingly, businesses) on the same platform.”), 
                            <E T="03">https://home.treasury.gov/system/files/136/Assessing-the-Impact-of-New-Entrant-Nonbank-Firms.pdf</E>
                             (last visited Nov. 7, 2024); Pew Research Center, 
                            <E T="03">Who Uses Mobile Payments?</E>
                             (May 26, 2016) at 1 (defining “[m]obile payment users” as “consumers who have made an online or point-of-sale purchase, paid a bill, or sent or received money using a Web browser, text message, or app on a smartphone”), 
                            <E T="03">https://www.pewtrusts.org/-/media/assets/2016/05/who_uses_mobile_payments.pdf</E>
                             (last visited Nov. 7, 2024); Pew Research Center, 
                            <E T="03">Are Americans Embracing Mobile Payments?</E>
                             (Oct. 3, 2019) at 3 (defining “mobile payment” and “mobile payment apps” in similarly broad manner), 
                            <E T="03">https://www.pewtrusts.org/-/media/assets/2019/10/mobilepayments_brief_final.pdf</E>
                             (last visited Nov. 7, 2024); U.K. Payment Systems Regulator &amp; Financial Conduct Authority, 
                            <E T="03">Call for Information: Big tech and digital wallets,</E>
                             Doc. CP24/9 (July 2024), sec. 2.1-2.3 (“Digital wallets can be defined as apps, software or online services that allow consumers to make payments, quickly and conveniently, using mobile phones or other electronic devices . . . . Some digital wallets facilitate retail transactions, others allow peer-to-peer payments, and others do both . . . . Digital wallets can be either `staged' [by holding funds] or `pass-through' [because they do not hold funds themselves but instead allow users to make payments from a payment card] . . . . While the features and functionality of digital wallets vary, in general terms, they offer consumers a quick and convenient way to make payments.”), 
                            <E T="03">https://psr.org.uk/media/yqinyhhn/cp24-9-cfi-digital-wallets-july-2024-v2.pdf</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <P>
                        In addition, commenters claiming that the rule encompassed multiple markets rather than a single market did not provide evidence regarding consumer understanding to support their claims. By contrast, through its experience and expertise developed through its market monitoring and other activities, the CFPB has seen that several well-known general-use digital consumer payment applications engage in many of the activities industry commenters characterized as distinct markets. For example, when consumers open what some describe as a peer-to-peer payment app, now they often may access a screen to send money to other persons they identify, whether consumers or businesses.
                        <SU>188</SU>
                        <FTREF/>
                         In addition, market participants often design their general-use digital consumer payment application so that a single screen can display all available methods for making a given payment, including prepaid accounts, debit cards linked to deposit accounts, and credit cards, whether issued by the digital application provider or by third-party financial institutions.
                        <SU>189</SU>
                        <FTREF/>
                         The CFPB therefore declines to differentiate the market in ways suggested by industry commenters that do not align with the more seamless, undifferentiated common user experience that well-known market participants themselves create for consumers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>188</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Venmo, 
                            <E T="03">Show some local love: Pay businesses—like your favorite neighborhood spots—the same easy way you pay friends on Venmo</E>
                             (describing how consumer can use a merchant's Venmo QR code to identify the merchant as a payment recipient), 
                            <E T="03">https://venmo.com/pay/businesses/</E>
                             (last visited Nov. 7, 2024); Venmo, 
                            <E T="03">Adding &amp; Removing Friends</E>
                             (describing how consumers can use QR codes from other consumers to identify them as recipients), 
                            <E T="03">https://help.venmo.com/hc/en-us/articles/217532217-Adding-Removing-Friends</E>
                             (last visited Nov. 7, 2024); Block Investor Day 2022, 
                            <E T="03">Cash App</E>
                             at 8 (stating that Cash App “started with peer-to-peer payments”) &amp; at 71 (showing screenshot of how a consumer can add a business account to receive payments), 
                            <E T="03">https://s29.q4cdn.com/628966176/files/doc_presentations/2022/05/Cash-App-Block-Investor-Day-2022.pdf</E>
                             (last visited Nov. 7, 2024). Other payment apps also bundle money transfers to individual consumers and bill pay functionalities. 
                            <E T="03">See, e.g.,</E>
                             Western Union, 
                            <E T="03">Send and Track Money Online</E>
                             (U.S. consumer home page describing how a consumer can use the Western Union app to “[s]end money, pay bills, check exchange rates, or start a transfer in the app and pay in-store-all on the go.”), 
                            <E T="03">https://www.westernunion.com/us/en/home.html</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>189</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Apple, 
                            <E T="03">Wallet Carry one thing. Everything</E>
                             (consumer-facing website showing screenshot of Apple Wallet displaying payment methods including a Discover credit card, an Apple Cash prepaid account card, and an Apple MasterCard), 
                            <E T="03">https://www.apple.com/wallet/</E>
                             (last visited Nov. 7, 2024); PayPal, 
                            <E T="03">Add. Pay. Earn. Smile</E>
                             (consumer-facing website showing screenshot of PayPal payment method screen where consumer can “[u]se your bank or cards to pay or send money”), 
                            <E T="03">https://www.paypal.com/us/digital-wallet/ways-to-pay/add-payment-method</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <P>
                        Even when firms choose to discontinue offering payments to other consumers,
                        <SU>190</SU>
                        <FTREF/>
                         or have not yet enabled that capability in the United States,
                        <SU>191</SU>
                        <FTREF/>
                         their general-use digital payment applications still comprise part of the overall market described in the Final Rule, which includes but is not limited to digitally facilitating consumer payment transactions for purchases.
                    </P>
                    <FTNT>
                        <P>
                            <SU>190</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Google, 
                            <E T="03">Simplifying our payment apps in the U.S.</E>
                             (Feb. 22, 2024) (announcing that effective June 4, 2024, the U.S. version of the Goole Pay app will no longer be available to send money to other consumers but that consumers can continue to use Google Pay to check out online and to tap-to-pay in stores), 
                            <E T="03">https://blog.google/products/google-pay/payment-apps-update/?sjid=232731559998132243-NA</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>191</SU>
                             
                            <E T="03">See</E>
                             Amazon, 
                            <E T="03">Unified Payment Interface (UPI) FAQs</E>
                             (describing how consumers in India can use the Amazon Pay Unified Payment Interface to send money to other consumers), 
                            <E T="03">https://www.amazon.in/gp/help/customer/display.html?nodeId=202212990</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Final Rule</HD>
                    <P>
                        For the reasons described in this Final Rule, including the CFPB's consideration of and responses to the comments on the Proposed Rule, the CFPB concludes that the set of activities covered by the market definition in the Final Rule, all of which digitally facilitate consumer payment transactions to multiple unaffiliated persons, regardless of the payment method, source, or account used to fund the payment, reasonably describes a market for purposes of CFPA section 1024(a)(1)(B). In addition, the Final Rule makes several revisions to market-related definitions as described in the section-by-section analysis of § 1090.109(a)(2) below. Because the 
                        <PRTPAGE P="99606"/>
                        market definition incorporates those defined terms, those revisions also affect the scope of the market the Final Rule defines.
                    </P>
                    <HD SOURCE="HD2">109(a)(2) Market-Related Definitions</HD>
                    <P>Proposed § 1090.109(a)(2) would have defined several terms that are relevant to the proposed market definition described above. Below the CPFB summarizes and responds to comments on each proposed definition and describes changes to these definitions in the Final Rule, which also numbers each definition for clarity.</P>
                    <HD SOURCE="HD3">Consumer Payment Transaction(s)</HD>
                    <HD SOURCE="HD3">Proposed Rule</HD>
                    <P>
                        The proposed market definition would have encompassed providing covered payment functionalities through a digital application for a consumer's general use in making consumer payment transactions. Proposed § 1090.109(a)(2) would have defined the term “consumer payment transactions” to mean the transfer of funds by or on behalf of a consumer physically located in a State to another person primarily for personal, family, or household purposes.
                        <SU>192</SU>
                        <FTREF/>
                         The proposed definition would have clarified that, except for transactions excluded under paragraphs (A) through (D), the term applies to transfers of consumer funds and transfers made by extending consumer credit. Paragraphs (A) through (D) of the proposed definition would have excluded the following four types of transactions: (A) An international money transfer as defined in § 1090.107(a) of this part; (B) A transfer of funds that is (
                        <E T="03">1</E>
                        ) linked to the consumer's receipt of a different form of funds, such as a transaction for foreign exchange as defined in 12 U.S.C. 5481(16), or (
                        <E T="03">2</E>
                        ) that is excluded from the definition of “electronic fund transfer” under § 1005.3(c)(4) of this chapter; (C) A payment transaction conducted by a person for the sale or lease of goods or services that a consumer selected from an online or physical store or marketplace operated prominently in the name or such person or its affiliated company; and (D) An extension of consumer credit that is made using a digital application provided by the person who is extending the credit or that person's affiliated company.
                        <SU>193</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>192</SU>
                             The Proposed Rule would have defined the term “consumer payment transaction” for purposes of the Proposed Rule. Payment transactions that are excluded from, or otherwise do not meet, the definition of “consumer payment transaction” in the Proposed Rule would not have been covered by the market definition in the Proposed Rule. However, persons facilitating those transactions may still have been subject to other aspects of the CFPB's authorities besides its larger participant supervisory authority established by the Proposed Rule.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>193</SU>
                             Subpart A of the CFPB's existing larger-participant rule includes a definition of “affiliated company” that would have applied to the use of that term in the Proposed Rule. 
                            <E T="03">See</E>
                             12 CFR 1090.101.
                        </P>
                    </FTNT>
                    <P>
                        The first component of the proposed definition of “consumer payment transaction” was that the payment transaction must result in a transfer of funds by or on behalf of the consumer. This component therefore would have focused on the sending of a payment, and not on the receipt. The proposed definition would have encompassed a consumer's transfer of their own funds—such as funds held in a linked deposit account or in a stored value account. It also would have encompassed a creditor's transfer of funds to another person on behalf of the consumer as part of a consumer credit transaction.
                        <SU>194</SU>
                        <FTREF/>
                         For example, a nonbank's wallet functionality may hold a credit card account or payment credential that a consumer uses to obtain an extension of credit from an unaffiliated depository institution. If the consumer uses the digital wallet functionality to purchase nonfinancial goods or services using such a credit card, the credit card issuing bank may settle the transaction by transferring funds to the merchant's bank for further transfer to the merchant, and a charge may appear on the consumer's credit card account. That transfer of funds may have constituted part of a consumer payment transaction under the Proposed Rule regardless of whether it is an electronic fund transfer subject to Regulation E.
                        <SU>195</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>194</SU>
                             In certain circumstances, consumer credit transactions would have been excluded from the proposed definition of “consumer payment transaction,” for example as described in the exclusion in proposed paragraph (D) discussed below.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>195</SU>
                             
                            <E T="03">See also generally</E>
                             § 1005.12(a) (describing relationship between Regulation E and other laws including the Truth in Lending Act and its implementing regulation, Regulation Z).
                        </P>
                    </FTNT>
                    <P>
                        The CFPA did not include a specific definition for the term “funds” used in the Proposed Rule. As the Proposed Rule explained, that term is used in various provisions of the CFPA, including in section 1002(15)(A)(iv), which defines the term “financial product or service” to include “engaging in deposit-taking activities, transmitting or exchanging funds, or otherwise acting as a custodian of funds or any financial instrument for use by or on behalf of a consumer.” 
                        <SU>196</SU>
                        <FTREF/>
                         Without fully addressing the scope of that term, the Proposed Rule interpreted the term “funds” in the CFPA to not be limited to fiat currency or legal tender, and to include digital assets that have monetary value and are readily useable for financial purposes, including as a medium of exchange, such as crypto-assets, which are sometimes referred to as virtual currency.
                        <SU>197</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>196</SU>
                             12 U.S.C. 5481(15)(A)(iv).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>197</SU>
                             
                            <E T="03">See generally</E>
                             U.S. Treas. Fin. Stability Oversight Council, 
                            <E T="03">Report on Digital Asset Financial Stability Risks and Regulation</E>
                             (Oct. 3, 2022) at 7 (“For this report, the term `digital assets' refers to two categories of products: `central bank digital currencies' (CBDCs) and `crypto-assets.' This report largely focuses on crypto-assets. Crypto-assets are a private sector digital asset that depends primarily on cryptography and distributed ledger or similar technology. For this report, the term crypto-assets encompasses many assets commonly referred to as `coins' or `tokens' by market participants.”), 
                            <E T="03">https://home.treasury.gov/system/files/261/FSOC-Digital-Assets-Report-2022.pdf</E>
                             (last visited Oct. 23, 2023).
                        </P>
                    </FTNT>
                    <P>The second component of the proposed definition of “consumer payment transaction” was that the consumer must be physically located in a State, a term the proposal would have defined by reference to jurisdictions that are part of the United States as discussed in the section-by-section analysis below. The CFPB requested comment on this limitation.</P>
                    <P>The third component of the proposed definition of “consumer payment transaction” was that the funds transfer must be made to another person besides the consumer. For example, the other person could be another consumer, a business, or some other type of entity. This component would have distinguished the proposed market for general-use digital payment applications that facilitate payments consumers make to other persons from adjacent but distinct markets that include other consumer financial products and services, including the activities of taking deposits; selling, providing, or issuing of stored value; and extending consumer credit by transferring funds directly to the consumer. For example, this component of the proposed definition would have excluded transfers between a consumer's own deposit accounts, transfers between a consumer deposit account and the same consumer's stored value account held at another financial institution, such as loading or redemptions, as well as a consumer's withdrawals from their own deposit account such as by an automated teller machine (ATM).</P>
                    <P>
                        The fourth component of the proposed definition of “consumer payment transaction” is that the funds transfer must be primarily for personal, family, or household purposes.
                        <SU>198</SU>
                        <FTREF/>
                         As a 
                        <PRTPAGE P="99607"/>
                        result, the Proposed Rule would have defined the relevant market activity (providing a general-use digital consumer payments application) by reference to its use with respect to consumer payment transactions. Although a general-use digital consumer payment application also could help individuals to make payments that are not for personal, family, or household purposes, such as purely commercial (or business-to-business) payments, those payments would not have fallen within the proposed definition of “consumer payment transaction.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>198</SU>
                             Under a relevant definition of consumer financial products and services in CFPA section 1002(5)(A), a financial product or service is a 
                            <PRTPAGE/>
                            consumer financial product or service when it is offered or provided for use by consumers primarily for personal, family, or household purposes. 12 U.S.C. 5481(5)(A).
                        </P>
                    </FTNT>
                    <P>
                        In addition, the proposed definition of “consumer payment transaction” would have excluded four types of transfers. First, paragraph (A) of the proposed definition would have excluded international money transfers as defined in § 1090.107(a). The CFPB defined larger participants in a market for international money transfers in its 2014 rule.
                        <SU>199</SU>
                        <FTREF/>
                         In proposing this larger participant rule, the CFPB did not propose to alter the international money transfer larger participant rule. Rather, the CFPB proposed this larger participant rule to define a separate market, focused on the use of digital payment technologies to help consumers make payment transactions that are not international money transfers as defined in the international money transfer larger participant rule. Accordingly, the proposed definition of “consumer payment transaction” would have excluded an international money transfer as defined in § 1090.107(a). As the Proposed Rule explained, to the extent that nonbank international money transfer providers facilitate those transactions, whether through a digital application or otherwise,
                        <SU>200</SU>
                        <FTREF/>
                         that activity remains part of the international money transfer market, and the CFPB may be able to supervise such a nonbank if it meets the larger-participant test in the international money transfer larger participant rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>199</SU>
                             79 FR 56631.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>200</SU>
                             
                            <E T="03">See</E>
                             CFPB, 
                            <E T="03">Remittance Rule Assessment Report</E>
                             (Oct. 2018, rv. April 2019) at 143 (describing trends including “widespread use of mobile phones to transfer remittances and the growth of online-only providers[]”), 
                            <E T="03">https://files.consumerfinance.gov/f/documents/bcfp_remittance-rule-assessment_report.pdf</E>
                             (last visited Oct. 25, 2023).
                        </P>
                    </FTNT>
                    <P>
                        Second, for clarity, paragraph (B) of the proposed definition of “consumer payment transaction” would have excluded a transfer of funds by a consumer (
                        <E T="03">1</E>
                        ) that is linked to the consumer's receipt of a different form of funds, such as a transaction for foreign exchange as defined in 12 U.S.C. 5481(16), or (
                        <E T="03">2</E>
                        ) that is excluded from the definition of “electronic fund transfer” under § 1005.3(c)(4) of this chapter. Paragraph (
                        <E T="03">1</E>
                        ) of this proposed exclusion would have clarified, for example, that the market as defined in the Proposed Rule does not include transactions consumers conduct for the purpose of exchanging one type of funds for another, such as exchanges of fiat currencies (
                        <E T="03">i.e.,</E>
                         the exchange of currency issued by the United States or of a foreign government for the currency of a different government). Paragraph (
                        <E T="03">2</E>
                        ) would have clarified that transfers of funds the primary purpose of which is the purchase or sale of a security or commodity in circumstances described in Regulation E section 3(c)(4) and its associated commentary also would not have qualified as consumer payment transactions for purposes of the Proposed Rule.
                        <SU>201</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>201</SU>
                             12 CFR 1005.3(c)(4).
                        </P>
                    </FTNT>
                    <P>
                        Third, proposed paragraph (C) would have excluded a payment transaction conducted by a person for the sale or lease of goods or services that a consumer selected from an online or physical store or marketplace operated prominently in the name of such person or its affiliated company.
                        <SU>202</SU>
                        <FTREF/>
                         This exclusion would have clarified that, when a consumer selects goods or services in a store or website operated in the merchant's name and the consumer pays using account or payment credentials stored by the merchant who conducts the payment transaction, such a transfer of funds generally is not a consumer payment transaction included within the market defined by the Proposed Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>202</SU>
                             
                            <E T="03">See</E>
                             12 CFR 1090.101 (definition of “affiliated company”).
                        </P>
                    </FTNT>
                    <P>
                        This exclusion also would have clarified that when a consumer selects goods or services in an online marketplace and pays using account or payment credentials stored by the online marketplace operator or its affiliated company,
                        <SU>203</SU>
                        <FTREF/>
                         such a transfer of funds generally is not a consumer payment transaction included within the market defined by the Proposed Rule. For such transactions to qualify for this exclusion, the funds transfer must have been for the sale or lease of a good or service the consumer selected from a digital platform operated prominently in the name (whether entity or trade name) of an online marketplace operator or their affiliated company.
                        <SU>204</SU>
                        <FTREF/>
                         However, this proposed exclusion would not have applied when a consumer uses a payment or account credential stored by a general-use digital consumer payment application provided by an unaffiliated person to pay for goods or services on the merchant's website or an online marketplace. For example, when a consumer selects goods or services for purchase or lease on a website of a merchant, and then from within that website chooses an unaffiliated person's general-use digital consumer payment application as a payment method, then proposed paragraph (C) would not have excluded the resulting consumer payment transaction.
                    </P>
                    <FTNT>
                        <P>
                            <SU>203</SU>
                             The Proposed Rule noted that a common industry definition of an online marketplace operator is an entity that engages in certain activities, including “[b]ring[ing] together [consumer payment card holders] and retailers on an electronic commerce website or mobile application” where “[i]ts name or brand is: []Displayed prominently on the website or mobile application[; ] Displayed more prominently than the name and brands of retailers using the Marketplace[; and is p]art of the mobile application name or [uniform resource locator.]” 88 FR 80197 at 80203 n.59 (citing VISA, 
                            <E T="03">Visa Core Rules and Visa Product and Service Rules</E>
                             (Apr. 15, 2023) (“VISA Rules”), Rule 5.3.4.1 (defining the criteria for an entity to qualify as a “Marketplace” for purposes of the VISA Rules), Oct. 2024 edition last updated Apr. 2023, 
                            <E T="03">https://usa.visa.com/dam/VCOM/download/about-visa/visa-rules-public.pdf</E>
                             (last visited Nov. 7, 2024)).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>204</SU>
                             The Proposed Rule noted that this aspect of the example is consistent with what some significant payments industry standards consider to be a digital marketplace. 
                            <E T="03">See id.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Proposed Rule explained that the CFPB proposed this exclusion to the definition of “consumer payment transaction” to clarify the scope of the proposed market and to clarify which transactions count toward the proposed threshold in the larger-participant test in proposed § 1090.109(b). For example, some online marketplace operators may provide general-use digital consumer payment applications for consumers to use for the purchase or lease of goods or services the consumer selects on websites of unaffiliated merchants. Absent the proposed exclusion in paragraph (C), the providing of such a general-use digital consumer payment application could result in counting all transactions through such an application, including for goods and services the consumer selects from the online marketplace, toward the larger-participant test threshold in proposed § 1090.109(b). Yet the Proposed Rule noted that the CFPB was not seeking to define a market or determine larger-participant status in this rulemaking by reference to payment transactions conducted by merchants or online marketplaces through their own payment functionalities for their own sales transactions. The CFPB therefore believed it was appropriate to propose excluding the former type of payment 
                        <PRTPAGE P="99608"/>
                        transactions from the market defined in the Proposed Rule.
                    </P>
                    <P>
                        The Proposed Rule explained how, in this regard, the scope of the proposed term “consumer payment transaction” is narrower than the CFPB's authority under the CFPA, which can extend to payment transactions conducted by merchants or online marketplaces for sales through their own platforms under certain circumstances. The CFPA defines a consumer financial product or service to include “providing payments or other financial data processing products or services to a consumer by any technological means, including processing or storing financial or banking data for any payment instrument . . .” 
                        <SU>205</SU>
                        <FTREF/>
                         The Proposed Rule explained that such activities generally are consumer financial products or services under the CFPA unless a narrow exclusion for financial data processing in the context of the direct sale of nonfinancial goods or services applies.
                        <SU>206</SU>
                        <FTREF/>
                         The Proposed Rule explained that exclusion would not apply if a merchant or online marketplace's digital consumer application stores, transmits, or otherwise processes payments or financial data for any purpose other than initiating a payments transaction by the consumer to pay the merchant or online marketplace operator for the purchase of a nonfinancial good or service sold directly by that merchant or online marketplace operator. Other purposes beyond payments for direct sales could include using or sharing such data for targeted marketing, data monetization, or research purposes. The Proposed Rule explained that the exclusion also would not apply if an online marketplace operator's digital consumer application processes payments or other financial data associated with the consumer's purchase of goods or services at unaffiliated online or physical stores or third-party goods or services on the operator's online marketplace.
                    </P>
                    <FTNT>
                        <P>
                            <SU>205</SU>
                             12 U.S.C. 5481(15)(A)(vii).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>206</SU>
                             “[A] person shall not be deemed to be a covered person with respect to financial data processing solely because the person . . . is a merchant, retailer, or seller of any nonfinancial good or service who engages in financial data processing by transmitting or storing payments data about a consumer exclusively for purpose of initiating payments instructions by the consumer to pay such person for the purchase of, or to complete a commercial transaction for, such nonfinancial good or service sold directly by such person to the consumer[.]” 12 U.S.C. 5481(15)(A)(vii)(I). The Proposed Rule stated that this narrow exclusion is descriptive of the limited role that many merchants play in processing consumer payments or financial data. 88 FR 80197 at 80204 n.62.
                        </P>
                    </FTNT>
                    <P>
                        Finally, proposed paragraph (D) would have excluded an extension of consumer credit that is made using a digital application provided by the person who is extending the credit or that person's affiliated company. As the Proposed Rule explained, the CFPB proposed this exclusion so that the market definition does not encompass consumer lending activities by lenders through their own digital applications. In this rulemaking, the CFPB did not propose to define a market for extending consumer credit, as it did, for example, in the larger participant rule for the automobile financing market.
                        <SU>207</SU>
                        <FTREF/>
                         As a result of this proposed exclusion, for example, a nonbank would not have been participating in the proposed market simply by providing a digital application through which it lends money to consumers to buy goods or services.
                        <SU>208</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>207</SU>
                             12 CFR 1090.108.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>208</SU>
                             Thus, to the extent consumer credit transactions would have fallen within the proposed definition of consumer payment transactions, this would have been because the relevant market participant engaged in covered payment-related activities beyond extending credit to the consumer. For example, a nonbank may provide a wallet functionality through a digital application that stores payment credentials for a credit card through which an unaffiliated depository institution or credit union extends consumer credit. The CFPB proposed a market definition that would have reached that nonbank covered person's activities because their role in the transaction is to help the consumer to make a payment, not to themselves extend credit to the consumer.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Comments Received</HD>
                    <P>Some commenters addressed certain terms in the proposed definition of “consumer payment transaction” including, in relation to its reference to the “transfer of funds,” how the Proposed Rule stated that the CFPB interprets “funds” to include digital assets in certain circumstances, as described above. A few commenters also commented on how the Proposed Rule sought to define covered transactions based on the location of the consumer in a State. Finally, some commenters addressed certain proposed exclusions from the definition, including specifically paragraphs (C) and (D).</P>
                    <P>Many of the comments on the proposed definition of “consumer payment transaction” related to the proposed inclusion of certain transfers of digital assets in this definition, when they transfer “funds” under the CFPA. Several consumer groups and a nonprofit expressed general support for including digital assets within the market definition. The nonprofit stated that the firms providing cryptocurrency products and services have been marked by a wide assortment of investor and consumer abuses. Consumer groups agreed, noting that reports coming out of the late 2022 downturn in the sector illustrated that that consumers would benefit from broader oversight, including CFPB supervision of digital assets activities involved in consumer payment transactions. They stated that such oversight could address risks consumers have faced, such as improper restrictions that distressed digital asset platforms have placed on consumers' access to hosted digital asset wallets. The consumer groups also stated that consumers increasingly are relying on cryptocurrencies for consumer payment transactions, as industry emphasizes a long-term strategy of promoting such activity. They cited examples of a long-time, well-known market participant introducing a stablecoin expressly to facilitate consumer purchases, and another digital asset firm contracting with merchants for acceptance of crypto assets the firm holds for consumers. A banking industry association also supported the coverage of virtual currency and crypto assets, which it stated consumers use for personal, family, and household purposes, and should be regulated on par with fiat currency consistent with the “same activity, same risk, same regulation” principle. An individual commenter agreed that crypto asset users face significant risks, and called for the Final Rule to clarify how it applies to digital assets.</P>
                    <P>
                        On the other hand, for several reasons described below, several nonprofits, providers of digital asset products and services, and digital asset industry associations, banking industry associations, and other industry associations opposed inclusion of digital assets in the market definition. They called for exclusion of these transactions from the rule and, if warranted, a re-proposal based on addressing the various issues they described; a payment network and nonprofit added that, to facilitate regulatory certainty and transparency and avoid unintended consequences, the Final Rule should only apply to fiat currency and legal tender. They stated that the rule should accomplish that goal by limiting the interpretation of “funds.” 
                        <SU>209</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>209</SU>
                             As discussed at the outset of the section-by-section analysis above, an industry association commenter also stated that if the CFPB excludes digital assets from the Final Rule, then the CFPB precludes its examination of that activity by larger participants under the Final Rule. The CFPB summarizes and responds to that comment separately above.
                        </P>
                    </FTNT>
                    <P>
                        First, some industry commenters stated that the CFPB should not adopt this aspect of the Proposed Rule because, in their view, the CFPB has not 
                        <PRTPAGE P="99609"/>
                        conducted adequate market monitoring of digital assets activities and does not in general have data, experience, or expertise in this area sufficient to assess risk to consumers and finalize a regulation covering them. One industry commenter added that the CFPB would have benefited from issuing market-monitoring orders to larger digital asset firms as the CFPB had done to Big Tech firms offering consumer payment applications that transfer U.S. dollars. One commenter stated that the Proposed Rule did not rely on public blockchain data from industry sources such as Elliptic, Chain Analysis, and TRM, as well as trends data published by Circle, and insufficiently disclosed any data on which it did rely.
                    </P>
                    <P>
                        Second, several comments from industry, nonprofits, and some Members of Congress stated that the Proposed Rule did not consider the impact of covering digital assets. For example, some industry commenters stated that the Proposed Rule underestimated the number of larger participants, citing uncertainty over the rule's application to digital assets and ineligibility for the proposed small business exclusion by small businesses in the digital assets sector that are based abroad, organized as nonprofits, or dominant in their field. Further, some industry associations, digital assets firms, and a nonprofit stated that it was uncertain which digital assets transactions would be covered because it is uncertain which are for personal, family, or household purposes. In addition, some commenters suggested that the Proposed Rule would impose significant burdens on the digital asset sector, whether due to the proposed interpretation of “funds” in the CFPA as including digital assets which they viewed as a change in substantive consumer protections, or to what they anticipated would be exposure to potentially arbitrary and shifting CFPB interpretations as to whether Regulation E covers digital assets.
                        <SU>210</SU>
                        <FTREF/>
                         Finally, an industry firm stated that the Proposed Rule did not adequately consider the potential for digital asset firms to pass through costs of this rule to consumers. Some Members of Congress and an industry association added that covering digital assets would discourage competition and innovation in payments.
                    </P>
                    <FTNT>
                        <P>
                            <SU>210</SU>
                             One industry association stated that the Final Rule should clarify that it does not serve as a basis for subjecting virtual currencies or other digital assets to Regulation E. Another trade association called for the CFPB to consult with stakeholders in industry, other agencies, and Congress to understand the potential implications of applying Regulation E in this context.
                        </P>
                    </FTNT>
                    <P>
                        In addition, many of these commenters emphasized potential impacts of what they described as the proposal's apparent coverage of so-called “unhosted” or “self-hosted” digital asset wallets. They stated that providers of these products and services must be excluded from the rule because they are merely providing software with no ongoing customer relationship or intermediary role, no access to information about the existence, nature, or use of any digital asset held in the wallet, and no control over the use of the wallet for any purpose including to make payments.
                        <SU>211</SU>
                        <FTREF/>
                         They added that unhosted digital asset wallets cannot block transactions, reverse transactions to correct unauthorized transfers, close accounts, or track or monetize consumer data. As such, they stated that they also do not know whether the wallet holds funds at all (even under the CFPB's interpretation) versus other uses of distributed ledger technology including an estimated 1.8 million types of crypto assets, nonfungible tokens (NFTs), and loyalty points among others. They stated they do not know where the consumer is located for the purposes of the proposed definition of “consumer payment transaction.” They also stated they do not know when a transaction occurs at all much less whether it is a consumer payment transaction. They stated that the lack of provider collection of such data is a critical feature of their product from the perspective of the consumer, and that this feature reduces risk to consumers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>211</SU>
                             One commenter stated that an exclusion for what it called “unhosted” digital asset wallets would be consistent with FinCEN 2019 guidance that they described as excluding software providers of unhosted digital asset wallets from the scope of Federal money transmitter regulation. Another commenter stated that the First Amendment of the U.S. Constitution protects software code writing as speech, and that the proposed small business concern exclusion discriminated between speakers based on the size of their business, constituting speaker and viewpoint discrimination that it did not believe would survive strict constitutional scrutiny.
                        </P>
                    </FTNT>
                    <P>
                        Third, some commenters raised legal objections to including digital assets in the rulemaking or certain digital asset products and services. For example, some industry commenters disagreed generally with the proposal's interpretation of “funds” as including digital assets. These commenters stated that the CFPB did not provide sufficient reasoning or evidence to support what they viewed as a change in its legal position, that the interpretation ran contrary to the statute, Congress' understanding at the time of its enactment,
                        <SU>212</SU>
                        <FTREF/>
                         relevant case law, and the “major questions” doctrine,
                        <SU>213</SU>
                        <FTREF/>
                         that digital asset products and services are not part of a consumer financial products or services market because they are not provided for use by consumers primarily for personal, family, or household purposes, and that the CFPA precludes CFPB oversight over such activities overseen by the SEC or CFTC.
                        <SU>214</SU>
                        <FTREF/>
                         Some commenters stated more specifically that the CFPB lacks authority over unhosted digital asset wallets because, for example, they function similarly to a web browser or password manager with a variety of uses beyond payments,
                        <SU>215</SU>
                        <FTREF/>
                         they have no more power to intervene in a consumer payment transaction than an internet service provider, and these activities are eligible for the “electronic conduit services” exception in CFPA section 1002(15)(C)(ii).
                    </P>
                    <FTNT>
                        <P>
                            <SU>212</SU>
                             Some commenters noted that very few cryptocurrencies existed as of 2010, and noted that stablecoins were not introduced until several years later.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>213</SU>
                             These commenters pointed to the size of digital asset activity, including an estimated $130 billion U.S. stablecoin market, as well as varied uses of digital assets and efforts in Congress to enact a legislative oversight framework.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>214</SU>
                             In addition, a nonprofit commenter and other industry commenters stated that the CFPB should not finalize this aspect of the Proposed Rule because, in their view, it reflects inadequate coordination by the CFPB across government as called for under an executive order relating to digital assets and reflects inadequate CFPB consultation with the SEC and CFTC, which have asserted regulatory authority over digital assets.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>215</SU>
                             This commenter added that, although the Proposed Rule did not specifically address covering unhosted digital asset wallets and thus such coverage may not have been intended, based on the interpretation of “funds” in the Proposed Rule, its proposed definition of “covered payment functionality” could be viewed as reaching them, which, as noted, would be legally impermissible in its view.
                        </P>
                    </FTNT>
                    <P>
                        With respect to other aspects of the proposed definition of “consumer payment transaction” beyond the context of digital assets, two commenters addressed the part of the proposed definition of “consumer payment transaction” that limited the term to payments by or on behalf of a consumer “located in a State” in the United States as described above. A nonprofit stated that a survey indicated that the majority of its members (59 percent) did not believe that larger participants would be able to determine whether the consumer is located within a State, such as based on the consumer's internet Protocol address at the time of a transaction. An industry association stated that this part of the proposed definition was overbroad because it extended beyond Federal consumer financial laws that the Proposed Rule identified as applicable in the market. Specifically, the commenter stated that basing market scope on the location of 
                        <PRTPAGE P="99610"/>
                        the consumer leads the market to include electronic fund transfers that are not covered by Regulation E, such as payments that foreign firms facilitate for foreign nationals who do not reside in the United States, including while traveling within the United States.
                        <SU>216</SU>
                        <FTREF/>
                         They suggested that, in order to avoid being subject to a U.S. supervisory regime, foreign providers may abandon support of such foreign national customers when traveling in the United States. They also pointed to foreign providers' provision of payment accounts located outside the United States as another example that they believed generally falls outside of Regulation E. As a result, they called for narrowing the transactions included in the market. In addition to the proposed limitation requiring that the consumer be located in a State in the United States, in their view, the definition of “consumer payment transaction” also should be limited to U.S. residents making payments from payment cards or stored value accounts issued by U.S. financial institutions. In their view, those additional limitations would better align the scope of the market with the scope of regulations the CFPB proposes to apply in its examination of larger participants, including Regulation E, whose scope with respect to transnational activity is described in its comment 3(a)-3.
                    </P>
                    <FTNT>
                        <P>
                            <SU>216</SU>
                             They also suggested that Regulation P may not apply to those transactions.
                        </P>
                    </FTNT>
                    <P>Commenters presented a range of views on the exclusion in paragraph (C) of the proposed definition of “consumer payment transaction” for payment transactions conducted by merchants or marketplaces for the sale or lease of goods or services the consumer selected from a store or marketplace the merchant or marketplace operates prominently in its name or the name of an affiliated company. Some commenters also addressed the statement in the Proposed Rule describing circumstances in which merchant or marketplace payment processing activities that fall outside the proposed market definition because they are excluded by paragraph (C) nonetheless may qualify as a consumer financial product or service under the CFPA.</P>
                    <P>
                        Consumer group commenters generally opposed the proposed exclusion in paragraph (C). One consumer group noted stated that certain nonbank payments companies sell consumers' payments data, including information about how much people spend, where, and on what, as described in a 2023 report the commenter published and linked to in its comment.
                        <SU>217</SU>
                        <FTREF/>
                         In their view, to the extent a marketplace collects payments data and uses it for purposes beyond completing the payment transaction, the marketplace should be brought under supervisory authority, including when “its transactions fall within its own marketplace[.]” Meanwhile, other consumer groups stated that marketplace payment functions can comprise a significant portion of the marketplace's revenues, can expand into or spin off as general-use digital consumer payment apps, and also can engage in practices that the FTC has alleged to violate competition laws.
                    </P>
                    <FTNT>
                        <P>
                            <SU>217</SU>
                             R.J. Cross, 
                            <E T="03">How Mastercard sells its `gold mine' of transaction data</E>
                             (Sept. 30, 2023, updated June 17, 2024), 
                            <E T="03">https://pirg.org/edfund/resources/how-mastercard-sells-data</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <P>
                        A law firm commenter agreed that the rule should exclude payment transactions conducted by online marketplaces for sales through their own platforms. This commenter stated that consumers seek out online marketplace platforms for their ability to sell goods and services including primarily from third-party retailers hosted on the marketplace. It called for clarifying the definition of marketplace in proposed paragraph (C) to better achieve the CFPB's stated goal of excluding payment transactions conducted by merchants for their own sales and payment transactions conducted by online marketplaces for sales made through their platform. As noted, the scope of the exclusion in proposed paragraph (C) would apply to marketplaces operated prominently in the name of the person that conducts the payment transaction. This commenter described this aspect of the exclusion as unduly focused on branding. It stated that different online marketplace operators have different levels of branding and name display, suggesting uncertainty about which marketplaces would have qualified under the “prominently” standard. To the extent that a platform did not meet the “prominently” standard in the Proposed Rule, in the view of this commenter, the exclusion would be arbitrary because a platform would be ineligible despite being a marketplace as defined in a Federal law administered by the FTC, despite consumers still plainly understanding it to be a marketplace, and despite the platform presenting different consumer protection concerns as the Proposed Rule recognized was the case for excluded marketplaces. For all of these reasons, it stated that the Final Rule should adopt the definition of “online marketplace” Congress adopted in the Integrity, Notification, and Fairness in Online Retail Marketplaces for Consumers Act (INFORM Act).
                        <SU>218</SU>
                        <FTREF/>
                         That statute defined a marketplace based on its function, and not its level of name branding. The commenter added that, by incorporating the INFORM Act definition, the exclusion would apply both when the marketplace is paid and when a third-party seller selling through the marketplace is paid.
                    </P>
                    <FTNT>
                        <P>
                            <SU>218</SU>
                             15 U.S.C. 45f(f)(4).
                        </P>
                    </FTNT>
                    <P>
                        Some industry commenters addressed whether the Rule should include consumer payment transactions consumers initiate through “buttons” on merchant websites. One industry association indicated that it was important for the rule to provide for universal coverage of digital wallets, including those a consumer uses by pressing a payment button a checkout screen on a merchant website. It suggested that broad coverage was important to achieve consistent supervision across providers, which promotes competition. On the other hand, some industry commenters called for adding an exclusion for what they described as express checkout options that nonbanks facilitate for third-party merchant websites and apps, including “buy buttons.” 
                        <SU>219</SU>
                        <FTREF/>
                         One industry association called for the rule to clarify that payment checkout buttons are excluded from the market because they do not function generally across merchants but instead require individual merchant acceptance agreements.
                        <SU>220</SU>
                        <FTREF/>
                         Another industry association cited research indicating that many online merchants including small businesses facilitate consumers' purchases by offering these buttons, and suggested that the Proposed Rule was unnecessarily directing its coverage to merchant payment processing.
                        <SU>221</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>219</SU>
                             A few industry commenters suggested that the integration of general-use digital consumer payment applications into merchant websites through payment buttons does not pose any risk to consumers, and that this type of activity should not be included in the market definition. The CFPB considers and responds to comments related to risks to consumers separately in the response to general comments above.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>220</SU>
                             This commenter cited this fact as supporting its view that such checkout buttons do not have “general use”—which the Final Rule discusses in the section-by-section analysis of that term further below. To ensure full consideration of all related comments, the CFPB also describes that comment here in the context of other comments regarding checkout buttons associated with general-use digital consumer payment applications provided by nonbank covered persons.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>221</SU>
                             As discussed in the impacts analysis in parts VII and VIII, a comment from certain Members of Congress also stated that providers of general-use digital consumer payment apps could pass the cost of the rule onto merchants, including small 
                            <PRTPAGE/>
                            merchants, that accept the apps as a payment method. For the reasons explained in the impacts analysis, the CFPB does not have information to indicate that larger participants are likely to pass through a significant portion of these costs to merchants. As the impacts analyses further explain, the costs of the Final Rule are not high and, even if they were passed through, that would be spread across the very high number of merchants that accept one or more of these apps as a method of payment.
                        </P>
                    </FTNT>
                    <PRTPAGE P="99611"/>
                    <P>Some industry and nonprofit commenters appeared to have interpreted the statement in the preamble regarding the scope of the CFPB's authority under CFPA section 1002(15)(A)(vii) as potentially intended to narrow or alter the scope of the exclusion in paragraph (C). For example, several Members of Congress, stated that the scope of the market definition was ambiguous because, on the one hand, the Proposed Rule excluded merchant and marketplace payment functions in circumstances described in paragraph (C), but on the other hand, the preamble of the Proposed Rule stated that the statutory exclusion in CFPA section 1002(15)(A)(vii)(I) does not apply to these functions when they use payments data for purposes beyond processing a payments transaction. Similarly, an industry association commenter suggested that, due to the proposal's interpretation of 1002(15)(A)(vii)(I), the Proposed Rule would apply to merchants processing payments on their own behalf because retailers widely use financial data for purposes beyond processing transactions. Because it did not understand the CFPB to be seeking to cover merchants' payment processing in this rule, it called for the CFPB to remove this interpretation from the Final Rule to ensure that its scope is focused on the general-use digital consumer payment applications that create risks to consumers that the CFPB has identified. Another industry association suggested that the interpretation appeared designed to increase CFPB scrutiny of merchants through supervision. In their view, if the CFPB exercises jurisdiction over merchants on the basis described in the interpretation above, that could make it more difficult for merchants to combat fraud, cause merchants to raise prices or reduce discounts, and cause merchants to decrease reliance on newer, competitive forms of payment. Finally, a law firm also indicated it was unclear whether the interpretation of the CFPA was intended to narrow the scope of paragraph (C).</P>
                    <P>In addition to expressing uncertainty regarding its impact on the scope of paragraph (C), some industry commenters disagreed with the Proposed Rule's interpretation of the CFPB's payments processing authority in CFPA section 1002(15)(A)(vii). In particular, they asserted that the proposal's interpretation of the exclusion in CFPA section 1002(15)(A)(vii)(I) was invalid because it would have the result that many merchants would not satisfy the exclusion. In addition to the comments described above, comments from two industry associations stated that merchants use payments data for a variety of purposes that they described as beneficial to consumers, such as research, fraud prevention, targeted marketing of discounts, and even routing of transactions consistent with Federal Reserve Regulation II to reduce the cost of payment acceptance. Because they viewed those uses as potentially for purposes other than initiating the payment transaction, these commenters believed that merchants would almost never be eligible for the exclusion in 1002(15)(A)(vii)(I) under the CFPB's interpretation of it. One of these commenters added that that result would contravene general intent of Congress to exclude merchants from the CFPA, including pursuant to CFPA section 1027(a). Relatedly, they stated that the proposed interpretation would harm consumers by disincentivizing merchants from engaging in all of these uses of consumer payments data. On the other hand, a consumer group supported the proposal's interpretation of the exclusion in CFPA section 1002(15)(A)(vii)(I). This commenter stated that digital wallets collect and monetize high amounts of consumer data, including through transactions that occur on marketplaces, without oversight.</P>
                    <P>Some commenters addressed the inclusion of consumer credit transactions in the proposed definition of “consumer payment transactions” in general, as well as the related exclusion in paragraph (D) for extensions of credit made using a digital application provided by the person extending credit or its affiliated company.</P>
                    <P>With respect to the inclusion of consumer credit transactions generally, several commenters including an industry provider and two nonprofits generally recognized that pass-through payment wallets facilitate both debit card and credit card transactions (among other types of transactions). However, a nonprofit commenter disagreed with the proposal's inclusion of a creditor's transfer of funds in the definition of “consumer payment transaction.” In its view, expanding the scope of CFPB supervisory authority beyond electronic funds transfers subject to Regulation E could lead companies to invest less in tokenization and anti-fraud technologies and could disincentivize allocation or use of credit for consumers who prefer general-use digital consumer payment applications.</P>
                    <P>With respect to the proposed exclusion in paragraph (D), an industry association stated that the Final Rule should clarify that this exclusion applies to nonbanks that partner with other financial institutions to offer consumer credit products that fund consumer payment transactions. The commenter stated that in these arrangements, the nonbank may provide a consumer-facing digital application through which the consumer accesses an extension of credit made and issued by a third-party financial institution. It stated that the third-party financial institution extends credit by transferring funds directly to the consumer (which the commenter stated would not qualify as a payment by the consumer to another person). Through its mobile application, the nonbank then may facilitate the consumer's use of those funds to make a payment.</P>
                    <P>A banking trade association and a payment network stated that it was uncertain whether the proposed market included the extension of credit through what it referred to as buy-now-pay-later (BNPL) applications. It stated that the rule should provide illustrative examples of covered consumer credit products and clarify whether BNPL applications are eligible for the proposed exclusion in paragraph (D) in light of uncertainty as to whether BNPL providers are extending credit. They also stated that it was unclear why the CFPB would exclude BNPL applications, since they function similarly to other activities described in the Proposed Rule and also have grown rapidly as a means for consumers to pay for the purchase of goods and services. They stated that the CFPB should include participants in what they referred to as the BNPL market within the scope of this rule, or in a separate larger participant rulemaking.</P>
                    <P>Finally, several consumer groups called for the rule to clarify whether proposed paragraph (D) applies to funds transfers by earned wage advance products and services, given that some nonbanks that provide those products and services claim not to be extending consumer credit.</P>
                    <HD SOURCE="HD3">Response to Comments Received</HD>
                    <P>
                        After considering comments on the inclusion of certain digital assets transactions in the proposed definition of “consumer payment transaction,” the CFPB has decided, for purposes of this 
                        <PRTPAGE P="99612"/>
                        Final Rule, to exclude such transactions from coverage under the Rule. The CFPB intends to continue to gather data and information regarding the nature of such transactions and the impact of digital assets transactions on consumers, and to take further action as appropriate. For example, the CFPB has considered comments from industry and others stating that some digital asset products and services, such as so-called unhosted or self-hosted wallets, may not currently be able to collect the data necessary to administer the larger-participant test that would be applied to establish supervisory authority. Based on the limited data and information these commenters provided in their comments, the CFPB is not prepared in this Final Rule to determine whether and how to distinguish between hosted and unhosted wallets. As further discussed below, the CFPB is implementing this change by updating the larger participant threshold to only consider U.S. dollar transactions (
                        <E T="03">see</E>
                         section-by-section analysis of “threshold” below).
                    </P>
                    <P>
                        In addition, for purposes of defining what qualifies as a “consumer payment transaction” covered by the Final Rule, the CFPB has considered the industry association and nonprofit comments, including the survey described above, which indicate that most market participants may be more familiar with assessing where a consumer resides 
                        <SU>222</SU>
                        <FTREF/>
                         than where the consumer is located at the time of any given consumer payment transaction (which can change from transaction to transaction, especially when consumers make payments using mobile phones). Thus, to facilitate administration of the larger-participant test, rather than adopting the proposal to base coverage of consumer payment transactions on whether the consumer is physically located in a State at the time of the transaction, the Final Rule defines “consumer payment transactions” as subject to the rule based on whether the consumer is a U.S. resident, as described further below.
                        <SU>223</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>222</SU>
                             
                            <E T="03">See</E>
                             Reg. E, cmt. 3(a)-3 (stating that regulation E applies to all persons providing EFT services to U.S. residents through U.S.-located accounts). Regulation Z, which governs consumer credit card transactions, also links its scope to residency in a State. 
                            <E T="03">See</E>
                             Reg. Z, cmt. 1(c)-1.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>223</SU>
                             The CFPB declines the industry association suggestion to further narrow “consumer payment transactions” to those that U.S. residents make (1) from a location in a State (2) using a payment card issued by a U.S. bank or a stored value account provided by a U.S. financial institution. The CFPB believes that limiting “consumer payment transactions” to U.S. residents will address the commenter's concerns regarding the inadvertent coverage of foreign residents' transactions using accounts issued by foreign institutions while traveling to the United States. The additional changes the commenter suggests are not necessary or appropriate in the context of this rule. This rulemaking is not defining a market for payment cards or stored value accounts. The market activity is not providing an “account”; rather, it is facilitating consumer payment transactions through a general-use digital consumer payment application. Such activity can facilitate payments from accounts held by third-party financial institutions. Therefore, the nationality of the provider of the underlying account is not necessarily relevant.
                        </P>
                    </FTNT>
                    <P>
                        With regard to comments on the proposed exclusion in paragraph (C) of the definition of “consumer payment transaction,” the CFPB agrees with the consumer group comments that online marketplaces can pose risks to consumers when they sell payments data. Nonetheless, as discussed above, the market definition does not include or exclude activities based on the level of risk they pose. In addition, the law firm commenter reasonably notes that consumers seek out marketplace platforms for the goods and services they offer, including from third-party marketplace sellers.
                        <SU>224</SU>
                        <FTREF/>
                         In that way, consumers seek out a marketplace platform for purposes that differ from the payment-focused purposes for which they seek out a general-use digital consumer payment application. Therefore, the Final Rule treats a merchant or marketplace conducting payment transactions for sales through its own platform as distinct from the activity included in the market defined in this rule.
                        <SU>225</SU>
                        <FTREF/>
                         The CFPB believes that it is therefore appropriate to exclude such transactions from this Final Rule in paragraph (C). Finally, with regard to the consumer group comment that marketplace operators can grow into general-use consumer payment applications, the Rule accounts for that. If those operators do expand into general-use consumer payment applications and qualify as larger participants under this rule, they will be subject to the CFPB's supervisory authority.
                    </P>
                    <FTNT>
                        <P>
                            <SU>224</SU>
                             
                            <E T="03">See also</E>
                             FTC, 
                            <E T="03">Buying From an Online Marketplace</E>
                             (Sept. 2022) (“In general, online marketplaces connect buyers and sellers.”), 
                            <E T="03">https://consumer.ftc.gov/articles/buying-online-marketplace</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>225</SU>
                             Relatedly, the CFPB also disagrees with the law firm commenter to the extent it was suggesting that the proposed exclusion in paragraph (C) would not apply to a payment transaction conducted by an online marketplace on behalf of a third-party seller. Under the terms of the proposed exclusion, when a consumer selects goods or services from an online marketplace and the marketplace operator conducts the consumer payment transaction, that would have been excluded by paragraph (C) even if a third-party seller was involved in the sale.
                        </P>
                    </FTNT>
                    <P>Regarding the definition of “marketplace” in proposed paragraph (C), the CFPB agrees that in some circumstances it may be complex to evaluate the level of prominence of an entity's branding on a marketplace platform. As the proposal noted, major payment network rules include that standard to define a marketplace. However, it is unclear to the CFPB how administrable that standard is in that context. Accordingly, as discussed further below, the Final Rule does not adopt the proposed limitation on the exclusion related to the prominence of branding.</P>
                    <P>
                        The CFPB declines the commenter's further suggestion that the rule expressly incorporate a definition of “marketplace” in the INFORM Act.
                        <SU>226</SU>
                        <FTREF/>
                         While the CFPB believes that platforms that qualify as “online marketplaces” under the INFORM Act generally would qualify as marketplaces for purposes of the exclusion in paragraph (C), the INFORM Act definition is limited to online marketplaces for third party sellers of a “consumer product,” defined by reference to certain “tangible personal property[.]” 
                        <SU>227</SU>
                        <FTREF/>
                         The Proposed Rule referred more broadly to a marketplace for sale of goods or services. And, as noted above, incorporating the INFORM Act is not necessary to ensure exclusion of marketplace platform payments to third-party sellers. For these reasons, the CFPB believes the language in the Proposed Rule is more appropriate in this context and expressly incorporating the definition in the INFORM Act is unnecessary.
                    </P>
                    <FTNT>
                        <P>
                            <SU>226</SU>
                             15 U.S.C. 45f(f)(4).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>227</SU>
                             15 U.S.C. 45f(f)(2) (incorporating definition of “consumer product” in 15 U.S.C. 2301(1) and associated implementing regulations).
                        </P>
                    </FTNT>
                    <P>
                        The CFPB agrees with the industry association commenter that stated that the rule should apply to general-use digital consumer payment applications on a consistent basis, including when consumers click on buttons on merchant or online marketplace websites to access general-use digital consumer payment applications provided by third parties. As the commenter suggested, covering these consumer financial products and services serves the CFPB's statutory objective of ensuring consistent enforcement of Federal consumer financial law to promote fair competition, as discussed further above. However, in response to comments about coverage of consumer payment transactions initiated through online merchant checkout processes that rely on payment buttons, the CFPB seeks to clarify the scope of the market definition. The market consists of providing, through a digital payment application, a general-use covered payment functionality. As discussed above, some market participants have 
                        <PRTPAGE P="99613"/>
                        pursued a deliberate strategy of “embedded finance,” through which nonbank providers of general-use digital consumer payment applications embed them into nonfinancial digital applications. Given the market reliance upon “embedded finance” as a way of promoting general-use digital consumer payment applications, it is reasonable for the Rule not to exclude that activity merely because it is embedded. However, that does not mean the Rule covers the merchant that embeds a payment button on its ecommerce website. When a merchant displays on its ecommerce website a payment button for an unaffiliated third-party's general-use digital consumer payment application, the merchant is not itself providing a covered payment functionality as defined in the Rule. The CFPB understands that these buttons operate as application programming interfaces (APIs) or redirects to launch the general-use digital consumer payment application provided by the third party.
                        <SU>228</SU>
                        <FTREF/>
                         In these circumstances, for purposes of the market definition in this Rule, the third party is providing the general-use digital consumer payment application, not the merchant. For these reasons, the CFPB disagrees with industry commenters' suggestions that the Rule needs an exclusion for ecommerce checkout processes. Further, the CFPB does not agree that, because merchants individually agree to offer payment buttons linking to digital consumer payment applications provided by unaffiliated nonbanks, this indicates that the third party's digital consumer payment application does not have general use. Under the Final Rule, as discussed further below, “general use” is based on whether the consumer can use the digital consumer payment application to pay more than one unaffiliated person. For example, the same payment button may appear on the websites of thousands of different merchants, each of which may have its own acceptance agreement with the provider of the associated general-use digital consumer payment application.
                        <SU>229</SU>
                        <FTREF/>
                         The app associated with the payment button can have general use for the consumer, who can use it to make online purchases virtually anywhere that payment button appears on an ecommerce site on the internet.
                        <SU>230</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>228</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Lotus Lin, 
                            <E T="03">E-commerce APIs Introduction,</E>
                              
                            <E T="03">Medium.com</E>
                             (Mar. 24, 2023) (describing how some providers of general-use digital consumer payment applications provide payment gateway APIs), 
                            <E T="03">https://medium.com/@lotus.lin/e-commerce-apis-introduction-29664558a3b0</E>
                             (last visited Nov. 7, 2024); PYMNTS, 
                            <E T="03">Buy Buttons</E>
                             (“Branded buy buttons are usually placed underneath the standard `buy' or `pay' button on the merchant's checkout page and make it possible for consumers to pay for something without establishing an account with that merchant. Branded buy buttons use payment credentials that consumers have stored with the buy button brands. PayPal is the most widely accepted buy button, with Amazon Pay, Google Pay and Apple Pay also gaining acceptance in apps and online.”), 
                            <E T="03">https://www.pymnts.com/tag/buy-buttons/</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>229</SU>
                             Merchants often accept consumers' payments through well-known digital payment applications by agreeing to the terms and conditions imposed by the provider. One-way digital consumer payment applications gain general use is through acceptance across multiple unaffiliated merchants. 
                            <E T="03">See, e.g.,</E>
                             Apple, 
                            <E T="03">Tap to Pay on iPhone</E>
                             (“Before your app can enable Tap to Pay on iPhone and configure a merchant's device, the merchant must accept the relevant terms and conditions.”), 
                            <E T="03">https://developer.apple.com/design/human-interface-guidelines/tap-to-pay-on-iphone</E>
                             (last visited Nov. 7, 2024); Apple Pay Platform Web Merchant Terms at 
                            <E T="03">https://developer.apple.com/apple-pay/terms/apple-pay-web/</E>
                             (last visited Nov. 7, 2024); Amazon Pay, 
                            <E T="03">Getting started for merchants</E>
                             at 
                            <E T="03">https://pay.amazon.com/business/getting-started</E>
                             (last visited Nov. 7, 2024); Google Pay API Terms of Service at 
                            <E T="03">https://payments.developers.google.com/terms/sellertos</E>
                             (last visited Nov. 7, 2024); Meta Pay onboarding contract described at 
                            <E T="03">https://developers.facebook.com/docs/meta-pay/overview#onboarding</E>
                             (last visited Nov. 7, 2024); PayPal Developer Agreement (Mar. 21, 2022) (describing how holders of business accounts can use APIs and a PayPal Button) at 
                            <E T="03">https://www.paypal.com/us/legalhub/xdeveloper-full?locale.x=en_US</E>
                             (last visited Nov. 7, 2024); Samsung Pay, 
                            <E T="03">Web Payments Integration Guide</E>
                             at 
                            <E T="03">https://developer.samsung.com/internet/android/web-payments-integration-guide.html</E>
                             (last visited Nov. 7, 2024); Venmo Approved Business Account Addendum (effective date Jan. 24, 2019) at 
                            <E T="03">https://venmo.com/legal/us-business-addendum/</E>
                             (last visited Nov. 7, 2024). In addition, a payment processor that online merchants use describes examples of digital wallets that merchants can accept through its software. 
                            <E T="03">See</E>
                             Stripe, 
                            <E T="03">Wallets: Learn about wallet payments with Stripe</E>
                             (stating that the payment processor has “created a single integration for all wallets that works across [its] products” and identifying numerous such payment methods it enables), 
                            <E T="03">https://stripe.com/docs/payments/wallets</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>230</SU>
                             With regard to industry comments that payment buttons do not pose risks to consumers, the CFPB considers the comments about risks to consumers from various types of market activity in the response to general comments above. For the reasons discussed above, this rulemaking is not the vehicle in which the CFPB must assess such risks. Rather, the CFPB takes risk into account when prioritizing entities for examination and scoping examinations. As a result, to the extent that any given larger participant's general-use digital consumer payment application does in fact pose low risks to consumers, then the CFPB supervision program is designed to ensure they are at low risk for examination.
                        </P>
                    </FTNT>
                    <P>The CFPB also seeks to clarify that the CFPB's statement regarding the scope of its authority under CFPA section 1002(15)(A)(vii) was not intended to narrow or otherwise alter the scope of the exclusion in paragraph (C). Paragraph (C) generally excludes transactions in which a merchant or online marketplace conducts payments to itself for sales through its platform. The Proposed Rule discussed the scope of CFPA section 1002(15)(A)(vii) to clarify that the CFPA describes a broader set of activities including in some circumstances those that may be excluded by paragraph (C). In other words, certain payment transactions may fall within the CFPA's authority under the CFPA but not qualify as “consumer payment transactions” for purposes of this larger participant rule. In summary, the CFPB proposed the exclusion in paragraph (C) for the purpose of defining the scope of the market and not the scope of its statutory authority under CFPA section 1002(15)(A)(vii). That said, the CFPB does not share the view expressed by some industry commenters that the proposal's discussion of the exclusion in CFPA section 1002(15)(A)(vii) was contrary to the provision's language or would lead to results that Congress did not intend. However, the validity of this Final Rule does not depend on the correctness of the proposal's interpretation of CFPA section 1002(15)(A)(vii) because, as noted above, the market definition does not encompass the full extent of the CFPB's authority under that provision. Therefore, it is not necessary for the CFPB to further address comments regarding that interpretation in this Final Rule.</P>
                    <P>
                        With regard to the proposed coverage of consumer credit transactions in the definition of “consumer payment transaction,” as several commenters acknowledged, pass-through payment wallets commonly facilitate transactions using both debit cards and credit cards. Because market participants commonly provide digital applications that facilitate consumer payment transactions using both debit card and credit cards (among other payment methods), the Final Rule appropriately includes consumer payment transactions that use both types of payment cards in the market. The CFPB disagrees with the nonprofit commenter to the extent it was suggesting that paragraph (D) should have excluded all consumer credit transactions or that the definition of “consumer payment transaction” should only apply to payments made from a consumer's asset accounts.
                        <SU>231</SU>
                        <FTREF/>
                         Excluding all consumer credit transactions from the market would not be consistent with the way nonbanks often provide these consumer 
                        <PRTPAGE P="99614"/>
                        financial product and services in the market.
                        <SU>232</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>231</SU>
                             Contrary to the commenter's suggestion, by including consumer credit transactions in the definition of “consumer payment transactions,” the Proposed Rule would not have expanded the scope of substantive consumer protections including Regulation E. This rulemaking does not amend or modify Regulation E. As the Proposed Rule explained, a larger participant rule merely establishes supervisory authority and does not impose any new substantive consumer protection regulation.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>232</SU>
                             The Final Rule discusses other comments seeking exclusion of pass-through payment wallets in the discussion of “covered payment functionality” further below.
                        </P>
                    </FTNT>
                    <P>
                        In addition, the commenter did not provide support for its view that including consumer credit transactions in the definition of “consumer payment transactions” could create economic incentives for firms to reduce credit card lines or fraud protections. For several reasons, the CFPB disagrees with the commenter, to the extent it was suggesting that its general concerns over potential incentives warranted excluding general-use digital consumer payment applications' facilitation of consumer credit transactions. First, the commenter did not offer a persuasive rationale for the Rule to treat consumer credit transactions that nonbanks facilitate through digital payment applications differently from payments from asset accounts, when general-use digital consumer payment applications facilitate both, as noted above. Second, the commenter did not explain why it believed that the supervisory authority the rule would establish over nonbank larger participants could disincentivize allocation or usage of revolving lines of consumer credit through general-use digital consumer payment application. Such an impact is unlikely, given that the lender's own app-based lending activity can be excluded by paragraph (D) and the CFPB already supervises much of the lending activity in the credit card market.
                        <SU>233</SU>
                        <FTREF/>
                         Finally, with regard to market participants' investments in tokenization and anti-fraud protections, the commenter did not explain why larger participants would seek to offset the costs of CFPB examination by specifically reducing investment in anti-fraud protections or provide evidence or otherwise show that the rule would create a meaningful disincentive to engage in these activities. The CFPB believes that it is also possible that, after the Final Rule takes effect, larger participants will continue investing in such technologies as part of their efforts to avoid risks to consumers and non-compliance with Federal consumer financial law. As with the commenters' other concerns, the CFPB does not believe that this general concern regarding potential incentives warrants excluding the facilitation of consumer credit transactions from the Final Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>233</SU>
                             Proposed paragraph (D) already clarified that the market definition is not based on the activity of extending credit. Moreover, the CFPB already supervises very large insured depository institutions and insured credit unions, which issue the bulk of consumer credit cards in the United States, as well as their service providers. CFPB, 
                            <E T="03">The Consumer Credit Card Market</E>
                             (Oct. 2023), sec. 2.21 (annual CARD Act report discussing concentration in the credit card issuance market, with the top 30 issuers representing 95 percent of credit card loans in 2022, and 3,800 smaller banks and credit unions accounting for five to six percent of the market). With regard to the potential for larger participants to pass through costs of the Rule to others, the Final Rule discusses this issue in part VII below.
                        </P>
                    </FTNT>
                    <P>
                        However, as the Proposed Rule explained,
                        <SU>234</SU>
                        <FTREF/>
                         by including consumer credit transactions in the definition of “consumer payment transaction,” the CFPB does not seek to define this payments market in a manner that encompasses “consumer lending activities by lenders through their own digital applications.” In particular, the CFPB is not seeking to define a market for extending consumer credit, such as the market it defined in the larger participant rule for automobile financing originations. The CFPB therefore proposed the exclusion in paragraph (D) to maintain a distinction between payments-focused activity (included in the market) and consumer credit originations (excluded by paragraph (D)). The CFPB declines the suggestion by the industry comment to expand the scope of this market to include what it described as the buy-now-pay-later market.
                        <SU>235</SU>
                        <FTREF/>
                         For the same reason, the CFPB agrees with the industry association commenter that a nonbank should be eligible for the exclusion in paragraph (D) when it provides a digital application to initiate a consumer credit transaction and also engages in a set of activities directed at originating the extension of consumer credit, regardless of who is extending the credit (and even if a third-party financial institution such as a bank or credit union is extending the credit). Accordingly, the CFPB is clarifying paragraph (D) in the Final Rule as described below to describe additional activities integral to consumer credit originations that would be part of the eligibility criteria for the exclusion, including brokering, purchasing, or acquiring the extension of credit.
                        <SU>236</SU>
                        <FTREF/>
                         If a nonbank provides a digital application to initiate consumer credit transactions and engages in those other activities in connection with those consumer credit transactions, then the CFPB believes it generally is engaged in consumer credit origination activity, which is not the focus of this rulemaking. By excluding extensions of consumer credit in the circumstances described in paragraph (D), the Final Rule excludes the transfer of funds resulting from that extension of credit, such as a consumer's payment to a merchant for goods and services from the funds provided by a credit card issuer. In light of the distinguishing characteristics of loan origination activities and the other reasons set forth above, the Bureau declines to include such loan origination activity in the market for which this Final Rule defines larger participants. As the Bureau has explained, this larger-participant rulemaking is only one in a series. Nothing in this Final Rule precludes the Bureau from considering in future larger-participant rulemakings other markets for consumer financial products or services that might include certain types of consumer credit origination activity.
                    </P>
                    <FTNT>
                        <P>
                            <SU>234</SU>
                             88 FR 80197 at 80204.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>235</SU>
                             
                            <E T="03">See also</E>
                             CFPB, Interpretive Rule, Truth in Lending (Regulation Z); Use of Digital User Accounts to Access Buy Now, Pay Later Loans, 89 FR 47068, 47071 (May 31, 2024) (BNPL Interpretive Rule) (discussing how BNPL providers facilitate extension of consumer credit marketed as BNPL loans). The CFPB also notes that the exclusion in paragraph (D) is not limited to extension of consumer credit by “creditors” as defined in TILA.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>236</SU>
                             
                            <E T="03">See, e.g.,</E>
                             CFPB section 1002(15)(A)(i) (describing activities associated with consumer credit origination “including acquiring, purchasing, selling, brokering, or other extensions of credit[]”); CFPB Automobile Financing Larger Participant Rule, 12 CFR 1090.108(a)(i)(
                            <E T="03">4</E>
                            ) (defining automobile financing “originations” as including “[p]urchases or acquisitions” of automobile purchase loans, their refinancings, and leases).
                        </P>
                    </FTNT>
                    <P>
                        However, as revised, paragraph (D) does not exclude pass-through payment wallet functionalities that facilitate consumer payments from accounts issued by third-party financial institutions that the pass-through payment wallet functionality provider did not originate by engaging in the activities described above (such as extending, brokering, acquiring, or purchasing the extension of credit). As a result, the definition of “consumer payment transaction” adopted in the Final Rule still captures the general activities of pass-through payment wallets, which often facilitate consumer payment transactions, whether through funds they hold, funds they receive, or debit cards or credit cards provided by third-party financial institutions.
                        <SU>237</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>237</SU>
                             This approach is consistent with other Federal consumer financial laws and their implementing regulations, which treat that activity as part of a consumer payments market. 
                            <E T="03">See e.g.,</E>
                             Regulation Z, cmt. 13(a)(3)-2 (describing a “third-party payment intermediary, such as a person-to-person internet payment service, funded through the use of a consumer's open-end credit plan[ ]”). In light of the examples discussed in this paragraph, the CFPB does not believe changes to paragraph (D) or specification of illustrative examples in that paragraph are needed. It also is not the purpose of this Final Rule to define who is extending credit, which will depend on facts and circumstances that are beyond the scope of this rulemaking or the comments received.
                        </P>
                    </FTNT>
                    <P>
                        The CFPB also seeks to provide clarification about the scope of 
                        <PRTPAGE P="99615"/>
                        “consumer payment transactions” in light of the consumer groups' comment noting that some providers of earned wage products do not treat their transactions as extensions of consumer credit, and seeking clarification of whether they qualify as “consumer payment transactions” included in the market. Specifically, the CFPB seeks to clarify how the proposed definition of “consumer payment transaction” applied to a payment by or on behalf of a consumer to another person. As explained above, “consumer payment transaction” for purposes of the proposed market definition did not include “transfers between a consumer's own deposit accounts[ or] transfers between a consumer deposit account and the same consumer's stored value account held at another financial institution, such as loading or redemptions[.]” 
                        <SU>238</SU>
                        <FTREF/>
                         Consistent with that approach, the CFPB also did not intend and does not believe that earned wage products generally would be included in the market because they transfer wages belonging to or advanced on behalf of a consumer to that same consumer.
                        <SU>239</SU>
                        <FTREF/>
                         Similarly, for clarity and administrability, the CFPB does not interpret the market definition as including payments by or on behalf of a consumer to other accounts the consumer owns or controls in which another person, such as a spouse co-owner or minor child, also holds an interest.
                        <SU>240</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>238</SU>
                             88 FR 80197 at 80203.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>239</SU>
                             
                            <E T="03">See, e.g.,</E>
                             CFPB, 
                            <E T="03">Data Spotlight: Developments in the Paycheck Advance Market</E>
                             (July 18, 2024) (“Earned wage products provide workers access, before their payday, to a portion of their earned but unpaid wages or to funds that purport to equal or approximate a portion of their unpaid wages.”), 
                            <E T="03">https://www.consumerfinance.gov/data-research/research-reports/data-spotlight-developments-in-the-paycheck-advance-market/</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>240</SU>
                             For example, a payment functionality usable for an adult to transfer funds to K-12 school lunch accounts for the benefit of two or more minor children would not be included in the market because the adult transferor typically owns or controls the recipient account.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Final Rule</HD>
                    <P>For the reasons described above, the CFPB adopts the proposed definition of “consumer payment transaction” with four changes, as described below.</P>
                    <P>First, for the reasons discussed above in the responses to comments, the Final Rule covers consumer payment transactions made by or on behalf of a consumer “who resides in” a State, rather than a consumer “physically located” in a State as stated in the Proposed Rule. As a result, when a nonbank provides a general-use digital consumer payment application to a person who does not reside in a State, the transactions it facilitates for that person would not be included in the market. The CFPB believes that this change will make the larger-participant test for this Final Rule more administrable because, unlike a consumer's physical location, a consumer's country of residence does not constantly change. Since the comments indicate that some companies may not currently collect data on consumer location at the time of making a payment, this change in the Final Rule also will avoid inadvertently creating a potential incentive for market participants to collect such data to determine larger participant status.</P>
                    <P>Second, for reasons discussed above in the responses to comments, the Final Rule clarifies the exclusion in paragraph (C) for payment transactions conducted by certain merchants and marketplace operators. Specifically, the Final Rule does not adopt the proposed requirement that the marketplace be operated “prominently in the name of” the excluded person or its affiliated company. This change will make the larger-participant test more administrable by avoiding the need to evaluate the form or extent of name branding when evaluating which entities qualify for the exclusion, as discussed above.</P>
                    <P>Third, the Final Rule modifies paragraph (C) to confirm that the Final Rule excludes a payment transaction conducted by a person for a donation to a fundraiser that a consumer selected from the person or its affiliated company's platform. In the Proposed Rule, the CFPB did not intend to include payment platforms provided solely to facilitate donations to fundraisers. Such donation platforms would not have had “general use” under the proposal and therefore transactions would not have been within the scope of the proposed market. Because the Final Rule revises the definition of “general use” as described below to generally apply to payment functionalities that are usable to facilitate consumer payment transactions to more than one unaffiliated person, a platform that facilitates donations to multiple unaffiliated persons could be part of the market in some circumstances in the absence of another exclusion. Thus, consistent with the scope of the Proposed Rule, the Final Rule modifies the definition of “consumer payment transaction” to clarify that those transactions would not be in the market.</P>
                    <P>Fourth, for the reasons discussed above in responses to comments, the Final Rule clarifies paragraph (D) to exclude extensions of consumer credit initiated through a digital application that is provided by a person who is extending, brokering, acquiring, or purchasing the credit or that person's affiliated company. As explained above, by referring to digital application-based initiations of consumer credit transactions by persons engaged in these additional activities of brokering, acquiring, or purchasing the extension of credit, the exclusion in paragraph (D) better defines a payments market in this Rule by excluding activities that are distinguishable as being part of a market for consumer credit originations.</P>
                    <HD SOURCE="HD3">Covered Payment Functionality</HD>
                    <HD SOURCE="HD3">Proposed Rule</HD>
                    <P>The proposed market definition would have applied to providing covered payment functionalities through a digital application for a consumer's general use in making payment transactions. Proposed § 1090.109(a)(2) would have defined two types of payment functionalities as covered payment functionalities: a funds transfer functionality and a wallet functionality. Proposed § 1090.109(a)(2) would have defined each of those two functionalities as described below. The CFPB requested common on each proposed definition, and whether it should be modified, and if so, how and why.</P>
                    <P>A nonbank covered person would have been participating in the proposed market if its market activity includes only one of the two functionalities, or both functionalities. Similarly, a particular digital application may provide one or both functionalities. A nonbank's level of participation in the proposed market would not have been based on which functionality is involved; rather, it would have been based on the annual covered payment transaction volume as defined in proposed § 1090.109(b).</P>
                    <P>
                        The CFPB proposed to treat these two covered payment functionalities as part of a single market for general-use digital consumer payment applications. As the Proposed Rule noted, the technological and commercial processes these two payment functionalities use to facilitate consumer payments may differ in some ways. However, consumers can use both types of covered payment functionalities for the same common purposes, such as to make payments for retail spending and sending money to friends and family. For example, a funds transfer functionality may transfer a consumer's funds in a linked stored value account to a merchant to pay for goods or services, or to friends or 
                        <PRTPAGE P="99616"/>
                        family. Similarly, a wallet functionality may transmit a stored payment credential to facilitate a consumer's payment to a merchant or to friends and family. Indeed, the same nonbank covered person may provide a digital application that encompasses both functionalities depending on the payment method a consumer chooses. For example, a nonbank covered person's digital application may allow the consumer to access a wallet functionality to make a payment using a credit card for which a third party extends credit, or a funds transfer functionality to make a payment from a stored value account the nonbank provides. The role these two functionalities play in a single market therefore was driven by their common uses, not their specific technological and commercial processes.
                    </P>
                    <HD SOURCE="HD3">(A) Funds Transfer Functionality</HD>
                    <P>
                        The first payment functionality included in the definition in covered payment functionality in proposed § 1090.109(a)(2) was a funds transfer functionality. Paragraph (A) would have defined the term “funds transfer functionality” for the purpose of this rule to mean, in connection with a consumer payment transaction: (
                        <E T="03">1</E>
                        ) receiving funds for the purpose of transmitting them; or (
                        <E T="03">2</E>
                        ) accepting and transmitting payment instructions.
                        <SU>241</SU>
                        <FTREF/>
                         These two types of funds transfer functionalities generally described how nonbanks help to transfer a consumer's funds to other persons, sometimes referred to as P2P transfers. The nonbank either already holds or receives the consumer's funds for the purpose of transferring them, or it transmits the consumers payment instructions to another person who does so. Paragraph (
                        <E T="03">1</E>
                        ), for example, would have applied to a nonbank transferring funds it holds for the consumer, such as in a stored value account, to another person for personal, family, or household purposes. Even if the nonbank providing the funds transfer functionality does not hold or receive the funds to be transferred, it generally would have qualified under paragraph (
                        <E T="03">2</E>
                        ) by transmitting the consumer's payment instructions to the person that does hold or receive the funds for transfer. Paragraph (
                        <E T="03">2</E>
                        ), for example, would have applied to a nonbank that accepts a consumer's instruction to send money from the consumer's banking deposit account to another person for personal, family, or household purposes, and then transmits that instruction to other persons to accomplish the fund transfer. As the Proposed Rule noted, a common way a nonbank may engage in such activities is by acting as a third-party intermediary to initiate an electronic fund transfer through the automated clearinghouse (ACH) network. Another common way to do so noted in the Proposed Rule is to transmit the payment instructions to a partner depository institution. However, in some circumstances, a nonbank may be able to execute a consumer's payment instructions on its own, such as by debiting the consumer's account and crediting the account of the friend or family member, without transmitting the payment instructions to another person. In those circumstances, the nonbank generally would have been covered by paragraph (
                        <E T="03">1</E>
                        ) because, to conduct the transaction in this manner, the nonbank typically would be holding or receiving the funds being transferred.
                    </P>
                    <FTNT>
                        <P>
                            <SU>241</SU>
                             As stated in the Proposed Rule, 88 FR 80197 at 80205 n.64, such funds transfer services are consumer financial products or services under the CFPA. 
                            <E T="03">See</E>
                             12 U.S.C. 5481(5)(A) (defining “consumer financial product or service” to mean a financial product or service “offered or provided for use by consumers primarily for personal, family, or household purposes[ ]”). The CFPA defines a “financial product or service” to include “engaging in deposit-taking activities, transmitting or exchanging funds, or otherwise acting as a custodian of funds or any financial instrument for use by or on behalf of a consumer[.]” 12 U.S.C. 5481(15)(A)(iv); 
                            <E T="03">see also</E>
                             12 U.S.C. 5481(29) (defining “transmitting or exchanging funds”). The CFPA also defines a “financial product or service” to include generally “providing payments or other financial data processing products or services to a consumer by any technological means, including processing or storing financial or banking data for any payment instrument,” subject to certain exceptions. 12 U.S.C. 5481(15)(A)(vii).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(B) Wallet Functionality</HD>
                    <P>
                        The other payment functionality included in the definition in covered payment functionality in proposed § 1090.109(a)(1) was a wallet functionality. Paragraph (B) would have defined the term wallet functionality as a product or service that: (
                        <E T="03">1</E>
                        ) stores account or payment credentials, including in encrypted or tokenized form; and (
                        <E T="03">2</E>
                        ) transmits, routes, or otherwise processes such stored account or payment credentials to facilitate a consumer payment transaction.
                        <SU>242</SU>
                        <FTREF/>
                         Through this proposed definition, the proposed market would have included payment functionalities that work together first to store account or payment credentials and second, to process such data to facilitate a consumer payment transaction.
                    </P>
                    <FTNT>
                        <P>
                            <SU>242</SU>
                             As stated in the Proposed Rule, 88 FR 80197 at 80205 n.65, the wallet functionality as described above is a consumer financial product or service under the CFPA. 
                            <E T="03">See</E>
                             12 U.S.C. 5481(15)(A)(vii) (defining “financial product or service” to include “providing payments or other financial data processing products or services to a consumer by any technological means, including processing or storing financial or banking data for any payment instrument, or through any payments systems or network used for processing payments data, including payments made through an online banking system or mobile telecommunications network,” subject to certain exceptions); 
                            <E T="03">see also</E>
                             12 U.S.C. 5481(5)(A) (defining “consumer financial product or service” to mean a financial product or service “offered or provided for use by consumers primarily for personal, family, or household purposes”).
                        </P>
                    </FTNT>
                    <P>
                        As indicated above, paragraph (B)(
                        <E T="03">1</E>
                        ) of the proposed definition of “wallet functionality” would have clarified that “account or payment credentials” can take the form of encrypted or tokenized data. Storage of account or payment credentials in these forms would have satisfied the first prong of the “wallet functionality” definition. For example, the first prong would have been satisfied by storing an encrypted version of a payment account number or a token 
                        <SU>243</SU>
                        <FTREF/>
                         that is specifically derived from or otherwise associated with a consumer's payment account number.
                    </P>
                    <FTNT>
                        <P>
                            <SU>243</SU>
                             As the Proposed Rule noted, tokens now are often used for wallets to store a variety of payment credentials including network-branded payment cards. 
                            <E T="03">See, e.g.,</E>
                             Manya Saini, 
                            <E T="03">Visa tokens overtake payments giant's physical cards in circulation,</E>
                              
                            <E T="03">Reuters.com</E>
                             (Aug. 24, 2022) (describing how VISA's token service “replaces 16-digital Visa account numbers with a token that only Visa can unlock, protecting the underlying account information.”), 
                            <E T="03">https://www.reuters.com/business/finance/visa-tokens-overtake-payments-giants-physical-cards-circulation-2022-08-24/</E>
                             (last visited Oct. 23, 2023); 
                            <E T="03">In re Mastercard Inc.,</E>
                             FTC Docket No. C-4795 (Complaint dated May 13, 2023) ¶¶ 24-32 (describing how payment cards are “tokenized” for use digital wallets by “replacing the cardholder's primary account number (`PAN') [ ] with a different number to protect the PAN during certain stages of the [ ] transaction.”), 
                            <E T="03">https://www.ftc.gov/system/files/ftc_gov/pdf/2010011C4795MastercardDurbinComplaint.pdf</E>
                             (last visited Oct. 23, 2023); American Express, 
                            <E T="03">American Express Tokenization Service, https://network.americanexpress.com/globalnetwork/products-and-services/security/tokenization-service/</E>
                             (last visited Oct. 23, 2023); Discover Digital Exchange, 
                            <E T="03">Powering digital payment experiences, https://www.discoverglobalnetwork.com/solutions/technology-payment-platforms/discover-digital-exchange-ddx/</E>
                             (last visited Oct. 23, 2023).
                        </P>
                    </FTNT>
                    <P>
                        Paragraph (B)(
                        <E T="03">2</E>
                        ) of the proposed definition of “wallet functionality” described the types of processing of stored account or payment credentials that would have fallen within this definition. For example, consumers commonly use wallet functionalities provided through digital applications to pay for purchases of goods or services on merchant websites. To facilitate such a consumer payment transaction, a consumer financial product or service may transmit a stored payment credential to a merchant, its payment processor, or its website designed to accept payment credentials provided by the wallet functionality. This type of product or service would have been covered by paragraph (B)(
                        <E T="03">2</E>
                        ).
                        <PRTPAGE P="99617"/>
                    </P>
                    <HD SOURCE="HD3">Comments Received</HD>
                    <P>Some commenters supported the inclusion of the range of payment functionalities described in the proposed definition of “covered payment functionality.” For example, one nonprofit stated that its members surveyed generally supported the proposed definitions of “funds transfer functionality” and “wallet functionality” and that the latter adequately described digital wallets in use today. A merchant trade association stated that the market should include digital wallet offerings from nonbanks, including when offered by nonbanks through joint ventures or partnerships with banks or payment networks. In their view, if a nonbank develops and determines how the service operates, then regardless of the involvement by a bank or payment network, the CFPB should supervise the nonbank to ensure fair competition. In addition, as described at the outset of the section-by-section analysis above, other commenters including consumer groups and banking industry associations generally supported the Proposed Rule without raising concerns regarding the proposed definition of “covered payment functionality.”</P>
                    <P>On the other hand, as discussed in the section-by-section analysis of general comments on the proposed market definition in § 1090.109(a)(1) above, several industry and nonprofit commenters stated that the Proposed Rule inappropriately grouped what they described as different markets, including funds transfer functionalities and wallet functionalities, as well as a number of subtypes of each, into a single market. The Final Rule responds to those comments above. In addition, as described below, some commenters stated that the rule should exclude certain activities from the proposed definition of “covered payment functionality.” These comments either sought to remove entire components of the proposed definition of “covered payment functionality,” to limit the scope of the term in the context of nonbank/bank partnerships, or to clarify that the term did not include what they described as business-to-business services.</P>
                    <P>
                        Some comments stated that the market definition should not include what they called payment-method or pass-through wallets captured by the proposed definition of “wallet functionality.” For consistency, the Final Rule refers to these products and services as pass-through payment wallets. A nonbank firm stated that the rule should exclude from the definition of “wallet functionality” the storage and transmission of payment credentials for accounts held at or issued by third-party financial institutions (which it called a “payment method wallet”). In its view, payment method wallets do not provide consumers access to their funds because they do not store the funds.
                        <SU>244</SU>
                        <FTREF/>
                         It stated that supervising the nonbank provider of the payment method wallet would provide no benefit beyond existing supervision by CFPB and other Federal agencies of these third-party financial institutions, which includes supervision for compliance with protections under Regulation Z against billing errors in credit card transactions and Regulation E in debit card transactions. In support of that conclusion, it outlined its position that payment method wallets are not subject to EFTA or Regulation E because they do not issue an asset account used to make the payment and they do not provide an “access device” for an asset account because any stored debit card is the access device for purposes of Regulation E.
                        <SU>245</SU>
                        <FTREF/>
                         Some industry association commenters also stated that some market participants were not financial institutions under either Regulation E or under Regulation P implementing the GLBA, and that the Proposed Rule therefore did not articulate why CFPB supervision of those firms would be beneficial or overstated its benefits.
                        <SU>246</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>244</SU>
                             In its view, they also do not receive funds for purpose of transmitting them on behalf of the consumer because they generally agree to accept payments as an agent of the merchant.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>245</SU>
                             Another industry association suggested that the Final Rule clarify whether the CFPB considers a mobile phone to be an access device for purposes of Regulation E. The commenter also stated that entities may face competing obligations or burdens under this larger participant rule and a personal financial data rights rule the CFPB may adopt. It stated that both rules would apply to “digital wallets” but, in its view, define them differently. It called for the CFPB to establish a regulatory safe harbor under which compliance with a personal financial data rights rule does not determine application of the larger participant rule, and vice-versa.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>246</SU>
                             The nonbank firm mentioned above generally stated that payment method wallets generally posed low if any risk to consumers and stated that the Proposed Rule did not establish that payment method wallets pose any special or heightened risk to consumers' data related to GLBA/Regulation P compliance compared with other products and services not included within the market definition. In response to general comments further above, the Final Rule responds to comments about the consideration of risk in larger participant rules.
                        </P>
                    </FTNT>
                    <P>
                        A law firm commenter also stated that the term “wallet functionality” should be removed from the market definition. It stated that, because the proposal defined “consumer payment transaction” as involving a transfer of funds, all such transactions will involve a “funds transfer functionality” that will always be subject to supervision. It also viewed providers of a “wallet functionality” that does not hold and move funds as excluded from the scope of EFTA and Regulation E. As a result, in its view, supervision of persons providing a “wallet functionality” would be unnecessary, duplicative, and not responsive to the same level of risk to consumers.
                        <SU>247</SU>
                        <FTREF/>
                         Alternatively, this commenter and another industry trade association stated that the rule should address uncertainty over potential coverage of internet browsers; the Final Rule describes and responds to those comments in more detail in the section-by-section analysis of “digital application” further below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>247</SU>
                             Again, as noted above, the Final Rule summarizes and responds to comments regarding the consideration of risk to consumers at the outset of the section-by-section analysis above.
                        </P>
                    </FTNT>
                    <P>An industry association stated that the rule should narrow the proposed definition of “wallet functionality” by dropping the reference to storage and transmission of payment credentials that are in “tokenized form.” It noted that consumers' personal identification information, such as a driver's license, can be tokenized to create digital “identity credentials” that consumers can use for what it described as non-financial purposes such as identity verification and “commerce purposes.” It stated that if the rule does not remove the reference to “tokenized form” form, then it should clarify that term only applies to tokenization of what it called “existing” payment credentials. It stated that the clarification was necessary to ensure that the market definition does not cover non-financial applications of tokenization that the CFPB lacks the authority to regulate.</P>
                    <P>
                        Finally, two industry associations stated that the proposed term “wallet functionality” includes “pass-through digital wallets” that cannot legally be included in the market definition because they qualify as “electronic conduit services” defined in CFPA section 1002(15). They described pass-through payment wallets as holding and passing on payment information, such as card numbers, and as maintaining a record of such information. They stated that “pass-through digital wallets” are electronic conduit services because only data, not funds, flow through the wallet.
                        <SU>248</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>248</SU>
                             One of these commenters noted that certain pass-through payment wallets may participate in the flow of funds when they act as a third-party payment processor, but even in those circumstances, pass-through payment wallets should not be covered either because they, in the commenter's view, pose low risk as evidenced by their being excluded from money transmitter laws.
                        </P>
                    </FTNT>
                    <PRTPAGE P="99618"/>
                    <P>Other industry comments called for removing part of the definition of “funds transfer functionality.” A few industry trade associations stated that the rule should remove accepting and transmitting payment instructions from the definition of “funds transfer functionality.” They stated that many firms transmit payment instructions, and State money transmitter laws generally exclude this type of payment processing because, in their view, that is a lower-risk activity due the payment processor not holding or receiving funds, which instead are held at Federally-regulated financial institutions.</P>
                    <P>
                        Other industry comments called for excluding activities that do not involve the holding or receipt of funds in certain circumstances, which they generally described as posing lower risk than other market participants. An industry association and a nonbank firm stated that the rule should exclude nonbanks providing payment services in partnership with or as service providers to depository institutions. According to their description, these nonbanks typically develop, market, and provide a digital application to consumers on behalf of as and a service provider to a bank or credit union. They described the nonbank as serving solely as a service provider, regardless of whether the digital application is branded in the name of the nonbank. They stated that the nonbank provides these services solely to establish the consumer as a customer of the bank or credit union and to facilitate consumer payment transactions from accounts held by the bank or credit union either in the name of or “for benefit of” the consumer. They stated that the bank or credit union processes the consumer payment transactions. For example, the nonbank may receive and transmit the consumer's payment instructions to the partner bank to transmit funds. The nonbank commenter acknowledged that covering nonbank activities that facilitate payments from accounts held by nonbanks would help align supervision of nonbanks and banks. However, in the view of these commenters, facilitating payments of funds held in accounts at partner banks or credit unions is a different activity that should not be included in the market. For example, compared to what they described as “stand-alone” nonbank payment applications, they stated the digital applications that nonbanks provide as partners with banks and credit unions pose lower risk to consumers due to existing Federal prudential regulators' oversight of the banks and credit unions and their third-party relationships.
                        <SU>249</SU>
                        <FTREF/>
                         These commenters also stated that, in their view, excluding this type of activity from the market definition (or otherwise from the larger-participant test) would prevent duplicative Federal supervision between the CFPB and prudential banking regulators. One of these commenters also stated the exclusion would be consistent with the rule's goal of defining the market to exclude taking of deposits.
                        <SU>250</SU>
                        <FTREF/>
                         For example, this commenter stated that this type of activity is subject not only to the prohibition against unfair, deceptive, and abusive practices, but also to consumer protections governing deposit accounts. They also stated that, to meet the expectations of Federal prudential banking regulators, banks have extensive mechanisms for overseeing the third-party nonbanks that provide the consumer-facing or “front end” digital application, and that these mechanisms further reduce risks posed by these activities. Another industry association called for CFPB to make unspecified clarifications to the scope and requirements of the Proposed Rule to ensure close coordination between the CFPB and other regulators to prevent duplicative or diverging regulatory requirements of nonbanks that partner with depository institutions and credit unions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>249</SU>
                             These commenters also asserted that existing oversight of the depository institutions provides sufficient oversight of this type of activity; the Final Rule addresses comments regarding existing oversight above. One commenter also suggested that establishing oversight in this rulemaking would violate a memorandum of understanding between the CFPB and prudential regulators that called for the CFPB to prevent unnecessary duplication of effort. However, the comment misconstrued that memorandum of understanding. As explained further above in the discussion of comments on existing oversight, that memorandum of understanding does not seek to prevent overlapping authority; instead, where overlapping authority exists, it provides mechanisms for coordinating across agencies to minimize the types of duplication these commenters mentioned.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>250</SU>
                             The nonbank firm also suggested that the Proposed Rule appeared to purport to establish supervisory authority over a nonbank that acts as a service provider to a bank with assets of $10 billion or less and not to a substantial number of such banks. In its view, such a service provider is subject to the exclusive supervision of a Federal banking agency, and assertion of CFPB supervisory authority over the service provider would conflict with CFPA section 1026(e), which only establishes authority over service providers to a substantial number of such banks. It stated that the CFPB may not take supervisory or enforcement action directly against such a service provider, and instead may only take certain actions specified in the CFPA related to the service provider, such as accessing the Federal prudential regulators' reports of examination of the service provider under CFPA section 1022(c)(6)(B).
                        </P>
                    </FTNT>
                    <P>
                        In addition, a few industry associations requested that the rule clarify that the market definition does not include activities that they described in four different ways as business-to-business services that nonbanks provide in connection with consumer payment transactions for the purchase of goods and services. First, both commenters stated that the market definition should exclude any portions of the process or lifecycle associated with a consumer payment transaction that involve exclusively business-to-business transactions and do not directly involve the consumer. Second, both commenters stated that companies that provide merchant payment processing would fall within the market definition (and, as noted above, disagreed with that result). However, one of the commenters pointed to what it viewed as significant uncertainty over whether the market definition included what it described as traditional third-party payment processing by entities that enable merchants to accept payments. Third, both commenters also referred to what they called covered payment functionalities provided by a nonbank that its merchant customer offers to consumers, who use the end product. Although the consumer is an end user, they described such nonbank activities as facilitating application functionalities between businesses that should be excluded from the market definition.
                        <SU>251</SU>
                        <FTREF/>
                         Fourth, one of these commenters stated that, to avoid what it described as an unintended expansion of the scope of the proposal, the CFPB should clarify that the rule does not include what it described as “back-office service providers or other vendors.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>251</SU>
                             This commenter suggested this exclusion appear in the definition of “digital application.” However, the Final Rule considers the comment more broadly in relation to other comments seeking exclusion of what they described as business-to-business offerings.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Response to Comments Received</HD>
                    <P>
                        As discussed above in the Final Rule's response to comments on the market definition in proposed § 1090.109(a)(1), the CFPB disagrees with comments suggesting that the market should be confined to entities that receive or hold the funds being transferred in consumer payment transactions, or that the market should cover consumer payment transactions that transfer funds from nonbank accounts but not from accounts provided by banks or credit unions. As the Proposed Rule explained, the CFPB is seeking to define a market for general-use digital consumer payment applications that facilitate consumer payment transactions that transfer funds by or on behalf of the consumer, 
                        <PRTPAGE P="99619"/>
                        regardless of where those funds may be held. As some industry association comments regarding bank/fintech partnerships acknowledged, the CPFB is not seeking to define a market for taking deposits in this rule. Consistent with that purpose, nothing in the proposed definition of “covered payment functionality” referred to engaging in the “taking of deposits.” Relatedly, holding or receiving funds is not a requirement for facilitating consumer payment transactions and participating in the market. Specifically, neither the form of “funds transfer functionality” described in paragraph (
                        <E T="03">2</E>
                        ) of the definition of that term nor the proposed “wallet functionality” definition were based on receiving or holding funds.
                        <SU>252</SU>
                        <FTREF/>
                         Excluding nonbanks that do not hold or receive funds (or that only facilitate payment of funds held at partner depository institutions) would result in an unduly narrow market definition that essentially is limited to money transmission, ignoring the role that other nonbank activities play in initiating other very common consumer payment transactions through general-use digital consumer payment applications. For example, consumers have significantly increased their use of digital wallets to make payments using network-branded payment cards issued by third-party financial institutions.
                        <SU>253</SU>
                        <FTREF/>
                         These include consumer credit card transactions in which the lender transfers funds on behalf of the consumer as part of an extension of credit. In these transactions and in debit card transactions, the nonbank may not hold or receive funds but it does initiate the consumer payment transaction at the consumer's request by receiving and transmitting payment instructions or storing and transmitting payment credentials.
                        <SU>254</SU>
                        <FTREF/>
                         And in this way, it also facilitates consumers' access to their funds, contrary to the suggestion by an industry commenter.
                    </P>
                    <FTNT>
                        <P>
                            <SU>252</SU>
                             In addition, while the first prong of “funds transfer functionality” refers to receiving funds, that prong requires that the funds be received for the purpose of transmitting them.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>253</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Worldpay, 
                            <E T="03">2024 Global Payments Report,</E>
                             at 6 (describing “key insight[ ]” that “[c]onsumer attraction to digital wallets isn't a turn away from cards. In card-dominated markets, card spend is simply shifting to digital wallets like Apple Pay, Google Pay and PayPal. Viewed in total, card transaction values are at an all-time high and continue to rise.”), at 148 (reporting use of payment cards through digital wallets under the heading “digital wallets” and separately reporting “direct card use” for debit cards and credit cards), 
                            <E T="03">https://worldpay.globalpaymentsreport.com/</E>
                             (last downloaded Aug. 22, 2024); Worldpay, Press Release, 
                            <E T="03">Worldpay Global Payments Report 2024: Digital Wallet Maturity Ushers in a Golden Age of Payments</E>
                             (Mar. 21, 2024) (finding that “in the U.S., credit and debit cards fund 65 percent of digital wallets in the market.”), 
                            <E T="03">https://www.businesswire.com/news/home/20240321666428/en/Worldpay-Global-Payments-Report-2024-Digital-Wallet-Maturity-Ushers-in-a-Golden-Age-of-Payments</E>
                             (last visited Nov. 7, 2024); 
                            <E T="03">How Are Consumers Funding Mobile Wallets?</E>
                             PaymentsJournal (Apr. 1, 2024) (reporting that most consumers use a debit card or credit card to fund a mobile wallet, versus 36 percent who use the balance within the app, based on Christopher Miller, 
                            <E T="03">2023 North American PaymentInsights: U.S.: Financial Services and Emerging Technologies Exhibit,</E>
                             Javelin Research (July 21, 2023)), 
                            <E T="03">https://javelinstrategy.com/research/2023-north-american-paymentinsights-us-financial-services-and-emerging-technologies</E>
                             (last visited Nov. 7, 2024)), 
                            <E T="03">https://www.paymentsjournal.com/how-are-consumers-funding-mobile-wallets/</E>
                             (last visited Nov. 7, 2024); Steve Cocheo, 
                            <E T="03">Consumers Have Embraced Digital Wallets. But They Also Want Them to Be Better,</E>
                             The Financial Brand (Mar. 28, 2024) (discussing the “overlap between digital wallets and cards.”), 
                            <E T="03">https://thefinancialbrand.com/news/payments-trends/digital-wallets-absorb-credit-cards-as-they-boom-worldwide-176418/</E>
                             (last visited Oct. 24, 2024); J.D. Power, 
                            <E T="03">Debit Cards Still Lead in Customer Satisfaction and Utilization, Even as Use of Digital Wallets Grows</E>
                             (May 23, 2024) (survey projecting “slow deterioration” in share of customers using physical version of debit cards as they opt instead to use the debit cards as a payment method stored in digital wallets), 
                            <E T="03">https://www.jdpower.com/business/resources/debit-cards-still-lead-customer-satisfaction-and-utilization-even-use-digital</E>
                             (last visited Nov. 7, 2024): Nicole Murgia &amp; Lily Varon, 
                            <E T="03">Digital Payments Have Surpassed Traditional Payments In The US,</E>
                             Forrester Research (Feb. 29, 2024) (reporting survey data finding that “69% of U[.]S[.] online adults said that they had used a digital payment method over the past three months to make a purchase. That's well ahead of the just over half of online adults who used a credit card or who used cash. That said, it's important to remember that cards often are the underlying payment instrument in growing digital payment scenarios.”), 
                            <E T="03">https://www.forrester.com/blogs/digital-payments-have-surpassed-traditional-payments-in-the-us/</E>
                             (last visited Nov. 7, 2024); Mastercard, 
                            <E T="03">Mastercard reimagines online checkout; commits to reaching 100% e-commerce tokenization by 2030 in Europe</E>
                             (June 11, 2024), 
                            <E T="03">https://www.mastercard.com/news/press/2024/june/mastercard-reimagines-online-checkout-commits-to-reaching-100-e-commerce-tokenization-by-2030-in-europe/</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>254</SU>
                             The Final Rule responds to general comments about the applicability of Regulation E and Regulation P in the section-by-section analysis of the market definition further above.
                        </P>
                    </FTNT>
                    <P>
                        Excluding these activities from the market would result in a gap in the CFPB's supervisory oversight at the very start of the chain of activities that lead a consumer payment transaction to occur. Yet consumers naturally may look to the provider of that consumer financial product or service for help resolving problems. And a credit union trade association commenter stated that credit union customers can find it difficult to obtain prompt resolution of errors that involve a nonbank platform. A group of State attorneys general also cited a survey indicating that more 77 percent of consumers encountered difficulty obtaining resolution from the nonbank's customer service.
                        <SU>255</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>255</SU>
                             
                            <E T="03">Consumer Reports P2P Survey</E>
                             at 9 (reporting results of questions about services provided by payment apps such as PayPal, Venmo, Apple Pay, Google Pay, or Zelle). The Proposed Rule, 88 FR 80197 at 80200 n.25, also identified this survey.
                        </P>
                    </FTNT>
                    <P>
                        As to industry commenter claims that nonbank market participants pose lower risk because the funds consumers use to make payments are held by other regulated and supervised financial institutions such as banks, credit unions, or money transmitters, this rulemaking does not define who is included or excluded in the market based on findings of relative risk. More specifically, the CFPB does not assess in this rulemaking the relative risk of activities to initiate payments from funds held or received by others; rather, as explained further above, the CFPB considers the risks that a market and its larger participants pose to consumers when determining how to 
                        <E T="03">exercise</E>
                         its authority to conduct examinations of such persons.
                    </P>
                    <P>
                        The CFPB also disagrees that the market should exclude nonbanks with a service-providing or partnership relationship with the depository institution that holds the funds used to make the payment. As discussed in the response to general comments above, covering these activities furthers the CFPB's statutory objective of ensuring consistent compliance with Federal consumer financial law without regard to the status of a person as a depository institution to promote fair competition. The CFPB similarly disagrees with the law firm commenter's claim that, when a consumer initiates a consumer payment transaction in reliance on a general-use wallet functionality a nonbank provides through a digital application, there is no need to include that activity in the market because another supervised institution, such as a depository institution, may be providing a funds transfer functionality. Two institutions, including a depository institution and a nonbank, may work together to provide a covered payment functionality. For example, a depository institution may accept payment instructions from a nonbank general-use digital consumer payment application provider. A supervisory review that only considers how the depository institution processes those instructions would presume that there is no significance to the role of the nonbank in relaying those instructions to the depository institution. Yet by design, the conduct of both institutions can affect the degree to which consumers' payments data is protected, legitimate transactions proceed without error or delay, and unauthorized transactions do not occur. The nonbank may even assume primary responsibility for providing the consumer interface, such 
                        <PRTPAGE P="99620"/>
                        as a digital application, and making representation to consumers about the speed, cost, and other aspects of payments it facilitates. As noted, it is not the purpose of this rule to enumerate, quantify, and weigh such risks because the rule does not seek to define a market that includes only high-risk activity. Rather, the purpose of this rule is to establish authority to examine larger participants in this market. Through operation of that program the CFPB can detect, assess, and as needed, address risks to consumers and markets, and otherwise conduct its risk-based supervision program for the purposes established in CFPA section 1024(b)(1).
                    </P>
                    <P>
                        In addition, for the reasons explained above in response to general comments about existing Federal and State oversight of some aspects of market activity, the CFPB does not define the market based on the degree to which another regulator oversees certain persons, such as a partner bank, its nonbank partner, or any other nonbank that facilitates a given consumer payment transaction. The CFPB also does not define the market based on whether market participants also may act as a service provider to another financial institution.
                        <SU>256</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>256</SU>
                             The CFPB disagrees with the nonbank firm's comment to the extent it was suggesting that in general a service provider to financial institutions cannot also be a nonbank covered person, or, more specifically that provisions in CFPA sections 1025(d) or 1026(e) describing the CFPB's supervisory authority over service providers to banks and credit unions displace the CFPB's authority under section 1024(a) over nonbank covered persons. Under the CFPA, a firm can act both as a service provider and as a provider of a consumer financial product or service. 
                            <E T="03">See</E>
                             12 U.S.C. 5481(26)(C) (“A person that is a service provider shall be deemed to be a covered person to the extent that such person engages in the offering or provision of its own consumer financial product or service.”). And with respect to the CFPB's supervisory authority, no provision in CFPA sections 1024, 1025(d), or 1026(e) states that 1024(a) is displaced by 1025(d) or 1026(e). By contrast, CFPA section 1024(a)(3)(A) expressly provides that CFPA section 1024, which includes the larger participant rulemaking authority in CFPA section 1024(a)(1)(B), shall not apply to persons described in section 1025(a) and 1026(a), which refer to insured depository institutions, insured credit unions, and certain of their affiliates. It does not refer to 1025(d) or 1026(e). Accordingly, if a nonbank is a covered person because it provides a consumer financial product or service, then the CFPB may establish supervisory authority over the nonbank covered person via a larger participant rulemaking under section 1024(a)(1)(B) even if in the course of its activity the nonbank also acts as a service provider to a bank or credit union.
                        </P>
                    </FTNT>
                    <P>
                        The CFPB also disagrees with the two industry associations that argued that certain pass-through digital wallets are subject to the CFPA's exclusion for “electronic conduit services” because they only store and transmit card information, and not funds.
                        <SU>257</SU>
                        <FTREF/>
                         The commenters did not meaningfully analyze the language of the CFPA's definition of “electronic conduit services,” which undermines their argument in at least two ways.
                        <SU>258</SU>
                        <FTREF/>
                         First, the definition applies to the “intermediate or transient storage” of electronic data—
                        <E T="03">i.e.,</E>
                         to data storage for a limited time.
                        <SU>259</SU>
                        <FTREF/>
                         However, as the commenters appear to acknowledge, pass-through digital wallets generally store payment credential or account information on a persistent or indefinite basis (so that it can be used to make payments as needed). Because they do so, pass-through digital wallets do not qualify for the exclusion for electronic conduit services. Second, the commenters incorrectly conclude that the electronic conduit service exclusion necessarily applies where a provider only handles data (and not funds). For example, by its terms, that exclusion does not apply to a provider who “selects . . . the content of the electronic data” being stored or transmitted.
                        <SU>260</SU>
                        <FTREF/>
                         Pass-through digital wallets generally are designed to store and transmit specific data regarding a payment card (the card number, expiration date, and CVV) provided by the consumer. Providers of such wallets thus “select[ ] . . . the content of the electronic data” that the wallets store and transmit, and therefore do not qualify for the electronic conduit services exclusion.
                        <SU>261</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>257</SU>
                             The CFPA excludes “electronic conduit services” from the definition of “financial product or service.” 12 U.S.C. 5481(15)(C)(ii). The term “electronic conduit services” “(A) means the provision, by a person, of electronic data transmission, routing, intermediate or transient storage, or connections to a telecommunications system or network; and (B) does not include a person that provides electronic conduit services if, when providing such services, the person—(i) selects or modifies the content of the electronic data; (ii) transmits, routes, stores, or provides connections for electronic data, including financial data, in a manner that such financial data is differentiated from other types of data of the same form that such person transmits, routes, or stores, or with respect to which, provides connections; or (iii) is a payee, payor, correspondent, or similar party to a payment transaction with a consumer.” 12 U.S.C. 5481(11).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>258</SU>
                             Because the commenters do not provide any information regarding how the pass-through digital wallets they describe operate on a technological level, there may be additional reasons, beyond those discussed in this Final Rule, why such wallets do not qualify as electronic conduit services. For example, providers of such wallets may transmit financial data “in a manner that such financial data is differentiated from other types of data of the same form” that the providers transmit. 12 U.S.C. 5481(11)(B)(ii).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>259</SU>
                             12 U.S.C. 5481(11)(A); 
                            <E T="03">cf. Hately</E>
                             v. 
                            <E T="03">Watts,</E>
                             917 F.3d 770, 785 (4th Cir. 2019) (construing similar phrase “temporary, intermediate storage” in Stored Communications Act to refer to electronic communications “while they are stored `for a limited time' `in the middle' of transmission” (quoting 
                            <E T="03">In re DoubleClick Inc. Privacy Litig.,</E>
                             154 F. Supp. 2d 497, 512 (S.D.N.Y. 2001)).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>260</SU>
                             
                            <E T="03">See id.</E>
                             5481(11)(B)(i). Similarly, the exception for differentiated electronic data in subsection 1002(11)(B)(ii) could apply where a provider only handles data, and not funds. 
                            <E T="03">See id.</E>
                             5481(11)(B)(ii).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>261</SU>
                             In addition, as discussed above, some digital wallets “tokenize” payment information, which involves replacing the cardholder's account number with a different number at certain stages of the transaction, in order to protect the account number. That activity of creating new payment information to facilitate a payment goes beyond the role of a mere conduit, which is limited to providing “electronic data transmission, routing, intermediate or transient storage, or connections to a telecommunications system or network[.]” 12 U.S.C. 5481(11)(A).
                        </P>
                    </FTNT>
                    <P>
                        With regard to the industry association commenters that sought exclusion of business-to-business services that nonbanks provide in connection with consumer payment transactions for the purchase of goods and services, the CFPB disagrees that a new exclusion is needed. With regard to ecommerce websites where the consumer can use a payment button, as explained above in the discussion of comments on the definition of “consumer payment transaction,” the market does not include a merchant on the basis of it placing a payment button on its website that launches a general-use digital consumer payment application provided by an unaffiliated third party (rather, the market simply includes the third-party app that the payment button launches). With regard to other examples that the industry association commenter cited—service providers or other vendors, including those that may act as traditional payment processors and participate in facilitating business-to-business transactions during the lifecycle of a consumer payment transaction—the Final Rule clarifies that the market generally does not cover that activity. For purposes of this Final Rule, the term “covered payment functionality” would not cover a nonbank that operates in a consumer payment transaction process solely as an intermediary between two businesses, such as where the consumer does not “access” a “digital application” to make a payment.
                        <SU>262</SU>
                        <FTREF/>
                         In addition, when consumers provide their payment credential through the website of a single merchant solely for use at that merchant and its affiliated companies, the merchant payment processor processing that payment credential (whether for a single transaction or by storing the card on file for repeat use) is not providing covered payment functionality that has “general 
                        <PRTPAGE P="99621"/>
                        use” based on how the Final Rule defines that term as usable for making payments to multiple unaffiliated persons as discussed below.
                        <SU>263</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>262</SU>
                             In any event, the Final Rule also adopts a revised definition of the term “covered payment functionality” that focuses on receiving funds “from” the consumer or storing account or payment credentials “for” a consumer.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>263</SU>
                             Similarly, a consumer may use a general-use digital consumer payment application to make a payment in a physical store by “tapping” their mobile phone that contains the app on a gateway payment terminal at the checkout counter. As the proposed Rule explained, a gateway terminal, which is a computing device merchants acquire, is not a “digital application” as defined in the Proposed Rule because it is not a personal computing device of the consumer. 88 FR 80197 at 80206. Thus a merchant payment processor would not be engaged in market activity solely based on operating or accepting payments data through such a terminal.
                        </P>
                    </FTNT>
                    <P>
                        In light of these clarifications and changes adopted in the Final Rule, the CFPB disagrees that a broader, general “business-to-business” exclusion is warranted.
                        <SU>264</SU>
                        <FTREF/>
                         Such an exclusion would not be consistent with the structure of nonbank provider's market activities, which involve intermediation between consumers and payment recipients. When consumers sign up as a customer for a nonbank's general-use digital consumer payment application, they do so in order to use the app to make payments to multiple unaffiliated persons. The consumer payment transactions they make by accessing that digital application fall within the market, even though the app provider also may conduct those transactions under the umbrella of a business-to-business contract such as a merchant acceptance agreement.
                        <SU>265</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>264</SU>
                             These clarifications relate to the scope of the market. Some entities may be acting as a service provider to a market participant. The Final Rule does not alter the scope of CFPB authority over service providers conferred by the CFPA. As the Proposed Rule explained, CFPA section 1024(e) expressly authorizes the supervision of service providers to nonbank covered persons encompassed by CFPA section 1024(a)(1), which includes larger participants. Adding an express exclusion for service providers in the Final Rule could cause confusion over the CFPB's authority to supervise such entities.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>265</SU>
                             As discussed above, many businesses provide general-use digital consumer payment applications to consumers and facilitate their payments through business-to-business acceptance agreements with merchants. At the same time, as also discussed above, the market definition adopted in the Final Rule does not cover the merchant, even when it provides a payment button that launches the third-party's general-use digital consumer payment application.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Final Rule</HD>
                    <P>For the reasons described above, the CFPB adopts the proposed definition of “covered payment functionality” with certain minor clarifying changes.</P>
                    <P>
                        First, the Final Rule changes “wallet functionality” to “payment wallet functionality.” As discussed above, some commenters raised questions about whether the Proposed Rule would have applied to digital wallets (or the part of their functionalities) that store and transmit data unrelated to consumer payments. Because the terms “digital wallet” and “wallet” have varied uses, this revision provides greater precision and prevents confusion.
                        <SU>266</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>266</SU>
                             The CFPB declines to adopt the industry commenter's suggestion that the Final Rule include a safe harbor under which compliance with the CFPB's personal financial data rights rule does not determine application of this larger participant rule, and coverage under the larger participant rule does not determine application of the personal financial data rights rule. The comment did not identify any specific differences between the two proposals' approach to covering digital wallets that it found to be significant, or explain how application of one rule could affect application of the other. In fact, application of one rule does not determine application of the other. The text of each rule governs its scope. Further, because this Final Rule does not impose substantive consumer protection obligations, it does not modify the scope of the personal financial data rights rule. In any event, as noted above, to the extent an entity is a larger participant under this rule and also is subject to the personal financial data rights rule when compliance is required in the future, CFPB examinations of that entity may review compliance with the personal financial data rights rule. Further, this treatment is consistent with CFPB examinations of depository institutions with more than $10 billion in assets; 
                            <E T="03">i.e.,</E>
                             the CFPB currently examines these institutions' compliance with applicable requirements of Federal consumer financial law (
                            <E T="03">e.g.,</E>
                             the EFTA and its implementing Regulation E) and may examine their compliance with the personal financial data rights rule after compliance is required.
                        </P>
                    </FTNT>
                    <P>Second, the definition of “funds transfer functionality” is revised to clarify that the funds received or instructions accepted must be “from a consumer” to qualify as market activity. Similarly, the definition of “payment wallet functionality” is revised to clarify that account or payment credentials must be stored “for a consumer” to satisfy the first prong of that that definition. As discussed above, nonbanks are not participating in the market when providing a payment functionality that a consumer does not access through a digital application. Consistent with that approach, these clarifications to the definition of “covered payment functionality” similarly confirm that nonbank firms that do not engage with consumers through digital applications would not be providing a “covered payment functionality.” For example, for purposes of this Final Rule that term would not cover a nonbank that operates in a consumer payment transaction process solely as an intermediary between two businesses. The CFPB does not believe this is a significant change from the Proposed Rule, since the proposed market definition only would have applied to providing a payment functionality “for consumers' general use” in the first place. But for the avoidance of doubt, the Final Rule includes this additional clarification on this point.</P>
                    <HD SOURCE="HD3">Digital Application</HD>
                    <HD SOURCE="HD3">Proposed Rule</HD>
                    <P>
                        The proposed market definition would have applied to providing covered payment functionalities through a digital application for a consumer's general use in making consumer payment transactions. Proposed § 1090.109(a)(2) would have defined the term “digital application” as a software program accessible to a consumer through a personal computing device, including but not limited to a mobile phone, smart watch, tablet, laptop computer, or desktop computer.
                        <SU>267</SU>
                        <FTREF/>
                         The proposed definition would have specified that the term includes a software program, whether downloaded to a personal computing device, accessible from a personal computing device via a website using an internet browser, or activated from a personal computing device using a consumer's biometric identifier, such as a fingerprint, palmprint, face, eyes, or voice.
                        <SU>268</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>267</SU>
                             The Proposed Rule noted that the definition considers whether the digital application is accessible through a personal computing device, not whether a particular payment is made using a computing device that a consumer personally owns. For example, if a consumer logs into a digital application through a website using a work or library computer and makes a consumer payment transaction, the transfer would be subject to the Proposed Rule if that digital application is one a consumer also may access through a personal computing device.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>268</SU>
                             The Proposed Rule noted for example that some nonbanks allow consumers to use interactive voice technology to operate the nonbank's application that resides on the phone itself. 
                            <E T="03">See, e.g.,</E>
                             Lory Seraydarian, 
                            <E T="03">Voice Payments: The Future of Payment Technology?,</E>
                             PlatAI Blog (Mar. 7, 2022) (software firm analysis reporting that major P2P participants “allow their customers to use voice commands for peer-to-peer transfers.”), 
                            <E T="03">https://plat.ai/blog/voice-payments/</E>
                             (last visited Oct. 23, 2023).
                        </P>
                    </FTNT>
                    <P>
                        The Proposed Rule explained how market participants may provide covered payment functionalities through digital applications in many ways. For example, a consumer may access a nonbank covered person's covered payment functionality through a digital application provided by that nonbank covered person. Or, a consumer may access a nonbank covered person's covered payment functionality through a digital application provided by an unaffiliated third-party such as another nonbank, a bank, or a credit union.
                        <SU>269</SU>
                        <FTREF/>
                         In either case, 
                        <PRTPAGE P="99622"/>
                        a consumer typically first opens the digital application on a personal computing device and follows instructions for associating their deposit account, stored value account, or other payment account information with the covered payment functionality for use in a future consumer payment transaction. Then, when the consumer is ready to initiate a payment, the consumer may access the digital application again to authorize the payment.
                    </P>
                    <FTNT>
                        <P>
                            <SU>269</SU>
                             As the Proposed Rule noted, if a nonbank covered person provides a covered payment functionality a consumer may access through a digital application provided by a bank or credit union, the Proposed Rule would have only applied 
                            <PRTPAGE/>
                            to the nonbank. Insured depository institutions, insured credit unions, and certain of their affiliates are not subject to the CFPB's larger participant rules, which rely upon authority in CFPA section 1024 that applies to nonbanks. 12 U.S.C. 5514(a)(3)(A).
                        </P>
                    </FTNT>
                    <P>
                        The Proposed Rule also explained how consumers have many ways to access covered payment functionalities through digital applications to initiate consumer payment transactions. To make a P2P payment, a consumer may use an internet browser or other app on a mobile phone or computer to access a nonbank covered person's funds transfer functionality, such as a feature to initiate a payment to friends or family or to access a general-use bill-payment function. The consumer then may direct the nonbank covered person to transmit funds to the recipient or the consumer may provide payment instructions for the nonbank covered person to relay to the person holding the funds to be transferred. Or, in an online retail purchase transaction, a consumer may access a wallet functionality by clicking on or pressing a payment button on a checkout screen on a merchant website. The consumer then may log into the digital application or display a biometric identifier to their personal computing device to authorize the use of a previously-stored payment credential. Or, in an in-person retail purchase transaction, a consumer may activate a covered payment functionality by placing their personal computing device next to a merchant's retail payment terminal. The digital application then may transmit payment instructions or payment credentials to a merchant payment processor. For example, a mobile phone may transmit such data by using near-field communication (NFC) technology built into the mobile phone,
                        <SU>270</SU>
                        <FTREF/>
                         by generating a payment-specific quick response (QR) code on the mobile phone screen that the consumer displays to the merchant payment terminal, or by using the internet, a text messaging system, or other communications network accessible through the mobile phone.
                    </P>
                    <FTNT>
                        <P>
                            <SU>270</SU>
                             
                            <E T="03">See generally CFPB Contactless Payments Spotlight, supra.</E>
                        </P>
                    </FTNT>
                    <P>Through the proposed definition of digital application, the Proposed Rule would have excluded from the proposed market payment transactions that do not rely upon use of a digital applications. For example, gateway terminals merchants obtain to process the consumer's personal card information are not personal computing devices of the consumer. Merchants generally select these types of payment processing services, which are provided to consumers at the point of sale to pay for the merchant's goods or services. Their providers may be participating in a market that is distinct in certain ways from a market for general-use digital consumer payment applications. In addition, the proposed definition of “digital application” would not have covered the consumer's presentment of a debit card, a prepaid card, or a credit card in plastic, metallic, or similar form at the point of sale. In using physical payment cards at the point of sale, a consumer generally is not relying upon a “digital application” because the consumer is not engaging with software through a personal computing device to complete the transaction. However, when a consumer uses the same payment card account in a wallet functionality provided through a digital application, then those transactions would have fallen within the market definition.</P>
                    <P>The Proposed Rule requested comment on the proposed definition of “digital application,” and whether it should be modified, and if so, how and why. For example, the Proposed Rule requested comment regarding whether defining the term “digital application” by reference to software accessible through a personal computing device is appropriate, and if so, why, and if not, why not and what alternative approach should be used and why.</P>
                    <HD SOURCE="HD3">Comments Received</HD>
                    <P>
                        A consumer group supported the proposal's definition of a market based on use of a “digital application.” It cited a 2021 industry white paper observing that most financial transactions happen via mobile apps, websites, email, text messages, and other digital communications.
                        <SU>271</SU>
                        <FTREF/>
                         In addition, as discussed above, many commenters agreed that the market for general-use digital consumer payment applications has grown rapidly and expressed support for the proposal to supervise larger participants providing general-use digital consumer payment applications. These commenters generally did not take issue with or appeared to agree with the proposal's defining the market as a digital market.
                    </P>
                    <FTNT>
                        <P>
                            <SU>271</SU>
                             
                            <E T="03">Google LLC Embedded Finance White Paper, supra,</E>
                             at 3.
                        </P>
                    </FTNT>
                    <P>Some consumer group commenters urged the CFPB to expand the market definition beyond payments facilitated through digital applications, to cover in-person domestic money transfers as well as payments consumers make via telephone call to transfer funds to persons while incarcerated and prepaid cards issued to such persons upon their release from incarceration. They indicated this approach would be consistent with the market definition in the international money transfer larger participant rule, which was not limited to app-based payments. They stated that some consumers that send funds to friends and family who are incarcerated have incomes that are too low to afford easy access to digital applications. They also described a risk of abusive practices with release cards due to consumers' lack of choice among card issuers. They further noted that the proposed market definition would not encompass consumers' use of release cards outside of digital applications, which they often do because they likely do not have smartphones when they are released and need to use the funds immediately.</P>
                    <P>
                        Meanwhile, an industry association suggested that the “digital application” limitation invalidates the market definition because it does not satisfy principles of antitrust law due to excluding reasonably interchangeable non-products with the same use case, such as network-branded payment cards when used outside of a digital application, whether by swiping a plastic card in-person or inputting the card information manually to make a digital payment. This commenter cited data that in its view indicated that those cards are still preferred by consumers. Thus, in its view, general-use digital consumer payment applications compete with physical payment methods as part of a broader payment industry. In addition, a nonprofit commenter disagreed with the “digital application” limitation because, in its view, it incorrectly ascribes a special status to payments undertaken digitally.
                        <SU>272</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>272</SU>
                             A few industry associations also described the proposed definition of “digital application” as vague. Their comments appeared principally concerned not with what is a digital application, but with who is providing a covered payment functionality through a digital payment application. The Final Rule responds to their comments in the section-by-section analysis of “covered payment functionality” above.
                        </P>
                    </FTNT>
                    <PRTPAGE P="99623"/>
                    <P>Other consumer groups and a nonprofit commenter called for clarification of the definition of “digital application” including its reference to use of a “personal computing device.” For example, one consumer group suggested that the rule include additional examples of a “personal computing device” because computer chips are versatile and industry can use everyday items to facilitate payments and collect consumers' payments data. They stated that some automobiles already have “smart dashboards” that consumers may use to make purchases. They added that home appliances, such as televisions and refrigerators, also could be designed to facilitate purchases. They stated that some smart appliances already allow consumers to use a digital wallet provided by a third-party that is dominant in the market. They stated that these devices should be included as examples of personal computing devices that may facilitate market activity. On the other hand, a nonprofit commenter stated that some of its members believed the definition of “personal computing device” is vague and the rule needs to expressly exclude public computers from that definition. This commenter also stated some of its members believed that the definition of “digital application” should be clarified to provide additional examples of how a consumer “may access” the underlying software program. They stated that the use of PINs and passwords should be added to the examples in the definition.</P>
                    <P>
                        Finally, two commenters raised questions about the applicability of the Proposed Rule to internet browsers and functionalities they provide. An industry association stated that the rule should clarify whether internet browsers that store credit card information would be considered to facilitate a consumer payment within the meaning of the definition of “covered payment functionality.” In addition, a law firm commenter stated that it did not understand the goal of the Proposed Rule to cover generic web browser activity, but a clarification would be necessary to avoid inadvertent coverage of that activity because of what it described as “payment-autofill functions” provided by online platforms and applications. It cited specific popular internet browsers as examples. It described payment autofill functions as prepopulating a consumer's stored payment credential information into checkout forms on a merchant website within the platform's browser.
                        <SU>273</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>273</SU>
                             Although it stated that it did not understand that the goal of the Proposed Rule was to cover autofill functions of generic web browsers, it stated that the autofill functionality could be viewed as transmitting or otherwise processing a stored payment credential under a broad reading of the proposed definition of “wallet functionality” discussed further above. However, in its view, such a broad reading would be incorrect because transmission of the payment credential for processing does not occur until the consumer clicks the merchant's payment button and because it is the merchant and their payment service providers that process the payment.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Response to Comments Received</HD>
                    <P>The CFPB agrees with the consumer group commenter that it is appropriate to define the market at issue in this Final Rule as one involving “digital applications.” As discussed above, such digital applications have grown dramatically and become increasingly important to the everyday financial lives of consumers.</P>
                    <P>
                        With respect to the industry associations' comments suggesting that the limitation of the market to “digital application” would be inappropriate from the perspective of antitrust law because it excludes consumers' use of physical network-branded payment cards, as discussed above this Final Rule does not define a market for purposes of antitrust law. As a consequence, CFPA section 1024(a)(1) does not require a larger participant rule to define a market to include all reasonably-interchangeable substitutes for a given consumer financial product or service whether provided by nonbanks or insured banks or credit unions.
                        <SU>274</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>274</SU>
                             In any event, the CFPB notes that loading the card into a third-party app for app-based use may be an indicator that the app is a compliment rather than a substitute for the card. 
                            <E T="03">See Racing for Mobile Payments, supra,</E>
                             sec. 2.1.2 (describing “card-complementing mobile payment systems” like those provided by Apple, Google, and Samsung in the United States).
                        </P>
                    </FTNT>
                    <P>
                        In addition, the CFPB disagrees with the industry association's comments because general-use digital consumer payment applications often function in ways that are distinct from network-branded payment cards, making it appropriate for the market defined in this Rule to be limited to such digital applications. For example, as the most recent Federal Reserve annual report on consumer payment preferences indicates, consumers generally cannot or do not use network-branded payment cards for making payments to friends and family outside of the nonbank general-use digital consumer payment applications.
                        <SU>275</SU>
                        <FTREF/>
                         Similarly, well-known general-use digital consumer payment applications often provide a functionality that physical payment cards generally do not have—the ability to load payment credentials for accounts held at multiple unaffiliated financial institutions.
                        <SU>276</SU>
                        <FTREF/>
                         This functionality can be a significant one. According to one recent report, the average consumer may have as many as eight network-branded payment cards.
                        <SU>277</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>275</SU>
                             
                            <E T="03">See 2024 Diary Findings, supra</E>
                             at 16 (indicating that when used by themselves and not through payment apps, “[d]ebit and credit cards . . . typically are impractical or costly for P2P transactions”). For example, American Express National Bank has used PayPal and Venmo to facilitate credit card holders' P2P transactions, as described at 
                            <E T="03">https://help.venmo.com/hc/en-us/articles/360058686993-Amex-Send-Split</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>276</SU>
                             Some banks and credit unions offer an app-based wallet functionality that facilitates payments using cards issued by multiple unaffiliated card issuers. 
                            <E T="03">See</E>
                             Paze FAQs (describing how consumers can add participating cards into the wallet from the Paze website or through the bank or credit union's digital application), 
                            <E T="03">https://www.paze.com/faqs</E>
                             (last visited Nov. 17, 2024); 
                            <E T="03">see also</E>
                             VISA Blog, 
                            <E T="03">One card to rule them all</E>
                             (May 16, 2024) (describing VISA plans to launch a new service in the United States allowing consumers to use their card issuer's app to “swap funding sources” between different accounts the consumer holds with that same issuer), 
                            <E T="03">https://usa.visa.com/visa-everywhere/blog/bdp/2024/05/14/one-card-to-1715696707658.html</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>277</SU>
                             Jack Caporal, 
                            <E T="03">Credit and Debit Card Market Share by Network and Issuer</E>
                             (Jan. 24, 2024) (citing Nilson Report data for 2022), 
                            <E T="03">https://www.fool.com/the-ascent/research/credit-debit-card-market-share-network-issuer/</E>
                             (last visited Nov. 7, 2024).
                        </P>
                    </FTNT>
                    <P>
                        The CFPB disagrees with the consumer group and nonprofit comments to the extent they were suggesting that the “digital application” component of the proposed market definition would leave a significant gap in the CFPB's supervisory authority with respect to the use of network-branded payment cards including prison release cards. CFPA section 1025(a) already grants the CFPB supervisory authority over very large insured depository institutions and insured credit unions that are among the largest issuers of network-branded payment cards. While some insured depository institutions and insured credit unions with assets of $10 billion or less also issue payment cards, including prepaid cards, CFPA section 1024(a)(3)(A) specifically excludes 
                        <E T="03">all</E>
                         insured depository institutions and insured credit unions from the scope of a larger participant rule under CFPA section 1024(a)(1)(B). Therefore, the CFPB does not have authority to use this rule to define insured depository institutions or insured credit unions as larger participants in this market. In any event, when a nonbank prepaid card program manager facilitates consumers' use of these cards through the card's proprietary digital application, such as to make payments to friends and family, this activity may qualify as a consumer financial product or service of the nonbank that already is included in the 
                        <PRTPAGE P="99624"/>
                        market definition. And when consumers load these cards into a third-party general-use digital consumer payment applications, the use of the cards through those apps also would be included in the market definition.
                    </P>
                    <P>The CFPB also declines the suggestion by consumer group and nonprofit commenters that the CFPB adopt in this Final Rule a market that includes all domestic money transfers including those facilitated by telephone call and through in-person transfers not mediated by a digital application. As discussed above, a trend in the consumer payments area has been the rapid growth in general-use digital consumer payment applications including their payment wallet functionalities that do not necessarily involve domestic money transmitting. The CFPB adopts this Final Rule in response to that growth in an effort to promote compliance with Federal consumer financial law and detect and assess risks to consumers and the market, including emerging risks, and to ensure consistent enforcement of Federal consumer financial law in this area. When consumers make telephone- or in-person-based domestic payments, the CFPB has other means of assessing risks they may pose to consumers. For example, if a nonbank covered person has significant involvement in that activity through the provision of a consumer financial product or service, the CFPB can evaluate whether that poses a risk to consumers sufficient to warrant a supervisory designation under CFPA section 1024(a)(1)(C).</P>
                    <P>
                        Further, consistent with its approach in the international money transfer larger participant rule,
                        <SU>278</SU>
                        <FTREF/>
                         the CFPB notes that it does not seek in this rule to define a market that covers the entire universe of consumer payment transactions that fall within the scope of the CFPB's authority under the CFPA. This larger-participant rulemaking is only one in a series, and nothing in this Final Rule precludes the Bureau from considering in future larger-participant rulemakings other markets for consumer financial products or services that might include non-digital payment activities not included in the market defined by this rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>278</SU>
                             79 FR 56631 at 56635-56636.
                        </P>
                    </FTNT>
                    <P>
                        With regard to comments on specific aspects of the “digital application” definition, the CFPB agrees with the members of the nonprofit commenter that PINs and passwords may be common ways that consumers use to access general-use digital consumer payment applications. Device-specific codes called passkeys also are an increasingly common way for digital applications, including general-use digital consumer payment applications, to authenticate a consumer's identity.
                        <SU>279</SU>
                        <FTREF/>
                         The Final Rule therefore accounts for these examples, as described below.
                        <SU>280</SU>
                        <FTREF/>
                         The CFPB does not agree with the consumer group commenter to the extent it was suggesting that the prospect of future participation in the market by manufacturers of automobiles and smart appliances such as televisions and refrigerators warranted adding those types of devices to the list of example of personal computing devices in the definition of “digital application.” Because the proposed definition did not state that the list of examples of personal computing devices was exhaustive, other devices may qualify as personal computing devices. However, the research described in the Proposed Rule indicates that general-use digital consumer payment applications are predominantly distributed via mobile phones and computers. For that reason, it is not necessary for the regulation text to identify automobiles and smart appliances such as televisions and refrigerators as additional examples of personal computing devices. The proposed definition already was flexible enough to capture this activity if it were to become common in the future. To the extent existing market participants make their general-use digital consumer applications accessible to consumers not only via mobile phones or computers, but also via automobiles or smart home appliances manufactured by others, that activity already would fall within the market definition regardless of whether automobiles or smart home appliances qualify as personal computing devices. As the Proposed Rule noted,
                        <SU>281</SU>
                        <FTREF/>
                         if a consumer may access a digital application through a personal computing device, then consumers' use of the application would be included in the market regardless of whether they access the application through other means, such as a work or library computer. For that reason, the CFPB also disagrees with the members of the nonprofit commenter that suggested the rule needs to further differentiate between a personal and a public computing device. They did not point to any examples that should be classified in one category or the other.
                        <SU>282</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>279</SU>
                             
                            <E T="03">See, e.g.,</E>
                             PayPal, 
                            <E T="03">PayPal Introduces More Secure Payments with Passkeys</E>
                             (Oct. 24, 2022), 
                            <E T="03">https://newsroom.paypal-corp.com/2022-10-24-PayPal-Introduces-More-Secure-Payments-with-Passkeys</E>
                             (last visited Nov. 8, 2024); Apple iPhone User Guide iOS 17, 
                            <E T="03">Use passkeys to sign in to apps and websites on iPhone, https://support.apple.com/guide/iphone/use-passkeys-to-sign-in-to-apps-and-websites-iphf538ea8d0/ios</E>
                             (last visited Nov. 8, 2024); Google, 
                            <E T="03">Passkey support on Android and Chrome, https://developers.google.com/identity/passkeys/supported-environments</E>
                             (last visited Nov. 8, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>280</SU>
                             However, the inclusion of these examples does not necessarily mean that a nonbank is participating in the market by providing a product or service to manage a consumer's passwords. Whether or not that activity falls within the market definition will depend on whether it is conducted by a nonbank covered person as part of providing a “covered payment functionality” with “general use.”
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>281</SU>
                             88 FR 80197 at 80206 n.67.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>282</SU>
                             In addition, as explained in the discussion of general comments further above, through supervisory activity at larger participants defined in this Final Rule, the CFPB can detect and assess emerging risks to consumers, including as a result of developments in the software or personal computing devices involved in the delivery of general-use digital consumer payment applications.
                        </P>
                    </FTNT>
                    <P>
                        Finally, with regard to comments seeking clarification or exclusion of internet browser activities including payment autofill functions, the CFPB clarifies that the Proposed Rule was not intended to treat the operation of a web browser itself as a form of market activity.
                        <SU>283</SU>
                        <FTREF/>
                         As noted above, the proposed definition of “digital application” included several examples of software programs accessed by a personal computing device, including “a website a consumer accesses by using an internet browser on a personal computing device.” As that example indicates, the relevant “digital application” that the consumer accesses using a web browser is the website, and not the web browser itself. Excluding web browsers from the definition of “digital application” is consistent with the CFPB's goal of covering payment applications in the rule. While some web browsers may store and automatically populate payment forms on merchant websites with consumer payment account information, that activity alone does not convert a web browser into a payments-focused digital application that is participating in this market. Nor is the CFPB aware of market research studies or surveys on consumer payment applications that identify web browsers as competing with larger participants in the market.
                    </P>
                    <FTNT>
                        <P>
                            <SU>283</SU>
                             
                            <E T="03">See, e.g., United States</E>
                             v. 
                            <E T="03">Microsoft Corporation,</E>
                             Case No. 98cv1232, D.D.C. (Complaint filed May 18, 1998) ¶ 6 (defining an “internet browser” as “specialized software programs that allow PC users to locate, access, display, and manipulate content and applications located on the internet's World Wide Web”), 
                            <E T="03">https://www.justice.gov/sites/default/files/atr/legacy/2012/08/09/1763.pdf</E>
                             (last visited Nov. 8, 2024).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Final Rule</HD>
                    <P>
                        For the reasons described above, the CFPB adopts the proposed definition of “digital application” with certain clarifying changes described below, including changing the term to “digital payment application.”
                        <PRTPAGE P="99625"/>
                    </P>
                    <P>First, consistent with the Final Rule changing “wallet functionality” to “payment wallet functionality” for the sake of precision and clarity, the Final Rule also adopts the term “digital payment application” instead of the more generic term “digital application.” Based on how the CFPB proposed the market definition for a “general-use digital consumer payment application,” the concept of a “digital payment application” already was incorporated into the market definition itself. This conforming change to the component definition of “digital application” therefore aligns that term more clearly with the general market definition. Relatedly, for the reasons discussed above in the CFPB's response to comments regarding web browsers, the Final Rule clarifies that operating a web browser is not an example of providing a digital payment application.</P>
                    <P>Second, in response to a nonprofit commenter, the Final Rule adds to the list of examples of how a consumer may access a personal computing device to include other common means, such as using a personal identifier, such as a passkey, password, or PIN.</P>
                    <HD SOURCE="HD3">General Use</HD>
                    <HD SOURCE="HD3">Proposed Rule</HD>
                    <P>The proposed market definition would have applied to providing covered payment functionalities through a digital application for a consumer's general use in making consumer payment transactions. Proposed § 1090.109(a)(2) would have defined the term “general use” as the absence of significant limitations on the purpose of consumer payment transactions facilitated by the covered payment functionality provided through the digital consumer payment application. The Proposed Rule explained that the CFPB sought to confine the market definition to those digital payment applications that consumers can use for a wide range of purposes. The Proposed Rule noted how digital payment applications with general use can serve broad functions for consumers, such as sending funds to friends and family, buying a wide range of goods or services at different stores, or both. As reflected in the non-exhaustive list of examples in the Proposed Rule discussed below, other consumer financial products and services provide payment functionalities for more limited purposes. While those other products and services also serve important functions for consumers, they do not have the same broad use cases for consumers. As a result, in the Proposed Rule, the CFPB viewed those products as participating in a market or markets distinguishable from a market from general-use digital consumer payment applications.</P>
                    <P>
                        The proposed definition of general use would have clarified that a digital consumer payment application that would facilitate person-to-person, or peer-to-peer (P2P), transfers of funds would have qualified as having general use under the Proposed Rule. Even if a payment functionality provided through a digital application is limited to P2P payments, and that constitutes a limitation on the purpose of payments, that limitation would not have been a significant limitation for purposes of the proposed market definition. For example, a P2P application that permits a consumer to send funds to any family member, friend, or other person would have qualified as having general use, even if that P2P application could not be used as a payment method at checkout with merchants, retailers, or other sellers of goods or services. A P2P application also would have qualified as having general use even if it can only transfer funds to recipients who also register with the application provider, or otherwise participate in a certain network (which the Proposed Rule noted some refer to as “closed loop” P2P systems). As the Proposed Rule noted, although the network of potential recipients in such a system may be limited in certain respects, often any potential recipient may have the option of joining such a system (and many consumers already may have joined such systems), so the universe of potential recipients for such payments often is still broad. The Proposed Rule also stated that a digital consumer payment application still may have qualified as having general use even when the universe of potential recipients for a funds transfer is fixed, such as when a consumer can only make a transfer of funds to friends or family located in a prison, jail, or other secure facility.
                        <SU>284</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>284</SU>
                             Such funds may be available to the recipient for a variety of purposes, including to purchase food, toiletries, medical supplies, or phone credits while incarcerated, and, if not used by the recipient while incarcerated, may revert upon release to an unrestricted account. 
                            <E T="03">See, e.g.,</E>
                             CFPB Report, 
                            <E T="03">Justice-Involved Individuals and the Consumer Financial Marketplace</E>
                             (Jan. 2022), sec. 3.1 (n.87 describing uses of these types of funds transfers) and sec. 4.1 (describing how, as observed in a CFPB enforcement action and an investigative report on prison release cards, “[w]hen released, people exiting jail receive the money they had when arrested, and prisons disburse the balance of a person's commissary account, including wages from prison jobs, public benefits, and money sent by friends and family.”), 
                            <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_jic_report_2022-01.pdf</E>
                             (last visited Oct. 23, 2023).
                        </P>
                    </FTNT>
                    <P>
                        To provide clarity as to the proposed market definition, the proposed definition of general use would have included examples of limitations that would be significant for purposes of the proposal, such that a covered payment functionality offered through a digital consumer payment application with such limitations would not have had general use.
                        <SU>285</SU>
                        <FTREF/>
                         The examples would have illustrated some types of digital consumer payment applications that would not have had general use. The list of examples was not exhaustive, and other types of digital consumer payment applications would not have had general use to the extent they cannot be used for a wide range of purposes.
                    </P>
                    <FTNT>
                        <P>
                            <SU>285</SU>
                             The Proposed Rule includes these examples to illustrate the scope of the term “general use” in the Proposed Rule, and thus the scope of the proposed market definition. The examples are not a statement of the CFPB's views regarding the scope of its authority over consumer financial products and services under the CFPA.
                        </P>
                    </FTNT>
                    <P>In addition, the Proposed Rule noted that some payment functionalities may be provided through two different digital consumer applications. For example, from a merchant's ecommerce digital application, a consumer may click on a payment button that links to a third-party general-use digital consumer payment application, where the consumer authenticates their identity and provides payment instructions or otherwise authorizes the payment. Even if the merchant's digital application itself would not have qualified as having general use, the consumer's use of the third-party general-use digital consumer payment application still would have constituted covered market activity with respect to the third-party provider.</P>
                    <P>
                        The first example of a payment functionality with a significant limitation such that it would not have general use would have been a digital consumer payment application whose payment functionality is used solely to purchase or lease a specific type of services, goods, or property, such as transportation, lodging, food, an automobile, a dwelling or real property, or a consumer financial products and service.
                        <SU>286</SU>
                        <FTREF/>
                         The Proposed Rule listed this 
                        <PRTPAGE P="99626"/>
                        example in paragraph (A) of the proposed definition of general use.
                    </P>
                    <FTNT>
                        <P>
                            <SU>286</SU>
                             For example, when a consumer uses a payment functionality in a digital application for a consumer financial product or service to pay for that consumer financial product or service, such as by providing payment card information to a credit-monitoring app to pay for credit-monitoring services, this limited purpose for that payment functionality would not have had general use under the Proposed Rule. The term “consumer financial product or service” is defined in CFPA section 1002(5) and includes a range of consumer financial products and services including those in markets 
                            <PRTPAGE/>
                            that the CFPB supervises, described in the Proposed Rule, as well as other consumer financial products and services outside of supervised markets over which the CFPB generally has enforcement and market-monitoring authority. 
                            <E T="03">See generally</E>
                             12 U.S.C. 5481(5) (definition of “consumer financial product or service”) and 12 U.S.C. 5481(15) (definition of “financial product or service”).
                        </P>
                    </FTNT>
                    <P>
                        Second, as indicated in paragraph (B), accounts that are expressly excluded from the definition of “prepaid account” in paragraphs (A), (C), and (D) of § 1005.2(b)(3)(ii) of Regulation E 
                        <SU>287</SU>
                        <FTREF/>
                         also would not have had general use for purposes of the Proposed Rule. Those provisions in Regulation E exclude certain tax-advantaged health medical spending accounts, dependent care spending accounts, transit or parking reimbursement arrangements, closed-loop accounts for spending at certain military facilities, and many types of gift certificates and gift cards. The Proposed Rule explained that, while these types of accounts may support payments through digital applications with varied purposes to different types of recipients, the accounts remain sufficiently restricted as to the purpose to warrant exclusion from the proposed market.
                    </P>
                    <FTNT>
                        <P>
                            <SU>287</SU>
                             12 CFR 1005.2(b)(3)(ii).
                        </P>
                    </FTNT>
                    <P>
                        Third, as indicated in proposed paragraph (C), a payment functionality provided through a digital consumer payment application that solely supports payments to pay a specific debt or type of debt or repayment of an extension of consumer credit would not have qualified as having general use. For example, a consumer mortgage lender's mobile app or website may provide a functionality that allows a consumer to pay a loan. Or a debt collector's website may provide a means for a consumer to pay a debt. These digital consumer payment applications have a use that is significantly limited, to only pay a specific debt or type of debt. In general, digital applications that solely support payments to specific lenders, loan servicers, and debt collectors would not have fallen within the proposed market definition.
                        <SU>288</SU>
                        <FTREF/>
                         The Proposed Rule noted that the CFPB considers such digital applications generally to be more part of the markets for consumer lending, loan servicing, and debt collection. The CFPB has issued separate larger participant rules for such markets and CFPA section 1024(a) also grants the CFPB supervisory authority over participants in certain lending markets, including mortgage lending, private student lending, and payday lending. In addition, other digital applications may only help a consumer to pay certain other types of debts, such as taxes or other amounts owed to the government, including fines. Under this proposed example, those payment functionalities provided through those applications also would not have qualified as having general use.
                    </P>
                    <FTNT>
                        <P>
                            <SU>288</SU>
                             By contrast, as noted in the section-by-section analysis of the proposed exclusion in paragraph (C) of the definition of a “consumer payment transaction,” if a consumer uses a general-use digital consumer payment application as a method of making a payment to such a payee, that general-use digital consumer payment application would have been participating in the market for those consumer payment transactions.
                        </P>
                    </FTNT>
                    <P>Fourth, as indicated in proposed paragraph (D), a payment functionality provided through a digital application that solely helps consumers to divide up charges and payments for a specific type of goods or services would have been excluded. Some payment applications, for example, may be focused solely on helping consumers to split a restaurant bill. This example is a corollary of the example in paragraph (A). Since a payment functionality limited to paying for food would not have qualified as having general use under paragraph (A), paragraph (D) would have clarified that a payment functionality that enables splitting a bill for food have also would not have qualified as having general use.</P>
                    <P>The CFPB requested comment on the proposed definition of general use and examples of significant limitations that take a payment functionality provided through a digital consumer application out of the general use category. The CFPB also requested comment on whether the examples of significant limitations should be changed or clarified, and whether additional examples of significant limitations should be included, and if so, what examples and why.</P>
                    <HD SOURCE="HD3">Comments Received</HD>
                    <P>
                        Some commenters stated that the proposed “general use” limitation was excessively ambiguous or uncertain, though they did not agree on how to clarify the definition. For example, two industry associations criticized defining “general use” as the “absence of significant limitations on the purpose of consumer payment transactions facilitated by the covered payment functionality” on the ground that that standard was ambiguous and that the associated examples in the proposed definition did not provide sufficient guidance to ascertain the scope of “general use.” These commenters stated that additional clarification or limitations on the definition were necessary, and that if the Final Rule did not clarify this term, then firms would incur unnecessary costs and confusion as to whether they need to prepare their compliance management systems for CFPB supervision. Similarly, another industry association criticized the definition of “general use” as ambiguous, and suggested that such ambiguity would generate confusion for providers. The commenter suggested clarifying how the definition applies to diverse features and functionalities within payment applications. An individual commenter stated that the proposal did not clearly define “general use” and suggested that the rule instead adopt a bright-line test, providing that general use means use with more than 100 merchants, 10 platforms, or 5 different purposes. A nonprofit commenter stated that while a vast majority of its members approved of the proposed definition of “general use,” a majority also recommended adding examples to the definition. A payments industry firm stated that the rule should clarify the example described in proposed paragraph (B) related to certain gift cards and other products and services that do not have general use.
                        <SU>289</SU>
                        <FTREF/>
                         Finally, a comment from consumer groups stated that the Rule should clarify that online marketplace payment functions meet the definition of “general use” (and not exclude them from the definition of “consumer payment transactions” included in the market as discussed above). These commenters also stated that the Final Rule should clarify that if a payment app aimed at servicemembers is not eligible for the narrow Regulation E exclusion cited in paragraph (B) of the proposed definition of “general use,” then it would meet the definition of “general use.” 
                        <SU>290</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>289</SU>
                             Specifically, this commenter requested that the CFPB clarify that the definition of “general use” also excludes certain types of cards, codes, and other devices described in Regulation E section 1005.20(b). It stated that the Proposed Rule was unclear on this point because it referred only to an account described in Regulation E section 1005.2(b)(3)(ii)(D). Regulation E section 1005.20(b) describes cards, codes, and other devices that are excluded from Regulation E section 1005.20(a), which defines the accounts identified in 1005.2(b)(3)(ii)(D). As a result, in its view there is uncertainty over whether the CFPB views those cards, codes, and devices has having general use. In its view, section 1005.20(b) refers to certain types of cards, codes, and other devices with limited uses and the CFPB should confirm those types of cards, codes, and other devices to do not have general use.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>290</SU>
                             The comment did not provide an example or state whether such consumer financial products or services currently exist.
                        </P>
                    </FTNT>
                    <P>
                        In addition, commenters had differing views regarding the appropriateness of the breadth of the proposed definition of “general use.” Some commenters agreed with the breadth of “general use” or suggested it should be expanded. For example, the comment from consumer groups expressed general support for the 
                        <PRTPAGE P="99627"/>
                        definition, which they characterized as appropriately broad. Several consumer group and nonprofit comments expressed support for the definition of “general use” based on how the proposed term reflected what they described as the broad functions of services to transfer funds to people who are incarcerated. Some of these commenters added that some large companies provide app-based money transfers both to people who are incarcerated and to people who are not.
                        <SU>291</SU>
                        <FTREF/>
                         In addition, without directly addressing the exclusion in paragraph (D) of the definition of “general use” for payment functionalities solely to split a charge for a specific type of goods or services, an industry association stated that consumers use general-use digital consumer payment applications for, among other purposes, paying expenses informally split between consumers. An industry association suggested that at least in certain ways, the proposed definition of “general use” unduly narrowed the market because it excluded digital applications that help consumers to make payment for the same types of purchases, such as food and automobiles, using the same underlying payment methods as applications that meet the proposed definition of “general use.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>291</SU>
                             In addition, they stated that the “general use” of these payment systems is reflected in the significant number of people who are incarcerated (nearly two million at any one time with one estimate that people were incarcerated nearly seven million times in 2021), broad available uses those people have for transferring the funds while they are incarcerated, and the universal acceptance of release cards loaded with funds remaining at the time of release. As discussed in the section-by-section analysis of the comments on the proposed definition of “digital application,” these commenters also called for expansion of the market to include the full range of payment services that support payments to people while incarcerated, payments by people while incarcerated, and payments by people who are recently released from incarceration using payment cards issued upon release. They added that these products and services pose large risks to consumers, due to, among other features, high fees and the lack of competition for such products and services.
                        </P>
                    </FTNT>
                    <P>On the other hand, several industry commenters stated that the proposed definition of “general use” was too broad and that it should be narrowed in various ways. These comments generally stated that the “general use” limitation on the proposed market definition did not adequately limit the scope of the market definition in the context of payments for consumer purchases, in the context of peer-to-peer payments, or both.</P>
                    <P>
                        In the context of digital payments for purchases, two industry associations stated that the rule should exclude from “general use” what it called “closed-loop transactions” which it described as transactions that can only occur at a “finite” group of merchants. These comments stated that the exclusion should be consistent with the CFPB's understanding of “closed-loop transactions” in the context of its prepaid account rule under Regulation E.
                        <SU>292</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>292</SU>
                             While these commenters quoted a description of “closed-loop prepaid cards” they stated came from the CFPB's rules concerning prepaid accounts, the citation they identified is to a CFPB website that contains consumer education materials regarding general-use prepaid cards, prepaid gift cards, and other prepaid cards at 
                            <E T="03">https://www.consumerfinance.gov/consumer-tools/prepaid-cards/answers/key-terms</E>
                             (last visited Nov. 17, 2024).
                        </P>
                    </FTNT>
                    <P>
                        In the context of digital peer-to-peer payment applications or functionalities, several industry and other commenters stated that the proposal's approach to defining “general use” was too broad. A nonprofit stated that the Proposed Rule incorrectly treated any peer-to-peer funds transfer functionality as having general use. Another nonprofit stated that peer-to-peer payment applications should not have general use unless also enabled for purchases. In its view, the absence of a purchase functionality constitutes a “significant limitation” within the meaning of the proposed definition of “general use.” Another industry association stated that the Proposed Rule should not have classified a peer-to-peer payment application as having general use when it restricts the universe of payment recipients to other persons who are registered users of the same application. Finally, several industry trade associations stated that the Proposed Rule was internally inconsistent by treating a payment functionality used exclusively by people who are incarcerated to make commissary purchases as having “general use” while simultaneously excluding payment functionalities provided solely for purchase of certain types of goods, services, or other property, such as food.
                        <SU>293</SU>
                        <FTREF/>
                         Two trade associations also suggested that the Proposed Rule's assessment that persons who are incarcerated may put funds received to general use in a closed environment is inconsistent with how the CFPB views closed-loop prepaid cards under, Regulation E. Another industry association stated that a payment functionality for people who are incarcerated to pay for goods and services does not have “general use” within its conventional meaning.
                        <SU>294</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>293</SU>
                             In addition, they stated that the proposal's different treatment of these examples created confusion about the identity of the estimated 17 larger participants. The CFPB discusses comments on that issue in the section-by-section analysis of the larger-participant test below.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>294</SU>
                             Some of these commenters further claimed the cost-benefit analysis did not consider potential impacts on money transfer services for incarcerated people, which they considered to be a distinct product market. In the response to general comments above, the CFPB responds to comments calling for the CFPB to divide the proposed market into separate markets for purposes of this rulemaking. The impacts analysis in part VII further explains how it analyzes the impacts in the market adopted in the Final Rule.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Response to Comments Received</HD>
                    <P>With respect to comments that the proposed definition of “general use” was excessively ambiguous or uncertain, the CFPB also shares the commenters' goal of reducing ambiguity and uncertainty in the definition of “general use.” Accordingly, the CFPB declines to adopt the proposal to define “general use” as the absence of significant limitations on the purposes of a consumer payment transactions facilitated by the covered payment functionality provided through the digital consumer payment application. Instead, as discussed further below, the Final Rule adopts an alternative standard for defining “general use” as usable to transfer funds in a consumer payment transaction to multiple unaffiliated persons, with limited exceptions.</P>
                    <P>With respect to comments on the breadth of the term “general use,” the CFPB believes that the definition of “general use” adopted in this Final Rule is appropriately broad given the characteristics of the market defined in this Final Rule. The term encompasses digital consumer payment applications capable of being used for a range of purposes such as sending funds to friends and family, buying a range of goods or services at different stores, or both. As discussed above in response to comments on the market definition in § 1090.109(a)(1), treating those functions as part of a single market is consistent with the CFPB's experience and expertise, the views of certain other market observers, and with common consumer user experience.</P>
                    <P>
                        In response to the commenter that raised concerns about the rule including a “general use” limitation at all, the CFPB notes that the “general use” limitation reduces the breadth of the market, which the commenter stated already was overly broad. The CFPB also declines to drop the “general use” limitation based on that industry association's comments suggesting that this limitation impermissibly excludes economic substitutes. The commenter cited examples of food delivery applications and automobile purchase 
                        <PRTPAGE P="99628"/>
                        applications that facilitating payments that consumers also can make through payment functionalities that have general use.
                        <SU>295</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>295</SU>
                             For the reasons described at the outset of the section-by-section analysis above, the CFPB disagrees with the industry association comment that concluded that antitrust law governs how the CFPB must define larger participants in a market for consumer financial products or services pursuant to CFPB section 1024(a)(1)(B). In addition, as discussed further above, the CFPB disagrees that it would be appropriate for the market to include merchant and marketplace payment functionalities described by the exclusion in paragraph (C) of the definition of “consumer payment transaction.”
                        </P>
                    </FTNT>
                    <P>The CFPB similarly declines the consumer group comments suggesting that the Final Rule clarify that marketplaces meet the definition of “general use.” Regardless of whether they meet that definition, for the reasons discussed in the section-by-section analysis of “consumer payment transaction” above, the Final Rule adopts the proposed exclusion in paragraph (C) of the definition of that term for marketplace payment functionalities.</P>
                    <P>The CFPB disagrees with the industry and nonprofit comments stating that the CFPB should adopt a narrower definition of “general use” that would exclude some or all peer-to-peer payment applications. Like a payment functionality that can be used to pay two or more unaffiliated merchants, a peer-to-peer payment functionality enables transfers for consumer payment transactions to multiple, unaffiliated individuals. Thus, it is appropriate to for payment functionalities that solely support payments to friends and family to fall within the definition of “general use” in the Final Rule. In addition, the market increasingly bundles both types of payments and many peer-to-peer payment functionalities can be used formally or informally to make payments for purchases. Defining the market based on the status of the recipient as a consumer or a business, as the commenter suggests, would be inconsistent with how the market has evolved, as further discussed above in the response to comments on the market definition in § 1090.109(a)(1).</P>
                    <P>
                        In addition, peer-to-peer digital consumer payment applications often support payments to millions if not tens of millions of other users including in some circumstances that industry describes as a “closed loop” system. For example, even in such a system, often any adult consumer who can pass identity verification can enroll to receive funds.
                        <SU>296</SU>
                        <FTREF/>
                         The Final Rule therefore does not treat the need for a recipient to sign up for an account to receive funds as a basis for excluding the corresponding covered payment functionality from the definition of “general use.” This approach also promotes consistent oversight of consumer financial products and services that allow consumers to send funds to other consumers, without regard to whether they operate through depository institutions.
                        <SU>297</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>296</SU>
                             
                            <E T="03">CFPB Deposit Insurance Spotlight, supra</E>
                             (“In closed loop systems, transactions are enabled through a single provider. Under this model, both payer and receiver must have an account with the same provider to complete the payment.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>297</SU>
                             
                            <E T="03">See also</E>
                             Julian Morris, 
                            <E T="03">Peer-to-Peer and Real Time Payments: A Primer,</E>
                             Int'l Ctr. For Law &amp; Econ. (Aug. 21, 2023) (generally describing how “closed loop” is more of an indicator that the platform may operate outside of the banking system), 
                            <E T="03">https://laweconcenter.org/resources/peer-to-peer-and-real-time-payments-a-primer/</E>
                             (last visited Oct. 24, 2024). The Final Rule also does not define “general use” by reference to peer-to-peer payment systems that may be described as “closed loop” because usage of the term “closed loop” in that context varies and the market is rapidly evolving. 
                            <E T="03">See, e.g., CFPB Deposit Insurance Spotlight, supra</E>
                             (describing how “[c]losed loop payment systems are often connected to traditional open loop systems, so funds can be deposited or withdrawn out of the closed loop system.”); 
                            <E T="03">Getting the U.S. Banking Market Ready for Instant Payments,</E>
                             PaymentsJournal (May 21, 2024) (“In other parts of the world, fintechs have taken the lead by converting their closed-loop stored value wallet propositions and making them interoperable on the back of real-time payment systems. U.S. fintechs have the same opportunity.”), 
                            <E T="03">https://www.paymentsjournal.com/getting-the-u-s-banking-market-ready-for-instant-payments/</E>
                             (last visited Nov. 8, 2024); VISA, 
                            <E T="03">In 2024, payments to get global, open, tailored and interoperable</E>
                             (Dec. 15, 2023) (describing how “money-moving apps and wallets” operating within their own “siloed ecosystem . . . is beginning to change. With payments players prioritizing interoperability, we will soon see a more seamless future-state of global money movement—one where paying across services is as seamless as using any one service”), 
                            <E T="03">https://usa.visa.com/visa-everywhere/blog/bdp/2023/12/14/in-2024-payments-1702577675756.html</E>
                             (last visited Nov. 8, 2024); VISA, 
                            <E T="03">Introducing Visa+</E>
                             (describing new Visa+ product launched in the United States where “users set up one payname in their preferred wallet, and pay or get paid regardless of the participating app their peers use.”), 
                            <E T="03">https://usa.visa.com/products/visa-plus.html.</E>
                             (last visited Nov. 8, 2024).
                        </P>
                    </FTNT>
                    <P>
                        The CFPB declines to adopt the suggestion by some industry commenters that the Final Rule exclude payment functionalities based on whether they are limited to use at what the industry association commenters described as a “finite” number of merchants. The term “finite” is not a workable standard for this Rule, and the CFPB disagrees with the industry commenters' further suggestion that if it does not adopt that exclusion (or an exclusion for some other definite number), the rule would have the paradoxical effect of treating the universe of potential recipients in closed-loop payment systems for retail spending as infinite. These comments did not recognize that paragraph (B) of the proposed definition of “general use” already excluded closed-loop gift cards.
                        <SU>298</SU>
                        <FTREF/>
                         And the comment did not provide a justification for this Rule to adopt a broader exclusion, such as for payment functionalities usable at multiple unaffiliated merchants. The CFPB also disagrees with the individual commenter that the Rule should define “general use” based on the reaching a specific quantity of merchants, platforms, and purposes. The commenter did not provide any justification for the specific numbers of merchants, platforms, and purposes they proposed. In addition, the range of goods and services offered by an individual merchant can vary widely across merchants. As a result, the number of merchants where a consumer can make purchases is not necessarily an indicator of “general use.” However, the CFPB agrees that additional clarification may be helpful as to whether the type of payment account excluded from Regulation E (by virtue of only being usable at a single merchant or its affiliates) also would be excluded from the market definition here based on lacking “general use.” The CFPB provides those clarifications below in the discussion of the revised definition of “general use” adopted in Final Rule.
                        <SU>299</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>298</SU>
                             In describing the exclusion they were seeking, these commenters referred to a description of “closed-loop prepaid cards” without acknowledging that term included gift cards, which the Proposed Rule already proposed to exclude in paragraph (B) of the definition of “general use.” 
                            <E T="03">See also</E>
                             CFPB, Final Prepaid Account Rule, 81 FR 83934, 83936 (Nov. 22, 2016) (explaining how “consumers can only use funds stored on closed-loop prepaid products at designated locations (
                            <E T="03">e.g.,</E>
                             at a specific merchant 
                            <E T="03">or group of merchants in the case of certain gift cards;</E>
                             within a specific transportation system in the case of transit cards)”) (emphasis added).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>299</SU>
                             The Final Rule does not adopt the consumer group suggestion of clarifying that online marketplace payment functionalities have “general use” because, for the reasons discussed in the section-by-section analysis of “consumer payment transaction” above, the Final Rule does not drop the exclusion in paragraph (C) of the definition of that term. The requested clarification would create confusion, suggesting online marketplace payment functionalities excluded by paragraph (C) are covered by the definition of “general use.”
                        </P>
                    </FTNT>
                    <P>
                        Finally, the CFPB does not agree with the industry firm commenter that the Proposed Rule created significant uncertainty as to whether certain cards, codes, or other devices described in Regulation E section 1005.20(b) would have general use for purposes of this rule. No other commenter raised this issue, and the commenter that raised the issue did not explain why it believed that the CFPB would view all of the cards, codes, or other devices described in Regulation E section 1005.20(b) as 
                        <PRTPAGE P="99629"/>
                        having general use, especially in light of the other examples of accounts that would not have general use described in proposed paragraph (B). In any event, the CFPB disagrees that Regulation E section 1005.20(b)(2) describes accounts that would not have general use for purposes of this rule. Section 1005.20(b)(2) describes general-purpose reloadable cards that are not marketed as gift cards or gift certificates. But the absence of gift marketing does not render these cards lacking in general use, and if they are loaded into a general-use digital consumer payment application, then they may fall within the market definition.
                    </P>
                    <HD SOURCE="HD3">Final Rule</HD>
                    <P>In response to the comments analyzed above, the CFPB includes the proposed term “general use” in the Final Rule but defines it differently than the proposal did. Rather than adopting the proposal to define “general use” using the “absence of significant limitations on the purpose” standard and providing illustrative examples of activities that would or would not meet the standard, the Final Rule adopts an alternative standard that is clearer and more administrable, along with specific, enumerated exceptions. This approach addresses comments as discussed above and described below.</P>
                    <P>
                        For purposes of the Final Rule, “general use” is defined as usable for a consumer to transfer funds in a consumer payment transaction to multiple, unaffiliated persons. The CFPB is adopting this new standard because it is clearer and more administrable, and more closely aligns with the similar concept in Regulation E.
                        <SU>300</SU>
                        <FTREF/>
                         The definition is subject to specific exceptions as described below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>300</SU>
                             The term “general use” in the Final Rule has certain similarities to terms in Regulation E, 12 CFR part 1005, but differs in some substantive respects as specified below. Usage, or omission, of specific language from EFTA or Regulation E in the Final Rule is not an endorsement by the CFPB of any specific interpretation of EFTA or Regulation E.
                        </P>
                    </FTNT>
                    <P>
                        This approach is based upon similar concepts in Regulation E, and therefore improves clarity and reduces uncertainty. For example, Regulation E defines a prepaid card that has “general use” for purchases based on being “[r]edeemable upon presentation at multiple, unaffiliated merchants for goods and services[.]” 
                        <SU>301</SU>
                        <FTREF/>
                         Similarly, under the Final Rule, a payment functionality that facilitates payments to multiple, unaffiliated merchants for goods and services also would have “general use,” unless an exception applies. Also similar to Regulation E, a payment functionality would not meet the definition of “general use” in the Final Rule if the consumer payment transactions it facilitates are solely for a single merchant and its affiliated companies.
                    </P>
                    <FTNT>
                        <P>
                            <SU>301</SU>
                             12 CFR 1005.20(a)(3)(ii).
                        </P>
                    </FTNT>
                    <P>
                        In addition, consumers use digital consumer payment applications to transfer funds from additional types of payment methods beyond prepaid cards (
                        <E T="03">e.g.,</E>
                         other prepaid accounts, bank accounts, and credit cards) and to make payments to additional types of entities beyond merchants. Therefore, the CFPB does not view Regulation E as encompassing the full scope of activity that market participants include within their general-use digital consumer payment applications. For that reason, the Final Rule does not adopt the precise phrase used to define “general use” in the Regulation E definition of prepaid cards, which generally facilitate purchase transactions from merchants. The Final Rule instead adopts the phrase “multiple, unaffiliated persons” to define the universe of potential recipients of transfers of funds that determine whether a payment functionality has “general use.” 
                        <SU>302</SU>
                        <FTREF/>
                         If a covered payment functionality facilitates consumer payment transactions to multiple unaffiliated entities that are not merchants, it would qualify as having “general use,” unless an exception applies. Further, if a covered payment functionality facilitates consumer payment transactions to multiple individuals such as family or friends not acting as merchants, that covered payment functionality still would qualify as “general use” for purposes of the Final Rule, unless an exception applies.
                        <SU>303</SU>
                        <FTREF/>
                         Although this approach includes many common peer-to-peer transfer systems in the definition of “general use,” the CFPB disagrees with the industry commenters that this indicates the definition is too broad.
                        <SU>304</SU>
                        <FTREF/>
                         As discussed above, given their mixed use, these covered payment functionalities often facilitate consumer payment transactions to sole proprietors and other small businesses anyway.
                    </P>
                    <FTNT>
                        <P>
                            <SU>302</SU>
                             
                            <E T="03">See also</E>
                             Regulation E, 12 CFR 1005.2(b)(3)(i)(D)(
                            <E T="03">2</E>
                            ) (defining “prepaid account” to include accounts with the “primary function [ ] to conduct person-to-person transfers”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>303</SU>
                             The CFPA defines “affiliate” in section 1002(1) on the basis of a control relationship between two persons. Two consumers generally would not qualify as “affiliates” because they generally do not “control” one another for purposes of the CFPA.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>304</SU>
                             A number of industry commenters suggested the proposed definition was too broad because the Proposed Rule stated that a covered payment functionality dedicated to transferring funds to incarcerated people may have “general use” based on recipients' ability to use transferred funds for purchase of a variety of types of goods, even when those uses might not be subject to Regulation E. The Final Rule does not adopt that approach because the definition of “general use” in the Final Rule does not depend on the uses of funds by payment recipients.
                        </P>
                    </FTNT>
                    <P>With regard to the list of examples in proposed paragraphs (A)-(D) that would not have met the proposed definition of “general use,” as described below, some are not adopted in the Final Rule because it already excludes them in other ways, others are maintained with modifications, and two are not adopted because the Final Rule includes the corresponding examples in the market.</P>
                    <P>
                        First, the Final Rule need not adopt proposed paragraph (A) because the CFPB understands that other revisions the Final Rule would make the exclusion in proposed paragraph (A) unnecessary.
                        <SU>305</SU>
                        <FTREF/>
                         First, the Final Rule need not adopt proposed paragraph (A) because the CFPB understands that other revisions the Final Rule would make the exclusion in proposed paragraph (A) unnecessary. Specifically, if a merchant or marketplace sells or leases only specific types of goods, services, or other property, then a payment functionality that is limited to facilitating payments to that merchant or marketplace already would be excluded from the Final Rule for other reasons. For example, the definition of “general use” in the Final Rule already does not cover a payment functionality that facilities consumer payment transactions solely by facilitating a purchase from a single merchant or its affiliated companies, including a merchant providing any of the types of goods, services, or other property listed in proposed paragraph (A).
                        <SU>306</SU>
                        <FTREF/>
                         Such activities do not facilitate payments to “multiple, unaffiliated persons” in the definition of “general use.” In addition, to the extent an online marketplace 
                        <PRTPAGE P="99630"/>
                        operator's payment functionality facilitates payments to multiple, unaffiliated persons for the purchase of goods or services a consumer selects from the online marketplace (including a marketplace offering only specific types of goods or services), the online marketplace operator's conduct of those payment transactions already would be excluded from the definition of “consumer payment transaction” as described above.
                    </P>
                    <FTNT>
                        <P>
                            <SU>305</SU>
                             This approach also makes the definition of “general use” more consistent with similar concepts in Regulation E. Under paragraph (A) in the proposed definition of “general use,” a payment functionality that solely supports the purchase or lease of a specific type of services, goods, or other property from multiple, unaffiliated merchants would not have had “general use.” However, the relevant provisions of the definitions of “prepaid account” and “general-use prepaid card” in Regulation E apply to accounts redeemable at multiple unaffiliated merchants, regardless of whether they sell the same specific type of services, goods, or other property. 12 CFR 1005.2(b)(3)(i)(D)(
                            <E T="03">2</E>
                            ) &amp; 1005.20(a)(3)(ii). By not including that exception, the definition of “general use” in the Final Rule is more consistent with Regulation E, which contains no such exclusion from the definition of “general-use prepaid card” or “prepaid account” discussed above.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>306</SU>
                             The definition of “general use” in the Final Rule also does not include a payment functionality that facilitates consumer payment transactions solely to purchase consumer financial products or services from a single provider and their affiliated companies.
                        </P>
                    </FTNT>
                    <P>
                        Second, the Final Rule adopts other examples described in proposed paragraphs (B) and (C) with certain modifications described below for clarity. In paragraph (B) of the proposed definition of “general use,” the CFPB proposed to exclude using certain accounts described in Regulation E section 1005.2(b)(3)(ii)(A), (C), and (D), which Regulation E excludes from the definition of “prepaid account.” The CFPB did not receive any comments agreeing or disagreeing with the exclusions described in proposed paragraph (B).
                        <SU>307</SU>
                        <FTREF/>
                         Notwithstanding the adoption of a more specific definition of “general use” described above, the CFPB does not view these types of highly-specialized payment functionalities as having “general use” for purposes of this rule. For the reasons explained in the Proposed Rule as described above, the Final Rule therefore maintains these exclusions by listing them as exceptions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>307</SU>
                             As noted above, two industry associations expressed general support for excluding closed-loop transactions in a manner consistent with Regulation E. In addition, while acknowledging the exclusion for using accounts described in 12 CFR 1005.2(b)(3)(ii)(C), some consumer groups suggested that the Final Rule should clarify that other payment apps directed at servicemembers can have “general use.” Subject to the exceptions discussed here, the definition of “general use” in the Final Rule applies when to a covered payment functionality that facilitates payments to multiple, unaffiliated persons, regardless of whether the functionality is directed at servicemembers. In addition, as discussed above, one commenter sought clarification regarding how the CFPB reads the exclusion for using accounts described in 12 CFR 1005.2(b)(3)(ii)(D), which the CFPB discusses above.
                        </P>
                    </FTNT>
                    <P>
                        In addition, the Final Rule adopts the exception in proposed paragraph (C) to pay a specific debt or type of debt. The Final Rule also clarifies that this exception excludes additional examples beyond loan servicing functionalities that facilitate repayment of extensions of consumer credit. The Final Rule states that this exception excludes payment functionalities provided solely for paying the following two types of debts: (
                        <E T="03">1</E>
                        ) Debts owed in connection with origination or repayment of an extension of consumer credit; or (
                        <E T="03">2</E>
                        ) Debts in default. Through these exceptions, the Final Rule separates the market it defines from other distinct markets as described below. It therefore does not include those payment functionalities in the definition of this market. With respect to the type of debts described in paragraph (
                        <E T="03">1</E>
                        ), just as the Proposed Rule did not seek to cover loan servicing such as the servicing of mortgage loans (which is part of the mortgage market), it also did not seek to cover payment functionalities that facilitate payments made in connection with origination of a mortgage loan (such as payments through closing or escrow accounts maintained by providers of real estate settlement services described in CFPA section 1002(15)(A)(viii)).
                        <SU>308</SU>
                        <FTREF/>
                         The revised exception clarifies this. In addition, in paragraph (
                        <E T="03">1</E>
                        ), the Final Rule specifies the payment of debts in default as a second type of debt payment functionality that is excluded by paragraph (B). Specifically, consumers may pay debts in default through a debt collector as defined in 15 U.S.C. 1692a(6).
                        <SU>309</SU>
                        <FTREF/>
                         As noted in part III above, the CFPB already has issued a rule defining larger participants in a market for consumer debt collection, and may supervise service providers to such persons under CFPA section 1024(e). And consumers may repay extensions of credit or debts in default through a debt settlement firm as described in CFPA section 1002(15)(A)(viii)(II).
                        <SU>310</SU>
                        <FTREF/>
                         The CFPB also views the market for debt relief services as separate from the market for general-use digital consumer payment applications.
                        <SU>311</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>308</SU>
                             12 U.S.C. 5481(15)(A)(iii). Real estate settlement services generally are part of a distinct market for mortgage lending that is subject to additional applicable Federal consumer financial laws such as the Real Estate Settlement Procedures Act, 12 U.S.C. 2601 
                            <E T="03">et seq.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>309</SU>
                             Fair Debt Collection Practices Act, 15 U.S.C. 1692a(6).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>310</SU>
                             12 U.S.C. 5481(15)(A)(viii)(II) (one type of “financial product or service”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>311</SU>
                             Debt settlement is part of a distinct market that is subject to additional applicable Federal consumer financial laws such as the Telemarketing Sales Rule. 16 CFR part 310.
                        </P>
                    </FTNT>
                    <P>
                        Third, for the reasons described below, the Final Rule does not exclude the example described in proposed paragraph (D) for splitting charges for specific types of goods or services. As the industry association comment described above noted, consumers can use general-use consumer payment applications to make payments for split expenses. For example, a consumer may transfer funds to a friend or family member as reimbursement for food or other expenses. Whether the provider markets its digital application primarily for that use, or for other uses, it can meet the definition of “general use” adopted in this Final Rule. The CFPB does not believe this change significantly affects the market-related estimates discussed in the section-by-section analysis of the larger-participant test below or the impacts analyses in part VII below. For example, online marketplaces may help consumers to split bills and make associated payments in circumstances that already are excluded from the definition of “consumer payment transaction.” 
                        <SU>312</SU>
                        <FTREF/>
                         In addition, other products and services marketed as “bill splitting apps” may help consumers to calculate the amount each consumer will pay, but either do not help consumers to make the associated payments or refer consumers to a third-party's general-use digital consumer payment application to make the associated payments.
                    </P>
                    <FTNT>
                        <P>
                            <SU>312</SU>
                             For example, if a consumer selects food for purchase by placing a restaurant order through an online marketplace platform operator that also conducts transactions to split the bill for that purchase, such activity may qualify for the exclusion in paragraph (C) of the definition of “consumer payment transaction.”
                        </P>
                    </FTNT>
                    <P>Finally, the CFPB reiterates that each of the exceptions from the definition of “general use” in paragraphs (A) through (C) of the Final Rule is for a payment functionality provided through a digital application solely to support payments of the type listed in the exception. If a nonbank provides a payment functionality through a digital application to support one of the types of payments in paragraphs (A) through (C), but also to support peer-to-peer transfers to other accountholders generally, then it would still have general use, as described above.</P>
                    <HD SOURCE="HD3">State</HD>
                    <P>
                        Proposed § 1090.109(a) would have defined the term “State” to mean any State, territory, or possession of the United States; the District of Columbia; the Commonwealth of Puerto Rico; or any political subdivision thereof. For consistency, the CFPB proposed to use the same definition of “State” as used in the international money transfer larger participant rule, § 1090.107(a), which drew its definition from Regulation E subpart A.
                        <SU>313</SU>
                        <FTREF/>
                         The CFPB requested comment on the proposed definition of State. No commenters addressed this aspect of the Proposed Rule, which the Final Rule adopts as proposed.
                    </P>
                    <FTNT>
                        <P>
                            <SU>313</SU>
                             
                            <E T="03">See</E>
                             International Money Transfer Larger Participant Final Rule, 79 FR 56631 at 56641.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">109(b) Test To Define Larger Participants</HD>
                    <P>
                        Proposed § 1090.109(b) would have set forth a test to determine which 
                        <PRTPAGE P="99631"/>
                        nonbank covered persons are larger participants in a market for general-use digital consumer payment applications as described in proposed § 1090.109(a). Under the proposed test, a nonbank covered person would have been a larger participant if it meets each of two criteria set forth in paragraphs (1) and (2) of proposed § 1090.109(b) respectively. First, paragraph (1) specified that the nonbank covered person must provide annual covered consumer payment transaction volume as defined in paragraph (3) of proposed § 1090.109(b) of at least five million transactions. Second, paragraph (2) specified that the nonbank covered person must not be a small business concern based on the applicable SBA size standard listed in 13 CFR part 121 for its primary industry as described in 13 CFR 121.107. The Final Rule summarizes and responds to comments about the test in the section-by-section analysis of this proposed definition below.
                        <SU>314</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>314</SU>
                             As the Proposed Rule noted, prior to issuing the Proposed Rule, the CFPB conducted analysis of data sources as described in parts IV, V and VI of the Proposed Rule to identify likely market participants, and, to the extent of available data: (1) to inform its general understanding of the market; and, relatedly, (2) to estimate the level of market activity by market participants, the degree to which market participants would be small entities, and the level of market activity by larger participants. These estimates therefore relied to some degree on preliminary entity-level analysis that is not dispositive of whether the CFPB would ever seek to initiate supervisory activity at a given entity or whether, in the event of a person's assertion that it is not a larger participant, the person would be found to be a larger participant.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Comments Received</HD>
                    <P>Comments from two industry providers, two trade associations, and some Members of Congress commenters stated that the description in the Proposed Rule of the confidential data it relied upon was insufficient to allow for meaningful comment. As described below, these comments generally focused on two types of data the Proposed Rule did not release: confidential data about market participants' activities that the CFPB used to estimate their larger participant status, and, relatedly, the identities of the individual entities included in the Proposed Rule's estimate of the number of market participants that would qualify as larger participants.</P>
                    <P>With regard to the proposal's estimate of 17 larger participants, several Members of Congress criticized the Proposed Rule for not identifying the individual firms included in the estimate. They stated that the Proposed Rule was not specific enough to allow the public to identify larger participants, which they stated was necessary for the public to understand the implications of the proposal and to provide comprehensive feedback on its impact. A group of industry associations also stated that uncertainty in the proposed definition of “general use” left uncertainty about the identities of firms included in the estimate. Meanwhile, a banking industry association suggested that, separate from the rulemaking, the CFPB should publish a list of larger participants that are subject to supervision to help consumers and industry to better evaluate their relationships with these nonbanks.</P>
                    <P>Some of these industry commenters also stated that the CFPB should release information about the confidential transaction data for individual firms that it used to make its estimates concerning the number of larger participants and their share of market participant that the Proposed Rule used in support of the proposed threshold. Two of these comments stated that the CFPB must release the data it relied upon, while the other comment called for releasing what it called a sanitized version of the NMLS data it used. One indicated that it needed such additional information to comment on the Proposed Rule's estimate of the percentage of the market that larger participants comprised. This commenter also noted the acknowledgment in the Proposed Rule that the NMLS data may be overinclusive or underinclusive, and its acknowledgment about the lack of sufficient data to estimate larger participant status for certain market participants. Some of these commenters added that, in their view, more than 17 companies would qualify as larger participants, due in significant part to the inclusion of pass-through payment wallet functionalities within the market definition.</P>
                    <P>
                        Another industry association stated more generally that the Proposed Rule was not sufficiently transparent and that the rulemaking needs to provide more comprehensive information and justification for the threshold, which it stated should be sector-specific.
                        <SU>315</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>315</SU>
                             An industry commenter also noted in a footnote that they believed the CFPB could not rely upon data collected through its 2021 section 1022(c)(4) orders because, in their view, the CFPB did not comply with the Paperwork Reduction Act (PRA).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Response to Comments Received</HD>
                    <P>
                        The CFPB disagrees with commenters that the Proposed Rule did not provide sufficient information for commenters to offer meaningful comment. As discussed in the proposal and further below, the CFPB provided commenters with extensive information about the data and other evidence supporting the rule to enable informed comment, including the sources of data, the CFPB's methodology for analyzing the data, descriptions of market concentration, and the limitations of the data. While the Proposed Rule did not disclose entity-level transaction volume and revenue data, entities in this market generally keep this information confidential and do not disclose it to the public.
                        <SU>316</SU>
                        <FTREF/>
                         The Bureau has routinely gathered this information in carrying out its statutory functions with the understanding that such information will be kept confidential consistent with the CFPA and its implementing rules.
                    </P>
                    <FTNT>
                        <P>
                            <SU>316</SU>
                             As noted below, the only exception is well-known entities in the market that are public companies, which disclose revenue information in public securities filings.
                        </P>
                    </FTNT>
                    <P>
                        Congress anticipated that the CFPB would collect and rely on confidential data from a variety of sources to support its rulemaking and other statutory functions, and that it would use that information in a way designed to protect its confidentiality.
                        <SU>317</SU>
                        <FTREF/>
                         The confidential transaction and revenue data that the CFPB relied on in the Proposed Rule came from two sources that the Bureau had access to: confidential supervisory information regularly shared by the States through NMLS and data obtained via the CFPB's market monitoring functions.
                        <SU>318</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>317</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5512(c)(1), (c)(3)(B), (c)(4), (c)(6), (c)(8); 
                            <E T="03">see also</E>
                             12 CFR part 1070.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>318</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5512(c)(8); 12 CFR part 1070.
                        </P>
                    </FTNT>
                    <P>
                        As the Proposed Rule indicated, the States collect nonpublic NMLS money services business call report data under explicit assurances of confidentiality.
                        <SU>319</SU>
                        <FTREF/>
                         The NMLS collects all of this commercial or financial information from the States as part of State supervisory functions, also under assurances of confidentiality. On behalf of the States, the State financial regulator association that operates NMLS authorized the CFPB to use this robust dataset if it complied with the NMLS confidentiality conditions. When this information is shared with the CFPB, the CFPB also treats it as confidential supervisory information, which is generally protected from 
                        <PRTPAGE P="99632"/>
                        disclosure by statute and CFPB implementing regulations.
                        <SU>320</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>319</SU>
                             The Proposed Rule (88 FR 80107 at 80209-10 n.83 &amp; n.90) identified the public NMLS website with detailed information about the type of data collected in NMLS money services business call reports. In those materials, NMLS emphasizes to money services business that “[a]ll data submitted in the [MSB call] report is confidential[.]” 
                            <E T="03">NMLS MSB Call Report Overview and Definitions</E>
                             at 6 (“Information Sharing”), 
                            <E T="03">https://mortgage.nationwidelicensingsystem.org/licensees/resources/LicenseeResources/MSBCR%20Overview%20-%20(FINAL).pdf</E>
                             (last visited Nov. 8, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>320</SU>
                             CFPA sec. 1022(c)(6), 12 U.S.C. 5512(c)(6); 12 CFR 1070.40-48. The CFPB similarly would be obligated to keep such information confidential had it collected the information directly from the entities, 
                            <E T="03">see</E>
                             12 CFR 1070.40-1070.48, in addition to increasing the burden on industry with duplicative requests, 
                            <E T="03">cf.</E>
                             12 U.S.C. 5514(b)(3).
                        </P>
                    </FTNT>
                    <P>
                        The Proposed Rule explained that the CFPB also collected certain information pursuant to orders issued pursuant to section 1022(c)(4) of the CFPA. Those orders provided that the CFPB will treat the information received in response to the order in accordance with its confidentiality regulations at 12 CFR 1070.40 through 1070.48.
                        <SU>321</SU>
                        <FTREF/>
                         Confidential commercial or financial information about specific transaction volume collected through those orders also generally would be protected by FOIA exemption 4,
                        <SU>322</SU>
                        <FTREF/>
                         and therefore would qualify as confidential information under 12 CFR 1070.2(f).
                        <SU>323</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>321</SU>
                             
                            <E T="03">See https://files.consumerfinance.gov/f/documents/cfpb_section-1022_generic-order_2021-10.pdf</E>
                             (last visited Nov. 7, 2024) (sample 1022 order on website cited in proposal, 88 FR 80197 at 80210 n.90, where the CFPB explained that “it obtained transaction and revenue data from six technology platforms offering payment services through a CFPB request pursuant to CFPA section 1022(c)(4)”). 
                            <E T="03">See CFPB Orders Tech Giants to Turn Over Information on their Payment System Plans</E>
                             (Oct. 21, 2021) (CFPB 1022 Orders Press Release), 
                            <E T="03">https://www.consumerfinance.gov/about-us/newsroom/cfpb-orders-tech-giants-to-turn-over-information-on-their-payment-system-plans/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>322</SU>
                             
                            <E T="03">See Food Mktg. Inst.</E>
                             v. 
                            <E T="03">Argus Leader Media,</E>
                             588 U.S. 427 (2019).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>323</SU>
                             The CFPB also disagrees with the comment suggesting that the CFPB's section 1022(c)(4) orders did not comply with the PRA. These orders, which the CFPB addressed to six entities, were not subject to the PRA requirements. 
                            <E T="03">See</E>
                             5 CFR 1320.3(c)(4) (defining “collection of information” from “ten or more persons” as subject to PRA).
                        </P>
                    </FTNT>
                    <P>
                        In the CFPB's experience, virtually no market participants publicly disclose their volume of consumer payment transactions as defined in the Proposed Rule, and unless a firm is a public company, it does not disclose its revenues. No commenters suggested that the individual firm-level transaction volume data or the revenue data of companies that are not public companies was 
                        <E T="03">not</E>
                         confidential information or generally available to anyone but the individual company itself. As discussed in the impacts analyses, in response to the proposal's request for data, no commenters provided or pointed to sources of additional relevant data.
                        <SU>324</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>324</SU>
                             88 FR 80197 at 80211. As discussed in the section-by-section analysis above, some commenters stated that the CFPB should use additional data sources to estimate the volume of consumer payment transactions that transfer digital assets such as crypto-assets and stablecoins. However, as discussed below, the Final Rule does not cover those transactions. Therefore, those data sources are not pertinent to the Final Rule.
                        </P>
                    </FTNT>
                    <P>The CFPB reasonably relied on this confidential transaction data and revenue data in the Proposed Rule to provide estimates of the number of firms that would qualify as larger participants compared to the overall number of estimated market participants and estimates of larger participants' market participation share of market activity. To conduct a preliminary entity-level analysis of which market participants may qualify as a larger participant under the Proposed Rule, the CFPB generally needed to use available data about the two criteria for the proposed larger-participant test—an entity's consumer payment transaction volume and its revenues (which generally governs small business concern status under applicable size standards).</P>
                    <P>The absence of such information provided by commenters supports the conclusion that the money services business call reports when combined with the CFPB's section 1022(b) order responses are the most comprehensive sources available for estimating transaction volume at the firm level for purposes of this rule. Both sources collect information about consumer payments facilitated in the United States by market participants. In addition, no commenter indicated that an individual firm itself did not have access to its own transaction volume data or its revenue data with which to assess its own larger participant status under the Proposed Rule. Comments describing potential difficulty individual firms could face in relying on available data to assess larger participant status referred to difficulties in counting of digital assets transactions, which the Final Rule does not include in the larger-participant test, as described below.</P>
                    <P>
                        Courts have held that an agency can rely on confidential information in its rulemaking so long as the agency discloses “sufficient factual detail and rationale for the rule to permit interested parties to comment meaningfully.” 
                        <SU>325</SU>
                        <FTREF/>
                         Here, the Proposed Rule disclosed, among other information: (1) the sources of the data; (2) meaningful sources of additional public information about the data; 
                        <SU>326</SU>
                        <FTREF/>
                         (3) the methodologies used to analyze the data; (4) the results of deploying those methodologies; (5) that the data indicated that the market was highly concentrated, with a few entities facilitating hundreds of millions or billions of consumer payment transactions annually; 
                        <SU>327</SU>
                        <FTREF/>
                         (6) that only about one percent of market activity was conducted by an estimated three entities with transaction volume between the five and 10 million transaction thresholds considered in the Proposed Rule; 
                        <SU>328</SU>
                        <FTREF/>
                         (7) aggregate transaction estimates for the proposal's estimated 17 larger participants; (8) the extent to which the data sources did not include relevant data; and (9) the potential for uncertainty in its estimates based on the nature of the data. This detailed information enabled commenters to provide meaningful comment on, and criticize, the basis for the proposed test to define “larger participants” in the proposed market, and meaningful comment on whether the Final Rule should adopt a higher, lower, or different threshold for the larger-participant test. As described further below, the CFPB received extensive, meaningful comment on these very questions (as well as numerous other aspects of the rule). The industry commenters described above also did not explain what additional information could be provided that would address their comments.
                    </P>
                    <FTNT>
                        <P>
                            <SU>325</SU>
                             
                            <E T="03">See Fla. Power &amp; Light Co.</E>
                             v. 
                            <E T="03">United States,</E>
                             846 F.2d 765, 771 (D.C. Cir. 1988); 
                            <E T="03">see also Riverkeeper Inc.</E>
                             v. 
                            <E T="03">EPA,</E>
                             475 F.3d 83, 112 (2d Cir. 2007); 
                            <E T="03">rev'd on other grounds,</E>
                             556 U.S. 208 (2009).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>326</SU>
                             88 FR 80197 at 80210 n.90 (providing links to NMLS and CFPB public websites where commenters could review descriptions of the type of data identified in the proposed rule and how the data was collected, including sample 1022 order and 
                            <E T="03">NMLS Money Services Business Call Report Overview</E>
                             described above).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>327</SU>
                             88 FR 80197 at 80210. 
                            <E T="03">See also, e.g., FIS 2023 Global Payments Report</E>
                             at 16 (“North America's credit and debit card markets are increasingly intermediated by a handful of major digital wallet brands. These initially consisted of PayPal, Google Pay and Apple Pay, but challengers such as Shop Pay (Shopify's checkout solution) and Cash App Pay (recently becoming an open loop wallet) have joined the playing field.”); 
                            <E T="03">2022 Survey and Diary of Consumer Payment Choice: Summary Results, supra,</E>
                             at 1 (noting that two-thirds of consumers reported that they had adopted an online payment account such as PayPal, Venmo, or Zelle). The Proposed Rule cited both of these sources at 88 FR 80197 at 80200 n.25.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>328</SU>
                             88 FR 80197 at 80210.
                        </P>
                    </FTNT>
                    <P>
                        The CFPB disagrees with the industry comments stating that it was necessary for the Proposed Rule to unmask confidential data, or otherwise provide additional information regarding confidential data, in order to allow for meaningful comment. As discussed above, the CFPB is obligated to maintain the confidentiality of the confidential transaction volume and revenue data described above. The CFPB could not provide a de-identified list of entities linked to their transaction and revenue data without significant risk of unmasking confidential data, nor did commenters provide any suggestions as to how the CFPB could disclose the data in a way that would both preserve confidentiality and improve commenters' ability to provide 
                        <PRTPAGE P="99633"/>
                        meaningful comment on the Proposed Rule.
                    </P>
                    <P>
                        The CFPB also declines the request by certain industry commenters to publicly disclose the identities of individual firms that comprised the rule's estimate of the number of larger participants. That CFPB notes that, in their comments, several commenters specifically identified firms they believed would be larger participants, indicating that many commenters believed that they did not need the CFPB to identify those larger participants in order to provide meaningful comment on the rule. In any event, the CFPB disagrees that the identities of the estimated larger participants were critical facts that commenters needed in order to provide meaningful comment. As disclosed in the proposal, the CFPB relied on a number of considerations to define the market (discussed above) and the larger participant test (discussed below), none of which were the identities of potential larger participants. Based on those considerations, the information in the proposal described above, and the rest of the proposal, many commenters made specific comments on the proposed market definition and proposed threshold, which the CFPB has fully considered and responded to above (on the market definition) and below (on the larger participant test).
                        <SU>329</SU>
                        <FTREF/>
                         The industry commenters seeking release of the list of 17 firms did not explain how public disclosure of their identities would allow for more meaningful comment. Further, these industry comments did not explain how the CFPB could make the disclosures they requested without disclosing confidential information, such as implications from such disclosure that could reveal confidential entity-level transaction information that the States obtained through their supervisory functions and made available to the CFPB through NMLS or information that an entity may customarily and actually treat as private.
                        <SU>330</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>329</SU>
                             For example, many industry and some nonprofit commenters explained in detail why they believed the proposed market definition was too broad and why the proposed larger participant test would cover more larger participants than the CFPB estimated. However, none of those commenters stated how the methodology and data sources the proposal used and disclosed would have led the CFPB to fail to estimate any particular entity as a larger participant. And, as noted above, no firms provided additional data in response to the CFPB request.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>330</SU>
                             For example, disclosing the identities of the 17 estimated larger participants in the Proposed Rule would have revealed that the entities had greater than 5 million consumer payment transactions based on the data available to the CFPB. And disclosing the names of all seven entities estimated to be larger participants in this Final Rule would then reveal that the 10 entities who are no longer estimated to be larger participants have between 5 and 50 million consumer payment transactions per year.
                        </P>
                    </FTNT>
                    <P>
                        Finally, even if the CFPB's estimates had relied entirely on public data (which they could not), public disclosure of the identities of estimated larger participants also may be misleading and incompatible with the administrative process that CFPB has established to determine which entities are larger participants.
                        <SU>331</SU>
                        <FTREF/>
                         As the Proposed Rule noted, the market-wide estimates of the rule's scope and impact are based only on “preliminary entity-level analysis that is not dispositive” of larger participant status or whether the CFPB would conduct supervisory activity of the entity.
                        <SU>332</SU>
                        <FTREF/>
                         As a result, publishing the CFPB's preliminary entity-level analysis could misleadingly suggest that the CFPB already has determined these entities' larger participant status. However, that is not the purpose of the CFPB's preliminary entity-level analysis, which instead informs market-wide estimates of the aggregate scope and impact of the rule. By contrast, for markets in which the CFPB has finalized larger participant rules, the CFPB administers a separate process for such evaluation under section 103 of its larger participant regulation at part 1090. Based on notice-and-comment rulemaking, it designed that process to assess which entities qualify as larger participants. As described in the Proposed Rule, to determine if an individual entity qualifies as a larger participant, the CFPB can use that same section 103 process to request confidential supervisory information from the entity and the entity may voluntarily submit such information including to dispute it qualifies as a larger participant.
                        <SU>333</SU>
                        <FTREF/>
                         The confidential supervisory process established in section 103 of part 1090 is an appropriate means for the CFPB to determine which entities are a larger participants.
                        <SU>334</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>331</SU>
                             
                            <E T="03">See</E>
                             12 CFR 1090.103(d) &amp; (a). 
                            <E T="03">See also</E>
                             88 FR 80197 at 80198.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>332</SU>
                             88 FR 80197 at 80208 n.77. Even when publishing the highlights of supervisory findings of violations of Federal consumer financial law, the CFPB does not identify individual entities. 
                            <E T="03">See CFPB Supervisory Highlights Issue 35, Fall 2024</E>
                             at 3 (“To maintain the anonymity of the supervised institutions discussed in 
                            <E T="03">Supervisory Highlights,</E>
                             references to institutions generally are in the plural and the related findings may pertain to one or more institutions.”), 
                            <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_supervisory-highlights-special-ed-auto-finance_2024-10.pdf</E>
                             (last visited Nov. 6, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>333</SU>
                             
                            <E T="03">See</E>
                             12 CFR 1090.103(d) and (a). 
                            <E T="03">See also</E>
                             88 FR 80197 at 80198.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>334</SU>
                             With regard to the banking industry association's comment seeking publication, outside of the rulemaking process, of the names of larger participants, the CFPB declines to address that comment because it is beyond the scope of the rulemaking itself.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Final Rule</HD>
                    <P>In consideration of the comments described above on data used in the Proposed Rule and comments on the criteria and threshold for the proposed larger-participant test described below, the Final Rule adopts the two proposed criteria—annual covered consumer payment transaction volume and small business concern status. As described below, the Final Rule makes certain adjustments to the calculation of annual covered consumer payment transaction volume (by counting only those transactions denominated in U.S. dollars) and the threshold volume that determines when entities that are not small business concerns qualify as larger participants (adopting a significantly higher volume, of 50 million).</P>
                    <HD SOURCE="HD3">Criteria</HD>
                    <HD SOURCE="HD3">Proposed Rule</HD>
                    <P>
                        The Proposed Rule reiterated that the CFPB has discretion in choosing criteria for assessing whether a nonbank covered person is a larger participant of a market.
                        <SU>335</SU>
                        <FTREF/>
                         It explained how the CFPB selects criteria that provide “a reasonable indication of a person's level of market participation and impact on consumers.” 
                        <SU>336</SU>
                        <FTREF/>
                         It noted how previous larger participant rulemakings acknowledged that, for any given market, there may be “several criteria, used alone or in combination, that could be viewed as reasonable alternatives.” 
                        <SU>337</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>335</SU>
                             
                            <E T="03">See, e.g.,</E>
                             77 FR 42874 at 42887 (consumer reporting larger participant rule describing such discretion); 77 FR 65775 at 65785 (same, in consumer debt collection larger participant rule).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>336</SU>
                             77 FR 42874 at 42887 (consumer reporting larger participant rule); 
                            <E T="03">see also</E>
                             80 FR 34796 at 37513 (automobile financing larger participant rule describing how aggregate annual originations are a “meaningful measure” of such participation and impact); 78 FR 73383 at 73393-94 (same, for account volume criterion in student loan servicing larger participant rule).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>337</SU>
                             77 FR 65775 at 65785 (consumer debt collection larger participant rule).
                        </P>
                    </FTNT>
                    <P>
                        Here, the CFPB proposed to combine the two criteria described above: the annual covered consumer payment transaction volume and the size of the entity by reference to SBA size standards. The Proposed Rule's larger-participant test would have combined these criteria as follows: a nonbank covered person would have been a larger participant if its annual covered consumer payment transaction volume exceeded the proposed threshold, discussed in the section-by-section 
                        <PRTPAGE P="99634"/>
                        analysis further below, and, during the same time period (
                        <E T="03">i.e.,</E>
                         the preceding calendar year), it was not a small business concern.
                    </P>
                    <P>
                        The first criterion would have been based on the number of consumer payment transactions. Specifically, proposed § 1090.109(b)(3) would have defined the term “annual covered consumer payment transaction volume” as the sum of the number of the consumer payment transactions that the nonbank covered person and its affiliated companies facilitated by providing general-use digital consumer payment applications in the preceding calendar year.
                        <SU>338</SU>
                        <FTREF/>
                         The Proposed Rule explained how the CFPB viewed this to be an appropriate criterion for defining larger participants in a market defined by reference to products that facilitate certain consumer payments. Each transaction counted under this criterion also generally is a payment. In that way, a transaction is essentially a well-understood unit of market activity.
                    </P>
                    <FTNT>
                        <P>
                            <SU>338</SU>
                             Under the CFPA, the activities of affiliated companies are to be aggregated for purposes of computing activity levels in larger participant rules. 
                            <E T="03">See</E>
                             12 U.S.C. 5514(a)(1)(B), (3)(B).
                        </P>
                    </FTNT>
                    <P>
                        The Proposed Rule further noted that, as in the CFPB's international money transfer larger participant rule, here the number of transactions also reflects the extent of interactions between the nonbank covered person providing the in-market consumer financial product or service. Each one-time consumer payment transaction typically results from a single interaction with at least one consumer.
                        <SU>339</SU>
                        <FTREF/>
                         And, in the case of recurring consumer payment transactions, consumers also have at least one interaction with the covered persons in the market. The number of transactions also is a common indicator of market participation.
                        <SU>340</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>339</SU>
                             
                            <E T="03">See, e.g.,</E>
                             79 FR 56631 at 56641 (international money transfer larger participant rule noting that the absolute number of transactions “reflects the extent of interactions” between the provider and the consumer because “each transfer represents a single interaction with at least one consumer”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>340</SU>
                             State regulators, for example, require money transmitters to report this metric. 
                            <E T="03">See generally</E>
                             NMLS, 
                            <E T="03">Money Services Business Call Report, https://mortgage.nationwidelicensingsystem.org/slr/common/Pages/MoneyServicesBusinessesCallReport.aspx</E>
                             (last visited Oct. 23, 2023).
                        </P>
                    </FTNT>
                    <P>
                        The Proposed Rule stated that the CFPB considered proposing different criteria, such as the dollar value of transactions or the annual receipts from market activity, and explained why it did not propose either of those alternatives. First, digital wallets often are used for consumer retail spending, which can grow in amount through inflation. For the proposed market that included digital wallets, a dollar value criterion may become affected by inflation or other factors.
                        <SU>341</SU>
                        <FTREF/>
                         At the same time, as the Proposed Rule noted, in general, a higher number of transactions also may often comprise a higher dollar value of transactions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>341</SU>
                             In addition, as discussed in the impacts analyses in parts V and VI of the Proposed Rule, some of the data sources the CFPB relied upon in formulating the Proposed Rule may be overinclusive by including certain payments that are not within the market defined in the Proposed Rule, such as certain business-to-business payments. Those payments may have higher dollar values. The Proposed Rule noted how it would have been less affected by those data distortions by proposing number of transactions as a criterion.
                        </P>
                    </FTNT>
                    <P>With respect to annual receipts, the Proposed Rule explained that data was less available, especially for market participants that are not publicly traded or that do not file call reports on money transmission at the State level. In addition, in the context of the market at issue, the Proposed Rule noted that an annual receipts criterion could miss significant market participation and consumer impacts, such as where a provider is subsidizing a product or otherwise not earning significant per-transaction revenues.</P>
                    <P>
                        As noted above, the CFPB proposed a second criterion that also must be satisfied for a nonbank covered person to be a larger participant, in addition to the annual covered payment volume criterion. Under the second criterion, in the previous calendar year, the nonbank must not have been a “small business concern” as that term is defined by section 3(a) of the Small Business Act, 15 U.S.C. 632(a), and implemented by the SBA under 13 CFR part 121, or any successor provisions. Thus, under the Proposed Rule, an entity would have been a small business concern if its size were at or below the SBA standard listed in 13 CFR part 121 for its primary industry as described in 13 CFR 121.107.
                        <SU>342</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>342</SU>
                             In addition, under the SBA's regulations, a concern's size is measured by aggregating the relevant size metric across affiliates. 
                            <E T="03">See</E>
                             13 CFR 121.103(a)(6) (“In determining the concern's size, SBA counts the receipts, employees, or other measure of size of the concern whose size is at issue and all of its domestic and foreign affiliates, regardless of whether the affiliates are organized for profit.”).
                        </P>
                    </FTNT>
                    <P>
                        The CFPB proposed this second criterion because it was not seeking to use this rulemaking as a means of expending its limited supervisory resources to examine small business concerns. The consumer digital payments applications market is potentially broad and dynamic, with rapid technological developments and new entrants. But many well-known market participants have large business operations that have an impact on millions of consumers. As explained in the Proposed Rule, in light of its resources, the CFPB believes that it would be preferable to focus on larger entities, instead of requiring all entities with an annual covered consumer payment transaction volume over five million to be subject to supervisory review under the Proposed Rule. If a particular nonbank covered person were a small business concern participating in this market in a manner that posed risks to consumers, the CFPB has authority to pursue risk-based supervision of such an entity pursuant to CFPA section 1024(a)(1)(C).
                        <SU>343</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>343</SU>
                             12 U.S.C. 5514(a)(1)(C). 
                            <E T="03">See generally</E>
                             12 CFR part 1091 (regulations implementing CFPA section 1024(a)(1)(C)).
                        </P>
                    </FTNT>
                    <P>The CFPB requested comment on its proposed criteria, including whether, instead of basing the annual volume criterion described above on number of consumer payment transactions, it should be based on a different metric, such as the dollar value of consumer payment transactions, and, if so, why.</P>
                    <HD SOURCE="HD3">Comments Received</HD>
                    <P>
                        A few industry commenters addressed the proposed criteria of volume of consumer payment transactions. Two industry associations and a law firm commenter stated that the amount (value) of a consumer payment transaction more directly correlates with risks to consumers than their frequency (volume).
                        <SU>344</SU>
                        <FTREF/>
                         In their view, if two entities have the same transaction volume, then the one facilitating the higher dollar amount typically poses greater risk to consumers.
                        <SU>345</SU>
                        <FTREF/>
                         Thus, in the view of one of these commenters, a test based on transaction value would better facilitate the CFPB's operation of a risk-based nonbank supervision program as required by CFPA section 1024(b)(2). The second commenter stated that the CFPB should consider either a transaction value threshold alone or in conjunction with transaction volume. In its view, the proposal field to articulate a connection between transaction volume and risks to consumers across the various different types of activity in the market. The third commenter stated that either approach could be done, but recommended the combined approach in order to ensure the rule captures only larger participants. Finally, another industry association stated that to profitably 
                        <PRTPAGE P="99635"/>
                        serve lower-income consumers who conduct transactions with lower values, companies needed to engage in higher volumes of activity; but rather than describing this as a reason to use a different criteria, it described this as a reason to increase the transaction volume threshold, as discussed below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>344</SU>
                             The industry association commenters also stated that the risks are different for firms that hold or transmit funds compared to those that transmit payment instructions or act as merchant payment processors.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>345</SU>
                             At the same time, the law firm commenter indicated that, in its view, entities with lower consumer payment transaction volumes also generally pose less risk to consumers.
                        </P>
                    </FTNT>
                    <P>
                        Some comments also addressed the proposed second criteria, an exclusion for entities that qualified as a small business concern in the previous year. Several commenters supported an exclusion for small businesses in general,
                        <SU>346</SU>
                        <FTREF/>
                         though some stated that the exclusion did not change their views, discussed further below, that the proposed consumer payment transaction volume threshold was much too low. No commenter disagreed with excluding small business concerns from larger participant status with respect to transactions covered by the Final Rule.
                        <SU>347</SU>
                        <FTREF/>
                         For example, two banking industry associations supported the proposed exclusion for a small business concern. Another industry association stated that it supported the proposed exclusion because it believed small business concerns should be provided more flexibility than its competitors to innovate and grow. This commenter also stated that the rulemaking should provide a fuller explanation of its impact, including whether the CFPB had identified any companies that exceed an annual consumer payment transaction volume threshold but would have qualified as small business concerns. It suggested that to the extent that small business concerns have a volume that exceeds the proposed threshold, this would support their view that the proposed transaction threshold was too low. It stated that consideration would be relevant not only with regard to the proposed threshold of five million annual consumer payment transactions, but also to potential thresholds of 50 million and 500 million annual consumer payment transactions. It also stated that the rule should consider what advantages a small business concern would have as a result of such an exclusion. Another industry association stated that the proposed small business exclusion was inadequate for identifying larger participants in this market for several reasons, including that the small business size standard updates every five years are not frequent enough for this market in light of its ongoing growth, the variety of product offerings market participants have means they can exceed the small business threshold even with small volumes of market activity, and, by their estimate, even based only on the market activity alone a small or medium-sized market participant serving approximately 220,000 consumers could exceed the highest potentially-applicable small business concern cutoff by charging a one percent fee on the value of the average consumer activity levels. Finally, another industry association agreed that many small businesses and startups have annual receipts that exceed small business concern size standards, in light of users' average annual digital payment transaction values (which it stated were $7,610 in 2023).
                    </P>
                    <FTNT>
                        <P>
                            <SU>346</SU>
                             An individual commenter that expressed general support for the Proposed Rule also stated that the CFPB should clarify the methods and data sources the CFPB would use to determine small business concern status.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>347</SU>
                             Some commenters focused on the digital asset industry stated that the exclusion would be unfair to entities not eligible for small business status such as foreign businesses or nonprofits or entities that may be small but ineligible for small business concern status because they are dominant in their field.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Response to Comments Received</HD>
                    <P>
                        With regard to comments calling for the Final Rule to use a criteria other than the volume of consumer payment transactions, none of these commenters addressed the Proposed Rule's rationale for proposing a volume rather than value-based criterion: the potential for inflation to shrink the coverage of the rule under a value-based criterion, and the potential for greater distortion to the extent data relied upon included business-to-business transactions that would not be in the market.
                        <SU>348</SU>
                        <FTREF/>
                         For those reasons, the CFPB continues to favor use of a transaction volume criterion. In addition, the CFPB agrees with the industry comment noting that lower-income consumers have significant adoption levels for general-use digital consumer payment applications. Compared with consumers that have higher incomes, smaller-dollar transactions by lower-income consumers generally would comprise a larger share of their disposable income. Their payment activity therefore may be better captured by a transaction volume criterion. Finally, the CFPB disagrees with the suggestion by a few commenters that the rule adopt an additional criteria, such as combining transaction volume and value. That approach would increase complexity in the administration of the rule and, given the significantly higher consumer payment transaction volume threshold adopted in the Final Rule discussed below, would not be necessary to ensure the rule only identifies 
                        <E T="03">bona fide</E>
                         larger participants. In any event, when the CFPB prioritizes entities for examination based on indicators of risk, the CFPA provides a basis for the CFPB to consider, among other factors, not just the number but also the value of consumer payment transactions facilitated.
                        <SU>349</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>348</SU>
                             88 FR 80197 at 80209.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>349</SU>
                             
                            <E T="03">See</E>
                             CFPA section 1024(b)(2)(B), (E). 12 U.S.C. 5514(b)(2)(B), (E).
                        </P>
                    </FTNT>
                    <P>The CFPB agrees with the commenters that a small business concern exclusion is appropriate for this larger participant rule. This exclusion will ensure that the CPFB's exercise of its larger participant supervisory authority under this rule does not extend to small business concerns. The CFPB disagrees with the industry association commenter to the extent it was suggesting this exclusion is likely to confer undue advantages on small business concerns. As discussed in the below section-by-section analysis of the threshold for the larger-participant test, which the Final Rule sets at 50 million consumer payment transactions annually, available data does not establish that any nonbank market participant that exceeds that threshold would qualify as a small business concern. And even if a small business concern were to exceed the threshold, it would not necessarily avoid CFPB supervision simply due to not qualifying as a larger participant under this rule. For example, if its risk profile warranted prioritization for an exam, then the CFPB also may consider it for supervisory designation under CFPA section 1024(a)(1)(C). Finally, with regard to comments that the exclusion is inadequate to define larger participants (including comments stating that companies with volumes at or slightly above the proposed threshold of five million annual consumer payment transactions are unlikely to qualify as small business concerns under SBA size standards), the CFPB understands those comments to be primarily focused on the threshold for the other proposed criteria for the larger-participant test (the annual covered consumer payment transaction volume threshold). The CFPB further discusses comments on that threshold below.</P>
                    <HD SOURCE="HD3">Final Rule</HD>
                    <P>
                        As explained further above, the Final Rule adopts the two proposed criteria, and makes certain changes to the threshold and its calculation, as described below.
                        <PRTPAGE P="99636"/>
                    </P>
                    <HD SOURCE="HD3">Threshold</HD>
                    <HD SOURCE="HD3">Proposed Rule</HD>
                    <P>
                        Under the Proposed Rule, a nonbank covered person would have been a larger participant in a market for general-use digital consumer payment applications if the nonbank covered person satisfies two criteria. First, it must facilitate an “annual covered consumer payment transaction volume,” as defined in proposed § 1090.109(b)(3), of at least five million transactions. As explained in proposed § 1090.109(b)(3)(i), the volume is aggregated across affiliated companies, as required by CFPA section 1024(a)(3)(B).
                        <SU>350</SU>
                        <FTREF/>
                         Thus, the proposed threshold included the aggregate annual volume of consumer payment transactions facilitated by all general-use digital consumer payment applications provided by the nonbank covered person and its affiliated companies in the preceding year.
                        <SU>351</SU>
                        <FTREF/>
                         Second, under proposed § 1090.109(b)(2) as explained above, the CFPB also proposed to exclude from larger-participant status any entity in the proposed market that was a small business concern in the previous calendar year based on applicable SBA size standards.
                        <SU>352</SU>
                        <FTREF/>
                         The Proposed Rule stated that the CFPB viewed this proposed threshold and the proposed small entity exclusion, discussed above, to be a reasonable means of defining larger participants in this market.
                        <SU>353</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>350</SU>
                             12 U.S.C. 5514(a)(3)(B) (providing that, “[f]or purposes of computing activity levels under [CFPA section 1024(a)(1)] or rules issued thereunder [including larger participant rules issued under CFPA section 1024(a)(1)(B)], activities of affiliated companies (other than insured depository institutions and insured credit unions) shall be aggregated”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>351</SU>
                             The Proposed Rule noted that the available data do not always conform to the precise market scope of covered consumer payment transactions. For example, the data do not always distinguish between transactions in which a business sent funds, which would not be covered consumer payment transactions, from transactions in which a consumer sent funds. In addition, in some cases the data may include funds a consumer transfers between one deposit or stored value account and another, both of which belong to the consumer. As the Proposed Rule further noted, the analysis in the Proposed Rule included transaction volume broadly defined, and the CFPB cannot distinguish between this overall activity and covered market activity (to the extent they differ). Therefore, the analysis in the Proposed Rule may be an overestimate of covered market activity and larger-participant status of providers of general-use digital consumer payment applications subject to the larger-participant threshold.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>352</SU>
                             As discussed above and below, the proposed exclusion would have applied to any nonbank that, together with its affiliated companies, in the previous calendar year was a small business concern based on the applicable SBA size standard listed in 13 CFR part 121 for its primary industry as described in 13 CFR 121.107. The SBA defines size standards using North American Industry Classification System (NAICS) codes. The Proposed Rule noted that the CFPB believed that many—but not all—entities in the proposed market for general-use digital consumer payment applications are likely classified in NAICS code 522320, “Financial Transactions Processing, Reserve, and Clearinghouse Activities,” or NAICS code 522390, “Other Activities Related to Credit Intermediation.” Entities associated with NAICS code 522320 that have $47 million or less in annual receipts are currently defined by the SBA as small business concerns; for NAICS code 522390, the size standard is $28.5 million. However, the Proposed Rule noted that other entities that the CFPB believes to be operating in the proposed market may be classified in other NAICS codes industries that use different standards, including non-revenue-based SBA size standards, such as the number of employees. While the CFPB had data to estimate the SBA size status of some market participants in the Proposed Rule, such as publicly-traded companies, the CFPB lacked data sufficient to estimate the SBA size status of some market participants. 
                            <E T="03">See</E>
                             SBA, Table of Small Business Size Standards Matched to North American Industry Classification System Codes, effective March 17, 2023, Sector 52 (Finance and Insurance), 
                            <E T="03">https://www.sba.gov/document/support--table-size-standards</E>
                             (last visited Oct. 26, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>353</SU>
                             The Proposed Rule stated that the CFPB identified approximately 190 entities from available data that provide general-use digital consumer payment applications and may be subject to the Proposed Rule. Of those entities, the CFPB had data on about half sufficient to estimate larger-participant status, including whether those entities would be subject to the small business exclusion built into the larger-participant test. The estimate that approximately 17 entities would have been larger participants was based on the set of entities for which the CFPB had sufficient information to estimate larger participant status.
                        </P>
                    </FTNT>
                    <P>
                        The CFPB estimated in the Proposed Rule that the proposed threshold would have brought within the CFPB's supervisory authority approximately 17 entities,
                        <SU>354</SU>
                        <FTREF/>
                         about 9 percent of all known nonbank covered persons in the market for general-use digital consumer payment applications.
                        <SU>355</SU>
                        <FTREF/>
                         The Proposed Rule noted that this was a rough estimate because the available data on entities operating in the proposed market for general-use digital consumer payment applications was incomplete.
                        <SU>356</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>354</SU>
                             The Proposed Rule noted that the estimate of 17 entities excluded entities where either (1) available information indicated that the small entity exclusion would have applied or (2) the CFPB lacked sufficient information regarding the entity's size to assess whether the small entity exclusion would have applied.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>355</SU>
                             The Proposed Rule described in detail how the CFPB based its market estimates on data from several sources. The CFPB obtained transaction and revenue data from six technology platforms offering payment services through a CFPB request pursuant to CFPA section 1022(c)(4). 
                            <E T="03">See CFPB 1022 Orders Press Release, supra.</E>
                             The CFPB was also able to access nonpublic transaction and revenue data for potential larger participants from the Nationwide Mortgage Licensing System &amp; Registry (NMLS), a centralized licensing database used by many States to manage their license authorities with respect to various consumer financial industries, including money transmitters. Specifically, the CFPB accessed quarterly 2022 and 2023 filings from nonbank money transmitters in the Money Services Businesses (MSB) Call Reports data (for a description of the types of data reported in MSB call reports, see NMLS, 
                            <E T="03">Money Services Business Call Report</E>
                            ). Additionally, the CFPB compiled a list of likely market participants, as well as transaction and revenue data where available, from several industry sources (including Elliptic Enterprises Limited) and various public sources including the CFPB's Prepaid Card Agreement Database, 
                            <E T="03">https://www.consumerfinance.gov/data-research/prepaid-accounts/search-agreements</E>
                             (last visited Oct. 23, 2023), company websites, press releases, and annual report filings with the U.S. Securities and Exchange Commission.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>356</SU>
                             The Proposed Rule noted that its estimate that approximately 190 entities are participating in the market may have been an underestimate because, for certain entities, the CFPB lacked sufficient information to assess whether they provide a general-use digital consumer payment application. In addition, it noted that for some entities that are among the approximately 190 participants in the market, the CFPB lacked sufficient information to assess whether certain products they offer constitute a general-use digital consumer payment application.
                        </P>
                    </FTNT>
                    <P>In the Proposed Rule, the CFPB anticipated that the proposed annual covered consumer payment transaction volume threshold of five million would have allowed the CFPB to supervise market participants that represent a substantial portion of the market for general-use digital consumer payment applications and have a significant impact on consumers. Available data indicated that the market for general-use digital consumer payment applications is highly concentrated, with a few entities that facilitate hundreds of millions or billions of consumer payment transactions annually, and a much larger number of firms facilitating fewer transactions. The Proposed Rule stated that the CFPB believed that a threshold of five million was reasonable, in part, because it would have enabled the CFPB to cover in its nonbank supervision program both the very largest providers of general-use digital consumer payment applications as well as a range of other providers of general-use digital consumer payment applications that play an important role in the marketplace. Further, certain populations of consumers, including more vulnerable consumers, may not transact with the very largest providers and instead may transact with the range of other providers that exceed the five million transaction threshold.</P>
                    <P>
                        According to the CFPB's estimates in the Proposed Rule, the approximately 17 providers of general-use digital consumer payment applications that meet the proposed threshold collectively facilitated about 12.8 billion transactions in 2021, with a total dollar value of about $1.7 trillion. The CFPB estimated that these nonbanks were responsible for approximately 88 percent of known transactions in the nonbank market for general-use digital 
                        <PRTPAGE P="99637"/>
                        consumer payment applications.
                        <SU>357</SU>
                        <FTREF/>
                         At the same time, this threshold likely would have subjected to the CFPB's supervisory authority only entities that can reasonably be considered larger participants of the market defined in the Proposed Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>357</SU>
                             
                            <E T="03">See</E>
                             88 FR 80197 at 80209-10 nn.86-91. The Proposed Rule noted that the 88 percent estimate was calculated among all of the entities for which the CFPB has transaction information. 
                            <E T="03">Id.</E>
                             n.92.
                        </P>
                    </FTNT>
                    <P>Proposed § 1090.109(b)(3)(i) also would have clarified how the activities of affiliated companies of the nonbank covered person are included in the test when the affiliated companies also participate in the proposed market. It provided that, in aggregating transactions across affiliated companies, an individual consumer payment transaction would only have been counted once even if more than one affiliated company facilitated the transaction. It also provided that the annual covered consumer payment transaction volumes of the nonbank covered person and its affiliated companies would have been aggregated for the entire preceding calendar year, even if the affiliation did not exist for the entire calendar year.</P>
                    <P>The Proposed Rule noted that because the general-use digital consumer payment applications market has evolved rapidly and market participants can grow quickly, the CFPB also was not proposing a test that is based on averaging multiple years of market activity. As a result, if an entity has less than the threshold amount for one or more calendar years but exceeds the threshold amount in the most recent calendar year, it would have been a larger participant. The Proposed Rule stated that this would have ensured that the CFPB can supervise nonbanks that quickly become larger participants, without waiting several years.</P>
                    <P>
                        The Proposed Rule further stated that the CFPB was considering a lower or higher threshold.
                        <SU>358</SU>
                        <FTREF/>
                         Lowering the threshold therefore would not have substantially increased the number of entities subject to supervision, in part because many entities that exceed a lower threshold would have been excluded as small entities. Thus the Proposed Rule noted that lowering the threshold would have resulted in only a marginal increase in market coverage. The Proposed Rule provided an example of a higher threshold. The Proposed Rule estimated that an annual covered consumer payment transaction volume threshold of 10 million would have allowed the CFPB to supervise approximately 14 entities, representing approximately 87 percent of activity in this market.
                        <SU>359</SU>
                        <FTREF/>
                         However, at this higher threshold the CFPB would not have been able to supervise as varied a mix of nonbank larger participants that, as discussed above, have a substantial impact on the full spectrum of consumers in the market.
                    </P>
                    <FTNT>
                        <P>
                            <SU>358</SU>
                             The Proposed Rule discussed an example of a lower threshold. An annual covered consumer payment transaction volume threshold of one million might have allowed the CFPB to supervise approximately 19 entities, still representing approximately 88 percent of activity in this market. 
                            <E T="03">See id.</E>
                             at 80210.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>359</SU>
                             
                            <E T="03">See id.</E>
                        </P>
                    </FTNT>
                    <P>The CFPB sought comment, including suggestions of alternatives on the proposed threshold for defining larger participants of the market for general-use digital consumer payment applications as defined in the Proposed Rule.</P>
                    <HD SOURCE="HD3">Comments Received</HD>
                    <P>
                        Many of the industry association commenters, a law firm, and some nonprofits stated that the proposed five million consumer payment transaction volume threshold was too low and did not identify 
                        <E T="03">bona fide</E>
                         larger participants. A nonprofit stated the threshold appeared designed to maximize oversight rather than define true larger participants. Some of these commenters stated that the proposed threshold was so low that it would treat virtually all market participants as larger participants, including those with very small market shares, exposing small/mid-size companies to supervision when they cannot support the cost of exams, and more generally stifling market entry, innovation, and competition. These commenters generally stated that the proposal did not adequately explain the reasoning and evidence in support of such a threshold.
                        <SU>360</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>360</SU>
                             One nonprofit commenter also encouraged the CFPB to consider setting different thresholds in the Final Rule for what it referred to as different sectors within the proposed market. However, it did not state which parts of the market should be differentiated. The CFPB generally considers comments further above on whether to define a single market in this Final Rule. Because it has determined to do so, it is not finalizing a larger-participant test that works differently for different parts of the market.
                        </P>
                    </FTNT>
                    <P>
                        One industry association commenter encouraged the CFPB to set the threshold here cautiously, in consideration of the stage of this market's development. It stated that, unlike in prior larger participant rules, this market is in the growth stage not the maturity stage, where data and settled expectations can be more helpful in the development of larger-participant tests. It viewed the proposed threshold as too low given the market's current stage and stated that a higher threshold as necessary for properly determining the true larger participants in the market as it matures and to allow for proper scalability within the market without impeding competition.
                        <SU>361</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>361</SU>
                             This commenter also encouraged the CFPB to conduct periodic reviews of the threshold as the market grows to ensure it continues to capture larger participants. The CFPB notes that it already monitors this market, among others, as part of its statutory functions. 
                            <E T="03">See</E>
                             12 U.S.C. 5512(c). The CFPB will continue to monitor this market and may consider adjustments to the threshold, to the extent necessary or appropriate through future rulemakings.
                        </P>
                    </FTNT>
                    <P>Another industry association stated that the proposal of a small business exclusion for the first time in a larger participant rule appeared to support its concern that the proposed threshold was too low, and still would discourage firms that are not small businesses from entering the market. It suggested that the rulemaking should specifically consider a volume of 50 million or 500 million annual consumer payment transactions. It also criticized the Proposed Rule for not making clear whether entities who were small business concerns would have otherwise met the transaction volume threshold. It also stated that the rule should consider a threshold more in line with the debt collection larger participant rule, under which larger participants comprised an estimated 63 percent of market activity.</P>
                    <P>Several industry associations offered rough estimates to illustrate how the proposed threshold would treat firms with very small market shares (ranging from, in their estimates, as low as 0.005 percent of overall consumer payment transactions to no more than two percent of app-based transactions) as larger participants, which in their view would not make them “larger” participants under the statute.</P>
                    <P>Several of these commenters added that the proposed threshold would discourage entry into the market and innovation and competition. A nonprofit commenter suggested that the threshold would deter small and mid-sized businesses from expanding. One of the industry associations stated these effects could limit access to payment products for low-/moderate-income consumers, and urged the CPFB to set the threshold dynamically, at a level that represents a significant share of market activity.</P>
                    <P>
                        The law firm commenter added that the proposal would subject firms with barely five million consumer payment transactions annually to the same supervision as firms with hundreds of millions or billions of such transactions, when the smaller larger participants cannot sustain the costs of exams.
                        <PRTPAGE P="99638"/>
                    </P>
                    <P>
                        On the other hand, banking and credit union industry trade associations supported the proposed five million consumer payment transaction volume threshold to define nonbanks that are larger participants. One of them called for periodic CFPB evaluation of this threshold including to see whether entities may be structuring their activities to evade it and publication of the results, while another called for adding criteria to capture large, well-resources, fast-growing organizations with fewer transactions.
                        <SU>362</SU>
                        <FTREF/>
                         A nonprofit stated that two thirds of its members surveyed supported the proposed threshold, and that some of its members supported lowering the threshold to one million annual consumer payment transactions. Some consumer groups and part of the membership of a nonprofit also stated that the proposed threshold was too high because, among other reasons, some money transfer services for incarcerated people have a dominant position within that area despite facilitating less than five million consumer payment transactions. Other consumer groups estimated that large firms that contract with incarceration facilities to provide money transfer services would qualify as larger participants under the proposed larger-participant test. They added that the CFPB should ensure that they are subject to the CFPB's supervisory authority under a Final Rule.
                        <SU>363</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>362</SU>
                             This commenter did not offer a specific criteria for achieving its goal, which may better be achieved through the more flexible supervisory designation process than through a regulatory test.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>363</SU>
                             These commenters also stated that the threshold test should include all consumer payment transactions a market participant facilitates, even when they are not facilitated through the digital application that made the entity a market participant. These commenters called for counting in-person, kiosk-based, and telephonic transfers, which they stated would qualify more correctional money-transfer companies as larger participants, and the test may be more efficient to administer because it would not require breaking out which transactions occur through the digital app channel.
                        </P>
                    </FTNT>
                    <P>
                        An industry association stated that the test should be applied over a longer period (at least two years) than the proposal (one year). They stated that short-term fluctuations could create an inaccurate determination of market share. They also noted that, given how the market has been growing, the CFPB should consider a threshold that is dynamic and grows as the market grows, so that if the market grows for example more than ten-fold in the future, the test still would reasonably identify larger participants. In addition, in their view, a one-year period would not provide sufficient time for entities to undertake the compliance improvements the proposal stated larger participants would undertake to prepare for supervision. Another commenter, a nonprofit, stated that an unspecified minority of its membership suggested applying the test over multiple years.
                        <SU>364</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>364</SU>
                             This commenter noted, without further elaboration, a suggestion of at least one member to set a first-year threshold of 10 million and a second-year threshold at 5 million.
                        </P>
                    </FTNT>
                    <P>Several consumer groups supported aggregating activities of affiliates for purposes of the transaction threshold in the proposed larger-participant test. In their view, without aggregation, market participants could avoid larger participant status by structuring different types of consumer payment transactions, such as consumer payment transactions using different types of stored value, through different entities within a corporate family. However, two industry commenters stated that the larger-participant test should not consider activities of affiliates. An industry association stated that aggregation would allow the CFPB to supervise activities of individual entities whose activity levels alone do not qualify them as larger participants, resulting in an internally contradictory result. Another industry association stated that, to avoid covering entities with low market shares, the rule should not count receipts of affiliates not engaged in market activity toward the small business concern test.</P>
                    <HD SOURCE="HD3">
                        Response to Comments Received 
                        <SU>365</SU>
                        <FTREF/>
                    </HD>
                    <FTNT>
                        <P>
                            <SU>365</SU>
                             As noted in the section-by-section analysis further above, the CFPB is not including transfers of digital assets in the Final Rule. The CFPB considers the above comments on the proposed threshold in light of this update, which the Final Rule implements through a limitation in the threshold described further below.
                        </P>
                    </FTNT>
                    <P>
                        In consideration of comments on the Proposed Rule stating that the proposed threshold of five million annual consumer payment transactions was too low and could capture certain entities with very small market shares, as well as the comment suggesting that the CFPB consider thresholds of 50 million or 500 million annual consumer payment transactions, the Final Rule adopts the significantly higher threshold of 50 million annual consumer payment transactions. As discussed below, this higher threshold encompasses the group of firms that have considerably higher transaction volumes and are in the concentrated part of the market. The CFPB finds the higher threshold to be appropriate, considering the concentrated market structure and how a significant number of market participants that would not qualify as larger participants as discussed below. To the extent any firm has activity levels at or slightly above the threshold, it may have an individual market share of less than one percent. But such a firm still has larger participation than the vast majority of participants.
                        <SU>366</SU>
                        <FTREF/>
                         The CFPB also declines to adopt the industry association suggestion to make the threshold dynamic because that approach would be unnecessary and difficult to administer.
                        <SU>367</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>366</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Automobile Finance Larger Participant Rule, 80 FR 37496, 37515 (June 30, 2015) (“Each of the [larger participants] provides or engages in hundreds of automobile originations each week and falls in the top 10 percent of nonbank entities in the market according to the Bureau's estimates. They can reasonably be considered larger participants of the market. Some entities that meet this threshold will have considerably less than 1 percent market share, but that is due in large part to the fragmentation of the market and does not change the fact [that] they are `larger' than the vast majority of participants.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>367</SU>
                             As noted above, to the extent necessary or appropriate, the CFPB may adjust the threshold through future rulemakings that may reflect shifts in the market and other data that may be available to the CFPB.
                        </P>
                    </FTNT>
                    <P>
                        For the reasons described above, the CFPB disagrees with the comments that supported the proposed threshold of five million annual consumer payment transactions. Based on available data, the CFPB estimates in the Final Rule suggest that all of those nonbanks with annual covered consumer payment transaction volume between 5 million and 50 million combined facilitate at most a few percent of the market activity. While some consumer groups estimated that a much higher threshold than the CFPB proposed may not capture some firms providing what they described as high-risk money transfer services to people who are incarcerated, those comments also stated that other large corporations provide a broad suite of money transfer services to people who are and are not incarcerated alike. In any event, as discussed above, the CFPB declines to define larger participants based on the goal of targeting activities that may pose specific types of levels of risk to consumers. As discussed in the section-by-section analysis of the market definition further above, the CFPB accounts for risk when operating its nonbank supervision program. Any nonbank covered person, including firms providing digital services for consumers to transfer funds to incarcerated people, can qualify as a larger participant if it meets or exceeds the threshold in the Final Rule. And through operation of its risk-based larger participant supervision program, the CFPB may determine how to exercise its supervisory authority with respect to such a larger participant. Given the number of consumers those types of firms serve, even the higher threshold 
                        <PRTPAGE P="99639"/>
                        that the Final Rule adopts is reasonably likely to allow it to conduct some supervisory activities in this area.
                    </P>
                    <P>In addition, given that the Final Rule adopts a higher threshold of 50 million annual consumer payment transactions as discussed below, the CFPB is not persuaded by claims by some commenters that nonbank firms would be discouraged from entry, innovation, or growth due to the potential exposure to CFPB examinations resulting from this rule. The CFPB notes its existing enforcement authority over market participants generally regardless of size, their existing obligations to comply with Federal consumer financial law regardless of size, how this rule imposes no substantive consumer protection obligations, how the CFPB uses a prioritization process to allocate limited supervisory resources toward those nonbanks that pose relatively higher risks to consumers, and that no firm that is a small business concern would incur the cost of examination under this rule. Considering all of these factors, the CFPB does not believe that this rule is likely to shape market participation patterns in the way those commenters describe.</P>
                    <P>With regard to the industry association commenter asking whether any firms would have exceeded the proposed threshold but qualified for the small business concern exclusions, the CFPB notes that it did not include any such firms in its estimate of 17 larger participants because such firms would not have qualified as larger participants under the Proposed Rule. The Final Rule discusses this question further in the explanation below of the threshold adopted in the Final Rule.</P>
                    <P>
                        With regard to comments on the look-back period for applying the proposed larger-participant test, the CFPB disagrees that the rule should apply a longer period such as two years. Fluctuations in market participants' transaction volumes may occur over time, but if their volumes exceed the threshold in a calendar year, then they would be sufficient, over a long enough time period (12 months), to conclude that the entity's market activity has been having a significant impact on consumers. As the international money transfer larger participant rule noted in adopting a one-year lookback period, “[b]ecause the criterion directly measures the number of transfers in the market, it should not be subject to temporary fluctuations that are unrelated to an entity's market participation.” 
                        <SU>368</SU>
                        <FTREF/>
                         In addition, for this rule, as with the international money transfer larger participant rule, the CFPB “believes that the single-year approach will make the Final Rule's definitions easier to apply . . . and alleviate the concern expressed by some commenters about the overall complexity of” certain provisions. For example, this is the first larger participant rule that adopts a larger-participant test with two criteria, and the first larger participant rule that adopts an exclusion for small business concerns as one of the criteria. It would significantly increase complexity in the administration of the test to judge two different criteria, which generally are measured over a calendar year (such as small business concern criteria measured by annual receipts) over multiple years.
                        <SU>369</SU>
                        <FTREF/>
                         Further, to the extent commenters assumed that all entities that exceed the proposed threshold in the prior year for the first time would face immediate examination the following year, that assumption is an incorrect reading of the Proposed Rule. First, if the entity were a small business concern in the previous calendar year, under the proposed larger-participant test, it would not have qualified as a larger participant, even if its volume of consumer payment transactions did exceed the threshold for the first time in that same calendar year. Second, as the Proposed Rule explained, consistent with the CFPA, the CFPB conducts a risk-based supervision program for nonbanks subject to supervisory authority under CFPA section 1024(a). This includes a process for prioritizing entities for examination as described in its public Supervision and Examination Manual cited in the Proposed Rule and discussed in part I above. As part of that process, where appropriate, the CFPB can consider the entity's volume of consumer payment transactions, including the degree to which it exceeds the transaction threshold and for how long it has exceeded that threshold.
                    </P>
                    <FTNT>
                        <P>
                            <SU>368</SU>
                             79 FR 56631 at 56637.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>369</SU>
                             Although the CFPB's first larger participant rules averaged annual receipts over time, those rules only adopted that single criterion (annual receipts).
                        </P>
                    </FTNT>
                    <P>With regard to comments on the proposal to aggregate activities of affiliated companies, CFPA section 1024(a)(3)(B) requires aggregation of activity across affiliated companies for purposes of determining activity levels in larger participant rules. To clarify that the purpose of paragraph (b)(3) is to implement that requirement, the Final Rule adds language to the header for paragraph (b)(3) that describes the provision as outlining the “method” for computing aggregate activity levels. With regard to the industry association comment calling for the rule to assess small business concern status without counting receipts of affiliated companies, the CFPB disagrees. The overall size of the business organization, including affiliates, is a relevant reference point as the CFPB considers which types of entities may incur the estimated cost of examination pursuant to this rule.</P>
                    <HD SOURCE="HD3">Final Rule</HD>
                    <P>
                        The Final Rule adopts in paragraph (b)(3) a threshold annual covered consumer payment transaction volume of 50 million consumer payment transactions denominated in U.S. dollars as described further below.
                        <SU>370</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>370</SU>
                             The Final Rule also makes non-substantive clarifying revisions to paragraph (b), including identifying in paragraph (b) that both criteria in paragraphs (b)(1) and (2) are based on the preceding calendar year and associated revisions.
                        </P>
                    </FTNT>
                    <P>
                        The CFPB estimates that seven nonbanks that are not small business concerns have annual consumer payment transaction volumes that exceed this threshold, that these seven nonbank firms account for approximately eight percent of the 85 market participants for which the CFPB has sufficient data to estimate larger participant status (and an even lower share of the approximately 130 known market participants),
                        <SU>371</SU>
                        <FTREF/>
                         and that these 
                        <PRTPAGE P="99640"/>
                        seven nonbank firms facilitated approximately 13.3 billion consumer payment transactions, accounting for approximately 98 percent of the over 13.5 billion consumer payment transactions market participants provide.
                        <SU>372</SU>
                        <FTREF/>
                         Despite the increase in the threshold, larger participants' share of market activity also increased largely because the nonbank market size estimate in the Final Rule does not include an entity that the Final Rule estimates, based on further research in response to a comment described above, may not be a nonbank covered person.
                        <SU>373</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>371</SU>
                             Due to the Final Rule's adoption of a threshold limited to transfers of funds denominated in U.S. dollars discussed further below, the Final Rule does not include in its estimate of nonbank market participants firms that appear to provide consumer payment transactions solely in the form of digital assets. The Final Rule also does not include in this estimate two firms that public information indicates are not nonbank market participants, as described in n.373 below.
                        </P>
                        <P>In addition, the estimated 130 nonbank market participants includes four additional nonbank financial firms, as follows: (1) Based on its review of the clarified definition of “general use” described above, the Final Rule has identified two nonbank financial firms that provide payment functionalities for family and friends to transfer funds to postsecondary students; (2) The removal of the proposed exclusion for bill splitting in the definition of “general use” described above also results in one estimated additional nonbank market participant; and (3) Through its general activities, the CFPB became aware of one additional nonbank providing a peer-to-peer app-based payment functionality for a deposit account. Nonbank financial institutions providing these services generally do not appear to be licensed as money transmitters and the account agreements do not appear to be filed in the CFPB's prepaid account agreement database.</P>
                        <P>
                            Further, as noted above and in the Proposed Rule, an entity is included in the estimated number of nonbank market participants if public information indicates it currently offers at least one consumer financial product or service within the market definition; however, for some of these 130 estimated nonbank market participants, the CFPB lacks sufficient information to assess whether certain other products they offer or are developing constitute a general-use digital consumer payment application. As also noted in the Proposed Rule, the CFPB's estimate of the number of nonbank market 
                            <PRTPAGE/>
                            participants may be an underestimate because, for certain entities, the CFPB lacks sufficient information to assess whether they provide a general-use digital consumer payment application.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>372</SU>
                             Due to the threshold's limitation to transfers of funds denominated in U.S. dollars discussed further below, the Final Rule does not include in the market transactions that the data sources specifically identify as digital assets transactions. In addition, as a result of that limitation on the threshold in the Final Rule, the Final Rule does not use the transaction volume data from the CFPB's section 1022 order responses for one of the estimated larger participants and instead uses money service business call report data in NMLS.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>373</SU>
                             To respond to the industry association comment (described above) asking whether any of the rulemaking's estimated nonbank market participants would have exceeded the consumer payment transactions volume threshold and also qualified as a small business concern, the CFPB has reviewed public information and makes two updates to the estimates in the Final Rule. First, the CFPB identified one entity that would have exceeded the proposed transaction volume threshold that the proposal did not estimate to be a larger participant because the data sources described in the proposal did not indicate whether the entity was a small business concern. To respond to the comment, the CFPB reviewed public information, which suggested the entity may not be a nonbank covered person, and the Final Rule does not include that entity among the estimated nonbank market participants or its transaction volume in the market size estimate. Second, for another entity that had that level of transaction volume and which the proposal estimated was not a small business concern, the CFPB reviewed public information and found that the firm had previously sold its general-use digital consumer financial application to an unaffiliated entity, for which the CFPB lacks data to estimate its transaction volume data or whether it is a small business concern. Therefore, the Final Rule does not include the selling entity among the estimated market participants or its transaction volume in the market size estimate. As a result of these two updates, the CFPB estimates that all nonbank entities with data indicating over 50 million consumer payment transactions are not small business concerns. As noted, the CFPB still does not have transaction volume data for some market participants; to the extent any of them have over 50 million consumer payment transactions, it is possible they could be a small business concern. But given that the CFPB estimates that none of the seven nonbank firms that available transaction volume data indicates have over 50 million consumer payment transactions are small business concerns, it may be unlikely that if any other firms did have a volume that exceeds the threshold, they would be a small business concern.
                        </P>
                    </FTNT>
                    <P>
                        As some commenters noted, the market continues to grow and evolve rapidly and that some new entrants may quickly exceed the proposed threshold of five million transactions. For the reasons explained above, the CFPB does not believe the threshold used to define a larger participant in this Final Rule is likely to significantly affect market activity such as new entry, innovation, and growth. But the significantly higher threshold the Final Rule adopts nonetheless would provide new entrants and others with smaller volumes more room to grow before coming under the CFPB umbrella of larger participant supervision in this rulemaking. For example, based on the estimates in the Final Rule at this threshold, eight fewer entities would qualify as larger participants because their volume of consumer payment transactions falls between 5 and 50 million annual consumer payment transactions (and another two are no longer estimated to be nonbank market participants, as noted above). Yet, the remaining entities that the CFPB estimates qualify as larger participants under the higher threshold adopted in the Final Rule still account for approximately 98 percent of the market activity as noted above. In addition, this higher threshold would allow CFPB supervision to focus more consistently on nonbank firms that account for almost all market activity including the part of the market that the Proposed Rule described as “highly concentrated, with a few entities that facilitate hundreds of millions or billions of consumer payments annually[.]” 
                        <SU>374</SU>
                        <FTREF/>
                         At the same time, based on its estimates, the CPFB finds that the higher threshold still would serve the goal described in the Proposed Rule of covering larger participants that serve a mix of consumer populations including more vulnerable consumers such as justice-involved individuals as well as lower-income consumers and the unbanked or underbanked populations more generally. In any event, because the seven nonbank firms that the CFPB estimates would be larger participants at the threshold of 50 million account for approximately 98 percent of market activity, the CFPB does not believe that adopting a lower threshold that would cover additional market activity would be warranted. The CFPB also does not believe that it would be appropriate to adopt a threshold that would result in substantially less market activity being covered, such as the estimated 63 percent in the consumer debt collection rulemaking that one industry association commenter suggested the CPFB consider here. As that rulemaking noted, the data used to estimate overall market activity included receipts from the collection of medical debt, which were not included in the larger-participant test.
                        <SU>375</SU>
                        <FTREF/>
                         As a result, the circumstances surrounding that estimate in that rule were unique to that rule and that test. In addition, due to the highly-concentrated nature of the market described above, adopting any higher threshold (even 500 million transactions, as one commenter suggested the CFPB consider) would not significantly reduce larger participants' share of market activity. A threshold of 500 million transactions would result in an estimated four larger participants with an estimated 96 percent share of market activity. The CFPB also does not seek to adopt a threshold at a level that is so high that it only captures the few largest participants, which would have the incongruous effect of treating only the largest participants as “larger” participants, and in any event would not achieve the CFPB's stated goal of covering a mix of activities described above.
                    </P>
                    <FTNT>
                        <P>
                            <SU>374</SU>
                             88 FR 80197 at 80210.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>375</SU>
                             77 FR 65775, 65788 n.98.
                        </P>
                    </FTNT>
                    <P>In addition to increasing the threshold as described above, the Final Rule limits the definition of “annual covered consumer payment transaction volume” to transactions denominated in U.S. dollars. With this clarification (and a corresponding edit to paragraph (b)(3)(i)), the larger-participant test in this Final Rule excludes transfers of digital assets, including crypto-assets such as Bitcoin and stablecoins. For the reasons discussed in the section-by-section analysis of “consumer payment transaction” above, the Final Rule excludes these transactions from the threshold to ensure the administrability of the larger-participant test while the CPFB continues to monitor developments in the market for consumer payments involving digital assets.</P>
                    <HD SOURCE="HD1">VI. Effective Date of Final Rule</HD>
                    <P>
                        The Administrative Procedure Act generally requires that rules be published not less than 30 days before their effective dates.
                        <SU>376</SU>
                        <FTREF/>
                         In the Proposed Rule, the CFPB proposed that, once issued, the Final Rule for this proposal would be effective 30 days after the Final Rule is published in the 
                        <E T="04">Federal Register</E>
                        . For the reasons discussed below, in consideration of the comments, the Final Rule adopts that effective date.
                    </P>
                    <FTNT>
                        <P>
                            <SU>376</SU>
                             5 U.S.C. 553(d).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">Comments Received</HD>
                    <P>
                        An industry trade association stated that nonbanks would need at least 90 
                        <PRTPAGE P="99641"/>
                        days from publication in the 
                        <E T="04">Federal Register</E>
                         to prepare for CFPB supervision. This commenter stated that some companies may not have reasonable notice from the Proposed Rule that they are participating in the proposed market. The commenter also pointed to effective date periods of 60 or more days in previous larger participant rules as a precedent. A law firm made similar points in support of its view that a 60-day pre-effective date period is needed. It also noted that the rationale the CFPB adopted in the consumer reporting larger participant rule for a 60-day period—including recognizing the need for entities that have never been examined to conduct training to prepare for the CFPB examination process 
                        <SU>377</SU>
                        <FTREF/>
                        —also applies here.
                        <SU>378</SU>
                        <FTREF/>
                         Finally, although two trade associations representing depository institutions and a trade association representing credit unions called for the CFPB to use or develop examination procedures for larger participants in a manner consistent with its procedures for examining banks and credit unions, they did not call for extending the effective date period.
                    </P>
                    <FTNT>
                        <P>
                            <SU>377</SU>
                             
                            <E T="03">See</E>
                             77 FR 65775 at 65778-79 &amp; n.30 (consumer debt collection larger participant rule adopting rationale for a 60-day effective date period in the consumer reporting larger participant rule, recognizing that “companies affected by the Consumer Reporting Rule might not previously have been supervised at the Federal or State level”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>378</SU>
                             A digital assets payment provider stated that a two-year implementation period would be needed to allow these types of firms and the CFPB time to prepare for supervision. A digital assets industry trade association stated that firms in this area would need more time to assess whether they are larger participants. The Final Rule does not include digital assets in the larger-participant test and therefore those issues are not relevant to setting the effective date.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">Response to Comments Received</HD>
                    <P>
                        The CFPB disagrees that additional time, beyond the minimum 30-day period prescribed by the APA noted above, is necessary before this Final Rule can take effect. Larger participant rules do not impose substantive consumer protection obligations. Although larger participants might choose to increase their compliance with Federal consumer financial law in response to the possibility of supervision, market participants are already obligated to comply, and should already comply with, applicable Federal consumer financial law, regardless of whether they are subject to supervision. Thus, entities that qualify as larger participants under the Final Rule should not require additional time to come into compliance with Federal consumer financial law. Moreover, the CFPB designs its examination procedures and process to allow companies a reasonable amount of time to provide responses to information requests before examiners begin the examination. This is in addition to a 45-day period in which the entity may challenge the assertion that it is a larger participant under 12 CFR 1090.103(a). In addition, the CFPB believes that many larger participants have examination experience at the State level, and in some cases with the CFPB.
                        <SU>379</SU>
                        <FTREF/>
                         As noted in the Proposed Rule, some larger participants may already be subject to CFPB examination authority, including but not limited to as larger participants pursuant to the international money transfer larger participant rule. For all of these reasons, the CFPB disagrees that a later effective date is necessary to allow companies more time to prepare for CFPB supervision.
                        <SU>380</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>379</SU>
                             The law firm commenter's claim that many larger participants have not previously been examined was not supported by examples or specifics. It was unclear whether the commenter was considering examination at the State level, which was part of the rationale for the 60-day effective date in the consumer reporting larger participant rule as noted above. As noted above, many industry commenters stated that many market participants are money transmitters subject to examination at the State level.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>380</SU>
                             With regard to an individual commenter's suggestion of a two-phased adoption process, prior rules have not taken that approach and the CFPB believes it is not warranted here since, as noted above, larger participant rules do not impose substantive consumer protection obligations, and the Final Rule does not include digital assets transactions.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">VII. Dodd-Frank Act Section 1022(b) Analysis</HD>
                    <HD SOURCE="HD2">A. Overview</HD>
                    <P>
                        In developing this Final Rule, the CFPB has considered the potential benefits, costs, and impacts of the Rule as required by section 1022(b)(2) of the CFPA.
                        <SU>381</SU>
                        <FTREF/>
                         The Proposed Rule set forth a preliminary analysis of these effects, and the Bureau requested and received comments on the topic.
                    </P>
                    <FTNT>
                        <P>
                            <SU>381</SU>
                             Specifically, CFPA section 1022(b)(2)(A) calls for the Bureau to consider the potential benefits and costs of a regulation to consumers and covered persons, including the potential reduction of access by consumers to consumer financial products or services; the impact on insured depository institutions and insured credit unions with $10 billion or less in total assets as described in CFPA section 1026; and the impact on consumers in rural areas. The manner and extent to which the provisions of 12 U.S.C. 5512(b)(2) apply to a rulemaking of this kind that does not establish standards of conduct are unclear. Nevertheless, to inform this rulemaking more fully, the CFPB performed the analysis described in those provisions of the CFPA.
                        </P>
                    </FTNT>
                    <P>
                        The CFPB is issuing this Rule to establish supervisory authority over larger participants in the defined market for general-use digital consumer payment applications. Participation in this market will be measured on the basis of the aggregate number of annual consumer payment transactions denominated in U.S. dollars that a nonbank facilitates through general-use digital consumer payment applications, defined in the Final Rule as “annual covered consumer payment transaction volume.” If a nonbank covered person, together with its affiliated companies, has an annual covered consumer payment transaction volume (measured for the preceding calendar year) of at least 50 million and is not a small business concern, it will be a larger participant in the market for general-use digital consumer payment applications. As prescribed by existing § 1090.102, any nonbank covered person that qualifies as a larger participant will retain larger participant status until two years from the first day of the tax year in which the person last met the larger-participant test.
                        <SU>382</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>382</SU>
                             12 CFR 1090.102.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Baseline for Analysis and Data Limitations</HD>
                    <P>
                        The discussion below relies on information that the CFPB has obtained from industry, other regulatory agencies, and publicly-available sources, as well as on CFPB expertise. These sources form the basis for the CFPB's consideration of the likely impacts of the Final Rule. The CFPB provides estimates, to the extent possible, of the potential benefits and costs to consumers and covered persons of this Final Rule, against a baseline in which the CFPB takes no action. This baseline includes the current state of the market and existing regulation, including the CFPB's existing rules defining larger participants in certain markets.
                        <SU>383</SU>
                        <FTREF/>
                         Many States have supervisory programs relating to money transfers, which may consider aspects of Federal consumer financial law.
                        <SU>384</SU>
                        <FTREF/>
                         Federal prudential regulators' supervisory programs for banks also may extend to certain nonbank service providers, and may consider aspects of Federal consumer financial law related to the banking institutions subject to the jurisdiction of 
                        <PRTPAGE P="99642"/>
                        those regulators. However, the activities of larger participants in this market extend beyond State-regulated money transmitting and acting as service providers to banks. In addition, at present and other than the CFPB's activities, no program for supervision of nonbanks that participate in the general-use digital consumer payment applications market is dedicated exclusively to promoting compliance with Federal consumer financial law.
                    </P>
                    <FTNT>
                        <P>
                            <SU>383</SU>
                             
                            <E T="03">See, e.g.,</E>
                             12 CFR 1090.107 (defining larger participants of a market for international money transfers subject to the CFPB's supervisory authority under 12 U.S.C. 5514(a)(1)(B)). The CFPB has discretion in any rulemaking to choose an appropriate scope of analysis with respect to potential benefits and costs and an appropriate baseline. The CFPB, as a matter of discretion, has chosen to describe a broader range of potential effects to inform the rulemaking more fully.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>384</SU>
                             The Financial Crimes Enforcement Network's (FinCEN) Federal regulation of money transmitters generally does not apply Federal consumer financial law.
                        </P>
                    </FTNT>
                    <P>To the extent that this rule establishes supervisory authority over entities or their activities that already are subject to State or Federal supervisory oversight, as discussed in parts I and V above, the CFPB coordinates with the applicable State and Federal regulators in the operation of its risk-based nonbank supervision program to prevent unnecessary duplication and burden. To the extent that entities already are subject to the CFPB's supervisory authority (such as entities subject to supervision as service providers under section 1025(d) or 1026(e) of the CFPA or larger participants under a prior larger participant rulemaking), this rule will establish an additional basis for the CFPB to supervise those entities.</P>
                    <P>
                        The CFPB notes at the outset that limited data are available with which to quantify the potential benefits, costs, and impacts of the Final Rule. As described above, the CFPB has utilized various sources for quantitative information on the number of market participants, their annual revenue, and their number and dollar volume of transactions.
                        <SU>385</SU>
                        <FTREF/>
                         However, the CFPB lacks detailed information about their rate of compliance with Federal consumer financial law and about the range of, and costs of, compliance mechanisms used by market participants. Further, as noted above in the section-by-section analysis of the threshold for the larger participant test, the CFPB lacks sufficient information on approximately one-third of known market participants necessary to estimate their larger-participant status.
                        <SU>386</SU>
                        <FTREF/>
                         Compared to the lower threshold test of five million annual transactions that the CFPB proposed in the Proposed Rule, it is less likely that those entities would be larger participants at the higher threshold test of 50 million annual transactions in the Final Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>385</SU>
                             
                            <E T="03">See</E>
                             section-by-section analysis of § 1090.109(b).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>386</SU>
                             As stated above, the CFPB estimates that approximately 130 entities operate in the market for providing general-use digital consumer payment applications as defined in the Final Rule. Of those entities, the CFPB has data on roughly two-thirds sufficient to estimate larger-participant status, including whether those entities would be subject to the exclusion for small business concerns. The CFPB estimates that approximately seven of those would be larger participants under the larger-participant test defined in the Final Rule.
                        </P>
                    </FTNT>
                    <P>In light of these data limitations, this analysis generally provides a qualitative discussion of the benefits, costs, and impacts of the Final Rule. General economic principles, together with the limited data that are available and the CFPB's experience operating its supervision program, provided insight into these benefits, costs, and impacts. Where possible, the CFPB has made quantitative estimates based on these principles and data as well as on its experience of undertaking supervision in other markets.</P>
                    <HD SOURCE="HD2">C. General Comments Received on the 1022(b) Analysis</HD>
                    <P>
                        Several industry commenters and some Members of Congress generally asserted that the cost-benefit analysis for the proposal was inadequate. For example, three industry associations stated that the proposal overlooked various direct and indirect costs associated with supervision and that it underestimated the costs, or that it opportunistically framed the costs and benefits, or that it overstated benefits of supervision with respect to larger participants that are not “financial institutions” under Regulation E implementing the EFTA and Regulation P implementing the GLBA. One industry association commenter referenced the cost to what it referred to as custodial and non-custodial cryptocurrency-asset wallet developers to change their business model in order to collect and verify identity and transaction information. Another industry association commenter stated that the cost of any new regulation, including this Rule, would be incorporated into production costs and passed on to the consumer. Similarly, another industry association commenter claimed the CFPB failed to explain how expanding its supervisory authority would bring about consumer benefits from increased compliance. In addition, a company commenter claimed that the proposal failed to account for all costs, to accurately quantify the benefits and costs, and to find that the benefits would outweigh the costs of the Rule. A law firm commenter stated that the costs of CFPB examinations would outweigh benefits to consumers for firms at or near the proposed threshold of five million transactions.
                        <SU>387</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>387</SU>
                             Some commenters stated that the CFPB should conduct separate cost-benefit analyses for what they characterized as disparate markets. The CFPB responds to comments on the market definition above, in § 1090.109(a)(1). This section analyzes the costs and benefits of the Rule for the market defined in the Final Rule.
                        </P>
                    </FTNT>
                    <P>
                        The CFPB disagrees with the general assertion that its consideration of benefits and costs under section 1022(b) of the CFPA in the proposal was inadequate. The CFPB conducted a thorough analysis of the reasonably-available data to estimate and quantify benefits and costs to the extent possible. As noted in the proposal as well as above, where data do not support reliable quantitative estimates, the CFPB has qualitatively discussed potential benefits and costs based on general economic principles and its experience engaging in supervisory activities in other markets. The CFPB has provided additional responses to particular comments below, and where appropriate has updated its consideration of the Rule's benefits and costs in response to comments. For example, some industry commenters provided additional information on wages and salaries as well as predictions of larger participants' likely future staffing levels for CFPB supervisory examinations in this market and the CFPB has incorporated this information into cost calculations below. The CFPB notes that the general criticism of a lack of quantification generally was not accompanied by submissions of data that would aid in further quantifying potential costs or benefits that were not quantified in the proposal.
                        <SU>388</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>388</SU>
                             The Proposed Rule sought “submissions of additional data that could inform the CFPB's analysis of the costs, benefits, and impacts of the Proposed Rule.” 88 FR 80197, 80211.
                        </P>
                    </FTNT>
                    <P>Above and further below, the Rule discusses how expanding the supervisory authority of the CFPB to cover this market will help increase compliance.</P>
                    <HD SOURCE="HD2">D. Potential Benefits and Costs to Consumers and Covered Persons</HD>
                    <P>
                        The discussion below describes three categories of potential benefits and costs. First, the Final Rule authorizes the CFPB's supervision of larger participants of a market for general-use digital consumer payment applications. Larger participants of the market may respond to the possibility of CFPB supervision by changing their compliance systems and conduct, and those changes may result in costs, benefits, or other impacts. Second, if the CFPB undertakes supervisory activity of specific larger participant providers of general-use digital consumer payment applications, those entities may incur costs from responding to supervisory activity, and the results of these 
                        <PRTPAGE P="99643"/>
                        individual supervisory activities also may produce benefits and costs. Third, the CFPB analyzes the costs that might be associated with entities' efforts to assess whether they would qualify as larger participants under the Rule.
                    </P>
                    <HD SOURCE="HD3">1. Benefits and Costs of Responses to the Possibility of CFPB Supervision Conducting an Examination or Other Supervisory Activities</HD>
                    <P>
                        The Final Rule subjects larger participants of a market for general-use digital consumer payment applications to CFPB supervision. As described in the Proposed Rule, that the CFPB will be authorized to undertake supervisory activities with respect to a nonbank covered person who qualifies as a larger participant would not necessarily mean that the CFPB would in fact undertake such activities regarding that covered person in the near future. Rather, the CFPB generally would examine certain larger participants on a periodic or occasional basis. The CFPB's decisions about supervision are informed, as applicable, by the factors set forth in CFPA section 1024(b)(2) 
                        <SU>389</SU>
                        <FTREF/>
                         relating to the size and transaction volume of larger participants, the risks to consumers created by their provision of consumer financial products and services, the extent of State consumer protection oversight, and other factors the CFPB may determine are relevant. Part I of the Final Rule provides additional background on the CFPB's risk-based prioritization process (including how it considers field market intelligence), which is not the subject of this rulemaking. Each entity that believes it qualifies as a larger participant will know that it is subject to CFPB supervision and might gauge, given its circumstances, the likelihood that the CFPB would initiate an examination or other supervisory activity.
                    </P>
                    <FTNT>
                        <P>
                            <SU>389</SU>
                             12 U.S.C. 5514(b)(2).
                        </P>
                    </FTNT>
                    <P>The prospect of potential CFPB supervisory activity could create an incentive for larger participants to allocate additional resources and attention to compliance with Federal consumer financial law, potentially leading to an increase in the level of compliance. They might anticipate that by doing so (and thereby decreasing risk to consumers), they could decrease the likelihood of their actually being subject to supervisory activities as the CFPB evaluated the factors outlined above. In addition, an actual examination would be likely to reveal past or present noncompliance, which the CFPB could seek to correct through supervisory activity or, in some cases, enforcement actions. Larger participants therefore might judge that the prospect of CFPB supervision increases the potential consequences of noncompliance with Federal consumer financial law, and they might seek to decrease that risk by taking steps to identify and cure or mitigate any noncompliance before the CFPB conducts an examination.</P>
                    <P>
                        The CFPB believes it is likely that many larger participants would increase compliance in response to the CFPB's supervisory activity authorized by the Final Rule. However, because the Final Rule itself would not require any provider of general-use digital consumer payment applications to take such action, any estimate of the amount of increased compliance would require both an estimate of current compliance levels and a prediction of market participants' behavior in response to a Final Rule. The data that the CFPB currently has do not support a specific quantitative estimate or prediction. But, to the extent that nonbank entities allocate resources to increasing their compliance in response to the Final Rule, that response would result in both benefits and costs.
                        <SU>390</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>390</SU>
                             Another approach to considering the benefits, costs, and impacts of the Proposed Rule would be to focus almost entirely on the supervision-related costs for larger participants and related benefits of any increased compliance resulting from examination activity and omit a broader consideration of the benefits and costs of increased compliance by entities in anticipation of such examination activity. As noted above, the CFPB has, as a matter of discretion, chosen to describe a broader range of potential effects to inform the rulemaking more fully.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Benefits From Increased Compliance Based on Possibility of CFPB Examination</HD>
                    <P>Increased compliance with Federal consumer financial laws by larger participants in the market for general-use digital consumer payment applications would be beneficial to consumers who use general-use digital payment applications. Increasing the rate of compliance with Federal consumer financial laws would benefit consumers and this market by providing more of the protections mandated by those laws.</P>
                    <P>
                        Entities are aware that the CFPB would be examining for compliance with applicable provisions of Federal consumer financial laws, including the EFTA and its implementing Regulation E, as well as the privacy provisions of the GLBA and their implementing Regulation P.
                        <SU>391</SU>
                        <FTREF/>
                         In addition, the CFPB would be examining for whether larger participants of the market for general-use digital consumer payment applications engage in unfair, deceptive, or abusive acts or practices.
                        <SU>392</SU>
                        <FTREF/>
                         Conduct that does not violate an express requirement of another Federal consumer financial law may nonetheless constitute an unfair, deceptive, or abusive act or practice. To the extent that any provider of general-use digital consumer payment applications is currently engaged in any unfair, deceptive, or abusive acts or practices, the cessation of the unlawful act or practice would benefit consumers. Providers of general-use digital consumer payment applications might improve compliance policies and procedures in response to possible supervision in order to avoid engaging in unfair, deceptive, or abusive acts or practices.
                    </P>
                    <FTNT>
                        <P>
                            <SU>391</SU>
                             The CFPB also can supervise larger participants for other Federal consumer financial laws that apply, including rules that have recently taken effect, such as the CFPB's nonbank registration regulation at 12 CFR part 1092, or for which compliance is mandatory in the future, such as its Personal Financial Data Rights Rule.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>392</SU>
                             12 U.S.C. 5531.
                        </P>
                    </FTNT>
                    <P>The possibility of CFPB supervision also may help to make incentives to comply with Federal consumer financial laws more consistent between the likely larger participants and insured banks and insured credit unions, which are subject to Federal supervision with respect to Federal consumer financial laws. Although some nonbank market participants already are subject to State supervision and also may be supervised by Federal prudential regulators in certain capacities, introducing the possibility of Federal supervision that applies to market activities regardless of the degree to which they are subject to State or Federal prudential regulatory oversight could encourage nonbanks that likely are larger participants to devote additional resources to compliance. It also could help to ensure that the benefits of Federal oversight reach consumers who do not have ready access to bank-provided general-use digital consumer payment applications.</P>
                    <HD SOURCE="HD3">Comments Concerning Benefits of Increased Compliance Based on Possibility of CFPB Examination</HD>
                    <P>
                        Two industry association commenters expressed doubt about whether there would be benefits to consumers from larger participants increasing compliance with Federal consumer financial laws in anticipation of a possible CFPB supervisory examination due to the data gaps described in the proposal and the lack of an estimate regarding the number of supervisory examinations the CFPB plans to undertake in any given year. These commenters moreover suggested that companies that believe they are larger participants will have to assume they 
                        <PRTPAGE P="99644"/>
                        will be examined such that all potential larger participants would experience the increased anticipation cost associated with being subject to the rule.
                    </P>
                    <HD SOURCE="HD3">Response to Comments</HD>
                    <P>With respect to data gaps in the analysis of larger participant status, the CFPB notes that larger participants likely possess more information than the CFPB regarding their own transaction volume, revenue and/or employee counts necessary to determine their larger participant status. The CFPB expects the higher threshold of 50 million annual transactions to reduce uncertainty among potential larger participants as to their larger participant status. While the CFPA and CFPB regulations thereunder do not require larger participants to prepare for the examination process before they receive notice of an actual examination, the CFPB believes it is plausible that many larger participants would respond to the incentives described above as part of their risk-management strategy, especially if they expect there to be a reasonable chance of examination in the near future. Commenters did not offer evidence to the contrary. Part V of the Final Rule above provides additional discussion of general comments concerning the Final Rule's promotion of compliance with Federal consumer financial law.</P>
                    <HD SOURCE="HD3">Costs of Increased Compliance Based on Possibility of CFPB Examination</HD>
                    <P>To the extent that nonbank larger participants would decide to increase resources dedicated to compliance in response to the possibility of increased supervision, the entities would bear any cost of any changes to their systems, protocols, or personnel. Whether and to what extent entities would increase resources dedicated to compliance and/or pass those costs on to consumers would depend not only on the entities' current practices and the changes they decide to make, but also on market conditions. The CFPB lacks detailed information with which to predict the extent to which increased costs would be borne by providers or passed on to consumers, to predict how providers might respond to higher costs, or to predict how consumers might respond to increased prices, and commenters did not provide such detailed information in their comments. The CFPB further considers and responds to related comments about the cost of compliance enhancements below.</P>
                    <HD SOURCE="HD3">2. Benefits and Costs of Individual Supervisory Activities</HD>
                    <P>In addition to the responses of larger participants anticipating supervision, the possible consequences of the Final Rule would include the responses to and effects of individual examinations or other supervisory activity that the CFPB might conduct with respect to larger participants in the market for general-use digital consumer payment applications.</P>
                    <HD SOURCE="HD3">Benefits of Supervisory Activities</HD>
                    <P>
                        In the CFPB's experience, supervisory activity generally provides several types of benefits. As discussed above, the CFPB operates a risk-based nonbank supervision program, and prioritizes markets and individual entities for supervisory activity on the basis of a risk assessment that considers the factors listed in CFPA section 1024(b)(2). Due to this risk-based approach, in the CFPB's experience, the CFPB's nonbank supervisory activities often uncover compliance deficiencies indicating harm or risks of harm to consumers.
                        <SU>393</SU>
                        <FTREF/>
                         In its supervision and examination program, the CFPB generally prepares a supervisory letter or report of each examination. The CFPB shares examination findings with the supervised entity because one purpose of supervision is to inform the entity of problems detected by examiners. Thus, for example, an examination may find evidence of widespread noncompliance with Federal consumer financial law, or it may identify specific areas where an entity has inadvertently failed to comply, or it may identify weaknesses in compliance management systems including policies and procedures. These examples are only illustrative of the kinds of information an individual examination may identify.
                    </P>
                    <FTNT>
                        <P>
                            <SU>393</SU>
                             
                            <E T="03">See, e.g.,</E>
                             response to general comments in part V above citing examples of 
                            <E T="03">Supervisory Highlights</E>
                             issues that identified compliance deficiencies, violations of Federal consumer financial law, and risks of violations of Federal consumer financial law by nonbank covered persons, including larger participants in other markets.
                        </P>
                    </FTNT>
                    <P>
                        Detecting and informing supervised entities about such problems is generally beneficial to consumers including by identifying issues before they become systemic or cause significant harm. When the CFPB notifies entities about risks or noncompliance associated with aspects of their activities, the entities are expected to adjust their practices to reduce those risks. In the CFPB's experience, those responses frequently result in increased compliance with Federal consumer financial law, with benefits like those described above in connection with the possibility of CFPB examination. However, the benefits in connection with individual supervisory activities may be greater because the CFPB often will identify specific acts or practices that violate Federal consumer financial law and direct specific corrective actions including compliance improvements as well as restitution and remediation. For more than a decade, the CFPB has regularly described these corrective actions, including by larger participants, in its 
                        <E T="03">Supervisory Highlights</E>
                         publication.
                        <SU>394</SU>
                        <FTREF/>
                         Such responses can also avert violations that would have occurred if CFPB supervision did not detect the risk or noncompliance promptly. In some circumstances, the CFPB also informs entities about acts or practices that risk violating Federal consumer financial law. Action to reduce those risks is also a benefit to consumers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>394</SU>
                             
                            <E T="03">See, e.g., id.; see also Supervisory Highlights</E>
                             (website compendium of all of these publications), 
                            <E T="03">supra,</E>
                             at 
                            <E T="03">https://www.consumerfinance.gov/compliance/supervisory-highlights/</E>
                             (last visited Oct. 17, 2024).
                        </P>
                    </FTNT>
                    <P>
                        Given the obligations providers of general-use digital consumer payment applications have under Federal consumer financial law and the existence of efforts to enforce such laws, including by the CFPB and States,
                        <SU>395</SU>
                        <FTREF/>
                         and based on the CFPB's supervisory experience in other markets, the CFPB also expects that the results of CFPB supervision will benefit larger participants under supervision by detecting compliance problems early. When an entity's noncompliance results in litigation or an enforcement action, the entity must face both the costs of defending its action and the penalties for noncompliance, including potential liability to private plaintiffs. The entity must also adjust its systems to ensure future compliance. Changing practices that have been in place for long periods of time can be expected to be relatively difficult because they may be severe enough to represent a serious failing of an entity's systems. Supervision may detect flaws at a point when correcting them would be relatively inexpensive. Catching problems early, in some situations, can forestall costly litigation. To the extent early correction limits the amount of consumer harm caused by a violation, it can help limit the cost of redress. In short, supervision is likely to benefit providers of general-use digital consumer payment applications under 
                        <PRTPAGE P="99645"/>
                        supervision by, in the aggregate, reducing the need for other more expensive activities to achieve compliance.
                        <SU>396</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>395</SU>
                             
                            <E T="03">See, e.g.,</E>
                             CFPB, Interpretive Rule, Authority of States to Enforce the Consumer Financial Protection Act of 2020, 87 FR 31940 (May 26, 2022) (interpreting CFPA section 1042 and related provisions).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>396</SU>
                             Further potential benefits to consumers, covered persons, or both might arise from the CFPB's gathering of information during supervisory activities. The goals of supervision include informing the CFPB about activities of market participants and assessing risks to consumers and to markets for consumer financial products and services. The CFPB may use this information to improve regulation of consumer financial products and services and to improve enforcement of Federal consumer financial law, in order to better serve its mission of ensuring consumers' access to fair, transparent, and competitive markets for such products and services. Benefits of this type would depend on what the CFPB learns during supervision and how it uses that knowledge. For example, because the CFPB might examine a number of larger participants in the market for general-use digital consumer payment applications, the CFPB would build an understanding of how effective compliance systems and processes function in that market.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">Comments Regarding Benefits to Compliance</HD>
                    <P>The CFPB received differing comments regarding the potential compliance benefits of the Rule. Three nonprofits and one company commented that the proposal lacked support for the claimed benefit to consumers from increased compliance because the CFPB failed to demonstrate a baseline lack of compliance with Federal consumer financial laws. For example, one commenter stated that the proposal did not provide data to show that supervision and compliance positively correlate with consumer welfare. The company commenter criticized that the Bureau did not explain how much compliance there currently is and how much incremental compliance would be achieved by supervision. None of these commenters provided additional information that would aid in quantifying current compliance levels. In contrast, other commenters, including consumer groups, an industry commenter, and a group of State attorneys general, discussed related and additional potential benefits of the Rule without quantifying these specifically, including: ensuring compliance of payment applications and digital wallet providers with EFTA and the error resolution responsibilities of Regulation E; the improved ability of the CFPB to coordinate with State regulators to prevent or address violations of the prohibition against unfair, deceptive, and abusive acts and practices; effective oversight of compliance with the privacy provisions of the GLBA in order to address data privacy issues imposed by digital payment applications; and an improved ability of the CFPB to monitor payment fraud, which one consumer advocate commenter described as extremely common.</P>
                    <P>Three industry association commenters claimed that the proposal overstated the benefits of supervision under the Federal consumer financial laws it referenced because, commenters asserted, many market participants are not financial institutions under the EFTA and GLBA and their respective implementing regulations, and the Rule would therefore not have the stated compliance benefits for consumers of the products of those firms. Similarly, another industry association and one company asserted that pass-through wallets or payment method wallets are not subject to Regulation E.</P>
                    <P>Two of the above-mentioned commenters from industry associations further stated that the proposal overstated benefits to consumers of supervision due to already-existing State and Federal oversight that they argued would be duplicative of the additional oversight established by this Rule. In contrast, several State attorneys general submitted a comment letter stating that the Rule would help existing regulatory oversight efforts in the market and would allow Federal and State authorities to coordinate to prevent unlawful conduct.</P>
                    <HD SOURCE="HD3">Response to Comments</HD>
                    <P>The CFPB agrees with several commenters that this Rule provides potential benefits to consumers that may arise through increased supervision for compliance with Federal consumer financial laws including the CFPA's prohibition against unfair, deceptive, and abusive acts and practices, EFTA and Regulation E, and Regulation P and the privacy protections of the GLBA.</P>
                    <P>
                        The CFPB disagrees with comments suggesting that the CFPB must estimate or quantify the baseline level of non-compliance in the market in order to conclude that the Rule is likely to increase compliance. Such comments are inconsistent with the CFPB's supervisory experience. As discussed above, the CFPB's risk-based supervision program is designed to prioritize supervisory activity among nonbank covered persons on the basis of risk, and thus to focus on those activities where consumers have the greatest potential to be harmed. Further, following the issuance of its five prior larger participant rules, the CFPB has successfully used its supervisory authority to detect violations and promote compliance in each of the markets covered by those rules, as reflected in its 
                        <E T="03">Supervisory Highlights</E>
                         publication.
                        <SU>397</SU>
                        <FTREF/>
                         Above, the CFPB provides additional discussion of comments concerning the Final Rule's promotion of compliance with Federal consumer financial law, including comments stating that the CFPB should measure the baseline level of non-compliance before issuing this Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>397</SU>
                             
                            <E T="03">See</E>
                             CFPB, 
                            <E T="03">Supervisory Highlights</E>
                             (website compendium of all of these publications), 
                            <E T="03">at https://www.consumerfinance.gov/compliance/supervisory-highlights/</E>
                             (last visited Oct. 17, 2024).
                        </P>
                    </FTNT>
                    <P>
                        With respect to comments that some market participants are not financial institutions subject to EFTA and GLBA, as discussed in the section-by-section analysis above, this rulemaking does not prescribe substantive consumer protections or otherwise determine the scope of those laws. Regardless, supervision of those entities that are financial institutions for their compliance with those laws will still benefit consumers. More broadly, the Bureau will examine whether larger participants in the market for general use digital payment applications engage in unfair, deceptive, or abusive acts or practices.
                        <SU>398</SU>
                        <FTREF/>
                         As covered persons, larger participants are subject to the CFPA's prohibition against such acts and practices. To the extent that any larger participant or its service provider currently is engaged in any such act or practice, the cessation of the unlawful act or practice will benefit consumers.
                        <SU>399</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>398</SU>
                             12 U.S.C. 5531.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>399</SU>
                             The CFPB Supervision and Examination Manual provides further guidance to CFPB examiners on how the prohibition against unfair, deceptive, and abusive acts and practices applies to supervised entities. 
                            <E T="03">See CFPB Supervision and Examination Manual,</E>
                             part II.C (UDAAP statutory-based procedures).
                        </P>
                    </FTNT>
                    <P>
                        With respect to comments regarding existing oversight, as discussed further above, the CFPB agrees with the group of State attorneys general who stated that the rule would help existing regulatory oversight efforts in the market and would allow Federal and State authorities to coordinate to prevent unlawful conduct. The CFPB disagrees with comments suggesting that the CFPB's supervision will be duplicative of existing State and other Federal regulatory oversight. As discussed further above, in the response to general comments on this topic in the section-by-section analysis of the Final Rule, and in the background section of the rule in part II, the CFPB coordinates its supervisory activities with Federal prudential regulators, the FTC, and States in order to avoid duplication. Furthermore, there is currently no Federal program for supervision of nonbank covered persons in the market for general-use digital consumer 
                        <PRTPAGE P="99646"/>
                        payment applications with respect to Federal consumer financial law compliance, and this Rule will fill that gap.
                    </P>
                    <HD SOURCE="HD3">Costs of Supervisory Activities</HD>
                    <P>
                        The potential costs of actual supervisory activities would arise in two categories. The first category would be the cost to individual larger participants of supporting supervisory activity itself. The second category would involve any costs to individual larger participants of increasing compliance in response to the CFPB's findings during supervisory activity and to supervisory actions. These costs in the second category, discussed further below, would be similar in nature to the possible compliance costs based on the possibility of CFPB examination, described above, that larger participants in general may incur in anticipation of possible supervisory actions. This analysis will not repeat that discussion. As the CFPB Supervision and Examination Manual notes, the reason entities need a sound compliance management system is “[t]o maintain legal compliance” with Federal consumer financial law.
                        <SU>400</SU>
                        <FTREF/>
                         That is the case regardless of whether the entity is examined by the CFPB. For that reason, if a company already has established a sound compliance management system or improves that system in anticipation of possible CFPB supervisory actions as discussed above, then it is less likely to incur the costs in this second category described further below in response to actual CFPB supervisory activities.
                        <SU>401</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>400</SU>
                             
                            <E T="03">See CFPB Supervision and Examination Manual,</E>
                             part II.A (compliance management review examination procedures).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>401</SU>
                             A comment by an industry association stated that the proposal's estimate of the cost of supporting an examination “seem[ed] to ignore” costs related to establishing compliance programs and systems. However, that comment appears to have misunderstood the scope of that estimate. The CFPB does not consider the costs of establishing a compliance management system to be part of the cost of supporting the supervisory activity itself. Rather, the CFPB considers the costs of establishing or improving a compliance management system, if they are incurred, as either borne in anticipation of its supervisory activity (discussed above) or in response to findings of its supervisory activity (the second category of costs, discussed below). In any event, the Final Rule itself does not impose any requirements related to the establishment of a compliance management system. Firms are expected to have the systems and policies necessary to ensure they comply with existing, applicable substantive legal requirements, such as EFTA, its implementing Regulation E, the privacy provisions of the GLBA, their implementing Regulation P, and the CFPA's prohibition against unfair, deceptive, or abusive acts or practices. The CFPB's Supervision and Examination Manual describes aspects of compliance management that examiners review, but does not impose requirements; firms have flexibility in designing those systems and policies.
                        </P>
                    </FTNT>
                    <P>With respect to the first category of cost of supervisory activities, those activities may involve requests for information or records, on-site or off-site examinations, or some combination of these activities. For example, in an on-site examination, CFPB examiners generally contact the entity for an initial conference with management. That initial contact often is accompanied by a request for information or records. Based on the discussion with management and an initial review of the information received, examiners determine the scope of the on-site exam. While on-site, examiners spend some time in further conversation with management about the entity's policies, procedures, and processes. The examiners also review documents, records, and accounts to assess the entity's compliance and evaluate the entity's compliance management system. As with the CFPB's other examinations, examinations of nonbank larger participants in the market for general-use digital consumer payment applications may involve issuing confidential supervisory letters or examination reports and compliance ratings. The CFPB Supervision and Examination Manual describes the supervision process and indicates what materials and information an entity could expect examiners to request and review, both before they arrive and during their time on-site.</P>
                    <P>
                        The primary costs an entity would face in connection with supporting an examination would be the cost of employees' time to collect and provide the necessary information. The frequency, duration, and scope of examinations of any particular entity would depend on a number of factors, including the size and transaction volume of the entity, the compliance or other risks identified, the extent of State consumer protection oversight, and other relevant factors, such as whether the entity has been examined previously, and the demands on the CFPB's supervisory resources imposed by other entities and markets. Nevertheless, some rough estimates may provide a sense of the magnitude of potential staff costs that larger participants may incur in supporting the examination of their consumer financial products and services.
                        <SU>402</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>402</SU>
                             In addressing comments in part V above, the Final Rule notes that the market definition, market-related definitions, and larger participant test do not depend or rely on the CFPB's position that the CFPA authorizes supervision and examination of all of the consumer financial products and services provided by nonbank covered persons subject to CFPA section 1024(a). This rule does not determine the extent to which the CFPB would examine other consumer financial products and services provided by larger participants besides general-use digital consumer payment applications. Nonetheless, the CFPB considers that the cost to a larger participant of supporting a typical eight-week on-site examination should not vary significantly depending on which consumer financial products or services are scoped into the examination.
                        </P>
                    </FTNT>
                    <P>
                        The cost of supporting supervisory activity may be calibrated using prior CFPB experience in supervision. In the proposal, the CFPB outlined that examinations of larger participants in the market for general-use digital consumer payment applications would be anticipated to be approximately eight weeks on average,
                        <SU>403</SU>
                        <FTREF/>
                         with an additional two weeks of preparation. This estimate assumed that each examination would require two weeks of preparation time by staff of larger participant providers of general-use digital consumer payment applications prior to the examination as well as on-site assistance by staff throughout the duration of the examination. The CFPB has not suggested that counsel or any particular staffing level is required during an examination. However, based on prior estimates, the CFPB assumed in the Proposed Rule that an entity might dedicate the equivalent of one full-time compliance officer and one-tenth of the time of a full-time attorney to assist with an exam. The national average hourly wage of a compliance officer is $39; the national average hourly wage for an attorney is $85.
                        <SU>404</SU>
                        <FTREF/>
                         These averages accounted for the likelihood that some compliance officers and attorneys will earn below or above the national average. Assuming that wages and salaries account for 70.3 percent of total compensation for private industry workers, the CFPB estimated in the proposal that the total employer cost of labor to comply with an examination would amount to approximately $25,000.
                        <SU>405</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>403</SU>
                             For an estimate of the length of examination, see Board of Gov. of Fed. Res. System Office of Inspector General, 
                            <E T="03">The Bureau Can Improve Its Risk Assessment Framework for Prioritizing and Scheduling Examination Activities</E>
                             (Mar. 25, 2019) at 13, 
                            <E T="03">at https://oig.federalreserve.gov/reports/bureau-risk-assessment-framework-mar2019.pdf.</E>
                             (last visited Oct. 31, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>404</SU>
                             For current U.S. Bureau of Labor Statistics (BLS) estimates of mean hourly wages of these occupations, see BLS, 
                            <E T="03">Occupational Employment and Wages, May 2023, 13-1041 Compliance Officers, at</E>
                              
                            <E T="03">https://www.bls.gov/oes/current/oes131041.htm#(1)</E>
                             (last visited Aug. 15, 2024); BLS, 
                            <E T="03">Occupational employment and Wages, May 2023, 23-1011 Lawyers, at</E>
                              
                            <E T="03">https://www.bls.gov/oes/current/oes231011.htm</E>
                             (last visited Aug. 15, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>405</SU>
                             
                            <E T="03">See</E>
                             BLS, 
                            <E T="03">Employer Costs for Employee Compensation—March 2024</E>
                             (table 1 for 2024 Q1 estimates of the share of wages and salaries in total compensation of private sector workers), 
                            <E T="03">at https://www.bls.gov/news.release/pdf/ecec.pdf.</E>
                             (last visited Aug. 15, 2024). This cost is calculated as follows: ((((0.1 × $84.84) + $38.55)/0.703)) × 40 hours × 10 weeks.
                        </P>
                    </FTNT>
                    <PRTPAGE P="99647"/>
                    <HD SOURCE="HD3">Comments Received</HD>
                    <P>The CFPB received comments on the Proposed Rule advocating for higher estimates of the entity's cost of supporting supervisory activity, including on the wage and or salary level used in the analysis and on the number of employees typically called upon to support a supervisory exam. For example, two industry associations and one commenter stated that the types of staff tasked with supervisory examinations at large technology firms are highly specialized and compensated at rates that are higher than the national average. Two of these commenters provided alternative estimates for wages and salaries based on industry publications or U.S. Bureau of Labor Statistics (BLS) compensation estimates for firms with 500 workers or more. A commenter from a non-profit associated with the cryptocurrency industry stated that companies would devote “hundreds of thousands of dollars on support services” but did not describe the components of these costs or provide evidence to substantiate this claim. A law firm representing an interested party likewise criticized the examination cost estimate of approximately $25,000 as an underestimate and cited a former CFPB Deputy Director stating that the costs would amount to “at least ten times that” estimate, but did not provide a detailed explanation of the estimated cost components.</P>
                    <P>Relatedly, two industry associations stated that companies may hire consultants and outside counsel to support an examination, in addition to attorneys, compliance officers and other staff. Another industry commenter provided a link to an industry study finding that the top 100 U.S. law firms charge clients on average $917 per hour for outside counsel. Neither commenter elaborated on the frequency or magnitude of this practice, including the share of firms that would hire outside counsel or the number of hours they would contract to support company responses to requests for information from CFPB examiners.</P>
                    <P>Several industry commenters suggested larger participants would be likely to dedicate multiple compliance officers and attorneys to the preparation and support of a supervisory examination. For example, one company commenter asserted that both the preparation and the support for an actual examination would require multiple full-time compliance personnel and attorneys. Two other industry association commenters asserted that supporting an examination and meeting the CFPB's expectations for entities' compliance management systems would require “dozens of employees” who collaborate across multiple departments in order to respond to information requests. One industry association stated that firms not previously supervised may increase staffing due to the lack of previous experience with CFPB examinations, and also due to what the commenter stated was antagonistic rhetoric by the CFPB toward this industry.</P>
                    <P>The CFPB also received comments regarding the estimated length of a typical supervisory examination that asserted that the true length would be longer than two weeks of preparation and eight weeks of examination engagement. For example, one company stated that it takes a year to prepare for examinations and two industry association commenters stated that the full examination process including responding to follow-up requests spans multiple months and oftentimes over a year. However, none of these commenters provided a detailed accounting of specific duties, time estimates, or other evidence to substantiate these statements. Two further industry association commenters likewise questioned the two- plus eight-week examination timeline, indicating they thought a longer period to be more accurate, although neither provided an alternative length estimate.</P>
                    <P>One industry association criticized that the CFPB declined to state the expected frequency of examinations. Several commenters stated that the cost of supervision could stifle new entry, innovation, competition and consumer access to the covered products, and that the proposal did not adequately account for these costs. For example, one commenter from a non-profit stated that the proposal's coverage of pass-through wallets could disincentivize offerings such as the tokenization of payments and credit products offered through wallets. Three additional commenters from industry associations asserted that the proposed transaction test of five million covered transactions was so low that it could lead to barriers to market entry, innovation, competition, and consumer access to these products. None of the commenters offered specific estimates or research to help quantify such potential costs, nor did they make suggestions of how to more adequately evaluate them qualitatively.</P>
                    <P>
                        Related to the impact of costs on consumers' access to covered products, some commenters claimed the proposal inadequately considered potential pass-through costs to consumers and merchants. For example, some Members of Congress expressed concern that supervisory costs could have a negative impact on merchants that use covered products. They cited an industry study that finds that, of the small and medium-sized businesses throughout nine global markets, including the United States, that responded to their survey, 73 percent reported digital payments to be “fundamental to their growth.” 
                        <SU>406</SU>
                        <FTREF/>
                         A non-profit and an industry association representative called for the CFPB to provide evidence that the Rule will not significantly impact small businesses or consumers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>406</SU>
                             
                            <E T="03">See</E>
                             VISA, 
                            <E T="03">Back to Business Global Study: 2022 Small Business Outlook, at</E>
                              
                            <E T="03">https://usa.visa.com/dam/VCOM/blogs/visa-back-to-business-study-2022-outlook-jan22.pdf</E>
                             (last visited Aug. 26, 2024). The nine markets include Brazil, Canada, Germany, Hong Kong, Ireland, Russia, Singapore, UAE and the United States. Percentages in the study are not necessarily representative of small and medium-sized businesses in the United States.
                        </P>
                    </FTNT>
                    <P>Some of these same commenters as well as a company commenter claimed the proposal did not adequately consider the potential for supervisory costs to be passed through to consumers. For example, the nonprofit commenter noted that supervisory costs could create barriers to entry into the market and increase prices to consumers. The company stated that payment method wallets are free to consumers and that the Rule's costs could lead to firms charging consumers for the product. An individual consumer questioned whether the Rule would lead firms to charge fees for covered products. One industry association suggested the use of the average dollar amount of transactions to estimate potential pass-through costs to consumers.</P>
                    <P>Finally, an industry association commenter suggested that the Rule could increase the risk of privacy breaches and data leaks by increasing the number of individuals with access to sensitive, private information about customers of larger participants.</P>
                    <HD SOURCE="HD3">Response to Comments</HD>
                    <P>
                        The CFPB acknowledges the concerns raised by industry comments that, in the context of this market, the cost of supervisory activities may generally be higher than suggested in the Proposed Rule, and the CFPB is revising certain estimates in the discussion that follows in response to those comments. As noted above and discussed further below, the cost of supervisory activities can vary based on a number of factors, and thus the costs of examination activities may differ among larger participants within the market defined in this Rule. Those costs are partly 
                        <PRTPAGE P="99648"/>
                        within the control of larger participants, some of whom may choose to devote more resources to responding to supervisory activities than others (
                        <E T="03">e.g.,</E>
                         more staff time or support from outside counsel and consultants). In addition, as a general matter, the costs of supervisory activities are likely to be greater where examiners identify compliance violations or other risks to consumers, which are more likely to generate follow-up information requests and more extensive engagement with an entity as the CFPB attempts to correct the identified violations and address other risks.
                        <SU>407</SU>
                        <FTREF/>
                         These variations mean that the cost figures provided in this section are necessarily rough estimates, and that individual larger participants' costs may diverge from these estimates.
                    </P>
                    <FTNT>
                        <P>
                            <SU>407</SU>
                             For the same reason, as a general matter, examinations with more extensive follow-up activities are more likely to provide benefits to consumers.
                        </P>
                    </FTNT>
                    <P>While none of the commenters provided alternative estimates of examination costs that included specific salaries combined with staffing levels and alternative proposals of the average examination length, the following paragraphs describe how estimates would change under different salary, staffing and length assumptions. For these scenarios, the CFPB draws on comments provided on the proposal. In a first scenario, the alternative estimates below incorporate higher salary levels that some commenters suggested would be more accurate in this market. In a second scenario, the CFPB uses these higher salary estimates in conjunction with higher staffing levels than those discussed in the proposal. A third scenario introduces an example of when the combined preparation and examination time would be longer than the proposed ten weeks. Under this scenario, the CFPB provides alternative estimates for an examination lasting 12 weeks, under the assumption of the higher salaries from scenario one as well as under both the higher salary and higher staffing levels from scenario two.</P>
                    <P>
                        The CFPB does not have complete information pertaining to wages and salaries paid by all entities that may be subject to the Rule, and does not advocate for any particular wage or salary level for staff that support supervisory activities. However, the CFPB acknowledges that the cost to larger participants in this market of complying with a supervisory examination are likely to be higher than that of the average firm, in part because of where larger participants are located. For example, the top-paying metropolitan area for both compliance officers and lawyers is San Jose-Sunnyvale-Santa Clara, California, where the mean hourly wage for compliance officers is $56 and for lawyers is $129. Using these wage levels and the staffing assumptions set forth in the Proposed Rule,
                        <SU>408</SU>
                        <FTREF/>
                         the estimated total employer cost of labor to comply with an examination would increase to approximately $39,000.
                        <SU>409</SU>
                        <FTREF/>
                         This estimate is roughly $8,000 higher than the equivalent employer cost of labor suggested by one industry commenter on the Proposed Rule.
                        <SU>410</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>408</SU>
                             88 FR 80197, 80213 (describing assumption of one full-time compliance officer and one-tenth of the time of a full-time attorney to assist with the examination for 10 weeks).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>409</SU>
                             This cost is calculated as follows: ((((0.1 × $129.12) + $55.83)/0.703)) × 40 hours × 10 weeks. An alternative way to calculate the costs imposed on entities that pay some of the highest national wages for compliance officers and attorneys would be to use, for example, the 90th percentile of wages rather than the mean. However, the BLS top codes (suppresses) wages above $115/hour for lawyers such that the official wage estimates above that threshold would be imprecise. The 90th percentile of national hourly wages for compliance officers was $59/hour. Using these wage estimates would yield a total employer cost of labor of approximately $40,000 to comply with a supervisory exam.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>410</SU>
                             One industry commenter, citing three industry publications, asserted that the median rate for a compliance officer with four-six years of experience is $91,500 and the annual base pay for the majority of in-house counsel in large cities is “at least $200,000.” Using these numbers, the total employer cost of an examination would be approximately $31,000 ((0.1 ×  (($200000 × 10)/52)) + (91500 × 10/52))/0.703.
                        </P>
                    </FTNT>
                    <P>
                        Based on its review of comments, and in light of the higher transaction threshold in this Final Rule, the CFPB is providing additional estimates with respect to staffing the preparation and support of a supervisory examination in order to account for the fact that many entities are likely to choose higher staffing levels than those set forth in the proposal. The estimate of one full-time compliance officer and one tenth of one attorney took into account that there could be multiple individuals engaged part-time in an examination and part-time in other non-examination obligations. Although commenters did not provide precise or entirely consistent estimates regarding how larger participants are likely to staff examinations, the CFPB acknowledges that many larger participants in this market may choose to staff examinations with more full-time equivalent attorneys, compliance officers and other staff than is typically the case in previously supervised larger participant markets. The larger participants in this market are larger in terms of revenue compared to larger participants in other established larger participant markets.
                        <SU>411</SU>
                        <FTREF/>
                         For illustrative purposes, the CFPB has estimated that an entity that pays salaries at the level of the highest-paying metropolitan area and staffs an examination with three full-time compliance officers, two full-time attorneys and one outside counsel that spends 30 hours throughout the duration of the two-week preparation and eight-week examination period, would incur costs close to $270,000 per examination.
                        <SU>412</SU>
                        <FTREF/>
                         Alternatively, at this cost, the entity could staff the examination with more than five in-house staff if some of them work part-time on the examination and part-time on other duties. For example, some additional personnel may spend some number of hours on data analysis or coding or otherwise preparing materials for presentations to the CFPB, or may attend and provide information at the standard opening and closing meetings 
                        <PRTPAGE P="99649"/>
                        for the examination, or other initial meetings where they provide a brief overview of discrete issues. These meetings typically last only a few hours. The CFPB does not have detailed information to reliably quantify the exact amount of time these additional employees would devote to such supporting activities, but does not expect these limited engagements to materially affect this estimate.
                    </P>
                    <FTNT>
                        <P>
                            <SU>411</SU>
                             For example, the 2012 debt collection rule estimated that 168 of the 175 larger participants had annual receipts between $10 million and $250 million, 
                            <E T="03">see</E>
                             77 FR 65775, 65789. Among larger participants in the market covered by this Rule, average annual revenue was $208 billion in 2023. Higher revenue may indicate more complexity, or firms with higher revenue may decide to devote more resources to a supervisory examination because those costs comprise a small fraction of their operating budget. While it is reasonable to expect that larger participants in this market generally would devote more resources to a supervisory examination compared to many previous larger participants, the CFPB does not have information indicating that would necessarily always be the case.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>412</SU>
                             Without stating a specific number, one individual firm commented on the Proposed Rule that firms likely would staff supervisory examinations with multiple full-time compliance officers and multiple full-time attorneys and another industry association commenter asserted that firms would hire outside counsel to support an examination. Two industry trade associations stated that they expect larger participants to devote “dozens” of staff to a supervisory examination, but did not elaborate on the number of hours they would work or otherwise provide more specific numbers or information to substantiate that claim. Based on supervisory experience in other markets, the CFPB assumes in-house compliance officers spend more time on examinations than in-house attorneys. Therefore, in line with the general views of these commenters, the Bureau has assumed for purposes of its estimate that an entity would devote three full-time compliance officers, two full-time attorneys, and one outside counsel. Because outside counsel does not typically engage directly with examiners during the 10-week examination process described above, based on supervisory experience in other markets, the CFPB does not have data on how outside counsel is typically involved during a standard examination, but acknowledges that the larger participants in this specific market may seek outside advice on how to respond to and participate in an examination. The CFPB assumes the number of hours of outside counsel support in this scenario could be approximately 20 hours of preparation and 10 hours of support during the examination and assumes for illustrative purposes an hourly fee of $917 for outside counsel, as provided by one commenter. The cost of $270,000 is calculated as follows: ((((2 × $129.12) + (3 × $55.83))/0.703)) × 40 hours × 10 weeks + (917 × 30).
                        </P>
                    </FTNT>
                    <P>
                        With regard to the company comment that claimed that preparation for supervisory examinations of nonbanks is generally “a year-round affair,” this commenter did not explain or support this claim. Nor does it fit with the CFPB's experience since entities generally do not receive notice a year in advance of a scheduled examination. This assumption also is not in line with the experience of the CFPB from the supervision of other larger-participant markets. Supervision typically involves requiring documents from time to time and conducting occasional in-depth examinations of a company typically over the 10-week engagement period described above. For example, the CFPB may conduct supervisory monitoring activities throughout the year, including “contacting the appropriate officer of the institution to discuss new products or services, events that may impact compliance management, and any questions raised by information reviewed by the [CFPB's central point of contact for supervision].” 
                        <SU>413</SU>
                        <FTREF/>
                         However, these engagements generally are brief and often occur in the form of one phone call or videoconference. In contrast, during an in-depth examination of a company, CFPB examiners may ask to see a company's existing compliance policies and procedures, otherwise review a company's records and operations including for selected customer accounts, conduct interviews with personnel, and assess how the company complies with applicable Federal consumer financial laws. The scope of an examination will depend on, among other factors, the size and complexity of the firm.
                    </P>
                    <FTNT>
                        <P>
                            <SU>413</SU>
                             
                            <E T="03">See CFPB Supervision and Examination Manual,</E>
                             part I.A (page 13 of Overview section).
                        </P>
                    </FTNT>
                    <P>
                        With respect to comments regarding post-examination costs, the CFPB acknowledges that entities may face such costs. While the estimated cost for a larger participant in this market to support a supervisory examination described above assumes two weeks of preparation and eight weeks of engagement with the CFPB, some examinations may result in a Potential Action and Request for Response (PARR) letter, which provides a supervised entity with notice of preliminary findings of conduct that may violate Federal consumer financial laws and advises the entity that the Bureau is considering taking supervisory action against the entity.
                        <SU>414</SU>
                        <FTREF/>
                         In such an event, the CFPB estimates an additional two weeks of staff time necessary to respond to the PARR. In this third scenario of potentially higher examination costs, an additional two weeks would result in the cost of an examination increasing by approximately $8,000, to approximately $47,000, using the average wages of the top-paying metropolitan area, assuming staffing at the level set forth in the Proposed Rule. Under the higher salary and staffing assumptions described above, including three full-time compliance officers, two full-time attorneys and one outside counsel contracted for 80 additional hours of work on a PARR, an additional two weeks would increase the examination cost by approximately $122,000, to approximately $392,000.
                        <SU>415</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>414</SU>
                             
                            <E T="03">See</E>
                             CFPB, Request for Information Regarding the Bureau's Supervision Program, 83 FR 7166, 7168 (Feb. 20, 2018).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>415</SU>
                             This scenario assumes that outside counsel become more intensively involved in the event of a PARR and devoted 80 hours to support the larger participant in responding to the PARR, in the event that the larger participant chose to engage outside counsel for $917 hourly. Examination costs of approximately $47,000 and $392,000 in scenarios with a PARR are calculated as (((0.1 × $129.12) + $55.83)/0.703) × 40 hours × 12 weeks and as (((2 × 129.12) + (3 × 55.83))/0.703) × 40 hours × 12 weeks + (917 × 110), respectively.
                        </P>
                    </FTNT>
                    <P>
                        As stated in the proposal, the overall costs of supervision in the market for general-use digital consumer payment applications would depend on the frequency and extent of CFPB examinations and other supervisory activity. Neither the CFPA nor the Final Rule specifies a particular level or frequency of examinations.
                        <SU>416</SU>
                        <FTREF/>
                         The frequency of examinations would depend on a number of factors, including the larger participants' size and volume of transactions; the CFPB's understanding of the conduct of market participants and the specific risks they pose to consumers; the extent of existing State consumer protection oversight; and other relevant factors, including the responses of larger participants to prior examinations and the demands that other markets make on the CFPB's supervisory resources. These factors can be expected to change over time, and the CFPB's understanding of these factors may change as it gathers more information about the market through its supervision and by other means. The CFPB therefore declines to predict, at this point, precisely how many examinations in the market for general-use digital consumer payment applications it would undertake in a given year.
                    </P>
                    <FTNT>
                        <P>
                            <SU>416</SU>
                             The CFPB declines to predict at this time precisely how many examinations it will undertake at each larger participant of general-use digital consumer payment applications. Based on its experience in examining larger participants in other markets, it does not expect to conduct an examination of each larger participant in this market each year. If the CFPB were to examine each entity estimated to be a larger participant of the market for general-use consumer digital payment applications once every two years, the expected annual labor cost of supervision per larger participant under the higher salary, staffing and examination length assumptions would be approximately $196,000 (the cost of one examination, divided by two), depending on the staffing and remuneration decisions of the larger participant as well as on whether the examination is followed up with a PARR.
                        </P>
                    </FTNT>
                    <P>However, the CFPB notes that it is unlikely that all seven potential larger participants would undergo supervisory examinations in the same year. The frequency with which entities undergo supervision will determine the industry-wide costs. If each of the seven larger participants underwent examination every other year, the estimated annual direct cost of supervision would be around $137,000 industry-wide using average wages of the top-paying metropolitan area and the examination length and staffing levels set forth in the proposal. Even at the highest range of estimates, where each entity devoted three full-time compliance officers, two full-time attorneys, and contracted 110 hours of outside counsel with one of the largest 100 U.S. law firms, and all received a PARR, and half of the larger participants undergo supervision in any given year, the industry-wide estimated cost using the highest-paying metropolitan area wages would be approximately $1.4 million, or $392,000 × 3.5.</P>
                    <P>
                        With respect to the consideration of pass-through costs to consumers and merchants, the CFPB disagrees that it did not consider such potential impacts. The CFPB recognizes that many merchants provide website pay buttons that link to general-use digital consumer payment applications provided by unaffiliated third parties and that small businesses in particular may rely on those consumer financial products and services for growth. However, the CFPB expects the costs of supervisory examinations to not exceed $1.4 million industry-wide annually even if half of the larger participants were to undergo an extended supervisory examination every year, which is unlikely.
                        <SU>417</SU>
                        <FTREF/>
                         As 
                        <PRTPAGE P="99650"/>
                        stated in the proposal, the CFPB cannot foresee how larger participants may respond to the cost of supervision. One possibility is that larger participants absorb the entire cost of supervision. Another possibility is that they pass through the entire cost of supervision, or some fraction of the cost of supervision, to merchants and consumers. The extent to which larger participants would pass through their costs of supervision to merchants (for products that support payments for purchases) or consumers (for products that support purchases and/or payments to other consumers) will be limited by competitive forces in the market. For example, if one larger participant increases its fees for services, merchants or consumers may switch providers. This potential response to increased prices and competition for merchants' and consumers' business could prevent a full pass-through of costs. Moreover, the highest estimate of examination costs described in the scenarios above amounts to approximately $392,000 per larger participant, or 0.0002 percent of the average revenue (approx. $208 billion) of the estimated seven larger participants.
                        <SU>418</SU>
                        <FTREF/>
                         Because the examination support costs are a small fraction of the total revenue of larger participants, the CFPB believes it is less likely that these costs would cause firms to substantially change their business models.
                    </P>
                    <FTNT>
                        <P>
                            <SU>417</SU>
                             As discussed in the section-by-section analysis in part V, the estimates in this Rule do not reflect 
                            <PRTPAGE/>
                            supervisory conclusions that particular entities are larger participants; once the Final Rule takes effect, the CFPB will make those assessments and will prioritize conducting supervisory activity at specific larger participants in this market based on risk as described in the Supervision and Examination Manual, consistent with CFPA section 1024(b)(2). Therefore, the CFPB cannot predict in this Final Rule how many examinations or other types of supervisory events it will conduct at larger participants of this market in a given year. However, based on its experience with prioritization of supervisory activity at larger participants in five other markets, the CFPB believes it is unlikely that it would conduct eight-week on-site examinations of most or even many larger participants in a single year.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>418</SU>
                             Using revenue information from annual report filings with the U.S. Securities and Exchange Commission described above, the CFPB estimates the average total annual revenue of larger participants to be approximately $208 billion in 2023. As an alternative comparison, and in response to one industry commenter, this cost comprises approximately 0.0003 percent of larger participants' average annual total transaction value in 2021-2023. This number is likely higher in 2024, as the majority of data points for transaction values stem from 2021 and the market continued to expand during this period. In any event, the CFPB views this number as small.
                        </P>
                    </FTNT>
                    <P>
                        Even in the event that larger participants pass through the entire cost of the higher end of the CFPB examination support cost estimates to merchants that use these products, the cost per merchant likely would be very small. One industry study estimates that there were 13.7 million online stores in 2024.
                        <SU>419</SU>
                        <FTREF/>
                         If 59 percent of merchants use buy buttons, as indicated by one industry report,
                        <SU>420</SU>
                        <FTREF/>
                         then roughly 8.1 million online merchants use these products. The CFPB estimates that seven larger participants are responsible for approximately 98 percent of transactions in the market. Therefore, even if larger participants that underwent an examination were to pass through 100 percent of $1.4 million in estimated annual examination costs (under the higher estimate) to approximately eight million merchants, the amount per merchant would likely be low. Measured against the $1.1 trillion in online retail sales in 2023, the Bureau views this cost to be negligible and not large enough to discourage entry, innovation or growth among merchants that use or would like to use these products.
                        <SU>421</SU>
                        <FTREF/>
                         Likewise, the CFPB views the cost relative to the gains from doing business in this market as too low to disincentivize offering credit products through wallets, in particular as a lender's own app-based lending activity can be excluded by paragraph (D) of the definition of “consumer payment transaction” as discussed in part V of the rule. With respect to the statement by one commenter that the cost of the Rule could disincentivize investments in the tokenization of payments, as discussed in part V above, the commenter did not commenter did not explain why larger participants would seek to offset the costs of CFPB examination by reducing investment specifically in anti-fraud protections or provide evidence to support its view, and the CPFB notes that the Rule also could incentivize investments.
                    </P>
                    <FTNT>
                        <P>
                            <SU>419</SU>
                             
                            <E T="03">See</E>
                             Capital One, 
                            <E T="03">Total Number of Online Stores</E>
                             (July 24, 2024), 
                            <E T="03">at https://capitaloneshopping.com/research/number-of-online-stores/</E>
                             (last visited Aug. 26, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>420</SU>
                             See PYMNTS, 
                            <E T="03">6 in 10 Subscription Merchants Drive Conversion with `Buy Buttons,' at https://www.pymnts.com/subscriptions/2023/60percent-subscription-merchants-drive-conversion-with-buy-buttons/</E>
                             (last visited Aug. 26, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>421</SU>
                             For e-commerce retail sales, see the Federal Reserve Bank of St. Louis, 
                            <E T="03">E-Commerce Retail Sales, at</E>
                              
                            <E T="03">https://fred.stlouisfed.org/series/ECOMSA</E>
                             (last visited Aug. 26, 2024).
                        </P>
                    </FTNT>
                    <P>
                        As explained above, the CFPB also does not expect larger participants to pass through the full cost of supervisory examinations to consumers directly. However, even if they passed through $1.4 million annually to the millions of consumers who use these products, the cost per consumer would likely be low.
                        <SU>422</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>422</SU>
                             
                            <E T="03">See</E>
                             U.S. Census Bureau, 
                            <E T="03">National Population by Characteristics: 2020-2023,</E>
                             at 
                            <E T="03">https://www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html</E>
                             (last visited Aug. 26, 2024); 
                            <E T="03">see, e.g., Pew 2022 Payment App Article, supra.</E>
                        </P>
                    </FTNT>
                    <P>
                        As a result of some examinations, supervised entities may incur costs associated with addressing the CFPB's supervisory communications and actions, such as by making changes to its compliance systems or procedures. As noted above, the CFPB considers these costs as a separate category of costs from the costs of supporting an exam. Where appropriate, in exercising its supervisory authority, the CFPB conveys its findings, conclusions, expectations, and recommendations to a supervised entity regarding its compliance, and utilizes various forms of supervisory communications and actions to promote compliance and address associated risks.
                        <SU>423</SU>
                        <FTREF/>
                         The CFPB's supervisory communications may specify corrective actions such as changes to practices and operations, payment of remediation to consumers,
                        <SU>424</SU>
                        <FTREF/>
                         and steps to prevent such violations from occurring or recurring, including compliance-management-system improvements. In the CFPB's experience, when an entity adopts preventive measures in response to those types of CFPB supervisory communications and actions, the entity's actions generally will reduce risk of violation of Federal consumer financial law. As such, these costs may be necessary to maintain compliance with Federal consumer financial law, as described in the CFPB Supervision and Examination Manual. In any event, the CFPB is not able to estimate these costs in advance, as such costs will vary depending on the nature and scope of the CFPB's supervisory communications and actions and the entity's response. As discussed above, in many cases CFPB supervision also may benefit providers under supervision by detecting compliance problems early, which can reduce costs in the long run.
                    </P>
                    <FTNT>
                        <P>
                            <SU>423</SU>
                             
                            <E T="03">See, e.g., CFPB Bulletin 2021-01, supra.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>424</SU>
                             
                            <E T="03">See id.</E>
                        </P>
                    </FTNT>
                    <P>
                        Regarding the risk of privacy breaches, the CFPB agrees with the commenter that consumer data privacy is important. The CFPB recognizes that data privacy breaches can impose costs on consumers and firms and therefore adheres to the Federal requirements to reduce the risk of data and other privacy breaches. For example, the CFPB complies with requirements provided in the Presidential Executive Orders, Federal Information Security Management Act (FISMA), applicable Office of Management and Budget (OMB) Memoranda, U.S. Department of Homeland Security (DHS) Cybersecurity 
                        <PRTPAGE P="99651"/>
                        and Infrastructure Security Agency (CISA) Binding Operational Directives, as well as National Institute of Standards and Technology (NIST) Federal Information Processing Standards and Special Publications, and other applicable guidance. Further, CFPB implements improvements from annual information security audits of its data security practices by the Office of Inspector General (OIG), the Government Accountability Office (GAO) and other auditors, as recommended. The CFPB believes that these steps mitigate the risk of privacy breaches.
                    </P>
                    <HD SOURCE="HD3">3. Costs of Assessing Larger-Participant Status</HD>
                    <P>
                        Providers of general-use digital consumer payment applications might decide to incur costs to assess whether they qualify as larger participants, to respond to CFPB requests for information to assess larger participant status under 12 CFR 1090.103(d), or potentially to dispute their status.
                        <SU>425</SU>
                        <FTREF/>
                         Larger-participant status would depend on both a nonbank's aggregate annual covered consumer payment transaction volume and whether the entity is a small business concern based on the applicable SBA size standard. The CFPB expects that many market participants already assemble general data related to the number of transactions that they provide for general-use digital consumer payment applications. Moreover, many providers are required to report certain transaction data to State regulators.
                        <SU>426</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>425</SU>
                             A nonbank covered person that is subject to certain orders may be required to register pursuant to the CFPB's nonbank registration regulation, 12 CFR part 1092. If such a registered entity is not already supervised by the CFPB under section 1024(a), and it participates in this market, then it may need to assess its larger participant status to determine whether it must comply with certain additional requirements under that rule that may apply to persons supervised under CFPA section 1024(a), including larger participants. 
                            <E T="03">See also</E>
                             response to general comments on promoting compliance with Federal consumer financial law, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>426</SU>
                             As noted above, the States have been active in regulation of money transmission by money services businesses. For example, 49 States and the District of Columbia requiring entities to obtain a license to engage in money transmission, as defined by applicable law. Further, many States also actively examine money transmitters, including certain products and services they provide through general-use digital consumer payment applications. 
                            <E T="03">See, e.g., CSBS Reengineering Nonbank Supervision MSB Chapter</E>
                             at 4 (discussing how providers of digital wallets hold and transmit monetary value).
                        </P>
                    </FTNT>
                    <P>To the extent that some providers of general-use digital consumer payment applications do not already know whether their transactions exceed the threshold, such nonbanks might, in response to the Final Rule, develop new systems to count their transactions in accordance with the proposed market-related definitions of “consumer payment transactions,” “covered payment functionality,” “general use,” and “digital application” discussed above. The data that the CFPB had at the time of the Proposed Rule did not support a detailed estimate of how many providers of general-use digital consumer payment applications would engage in such development or how much they would spend, and commenters did not provide this information. Commenters also did not provide any estimates or data to support estimates. Regardless, providers of general-use digital consumer payment applications would be unlikely to spend significantly more on specialized systems to count transactions than it would cost to be supervised by the CFPB as larger participants.</P>
                    <P>The CFPB notes that larger-participant status also depends on whether an entity is subject to the proposed small business exclusion. In certain circumstances, larger-participant status may depend on determinations of which SBA size standard applies, and by extension, which NAICS code is most applicable. Therefore, providers of general-use digital consumer payment applications may choose to incur some administrative costs to evaluate whether the small business exclusion applies. However, providers would not need to engage in this evaluation if they could establish that their annual covered consumer payment transaction volume was below 50 million.</P>
                    <P>
                        It bears emphasizing that even if a nonbank market participant's expenditures on a new transaction counting system enabled it to successfully prove that it was not a larger participant (which, again, it would not need to do if it was a small business concern according to SBA standards), it would not necessarily follow that this entity could not be supervised under other supervisory authorities the CFPB has that this rulemaking does not establish. For example, the CFPB can supervise a nonbank entity whose conduct the CFPB determines, pursuant to CFPA section 1024(a)(1)(C) and regulations implementing that provision, poses risks to consumers.
                        <SU>427</SU>
                        <FTREF/>
                         Thus, a nonbank entity choosing to spend significant amounts on a transaction counting system directed toward the larger-participant transaction volume test could not be sure it would not be subject to CFPB supervision notwithstanding those expenses. The CFPB therefore believes very few if any nonbank entities would be likely to undertake such expenditures.
                    </P>
                    <FTNT>
                        <P>
                            <SU>427</SU>
                             
                            <E T="03">See</E>
                             12 U.S.C. 5514(a)(1)(C); 12 CFR part 1091.
                        </P>
                    </FTNT>
                    <P>Commenters on the Proposed Rule stated that providers of digital applications to make payments using cryptocurrency-assets may need to change their product design to capture data that would allow them to identify consumer payment transactions that would determine larger participant status under the Proposed Rule. However, because the Final Rule adopts a larger participant test based on the transfer of funds in consumer payment transactions denominated in U.S. dollars, those providers would not face the potential for those types of impacts.</P>
                    <P>An industry association commented that the ambiguity of the proposal could cause firms to incur costs when assessing their larger participant status. The significantly higher threshold test of 50 million annual transactions adopted in the Final Rule should substantially diminish the level of uncertainty compared to the proposal regarding an entity's larger participant status. Additional clarifications of the market in the Final Rule, including clarifying the definition of “general use” and limiting the definition of “annual covered consumer payment transaction volume” to transactions denominated in U.S. dollars, should further facilitate the determination of whether an entity is a larger participant.</P>
                    <HD SOURCE="HD2">E. Potential Specific Impacts of the Final Rule</HD>
                    <HD SOURCE="HD3">1. Insured Depository Institutions and Insured Credit Unions With $10 Billion or Less in Total Assets, as Described in Dodd-Frank Act Section 1026</HD>
                    <P>
                        The Rule does not apply to insured depository institutions or insured credit unions of any size. However, as noted in the section-by-section analysis of “digital application” above, it may apply to nonbank covered persons to the extent that they provide covered payment functionalities through a digital application of an insured depository institution or insured credit union. In addition, it might have some competition-related impact on insured depository institutions or insured credit unions that provide general-use digital consumer payment applications. For example, if the relative price of nonbanks' general-use digital consumer payment applications were to increase due to increased costs related to supervision, then insured depository institutions or insured credit unions of any size might benefit by the relative change in costs. These effects, if any, would likely be small.
                        <PRTPAGE P="99652"/>
                    </P>
                    <HD SOURCE="HD3">2. Impact of the Provisions on Consumers in Rural Areas</HD>
                    <P>Because the Rule would apply uniformly to consumer payment transactions that both rural and non-rural consumers make through general-use digital consumer payment applications, the Rule should not have a unique impact on rural consumers. The CFPB is not aware of any evidence suggesting that rural consumers have been disproportionately harmed by Federal consumer financial law noncompliance by providers of general-use digital consumer payment applications.</P>
                    <HD SOURCE="HD3">Comments Received</HD>
                    <P>The CFPB sought information from commenters related to how digital consumer payments affect rural consumers. A nonprofit associated with decentralized finance commented that rural communities in particular may benefit from digital payment technologies due to limited access to brick-and-mortar financial services and suggested that costs imposed by this Rule could limit rural communities' access to such technology. That commenter did not offer research to substantiate this assertion. In contrast, a nonprofit commented that 94 percent of their member webinar participants did not believe that digital consumer payments impacted rural consumers differentially. Several State attorneys general advocated for increased oversight in this market in part because they believe it would benefit in particular some consumers who rely on applications covered by this Rule and who do not use traditional banks and their bank-provided digital consumer payment applications.</P>
                    <HD SOURCE="HD3">Response to Comments</HD>
                    <P>The CFPB believes that both rural and non-rural consumers may benefit from general-use digital consumer payment applications as defined in the Final Rule. As discussed further above, the Bureau does not expect the costs imposed by this Rule to be high enough to impact the availability of this technology to consumers irrespective of whether they reside in rural or non-rural areas. Moreover, the Final Rule does not cover transactions in cryptocurrencies or stablecoins.</P>
                    <HD SOURCE="HD1">VIII. Regulatory Flexibility Act Analysis</HD>
                    <P>
                        The Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, requires each agency to consider the potential impact of its regulations on small entities, including small businesses, small governmental units, and small not-for-profit organizations.
                        <SU>428</SU>
                        <FTREF/>
                         The RFA defines a “small business” as a business that meets the size standard developed by the SBA pursuant to the Small Business Act.
                        <SU>429</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>428</SU>
                             5 U.S.C. 601 
                            <E T="03">et seq.</E>
                             The term “ `small organization' means any not-for-profit enterprise which is independently owned and operated and is not dominant in its field, unless an agency establishes [an alternative definition after notice and comment].” 5 U.S.C. 601(4). The term “ `small governmental jurisdiction' means governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand, unless an agency establishes [an alternative definition after notice and comment].” 5 U.S.C. 601(5). The CFPB is not aware of any small governmental units or small not-for-profit organizations to which the Proposed Rule would apply.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>429</SU>
                             5 U.S.C. 601(3). The CFPB may establish an alternative definition after consultation with SBA and an opportunity for public comment. As mentioned above, the SBA defines size standards using NAICS codes that align with an entity's primary line of business. The CFPB believes that many—but not all—entities in the proposed market for general-use digital consumer payment applications are primarily engaged in financial services industries. 
                            <E T="03">See, e.g.,</E>
                             SBA, 
                            <E T="03">Table of Small Business Size Standards Matched to North American Industry Classification System Codes</E>
                             (eff. Mar. 17, 2023), sector 52 (Finance and Insurance), 
                            <E T="03">at https://www.sba.gov/document/support--table-size-standards</E>
                             (last visited Oct. 26, 2023).
                        </P>
                    </FTNT>
                    <P>
                        The RFA generally requires an agency to conduct an initial regulatory flexibility analysis (IRFA) of any Proposed Rule subject to notice-and-comment rulemaking requirements, unless the agency certifies that the Proposed Rule would not have a significant economic impact on a substantial number of small entities.
                        <SU>430</SU>
                        <FTREF/>
                         The CFPB also is subject to certain additional procedures under the RFA involving the convening of a panel to consult with small entity representatives prior to proposing a rule for which an IRFA is required.
                        <SU>431</SU>
    