<?xml version="1.0" encoding="UTF-8"?>
<FEDREG xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:noNamespaceSchemaLocation="FRMergedXML.xsd">
    <VOL>88</VOL>
    <NO>102</NO>
    <DATE>Friday, May 26, 2023</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>
                <DOCENT>
                    <DOC>Meetings, </DOC>
                    <PGS>34154-34155</PGS>
                    <FRDOCBP>2023-11303</FRDOCBP>
                </DOCENT>
                <SJ>Supplemental Evidence and Data Request:</SJ>
                <SJDENT>
                    <SJDOC>Measures for Primary Healthcare Spending, </SJDOC>
                    <PGS>34155</PGS>
                    <FRDOCBP>2023-11252</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Agriculture</EAR>
            <HD>Agriculture Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Forest Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Rural Utilities Service</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Centers Disease</EAR>
            <HD>Centers for Disease Control and Prevention</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>34156-34159</PGS>
                    <FRDOCBP>2023-11264</FRDOCBP>
                      
                    <FRDOCBP>2023-11265</FRDOCBP>
                      
                    <FRDOCBP>2023-11266</FRDOCBP>
                </DOCENT>
                <SJ>Charter Amendments, Establishments, Renewals and Terminations:</SJ>
                <SJDENT>
                    <SJDOC>World Trade Center Health Program Scientific/Technical Advisory Committee, </SJDOC>
                    <PGS>34159</PGS>
                    <FRDOCBP>2023-11326</FRDOCBP>
                </SJDENT>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>World Trade Center Health Program Scientific/Technical Advisory Committee, </SJDOC>
                    <PGS>34159-34161</PGS>
                    <FRDOCBP>2023-11327</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Centers Medicare</EAR>
            <HD>Centers for Medicare &amp; Medicaid Services</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Medicaid Program:</SJ>
                <SJDENT>
                    <SJDOC>Misclassification of Drugs, Program Administration and Program Integrity Updates under the Medicaid Drug Rebate Program, </SJDOC>
                    <PGS>34238-34296</PGS>
                    <FRDOCBP>2023-10934</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Children</EAR>
            <HD>Children and Families Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Adoption and Foster Care Analysis and Reporting System, </SJDOC>
                    <PGS>34161</PGS>
                    <FRDOCBP>2023-11291</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Coast Guard</EAR>
            <HD>Coast Guard</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Safety Zone:</SJ>
                <SJDENT>
                    <SJDOC>Fireworks Displays in the Fifth Coast Guard District, Philadelphia, PA, </SJDOC>
                    <PGS>34085</PGS>
                    <FRDOCBP>2023-11316</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Illinois River Mile Markers 163.3 to 162.7, Peoria, IL, </SJDOC>
                    <PGS>34085-34087</PGS>
                    <FRDOCBP>2023-11294</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>La Quinta and Corpus Christi Shipping Channel, Ingleside, TX, </SJDOC>
                    <PGS>34087-34089</PGS>
                    <FRDOCBP>2023-11387</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Commerce</EAR>
            <HD>Commerce Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Foreign-Trade Zones Board</P>
            </SEE>
            <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>Committee for Purchase</EAR>
            <HD>Committee for Purchase From People Who Are Blind or Severely Disabled</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Procurement List; Additions and Deletions, </DOC>
                    <PGS>34139-34140</PGS>
                    <FRDOCBP>2023-11269</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Commodity Futures</EAR>
            <HD>Commodity Futures Trading Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>34140-34141</PGS>
                    <FRDOCBP>2023-11309</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Education Department</EAR>
            <HD>Education Department</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Assistance to States for the Education of Children with Disabilities; Correction, </DOC>
                    <PGS>34100</PGS>
                    <FRDOCBP>2023-11256</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Application Forms and Instructions for the Fulbright-Hays Training Grants: Doctoral Dissertation Research Abroad and Faculty Research Abroad, </SJDOC>
                    <PGS>34141-34142</PGS>
                    <FRDOCBP>2023-11255</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Energy Department</EAR>
            <HD>Energy Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Energy Regulatory Commission</P>
            </SEE>
            <CAT>
                <HD>RULES</HD>
                <SJ>Energy Conservation Program:</SJ>
                <SJDENT>
                    <SJDOC>Energy Conservation Standards for Room Air Conditioners, </SJDOC>
                    <PGS>34298-34364</PGS>
                    <FRDOCBP>2023-10287</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Environmental Management Site-Specific Advisory Board, Northern New Mexico, </SJDOC>
                    <PGS>34142-34143</PGS>
                    <FRDOCBP>2023-11234</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Environmental Protection</EAR>
            <HD>Environmental Protection Agency</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Air Quality State Implementation Plans; Approvals and Promulgations:</SJ>
                <SJDENT>
                    <SJDOC>California; Los Angeles-South Coast Air Basin, </SJDOC>
                    <PGS>34093-34096</PGS>
                    <FRDOCBP>2023-11317</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Idaho; State Board Composition, </SJDOC>
                    <PGS>34091-34093</PGS>
                    <FRDOCBP>2023-11261</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>New Chemicals Regulations under the Toxic Substances Control Act, </DOC>
                    <PGS>34100-34125</PGS>
                    <FRDOCBP>2023-10735</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals</SJ>
                <SJDENT>
                    <SJDOC>Performance Evaluation Studies on Wastewater Laboratories, </SJDOC>
                    <PGS>34152-34153</PGS>
                    <FRDOCBP>2023-11315</FRDOCBP>
                </SJDENT>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Chromium Finishing Industry; Correction, </SJDOC>
                    <PGS>34153</PGS>
                    <FRDOCBP>2023-11262</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Environmental Impact Statements; Availability, etc., </DOC>
                    <PGS>34151</PGS>
                    <FRDOCBP>2023-11292</FRDOCBP>
                </DOCENT>
                <SJ>Proposed Settlements:</SJ>
                <SJDENT>
                    <SJDOC>Bennett Landfill Fire Superfund Site, Chester, SC, </SJDOC>
                    <PGS>34151-34152</PGS>
                    <FRDOCBP>2023-11348</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Aviation</EAR>
            <HD>Federal Aviation Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Airworthiness Directives:</SJ>
                <SJDENT>
                    <SJDOC>The Boeing Company Airplanes, </SJDOC>
                    <PGS>34081-34084</PGS>
                    <FRDOCBP>2023-11305</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Transport and Commuter Category Airplanes, </SJDOC>
                    <PGS>34065-34081</PGS>
                    <FRDOCBP>2023-11371</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Airworthiness Directives:</SJ>
                <SJDENT>
                    <SJDOC>Airbus SAS Airplanes, </SJDOC>
                    <PGS>34097-34100</PGS>
                    <FRDOCBP>2023-11233</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>NextGen Advisory Committee, </SJDOC>
                    <PGS>34206-34207</PGS>
                    <FRDOCBP>2023-11340</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Emergency</EAR>
            <HD>Federal Emergency Management Agency</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Community Disaster Resilience Zones and the National Risk Index, </DOC>
                    <PGS>34171-34176</PGS>
                    <FRDOCBP>2023-11268</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>
                Federal Energy
                <PRTPAGE P="iv"/>
            </EAR>
            <HD>Federal Energy Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Application:</SJ>
                <SJDENT>
                    <SJDOC>PPG Shawville Pipeline, LLC, </SJDOC>
                    <PGS>34149-34150</PGS>
                    <FRDOCBP>2023-11296</FRDOCBP>
                </SJDENT>
                <SJ>Authorization for Continued Project Operation:</SJ>
                <SJDENT>
                    <SJDOC>Boott Hydropower, LLC, </SJDOC>
                    <PGS>34143</PGS>
                    <FRDOCBP>2023-11242</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Town of Bedford, VA, </SJDOC>
                    <PGS>34147</PGS>
                    <FRDOCBP>2023-11238</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Combined Filings, </DOC>
                    <PGS>34143, 34147</PGS>
                    <FRDOCBP>2023-11343</FRDOCBP>
                      
                    <FRDOCBP>2023-11345</FRDOCBP>
                </DOCENT>
                <SJ>Environmental Assessments; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Little Falls Hydroelectric Associates, LP, </SJDOC>
                    <PGS>34150-34151</PGS>
                    <FRDOCBP>2023-11295</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Venture Global Plaquemines LNG, LLC; Proposed Plaquemines LNG Amendment Project, </SJDOC>
                    <PGS>34143-34144</PGS>
                    <FRDOCBP>2023-11237</FRDOCBP>
                </SJDENT>
                <SJ>Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations:</SJ>
                <SJDENT>
                    <SJDOC>Appaloosa Solar I, LLC, </SJDOC>
                    <PGS>34146</PGS>
                    <FRDOCBP>2023-11344</FRDOCBP>
                </SJDENT>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Staff Attendance at North American Electric Reliability Corp. Standard Drafting Team Meeting, </SJDOC>
                    <PGS>34146-34147</PGS>
                    <FRDOCBP>2023-11297</FRDOCBP>
                </SJDENT>
                <SJ>Onsite Environmental Review:</SJ>
                <SJDENT>
                    <SJDOC>Spire STL Pipeline LLC, </SJDOC>
                    <PGS>34146</PGS>
                    <FRDOCBP>2023-11288</FRDOCBP>
                </SJDENT>
                <SJ>Request under Blanket Authorization:</SJ>
                <SJDENT>
                    <SJDOC>MountainWest Overthrust Pipeline, LLC, </SJDOC>
                    <PGS>34144-34146</PGS>
                    <FRDOCBP>2023-11293</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Natural Gas Pipeline Co. of America, LLC, </SJDOC>
                    <PGS>34148-34149</PGS>
                    <FRDOCBP>2023-11241</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Highway</EAR>
            <HD>Federal Highway Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>State Right-of-Way Manuals, </SJDOC>
                    <PGS>34207-34208</PGS>
                    <FRDOCBP>2023-11319</FRDOCBP>
                </SJDENT>
            </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>34153</PGS>
                    <FRDOCBP>2023-11314</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Fish</EAR>
            <HD>Fish and Wildlife Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Endangered and Threatened Species:</SJ>
                <SJDENT>
                    <SJDOC>Proposed Low-Effect Habitat Conservation Plan for the Sweetwater Authority Habitat Management Program and Habitat Recovery Project, County of San Diego, CA, </SJDOC>
                    <PGS>34176-34178</PGS>
                    <FRDOCBP>2023-11226</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Food and Drug</EAR>
            <HD>Food and Drug Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Guidance:</SJ>
                <SJDENT>
                    <SJDOC>Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products, </SJDOC>
                    <PGS>34163-34164</PGS>
                    <FRDOCBP>2023-11263</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products, </SJDOC>
                    <PGS>34164-34166</PGS>
                    <FRDOCBP>2023-11321</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures, </SJDOC>
                    <PGS>34161-34163</PGS>
                    <FRDOCBP>2023-11260</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Foreign Trade</EAR>
            <HD>Foreign-Trade Zones Board</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Application for Expansion of Subzone:</SJ>
                <SJDENT>
                    <SJDOC>Mercedes-Benz U.S. International, Inc., Foreign-Trade Zone 98, Moundville, Vance and Woodstock, AL, </SJDOC>
                    <PGS>34127-34128</PGS>
                    <FRDOCBP>2023-11259</FRDOCBP>
                </SJDENT>
                <SJ>Approval of Expansion of Subzone:</SJ>
                <SJDENT>
                    <SJDOC>Nissan North America, Inc., Subzone 78A, Smyrna, TN, </SJDOC>
                    <PGS>34128</PGS>
                    <FRDOCBP>2023-11257</FRDOCBP>
                </SJDENT>
                <SJ>Reorganization under Alternative Site Framework:</SJ>
                <SJDENT>
                    <SJDOC>Foreign-Trade Zone 28, New Bedford, MA, </SJDOC>
                    <PGS>34128</PGS>
                    <FRDOCBP>2023-11258</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Forest</EAR>
            <HD>Forest Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Record of Decision:</SJ>
                <SJDENT>
                    <SJDOC>Sequoia and Sierra National Forests, </SJDOC>
                    <PGS>34126</PGS>
                    <FRDOCBP>2023-11347</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>General Services</EAR>
            <HD>General Services Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Acquisition Regulation:</SJ>
                <SJDENT>
                    <SJDOC>Personal Identity Verification Requirements Clause Reference; Correcting Amendment, </SJDOC>
                    <PGS>34096</PGS>
                    <FRDOCBP>2023-11249</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Environmental Impact Statements; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>New Federal Courthouse in Hartford, CT, </SJDOC>
                    <PGS>34153-34154</PGS>
                    <FRDOCBP>2023-11267</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 Disease Control and Prevention</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Centers for Medicare &amp; Medicaid Services</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Children and Families Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Food and Drug Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Institutes of Health</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Presidential Advisory Council on HIV/AIDS, </SJDOC>
                    <PGS>34166</PGS>
                    <FRDOCBP>2023-11250</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Homeland</EAR>
            <HD>Homeland Security Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Coast Guard</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Emergency Management Agency</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>Ocean Energy Management Bureau</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>International Trade Adm</EAR>
            <HD>International Trade Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Antidumping or Countervailing Duty Investigations, Orders, or Reviews:</SJ>
                <SJDENT>
                    <SJDOC>Stainless Steel Wire Rod from the Republic of Korea, </SJDOC>
                    <PGS>34128-34129</PGS>
                    <FRDOCBP>2023-11312</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Steel Concrete Reinforcing Bar from the Republic of Turkey, </SJDOC>
                    <PGS>34129-34131</PGS>
                    <FRDOCBP>2023-11311</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>International Trade Com</EAR>
            <HD>International Trade Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>34184-34185</PGS>
                    <FRDOCBP>2023-11360</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Justice Department</EAR>
            <HD>Justice Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Parole Commission</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Application for Registration and Application for Registration Renewal, </SJDOC>
                    <PGS>34185-34186</PGS>
                    <FRDOCBP>2023-11329</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Firearms Transaction Record/Registro de Transaccion de Armas de Fuego, </SJDOC>
                    <PGS>34185</PGS>
                    <FRDOCBP>2023-10421</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Labor Department</EAR>
            <HD>Labor Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Occupational Safety and Health Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Land</EAR>
            <HD>Land Management Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Environmental Impact Statements; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Proposed Greenlink North Project in White Pine, Eureka, Lander, Churchill, and Lyon Counties, NV, </SJDOC>
                    <PGS>34178-34180</PGS>
                    <FRDOCBP>2023-11070</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <PRTPAGE P="v"/>
                    <SJDOC>Resource Management Plan Amendments for the Greenlink West Project in Clark, Esmeralda, Lyon, Mineral, Nye, Storey, and Washoe Counties, NV, </SJDOC>
                    <PGS>34180-34182</PGS>
                    <FRDOCBP>2023-11102</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Maritime</EAR>
            <HD>Maritime Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel:</SJ>
                <SJDENT>
                    <SJDOC>Allora (Sail), </SJDOC>
                    <PGS>34212-34213</PGS>
                    <FRDOCBP>2023-11271</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Baby Bear (Motor), </SJDOC>
                    <PGS>34209-34210</PGS>
                    <FRDOCBP>2023-11272</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Batman (Motor), </SJDOC>
                    <PGS>34216</PGS>
                    <FRDOCBP>2023-11273</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Camelot (Motor), </SJDOC>
                    <PGS>34217</PGS>
                    <FRDOCBP>2023-11274</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Deep Plane (Motor), </SJDOC>
                    <PGS>34208-34209</PGS>
                    <FRDOCBP>2023-11275</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Dream On (Motor), </SJDOC>
                    <PGS>34219-34220</PGS>
                    <FRDOCBP>2023-11276</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Grandiego (Motor), </SJDOC>
                    <PGS>34211-34212</PGS>
                    <FRDOCBP>2023-11277</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Hummingbird (Motor), </SJDOC>
                    <PGS>34214-34215</PGS>
                    <FRDOCBP>2023-11278</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Jah Reel (Motor), </SJDOC>
                    <PGS>34210-34211</PGS>
                    <FRDOCBP>2023-11279</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Kanina (Sail), </SJDOC>
                    <PGS>34223-34224</PGS>
                    <FRDOCBP>2023-11280</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Landy Leenie II (Motor), </SJDOC>
                    <PGS>34220-34221</PGS>
                    <FRDOCBP>2023-11281</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Luna Blu (Motor), </SJDOC>
                    <PGS>34215-34216</PGS>
                    <FRDOCBP>2023-11283</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Pacific Bear (Motor), </SJDOC>
                    <PGS>34224-34225</PGS>
                    <FRDOCBP>2023-11284</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Runnamuck V (Motor), </SJDOC>
                    <PGS>34213-34214</PGS>
                    <FRDOCBP>2023-11286</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>The Lily Pads (Motor), </SJDOC>
                    <PGS>34217-34218</PGS>
                    <FRDOCBP>2023-11282</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>The Rowan (Motor), </SJDOC>
                    <PGS>34218-34219</PGS>
                    <FRDOCBP>2023-11285</FRDOCBP>
                </SJDENT>
                <SJ>Request for Applications:</SJ>
                <SJDENT>
                    <SJDOC>Award of Two Maritime Security Program Operating Agreements, </SJDOC>
                    <PGS>34221-34223</PGS>
                    <FRDOCBP>2023-11287</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>NASA</EAR>
            <HD>National Aeronautics and Space Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Grant Application Demographic Data, </SJDOC>
                    <PGS>34191</PGS>
                    <FRDOCBP>2023-11323</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Improving Customer Experience, </SJDOC>
                    <PGS>34190-34191</PGS>
                    <FRDOCBP>2023-11324</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Safety and Health Measures and Mishap Reporting, </SJDOC>
                    <PGS>34191-34192</PGS>
                    <FRDOCBP>2023-11328</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Highway</EAR>
            <HD>National Highway Traffic Safety Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>New Car Assessment Program, </DOC>
                    <PGS>34366-34410</PGS>
                    <FRDOCBP>2023-11201</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Institute</EAR>
            <HD>National Institutes of Health</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Chimpanzee Research Use Form Office of the Director, </SJDOC>
                    <PGS>34167</PGS>
                    <FRDOCBP>2023-11322</FRDOCBP>
                </SJDENT>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Center for Scientific Review, </SJDOC>
                    <PGS>34169</PGS>
                    <FRDOCBP>2023-11334</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Interagency Pain Research Coordinating Committee, </SJDOC>
                    <PGS>34166</PGS>
                    <FRDOCBP>2023-11230</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Center for Advancing Translational Sciences, </SJDOC>
                    <PGS>34167-34168</PGS>
                    <FRDOCBP>2023-11229</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of Allergy and Infectious Diseases, </SJDOC>
                    <PGS>34168</PGS>
                    <FRDOCBP>2023-11228</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of Diabetes and Digestive and Kidney Diseases, </SJDOC>
                    <PGS>34168, 34170</PGS>
                    <FRDOCBP>2023-11332</FRDOCBP>
                      
                    <FRDOCBP>2023-11333</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of General Medical Sciences, </SJDOC>
                    <PGS>34170</PGS>
                    <FRDOCBP>2023-11331</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of Neurological Disorders and Stroke, </SJDOC>
                    <PGS>34170-34171</PGS>
                    <FRDOCBP>2023-11227</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute on Aging, </SJDOC>
                    <PGS>34168</PGS>
                    <FRDOCBP>2023-11339</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute on Drug Abuse, </SJDOC>
                    <PGS>34170</PGS>
                    <FRDOCBP>2023-11231</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Oceanic</EAR>
            <HD>National Oceanic and Atmospheric Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Advisory Committee Open Session on Management Strategy Evaluation for North Atlantic Swordfish, </SJDOC>
                    <PGS>34134-34135</PGS>
                    <FRDOCBP>2023-11236</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>New England Fishery Management Council, </SJDOC>
                    <PGS>34133-34136</PGS>
                    <FRDOCBP>2023-11336</FRDOCBP>
                      
                    <FRDOCBP>2023-11337</FRDOCBP>
                      
                    <FRDOCBP>2023-11338</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Pacific Fishery Management Council, </SJDOC>
                    <PGS>34136</PGS>
                    <FRDOCBP>2023-11335</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Pacific Fishery Management Council; Correction, </SJDOC>
                    <PGS>34135</PGS>
                    <FRDOCBP>2023-11251</FRDOCBP>
                </SJDENT>
                <SJ>Permits; Applications, Issuances, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Atlantic Coastal Fisheries Cooperative Management Act Provisions; General Provisions for Domestic Fisheries, </SJDOC>
                    <PGS>34132-34133</PGS>
                    <FRDOCBP>2023-11235</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Pacific Island Fisheries; Marine Conservation Plan for Pacific Insular Areas other than American Samoa, Guam, and the Northern Mariana Islands; Western Pacific Sustainable Fisheries Fund, </SJDOC>
                    <PGS>34131-34132</PGS>
                    <FRDOCBP>2023-11232</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Nuclear Regulatory</EAR>
            <HD>Nuclear Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>34192-34193</PGS>
                    <FRDOCBP>2023-11374</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Occupational Safety Health Adm</EAR>
            <HD>Occupational Safety and Health Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>The Construction Fall Protection Systems Criteria, Practices, and Training Requirements Standard, </SJDOC>
                    <PGS>34186-34188</PGS>
                    <FRDOCBP>2023-11253</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>The Standard on Presence Sensing Device Initiation, </SJDOC>
                    <PGS>34188-34190</PGS>
                    <FRDOCBP>2023-11254</FRDOCBP>
                </SJDENT>
                <SJ>Membership Appointments:</SJ>
                <SJDENT>
                    <SJDOC>Advisory Committee on Construction Safety and Health, </SJDOC>
                    <PGS>34188</PGS>
                    <FRDOCBP>2023-11248</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Ocean Energy Management</EAR>
            <HD>Ocean Energy Management Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Negotiated Noncompetitive Agreement for the Use of Sand, Gravel, and Shell Resources on the Outer Continental Shelf, </SJDOC>
                    <PGS>34182-34184</PGS>
                    <FRDOCBP>2023-11308</FRDOCBP>
                </SJDENT>
                <SJ>Environmental Impact Statements; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Ocean Wind LLC's Proposed Wind Energy Facility Offshore New Jersey, </SJDOC>
                    <PGS>34184</PGS>
                    <FRDOCBP>2023-10890</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Parole</EAR>
            <HD>Parole Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>34186</PGS>
                    <FRDOCBP>2023-11381</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Patent</EAR>
            <HD>Patent and Trademark Office</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Adoption of Updated World Intellectual Property Organization Standard; Revision to Incorporation by Reference, </DOC>
                    <PGS>34089-34091</PGS>
                    <FRDOCBP>2023-11365</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Proposed Track Three Pilot Program with a Pre-Examination Search Option, </DOC>
                    <PGS>34136-34139</PGS>
                    <FRDOCBP>2023-11349</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Pipeline</EAR>
            <HD>Pipeline and Hazardous Materials Safety Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Hazardous Materials: Adjusting Registration and Fee Assessment Program, </SJDOC>
                    <PGS>34227-34228</PGS>
                    <FRDOCBP>2023-11298</FRDOCBP>
                </SJDENT>
                <SJ>Permits; Applications, Issuances, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Hazardous Materials, </SJDOC>
                    <PGS>34225-34229</PGS>
                    <FRDOCBP>2023-11300</FRDOCBP>
                      
                    <FRDOCBP>2023-11301</FRDOCBP>
                      
                    <FRDOCBP>2023-11302</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>
                Postal Regulatory
                <PRTPAGE P="vi"/>
            </EAR>
            <HD>Postal Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>New Postal Products, </DOC>
                    <PGS>34193-34194</PGS>
                    <FRDOCBP>2023-11247</FRDOCBP>
                      
                    <FRDOCBP>2023-11304</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Rural Utilities</EAR>
            <HD>Rural Utilities Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Rural eConnectivity (ReConnect) Program, </SJDOC>
                    <PGS>34126-34127</PGS>
                    <FRDOCBP>2023-11310</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Science Technology</EAR>
            <HD>Science and Technology Policy Office</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Request for Information:</SJ>
                <SJDENT>
                    <SJDOC>National Priorities for Artificial Intelligence, </SJDOC>
                    <PGS>34194-34196</PGS>
                    <FRDOCBP>2023-11346</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Securities</EAR>
            <HD>Securities and Exchange Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>34196-34199</PGS>
                    <FRDOCBP>2023-11313</FRDOCBP>
                </DOCENT>
                <SJ>Self-Regulatory Organizations; Proposed Rule Changes:</SJ>
                <SJDENT>
                    <SJDOC>Nasdaq BX, Inc., </SJDOC>
                    <PGS>34201-34203</PGS>
                    <FRDOCBP>2023-11239</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Nasdaq PHLX LLC, </SJDOC>
                    <PGS>34199-34201</PGS>
                    <FRDOCBP>2023-11240</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Selective</EAR>
            <HD>Selective Service System</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>34203</PGS>
                    <FRDOCBP>2023-11320</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Small Business</EAR>
            <HD>Small Business Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Disaster Declaration:</SJ>
                <SJDENT>
                    <SJDOC>Soboba Band of Luiseno Indians, </SJDOC>
                    <PGS>34203-34204</PGS>
                    <FRDOCBP>2023-11244</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>State Department</EAR>
            <HD>State Department</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Schedule of Fees for Consular Services—Nonimmigrant and Special Visa Fees:</SJ>
                <SJDENT>
                    <SJDOC>Delay of effective date, </SJDOC>
                    <PGS>34084</PGS>
                    <FRDOCBP>2023-11420</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Shipping Coordinating Committee, Preparation for International Maritime Organization Marine Environment Protection Committee 80 Meeting, </SJDOC>
                    <PGS>34204</PGS>
                    <FRDOCBP>2023-11325</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Surface Transportation</EAR>
            <HD>Surface Transportation Board</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Exemption:</SJ>
                <SJDENT>
                    <SJDOC>Change in Operator; Bogalusa and Northern Railway, LLC, Bogalusa Bayou Railroad, LLC, </SJDOC>
                    <PGS>34205</PGS>
                    <FRDOCBP>2023-11223</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Continuance in Control; Rio Grande Pacific Corp., Bogalusa and Northern Railway, LLC, </SJDOC>
                    <PGS>34204-34205</PGS>
                    <FRDOCBP>2023-11224</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Lease and Operation; Chesapeake and Indiana Railroad Co,, LLC, Northern Indiana Railroad Co., LLC, </SJDOC>
                    <PGS>34205-34206</PGS>
                    <FRDOCBP>2023-11342</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>Maritime Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Highway Traffic Safety Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Pipeline and Hazardous Materials Safety Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Treasury</EAR>
            <HD>Treasury Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>34229-34233</PGS>
                    <FRDOCBP>2023-11330</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>U.S. Sentencing</EAR>
            <HD>United States Sentencing Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Request for Applications:</SJ>
                <SJDENT>
                    <SJDOC>Tribal Issues Advisory Group, </SJDOC>
                    <PGS>34233-34234</PGS>
                    <FRDOCBP>2023-11307</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Veteran Affairs</EAR>
            <HD>Veterans Affairs Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Annual Pay Ranges for Physicians, Dentists, and Podiatrists, </DOC>
                    <PGS>34234-34235</PGS>
                    <FRDOCBP>2023-11306</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>34238-34296</PGS>
                <FRDOCBP>2023-10934</FRDOCBP>
            </DOCENT>
            <HD>Part III</HD>
            <DOCENT>
                <DOC>Energy Department, </DOC>
                <PGS>34298-34364</PGS>
                <FRDOCBP>2023-10287</FRDOCBP>
            </DOCENT>
            <HD>Part IV</HD>
            <DOCENT>
                <DOC>Transportation Department, National Highway Traffic Safety Administration, </DOC>
                <PGS>34366-34410</PGS>
                <FRDOCBP>2023-11201</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>88</VOL>
    <NO>102</NO>
    <DATE>Friday, May 26, 2023</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <RULES>
        <RULE>
            <PREAMB>
                <PRTPAGE P="34065"/>
                <AGENCY TYPE="F">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2022-1647; Project Identifier AD-2022-01379-T; Amendment 39-22438; AD 2023-10-02]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Transport and Commuter Category Airplanes</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>The FAA is superseding Airworthiness Directive (AD) 2021-23-12, which applied to all transport and commuter category airplanes equipped with a radio (also known as radar) altimeter. AD 2021-23-12 required revising the limitations section of the existing airplane/aircraft flight manual (AFM) to incorporate limitations prohibiting certain operations requiring radio altimeter data when in the presence of 5G C-Band interference as identified by Notices to Air Missions (NOTAMs). Since the FAA issued AD 2021-23-12, the FAA determined that additional limitations are needed due to the continued deployment of new 5G C-Band stations whose signals are expected to cover most of the contiguous United States at transmission frequencies between 3.7-3.98 GHz. For certain airplanes, this AD requires revising the limitations section of the existing AFM to incorporate limitations prohibiting certain operations requiring radio altimeter data, due to the presence of 5G C-Band interference. This AD also requires modifying certain airplanes to allow safe operations in the U.S. 5G C-Band radio frequency environment. The FAA is issuing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This AD is effective May 26, 2023.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        <E T="03">AD Docket:</E>
                         You may examine the AD docket at 
                        <E T="03">regulations.gov</E>
                         under Docket No. FAA-2022-1647; 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 final rule, any comments received, and other information. The address for Docket Operations is 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>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Brett Portwood, Continued Operational Safety Technical Advisor, COS Program Management Section, Operational Safety Branch, FAA, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 817-222-5390; email: 
                        <E T="03">operationalsafety@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2021-23-12, Amendment 39-21810 (86 FR 69984, December 9, 2021) (AD 2021-23-12). AD 2021-23-12 applied to all transport and commuter category airplanes equipped with a radio (also known as radar) altimeter. The NPRM published in the 
                    <E T="04">Federal Register</E>
                     on January 11, 2023 (88 FR 1520). The NPRM was prompted by the determination that radio altimeters cannot be relied upon to perform their intended function if they experience 5G C-Band interference.
                </P>
                <P>In the NPRM, the FAA proposed to maintain the requirements of AD 2021-23-12, except for the limitations pertaining to Required Navigation Performance with Authorization Required (RNP AR) instrument approach procedures (IAPs), by requiring revising the existing AFM to incorporate limitations prohibiting certain operations in the presence of 5G C-Band wireless broadband interference as identified by NOTAM. Alternatively, the FAA proposed to allow operators to retain the AFM revision required by paragraph (g) of AD 2021-23-12. The FAA also proposed, on or before June 30, 2023, to require revising the existing AFM to incorporate limitations prohibiting these same operations at all airports for non-radio altimeter tolerant airplanes. For radio altimeter tolerant airplanes, the prohibited operations would be allowed at 5G C-Band mitigated airports (5G CMAs) as identified in an FAA Domestic Notice.</P>
                <P>
                    Lastly, the FAA proposed, on or before February 1, 2024, to require that airplanes operating under 14 CFR part 121 be modified from a non-radio altimeter tolerant airplane to a radio altimeter tolerant airplane. The FAA proposed this AD because radio altimeter anomalies that are undetected by the automation or pilot, particularly close to the ground (
                    <E T="03">e.g.,</E>
                     landing flare), could lead to loss of continued safe flight and landing. Additionally, radio altimeter anomalies could lead to increased flightcrew workload and flightcrew desensitization to warnings.
                </P>
                <HD SOURCE="HD1">Discussion of Final Airworthiness Directive</HD>
                <HD SOURCE="HD1">Comments</HD>
                <P>The FAA provided the public with an opportunity to comment on the proposed AD and received 82 submissions to Docket No. FAA-2022-1647. The FAA received comments from individual commenters as well as from organizations. The majority of the comments were from organizations such as the International Air Transport Association (IATA), Airlines for America (A4A), the Cargo Airline Association, the Aerospace Industries Association (AIA), the Air Line Pilots Association, International (ALPA), the Allied Pilots Association, the Regional Airline Association (RAA), CTIA-The Wireless Association (CTIA), and the American Association of Airport Executives (AAAE); manufacturers such as Airbus DS (Airbus Defence and Space), Airbus SAS (Airbus), The Boeing Company (Boeing), MHI RJ Aviation ULC (MHI RJ), Gulfstream Aerospace Corporation (Gulfstream), Bombardier Inc. (Bombardier), Textron Aviation (Textron), and Thales; and operators such as Atlas Air, Inc. (Atlas), Frontier Airlines (Frontier), Southwest Airlines, and Virgin Atlantic Airways.</P>
                <P>The following summarizes the comments received on the NPRM, and provides the FAA's responses.</P>
                <HD SOURCE="HD2">A. Support for the NPRM</HD>
                <P>
                    CTIA supported the NPRM without change.
                    <PRTPAGE P="34066"/>
                </P>
                <HD SOURCE="HD2">B. Alternative Methods of Compliance (AMOCs)</HD>
                <HD SOURCE="HD3">1. Request for Continued NOTAMs and AMOCs</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Some commenters asked if the FAA will continue approving AMOCs for radio altimeter tolerant airplanes at non-5G CMAs consistent with the process used for AD 2021-23-12. Airbus Defence and Space asked whether the FAA will still allow AMOCs between July 1, 2023, and January 31, 2024. One commenter asked whether the FAA will take into account the availability of a certified solution before ceasing to process new AMOCs and, if not, when will FAA stop processing AMOCs for non-radio altimeter tolerant airplanes. Other commenters requested that the FAA continue to use NOTAMs and AMOCs until relevant airplanes are retrofitted. Airbus asked when the FAA will stop issuing NOTAMs for identification of the 5G environment.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     Since the publication of the NPRM, the FAA has conducted further analysis of possible 5G C-Band interference to radio altimeter tolerant airplanes at non-5G CMAs and has determined that the risks associated with category (CAT) I autoland, CAT I head-up display (HUD) to touchdown, and enhanced flight vision system (EFVS) to touchdown operations, are mitigated to an acceptable level. The FAA found a lower-than-expected likelihood of interference because of current tower locations, a high percentage of flat terrain around airports, and the expectation that future tower locations will impose no additional interference than current towers do. Risks associated with CAT II/III, SA CAT I, and SA CAT II have been mitigated at non-5G CMAs because all current CAT II/III and SA CAT I/II operations are only at 5G CMAs.
                    <SU>1</SU>
                    <FTREF/>
                     Therefore, the FAA has determined that radio altimeter tolerant airplanes may conduct these operations to all airports in the contiguous U.S. without limitation.
                    <SU>2</SU>
                    <FTREF/>
                     As a result, there is no need to use a domestic notice to identify specific airports where radio altimeter tolerant airplanes can perform these procedures. The FAA has removed the references to 5G CMAs and Domestic Notices from the regulatory requirements of this final rule.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Locations of 5G CMAs can be found on the FCC's website at: 
                        <E T="03">https://www.fcc.gov/ecfs/search/search-filings/filing/1033142661477.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         This determination applies only to the unsafe condition identified in this AD, and not to the model-specific unsafe conditions addressed in AD 2022-02-16, AD 2022-03-05, AD 2022-03-20, AD 2022-04-05, AD 2022-05-04, AD 2022-06-16, AD 2022-09-18, AD 2023-03-06, and AD 2023-06-13. Copies of those ADs may be found on the FAA's Dynamic Regulatory System website at 
                        <E T="03">www.drs.faa.gov.</E>
                    </P>
                </FTNT>
                <P>NOTAMs identifying the 5G environment are no longer practical because the environment is expected to cover most of the contiguous U.S. In addition, limitations required by this AD apply to non-radio altimeter tolerant airplanes at all airports in the contiguous U.S. For those airplanes, the FAA has determined that the AMOC process used for AD 2021-23-12, which included generating monthly cleared runway lists based on base station data for non-5G CMAs, will be untenable beyond June 30, 2023, due to complexities associated with the continued operational expansion of 5G C-Band emissions.</P>
                <HD SOURCE="HD3">2. Request for Alternative Mitigation</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Thales requested that the proposed AD be revised to allow for other mitigations at the airplane level, based on airplane-level architecture, including alerts and crew procedures related to radio altimeter NCD (no computed data) or failure. Thales stated that radio altimeter compliance with the tolerances specified in paragraphs (g)(2)(i) and (ii) of the proposed AD is not the only way to prevent the unsafe condition. Additionally, Airbus Defence and Space stated that it expected stronger operations limitations for non-radio altimeter tolerant airplanes, rather than full prohibition of the operations.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     Although the FAA acknowledges that there may be other ways to prevent the unsafe condition, the alternatives proposed by the commenters must be evaluated on a case-by-case basis to determine an acceptable level of safety. Because including such language to address all airplane type designs would not be feasible in this AD, anyone may propose alternative actions to address the unsafe condition under the AMOC procedures referenced in paragraph (k) of this AD.
                </P>
                <HD SOURCE="HD3">3. Request To Clarify Credit for Prior AMOCs</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Bombardier stated that the existing AMOC methodology remains valid, and therefore radio altimeter/airplane configurations that receive approved AMOCs for 5G CMAs in June 2023 would meet the definition of radio altimeter tolerant airplanes. Bombardier requested that the FAA clarify whether an FAA-approved AMOC for AD 2021-23-12 is a “method approved by the FAA” for demonstrating that an airplane is a radio altimeter tolerant airplane for purposes of the AFM limitations that would otherwise be required by paragraph (i) of the proposed AD.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     In the NPRM, the FAA proposed that AMOCs approved for AD 2021-23-12 would only be approved for the AFM revision in paragraph (h) of the proposed AD. The FAA approved AMOCs for AD 2021-23-12 before the radio altimeter tolerant PSD (power spectral density) curve proposed in the NPRM was defined. Although the FAA expects that the airplanes with AMOCs approved for AD 2021-23-12 will be able to meet the definition of “radio altimeter tolerant airplane,” operators will need to provide the FAA with data showing explicitly that the airplane meets the tolerances in paragraph (g)(2) before the FAA will approve the method they propose to use.
                </P>
                <HD SOURCE="HD2">C. AFM Limitations</HD>
                <HD SOURCE="HD3">1. Request To Change AFM Limitations</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Frontier requested that the AD include language allowing operators to omit any portion of the radio altimeter flight restrictions that is not applicable to the operator, such as HUD and EFVS. Frontier stated that this would eliminate confusion when the specified equipment is not installed in the airplane or the operator is not authorized to utilize the equipment.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA disagrees, as operators may change or add equipment and approvals at a future time. If an airplane is not equipped or approved for an approach, then the operational restrictions would still broadly apply, but would have no impact to the operator.
                </P>
                <HD SOURCE="HD3">2. AFM Limitations Inappropriate for General Operational Restrictions</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     MHI RJ and Air Wisconsin Airlines stated that the AFM limitations section was not the appropriate area to document operational restrictions not related to a specific airplane. An individual commenter suggested that the proposed AFM revision does not follow “FAA AFM criteria.” Gulfstream stated that the proposed requirement to revise the AFM with limitations places an unnecessary burden on original equipment manufacturers (OEMs). Gulfstream requested that instead the FAA require that operators obtain Letters of Authorization or operations specifications.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA disagrees. 14 CFR 91.9 prohibits any person from operating a civil aircraft without complying with the operating limitations specified in the AFM. The FAA routinely issues ADs to mandate 
                    <PRTPAGE P="34067"/>
                    changes to the limitations section of an FAA-approved AFM for airplanes in service.
                </P>
                <HD SOURCE="HD3">3. Requests for Different Method of Incorporating AFM Limitations</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Bombardier and Gulfstream requested the FAA allow other options for incorporating the proposed limitations into the AFM, due to the complexity of updating entire catalogs of flight manual documentation and authoring, approving, and publishing customized limitations based on the unique configuration and characteristics of each airplane model. Specifically, Bombardier requested that the AD include language to automatically delegate approval of AFM changes to civil aviation authorities; automatically recognize AFM changes that have been approved by Transport Canada Civil Aviation Authority for Bombardier airplane models; and state that airplanes with specific AFM revisions meet the intent of the proposed AD. Lastly, Bombardier requested that the proposed AD allow compliance by either incorporating or referencing an electronic or paper copy of the AD, since Bombardier plans on making an electronic copy of the FAA AD available through the Bombardier flight deck application's supplemental documents function.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA acknowledges that each owner/operator may have a different method for incorporating revisions into the AFM for its airplanes. This is why the FAA did not propose a specific method of complying with this requirement. As long as the language added to the limitations section of the AFM is identical to the language specified in the applicable figure, owners/operators may make the revision electronically, with pen-and-ink changes, by inserting a copy of the AD, by inserting a copy of the applicable figure, by adopting the OEM's AFM revision, or by any other method. To provide clarification, the FAA has changed paragraphs (h), (i)(1), and (j)(1) of this AD to require including “the information” specified in the figure instead of “the limitations” specified in the figure. With regard to Bombardier's request that the proposed AD be revised to state that Bombardier airplanes meet the intent of paragraph (h) of this AD if they have incorporated certain AFM revisions, the FAA disagrees. Although the requested changes to the proposed AD may minimize some requests for AMOC approvals, including language specific to all possible current and future state-of-design 5G C-Band-related ADs, is out of the scope of the intent of this AD.
                </P>
                <P>
                    <E T="03">Comment summary:</E>
                     In order to minimize unnecessary revisions to the AFM language in the future, Bombardier asked the FAA to clarify why the flight restrictions in the figures required by June 30, 2023, are limited to the contiguous U.S. airspace and whether the situation will evolve as various telecommunications companies deploy 5G services in the C-Band outside the contiguous U.S.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA limited the flight restrictions in the proposed figures to the contiguous U.S. based on Federal Communications Commission (FCC) Report and Order FCC 20-22,
                    <SU>3</SU>
                    <FTREF/>
                     which identifies radio frequencies and power level conditions for the new C-Band services only in the contiguous lower-48 states. In the event the FCC updates the report and order to include additional states and U.S. territories, the FAA might consider future rulemaking.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         FCC Report and Order (R&amp;O) FCC 20-22 in the Matter of Expanding Flexible Use of the 3.7-4.2 GHz Band, adopted February 28, 2020, and released March 3, 2020. This document is available in Docket No. FAA-2022-1647, and at 
                        <E T="03">https://www.fcc.gov/document/fcc-expands-flexible-use-cband-5g-0.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD2">D. Effect of Winglets on Accomplishment of the Proposed Actions</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Aviation Partners Boeing stated that installing winglets under supplemental type certificate (STC) ST00830SE, STC ST01219SE, STC ST01518SE, and STC ST01920SE on applicable Boeing models does not affect accomplishment of the actions specified in the proposed AD.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA agrees. The FAA has not changed this AD in this regard.
                </P>
                <HD SOURCE="HD2">E. Clarifications</HD>
                <HD SOURCE="HD3">1. Request To Clarify Terminology</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     In the NPRM preamble, the FAA explained that if the unsafe condition is not addressed, it may result in a catastrophic accident, incident, or event. Airbus stated that because “catastrophic” is part of the analysis conducted under 14 CFR 25.1309, the FAA's use of it in the NPRM could be misleading. Textron requested that the FAA add language to the unsafe condition statement in paragraph (e) of the proposed AD to clarify the severity of possible failure conditions (catastrophic, hazardous) associated with 5G C-Band interference.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA used the term “catastrophic” in the preamble of the NPRM to indicate an event that would result in multiple fatalities, usually with loss of the airplane. The unsafe condition statement in paragraph (e) of this AD, which states that radio altimeter anomalies could result in loss of continued safe flight and landing or increased flightcrew workload and desensitization to warnings, is sufficiently clear. No change to this AD is necessary based on these comments.
                </P>
                <HD SOURCE="HD3">2. Request To Clarify Relaxation on Non-Precision Approaches (NPAs) to Certain Airports</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Qatar Airways referenced the statement in the NPRM that the proposed AD would no longer prohibit RNP AR IAPs and asked whether the FAA was relaxing NPAs for non-radio altimeter-tolerant airplanes other than RNP AR operations to airports with potential 5G C-Band interference.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     NPAs were not included in the list of prohibited operations in AD 2021-23-12, since an NPA is an instrument approach that provides lateral guidance only, and does not rely on radio altimeter inputs. Therefore, this AD does not address NPAs.
                </P>
                <HD SOURCE="HD3">3. Request To Clarify Whether Compliance With AD 2021-23-12 Satisfies AFM Revision Requirement</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Qatar Airways asked the FAA to clarify the statement in paragraph (h) of the proposed AD that “If an operator has complied with paragraph (g) of AD 2021-23-12, that action satisfies the requirements of this paragraph.” The commenter noted that RNP AR IAPs are included in the list of prohibited operations in paragraph (g) of AD 2021-23-12; however, the NPRM states that, after further FAA analysis, those operations would no longer be prohibited by the proposed AD.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The commenter is correct that the prohibition in paragraph (g) of AD 2021-23-12 includes RNP AR approaches, and the prohibition in paragraph (h) of this AD does not. However, since all of the requirements of paragraph (h) of this AD are included in paragraph (g) of AD 2021-23-12, operators have the option of retaining the AFM revision required AD 2021-23-12 instead of revising the AFM again to comply with paragraph (h) of this AD even though it prohibits RNP AR approaches that are not required by this AD. No change to this AD is necessary based on this comment.
                </P>
                <HD SOURCE="HD3">4. Request To Clarify Limitations for Tolerant and Non-Tolerant Airplanes</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Singapore Airlines, Airbus Defence and Space, Airbus, Qatar Airways, AIA, AFR, and Air France requested clarification of the limitations for radio altimeter tolerant 
                    <PRTPAGE P="34068"/>
                    airplanes and non-radio altimeter tolerant airplanes, as related to 5G CMAs and non-5G CMAs. Airbus also requested clarification regarding retrofitting with a 5G tolerant radio altimeter and the effect of a future technical standard order (TSO).
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     In the NPRM, the FAA proposed that radio altimeter tolerant airplanes could perform the otherwise prohibited operations at 5G CMAs, while non-radio altimeter tolerant airplanes would be prohibited from performing those operations at all airports. As explained in section B.1. of this final rule, since the NPRM was published, the FAA has determined that radio altimeter tolerant airplanes may perform the prohibited operations at all airports in the contiguous U.S., as long as the telecommunications companies continue to transmit within mitigated parameters.
                    <SU>4</SU>
                    <FTREF/>
                     As a result, the FAA has removed paragraph (j) of the proposed AD from this final rule. The FAA's determination that non-radio altimeter tolerant airplanes will not be able to safely perform the four prohibited operations at any airport remains unchanged.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         A copy of the letter from AT&amp;T, Verizon, T-Mobile, and UScellular dated March 31, 2023, documenting their voluntary commitments to transmit within mitigated parameters (hereinafter referred to as “voluntary commitments” or “voluntary agreement letter dated March 31, 2023”) is in Docket No. FAA-2022-1647 and can be found on the FCC's website at: 
                        <E T="03">https://www.fcc.gov/ecfs/search/search-filings/filing/1033142661477.</E>
                    </P>
                </FTNT>
                <P>Some radio altimeters may already demonstrate tolerance to 5G C-Band emissions without modification. Some may need to install filters between the radio altimeter and antenna to increase a radio altimeter's tolerance. For others, the radio altimeter will need to be replaced with an upgraded radio altimeter as established by a new radio altimeter TSO, which will follow the existing international technical consensus on the establishment of the minimum operational performance standards (MOPS). The FAA considers this AD an interim action because additional rulemaking may be necessary once a new radio altimeter TSO is developed, approved, and available.</P>
                <HD SOURCE="HD3">5. Request To Clarify Multiple AFM Limitations</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Textron asked the FAA to clarify the relationship between the AFM limitation requirements in paragraphs (h) and (i) of the proposed AD.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     As explained in section B.1. of this final rule, since the NPRM was published, the FAA has determined that radio altimeter tolerant airplanes may perform the prohibited operations at all airports in the contiguous U.S. As a result, the FAA has revised this AD so that all of the AFM revisions are required only for non-radio altimeter tolerant airplanes. Those airplanes must incorporate either the limitations in paragraph (h) of this AD or paragraph (g) of AD 2021-23-12 until June 30, 2023. After June 30, 2023, non-radio altimeter tolerant airplanes must replace those limitations with the limitations in paragraph (i) of this AD. For operators of radio altimeter tolerant airplanes, this AD terminates the AFM limitations required by AD 2021-23-12.
                </P>
                <HD SOURCE="HD3">6. Request To Clarify Applicability for Military Airplanes</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     The Department of Defense requested that the FAA revise the NPRM to clarify that military aircraft, including civil derivatives, are exempt. The commenter stated that the NPRM's reference to part 121 operations creates confusion as to whether the AD applies to civil derivative airplanes operated by the Department of Defense.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA disagrees. This AD applies to all airplanes with an FAA type certificate in the transport or commuter category, including military surplus airplanes and civil derivatives of military airplanes. To the extent that the AFM revisions required by this AD impose operational restrictions that apply only to civil aircraft, those restrictions do apply to Department of Defense airplanes used in civil operations in the national airspace system.
                </P>
                <HD SOURCE="HD3">7. Factors Affecting Accomplishment of Required Actions</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     AIA requested that the NPRM preamble be revised to acknowledge that quickly accomplishing alterations depends on many factors, including adequate specification of the replacement equipment and availability of updated equipment.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA acknowledges that factors including those cited by the commenter impact the ability to accomplish the modification of the radio altimeters as required by this AD. Since the language from the NRPM that the commenter cited does not appear in this final rule, no change to the AD is necessary.
                </P>
                <HD SOURCE="HD2">F. 5G CMAs</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     The FAA received many comments concerning the airports that will be included as a 5G CMA. All Nippon Airways requested the FAA establish a system that allows radio altimeter tolerant airplanes to operate at all U.S. airports without restrictions. MHI RJ, Thales, Airbus, Qatar Airlines, Japan Airlines, ALPA, and two individual commenters asked for information about the list of 5G CMAs. Aerologic, Emirates Airline, Atlas, the Department of Defense, and the Cargo Airline Association requested the FAA expand the list to include as many airports as possible. Multiple commenters, including A4A, Boeing, Airbus, AIA, ALPA, RAA, and the Cargo Airline Association, requested clarification of the criteria used to determine the 5G CMAs. Thales, Airbus, Allied Pilots Association, AIA, ALPA, Gulfstream, and AAAE requested guidance for safe aviation operations at non-5G CMAs.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     As mentioned in section B.1. of this final rule, since the NPRM was published, the FAA conducted further analysis of possible 5G C-Band interference with radio altimeter tolerant airplanes and determined that radio altimeter tolerant airplanes are not susceptible to the 5G C-Band interference this AD is addressing. Therefore, this AD will not require operators of radio altimeter tolerant airplanes to revise their AFM to prohibit the low-visibility operations proposed in the NPRM. The FAA has revised this final rule accordingly.
                </P>
                <HD SOURCE="HD2">G. Compliance Time</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     While CTIA agreed with the FAA's proposed compliance times, China Airlines, SkyWest Airlines, Embraer S.A., Airbus Defence and Space, the Association of Asia Pacific Airlines, Qatar Airways, Endeavor Air, Virgin Atlantic Airways, Atlas Air, ATR, Gulf Air Group, the Cargo Airline Association, Air Wisconsin Airlines, Lynden Air Cargo, EVA Airways, AAAE, A4A, RAA, and an individual commenter expressed concern, with many stating that modification of the fleet would not be achievable by June 30, 2023, or by February 1, 2024. The commenters requested extensions ranging from three months to two years, based on the size of each operator's fleet and availability of parts.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA carefully considered the impact of the loss of low-visibility operations on the remaining unmodified fleet after June 30, 2023, and did not take the decision to prohibit these operations lightly. The June 30, 2023, date was driven by the unsafe condition over which the FAA has no control. After refraining from operating at their FCC-authorized levels for a year and a half, wireless companies are now able to operate at higher levels, yet still not at the levels authorized. 
                    <PRTPAGE P="34069"/>
                    Specifically, wireless companies expect to operate their networks in urban areas with minimal restrictions due to the completion of retrofits.
                    <SU>5</SU>
                    <FTREF/>
                     Additionally, the FAA anticipates 19 additional telecommunication companies will begin transmitting in the C-Band after June 30, 2023. Although the FAA continues to work with the companies that intend to transmit in the 3.7-3.98-GHz band near 5G CMAs, the FAA has no agreement with those companies to provide the FAA with tower locations and other information necessary to support the current NOTAM/AMOC process. Therefore, the FAA will not be able to extend the June 30, 2023, date.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         See the FAA website 
                        <E T="03">faa.gov/newsroom/faa-statements-5g.</E>
                    </P>
                </FTNT>
                <P>The FAA re-evaluated the February 1, 2024, date based on the latest radio altimeter equipage data and determined that an extension is not justified. The only airplanes operating under part 121 that are forecast to be at risk of not being equipped by February 1, 2024, are approximately 164 transport category airplanes that have older radio altimeters with no support from the airplane OEMs or radio altimeter manufacturers. Operators of those airplanes will need to make a business decision to equip with later model radio altimeters or retire those airplanes from part 121 operations, as after February 1, 2024, this AD prohibits unmodified airplanes from operating under part 121 in the contiguous U.S. The FAA and its foreign civil aviation authority partners plan to expedite radio altimeter approvals for both part 121 and part 129 operators, and the FAA has used means such as approved model list (AML) STCs to help with equipage.</P>
                <P>In addition, because some airplanes operate under part 121 solely outside of the contiguous U.S. airspace where the AD's requirements do not apply, the FAA has revised figure 4 to paragraph (i) of this AD to include a prohibition that states, “As of February 1, 2024, [non-radio altimeter tolerant airplanes] must not operate under 14 CFR part 121 in the contiguous U.S.” The FAA has also revised paragraph (k) of the NPRM (paragraph (j) of this AD) from a modification requirement to a terminating action for airplanes that have been modified to radio altimeter tolerant airplanes by allowing for the removal of the limitations from the AFM.</P>
                <HD SOURCE="HD2">H. Costs</HD>
                <HD SOURCE="HD3">1. Small Business Status for Business Airplanes</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     One commenter stated that the vast majority of business airplane operators under part 91 are small businesses as defined by the Small Business Administration (SBA). The commenter requested that the FAA not underestimate the choice small businesses will have to make between an $80,000 retrofit and loss of utility of the airplane during adverse weather conditions.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA has complied with the Regulatory Flexibility Act for this AD and analyzed its impact on small businesses. However, the FAA has identified an unsafe condition for which the agency could not identify an appropriate alternative that sufficiently addresses the safety problem. Further information regarding that analysis is provided in section 2. of the Regulatory Flexibility Determination of the preamble of this final rule.
                </P>
                <HD SOURCE="HD3">2. Costs Underestimated for Legacy Airplanes</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Lynden Air Cargo commented that the NPRM underestimates the cost of modification for legacy airplanes that are no longer in the “as-delivered” configuration and therefore lack support from the OEM. The commenter stated there are significant costs associated with the research and development, approval, and type design amendment for new equipment.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA acknowledges that the certification cost is not included in the estimate in this final rule. The FAA appreciates the impact on operators of legacy fleets that do not have the support of the airplane OEM. The FAA has been issuing letters accepting 5G C-Band-resistant test data from the holders of TSO authorizations (TSOAs) in order to assist independent entities in seeking approval in situations like these to mitigate the cost impact. These letters are available through the TSOA holders.
                </P>
                <P>Regarding Lynden Air Cargo's comment on additional significant costs, that comment is addressed in section 2. of the Regulatory Flexibility Determination in the preamble of this AD. The FAA did not change this AD as a result of this comment.</P>
                <HD SOURCE="HD3">3. Request To Include Indirect Costs</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Some commenters requested that FAA include costs associated with development and certification, as well as with operational impacts of the proposed AD such as delayed and canceled flights.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     These comments are addressed in section 2. of the Regulatory Flexibility Determination in the preamble of this AD. The FAA did not change this AD as a result of these comments.
                </P>
                <HD SOURCE="HD3">4. Request To Consider Costs for Non-Part 121 Operations</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Textron commented that the FAA's estimated costs almost exclusively addressed part 121 operations. Textron asked whether airplanes that do not operate under part 121 are affected by the prohibited operations and requested that the FAA include those airplanes in the cost analysis.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     While part 121 operators own most of the affected airplanes and bear the greatest cost associated with this AD, the FAA is aware of the impact on other operators who choose not to modify their airplanes to become radio altimeter tolerant. Regarding Textron's request to include the cost of the impact of restricted operations for those airplanes, that comment is addressed in section 2. of the Regulatory Flexibility Determination in the preamble of this AD. The FAA did not change this AD as a result of these comments.
                </P>
                <HD SOURCE="HD3">5. Work-Hours Underestimated for AFM Updates</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Bombardier and an individual stated that the estimated cost of 1 work-hour per airplane at $85 per hour for revising an AFM was too low.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     These comments are addressed in section 2. of the Regulatory Flexibility Determination in the preamble of this AD. The FAA did not change this AD as a result of these comments.
                </P>
                <HD SOURCE="HD3">6. Cost Impact on Part 129 Operators</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     IATA stated the FAA's cost estimate is vastly understated because it does not include costs for airplanes operating under part 129. Ten other commenters agreed with IATA's comments.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     Although the FAA acknowledges and appreciates the costs of retrofit for part 129 operators, the FAA did not include costs for airplanes operating under part 129 because this AD does not impose any requirements on non-U.S. registered airplanes operating into the United States under part 129. Under International Civil Aviation Organization (ICAO) Annex 8, Airworthiness of Aircraft, the state of registry of an airplane is the state responsible for its airworthiness. For this reason, FAA ADs apply only to U.S.-registered airplanes.
                    <PRTPAGE P="34070"/>
                </P>
                <HD SOURCE="HD3">7. Inquiry Regarding Payment for Additional Upgrades</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Emirates requested that, in the event additional upgrades are needed due to the telecommunications companies not following their voluntary agreements, the telecommunications companies should be responsible for the cost of the upgrades.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA, as a federal agency, is responsible for all directives, policies, and mandates issued under its authority. The FAA does not have the authority to require telecommunications companies to bear costs incurred in modifying privately owned aircraft.
                </P>
                <HD SOURCE="HD3">8. Request To Revise Costs for Filters</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     SkyWest Airlines requested that the FAA re-evaluate the part and labor costs for filter installation.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     This comment is addressed in section 2. of the Regulatory Flexibility Determination in the preamble of this final rule.
                </P>
                <HD SOURCE="HD3">9. Request To Revise Cost Estimate Including Equipment To Meet Tolerant Criteria</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Airbus and the Cargo Airline Association stated the FAA's cost estimate is too low. These commenters requested that the FAA reconsider the cost estimate, including conducting a regulatory evaluation, but did not provide cost data. Bombardier requested that the FAA include a cost estimate for operators who are not required to equip with an updated radio altimeter but chose to voluntarily do so.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA's cost evaluation reflects both a cost per product and an estimated fleet cost, which the agency based on feedback from airplane manufacturers, radio altimeter manufacturers, and airlines. The FAA did conduct a regulatory evaluation in both the NPRM and this final rule. Further information regarding that analysis is provided in the Regulatory Flexibility Determination section of the preamble of this final rule. As explained in section 2. of the Regulatory Flexibility Determination, based on feedback from other commenters, the FAA has revised some of the cost estimates in this final rule.
                </P>
                <HD SOURCE="HD2">I. Domestic Notice</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Many commenters expressed concern about the use of a Domestic Notice in the proposed AD and the additional burden it would create for operators, as there is no routine subscription and notification process for Domestic Notices (as there is with NOTAMs). British Airways, Qatar Airways, A4A, Boeing, AIA, ALPA, AAAE, and EVA Airways requested guidance on the process and revision cycle for the FAA 5G C-Band Domestic Notice. Qatar Airways and Virgin Atlantic Airways asked how the FAA 5G C-Band Domestic Notice will be disseminated to foreign-registered operators.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     As explained in section B.1. of this final rule, since the NPRM published, the FAA performed additional analysis and determined that radio altimeter tolerant airplanes may conduct operations at all airports in the contiguous U.S. without the limitations imposed by this AD. As a result, there is no need to identify specific airports where the radio altimeter tolerant airplanes may operate. The FAA has removed the references to the FAA 5G C-Band Domestic Notice from the regulatory text of this final rule.
                </P>
                <HD SOURCE="HD2">J. FCC Codification</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Many commenters expressed concern that the FAA does not have authority to enforce the voluntary agreements between the FAA and the telecommunications companies and questioned the possible impacts if those companies stop honoring the agreements or change their position. Airbus and Bombardier requested the FAA provide additional information about the time duration of the agreements. Several of these commenters asked the FAA to verify that the additional 19 telecommunications companies will also voluntarily agree to these mitigations. Several commenters urged the FAA, the FCC, and the National Telecommunications and Information Administration (NTIA) to work together to develop binding long-term agreements. CTIA, however, stated that the voluntary and coordinated approach has proven successful for this issue so far and noted that the wireless industry will continue to engage with the FAA and aviation industry.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The commenters are correct that the agreements between the FAA and the telecommunications companies have been voluntary because the FAA does not have enforcement authority over the companies' use of licenses they receive from the FCC. However, the FAA, NTIA, and FCC have worked extensively and collaboratively with the licensees to ensure that the agreements confirm necessary notification and coordination, that mitigations are in place with network deployments, and that the agreements are enforceable by the FCC. These March 31, 2023, voluntary agreements allow the FAA to continue to address aviation safety by coordinating 5G C-Band effective isotropic radiated power (EIRP) reductions when analysis indicates that a proposed base station will exceed the permitted PSD values in the runway safety zone of a 5G CMA runway, which ensures the FAA can protect SA CAT I, SA CAT II, CAT II, and CAT III approach operations without limitations.
                </P>
                <P>The FAA will continue to work with the FCC and NTIA in this regard to ensure continuing aviation safety. As stated in the voluntary agreement letter dated March 31, 2023, AT&amp;T, T-Mobile, UScellular, and Verizon's commitment will last until January 1, 2028, at which point it will sunset unless extended or reduced by mutual agreement. A mid-term check-in involving the FAA, the FCC, and telecommunications companies will occur in July 2026 to assess the status of aviation's long-term migration to next-generation radio altimeters and the need for the sustainment of these commitments.</P>
                <HD SOURCE="HD2">K. Special Flight Permit Provisions</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Go Jet Airlines and RAA asked whether the FAA will issue special flight permits to allow operators to ferry airplanes to a location to perform a radio altimeter upgrade.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     As provided in 14 CFR 39.23, the FAA may issue a special flight permit to allow operators to fly their airplane to a repair facility to perform work required by an AD unless the AD states otherwise. Because this AD does not prohibit or limit the issuance of special flight permits, they are allowed.
                </P>
                <HD SOURCE="HD2">L. Interference Reports</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     In the NPRM, the FAA stated it had received over 420 reports of radio altimeter anomalies within a known location of a 5G C-Band deployment. Airbus and CTIA requested the FAA provide the number of reports of radio altimeter anomalies collected by the FAA in the same period of time in a comparable area before the deployment of 5G base stations. IATA and CTIA requested the FAA share the approximately 100 reports of possible radio altimeter interference so carriers can better understand and address the unsafe condition. CTIA suggested the public would benefit from understanding the connection between the data and the nature and scope of any coexistence concerns. CTIA further suggested it would be helpful to understand how those factors have been evaluated, how often reports in other contexts are found to be unattributable, and what findings the FAA makes in those other circumstances.
                    <PRTPAGE P="34071"/>
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA received the reports referenced in the NPRM from various sources and first determined which reports were associated with radio altimeter-related systems in the vicinity of 5G C-Band emitters. The FAA then reviewed all supporting information (
                    <E T="03">e.g.,</E>
                     maintenance data, aircraft and airport trends, and event description), and closed reports where the event was due to maintenance, other interference, or insufficient data. Because the FAA lacks the means to definitively attribute a particular event to 5G C-Band interference, the FAA determined that for the remaining events, 5G C-Band interference could not be ruled out.
                </P>
                <P>To the extent some commenters requested comparable data from before and after the deployment of 5G C-Band base stations, no such data exists. The FAA did not collect 5G C-Band interference report data prior to activation of the C-Band. Therefore, a direct comparison is not possible.</P>
                <HD SOURCE="HD2">M. Non-Part 121 Flights</HD>
                <HD SOURCE="HD3">1. Request To Clarify Requirements for Airplanes Not Operating Under Part 121</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Numerous commenters asked about the proposed requirements for airplanes not operating under part 121. AIA and five other commenters asked why the modification is not required for airplanes not operating under part 121, as all airplanes will see degraded capabilities if the radio altimeter is not retrofitted. Singapore Airlines requested that the FAA explain figure 3 to paragraph (i) of the proposed AD, and whether airplanes not operating under part 121 can perform Instrument Landing System (ILS) CAT I IAPs after February 1, 2024. Gulfstream and Bahamasair requested clarification of the FAA's intent for future rulemaking to impose a modification requirement for part 91 and part 135 operators.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     After June 30, 2023, this AD prohibits all transport and commuter category airplanes, regardless of the type of operation (part 91, part 135, part 121, etc.), from performing certain low-visibility landing operations at any airport (as specified in figure 4 to paragraph (i) of this AD) unless they have upgraded their radio altimeters. Airplanes without upgraded radio altimeters will be able to operate into any airport, but cannot fly the prohibited low-visibility operations. For airplanes that do not operate under part 121, these restrictions, as well as the option to equip with an upgraded radio altimeter, remain unchanged after February 1, 2024.
                </P>
                <P>Only airplanes operating under part 121, in the contiguous U.S., must have a 5G C-Band-compatible radio altimeter (or install a retrofit) prior to February 1, 2024. The FAA proposed this requirement to address the accumulating risk for systems that are less hazardous than low-visibility landings (for example, repeated false warnings from the collision avoidance system from erroneous radio altimeter data). The FAA determined that this accumulating risk will reach unacceptable levels for part 121 operations in the contiguous U.S. after February 1, 2024. The FAA does not anticipate future rulemaking until a TSO standard for radio altimeters is established.</P>
                <HD SOURCE="HD3">2. Request To Clarify Part 129 Requirements</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Eleven commenters asked for clarification of the proposed AD with regard to airplanes operating under 14 CFR part 129. British Airways, Virgin Atlantic Airways, and Qatar Airways asked the FAA to explain the proposed requirements for airplanes operating under part 129. The Association of Asia Pacific Airlines requested that the FAA extend the proposed compliance date for part 129 operators. Boeing requested that the FAA require the proposed modification for part 129 operators. Singapore Airways commented that the risk and unsafe condition described in the NPRM would likely prompt the FAA's foreign counterparts to mandate the upgrade to a radio altimeter-tolerant airplane when operating in U.S. airspace and asked for clarification that non-radio altimeter tolerant airplanes operating under part 129 could continue to use CAT I ILS approaches after February 1, 2024. Airbus Defence and Space asked what the process would be for foreign manufacturers and operators if the FAA's foreign counterparts do not adopt the FAA's AD. A4A stated concern that the FAA is considering different standards for domestic operators versus foreign operators, which does not reflect a “safety first” approach.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     This AD does not impose any requirements, including CAT I ILS, on non-U.S.-registered airplanes operating into the U.S. under part 129. Under ICAO Annex 8, Airworthiness of Aircraft, the state of registry of an airplane is the state responsible for its airworthiness. For this reason, FAA ADs apply only to U.S.-registered airplanes. To the extent the FAA's bilateral partners agree with the FAA's finding of an unsafe condition in U.S. airspace, the FAA encourages those authorities to adopt the FAA AD or similar requirements as mandatory continuing airworthiness instructions for airplanes registered in other countries. The FAA also plans to publish information in the FAA's Aeronautical Information Publication to alert international operators to the 5G C-Band situation in the U.S., including the agency's use of Domestic Notices. The FAA strongly urges operators of foreign-registered airplanes to voluntarily comply with the actions required by this AD when operating in the contiguous U.S. given the unsafe condition affects their airplanes as much as the airplanes subject to this AD.
                </P>
                <HD SOURCE="HD3">3. Burden of Modification Requirement on Part 129 Operators</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     IATA commented that the part 129 carriers are being disadvantaged by the proposed requirement to retrofit airplanes with an upgraded radio altimeter. Specifically, IATA stated that radio altimeter manufacturers are understandably prioritizing the equipment needs of the U.S. fleet over non-U.S. air carriers; IATA also referred to the FAA's exclusion of part 129 carriers from the roundtable discussions the FAA has held to consult with impacted carriers on the overall issue of 5G C-Band. Lufthansa Group, A4A, and ten other commenters (air carriers and trade associations) expressly agreed with IATA or stated similar concerns. Singapore Airways stated that the required modification will worsen the supply chain issue with upgraded radio altimeters.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     Although supply chain disparities and issues are business matters beyond the authority of the FAA, the agency has worked with radio altimeter manufacturers and airplane operators to help ensure that filters and replacement units are available as quickly as possible. The FAA is aware of these issues and acknowledges the concerns regarding supply chain disruptions; however, due to the reliance on the radar altimeter inputs for low-visibility landings and the impending changes discussed in this final rule, the FAA has determined that the restrictions are necessary to correct the unsafe condition discussed in this AD.
                </P>
                <P>
                    To the extent that the commenters expressed concern about the roundtable discussions, those discussions have been an overall collaboration among the many stakeholders affected by 5G C-Band deployment (U.S. federal agencies, the aerospace industry, the telecommunications companies, and foreign civil aviation authorities) and 
                    <PRTPAGE P="34072"/>
                    have not been limited to the FAA's ADs. Participants in these discussions varied at each meeting; however, IATA was represented at some of the meetings.
                </P>
                <HD SOURCE="HD2">N. Operator Involvement</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     The Cargo Airlines Association commented that in addition to the airplane OEMs and radio altimeter manufacturers, airlines should participate in any future radio altimeter standards development activity.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     Although airline operators are not usually members of a standards development activity, they have sometimes been members in the past for certain standards that have been airline operator centric. Individuals may apply for membership on a committee, and acceptance will be based on the committee chair's evaluation of the applicant.
                </P>
                <HD SOURCE="HD2">O. PSD Curve and Associated Compliance Policy</HD>
                <HD SOURCE="HD3">1. Request for Part Numbers/Criteria for Radio Altimeter Tolerance</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Many commenters stated concern that the process for determining whether a radio altimeter meets the fundamental PSD curve, as specified in the proposed AD, is not well defined and that the requirement in the proposed AD of “using a method approved by the FAA” is not adequate. Thales requested that the FAA provide an Issue Paper, Advisory Circular, or other publicly available means of compliance document. Airbus requested that the FAA clarify where operators could find specific part numbers of radio altimeters that would meet the definition in the proposed AD. Fourteen commenters, as well as IATA and A4A, requested that the FAA provide a list of all radio altimeters by part number that are considered tolerant under the criteria discussed in the proposed AD. Gulf Air Group stated that developing an FAA-approved method to demonstrate that an airplane is radio altimeter tolerant should be the responsibility of the OEM, radio altimeter manufacturer, or system integrator.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA has developed a policy statement that provides a means of compliance with this AD for all transport and commuter category airplanes and rotorcraft equipped with a radio altimeter. The FAA requested public comments on this proposed policy on May 8, 2023 [88 FR 29554]. The proposed policy describes an acceptable framework and method for demonstrating that an airplane or rotorcraft is radio altimeter tolerant. The policy discusses compliance methods that should be applied to programs for type certificates, amended type certificates, STCs, and amended STCs. Furthermore, the FAA does not maintain a list of tolerant radio altimeters because the determination of a radio altimeter tolerant airplane must consider the installation details, which vary from airplane to airplane. The proposed policy addresses how to assess 5G C-Band tolerance. Although most data submitted to demonstrate compliance in accordance with the FAA policy statement will be proposed by design approval holders, any person/entity can propose a method to demonstrate compliance.
                </P>
                <HD SOURCE="HD3">2. Request To Clarify Acceptability of External Filters</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Thales requested that the proposed AD be revised to clearly state that installations with external filters can also be used for compliance.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA stated in the preamble of the NPRM that radio altimeter installations with external filters may be acceptable for compliance with the requirements of this AD. The FAA is not requiring a specific type of radio altimeter installation; the AD requires only that the radio altimeter installation meet the radio altimeter tolerance PSD curves. No change to this AD based is necessary based on this comment.
                </P>
                <HD SOURCE="HD3">3. Request To Identify Spurious Emissions Data</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     To determine what action may be necessary to ensure safe aviation operations in the U.S., Thales requested that the proposed AD include necessary spurious data that 5G network operators should disclose to the FAA.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA disagrees. The spurious PSD curve that defines a radio altimeter tolerant airplane for purposes of this AD is based on the spurious emission limits documented in the voluntary agreement letter dated March 31, 2023.
                </P>
                <HD SOURCE="HD3">4. Request To Clarify Figure 1</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Textron Aviation requested the FAA clarify at what reference point the PSD requirements apply. The commenter stated it assumed that they apply at the radio altimeter receive antenna input, such that antenna characteristics, coax loss, and filter characteristics would be included in the determination.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA agrees and has changed the title of figure 1 to paragraph (g)(1)(i) of this AD to reflect that the PSD requirements apply at the antenna input to the radio altimeter, and that the figure applies to the outward facing side of the antenna.
                </P>
                <HD SOURCE="HD3">5. Request To Provide Additional Information on the Spurious Emission Tolerance</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     AIA requested that the FAA provide more information about the tolerances for determination of whether an airplane is radio altimeter tolerant. Several commenters requested that the FAA add a new figure indicating the spurious tolerance, similar to the figure with the PSD tolerance curve, and a specification of the altitude dependence for spurious tolerance.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA agrees and has replaced the proposed fixed emission level with a spurious PSD tolerance curve in figure 2 to paragraph (g)(1)(ii) of this AD. Subsequent figures have been redesignated accordingly.
                </P>
                <HD SOURCE="HD3">6. Request To Recognize Installations as Minor Changes</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Two commenters requested that the FAA revise the proposed AD to allow modification of the airplane to a radio altimeter tolerant airplane as a minor change to type design, to help expedite approvals and make best use of resources.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA disagrees. Under 14 CFR 21.95, minor design changes may be approved before an applicant submits to the FAA any substantiating data. Radio altimeters are critical sensors that must be shown to perform their intended function, and the modified hardware or software must be shown to still meet the airplane-level system safety requirements. For example, a filter may alter the radio altimeter performance, which may have an appreciable effect on reliability, operational characteristics, or other characteristics affecting airworthiness. For this reason, the FAA determined that FAA approval of the method used for the modification was necessary before operators could show compliance with this AD.
                </P>
                <HD SOURCE="HD3">7. Request To Revise Tolerance Definition</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Textron and Embraer asked the FAA to add language to the definition of radio altimeter tolerant airplane to indicate the frequency band being referenced (3.7-3.98 GHz).
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA agrees and has changed paragraphs (g)(1)(i) and (ii) of this AD to include the applicable frequency bands.
                    <PRTPAGE P="34073"/>
                </P>
                <HD SOURCE="HD3">8. Request To Add Certain PSD Limit</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Airbus and Bombardier requested that the FAA revise the table at the bottom of the proposed PSD curve to add the limit for 2500 feet above ground level. The commenters stated that this would be consistent with the maximum operating range of popular radio altimeter models installed on many airplanes and would avoid extrapolation errors.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA disagrees. The FAA developed the PSD curve to cover all transport and commuter radio altimeters and has determined that any extrapolation errors are sufficiently small and will not affect compliance or compromise safety.
                </P>
                <HD SOURCE="HD3">9. Request To Revise Tolerance Requirements for Certain Operations</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     One commenter stated the proposed PSD values are not appropriate for some airplane operations. In support, the commenter stated that CAT I-only qualified airplanes do not require radio altimeter data, and that CAT II and CAT I qualified airplanes do not use radio altimeter data below 100 feet.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA infers that the commenter is requesting that the proposed AD be revised for operators that perform only CAT I and CAT II approaches. The FAA disagrees. The unsafe condition identified by the FAA is related not only to low-visibility operations but also to the various flight deck effects such as erroneous Terrain Awareness and Warning System (TAWS) warnings, erroneous Traffic Collision Avoidance System (TCAS) warnings, erroneous landing gear warnings, and the erroneous display of radio altimeter data. Although these flight deck effects are less severe than the hazards associated with low-visibility landings, the FAA is concerned the effects will occur more frequently as 5G C-Band services continue to be deployed throughout the contiguous U.S. The erroneous warnings increase flightcrew workload as they try to ascertain the validity of the warning. Repeated determinations that the warning occurred in error will lead to flightcrew desensitization to warnings from these safety systems. Meeting the radio altimeter tolerant PSD curve will minimize erroneous flight deck warnings.
                </P>
                <HD SOURCE="HD3">10. Request for Clarification of Spurious Emissions Limit</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     MHI RJ stated that demonstrating tolerance to the aggregate base station conducted spurious emissions level is not possible at an airplane level since the received signal will depend on many other undefined factors, such as distance from base station and base station antenna performance. An individual commenter stated the spurious signal level of −48 dBm/MHz is not consistent with the FCC's regulator limit and free air attenuation, as the spurious signal and radio altimeter signals will attenuate as the airplanes gets farther from the 5G C-Band station.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     As stated in section O.5. of this final rule, the FAA has determined that a spurious emissions PSD curve is a more appropriate method to define performance than a single aggregate spurious emissions level and revised this final rule accordingly.
                </P>
                <HD SOURCE="HD3">11. Request for Different PSD Criteria</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     An individual commenter stated the proposed AD would establish PSD criteria as though the 5G C-Band transmitter is located on the runway between threshold and touchdown zone, which is not realistic given the FAA approach criteria. The Department of Defense stated the PSD curve is lacking information to properly determine the impact to radio altimeters.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA disagrees. The proposed PSD curve was validated using the actual locations of 5G C-Band transmitters with respect to runway safety zones at 5G CMAs.
                </P>
                <HD SOURCE="HD3">12. Request To Revise Unit of Measurement</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     AIA and ATR requested the FAA correct the references of dBm from “decibels per megahertz” to “decibel-milliwatts per megahertz.”
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA agrees; however, because the cited reference does not appear in this final rule, no change to the AD is necessary.
                </P>
                <HD SOURCE="HD3">13. Request for AD Coverage of 65 dBm/MHz (Rural)</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Thales requested that the radio altimeter performance criteria specified in figure 1 to paragraph (g)(2) of the proposed AD be revised to explicitly cover any 5G emitter station up to 65 dB/MHz in the applicable 3.7-3.98 GHz band.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA performed additional analysis, considering both rural power levels (65 dBm/MHz) and urban power levels (62 dBm/MHz), and determined that radio altimeter tolerant airplanes are safe to fly to all airports in the contiguous U.S. However, no change to the AD is necessary based on this comment.
                </P>
                <HD SOURCE="HD2">P. RNP AR</HD>
                <HD SOURCE="HD3">1. Operation Under RNP AR IAP</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Some commenters expressed concern over the FAA's proposal to remove RNP AR IAPs from the list of prohibited operations. Allied Pilots Association and AIA stated RNP AR approaches are commonly used in high terrain environments where reliable TAWS functionality is necessary. ALPA requested information on maintaining operational safety while conducting RNP AR IAPs, especially at terrain-impacted runways.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA included RNP AR in the original list of prohibited operations because it was unclear how 5G C-Band wireless broadband interference would affect this operation. Unlike other operations prohibited by the AD, RNP AR operations do not rely on direct radio altimeter inputs to determine arrival at minimums or for direct inputs that affect the flight path of the airplane. RNP AR operations require operational TAWS equipment; however, TAWS is not directly required for the procedure. An erroneous radio altimeter output could affect maximum allowed bank angle, which could affect course adherence. However, pilots would get an “unable RNP” message and take appropriate action. After further analysis, the FAA determined that 5G C-Band interference does not create an unsafe condition specific to the conduct of an RNP AR IAP. While there is a risk of erroneous TAWS warnings in the presence of 5G C-Band, that risk is not limited to RNP AR operations, but rather applies to all operations. To minimize the number of erroneous system messages and the unsafe condition they produce, the FAA is requiring that all airplanes operating under part 121 meet the PSD performance curves to operate in the contiguous U.S. after February 1, 2024.
                </P>
                <HD SOURCE="HD3">2. Request To Clarify AFM Prohibitions</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Emirates stated that figure 3 to paragraph (i) and figure 4 to paragraph (j) of the proposed AD contain prohibitions for RNP AR IAPs and requested that the FAA clarify whether this is a typographical error.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     In the NPRM, the FAA intentionally removed RNP AR from the proposed figures referenced by the commenter. This AD does not prohibit RNP AR IAPs.
                </P>
                <HD SOURCE="HD2">Q. Additional Changes to NPRM</HD>
                <HD SOURCE="HD3">1. Request To Correct Paragraph Reference</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     Qatar Airways suggested that the reference to 
                    <PRTPAGE P="34074"/>
                    “paragraphs (k)(i) and (ii)” in paragraph (k)(1) of the proposed AD be changed to “paragraphs (k)(1)(i) and (ii).”
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The commenter correctly noted this error in the proposed AD; however, because of other changes to paragraph (k)(1) of the proposed AD (paragraph (j) of this final rule), as described in section B.1. of this final rule, the requested change is not necessary.
                </P>
                <HD SOURCE="HD3">2. Request To Remove Yaborã From Applicability</HD>
                <P>
                    <E T="03">Comment summary:</E>
                     An individual noted that the AD applicability includes Yaborã Indústria Aeronáutica S.A. (Yaborã), but the type certificate for Yaborã models is currently held by Embraer. The commenter suggested that Yaborã be removed from the applicability of this AD.
                </P>
                <P>
                    <E T="03">FAA response:</E>
                     The FAA has removed Yaborã Indústria Aeronáutica S.A. from the applicability of this AD and corrected the clerical error by changing paragraph (c)(4) of this AD to state that type certificates previously held by Yaborã are now held by Embraer S.A. However, because paragraph (c) of this AD uses the language “including, but not limited to,” before listing the names of various type certificate holders, the AD applies to any transport or commuter category airplane equipped with a radio altimeter, regardless of the name of the type certificate holder. In this case, the AD applies to the airplanes whose type certificates were previously held by Yaborã that are now held by Embraer S.A.
                </P>
                <HD SOURCE="HD2">R. Comments Outside Scope of NPRM</HD>
                <P>
                    <E T="03">Comment summary and FAA response:</E>
                     The FAA also received and reviewed several comments that were very general, stated the commenter's viewpoint without a suggestion specific to the AD, or did not make a request the FAA can act on. Some comments asked about other Boeing-specific ADs or about the updated radio altimeter MOPS. These comments are outside the scope of this AD.
                </P>
                <HD SOURCE="HD1">Conclusion</HD>
                <P>The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed in the NPRM, except for the changes described previously. None of the changes will increase the economic burden on any operator. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products.</P>
                <HD SOURCE="HD1">Interim Action</HD>
                <P>The FAA considers that this AD is an interim action. Once the TSO standard for radio altimeters is established, which will follow the existing international technical consensus on the establishment of the MOPS, the FAA anticipates that the MOPS will be incorporated into the TSO. Once a new radio altimeter TSO is developed, approved, and available, the FAA might consider additional rulemaking.</P>
                <HD SOURCE="HD1">Effective Date</HD>
                <P>
                    Section 553(d) of the Administrative Procedure Act (APA) (5 U.S.C. 551 
                    <E T="03">et seq.</E>
                    ) requires publication of a rule not less than 30 days before its effective date. However, section 553(d) authorizes agencies to make rules effective in less than 30 days when the agency finds “good cause.” Radio altimeter anomalies that are undetected by the aircraft automation or pilot, particularly close to the ground (
                    <E T="03">e.g.,</E>
                     landing flare), could lead to loss of continued safe flight and landing. Additionally, radio altimeter anomalies could lead to increased flightcrew workload and flightcrew desensitization to warnings. To address this unsafe condition, the actions required by this AD must be accomplished before the compliance date of June 30, 2023. The FAA based this date on the changes to the 5G C-Band environment beginning on July 1, 2023. These changes include increased wireless broadband deployment and transmissions closer to the parameters authorized by the FCC. The earlier operators learn of the requirements in this AD, the earlier they can take action to ensure compliance. An effective date less than 30 days would ensure the AD is codified earlier, thereby increasing awareness of its requirements. Therefore, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment immediately effective.
                </P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD affects approximately 1,000 airplanes of U.S. registry.</P>
                <P>As of the date of publication of this AD, there are approximately 8,000 transport and commuter category airplanes of U.S. registry. In Special Airworthiness Information Bulletin AIR-21-18R2, the FAA requested radio altimeter retrofit plans, timelines, and completion information from the aviation industry. The FAA did not receive comprehensive data, but based on the limited information the agency did receive, the FAA extrapolated impacts across industry. Based on that information, the FAA roughly estimates that almost 7,000 airplanes on the U.S. registry have already been equipped or are being retrofitted to address radio altimeter interference tolerance, and thus will have to take no actions to comply with this AD. Based on information received, some operators will comply with the modification requirement by replacing the radio altimeter with a new upgraded or modified radio altimeter, and others will comply by installing an externally mounted filter. The FAA estimates that approximately 180 airplanes will require radio altimeter replacement and 820 airplanes will require addition of radio altimeter filters to comply with the modification requirement. As such, the FAA estimates the following costs to comply with this AD, for a total U.S. fleet cost of compliance of up to $35,152,000.</P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,r50,xs70,r50,r70">
                    <TTITLE>Estimated Costs</TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">Cost per product</CHED>
                        <CHED H="1">Cost on U.S. operators</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">AFM revision until June 30, 2023</ENT>
                        <ENT>1 work-hour × $85 per hour = $85</ENT>
                        <ENT>$0</ENT>
                        <ENT>$85</ENT>
                        <ENT>$85,000 for 1,000 affected airplanes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AFM revision after June 30, 2023</ENT>
                        <ENT>1 work-hour × $85 per hour = $85</ENT>
                        <ENT>$0</ENT>
                        <ENT>$85</ENT>
                        <ENT>$85,000 for 1,000 affected airplanes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Modification (radio altimeter replacement option)</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>Up to $80,000 (includes parts and labor)</ENT>
                        <ENT>Up to $14,400,000 for 180 affected airplanes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Modification (filter addition option)</ENT>
                        <ENT>24 work-hours × $85 per hour = $2,040 per filter</ENT>
                        <ENT>$8,000 per filter</ENT>
                        <ENT>$10,040 per filter</ENT>
                        <ENT>Up to $20,582,000 for 820 affected airplanes with 2 or 3 filters per airplane.</ENT>
                    </ROW>
                </GPOTABLE>
                <PRTPAGE P="34075"/>
                <P>The benefits of the AD include the value of reducing aviation accident risks that are mitigated by TAWS, TCAS, and airborne windshear warning and flight guidance systems (windshear systems), all of which rely on proper performance of radio altimeters to perform their intended function. TAWS, TCAS, and windshear systems are examples of safety-enhancing systems required for operation under 14 CFR part 121. The FAA required these systems to address hazards that have caused accidents and fatalities during commercial air transportation in the U.S. This AD will maintain the same level of safety afforded by these and other safety systems before the use of the C-Band by 5G broadband networks. This AD will also minimize erroneous system messages and the unsafe condition they produce.</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 Flexibility Determination</HD>
                <P>The Regulatory Flexibility Act (RFA) of 1980, Public Law 96-354, 94 Stat. 1164 (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 857, Mar. 29, 1996) and the Small Business Jobs Act of 2010 (Pub. L. 111-240, 124 Stat. 2504, Sept. 27, 2010), requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact.</P>
                <P>Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA.</P>
                <P>The FAA published an Initial Regulatory Flexibility Analysis (IRFA) (88 FR 1520, January 11, 2023) for Docket No. FAA-2022-1647, Project Identifier AD-2022-01379-T, to aid the public in commenting on the potential impacts to small entities. The FAA considered the public comments in developing both the final rule and this Final Regulatory Flexibility Analysis (FRFA). A FRFA must contain the following:</P>
                <P>(1) A statement of the need for, and objectives of, the rule;</P>
                <P>(2) A statement of the significant issues raised by the public comments in response to the IRFA, a statement of the assessment of the agency of such issues, and a statement of any changes made in the final rule as a result of such comments;</P>
                <P>(3) The response of the agency to any comments filed by the Chief Counsel for Advocacy of the SBA in response to the proposed rule, and a detailed statement of any change made in the final rule as a result of the comments;</P>
                <P>(4) A description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available;</P>
                <P>(5) A description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities that will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and</P>
                <P>(6) A description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each of the other significant alternatives to the rule considered by the agency that affect the impact on small entities was rejected.</P>
                <HD SOURCE="HD2">1. Need for and Objectives of the Rule</HD>
                <P>This AD replaces AD 2021-23-12 and requires revising the limitations section of the existing AFM to incorporate limitations prohibiting certain operations requiring radio altimeter data for airplanes susceptible to 5G C-Band interference. This AD also requires modifying certain airplanes to allow safe operations in the U.S. 5G C-Band radio frequency environment by February 1, 2024. The more restrictive limitations in this AD are needed due to the continued deployment of new 5G C-Band base stations whose signals are expected to cover most of the contiguous U.S. at transmission frequencies between 3.7-3.98 GHz. This AD addresses the unsafe condition resulting from the continued deployment of 5G C-Band transmissions and their interference to radio altimeters.</P>
                <P>The FAA's legal basis for this AD is discussed in detail under the “Authority for this Rulemaking” section.</P>
                <HD SOURCE="HD2">2. Significant Issues Raised in Public Comments</HD>
                <P>The FAA published an IRFA for Docket No. FAA-2022-1647, Project Identifier AD-2022-01379-T, and requested comments.</P>
                <P>One commenter stated that the vast majority of business airplane operators under part 91 are small businesses as defined by the SBA. The commenter requested that the FAA not underestimate the choice small businesses will have to make between an $80,000 retrofit and loss of utility of the airplane during adverse weather conditions.</P>
                <P>As explained in more detail in section 4. of this Regulatory Flexibility Determination, the FAA identified 31 small entities that own and operate airplanes affected by this AD. Those entities fall under North American Industry Classification System (NAICS) code 481111, 481112, 481211, or 481212 with a small business size standard of a maximum of 1,500 employees, or under NAICS code 481219 with a small business size standard of a maximum of $25 million in average annual receipts, to be considered small business. The FAA did not receive any comments with data concerning this part of the FAA's regulatory analysis or concerning the estimated revenue impact for small businesses to comply with this AD. The FAA determined that no changes are necessary as a result of these comments.</P>
                <P>Lynden Air Cargo commented that there are significant costs associated with the research and development, approval, and type design amendment for new equipment. Textron commented that the costs associated with development and certification were not included in the FAA's cost estimate. Textron, Atlas Air, A4A, and Bombardier requested that the FAA include costs associated with impacts of the AD, such as delayed and canceled flights and the costs of restricted operations.</P>
                <P>
                    The commenters are correct that these additional costs were not included in the FAA's estimated costs. The cost analysis in FAA AD rulemaking actions typically only contain the direct costs associated with the specific actions 
                    <PRTPAGE P="34076"/>
                    required by the AD. The FAA does not include secondary costs such as the time necessary for planning or time necessitated by other administrative actions, or indirect costs such as those resulting from delayed or canceled flights and restricted operations. The FAA lacks the data necessary to quantify those costs, which might vary significantly among operators; the commenters did not provide such data either.
                </P>
                <P>Bombardier and an individual stated that the estimated cost of one work-hour per airplane at $85 per hour for revising an AFM was too low and omitted the costs of authoring the revisions, reviewing the revisions, and briefing flight crews.</P>
                <P>The FAA disagrees. The FAA uses one work-hour as a standard estimate in ADs that require an administrative function such as a revision to a flight manual. Operators and pilots must become familiar with the AFM before beginning a flight because of other FAA regulations, so that is not a cost associated with this AD.</P>
                <P>SkyWest Airlines commented that its part and labor costs for filter installation were nearly twice the costs specified in the NPRM and requested the FAA re-evaluate the cost estimate.</P>
                <P>The cost for filters specified in the NPRM was based on preliminary estimates. Based on this comment, the FAA has revised the cost estimate for the filter installation in this final rule.</P>
                <HD SOURCE="HD2">3. Response to SBA Comments</HD>
                <P>The Chief Counsel for Advocacy of the SBA did not file any comments in response to the NPRM.</P>
                <HD SOURCE="HD2">4. Small Entities to Which the Rule Will Apply</HD>
                <P>The FAA used the definition of small entities in the RFA for this analysis. The RFA defines small entities as small businesses, small governmental jurisdictions, or small organizations. In 5 U.S.C. 601(3), the RFA defines “small business” to have the same meaning as “small business concern” under section 3 of the Small Business Act. The Small Business Act authorizes the SBA to define “small business” by issuing regulations.</P>
                <P>
                    SBA has established size standards for various types of economic activities, or industries, under the NAICS.
                    <SU>6</SU>
                    <FTREF/>
                     These size standards generally define small businesses based on the number of employees or annual receipts.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         SBA Table of Size Standards. Effective March 17, 2023. 
                        <E T="03">https://www.sba.gov/document/support--table-size-standards.</E>
                    </P>
                </FTNT>
                <P>The following table shows the SBA size standards for FAA certificate holders. Note that the SBA definition of a small business applies to the parent company and all affiliates as a single entity.</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="xs60,r50,xs80">
                    <TTITLE>Small Business Size Standards: Air Transportation</TTITLE>
                    <BOXHD>
                        <CHED H="1">NAICS code</CHED>
                        <CHED H="1">Description</CHED>
                        <CHED H="1">SBA size standard</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">481111</ENT>
                        <ENT>Scheduled Passenger Air Transportation</ENT>
                        <ENT>1,500 employees.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">481112</ENT>
                        <ENT>Scheduled Freight Air Transportation</ENT>
                        <ENT>1,500 employees.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">481211</ENT>
                        <ENT>Nonscheduled Chartered Passenger Air Transportation</ENT>
                        <ENT>1,500 employees.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">481212</ENT>
                        <ENT>Nonscheduled Chartered Freight Air Transportation</ENT>
                        <ENT>1,500 employees.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">481219</ENT>
                        <ENT>Other Nonscheduled Air Transportation</ENT>
                        <ENT>$25 million.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    The modification costs of this AD affect certificate holders authorized to conduct operations under 14 CFR part 121. To identify which of those certificate holders may be small entities, the FAA reviewed readily available data sources (
                    <E T="03">e.g.,</E>
                     company websites) and data available to the FAA through its certificate oversight functions to determine whether the certificate holder meets the applicable size standard. The following table provides a summary of the estimated number of small entities to which this AD applies.
                </P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,10,14,14">
                    <TTITLE>Estimated Number of Small Entities</TTITLE>
                    <BOXHD>
                        <CHED H="1">Category</CHED>
                        <CHED H="1">
                            Number of
                            <LI>entities</LI>
                        </CHED>
                        <CHED H="1">
                            Number
                            <LI>small entities</LI>
                        </CHED>
                        <CHED H="1">
                            Percent
                            <LI>small entities</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Major</ENT>
                        <ENT>6</ENT>
                        <ENT>0</ENT>
                        <ENT>0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">National</ENT>
                        <ENT>15</ENT>
                        <ENT>7</ENT>
                        <ENT>47</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Passenger and Cargo Charter</ENT>
                        <ENT>12</ENT>
                        <ENT>8</ENT>
                        <ENT>67</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Regional</ENT>
                        <ENT>15</ENT>
                        <ENT>7</ENT>
                        <ENT>47</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">Specialty Cargo</ENT>
                        <ENT>14</ENT>
                        <ENT>9</ENT>
                        <ENT>64</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT>62</ENT>
                        <ENT>31</ENT>
                        <ENT>50</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Therefore, the FAA estimated that this AD impacts 31 small entities.</P>
                <HD SOURCE="HD2">5. Projected Reporting, Recordkeeping, and Other Compliance Requirements</HD>
                <P>
                    No new recordkeeping or reporting requirements are associated with the AD. As discussed previously, the FAA estimates that the majority of airplanes operated by small entities will already be equipped in a manner that requires no actions to comply with this AD. For the remaining number of airplanes, small entity compliance with the AD would entail incorporation of AFM revisions at an approximate cost of $170 per airplane. For the modification requirement of this AD, the FAA anticipates that a small number of airplanes will need to have radio altimeter filters installed (at an approximate cost of $10,040 per filter), and a smaller number of airplanes will require a radio altimeter replacement (at an approximate cost of up to $80,000 per airplane). These costs represent a small percentage of the overall cost of owning and operating a transport category airplane. To the extent that small entities provide more unique services or serve markets with less 
                    <PRTPAGE P="34077"/>
                    competition, these entities might be able to pass on these compliance costs to their customers in the form of price increases.
                </P>
                <HD SOURCE="HD2">6. Significant Alternatives Considered</HD>
                <P>As part of the FRFA, the FAA is required to consider regulatory alternatives that may be less burdensome. The FAA did not find any significant regulatory alternatives that would still accomplish the safety objectives of this AD.</P>
                <P>Operators may also propose a less burdensome method for mitigating the unsafe condition using the AMOC procedures found in 14 CFR 39.19.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>This AD will not have federalism implications under Executive Order 13132. This AD will 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 this AD:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866, and</P>
                <P>(2) Will not affect intrastate aviation in Alaska.</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 Amendment</HD>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <REGTEXT TITLE="14" PART="39">
                    <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>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 39.13</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>2. The FAA amends § 39.13 by:</AMDPAR>
                    <AMDPAR>a. Removing Airworthiness Directive (AD) 2021-23-12, Amendment 39-21810 (86 FR 69984, December 9, 2021); and</AMDPAR>
                    <AMDPAR>b. Adding the following new AD:</AMDPAR>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2023-10-02 Transport and Commuter Category Airplanes:</E>
                             Amendment 39-22438; Docket No. FAA-2022-1647; Project Identifier AD-2022-01379-T.
                        </FP>
                        <HD SOURCE="HD1">(a) Effective Date</HD>
                        <P>This airworthiness directive (AD) is effective May 26, 2023.</P>
                        <HD SOURCE="HD1">(b) Affected ADs</HD>
                        <P>This AD replaces AD 2021-23-12, Amendment 39-21810 (86 FR 69984, December 9, 2021) (AD 2021-23-12).</P>
                        <HD SOURCE="HD1">(c) Applicability</HD>
                        <P>This AD applies to all transport and commuter category airplanes equipped with a radio (also known as radar) altimeter. These radio altimeters are installed on various transport and commuter category airplanes including, but not limited to, the airplanes for which the design approval holder is identified in paragraphs (c)(1) through (18) of this AD.</P>
                        <P>(1) The Boeing Company</P>
                        <P>(2) Airbus SAS</P>
                        <P>(3) Bombardier Inc.</P>
                        <P>(4) Embraer S.A. (including type certificates previously held by Yaborã Indústria Aeronáutica S.A., which are now held by Embraer S.A.)</P>
                        <P>(5) Gulfstream Aerospace Corporation</P>
                        <P>(6) Gulfstream Aerospace LP</P>
                        <P>(7) Textron Aviation Inc.</P>
                        <P>(8) Pilatus Aircraft Limited</P>
                        <P>(9) Fokker Services B.V.</P>
                        <P>(10) Saab AB, Support and Services</P>
                        <P>(11) DeHavilland Aircraft of Canada Limited</P>
                        <P>(12) Airbus Canada Limited Partnership</P>
                        <P>(13) ATR-GIE Avions de Transport Régional</P>
                        <P>(14) MHI RJ Aviation ULC</P>
                        <P>(15) BAE Systems (Operations) Limited</P>
                        <P>(16) Lockheed Martin Corporation/Lockheed Martin Aeronautics Company</P>
                        <P>(17) Viking Air Limited</P>
                        <P>(18) Dassault Aviation</P>
                        <HD SOURCE="HD1">(d) Subject</HD>
                        <P>Air Transport Association (ATA) of America Code 31, Indicating/Recording System; 34, Navigation.</P>
                        <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                        <P>
                            This AD was prompted by determination that radio altimeters cannot be relied upon to perform their intended function if they experience interference from wireless broadband operations in the 3.7-3.98 GHz frequency band (5G C-Band). The FAA is issuing this AD because radio altimeter anomalies that are undetected by the automation or pilot, particularly close to the ground (
                            <E T="03">e.g.,</E>
                             landing flare), could lead to loss of continued safe flight and landing. Additionally, radio altimeter anomalies could lead to increased flightcrew workload and flightcrew desensitization to warnings.
                        </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) Definitions</HD>
                        <P>(1) For purposes of this AD, a “radio altimeter tolerant airplane” is one for which the radio altimeter, as installed, demonstrates the tolerances specified in paragraphs (g)(1)(i) and (ii) of this AD, using a method approved by the FAA. No actions are required by this AD for radio altimeter tolerant airplanes.</P>
                        <P>(i) Tolerance to radio altimeter interference, for the fundamental emissions (3.7-3.98 GHz), at or above the power spectral density (PSD) curve threshold specified in figure 1 to paragraph (g)(1)(i) of this AD.</P>
                        <FP SOURCE="FP-1">
                            Figure 1 to paragraph (g)(1)(i)—
                            <E T="03">Fundamental Effective Isotropic PSD at Outside Interface of Airplane Antenna</E>
                        </FP>
                        <BILCOD>BILLING CODE 6820-61-P</BILCOD>
                        <GPH SPAN="3" DEEP="300">
                            <PRTPAGE P="34078"/>
                            <GID>ER26MY23.030</GID>
                        </GPH>
                        <P>(ii) Tolerance to radio altimeter interference, for the spurious emissions (4.2-4.4 GHz), at or above the PSD curve threshold specified in figure 2 to paragraph (g)(1)(ii) of this AD.</P>
                        <FP SOURCE="FP-1">
                            Figure 2 to paragraph (g)(1)(ii)—
                            <E T="03">Spurious Effective Isotropic PSD at Outside Interface of Airplane Antenna</E>
                        </FP>
                        <GPH SPAN="3" DEEP="420">
                            <PRTPAGE P="34079"/>
                            <GID>ER26MY23.031</GID>
                        </GPH>
                        <P>(2) For purposes of this AD, a “non-radio altimeter tolerant airplane” is one for which the radio altimeter, as installed, does not demonstrate the tolerances specified in paragraphs (g)(1)(i) and (ii) of this AD.</P>
                        <HD SOURCE="HD1">(h) Airplane Flight Manual (AFM) Revision Until June 30, 2023</HD>
                        <P>For non-radio altimeter tolerant airplanes, before further flight, revise the Limitations Section of the existing AFM to include the information specified in figure 3 to paragraph (h) of this AD. This may be done by inserting a copy of figure 3 to paragraph (h) of this AD into the existing AFM. If an operator has complied with paragraph (g) of AD 2021-23-12, that action satisfies the requirements of this paragraph.</P>
                        <FP SOURCE="FP-1">
                            Figure 3 to paragraph (h)—
                            <E T="03">AFM Revision</E>
                        </FP>
                        <GPH SPAN="3" DEEP="201">
                            <PRTPAGE P="34080"/>
                            <GID>ER26MY23.032</GID>
                        </GPH>
                        <HD SOURCE="HD1">(i) AFM Revision After June 30, 2023</HD>
                        <P>For non-radio altimeter tolerant airplanes, do the actions specified in paragraphs (i)(1) and (2) of this AD.</P>
                        <P>(1) On or before June 30, 2023, revise the Limitations Section of the existing AFM to include the information specified in figure 4 to paragraph (i) of this AD. This may be done by inserting a copy of figure 4 to paragraph (i) of this AD into the existing AFM. Incorporating the AFM revision required by this paragraph terminates the AFM revision required by paragraph (h) of this AD.</P>
                        <P>(2) Before further flight after incorporating the limitations specified in figure 4 to paragraph (i) of this AD, remove the AFM revision required by paragraph (h) of this AD.</P>
                        <FP SOURCE="FP-1">
                            Figure 4 to paragraph (i)—
                            <E T="03">AFM Revision for Non-Radio Altimeter Tolerant Airplanes</E>
                        </FP>
                        <GPH SPAN="3" DEEP="205">
                            <GID>ER26MY23.033</GID>
                        </GPH>
                        <HD SOURCE="HD1">(j) Terminating Action for AFM Limitations</HD>
                        <P>(1) Modifying the airplane from a non-radio altimeter tolerant airplane to a radio altimeter tolerant airplane terminates the limitations in paragraph (i) of this AD for that airplane.</P>
                        <P>(2) After modifying the airplane to a radio altimeter tolerant airplane, the limitations specified by paragraph (i) of this AD may be removed from the AFM.</P>
                        <HD SOURCE="HD1">(k) Alternative Methods of Compliance (AMOCs)</HD>
                        <P>
                            (1) The Manager, Operational Safety 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 responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the Operational Safety 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 responsible Flight Standards Office.</P>
                        <P>(3) AMOCs approved for AD 2021-23-12 are approved as AMOCs for the requirements specified in paragraph (h) of this AD.</P>
                        <HD SOURCE="HD1">(l) Related Information</HD>
                        <P>
                            For more information about this AD, contact Brett Portwood, Continued Operational Safety Technical Advisor, COS Program Management Section, Operational Safety Branch, FAA, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 817-222-5390; email: 
                            <E T="03">operationalsafety@faa.gov</E>
                            .
                        </P>
                        <HD SOURCE="HD1">(m) Material Incorporated by Reference</HD>
                        <P>None.</P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <PRTPAGE P="34081"/>
                    <DATED>Issued on May 23, 2023.</DATED>
                    <NAME>Michael Linegang,</NAME>
                    <TITLE>Acting Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11371 Filed 5-24-23; 11:15 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-C</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2022-1312; Project Identifier AD-2022-00551-T; Amendment 39-22420; AD 2023-08-05]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; The Boeing Company Airplanes</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>The FAA is adopting a new airworthiness directive (AD) for certain The Boeing Company Model 777 airplanes. This AD was prompted by reports of cracks found in the pivot bulkhead forward outer chord of a certain station. Analysis revealed higher bending stresses across the chord than originally assessed. This AD requires repetitive detailed and high frequency eddy current (HFEC) inspections of the pivot bulkhead forward outer chord of a certain station and longeron fitting for cracking and applicable on-condition actions. The FAA is issuing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This AD is effective June 30, 2023.</P>
                    <P>The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of June 30, 2023.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <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-2022-1312; 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 final rule, any comments received, and other information. The address for Docket Operations is 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">Material Incorporated by Reference:</E>
                    </P>
                    <P>
                        • For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Contractual &amp; Data Services (C&amp;DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; website 
                        <E T="03">myboeingfleet.com</E>
                        .
                    </P>
                    <P>
                        • You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available at 
                        <E T="03">regulations.gov</E>
                         under Docket No. FAA-2022-1312.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Luis Cortez-Muniz, Aerospace Engineer, Airframe Sections, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3958; email: 
                        <E T="03">luis.a.cortez-muniz@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 777 airplanes. The NPRM published in the 
                    <E T="04">Federal Register</E>
                     on December 8, 2022 (87 FR 75179). The NPRM was prompted by reports of cracks found in the station (STA) 2370 pivot bulkhead forward outer chord. Analysis revealed higher bending stresses across the chord than originally assessed. In the NPRM, the FAA proposed to require repetitive detailed and HFEC inspections of the STA 2370 pivot bulkhead forward outer chord and longeron fitting for cracking and applicable on-condition actions. The FAA is issuing this AD to address cracking in the STA 2370 pivot bulkhead forward outer chord. Such cracking, if not detected and corrected, could result in a severed pivot bulkhead outer chord, loss of horizontal stabilizer control, and loss of controllability of the airplane.
                </P>
                <HD SOURCE="HD1">Discussion of Final Airworthiness Directive</HD>
                <HD SOURCE="HD1">Comments</HD>
                <P>The FAA received comments from Boeing and the Air Line Pilots Association, International (ALPA), who supported the NPRM without change.</P>
                <P>The FAA received additional comments from three commenters, including Air France (AFA), Federal Express (FedEx) and United Airlines (UAL). The following presents the comments received on the NPRM and the FAA's response to each comment.</P>
                <HD SOURCE="HD1">Request To Change Estimated and On-Condition Cost Sections</HD>
                <P>FedEx requested a change to the Estimated and On-Condition Costs tables in the proposed AD. FedEx noted that, based on the estimates in Boeing Alert Service Bulletin 777-53A0098, dated April 5, 2022, the detailed and HFEC inspections require parts totaling $3,540, as well as 62 work-hours for replacement for the on-condition requirements. FedEx added that the proposed AD states $0 parts cost for detailed and HFEC inspections and 7 work-hours for replacement if on-condition requirements are met.</P>
                <P>The FAA agrees with revising the parts cost and labor hours because the cost estimates provided in the proposed AD inadvertently excluded the parts costs for the inspections and the on-condition costs inadvertently omitted access and close-up costs. However, the FAA notes that the labor hours listed in Boeing Alert Service Bulletin 777-53A0098, dated April 5, 2022, estimate 28 hours for the detailed and open hole HFEC inspection and 38 hours for the replacement (each estimate is for one side of the airplane). The FAA has revised the Costs of Compliance section of this AD accordingly.</P>
                <HD SOURCE="HD1">Request To Change Work-Hour Estimates</HD>
                <P>AFA suggested that Boeing Alert Service Bulletin 777-53A0098, dated April 5, 2022, greatly underestimates the total manpower hours required to perform the modification, which could lead to a maintenance program disruption if not taken into account by operators. AFA noted in its experience performing similar pivot bulkhead inspections and modification using similar service information, it took 1,200 work-hours to complete the modification on both sides of the airplane. AFA added that, due to the time indicated to complete these service bulletins, resources were not available and the airplane was grounded for 3 weeks. AFA noted that it contacted two other operators, who confirmed they also spent between 900 and 1,100 hours to complete the modification on both sides of the airplane. AFA requested that the proposed AD highlight this work-hour discrepancy so operators can plan accordingly.</P>
                <P>
                    The FAA acknowledges there may be discrepancies between the operator labor hours and the hours listed in Boeing Alert Service Bulletin 777-53A0098, dated April 5, 2022. Based on the best data available, the manufacturer provided the number of work hours necessary to do the required actions. 
                    <PRTPAGE P="34082"/>
                    This number represents the time necessary to perform only the actions actually required by this AD. The FAA recognizes that, in doing the actions required by an AD, operators might incur incidental costs in addition to the direct costs. The cost analysis in AD rulemaking actions, however, typically does not include incidental costs such as the time necessary for planning or time necessitated by other administrative actions. Those incidental costs, which might vary significantly among operators, are almost impossible to calculate. In this case, the FAA has no way of knowing how much of the time estimates AFA provided are “incidental” costs. Further, as previously noted, the cost estimates in this AD have been revised to match those specified in the service information and are estimates for performing those actions on one side of the airplane. Therefore, the FAA has not revised this AD regarding this issue.
                </P>
                <HD SOURCE="HD1">Request To Change Special Tooling Requirements</HD>
                <P>AFA noted that Boeing Alert Service Bulletin 777-53A0098, dated April 5, 2022, paragraph 2.E advises no special tooling is needed, while paragraph 2.F advises that certain maintenance and overhaul tools are required. AFA explained that during similar modification they discovered that special big diameter reamers, drill bits and guides are required, which led to delays in work being performed because required reamers and drill bits were not available. AFA stated that Boeing advised that the tooling required is part of standard [maintenance, repair, and overhaul] MRO tools. However, AFA indicated these range of reamers and drill bit diameters are not common and not part of the standard available tools for an MRO. AFA requested that the proposed AD be revised to highlight the incomplete tooling information for operators to take into account before accomplishing the proposed requirements.</P>
                <P>The FAA acknowledges that additional tooling required may not be standard available tools for an MRO. However, the FAA has no definitive data regarding the standard MRO tools or what additional tools might be required. Further, the FAA notes that paragraphs 2.E. and 2.F. in Boeing Alert Service Bulletin 777-53A0098, dated April 5, 2022, are informational, and not required for compliance with this AD. The FAA has not changed this AD regarding this issue.</P>
                <HD SOURCE="HD1">Request for Detailed Access Instructions</HD>
                <P>AFA requested the proposed AD highlight that Chapter 3.B access and preparation instructions in Boeing Alert Service Bulletin 777-53A0098, dated April 5, 2022, are not detailed enough. AFA claimed a similar modification using different service information required removal of multiple systems and structural parts to get access to the damaged area. This required AFA to develop task cards on a daily basis and at mechanics' requests. AFA noted that it spent 300 work-hours after modification to restore access and perform tests. AFA stated that the additional work was not identified in the bulletin and caused delays completing the corresponding AD.</P>
                <P>The FAA acknowledges the commenters concerns, but notes that the access instructions are not required for compliance for this AD. Further, Boeing, as the design approval holder (DAH), is responsible for the development of these instructions. The FAA has no definitive guidance to provide access and preparation instructions. The FAA has not changed this AD regarding this issue.</P>
                <HD SOURCE="HD1">Request To Allow Simultaneous Inspections of Both Sides of Aircraft</HD>
                <P>UAL requested the proposed AD be revised to allow simultaneous inspections of both sides of the aircraft. UAL noted that paragraph 3.B of Boeing Alert Requirements Bulletin 777-53A0098 RB, dated April 5, 2022, states “Do all actions on one side before you do any action on the opposite side.” UAL stated that it finds the restriction to be inconsistent with related service information requiring similar actions on other airplanes. UAL claimed that other service information stated that removal of structure (for repair or modification) simultaneously on both sides of the aircraft was unacceptable, but that removal of skin panels (for inspection) simultaneously on both sides of the aircraft was acceptable. UAL noted that the repair or replacement work is involved and lengthy, with the horizontal stabilizer immobilized and internally jacked, likely precluding other maintenance work in the area. UAL added that the repair process therefore disrupts the maintenance check, forcing the rescheduling of other planned maintenance action. UAL explained that inspecting both sides of the aircraft early and simultaneously would allow it to know the full scope of the project and plan accordingly. UAL noted that it asked Boeing to edit the service information to include this allowance, and Boeing agreed to incorporate the allowance in a proposed revision. For these reasons, UAL requested allowing the detailed and HFEC inspections simultaneously on both sides of the aircraft; or simultaneously with applicable on-condition actions on the opposite side of the aircraft; provided any on-condition repairs or replacements are not performed simultaneously on both sides of the aircraft.</P>
                <P>The FAA acknowledges the commenter's concern and the impact on maintenance planning. However, UAL has not provided substantiation in support of these exceptions. The FAA requires substantiation to support that no structural concerns are introduced with the requested exceptions and will consider their approval via alternative method of compliance (AMOC) request in accordance with paragraph (i) of this AD, provided an acceptable level of safety is maintained.</P>
                <HD SOURCE="HD1">Request To Refer to Revised Service Information</HD>
                <P>UAL requested that the FAA revise the proposed AD to refer to Revision 1 of Boeing Requirements Bulletin 777-53A0098 RB. UAL noted that it received a preliminary copy of the revised requirements bulletin for review, and that the revision corrects elements of the illustrations, step tables, and fastener code tables in the Accomplishment Instructions, including to figures which are Required for Compliance (RC). UAL stated that Revision 1 is expected to be published later this year, and mandating it would prevent operators from having to obtain AMOCs to use the corrected instructions.</P>
                <P>
                    The FAA acknowledges the commenter's request. However, the FAA has not reviewed and approved Revision 1 of Boeing Requirements Bulletin 777-53A0098 RB and notes that UAL did not request any specific changes to be able to comply with this AD. Further, the FAA may not refer to any document that does not yet exist in an AD. In general terms, the FAA is required by Office of the Federal Register (OFR) regulations for approval of materials incorporated by reference, as specified in 1 CFR 51.1(f), to either publish the service document contents as part of the actual AD language; or submit the service document to the OFR for approval as referenced material, in which case the FAA may only refer to such material in the text of an AD. The AD may refer to the service document only if the OFR approved it for incorporation by reference. See 1 CFR part 51.
                    <PRTPAGE P="34083"/>
                </P>
                <P>Given the urgency of the identified unsafe condition, the FAA has determined that delaying this AD while the revised service information is developed, reviewed, and approved would be inappropriate. However, once the revised service information is approved, the FAA may consider granting an AMOC to allow the use of the revised service information.</P>
                <HD SOURCE="HD1">Conclusion</HD>
                <P>The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>The FAA reviewed Boeing Alert Requirements Bulletin 777-53A0098 RB, dated April 5, 2022. This service information specifies procedures for repetitive detailed and HFEC inspections of the STA 2370 pivot bulkhead forward outer chord and longeron fitting for cracking and applicable on-condition actions. On-condition actions include replacing the pivot bulkhead forward outer chord and splice angle; a detailed inspection of the upper aft longeron extension fittings at STA 2370 to STA 2380 and open hole HFEC inspection of the STA 2370 pivot bulkhead web, aft outer chord, upper and lower outer chord, and skin for any crack; and repair.</P>
                <P>
                    This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in 
                    <E T="02">ADDRESSES</E>
                    .
                </P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD affects 223 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:</P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,r50,r50,r50,r50">
                    <TTITLE>Estimated Costs</TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">Cost per product</CHED>
                        <CHED H="1">
                            Cost on U.S.
                            <LI>operators</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Detailed and HFEC inspections</ENT>
                        <ENT>10 work-hours × $85 per hour = $850 per inspection cycle</ENT>
                        <ENT>$3,540 per inspection cycle</ENT>
                        <ENT>$4,390 per inspection cycle</ENT>
                        <ENT>$978,970 inspection cycle.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The FAA estimates the following costs to do any necessary replacements or inspections that would be required based on the results of the required inspection. The agency has no way of determining the number of aircraft that might need these replacements or inspections:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,r50,12,12">
                    <TTITLE>On-Condition Costs</TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Replacement (one side of airplane)</ENT>
                        <ENT>38 work-hours × $85 per hour = $3,230</ENT>
                        <ENT>$37,720</ENT>
                        <ENT>$40,950</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Detailed and open hole HFEC inspections (one side of airplane)</ENT>
                        <ENT>28 work-hours × $85 per hour = $2,380</ENT>
                        <ENT>0</ENT>
                        <ENT>2,380</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The FAA has received no definitive data on which to base the cost estimates for the on-condition repairs specified in this AD.</P>
                <P>The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.</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>This AD will not have federalism implications under Executive Order 13132. This AD will 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 this AD:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866,</P>
                <P>(2) Will not affect intrastate aviation in Alaska, and</P>
                <P>(3) Will 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 Amendment</HD>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <REGTEXT TITLE="14" PART="39">
                    <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>
                </REGTEXT>
                <SECTION>
                    <PRTPAGE P="34084"/>
                    <SECTNO>§ 39.13</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive:</AMDPAR>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2023-08-05 The Boeing Company:</E>
                             Amendment 39-22420; Docket No. FAA-2022-1312; Project Identifier AD-2022-00551-T.
                        </FP>
                        <HD SOURCE="HD1">(a) Effective Date</HD>
                        <P>This airworthiness directive (AD) is effective June 30, 2023.</P>
                        <HD SOURCE="HD1">(b) Affected ADs</HD>
                        <P>None.</P>
                        <HD SOURCE="HD1">(c) Applicability</HD>
                        <P>This AD applies to The Boeing Company Model 777-200, -200LR, -300, -300ER, and 777F airplanes, certificated in any category, as identified in Boeing Alert Requirements Bulletin 777-53A0098 RB, dated April 5, 2022.</P>
                        <HD SOURCE="HD1">(d) Subject</HD>
                        <P>Air Transport Association (ATA) of America Code 53, Fuselage.</P>
                        <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                        <P>This AD was prompted by reports of cracks found in the station (STA) 2370 pivot bulkhead forward outer chord. Analysis revealed higher bending stresses across the chord than originally assessed. The FAA is issuing this AD to address cracking in the STA 2370 pivot bulkhead forward outer chord. Such cracking, if not detected and corrected, could result in a severed pivot bulkhead outer chord, loss of horizontal stabilizer control, and loss of controllability of the airplane.</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) Required Actions</HD>
                        <P>Except as specified by paragraph (h) of this AD: At the applicable times specified in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 777-53A0098 RB, dated April 5, 2022, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing Alert Requirements Bulletin 777-53A0098 RB, dated April 5, 2022.</P>
                        <P>
                            <E T="04">Note 1 to paragraph (g):</E>
                             Guidance for accomplishing the actions required by this AD can be found in Boeing Alert Service Bulletin 777-53A0098, dated April 5, 2022, which is referred to in Boeing Alert Requirements Bulletin 777-53A0098 RB, dated April 5, 2022.
                        </P>
                        <HD SOURCE="HD1">(h) Exceptions to Service Information Specifications</HD>
                        <P>(1) Where the Compliance Time columns of the tables in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 777-53A0098 RB, dated April 5, 2022, use the phrase “the original issue date of Requirements Bulletin 777-53A0098 RB,” this AD requires using “the effective date of this AD.”</P>
                        <P>(2) Where Boeing Alert Requirements Bulletin 777-53A0098 RB, dated April 5, 2022, specifies contacting Boeing for repair instructions: This AD requires doing the repair using a method approved in accordance with the procedures specified in paragraph (i) of this AD.</P>
                        <HD SOURCE="HD1">(i) Alternative Methods of Compliance (AMOCs)</HD>
                        <P>
                            (1) The Manager, Seattle ACO 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 responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j)(1) of this AD. Information may be emailed to: 
                            <E T="03">9-ANM-Seattle-ACO-AMOC-Requests@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 responsible Flight Standards Office.</P>
                        <P>(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by The Boeing Company Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO Branch, FAA, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.</P>
                        <HD SOURCE="HD1">(j) Related Information</HD>
                        <P>
                            (1) For more information about this AD, contact Luis Cortez-Muniz, Aerospace Engineer, Airframe Sections, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3958; email: 
                            <E T="03">luis.a.cortez-muniz@faa.gov.</E>
                        </P>
                        <P>(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (k)(3) and (4) of this AD.</P>
                        <HD SOURCE="HD1">(k) Material Incorporated by Reference</HD>
                        <P>(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                        <P>(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.</P>
                        <P>(i) Boeing Alert Requirements Bulletin 777-53A0098 RB, dated April 5, 2022.</P>
                        <P>(ii) [Reserved]</P>
                        <P>
                            (3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual &amp; Data Services (C&amp;DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; website 
                            <E T="03">myboeingfleet.com.</E>
                        </P>
                        <P>(4) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.</P>
                        <P>
                            (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, 
                            <E T="03">fr.inspection@nara.gov,</E>
                             or go to: 
                            <E T="03">www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                        </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued on April 18, 2023.</DATED>
                    <NAME>Christina Underwood,</NAME>
                    <TITLE>Acting Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11305 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF STATE</AGENCY>
                <CFR>22 CFR Part 22</CFR>
                <DEPDOC>[Public Notice: 12091]</DEPDOC>
                <RIN>RIN 1400-AF33</RIN>
                <SUBJECT>Schedule of Fees for Consular Services—Nonimmigrant and Special Visa Fees</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of State.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; delay of effective date.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Department of State (the Department) is delaying the effective date of a final rule that appeared in the 
                        <E T="04">Federal Register</E>
                         on March 28, 2023, to provide for a 60-day delay in the effective date after receipt of the final rule in the Congress.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The effective date of the rule amending 22 CFR part 22 published at 88 FR 18243, March 28, 2023, is delayed until June 17, 2023.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Johanna Cruz, Management Analyst, Office of the Comptroller, Bureau of Consular Affairs, Department of State; phone: 202-485-8915; email: 
                        <E T="03">fees@state.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Government Accountability Office (GAO) has informed the Department that the report prepared pursuant to the Congressional Review Act, 5 U.S.C. 801 
                    <E T="03">et seq.,</E>
                     was not delivered to the U.S. Senate until April 17, 2023 (the reports to the House of Representatives and GAO were delivered on March 29, 2023). Accordingly, the Department is correcting the final rule to provide for an effective date of June 17, 2023. 
                    <E T="03">See</E>
                     5 U.S.C. 801(a)(3).
                </P>
                <SIG>
                    <NAME>Kevin E. Bryant,</NAME>
                    <TITLE>Deputy Director, Office of Directives Management, U.S. Department of State.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11420 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4710-06-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <PRTPAGE P="34085"/>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Coast Guard</SUBAGY>
                <CFR>33 CFR Part 165</CFR>
                <DEPDOC>[Docket No. USCG-2023-0227]</DEPDOC>
                <SUBJECT>Safety Zones; Fireworks Displays in the Fifth Coast Guard District—Philadelphia, PA</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notification of enforcement of regulation.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Coast Guard will enforce the Delaware River, Philadelphia, PA; Safety Zone for fireworks displays on three separate periods. The safety zone will first be enforced from 9:15 p.m. through 10 p.m. on June 24, 2023, and again, during those same hours, on June 25, 2023, or on a rain date of June 26, 2023. The third period the safety zone will be enforced will be from 9 p.m. to 10 p.m. on July 4, 2023, or on a rain date of July 5, 2023. This is to provide for the safety of life on navigable waterways during each of the three separate barge-based fireworks displays. Our regulation for marine events within the Fifth Coast Guard District identifies the regulated area for this event in Philadelphia, PA. During the enforcement period, no person or vessel may enter, remain in, or transit through the regulated area, and anyone in the vicinity must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The regulation 33 CFR 165.506 for Philadelphia, PA, will be enforced for the location identified in entry 10 of table 1 to paragraph (h)(1) from 9:15 p.m. through 10 p.m. on June 24, 2023, and for the same hours on June 25, 2023, or on a rain date of June 26, 2023, and from 9 p.m. to 10 p.m. on July 4, 2023, or on a rain date of July 5, 2023.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        If you have questions about this notice of enforcement, you may call or email Petty Officer Dylan Caikowski, U.S. Coast Guard, Sector Delaware Bay, Waterways Management Division, telephone 215-271-4814, email 
                        <E T="03">SecDelBayWWM@uscg.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Coast Guard will enforce the safety zone in table 1 to paragraph (h)(1) to 33 CFR 165.506, entry No. 10 for three periods, for three separate barge-based fireworks displays. The first two enforcement periods will be 9:15 p.m. through 10 p.m. on June 24, 2023, and 9:15 p.m. through 10 p.m. on June 25, 2023, or on a rain date of June 26, 2023. The third enforcement period will be from 9 p.m. to 10 p.m. on July 4, 2023, or on a rain date of July 5, 2023. This action is necessary to ensure safety of life on the navigable waters of the United States immediately prior to, during, and immediately after fireworks displays. Our regulation for safety zones of fireworks displays within the Fifth Coast Guard District, table 1 to paragraph (h)(1) to 33 CFR 165.506, entry 10 specifies the location of the regulated area as all waters of the Delaware River, adjacent to Penn's Landing, Philadelphia, PA, within a 500-yard radius of the fireworks barge position. The approximate position for the displays is latitude 39°56′49″ N, longitude 075°08′11″ W. During the enforcement period, as reflected in § 165.506(d), vessels may not enter, remain in, or transit through the safety zone unless authorized by the Captain of the Port or designated Coast Guard patrol personnel on-scene.</P>
                <P>
                    In addition to this notice of enforcement in the 
                    <E T="04">Federal Register</E>
                    , the Coast Guard will provide notification of this enforcement period via Local Notice to Mariners and Broadcast Notice to Mariners.
                </P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Jonathan D. Theel,</NAME>
                    <TITLE>Captain, U.S. Coast Guard, Captain of the Port, Sector Delaware Bay.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11316 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-04-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Coast Guard</SUBAGY>
                <CFR>33 CFR Part 165</CFR>
                <DEPDOC>[Docket Number USCG-2023-0229]</DEPDOC>
                <RIN>RIN 1625-AA00</RIN>
                <SUBJECT>Safety Zone; Illinois River Mile Markers 163.3 to 162.7, Peoria, IL</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Temporary final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Coast Guard is establishing a temporary safety zone for all navigable waters in the Illinois Waterway at Mile Marker (MM) 162.7 through 163.3. The safety zone is needed to protect personnel, vessels, and the marine environment from all potential hazards associated with an aerial drone display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Upper Mississippi River (COTP) or a designated representative.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective from 8:45 p.m. through 10:15 p.m. on June 10, 2023.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        To view documents mentioned in this preamble as being available in the docket, go to 
                        <E T="03">https://www.regulations.gov,</E>
                         type USCG-2023-0229 in the search box and click “Search.” Next, in the Document Type column, select “Supporting &amp; Related Material.”
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        If you have questions on this rule, call or email Lieutenant Commander Richard Cherkauer, Sector Upper Mississippi River Waterways Management Division, U.S. Coast Guard; telephone 314-269-2560, email 
                        <E T="03">Richard.G.Cherkauer@uscg.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. Table of Abbreviations</HD>
                <EXTRACT>
                    <FP SOURCE="FP-1">CFR Code of Federal Regulations</FP>
                    <FP SOURCE="FP-1">DHS Department of Homeland Security</FP>
                    <FP SOURCE="FP-1">FR Federal Register</FP>
                    <FP SOURCE="FP-1">MM Mile marker</FP>
                    <FP SOURCE="FP-1">NPRM Notice of proposed rulemaking</FP>
                    <FP SOURCE="FP-1">§ Section </FP>
                    <FP SOURCE="FP-1">U.S.C. United States Code</FP>
                </EXTRACT>
                <HD SOURCE="HD1">II. Background Information and Regulatory History</HD>
                <P>On February 3, 2023, the Peoria Parks District notified the Coast Guard that from 9 to 10 p.m. on June 10, 2023, it will be conducting an aerial drone entertainment display launched landside from Peoria Riverfront Park and flown over the Illinois River north of the Illinois River Bridge at MM 162.9. In response, on April 20, 2023, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Illinois River Mile Markers 163.3 to 162.7, Peoria, IL (88 FR 24375). There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to aerial drone display. During the comment period that ended April 30, 2023, we received no comments.</P>
                <P>
                    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the 
                    <E T="04">Federal Register</E>
                    . Delaying the effective date of this rule would be impracticable because the event takes place on June 10, 2023 and immediate action is needed to protect personnel, vessels, and the marine environment from all potential hazards associated with the aerial drone display.
                </P>
                <HD SOURCE="HD1">III. Legal Authority and Need for Rule</HD>
                <P>
                    The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Upper 
                    <PRTPAGE P="34086"/>
                    Mississippi River (COTP) has determined that potential hazards associated with the aerial drone event to be used in this June 10, 2023, display will be a safety concern for anyone within a half mile radius of the display. The purpose of this rule is to ensure safety of vessels and the navigable waters in the safety zone before, during, and after the scheduled event.
                </P>
                <HD SOURCE="HD1">IV. Discussion of Comments, Changes, and the Rule</HD>
                <P>As noted above, we received no comments on our NPRM published April 20, 2023. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.</P>
                <P>This rule establishes a safety zone from 8:45 to 10:15 p.m. on June 10, 2023. The safety zone will cover all navigable waters from MM 162.7 through 163.3 in the Illinois River. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 9 to 10 p.m. aerial drone display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.</P>
                <HD SOURCE="HD1">V. Regulatory Analyses</HD>
                <P>We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.</P>
                <HD SOURCE="HD2">A. Regulatory Planning and Review</HD>
                <P>Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).</P>
                <P>This regulatory action determination is based on safety concerns associated with an aerial drone display at MM 162.9 and the consequential safety zone located on the Illinois Waterway from MM 162.7 through 163.3 near Peoria, IL.</P>
                <HD SOURCE="HD2">B. Impact on Small Entities</HD>
                <P>The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received 00 comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.</P>
                <P>While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.</P>
                <P>
                    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section.
                </P>
                <P>Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.</P>
                <HD SOURCE="HD2">C. Collection of Information</HD>
                <P>This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).</P>
                <HD SOURCE="HD2">D. Federalism and Indian Tribal Governments</HD>
                <P>A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.</P>
                <P>Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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.</P>
                <HD SOURCE="HD2">E. Unfunded Mandates Reform Act</HD>
                <P>The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.</P>
                <HD SOURCE="HD2">F. Environment</HD>
                <P>
                    We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone encompassing the width of the Illinois River from MM 162.7 through 163.3. It is categorically excluded from further review under paragraph L60 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the 
                    <E T="02">ADDRESSES</E>
                     section of this preamble.
                </P>
                <HD SOURCE="HD2">G. Protest Activities</HD>
                <P>
                    The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.
                </P>
                <LSTSUB>
                    <PRTPAGE P="34087"/>
                    <HD SOURCE="HED">List of Subjects in 33 CFR Part 165</HD>
                    <P>Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.</P>
                </LSTSUB>
                <P>For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS</HD>
                </PART>
                <REGTEXT TITLE="33" PART="165">
                    <AMDPAR>1. The authority citation for part 165 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> Authority: 46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="33" PART="165">
                    <AMDPAR>2. Add § 165.T08-0229 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 165.T08-0229</SECTNO>
                        <SUBJECT>Safety Zone; Illinois River from MM 162.7 through 163.3, Peoria, IL</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Location.</E>
                             The following area is a safety zone: all navigable waters within the Illinois River from MM 162.7 through 163.3.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Enforcement period.</E>
                             This section will be subject to enforcement on June 10, 2023, from 8:45 p.m. to 10:15 p.m.
                        </P>
                        <P>
                            (c) 
                            <E T="03">Regulations.</E>
                             (1) In accordance with the general safety zone regulations in § 165.23, entry of persons or vessels into this safety zone described in paragraph (a) of this section is prohibited unless authorized by the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard (USCG) assigned to units under the operational control of USCG Sector Upper Mississippi River.
                        </P>
                        <P>(2) To seek permission to enter, contact the COTP or a designated representative via VHF-FM channel 16, or through USCG Sector Upper Mississippi River at 314-269-2332. Persons and vessels permitted to enter the safety zone must comply with all lawful orders or directions issued by the COTP or designated representative.</P>
                        <P>
                            (d) 
                            <E T="03">Informational broadcasts.</E>
                             The COTP or a designated representative will inform the public of the effective period for the safety zone as well as any changes in the dates and times of enforcement, as well as reductions in size or scope of the safety zone, through Local Notice to Mariners (LNMs), Broadcast Notices to Mariners (BNMs), and/or Safety Marine Information Broadcast (SMIB) as appropriate.
                        </P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: May 20, 2023.</DATED>
                    <NAME>A.R. Bender,</NAME>
                    <TITLE>Captain, U.S. Coast Guard, Captain of the Port, Sector Upper Mississippi River.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11294 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-04-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Coast Guard</SUBAGY>
                <CFR>33 CFR Part 165</CFR>
                <DEPDOC>[Docket Number USCG-2023-0390]</DEPDOC>
                <RIN>RIN 1625-AA00</RIN>
                <SUBJECT>Safety Zone; La Quinta and Corpus Christi Shipping Channel, Ingleside, TX</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Temporary final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Coast Guard is establishing a temporary safety zone for all navigable waters of the La Quinta and Corpus Christi Shipping Channel between gated pair lights 11 and 12 to the Sea buoy. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the rig CHEVRON ANCHOR FPU HULL while it is towed offshore from Kiewit Offshore Services. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Corpus Christi or a designated representative.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective from 11 p.m. on May 27, 2023 through 11 a.m. on May 28, 2023.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        To view documents mentioned in this preamble as being available in the docket, go to 
                        <E T="03">https://www.regulations.gov,</E>
                         type USCG-2023-0390 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        If you have questions on this rule, call or email Lieutenant Commander Anthony Garofalo, Sector Corpus Christi Waterways Management Division, U.S. Coast Guard; telephone 361-939-5130, email 
                        <E T="03">Anthony.M.Garofalo@uscg.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. Table of Abbreviations</HD>
                <EXTRACT>
                    <FP SOURCE="FP-1">CFR Code of Federal Regulations</FP>
                    <FP SOURCE="FP-1">DHS Department of Homeland Security</FP>
                    <FP SOURCE="FP-1">FR Federal Register</FP>
                    <FP SOURCE="FP-1">NPRM Notice of proposed rulemaking</FP>
                    <FP SOURCE="FP-1">§ Section </FP>
                    <FP SOURCE="FP-1">U.S.C. United States Code</FP>
                </EXTRACT>
                <HD SOURCE="HD1">II. Background Information and Regulatory History</HD>
                <P>The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. We must establish this safety zone immediately to protect personnel, vessels, and the marine environment from potential hazards created by float-off of a Floating Production Unit from a heavy-lift vessel and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.</P>
                <P>
                    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the 
                    <E T="04">Federal Register</E>
                    . Delaying the effective date of this rule would be contrary to the public interest because immediate action is needed to respond to the potential safety hazards associated with towing the offshore rig through the La Quinta Channel and Corpus Christi Shipping Channel.
                </P>
                <HD SOURCE="HD1">III. Legal Authority and Need for Rule</HD>
                <P>The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Corpus Christi (COTP) has determined that potential hazards associated with float-off of the rig CHEVRON ANCHOR FPU HULL while it is towed on May 27, 2023 and May 28, 2023 will be a safety concern for anyone within the La Quinta and Corpus Christi Shipping Channel between gated pair lights 11 and 12 to the Sea buoy. The purpose of this rule is to ensure safety of vessels and persons on these navigable waters in the safety zone while the float-off is occurring.</P>
                <HD SOURCE="HD1">IV. Discussion of the Rule</HD>
                <P>
                    This rule is effective from 11 p.m. on May 27, 2023 through 11 a.m. on May 28, 2023. The transit will occur at Kiewit Offshore Services adjacent to the La Quinta Channel between gated pair lights 11 and 12 to the Sea buoy. The safety zone is needed to protect personnel, vessels, and the marine 
                    <PRTPAGE P="34088"/>
                    environment from potential hazards created by the rig CHEVRON ANCHOR FPU HULL while it is towed from Kiewit Offshore Services. No vessel or person is permitted to enter the temporary safety zone during the effective period without obtaining permission from the COTP or a designated representative, who may be contacted on Channel 16 VHF-FM (156.8 MHz) or by telephone at 361-939-0450. The Coast Guard will issue Broadcast Notices to Mariners, Local Notices to Mariners, and/or Safety Marine Information Broadcasts as appropriate.
                </P>
                <HD SOURCE="HD1">V. Regulatory Analyses</HD>
                <P>We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.</P>
                <HD SOURCE="HD2">A. Regulatory Planning and Review</HD>
                <P>Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).</P>
                <P>This regulatory action determination is based on the size, location, and duration of the safety zone. This safety zone covers a 5 nautical mile area of the La Quinta and Corpus Christi Shipping Channel near Ingleside, TX. The temporary safety zone will be enforced for a period of only 12 hours on May 27, 2023 and May 28, 2023. The rule does not completely restrict the traffic within a waterway and allows mariners to request permission to enter the zone.</P>
                <HD SOURCE="HD2">B. Impact on Small Entities</HD>
                <P>The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.</P>
                <P>While some owners or operators of vessels intending to transit the temporary safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.</P>
                <P>
                    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section.
                </P>
                <P>Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.</P>
                <HD SOURCE="HD2">C. Collection of Information</HD>
                <P>This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).</P>
                <HD SOURCE="HD2">D. Federalism and Indian Tribal Governments</HD>
                <P>A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.</P>
                <P>
                    Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section above.
                </P>
                <HD SOURCE="HD2">E. Unfunded Mandates Reform Act</HD>
                <P>The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.</P>
                <HD SOURCE="HD2">F. Environment</HD>
                <P>We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishment of a temporary safety zone for navigable waters of the La Quinta Channel between gated pair lights 11 and 12 to the Sea buoy. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the rig CHEVRON ANCHOR FPU HULL while it is towed from Kiewit Offshore Services. It is categorically excluded from further review under paragraph L60 Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.</P>
                <HD SOURCE="HD2">G. Protest Activities</HD>
                <P>
                    The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 33 CFR Part 165</HD>
                    <P>Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.</P>
                </LSTSUB>
                <PRTPAGE P="34089"/>
                <P>For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS</HD>
                </PART>
                <REGTEXT TITLE="33" PART="165">
                    <AMDPAR>1. The authority citation for part 165 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="33" PART="165">
                    <AMDPAR>2. Add § 165.T08-0390 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 165.T08-0390</SECTNO>
                        <SUBJECT>Safety Zone; La Quinta and Corpus Christi Shipping Channel, Ingleside, TX.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Location.</E>
                             The following area is a safety zone: all navigable waters of the La Quinta Channel between gated pair lights 11 and 12 to the Sea buoy. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Corpus Christi (COTP) or a designated representative.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Enforcement period.</E>
                             This section will be enforced from 11 p.m. on May 27, 2023 through 11 a.m. on May 28, 2023.
                        </P>
                        <P>
                            (c) 
                            <E T="03">Regulations.</E>
                             (1) According to the general regulations in § 165.23 of this part, entry into this temporary safety zone is prohibited unless authorized by the COTP or a designated representative. They may be contacted on Channel 16 VHF-FM (156.8 MHz) or by telephone at 361-939-0450.
                        </P>
                        <P>(2) If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.</P>
                        <P>
                            (d) 
                            <E T="03">Information broadcasts.</E>
                             The COTP or a designated representative will inform the public of the enforcement times and date for this safety zone through Broadcast Notices to Mariners, Local Notices to Mariners, and/or Safety Marine Information Broadcasts as appropriate.
                        </P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>J.B. Gunning,</NAME>
                    <TITLE>Captain, U.S. Coast Guard, Captain of the Port Sector Corpus Christi.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11387 Filed 5-24-23; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 9110-04-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Patent and Trademark Office</SUBAGY>
                <CFR>37 CFR Part 1</CFR>
                <DEPDOC>[Docket No. PTO-P-2023-0013]</DEPDOC>
                <RIN>RIN 0651-AD69</RIN>
                <SUBJECT>Adoption of Updated WIPO Standard ST.26; Revision to Incorporation by Reference</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>United States Patent and Trademark Office, Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The United States Patent and Trademark Office (USPTO or Office) is adopting the recently revised World Intellectual Property Organization (WIPO) Standard ST.26, version 1.6, approved November 25, 2022, for incorporation by reference into its regulations addressing application disclosures containing nucleotide and/or amino acid sequences. The USPTO is also correcting a grammatical oversight in one of its sequence regulations. The USPTO first amended its rules in 2022 to incorporate by reference certain provisions of WIPO Standard ST.26. In addition to simplifying the process for applicants filing in multiple countries, the ST.26 requirement to submit a single sequence listing in eXtensible Mark-up Language (XML) format provides better preservation, accessibility, and sorting of the submitted sequence data for the public. Among other improvements, the new version of ST.26 clarifies requirements, improves descriptions, and corrects editorial mistakes.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective on July 1, 2023. The incorporation by reference of certain publications listed in this rule is approved by the Director of the Federal Register as of July 1, 2023.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Mary C. Till, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patents, at 
                        <E T="03">Mary.Till@uspto.gov</E>
                         or 571-272-7755; or Ali Salimi, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patents, at 
                        <E T="03">Ali.Salimi@uspto.gov</E>
                         or 571-272-0909.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The “WIPO Handbook on Intellectual Property Information and Documentation” (formerly the “WIPO Handbook on Industrial Property Information and Documentation”) sets forth standards for the presentation of data in many contexts. One such standard is WIPO Standard ST.26, which is titled “RECOMMENDED STANDARD FOR THE PRESENTATION OF NUCLEOTIDE AND AMINO ACID SEQUENCE LISTINGS USING XML (EXTENSIBLE MARKUP LANGUAGE).” WIPO Standard ST.26 defines the disclosures of nucleotide and/or amino acid sequences in patent applications that must be presented in a sequence listing in XML format in the manner specified in the standard.</P>
                <P>In a rulemaking published May 20, 2022, at 87 FR 30806, the USPTO created new rules 37 CFR 1.831-1.839 that incorporate by reference WIPO Standard ST.26. 37 CFR 1.839(b)(1) specifically identifies the version of WIPO Standard ST.26 that has been incorporated by reference as “version 1.5, approved November 5, 2021.” On November 25, 2022, WIPO adopted a new version (version 1.6) of WIPO Standard ST.26. As a result, the USPTO is updating 37 CFR 1.839(b)(1) to reflect the new version.</P>
                <P>
                    WIPO provides free online public access to view copies of its standards. WIPO standards that are incorporated into Federal regulations are available to the public for free viewing on WIPO's website at 
                    <E T="03">https://www.wipo.int/export/sites/www/standards/en/pdf/03-26-01_v1_6.pdf.</E>
                     In addition to the free online availability of this standard on WIPO's website, WIPO Standard ST.26 is available on the USPTO's Sequence Listing Resource Center at 
                    <E T="03">https://www.uspto.gov/patents/apply/sequence-listing-resource-center.</E>
                </P>
                <P>WIPO Standard ST.26 is composed of eight documents, namely, the main body of the standard, a first annex (Annex I) setting forth the controlled vocabulary for use with the main body, a second annex (Annex II) setting forth the Document Type Definition (DTD) for the Sequence Listing, a third annex (Annex III) containing a sequence listing specimen (XML file), a fourth annex (Annex IV) setting forth the character subset from the Unicode Basic Latin Code Table, a fifth annex (Annex V) setting forth additional data exchange requirements for IPOs, a sixth annex (Annex VI) containing a guidance document with illustrated examples, and a seventh annex (Annex VII) setting forth recommendations for the transformation of a sequence listing from WIPO Standard ST.25 format to WIPO Standard ST.26 format, including guidance on how to avoid adding or deleting subject matter.</P>
                <P>
                    Revisions to WIPO Standard ST.26 under the newly adopted version affect the main body, Annex I, Annex II, Annex VI, and Annex VII. The changes to the main body serve to clarify requirements, improve descriptions (for example, by better defining the value 
                    <PRTPAGE P="34090"/>
                    needed for an application number), and correct editorial mistakes. Similarly, the changes to Annex I, Annex II and Annex VII clarify the format of values for identifiers that are part of the “Sequence Listing XML,” revise grammar, and clarify values that are language-dependent. Annex VI includes three new examples of the manner in which (1) a circular nucleotide sequence is exemplified, (2) a post-translationally modified amino acid is exemplified, and (3) representation of a single sequence with enumerated alternative amino acids that may be modified amino acids is exemplified. Throughout the main body of WIPO Standard ST.26, reference to “international, national or regional procedures” have been updated to reflect that order for consistency. Furthermore, all instances of “industrial property” in the main body of WIPO Standard ST.26 have been updated to “intellectual property.” Thus, the changes in newly adopted version 1.6 of WIPO Standard ST.26 are ministerial changes that will not have a meaningful substantive impact on disclosing parties.
                </P>
                <P>Additionally, the USPTO revises 37 CFR 1.831(a) to correct a grammatical oversight. 37 CFR 1.831(d) corresponds to WIPO Standard ST.26, paragraph 3(c)(i) and (ii), and recites “enumeration of its residues,” but 37 CFR 1.831(a), as implemented in the May 2022 rulemaking, recited “enumeration of their residues.” This grammatical error was an oversight, and the changes in § 1.831(a) to replace “enumeration of their residues” with “enumeration of its residues” do not impact compliance with how an amino acid and/or nucleotide sequence(s), which is enumerated by its residues, must be shown in the “Sequence Listing XML.”</P>
                <HD SOURCE="HD1">Discussion of Specific Rules</HD>
                <P>
                    <E T="03">Section 1.831:</E>
                     Section 1.831(a) is amended to replace “Patent applications disclosing nucleotide and/or amino acid sequences by enumeration of their residues . . .” with “Patent applications disclosing a nucleotide and/or amino acid sequence(s) by enumeration of its residues . . .” for consistency with § 1.831(d) and WIPO Standard ST.26, paragraph 3(c)(i) and (ii), to which § 1.831(d) corresponds. A subsequent iteration of “nucleotide and/or amino acid sequences” in § 1.831(a) is revised to “nucleotide and/or amino acid sequence(s)” for consistency.
                </P>
                <P>
                    <E T="03">Section 1.839:</E>
                     Section 1.839(b)(1) is amended to provide an updated citation to the WIPO Standard ST.26 that is being incorporated by reference. Additionally, § 1.839(b)(1) is revised to reflect an update to the name of the WIPO handbook. Specifically, the “WIPO Handbook on Industrial Property Information and Documentation” is now the “WIPO Handbook on Intellectual Property Information and Documentation.”
                </P>
                <HD SOURCE="HD1">Rulemaking Considerations</HD>
                <P>
                    <E T="03">A. Administrative Procedure Act:</E>
                     The changes in this rulemaking involve rules of agency practice and procedure, and/or interpretive rules. See 
                    <E T="03">Bachow Commc'ns Inc.</E>
                     v. 
                    <E T="03">FCC,</E>
                     237 F.3d 683, 690 (D.C. Cir. 2001) (changes to procedural rules are not subject to notice and comment review under the Administrative Procedure Act (APA)); 
                    <E T="03">Inova Alexandria Hosp.</E>
                     v. 
                    <E T="03">Shalala,</E>
                     244 F.3d 342, 349 (4th Cir. 2001) (rules for handling appeals are procedural where they do not change the substantive standard for reviewing claims); 
                    <E T="03">Nat'l Org. of Veterans' Advocates</E>
                     v. 
                    <E T="03">Sec'y of Veterans Affairs,</E>
                     260 F.3d 1365, 1375 (Fed. Cir. 2001) (Substantive rules “effect a change in existing law or policy or which affect individual rights and obligations,” whereas interpretative rules “clarify or explain existing law or regulation and are exempt from notice and comment” review under the APA.).
                </P>
                <P>
                    Accordingly, prior notice and opportunity for public comment for the changes in this rulemaking are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law. See 
                    <E T="03">Cooper Techs. Co.</E>
                     v. 
                    <E T="03">Dudas,</E>
                     536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), do not require notice and comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice” (quoting 5 U.S.C. 553(b)(A))).
                </P>
                <P>In addition, the Office finds good cause pursuant to the authority at 5 U.S.C. 553(b)(B) to dispense with prior notice and opportunity for public comment because such procedures are unnecessary in this instance. The changes in this rulemaking merely update the regulations to incorporate by reference version 1.6 of WIPO Standard ST.26, which was adopted on November 25, 2022, by the WIPO Committee on Standards, and to make a correction to the regulations at 37 CFR 1.831(a) to correct a grammatical oversight in a definition. These revisions are largely procedural in nature, and do not impose any additional requirements or fees on applicants. Thus, the USPTO implements this final rule without prior notice and opportunity for comment.</P>
                <P>
                    <E T="03">B. Regulatory Flexibility Act:</E>
                     As prior notice and an opportunity for public comment are not required pursuant to 5 U.S.C. 553 or any other law, neither a Regulatory Flexibility Act analysis nor a certification under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ) is required. See 5 U.S.C. 603.
                </P>
                <P>
                    <E T="03">C. Executive Order 12866 (Regulatory Planning and Review):</E>
                     This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).
                </P>
                <P>
                    <E T="03">D. Executive Order 13563 (Improving Regulation and Regulatory Review):</E>
                     The USPTO has complied with Executive Order 13563 (Jan. 18, 2011). Specifically, to the extent feasible and applicable, the USPTO has: (1) reasonably determined that the benefits of the rule justify its costs; (2) tailored the rule to impose the least burden on society consistent with obtaining the agency's regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole, and provided online access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens while maintaining flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.
                </P>
                <P>
                    <E T="03">E. Executive Order 13132 (Federalism):</E>
                     This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).
                </P>
                <P>
                    <E T="03">F. Executive Order 13175 (Tribal Consultation):</E>
                     This rulemaking will not: (1) have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (Nov. 6, 2000).
                </P>
                <P>
                    <E T="03">G. Executive Order 13211 (Energy Effects):</E>
                     This rulemaking is not a significant energy action under Executive Order 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).
                </P>
                <P>
                    <E T="03">H. Executive Order 12988 (Civil Justice Reform):</E>
                     This rulemaking meets 
                    <PRTPAGE P="34091"/>
                    applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).
                </P>
                <P>
                    <E T="03">I. Executive Order 13045 (Protection of Children):</E>
                     This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997).
                </P>
                <P>
                    <E T="03">J. Executive Order 12630 (Taking of Private Property):</E>
                     This rulemaking will not effect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).
                </P>
                <P>
                    <E T="03">K. Congressional Review Act:</E>
                     Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 
                    <E T="03">et seq.</E>
                    ), the USPTO will submit a report containing the final rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this rulemaking are not expected to result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this rulemaking is not expected to result in a “major rule” as defined in 5 U.S.C. 804(2).
                </P>
                <P>
                    <E T="03">L. Unfunded Mandates Reform Act of 1995:</E>
                     The changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of $100 million (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of $100 million (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 
                    <E T="03">et seq.</E>
                </P>
                <P>
                    <E T="03">M. National Environmental Policy Act of 1969:</E>
                     This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                </P>
                <P>
                    <E T="03">N. National Technology Transfer and Advancement Act of 1995:</E>
                     The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions that involve the use of technical standards.
                </P>
                <P>
                    <E T="03">O. Paperwork Reduction Act of 1995:</E>
                     This final rule does not impact information collection requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <P>Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information has a currently valid OMB control number.</P>
                <P>
                    <E T="03">P. E-Government Act Compliance:</E>
                     The USPTO is committed to compliance 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>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 37 CFR Part 1</HD>
                    <P>Administrative practice and procedure, Biologics, Courts, Freedom of information, Incorporation by reference, Inventions and patents, Reporting and recordkeeping requirements, Small businesses.</P>
                </LSTSUB>
                <P>For the reasons stated in the preamble and under the authority contained in 35 U.S.C. 2, as amended, the USPTO amends 37 CFR part 1 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 1—RULES OF PRACTICE IN PATENT CASES</HD>
                </PART>
                <REGTEXT TITLE="37" PART="1">
                    <AMDPAR>1. The authority citation for part 1 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>35 U.S.C. 2(b)(2), unless otherwise noted.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="37" PART="1">
                    <AMDPAR>2. In § 1.831, revise paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1.831</SECTNO>
                        <SUBJECT>Requirements for patent applications filed on or after July 1, 2022, having nucleotide and/or amino acid sequence disclosures.</SUBJECT>
                        <P>(a) Patent applications disclosing a nucleotide and/or amino acid sequence(s) by enumeration of its residues, as defined in paragraph (b) of this section, must contain, as a separate part of the disclosure, a computer readable Sequence Listing in XML format (a “Sequence Listing XML”). Disclosed nucleotide or amino acid sequences that do not meet the definition in paragraph (b) of this section must not be included in the “Sequence Listing XML.” The “Sequence Listing XML” contains the information of the nucleotide and/or amino acid sequence(s) disclosed in the patent application using the symbols and format in accordance with the requirements of §§ 1.832 through 1.834.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="37" PART="1">
                    <AMDPAR>3. In § 1.839, revise paragraph (b)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1.839</SECTNO>
                        <SUBJECT>Incorporation by reference.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(1) WIPO Standard ST.26. WIPO Handbook on Intellectual Property Information and Documentation, Standard ST.26: Recommended Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language) including Annexes I-VII, version 1.6, approved November 25, 2022; IBR approved for §§ 1.831 through 1.834.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <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. 2023-11365 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-16-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R10-OAR-2022-0753, FRL-10190-02-R10]</DEPDOC>
                <SUBJECT>Air Plan Approval; ID; State Board Composition</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is approving a revision to the Idaho State Implementation Plan (SIP) submitted on August 9, 2022. The revision was submitted to meet the state board composition requirements of the Clean Air Act.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective June 26, 2023.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2022-0753. 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 or other information the disclosure of which is restricted by statute. Certain other material, such as 
                        <PRTPAGE P="34092"/>
                        copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available at 
                        <E T="03">https://www.regulations.gov,</E>
                         or please contact the person listed in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section for additional availability information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kristin Hall (15-H13), EPA Region 10, 1200 Sixth Avenue, (Suite 155), Seattle, WA 98101, (206) 553-6357, 
                        <E T="03">hall.kristin@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document wherever “we” or “our” is used, it means the EPA.</P>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Background</FP>
                    <FP SOURCE="FP-2">II. Final Action</FP>
                    <FP SOURCE="FP-2">III. Incorporation by Reference</FP>
                    <FP SOURCE="FP-2">IV. Statutory and Executive Order Reviews</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Background</HD>
                <P>On August 9, 2022, Idaho submitted a SIP revision to meet the state board composition requirements of Clean Air Act section 128(a)(1). On February 17, 2023, we proposed to approve the submitted SIP revision (88 FR 10256). The reasons for our proposed approval are included in the proposal and will not be restated here. The public comment period closed on March 20, 2023. We received one anonymous comment in support of our proposed action, therefore we are finalizing our action as proposed.</P>
                <HD SOURCE="HD1">II. Final Action</HD>
                <P>The EPA is approving and incorporating by reference a revision to the Idaho SIP submitted on August 9, 2022. Upon the effective date of this action, the Idaho SIP will include Idaho Code section 39-107(1)(a), state effective July 1, 2022. This provision establishes the composition requirements for the Idaho Board of Environmental Quality.</P>
                <HD SOURCE="HD1">III. Incorporation by Reference</HD>
                <P>
                    In this document, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, we are finalizing the incorporation by reference of the Idaho statutory provision described in section II of this preamble and set forth in the amendments to 40 CFR part 52 in this document. The EPA has made, and will continue to make, these materials 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). Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the Clean Air Act as of the effective date of the final rule of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         62 FR 27968 (May 22, 1997).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Statutory and Executive Order Reviews</HD>
                <P>Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act 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 Clean Air Act. 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 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 13563 (76 FR 3821, January 21, 2011);</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 an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);</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 Clean Air 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 minority populations and low-income populations to the greatest extent practicable and permitted by law. The EPA defines environmental justice (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.”</P>
                <P>The air agency did not evaluate environmental justice considerations as part of its SIP submittal; the Clean Air Act 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 this action, it 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 Executive Order 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples.</P>
                <P>In addition, the SIP is not approved to apply on any Indian reservation land or 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 rule does not have tribal implications and it will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).</P>
                <P>This action is subject to the Congressional Review Act, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).</P>
                <P>
                    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 25, 2023. 
                    <PRTPAGE P="34093"/>
                    Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).
                </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>
                <SIG>
                    <DATED>Dated: May 17, 2023.</DATED>
                    <NAME>Casey Sixkiller,</NAME>
                    <TITLE>Regional Administrator, Region 10.</TITLE>
                </SIG>
                <P>For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS</HD>
                </PART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>1. The authority citation for part 52 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                            42 U.S.C. 7401 
                            <E T="03">et seq.</E>
                        </P>
                    </AUTH>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart N—Idaho</HD>
                    </SUBPART>
                </REGTEXT>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>2. In § 52.670:</AMDPAR>
                    <AMDPAR>a. The table in paragraph (c) is amended by adding the entry “Idaho Code section 39-107(1)(a)” at the end of the table; and</AMDPAR>
                    <AMDPAR>b. The table in paragraph (e) is amended by removing entry “Idaho State Board SIP Revision; Executive Order 2013-06; dated June 26, 2013”.</AMDPAR>
                    <P>The addition reads as follows:</P>
                    <SECTION>
                        <SECTNO>§ 52.670</SECTNO>
                        <SUBJECT>Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <GPOTABLE COLS="5" OPTS="L1,i1" CDEF="s50,r100,10,r50,r50">
                            <TTITLE>EPA Approved Idaho Regulations and Statutes</TTITLE>
                            <BOXHD>
                                <CHED H="1">State citation</CHED>
                                <CHED H="1">Title/subject</CHED>
                                <CHED H="1">
                                    State
                                    <LI>effective</LI>
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">
                                    EPA approval
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">Explanations</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">State Statutes</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Idaho Code section 39-107(1)(a)</ENT>
                                <ENT>Board—Composition—Officers—Compensation—Powers—Subpoena—Depositions—Review—Rules</ENT>
                                <ENT>7/1/2022</ENT>
                                <ENT>
                                    5/26/2023 [Insert 
                                    <E T="02">Federal Register</E>
                                     Citation]
                                </ENT>
                                <ENT>To satisfy the requirements of CAA section 128(a)(1) and CAA section 110(a)(2)(E)(ii) for all criteria pollutants.</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11261 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R09-OAR-2023-0261; FRL-10932-01-R9]</DEPDOC>
                <SUBJECT>Finding of Failure To Submit State Implementation Plan Submissions for the 2012 Fine Particulate Matter National Ambient Air Quality Standards; California; Los Angeles-South Coast Air Basin</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Environmental Protection Agency (EPA) is taking final action to find that California has failed to submit state implementation plan (SIP) elements required under the Clean Air Act (CAA or “Act”) to implement the 2012 national ambient air quality standards (NAAQS) for fine particulate matter (PM
                        <E T="52">2.5</E>
                        ) in the Los Angeles-South Coast Air Basin (“South Coast”). California was required to submit by June 9, 2022, a SIP submission that meets the Serious area plan requirements for a base year emissions inventory and best available control measures (BACM). The State submitted the required SIP elements, but subsequently withdrew its submission. If the EPA has not affirmatively found that the State has submitted a complete SIP to correct these deficiencies within 18 months of this finding, the offset sanction will apply in the area. If within six additional months the EPA has still not affirmatively determined that the State has submitted a complete SIP to correct the deficiencies, the highway funding sanction will apply in the area. No later than two years after the EPA makes this finding, if the State has not submitted and the EPA has not approved each of the required SIP elements, the EPA must promulgate a federal implementation plan (FIP) to address the remaining requirements.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The effective date of this action is June 26, 2023.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-0261. 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 through 
                        <E T="03">https://www.regulations.gov,</E>
                         or please contact the person identified in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section for additional availability information. If you need assistance in a language other than English or if you are a person with a disability who needs a reasonable accommodation at no cost to you, please contact the person identified in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ginger Vagenas, EPA Region IX, 75 Hawthorne St., San Francisco, CA 
                        <PRTPAGE P="34094"/>
                        94105. By phone: (415) 972-3964 or by email at 
                        <E T="03">vagenas.ginger@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 553 of the Administrative Procedure Act (APA), U.S.C. 553(b)(B), provides that an agency may issue a rule without providing notice and an opportunity for public comment when that agency finds for good cause that notice and public procedure are impracticable, unnecessary, or contrary to public interest. The EPA has determined that there is a good cause for issuing this finding without prior proposal and opportunity for comment because there is little or no judgment involved for the EPA to make a finding of failure to submit SIPs or elements of SIPs required by the CAA, where states have not submitted a required SIP revision by the date specified by the statute, made incomplete submissions, or, as in this case, withdrawn an existing submission. In such circumstances, the EPA finds that notice and public procedures are unnecessary and that this constitutes good cause under 5 U.S.C 553(b)(B).</P>
                <P>Throughout this document, “we,” “us,” and “our” refer to the EPA.</P>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Background</FP>
                    <FP SOURCE="FP-2">II. Consequences of Findings of Failure To Submit</FP>
                    <FP SOURCE="FP-2">III. Final Action</FP>
                    <FP SOURCE="FP-2">IV. Statutory and Executive Order Reviews</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    Airborne particulate matter (PM) can be composed of a complex mixture of particles in both solid and liquid form. Particulate matter can be of different sizes, commonly referred to as “coarse” and “fine” particles. Fine particles, in general terms, are PM with an aerodynamic diameter less than or equal to a nominal 2.5 micrometers. For this reason, particles of this size are referred to as PM
                    <E T="52">2.5</E>
                    .
                </P>
                <P>
                    The EPA first promulgated annual and 24-hour NAAQS for PM
                    <E T="52">2.5</E>
                     in July 1997 
                    <SU>1</SU>
                    <FTREF/>
                     and then revised the 24-hour PM
                    <E T="52">2.5</E>
                     NAAQS in October 2006.
                    <SU>2</SU>
                    <FTREF/>
                     Most recently, on December 14, 2012, the EPA revised the primary annual PM
                    <E T="52">2.5</E>
                     standard by lowering the level from 15.0 to 12.0 micrograms per cubic meter of air (μg/m
                    <SU>3</SU>
                    ) to provide increased protection against health effects associated with long- and short-term PM
                    <E T="52">2.5</E>
                     exposures. The EPA did not revise the secondary annual PM
                    <E T="52">2.5</E>
                     standard, which remains at 15.0 μg/m
                    <SU>3</SU>
                    .
                    <SU>3</SU>
                    <FTREF/>
                     In addition, the EPA retained the level and form of the primary and secondary 24-hour PM
                    <E T="52">2.5</E>
                     standards to continue to provide supplemental protection against health and welfare effects associated with short-term PM
                    <E T="52">2.5</E>
                     exposures.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         62 FR 38652 (July 18, 1997).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         71 FR 61143 (October 17, 2006).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         78 FR 3086 (January 15, 2013).
                    </P>
                </FTNT>
                <P>
                    Promulgation of a revised NAAQS triggers a requirement for the EPA to designate areas of the country as nonattainment, attainment, or unclassifiable for the standards. As prescribed by CAA section 188(a), areas designated as nonattainment for a PM
                    <E T="52">2.5</E>
                     NAAQS are initially classified as Moderate. The designation and initial classification for the South Coast as Moderate nonattainment for the 2012 PM
                    <E T="52">2.5</E>
                     NAAQS became effective on April 15, 2015.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         80 FR 2206 (January 15, 2015).
                    </P>
                </FTNT>
                <P>
                    Nonattainment areas for PM
                    <E T="52">2.5</E>
                     are subject to the general nonattainment area planning requirements of CAA section 172 and to the PM-specific planning requirements of CAA sections 188-189. On August 24, 2016, the EPA established a final implementation rule (“PM
                    <E T="52">2.5</E>
                     SIP Requirements Rule”) outlining the attainment planning and control requirements for current and future PM
                    <E T="52">2.5</E>
                     NAAQS.
                    <SU>5</SU>
                    <FTREF/>
                     The PM
                    <E T="52">2.5</E>
                     SIP Requirements Rule also established the due date for Moderate area PM
                    <E T="52">2.5</E>
                     SIP submissions as no later than 18 months from the effective date of area designations.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the areas designated as nonattainment for the 2012 PM
                    <E T="52">2.5</E>
                     NAAQS (with an effective date of April 15, 2015) were required to submit Moderate area attainment plans to EPA no later than October 15, 2016.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Fine Particulate Matter National Ambient Air Quality Standards: State Implementation Plan Requirements; Final rule; 81 FR 58009 (August 24, 2016).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         40 CFR 51.1003(a)(1).
                    </P>
                </FTNT>
                <P>
                    On April 27, 2017, California submitted the “Final 2016 Air Quality Management Plan” (“2016 Plan”), as adopted on March 3, 2017 by the Governing Board for the South Coast Air Quality Management District (SCAQMD or “District”) to the EPA to address CAA requirements associated with the 2012 PM
                    <E T="52">2.5</E>
                     NAAQS.
                    <SU>7</SU>
                    <FTREF/>
                     The 2016 Plan included a demonstration, consistent with the requirements of CAA section 189(a)(1)(B), that attainment of the 2012 PM
                    <E T="52">2.5</E>
                     NAAQS by the December 31, 2021 Moderate area attainment date was impracticable, despite the implementation of required control measures.
                    <SU>8</SU>
                    <FTREF/>
                     The 2016 Plan also included a request that the EPA reclassify the nonattainment area from Moderate to Serious, and included a Serious area attainment demonstration, an emission inventory, attainment related plan elements, and control measure provisions.
                    <SU>9</SU>
                    <FTREF/>
                     Effective December 9, 2020, we approved or conditionally approved the portions of the 2016 Plan that addressed the CAA Moderate area requirements for the 2012 PM
                    <E T="52">2.5</E>
                     NAAQS in the South Coast nonattainment area and reclassified the South Coast as a Serious nonattainment area under CAA section 188(b)(1).
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         85 FR 71264 (November 9, 2020). For additional background, see the associated proposed rulemaking at 85 FR 40026 (July 2, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         85 FR 71264, 71266.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         85 FR 71264, 71268.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         85 FR 71264.
                    </P>
                </FTNT>
                <P>
                    Our final action on the 2016 Plan's Moderate area requirements and reclassification of the nonattainment area to Serious also noted that the submitted 2016 Plan included Serious area planning elements for the 2012 PM
                    <E T="52">2.5</E>
                     NAAQS and stated that we would evaluate and act on them through subsequent rulemakings as appropriate.
                    <SU>11</SU>
                    <FTREF/>
                     At the same time, our final action explained that our reclassification of the South Coast nonattainment area from Moderate to Serious for the 2012 PM
                    <E T="52">2.5</E>
                     NAAQS triggered statutory and regulatory timelines for submittal of Serious area planning elements. Specifically, we stated that section 189(b)(2) of the CAA requires a state to submit the required BACM provisions no later than 18 months after the effective date of final reclassification (
                    <E T="03">i.e.,</E>
                     June 9, 2022). Because an effective BACM evaluation requires in up-to-date emissions inventory and an evaluation of the precursor pollutants that must be controlled to provide for expeditious attainment, we also required the State to submit the emissions inventory required under CAA section 172(c)(3) and any optional precursor demonstrations by this same date. In addition, we established a deadline of December 31, 2023, for the submittal of the attainment demonstration and all other attainment-related plan elements.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         85 FR 71264, 71268.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         85 FR 71268. The Serious area SIP elements for the 2012 PM
                        <E T="52">2.5</E>
                         NAAQS include provisions to assure that best available control measures (including best available control technology) shall be implemented no later than four years after the area is reclassified, a base year emissions inventory, an attainment projected emissions inventory, an attainment demonstration with air quality modeling, a reasonable further progress (RFP) demonstration, quantitative milestones, contingency measures, and a nonattainment new source review (NNSR) program with the major source threshold set at 70 tons per year. CAA section 189(b).
                    </P>
                </FTNT>
                <P>
                    On March 29, 2023, the State of California and the District notified the EPA of their determination that the portions of the 2016 Plan relating to Serious area planning elements for the 2012 PM
                    <E T="52">2.5</E>
                     NAAQS were no longer appropriate for inclusion in the SIP and 
                    <PRTPAGE P="34095"/>
                    requested that those portions of the submittal be considered withdrawn.
                    <E T="51">13 14</E>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Letter dated March 8, 2023, from Sarah Rees, Ph.D., Deputy Executive Officer, Planning, Rule Development &amp; Implementation, South Coast Air Quality Management District to Michael Benjamin, D. Env., Chief, Air Quality Planning and Science Division, California Air Resources Board.
                    </P>
                    <P>
                        <SU>14</SU>
                         Letter dated March 29, 2023, from Michael Benjamin, Chief, Air Quality Planning and Science Division, California Air Resources Board to Martha Guzman, Regional Administrator, EPA Region IX.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Consequences of Findings of Failure To Submit</HD>
                <P>
                    For plan requirements under part D, title I of the CAA, such as those for PM
                    <E T="52">2.5</E>
                     nonattainment areas, if the EPA finds that a state has failed to make the required SIP submission, then CAA section 179 establishes specific consequences, including the eventual imposition of mandatory sanctions for the affected area. Additionally, such a finding triggers an obligation under CAA section 110(c) for the EPA to promulgate a FIP no later than two years from the effective date of the finding, if the affected state has not submitted, and the EPA has not approved, the required SIP submissions.
                </P>
                <P>If the EPA has not affirmatively determined that a state has submitted a complete SIP addressing the deficiency that is the basis for these findings within 18 months of the effective date of this rulemaking, or the submission has not become complete by operation of law six months after submission, then, pursuant to CAA sections 179(a) and (b) and 40 CFR 52.31, the emissions offset sanction identified in CAA section 179(b)(2) will apply to the affected nonattainment area. If the EPA has not affirmatively determined that the state has submitted a SIP addressing the deficiencies that are a basis for these findings within six months after the offset sanction is imposed, or the submission has not become complete by operation of law six months after submission, then the highway funding sanction will apply in the affected nonattainment area, in accordance with CAA section 179(b)(1) and 40 CFR 52.31. The State must make the required SIP submission and the EPA must take final action to approve the submission within two years of the effective date of these finding; otherwise, the EPA is required to promulgate a FIP to address the relevant requirements. This is required pursuant to CAA section 110(c) for the affected nonattainment area.</P>
                <P>
                    Based upon the withdrawal of the Serious area plan elements submitted with the 2016 Plan as described in Section I of this rulemaking, the EPA is finding that California has failed to make required base year emissions inventory and BACM submittals for the 2012 PM
                    <E T="52">2.5</E>
                     NAAQS for the South Coast nonattainment area. The remaining required elements of the Serious area plan for the 2012 p.m.2.5 NAAQS are not due until December 31, 2023; therefore, this finding applies only to the required base year emission inventory and BACM submittals that were due no later than June 9, 2022. With this finding, section 179 of the CAA starts sanctions clocks and a FIP clock. California may avoid these sanctions by taking timely action to remedy this finding. The 18-month clock governing the CAA's imposition of sanctions for these areas will stop and sanctions will not take effect if the EPA finds that the State has made a complete SIP submission addressing the BACM and emissions inventory requirements for this area within 18 months of the date of this finding. Similarly, the EPA is not required to promulgate a FIP if California makes the required SIP submissions and the EPA takes final action to approve the submissions within two years of this finding of failure to submit a required SIP. In sum, the CAA does not require sanctions or a FIP if the State and the EPA take timely action to remedy this finding.
                </P>
                <HD SOURCE="HD1">III. Final Action</HD>
                <P>
                    In this action, the EPA is finding that California has failed to submit certain Serious area SIP elements for the 2012 PM
                    <E T="52">2.5</E>
                     NAAQS required under subpart 4 of part D of title I of the CAA. Specifically, California has failed to submit the base year emissions inventory and BACM elements that were due no later than June 9, 2022. The consequences of this finding are discussed in Section II of this action.
                </P>
                <HD SOURCE="HD1">IV. Statutory and Executive Order Reviews</HD>
                <P>
                    Additional information about these statutes and Executive orders can be found at 
                    <E T="03">https://www2.epa.gov//laws-regulations/laws-and-executive-orders.gov.</E>
                </P>
                <HD SOURCE="HD2">A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review</HD>
                <P>This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.</P>
                <HD SOURCE="HD2">B. Paperwork Reduction Act (PRA)</HD>
                <P>This action does not impose an information collection burden under the provisions of the PRA because it does not impose additional requirements beyond those imposed by state law.</P>
                <HD SOURCE="HD2">C. Regulatory Flexibility Act (RFA)</HD>
                <P>I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities beyond those imposed by state law.</P>
                <HD SOURCE="HD2">D. Unfunded Mandates Reform Act (UMRA)</HD>
                <P>This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action does not impose additional requirements beyond those imposed by state law. Accordingly, no additional costs to State, local, or Tribal Governments, or to the private sector, will result from this action.</P>
                <HD SOURCE="HD2">E. Executive Order 13132: Federalism</HD>
                <P>This action does not have federalism implications. 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.</P>
                <HD SOURCE="HD2">F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</HD>
                <P>This action does not have tribal implications as specified in Executive Order 13175, because this action does not apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, and will not impose substantial direct compliance costs on Tribal Governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this action.</P>
                <HD SOURCE="HD2">G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks</HD>
                <P>
                    The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive order. This action is not subject to Executive Order 13045 because it does impose additional requirements beyond those imposed by state law.
                    <PRTPAGE P="34096"/>
                </P>
                <HD SOURCE="HD2">H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use</HD>
                <P>This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.</P>
                <HD SOURCE="HD2">I. National Technology Transfer Advancement Act (NTTAA)</HD>
                <P>This rule does not involve technical standards.</P>
                <HD SOURCE="HD2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations</HD>
                <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 minority populations and low-income populations to the greatest extent practicable and permitted by law. EPA defines environmental justice (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.” 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.”</P>
                <P>The EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action because the EPA is performing a non-discretionary duty to find that a required State submission was not timely submitted, and there is no information in the record inconsistent with the stated goals of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and indigenous peoples.</P>
                <HD SOURCE="HD2">K. Congressional Review Act (CRA)</HD>
                <P>This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).</P>
                <HD SOURCE="HD2">L. Petitions for Judicial Review</HD>
                <P>Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 25, 2023. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Administrative practice and procedures, Air pollution control, Approval and promulgation of implementation plans, Incorporation by reference, Intergovernmental relations, Particulate matter, and Reporting and recordkeeping requirements.</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: May 19, 2023.</DATED>
                    <NAME>Martha Guzman Aceves,</NAME>
                    <TITLE>Regional Administrator, Region IX.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11317 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">GENERAL SERVICES ADMINISTRATION</AGENCY>
                <CFR>48 CFR Part 552</CFR>
                <DEPDOC>[GSAR-TA-2023-02; Docket No. GSA-GSAR-2023-0014; Sequence No. 1]</DEPDOC>
                <SUBJECT>General Services Administration Acquisition Regulation (GSAR); Personal Identity Verification Requirements Clause Reference; Correcting Amendment</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Acquisition Policy, General Services Administration (GSA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Correcting amendment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The General Services Administration published GSAR-TA-2023-02, Technical Amendment in the 
                        <E T="04">Federal Register</E>
                         on May 19, 2023. There was an error in the amendatory instruction 2, and the amendment couldn't be incorporated. GSA is publishing this new document to correct the error.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective May 26, 2023.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For clarification of content, contact Mr. Clarence Harrison at 
                        <E T="03">GSARPolicy@gsa.gov</E>
                         or 202-227-7051. For information pertaining to status or publication schedules, contact the Regulatory Secretariat Division at 
                        <E T="03">GSARegSec@gsa.gov</E>
                         or 202-501-4755.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    In rule FR Dec. 2023-10669, published in the 
                    <E T="04">Federal Register</E>
                     at 88 FR 32142, on May 19, 2023, amendatory instruction 2 for GSAR 552.204-9 incorrectly referenced paragraph (b) when the web link is actually in paragraph (a). This correcting amendment fixes the error.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 48 CFR Part 552</HD>
                    <P>Government procurement.</P>
                </LSTSUB>
                <P>Therefore, GSA amends 48 CFR part 552 by making the following correcting amendment:</P>
                <PART>
                    <HD SOURCE="HED">PART 552—SOLICITATION PROVISIONS AND CONTRACT CLAUSES</HD>
                </PART>
                <REGTEXT TITLE="48" PART="552">
                    <AMDPAR>1. The authority citation for 48 CFR part 552 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 40 U.S.C. 121(c).</P>
                    </AUTH>
                </REGTEXT>
                <SECTION>
                    <SECTNO>552.204-9</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="48" PART="552">
                    <AMDPAR>
                        2. Amend section 552.204-9 in paragraph (a) of the clause by removing the web link “
                        <E T="03">https://www.gsa.gov/hspd12</E>
                        ” and adding “
                        <E T="03">https://www.gsa.gov/resources/for-federal-employees/access-gsa-facilities-and-systems-with-a-piv-card</E>
                        ” in its place.
                    </AMDPAR>
                </REGTEXT>
                <SIG>
                    <NAME>Jeffrey A. Koses,</NAME>
                    <TITLE>Senior Procurement Executive, Office of Acquisition Policy, Office of Government-wide Policy, General Services Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11249 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-61-P</BILCOD>
        </RULE>
    </RULES>
    <VOL>88</VOL>
    <NO>102</NO>
    <DATE>Friday, May 26, 2023</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <PRORULES>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="34097"/>
                <AGENCY TYPE="F">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2023-1051; Project Identifier MCAI-2022-01565-T]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Airbus SAS Airplanes</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 adopt a new airworthiness directive (AD) for all Airbus SAS Model A320-200 series airplanes, Model A330-200 Freighter series airplanes, Model A330-300 series airplanes, Model A340-200 series airplanes, and Model A340-300 series airplanes. This proposed AD was prompted by a report that certain overheat detection system (OHDS) sensing elements, produced before January 31, 2021, may not properly detect thermal bleed leak events due to a quality escape during the manufacturing process. This proposed AD would require a one-time special detailed inspection (SDI) for discrepancies of each affected part installed at an affected position, and replacement of discrepant parts, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference (IBR). This proposed AD would also prohibit the installation of affected parts. 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 proposed AD by July 10, 2023.</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-2023-1051; 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 material that is proposed for IBR in this NPRM, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +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>
                         It is also available at 
                        <E T="03">regulations.gov</E>
                         under Docket No. FAA-2023-1051.
                    </P>
                    <P>
                        • For Kidde Aerospace &amp; Defense service information identified in this NPRM, contact Kidde Aerospace &amp; Defense, 4200 Airport Drive NW, Building B, Wilson, NC 27896; telephone 319-295-5000; website 
                        <E T="03">kiddetechnologies.com/aviation.com.</E>
                    </P>
                    <P>• You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Vladimir Ulyanov, Aerospace Engineer, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-2313229; email 
                        <E T="03">Vladimir.Ulyanov@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <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 
                    <E T="02">ADDRESSES</E>
                    . Include “Docket No. FAA-2023-1051; Project Identifier MCAI-2022-01565-T” 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 this 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 Vladimir Ulyanov, Aerospace Engineer, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3229; email 
                    <E T="03">Vladimir.Ulyanov@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>
                    EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2022-0243, dated December 8, 2022 (EASA AD 2022-0243) (also referred to as the MCAI), to correct an unsafe condition for all Airbus SAS Model A320-200 series airplanes, Model A330-200 Freighter series airplanes, Model A330-300 series airplanes, Model A340-200 
                    <PRTPAGE P="34098"/>
                    series airplanes, and Model A340-300 series airplanes. The MCAI states that the affected part manufacturer, Kidde Aerospace &amp; Defense, reported that certain OHDS sensing elements, produced before January 31, 2021, may not properly detect thermal bleed leak events due to a quality escape during the manufacturing process. This condition, if not addressed, could lead to an air leak remaining undetected by the OHDS and not being isolated during flight, possibly resulting in localized areas of the airplane being exposed to high temperatures, with consequent reduced structural integrity of the airplane.
                </P>
                <P>The FAA is proposing this AD to address the unsafe condition on these products.</P>
                <P>
                    You may examine the MCAI in the AD docket at 
                    <E T="03">regulations.gov</E>
                     under Docket No. FAA-2023-1051.
                </P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>EASA AD 2022-0243 specifies procedures for a one-time SDI for discrepancies of each affected part installed at an affected position, and replacement of discrepant parts where the displayed electronic centralized aircraft monitoring (ECAM) warning is not related to results of a heat gun test at certain locations. EASA AD 2022-0243 also prohibits the installation of affected parts.</P>
                <P>The FAA reviewed Kidde Aerospace &amp; Defense Service Bulletin CFD-26-3, dated January 13, 2022; and Revision 1, dated March 29, 2022, which identify affected OHDS sensing elements (those having certain part numbers and corresponding date codes). These documents are distinct because Revision 1 corrects typographical errors and clarifies wording.</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 
                    <E T="02">ADDRESSES</E>
                    .
                </P>
                <HD SOURCE="HD1">FAA's Determination</HD>
                <P>This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop in other products of the same type design.</P>
                <HD SOURCE="HD1">Proposed AD Requirements in This NPRM</HD>
                <P>This proposed AD would require accomplishing the actions specified in EASA 2022-0243 described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD. This proposed AD would also prohibit the installation of affected parts.</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 2022-0243 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2022-0243 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 in EASA AD 2022-0243 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 2022-0243. Service information required by EASA AD 2022-0243 for compliance will be available at 
                    <E T="03">regulations.gov</E>
                     under Docket No. FAA-2023-1051 after the FAA final rule is published.
                </P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD, if adopted as proposed, would affect 119 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12C,12C,12C">
                    <TTITLE>Estimated Costs for Required Actions</TTITLE>
                    <BOXHD>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                        <CHED H="1">
                            Cost on U.S.
                            <LI>operators</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Up to 64 work-hours × $85 per hour = $5,440</ENT>
                        <ENT>$0</ENT>
                        <ENT>$5,440</ENT>
                        <ENT>$647,360</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The FAA estimates the following costs to do any necessary on-condition actions that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need these on-condition actions:</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,12C,12C">
                    <TTITLE>Estimated Costs of On-Condition Actions</TTITLE>
                    <BOXHD>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">13 work-hours × $85 per hour = $1,105</ENT>
                        <ENT>(*)</ENT>
                        <ENT>$1,105</ENT>
                    </ROW>
                    <TNOTE>* The FAA has received no definitive data on which to base the parts cost.</TNOTE>
                </GPOTABLE>
                <P>The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators.</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.
                    <PRTPAGE P="34099"/>
                </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 this 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 adding the following new airworthiness directive:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">Airbus SAS:</E>
                         Docket No. FAA-2023-1051; Project Identifier MCAI-2022-01565-T.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this airworthiness directive (AD) by July 10, 2023.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>None.</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to all Airbus SAS airplanes specified in paragraphs (c)(1) through (5) of this AD, certificated in any category.</P>
                    <P>(1) Model A330-201, -202, -203, -223, and -243 airplanes.</P>
                    <P>(2) Model A330-223F and -243F airplanes.</P>
                    <P>(3) Model A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.</P>
                    <P>(4) Model A340-211, -212, and -213 airplanes.</P>
                    <P>(5) Model A340-311, -312, and -313 airplanes.</P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Air Transport Association (ATA) of America Code 36, Pneumatic.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>This AD was prompted by a report that certain overheat detection system (OHDS) sensing elements, produced before January 31, 2021, may not properly detect the thermal bleed leak events due to a quality escape during the manufacturing process. The FAA is issuing this AD to address an air leak remaining undetected by the OHDS sensing element and not being isolated during flight. The unsafe condition, if not addressed, could possibly result in localized areas of the airplane being exposed to high temperatures, with consequent reduced structural integrity of the airplane.</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 paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation Safety Agency (EASA) AD 2022-0243, dated December 8, 2022 (EASA AD 2022-0243).</P>
                    <HD SOURCE="HD1">(h) Exceptions to EASA AD 2022-0243</HD>
                    <P>(1) Where EASA AD 2022-0243 refers to its effective date, this AD requires using the effective date of this AD.</P>
                    <P>(2) This AD does not adopt the “Remarks” section of EASA AD 2022-0243.</P>
                    <P>(3) Where EASA AD 2022-0243 defines “affected part” and refers to “the VSB,” for the part numbers and date codes, for this AD, use Kidde Aerospace &amp; Defense Service Bulletin CFD-26-3, dated January 13, 2022; or Revision 1, dated March 29, 2022, as “the VSB” for the part numbers and date codes.</P>
                    <P>(4) Where EASA AD 2022-0243 defines Groups, replace the text “the SB” with “Airbus Service Bulletin A330-36-3052, dated June 27, 2022; or Airbus SB A340-36-4036, dated June 27, 2022; as applicable.”</P>
                    <P>(5) Where paragraph (2) of EASA AD 2022-0234 specifies action if “any discrepancy as defined in the SB is detected,” for this AD a discrepancy is when the displayed electronic centralized aircraft monitoring (ECAM) warning is not related to results of a heat gun test at certain location.</P>
                    <HD SOURCE="HD1">(i) No Reporting Requirement and No Return of Parts</HD>
                    <P>(1) Although the service information referenced in EASA AD 2022-0243 specifies to submit certain information to the manufacturer, this AD does not include that requirement.</P>
                    <P>(2) Although the service information referenced in EASA AD 2022-0243 specifies to return certain parts to the manufacturer, this AD does not include that requirement.</P>
                    <HD SOURCE="HD1">(j) Additional AD Provisions</HD>
                    <P>The following provisions also apply to this AD:</P>
                    <P>
                        (1) 
                        <E T="03">Alternative Methods of Compliance (AMOCs):</E>
                         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 responsible Flight Standards Office, as appropriate. If sending information directly to the International Validation Branch, send it to the attention of the person identified in paragraph (k) of this AD. Information may be emailed to: 
                        <E T="03">9-AVS-AIR-730-AMOC@faa.gov.</E>
                         Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Contacting the Manufacturer:</E>
                         For any requirement in this AD to obtain instructions from a manufacturer, the instructions must be accomplished using a method approved by the Manager, International Validation Branch, FAA; or EASA; Airbus SAS's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Required for Compliance (RC):</E>
                         Except as required by paragraph (j)(2) of this AD, if any service information contains procedures or tests that are identified as RC, those procedures and tests must be done to comply with this AD; any procedures or tests that are not identified as RC are recommended. Those procedures and tests that are not identified as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the procedures and tests identified as RC can be done and the airplane can be put back in an airworthy condition. Any substitutions or changes to procedures or tests identified as RC require approval of an AMOC.
                    </P>
                    <HD SOURCE="HD1">(k) Additional Information</HD>
                    <P>
                        For more information about this AD, contact Vladimir Ulyanov, Aerospace Engineer, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone 206-231-3229; email 
                        <E T="03">Vladimir.Ulyanov@faa.gov.</E>
                    </P>
                    <HD SOURCE="HD1">(l) Material Incorporated by Reference</HD>
                    <P>(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                    <P>
                        (2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
                        <PRTPAGE P="34100"/>
                    </P>
                    <P>(i) European Union Aviation Safety Agency (EASA) AD 2022-0243, dated December 8, 2022.</P>
                    <P>(ii) Kidde Aerospace &amp; Defense Service Bulletin CFD-26-3, dated January 13, 2022.</P>
                    <P>(iii) Kidde Aerospace &amp; Defense Service Bulletin CFD-26-3, Revision 1, dated March 29, 2022.</P>
                    <NOTE>
                        <HD SOURCE="HED">Note 1 to paragraph (l)(2)(iii):</HD>
                        <P> The revision level of this document is identified on only the transmittal page; no other page of the document contains this information.</P>
                    </NOTE>
                    <P>
                        (3) For EASA AD 2022-0243, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +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 EASA AD on the EASA website at 
                        <E T="03">ad.easa.europa.eu.</E>
                    </P>
                    <P>
                        (4) For Kidde Aerospace &amp; Defense service information identified in this AD, contact Kidde Aerospace &amp; Defense, 4200 Airport Drive, NW, Building B, Wilson, NC 27896; telephone 319-295-5000; website 
                        <E T="03">kiddetechnologies.com/aviation.com.</E>
                    </P>
                    <P>(5) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.</P>
                    <P>
                        (6) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email 
                        <E T="03">fr.inspection@nara.gov,</E>
                         or go to: 
                        <E T="03">www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                    </P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued on May 22, 2023.</DATED>
                    <NAME>Michael Linegang, Acting Director,</NAME>
                    <TITLE>Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11233 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF EDUCATION</AGENCY>
                <CFR>34 CFR Part 300</CFR>
                <DEPDOC>[Docket ID ED-2023-OSERS-0052]</DEPDOC>
                <RIN>RIN 1820-AB82</RIN>
                <SUBJECT>Assistance to States for the Education of Children With Disabilities; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Special Education and Rehabilitative Services, Department of Education.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule; correction.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        On May 18, 2023, the Department of Education (Department) published in the 
                        <E T="04">Federal Register</E>
                         a notice of proposed rulemaking (NPRM) to amend regulations under Part B of the Individuals with Disabilities Education Act (Part B of IDEA or the Act) that govern the Assistance to States for the Education of Children with Disabilities program, including the Preschool Grants program. We are correcting the Docket ID used for submitting public comments. All other information in the NPRM remains the same.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This correction is applicable May 26, 2023.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Rebecca Walawender, U.S. Department of Education, 400 Maryland Avenue SW, Room 5130, Potomac Center Plaza, Washington, DC 20202-5076. Telephone: (202) 245-7399. Email: 
                        <E T="03">Rebecca.Walawender@ed.gov.</E>
                    </P>
                    <P>If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On May 18, 2023, we published the NPRM in the 
                    <E T="04">Federal Register</E>
                     (88 FR 31659) with a Docket ID of ED-2022-OSERS-0052. We are correcting the NPRM to reflect the correct Docket ID ED-2023-OSERS-0052.
                </P>
                <P>Other than correcting the Docket ID, all other information in the NPRM remains the same.</P>
                <P>
                    <E T="03">Program Authority:</E>
                     20 U.S.C. 1221e-3, 1406, 1411- 1419, and 3474; Pub. L. 111-256, 124 Stat. 2643.
                </P>
                <P>
                    <E T="03">Correction:</E>
                </P>
                <P>
                    In FR Doc. 2023-10542, appearing on page 31659 of the 
                    <E T="04">Federal Register</E>
                     of May 18, 2023 (88 FR 31659), we make the following correction:
                </P>
                <P>On page 31659, in the right column, below the heading “34 CFR part 300”, remove “[Docket ID ED-2022-OSERS-0052]” and add, in its place, “[Docket ID ED-2023-OSERS-0052]”.</P>
                <P>
                    <E T="03">Accessible Format:</E>
                     On request to the program contact person listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    , individuals with disabilities can obtain this document and the NPRM in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (TXT), a thumb drive, an MP3 file, braille, large print, audiotape, or compact disc, or other accessible format.
                </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>
                    . You may access the official edition of the 
                    <E T="04">Federal Register</E>
                     and the Code of Federal Regulations at 
                    <E T="03">www.govinfo.gov.</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 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>
                <SIG>
                    <NAME>Miguel A. Cardona,</NAME>
                    <TITLE>Secretary of Education.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11256 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Parts 720, 721, 723, and 725</CFR>
                <DEPDOC>[EPA-HQ-OPPT-2022-0902; FRL-7906-01-OCSPP]</DEPDOC>
                <RIN>RIN 2070-AK65</RIN>
                <SUBJECT>Updates to New Chemicals Regulations Under the Toxic Substances Control Act (TSCA)</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 United States Environmental Protection Agency (EPA) is proposing amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). These amendments are intended to align the regulatory text with the amendments to TSCA's new chemicals review provisions contained in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted on June 22, 2016, improve the efficiency of EPA's review processes, and update the regulations based on existing policies and experience implementing the New Chemicals Program. The proposal includes amendments that would reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review. EPA is also proposing several amendments to the regulations for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA's 1999 PBT policy.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before July 25, 2023.</P>
                </EFFDATE>
                <ADD>
                    <PRTPAGE P="34101"/>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2022-0902 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 or 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 technical information contact:</E>
                         Tyler Lloyd, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4016; email address: 
                        <E T="03">lloyd.tyler@epa.gov.</E>
                    </P>
                    <P>
                        <E T="03">For general information contact:</E>
                         The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: 
                        <E T="03">TSCA-Hotline@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. Executive Summary</HD>
                <HD SOURCE="HD2">A. Does this action apply to me?</HD>
                <P>You may be potentially affected by this action if you intend to manufacture a new chemical substance, or manufacture or process a chemical substance for a significant new use. The following list of North American Industry Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:</P>
                <P>• Chemical Manufacturers (NAICS code 325).</P>
                <P>• Petroleum and Coal Products (NAICS code 324).</P>
                <P>• Merchant Wholesalers, Nondurable Goods (NAICS code 424).</P>
                <P>
                    If you have any questions regarding the applicability of this action, please consult the technical person listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    .
                </P>
                <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD>
                <P>
                    Section 5(a)(1) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2604(a)(1), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016 (Pub. L. 114-182) (herein referred to as the “2016 Lautenberg Amendments”), provides that no person, as defined at 40 CFR 720.3, may manufacture (which includes import under TSCA) a new chemical substance or manufacture or process a chemical substance for a use which EPA has determined is a significant new use, unless at least 90 days prior to such manufacture or processing that person submits a notice to EPA containing the information required by TSCA section 5(d). EPA must conduct a review of the notice, make one of five possible determinations pertaining to the likelihood of unreasonable risk of injury to health or the environment, and take any actions required as a result of that determination, all within the applicable review period. The submitted notice must include the information described in TSCA section 5(d)(1): insofar as known to the submitter or reasonably ascertainable, information described in certain provisions of TSCA section 8(a)(2) (
                    <E T="03">e.g.,</E>
                     chemical identity, use, and exposure information); in the form and manner prescribed by EPA, information in the possession or control of the submitter related to the health or environmental effects of the chemical substance; and a description of any other information concerning the environmental and health effects of the chemical substance, insofar as known to the submitter or reasonably ascertainable. EPA is issuing this proposed rule under TSCA section 5, 15 U.S.C. 2604.
                </P>
                <HD SOURCE="HD2">C. What action is the Agency taking?</HD>
                <P>When EPA receives a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN), the Agency is required to assess the risk associated with the new chemical substance or significant new use that is the subject of the notice under the conditions of use and make a determination for the chemical substance pertaining to the likelihood of such risk. Under TSCA, the term “chemical substance” includes microorganisms. To improve the effectiveness and efficiency of these reviews, EPA is proposing to amend the procedural regulations at 40 CFR parts 720, 721, and 725 to align with the requirements in TSCA section 5, as amended by the 2016 Lautenberg Amendments, and to make additional updates. In particular, EPA is proposing to amend the regulations to specify that EPA must make a determination on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing of the chemical substance that is the subject of the notice, and to list the five possible determinations and the actions required in association with those determinations. In addition, EPA is proposing to clarify the level of detail expected for the information that a submitter is required to include in a PMN, SNUN, or exemption notice in order for the notice to be considered complete. EPA is also proposing amendments to the procedures for reviewing PMNs and SNUNs; specifically, procedures for addressing PMNs and SNUNs that have errors or are incomplete or that are amended during the applicable review period. Additionally, EPA is proposing to make several amendments to the regulations at 40 CFR 723.50 for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs). These amendments would require EPA approval of an exemption notice before the submitter may commence manufacture, allow EPA to inform an LVE or LoREX holder when the chemical substance that is the subject of the exemption becomes subject to a significant new use rule (SNUR) under TSCA and the chemical identity is confidential, make perfluoroalkyl and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and codify EPA's use of the 1999 PBT policy for these exemptions by making certain PBTs ineligible for these exemptions. Finally, EPA is proposing to amend the regulations pertaining to suspensions for all TSCA section 5 notices to allow submitters to request suspensions for up to 30 days via oral or email request.</P>
                <HD SOURCE="HD2">D. Why is the Agency taking this action?</HD>
                <P>
                    Under amended TSCA, EPA must review all notices submitted under TSCA section 5(a)(1) and make a determination pertaining to the risks of new chemical substances or significant new uses of chemical substances described in such notices before they can proceed to the marketplace. Before the 2016 Lautenberg Amendments, TSCA allowed the PMN submitter to commence manufacturing or processing upon expiration of the review period, unless EPA made an affirmative finding of unreasonable risk. Under amended TSCA, EPA must review all notices submitted under TSCA section 5(a)(1) and make a determination pertaining to the risks of every new chemical substance or significant new use of chemical substances described in such notices before they can proceed to the marketplace. To reflect and better meet these requirements, EPA is proposing to align the procedural regulations codified at 40 CFR parts 720 and 725 with amended TSCA and to make additional updates based on existing policies or lessons learned from 
                    <PRTPAGE P="34102"/>
                    administering the New Chemicals Program since TSCA was amended in 2016.
                </P>
                <P>EPA is also proposing to clarify the information that is required to be included in PMNs, SNUNs, and exemption notices and to clarify EPA review procedures to make the review process more efficient, promote more complete submissions, and reduce the need to redo all or part of the risk assessment (“re-work”) due to late submissions of information that delay EPA review of PMNs, SNUNs, and exemption notices. In order to continue to meet amended TSCA's requirement for the Agency to make determinations for all PMNs and SNUNs within an applicable review period of 90 days from receipt (or up to 180 days with an extension), EPA needs to identify and implement efficiencies in the PMN and SNUN review process, ensure notices are complete and reduce re-work of risk assessments. This action, if finalized, is expected to reduce re-work of risk assessments by minimizing requests from submitters to amend their PMNs, SNUNs, or exemption notices with additional information after the review period has commenced. The Agency is also proposing to clarify the procedures that will be employed if submitters amend their PMNs or SNUNs during the applicable review period.</P>
                <P>EPA is also proposing to amend the regulations for LVEs and LoREXs so that submitters may not commence manufacture until EPA has issued a decision for the exemption notice, to better ensure that manufacture under LVEs and LoREXs will not present an unreasonable risk. Additionally, EPA is proposing amendments that would allow the Agency to notify submitters if a chemical substance for which they hold an LVE or LoREX becomes subject to a proposed or final SNUR and the chemical identity is confidential, so that chemical manufacturers are made aware that they may be subject to additional TSCA requirements.</P>
                <P>EPA is also proposing to make PFAS categorically ineligible for an LVE or LoREX, which would ensure that all new PFAS are reviewed through the full PMN process. In addition, EPA is proposing to codify EPA's 1999 PBT policy by making certain PBTs ineligible for these exemptions.</P>
                <P>Lastly, EPA is proposing to allow informal (oral or email) requests for review period suspensions of up to 30 days to reduce the number of repeated requests for 15-day suspensions, and because EPA believes that email may be more expedient than oral communication for many submitters.</P>
                <HD SOURCE="HD2">E. What are the estimated incremental impacts of this action?</HD>
                <P>EPA has evaluated the potential incremental impacts of this rulemaking in an economic analysis (EA), titled “Economic Analysis for the Proposed Rule: Updates to New Chemicals Regulations under the Toxic Substances Control Act” (Ref. 1), which is available in the docket, discussed in Unit IV, and briefly summarized here. The benefits of the rule include increased efficiency in both the submission and review processes for notices submitted through the PMN form. The changes under this proposed rule would clarify the information requirements on the PMN form in the Agency's Central Data Exchange (CDX) to make more transparent the level of detail that EPA needs in order to make a reasoned evaluation. As submitters provide more complete information in their initial submissions, the changes under this proposed rule are expected to reduce the frequency with which PMNs, SNUNs, and exemption notices are amended with additional information and the amount of re-work of risk assessments that the Agency conducts following such amendments.</P>
                <P>As a result of the changes presented in this proposed rule, the total annual burden to industry is expected to decrease by approximately 4,518 hours, while total annual costs to industry submitters are expected to have a net increase of $45,120. The Agency is expected to experience an annual cost savings of approximately $923,280.</P>
                <HD SOURCE="HD2">F. What should I consider as I prepare my comments for EPA?</HD>
                <HD SOURCE="HD3">1. Submitting CBI</HD>
                <P>
                    Do not submit CBI 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>
                <HD SOURCE="HD3">2. Tips for Preparing Your Comments</HD>
                <P>
                    When preparing and submitting your comments, see the commenting tips at 
                    <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E>
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>As enacted in 1976, TSCA provided EPA with authority to require reporting, recordkeeping, and testing, and to issue restrictions relating to chemical substances and/or mixtures. TSCA section 5(a)(1) required that a person submit to EPA a notice at least 90 days before commencing manufacture of a new chemical substance or manufacture or processing of a chemical substance for a use which EPA determined to be a significant new use. TSCA section 5(e) provided that EPA could issue a proposed order to regulate a chemical substance for which a notice was submitted under TSCA section 5(a)(1) if it determined that: (1) the information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance, and (2) the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance may present an unreasonable risk of injury to health or the environment in the absence of sufficient information, or the chemical substance is or will be produced in substantial quantities and may either enter the environment in substantial quantities or result in significant or substantial human exposure. Further, TSCA section 5(f) required EPA to issue a proposed rule or proposed order to regulate the chemical substance, or to seek an injunction to prohibit the manufacture, processing, or distribution in commerce of the chemical substance, if it found that there is a reasonable basis to conclude that the chemical substance presents or will present an unreasonable risk of injury to health or the environment.</P>
                <P>Under the 1976 law, EPA was not obligated to make a determination or finding regarding unreasonable risk for each notice submitted under TSCA section 5(a)(1). However, if EPA decided to take action under TSCA section 5(e) or 5(f), TSCA required EPA to do so within 90 days of receiving the notice (or up to 180 days if EPA extended the notice period pursuant to TSCA section 5(c)). If EPA did not take action during that time, manufacturing or processing of the chemical substance could commence.</P>
                <P>
                    EPA's obligations with respect to making determinations on notices submitted under TSCA section 5(a)(1) fundamentally changed with the passage of the 2016 Lautenberg Amendments. The 2016 Lautenberg Amendments added a new paragraph to TSCA at section 5(a)(3) titled “Review and Determination,” under which EPA must review and make a determination 
                    <PRTPAGE P="34103"/>
                    pertaining to the likelihood of risk on all notices received under TSCA section 5(a)(1), which include PMNs, SNUNs and MCANs, within the applicable review period and lists five types of risk determinations available to EPA.
                </P>
                <P>EPA's obligation to take action after making a determination on a notice submitted under TSCA section 5(a)(1) also changed with the passage of the 2016 Lautenberg Amendments. Under amended TSCA, EPA is required to issue an order pursuant to TSCA section 5(e) when it makes a determination under TSCA section 5(a)(3)(B) that: (1) the information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance or significant new use; (2) in the absence of sufficient information, the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance may present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation (PESS) identified as relevant by EPA; or (3) the chemical substance is or will be produced in substantial quantities and may either enter the environment in substantial quantities or result in significant or substantial human exposure. EPA must issue an order to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance to the extent necessary to protect against an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA under the conditions of use.</P>
                <P>Furthermore, TSCA section 5(f) requires EPA to issue either an order or a proposed rule under TSCA section 6(a) when EPA makes a determination under TSCA section 5(a)(3)(A) that a chemical substance or significant new use presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA under the conditions of use. If EPA issues an order under TSCA sections 5(e) or 5(f), it must do so no later than 45 days before the expiration of the applicable review period.</P>
                <P>
                    Lastly, when EPA makes a determination under TSCA section 5(a)(3)(C) that a chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA under the conditions of use, EPA must publish a statement of its finding in the 
                    <E T="04">Federal Register</E>
                     according to TSCA section 5(g).
                </P>
                <P>
                    In summary, the 2016 Lautenberg Amendments require EPA to review each notice submitted under TSCA section 5(a)(1), make a determination on that notice, and take the action required in association with that determination within the applicable review period. Under TSCA section 5(i)(3), the “applicable review period” means 90 days from the date EPA receives a notice under TSCA section 5(a)(1), or up to 180 days from that date if EPA extends the applicable review period according to the provisions in TSCA section 5(c). TSCA section 5(c) allows EPA to extend the original 90-day review period by up to another 90 days for good cause and requires the reasons for the extension to be published in the 
                    <E T="04">Federal Register</E>
                    . The 2016 Lautenberg Amendments also added TSCA section 5(a)(4) explaining that a failure by EPA to render a determination within the applicable review period would not relieve EPA of any requirement to make such determination, but would, with certain exceptions, result in a fee refund to the notice submitter.
                </P>
                <P>TSCA section 5(h) was not significantly amended by the 2016 Lautenberg Amendments. TSCA section 5(h) provides EPA the authority to exempt a person from certain TSCA section 5 requirements under certain situations, such as if the person will manufacture the chemical substance for test marketing purposes, in small quantities for scientific experimentation, or under other conditions that will not present an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified by EPA under the conditions of use. EPA developed the LVE and LoREX regulations in 1995 pursuant to TSCA section 5(h)(4) (60 FR 16336, March 29, 1995).</P>
                <P>EPA's regulations related to TSCA section 5 are codified in Title 40, Chapter I, Subchapter R of the Code of Federal Regulations (CFR). They include:</P>
                <P>• Regulations related to PMNs, which are codified at 40 CFR part 720;</P>
                <P>• Regulations pertaining to SNUNs, which are codified at 40 CFR part 721;</P>
                <P>• Regulations pertaining to certain exemptions, which are codified at 40 CFR part 723; and</P>
                <P>• Regulations pertaining to MCANs and microorganism-related exemptions, which are codified at 40 CFR part 725.</P>
                <P>The information requirements codified for PMNs in 40 CFR 720.45 generally also apply to SNUNs under 40 CFR part 721 (see 40 CFR 721.1(c) and 721.25(a), which cross-references 40 CFR part 720) and to LVEs and LoREXs submitted under 40 CFR 723.50 (see 40 CFR 723.50(e)(2), which cross-references 40 CFR 720.45). As a result, the proposed amendments to the requirements in 40 CFR 720.45 would apply to PMNs and also to SNUNs, LVEs, and LoREXs. The review procedures for PMNs codified in 40 CFR part 720 generally also apply to SNUNs under 40 CFR part 721 (see 40 CFR 721.25(c)) but not to exemptions under 40 CFR part 723, so the amendments to the part 720 review procedures proposed in this action would apply to PMNs and also to SNUNs but not to such exemptions. Neither the information requirements nor the review procedures in 40 CFR part 720 apply to MCANs or microorganism-related exemptions under 40 CFR part 725, so EPA is also proposing amendments to the MCAN and microorganism-related exemption regulations at 40 CFR part 725.</P>
                <HD SOURCE="HD1">III. Summary of Proposed Rule</HD>
                <HD SOURCE="HD2">A. Amendments To Conform Regulations to 2016 Lautenberg Amendments</HD>
                <P>
                    EPA is proposing changes to the PMN procedural regulations at 40 CFR part 720 to align them with the notice review and determination requirements in TSCA section 5, as amended by the 2016 Lautenberg Amendments. These procedural regulations also generally apply to SNUNs under 40 CFR part 721 (see 40 CFR 721.1(c) and 721.25(c)). EPA is also proposing similar changes to the MCAN procedural regulations at 40 CFR part 725 to align them with the same notice review and determination requirements added by the 2016 Lautenberg Amendments. EPA has been implementing the amended statutory requirements but has not yet codified these updates into the new chemicals procedural regulations. The Agency is now proposing to amend the regulations to specify that EPA must make a determination on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing (which includes importing) or processing and to list the five possible determinations and the 
                    <PRTPAGE P="34104"/>
                    actions required in association with those determinations. EPA is also proposing to add definitions for new terms and to update existing terminology introduced by the 2016 Lautenberg Amendments.
                </P>
                <HD SOURCE="HD3">1. Commencement of Manufacture or Processing</HD>
                <P>Prior to the passage of the 2016 Lautenberg Amendments, TSCA did not require EPA to make a risk determination on each notice submitted under TSCA section 5(a)(1). Rather, TSCA required the submission of a notice at least 90 days before manufacturing a new chemical substance, or manufacturing or processing a chemical substance for a significant new use. If EPA did not take any regulatory action on a notice, the submitter could commence the manufacturing or processing after 90 days (or up to 180 days if EPA extended the notice period pursuant to TSCA section 5(c)). Promulgated in 1983, the PMN procedural regulation at 40 CFR 720.75(d) reflects that prior statutory provision and states that “in the absence of regulatory action by EPA under section 5(e), 5(f), or 6(a) of the Act, the submitter may manufacture or import the chemical substance even if the submitter has not received notice of expiration [of the review period].” A similar provision was promulgated in the MCAN procedural regulations in 1997 at 40 CFR 725.170(b) and (c).</P>
                <P>The 2016 Lautenberg Amendments changed the requirements of TSCA section 5(a) by adding section 5(a)(1)(B)(ii) and (a)(3), which require EPA to conduct a review of each notice submitted under TSCA section 5(a)(1), make a determination on the notice, and take the action required in association with that determination before a submitter can commence the manufacture of a new chemical substance or the manufacture or processing of a chemical substance for a significant new use. Since amended TSCA went into effect, EPA has been implementing the new law by making a determination and taking any required action on each PMN, SNUN, and MCAN received. However, the outdated regulatory text at 40 CFR 720.75(d) and 725.170(b) and (c) is still in place, even though it has been superseded by the amendments to the statute.</P>
                <P>Therefore, in this action, EPA is proposing to amend 40 CFR 720.75(d) by removing the outdated language allowing the submitter to commence manufacture of a chemical substance when the review period expires and adding new language specifying that EPA must issue a determination and take any required action on each PMN before manufacture may commence. EPA is also proposing to amend 40 CFR 721.25(d) to state that any person submitting a SNUN shall not manufacture or process a chemical substance for a significant new use until EPA has issued a determination with respect to the significant new use and taken the actions required in association with that determination. Likewise, EPA is proposing to amend 40 CFR 725.170(b) and (c) by removing similar outdated language allowing the submitter to commence manufacture of a new microorganism or manufacture or processing of a microorganism for a significant new use when the review period expires and adding new language specifying that EPA must issue a determination and take any required action on each MCAN before manufacture may commence.</P>
                <HD SOURCE="HD3">2. Required Determinations and Associated Actions</HD>
                <P>As previously described, the 2016 Lautenberg Amendments added a new paragraph at TSCA section 5(a)(3) titled “Review and Determination,” which lists the five possible determinations that EPA may make on a notice. To improve clarity and help inform the regulated community about EPA's statutory obligations under TSCA section 5(a)(3), EPA is proposing to further amend 40 CFR 720.75(d) and 725.170 by listing the five possible determinations for each PMN, SNUN, or MCAN.</P>
                <P>EPA is also proposing to add language to 40 CFR 720.75(d) and 725.170(b) to describe the actions that EPA must take in association with its determination for a PMN, SNUN, or MCAN. EPA is proposing to codify those actions, which EPA has been implementing, as applicable, for every PMN, SNUN, and MCAN since the 2016 Lautenberg Amendments, to be clear about EPA's review process to the public. The five possible determinations and associated actions are as follows:</P>
                <P>
                    • When EPA makes a determination for a PMN, SNUN, or MCAN according to TSCA section 5(a)(3)(C) that the new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA under the conditions of use, EPA issues a determination document to the submitter of the PMN, SNUN, or MCAN. The submitter may commence manufacturing or processing of the chemical substance once they receive the determination document. As required by TSCA section 5(g), EPA also submits for publication in the 
                    <E T="04">Federal Register</E>
                     a statement of the “not likely” finding.
                </P>
                <P>• When EPA makes a determination for a PMN, SNUN, or MCAN according to TSCA section 5(a)(3)(B) that (1) the information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the new chemical substance or significant new use, (2) in the absence of sufficient information, the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance may present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA, or (3) the chemical substance is or will be produced in substantial quantities and may either enter the environment in substantial quantities or result in significant or substantial human exposure, EPA must issue an order pursuant to TSCA section 5(e). The order prohibits or limits the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance to the extent necessary to protect against an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA under the conditions of use. EPA may issue an order under TSCA section 5(e) that requires testing to be conducted and presented to EPA after the applicable review period has concluded.</P>
                <P>
                    • When EPA makes a determination for a PMN, MCAN, or SNUN according to TSCA section 5(a)(3)(A) that the chemical substance or significant new use presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA under the conditions of use, EPA must take one of the following actions described in TSCA section 5(f) to the extent necessary to protect against such risk: (1) issue an immediately effective proposed rule to limit the amount of such substance that may be manufactured, processed, or distributed in commerce or to impose other requirements described in TSCA 
                    <PRTPAGE P="34105"/>
                    section 6(a), or (2) issue an order to prohibit or limit the manufacture, processing or distribution in commerce of the substance, to take effect on the expiration of the applicable review period.
                </P>
                <P>After EPA issues an order under TSCA section 5(e) or (f) and the applicable review period concludes, the submitter may submit studies, tests, reports, or other additional information. If EPA concludes from an assessment of the additional information that one or more of the prohibitions or limitations contained in the order are no longer necessary to protect against an unreasonable risk of injury to health or the environment, EPA may modify or revoke the prohibitions or limitations of the order. If EPA determines that none of the order terms are warranted after assessment of the additional information, EPA may revoke all the requirements of the order. EPA is proposing amendments to 40 CFR 720.75(d) and 725.170 to state that EPA may modify or revoke the prohibitions and limitations in an order after the applicable review period has ended if the submitter submits to EPA additional testing, studies, reports, or other information that EPA determines, upon review, demonstrate that such prohibitions or limitations are no longer necessary to protect against an unreasonable risk of injury to health or the environment. While the current regulations do not specify that EPA may modify or revoke the prohibitions and limitations in an issued order, the proposed amendments at 40 CFR 720.75(d) and 725.170 would codify current practices. EPA believes that these existing processes and actions for modifying or revoking the prohibitions and limitations in an issued order fulfill the requirements of TSCA section 5, as amended by the 2016 Lautenberg Amendments.</P>
                <HD SOURCE="HD3">3. Other Updates</HD>
                <P>EPA is proposing to replace the terms “notice period,” “notification period,” “statutory review period,” and “notice review period” with the term “applicable review period” throughout 40 CFR part 720 to conform to the new terminology in TSCA section 5 added by the 2016 Lautenberg Amendments. EPA is proposing to add a definition for “applicable review period” to 40 CFR 720.3, which EPA would define as “the period starting on the date EPA receives a complete notice under section 5(a)(1) of the Act and ending 90 days after that date or on such date as is provided for in sections 5(b)(1) or 5(c) of the Act.” This proposed definition is based on the TSCA section 5(i)(3) definition for “applicable review period.”</P>
                <P>EPA is also proposing to add a definition for “potentially exposed or susceptible subpopulation” to 40 CFR 720.3, a term added to TSCA by the 2016 Lautenberg Amendments. Based on the definition in TSCA section 3(12), EPA would define “potentially exposed or susceptible subpopulation” as “a group of individuals within the general population identified by EPA who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, the elderly, or overburdened communities.”</P>
                <P>
                    EPA is also proposing to update 40 CFR 720.70(b) by revising paragraph (b)(3). The language in paragraph (b) describes the content of the document that EPA routinely publishes in the 
                    <E T="04">Federal Register</E>
                     under TSCA section 5(d)(2) to announce the receipt of PMNs submitted to EPA. Although not required by TSCA section 5(d)(2), the first sentence in 40 CFR 720.70(b)(3) specifies that the document EPA publishes in the 
                    <E T="04">Federal Register</E>
                     pursuant to TSCA section 5(d)(2) will also include a list of data submitted with the PMN in accordance with 40 CFR 720.50(a). In proposing to establish this requirement in the original 40 CFR part 720 regulations, EPA described its objective as providing relevant information to the public in terms of the PMNs submitted and under review with EPA. See 
                    <E T="03">e.g.,</E>
                     44 FR 2242, 2253 (January 10, 1979). That transparency goal is now better achieved through other more efficient and effective mechanisms that negate the need to publish that information in the 
                    <E T="04">Federal Register</E>
                    . Specifically, to provide streamlined access to information EPA receives and develops about chemicals, EPA has built and is constantly expanding content in an online searchable data base called ChemView (
                    <E T="03">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/introduction-chemview</E>
                    ), and currently makes the PMN itself, including test data submitted with it, available on ChemView (subject to confidentiality claims) generally within 5 workdays of receipt. In addition, EPA is making the list of new chemical submissions received available in one place on our website to increase transparency and make information on new chemicals easier to find (see 
                    <E T="03">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemical-notices-received-epa</E>
                    ). This approach was adopted several years ago to provide an alternative to searching individual 
                    <E T="04">Federal Register</E>
                     notices and dockets on 
                    <E T="03">https://www.regulations.gov.</E>
                     The links below provide a listing of the following types of new chemical submissions received. The lists on the website are updated on a regular basis and allow anyone to track the status of active new chemical cases by visiting our page on statistics for the new chemicals review program (
                    <E T="03">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/statistics-new-chemicals-review</E>
                    ).
                </P>
                <HD SOURCE="HD2">B. Amendments Related to Notice Information Requirements</HD>
                <P>EPA is proposing changes to the notice information requirements at 40 CFR 720.45, as well as corresponding changes to the reporting form in CDX, to clarify the level of detail expected for information that must be submitted to EPA in the PMN, SNUN, and certain exemption notices.</P>
                <HD SOURCE="HD3">1. Background</HD>
                <P>A notice submitted under TSCA section 5(a)(1) must include the information described in TSCA section 5(d)(1): (1) insofar as known to the submitter or reasonably ascertainable, information described in certain provisions of TSCA section 8(a)(2); (2) in the form and manner prescribed by EPA, information in the possession or control of the submitter related to the health or environmental effects of any manufacture, processing, distribution in commerce, use, or disposal of the chemical substance or any article containing such substance; and (3) a description of any other information concerning the environmental and health effects of the chemical substance, insofar as known to the submitter or reasonably ascertainable. EPA has promulgated regulations detailing these information requirements in 40 CFR 720.45 and 720.50.</P>
                <P>
                    EPA has developed an application form in CDX to collect such information from submitters. The user guide for CDX is listed in the references section of this proposed rule and can be found in the docket (Ref. 2). This form is prescribed by EPA for submission of PMNs, SNUNs, LVEs, LoREXs, and test marketing exemption (TME) applications. In this preamble, EPA refers to the form as the “PMN form” for simplicity, but the proposed changes outlined in this section would impact the other types of notices that use the same form (
                    <E T="03">i.e.,</E>
                     PMNs, SNUNs, LVEs, LoREXs, and TMEs).
                </P>
                <P>
                    EPA has observed that most PMN, SNUN, and exemption notices do not contain all required information at the 
                    <PRTPAGE P="34106"/>
                    level of detail that EPA needs to perform refined, quantitative risk assessments. When a submission is lacking detail, EPA typically uses conservative assumptions and default values to ensure the assessment is protective of human health and the environment. The Agency may make predictions using models concerning physical and chemical properties, environmental transport and partitioning, environmental fate, environmental toxicity, human health, engineering releases to the environment, and environmental concentrations—see the document titled “Points to Consider When Preparing TSCA New Chemical Notification” (Ref. 3) for more information on EPA's use of predictive models in the new chemical review process. EPA has repeatedly observed, however, that when submitters see the level of risk estimated by EPA using such conservative assumptions and default values, as well as the risk mitigation measures developed by EPA as a result, submitters often amend their initial notices to provide additional detailed information. In an effort to improve the accuracy of EPA's risk assessment, submitters often either provide information that was missing in their initial notice or clarify details about the manufacturing process. When EPA receives such information during the review process, EPA takes the information into consideration and may redo its risk assessments (“re-work”) to factor in the additional information. This longstanding practice of submitters amending their initial notices to provide additional information after the beginning of the review period and EPA having to consider the information late in the review process results in re-work by EPA and diverts EPA attention from processing new notices. This creates delays in the review of notices generally.
                </P>
                <P>EPA has previously worked to address the inefficiency of the review process associated with late submission of information by issuing several supplemental documents to aid submitters in providing all relevant information in the initial notice. EPA published a Points to Consider document in 2018 (Ref. 3) and provides a user guide and resource tab that are accessible within the CDX application and provide instructions on how to complete the submission (Ref. 2). To further address this issue, EPA began implementing a pre-screen process for notices in April 2020, which is detailed in Unit III.C. of this document. And in July 2022, the Agency launched the TSCA New Chemical Engineering Initiative to Increase Transparency and Reduce Re-work that included a broad outreach effort to describe and discuss with stakeholders how the Agency evaluates data provided with notices and common issues that cause EPA to have to re-work risk assessments (Ref. 4).</P>
                <P>EPA believes that amending the notice information requirements at 40 CFR 720.45 to specify the level of detail needed, as well as building that additional detail into the CDX user interface, would help submitters provide all relevant information in their initial notice submissions. EPA has observed that many data elements in notice submissions often lack the level of detail that EPA needs. EPA believes that specifying more detailed information requirements in 40 CFR 720.45 and data fields in the CDX user interface would promote more complete submissions upfront and help to minimize the need for EPA to use default values and conservative assumptions in its risk assessment. Therefore, EPA is proposing to amend the notice information requirements at 40 CFR 720.45, as well as implementing corresponding changes to the PMN form in CDX.</P>
                <HD SOURCE="HD3">2. Proposed Changes to 40 CFR 720.45 and the PMN Form</HD>
                <P>EPA is proposing to amend 40 CFR 720.45 and the PMN form in CDX to clarify the information requirements for a notice. Specifically, EPA is proposing to add details to certain information requirements already contained in 40 CFR 720.45 and to add additional reporting fields to the PMN form to reflect these details. This detailed information is already required by the broader information requirements contained in 40 CFR 720.45 and 720.50 and is reflected in the CDX user interface. In this action, EPA is proposing to add these details as separate, unique information requirements in 40 CFR 720.45 and make corresponding changes to the PMN form to clarify the level of detail needed for EPA's review of a notice and to ensure that the fields in the PMN form are consistent with the regulations. In some cases, reporting fields for detailed information are already included in the PMN form because they are covered by broader information requirements contained in 40 CFR 720.45 or 720.50. EPA is proposing to add those details to 40 CFR 720.45 so that the regulations and PMN form are consistent. See Ref. 5, which provides tables that list the detailed information requirements proposed to be added to 40 CFR 720.45 and indicate whether reporting fields for that information are already included in the PMN form.</P>
                <P>Consistent with TSCA section 5(d)(1), for all information requirements under 40 CFR 720.45, submitters are only required to provide information to the extent that it is known to or reasonably ascertainable by the submitter, as defined at 40 CFR 720.3(p). Under the proposed changes to 40 CFR 720.45, a submitter would be required to include in the PMN form the detailed information proposed in this action, along with all other information already required, to the extent the information is known to or reasonably ascertainable by the submitter. This is an important point because a submitter may not know or be able to reasonably ascertain certain details about the chemical substance that is the subject of the notice, such as details about manufacturing, processing, or use sites out of the submitter's control. In those situations, EPA would make conservative assumptions and use conservative default values for any information that is not known to or reasonably ascertainable by the submitter and therefore not provided in the PMN form.</P>
                <P>
                    Currently, if submitters have physical-chemical or environmental fate test data, they must provide the test data or a standard literature citation in accordance with 720.50(a)(2)-(3). Submitters must 
                    <E T="03">also</E>
                     submit this information in the corresponding PMN form fields in accordance with the proposed changes to 720.45(j). Data provided in the PMN form via CDX may be pulled from the test data provided by submitters per 720.50(a)(2)-(3), or the data can be submitted as standalone information for which submitters do not have underlying test data.
                </P>
                <HD SOURCE="HD3">a. Physical and Chemical Properties and Environmental Fate Characteristics</HD>
                <P>
                    The first set of detailed information requirements that EPA is proposing to add to 40 CFR 720.45 is about the physical and chemical properties and environmental fate characteristics of the chemical substance (see Table 1 in Ref. 5). EPA currently collects physical and chemical properties test data required by 40 CFR 720.50, “Submission of test data and other data concerning the health and environmental effects of a substance,” in two ways. First, the CDX user interface prompts the submitter to attach relevant documents, such as test data, to the PMN form using an attachment function. Second, the PMN form includes a CDX user interface screen with form fields for physical and chemical properties available for completion via a pick list. To ensure that the regulations are clear about what 
                    <PRTPAGE P="34107"/>
                    information fields are included in the PMN form itself, EPA believes that the information requirements in 40 CFR 720.45 should reflect the PMN form fields. EPA is therefore proposing to add relevant physical and chemical properties information requirements in a new provision at 40 CFR 720.45(j)(1) that are already specified within the PMN form.
                </P>
                <P>EPA is proposing several information requirements at 40 CFR 720.45(j)(1) that are not already specified within the PMN form for physical and chemical properties. EPA is proposing to require in 40 CFR 720.45(j)(1) that data on surface tension and ultraviolet-visible (UV-VIS) absorption, as well as any particle size distribution analysis, be submitted as part of the PMN form, to the extent it is known to or reasonably ascertainable by the submitter. Data on surface tension and UV-VIS absorption are not currently included on the pick list for physical and chemical properties in CDX, and their inclusion there as well as in the proposed regulations at 40 CFR 720.45(j)(1) will promote more complete submissions. The particle size distribution value is already a physical and chemical property that appears in the pick list on the CDX user interface screen, but it would improve EPA's ability to assess risk if the value were accompanied by the analysis data used to develop the value. Additionally, EPA proposes to require at 40 CFR 720.45(j)(1) information for aspect ratio, thickness, and number of layers or walls for nanomaterials. Information requirements for nanomaterial morphology do not currently appear on the pick list for physical and chemical properties on the CDX user interface screen or in the regulations. Requiring data for these properties will allow EPA to offer additional clarity to submitters providing notices for nanomaterials, since submitters might otherwise omit such data. Therefore, EPA is proposing to add these requirements to the regulations at 40 CFR 720.45(j)(1) and to add fields for attaching associated data on the physical and chemical properties screen of the PMN form.</P>
                <P>EPA also proposes to add information requirements for the environmental fate characteristics of the chemical substance (see Table 1 in Ref. 5) to 40 CFR 720.45(j)(2). Environmental fate characteristics test data are already required by 40 CFR 720.50; however, this provision does not describe in detail what these relevant characteristics include. In addition, this information is already collected by EPA as attachments to the PMN form; however, fields for environmental fate characteristics are not yet included on the CDX user interface screen pick list. EPA is proposing to add the relevant environmental fate characteristics to the information requirements at 40 CFR 720.45(j)(2) and to add form fields to the PMN form by expanding the pick list.</P>
                <HD SOURCE="HD3">b. Categories of Use</HD>
                <P>
                    The next set of information requirements that EPA is proposing to add to 40 CFR 720.45 relates to the categories of use of the chemical substance (see Table 2 in Ref. 5). The proposed requirements include detailed information on commercial and consumer uses, which already have form fields in the PMN form in CDX specifying in greater detail the broader information requirement in the regulations at 40 CFR 720.45(f) regarding categories of use. Although the regulations at 40 CFR 720.45(f) currently require a description of intended categories of use by function and application, the estimated percent of production volume devoted to each category of use, and the percent of the new substance in the formulation for each commercial or consumer use, certain specific information requirements for details on commercial and consumer uses are not yet specified. These information requirements include the types of products or articles that would incorporate the new chemical substance (
                    <E T="03">e.g.,</E>
                     household cleaners, plastic articles), how and where a product or article incorporating the new chemical substance would be used (
                    <E T="03">e.g.,</E>
                     spray applied indoors, brushed on outdoor surfaces), consumption rates and frequency and duration of use for products or articles containing the new chemical substance, and information related to the use of products or articles containing the new chemical substance by potentially exposed or susceptible subpopulations. EPA is proposing to add these requirements to 720.45(f). Additionally, EPA is proposing to add to 40 CFR 720.45(f) a requirement to designate applicable consumer and commercial product categories using Organisation for Economic Co-operation and Development (OECD)-based functional use codes, which would create consistency with TSCA section 8(a) Chemical Data Reporting (CDR) requirements in 40 CFR part 711. EPA is also proposing corresponding changes to the PMN form fields in CDX.
                </P>
                <HD SOURCE="HD3">c. Details Concerning Manufacture, Processing, and Use</HD>
                <P>
                    The third set of information requirements that EPA is proposing to add to 40 CFR 720.45 is information related to each site where the chemical substance will be manufactured, processed, or used. These requirements apply to sites controlled by submitters as well as sites controlled by others, and although the information requirements that EPA is proposing are similar for both, different types of activities (
                    <E T="03">e.g.,</E>
                     manufacturing versus processing) often occur at submitter-controlled sites versus those at sites controlled by others. Moreover, activities at sites controlled by others are typically not as well characterized by submitters compared to descriptions of the submitters' own activities, since in many cases the identity and number of sites controlled by others is unknown to the submitters when a notice is submitted. As such, some slight differences exist in the requirements EPA is proposing for information related to sites controlled by submitters versus sites controlled by others.
                </P>
                <P>For both sites controlled by submitters and sites controlled by others, EPA is proposing to add information requirements for site addresses (see Table 3 and Table 5 in Ref. 5). For submitter-controlled sites, EPA is also proposing to add requirements for whether a particular chemical substance is manufactured or processed via batch or continuous production, as well as the amount of the chemical substance manufactured or processed in a given batch and/or timeframe (see Table 5 in Ref. 5). These proposed information requirements already have a corresponding form field in the PMN form in CDX because they are each covered by the existing information requirements in 40 CFR 720.45(g)(1) and (2) and (h) for a process description of operations at such sites. Since these proposed information requirements are not yet specified in the regulations, EPA is proposing to add them at 40 CFR 720.45(g)(1) and (2) for sites controlled by the submitter and 40 CFR 720.45(h)(1) and (2) for sites not controlled by the submitter.</P>
                <P>
                    EPA is also proposing to add requirements for detailed information about the process diagram or description for each site controlled by the submitter (see Table 4 in Ref. 5) and for each site not controlled by the submitter (see Table 5 in Ref. 5). These requirements include descriptions of the identity, approximate weight per batch or per day for continuous production, and entry point of all starting materials and feedstocks; the identity, approximate weight per batch or per day for continuous production, and entry point of all products, recycle streams, and wastes, including frequency of any equipment cleaning; the type of containers used for interim storage and transport of the chemical substance; and 
                    <PRTPAGE P="34108"/>
                    identification, by number, of any points of release. Although these details are already covered by the existing information requirements in 40 CFR 720.45(g)(2) and (h) for a process description of operations at such sites, EPA is proposing to add them as separate, unique information requirements at 40 CFR 720.45(g)(2) and (h)(2) and in new fields in the PMN form to clarify the level of detail needed and to ensure that the regulations and PMN form are consistent.
                </P>
                <HD SOURCE="HD3">d. Worker Exposure</HD>
                <P>
                    EPA is also proposing to add requirements for detailed information about the possible worker exposure at each site controlled by the submitter (see Table 6 in Ref. 5), and at each site not controlled by the submitter (see Table 7 in Ref. 5). These requirements include types of potential worker exposure (
                    <E T="03">e.g.,</E>
                     dermal, inhalation), descriptions of any protective equipment and engineering controls in place, the moisture content of the chemical substance (if a solid), and the percentage of the chemical substance in the formulation at the time of exposure. In addition, for sites controlled by others, these requirements also include worker activities and descriptions of the physical form of the chemical substance. Although these details are already covered by the existing information requirements in 40 CFR 720.45(g)(3) and (h) regarding worker exposure information, and some already have a corresponding form field in the PMN form in CDX, EPA is proposing to add them as separate, unique information requirements at 40 CFR 720.45(g)(3) and (h)(3) and in new fields in the PMN form to clarify the level of detail needed and to ensure that the regulations and PMN form are consistent.
                </P>
                <HD SOURCE="HD3">e. Environmental Releases</HD>
                <P>
                    Finally, EPA is proposing to add detailed information requirements about the potential environmental releases at each site controlled by the submitter (see Table 8 in Ref. 5) and at each site not controlled by the submitter (see Table 9 in Ref. 5). These requirements include descriptions of the type of release (
                    <E T="03">e.g.,</E>
                     transport, interim storage, disposal, equipment cleaning); the amount of the chemical substance released directly to the environment or into control technology; the amount of the chemical substance released to the environment after control technology; for equipment cleaning releases, frequency of equipment cleaning and what is used to clean equipment; for transport and storage releases, how the chemical substance or the product containing the chemical substance is transported from the site and stored and information about the containers used; for releases into air, Clean Air Act operating permit numbers and a description of any Leak Detection and Repair program the site has implemented; for releases into water, National Pollutant Discharge Elimination System (NPDES) permit numbers and information on the navigable waterways and other destinations into which the release occurs; and for releases into wastewater treatment plants, information on the publicly owned treatment works (POTW) into which the release occurs. In addition, for sites controlled by others, these requirements also include a description of the media of release. Although each of these details are already covered by the existing information requirements in 40 CFR 720.45(g)(4) and (h) regarding environmental releases, and some already have a corresponding form field in the PMN form in CDX, EPA is proposing to add them as separate, unique information requirements at 40 CFR 720.45(g)(4) and (h)(4) and in new fields in the PMN form to clarify the level of detail needed and to ensure that the regulations and PMN form are consistent.
                </P>
                <P>If the information is not known to or reasonably ascertainable by the submitter for one or more sites, EPA makes conservative assumptions and uses default values to replace the missing information whether the site is controlled by the submitter or not. Therefore, EPA believes that the level of detail in the regulations for process description, worker exposure, and environmental release information for sites controlled by the submitter at 40 CFR 720.45(g) should mirror the level of detail in the regulations for process description, worker exposure, and environmental release information for sites not controlled by the submitter at 40 CFR 720.45(h). EPA is proposing to amend 40 CFR 720.45(g) and (h) to make them consistent. EPA recognizes that a submitter may not possess such information about sites not controlled by the submitter. Submitters are only required to supply information that is known to or reasonably ascertainable by them as defined at 40 CFR 720.3(p).</P>
                <P>
                    Additionally, EPA is proposing clarifying amendments to 40 CFR 720.45(g)(3) and (4) and 720.45(h)(3) and (4) to ensure that submitters include worker exposure and environmental release information from exempt manufacture or related use of the chemical substances under 40 CFR 720.30 (
                    <E T="03">e.g.,</E>
                     a chemical substance manufactured under the byproduct or impurity exemptions) at each site where the chemical substance will be manufactured, processed, or used, if known or reasonably ascertainable. EPA is also proposing clarifying amendments to 40 CFR 721.25(c) to ensure that submitters of SNUNs include in their notice both a description of the significant new use for which they are submitting a SNUN and of all other known or intended categories of use. Such categories of use may include uses that are ongoing and not subject to a significant new use rule (SNUR). Such information is valuable for EPA in determining necessary regulatory action should potential risks be identified during review of a SNUN.
                </P>
                <HD SOURCE="HD3">f. Pollution Prevention Information</HD>
                <P>Lastly, EPA is proposing to add optional pollution prevention information at 40 CFR 720.45(k). The PMN form in CDX currently includes an optional text field and attachment function for submitters who wish to provide pollution prevention information about the chemical substance, such as information about using alternative fuel sources, reducing the use of water and chemical inputs, modifying a production process to produce less waste, implementing water and energy conservation practices, or substituting for riskier existing products.</P>
                <P>EPA estimates that the proposed amendments, which are intended to clarify the level of detail required for existing data requirements under 40 CFR 720.45 and 720.50, would have a very minor impact on submitter burden because they are largely reflected in existing fields in the PMN form in CDX that submitters already are prompted to complete. Moreover, they are also already included in the Points to Consider document (Ref. 3) that submitters are encouraged to review before completing a notice. EPA's estimate of the burden impacts of these proposed information requirement amendments are presented in an Information Collection Request (ICR) document (Ref. 6), a copy of which is in the docket and is summarized in Unit VI.B.</P>
                <P>
                    EPA is seeking comment specifically on its burden estimate and on the general pros and cons of clarifying these information requirements in the regulations and making corresponding changes to the PMN form. EPA is also seeking comment from the public, including those who have submitted a notice to EPA in the past, on any information requirement details that are 
                    <PRTPAGE P="34109"/>
                    not clearly explained in the PMN form or the regulations.
                </P>
                <HD SOURCE="HD3">3. Other Modifications to the PMN Form in CDX</HD>
                <P>In addition to the proposed amendments to clarify the information requirements for a notice and the corresponding changes to the PMN form in CDX outlined in Unit III.B.1. and 2., EPA is also considering adding statements with accompanying check boxes to certain screens of the PMN form (such as when transitioning between the various worksheets completed by the submitter) that indicate that information fields can only be left blank if such information is not known to or reasonably ascertainable by the submitter. In other words, if a submitter leaves information fields blank, they would have to check a box on the screen to affirm that the information is not known to or reasonably ascertainable by the submitter before advancing to the next screen. Additionally, a statement would warn the submitter of the potential consequences of leaving the field blank and later amending the field. If a field is left blank, EPA would make conservative assumptions and use conservative default values when assessing risk, which could result in more stringent risk management requirements. If a field that has been left blank is later amended during the review process, EPA may declare the original submission incomplete (see Unit III.C.3. for a more detailed discussion on notice amendments indicating that the original submission was incomplete). This check box approach would not have a corresponding regulatory change, as it is consistent with the existing requirements to provide all information that is known to or reasonably ascertainable by the submitter and EPA's longstanding practice to use conservative assumptions and default values in the absence of information. The ICR document accompanying this proposed rule describes the potential modifications to each screen of the PMN form (Ref. 6).</P>
                <P>As an alternative to this check box approach, EPA considered adding automatic checks in CDX to make certain critical fields mandatory such that the user could not advance to the next screen in the PMN form or submit the form without entering information into the field. EPA does not favor this approach because information required on the PMN form is required to the extent it is known to or reasonably ascertainable by the submitter, and EPA understands that there may be situations where such information may not be known to or reasonably ascertainable by the submitter. EPA also considered adding a statement and check box to every screen in the PMN form that information in the form is required if it is known to or reasonably ascertainable by the submitter, and not just to certain screens as described above. EPA does not favor this approach because it would require significant resources to program such statements and check boxes on each screen. Furthermore, the PMN form is designed to allow users the flexibility of moving back and forth through the screens, skipping screens, and returning to previous screens as needed. EPA feels that implementing such check boxes on every screen may impede this flexibility and unnecessarily increase the burden of completing a PMN form. EPA seeks comment on these alternatives, as well as on whether there are other approaches to modifying the PMN form to encourage complete submission of data.</P>
                <HD SOURCE="HD2">C. Amendments Related to Pre-Screen, Incomplete Submissions, Correcting Errors, and New Information</HD>
                <P>EPA is proposing amendments to the regulations regarding how EPA acknowledges the receipt of a notice to account for EPA's pre-screen process and to clarify the start of the applicable review period, particularly when a notice contains errors or is incomplete. EPA is also proposing amendments to align the process for correcting errors in the notice with the existing process for incomplete submissions. EPA is also clarifying that a notice is not considered complete at the time of the initial notice submission if the submitter submits additional information at any time during the review period that was known to or reasonably ascertainable by the submitter at the time of initial notice submission. Finally, EPA is proposing amendments to clarify that new information about a chemical substance under EPA review must be submitted electronically via CDX and that certain notification to EPA of new information may be made by email.</P>
                <HD SOURCE="HD3">1. Background</HD>
                <P>The first step that EPA takes after the receipt of a new chemicals notice before the risk assessment begins is to conduct a pre-screen of the notice, which typically takes 2-3 days. During the pre-screen process, EPA determines whether a notice is required for the chemical substance under TSCA. For example, EPA determines whether the chemical substance is already on the TSCA Chemical Substance Inventory (also called the “TSCA Inventory” or “Inventory”), not a “chemical substance” as defined in TSCA section 3(2), or will be manufactured solely for export. If EPA determines that a notice is not required, EPA notifies the submitter that they are not required to submit a notice under TSCA in order to proceed commercially. EPA rejects the notice, and an applicable review period does not begin. See 40 CFR 720.62.</P>
                <P>During this pre-screen process, EPA also initiates a chemistry, engineering, and administrative screen of the notice. EPA chemists evaluate whether the chemical identity of the new chemical substance is clear, the starting materials add up to the final chemical substance, and the chemical structure is consistent with the name. EPA engineers evaluate whether certain information is contained in the notice, such as complete site identification information, manufacturing process descriptions, and information on environmental releases and worker exposure for each site. EPA also evaluates whether any of the other conditions for incomplete submissions outlined in 40 CFR 720.65(c)(1) have been met, such as a failure to properly sanitize for CBI a second copy of the notice or the failure to submit the notice in English. Finally, EPA checks for other errors in the notice. See 40 CFR 720.65(b).</P>
                <P>If EPA deems the notice complete after the pre-screen process, then the notice moves forward to the risk assessment process. If EPA does not deem the notice complete during the pre-screen period, EPA notifies the submitter that the notice is incomplete and explains the requirements for correcting the incomplete submission, per 40 CFR 720.65(c)(3). Once the submitter submits a complete notice according to the requirements previously provided by EPA, the applicable review period begins.</P>
                <P>
                    Currently, after EPA completes its risk assessment of a chemical substance, EPA reaches out to the submitter to explain the findings of the risk assessment and any proposed prohibitions or limitations on the manufacturing, processing, distribution in commerce, use, or disposal of the chemical substance. If the submitter disagrees with the potential risks identified in the risk assessment, the submitter may provide additional information intended to demonstrate that risks are lower than EPA estimated. The additional information may be detailed information on worker exposures or environmental releases that was missing from the initial notice submission, or it may be previously unsubmitted testing on the chemical substance to better characterize the 
                    <PRTPAGE P="34110"/>
                    potential risk that EPA identified in its assessment. These and other amendments could indicate that the original notice was incomplete if the additional information was known to or reasonably ascertainable by the submitter at the time of the original submission. See 40 CFR 720.65(c)(1)(v) and (vi), (c)(2)(ii). If an original notice is later found to have been incomplete, EPA may restart the review period at Day 1 when additional information is submitted that then makes the notice complete.
                </P>
                <P>Under its current practice, EPA may consider the additional information and, if warranted, conduct the risk assessment again to factor in the additional information. This is in line with EPA's longstanding objective to take into consideration reasonably available information and account for real-world conditions during manufacturing, processing, distribution, use, or disposal of a chemical substance. While this practice has the benefit of refining the risk assessments, it uses EPA resources inefficiently and adds significant time to the review process.</P>
                <HD SOURCE="HD3">2. Pre-Screening Procedures</HD>
                <P>
                    EPA is proposing to amend 40 CFR 720.65(a) to codify the pre-screen process that EPA conducts prior to moving forward to the risk assessment process. The new language would clarify, for purposes of transparency, EPA's current pre-screen practice as described in Unit III.C.1. If through the pre-screen process EPA finds that the initial notice submission is complete, Day 1 of the applicable review period is the day the notice was received by EPA via CDX, consistent with the existing regulations at 40 CFR 720.75(a). If the pre-screen process finds that the initial submission is incomplete, the applicable review period will not begin until EPA receives a complete notice, consistent with the existing regulation at 40 CFR 720.65(c)(2)(i). After the pre-screen, EPA may still determine within 30 days of receipt of the submission, once the risk assessment is underway and the information submitted more thoroughly evaluated, that the notice is incomplete, as currently described at 40 CFR 720.65(c)(2)(i). However, it has been EPA's experience that the pre-screen process helps minimize the number of submissions identified as incomplete or containing errors later in the review period. EPA is also proposing an amendment to 40 CFR 720.70 to clarify that a notice of receipt will be published in the 
                    <E T="04">Federal Register</E>
                     after EPA receives a complete notice, rather than merely receiving the notice, to accommodate the pre-screening procedures.
                </P>
                <HD SOURCE="HD3">3. Correcting Errors in Notices</HD>
                <P>EPA is proposing amendments to 40 CFR 720.65(a) and (b) to state that if EPA receives a notice with errors and EPA requests (as part of the pre-screen process or, at latest, within 30 days of receipt of the notice) that the submitter remedy such errors, the applicable review period will not begin until EPA receives a corrected notice. This proposed amendment will align the process for correcting errors with the current process for correcting an incomplete notice at 40 CFR 720.65(c)(2) through (5). The 1983 final rule that established the current process for correcting errors stated that “the submitter is under no obligation to make the correction, but failure to do so may cause EPA to extend the review period under section 5(c) of the Act.” ((Ref. 7) (48 FR 21735, May 13, 1983). While the current regulations and the proposed amendment give EPA discretion to request remedy of errors, EPA now believes that if the Agency exercises that discretion to request that the submitter remedy an error, review of the notice should not move forward until the error is corrected. EPA does recognize that some errors may be minor and not require correction prior to EPA initiating review of the notice, such as easily recognized spelling errors or an incorrectly numbered list—EPA does not intend to request correction of such errors. EPA's notification to the submitter that a submission contains errors would include (i) a statement of the basis of EPA's determination that the submission contains errors, (ii) the requirements for correcting the errors, and (iii) information on procedures for filing objections to the determination or requesting modification of the requirements for completing the submission. Additionally, EPA is proposing an amendment to remove “failure to date the notice form” as an example of an error because the electronic PMN form submitted through CDX automatically dates the notice upon submission and this error is no longer possible.</P>
                <HD SOURCE="HD3">4. Notice Amendments Indicating Original Notice Was Incomplete</HD>
                <P>If information required under 40 CFR 720.45 and 720.50 and specified in the PMN form is known to or reasonably ascertainable by a submitter, the submitter must report the information in the notice. EPA defines “known to or reasonably ascertainable by” at 40 CFR 720.3(p) to mean “all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” This definition is not overly prescriptive and is based on a concept of reasonableness that is fact specific. Furthermore, the existing regulation at 40 CFR 720.65(c)(2)(ii) states that if EPA obtains additional information during the review period that indicates the original submission was incomplete, EPA may declare the submission incomplete. Accordingly, if a submitter amends their notice during the applicable review period to add information required under 40 CFR 720.45 or 720.50 that was known to or reasonably ascertainable by the submitter at the time of the original submission, EPA would have cause to declare that the original submission was incomplete. Because the applicable review period does not begin until a submission is complete, EPA can restart the applicable review period to Day 1 if a submission is later amended during the review period and such amendment demonstrates that the original submission was incomplete.</P>
                <P>To date, EPA has generally not exercised its discretionary authority under section 720.65(c)(2)(ii) to declare original submissions incomplete when the Agency has received late submissions of information required by 40 CFR 720.45 or 720.50 that may have been known to or reasonably ascertainable by the submitter at the time of the original notice submission. Instead, EPA has considered the additional information and if applicable, conducted re-work on its risk assessments. To accomplish this re-work during the applicable review period, EPA has generally granted a submitter's request for a suspension of the review period, per 40 CFR 720.75(b).</P>
                <P>
                    EPA intends to change this longstanding practice of accepting amendments that contain information that was known or reasonably ascertainable at the time of the original submission and then accepting a request to suspend the review period under 40 CFR 720.75(b). As explained in Unit II.B., the 2016 Lautenberg Amendments impose additional obligations on EPA, and EPA believes that exercising its discretionary authority under the existing regulations to declare an original submission incomplete and restart the applicable review period upon submission of the complete notice is appropriate in order for EPA to efficiently meet current statutory requirements. Overall, amendments and re-work often lead to an inefficient use of EPA resources and a review timeline that is not predictable and/or reliable for all stakeholders. EPA would continue to 
                    <PRTPAGE P="34111"/>
                    accept amendments and, as necessary, refine risk assessments based on these amendments, but believes that the shift to restart the applicable review period would create a more transparent and predictable review process for submitters.
                </P>
                <P>To clearly communicate this intended change in longstanding practice, EPA is proposing to amend 40 CFR 720.65(c) by adding a paragraph (2), which would state that a notice submission may be declared incomplete if the submitter submits additional or revised information at any time during the review period without demonstrating to EPA's satisfaction that such information was not known to or reasonably ascertainable by the submitter at the time of initial notice submission. Additionally, EPA is proposing an amendment at 40 CFR 720.65(d)(5)(iii) to clarify that if EPA obtains additional information during the review period that leads EPA to declare the initial notice submission incomplete, in accordance with 40 CFR 720.65(d)(2) (proposed to be redesignated from current 40 CFR 720.65(c)(2)(ii)), the applicable review period would restart at Day 1 upon receipt of the complete notice.</P>
                <P>It is EPA's view that information on basic physical and chemical properties and on anticipated environmental releases or worker exposures at any sites controlled by the submitter, as required at 40 CFR 720.45, would be known to or reasonably ascertainable by the submitter at the time of the original submission. Furthermore, EPA believes that it is extremely unlikely that a submitter would neither know nor be able to reasonably ascertain such information at the time of the original submission, but could know or ascertain it 20 or 40 or 60 days after the original submission or at other times during the review period. In this action and with the amendment proposed at 40 CFR 720.65(c)(2), EPA is communicating to stakeholders that they must provide all information required by 40 CFR 720.45 and 720.50 upfront and submit a complete notice.</P>
                <P>
                    Based on its experience reviewing thousands of notices and amendments, EPA believes that it should be very uncommon for a submitter to amend their notice during the review period by adding information that they could not have known or reasonably ascertained at the time of the original submission, such as for new information as described at 40 CFR 720.40(f) or information from testing in progress at the time of the original submission, as described at 40 CFR 720.50(a)(4). Under the proposed amendment at 40 CFR 720.65(c)(2), the submitter of additional or revised information during the review period would have to demonstrate to EPA's satisfaction that the information was not known to or reasonably ascertainable by the submitter at the time of the original submission to preclude an EPA determination that the original notice was incomplete. As a matter of policy, EPA believes that the only amendments to a notice that would not indicate that the original notice was incomplete are: (1) amendments based on new data (as described at 40 CFR 720.40(f) and 720.50(a)(4)); (2) administrative, non-substantive amendments (
                    <E T="03">e.g.,</E>
                     submitter contact information); and (3) amendments made at the request of EPA. EPA, however, would take case-by-case facts into consideration when determining whether a late submission of information indicates that a notice was incomplete when originally submitted. If a submitter disagrees with EPA's determination that the original notice submission was incomplete, the submitter may object according to the existing procedures at 40 CFR 720.65(c)(4) and (5) (proposed to be redesignated as 40 CFR 720.65(d)(4) and (5)). Amendments based on new data, administrative or non-substantive amendments, and amendments made at the request of EPA would not impact the completeness of a submission.
                </P>
                <P>EPA offers the following example to illustrate the intended change to its longstanding practice: If a submitter leaves blank a field in the PMN form for information required under 40 CFR 720.45 to the extent it is known to or reasonably ascertainable by the submitter, EPA may use a conservative assumption or default factors in place of that information for the risk assessment and conclude that certain prohibitions or limitations on the chemical substance may be warranted. If after learning the findings of EPA's risk assessment, the submitter then amends its original notice in CDX by providing information in the field previously left blank, EPA would notify the submitter, according to the existing regulation at 40 CFR 720.65(c)(2)(ii) and (c)(3) (proposed to be redesignated as 40 CFR 720.65(d)(2) and (3)), that the original submission was incomplete. The submitter may then file an objection to the determination that the original notice was incomplete, at which time they may seek to demonstrate that the additional or revised information was not known to or reasonably ascertainable by them at the time of initial notice submission. If in response to the objection, EPA determines the original notice was complete, the applicable review period will be deemed suspended on the date EPA declared the notice incomplete and will resume on the date that the notice is declared complete. However, if EPA considers the objections and still determines that the original notice was incomplete, or if no objections are filed, EPA will restart the applicable review period and the new Day 1 will be the date the additional information that completed the notice was submitted to EPA.</P>
                <P>EPA believes that the meaning of “known to or reasonable ascertainable by” described in this preamble is generally consistent with EPA's original interpretation laid out in the 1983 final rule entitled “Premanufacture Notification; Premanufacture Notice Requirements and Review Procedures” (Ref. 7). That final rule states that “EPA believes that it is not possible to define `known to or reasonably ascertainable' more explicitly”; “EPA believes that `reasonably ascertainable' can be defined only on a case-by-case basis”; and “EPA generally can judge from the notice itself whether it includes information that is known to or reasonably ascertainable by the submitter” (Ref. 7 at page 21730). Further, that final rule provides an example of what would not be reasonably ascertainable to illustrate a rather high bar for information to qualify as not reasonably ascertainable: “Certainly, in most instances, data-gathering that is so costly as to preclude commercialization is not reasonable.” (Ref. 7 at page 21730)</P>
                <P>EPA is seeking comment on the proposed new provision at 40 CFR 720.65(c)(2) and proposed amendment to 40 CFR 720.65(c)(5)(iii) (proposed to be redesignated as 720.65(d)(5)(iii)), which clarify that EPA may deem an original notice incomplete, and restart the review period at Day 1 upon completion of the notice, if a submitter provides required information during the applicable review period without demonstrating that it was not known to or reasonably ascertainable by the submitter at the time of the initial notice submission. EPA is seeking comment on situations when this interpretation may not be appropriate.</P>
                <HD SOURCE="HD3">5. Notifying EPA of the Receipt of New Information on a Chemical Substance Under Review</HD>
                <P>
                    EPA acknowledges that in some cases new information can become available about a chemical substance during the course of its review. When this occurs, submitters are required to inform EPA in writing and provide the new information within ten days of receiving 
                    <PRTPAGE P="34112"/>
                    the new information, but no later than five days before the end of the notice review period. 40 CFR 720.40(f) and 40 CFR 720.50(a)(4)(ii) address the requirements for informing EPA of receipt of new information (including a study, report, or test that is completed during the notice review period), which require submitters to communicate receipt of new information to EPA via mail correspondence, or via telephone if the new information is received within five days of the end of the notice review period. EPA is proposing to amend 40 CFR 720.40(f) and 40 CFR 720.50(a)(4)(ii) to clarify that new information about a chemical substance under EPA review must be submitted electronically via CDX, consistent with the general electronic submission requirements in 40 CFR 720.40(a). In addition, when submitters receive new information within five days of the end of the review period, EPA is proposing to allow them to notify EPA by email of the receipt of new information. Email communication would provide an alternative means of notifying EPA of the receipt of new information in the event that an EPA contact is unavailable to receive a phone call. While the submitter could use phone or email to notify EPA of the receipt of new information, all new information would be submitted electronically to EPA via CDX. Additionally, emails should not contain CBI.
                </P>
                <HD SOURCE="HD2">D. Amendments to Low Volume Exemptions and Low Release and Exposure Exemptions</HD>
                <P>EPA is proposing several amendments to the current LVE and LoREX regulations. Specifically, EPA is proposing that: (1) submitters may not commence manufacture until EPA has approved the LVE or LoREX notice; (2) EPA may proactively inform LVE and LoREX holders if the chemical substance that is the subject of the LVE or LoREX becomes subject to a SNUR and the chemical identity is CBI, (3) PFAS be categorically ineligible for these exemptions; and (4) the regulations codify the ineligibility for exemptions of certain PBTs as described in EPA's 1999 PBT policy (Ref. 8).</P>
                <HD SOURCE="HD3">1. Amendments to Expiration of LVE and LoREX Review Period</HD>
                <P>By way of background, 40 CFR 723.50(a)(2)(i) currently requires that LVE and LoREX applicants submit a notice of intent to manufacture a chemical substance under an LVE or LoREX 30 days before commencing manufacture. 40 CFR 723.50(g)(1) provides that EPA will review the LVE or LoREX notice to determine whether manufacture of the chemical substance is eligible for the exemption. LVE and LoREX regulations are promulgated under the statutory authority of TSCA section 5(h)(4), 15 U.S.C. 2604(h)(4), which provides that EPA may, upon application and by rule, exempt the manufacturer of any new chemical substance from all or part of the requirements of TSCA section 5 if EPA determines that the manufacture, processing, distribution in commerce, use, or disposal of such chemical substance, or that any combination of such activities, “will not present an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified by [EPA] under the conditions of use.” At present, 40 CFR 723.50(g)(2) provides that the submitter may begin manufacture of a chemical substance under an LVE or LoREX upon expiration of the 30-day review period if EPA has taken no action. In practice, EPA would move to deny an LVE or LoREX notice at the end of the review period if it were not able to conclude by that time that the substance will not present unreasonable risk on the basis that there are issues concerning toxicity or exposure that require further review which cannot be accomplished within the 30-day review period. EPA's current practice when other delays occur during the review of an LVE is to agree to submitter requests to suspend the running of the review period while EPA completes its review and determines whether to approve or deny the exemption notice. See 40 CFR 723.50(g)(1).</P>
                <P>Elsewhere in this rulemaking, EPA is proposing to amend the regulations that allow submitters to begin manufacture or processing of chemical substances for which a PMN, MCAN, or SNUN was submitted upon expiration of the review period, so that those regulations would require a determination from EPA prior to commencement of manufacture or processing of such substances. As discussed in Unit III.A., these proposed changes to 40 CFR 720.75, 721.25(d), and 725.170 are intended to conform those regulations to the 2016 Lautenberg Amendments. EPA is proposing similar amendments to the LVE and LoREX regulations at 40 CFR 723.50 to align with the proposed amendments to the PMN, SNUN, and MCAN regulations and with the statutory framework and to better ensure that chemical substances manufactured under LVEs and LoREXs will not present an unreasonable risk. Specifically, EPA is proposing to amend the LVE and LoREX regulations at 40 CFR 723.50(g) to require a notification of approval of an LVE or LoREX from EPA prior to commencement of manufacture of the chemical substance under the exemption.</P>
                <HD SOURCE="HD3">2. Notification of LVE and LoREX Holders if the Chemical Substance Is Subject to a SNUR</HD>
                <P>
                    At present, when a chemical substance is reviewed via a PMN and becomes subject to a SNUR, confidentiality claims for the specific chemical identity in the PMN and reflected in the associated SNUR may, in the absence of submitting a 
                    <E T="03">bona fide,</E>
                     prevent holders of current LVEs and LoREXs for that same substance from being informed that the chemical substance is now subject to a SNUR. EPA is proposing to add language to 40 CFR 723.50 to allow EPA to inform an LVE or LoREX holder whenever the chemical substance that is the subject of that LVE or LoREX becomes subject to a proposed or final SNUR that describes the chemical substance by a generic chemical name due to a confidentiality claim for its specific chemical identity. This proposed amendment would, as a courtesy, help inform LVE and LoREX holders of regulatory requirements that they may have otherwise been unable to determine on their own without submitting an inquiry to EPA (also known as a 
                    <E T="03">bona fide</E>
                    ) pursuant to 40 CFR 721.11. EPA is proposing to amend the regulations at 40 CFR 723.50 to establish that a granted LVE or LoREX notice demonstrates a 
                    <E T="03">bona fide</E>
                     intent to manufacture the substance, such that a disclosure to an LVE or LoREX holder that the substance is the subject of a proposed or final rule under Part 721 will not be considered public disclosure of confidential business information under section 14 of the Act. EPA is not proposing in this rulemaking any revisions to the procedures in 40 CFR 723.50(l) for asserting and protecting confidential business information.
                </P>
                <P>
                    This amendment would also help inform certain LVE and LoREX holders that they may now or in the future become subject to chemical data reporting (CDR) requirements. The CDR requirements described at 40 CFR 711.8 differ for chemical substances subject to certain TSCA actions (
                    <E T="03">e.g.,</E>
                     SNURs). The annual production volume threshold at which reporting is ordinarily required is 25,000 pounds, and as such LVE holders are generally exempt, and LoREX holders may be exempt, from such reporting even if their chemical substance has been added to the Inventory. However, if a chemical substance previously approved as an LVE or LoREX is later reviewed as a 
                    <PRTPAGE P="34113"/>
                    PMN and becomes subject to certain new actions under TSCA (such as a SNUR) as well as being added to the Inventory, the threshold for reporting is lowered to 2,500 pounds annually. This creates the potential for inadvertent non-compliance with CDR requirements by those LVE and LoREX holders.
                </P>
                <P>EPA does not intend to proactively inform current LVE and LoREX holders about SNURs that predate this rule. EPA is seeking comment on its proposal to allow EPA to proactively inform an LVE or LoREX holder whenever the chemical substance that is the subject of that LVE or LoREX becomes subject to a proposed or final SNUR that describes the chemical substance by a generic chemical name. EPA would only start the practice of notifying LVE and LoREX holders subject to this proposed amendment after the date of the final rule.</P>
                <HD SOURCE="HD3">3. Making PFAS Categorically Ineligible for LVEs and LoREXs</HD>
                <P>EPA is proposing amendments to make PFAS categorically ineligible for LVEs and LoREXs going forward and proposing a structural definition of PFAS for purposes of the LVE and LoREX regulations. The Agency is proposing the same chemical structure definition for PFAS as the definition proposed in the recent rule entitled “Per- and Poly-fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory; Significant New Use Rule” (known as the “Inactive PFAS SNUR”) (88 FR 4937, January 26, 2023 (FRL-9655-01-OCSPP)).</P>
                <P>
                    In April 2021, EPA's New Chemicals Program began implementing a new policy for reviewing and managing LVE notices for PFAS. In the April 27, 2021 press release announcing the new PFAS LVE policy (Ref. 9), the Agency stated that “[g]iven the complexity of PFAS chemistry, potential health effects, and their longevity and persistence in the environment, an LVE notice for a PFAS is unlikely to be eligible for this kind of exemption under the regulations.” Prior to the new policy, EPA had approved more than 600 LVE notices for PFAS—many of which were granted prior to the 2016 Lautenberg Amendments and were often intended to be substitutes for longer chain PFAS, 
                    <E T="03">i.e.,</E>
                     substances having a fluorinated carbon chain length of C8 or longer. (In the past, long-chain PFAS were generally thought to present greater risks to humans and the environment than shorter-chain PFAS). In June 2021, EPA launched the “PFAS LVE Stewardship Program” to encourage the voluntary withdrawal of the more than 600 previously granted PFAS LVEs. Under that program, an eligible company that wishes to participate is asked to submit a voluntary withdrawal of their LVE. As of April 2023, there are 45 PFAS LVEs that have been voluntarily withdrawn under the PFAS LVE Stewardship Program. EPA has not granted an LVE for a PFAS since May 2020. EPA has not ever received or approved any PFAS LoREX notices.
                </P>
                <P>Under the current policy, manufacturers may still submit LVE and LoREX notices for PFAS, which EPA must review individually. The proposed amendments to the LVE and LoREX regulations would make PFAS categorically ineligible to be considered for these exemptions. Under the proposal, any LVE or LoREX notice for a PFAS that is submitted to the Agency would be denied upon receipt without substantive review. This includes any chemical substance where any of the reasonably anticipated metabolites, environmental transformation products, byproducts, or reasonably anticipated impurities are a PFAS. Persons who wish to manufacture a PFAS not on the TSCA Inventory would instead be required to submit a PMN at least 90 days prior to commencing manufacture for a non-exempt commercial purpose.</P>
                <P>The LVE and LoREX are predicated on strict production volume or release/exposure limits, respectively, and notices are subject to an abbreviated 30-day review by EPA designed to serve as a procedural safeguard to screen out substances that pose potential risks, rather than the more detailed and comprehensive 90-day review afforded to PMNs. See 60 FR 16336, March 29, 1995 (FRL-4923-1). The existing LVE and LoREX regulations at 40 CFR 723.50(h)(1) provide that if EPA determines during the review period that manufacture of the new chemical substance does not meet the terms of the LVE or LoREX requirements or that there are issues concerning toxicity or exposure that require further review which cannot be accomplished within the 30-day review period, EPA will notify the manufacturer that the substance is not eligible for the exemption.</P>
                <P>
                    When EPA initially proposed and then finalized the LVE requirements, EPA considered compiling a list of chemical categories, based on structure, that would not be eligible for the exemption. See the proposed rule entitled “Premanufacture Notification; Proposed Exemption for Site-Limited Intermediate Chemical Substances and Chemical Substances Manufactured in Quantities of 10,000 Kg or Less Per Year” (47 FR 33896, 33907, August 4, 1982 (FRL-2105-1)); and the final rule entitled “Premanufacture Notification Exemption; Exemption for Chemical Substances Manufactured in Quantities of 1,000 Kg or Less Per Year” (50 FR 16477, 16483, April 26, 1985 (FRL-2742-1)). EPA did not adopt categorical exclusions at the time because EPA believed that identifying such categories upfront would be unnecessarily resource-consuming and would provide no more protection than that already provided by EPA's LVE notice review requirements (50 FR at 16483). Neither reason, however, is currently persuasive for chemical substances that meet the proposed structural definition of PFAS. Under TSCA section 26(c), any action taken by EPA on a single chemical substance may also be taken with respect to a category of chemical substances, “the members of which are similar in molecular structure.” Here, it is not difficult or resource-consuming to identify a category to exclude, as the substances that meet the PFAS structural definition share a similar structure and are appropriately addressed as a category in this action. EPA has also committed to “[b]uild the evidence base on individual PFAS” and “use its authorities to impose appropriate limitations on the introduction of new unsafe PFAS into commerce and will, as appropriate, use all available regulatory and permitting authorities to limit emissions and discharges from industrial facilities.” (Ref. 10). Additionally, due to the scientific complexities associated with assessing PFAS and the lack of data on most PFAS with regards to toxicity and exposure to human health and the environment, EPA expects in most cases to be unable to determine pursuant to TSCA section 5(h)(4) that a PFAS “will not present an unreasonable risk” under the conditions of use within the 30-day review period provided for LVE and LoREX notices. Reviewing all new PFAS as PMNs also will preserve EPA's authority to address information gaps when there is insufficient information on the chemical substance and further support the Agency's PFAS Strategic Roadmap, which lays out a whole-of-agency approach to addressing PFAS (see 
                    <E T="03">https://www.epa.gov/pfas/pfas-strategic-roadmap-epas-commitments-action-2021-2024</E>
                    ).
                </P>
                <P>
                    Under the existing regulations at 40 CFR 723.50(h)(2), at any time after EPA approves an LVE or LoREX notice, EPA can determine that manufacture of the new chemical substance does not meet the exemption criteria. If the Agency does so, it would notify the manufacturer by certified letter that EPA believes that the new chemical substance does not meet the 
                    <PRTPAGE P="34114"/>
                    terms for the exemption. With these considerations in mind, EPA solicits comment on revoking previously granted LVEs for PFAS pursuant to the process set forth in 40 CFR 723.50(h)(2) and requiring those who wish to continue manufacture to submit a PMN.
                </P>
                <P>For the purpose of making PFAS ineligible for LVEs and LoREXs, EPA is proposing to define “PFAS” using a structural definition. EPA is proposing to define PFAS as a chemical substance that contains at least one of these three structures:</P>
                <P>(1) R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons</P>
                <P>(2) R-CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons</P>
                <P>(3) CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons.</P>
                <P>Manufacturers of substances that do not meet this structural definition would remain eligible to submit an LVE or LoREX notice. The proposed chemical structure definition for PFAS is the same definition used for the Inactive PFAS SNUR (88 FR 4937, January 26, 2023).</P>
                <P>
                    EPA determined that a structural definition was most appropriate for this rulemaking rather than developing a list of specifically identified substances. Since the substances that would be submitted in LVE or LoREX notices are new chemical substances, it is impractical to generate a comprehensive list of PFAS not on the TSCA Inventory that may be submitted in the future. Additionally, other TSCA requirements have relied on a structural definition when appropriate (
                    <E T="03">e.g.,</E>
                     the long-chain perfluoroalkyl carboxylate (LCPFAC) SNUR defines covered substances using a structural definition (40 CFR 721.10536), and the polymer exemption from PMN requirements defines covered PFAS polymers using structural definitions (40 CFR 723.250)). Furthermore, other scientific and regulatory bodies such as the OECD (Ref. 11) have defined PFAS using various structural definitions. Thus, there is clear precedent for using a structural definition for TSCA rules and other actions addressing PFAS.
                </P>
                <P>
                    The proposed definition for PFAS does not include substances that only have a single fluorinated carbon or unsaturated fluorinated moieties (
                    <E T="03">e.g.,</E>
                     fluorinated aromatic rings and olefins), which are more susceptible to chemical transformation than their saturated counterparts, and therefore less likely to persist in the environment. These potentially degradable substances, if submitted to EPA in a LVE or LoREX notice, would still be evaluated by EPA and a decision made to either deny or grant the exemption. The proposed three-part structural definition for PFAS includes fluoropolymers.
                </P>
                <P>The first sub-structure (R-(CF2)-C(F)(R′)R″), where both the CF2 and CF moieties are saturated carbons and none of the R groups (R, R′ or R″) can be hydrogen, has been the working definition of PFAS used by EPA's Office of Pollution Prevention and Toxics when identifying PFAS on the TSCA Inventory. For this rulemaking, EPA has decided to expand the working definition to include two additional sub-structures.</P>
                <P>The second sub-structure (R-CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons) aims to capture certain fluorinated ethers. Examples of substances that meet this sub-structure include, PFMOAA (CASRN 674-13-5) and other chemicals, with properties similar to hexafluoropropylene oxide (HFPO) dimer acid and its ammonium salt (known as “GenX chemicals”), that have been found in the Cape Fear River.</P>
                <P>Finally, the third sub-structure (CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons) aims to capture fluorinated substances that are more branched and would not otherwise meet the first or second sub-structure definitions due to their non-adjacent carbons. Although these substances have carbons that are not fully fluorinated and that may be more susceptible to degradation and metabolism, highly fluorinated moieties of the substance are still likely to be persistent.</P>
                <P>This proposed definition may not be identical to other definitions of PFAS used within EPA or by other organizations. The term “PFAS” has been used varyingly by many organizations for their distinct research and/or regulatory needs, and different definitions of the term “PFAS” may be appropriate for such purposes. The Agency notes that this perspective, that different users may have distinct needs and that no single PFAS characterization or definition meets all needs, is shared by many other organizations, including OECD (see page 29, Ref. 11). EPA proposes that the above definition of “PFAS” is the most appropriate definition for the proposal to make PFAS ineligible for future LVEs and LoREXs and acknowledges that there may be other rules or programs that apply different definitions to meet their own needs.</P>
                <HD SOURCE="HD3">4. PBT Chemicals and LVEs and LoREXs</HD>
                <HD SOURCE="HD3">a. Background</HD>
                <P>Currently, 40 CFR 723.50(d) describes certain criteria that EPA uses to determine the eligibility of chemical substances for manufacture under an LVE and LoREX. These criteria include the potential of a chemical substance to cause serious acute or chronic effects or significant environmental effects under anticipated conditions of manufacture, processing, distribution in commerce, use, or disposal. These criteria also extend to any reasonably anticipated metabolites, environmental transformation products, or byproducts of the chemical substance, as well as any reasonably anticipated impurities in the substance.</P>
                <P>Although numerous factors can contribute to the potential of a particular chemical substance to cause serious acute or chronic effects or significant environmental effects as described in 40 CFR 723.50(d), chemical substances that are persistent, bioaccumulative, and toxic (PBT) are of special concern because: (1) their persistence in the environment increases the likelihood of exposure of biological systems to those chemicals; (2) their bioaccumulative potential increases the probability that they will move vertically through and become embedded in trophic chains; and (3) their persistence and bioaccumulation potential, coupled with toxicity concerns, can result in risk to biological systems. Once PBT chemicals are released into the environment, they are often difficult or impossible to remediate.</P>
                <P>
                    On November 4, 1999, EPA issued its policy statement (64 FR 60194) (Ref. 8) identifying a category for PBT new chemical substances. The 1999 policy statement formally acknowledged PBT chemical substances as a category based on shared characteristics to facilitate premanufacture assessment and regulation. Furthermore, the PBT policy statement established EPA's current criteria for identifying PBT chemical substances for the New Chemicals Program, which involves using physical-chemical properties, as well as structural activity alerts, analogue data, and test data to quantify on a scale of 1 to 3 the potential for persistence (P), bioaccumulation (B), and toxicity (T) for a given new chemical substance. If a substance scores a 2 or above for all three characteristics, EPA considers the substance to be PBT. EPA emphasized in responses to comments received on the October 1998 draft policy released for public comment that the decision to identify and assess a new chemical 
                    <PRTPAGE P="34115"/>
                    substance as PBT would be based on the available data and would be made on a case-by-case basis.
                </P>
                <HD SOURCE="HD3">b. Codifying EPA's Policy Concerning PBT Chemicals and LVEs and LoREXs</HD>
                <P>
                    At present, the exemption regulations at 40 CFR 723.50 do not expressly disqualify PBT chemical substances from eligibility for the LVE or LoREX. However, under TSCA section 5(h)(4), EPA may exempt a chemical substance from section 5 requirements upon application and by rule only if EPA determines the manufacture, processing, distribution in commerce, use, or disposal of the substance will not present an unreasonable risk. And as explained above, the regulations at 40 CFR 723.50(d) provide that chemical substances that may cause serious acute or chronic effects or significant environmental effects are not eligible for the LVE or LoREX. When exposure of the environment or biological organisms (including humans) to a PBT chemical is expected, one or more of the conditions above (
                    <E T="03">i.e.,</E>
                     serious acute or chronic effects or significant environmental effects) is generally likely to occur, often making the PBT chemical ineligible for the exemptions. Whenever the potential for unreasonable exposures to a PBT chemical is identified during the review of an LVE or LoREX notice, EPA's longstanding policy has been to deny the exemption notice. However, EPA's specific concerns for PBT chemicals as they relate to LVEs and LoREXs are not separately codified in the existing regulations at 40 CFR 723.50.
                </P>
                <P>
                    EPA is therefore proposing amendments to 40 CFR 723.50(d) that would codify EPA's long-standing practice that, whenever EPA identifies a chemical substance under LVE or LoREX review (or any reasonably anticipated metabolites, environmental transformation products, or byproducts of the substance, or any reasonably anticipated impurities in the substance) as PBT with anticipated environmental releases and potentially unreasonable exposures to humans or environmental organisms, that substance would be ineligible for the LVE or LoREX. The proposed amendments clarify that PBT chemicals with anticipated environmental releases and potentially unreasonable human or environmental organism exposures would be ineligible for the LVE or LoREX but would not prevent companies from submitting an exemption notice for a given substance. The finding that a substance is PBT would be made by EPA during the review of the notice. While EPA has offered generic guidance regarding how it determines the PBT status of chemical substances, the policies and science used to ascribe discrete scores (
                    <E T="03">i.e.,</E>
                     1-3) to the persistence, bioaccumulative potential, and toxicity of a particular chemical substance are based on the available data and made on a case-by-case basis. As such, a submitter may not be able to determine in advance of submitting an exemption notice if EPA would find the substance to be PBT. Although EPA is ultimately responsible for assessing whether chemical substances are potentially PBT, submitters who possess data indicating that their new chemical substances could be PBT and could be handled in such a way as to result in anticipated or unreasonable exposures may be less likely to expend the time and resources to submit an LVE or LoREX notice for EPA review of those substances if the outcome of the review would almost certainly be denial of the notice.
                </P>
                <P>EPA is further proposing to define “PBT chemical substance” for purposes of 40 CFR 723.50 as “a chemical substance possessing characteristics of persistence (P) in the environment, accumulation in biological organisms (bioaccumulation (B)), and toxicity (T) resulting in potential risks to humans and ecosystems. For more information on EPA's Policy on new chemical substances that are PBT, see EPA's 1999 policy statement (64 FR 60194; November 4, 1999).”</P>
                <HD SOURCE="HD2">E. Amendments Related to Suspensions of the Review Period</HD>
                <P>EPA is proposing to amend 40 CFR 720.75(b)(2) to allow PMN, SNUN, LVE, and LoREX submitters to request a suspension of the notice review period for up to 30 days orally or in writing, including by email, without the need for a formal, written request submitted to EPA via CDX using e-PMN software. EPA is similarly proposing to amend 40 CFR 725.54(c) to permit MCAN submitters to request suspensions for up to 30 days orally or in writing, including by email, without the need for a formal, written request submitted to EPA via CDX using e-PMN software. EPA would continue to require that all requests for suspensions exceeding 30 days be submitted electronically to EPA via CDX using e-PMN software.</P>
                <P>When the notice or exemption review period for a PMN, SNUN, LVE, or LoREX approaches its end, submitters may request that EPA suspend the running of the notice review period so that the review period does not expire (40 CFR 720.75(b); see also 40 CFR 721.25(c) and 723.50(g)(1), applying the 720.75(b) suspension procedures to SNUNs, LVEs, and LoREXs). The existing regulations at 720.75(b) specify that such requests can be made orally to EPA, so long as the length of the suspension does not exceed 15 days; suspensions exceeding 15 days must be submitted to EPA in writing via CDX using EPA's e-PMN software. At the submitter's request, EPA can suspend a notice review period until the review is complete and a decision has been made for the notice. Once a final decision is made, any remaining suspension days are rescinded.</P>
                <P>
                    Currently, the regulations at 40 CFR 725.54, which pertain to the suspension of the review period for MCANs and exemptions related to microorganisms (
                    <E T="03">e.g.,</E>
                     TSCA Environmental Release Applications (TERA) and Tier II submissions) mirror those at 720.75(b) for PMNs, SNUNs, LVEs, and LoREXs. As in 40 CFR 720.75(b), the language at 40 CFR 725.54 indicates that submitters may suspend a notice or exemption review period for up to 15 days via oral request, or for greater than 15 days via a formal, written request submitted to EPA via CDX using EPA's e-PMN software. Although suspensions occur less frequently during the reviews of notices and exemptions for microorganisms than during reviews for PMNs, SNUNs, LVEs, and LoREXs, submitters do occasionally request suspensions in order to develop additional information.
                </P>
                <P>Given the relative ease and value of suspending a notice review period via informal oral request, most submitters who seek suspensions opt to suspend for 15 days whenever their case is nearing expiration of its review period to allow EPA to finalize its review. If a case is suspended, it is often suspended more than once, and submitters typically informally request multiple 15-day suspensions rather than requesting a longer suspension in writing via CDX. As such, EPA is proposing to allow for informal suspensions up to 30 days to reduce the number of repeated informal requests. Additionally, EPA believes that email may be more expedient than oral communication for many submitters. Therefore, EPA is proposing amendments to allow submitters to request suspensions for up to 30 days either orally or via email.</P>
                <P>
                    EPA is seeking comment on its proposal to increase the number of days permissible for suspensions not requiring a formal, written request submitted to EPA via CDX using e-PMN software. Specifically, EPA requests comment on its proposal to permit requests for suspensions up to 30 days to be communicated orally or via email, and to update the relevant regulations 
                    <PRTPAGE P="34116"/>
                    pertaining to suspension of microorganism-related submissions under 40 CFR 725.54 to mirror the proposed changes for suspension of PMNs, SNUNs, LVEs, and LoREXs. EPA is not considering, proposing, or requesting comment on any additional changes to the regulations regarding suspensions at this time.
                </P>
                <HD SOURCE="HD1">IV. Economic Analysis</HD>
                <P>The estimated incremental impacts of this rulemaking are briefly summarized in this unit and the complete Economic Analysis (Ref. 1) is available in the docket. The proposed rule is expected primarily to affect two types of firms:</P>
                <P>(1) Manufacturers of PFAS who would have submitted an LVE or LoREX in the baseline but would need to submit a PMN under the proposed rule due to the proposed amendment to make PFAS ineligible for the exemptions; and</P>
                <P>(2) Firms submitting any TSCA section 5 notices through the PMN form (PMNs, SNUNs, LVEs, LoREXs, TMEs) that are expected to submit fewer amendments to their original submissions due to the amended procedural requirements of the proposed rule.</P>
                <P>While the proposed rule includes additional amendments to the new chemicals regulations under TSCA, EPA expects that these additional amendments will not result in incremental burden or savings because they are largely already performed in the baseline.</P>
                <P>As a result of this proposed rule, EPA expects that the average number of amendments per notice will decrease from 1.81 to 0.9, with a decrease in burden to EPA of 12 hours per avoided amendment. In addition, EPA expects that the 12 annual average of LVE submissions for PFAS will instead be submitted as PMNs. It is expected that individual submitters of PMNs will experience an overall decrease in burden of 13 hours with an associated decrease in cost of approximately $1,120 per notice.</P>
                <P>Additionally, improvements in the submission process are expected to reduce inefficiency in the Agency's review process. As a result of the changes under the proposed rule, it is expected that the cost to the Agency associated with reviewing PMNs, SNUNs, and exemption notices will decrease by ten percent. Therefore, it is expected that the Agency will experience an annual cost savings of approximately $923,280.</P>
                <HD SOURCE="HD1">V. References</HD>
                <P>
                    The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    .
                </P>
                <EXTRACT>
                    <FP SOURCE="FP-2">1. EPA. Economic Analysis for Proposed Updates to New Chemicals Regulations under the Toxic Substances Control Act (TSCA). May 2023.</FP>
                    <FP SOURCE="FP-2">
                        2. EPA. Central Data Exchange Online User Guide. Accessible at: 
                        <E T="03">https://cdx.epa.gov/About/UserGuide.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        3. EPA. Points to Consider When Preparing TSCA New Chemical Notification. OMB Control No.: 2070-0012. June 2018. Accessible at: 
                        <E T="03">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/points-consider-when-preparing-tsca.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        4. EPA. TSCA New Chemical Engineering Initiative to Increase Transparency and Reduce Re-work. Accessible at: 
                        <E T="03">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-new-chemical-engineering.</E>
                    </FP>
                    <FP SOURCE="FP-2">5. EPA. Tables Detailing the Proposed Amendments to Add Details to 40 CFR part 720.45 Reporting Requirements and Enhancements to the CDX Reporting Form. May 2023.</FP>
                    <FP SOURCE="FP-2">6. EPA. Supporting Statement for an Information Collection Request (ICR) Under the Paperwork Reduction Act (PRA); Updates to New Chemicals Regulations under the Toxic Substances Control Act; Proposed Rule (RIN 2070-AK65); EPA ICR No. 2749.01; OMB Control No. 2070-[NEW]. May 2023.</FP>
                    <FP SOURCE="FP-2">
                        7. EPA. Premanufacture Notification; Premanufacture Notice Requirements and Review Procedures; Final Rule. 
                        <E T="04">Federal Register</E>
                        . 48 FR 21722; May 13, 1983 (TSH-FRL 2998-5).
                    </FP>
                    <FP SOURCE="FP-2">
                        8. EPA. Policy Statement on Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. 
                        <E T="04">Federal Register</E>
                        . (64 FR 60194, November 4, 1999) (FRL-6097-7).
                    </FP>
                    <FP SOURCE="FP-2">9. EPA. Press Release: EPA Announces Changes to Prevent Unsafe New PFAS from Entering the Market. April 27, 2021.</FP>
                    <FP SOURCE="FP-2">
                        10. EPA. PFAS Strategic Roadmap: EPA's Commitments to Action 2021-2024. October 18, 2021. Accessed at: 
                        <E T="03">https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        11. OECD. Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances: Recommendations and Practical Guidance. July 9, 2021. Accessed at: 
                        <E T="03">https://one.oecd.org/document/ENV/CBC/MONO(2021)25/En/pdf.</E>
                    </FP>
                </EXTRACT>
                <HD SOURCE="HD1">VI. Statutory and Executive Order Reviews</HD>
                <P>
                    Additional information about these 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 Orders 12866: Regulatory Planning and Review and 14094: Modernizing Regulatory Review</HD>
                <P>This action is not a significant regulatory action as defined in Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore not subject to review under Executive Order 12866.</P>
                <HD SOURCE="HD2">B. Paperwork Reduction Act (PRA)</HD>
                <P>
                    The information collection activities in this proposed rule have been submitted to OMB for review and approval under the PRA (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ). The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR No. 2749.01 (Ref. 6). This ICR represents an amendment to the currently approved ICR that covers the information collection activities contained in the existing regulations, which are approved under OMB control number 2070-0012 (EPA ICR No. 574.15). Estimates presented in the ICR below reflect the minor incremental changes associated with the rule that are presented in the Economic Analysis (Ref. 1). EPA is proposing amendments to the new chemicals procedural regulations under TSCA. These amendments are intended to align the regulatory text with the amendments to TSCA's new chemicals review provisions and improve the efficiency of EPA's review processes and update the regulations based on existing policies and experience implementing the New Chemicals Program. You can find copies of the Economic Analysis and ICR in the docket, and the ICR is briefly summarized here.
                </P>
                <P>
                    <E T="03">Respondents/affected entities:</E>
                     Certain manufacturers (including importers) and processors (see Unit I.A.).
                </P>
                <P>
                    <E T="03">Respondent's obligation to respond:</E>
                     Mandatory under TSCA section 5.
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                     560.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion, 
                    <E T="03">i.e.,</E>
                     upon submission of a PMN, SNUN, LVE, LoREX, or MCAN.
                </P>
                <P>
                    <E T="03">Total estimated incremental burden:</E>
                     Estimates show that this proposed rule will decrease existing approved burden by 4,518 hours per year. Burden is defined at 5 CFR 1320.3(b).
                </P>
                <P>
                    <E T="03">Total estimated incremental cost:</E>
                     Estimates show that this proposed rule 
                    <PRTPAGE P="34117"/>
                    will increase existing approved costs by $45,120 per year. This includes $0 annualized capital or operation and maintenance costs.
                </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. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.</P>
                <P>
                    Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to EPA using the docket identified at the beginning of this rulemaking. EPA will respond to any ICR-related comments in the final rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs using the interface at 
                    <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E>
                     Find this particular ICR by selecting “Currently under Review—Open for Public Comments” or by using the search function. OMB must receive comments no later than July 25, 2023.
                </P>
                <HD SOURCE="HD2">C. Regulatory Flexibility Act (RFA)</HD>
                <P>
                    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 
                    <E T="03">et seq.</E>
                     The Agency's basis is briefly summarized here and is detailed in the Economic Analysis (Ref. 1).
                </P>
                <P>The majority of firms that submit a TSCA section 5 notice will realize either no change or a decrease in costs associated with form submission. However, EPA expects that firms that submit LVE notices for PFAS will incur an estimated cost of approximately $45,863 per notice due to the greater burden and non-labor costs associated with submitting a PMN form. EPA estimates that 99 percent of small firms (185 firms) will have cost impacts of less than 1 percent of revenues, less than 1 percent (1 firms) will have cost impacts between 1 and 3 percent of revenues, and 1 percent (2 firms) will have cost impacts greater than 3 percent of revenues.</P>
                <HD SOURCE="HD2">D. Unfunded Mandates Reform Act (UMRA)</HD>
                <P>This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments and the incremental cost on the private sector is estimated to be less than $50,000. Based on EPA's experience with reviewing actions under TSCA section 5, state, local, and tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any state, local, or tribal government would engage in the activities such that they would be impacted by this rulemaking. In addition, based on the Economic Analysis prepared for this proposed rule (Ref. 1), EPA concludes that this rulemaking is not expected to result in expenditures by the private sector of $100 million or more (when adjusted annually for inflation) in any one year. Accordingly, this rulemaking is not subject to the requirements of UMRA sections 202, 203, or 205. The Economic Analysis (Ref. 1) for this action is summarized in Unit IV. and is available in the docket.</P>
                <HD SOURCE="HD2">E. Executive Order 13132: Federalism</HD>
                <P>This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), 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.</P>
                <HD SOURCE="HD2">F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</HD>
                <P>This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.</P>
                <HD SOURCE="HD2">G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks</HD>
                <P>EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-201 of the Executive Order. Therefore, this action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk. Since this action does not concern human health risks, EPA's Policy on Children's Health also does not apply. This procedural rule would align the procedural regulations codified at 40 CFR parts 720 and 725 with amended TSCA and make additional updates based on existing policies or lessons learned from administering the New Chemicals Program since TSCA was amended in 2016.</P>
                <P>Although this procedural rule itself would not directly affect the level of protection provided to human health or the environment, EPA expects that the rule would improve the Agency's consideration of risks to children—in furtherance of EPA's Policy on Children's Health—and other PESS. In turn, EPA anticipates that the proposed amendments would help better inform the Agency's determinations for each new chemical substance or significant new use for which it received a notice under TSCA section 5(a)(1), pertaining to the likelihood of unreasonable risk to human health or the environment under known, intended or reasonably foreseen conditions of use. EPA uses an integrated approach that draws on knowledge and experience across disciplinary and organizational lines to identify and evaluate concerns regarding health and environmental effects, and exposure and release.</P>
                <HD SOURCE="HD2">H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use</HD>
                <P>This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution or use of energy and has not otherwise been designated as a significant energy action by the Administrator of the Office of Information and Regulatory Affairs.</P>
                <HD SOURCE="HD2">I. National Technology Transfer and Advancement Act (NTTAA)</HD>
                <P>This rulemaking does not involve technical standards under the NTTAA section 12(d), 15 U.S.C. 272.</P>
                <HD SOURCE="HD2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations</HD>
                <P>
                    Executive Order 12898 (59 FR 7629, February 16, 1994) directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations (people of color and/or Indigenous peoples) and low-income 
                    <PRTPAGE P="34118"/>
                    populations. This action is procedural in nature. Therefore, EPA believes that it is not practicable to assess whether the human health or environmental conditions that exist prior to this action result in disproportionate and adverse effects on people of color, low-income populations and/or Indigenous peoples. By proposing, among other things, to include overburdened communities in the regulatory definition of PESS.
                </P>
                <P>The Agency believes that this action would assist EPA and others in determining the potential exposures, hazards and risks to overburdened communities associated with the manufacture, processing, distribution in commerce, use, or disposal of the new chemical substances and significant new uses of chemical substances subject to this rulemaking. EPA anticipates that the inclusion of overburdened communities among the PESS considered in the Agency's review of a TSCA section 5 submission would also enable the Agency, if necessary, to design appropriate future risk management actions to address an unreasonable risk that the Agency may determine is presented by that chemical substance and to consider how such risk management actions would affect communities with environmental justice concerns.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Parts 720, 721, 723, and 725</HD>
                    <P>Environmental protection, Chemicals, Hazardous materials, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: May 16, 2023.</DATED>
                    <NAME>Michal Freedhoff,</NAME>
                    <TITLE>Assistant Administrator, Office of Chemical Safety and Pollution Prevention.</TITLE>
                </SIG>
                <P>Therefore, for the reasons set forth in the preamble, 40 CFR chapter I is amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 720—PREMANUFACTURE NOTIFICATION</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 720 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>15 U.S.C. 2604, 2607, and 2613.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 720.1</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. Amend § 720.1 by removing the phrase “The rule” and adding in its place the phrase “This part” wherever it appears.</AMDPAR>
                <AMDPAR>3. Amend § 720.3 by adding new paragraphs (ll) and (mm) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 720.3</SECTNO>
                    <SUBJECT>Definitions.</SUBJECT>
                    <STARS/>
                    <P>
                        (ll) 
                        <E T="03">Applicable review period</E>
                         means the period starting on the date EPA receives a complete notice under section 5(a)(1) of the Act and ending 90 days after that date or on such date as is provided for in sections 5(b)(1) or 5(c) of the Act.
                    </P>
                    <P>
                        (mm) 
                        <E T="03">Potentially exposed or susceptible subpopulation</E>
                         means a group of individuals within the general population identified by EPA who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, the elderly, or overburdened communities.
                    </P>
                    <STARS/>
                </SECTION>
                <AMDPAR>4. Amend § 720.40 by revising paragraph (f) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 720.40</SECTNO>
                    <SUBJECT>General.</SUBJECT>
                    <STARS/>
                    <P>
                        (f) 
                        <E T="03">New information.</E>
                         During the applicable review period, if the submitter possesses, controls, or knows of new information that materially adds to or changes the information included in the notice, the submitter must submit that information to EPA within ten days of receiving the new information, but no later than five days before the end of the applicable review period. The new information must be submitted electronically to EPA via CDX and must clearly identify the submitter and the notice to which the new information is related. If the new information becomes available during the last five days of the applicable review period, the submitter must immediately inform its EPA contact for that notice by telephone or email and submit the new information electronically to EPA via CDX.
                    </P>
                    <STARS/>
                </SECTION>
                <AMDPAR>5. Amend § 720.45 by:</AMDPAR>
                <AMDPAR>a. Revising paragraphs (a)(4) and (5);</AMDPAR>
                <AMDPAR>b. Revising paragraphs (f) through (h); and</AMDPAR>
                <AMDPAR>c. Adding paragraphs (j) and (k).</AMDPAR>
                <P>The revisions and additions read as follows:</P>
                <SECTION>
                    <SECTNO>§ 720.45</SECTNO>
                    <SUBJECT>Information that must be included in the notice form.</SUBJECT>
                    <P>(a) * * *</P>
                    <P>(4) If an importer submitting the notice cannot provide all the information specified in paragraphs (a)(1) and (2) of this section because it is claimed as confidential by the foreign supplier of the substance, the importer must have the foreign supplier follow the procedures in paragraph (a)(3) of this section and provide the correct chemical identity information specified in paragraphs (a)(1) and (2) of this section directly to EPA in a joint submission or as a letter of support to the notice, which clearly references the importer's notice and PMN User Fee Identification Number. The statutory review period will commence upon receipt of both the notice and the complete, correct information, in accordance with § 720.65.</P>
                    <P>(5) If a manufacturer cannot provide all the information specified in paragraphs (a)(1) and (2) of this section because the new chemical substance is manufactured using a reactant having a specific chemical identity claimed as confidential by its supplier, the manufacturer must submit a notice directly to EPA containing all the information known by the manufacturer about the chemical identity of the reported substance and its proprietary reactant. In addition, the manufacturer must ensure that the supplier of the confidential reactant submit a letter of support directly to EPA providing the specific chemical identity of the confidential reactant, including the CAS number, if available, and the appropriate PMN or exemption number, if applicable. The letter of support must reference the manufacturer's name and PMN Fee Identification Number. The statutory review period will commence upon receipt of the notice, the letter of support, and the complete, correct information in accordance with § 720.65.</P>
                    <STARS/>
                    <P>(f)(1) A description of the intended category or categories of consumer or commercial use by function and application, which includes a description of the following:</P>
                    <P>(i) The estimated percent of production volume devoted to each category of use.</P>
                    <P>(ii) The percent of the new chemical substance in the formulation for each commercial or consumer use.</P>
                    <P>
                        (iii) The types of products or articles that would incorporate the new chemical substance (
                        <E T="03">e.g.,</E>
                         household cleaners, plastic articles).
                    </P>
                    <P>(iv) Information related to the use of products or articles containing the new chemical substance by potentially exposed or susceptible subpopulations.</P>
                    <P>
                        (v) How and where a product or article incorporating the new chemical substance would be used (
                        <E T="03">e.g.,</E>
                         spray applied indoors, brushed on outdoor surfaces).
                    </P>
                    <P>(vi) Consumption rates and frequency and duration of use of products or articles incorporating the new chemical substance.</P>
                    <P>
                        (2) Using the applicable codes listed in table 1 to paragraph (f)(2), submitters must designate the consumer and commercial product category or categories that best describe the 
                        <PRTPAGE P="34119"/>
                        consumer and commercial products in which the new chemical substance is intended or known to be used.
                    </P>
                    <GPOTABLE COLS="2" OPTS="L2,nj,i1" CDEF="xs60,r200">
                        <TTITLE>
                            Table 1 to Paragraph (
                            <E T="01">f</E>
                            )(2)—Codes for Reporting Consumer and Commercial Product Categories
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">Code</CHED>
                            <CHED H="1">Category</CHED>
                        </BOXHD>
                        <ROW EXPSTB="01" RUL="s">
                            <ENT I="21">
                                <E T="02">Chemical Substances in Furnishing, Cleaning, Treatment Care Products</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">CC101</ENT>
                            <ENT>Construction and building materials covering large surface areas including stone, plaster, cement, glass and ceramic articles; fabrics, textiles, and apparel.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC102</ENT>
                            <ENT>Furniture &amp; furnishings including plastic articles (soft); leather articles.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC103</ENT>
                            <ENT>Furniture &amp; furnishings including stone, plaster, cement, glass and ceramic articles; metal articles; or rubber articles.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC104</ENT>
                            <ENT>Leather conditioner.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC105</ENT>
                            <ENT>Leather tanning, dye, finishing, impregnation and care products.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC106</ENT>
                            <ENT>Textile (fabric) dyes.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC107</ENT>
                            <ENT>Textile finishing and impregnating/surface treatment products.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC108</ENT>
                            <ENT>All-purpose foam spray cleaner.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC109</ENT>
                            <ENT>All-purpose liquid cleaner/polish.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC110</ENT>
                            <ENT>All-purpose liquid spray cleaner.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC111</ENT>
                            <ENT>All-purpose waxes and polishes.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC112</ENT>
                            <ENT>Appliance cleaners.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC113</ENT>
                            <ENT>Drain and toilet cleaners (liquid).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC114</ENT>
                            <ENT>Powder cleaners (floors).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC115</ENT>
                            <ENT>Powder cleaners (porcelain).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC116</ENT>
                            <ENT>Dishwashing detergent (liquid/gel).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC117</ENT>
                            <ENT>Dishwashing detergent (unit dose/granule).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC118</ENT>
                            <ENT>Dishwashing detergent liquid (hand-wash).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC119</ENT>
                            <ENT>Dry cleaning and associated products.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC120</ENT>
                            <ENT>Fabric enhancers.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC121</ENT>
                            <ENT>Laundry detergent (unit-dose/granule).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC122</ENT>
                            <ENT>Laundry detergent (liquid).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC123</ENT>
                            <ENT>Stain removers.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC124</ENT>
                            <ENT>Ion exchangers.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC125</ENT>
                            <ENT>Liquid water treatment products.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC126</ENT>
                            <ENT>Solid/Powder water treatment products.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC127</ENT>
                            <ENT>Liquid body soap.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC128</ENT>
                            <ENT>Liquid hand soap.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC129</ENT>
                            <ENT>Solid bar soap.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC130</ENT>
                            <ENT>Air fresheners for motor vehicles.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC131</ENT>
                            <ENT>Continuous action air fresheners.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC132</ENT>
                            <ENT>Instant action air fresheners.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC133</ENT>
                            <ENT>Anti-static spray.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC134</ENT>
                            <ENT>Apparel finishing, and impregnating/surface treatment products.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC135</ENT>
                            <ENT>Insect repellent treatment.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC136</ENT>
                            <ENT>Pre-market waxes, stains, and polishes applied to footwear.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC137</ENT>
                            <ENT>Post-market waxes, and polishes applied to footwear (shoe polish).</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">CC138</ENT>
                            <ENT>Waterproofing and water-resistant sprays.</ENT>
                        </ROW>
                        <ROW EXPSTB="01" RUL="s">
                            <ENT I="21">
                                <E T="02">Chemical Substances in Construction, Paint, Electrical, and Metal Products</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">CC201</ENT>
                            <ENT>Fillers and putties.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC202</ENT>
                            <ENT>Hot-melt adhesives.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC203</ENT>
                            <ENT>One-component caulks.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC204</ENT>
                            <ENT>Solder.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC205</ENT>
                            <ENT>Single-component glues and adhesives.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC206</ENT>
                            <ENT>Two-component caulks.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC207</ENT>
                            <ENT>Two-component glues and adhesives.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC208</ENT>
                            <ENT>Adhesive/Caulk removers.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC209</ENT>
                            <ENT>Aerosol spray paints.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC210</ENT>
                            <ENT>Lacquers, stains, varnishes and floor finishes.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC211</ENT>
                            <ENT>Paint strippers/removers.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC212</ENT>
                            <ENT>Powder coatings.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC213</ENT>
                            <ENT>Radiation curable coatings.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC214</ENT>
                            <ENT>Solvent-based paint.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC215</ENT>
                            <ENT>Thinners.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC216</ENT>
                            <ENT>Water-based paint.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC217</ENT>
                            <ENT>Construction and building materials covering large surface areas, including wood articles.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC218</ENT>
                            <ENT>Construction and building materials covering large surface areas, including paper articles; metal articles; stone, plaster, cement, glass and ceramic articles.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC219</ENT>
                            <ENT>Machinery, mechanical appliances, electrical/electronic articles.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC220</ENT>
                            <ENT>Other machinery, mechanical appliances, electronic/electronic articles.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC221</ENT>
                            <ENT>Construction and building materials covering large surface areas, including metal articles.</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">CC222</ENT>
                            <ENT>Electrical batteries and accumulators.</ENT>
                        </ROW>
                        <ROW EXPSTB="01" RUL="s">
                            <PRTPAGE P="34120"/>
                            <ENT I="21">
                                <E T="02">Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">CC301</ENT>
                            <ENT>Packaging (excluding food packaging), including paper articles.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC302</ENT>
                            <ENT>Other articles with routine direct contact during normal use, including paper articles.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC303</ENT>
                            <ENT>Packaging (excluding food packaging), including rubber articles; plastic articles (hard); plastic articles (soft).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC304</ENT>
                            <ENT>Other articles with routine direct contact during normal use including rubber articles; plastic articles (hard).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC305</ENT>
                            <ENT>Toys intended for children's use (and child dedicated articles), including fabrics, textiles, and apparel; or plastic articles (hard).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC306</ENT>
                            <ENT>Adhesives applied at elevated temperatures.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC307</ENT>
                            <ENT>Cement/concrete.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC308</ENT>
                            <ENT>Crafting glue.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC309</ENT>
                            <ENT>Crafting paint (applied to body).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC310</ENT>
                            <ENT>Crafting paint (applied to craft).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC311</ENT>
                            <ENT>Fixatives and finishing spray coatings.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC312</ENT>
                            <ENT>Modelling clay.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC313</ENT>
                            <ENT>Correction fluid/tape.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC314</ENT>
                            <ENT>Inks in writing equipment (liquid).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC315</ENT>
                            <ENT>Inks used for stamps.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC316</ENT>
                            <ENT>Toner/Printer cartridge.</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">CC317</ENT>
                            <ENT>Liquid photographic processing solutions.</ENT>
                        </ROW>
                        <ROW EXPSTB="01" RUL="s">
                            <ENT I="21">
                                <E T="02">Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">CC401</ENT>
                            <ENT>Exterior car washes and soaps.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC402</ENT>
                            <ENT>Exterior car waxes, polishes, and coatings.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC403</ENT>
                            <ENT>Interior car care.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC404</ENT>
                            <ENT>Touch up auto paint.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC405</ENT>
                            <ENT>Degreasers.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC406</ENT>
                            <ENT>Liquid lubricants and greases.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC407</ENT>
                            <ENT>Paste lubricants and greases.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC408</ENT>
                            <ENT>Spray lubricants and greases.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC409</ENT>
                            <ENT>Anti-freeze liquids.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC410</ENT>
                            <ENT>De-icing liquids.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC411</ENT>
                            <ENT>De-icing solids.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC412</ENT>
                            <ENT>Lock de-icers/releasers.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC413</ENT>
                            <ENT>Cooking and heating fuels.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC414</ENT>
                            <ENT>Fuel additives.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC415</ENT>
                            <ENT>Vehicular or appliance fuels.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC416</ENT>
                            <ENT>Explosive materials.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC417</ENT>
                            <ENT>Agricultural non-pesticidal products.</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">CC418</ENT>
                            <ENT>Lawn and garden care products.</ENT>
                        </ROW>
                        <ROW EXPSTB="01" RUL="s">
                            <ENT I="21">
                                <E T="02">Chemical Substances in Products Not Described by Other Codes</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">CC980</ENT>
                            <ENT>Other (specify).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">CC990</ENT>
                            <ENT>Non-TSCA use.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>(g) For sites controlled by the submitter:</P>
                    <P>(1) The identity and address of each site where the new chemical substance will be manufactured, processed, or used.</P>
                    <P>(2) A process description of each manufacture, processing, and use operation which includes a diagram of the major unit operations and chemical conversions; indication of whether batch or continuous manufacturing or processing occurs at the site, and the amount manufactured or processed per batch or per day if continuous and per year; the identity, approximate weight per batch or per day for continuous production, and entry point of all starting materials and feedstocks (including reactants, solvents, catalysts, etc.); the identity, approximate weight per batch or per day for continuous production, and entry point of all products, recycle streams, and wastes, including frequency of any equipment cleaning; the type of interim storage and transport containers used; and the points of release of the new chemical substance numbered. If the new chemical substance is released to two media at the same step in the process, assign a second number for the second medium.</P>
                    <P>
                        (3) Worker exposure information, including worker exposure information from exempt manufacture or related use of the new chemical substance under § 720.30 (
                        <E T="03">e.g.,</E>
                         byproduct, impurity). This information includes:
                    </P>
                    <P>(i) Worker activities.</P>
                    <P>
                        (ii) Type of potential worker exposure (
                        <E T="03">e.g.,</E>
                         dermal, inhalation).
                    </P>
                    <P>(iii) Protective equipment in place, if any, including a description of the kind of gloves, protective clothing, goggles, or respirator that limit worker exposure, if any.</P>
                    <P>(iv) Engineering controls in place, if any.</P>
                    <P>(v) Physical form of the new chemical substance to which workers may be exposed and moisture content if physical form is solid.</P>
                    <P>(vi) The percent of new chemical substance in formulation at time of worker exposure.</P>
                    <P>(vii) The number of workers reasonably likely to be exposed.</P>
                    <P>(viii) The duration of activities.</P>
                    <P>
                        (4) Information on release of the new chemical substance to the environment, including releases from the exempt manufacture or related use of the new 
                        <PRTPAGE P="34121"/>
                        chemical substance under § 720.30 (
                        <E T="03">e.g.,</E>
                         byproduct, impurity). This information includes the type of release (
                        <E T="03">e.g.,</E>
                         transport, interim storage, disposal, equipment cleaning), the quantity of the new chemical substance released directly to the environment, the quantity of the new chemical substance released into control technology, the quantity of the new chemical substance released to the environment after control technology, the media of release, the type of control technology used, and the following additional information based on the type of release:
                    </P>
                    <P>(i) For equipment cleaning releases, frequency of equipment cleaning and what is used to clean the equipment.</P>
                    <P>(ii) For transport and storage releases, how the new chemical substance or product containing the new chemical substance is transported from the site and stored, whether dedicated containers are used, whether the cleaning and disposal of the containers is under the submitter's control, the container cleaning method, the frequency of container cleaning, and the amount of release per container cleaning.</P>
                    <P>(iii) For releases into air, Clean Air Act operating permit numbers and a description of any Leak Detection and Repair program in accordance with 40 CFR parts 60, 61, 63, 65, 264 or 265 (related to the monitoring and management of fugitive releases) the site has implemented.</P>
                    <P>(iv) For releases into water, the National Pollutant Discharge Elimination System (NPDES) permit number(s), the name(s) of the navigable waterway(s) into which the release occurs, and other destination(s) into which the release occurs.</P>
                    <P>(v) For releases into wastewater treatment plants, the name(s) of the publicly owned treatment work(s) (POTW) into which the release occurs and the corresponding NPDES permit number(s).</P>
                    <P>(h) For sites not controlled by the submitter:</P>
                    <P>(1) The identity and address of each site where the new chemical substance will be manufactured, processed, or used.</P>
                    <P>(2) A description of each type of processing and use operation involving the new chemical substance, including identification of the estimated number of processing or use sites; a process description of each operation which includes a diagram of the major unit operations and chemical conversions; the identity, approximate weight per batch or per day for continuous production, and entry point of all starting materials and feedstocks (including reactants, solvents, catalysts, etc.); the identity, approximate weight per batch or per day for continuous production, and entry point of all products, recycle streams, and wastes, including frequency of any equipment cleaning; the type of interim storage and transport containers used; and the points of release of the new chemical substance numbered. If the new chemical substance is released to two media at the same step in the process, assign a second number for the second medium.</P>
                    <P>
                        (3) Worker exposure information, including worker exposure information from exempt manufacture or related use of the new chemical substance under § 720.30 (
                        <E T="03">e.g.,</E>
                         byproduct, impurity). This information includes:
                    </P>
                    <P>(i) Worker activities.</P>
                    <P>
                        (ii) Type of potential worker exposure (
                        <E T="03">e.g.,</E>
                         dermal, inhalation).
                    </P>
                    <P>(iii) Protective equipment in place, if any, including a description of the kind of gloves, protective clothing, goggles, or respirator that limit worker exposure, if any.</P>
                    <P>(iv) Engineering controls in place if any.</P>
                    <P>(v) Physical form of the new chemical substance to which workers may be exposed and moisture content if physical form is solid.</P>
                    <P>(vi) The percent of new chemical substance in formulation at time of worker exposure.</P>
                    <P>(vii) The number of workers reasonably likely to be exposed.</P>
                    <P>(viii) The duration of activities.</P>
                    <P>
                        (4) Information on release of the new chemical substance to the environment, including releases from the exempt manufacture or related use of the new chemical substance under § 720.30 (
                        <E T="03">e.g.,</E>
                         byproduct, impurity). This information includes the type of release (
                        <E T="03">e.g.,</E>
                         transport, interim storage, disposal, equipment cleaning), the quantity of the new chemical substance released directly to the environment, the quantity of the new chemical substance released into control technology, the quantity of the new chemical substance released to the environment after control technology, the media of release, the type of control technology used, and the following additional information based on the type of release:
                    </P>
                    <P>(i) For equipment cleaning releases, frequency of equipment cleaning and what is used to clean the equipment.</P>
                    <P>(ii) For transport and storage releases, how the new chemical substance or product containing the new chemical substance is transported from the site and stored, whether dedicated containers are used, whether the cleaning and disposal of the containers is under the submitter's control, the container cleaning method, the frequency of container cleaning, and the amount of release of the new chemical substance per container cleaning.</P>
                    <P>(iii) For releases into air, Clean Air Act operating permit numbers and a description of any Leak Detection and Repair program in accordance with 40 CFR parts 60, 61, 63, 65, 264 or 265 (related to the monitoring and management of fugitive releases) the site has implemented.</P>
                    <P>(iv) For releases into water, the National Pollutant Discharge Elimination System (NPDES) permit number(s), the name(s) of the navigable waterway(s) into which the release occurs, and other destination(s) into which the release occurs.</P>
                    <P>(v) For releases into wastewater treatment plants, the name(s) of the publicly owned treatment work(s) (POTW) into which the release occurs and the corresponding NPDES permit number(s).</P>
                    <STARS/>
                    <P>(j) The physical and chemical properties and environmental fate characteristics of the new chemical substance, which includes the following:</P>
                    <P>(1) For physical and chemical properties, such information includes boiling/sublimation temperature, density/relative density, dissociation constant, explodability, flammability, melting temperature, octanol/water partition coefficient, particle size distribution, particle size distribution analysis, the physical state of the neat substance, pH, solubility, vapor pressure, volatilization from water, volatilization from soil, spectra, UV-VIS absorption data, and surface tension. For nanomaterials, such information also includes aspect ratio, thickness, and number of layers or walls.</P>
                    <P>(2) For environmental fate characteristics, such information includes hydrolysis, photolysis, aerobic and anaerobic biodegradation, atmospheric oxidation half-lives, Henry's law constant, adsorption/desorption coefficient, bioaccumulation or bioconcentration factor, Incineration Removal Efficiency (Destruction and Removal Efficiencies or DREs), and Sewage Treatment (WWTP) Removals.</P>
                    <P>
                        (k) Information about pollution prevention efforts, such as using alternative fuel sources, reducing the use of water and chemical inputs, modifying a production process to produce less waste, or implementing water and energy conservation practices, or substituting for riskier existing products. Inclusion of this information is optional.
                        <PRTPAGE P="34122"/>
                    </P>
                </SECTION>
                <AMDPAR>6. Amend § 720.50 by revising paragraph (a)(4)(ii) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 720.50</SECTNO>
                    <SUBJECT>Submission of test data and other data concerning the health and environmental effects of a substance.</SUBJECT>
                    <P>(a) * * *</P>
                    <P>(4) * * *</P>
                    <P>(ii) If a test or experiment is completed before the applicable review period ends, the person must submit the study, report, or test electronically to EPA via CDX, as specified in paragraph (a)(3)(i) of this section, within ten days of receiving it, but no later than five days before the end of the review period. If the test or experiment is completed during the last five days of the review period, the submitter must inform its EPA contact for that notice by telephone or email prior to the end of the review period and submit the study, report, or test electronically to EPA via CDX.</P>
                    <STARS/>
                </SECTION>
                <AMDPAR>7. Amend § 720.65 by:</AMDPAR>
                <AMDPAR>a. Revising paragraphs (a) through (c);</AMDPAR>
                <AMDPAR>b. Redesignating paragraph (d) as paragraph (e);</AMDPAR>
                <AMDPAR>c. Adding a new paragraph (d); and</AMDPAR>
                <AMDPAR>d. Revising newly redesignated paragraph (e).</AMDPAR>
                <P>The revisions and addition read as follows:</P>
                <SECTION>
                    <SECTNO>§ 720.65</SECTNO>
                    <SUBJECT>Acknowledgement of receipt of a notice; errors in the notice; incomplete submissions; and false and misleading statements.</SUBJECT>
                    <P>
                        (a) 
                        <E T="03">Notification to the submitter.</E>
                         (1) EPA will acknowledge receipt of each notice by sending a letter via CDX or U.S. mail to the submitter that identifies the premanufacture notice number assigned to the new chemical substance and date on which the applicable review period begins as described in paragraph (a)(2) of this section.
                    </P>
                    <P>(2) Before EPA sends an acknowledgement of receipt of a notice pursuant to paragraph (a)(1) of this section, EPA will conduct a pre-screen of the notice, typically taking 2-3 days and according to the criteria under paragraphs (b)(1) and (c)(1) of this section.</P>
                    <P>(i) If EPA concludes that the notice contains errors warranting remedy or is incomplete, EPA will notify the submitter according to paragraph (d)(3) of this section. The applicable review period will not begin. Once the submitter corrects the errors or incomplete submission according to the requirements provided by EPA and re-submits it to EPA, EPA will follow the procedures of paragraph (a)(2) of this section.</P>
                    <P>(ii) If EPA does not identify errors or determine the notice to be incomplete during screening, EPA will notify the submitter according to paragraph (a)(1) of this section. The applicable review period will begin on the date EPA received the complete notice.</P>
                    <P>
                        (b) 
                        <E T="03">Errors in the notice.</E>
                         (1) Within 30 days of receipt of the notice, EPA may request that the submitter remedy errors in the notice. The following are examples of such errors:
                    </P>
                    <P>(i) Typographical errors that cause data to be misleading or answers to any questions to be unclear.</P>
                    <P>(ii) Contradictory information.</P>
                    <P>(iii) Ambiguous statements or information.</P>
                    <P>(2) The applicable review period does not begin for notices containing errors that EPA asks the submitter to remedy until corrections are made following the procedures of paragraph (d) of this section.</P>
                    <P>
                        (c) 
                        <E T="03">Incomplete submissions.</E>
                         (1) A submission is not complete, and the applicable review period does not begin, if:
                    </P>
                    <P>(i) The wrong person submits the notice form.</P>
                    <P>(ii) The submitter does not sign the notice form.</P>
                    <P>(iii) Some or all of the information in the notice or the attachments are not in English, except for published scientific literature.</P>
                    <P>(iv) The submitter does not submit the notice in the manner set forth in § 720.40(a)(2).</P>
                    <P>(v) The submitter does not provide information that is required by section 5(d)(1)(B) and (C) of the Act and § 720.50.</P>
                    <P>(vi) The submitter does not provide information required by § 720.45 or indicate that it is not known to or reasonably ascertainable by the submitter.</P>
                    <P>(vii) The submitter does not submit a second copy of the submission with all confidential information deleted for the public file, as required by § 720.80(b)(2).</P>
                    <P>(viii) The submitter does not include any information required by section 5(b)(1) of the Act and pursuant to a rule promulgated under section 4 of the Act, as required by § 720.40(g).</P>
                    <P>(ix) The submitter does not submit data which the submitter believes show that the chemical substance will not present an unreasonable risk of injury to health or the environment, if EPA has listed the chemical substance under section 5(b)(4) of the Act, as required in § 720.40(h).</P>
                    <P>(x) The submitter does not include an identifying number and a payment identity number as required by 40 CFR 700.45(e)(3).</P>
                    <P>
                        (2) The submission may be declared incomplete if at any time during the applicable review period the submitter submits additional or revised information without demonstrating to EPA's satisfaction that the additional or revised information in the amended notice was not known to or reasonably ascertainable by the submitter at the time of initial notice submission (
                        <E T="03">e.g.,</E>
                         new information as described in § 720.40(f) or information from testing in progress at the time of the original submission, as described in § 720.50(a)(4)), unless it relates to administrative or non-substantive amendments (
                        <E T="03">e.g.,</E>
                         changing the technical point of contact) or amendments made at the request of EPA.
                    </P>
                    <P>
                        (d) 
                        <E T="03">Corrections to errors in the notice or incomplete submissions.</E>
                         (1) If EPA receives an incomplete submission or seeks remedy of errors identified in a notice, EPA will notify the submitter within 30 days of receipt that the submission contains errors or is incomplete and that the applicable review period will not begin until EPA receives a correct and complete notice.
                    </P>
                    <P>(2) If EPA obtains additional information during the applicable review period that indicates the original submission was incomplete, EPA may declare the submission incomplete within 30 days after EPA obtains the additional information and so notify the submitter.</P>
                    <P>(3) The notification that a submission contains errors or is incomplete under paragraph (d)(1) or (2) of this section will include:</P>
                    <P>(i) A statement of the basis of EPA's determination that the submission contains errors or is incomplete.</P>
                    <P>(ii) The requirements for correcting the errors or incomplete submission.</P>
                    <P>(iii) Information on procedures under paragraph (d)(4) of this section for filing objections to the determination or requesting modification of the requirements for completing the submission.</P>
                    <P>(4) Within ten days after receipt of notification by EPA that a submission contains errors or is incomplete, the submitter may file written objections requesting that EPA accept the submission as a complete notice or modify the requirements necessary to complete the submission.</P>
                    <P>
                        (5)(i) EPA will consider the objections filed by the submitter. EPA will determine whether the submission was complete or incomplete, or whether to modify the requirements for completing the submission. EPA will notify the submitter in writing of EPA's response within ten days of receiving the objections.
                        <PRTPAGE P="34123"/>
                    </P>
                    <P>(ii) If EPA determines, in response to the objection, that the submission was complete, the applicable review period will be deemed suspended on the date EPA declared the notice incomplete, and will resume on the date that the notice is declared complete. The submitter need not correct the notice as EPA originally requested. If EPA can complete its review within 90 days from the date of the original submission, EPA may inform the submitter that the running of the review period will resume on the date EPA originally declared it incomplete.</P>
                    <P>(iii) If EPA modifies the requirements for completing the submission or affirms its original determination that the submission contains errors or is incomplete, or if no objections are filed, the applicable review period will begin (or if previously begun, will restart at Day 1) when EPA receives a complete notice.</P>
                    <P>
                        (e) 
                        <E T="03">Materially false or misleading statements.</E>
                         If EPA discovers at any time that a person submitted materially false or misleading statements in the notice, EPA may find that the notice was incomplete from the date it was submitted and take any other appropriate action.
                    </P>
                </SECTION>
                <AMDPAR>8. Amend § 720.70 by revising paragraphs (a) and (b)(3) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 720.70</SECTNO>
                    <SUBJECT>Notice in the Federal Register.</SUBJECT>
                    <P>
                        (a) 
                        <E T="03">Filing notice of receipt.</E>
                         In accordance with section 5(d)(2) of the Act, after EPA has received a complete notice, EPA will file a notice of receipt with the Office of the Federal Register including the information specified in paragraph (b) of this section.
                    </P>
                    <P>(b) * * *</P>
                    <P>(3) For test data submitted in accordance with § 720.40(g), a summary of the data received.</P>
                    <STARS/>
                </SECTION>
                <AMDPAR>9. Amend § 720.75 by:</AMDPAR>
                <AMDPAR>a. Revising the section heading;</AMDPAR>
                <AMDPAR>b. Removing the phrase “notice review period” and adding in its place the phrase “applicable review period;” wherever it appears; and</AMDPAR>
                <AMDPAR>c. Revising paragraphs (a), (b), (c)(4) and (d) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 720.75</SECTNO>
                    <SUBJECT>Applicable review period and determination.</SUBJECT>
                    <P>
                        (a) 
                        <E T="03">Length of applicable review period.</E>
                         The applicable review period specified in section 5(a) of the Act runs for 90 days from the date EPA receives a complete notice, or the date EPA determines the notice is complete under § 720.65(d), unless the Agency extends the applicable review period under section 5(c) of the Act and paragraph (c) of this section.
                    </P>
                    <P>
                        (b) 
                        <E T="03">Suspension of the running of the applicable review period.</E>
                         (1) A submitter may voluntarily suspend the running of the applicable review period if EPA agrees. If EPA does not agree, the review period will continue to run, and EPA will notify the submitter. A submitter may request a suspension at any time during the applicable review period. The suspension must be for a specified period of time.
                    </P>
                    <P>
                        (2)(i) 
                        <E T="03">Requests for suspension 30 days or less.</E>
                         A request for a suspension of 30 days or less may be made orally, including by telephone, or in writing, including by email, to the submitter's EPA contact for that notice. Any request for a suspension exceeding 30 days must be submitted in the manner set forth in paragraph (b)(2)(ii) of this section. The running of the applicable review period will be suspended upon approval of the oral or written request by EPA.
                    </P>
                    <P>
                        (ii) 
                        <E T="03">Requests for suspensions greater than 30 days.</E>
                         Requests for suspensions exceeding 30 days must be submitted electronically to EPA via CDX using e-PMN software. Requests for suspensions of 30 days or less may also be submitted electronically to EPA via CDX using e-PMN software. See § 720.40(a)(2)(ii) for information on how to access the e-PMN software. The running of the applicable review period will be suspended upon approval of the request submitted electronically to EPA via CDX using e-PMN software by EPA.
                    </P>
                    <P>(c) * * *</P>
                    <P>(4) The following are examples of situations in which EPA may find that good cause exists for extending the applicable review period:</P>
                    <P>(i) EPA has reviewed the notice and determined that there is a significant possibility that the chemical substance will be regulated under sections 5(e) or 5(f) of the Act, but EPA is unable to initiate regulatory action within the initial 90-day period.</P>
                    <P>(ii) EPA has reviewed the submission and is seeking additional information.</P>
                    <P>(iii) EPA has received significant additional information during the applicable review period, which was not known to or reasonably ascertainable by the submitter at the time of initial notice submission.</P>
                    <P>
                        (d) 
                        <E T="03">Determinations.</E>
                         (1) Within the applicable review period, EPA will make one of the following five determinations, as set forth in section 5(a)(3) of the Act:
                    </P>
                    <P>(i) The chemical substance presents an unreasonable risk of injury to health or the environment, as set forth in section 5(a)(3)(A) of the Act.</P>
                    <P>(ii) Information available to EPA is insufficient to permit a reasoned evaluation of the health and the environmental effects of the relevant chemical substance, as set forth in section 5(a)(3)(B)(i) of the Act.</P>
                    <P>(iii) In the absence of sufficient information to permit EPA to make such an evaluation, the chemical substance may present an unreasonable risk of injury to health or the environment, as set forth in section 5(a)(3)(B)(ii)(I) of the Act.</P>
                    <P>(iv) The chemical substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance, as set forth in section 5(a)(3)(B)(ii)(II) of the Act.</P>
                    <P>(v) The chemical substance is not likely to present an unreasonable risk of injury to health or the environment, as set forth in section 5(a)(3)(C) of the Act.</P>
                    <P>(2) EPA will take the following actions required in association with the determination:</P>
                    <P>(i) For determinations described in paragraph (d)(1)(i) of this section, EPA will issue the submitter an order to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance, or any combination of such activities, to the extent necessary to protect against an unreasonable risk of injury to health or the environment, as set forth in section 5(f) of the Act, or will issue a proposed rule under section 6(a) of the Act, as set forth in section 5(f) of the Act.</P>
                    <P>(ii) For determinations described in paragraphs (d)(1)(ii), (iii), or (iv) of this section, EPA will issue the submitter an order to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance, or any combination of such activities, to the extent necessary to protect against an unreasonable risk of injury to health or the environment, as set forth in section 5(e) of the Act. EPA may issue an order under section 5(e) of the Act that requires certain testing to be conducted and presented to EPA after the applicable review period has concluded.</P>
                    <P>
                        (iii) Following a determination described in paragraph (d)(1)(v) of this section, EPA will issue the submitter a document describing that determination and will submit for publication in the 
                        <E T="04">Federal Register</E>
                         a statement of the finding, as set forth in section 5(g) of the Act. Upon EPA's issuance of the determination, the submitter may commence the manufacture of the 
                        <PRTPAGE P="34124"/>
                        chemical substance without waiting for the end of the applicable review period.
                    </P>
                    <P>(3) EPA may modify or revoke the prohibitions and limitations in an order issued under paragraph (d)(2)(i) or (ii) of this section after the applicable review period has ended if the submitter submits to EPA additional testing, studies, reports, or other information that EPA determines, upon review, demonstrate that such prohibitions or limitations are no longer necessary to protect against an unreasonable risk of injury to health or the environment.</P>
                    <P>(4) No person submitting a notice in response to the requirements of this part may manufacture a chemical substance subject to this part until EPA has issued a determination in accordance with paragraph (d)(1) of this section and taken the associated action required under paragraph (d)(2) of this section.</P>
                </SECTION>
                <PART>
                    <HD SOURCE="HED">PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES</HD>
                </PART>
                <AMDPAR>10. The authority citation for part 721 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 15 U.S.C. 2604, 2607, and 2625(c).</P>
                </AUTH>
                <AMDPAR>11. Amend § 721.25 by revising paragraphs (c) and (d) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 721.25</SECTNO>
                    <SUBJECT>Notice requirements and procedures.</SUBJECT>
                    <STARS/>
                    <P>(c) EPA will process the notice in accordance with the procedures of part 720 of this chapter, except to the extent they are inconsistent with this part. When submitting a SNUN the provision at § 720.45(f)(1) of this chapter is modified to require a description of both known and intended categories of consumer or commercial use by function and application.</P>
                    <P>(d) Any person submitting a significant new use notice in response to the requirements of this part shall not manufacture or process a chemical substance identified in subpart E of this part for a significant new use until EPA has issued a determination with respect to the significant new use and taken the actions required in association with that determination in accordance with the procedures for new chemical substances at § 720.75(d) of this chapter.</P>
                </SECTION>
                <PART>
                    <HD SOURCE="HED">PART 723—PREMANUFACTURE NOTIFICATION EXEMPTIONS</HD>
                </PART>
                <AMDPAR>12. The authority citation for part 723 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 15 U.S.C. 2604.</P>
                </AUTH>
                <AMDPAR>13. Amend § 723.50 by:</AMDPAR>
                <AMDPAR>a. Revising paragraph (a)(1);</AMDPAR>
                <AMDPAR>b. Adding paragraphs (b)(11) and (12);</AMDPAR>
                <AMDPAR>c. Revising paragraphs (d), (g), and (h)(2)(v); and</AMDPAR>
                <AMDPAR>d. Adding paragraph (p).</AMDPAR>
                <P>The revisions and additions read as follows:</P>
                <SECTION>
                    <SECTNO>§ 723.50</SECTNO>
                    <SUBJECT>Chemical substances manufactured in quantities of 10,000 kilograms or less per year, and chemical substances with low environmental releases and human exposures.</SUBJECT>
                    <P>(a) * * *</P>
                    <P>(1) This section grants an exemption from the premanufacture notice requirements of section 5(a)(1)(A)(i) of the Toxic Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture of:</P>
                    <STARS/>
                    <P>(b) * * *</P>
                    <P>
                        (11) 
                        <E T="03">PFAS</E>
                         or 
                        <E T="03">per- and poly-fluoroalkyl substance</E>
                         means a chemical substance that contains at least one of these three structures:
                    </P>
                    <P>(i) R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons;</P>
                    <P>(ii) R-CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons; or</P>
                    <P>(iii) CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons.</P>
                    <P>
                        (12) 
                        <E T="03">PBT chemical substance</E>
                         means a chemical substance possessing characteristics of persistence (P) in the environment, accumulation in biological organisms (bioaccumulation (B)), and toxicity (T) resulting in potential risks to humans and ecosystems. For more information on EPA's Policy on new chemical substances that are PBTs, see EPA's 1999 policy statement (64 FR 60194, November 4, 1999 (FRL-6097-7)).
                    </P>
                    <STARS/>
                    <P>
                        (d) 
                        <E T="03">Chemical substances that cannot be manufactured under this exemption.</E>
                         A new chemical substance cannot be manufactured under this section, notwithstanding satisfaction of the criterion of paragraph (c)(1) or (2) of this section, if EPA determines, in accordance with paragraph (g) of this section, that the substance, any reasonably anticipated metabolites, environmental transformation products, or byproducts of the substance, or any reasonably anticipated impurities in the substance, under anticipated conditions of manufacture, processing, distribution in commerce, use, or disposal of the new chemical substance:
                    </P>
                    <P>(1) May cause:</P>
                    <P>(i) Serious acute (lethal or sublethal) effects;</P>
                    <P>(ii) Serious chronic (including carcinogenic and teratogenic) effects; or</P>
                    <P>(ii) Significant environmental effects.</P>
                    <P>(2) Or is:</P>
                    <P>(i) A PFAS.</P>
                    <P>(ii) A PBT chemical substance with anticipated environmental releases and potentially unreasonable exposures to humans or environmental organisms.</P>
                    <STARS/>
                    <P>
                        (g) 
                        <E T="03">Review period.</E>
                         (1) EPA will review the notice submitted under paragraph (e) of this section to determine whether manufacture of the new chemical substance is eligible for the exemption. The review period will run for 30 days from the date EPA receives a complete notice. To provide additional time to address any unresolved issues concerning an exemption application, the exemption applicant may, at any time during the review period, request a suspension of the review period pursuant to the provisions of § 720.75(b) of this chapter.
                    </P>
                    <P>(2) No person submitting a notice under paragraph (e) of this section may manufacture the new chemical substance until EPA notifies the submitter that the new chemical substance meets the terms of this section.</P>
                    <P>(h) * * *</P>
                    <P>(2) * * *</P>
                    <P>(v) If the Assistant Administrator determines that manufacture of the new chemical substance does not meet the terms of this section and that the manufacturer did not act with due diligence and in good faith to meet the terms of this section, the manufacturer must cease any continuing manufacture, processing, distribution in commerce, and use of the new chemical substance within 7 days of the written notification under paragraph (h)(2)(iii) of this section. The manufacturer may not resume manufacture, processing, distribution in commerce, and use of the new chemical substance until it submits a notice under section 5(a)(1) of the Act and part 720 of this chapter and EPA has made one of the five determinations as set forth in section 5(a)(3) of the Act and taken the action required in association with that determination.</P>
                    <STARS/>
                    <P>
                        (p) 
                        <E T="03">Subject to a significant new use rule.</E>
                         If a significant new use rule is proposed or finalized in part 721 of this chapter for a chemical substance described by a generic chemical name, EPA may make reasonable efforts to notify any persons who may also manufacture the same chemical substance under the terms of this section. A disclosure to a person with an approved exemption under this section that the chemical substance is subject to a proposed or final rule in part 721 of this chapter will not be considered public disclosure of 
                        <PRTPAGE P="34125"/>
                        confidential business information under section 14 of the Act. The notification will inform manufacturers subject to the terms of this section that the chemical substance is subject to a proposed or final significant new use rule under section 5(a)(2) of the Act, and identify the proposed or final section in subpart E of part 721 of this chapter that pertains to the chemical substance.
                    </P>
                </SECTION>
                <PART>
                    <HD SOURCE="HED">PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS</HD>
                </PART>
                <AMDPAR>14. The authority citation for part 725 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>15 U.S.C. 2604, 2607, 2613, and 2625.</P>
                </AUTH>
                <AMDPAR>15. Amend § 725.54 by revising paragraphs (b)(1), (c) and (d) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 725.54</SECTNO>
                    <SUBJECT>Suspension of the review period.</SUBJECT>
                    <STARS/>
                    <P>
                        (b)(1) 
                        <E T="03">Request for suspension.</E>
                         A request for suspension may only be submitted in a manner set forth in this paragraph. The request for suspension also may be made orally, including by telephone, or in writing, including by email, to the submitter's EPA contact for that notice, subject to paragraph (c) of this section.
                    </P>
                    <STARS/>
                    <P>(c) An oral or written request for suspension may be granted by EPA for a maximum of 30 days only. Requests for longer suspension must only be submitted in the manner set forth in paragraph (b)(2) of this section.</P>
                    <P>(d) If the submitter has not made a previous oral or written request, the running of the applicable review period is suspended as of the date of receipt of the CDX submission by EPA.</P>
                </SECTION>
                <AMDPAR>16. Amend § 725.60 by revising paragraph (a)(1) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 725.60</SECTNO>
                    <SUBJECT>Withdrawal of submission by the submitter.</SUBJECT>
                    <P>
                        (a)(1) 
                        <E T="03">Withdrawal of notice by the submitter.</E>
                         A submitter may withdraw a notice during the applicable review period by submitting a statement of withdrawal in a manner set forth in this paragraph. The withdrawal is effective upon receipt of the CDX submission by EPA.
                    </P>
                    <STARS/>
                </SECTION>
                <AMDPAR>17. Amend § 725.170 by:</AMDPAR>
                <AMDPAR>a. Revising paragraphs (a) and (b); and</AMDPAR>
                <AMDPAR>b. Removing paragraph (c).</AMDPAR>
                <P>The revisions read as follows.</P>
                <SECTION>
                    <SECTNO>§ 725.170</SECTNO>
                    <SUBJECT>EPA review of the MCAN.</SUBJECT>
                    <STARS/>
                    <P>
                        (a) 
                        <E T="03">Length of the review period.</E>
                         The MCAN review period specified in section 5(a) of the Act runs for 90 days from the date EPA receives a complete MCAN, or the date EPA determines the MCAN is complete under § 725.33, unless the Agency extends the period under section 5(c) of the Act and § 725.56.
                    </P>
                    <P>
                        (b) 
                        <E T="03">Determinations.</E>
                         (1) Within the applicable review period, EPA will make one of the following five determinations on the microorganism, as set forth in section 5(a)(3) of the Act:
                    </P>
                    <P>(i) The microorganism presents an unreasonable risk of injury to health or the environment, as set forth in section 5(a)(3)(A) of the Act.</P>
                    <P>(ii) Information available to EPA is insufficient to permit a reasoned evaluation of the health and the environmental effects of the microorganism, as set forth in section 5(a)(3)(B)(i) of the Act.</P>
                    <P>(iii) In the absence of sufficient information to permit EPA to make such an evaluation, the microorganism may present an unreasonable risk of injury to health or the environment, as set forth in section 5(a)(3)(B)(ii)(I) of the Act.</P>
                    <P>(iv) The microorganism is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance, as set forth in section 5(a)(3)(B)(ii)(II) of the Act.</P>
                    <P>(v) The microorganism is not likely to present an unreasonable risk of injury to health or the environment, as set forth in section 5(a)(3)(C) of the Act.</P>
                    <P>(2) EPA will take the following actions required in association with the determination.</P>
                    <P>(i) For determinations described in paragraph (b)(1)(i) of this section, EPA will issue the submitter an order to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of the microorganism, or any combination of such activities, to the extent necessary to protect against an unreasonable risk of injury to health or the environment, as set forth in section 5(f) of the Act, or will issue a proposed rule under section 6(a) of the Act, as set forth in section 5(f) of the Act.</P>
                    <P>(ii) For determinations described in paragraph (b)(1)(ii), (iii), or (iv), EPA will issue the submitter an order to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of the microorganism, or any combination of such activities, to the extent necessary to protect against an unreasonable risk of injury to health or the environment, as set forth in section 5(e) of the Act. EPA may issue an order under section 5(e) of the Act that requires certain testing to be conducted and presented to EPA after the applicable review period has concluded.</P>
                    <P>
                        (iii) For determinations described in paragraph (b)(1)(v) of this section, EPA will issue the submitter a document describing that determination and will submit for publication in the 
                        <E T="04">Federal Register</E>
                         a statement of the finding, as set forth in section 5(g) of the Act. Upon EPA's issuance of the determination, the submitter may commence the manufacture of the microorganism without waiting for the end of the applicable review period.
                    </P>
                    <P>(3) EPA may modify or revoke the prohibitions and limitations in an order issued under paragraph (b)(2)(i) or (ii) of this section after the applicable review period has closed if the submitter submits to EPA additional information, testing, studies, or reports that EPA determines, upon review, demonstrate that such prohibitions or limitations are no longer necessary to protect against an unreasonable risk of injury to health or the environment.</P>
                    <P>(4) No person submitting a MCAN in response to the requirements of this subpart may manufacture a microorganism subject to this subpart until EPA has issued a determination in accordance with paragraph (b)(1) of this section and taken any action as required under paragraph (b)(2) of this section.</P>
                </SECTION>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-10735 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </PRORULE>
    </PRORULES>
    <VOL>88</VOL>
    <NO>102</NO>
    <DATE>Friday, May 26, 2023</DATE>
    <UNITNAME>Notices</UNITNAME>
    <NOTICES>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="34126"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Forest Service</SUBAGY>
                <SUBJECT>Final Records of Decision for the Sequoia and Sierra National Forests</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Forest Service, Agriculture (USDA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of approval of the revised land management plans for the Sequoia and Sierra National Forests.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Teresa Benson, the Forest Supervisor for the Sequoia National Forest, Pacific Southwest Region, and Dean Gould, the Forest Supervisor for the Sierra National Forest, Pacific Southwest Region, signed final records of decision (RODs) for revised land management plans for the Sequoia and Sierra National Forests, respectively. The final RODs document the rationale for approving the revised land management plans and are consistent with the Reviewing Officer's response to objections and instructions.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The revised land management plans for the Sequoia and Sierra National Forests will become effective 30 days after the publication of this notice of approval in the 
                        <E T="04">Federal Register</E>
                         (36 CFR 219.17(a)(1)).
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        To view the final records of decision, final environmental impact statement (FEIS), revised land management plans, and other related documents, please visit the Sequoia and Sierra National Forests Plan Revision project website at: 
                        <E T="03">https://www.fs.usda.gov/project/?project=3375.</E>
                         A legal notice of approval is also being published in the Sequoia National Forest's newspaper of record, the 
                        <E T="03">Porterville Recorder,</E>
                         and the Sierra National Forest's newspaper of record, the 
                        <E T="03">Fresno Bee.</E>
                         A copy of this legal notice will be posted on the website listed above.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Bobbie Miller, Plan Revision Team Leader, Email: 
                        <E T="03">bobbie.miller@usda.gov</E>
                         or Phone: (530) 643-6226.
                    </P>
                    <P>Individuals who use telecommunication devices for the deaf and hard of hearing (TDD) may call the Federal Relay Service (FRS) at 800-877-8339, 24 hours a day, every day of the year, including holidays.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The revised land management plans were developed pursuant to the 2012 Forest Service Planning Rule (36 CFR 219) and will replace the 1988 Sequoia National Forest Land Management Plan and 1990 Mediated Settlement Agreement, and the 1992 Sierra National Forest Land Management Plan. The revised plans describe desired conditions, objectives, standards, and guidelines that will guide future projects and management activities on the forests and will become effective 30 days after the publication of this notice of approval in the 
                    <E T="04">Federal Register</E>
                     (36 CFR 219.17(a)(1)). The Forest Service initiated plan revision for these two national forests in 2013 and developed the revised plans through extensive collaboration and consultation with Tribes, interested public, and other stakeholders.
                </P>
                <P>The revised plans will help sustain forest and watershed health and productivity by addressing tree mortality, restoring forest conditions, facilitating use of fire to achieve desired conditions, and providing for sustainable recreation. The plans provide management direction that applies the best available science for conserving at-risk species like the Pacific fisher and California spotted owl. The revised land management plans, FEIS, and draft RODs were released in June 2022, initiating a 60-day objection filing period. The Forest Service received 27 eligible objections. The Reviewing Officer, Deputy Regional Forester Jody Holzworth, reviewed each of the objections, met with objectors and interested parties at an objection resolution meeting, and issued a written response to the objections on December 16, 2022. In her written response, the Reviewing Officer included instructions for the Responsible Officials to implement prior to signing final decisions.</P>
                <P>The forests updated the FEIS, revised land management plans, RODs, and planning record as needed, consistent with instructions from the Objection Reviewing Officer. The final RODs to approve the revised land management plans for the Sequoia and Sierra and National Forests have now been signed by the Responsible Officials and are available at the website listed above.</P>
                <P>
                    <E T="03">Responsible Official:</E>
                     The Responsible Official for approving the Sequoia National Forest revised land management plan is Forest Supervisor Teresa Benson. The Responsible Official for approving the Sierra National Forest revised land management plan is Forest Supervisor Dean Gould. The Responsible Official approving the list of species of conservation concern is Jacqueline Emanuel, Associate Deputy Chief, National Forest System.
                </P>
                <SIG>
                    <DATED>Dated: May 19, 2023.</DATED>
                    <NAME>Jacqueline Emanuel,</NAME>
                    <TITLE>Associate Deputy Chief, National Forest System.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11347 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3411-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Rural Utilities Service</SUBAGY>
                <DEPDOC>[Docket No. RUS-23-Telecom-RUS-23-TELECOM-0010]</DEPDOC>
                <SUBJECT>60-Day Notice of Proposed Information Collection: Rural eConnectivity (ReConnect) Program; OMB Control No.: 0572-0152</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Rural Utilities Service, USDA.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act of 1995, as amended, the United States Department of Agriculture (USDA), Rural Utilities Service (RUS) announces its' intention to request an extension of a currently approved information collection and invites comments on this information collection.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments on this notice must be received by July 25, 2023 to be assured of consideration.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be submitted electronically by the Federal eRulemaking Portal: Go to 
                        <E T="03">http://www.regulations.gov</E>
                         and, in the “Search Field” box, labeled “Search for dockets and documents on agency actions,” enter the following docket number: “0572-0152” then click search. To submit or view public comments, select the following document title: (60-Day Notice of Proposed Information 
                        <PRTPAGE P="34127"/>
                        Collection: Rural eConnectivity (ReConnect) Program; OMB Control No.: 0572-0152) from the “Search Results,” and select the “Comment” button. Before inputting your comments, you may also review the “Commenter's Checklist” (optional). Insert your comments under the “Comment” title, click “Browse” to attach files (if available). Input your email address and select “Submit Comment.” Information on using 
                        <E T="03">Regulations.gov,</E>
                         including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “FAQ” link.
                    </P>
                    <P>
                        <E T="03">Other Information:</E>
                         Additional information about Rural Development and its programs is available on the internet at 
                        <E T="03">http://www.rurdev.usda.gov/index.html.</E>
                    </P>
                    <P>
                        All comments will be available for public inspection online at the Federal eRulemaking Portal (
                        <E T="03">http://www.regulations.gov</E>
                        ).
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                         Crystal Pemberton, Management Analyst, Branch 1, Rural Development Innovation Center—Regulations Management Division, United States Department of Agriculture, 1400 Independence Avenue SW, South Building, Washington, DC 20250-1522. Telephone: (202) 260-8621. Email: 
                        <E T="03">Crystal.Pemberton@usda.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (
                    <E T="03">see,</E>
                     5 CFR 1320.8(d)). This notice identifies the following information collection that RUS is submitting to OMB as extension to an existing collection with Agency adjustment.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Rural eConnectivity (ReConnect) Program.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     0572-0152.
                </P>
                <P>
                    <E T="03">Expiration Date of Approval:</E>
                     December 31, 2023.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Extension of a currently approved information collection.
                </P>
                <P>
                    <E T="03">Estimate of Burden:</E>
                     Public reporting for this collection of information is estimated to average 325 hours per response.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Not-for-profit institutions and other businesses.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     480.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses per Respondent:</E>
                     59.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden on Respondents:</E>
                     156,090 hours.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The ReConnect Program was authorized by the Consolidated Appropriations Act, 2018 (Pub. L. 115-141), which directed the program to be conducted under the Rural Electrification Act of 1936 (7 U.S.C. 901, 
                    <E T="03">et seq.</E>
                    ). The program has received successive appropriations by Congress and has matured due to Agency experience, feedback, and comments provided by stakeholders.
                </P>
                <P>The ReConnect Program provides loans, grants, and loan/grant combinations to facilitate broadband deployment in rural areas. Loans and grants are furnished to provide funds for the costs of construction, improvement, or acquisition of facilities and equipment needed to provide broadband service in eligible rural areas. In facilitating the expansion of broadband services and infrastructure, the program fuels long-term rural economic development and opportunities across rural America. The eligibility requirements, application process, and criteria that RUS uses to assess applicants' creditworthiness for the ReConnect Program are published at 7 CFR 1740 subpart B. For a proposed funded service area to be eligible for funding, at least 90 percent of the households in the proposed funded service area must lack sufficient access to broadband.</P>
                <P>
                    <E T="03">Comments are invited on:</E>
                </P>
                <P>(a) 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>(b) the accuracy of the agency's estimate of the burden of the collection of information including the validity of the methodology and assumptions used;</P>
                <P>(c) ways to enhance the quality, utility and clarity of the information to be collected; and</P>
                <P>(d) ways to minimize the burden of the collection of information on respondents, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record.</P>
                <P>
                    Copies of this information collection can be obtained from Crystal Pemberton, Rural Development Innovation Center—Regulations Management Division, at (202) 260-8621. Email: 
                    <E T="03">Crystal.Pemberton@usda.gov.</E>
                     All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
                </P>
                <SIG>
                    <NAME>Andrew Berke,</NAME>
                    <TITLE>Administrator, Rural Utilities Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11310 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3410-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Foreign-Trade Zones Board</SUBAGY>
                <DEPDOC>[B-33-2023]</DEPDOC>
                <SUBJECT>Foreign-Trade Zone 98; Application for Expansion of Subzone 98A; Mercedes-Benz U.S. International, Inc.; Moundville, Vance and Woodstock, Alabama</SUBJECT>
                <P>An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the City of Birmingham, grantee of FTZ 98, requesting expanded subzone status for the facilities of Mercedes-Benz U.S. International, Inc., located in Moundville, Vance and Woodstock, Alabama. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on May 22, 2023.</P>
                <P>
                    The application requests authority to expand Subzone 98A to include the following new sites: 
                    <E T="03">Site 4</E>
                     (89 acres) 12068 Upper Hull Road, Moundville; 
                    <E T="03">Site 5</E>
                     (55 acres) 11549 Will Walker Road, Vance; 
                    <E T="03">Site 6</E>
                     (296 acres) 933 Scott G. Davis Parkway, Woodstock; 
                    <E T="03">Site 7</E>
                     (185 acres) 17710 Vance Municipal Drive, Vance; and, 
                    <E T="03">Site 8</E>
                     (5 acres) 10077 Brose Drive, Vance. No authorization for additional production activity has been requested at this time.
                </P>
                <P>In accordance with the FTZ Board's regulations, Christopher Kemp of the FTZ Staff is designated examiner to review the application and make recommendations to the FTZ Board.</P>
                <P>
                    Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary and sent to: 
                    <E T="03">ftz@trade.gov.</E>
                     The closing period for their receipt is July 5, 2023. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to July 20, 2023.
                </P>
                <P>
                    A copy of the application will be available for public inspection in the “Online FTZ Information Section” section of the FTZ Board's website, which is accessible via 
                    <E T="03">www.trade.gov/ftz.</E>
                    <PRTPAGE P="34128"/>
                </P>
                <P>
                    For further information, contact Christopher Kemp at 
                    <E T="03">Christopher.Kemp@trade.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Camille R. Evans,</NAME>
                    <TITLE>Acting Executive Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11259 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Foreign-Trade Zones Board</SUBAGY>
                <DEPDOC>[Order No. 2143]</DEPDOC>
                <SUBJECT>Reorganization of Foreign-Trade Zone 28 Under Alternative Site Framework; New Bedford, Massachusetts</SUBJECT>
                <EXTRACT>
                    <P>Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:</P>
                </EXTRACT>
                <P>
                    <E T="03">Whereas,</E>
                     the Foreign-Trade Zones (FTZ) Act provides for “. . . the establishment . . . of foreign-trade zones in ports of entry of the United States, to expedite and encourage foreign commerce, and for other purposes,” and authorizes the Board to grant to qualified corporations the privilege of establishing foreign-trade zones in or adjacent to U.S. Customs and Border Protection ports of entry;
                </P>
                <P>
                    <E T="03">Whereas,</E>
                     the Board adopted the alternative site framework (ASF) (15 CFR 400.2(c)) as an option for the establishment or reorganization of zones;
                </P>
                <P>
                    <E T="03">Whereas,</E>
                     the City of New Bedford, grantee of Foreign-Trade Zone 28, submitted an application to the Board (FTZ Docket B-49-2022, docketed November 7, 2022) for authority to reorganize under the ASF with a service area of Bristol, Barnstable, Dukes, Nantucket, Norfolk and Plymouth Counties, Massachusetts, in and adjacent to the New Bedford Customs and Border Protection port of entry, and FTZ 28's existing Sites 1 and 2 would be categorized as magnet sites;
                </P>
                <P>
                    <E T="03">Whereas,</E>
                     notice inviting public comment was given in the 
                    <E T="04">Federal Register</E>
                     (87 FR 68122-68123, November 14, 2022) and the application has been processed pursuant to the FTZ Act and the Board's regulations; and,
                </P>
                <P>
                    <E T="03">Whereas,</E>
                     the Board adopts the findings and recommendations of the examiner's report, and finds that the requirements of the FTZ Act and the Board's regulations would be satisfied if approval of the service area is limited to Bristol and Plymouth Counties, Massachusetts;
                </P>
                <P>
                    <E T="03">Now, therefore,</E>
                     the Board hereby orders:
                </P>
                <P>The application to reorganize FTZ 28 under the ASF is approved in part, with a service area limited to Bristol and Plymouth Counties, Massachusetts, subject to the FTZ Act and the Board's regulations, including section 400.13, to the Board's standard 2,000-acre activation limit for the zone, and to an ASF sunset provision for magnet sites that would terminate authority for Sites 1 and 2 if not activated within five years from the month of approval.</P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Lisa W. Wang,</NAME>
                    <TITLE>Assistant Secretary for Enforcement and Compliance, Alternate Chairman, Foreign-Trade Zones Board.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11258 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Foreign-Trade Zones Board</SUBAGY>
                <DEPDOC>[Order No. 2142]</DEPDOC>
                <SUBJECT>Approval of Expansion of Subzone 78A; Nissan North America, Inc., Smyrna, Tennessee</SUBJECT>
                <EXTRACT>
                    <P>Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:</P>
                </EXTRACT>
                <P>
                    <E T="03">Whereas</E>
                    , the Foreign-Trade Zones (FTZ) Act provides for “. . . the establishment . . . of foreign-trade zones in ports of entry of the United States, to expedite and encourage foreign commerce, and for other purposes,” and authorizes the Foreign-Trade Zones Board to grant to qualified corporations the privilege of establishing foreign-trade zones in or adjacent to U.S. Customs and Border Protection ports of entry;
                </P>
                <P>
                    <E T="03">Whereas</E>
                    , the Board's regulations (15 CFR part 400) provide for the establishment of subzones for specific uses;
                </P>
                <P>
                    <E T="03">Whereas</E>
                    , the Metropolitan Government of Nashville and Davidson County, grantee of Foreign-Trade Zone 78, has made application to the Board for expanded subzone status at the facilities of Nissan North America, Inc., located in Smyrna, Tennessee (FTZ Docket B-5-2023, docketed January 19, 2023);
                </P>
                <P>
                    <E T="03">Whereas</E>
                    , notice inviting public comment has been given in the 
                    <E T="04">Federal Register</E>
                     (88 FR 4151, January 24, 2023) and the application has been processed pursuant to the FTZ Act and the Board's regulations; and,
                </P>
                <P>
                    <E T="03">Whereas</E>
                    , the Board adopts the findings and recommendations of the examiner's memorandum, and finds that the requirements of the FTZ Act and the Board's regulations are satisfied;
                </P>
                <P>
                    <E T="03">Now, therefore,</E>
                     the Board hereby approves expanded subzone status at the facilities of Nissan North America, Inc., located in Smyrna, Tennessee (Subzone 78A), as described in the application and 
                    <E T="04">Federal Register</E>
                     notice, subject to the FTZ Act and the Board's regulations, including Section 400.13.
                </P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Lisa W. Wang,</NAME>
                    <TITLE>Assistant Secretary for Enforcement and Compliance, Alternate Chairman, Foreign-Trade Zones Board.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11257 Filed 5-25-23; 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>[A-580-829]</DEPDOC>
                <SUBJECT>Stainless Steel Wire Rod From the Republic of Korea: Final Negative Determination of Circumvention of the 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>The U.S. Department of Commerce (Commerce) determines that U.S. imports of stainless steel round wire (SSWire) from the Socialist Republic of Vietnam (Vietnam) are not circumventing the antidumping duty (AD) order on stainless steel wire rod (SSWR) from the Republic of Korea (Korea).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable May 26, 2023.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Hermes Pinilla, 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) 482-3477.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On December 16, 2022, Commerce published in the 
                    <E T="04">Federal Register</E>
                     its preliminary determination that imports of SSWire from Vietnam are not circumventing the AD order on SSWR from Korea.
                    <SU>1</SU>
                    <FTREF/>
                     On April 4, 2023, 
                    <PRTPAGE P="34129"/>
                    Commerce extended the deadline for the final determination of this circumvention inquiry to May 24, 2023.
                    <SU>2</SU>
                    <FTREF/>
                     For a summary of events that occurred since Commerce published the 
                    <E T="03">Preliminary Determination,</E>
                     as well as a full discussion of the issues raised by parties for the final determination, see the Issues and Decision Memorandum.
                    <SU>3</SU>
                    <FTREF/>
                     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>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Stainless Steel Wire Rod from the Republic of Korea: Preliminary Negative Determination of Circumvention of the Antidumping Order and Postponement of Final Determination,</E>
                         87 FR 77072 (December 16, 2022) (
                        <E T="03">Preliminary Determination</E>
                        ), and accompanying Preliminary Decision Memorandum (PDM); 
                        <E T="03">see also, Notice of Amendment of Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order: Stainless Steel Wire Rod from Korea,</E>
                         63 FR 49331 (September 15, 1998) (
                        <E T="03">Order</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         Commerce's Letter, “Second Extension of Deadline for Final Results of Circumvention Inquiry,” dated April 4, 2023.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Decision Memorandum for the Final Negative Determination of Circumvention Inquiry of the Antidumping Duty Order on Stainless Steel Wire Rod from the Republic of Korea,” dated concurrently with, and hereby adopted by, this notice (Issues and Decision Memorandum).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">
                    Scope of the Order 
                    <E T="51">4</E>
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See Order.</E>
                    </P>
                </FTNT>
                <P>
                    For a full description of the scope of the 
                    <E T="03">Order, see</E>
                     the Issues and Decision Memorandum.
                </P>
                <HD SOURCE="HD1">Merchandise Subject to the Circumvention Inquiry</HD>
                <P>This circumvention inquiry covers SSWire completed in Vietnam using Korea-origin SSWR and subsequently exported from Vietnam to the United States during the period of inquiry January 1, 2020, through December 31, 2021.</P>
                <HD SOURCE="HD1">Methodology</HD>
                <P>
                    Commerce is conducted this circumvention inquiry in accordance with section 781(c) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.226. 
                    <E T="03">See</E>
                     the 
                    <E T="03">Preliminary Determination</E>
                     PDM for a full description of the methodology.
                    <SU>5</SU>
                    <FTREF/>
                     We have continued to apply this methodology for this final determination.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See Preliminary Determination</E>
                         PDM at 4-19.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         Issues and Decision Memorandum.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Analysis of Comments Received</HD>
                <P>All issues raised in the case and rebuttal briefs by parties in this inquiry are addressed in the Issues and Decision Memorandum. A list of the issues raised is attached to this notice at the appendix.</P>
                <HD SOURCE="HD1">Final Negative Determination of Circumvention</HD>
                <P>
                    As detailed in the Issues and Decision Memorandum, Commerce determines that the imports of SSWire completed in Vietnam using Korea-origin SSWR and subsequently exported from Vietnam to the United States are not circumventing the 
                    <E T="03">Order</E>
                     on a country-wide basis. Accordingly, Commerce is making a negative finding of circumvention of the 
                    <E T="03">Order.</E>
                </P>
                <HD SOURCE="HD1">Administrative Protective Order</HD>
                <P>This notice will serve as the only reminder to all parties subject to an administrative protective order (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 return/destruction of APO materials or conversation to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.</P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>This determination is issued and published in accordance with section 781(c) of the Act and 19 CFR 351.226(g)(1).</P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Lisa W. Wang,</NAME>
                    <TITLE>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. Merchandise Subject to the Circumvention Inquiry</FP>
                    <FP SOURCE="FP-2">
                        IV. Scope of the 
                        <E T="03">Order</E>
                    </FP>
                    <FP SOURCE="FP-2">V. Period of Circumvention Inquiry</FP>
                    <FP SOURCE="FP-2">VI. Discussion of the Issues</FP>
                    <FP SOURCE="FP1-2">Comment 1: Whether Prior Agency Determinations Are Relevant to Whether</FP>
                    <FP SOURCE="FP1-2">Circumvention Has Occurred in this Case</FP>
                    <FP SOURCE="FP1-2">Comment 2: Whether Commerce Should Analyze if SSWire Is a Substitute for SSWR</FP>
                    <FP SOURCE="FP-2">VII. Recommendation</FP>
                </EXTRACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11312 Filed 5-25-23; 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-489-819]</DEPDOC>
                <SUBJECT>Steel Concrete Reinforcing Bar From the Republic of Turkey: Final Results of Countervailing Duty Administrative Review and Rescission, in Part; 2020</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 certain producers/exporters of steel concrete reinforcing bar (rebar) from the Republic of Turkey (Turkey) received countervailable subsidies during the period of review (POR) January 1, 2020, through December 31, 2020. Additionally, we are rescinding the review for 21 companies that had no shipments of subject merchandise to the United States during the POR.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable May 26, 2023.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>John McGowan, 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) 482-0461.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Commerce published the 
                    <E T="03">Preliminary Results</E>
                     on December 1, 2022,
                    <SU>1</SU>
                    <FTREF/>
                     and invited comments from interested parties. For a description of the events that occurred since the 
                    <E T="03">Preliminary Results, see</E>
                     the Issues and Decision Memorandum.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Steel Concrete Reinforcing Bar from the Republic of Turkey: Preliminary Results of Countervailing Duty Administrative Review and Intent to Rescind in Part; 2020,</E>
                         87 FR 73750 (December 1, 2022) (
                        <E T="03">Preliminary Results</E>
                        ), and accompanying Preliminary Decision Memorandum.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Issues and Decision Memorandum for the Final Results of the Countervailing Duty Administrative Review of Steel Concrete Reinforcing Bar from the Republic of Turkey; 2020,” dated concurrently with, and hereby adopted by, this notice (Issues and Decision Memorandum).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">
                    Scope of the Order 
                    <E T="51">3</E>
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See Steel Concrete Reinforcing Bar from the Republic of Turkey: Countervailing Duty Order,</E>
                         79 FR 65926 (November 6, 2014) (
                        <E T="03">Order</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    The merchandise covered by the 
                    <E T="03">Order</E>
                     is rebar. A full description of the scope of the 
                    <E T="03">Order</E>
                     is contained in the Issues and Decision Memorandum.
                </P>
                <HD SOURCE="HD1">Analysis of Comments Received</HD>
                <P>
                    All issues raised by interested parties in case briefs are addressed in the Issues and Decision Memorandum 
                    <PRTPAGE P="34130"/>
                    accompanying this notice. A list of issues raised by the interested parties, and to which Commerce responded in the Issues and Decision Memorandum, are provided in Appendix I 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">http://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 a review of the record and the comments received from interested parties, we revised the calculation of the net countervailable subsidy rates for Colakoglu Dis Ticaret A.S. (Colakoglu) and Kaptan Demir Celik Endustrisi ve Ticaret A.S. (Kaptan). For a discussion of the issues, 
                    <E T="03">see</E>
                     the Issues and Decision Memorandum.
                </P>
                <HD SOURCE="HD1">Methodology</HD>
                <P>
                    Commerce conducted this administrative review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (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>4</SU>
                    <FTREF/>
                     For a description of the methodology underlying all of Commerce's conclusions, 
                    <E T="03">see</E>
                     the Issues and Decision Memorandum.
                </P>
                <FTNT>
                    <P>
                        <SU>4</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">Rescission of Administrative Review, in Part</HD>
                <P>
                    It is Commerce's practice to rescind an administrative review of a countervailing duty order, pursuant to 19 CFR 351.213(d)(3), when there are no reviewable entries of subject merchandise during the POR for which liquidation is suspended.
                    <SU>5</SU>
                    <FTREF/>
                     Normally, upon completion of an administrative review, the suspended entries are liquidated at the countervailing duty assessment rate calculated for the review period.
                    <SU>6</SU>
                    <FTREF/>
                     Therefore, for an administrative review of a company to be conducted, there must be a reviewable, suspended entry that Commerce can instruct U.S. Customs and Border Protection (CBP) to liquidate at the countervailing duty assessment rate calculated for the review period.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See, e.g., Lightweight Thermal Paper from the People's Republic of China: Notice of Rescission of Countervailing Duty Administrative Review; 2015,</E>
                         82 FR 14349 (March 20, 2017); and 
                        <E T="03">Circular Welded Carbon Quality Steel Pipe from the People's Republic of China: Rescission of Countervailing Duty Administrative Review; 2017,</E>
                         84 FR 14650 (April 11, 2019).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.212(b)(2).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.213(d)(3).
                    </P>
                </FTNT>
                <P>
                    According to the CBP import data, except for the two mandatory respondents and the non-selected company, the remaining 21 companies subject to this review did not have reviewable entries of subject merchandise during the POR for which liquidation is suspended.
                    <SU>8</SU>
                    <FTREF/>
                     There is no evidence on the record of this segment of the proceeding to indicate that these companies had entries, exports, or sales of subject merchandise to the United States during the POR. Further, in response to the 
                    <E T="03">Preliminary Results,</E>
                     no party submitted information to contradict the information on the record. Therefore, in accordance with 19 CFR 351.213(d)(3), we are rescinding the administrative review with respect to the companies listed in Appendix II.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         Appendix II and 
                        <E T="03">Preliminary Results</E>
                         PDM at 5.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Rate for Non-Selected Companies Under Review</HD>
                <P>
                    There is one company, Icdas Celik Enerji Tersane ve Ulasim Sanayi A.S. (Icdas), for which a review was requested but which was not selected as a mandatory respondent or found to be cross-owned with a mandatory respondent. We made no changes to the methodology for determining a rate for companies not selected for individual examination from the Preliminary Results. However, due to changes in calculations for Colakoglu and Kaptan, the non-selected rate changed. Thus, for Icdas, the non-selected company in this review, we are applying an 
                    <E T="03">ad valorem</E>
                     subsidy rate of 2.15 percent.
                </P>
                <HD SOURCE="HD1">Final Results of the Administrative Review</HD>
                <P>
                    We find the following net countervailable subsidy rates for the POR January 1, 2020, through December 31, 2020:
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Commerce finds the following companies to be cross-owned with Kaptan: Martas Marmara Ereglisi Liman Tesisleri A.S.; Aset Madencilik A.S.; Kaptan Is Makinalari Hurda Alim Satim Ltd. Sti.; Efesan Demir San. Ve Tic. A.S.; and Nur Gemicilik ve Tic. A.S.
                    </P>
                    <P>
                        <SU>10</SU>
                         Commerce finds Colakoglu Dis Ticaret A.S. and Colakoglu Metalurji A.S to be cross-owned companies.
                    </P>
                    <P>
                        <SU>11</SU>
                         In the last review Commerce found the following companies to be cross-owned with Icdas: Mardas Marmara Deniz Isletmeciligi A.S.; Oraysan Insaat Sanayi ve Ticaret A.S.; Artim Demir Insaat Turizm Sanayi Ticaret Ltd. Sti.; Anka Entansif Hayvancilik Gida Tarim Sanayi ve Ticaret A.S.; Karsan Gemi Insaa Sanayi Ticaret A.S.; Artmak Denizcilik Ticaret Ve Sanayi A.S.; and Eras Tasimacilik Taahhut Ins.Tic A.S. 
                        <E T="03">See Steel Concrete Reinforcing Bar from the Republic of Turkey: Final Results of Countervailing Duty Administrative Review and Rescission, in Part; 2019,</E>
                         87 FR 21640 (April 12, 2022).
                    </P>
                </FTNT>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s150,20">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Company</CHED>
                        <CHED H="1">
                            Subsidy rate
                            <LI>
                                (percent 
                                <E T="03">ad valorem</E>
                                )
                            </LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            Kaptan Demir Celik Endustrisi ve Ticaret A.S., Kaptan Metal Dis Ticaret ve Nakliyat A.S., and their cross-owned affiliates 
                            <SU>9</SU>
                        </ENT>
                        <ENT>2.15</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Colakoglu Dis Ticaret A.S., Colakoglu Metalurji A.S.
                            <SU>10</SU>
                        </ENT>
                        <ENT>* 0.07</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Icdas Celik Enerji Tersane ve Ulasim Sanayi A.S., and its cross-owned affiliates 
                            <SU>11</SU>
                        </ENT>
                        <ENT>2.15</ENT>
                    </ROW>
                    <TNOTE>
                        * 
                        <E T="03">De minimis.</E>
                    </TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD1">Disclosure</HD>
                <P>
                    We intend to disclose the calculations and analysis performed for these final results of review within five days of the date of publication of this notice in the 
                    <E T="04">Federal Register</E>
                    , in accordance with 19 CFR 351.224(b).
                </P>
                <HD SOURCE="HD1">Assessment Requirements</HD>
                <P>
                    In accordance with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(2), Commerce shall determine, and CBP shall assess, countervailing duties on all appropriate entries covered by this review. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after 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).
                    <PRTPAGE P="34131"/>
                </P>
                <HD SOURCE="HD1">Cash Deposit Requirements</HD>
                <P>In accordance with section 751(a)(1) of the Act, we also intend to instruct CBP to collect cash deposits of estimated countervailing duties in the amounts shown above for the above-listed companies with regard to shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of these final results of review. For all non-reviewed firms, CBP will continue to collect cash deposits of estimated countervailing duties at the all-others rate or the 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</HD>
                <P>This notice also serves as a final reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the disposition 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>The final results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4) and 19 CFR 351.221(b)(5).</P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Lisa W. Wang,</NAME>
                    <TITLE>Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Appendix I</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 Order</FP>
                    <FP SOURCE="FP-2">IV. Rescission of Administrative Review, in Part</FP>
                    <FP SOURCE="FP-2">V. Non-Selected Rate</FP>
                    <FP SOURCE="FP-2">VI. Subsidies Valuation Information</FP>
                    <FP SOURCE="FP-2">VII. Analysis of Programs</FP>
                    <FP SOURCE="FP-2">VIII. Analysis of Comments</FP>
                    <FP SOURCE="FP1-2">Comment 1: Whether Commerce Should Use Kaptan's Land Benchmark, Not the Petitioner's Land Benchmark</FP>
                    <FP SOURCE="FP1-2">Comment 2: Whether Commerce Should Revise its Finding That General BITT Exemptions Are Not Countervailable</FP>
                    <FP SOURCE="FP1-2">Comment 3: Whether Commerce Should Include Geri Donusum's Benefits and Total POR Sales in the Benefit Calculation for BITT Exemptions</FP>
                    <FP SOURCE="FP1-2">Comment 4: Whether Commerce Should Rely on Respondents' Revised and Adjusted Sales Data</FP>
                    <FP SOURCE="FP1-2">Comment 5: Whether Commerce Should Tie Benefits Received Under the Assistance To Offset Costs Related to Antidumping Duty (AD)/CVD Investigations Program to Export Sales of Subject Merchandise</FP>
                    <FP SOURCE="FP-2">IX. Recommendation</FP>
                </EXTRACT>
                <HD SOURCE="HD1">Appendix II</HD>
                <EXTRACT>
                    <HD SOURCE="HD1">List of Rescinded Companies</HD>
                    <FP SOURCE="FP-2">1. Acemar International Limited</FP>
                    <FP SOURCE="FP-2">2. A G Royce Metal Marketing</FP>
                    <FP SOURCE="FP-2">3. Agir Haddecilik A.S.</FP>
                    <FP SOURCE="FP-2">4. Ans Kargo Lojistik Tas ve Tic.</FP>
                    <FP SOURCE="FP-2">5. As Gaz Sinai ve Tibbi Gazlar A.S.</FP>
                    <FP SOURCE="FP-2">6. Asil Celik Sanayi ve Ticaret A.S.</FP>
                    <FP SOURCE="FP-2">7. Bastug Metalurji Sanayi AS.</FP>
                    <FP SOURCE="FP-2">8. Baykan Dis Ticaret</FP>
                    <FP SOURCE="FP-2">9. Demirsan Haddecilik Sanayi Ve Ticaret A.S.</FP>
                    <FP SOURCE="FP-2">10. Diler Dis Ticaret A.S.</FP>
                    <FP SOURCE="FP-2">11. Ege CelikEndustrisi Sanayi ve Ticaret A.S.</FP>
                    <FP SOURCE="FP-2">12. Izmir Demir Celik Sanayi A.S.</FP>
                    <FP SOURCE="FP-2">13. Kibar dis Ticaret A.S.</FP>
                    <FP SOURCE="FP-2">14. Kocaer Haddecilik Sanayi Ve Ticar A.S.</FP>
                    <FP SOURCE="FP-2">15. Meral Makina Iml Ith Ihr Gida.</FP>
                    <FP SOURCE="FP-2">16. Mettech Metalurji Madencilik Muhendislik Uretim Danismanlik ve Ticaret Limited Sirketi.</FP>
                    <FP SOURCE="FP-2">17. MMZ Onur Boru Profil A.S.</FP>
                    <FP SOURCE="FP-2">18. Ozkan Demir Celik Sanayi A.S.</FP>
                    <FP SOURCE="FP-2">19. Sami Soybas Demir Sanayi ve Ticaret</FP>
                    <FP SOURCE="FP-2">20. Wilmar Europe Trading BV</FP>
                    <FP SOURCE="FP-2">21. Yucel</FP>
                </EXTRACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11311 Filed 5-25-23; 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-XC935]</DEPDOC>
                <SUBJECT>Pacific Island Fisheries; Marine Conservation Plan for Pacific Insular Areas other Than American Samoa, Guam, and the Northern Mariana Islands; Western Pacific Sustainable Fisheries Fund</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 of agency decision.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS announces approval of a Marine Conservation Plan (MCP) for Pacific Insular Areas other than American Samoa, Guam, and the Northern Mariana Islands.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This agency decision is effective from August 4, 2023, through August 3, 2026.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may obtain a copy of the MCP, identified by NOAA-NMFS-2023-0056, from the Federal e-Rulemaking Portal, 
                        <E T="03">https://www.regulations.gov/docket/NOAA-NMFS-2023-0056,</E>
                         or from the Western Pacific Fishery Management Council (Council), 1164 Bishop St., Suite 1400, Honolulu, HI 96813, 808-522-8220, 
                        <E T="03">https://www.wpcouncil.org.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Keith Kamikawa, Sustainable Fisheries, NMFS Pacific Islands Regional Office, 808-725-5177.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 204(e) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) authorizes the Secretary of State, with the concurrence of the Secretary of Commerce (Secretary), and in consultation with the Council, to negotiate and enter into a Pacific Insular Area fishery agreement (PIAFA). A PIAFA would allow foreign fishing within the U.S. Exclusive Economic Zone (EEZ) adjacent to a Pacific Insular Area other than American Samoa, Guam, or the Northern Mariana Islands, that is, in the EEZ around the Pacific Remote Island Areas (PRIA). The PRIA are Baker Island, Howland Island, Jarvis Island, Johnston Atoll, Kingman Reef, Midway Island, Palmyra Atoll, and Wake Island. Before entering into a PIAFA for the PRIA, the Council must develop and submit to the Secretary a 3-year MCP that details the uses for funds collected by the Secretary under the PIAFA. NMFS is the designee of the Secretary for MCP review and approval.</P>
                <P>The Magnuson-Stevens Act requires payments received under a PIAFA, and any funds or contributions received in support of conservation and management objectives for the MCP, to be deposited into the Western Pacific Sustainable Fisheries Fund (Fund) for use by the Council. Additionally, in the case of violations by foreign fishing vessels in the EEZ around the PRIA, amounts received by the Secretary attributable to fines and penalties imposed under the Magnuson-Stevens Act, including sums collected from the forfeiture and disposition or sale of property seized subject to its authority, are deposited into the Fund for use by the Council, after direct costs of the enforcement action are subtracted. Section 204(e)(7)(C) of the Magnuson-Stevens Act also authorizes the Council to use the Fund to meet conservation and management objectives in the State of Hawaii, if funds remain available.</P>
                <P>
                    An MCP must be consistent with the Council's fishery ecosystem plans (FEPs), must identify conservation and management objectives (including criteria for determining when such objectives have been met), and must 
                    <PRTPAGE P="34132"/>
                    prioritize planned marine conservation projects. Although no foreign fishing in the PRIA is being considered at this time, the Council reviewed and approved the draft MCP at its March 2023 meeting. On April 5, 2023, the Council's Executive Director submitted the MCP to NMFS for review and approval.
                </P>
                <P>The MCP contains the following five conservation and management objectives that are consistent with the FEP for the PRIA and the FEP for Pelagic Fisheries of the Western Pacific:</P>
                <P>1. Support quality research and monitoring to obtain the most complete scientific information available to assess and manage fisheries within an ecosystem approach;</P>
                <P>2. Conduct education and outreach to foster good stewardship principles and broad and direct public participation in the Council's decision making process;</P>
                <P>3. Promote regional cooperation to manage domestic and international fisheries;</P>
                <P>4. Encourage development of technologies and methods to achieve the most effective level of monitoring, control and surveillance (MCS) and to ensure safety at sea; and</P>
                <P>5. Western Pacific Community Development Program and Western Pacific Community Demonstration Projects Program.</P>
                <P>In addition, the MCP contains seven conservation and management objectives that are consistent with the FEP for the Hawaii Archipelago:</P>
                <P>1. Support quality research and monitoring to obtain the most complete scientific information available to assess and manage fisheries within an ecosystem approach;</P>
                <P>2. Promote an ecosystem approach to fisheries management including reducing bycatch in fisheries and minimizing impacts on marine habitat and impacts on protected species and addressing climate change adaptation and mitigation;</P>
                <P>3. Conduct education and outreach to foster good stewardship principles and broad and direct public participation in the Council's decision making process;</P>
                <P>4. Recognize the importance of island cultures and traditional fishing practices in managing fishery resources and foster opportunities for participation;</P>
                <P>5. Promote responsible domestic fisheries development to provide long term economic growth and stability by reducing foreign imports and increasing local seafood production;</P>
                <P>6. Promote regional cooperation and capacity building to manage domestic and international fisheries; and</P>
                <P>7. Encourage development of technologies and methods to achieve the most effective level of monitoring, control and surveillance and to ensure safety at sea.</P>
                <P>Please refer to the MCP for projects and activities designed to meet each objective, the evaluative criteria, and priority rankings.</P>
                <P>This notice announces that NMFS has reviewed the MCP and determined that it satisfies the requirements of the Magnuson-Stevens Act. Accordingly, we have approved the MCP for the 3-year period from August 4, 2023, through August 3, 2026. This MCP supersedes the one approved previously for August 4, 2020, through August 3, 2023 (85 FR 65389, October 15, 2020).</P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Ngagne Jafnar Gueye,</NAME>
                    <TITLE>Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11232 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XD002]</DEPDOC>
                <SUBJECT>Atlantic Coastal Fisheries Cooperative Management Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing Permit</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; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an exempted fishing permit renewal application from the Massachusetts Division of Marine Fisheries contains all of the required information and warrants further consideration. The exempted fishing permit would allow federally permitted fishing vessels to fish outside fishery regulations in support of exempted fishing activities proposed by the applicant. Regulations under the Magnuson-Stevens Fishery Conservation and Management Act and the Atlantic Coastal Fisheries Cooperative Management Act require publication of this notice to provide interested parties the opportunity to comment on applications for proposed exempted fishing permits.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 12, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit written comments by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Email: NMFS.GAR.EFP@noaa.gov.</E>
                         Include in the subject line “Comments on MA DMF Ventless Trap EFP.” If you cannot submit a comment through this method, please contact Allison Murphy at (978) 281-9122, or email at 
                        <E T="03">allison.murphy@noaa.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Allison Murphy, Fishery Policy Analyst, 978-281-9122, 
                        <E T="03">allison.murphy@noaa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Massachusetts Division of Marine Fisheries (MA DMF) submitted a complete application for an exempted fishing permit (EFP) to conduct commercial fishing activities that the regulations would otherwise restrict. This EFP would exempt the participating vessels from the following Federal regulations:</P>
                <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s100,r75,r100">
                    <TTITLE>Table 1—Requested Exemptions</TTITLE>
                    <BOXHD>
                        <CHED H="1">CFR Citation</CHED>
                        <CHED H="1">Regulation</CHED>
                        <CHED H="1">Need for exemption</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">50 Part 697.21(c)(1) and (2)</ENT>
                        <ENT>Gear specification requirements for Lobster Management Area 1 for Area 2</ENT>
                        <ENT>To allow for the use of traps without escape vents.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 697.19(a) and (b)</ENT>
                        <ENT>Trap limit requirements for Area 1 and 2</ENT>
                        <ENT>To allow for trap limits to be exceeded.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 697.19(i)</ENT>
                        <ENT>Trap tag requirements</ENT>
                        <ENT>To allow for alternatively-tagged traps.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§§ 697.20(a)(2) 697.20(b)(2), 697.20(a)(3), and 697.20(b)(3)</ENT>
                        <ENT>Minimum and maximum carapace length requirements for Areas 1 and 2</ENT>
                        <ENT>To allow sub-legal and over-sized lobsters to be landed for research purposes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 697.20(g)(1) and (3)</ENT>
                        <ENT>V-notch possession requirement for Areas 1 and 2</ENT>
                        <ENT>To allow landing of female lobsters for research purposes.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="34133"/>
                        <ENT I="01">§ 697.20(d)(1) and (3)</ENT>
                        <ENT>Berried female possession requirements</ENT>
                        <ENT>To allow landing of egg-bearing female lobsters for research purposes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§ 697.20(h)(1)</ENT>
                        <ENT>Minimum carapace width requirements</ENT>
                        <ENT>To allow sub-legal Jonah crabs to be landed for research purposes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">§§ 697.20(h)(2)(i) and (ii)</ENT>
                        <ENT>Berried female possession requirement</ENT>
                        <ENT>To allow landing of egg-bearing female Jonah crabs for research purposes.</ENT>
                    </ROW>
                </GPOTABLE>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s50,r150">
                    <TTITLE>Table 2—Project Summary</TTITLE>
                    <BOXHD>
                        <CHED H="1">Project title</CHED>
                        <CHED H="1">2023 MA DMF Ventless Trap Survey</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Institution</ENT>
                        <ENT>MA DMF.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Principal Investigator</ENT>
                        <ENT>Tracy Pugh.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Division action number</ENT>
                        <ENT>DA23-045.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Funding source</ENT>
                        <ENT>State funded.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Continuing project (yes/no)</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Project objectives</ENT>
                        <ENT>To provide fishery-independent data on lobster growth and abundance within Massachusetts State waters of statistical areas 514 and 538.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Initial application date</ENT>
                        <ENT>May 3, 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Final application date</ENT>
                        <ENT>N/A.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Project Start</ENT>
                        <ENT>June 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Project End</ENT>
                        <ENT>October 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Project location</ENT>
                        <ENT>Statistical Areas 514 and 538.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Number of vessels</ENT>
                        <ENT>Up to 4.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Number of trips</ENT>
                        <ENT>Approximately 10.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Trip duration (days)</ENT>
                        <ENT>1.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Total number of days</ENT>
                        <ENT>Approximately 40.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Gear type(s)</ENT>
                        <ENT>Lobster traps.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Number of tows or sets</ENT>
                        <ENT>n/a.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Duration of tows or sets</ENT>
                        <ENT>3 days soak time.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Project Narrative</HD>
                <P>The purpose of this survey is to provide fishery-independent data on lobster growth and abundance within Massachusetts State waters of statistical areas 514 and 538. MA DMF funds this lobster abundance survey through their commercial and recreational lobster license fees. This survey has occurred annually since 2006. At least one MA DMF scientist would be on board for the sampling trips. MA DMF personnel would not be on board when traps are baited and deployed. Exemptions would not substantively chance vessel operations. All catch during sampling trips would be retained temporarily to collect biological data. MA DMF staff may collect lobster and/or Jonah crab, including undersized, oversized, v-notched, and egg-bearing lobsters. Collected samples would be used for research projects on growth and maturity. No catch from the experimental traps would be landed for sale. All gear would be Atlantic Large Whale Take Reduction Plan compliant. Survey traps will be separate from each vessel's commercial lobster traps and would be tagged as, “MADMF Research Traps.”</P>
                <P>If approved, the applicant may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate the completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.</P>
                <P>
                    All comments received are a part of the public record and will generally be posted for public viewing in 
                    <E T="03">https://www.noaa.gov/organization/information-technology/foia-reading-room</E>
                     without change. All personal identifying information (
                    <E T="03">e.g.,</E>
                     name, address), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “anonymous” as the signature if you wish to remain anonymous).
                </P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Ngagne Jafnar Gueye,</NAME>
                    <TITLE>Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11235 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XD040]</DEPDOC>
                <SUBJECT>New England Fishery Management Council; Public Meeting</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 of public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The New England Fishery Management Council (Council) is scheduling a public meeting of its Herring Advisory Panel via webinar to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This webinar will be held on Wednesday, June 14, 2023, at 9 a.m.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                         Webinar registration URL information: 
                        <E T="03">https://attendee.gotowebinar.com/register/8047175401522362205.</E>
                    </P>
                    <P>
                        <E T="03">Council address:</E>
                         New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950.
                    </P>
                </ADD>
                <FURINF>
                    <PRTPAGE P="34134"/>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Agenda</HD>
                <P>The Herring Advisory Panel will receive a report from the Herring Plan Development Team (PDT) covering these agenda topics. They will revisit Amendment 8 Inshore Midwater Trawl Closure—suggest revisions to a draft problem statement and discuss preliminary PDT work on Committee tasking. The Panel will discuss a potential change in 2023 Council priorities to develop river herring and shad time/area closures. They will make recommendations to the Herring Committee, as appropriate, and discuss other business, as necessary.</P>
                <P>Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.</P>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.</P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Rey Israel Marquez,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11336 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XD045]</DEPDOC>
                <SUBJECT>New England Fishery Management Council; Public Meeting</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 of public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The New England Fishery Management Council (Council) is scheduling a hybrid meeting of its Scallop Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This meeting will be held on Thursday, June 15, 2023, at 9 a.m.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>This meeting will be held at the Hilton Garden Inn, 100 Boardman Street, Boston, MA 02128; phone: (617) 567-6789.</P>
                    <P>
                        <E T="03">Webinar registration URL information: https://attendee.gotowebinar.com/register/4979380730021207127.</E>
                    </P>
                    <P>
                        <E T="03">Council address:</E>
                         New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Agenda</HD>
                <P>The Committee will review the 2024/2025 Scallop Research Set-Aside (RSA) and develop research recommendations for the notice of funding opportunity announcement (NOFO). Also on the agenda are Scallop RSA program modifications: discuss recommending administrative changes to the Scallop RSA program, including the consideration of longer-term regional survey awards. The committee will also discuss scallop specifications and receive an update on the timeline and possible measures. This action will be initiated at the June 2023 Council meeting. The committee will discuss Northern Edge: progress report and timeline for action to potentially authorize scallop fishery access to habitat management area. Other business will be discussed, if necessary.</P>
                <P>Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.</P>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.</P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Rey Israel Marquez,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11338 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XD016]</DEPDOC>
                <SUBJECT>Advisory Committee Open Session on Management Strategy Evaluation for North Atlantic Swordfish</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 of meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS is holding a public meeting via webinar session for the Advisory Committee to the U.S. Section to the International Commission for the Conservation of Atlantic Tunas (ICCAT) and all interested stakeholders to receive an update and provide input on the development of the management strategy evaluation (MSE) for North Atlantic swordfish.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>A virtual meeting that is open to the public will be held by webinar session on June 16, 2023, from 3 p.m. to 5 p.m. EDT.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Please register to attend the meeting at: 
                        <E T="03">https://forms.gle/EeMbS76EHZ5s5CQg7.</E>
                         Registration will close on June 14, 2023, at 5 p.m. EDT. Instructions for accessing the webinar session will be emailed to registered participants.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Bryan Keller, Office of International Affairs, Trade, and Commerce, (202) 897-9208 or at 
                        <E T="03">Bryan.Keller@noaa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    MSE is a process that allows fishery managers and stakeholders (
                    <E T="03">e.g.,</E>
                     industry, scientists, and non-governmental organizations) to assess how well 
                    <PRTPAGE P="34135"/>
                    different strategies achieve specified management objectives for a fishery. ICCAT expects to finalize its North Atlantic swordfish MSE in 2023 and anticipates adopting a management procedure in November 2023 to set the total allowable catch for 2024 and future years for the stock. NMFS, and the United States Government more broadly, engages in this MSE development, an important part of which involves considering stakeholder input throughout the process through various means, including consultation with the Advisory Committee to the U.S. Section to ICCAT. The United States is also participating in the development of the North Atlantic swordfish MSE through the active involvement of U.S. scientists in the scientific work carried out by ICCAT's Standing Committee on Research and Statistics (SCRS).
                </P>
                <P>The June 16 meeting is intended to update U.S. stakeholders and solicit their input on the MSE approach being developed by ICCAT for North Atlantic swordfish. NMFS will provide information on the progress of the SCRS in developing initial candidate management procedures (CMPs) and testing them based on initial input on management objectives and other relevant matters from ICCAT's Panel 4. CMPs illustrate tradeoffs associated with achieving identified management objectives related to stock status, stock safety, yield, and catch stability over time. CMP testing assists ICCAT in refining management objectives and narrowing the number of viable CMPs for possible adoption by the Commission. This open session Advisory Committee meeting is primarily informational in nature and is intended to increase the opportunity for stakeholder awareness and input on the North Atlantic swordfish MSE process. Discussions at the meeting will help inform U.S. scientists who are participating in the work of the SCRS as well as U.S. managers participating in relevant Commission related meetings later in 2023 addressing the North Atlantic swordfish MSE.</P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 971 
                    <E T="03">et seq.;</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Alexa Cole,</NAME>
                    <TITLE>Director, Office of International Affairs, Trade, and Commerce, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11236 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XD025]</DEPDOC>
                <SUBJECT>Pacific Fishery Management Council; Public Meeting; Correction</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 of correction of a public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Pacific Fishery Management Council's (Pacific Council) Ad Hoc Marine Planning Committee (MPC) will hold an online public meeting.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The online meeting will be held Tuesday, June 6, 2023, from 10 a.m. to 4 p.m. Pacific Daylight Time or until business for the day has been completed.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        This meeting will be held online. Specific meeting information, including a proposed agenda and directions on how to attend the meeting and system requirements will be provided in the meeting announcement on the Pacific Council's website (see 
                        <E T="03">www.pcouncil.org</E>
                        ). You may send an email to Mr. Kris Kleinschmidt (
                        <E T="03">kris.kleinschmidt@noaa.gov</E>
                        ) or contact him at (503) 820-2412 for technical assistance.
                    </P>
                    <P>
                        <E T="03">Council address:</E>
                         Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Kerry Griffin, Staff Officer, Pacific Council; telephone: (503) 820-2409.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The original notice published in the 
                    <E T="04">Federal Register</E>
                     on May 22, 2023 (88 FR 32735). This notice adds agenda items.
                </P>
                <P>The purpose of this online meeting is for the MPC to consider current offshore wind (OSW) energy issues and to provide information and advice to the Pacific Council for consideration at its June 2023 meeting. The primary purpose of the meeting will be to discuss pending Fisheries Communications Plans for the five California OSW leases provisionally awarded in December 2022. We anticipate representatives of the five California OSW leases to be present to join the discussion. Other topics may be considered as appropriate.</P>
                <P>Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.</P>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>
                    Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (
                    <E T="03">kris.kleinschmidt@noaa.gov;</E>
                     (503) 820-2412) at least 10 days prior to the meeting date.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Rey Israel Marquez,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11251 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XD044]</DEPDOC>
                <SUBJECT>New England Fishery Management Council; Public Meeting</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 of public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The New England Fishery Management Council (Council) is scheduling a hyrbid meeting of its Scallop Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This meeting will be held on Wednesday, June 14, 2023, at 9 a.m.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>This meeting will be held at the Hilton Garden Inn, 100 Boardman Street, Boston, MA 02128; phone: (617) 567-6789.</P>
                    <P>
                        <E T="03">Webinar URL information (no pre-registration): https://meet.goto.com/243467597.</E>
                    </P>
                    <P>
                        <E T="03">Council address:</E>
                         New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <PRTPAGE P="34136"/>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Agenda</HD>
                <P>The Advisory Panel will review the 2024/2025 Scallop Research Set-Aside (RSA) and develop research recommendations for the notice of funding opportunity announcement (NOFO). Also on the agenda are Scallop RSA program modifications: discuss recommending administrative changes to the Scallop RSA program, including the consideration of longer-term regional survey awards. The panel will also discuss scallop specifications and receive an update on the timeline and possible measures. This action will be initiated at the June 2023 Council meeting. The panel will discuss Northern Edge: progress report and timeline for action to potentially authorize scallop fishery access to habitat management area. Other business will be discussed, if necessary.</P>
                <P>Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.</P>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.</P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Rey Israel Marquez,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11337 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XD038]</DEPDOC>
                <SUBJECT>Pacific Fishery Management Council; Public Meeting</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 of public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Pacific Fishery Management Council's (Pacific Council) Highly Migratory Species Advisory Subpanel (HMSAS) is holding an online meeting, which is open to the public.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The online meeting will be held Wednesday, June 14, 2023, from 1 p.m. to 4:30 p.m., Pacific Time.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        This meeting will be held online. Specific meeting information, including directions on how to join the meeting and system requirements will be provided in the meeting announcement on the Pacific Council's website (see 
                        <E T="03">www.pcouncil.org</E>
                        ). You may send an email to Mr. Kris Kleinschmidt (
                        <E T="03">kris.kleinschmidt@noaa.gov</E>
                        ) or contact him at (503) 820-2412 for technical assistance.
                    </P>
                    <P>
                        <E T="03">Council address:</E>
                         Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Kit Dahl, Staff Officer, Pacific Council; telephone: (503) 820-2422.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The purpose of this meeting is to familiarize the HMSAS with relevant topics to be taken up at the June 2023 Pacific Council meeting and begin considering the contents of reports the HMSAS may wish to submit to the Council. An agenda for the HMSAS meeting will be posted on the Council's website at least one week prior to the meeting.</P>
                <P>Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.</P>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>
                    Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (
                    <E T="03">kris.kleinschmidt@noaa.gov;</E>
                     (503) 820-2412) at least 10 days prior to the meeting date.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Rey Israel Marquez,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11335 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>United States Patent and Trademark Office</SUBAGY>
                <DEPDOC>[Docket No.: PTO-P-2023-0021]</DEPDOC>
                <SUBJECT>Request for Comments on a Proposed Track Three Pilot Program With a Pre-Examination Search Option</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>United States Patent and Trademark Office, Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The United States Patent and Trademark Office (USPTO or Office) seeks public comments on a proposed Track Three Pilot Program that would permit micro entity applicants to delay payment of the search fee and the examination fee for a period of 30 months from the earliest filing date claimed, under certain conditions. By lowering a barrier to intellectual property protection, the proposed Track Three Pilot Program reinforces the USPTO's commitment to providing the best and most accessible intellectual property system in the world. Under the proposed Track Three Pilot Program, micro entity applicants would need to submit a request to participate in the program when filing a nonprovisional utility or plant application, pay the basic filing fee, and satisfy other requirements, including the requirement that the application be in condition for publication to enable it to be published after the expiration of 18 months from the earliest filing date for which a benefit is sought. The USPTO is also exploring including in the Track Three Pilot Program an option that would permit micro entity applicants, under certain conditions, to obtain a pre-examination search report prior to the deadline for payment of the examination fee. The pre-examination search report would provide applicants with additional information as they consider potential commercialization and the value of their invention.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comment Deadline: Written comments must be received on or before July 25, 2023, to ensure consideration.</P>
                </DATES>
                <ADD>
                    <PRTPAGE P="34137"/>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        For reasons of Government efficiency, comments must be submitted through the Federal eRulemaking Portal at 
                        <E T="03">www.regulations.gov.</E>
                         To submit comments via the portal, enter docket number PTO-P-2023-0021 on the homepage and click “Search.” The site will provide a search results page listing all documents associated with this docket. Find a reference to this document and click on the “Comment” icon, complete the required fields, and enter or attach your comments. Attachments to electronic comments will be accepted in Adobe® portable document format (PDF) or Microsoft Word® format. Because comments will be made available for public inspection, information that the submitter does not desire to make public, such as an address or phone number, should not be included in the comments.
                    </P>
                    <P>Visit the Federal eRulemaking Portal for additional instructions on providing comments via the portal. If electronic submission of comments is not feasible due to a lack of access to a computer and/or the internet, please contact the USPTO using the contact information below for special instructions.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Eugenia A. Jones, Senior Legal Advisor, Office of Patent Legal Administration, at 571-272-7727; or Kristie A. Mahone, Senior Legal Advisor, Office of Patent Legal Administration, at 571-272-9016; or 
                        <E T="03">patent.practice@uspto.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The USPTO seeks public comments on a proposed Track Three Pilot Program directed at lowering a barrier to intellectual property protection. The proposed Track Three Pilot Program would be limited to micro entity applicants. Micro entity applicants are typically under-resourced and often need additional time for commercialization efforts and to ascertain the value of their inventions. The USPTO envisions permitting micro entity applicants to request a 30-month time period from the earliest filing date claimed to pay the search fee and the examination fee in a nonprovisional utility or plant application, filed under 35 U.S.C. 111(a), if certain conditions are met. The USPTO is also considering including an option that would permit micro entity applicants, under certain conditions, to additionally obtain a pre-examination search report prior to the deadline for payment of the examination fee.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    In June 2010, the USPTO requested comments from the public on a proposal to provide applicants with greater control over when their original utility or plant applications are examined and to promote work sharing between intellectual property offices. 
                    <E T="03">See</E>
                     Enhanced Examination Timing Control Initiative; Notice of Public Meeting, 75 FR 31763 (June 4, 2010), 1355 Off. Gaz. Pat. Office 323 (June 29, 2010). Specifically, the Office proposed to adopt procedures under which an applicant would be able to:
                </P>
                <P>(1) request prioritized examination of an original utility or plant nonprovisional application (Track One);</P>
                <P>(2) request a delay in docketing the application for examination by filing a request for delay in payment of the search fee, the examination fee, the claims fees, and the surcharge (if required) for a maximum period not to exceed 30 months in an original non-continuing utility or plant application, filed under 35 U.S.C. 111(a), that does not claim the benefit of a prior-filed foreign application (Track Three); or</P>
                <P>(3) obtain processing under the current examination procedure (Track Two) by not requesting either Track One or Track Three processing.</P>
                <P>
                    On September 16, 2011, the Leahy-Smith America Invents Act (AIA) was enacted, and section 11(h) included provisions for prioritized examination. A week later, the USPTO amended the rules of practice to implement the prioritized examination provisions of section 11(h) of the AIA. 
                    <E T="03">See</E>
                     Changes To Implement the Prioritized Examination Track (Track I) of the Enhanced Examination Timing Control Procedures Under the Leahy-Smith America Invents Act, 76 FR 59050 (Sept. 23, 2011), 1371 Off. Gaz. Pat. Office 151 (Oct. 18, 2011).
                </P>
                <P>
                    The USPTO currently has a deferred examination practice, under which any applicant (regardless of entity status) may request deferral of examination of an original utility or plant application for a period not extending beyond three years from the earliest filing date claimed under 35 U.S.C. 119, 120, 121, 365, or 386, if certain conditions are met. 
                    <E T="03">See</E>
                     37 CFR 1.103(d). It is the USPTO's practice to not grant a request for deferral of examination under 37 CFR 1.103(d) until all required fees (including the search fee and the examination fee) have been paid and the application is complete. A request for deferral of examination under 37 CFR 1.103(d) also requires payment of a processing fee. 
                </P>
                <P>Furthermore, a request for deferral of examination under 37 CFR 1.103(d) may be submitted after the application has been filed, but the request will not be granted if the USPTO has issued an Office action, under 35 U.S.C. 132, or a notice of allowance, under 35 U.S.C. 151.</P>
                <P>
                    The USPTO also has a practice (“missing parts” practice) that permits applications to be filed without claims, the inventor's oath or declaration, or fees being present on filing. 
                    <E T="03">See</E>
                     37 CFR 1.53(f). Specifically, under current practice, the USPTO will send a Notice to File Missing Parts of Nonprovisional Application (Notice to File Missing Parts) if a nonprovisional application, filed under 35 U.S.C. 111(a), has been accorded a filing date but does not include:
                </P>
                <P>(1) the basic filing fee (37 CFR 1.16(a) or (c));</P>
                <P>(2) the search fee (37 CFR 1.16(k) or (m));</P>
                <P>(3) the examination fee (37 CFR 1.16(o) or (q));</P>
                <P>(4) at least one claim; and/or</P>
                <P>(5) either the inventor's oath or declaration under 37 CFR 1.63 or an application data sheet in accordance with 37 CFR 1.76.</P>
                <P>The Notice to File Missing Parts will set a time period for the applicant to submit the missing items and pay the required surcharge under 37 CFR 1.16(f) to avoid abandonment. If excess claims fees under 37 CFR 1.16(h), (i), and/or (j); an application size fee under 37 CFR 1.16(s); and/or the non-electronic filing fee under 37 CFR 1.16(t) are required and any of these fees have not been paid, the Notice to File Missing Parts will also require that these fees be paid within the period for response to the Notice to File Missing Parts. Although the rules of practice do not specify the time period for response to the Notice to File Missing Parts, the USPTO currently sets a two-month time period for that response, with extensions of time of up to five months available under 37 CFR 1.136(a).</P>
                <P>Finally, under the Patent Cooperation Treaty (PCT), an applicant may seek patent protection in the United States, and other jurisdictions, by first filing an international application and then filing a national stage entry as to the United States as well as entry into other jurisdictions. This practice, subject to various conditions and requirements, permits a similar 30-month period for applicants to defer certain filing decisions. As is the case with the deferred examination practice and missing parts practice, this option requires payment of additional fees and the fulfillment of other requirements relative to the proposed Track Three Pilot Program.</P>
                <P>
                    The USPTO recognizes that under-resourced applicants may need a low-cost option with minimal requirements to allow them additional time for 
                    <PRTPAGE P="34138"/>
                    commercialization efforts and to ascertain the value of their inventions. To that end, the USPTO seeks public comments on a proposed Track Three Pilot Program.
                </P>
                <HD SOURCE="HD1">II. Summary of Proposed Track Three Pilot Program</HD>
                <P>On the filing of an application seeking benefit under the proposed Track Three Pilot Program, a micro entity applicant would be provided a 30-month (non-extendable) time period to pay the search fee and/or the examination fee if the applicant satisfies the following conditions:</P>
                <P>(1) the applicant must submit a request to participate in the Track Three Pilot Program with the nonprovisional application on filing, by using a USPTO form that would be provided for this purpose;</P>
                <P>(2) the nonprovisional application must be a utility or plant application filed under 35 U.S.C. 111(a) within the duration of the pilot program and be entitled to a filing date;</P>
                <P>(3) the nonprovisional application must not claim priority to or benefit of any prior-filed application other than a prior-filed provisional application(s);</P>
                <P>(4) the basic filing fee under 37 CFR 1.16(a) or (c) (as applicable) and any required non-electronic filing fee under 37 CFR 1.16(t) must have been paid;</P>
                <P>(5) the search fee under 37 CFR 1.16(k) or (m) (as applicable) and/or the examination fee under 37 CFR 1.16(o) or (q) (as applicable) must not have been paid;</P>
                <P>(6) the applicant must properly establish micro entity status under 37 CFR 1.29 in the nonprovisional application;</P>
                <P>(7) the applicant must not have filed a nonpublication request; and</P>
                <P>(8) the application must be in condition for publication as provided in 37 CFR 1.211(c) (including, for example, payment of any required application size fee under 37 CFR 1.16(s) and the inventor's oath or declaration or an application data sheet containing the information specified in 37 CFR 1.63(b)).</P>
                <P>To complete the application for examination and avoid abandonment, the search fee, the examination fee, and any other required fees would be due within 30 months from the earliest filing date claimed, including any filing date of a prior provisional application that is relied upon for benefit under 35 U.S.C. 119(e).</P>
                <P>Under 35 U.S.C. 122(b), the USPTO is required to publish the application promptly after the expiration of 18 months from the earliest filing date for which a benefit is sought (which may only be the filing date of a prior-filed U.S. provisional application for the proposed Track Three Pilot Program), as the application may not include a nonpublication request. Therefore, as noted above, the nonprovisional application must be in condition for publication as provided in 37 CFR 1.211(c). In addition to the basic filing fee and the inventor's oath or declaration or an application data sheet containing the information specified in 37 CFR 1.63(b), the USPTO requires the following in order for the nonprovisional application to be in condition for publication:</P>
                <P>(1) a specification in compliance with 37 CFR 1.52;</P>
                <P>(2) an abstract in compliance with 37 CFR 1.72(b);</P>
                <P>(3) drawings (if any) in compliance with 37 CFR 1.84;</P>
                <P>(4) any application size fee required under 37 CFR 1.16(s);</P>
                <P>(5) any English translation required under 37 CFR 1.52(d); and</P>
                <P>(6) a “Sequence Listing XML” in compliance with 37 CFR 1.831-1.835 (if applicable).</P>
                <P>If the requirements for publication are not met, the applicant would need to satisfy the publication requirements within a two-month extendable time period. The required publication of applications participating in the Track Three Pilot Program is similar to the required publication of international applications under the PCT and nonprovisional applications in which the applicant seeks deferred examination. In all three instances, the publication provides public notice of the existence of the application as well as access to the application.</P>
                <P>
                    The USPTO is also considering including an additional “plus” option in the Track Three Pilot Program in which, under certain conditions, the micro entity applicant could obtain a pre-examination search report prior to the deadline for payment of the examination fee. The USPTO recently added an artificial intelligence (AI) search feature as a tool for examiners (
                    <E T="03">see</E>
                     New Artificial Intelligence Functionality in PE2E Search, 1504 Off. Gaz. Pat. Office 359 (Nov. 15, 2022)). Under the “plus” option, relevant references from the AI search tool would be identified and would form the basis of a preexamination search report. The pre-examination search report would provide applicants with additional information as they consider potential commercialization and the value of their invention. If the micro entity applicant chooses the “plus” option, payment of the examination fee and any other required fees except the search fee may be delayed until the expiration of the later of:
                </P>
                <P>(1) six months (non-extendable) from the date of the search report; or</P>
                <P>(2) a period of 30 months (non-extendable) from the earlier of:</P>
                <P>(a) the actual filing date of the application; or</P>
                <P>(b) the filing date of the earliest provisional application for which benefit is claimed.</P>
                <P>The publication of the application under 35 U.S.C. 122(b) will still occur promptly after the expiration of 18 months from the earliest filing date for which a benefit is sought.</P>
                <P>The requirements for participation in the “plus” option would be identical to the basic Track Three Pilot Program requirements explained above, except that the following additional conditions must be met:</P>
                <P>(1) the applicant must submit a request to participate in the “plus” part of the program along with payment of the search fee under 37 CFR 1.16(k) or (m) (as applicable) prior to the expiration of a specified deadline;</P>
                <P>(2) the application may not contain more than 3 independent claims, more than 20 total claims, or any multiple dependent claims; and</P>
                <P>(3) the claims must be drawn to a single invention.</P>
                <P>To complete the application for examination and avoid abandonment, the examination fee and any other required fees would be due within the later of:</P>
                <P>(1) six months (non-extendable) from the date of the search report; or</P>
                <P>(2) a period of 30 months (non-extendable) from the earlier of:</P>
                <P>(a) the actual filing date of the application; or</P>
                <P>(b) the filing date of the earliest provisional application for which benefit is claimed.</P>
                <P>
                    The Consolidated Appropriations Act, 2023, Public Law 117-328, enacted on December 29, 2022, included the Unleashing American Innovators Act of 2022 (UAIA), containing a number of patent-related provisions. 136 Stat. 4459. Section 106 of the UAIA provides for a pre-prosecution assessment pilot program. Specifically, section 106(a) of the UAIA provides that “[n]ot later than [December 29, 2023], the Director shall establish a pilot program to assist first-time prospective patent applicants in assessing the strengths and weaknesses of a potential patent application submitted by such a prospective applicant.” Section 106(b) of the UAIA provides that “[i]n developing the pilot program required under subsection (a), the Director shall establish: (1) a notification process to notify a 
                    <PRTPAGE P="34139"/>
                    prospective patent applicant seeking an assessment described in that subsection that any assessment so provided may not be considered an official ruling of patentability from the Office; (2) conditions to determine eligibility for the pilot program, taking into consideration available resources; (3) reasonable limitations on the amount of time to be spent providing assistance to each individual first-time prospective patent applicant; (4) procedures for referring prospective patent applicants to legal counsel, including through the patent pro bono programs; and (5) procedures to protect the confidentiality of the information disclosed by prospective patent applicants.” The USPTO is planning to leverage the process for producing the pre-examination search report, as discussed in this notice, for the pilot program required by section 106(a) of the UAIA to assist first-time prospective patent applicants in assessing the strengths and weaknesses of their potential patent application.
                </P>
                <HD SOURCE="HD1">III. Additional Considerations</HD>
                <P>Fees are subject to change, and the fees due in an application are the fees in effect at the time of fee payment. Therefore, if the search fee, examination fee, excess claims fees, and/or the surcharge (or any other fees) have changed after the mailing or notification date of a Notice to File Missing Parts that sets a time period to pay such fees, the applicant would be required to pay the revised fee amounts. Applicants who are considering filing under the proposed Track Three Pilot Program should consider that the fee amounts due 30 months after the application is filed may be higher than the fee amounts in effect when the application was filed.</P>
                <P>
                    By statute, any patent term adjustment (PTA) accrued by an applicant based on delays by the USPTO is “reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application” (“applicant delay”). 
                    <E T="03">See</E>
                     35 U.S.C. 154(b)(2)(C)(i). Taking more than three months to respond to any Office action or notice is considered an “applicant delay.” 
                    <E T="03">See</E>
                     35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b). Thus, if an applicant replies to a Notice to File Missing Parts more than three months after the mailing of the notice, any positive PTA accrued by the applicant will be reduced by the period of time in excess of three months taken to reply to the Notice to File Missing Parts. In addition, the failure to place an application in condition for examination (defined in 37 CFR 1.704(f)) within eight months from the date on which the application was filed under 35 U.S.C. 111(a) is also an “applicant delay” and will result in a reduction of any positive PTA accrued by the applicant. 
                    <E T="03">See</E>
                     37 CFR 1.704(c)(13). However, if an “applicant delay” occurs under both these provisions on the same calendar day, the applicant will be assessed only one day of applicant delay (
                    <E T="03">i.e.,</E>
                     no overlapping reduction). It should be noted, however, that this proposed Track Three Pilot Program would not be considered a suspension of action under 37 CFR 1.103 at the applicant's request, and thus applicant delay would not be assessed under 37 CFR 1.704(c)(1). No change to the current regulations (including the PTA regulations) is contemplated to implement the proposed Track Three Pilot Program.
                </P>
                <P>The optional pre-examination search report contemplated by the USPTO is not an action under 35 U.S.C. 132, and no reply to the pre-examination search report itself is necessary to avoid abandonment. Thus, the pre-examination search report will not toll the 14-month time period under 35 U.S.C. 154(b)(1)(A)(i), and therefore, positive PTA will accrue after expiration of the 14-month time period under 35 U.S.C. 154(b)(1)(A)(i) until an action under 35 U.S.C. 132 or 151 is mailed. However, any positive PTA accrued by the applicant will be reduced by the period of time in excess of three months taken to reply to the Notice to File Missing Parts, as well as the period of time in excess of eight months taken to place the application in condition for examination as defined in 37 CFR 1.704(f), except that the applicant will be assessed only one day of applicant delay if both of these delays occur on the same calendar day.</P>
                <HD SOURCE="HD1">IV. Questions for Public Comment</HD>
                <P>The USPTO welcomes any comments from the public on the proposed program discussed in this notice. Commenters are also welcome to respond to any or all of the following questions:</P>
                <P>1. Should the USPTO implement the proposed Track Three Pilot Program? Why or why not?</P>
                <P>2. If the USPTO implements the proposed Track Three Pilot Program, do you or members of your organization believe that the public would use it for eligible applications?</P>
                <P>3. If the proposed Track Three Pilot Program is used, to what extent do you or members of your organization believe the public would use the “plus” option?</P>
                <P>4. If the proposed “plus” option in the Track Three Pilot Program is used, what information would you or members of your organization like to see in the pre-examination search report? For example, options may include a simple list of relevant references, a list of relevant references with a short explanation of why they are relevant, a PCT-style search report that identifies how references are pertinent to specific claims, or something different.</P>
                <P>5. Would the proposed “plus” option in the Track Three Pilot Program be used if the search is performed by a USPTO artificial intelligence search tool(s) only? For example, the search report may include a list of references generated by the artificial intelligence tool(s) or may include relevant references identified by a patent examiner from the artificial intelligence search results along with some level of context ranging from a short explanation to a full PCT-style report.</P>
                <P>6. Are there any conditions of the proposed Track Three Pilot Program that should be modified? For example, is the 30-month time period sufficient to determine whether to proceed with prosecution of the application?</P>
                <P>
                    7. Do the current practices discussed in this notice (
                    <E T="03">i.e.,</E>
                     deferred examination under 37 CFR 1.103(d), the missing parts practice, or PCT practice) provide sufficient additional time to determine whether to pay the fees and/or proceed with prosecution of the application?
                </P>
                <P>8. If an applicant participating in the proposed Track Three Pilot Program becomes aware that the application is no longer entitled to micro entity status, how should that discovery impact the status of the application in the proposed Track Three Pilot Program?</P>
                <P>For example, should the applicant be required to promptly pay the remaining fees and thereby complete the application so it can be forwarded for examination?</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. 2023-11349 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-16-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED</AGENCY>
                <SUBJECT>Procurement List; Additions</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Committee for Purchase From People Who Are Blind or Severely Disabled.</P>
                </AGY>
                <ACT>
                    <PRTPAGE P="34140"/>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Additions to the Procurement List.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action adds service(s) to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date added to the Procurement List:</E>
                         June 16, 2023.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Committee for Purchase From People Who Are Blind or Severely Disabled, 355 E Street SW, Suite 325, Washington, DC 20024.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael R. Jurkowski, Telephone: (703) 785-6404, or email 
                        <E T="03">CMTEFedReg@AbilityOne.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Additions</HD>
                <P>On 3/17/2023 the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to the Procurement List. This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3.</P>
                <P>After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the service(s) and impact of the additions on the current or most recent contractors, the Committee has determined that the service(s) listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.</P>
                <HD SOURCE="HD2">Regulatory Flexibility Act Certification</HD>
                <P>I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:</P>
                <P>1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the service(s) to the Government.</P>
                <P>2. The action will result in authorizing small entities to furnish the service(s) to the Government.</P>
                <P>3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the service(s) proposed for addition to the Procurement List.</P>
                <HD SOURCE="HD2">End of Certification</HD>
                <P>Accordingly, the following service(s) are added to the Procurement List:</P>
                <EXTRACT>
                    <HD SOURCE="HD2">Service(s)</HD>
                    <FP SOURCE="FP-2">
                        <E T="03">Service Type:</E>
                         Custodial Service
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Mandatory for:</E>
                         NASA, NASA Langley Research Center, Hampton, VA
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Designated Source of Supply:</E>
                         Brevard Achievement Center, Inc., Rockledge, FL
                    </FP>
                    <FP SOURCE="FP-2">
                        <E T="03">Contracting Activity:</E>
                         National Aeronautics and Space Administration, NASA Langley Research Center
                    </FP>
                </EXTRACT>
                <P>
                    The Committee finds good cause to dispense with the 30-day delay in the effective date normally required by the Administrative Procedure Act. See 5 U.S.C. 553(d). This addition to the Committee's Procurement List is effectuated because of the expiration of the NASA Langley Research Center, Custodial Service, Hampton, VA contract. The Federal customer contacted and has worked diligently with the AbilityOne Program to fulfill this service need under the AbilityOne Program. To avoid performance disruption, and the possibility that the NASA Langley Research Center will refer its business elsewhere, this addition must be effective on June 16, 2023, ensuring timely execution for a July 1, 2023 start date while still allowing 21 days for comment. The Committee also published a notice of proposed Procurement List addition in the 
                    <E T="04">Federal Register</E>
                     on March 17, 2023 and did not receive any comments from any interested persons. This addition will not create a public hardship and has limited effect on the public at large, but, rather, will create new jobs for other affected parties—people with significant disabilities in the AbilityOne program who otherwise face challenges locating employment. Moreover, this addition will enable Federal customer operations to continue without interruption.
                </P>
                <SIG>
                    <NAME>Michael R. Jurkowski,</NAME>
                    <TITLE>Acting Director, Business Operations.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11269 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6353-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">COMMODITY FUTURES TRADING COMMISSION</AGENCY>
                <SUBJECT>Agency Information Collection Activities Under OMB Review</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Commodity Futures Trading Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Information and Regulatory Affairs (OIRA), of the Office of Management and Budget (OMB), for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be submitted on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be submitted within 30 days of this notice's publication to OIRA, at 
                        <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E>
                         Please find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the website's search function. Comments can be entered electronically by clicking on the “comment” button next to the information collection on the “OIRA Information Collections Under Review” page, or the “View ICR—Agency Submission” page. A copy of the supporting statement for the collection of information discussed herein may be obtained by visiting 
                        <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E>
                    </P>
                    <P>
                        In addition to the submission of comments to 
                        <E T="03">https://Reginfo.gov</E>
                         as indicated above, a copy of all comments submitted to OIRA may also be submitted to the Commodity Futures Trading Commission (the “Commission” or “CFTC”) by clicking on the “Submit Comment” box next to the descriptive entry for OMB Control Number 3038-0049, at 
                        <E T="03">https://comments.cftc.gov/FederalRegister/PublicInfo.aspx.</E>
                    </P>
                    <P>Or by either of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery/Courier:</E>
                         Same as Mail above.
                    </P>
                    <P>
                        All comments must be submitted in English, or if not, accompanied by an English translation. Comments submitted to the Commission should include only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.
                        <SU>1</SU>
                        <FTREF/>
                         The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from 
                        <E T="03">https://www.cftc.gov</E>
                         that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the 
                        <PRTPAGE P="34141"/>
                        ICR will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             17 CFR 145.9.
                        </P>
                    </FTNT>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Rebecca Mersand, Special Counsel, Division of Market Oversight, (202) 941-8910, email: 
                        <E T="03">rmersand@cftc.gov;</E>
                         Jacob Chachkin, Associate Chief Counsel, Market Participants Division, (202) 418-5496, email: 
                        <E T="03">j</E>
                        <E T="03">chach</E>
                        <E T="03">k</E>
                        <E T="03">in@cftc.gov;</E>
                         or Steven A. Haidar, Assistant Chief Counsel, Division of Market Oversight, (202) 418-5611, email: 
                        <E T="03">shaidar@</E>
                        <E T="03">c</E>
                        <E T="03">ftc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title:</E>
                     Procedural Requirements for Requests for Interpretative, No-Action, and Exemptive Letters (OMB Control No. 3038-0049). This is a request for an extension of a currently approved information collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This collection covers the information requirements for voluntary requests for, and the issuance of, interpretative, no-action, and exemptive letters submitted to Commission staff pursuant to the provisions of section 140.99 of the Commission's regulations,
                    <SU>2</SU>
                    <FTREF/>
                     and related requests for confidential treatment pursuant to section 140.98(b) 
                    <SU>3</SU>
                    <FTREF/>
                     of the Commission's regulations.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 140.99. An archive containing CFTC staff letters may be found at 
                        <E T="03">http://www.cftc.gov/LawRegulation/CFTCStaffLetters/index.htm.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         17 CFR 140.98(b).
                    </P>
                </FTNT>
                <P>The collection requirements described herein are voluntary. They apply to parties that choose to request a benefit from Commission staff in the form of the regulatory action described in section 140.99. Such benefits may include, for example, relief from some or all of the burdens associated with other collections of information, relief from regulatory obligations that do not constitute collections of information, interpretations, or extensions of time for compliance with certain Commission regulations. It is likely that persons who would opt to request action under section 140.99 will have determined that the information collection burdens that they would assume by doing so will be outweighed substantially by the relief that they seek to receive.</P>
                <P>This information collection is necessary, and would be used, to assist Commission staff in understanding the type of relief that is being requested and the basis for the request. It is also necessary, and would be used, to provide staff with a sufficient basis for determining whether: (1) granting the relief would be necessary or appropriate under the facts and circumstances presented by the requestor; (2) the relief provided should be conditional and/or time-limited; and (3) granting the relief would be consistent with staff responses to requests that have been presented under similar facts and circumstances. In some cases, the requested relief might be granted upon the condition that those who seek the benefits of that relief fulfill certain conditions that are necessary to ensure that the relief granted by Commission staff is appropriate. Once again, it is likely that those who would comply with these conditions will have determined that the burden of complying with the conditions is outweighed by the relief that they seek to receive. This information collection also is necessary to provide a mechanism whereby persons requesting interpretative, no-action, and exemptive letters may seek temporary confidential treatment of their request and the Commission staff response thereto and the grounds upon which such confidential treatment is sought.</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.
                    <SU>4</SU>
                    <FTREF/>
                     On February 23, 2023, the Commission published in the 
                    <E T="04">Federal Register</E>
                     notice of the proposed extension of this information collection and provided 60 days for public comment on the proposed extension, 88 FR 11410 (“60-Day Notice”). The Commission did not receive any relevant comments on the 60-Day Notice.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         44 U.S.C. 3512, 5 CFR 1320.5(b)(2)(i) and 1320.8 (b)(3)(vi).
                    </P>
                </FTNT>
                <P>
                    <E T="03">Burden Statement:</E>
                     The Commission is revising its existing burden estimate for this information collection. The Commission is basing its new estimate of the annual number of respondents related to this information collection, in part, on the average number of interpretative, no-action, and exemptive letters issued by Commission staff in 2020, 2021, and 2022. The Commission generally estimates that each request was made by a unique respondent. To that number, the Commission is adding additional respondents that have incurred burden hours preparing requests for relief that did not generate a Commission staff letter in response.
                </P>
                <P>This estimate includes the burden hours for preparing, filing, and updating such request letters as well as the burden of complying with any conditions that may be contained in any interpretative, no-action, or exemptive letters granting relief. It also includes burden hours required to prepare and submit related requests for confidential treatment. The burden hours associated with individual requests will vary widely, depending upon the type and complexity of relief requested, whether the request presents novel or complex issues, the relevant facts and circumstances, and the number of requestors or other affected entities.</P>
                <P>The respondent burden is estimated to be as follows:</P>
                <P>
                    <E T="03">Estimated Number of Annual Respondents:</E>
                     45.
                </P>
                <P>
                    <E T="03">Estimated Average Annual Burden Hours per Respondent:</E>
                     40.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     1,800.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     Occasional.
                </P>
                <P>
                    <E T="03">Type of Respondents:</E>
                     Respondents include persons registered with the Commission (such as commodity pool operators, commodity trading advisors, derivatives clearing organizations, designated contract markets, futures commission merchants, introducing brokers, swap dealers, and swap execution facilities), persons seeking an exemption from registration, persons whose registration with the Commission is pending, trade associations and their members, eligible contract participants, and other persons seeking relief from discrete regulatory requirements.
                </P>
                <P>There are no capital costs or operating and maintenance costs associated with this collection.</P>
                <EXTRACT>
                    <FP>
                        (Authority 44 U.S.C. 3501 
                        <E T="03">et seq.</E>
                        )
                    </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Robert Sidman,</NAME>
                    <TITLE>Deputy Secretary of the Commission.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11309 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6351-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF EDUCATION</AGENCY>
                <DEPDOC>[Docket No.: ED-2023-SCC-0093]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Application Forms and Instructions for the Fulbright-Hays Training Grants: Doctoral Dissertation Research Abroad (CFDA Number 84.022A) and Faculty Research Abroad (CFDA Number 84.019A)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Postsecondary Education (OPE), Department of Education (ED).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).</P>
                </SUM>
                <DATES>
                    <PRTPAGE P="34142"/>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for proposed information collection requests should be submitted within 30 days of publication of this notice. Click on this link 
                        <E T="03">www.reginfo.gov/public/do/PRAMain</E>
                         to access the site. Find this information collection request (ICR) by selecting “Department of Education” under “Currently Under Review,” then check the “Only Show ICR for Public Comment” checkbox. 
                        <E T="03">Reginfo.gov</E>
                         provides two links to view documents related to this information collection request. Information collection forms and instructions may be found by clicking on the “View Information Collection (IC) List” link. Supporting statements and other supporting documentation may be found by clicking on the “View Supporting Statement and Other Documents” link.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>For specific questions related to collection activities, please contact Pamela Maimer, (202) 453-6891.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.</P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Application Forms and Instructions for the Fulbright-Hays Training Grants: Doctoral Dissertation Research Abroad (CFDA Number 84.022A) and Faculty Research Abroad (CFDA Number 84.019A).
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1840-0005.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Revision of a currently approved ICR.
                </P>
                <P>
                    <E T="03">Respondents/Affected Public:</E>
                     Private Sector .
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     495.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     11,875.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This information collection is a revision, the purpose of which is to make changes to the DDRA and FRA applications to be consistent with an NPRM to amend the programs' regulations. The programs' applications must be updated to reflect the regulatory changes relating to the programs' selection criteria in CFR part 662.21(c)(3) and 663.21(c)(3). These amendments will result in a change in DDRA student respondents and hour burden.
                </P>
                <P>The purpose of Section 102(b)(6) of the Mutual Educational and Cultural Exchange Act of 1961 (Fulbright-Hays Act) is to promote and develop modern foreign language training and area studies throughout the educational structure of the United States. To help accomplish this objective, fellowships are awarded through US institutions of higher education to American faculty and dissertation students enabling them to conduct overseas research and enhance their foreign language proficiency.</P>
                <P>Under the Fulbright-Hays Doctoral Dissertation Research Abroad (DDRA) and the Fulbright-Hays Faculty Research Abroad (FRA) programs, individual scholars apply through eligible institutions for an institutional grant to support the research fellowship. These institutions administer the program in cooperation with the US Department of Education (US/ED) as provided under the authority of Sections 102(b)(6) and 104(e)(1) of the Mutual Educational and Cultural Exchange Act of 1961, 34 CFR parts 662, and the Policy Statements of the J. William Fulbright Foreign Scholarship Board (FSB).</P>
                <P>This collection is being submitted under the Streamlined Clearance Process for Discretionary Grant Information Collections (1894-0001). Therefore, the 30-day public comment period notice will be the only public comment notice published for this information collection.</P>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Kun Mullan,</NAME>
                    <TITLE>PRA Coordinator, Strategic Collections and Clearance Governance and Strategy Division, Office of Chief Data Officer, Office of Planning, Evaluation and Policy Development.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11255 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF ENERGY</AGENCY>
                <SUBJECT>Environmental Management Site-Specific Advisory Board, Northern New Mexico</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Environmental Management, Department of Energy.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of open meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice announces an online virtual combined meeting of the Consent Order Subcommittee and Risk Evaluation and Management Subcommittee of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Wednesday, June 28, 2023; 10:00 a.m. to 12:00 p.m. MDT.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        This meeting will be held virtually via WebEx. To attend, please contact Menice Santistevan by email, 
                        <E T="03">Menice.Santistevan@em.doe.gov,</E>
                         no later than 5:00 p.m. MDT on Friday, June 23, 2023.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Menice Santistevan, Northern New Mexico Citizens' Advisory Board (NNMCAB), 94 Cities of Gold Road, Santa Fe, NM 87506. Phone (505) 709-7063 or Email: 
                        <E T="03">Menice.Santistevan@em.doe.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Purpose of the Board:</E>
                     The purpose of the Board is to provide advice and recommendations concerning the following EM site-specific issues: clean-up activities and environmental restoration; waste and nuclear materials management and disposition; excess facilities; future land use and long-term stewardship. The Board may also be asked to provide advice and recommendations on any EM program components.
                </P>
                <P>
                    <E T="03">Purpose of the Consent Order Subcommittee:</E>
                     The subcommittee reviews the 
                    <E T="03">2016 Compliance Order on Consent,</E>
                     evaluate its strengths and weaknesses, and draft recommendations for the full Board's consideration as to how to improve it.
                </P>
                <P>
                    <E T="03">Purpose of the Risk Evaluation and Management Subcommittee:</E>
                     The subcommittee drafts external citizen-based recommendations for the full Board's consideration on human and ecological health risk resulting from historical, current, and future hazardous and radioactive legacy waste operations at Los Alamos National Laboratory.
                </P>
                <HD SOURCE="HD2">Tentative Agenda</HD>
                <FP SOURCE="FP-1">• DOE Environmental Management Presentation</FP>
                <FP SOURCE="FP-1">• Deputy Designated Federal Officer Update</FP>
                <P>
                    <E T="03">Public Participation:</E>
                     The online virtual meeting is open to the public. To sign up for public comment, please contact Menice Santistevan by email, 
                    <E T="03">Menice.Santistevan@em.doe.gov,</E>
                     no later than 5:00 p.m. MDT on Friday, June 23, 2023. Written statements may be filed with the Committees either before or within five days after the meeting by sending them to Menice Santistevan at the aforementioned email 
                    <PRTPAGE P="34143"/>
                    address. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.
                </P>
                <P>
                    <E T="03">Minutes:</E>
                     Minutes will be available by writing or calling Menice Santistevan at the address or telephone number listed above. Minutes and other Board documents are on the internet at: 
                    <E T="03">http://energy.gov/em/nnmcab/meeting-materials.</E>
                </P>
                <SIG>
                    <DATED>Signed in Washington, DC, on May 22, 2023.</DATED>
                    <NAME>LaTanya Butler,</NAME>
                    <TITLE>Deputy Committee Management Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11234 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6450-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">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 &amp; Oil Pipeline Rate and Refund Report filings:</P>
                <HD SOURCE="HD1">Filings Instituting Proceedings</HD>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP23-774-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Equitrans, L.P.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: Negotiated Rate Agreement—5/20/2023 to be effective 5/20/2023.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/19/23.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20230519-5113.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 5/31/23.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP23-775-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Eastern Shore Natural Gas Company.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Annual Report of Operational Purchases and Sales of Eastern Shore Natural Gas Company.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/19/23.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20230519-5199.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 5/31/23.
                </P>
                <P>Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) 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>
                    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>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11345 Filed 5-25-23; 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. 2790-000]</DEPDOC>
                <SUBJECT>Boott Hydropower, LLC; Notice of Authorization for Continued Project Operation</SUBJECT>
                <P>The license for the Lowell Hydroelectric Project No. 2790 was issued for a period ending April 30, 2023.</P>
                <P>Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee(s) under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.</P>
                <P>If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 2790 is issued to Boott Hydropower, LLC for a period effective May 1, 2023, through April 30, 2024, or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first. If issuance of a new license (or other disposition) does not take place on or before April 30, 2024, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.</P>
                <P>If the project is not subject to section 15 of the FPA, notice is hereby given that Boott Hydropower, LLC is authorized to continue operation of the Lowell Hydroelectric Project under the terms and conditions of the prior license until the issuance of a new license for the project or other disposition under the FPA, whichever comes first.</P>
                <SIG>
                    <DATED>Dated: May 19, 2023.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11242 Filed 5-25-23; 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. CP17-66-001 and CP17-67-001]</DEPDOC>
                <SUBJECT>Venture Global Plaquemines LNG, LLC; Notice of Availability of the Environmental Assessment for the Proposed Plaquemines LNG Amendment Project</SUBJECT>
                <P>The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment (EA) for the Plaquemines LNG Amendment (Amendment), proposed by Venture Global Plaquemines LNG, LLC (Plaquemines LNG) in the above referenced docket.</P>
                <P>Plaquemines LNG proposes to increase the peak workforce from its current 3,600 personnel up to 6,000 personnel per day, increase traffic volumes, and implement a 24-hours-per-day, 7-days-per-week construction schedule for select activities during the remaining construction period at the Plaquemines LNG Terminal site in Plaquemines Parish, Louisiana. In addition, Plaquemines LNG is seeking approval for an additional 50-acre parking/laydown area referred to as the State Highway (SH) 23 Yard. Plaquemines LNG anticipates completing the Plaquemines LNG and Gator Express Pipeline Project (Plaquemines LNG Project) in 2025.</P>
                <P>
                    The EA assesses the potential environmental effects of the Amendment in accordance with the requirements of the National Environmental Policy Act (NEPA). The FERC staff concludes that approval of 
                    <PRTPAGE P="34144"/>
                    the proposed Amendment, with appropriate mitigating measures, would not constitute a major Federal action significantly affecting the quality of the human environment.
                </P>
                <P>The EA incorporates by reference the Commission staff's May 2019 Final Environmental Impact Statement issued in Docket Nos. CP17-66-000 and CP17-67-000 for the Plaquemines LNG Project, and the Commission's findings and conclusions in its September 30, 2019 Order. The EA addresses the potential environmental effects of the Amendment on water and wetlands resources, vegetation and wildlife, socioeconomics, environmental justice, visual resources, cultural resources, air quality, and noise. The EA also addresses cumulative impacts, including climate change, and alternatives to the proposed action.</P>
                <P>
                    The Commission mailed a copy of the 
                    <E T="03">Notice of Availability</E>
                     for the EA to Federal, State, and local government representatives and agencies; Native American tribes; potentially affected landowners; and other interested individuals and groups. The EA is only available in electronic format. It may be viewed and downloaded from the FERC's website (
                    <E T="03">www.ferc.gov</E>
                    ), on the natural gas environmental documents page (
                    <E T="03">https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents</E>
                    ). In addition, the EA may be accessed by using the eLibrary link on the FERC's website. Click on the eLibrary link (
                    <E T="03">https://elibrary.ferc.gov/eLibrary/search</E>
                    ), select “General Search” and enter the docket number in the “Docket Number” field (
                    <E T="03">i.e.</E>
                     CP17-66 or CP17-67). Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at 
                    <E T="03">FercOnlineSupport@ferc.gov</E>
                     or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659.
                </P>
                <P>The EA is not a decision document. It presents Commission staff's independent analysis of the environmental issues for the Commission to consider when addressing the merits of all issues in this proceeding. Any person wishing to comment on the EA may do so. Your comments should focus on the EA's disclosure and discussion of potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that the Commission has the opportunity to consider your comments prior to making its decision on this Amendment, it is important that we receive your comments in Washington, DC on or before 5:00 p.m. Eastern Time on June 20, 2023.</P>
                <P>
                    For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or 
                    <E T="03">FercOnlineSupport@ferc.gov.</E>
                     Please carefully follow these instructions so that your comments are properly recorded.
                </P>
                <P>
                    (1) You can file your comments electronically using the eComment feature on the Commission's website (
                    <E T="03">www.ferc.gov</E>
                    ) under the link to FERC Online. This is an easy method for submitting brief, text-only comments on a project;
                </P>
                <P>
                    (2) You can also file your comments electronically using the eFiling feature on the Commission's website (
                    <E T="03">www.ferc.gov</E>
                    ) under the link to FERC Online. With eFiling, you can provide comments in a variety of formats by attaching them as a file with your submission. New eFiling users must first create an account by clicking on “eRegister.” You must select the type of filing you are making. If you are filing a comment on a particular project, please select “Comment on a Filing”; or
                </P>
                <P>(3) You can file a paper copy of your comments by mailing them to the following address using the U.S. Postal Service. Be sure to reference the project docket numbers (CP17-66-001and CP17-67-001) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent through carriers other than the U.S. Postal Service must be sent to 12225 Wilkins Avenue, Rockville, Maryland 20852 for processing.</P>
                <P>
                    Filing environmental comments will not give you intervenor status, but you do not need intervenor status to have your comments considered. Only intervenors have the right to seek rehearing or judicial review of the Commission's decision. At this point in this proceeding, the timeframe for filing timely intervention requests has expired. Any person seeking to become a party to the proceeding must file a motion to intervene out-of-time pursuant to Rule 214(b)(3) and (d) of the Commission's Rules of Practice and Procedures (18 CFR 385.214(b)(3) and (d)) and show good cause why the time limitation should be waived. Motions to intervene are more fully described at 
                    <E T="03">https://www.ferc.gov/ferc-online/ferc-online/how-guides.</E>
                </P>
                <P>
                    Additional information about the Plaquemines LNG Amendment 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 eLibrary. The eLibrary link also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rulemakings.
                </P>
                <P>
                    In addition, the Commission offers a free service called eSubscription, which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, 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>
                <SIG>
                    <DATED>Dated: May 19, 2023.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11237 Filed 5-25-23; 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. CP23-478-000]</DEPDOC>
                <SUBJECT>MountainWest Overthrust Pipeline, LLC; Notice of Request Under Blanket Authorization and Establishing Intervention and Protest Deadline</SUBJECT>
                <P>Take notice that on May 12, 2023, MountainWest Overthrust Pipeline, LLC (Overthrust), 333 South State Street, Salt Lake City, Utah 84111, filed a prior notice request for authorization, in accordance with 18 CFR 157.205, 157.208(b), and 157.211 of the Federal Energy Regulatory Commission's (Commission) regulations under the Natural Gas Act and Overthrust's blanket certificate issued in Docket No. CP82-493-000, to construct, own and maintain additional piping, metering and valves to provide delivery service to an Electric Generation facility within the state of Wyoming. The Jim Bridger Delivery Project (Project) would facilitate the delivery of 267,000 dekatherms per day from various receipts on Overthrust's mainline to a new delivery site 25 miles outside of the City of Rock Springs, Wyoming. Overthrust states that the cost of the Project will be $12,677,000, all as more fully set forth in the application which is on file with the Commission and open to public inspection.</P>
                <P>
                    In addition to publishing the full text of this document in the 
                    <E T="04">Federal Register</E>
                    , the Commission provides all interested persons an opportunity to 
                    <PRTPAGE P="34145"/>
                    view and/or print the contents of this document via the internet through the Commission's Home Page (
                    <E T="03">http://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. At this time, the Commission has suspended access to the Commission's Public Reference Room. For assistance, contact FERC at 
                    <E T="03">FERCOnlineSupport@ferc.gov</E>
                     or call toll free, (886) 208-3676 or TTY (202) 502-8659.
                </P>
                <P>
                    Any questions concerning this application should be directed to Greg Williams, Supervisor, Rates and Regulatory, MountainWest Pipeline, LLC, 333 South State Street, Salt Lake City, Utah 84111, by phone at (801) 209-6764 or by email at 
                    <E T="03">greg.williams@mwpipe.com.</E>
                </P>
                <P>
                    Pursuant to section 157.9 of the Commission's Rules of Practice and Procedure,
                    <SU>1</SU>
                    <FTREF/>
                     within 90 days of this Notice the Commission staff will either: complete its environmental review and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or environmental assessment (EA) for this proposal. The filing of an EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         18 CFR (Code of Federal Regulations) 157.9.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Public Participation</HD>
                <P>There are three ways to become involved in the Commission's review of this project: you can file a protest to the project, you can file a motion to intervene in the proceeding, and you can file comments on the project. There is no fee or cost for filing protests, motions to intervene, or comments. The deadline for filing protests, motions to intervene, and comments is 5:00 p.m. Eastern Time on July 21, 2023. How to file protests, motions to intervene, and comments is explained below.</P>
                <HD SOURCE="HD2">Protests</HD>
                <P>
                    Pursuant to section 157.205 of the Commission's regulations under the NGA,
                    <SU>2</SU>
                    <FTREF/>
                     any person 
                    <SU>3</SU>
                    <FTREF/>
                     or the Commission's staff may file a protest to the request. If no protest is filed within the time allowed or if a protest is filed and then withdrawn within 30 days after the allowed time for filing a protest, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request for authorization will be considered by the Commission.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         18 CFR 157.205.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Persons include individuals, organizations, businesses, municipalities, and other entities. 18 CFR 385.102(d).
                    </P>
                </FTNT>
                <P>
                    Protests must comply with the requirements specified in section 157.205(e) of the Commission's regulations,
                    <SU>4</SU>
                    <FTREF/>
                     and must be submitted by the protest deadline, which is July 21, 2023. A protest may also serve as a motion to intervene so long as the protestor states it also seeks to be an intervenor.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         18 CFR 157.205(e).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Interventions</HD>
                <P>Any person has the option to file a motion to intervene in this proceeding. Only intervenors have the right to request rehearing of Commission orders issued in this proceeding and to subsequently challenge the Commission's orders in the U.S. Circuit Courts of Appeal.</P>
                <P>
                    To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure 
                    <SU>5</SU>
                    <FTREF/>
                     and the regulations under the NGA 
                    <SU>6</SU>
                    <FTREF/>
                     by the intervention deadline for the project, which is July 21, 2023. As described further in Rule 214, your motion to intervene must state, to the extent known, your position regarding the proceeding, as well as your interest in the proceeding. For an individual, this could include your status as a landowner, ratepayer, resident of an impacted community, or recreationist. You do not need to have property directly impacted by the project in order to intervene. For more information about motions to intervene, refer to the FERC website at 
                    <E T="03">https://www.ferc.gov/resources/guides/how-to/intervene.asp.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         18 CFR 385.214.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         18 CFR 157.10.
                    </P>
                </FTNT>
                <P>All timely, unopposed motions to intervene are automatically granted by operation of Rule 214(c)(1). Motions to intervene that are filed after the intervention deadline are untimely and may be denied. Any late-filed motion to intervene must show good cause for being late and must explain why the time limitation should be waived and provide justification by reference to factors set forth in Rule 214(d) of the Commission's Rules and Regulations. A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies (paper or electronic) of all documents filed by the applicant and by all other parties.</P>
                <HD SOURCE="HD2">Comments</HD>
                <P>Any person wishing to comment on the project may do so. The Commission considers all comments received about the project in determining the appropriate action to be taken. To ensure that your comments are timely and properly recorded, please submit your comments on or before July 21, 2023. The filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding.</P>
                <HD SOURCE="HD2">How To File Protests, Interventions, and Comments</HD>
                <P>There are two ways to submit protests, motions to intervene, and comments. In both instances, please reference the Project docket number CP23-478-000 in your submission.</P>
                <P>
                    (1) You may file your protest, motion to intervene, and comments by using the Commission's eFiling feature, which is located on the Commission's website (
                    <E T="03">www.ferc.gov</E>
                    ) under the link to Documents and Filings. New eFiling users must first create an account by clicking on “eRegister.” You will be asked to select the type of filing you are making; first select General” and then select “Protest”, “Intervention”, or “Comment on a Filing”; or 
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Additionally, you may file your comments electronically by using the eComment feature, which is located on the Commission's website at 
                        <E T="03">www.ferc.gov</E>
                         under the link to Documents and Filings. Using eComment is an easy method for interested persons to submit brief, text-only comments on a project.
                    </P>
                </FTNT>
                <P>(2) You can file a paper copy of your submission by mailing it to the address below. Your submission must reference the Project docket number CP23-478-000.</P>
                <FP SOURCE="FP-1">
                    <E T="03">To mail via USPS, use the following address:</E>
                     Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">To mail via any other courier, use the following address:</E>
                     Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852
                </FP>
                <P>
                    The Commission encourages electronic filing of submissions (option 1 above) and has eFiling staff available 
                    <PRTPAGE P="34146"/>
                    to assist you at (202) 502-8258 or 
                    <E T="03">FercOnlineSupport@ferc.gov.</E>
                </P>
                <P>
                    Protests and motions to intervene must be served on the applicant either by mail or email (with a link to the document) at: Greg Williams, Supervisor, Rates and Regulatory, MountainWest Pipeline, LLC, 333 South State Street, Salt Lake City, Utah 84111, by phone at (801) 209-6764 or by email at 
                    <E T="03">greg.williams@mwpipe.com.</E>
                </P>
                <P>Any subsequent submissions by an intervenor must be served on the applicant and all other parties to the proceeding. Contact information for parties can be downloaded from the service list at the eService link on FERC Online.</P>
                <HD SOURCE="HD1">Tracking the Proceeding</HD>
                <P>
                    Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at 
                    <E T="03">www.ferc.gov</E>
                     using the “eLibrary” link as described above. The eLibrary link also provides access to the texts of all formal documents issued by the Commission, such as orders, notices, and rulemakings.
                </P>
                <P>
                    In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to 
                    <E T="03">www.ferc.gov/docs-filing/esubscription.asp.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11293 Filed 5-25-23; 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. ER23-1928-000]</DEPDOC>
                <SUBJECT>Appaloosa Solar I, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization</SUBJECT>
                <P>This is a supplemental notice in the above-referenced proceeding of Appaloosa Solar I, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.</P>
                <P>Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.</P>
                <P>Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is June 12, 2023.</P>
                <P>
                    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at 
                    <E T="03">http://www.ferc.gov.</E>
                     To facilitate electronic service, persons with internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.
                </P>
                <P>Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.</P>
                <P>
                    In addition to publishing the full text of this document in the 
                    <E T="04">Federal Register</E>
                    , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the internet through the Commission's Home Page (
                    <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. At this time, the Commission has suspended access to the Commission's Public Reference Room, due to the proclamation declaring a National Emergency concerning the Novel Coronavirus Disease (COVID-19), issued by the President on March 13, 2020. For assistance, contact the Federal Energy Regulatory Commission at 
                    <E T="03">FERCOnlineSupport@ferc.gov</E>
                     or call toll-free, (886) 208-3676 or TYY, (202) 502-8659.
                </P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11344 Filed 5-25-23; 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. CP17-40-000, CP17-40-001]</DEPDOC>
                <SUBJECT>Spire STL Pipeline LLC; Notice of Onsite Environmental Review</SUBJECT>
                <P>
                    On May 31, 2023, Federal Energy Regulatory Commission (Commission) staff will conduct a restoration inspection of the Spire STL Pipeline Project (Spire Project) right-of-way in Greene, Jersey, and Scott Counties, Illinois. The purpose of the inspection is to assess the existing condition of right-of-way restoration along a portion of the Spire Project in Illinois and to evaluate Spire STL Pipeline LLC's (Spire) compliance with the restoration conditions of the Commission's August 3, 2018 Order Issuing Certificate, March 18, 2021 Order on Environmental Compliance, and December 15, 2022 Order on Remand and Reissuing Certificates. Other Commission staff, Spire's representatives, and the landowner's representatives will accompany the Office of Energy Projects staff during the inspection and will view the right-of-way from public access points and where landowners have granted Spire access outside of the permanent right-of-way easement. For additional information or questions, please contact the Office of External Affairs at (866) 208-FERC or email 
                    <E T="03">DG2E@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11288 Filed 5-25-23; 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 Staff Attendance at North American Electric Reliability Corporation Standard Drafting Team Meetings</SUBJECT>
                <P>The Federal Energy Regulatory Commission hereby gives notice that members of the Commission and/or Commission staff may attend the following meeting:</P>
                <PRTPAGE P="34147"/>
                <FP SOURCE="FP-1">North American Electric Reliability Corporation Standards Committee Executive Committee Special Call</FP>
                <FP SOURCE="FP-1">June 2, 2023 (12:00 p.m.-1:00 p.m.)</FP>
                <P>
                    Further information regarding these meetings may be found at: 
                    <E T="03">https://www.nerc.com/Pages/Calendar.aspx.</E>
                </P>
                <P>The discussions at the meetings, which are open to the public, may address matters at issue in the following Commission proceeding:</P>
                <FP SOURCE="FP-1">Docket Nos. RD23-1-000, RD23-1-001 Extreme Cold Weather Reliability Standards EOP-011-3 and EOP-012-1</FP>
                <P>
                    For further information, please contact Chanel Chasanov, 202-502-8569, or 
                    <E T="03">chanel.chasanov@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11297 Filed 5-25-23; 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. 5596-000]</DEPDOC>
                <SUBJECT>Town of Bedford, Virginia; Notice of Authorization for Continued Project Operation</SUBJECT>
                <P>The license for the Bedford Hydroelectric Project No. 5596 was issued for a period ending April 30, 2023.</P>
                <P>Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee(s) under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.</P>
                <P>If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 5596 is issued to the Town of Bedford, Virginia for a period effective May 1, 2023, through April 30, 2024 or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first. If issuance of a new license (or other disposition) does not take place on or before April 30, 2024, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.</P>
                <P>If the project is not subject to section 15 of the FPA, notice is hereby given that the Town of Bedford, Virginia. is authorized to continue operation of the Bedford Hydroelectric Project under the terms and conditions of the prior license until the issuance of a new license for the project or other disposition under the FPA, whichever comes first.</P>
                <SIG>
                    <DATED>Dated: May 19, 2023.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11238 Filed 5-25-23; 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>Combined Notice of Filings #1</SUBJECT>
                <P>Take notice that the Commission received the following electric rate filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-2460-005.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     New York Independent System Operator, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Compliance filing: NYISO Compliance Filing re: Apr 2023 Order on NYISO's Order No. 2222 Compliance to be effective 12/31/9998.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/22/23.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20230522-5156.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 6/12/23.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER23-1618-001.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Ocotillo Solar LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Tariff Amendment: Amendment to pending to be effective 4/13/2023.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/19/23.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20230519-5148.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 6/9/23.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER23-1926-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Missouri Joint Municipal Electric Utility Commission.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Request for Limited Waiver, et al. of Missouri Joint Municipal Electric Utility Commission.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/19/23.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20230519-5116.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 5/30/23.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER23-1929-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Saint Solar, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Baseline eTariff Filing: Saint Solar, LLC, Filing of Shared Facilities Agreement to be effective 5/20/2023.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/19/23.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20230519-5149.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 6/9/23.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER23-1930-000.
                </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 Nos. 2833 &amp; 2834—Sammis (amend) to be effective 7/22/2023.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/22/23.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20230522-5094.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 6/12/23.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER23-1931-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Pennsylvania Electric Company, PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: Pennsylvania Electric Company submits tariff filing per 35.13(a)(2)(iii: Penelec submits Borderline Service Agreement, Service Agreement No. 6635 to be effective 3/1/1997.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/22/23.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20230522-5152.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 6/12/23.
                </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 or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) 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">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>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11343 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="34148"/>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Docket No. CP23-477-000]</DEPDOC>
                <SUBJECT>Natural Gas Pipeline Company of America, LLC; Notice of Request Under Blanket Authorization and Establishing Intervention and Protest Deadline</SUBJECT>
                <P>Take notice that on May 10, 2023, Natural Gas Pipeline Company of America, LLC (NGPL), 3250 Lacey Road, Suite 700, Downers Grove, Illinois 60515, filed in the above referenced docket, a prior notice request pursuant to sections 157.205 and 157.216(b) of the Federal Energy Regulatory Commission's (Commission) regulations under the Natural Gas Act (NGA) and NGPL's blanket certificate issued in Docket No. CP82-402-000, seeking authorization to abandon in-place its Compressor Station 158 (CS 158) located in Dewey County, Oklahoma (Compressor Station 158 Abandonment Project).</P>
                <P>Specifically, NGPL states that the project consists of abandoning in-place CS 158 facilities including a 2,745 HP compressor unit, fuel gas heater, dehydrator, control room, auxiliary building, odorizer, positive meter, waste sump tank, waste oil storage tank, water well, meter building, and gas reservoir tank. NGPL states that the project will allow abandonment of CS 158 facilities that are no longer required due to the changes in receipt and delivery points utilized by shippers on its system and the current operating conditions of its Mountain View to Minneola (M&amp;M) Line, coupled with the steady decline since 2011 of gas produced in the Granite Wash producing area in the Anadarko Basin. Thus, NGPL asserts that the operation of CS 158 is not needed to meet its existing firm contractual commitments, and NGPL does not anticipate CS 158 will be needed to meet future service obligations. NGPL estimates the total cost of the Project to be $177,000, all as more fully set forth in the application which is on file with the Commission and open for public inspection.</P>
                <P>
                    In addition to publishing the full text of this document in the 
                    <E T="04">Federal Register</E>
                    <E T="03">,</E>
                     the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the internet through the Commission's Home Page (
                    <E T="03">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. At this time, the Commission has suspended access to the Commission's Public Reference Room. For assistance, contact the Federal Energy Regulatory Commission at 
                    <E T="03">FercOnlineSupport@ferc.gov</E>
                     or call toll-free, (886) 208-3676 or TTY (202) 502-8659.
                </P>
                <P>
                    Any questions concerning this request should be directed to Francisco Tarin, Director, Regulatory, for Kinder Morgan Inc., as Operator of Natural Gas Pipeline Company of America LLC, 2 North Nevada Avenue, Colorado Springs, Colorado 80903, at (719) 667-7515, or 
                    <E T="03">francisco_tarin@kindermorgan.com.</E>
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <P>There are three ways to become involved in the Commission's review of this project: you can file a protest to the project, you can file a motion to intervene in the proceeding, and you can file comments on the project. There is no fee or cost for filing protests, motions to intervene, or comments. The deadline for filing protests, motions to intervene, and comments is 5:00 p.m. Eastern Time on July 18, 2023. How to file protests, motions to intervene, and comments is explained below.</P>
                <HD SOURCE="HD1">Protests</HD>
                <P>
                    Pursuant to section 157.205 of the Commission's regulations under the NGA,
                    <SU>1</SU>
                    <FTREF/>
                     any person 
                    <SU>2</SU>
                    <FTREF/>
                     or the Commission's staff may file a protest to the request. If no protest is filed within the time allowed or if a protest is filed and then withdrawn within 30 days after the allowed time for filing a protest, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request for authorization will be considered by the Commission.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         18 CFR 157.205.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Persons include individuals, organizations, businesses, municipalities, and other entities. 18 CFR 385.102(d).
                    </P>
                </FTNT>
                <P>
                    Protests must comply with the requirements specified in section 157.205(e) of the Commission's regulations,
                    <SU>3</SU>
                    <FTREF/>
                     and must be submitted by the protest deadline, which is July 18, 2023. A protest may also serve as a motion to intervene so long as the protestor states it also seeks to be an intervenor.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         18 CFR 157.205(e).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Interventions</HD>
                <P>Any person has the option to file a motion to intervene in this proceeding. Only intervenors have the right to request rehearing of Commission orders issued in this proceeding and to subsequently challenge the Commission's orders in the U.S. Circuit Courts of Appeal.</P>
                <P>
                    To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure 
                    <SU>4</SU>
                    <FTREF/>
                     and the regulations under the NGA 
                    <SU>5</SU>
                    <FTREF/>
                     by the intervention deadline for the project, which is July 18, 2023. As described further in Rule 214, your motion to intervene must state, to the extent known, your position regarding the proceeding, as well as your interest in the proceeding. For an individual, this could include your status as a landowner, ratepayer, resident of an impacted community, or recreationist. You do not need to have property directly impacted by the project in order to intervene. For more information about motions to intervene, refer to the FERC website at 
                    <E T="03">https://www.ferc.gov/resources/guides/how-to/intervene.asp.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         18 CFR 385.214.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         18 CFR 157.10.
                    </P>
                </FTNT>
                <P>All timely, unopposed motions to intervene are automatically granted by operation of Rule 214(c)(1). Motions to intervene that are filed after the intervention deadline are untimely and may be denied. Any late-filed motion to intervene must show good cause for being late and must explain why the time limitation should be waived and provide justification by reference to factors set forth in Rule 214(d) of the Commission's Rules and Regulations. A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies (paper or electronic) of all documents filed by the applicant and by all other parties.</P>
                <HD SOURCE="HD1">Comments</HD>
                <P>Any person wishing to comment on the project may do so. The Commission considers all comments received about the project in determining the appropriate action to be taken. To ensure that your comments are timely and properly recorded, please submit your comments on or before July 18, 2023. The filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding.</P>
                <HD SOURCE="HD1">How To File Protests, Interventions, and Comments</HD>
                <P>There are two ways to submit protests, motions to intervene, and comments. In both instances, please reference the Project docket number CP23-477-000 in your submission.</P>
                <P>
                    (1) You may file your protest, motion to intervene, and comments by using the 
                    <PRTPAGE P="34149"/>
                    Commission's eFiling feature, which is located on the Commission's website (
                    <E T="03">www.ferc.gov)</E>
                     under the link to Documents and Filings. New eFiling users must first create an account by clicking on “eRegister.” You will be asked to select the type of filing you are making; first select General” and then select “Protest”, “Intervention”, or “Comment on a Filing”; or 
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Additionally, you may file your comments electronically by using the eComment feature, which is located on the Commission's website at 
                        <E T="03">www.ferc.gov</E>
                         under the link to Documents and Filings. Using eComment is an easy method for interested persons to submit brief, text-only comments on a project.
                    </P>
                </FTNT>
                <P>(2) You can file a paper copy of your submission by mailing it to the address below. Your submission must reference the Project docket number CP23-477-000.</P>
                <FP SOURCE="FP-1">
                    <E T="03">To file via USPS:</E>
                     Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">To file via any other method:</E>
                     Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852
                </FP>
                <P>
                    The Commission encourages electronic filing of submissions (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or 
                    <E T="03">FercOnlineSupport@ferc.gov.</E>
                </P>
                <P>
                    Protests and motions to intervene must be served on the applicant either by mail or email (with a link to the document) at: Francisco Tarin, Director, Regulatory, for Kinder Morgan Inc., as Operator of Natural Gas Pipeline Company of America LLC, 2 North Nevada Avenue, Colorado Springs, Colorado 80903, or 
                    <E T="03">francisco_tarin@kindermorgan.com.</E>
                     Any subsequent submissions by an intervenor must be served on the applicant and all other parties to the proceeding. Contact information for parties can be downloaded from the service list at the eService link on FERC Online.
                </P>
                <HD SOURCE="HD1">Tracking the Proceeding</HD>
                <P>
                    Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at 
                    <E T="03">www.ferc.gov</E>
                     using the “eLibrary” link as described above. The eLibrary link also provides access to the texts of all formal documents issued by the Commission, such as orders, notices, and rulemakings.
                </P>
                <P>
                    In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to 
                    <E T="03">www.ferc.gov/docs-filing/esubscription.asp.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 19, 2023.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11241 Filed 5-25-23; 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. CP23-475-000]</DEPDOC>
                <SUBJECT>PPG Shawville Pipeline, LLC; Notice of Application and Establishing Intervention Deadline</SUBJECT>
                <P>Take notice that on May 8, 2023, PPG Shawville Pipeline, LLC (PPG Shawville), 3500 East College Ave., Suite 1300, Box 6, State College, PA 16801, filed an application under section 7(b) of the Natural Gas Act (NGA) requesting: (1) permission for PPG Shawville, an existing interstate natural gas pipeline, to abandon its natural gas gathering facilities and services by transfer to PPG Gathering LLC; and (2) confirmation that, once owned and operated by PPG Gathering LLC, the facilities that are the subject of the Application and the services to be provided by PPG Gathering LLC will be exempt from the Commission's jurisdiction under section 1(b) of the Natural Gas Act, all as more fully set forth in the application which is on file with the Commission and open for public inspection.</P>
                <P>
                    In addition to publishing the full text of this document in the 
                    <E T="04">Federal Register</E>
                    , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the internet through the Commission's Home Page (
                    <E T="03">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. At this time, the Commission has suspended access to the Commission's Public Reference Room. For assistance, contact the Federal Energy Regulatory Commission at 
                    <E T="03">FERCOnlineSupport@ferc.gov</E>
                     or call toll-free, (886) 208-3676 or TTY, (202) 502-8659.
                </P>
                <P>
                    Any questions regarding this application may be directed to Josh Hull, PPG Shawville Pipeline LLC, 3500 East College Ave., Suite 1300, Box 6, State College, PA 16801, or by phone (814) 272-2470, or by email at 
                    <E T="03">jhull@pennproduction.com.</E>
                </P>
                <P>
                    Pursuant to section 157.9 of the Commission's Rules of Practice and Procedure,
                    <SU>1</SU>
                    <FTREF/>
                     within 90 days of this Notice the Commission staff will either: complete its environmental review and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or environmental assessment (EA) for this proposal. The filing of an EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         18 CFR (Code of Federal Regulations) 157.9.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Public Participation</HD>
                <P>There are three ways to become involved in the Commission's review of this project: you can file a protest to the project, you can file a motion to intervene in the proceeding, and you can file comments on the project. There is no fee or cost for filing protests, motions to intervene, or comments. The deadline for filing protests, motions to intervene, and comments is 5:00 p.m. Eastern Time on June 12, 2023. How to file protests, motions to intervene, and comments is explained below.</P>
                <HD SOURCE="HD2">Protests</HD>
                <P>
                    Pursuant to section 157.205 of the Commission's regulations under the NGA,
                    <SU>2</SU>
                    <FTREF/>
                     any person 
                    <SU>3</SU>
                    <FTREF/>
                     or the Commission's staff may file a protest to the request. If no protest is filed within the time allowed or if a protest is filed and then withdrawn within 30 days after the allowed time for filing a protest, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request for authorization will be considered by the Commission.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         18 CFR 157.205.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Persons include individuals, organizations, businesses, municipalities, and other entities. 18 CFR 385.102(d).
                    </P>
                </FTNT>
                <PRTPAGE P="34150"/>
                <P>
                    Protests must comply with the requirements specified in section 157.205(e) of the Commission's regulations,
                    <SU>4</SU>
                    <FTREF/>
                     and must be submitted by the protest deadline, which is June 12, 2023. A protest may also serve as a motion to intervene so long as the protestor states it also seeks to be an intervenor.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         18 CFR 157.205(e).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Interventions</HD>
                <P>Any person has the option to file a motion to intervene in this proceeding. Only intervenors have the right to request rehearing of Commission orders issued in this proceeding and to subsequently challenge the Commission's orders in the U.S. Circuit Courts of Appeal.</P>
                <P>
                    To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure 
                    <SU>5</SU>
                    <FTREF/>
                     and the regulations under the NGA 
                    <SU>6</SU>
                    <FTREF/>
                     by the intervention deadline for the project, which is June 12, 2023. As described further in Rule 214, your motion to intervene must state, to the extent known, your position regarding the proceeding, as well as your interest in the proceeding. For an individual, this could include your status as a landowner, ratepayer, resident of an impacted community, or recreationist. You do not need to have property directly impacted by the project in order to intervene. For more information about motions to intervene, refer to the FERC website at 
                    <E T="03">https://www.ferc.gov/how-guides.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         18 CFR 385.214.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         18 CFR 157.10.
                    </P>
                </FTNT>
                <P>All timely, unopposed motions to intervene are automatically granted by operation of Rule 214(c)(1). Motions to intervene that are filed after the intervention deadline are untimely and may be denied. Any late-filed motion to intervene must show good cause for being late and must explain why the time limitation should be waived and provide justification by reference to factors set forth in Rule 214(d) of the Commission's Rules and Regulations. A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies (paper or electronic) of all documents filed by the applicant and by all other parties.</P>
                <HD SOURCE="HD2">Comments</HD>
                <P>Any person wishing to comment on the project may do so. The Commission considers all comments received about the project in determining the appropriate action to be taken. To ensure that your comments are timely and properly recorded, please submit your comments on or before June 12, 2023. The filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding.</P>
                <HD SOURCE="HD2">How To File Protests, Interventions, and Comments</HD>
                <P>There are two ways to submit protests, motions to intervene, and comments. In both instances, please reference the Project docket number CP23-475-000 in your submission.</P>
                <P>
                    (1) You may file your protest, motion to intervene, and comments by using the Commission's eFiling feature, which is located on the Commission's website (
                    <E T="03">www.ferc.gov</E>
                    ) under the link to Documents and Filings. New eFiling users must first create an account by clicking on “eRegister.” You will be asked to select the type of filing you are making; first select General” and then select “Protest”, “Intervention”, or “Comment on a Filing”; or 
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Additionally, you may file your comments electronically by using the eComment feature, which is located on the Commission's website at 
                        <E T="03">www.ferc.gov</E>
                         under the link to Documents and Filings. Using eComment is an easy method for interested persons to submit brief, text-only comments on a project.
                    </P>
                </FTNT>
                <P>(2) You can file a paper copy of your submission by mailing it to the address below. Your submission must reference the Project docket number CP23-475-000.</P>
                <FP SOURCE="FP-1">
                    <E T="03">To mail via USPS, use the following address:</E>
                     Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">To send via any other courier, use the following address:</E>
                     Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852
                </FP>
                <P>
                    The Commission encourages electronic filing of submissions (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or 
                    <E T="03">FERCOnlineSupport@ferc.gov</E>
                    .
                </P>
                <P>
                    Protests and motions to intervene must be served to the applicant by mail to: Josh Hull, PPG Shawville Pipeline LLC, 3500 East College Ave., Suite 1300, Box 6, State College, PA 16801 or by email at 
                    <E T="03">jhull@pennproduction.com.</E>
                </P>
                <P>Any subsequent submissions by an intervenor must be served on the applicant and all other parties to the proceeding. Contact information for parties can be downloaded from the service list at the eService link on FERC Online.</P>
                <HD SOURCE="HD1">Tracking the Proceeding</HD>
                <P>
                    Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at 
                    <E T="03">www.ferc.gov</E>
                     using the “eLibrary” link as described above. The eLibrary link also provides access to the texts of all formal documents issued by the Commission, such as orders, notices, and rulemakings.
                </P>
                <P>
                    In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to 
                    <E T="03">www.ferc.gov/docs-filing/esubscription.asp.</E>
                </P>
                <P>
                    <E T="03">Intervention Deadline:</E>
                     5:00 p.m. Eastern Time on June 12, 2023.
                </P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11296 Filed 5-25-23; 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. 3509-042]</DEPDOC>
                <SUBJECT>Little Falls Hydroelectric Associates, LP; Notice of Availability of Environmental Assessment</SUBJECT>
                <P>In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the application for a new license to continue to operate and maintain the Little Falls Hydroelectric Project. The project is located on the Mohawk River, in the City of Little Falls, Herkimer County, New York. Commission staff has prepared an Environmental Assessment (EA) for the project.</P>
                <P>The EA contains the staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.</P>
                <P>
                    The Commission provides all interested persons with an opportunity to view and/or print the EA via the 
                    <PRTPAGE P="34151"/>
                    internet through the Commission's Home Page (
                    <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. For assistance, contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     or toll-free at (866) 208-3676, or for TTY, (202) 502-8659.
                </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>Any comments should be filed within 45 days from the date of this notice.</P>
                <P>
                    The Commission strongly encourages electronic filing. Please file comments 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>
                     You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support. In lieu of electronic filing, you may submit a paper copy. Submissions sent via the U.S. Postal Service must be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. The first page of any filing should include docket number P-3509-042.
                </P>
                <P>
                    For further information, contact Monir Chowdhury at (202) 502-6736 or by email at 
                    <E T="03">monir.chowdhury@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11295 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[FRL OP-OFA-071]</DEPDOC>
                <SUBJECT>Environmental Impact Statements; Notice of Availability</SUBJECT>
                <P>
                    <E T="03">Responsible Agency:</E>
                     Office of Federal Activities, General Information 202-564-5632 or 
                    <E T="03">https://www.epa.gov/nepa.</E>
                </P>
                <FP SOURCE="FP-1">Weekly receipt of Environmental Impact Statements (EIS)</FP>
                <FP SOURCE="FP-1">Filed May 15, 2023 10 a.m. EST Through May 22, 2023 10 a.m. EST</FP>
                <FP SOURCE="FP-1">Pursuant to 40 CFR 1506.9</FP>
                <HD SOURCE="HD1">Notice</HD>
                <P>
                    Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at: 
                    <E T="03">https://cdxapps.epa.gov/cdx-enepa-II/public/action/eis/search.</E>
                </P>
                <FP SOURCE="FP-1">
                    <E T="03">EIS No. 20230068, Draft, BLM, NV,</E>
                     Greenlink West Project, Comment Period Ends: 08/23/2023, Contact: Brian Buttazoni 775-861-6491.
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">EIS No. 20230069, Final, USFS, CA,</E>
                     Sequoia and Sierra National Forests Land Management Plans Revision,  Review Period Ends: 06/26/2023, Contact: Bobbie Miller 530-841-4418.
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">EIS No. 20230070, Final, BOEM, NJ,</E>
                     Ocean Wind 1 Offshore Wind Farm,  Review Period Ends: 06/26/2023, Contact: Jessica Stromberg 703-787-1730.
                </FP>
                <HD SOURCE="HD1">Amended Notice</HD>
                <FP SOURCE="FP-1">
                    <E T="03">EIS No. 20230051, Draft Supplement, BR, CO,</E>
                     WITHDRAWN—Near-term Colorado River Operations,  Comment Period Ends: 05/30/2023, Contact: Genevieve Johnson 602-609-6739
                </FP>
                <P>Revision to FR Notice Published 04/14/2023; Officially Withdrawn per request of the submitting agency.</P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Cindy S. Barger,</NAME>
                    <TITLE>Director, NEPA Compliance Division, Office of Federal Activities.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11292 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[CERCLA-04-2022-2508 et. al; FRL-10896-01-R4]</DEPDOC>
                <SUBJECT>Bennett Landfill Fire Superfund Site, Chester, South Carolina; Proposed Settlements</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed settlements.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), the United States Environmental Protection Agency is proposing to enter into forty-nine Individual settlements with fifty-three parties concerning the Bennett Landfill Fire Site located in Chester, South Carolina. The proposed settlements address recovery of CERCLA costs for a cleanup that was performed at the Site and costs incurred by EPA.</P>
                    <P>
                        The individual proposed settlements are as follows: Rock Hill School District 3, CERCLA-04-2023-2506(b); Carlisle Finishing LLC, CERCLA-04-2022-2506(b); Dominion Energy South Carolina, Inc. f/k/a South Carolina Electric &amp; Gas Company, CERCLA-04-2022-2512(b); Signet Mills, Inc. f/k/a Green Textile Associates, Inc., CERCLA-04-2022-2513(b); AstenJohnson, Inc., CERCLA-04-2022-2508; Hexion Inc., CERCLA-04-2022-2515(b); Target Contractors, LLC, CERCLA-04-2022-2517(b); Inman-Campobello Water District, CERCLA-04-2022-2523(b); Laurens County School District #56, CERCLA-04-2022-2520(b); McLeod Medical Center—Dillon, CERCLA-04-2022-2519(b); Michelin North America, Inc., CERCLA-04-2022-2521(b); Anderson County, South Carolina, CERCLA-04-2022-2511; Aiken County, South Carolina, CERCLA-04-2022-2510; Anderson County School District 5, CERCLA-04-2023-2500(b); Boulevard Baptist Church of Anderson, Inc., CERCLA-04-2023-2501(b); Owens Corning, CERCLA-04-2023-2502(b); School District of Pickens County, CERCLA-04-2023-2503(b); Midland Industries, LLC f/k/a Midland Capital Corp. CERCLA-04-2022-2522(b); Milliken &amp; Company, CERCLA-04-2022-2524(b); Mohawk Industries, Inc., CERCLA-04-2022-2525(b); Richloom Fabrics Group, Inc., CERCLA-042023-2504(b); South Carolina School for the Deaf and the Blind, CERCLA-04-2023-2508(b); Self Regional Healthcare, CERCLA-04-2023-2509(b); SERRUS Real Estate Fund II, LLC and SERRUS Capital Partners, Inc., CERCLA-04-2023-2510(b); Snyder Investments, Inc. and Snyder Electric Company, Inc., CERCLA-04-2023-2515(b); South Carolina Regional Housing Authority No. 1, CERCLA-04-2023-2516(b); Spartanburg County, CERCLA-04-2023-2517(b); Spartanburg District Five Schools, CERCLA-04-2023-2519(b); The Timken Company, CERCLA-04-2023-2518(b); Tri-County Technical College, CERCLA-04-2023-2511(b); Trinity United Methodist Church of Enoree, SC, CERCLA-04-2023-2512(b); Wells Fargo Bank, N.A., CERCLA-04-2023-2513(b); Wofford College, CERCLA-04-2023-2514(b); BASF Corporation, CERCLA-04-2022-2507; Cherokee Avenue Baptist Church, CERCLA-04-2022-2507(b); W.R. Floyd Services, Inc., d/b/a J. F. Floyd Mortuary, CERCLA-04-2022-2518(b); Greenville-Spartanburg Airport District, CERCLA-04-2022-2514(b); City of York, South Carolina, CERCLA-04-2022-2510(b); Converse University f/k/a Converse College, CERCLA-04-2022-
                        <PRTPAGE P="34152"/>
                        2516(b); Royal Adhesives and Sealants, LLC, and Simpsonville Properties LLC, CERCLA-04-2023-2507(b); Spartanburg County School District Three, CERCLA-04-2023-2520(b); City of Landrum, South Carolina, CERCLA-04-2022-2508(b); Cooper Standard Automotive Inc., CERCLA-04-2022-2511(b); Brixmor Property Group Inc., ERP Hillcrest, LLC, and Excel Realty Partners LP, CERCLA-04-2022-2509(b); School District of Newberry County, CERCLA-04-2023-2522(b); Mecklenburg County Alcoholic Beverage Control Board CERCLA-04-2022-2509; Inman Mills, CERCLA-04-2023-2528(b); Price Construction, Inc., CERCLA-04-2023-2525(b); Winthrop University, United States General Services Administration and United States Postal Service, CERCLA-04-2023-2527(b).
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The Agency will consider public comments on the proposed settlements until June 26, 2023. The Agency will consider all comments received and may modify or withdraw its consent to the proposed settlements if comments received disclose facts or considerations which indicate that the proposed settlement is inappropriate, improper, or inadequate.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Copies of the proposed settlements are available from the Agency by contacting Ms. Paula V. Painter, Program Analyst, using the contact information provided in this notice. Comments may also be submitted by referencing the Site's name through one of the following methods:</P>
                    <P>
                        <E T="03">Internet: https://www.epa.gov/aboutepa/about-epa-region-4-southeast#r4-public-notices.</E>
                    </P>
                    <P>
                        <E T="03">Email: Painter.Paula@epa.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Paula V. Painter at 404/562-8887.</P>
                    <SIG>
                        <NAME>Maurice Horsey,</NAME>
                        <TITLE>Branch Manager, Enforcement Branch, Superfund &amp; Emergency Management Division.</TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11348 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OECA-2013-0547; FRL-11006-01-OMS]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Performance Evaluation Studies on Wastewater Laboratories (Renewal)</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>
                        The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Performance Evaluation Studies on Wastewater Laboratories (EPA ICR Number 0234.14, OMB Control Number 2080-0021) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through May 31, 2023. Public comments were previously requested via the 
                        <E T="04">Federal Register</E>
                         on November 30, 2022 during a 60-day comment period. This notice allows for an additional 30 days for public comments.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments may be submitted on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2013-0547, to EPA online using 
                        <E T="03">www.regulations.gov</E>
                         (our preferred method), by email to 
                        <E T="03">docket.oeca@epa.gov,</E>
                         or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
                    </P>
                    <P>
                        Submit written comments and recommendations to OMB for the proposed information collection 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>
                        Gregory Savitske, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2601; fax number: (202) 564-0050; email address: 
                        <E T="03">savitske.gregory@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This is a proposed extension of the ICR, which is currently approved through May 31, 2023. 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>
                    Public comments were previously requested via the 
                    <E T="04">Federal Register</E>
                     November, 30, 2022 during a 60-day comment period (87 FR 73357). This notice allows for an additional 30 days for public comments. Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at 
                    <E T="03">www.regulations.gov</E>
                     or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit 
                    <E T="03">http://www.epa.gov/dockets.</E>
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Discharge Monitoring Report-Quality Assurance (DMR-QA) study program participation is mandatory for major and selected minor National Pollutant Discharge Elimination System (NPDES) permit holders in accordance with Clean Water Act Section 308. The DMR-QA study program is designed to evaluate the analytic ability of laboratories that perform chemical, microbiological and whole effluent toxicity (WET) analyses required in NPDES permits for reporting results in the Discharge Monitoring Reports (DMR). Under DMR-QA, the permit holder is responsible for having their in-house and/or contract laboratories analyze performance evaluation samples and submit results to proficiency testing (PT) providers for grading. Graded results are transmitted by either the permit holder or PT provider to the appropriate federal or state NPDES permitting authority. Permit holders are responsible for submitting corrective action reports to the appropriate permitting authority.
                </P>
                <P>
                    <E T="03">Form numbers:</E>
                     EPA Form 6400-01.
                </P>
                <P>
                    <E T="03">Respondents/affected entities:</E>
                     Major and selected minor permit holders under the Clean Water Act's National Pollutant Discharge Elimination System (NPDES).
                </P>
                <P>
                    <E T="03">Respondent's obligation to respond:</E>
                     Mandatory under Clean Water Act section 308(a).
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                     5,500 (total).
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     Annually, On occasion.
                </P>
                <P>
                    <E T="03">Total estimated burden:</E>
                     36,300 hours (per year). Burden is defined at 5 CFR 1320.03(b).
                </P>
                <P>
                    <E T="03">Total estimated cost:</E>
                     $5,852,825 (per year), which includes $3,781,470 annualized capital or operation &amp; maintenance costs.
                </P>
                <P>
                    <E T="03">Changes in the estimates:</E>
                     There is no change of hours in the total estimated 
                    <PRTPAGE P="34153"/>
                    respondent burden compared with the ICR currently approved by OMB. Non-labor costs for obtaining performance evaluation samples increased.
                </P>
                <SIG>
                    <NAME>Courtney Kerwin,</NAME>
                    <TITLE>Director, Regulatory Support Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11315 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OW-2022-0869; FRL-10916-02-OMS]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice, correction.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Environmental Protection Agency (EPA) published a notice in the 
                        <E T="04">Federal Register</E>
                         on April 21, 2023, requesting comments on a proposed Information Collection Request (EPA ICR Number 2723.01, OMB Control Number 2040-NEW) being submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. That notice contained an error in the Agency Docket ID Number. This document corrects that error.
                    </P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Dr. Phillip Flanders, Engineering and Analysis Division, Office of Science and Technology, 4303T, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-566-8323; email address: 
                        <E T="03">Flanders.Phillip@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Correction</HD>
                <P>
                    In the 
                    <E T="04">Federal Register</E>
                     of April 21, 2023, in FR Doc. 2023-08440, on page 24615:
                </P>
                <P>1. In the first column, correct the “Agency Docket Number” to read “EPA-HQ-OW-2022-0869”; and</P>
                <P>
                    2. In the second column, correct the 
                    <E T="02">ADDRESSES</E>
                     by correcting the “Agency Docket Number” to read “EPA-HQ-OW-2022-0869”.
                </P>
                <SIG>
                    <NAME>Courtney Kerwin,</NAME>
                    <TITLE>Director, Regulatory Support Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11262 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-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 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 June 12, 2023.</P>
                <P>
                    <E T="03">A. Federal Reserve Bank of Minneapolis</E>
                     (Stephanie Weber, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291. Comments can also be sent electronically to 
                    <E T="03">MA@mpls.frb.org:</E>
                </P>
                <P>
                    1. 
                    <E T="03">The Ann Elise Gaytko Revocable Trust For Frankson Investment Corporation Shares, Ann Gaytko, as trustee, and the Thomas Jerome Sankovitz Revocable Trust For Frankson Investment Corporation Shares, Thomas Sankovitz, as trustee, and individually, all of Waseca, Minnesota;</E>
                     to retain voting shares of Frankson Investment Corporation, and thereby indirectly retain voting shares of Keen Bank, National Association, both of Waseca, Minnesota.
                </P>
                <SIG>
                    <P>Board of Governors of the Federal Reserve System.</P>
                    <NAME>Michele Taylor Fennell,</NAME>
                    <TITLE>Deputy Associate Secretary of the Board.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11314 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">GENERAL SERVICES ADMINISTRATION</AGENCY>
                <DEPDOC>[Notice-PBS-2023-02; Docket No. 2023-0002; Sequence No. 18]</DEPDOC>
                <SUBJECT>Notice of Intent To Prepare an Environmental Impact Statement for a New Federal Courthouse in Hartford, Connecticut</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Public Buildings Service (PBS), U.S. General Services Administration (GSA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA), GSA intends to prepare an EIS to analyze potential impacts from the proposed acquisition of a site in Hartford, CT, and the subsequent design and construction of a new Federal Courthouse. The building would be owned and managed by GSA and occupied by various Federal agency tenants, with the United States District Court for the District of Connecticut (the Court) serving as the largest tenant.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The public scoping meeting for the EIS will be held on Tuesday, June 6, 2023, from 5:30 to 7:30 p.m., Eastern Daylight Time. Written comments must be submitted to GSA by July 6, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P> The meeting will be held at Park Street Library at the Lyric Community Room, 603 Park Street, Hartford, CT 06106.</P>
                    <P>Written comments must be submitted using one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">In-Person:</E>
                         Submit written comments at the public scoping meeting via comment forms. There will be a stenographer to capture the comments voiced during the meeting.
                    </P>
                    <P>
                        • 
                        <E T="03">Email:</E>
                         Send an email to 
                        <E T="03">HartfordCourthouse@gsa.gov</E>
                         and reference “Hartford Courthouse EIS” in the subject line.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Send direct written comments to: General Services Administration, Attention: Robert Herman, Project Manager, Abraham A. Ribicoff U.S. Courthouse, 450 Main Street, Suite 435, Hartford, CT 06103.
                    </P>
                    <P>
                        • 
                        <E T="03">Drop Box:</E>
                         Place written comments in the drop box at the main entrance of the Ribicoff Courthouse, at the following address: Abraham A. Ribicoff U.S. Courthouse, 450 Main Street, Hartford, CT 06103.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Robert Herman, Project Manager, GSA, at 413-244-9167.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The U.S. District Court for the District of Connecticut (the Court) currently 
                    <PRTPAGE P="34154"/>
                    operates at three existing Court facilities: the Abraham A. Ribicoff Federal Building and Courthouse (Ribicoff Courthouse) in Hartford, the Richard C. Lee U.S. Courthouse in New Haven, and the Brien McMahon Federal Building and U.S. Courthouse in Bridgeport. Long-range facilities planning for the Court and the Court Project Priorities process determined that Court operations in Hartford are projected to increase, and that Court headquarters would relocate from New Haven to Hartford.
                </P>
                <P>The Ribicoff Courthouse, constructed in 1963, does not have the space, functionality, security, and building systems to meet the current and projected needs of the Court. The facility also presents numerous functional challenges related to circulation, prisoner movement, and operational and safety needs of the Judiciary.</P>
                <P>GSA conducted feasibility studies to determine a suitable alternative that established the budget, site considerations, and basis for a project designed to provide long-term solutions to the Court's projected space requirements. The results from the feasibility studies led to GSA's decision to locate the Court's judicial operations at a new Federal Courthouse in Hartford, CT.</P>
                <HD SOURCE="HD1">Alternatives Under Consideration</HD>
                <P>The EIS will consider three “action” alternatives and one “no action” alternative. Under the action alternatives, GSA would acquire a site of at least two acres of land in Hartford, CT for the design and construction of a new Federal Courthouse. The no action alternative assumes that site acquisition and subsequent design and construction of a new Federal Courthouse would not occur. The Judiciary would continue to operate under current conditions at the Ribicoff Courthouse, and at the courthouses in New Haven and Bridgeport.</P>
                <P>A new Federal Courthouse would have the following features:</P>
                <P>• Total building gross square footage of approximately 281,000;</P>
                <P>• 11 courtrooms and 18 Judge chambers;</P>
                <P>• Offices for various Federal agency tenants; and</P>
                <P>• 66 secure parking spaces.</P>
                <P>GSA has identified three potential sites for the project, each corresponding to an action alternative (listed north to south):</P>
                <P>
                    • 
                    <E T="03">Woodland Site</E>
                    —encompasses one land parcel and is 10.10 acres. The property lies in Hartford's Asylum Hill neighborhood, a block south of Saint Francis Hospital. It is bounded by Asylum Ave. to the north, the North Branch of Park River to the west, healthcare-related buildings along its southern perimeter, and Woodland St. to the east. It is currently utilized as a State of Connecticut office building.
                </P>
                <P>
                    • 
                    <E T="03">Allyn Site</E>
                    —encompasses 10 land parcels and is 2.19 acres. The property lies downtown, two blocks north of Bushnell Park. It is bounded by Church St. to the north, High St. to the west, Allyn St. to the south, and mixed-use buildings along its eastern perimeter. It is currently utilized as a surface parking lot.
                </P>
                <P>
                    • 
                    <E T="03">Hudson Site</E>
                    —encompasses six land parcels and is 2.54 acres. The property lies downtown, two blocks south of Bushnell Park. The parcels are separated by Hudson St., with the larger property (2.24 acres) to the west of Hudson St. and the smaller property (0.3 acres) to the east of Hudson St. The larger property is bounded by Capitol Ave. to the north, West St. to the west, and Buckingham St. to the south. It is currently utilized as a surface parking lot and an auto detailing shop. The smaller property is bounded by Buckingham St. to the south and mixed-use buildings along its northern and eastern perimeters. It is currently utilized as a surface parking lot.
                </P>
                <HD SOURCE="HD1">Public Involvement and Scoping Meeting</HD>
                <P>The views and comments of the public are necessary to help determine the scope and content of the environmental analysis. Interested parties are encouraged to participate in the public scoping meeting and provide written comments regarding the scope of the EIS.</P>
                <P>
                    There will be a project presentation at 6:00 p.m. with a public comment period to follow. An American Sign language translator and a Spanish language interpreter will be available. After the meeting, GSA will post the following items at the Project website, 
                    <E T="03">http://gsa.gov/hartfordcourthouse:</E>
                </P>
                <FP SOURCE="FP-1">• Meeting handouts in English and Spanish</FP>
                <FP SOURCE="FP-1">• Presentation slide deck in English and Spanish</FP>
                <FP SOURCE="FP-1">• Meeting transcript in English</FP>
                <FP SOURCE="FP-1">• Audio/video of the meeting with closed captions</FP>
                <P>
                    Further information about the project can be viewed at: 
                    <E T="03">http://gsa.gov/hartfordcourthouse.</E>
                </P>
                <SIG>
                    <NAME>Surran D. Dilks,</NAME>
                    <TITLE>Director, Design &amp; Construction Division, PBS New England Region.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11267 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-RB-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Agency for Healthcare Research and Quality</SUBAGY>
                <SUBJECT>Notice of Meeting</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>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Agency for Healthcare Research and Quality (AHRQ) announces a Special Emphasis Panel (SEP) meeting on “Dissemination and Implementation of Equity-Focused Evidence-Based Interventions in Healthcare Delivery Systems (R18)”. This SEP meeting will be closed to the public.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>July 11-12, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Agency for Healthcare Research and Quality, (Video Assisted Review), 5600 Fishers Lane, Rockville, Maryland 20857.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Jenny Griffith, Committee Management Officer, Office of Extramural Research, Education and Priority Populations, Agency for Healthcare Research and Quality, (AHRQ), 5600 Fishers Lane, Rockville, Maryland 20857, Telephone: (301) 427-1557.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>A Special Emphasis Panel is a group of experts in fields related to health care research who are invited by AHRQ, and agree to be available, to conduct on an as needed basis, scientific reviews of applications for AHRQ support. Individual members of the Panel do not attend regularly scheduled meetings and do not serve for fixed terms or a long period of time. Rather, they are asked to participate in particular review meetings which require their type of expertise.</P>
                <P>The SEP meeting referenced above will be closed to the public in accordance with the provisions set forth in 5 U.S.C. 1009(d), 5 U.S.C. 552b(c)(4), and 5 U.S.C. 552b(c)(6). Grant applications for “Dissemination and Implementation of Equity-Focused Evidence-Based Interventions in Healthcare Delivery Systems (R18)” are to be reviewed and discussed at this meeting. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <P>Agenda items for this meeting are subject to change as priorities dictate.</P>
                <SIG>
                    <PRTPAGE P="34155"/>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Marquita Cullom,</NAME>
                    <TITLE>Associate Director.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11303 Filed 5-25-23; 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>Agency for Healthcare Research and Quality</SUBAGY>
                <SUBJECT>Supplemental Evidence and Data Request on Measures for Primary Healthcare Spending</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 submissions.</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">Measures for Primary Healthcare Spending,</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> Submission Deadline  on or before June 26, 2023. </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>
                    <P>
                        <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.
                    </P>
                    <P>
                        <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 06E53A, Rockville, MD 20857.
                    </P>
                </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">Measures for Primary Healthcare Spending.</E>
                     AHRQ is conducting this 
                    <E T="03">technical brief</E>
                     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 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">Measures for Primary Healthcare Spending,</E>
                     including those that describe adverse events. The entire research protocol is available online at: 
                    <E T="03">https://effectivehealthcare.ahrq.gov/products/primary-healthcare-spending</E>
                    .
                </P>
                <P>This is to notify the public that the EPC Program would find the following information on Measures for Primary Healthcare Spending helpful:</P>
                <P>
                     A list of completed studies that your organization has sponsored for this indication. 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: 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 indication.</E>
                     In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including 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 indication 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; or information on indications 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://www.effectivehealthcare.ahrq.gov/email-updates.</E>
                </P>
                <P>
                    <E T="03">The technical brief will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.</E>
                </P>
                <HD SOURCE="HD1">Guiding Questions</HD>
                <P>The five questions below guide our work in synthesizing a description of research, ongoing efforts, and directions in measuring primary care spending.</P>
                <P>1. What are the definitions, data sources, and methodologies used to estimate primary care spending in published reports?</P>
                <P>a. How do these various primary care spending estimation methods vary by:</P>
                <P>i. Relative pros and cons of each estimation method</P>
                <P>ii. Administrative burden</P>
                <P>iii. Range of spending estimates</P>
                <P>iv. Sensitivity analyses</P>
                <P>b. What is the evidence of the relationship between different primary care spending estimation methods and the absolute and relative levels of primary care spending and health outcomes including morbidity, mortality, quality of life, and health equity?</P>
                <P>2. What are the research gaps in understanding primary care spending estimation methods based on the findings of the evidence map?</P>
                <P>3. What are considerations for developing valid and standardized estimation of primary care spending?</P>
                <P>4. What are approaches that health economists, health services researchers, payers, health systems, and policymakers can employ to develop and implement a standardized measure of primary care spending and to assess spending over time, across payers/populations, and across states?</P>
                <P>5. Contextual Questions:</P>
                <P>a. Is there any emerging consensus among experts in the field toward a standard or preferred method for assessment of primary care spending?</P>
                <P>b. How have policymakers and other decision makers used primary care spending measures?</P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Marquita Cullom,</NAME>
                    <TITLE>Associate Director.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11252 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4160-90-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="34156"/>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Disease Control and Prevention</SUBAGY>
                <DEPDOC>[30Day-23-1301]</DEPDOC>
                <SUBJECT>Agency Forms Undergoing Paperwork Reduction Act Review</SUBJECT>
                <P>In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Templates for Extramural Data Management Plans” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on November 4, 2022 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.</P>
                <P>
                    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. 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. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.
                </P>
                <P>CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:</P>
                <P>(a) 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;</P>
                <P>(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;</P>
                <P>(c) Enhance the quality, utility, and clarity of the information to be collected;</P>
                <P>
                    (d) 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; and
                </P>
                <P>(e) Assess information collection costs.</P>
                <HD SOURCE="HD1">Proposed Project</HD>
                <P>Templates for Extramural Data Management Plans (OMB Control No. 0920-1301, Exp. 6/30/2023)—Extension—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).</P>
                <HD SOURCE="HD2">Background and Brief Description</HD>
                <P>This Information Collection Request (ICR) seeks continued approval for Data Management Plan (DMP) templates. DMPs are required annually of entities using CDC funds to collect or generate public health data. They are submitted to CDC by grant and cooperative agreement applicants and awardees for assessment to verify that they are compliant with CDC's data sharing policy. Having templates makes it easier for CDC awardees to create complete and compliant DMPs and easier for CDC project officers to assess them. Several CDC Centers have created customized templates. For this proposed Extension, some of the templates will undergo minor changes to increase utility and ease of use and the annual burden hour estimate has been updated based on the experience of the past three years and planned future use.</P>
                <P>CDC requests OMB approval for an estimated from 1450 annual burden hours. There is no cost to respondents other than their time to participate.</P>
                <HD SOURCE="HD2">Estimated Annualized Burden Hours</HD>
                <GPOTABLE COLS="5" OPTS="L2,tp0,i1" CDEF="s50,r50,12C,13C,12C">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Type of respondents</CHED>
                        <CHED H="1">Form name</CHED>
                        <CHED H="1">
                            Number of
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Number of
                            <LI>responses per</LI>
                            <LI>respondent</LI>
                        </CHED>
                        <CHED H="1">
                            Average
                            <LI>burden per</LI>
                            <LI>response</LI>
                            <LI>(in hours)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Applicants and Award Recipients</ENT>
                        <ENT>DMP Template</ENT>
                        <ENT>1450</ENT>
                        <ENT>1</ENT>
                        <ENT>60/60</ENT>
                    </ROW>
                </GPOTABLE>
                <SIG>
                    <NAME>Jeffrey M. Zirger,</NAME>
                    <TITLE>Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11265 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4163-18-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Disease Control and Prevention</SUBAGY>
                <DEPDOC>[30Day-23-1080]</DEPDOC>
                <SUBJECT>Agency Forms Undergoing Paperwork Reduction Act Review</SUBJECT>
                <P>In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “HIV Outpatient Study (HOPS)” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on February 17, 2023 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.</P>
                <P>CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:</P>
                <P>(a) 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;</P>
                <P>(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;</P>
                <P>(c) Enhance the quality, utility, and clarity of the information to be collected;</P>
                <P>
                    (d) 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, 
                    <PRTPAGE P="34157"/>
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses; and
                </P>
                <P>(e) Assess information collection costs.</P>
                <P>
                    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. 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. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.
                </P>
                <HD SOURCE="HD1">Proposed Project</HD>
                <P>HIV Outpatient Study (HOPS) (OMB Control No. 0920-1080, Exp. 2/29/2024)—Extension—National Center for HIV, Viral Hepatitis, STD, TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).</P>
                <HD SOURCE="HD2">Background and Brief Description</HD>
                <P>The Centers for Disease Control and Prevention (CDC) requests OMB approval to continue collecting information for HIV Outpatient Study (HOPS). The study is based on a prospective longitudinal cohort of adults with HIV in outpatient care at eight well-established private HIV care practices and university-based clinics in the U.S. The HOPS study sites are located in six cities: Tampa, Florida; Washington, DC; Stony Brook, New York; Chicago, Illinois; Denver, Colorado; and Philadelphia, Pennsylvania. The study currently collects information on a maximum of 2,700 outpatients per year. A portion of HOPS participants are lost to follow-up each year (most due to transferring out of the HOPS clinics), and our target goal is to enroll up to 450 new participants (50-60 per site) annually. Patients are approached during one of their routine clinic visits and invited to participate in the HOPS.</P>
                <P>There are two sources of information for the HOPS. First, clinical data are abstracted on an ongoing basis from the medical records of study participants. Medical records provide data in five general categories: demographics and risk behaviors for HIV infection; symptoms; diagnosed conditions (definitive and presumptive); medications prescribed (including dose, duration, and reasons for stopping); and all laboratory values, including CD4+ T lymphocyte (CD4+) cell counts, plasma HIV-RNA determinations, and genotype, phenotype, and trophile results. Clinic charts also provide data about visit frequency, AIDS, and death. Medical records abstraction is conducted by trained study staff and does not impose ongoing burden on HOPS participants. However, CDC does account for burden associated with the initial study consent and orientation process. The estimated burden per response is 15 minutes.</P>
                <P>The second source of HOPS information is the annual behavioral assessment, an optional activity scheduled in conjunction with the participant's annual clinic visit. For convenience, the behavioral assessment can be completed in either of two modes: a brief Telephone Audio-Computer Assisted Self-Interview (T-ACASI) survey or an identical Web-based Audio-Computer Assisted Self-Interview (W-ACASI). Data collection includes: age, sex at birth, use of alcohol and drugs, cigarette smoking, adherence to antiretroviral medications, types of sexual intercourse, condom use, and disclosure of HIV status to partners. The estimated burden per response is seven minutes.</P>
                <P>
                    The core areas of HOPS research extending through the present HIV treatment era include: (i) investigating and characterizing (new) problems associated with long-term HIV infection and its treatments using the longitudinal cohort data; (ii) monitoring death rates and causes of death; (iii) characterizing the optimal patient management strategies to reduce HIV related morbidity and mortality (
                    <E T="03">e.g.,</E>
                     effectiveness of antiretroviral therapies and other clinical interventions); (iv) assessing sexual and drug use behaviors and other patient reported outcomes that supplement data from chart abstraction; and (v) investigating disparities in the HIV care continuum by various demographic factors. In recent years, the HOPS has been instrumental in bringing attention to emerging issues in chronic HIV infection with actionable opportunities for prevention, including cardiovascular disease, fragility fractures, renal and hepatic disease, and cancers. The HOPS remains an important source for multi-year trend data concerning conditions and behaviors for which data are not readily available elsewhere, including: rates of opportunistic illnesses, rates of comorbid conditions (
                    <E T="03">e.g.,</E>
                     hypertension, obesity, diabetes) and antiretroviral drug resistance.
                </P>
                <P>OMB approval is requested for three years. The estimated number of participants in the annual behavioral assessment is 2,700 respondents. There are no changes to the information collection forms or methods. Participation is voluntary and there are no costs to respondents other than their time. The total estimated annualized burden is 428 hours.</P>
                <HD SOURCE="HD2">Estimated Annualized Burden Hours</HD>
                <GPOTABLE COLS="5" OPTS="L2,tp0,i1" CDEF="s50,r50,12,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Type of respondents</CHED>
                        <CHED H="1">Form name</CHED>
                        <CHED H="1">
                            Number of
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Number of
                            <LI>responses per</LI>
                            <LI>respondent</LI>
                        </CHED>
                        <CHED H="1">
                            Average
                            <LI>burden</LI>
                            <LI>per response</LI>
                            <LI>(in hours)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">HOPS Study Patients</ENT>
                        <ENT>Behavioral survey</ENT>
                        <ENT>2,700</ENT>
                        <ENT>1</ENT>
                        <ENT>7/60</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HOPS Study Patients</ENT>
                        <ENT>Consent form</ENT>
                        <ENT>450</ENT>
                        <ENT>1</ENT>
                        <ENT>15/60</ENT>
                    </ROW>
                </GPOTABLE>
                <SIG>
                    <PRTPAGE P="34158"/>
                    <NAME>Jeffrey M. Zirger,</NAME>
                    <TITLE>Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11264 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4163-18-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Disease Control and Prevention</SUBAGY>
                <DEPDOC>[30Day-23-23AP]</DEPDOC>
                <SUBJECT>Agency Forms Undergoing Paperwork Reduction Act Review</SUBJECT>
                <P>In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “TRANSCEND: Transgender status-neutral community-to-clinic models to end the HIV epidemic” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on November 16, 2022 to obtain comments from the public and affected agencies. CDC received three comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.</P>
                <P>CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:</P>
                <P>(a) 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;</P>
                <P>(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;</P>
                <P>(c) Enhance the quality, utility, and clarity of the information to be collected;</P>
                <P>
                    (d) 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; and
                </P>
                <P>(e) Assess information collection costs.</P>
                <P>
                    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. 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. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.
                </P>
                <HD SOURCE="HD1">Proposed Project</HD>
                <P>TRANSCEND: Transgender status-neutral community-to-clinic models to end the HIV epidemic—New—National Center for HIV, Viral Hepatitis, STD, TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).</P>
                <HD SOURCE="HD2">Background and Brief Description</HD>
                <P>The CDC requesting public comment and OMB approval on a New information collection request (ICR) for the demonstration project titled “TRANSCEND: Transgender status-neutral community-to-clinic models to end the HIV epidemic.”</P>
                <P>Transgender (TG) persons, especially transgender women (TGW), have a high prevalence of HIV and lifetime risk of acquiring HIV. In the 2019-2020 National HIV Behavioral Surveillance Trans cycle, 42% of TGW tested positive for HIV. Racial/ethnic disparities were also found, with HIV positivity rates of 62% among Black/African American TGW and 35% among Hispanic/Latina TGW compared to 17% among White TGW. Despite the disproportionate burden of HIV among TGW, receipt of HIV prevention and care services have been suboptimal. Many TG persons experience poverty, homelessness, abuse, and have substance use or mental health disorders, which impact access to and utilization of HIV prevention and care services. Many TG persons seek gender-affirming care, including hormone therapy, at transgender health care organizations (TG clinics), and these encounters provide opportunities for HIV testing and status-neutral HIV services.</P>
                <P>In the proposed demonstration project, TG clinics and transgender-serving community-based organizations (CBOs) will work collaboratively to evaluate community-to-clinic models to provide integrated status-neutral HIV prevention and care services, gender-affirming services including hormone therapy, and primary healthcare, as well as to ensure access to mental health, substance use, and social support services. All services will be culturally and linguistically responsive for TG persons to ensure that they feel welcomed, heard, and cared for. The recipients will also participate in a national learning collaborative to share lessons learned and best practices for TG clinic and TG CBO partnerships to provide status-neutral, community-to-clinic services for TG persons.</P>
                <P>This collection of data, which involves creation of a unique identifier so that CDC does not receive any personally identifiable information (PII), will allow CDC to assist TG clinics and CBOs in monitoring and evaluating their programs providing status-neutral HIV services and comprehensive healthcare for TG persons and for community-to-clinic models of service provision. Longitudinal person-level data collection will occur through the clinics' electronic health record (EHR Data Form) and the Client Intake Form, and additional program evaluation data will be collected through client surveys (Client Satisfaction Survey).</P>
                <P>The clients will complete the Client Intake Form once when they first join the program, with expected 800 clients per year for a total burden of 107 hours annually. A sample of 100 clients per site (400 total) will respond to the Client Satisfaction Survey once per year, for a total burden of 100 hours annually. The four data managers will extract data from the EHR, perform quality checks, code the data with a unique identifier, and transmit the deidentified data to CDC two times per year, for a total of 64 hours per year. The four data managers will also compile, link, deidentify, and report data from the Client Intake Forms two times per year, with an estimated burden of 16 hours annually. The four data managers will compile and report data from the Satisfaction Survey once per year, with an estimated burden of eight hours annually.</P>
                <P>
                    OMB approval is requested for three years. Participation of the funded recipients' data managers is required, and participation from the clients is voluntary. There is no cost to participants other than their time. The total estimated annualized burden is 295 hours.
                    <PRTPAGE P="34159"/>
                </P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,r50,12,12,12">
                    <TTITLE>Estimated Annualized Burden Hours</TTITLE>
                    <BOXHD>
                        <CHED H="1">Type of respondents</CHED>
                        <CHED H="1">Form name</CHED>
                        <CHED H="1">
                            Number of 
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Number of 
                            <LI>responses per </LI>
                            <LI>respondent</LI>
                        </CHED>
                        <CHED H="1">
                            Average 
                            <LI>burden per </LI>
                            <LI>response </LI>
                            <LI>(in hours)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">TRANSCEND Recipient Data Manager</ENT>
                        <ENT>Electronic Health Record Data Form</ENT>
                        <ENT>4</ENT>
                        <ENT>2</ENT>
                        <ENT>8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TRANSCEND Recipient Data Manager</ENT>
                        <ENT>Client Intake Form</ENT>
                        <ENT>4</ENT>
                        <ENT>2</ENT>
                        <ENT>2</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TRANSCEND Clients</ENT>
                        <ENT>Client Intake Form</ENT>
                        <ENT>800</ENT>
                        <ENT>1</ENT>
                        <ENT>8/60</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TRANSCEND Clients</ENT>
                        <ENT>Client Satisfaction Survey</ENT>
                        <ENT>400</ENT>
                        <ENT>1</ENT>
                        <ENT>15/60</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TRANSCEND Recipient Data Manager</ENT>
                        <ENT>Client Satisfaction Survey</ENT>
                        <ENT>4</ENT>
                        <ENT>1</ENT>
                        <ENT>2</ENT>
                    </ROW>
                </GPOTABLE>
                <SIG>
                    <NAME>Jeffrey M. Zirger,</NAME>
                    <TITLE>Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11266 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4163-18-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Disease Control and Prevention</SUBAGY>
                <SUBJECT>World Trade Center Health Program Scientific/Technical Advisory Committee; Notice of Charter Renewal</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of charter renewal.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the World Trade Center (WTC) Health Program Scientific/Technical Advisory Committee (STAC).</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Tania Carreón-Valencia, Ph.D., M.S., Designated Federal Officer, World Trade Center Health Program Scientific/Technical Advisory Committee, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop R-12, Atlanta, Georgia 30329-4027. Telephone: (513) 841-4515; Email: 
                        <E T="03">TCarreonValencia@cdc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>CDC is providing notice under 5 U.S.C. 1001-1014 of the renewal of the charter of the WTC Health Program STAC. The STAC was established by title I of Public Law 111-347 (the James Zadroga 9/11 Health and Compensation Act of 2010), as amended by Public Laws 114-113, 116-59, and 117-328. This charter has been renewed for a two-year period through May 12, 2025.</P>
                <P>
                    The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign 
                    <E T="04">Federal Register</E>
                     notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
                </P>
                <SIG>
                    <NAME>Kalwant Smagh,</NAME>
                    <TITLE>Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11326 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4163-18-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Disease Control and Prevention</SUBAGY>
                <DEPDOC>[Docket No. CDC-2023-0040; NIOSH 248-K]</DEPDOC>
                <SUBJECT>World Trade Center Health Program Scientific/Technical Advisory Committee</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of meeting and request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP-STAC). This virtual meeting is open to the public. Time will be available for public comment.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The meeting will be held on June 21, 2023, from 11 a.m. to 4 p.m., EDT, and June 22, 2023, from 11 a.m. to 1:30 p.m., EDT.</P>
                    <P>Written public comments must be received by June 22, 2023. Members of the public who wish to address the WTCHP-STAC during the oral public comment session must sign up to speak by June 14, 2023, at the email address provided in the Procedure for Oral Public Comment section below.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        This is a virtual meeting conducted via Zoom. The public is welcome to follow the proceedings via live webcast at the following link: 
                        <E T="03">https://www.ustream.tv/channel/QyXBRzYjVCS.</E>
                         No registration is required. For additional information, please visit the World Trade Center Health Program website at 
                        <E T="03">https://www.cdc.gov/wtc/stac_meeting.html.</E>
                    </P>
                    <P>You may submit comments, identified by Docket No. CDC-2023-0040; NIOSH 248-K by either of the methods listed below. CDC does not accept comments by email.</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>
                         Ms. Sherri Diana, NIOSH Docket Office, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, 1090 Tusculum Avenue, Mailstop C-34, Cincinnati, Ohio 45226. Attn: Docket No. CDC-2023-0040; NIOSH 248-K.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the Agency name and docket number (CDC-2023-0040; NIOSH 248-K). The docket will close on June 22, 2023. All relevant comments, including any personal information provided, will be posted without change to 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Tania Carreón-Valencia, Ph.D., M.S., Designated Federal Officer, World Trade Center Health Program Scientific/Technical Advisory Committee, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop R-12, Atlanta, Georgia 30329-4027. Telephone: (513) 841-4515; Email: 
                        <E T="03">wtc-stac@cdc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Background:</E>
                     The World Trade Center (WTC) Health Program, including the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP-STAC), was established by Title I of the James Zadroga 9/11 Health and Compensation Act of 2010, Public Law 111-347, as 
                    <PRTPAGE P="34160"/>
                    amended by Public Law 114-113, Public Law 116-59, and Public Law 117-328 (December 23, 2022), adding title XXXIII to the Public Health Service (PHS) Act (codified at 42 U.S.C. 300mm to 300mm-62). Title XXXIII of the PHS Act established the WTC Health Program within the Department of Health and Human Services. The WTC Health Program provides medical monitoring and treatment benefits to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), and to eligible persons who were present in the dust or dust cloud on September 11, 2001, or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area (survivors).
                </P>
                <P>All references to the Administrator in this document mean the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), or his or her designee.</P>
                <P>
                    <E T="03">Purpose:</E>
                     The purpose of the WTCHP-STAC is to review scientific and medical evidence and to make recommendations to the Administrator of the WTC Health Program regarding additional WTC Health Program eligibility criteria, potential additions to the List of WTC-Related Health Conditions (List), and research regarding certain health conditions related to the September 11, 2001, terrorist attacks. In accordance with section 3312(a)(6)(G)(i)(II), the Administrator must ask the WTCHP-STAC to review and evaluate any substantive amendment to any existing WTC Health Program policy or procedure used to determine whether sufficient evidence exists to support adding a health condition to the List of WTC-Related Health Conditions.
                </P>
                <P>The Administrator is responsible for the administration of the WTCHP-STAC. CDC and NIOSH provide funding, staffing, and administrative support services for the WTCHP-STAC. The WTCHP-STAC's charter was reissued on May 12, 2023, and will expire on May 12, 2025.</P>
                <P>
                    <E T="03">Matters To Be Considered:</E>
                     In December 2022, the Consolidated Appropriations Act, 2023 amended section 3341 of the PHS Act to direct the Administrator, in consultation with the Secretary of Education, to establish a new research cohort to conduct future research studies on the health and educational impacts of “exposure to airborne toxins, or any other hazard or adverse condition, resulting from the September 11, 2001, terrorist attacks, including on the population of individuals who were 21 years of age or younger at the time of exposure, including such individuals who are screening-eligible WTC survivors or certified-eligible WTC survivors.” The main focus of the WTC Health Program STAC meeting will be a discussion of the new youth research cohort being established by the WTC Health Program. The meeting agenda will include a presentation on establishing the cohort and the Program's perspectives, as well as an overview of young survivors. In addition, the WTC Survivors Steering Committee will lead presentations on young survivors' views and community-based participatory research.
                </P>
                <P>
                    The meeting will also include a presentation and discussion about substantive amendments to the existing 
                    <E T="03">Policy and Procedures for Adding Non-Cancer Health Conditions to the List of WTC-Related Health Conditions.</E>
                     Proposed revisions to the 
                    <E T="03">Policy and Procedures</E>
                     were initially presented to the STAC at its meeting on February 9, 2023; the presentation will detail further revisions made to the 
                    <E T="03">Policy and Procedures</E>
                     in response to recommendations of the STAC at its previous meeting.
                </P>
                <P>
                    Background documents as well as the agenda for this meeting are available on the WTC Health Program website at 
                    <E T="03">https://www.cdc.gov/wtc/stac_meeting.html.</E>
                     Agenda items are subject to change as priorities dictate.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <P>Interested parties may participate by submitting written views, opinions, recommendations, and data. You may submit comments on any topic related to the matters to be discussed by the Committee. Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your comments, that information will be on public display. CDC will review all submissions and may choose to redact, or withhold, submissions containing private or proprietary information such as Social Security numbers, medical information, inappropriate language, or duplicate/near-duplicate examples of a mass-mail campaign. CDC will carefully consider all comments submitted into the docket.</P>
                <P>
                    <E T="03">Oral Public Comment:</E>
                     The public is welcome to participate, via Zoom, during the public comment periods on June 21, 2023, from 1:20 p.m. to 1:50 p.m., EDT, and on June 22, 2023, from 11:05 a.m. to 11:35 a.m., EDT. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first-come, first-served basis.
                </P>
                <P>
                    <E T="03">Procedure for Oral Public Comment:</E>
                     Members of the public who wish to address the WTCHP-STAC during the oral public comment sessions at the June 21-22, 2023, WTCHP-STAC meeting must sign up to speak by providing their name to Ms. Mia Wallace, Committee Management Specialist, via email at 
                    <E T="03">MWallace@cdc.gov,</E>
                     by June 14, 2023. Zoom instructions and participation details will follow.
                </P>
                <P>
                    <E T="03">Written Public Comment:</E>
                     Written comments will also be accepted per the instructions provided in the Addresses section above. Written public comments received prior to the meeting will be part of the official record of the meeting. The docket will close on June 22, 2023.
                </P>
                <P>
                    <E T="03">Policy on Redaction of Committee Meeting Transcripts (Public Comment):</E>
                     Transcripts will be prepared and posted to 
                    <E T="03">https://www.regulations.gov</E>
                     within 60 days after the meeting. If individuals making a comment give their name, no attempt will be made to redact the name. NIOSH will take reasonable steps to ensure that individuals making public comments are aware that their comments (including their names, if provided) will appear in a transcript of the meeting posted on a public website. Such reasonable steps include a statement read at the start of the meeting stating that transcripts will be posted, and names of speakers will not be redacted. If individuals in making a statement reveal personal information (
                    <E T="03">e.g.,</E>
                     medical information) about themselves, that information will not usually be redacted. The CDC Freedom of Information Act coordinator will, however, review such revelations in accordance with the Freedom of Information Act and, if deemed appropriate, will redact such information. Disclosures of information concerning third-party medical information will be redacted.
                </P>
                <P>
                    The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign 
                    <E T="04">Federal Register</E>
                     notices pertaining to announcements of meetings and other 
                    <PRTPAGE P="34161"/>
                    committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
                </P>
                <SIG>
                    <NAME>Kalwant Smagh,</NAME>
                    <TITLE>Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11327 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4163-18-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Administration for Children and Families</SUBAGY>
                <SUBJECT>Submission for OMB Review: Adoption and Foster Care Analysis and Reporting System (AFCARS) (OMB #0970-0422)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Children's Bureau, Administration for Children and Families, Department of Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for public comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Children's Bureau (CB), the Administration for Children and Families (ACF) is requesting a three-year extension of the data information collection for the Adoption and Foster Care Analysis and Reporting System (AFCARS) that was implemented as part of the AFCARS final rule published in May 2020 (85 FR 28410). There are no proposed changes to the data information collection published as the regulation in May 2020. The estimated time per response related to record keeping has been revised since the previous published notice (88 FR 16449) due to feedback from the State and Tribal reporting agencies.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments due within 30 days of publication.</E>
                         OMB must make a decision about the collection of information between 30 and 60 days after publication of this document in the 
                        <E T="04">Federal Register</E>
                        . Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication.
                    </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. You can also obtain copies of the proposed collection of information by emailing 
                        <E T="03">infocollection@acf.hhs.gov.</E>
                         Identify all emailed requests by the title of the information collection.
                    </P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Description:</E>
                     State and Tribal title IV-E agencies are required to report AFCARS case-level information on all children in foster care and children who have been adopted or placed in a guardianship with title IV-E agency involvement. The data collected will inform policy decisions, program management, and responses to Congressional and Departmental inquiries. Specifically, the data are used for short/long-term budget projections, trend analysis, child and family service reviews, and to target areas for improved technical assistance. The data will provide information on the number of children in foster care, the reasons they enter and exit care, and how to prevent their unnecessary placement in foster care. Specifically, the data include information about children who enter foster care, their entries and exits, placement details, and foster/adoptive parent information. This extension request is unrelated to any potential new regulatory activity that may occur subsequently. This request is for public comment on the burden calculations. It does not seek comment on the data elements that have been through the rulemaking process.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Title IV-E State and Tribal Child Welfare Agencies.
                </P>
                <HD SOURCE="HD1">Annual Burden Estimates</HD>
                <P>The following annual burden estimates have been updated to reflect feedback received from the States and Tribes after the first notice published on May 15, 2023 (88 FR 16449). This feedback encouraged ACF to increase the estimated hours per response for recordkeeping.</P>
                <GPOTABLE COLS="6" OPTS="L2,tp0,i1" CDEF="s50,12,12,12,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Instrument</CHED>
                        <CHED H="1">
                            Total
                            <LI>number of</LI>
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Total
                            <LI>number of</LI>
                            <LI>responses per</LI>
                            <LI>respondent</LI>
                        </CHED>
                        <CHED H="1">
                            Average
                            <LI>burden hours</LI>
                            <LI>per response</LI>
                        </CHED>
                        <CHED H="1">
                            Total
                            <LI>burden hours</LI>
                        </CHED>
                        <CHED H="1">
                            Annual
                            <LI>burden hours</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">AFCARS—Recordkeeping</ENT>
                        <ENT>69</ENT>
                        <ENT>3</ENT>
                        <ENT>17,076</ENT>
                        <ENT>3,534,732</ENT>
                        <ENT>1,178,244</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AFCARS—Reporting</ENT>
                        <ENT>69</ENT>
                        <ENT>6</ENT>
                        <ENT>17</ENT>
                        <ENT>7,038</ENT>
                        <ENT>2,346</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     1,180,590.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     Section 479 of the Social Security Act and 45 CFR 1355.44-45.
                </P>
                <SIG>
                    <NAME>Mary B. Jones,</NAME>
                    <TITLE>ACF/OPRE Certifying Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11291 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4184-25-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <DEPDOC>[Docket No. FDA-2022-D-0737]</DEPDOC>
                <SUBJECT>Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures; Guidance for Industry and Food and Drug Administration Staff; Availability</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.” This guidance document provides recommendations that may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems (“tissue containment systems”). Tissue containment systems are used to enable isolation and containment of tissue during a power morcellation procedure performed following a laparoscopic procedure for the excision of benign tissue that is not suspected to contain malignancy.</P>
                </SUM>
                <DATES>
                    <PRTPAGE P="34162"/>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The announcement of the guidance is published in the 
                        <E T="04">Federal Register</E>
                         on May 26, 2023.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit either electronic or written comments on Agency guidances at any time as follows:</P>
                </ADD>
                <HD SOURCE="HD2">Electronic Submissions</HD>
                <P>Submit electronic comments in the following way:</P>
                <P>
                    • 
                    <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                     Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 
                    <E T="03">https://www.regulations.gov</E>
                     will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).</P>
                <HD SOURCE="HD2">Written/Paper Submissions</HD>
                <P>Submit written/paper submissions as follows:</P>
                <P>
                    • 
                    <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E>
                     Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                </P>
                <P>• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”</P>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the Docket No. FDA-2022-D-0737 for “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 
                    <E T="03">https://www.regulations.gov</E>
                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
                </P>
                <P>
                    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on 
                    <E T="03">https://www.regulations.gov.</E>
                     Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E>
                </P>
                <P>
                    <E T="03">Docket:</E>
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    <E T="03">https://www.regulations.gov</E>
                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
                </P>
                <P>You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).</P>
                <P>
                    An electronic copy of the guidance document is available for download from the internet. See the 
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                     section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures” to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Prasanna Hariharan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 2222, Silver Spring, MD 20993-0002, 301-796-2689 or by email at 
                        <E T="03">prasanna.hariharan@fda.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>This guidance document provides recommendations that may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems (“tissue containment systems”). Tissue containment systems are used to enable isolation and containment of tissue during a power morcellation procedure performed following a laparoscopic procedure for the excision of benign tissue that is not suspected to contain malignancy. This guidance recommends non-clinical test methods that may help manufacturers meet the non-clinical performance data requirements identified in the special controls codified in § 884.4050(b)(4) (21 CFR 884.4050(b)(4)) (for gynecologic use) and § 878.4825(b)(4) (21 CFR 878.4825(b)(4)) (for general use), and also includes other non-clinical testing recommendations to support a 510(k) submission/substantial equivalence determination. The recommendations in this guidance are based on FDA's experience evaluating the safety and effectiveness of tissue containment systems. However, manufacturers may use alternative approaches and provide different documentation so long as their approach and documentation satisfy premarket submission requirements in applicable statutory provisions and regulations.</P>
                <P>
                    A notice of availability of the draft guidance appeared in the 
                    <E T="04">Federal Register</E>
                     of June 21, 2022 (87 FR 36859). FDA considered comments received and revised the guidance as appropriate in response to the comments, including a clarification that material permeability testing is recommended to aid in demonstrating substantial equivalence but is not required in the special controls in § 884.4050(b)(4) and § 878.4825(b)(4); specifying that aged samples may be subject to accelerated or real time aging; and indicating that a manufacturer conducting final finished testing of a tissue containment system with multiple device sizes may use the worst-case size sample(s), but, if doing so, should provide a justification for the 
                    <PRTPAGE P="34163"/>
                    choice of worst-case size sample(s) in its submission.
                </P>
                <P>This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.</P>
                <HD SOURCE="HD1">II. Electronic Access</HD>
                <P>
                    Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at 
                    <E T="03">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products.</E>
                     This guidance document is also available at 
                    <E T="03">https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents.</E>
                     Persons unable to download an electronic copy of “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures” may send an email request to 
                    <E T="03">CDRH-Guidance@fda.hhs.gov</E>
                     to receive an electronic copy of the document. Please use the document number GUI00019015 and complete title to identify the guidance you are requesting.
                </P>
                <HD SOURCE="HD1">III. Paperwork Reduction Act of 1995</HD>
                <P>While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations, guidance, and forms have been approved by OMB as listed in the following table:</P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s100,r50,15">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">21 CFR part or guidance</CHED>
                        <CHED H="1">Topic</CHED>
                        <CHED H="1">OMB control No.</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">807, subpart E</ENT>
                        <ENT>Premarket notification</ENT>
                        <ENT>0910-0120</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">“Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”</ENT>
                        <ENT>Q-submissions</ENT>
                        <ENT>0910-0756</ENT>
                    </ROW>
                </GPOTABLE>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Lauren K. Roth,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11260 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <DEPDOC>[Docket No. FDA-2019-D-0934]</DEPDOC>
                <SUBJECT>Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products; Guidance for Industry; Availability</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.” The guidance represents the current thinking of FDA on adjusting for covariates in randomized clinical trials for drugs and biological products. The guidance discusses general recommendations for performing covariate adjustment, recommendations for performing covariate adjustment using linear models, and recommendations for performing covariate adjusting using nonlinear models. The guidance is intended to facilitate covariate adjustment in the analysis of randomized clinical trials of drugs and biological products and to clarify recommendations for its use. The guidance finalizes the revised draft guidance entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products” issued on May 21, 2021.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The announcement of the guidance is published in the 
                        <E T="04">Federal Register</E>
                         on May 26, 2023.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit either electronic or written comments on Agency guidances at any time as follows:</P>
                </ADD>
                <HD SOURCE="HD2">Electronic Submissions</HD>
                <P>Submit electronic comments in the following way:</P>
                <P>
                    • 
                    <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                     Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 
                    <E T="03">https://www.regulations.gov</E>
                     will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).</P>
                <HD SOURCE="HD2">Written/Paper Submissions</HD>
                <P>Submit written/paper submissions as follows:</P>
                <P>
                    • 
                    <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E>
                     Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                </P>
                <P>• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”</P>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the Docket No. FDA-2019-D-0934 for “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 
                    <E T="03">https://www.regulations.gov</E>
                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
                </P>
                <P>
                    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be 
                    <PRTPAGE P="34164"/>
                    made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on 
                    <E T="03">https://www.regulations.gov.</E>
                     Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E>
                </P>
                <P>
                    <E T="03">Docket:</E>
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    <E T="03">https://www.regulations.gov</E>
                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
                </P>
                <P>You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).</P>
                <P>
                    Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by calling CBER at 1-800-835-4709 or 240-402-8010. See the 
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                     section for electronic access to the guidance document.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Scott N. Goldie, Center for Drug Evaluation and Research, Office of Biostatistics, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993-0002, 301-796-2055, or Diane Maloney, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>FDA is announcing the availability of a guidance for industry entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.” The guidance provides recommendations on adjusting for covariates in the analysis of randomized clinical trials. The guidance discusses the acceptability of covariate adjustment, recommendations for implementing adjusted analyses, prespecification, selection of covariates, change from baseline analyses, statistical inference, estimands, and various statistical models. The guidance includes comments on covariate adjusting using both linear and nonlinear models.</P>
                <P>This guidance finalizes the revised draft guidance issued on May 21, 2021 (86 FR 27627). Changes from the draft to the final guidance include changes to wording and organization and updated and clarified recommendations on computing standard errors, stratified randomization, estimands, treatment by covariate interactions, and additional methods.</P>
                <P>This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.</P>
                <HD SOURCE="HD1">II. Paperwork Reduction Act of 1995</HD>
                <P>While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR 312 pertaining to the submissions of investigational new drug applications have been approved under OMB control number 0910-0014.</P>
                <HD SOURCE="HD1">III. Electronic Access</HD>
                <P>
                    Persons with access to the internet may obtain the guidance at 
                    <E T="03">https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs,</E>
                     or 
                    <E T="03">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Lauren K. Roth,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11263 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <DEPDOC>[Docket No. FDA-2023-D-0625]</DEPDOC>
                <SUBJECT>Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products; Draft Guidance for Industry; Availability</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products.” This draft guidance is intended to help sponsors develop antidiabetic drugs for adults and children with type 1 and type 2 diabetes mellitus. In this draft guidance, antidiabetic drug refers to drugs intended to improve glycemic control, including drugs intended to reduce diabetes-related hyperglycemia (
                        <E T="03">i.e.,</E>
                         antihyperglycemic drugs) and drugs intended to mitigate iatrogenic hypoglycemia associated with diabetes management.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit either electronic or written comments on the draft guidance by August 24, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.</P>
                </DATES>
                <ADD>
                    <PRTPAGE P="34165"/>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments on any guidance at any time as follows:</P>
                </ADD>
                <HD SOURCE="HD2">Electronic Submissions</HD>
                <P>Submit electronic comments in the following way:</P>
                <P>
                    • 
                    <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                     Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 
                    <E T="03">https://www.regulations.gov</E>
                     will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).</P>
                <HD SOURCE="HD2">Written/Paper Submissions</HD>
                <P>Submit written/paper submissions as follows:</P>
                <P>
                    • 
                    <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E>
                     Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                </P>
                <P>• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”</P>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the Docket No. FDA-2023-D-0625 for “Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 
                    <E T="03">https://www.regulations.gov</E>
                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
                </P>
                <P>
                    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on 
                    <E T="03">https://www.regulations.gov.</E>
                     Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E>
                </P>
                <P>
                    <E T="03">Docket:</E>
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    <E T="03">https://www.regulations.gov</E>
                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
                </P>
                <P>You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).</P>
                <P>
                    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the 
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                     section for electronic access to the draft guidance document.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Debra Reid, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4221, Silver Spring, MD 20993, 240-402-9143.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    FDA is announcing the availability of a draft guidance for industry entitled “Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products.” In this draft guidance we discuss approaches to demonstrating efficacy of antidiabetic drugs for adults and children with type 1 and type 2 diabetes mellitus. This draft guidance provides recommendations for demonstrating efficacy for drugs that are intended to reduce diabetes-related hyperglycemia (
                    <E T="03">i.e.,</E>
                     antihyperglycemic drugs) and to mitigate iatrogenic hypoglycemia associated with diabetes management. The use of hemoglobin A1c as a primary endpoint for glycemic-control trials is discussed along with recommendations for trial design and conduct to allow for adequate data interpretation. The draft guidance also provides hypoglycemia definitions, trial design considerations for hypoglycemia efficacy endpoints, and hypoglycemia measurement methods. Additional efficacy endpoints are also briefly considered.
                </P>
                <P>
                    This draft guidance replaces, in part, the draft guidance for industry “Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention” (73 FR 11420) published in February 2008 and withdrawn in 2020. In March 2020, FDA withdrew the February 2008 draft guidance because its recommendations for safety assessment were outdated. At the same time, FDA issued the draft guidance for industry “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control” March 10, 2020 (85 FR 13903) (available at 
                    <E T="03">https://www.fda.gov/media/135936/download</E>
                    ). This draft guidance, when finalized, will provide FDA's current recommendations on this issue.
                </P>
                <P>This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.</P>
                <HD SOURCE="HD1">II. Paperwork Reduction Act of 1995</HD>
                <P>
                    While this draft guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this draft guidance. The previously approved 
                    <PRTPAGE P="34166"/>
                    collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014.
                </P>
                <HD SOURCE="HD1">III. Electronic Access</HD>
                <P>
                    Persons with access to the internet may obtain the draft guidance at 
                    <E T="03">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Lauren K. Roth,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11321 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBJECT>Meeting of the Presidential Advisory Council on HIV/AIDS</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of a hybrid meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will convene the 77th full council meeting on Wednesday, June 28 and Thursday June 29, 2023. The meeting will convene in Phoenix, Arizona and it will also utilize virtual technologies. The meeting will be open to the public. Due to limited space, pre-registration is encouraged for members of the public who wish to attend the meeting in-person. Please email your name to 
                        <E T="03">PACHA@hhs.gov</E>
                         by close of business Tuesday, June 20, 2023 to pre-reigster. There will be a public comment session during the meeting; pre-registration is required to provide public comment. To pre-register to provide public comment, please send an email to 
                        <E T="03">PACHA@hhs.gov</E>
                         and include your name, organization, and title by close of business June 20, 2023. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing 
                        <E T="03">PACHA@hhs.gov</E>
                         by close of business July 12, 2023. The meeting agenda will be posted on the PACHA page on HIV.gov at 
                        <E T="03">https://www.hiv.gov/federal-response/pacha/about-pacha</E>
                         prior to the meeting.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The meeting will be held on Wednesday, June 28 from approximately 12 p.m.-9 p.m. (ET) and Thursday, March 29 from approximately 12 p.m.-6 p.m. (ET).</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The meeting will be located at the Kimpton Hotel, Palomar Phoenix located at 2 East Jefferson Street, Phoenix, AZ 85004. To attend the meeting virtually, please visit 
                        <E T="03">www.hhs.gov/live.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Caroline Talev, MPA, Senior Management Analyst, at 
                        <E T="03">PACHA@hhs.gov</E>
                         or 
                        <E T="03">Caroline.Talev@hhs.gov.</E>
                         Additional information can be obtained by accessing the Council's page on the HIV.gov site at 
                        <E T="03">www.hiv.gov/pacha.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>PACHA was established by Executive Order 12963, dated June 14, 1995, as amended by Executive Order 13009, dated June 14, 1996 and is currently operating under the authority given in Executive Order 14048, dated September 30, 2021. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective HIV diagnosis, treatment, prevention, and quality care services. The functions of the Council are solely advisory in nature. The Council consists of not more than 35 members. Council members are selected from prominent community leaders with particular expertise in, or knowledge of, matters concerning HIV and AIDS, public health, global health, population health, philanthropy, marketing or business, as well as other national leaders held in high esteem from other sectors of society. PACHA selections also include persons with lived HIV experience and racial/ethnic and sexual and gender minority persons disproportionately affected by HIV. Council members are appointed by the Secretary.</P>
                <SIG>
                    <DATED>Dated: May 17, 2023.</DATED>
                    <NAME>Caroline Talev,</NAME>
                    <TITLE>Senior Management Analyst, Office of Infectious Disease and HIV/AIDS Policy, Alternate Designated Federal Official, Presidential Advisory Council on HIV/AIDS, Office of the Assistant Secretary for Health, Department of Health and Human Services.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11250 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4150-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>Office of the Secretary; Notice of Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Interagency Pain Research Coordinating Committee.</P>
                <P>
                    The meeting will be held as a virtual meeting and will be open to the public as indicated below. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting, should notify the Contact Person listed below in advance of the meeting. The meeting can be accessed from the NIH Videocast at the following link: 
                    <E T="03">https://videocast.nih.gov/.</E>
                </P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Interagency Pain Research Coordinating Committee (IPRCC).
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 23, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         11:00 a.m. to 12:30 p.m. Eastern Time (ET).
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         The meeting will cover committee business items and IPRCC member updates. Items discussed will include updates on the Helping to End Addiction Long-Term (HEAL) Initiative and the Federal Pain Research Strategy (FPRS) research progress, and an update from the Centers for Medicare and Medicaid Services (CMS).
                    </P>
                    <P>
                        <E T="03">Deadline:</E>
                         Submission of intent to submit written/electronic statement for comments: Friday, June 16 by 5:00 p.m. ET.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Building 31, 31 Center Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Linda L. Porter, Ph.D., Director, Office of Pain Policy, and Planning, Office of the Director, National Institute of Neurological Disorders and Stroke, NIH, 31 Center Drive, Room 8A31, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Phone:</E>
                         (301) 451-4460.
                    </P>
                    <P>
                        <E T="03">Email: Linda.Porter@nih.gov.</E>
                    </P>
                    <P>Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.</P>
                    <P>
                        The meeting will be open to the public via NIH Videocast 
                        <E T="03">https://videocast.nih.gov/.</E>
                         Visit the IPRCC website for more information: 
                        <E T="03">http://iprcc.nih.gov.</E>
                         Agenda and any additional information for the meeting will be posted when available.
                    </P>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Tyeshia M. Roberson-Curtis, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11230 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="34167"/>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>Submission for OMB Review; 30-Day Comment Request Chimpanzee Research Use Form Office of the Director (OD)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Institutes of Health, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), plans to request review and approval by the Office of Management and Budget (OMB) of the information collection listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.</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 more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Lora Kutkat, Division of Program Coordination, Planning, and Strategic Initiatives, OD, NIH, Building 1, Room 260, 1 Center Drive, Bethesda, MD 20892; or call non-toll-free number 301-402-9852; or email your request, including your address, to 
                        <E T="03">dpcpsi@od.nih.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This proposed information collection was previously published in the 
                    <E T="04">Federal Register</E>
                     on February 21, 2023 (88 FR 10527) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The Office of the Director, National Institutes of Health (NIH), may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid Office of Management and Budget (OMB) control number.
                </P>
                <P>In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, NIH has submitted to OMB a request for review and approval of the information collection listed below.</P>
                <P>
                    <E T="03">Proposed Collection Title:</E>
                     Chimpanzee Research Use Form, 0925-0705, expiration date 9/30/2023, EXTENSION, Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH).
                </P>
                <P>
                    <E T="03">Need and Use of Information Collection:</E>
                     The purpose of this form is to obtain information needed by NIH to assess whether the proposed research satisfies the agency's policy for permitting only noninvasive research involving chimpanzees. NIH will consider the information submitted through this form prior to the agency making funding decisions or otherwise allowing the research to begin. Completion of this form is a mandatory step toward receiving NIH support or approval for noninvasive research involving chimpanzees. NIH does not fund any research involving chimpanzees proposed in new or other competing projects (renewals or revisions) unless the research is consistent with the definition of “noninvasive research,” as described in the “Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System” (42 CFR part 9). See NOT-OD-16-095 at 
                    <E T="03">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-095.html</E>
                     and 81 FR 6873.
                </P>
                <P>OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 10.</P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,12">
                    <TTITLE>Estimated Annualized Burden Hours</TTITLE>
                    <BOXHD>
                        <CHED H="1">Type of respondent</CHED>
                        <CHED H="1">
                            Number of
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Number of
                            <LI>responses per</LI>
                            <LI>respondent</LI>
                        </CHED>
                        <CHED H="1">
                            Average time
                            <LI>per response</LI>
                            <LI>(in hours)</LI>
                        </CHED>
                        <CHED H="1">
                            Total annual
                            <LI>burden hour</LI>
                        </CHED>
                    </BOXHD>
                    <ROW RUL="n,s">
                        <ENT I="01">Research Community</ENT>
                        <ENT>20</ENT>
                        <ENT>1</ENT>
                        <ENT>30/60</ENT>
                        <ENT>10</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT/>
                        <ENT>20</ENT>
                        <ENT/>
                        <ENT>10</ENT>
                    </ROW>
                </GPOTABLE>
                <SIG>
                    <DATED> Dated: May 17, 2023.</DATED>
                    <NAME>Tara A. Schwetz,</NAME>
                    <TITLE>Acting Principal Deputy Director, National Institutes of Health.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11322 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Center for Advancing Translational Sciences; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Center for Advancing Translational Sciences Special Emphasis Panel; Limited Competition: Small Grants Program for NCATS—CTSA.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 21, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         11 a.m. to 4 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Center for Advancing Translational Sciences, National Institutes of 
                        <PRTPAGE P="34168"/>
                        Health, 6701 Democracy Boulevard, Room 1078, Bethesda, MD 20892. (Virtual Meeting)
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Rahat (Rani) Khan, Ph.D., Scientific Review Officer, Office of Scientific Review, National Center for Advancing Translational Sciences, National Institutes of Health, 6701 Democracy Boulevard, Room 1078, Bethesda, MD 20892, 301-894-7319, 
                        <E T="03">khanr2@csr.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Melanie J. Pantoja, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11229 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute on Aging; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Aging Special Emphasis Panel; Dementia Care Pragmatic Trials.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 20, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         1:00 p.m. to 3:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Kimberly Firth, Ph.D., National Institutes of Health, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301-402-7702, 
                        <E T="03">firthkm@mail.nih.gov.</E>
                    </P>
                    <P>This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.</P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Miguelina Perez,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11339 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; NIDDK Information Network Coordinating Unit (U24).
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         August 1, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         2:00 p.m. to 4:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Democracy II, 6707 Democracy Blvd., Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Thomas A. Tatham, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Democracy II, Suite 7000A, 6707 Democracy Boulevard, Bethesda, MD 20892, (301) 594-3993, 
                        <E T="03">tathamt@mail.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Miguelina Perez,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11333 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID 2023 DMID Omnibus BAA (HHS-NIH-NIAID-BAA2023-1), Research Area 003—The Antiviral Program for Pandemics: Development of antivirals for specific RNA viral families of pandemic potential (N01).
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 22, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:30 a.m. to 4:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate contract proposals.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3E71, Rockville, MD 20892. (Virtual Meeting)
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Patricia A. Gonzales Hurtado, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities,  National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3E71A, Rockville, MD 20852, 240-627-3556, 
                        <E T="03">Patricia.Gonzales@nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS).</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Tyeshia M. Roberson-Curtis, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11228 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="34169"/>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>Center for Scientific Review; Notice of Closed Meetings</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Healthcare Delivery and Methodologies Integrated Review Group; Health Promotion in Communities Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 20-21, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 8:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Westin Washington, DC City Center, 1400 M Street NW, Washington, DC 20005.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Helena Eryam Dagadu, MPH, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3137, Bethesda, MD 20892, (301) 435-1266, 
                        <E T="03">dagaduhe@csr.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Vascular and Hematology Integrated Review Group; Basic Biology of Blood, Heart and Vasculature Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 22-23, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         8:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Bethesda North Marriott Hotel &amp; Conference Center, Montgomery County Conference Center Facility, 5701 Marinelli Road, North Bethesda, MD 20852.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Aisha Lanette Walker, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-3527, 
                        <E T="03">aisha.walker@nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Clinical Translational Imaging Science Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 22-23, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 8:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Eleni Apostolos Liapi, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20817, (301) 867-5309, 
                        <E T="03">eleni.liapi@nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Biobehavioral and Behavioral Processes Integrated Review Group; Adult Psychopathology and Disorders of Aging Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 22-23, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Hyatt Place Georgetown, 2121 M Street NW, Washington, MD 20037.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Benjamin G. Shapero, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3182, MSC 7848, Bethesda, MD 20892, (301) 402-4786, 
                        <E T="03">shaperobg@mail.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Brain Disorders and Clinical Neuroscience Integrated Review Group; Clinical Neuroplasticity and Neurotransmitters Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 22-23, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 7:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Suzan Nadi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5217B, MSC 7846, Bethesda, MD 20892, 301-435-1259, 
                        <E T="03">nadis@csr.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Healthcare Delivery and Methodologies Integrated Review Group; Organization and Delivery of Health Services Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 22-23, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Catherine Hadeler Maulsby, Ph.D., MPH, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 435-1266, 
                        <E T="03">maulsbych@csr.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Population Sciences and Epidemiology Integrated Review Group; Cancer and Hematologic Disorders Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 22-23, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 8:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Gianina Ramona Dumitrescu, Ph.D., MPH, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4193-C, Bethesda, MD 28092, 301-827-0696, 
                        <E T="03">dumitrescurg@csr.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Interdisciplinary Molecular Sciences and Training Integrated Review Group; Emerging Imaging Technologies in Neuroscience Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 22-23, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 7:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Double Tree by Hilton McLean Tysons, 1960 Chain Bridge Road, McLean, VA 22102.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Sharon S. Low, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5104, MSC 7846, Bethesda, MD 20892, 301-237-1487, 
                        <E T="03">lowss@csr.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Healthcare Delivery and Methodologies Integrated Review Group; Healthcare and Health Disparities Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 22-23, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Bethesda North Marriott Hotel &amp; Conference Center, Montgomery County Conference Center Facility, 5701 Marinelli Road, North Bethesda, MD 20852.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Tara Roshell Earl, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1007C, Bethesda, MD 20892, (301) 402-6857, 
                        <E T="03">earltr@mail.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Biobehavioral and Behavioral Processes Integrated Review Group; Motor Function, Speech and Rehabilitation Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 22-23, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 7:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA 22314.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Stephanie Nagle Emmens, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-6604, 
                        <E T="03">nagleemmenssc@csr.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Miguelina Perez, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11334 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="34170"/>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of General Medical Sciences; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of General Medical Sciences Special Emphasis Panel; Review of R13 Applications.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         July 21, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         1:00 p.m. to 4:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, National Institute of General Medical Sciences, Natcher Building, 45 Center Drive, Bethesda, Maryland 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         John J. Laffan, Ph.D., Scientific Review Officer, Office of Scientific Review ,National Institute of General Medical Sciences, National Institutes of Health Natcher Building, 45 Center Drive, Room 3AN18J, Bethesda, Maryland 20892, 301-594-2773, 
                        <E T="03">laffanjo@mail.nih.gov</E>
                        .
                    </P>
                    <P>
                        Information is also available on the Institute's/Center's home page: 
                        <E T="03">www.nigms.nih.gov/,</E>
                         where an agenda and any additional information for the meeting will be posted when available.
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program No. 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Miguelina Perez, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11331 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; RFA-DK-23-006 Advancing Research on Mechanisms and Management of Pain for Diseases and Conditions within NIDDK Mission Areas.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         July 20-21, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 2:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Democracy II, 6707 Democracy Blvd., Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Cheryl Nordstrom, Ph.D., M.P.H., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Democracy II, Suite 7000A, 6707 Democracy Boulevard, Bethesda, MD 20892, 301-402-6711, 
                        <E T="03">cheryl.nordstrom@nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Miguelina Perez, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11332 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute on Drug Abuse; Notice of Closed Meetings</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.</P>
                <P>The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Drug Abuse Initial Review Group; Medication Development Research Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         July 12, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 5:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications and/or proposals.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institute of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Preethy Nayar, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Drug Abuse, NIH, 301 North Stonestreet Avenue, MSC 6021, Bethesda, MD 20892, 301-443-4577, 
                        <E T="03">nayarp2@csr.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Drug Abuse Special Emphasis Panel; Receptor Binding and Predictive Toxicology.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         July 12, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         1:00 p.m. to 2:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate contract proposals.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institute of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Ipolia R. Ramadan, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, National Institute on Drug Abuse, NIH, 301 North Stonestreet Avenue, MSC 6021, Bethesda, MD 20892, (301) 827-4471, 
                        <E T="03">ramadanir@mail.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.277, Drug Abuse Scientist Development Award for Clinicians, Scientist Development Awards, and Research Scientist Awards; 93.278, Drug Abuse National Research Service Awards for Research Training; 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Tyeshia M. Roberson-Curtis,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11231 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting</SUBJECT>
                <P>
                    Pursuant to section 1009 of the Federal Advisory Committee Act, as 
                    <PRTPAGE P="34171"/>
                    amended, notice is hereby given of the following meeting.
                </P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Clinical trials and Biomarker studies in StrokeNet.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 27, 2023.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 3:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate cooperative agreement applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Nilkantha Sen, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, NINDS/NIH, NSC, 6001 Executive Boulevard, Rockville, MD 20852, 301-496-9223, 
                        <E T="03">nilkantha.sen@nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS.)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>Tyeshia M. Roberson-Curtis, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11227 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Federal Emergency Management Agency</SUBAGY>
                <DEPDOC>[Docket ID: FEMA-2023-0009]</DEPDOC>
                <SUBJECT>Community Disaster Resilience Zones and the National Risk Index</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Emergency Management Agency, Department of Homeland Security.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice and request for information.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Emergency Management Agency (FEMA) is issuing this notice and request for information (RFI) to seek input from the public on implementation of the Community Disaster Resilience Zones Act of 2022, including updates to the methodology and data used for the National Risk Index and any other hazard assessment products; potential improvements to FEMA's provision of hazard data; the process used to designate community disaster resilience zones; financial and technical assistance for resilience or mitigation projects primarily benefitting community disaster resilience zones; and the community disaster resilience zone project application and certification process.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received no later than July 25, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit comments at 
                        <E T="03">www.regulations.gov</E>
                         under Docket ID: FEMA-2023-0009. Follow the instructions for submitting comments. All submissions received must include the agency name and Docket ID, and will be posted, without change, to the Federal eRulemaking Portal at 
                        <E T="03">www.regulations.gov</E>
                         and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to read the Privacy and Security Notice that is available via a link on the homepage of 
                        <E T="03">www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Pamela Williams, Assistant Administrator, Grants Programs, Resilience, Federal Emergency Management Agency, 
                        <E T="03">FEMA-CDRZ-RFI@fema.dhs.gov,</E>
                         202-212-8007.
                    </P>
                    <HD SOURCE="HD1">I. Public Participation</HD>
                    <P>
                        Interested persons are invited to comment on this notice by submitting written data, views, or arguments using the method identified in the 
                        <E T="02">ADDRESSES</E>
                         section.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions must include the agency name and Docket ID for this notice. All comments received will be posted without change to 
                        <E T="03">www.regulations.gov.</E>
                         Commenters are encouraged to identify the number of the specific question or questions to which they are responding.
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         For access to the docket to read background documents or comments received, go to 
                        <E T="03">www.regulations.gov</E>
                         and search for the Docket ID.
                    </P>
                    <HD SOURCE="HD1">II. Background</HD>
                    <HD SOURCE="HD2">A. Community Disaster Resilience Zones Act</HD>
                    <P>
                        The Community Disaster Resilience Zones Act of 2022, Public Law 117-255, 136 Stat. 2363, amended title II of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121 
                        <E T="03">et seq.</E>
                        ) (Stafford Act) to add a new section 206 (42 U.S.C. 5136) that requires the: (1) maintenance of a natural hazard assessment program and development and maintenance of products for the public's use that show the risk of natural hazards through use of risk ratings at the census tract level; and (2) designation of, at the census tract level, community disaster resilience zones based on the natural hazard risk ratings derived from a natural hazard risk product maintained by the natural hazard assessment program.
                    </P>
                    <P>Section 206 also provides FEMA the discretion to: (1) increase the Federal cost share to not more than 90 percent under the Building Resilient Infrastructure and Communities grant program for mitigation projects within, or primarily benefiting, a community disaster resilience zone; (2) provide financial and technical assistance to State, local, Tribal, and Territorial governments for project planning assistance to carry out activities in preparation for a mitigation project; and (3) establish a process for FEMA certification, and provide certification for mitigation projects within, or primarily benefiting, a community disaster resilience zone.</P>
                    <HD SOURCE="HD2">B. FEMA National Risk Index</HD>
                    <P>
                        In November 2020, FEMA announced the availability of the National Risk Index with limited access to data. On August 16, 2021, FEMA released a full web application which enhanced the data and report functionality.
                        <SU>1</SU>
                        <FTREF/>
                         The National Risk Index data and application were updated on March 23, 2023 (detailed below). The National Risk Index is a publicly available dataset and online mapping application that identifies the U.S. communities at most risk for 18 different natural hazards. The 18 hazard types evaluated by the National Risk Index were chosen after reviewing FEMA-approved State Hazard Mitigation Plans for all 50 states in early 2016.
                        <SU>2</SU>
                        <FTREF/>
                         The National Risk Index application visualizes natural hazard risk metrics and includes important data about expected annual losses, social vulnerability, and community resilience.
                        <SU>3</SU>
                        <FTREF/>
                         All National Risk Index data 
                        <PRTPAGE P="34172"/>
                        are publicly available in spatial and tabular formats. The National Risk Index data are derived probabilistic data sources or built from historic event and historic loss information, and are aggregated to the county and census tract levels, thus providing a baseline risk assessment and natural hazard risk profiles. While natural hazard occurrences can induce secondary natural hazard occurrences, only primary natural hazard occurrences (and not their results or after-effects) are considered in the National Risk Index.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             FEMA, 
                            <E T="03">National Risk Index for Natural Hazards, https://www.fema.gov/nri.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             More information about data availability can be found in FEMA's National Risk Index Technical Documentation. FEMA, 
                            <E T="03">National Risk Index, Technical Documentation,</E>
                             Chapters 5-1 to 5-2 (March 2023), 
                            <E T="03">https://www.fema.gov/sites/default/files/documents/fema_national-risk-index_technical-documentation.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             More information about these risk components can be found in FEMA's 
                            <E T="03">National Risk Index Technical Documentation</E>
                             (March 2023), 
                            <E T="03">http://www.fema.gov/sites/default/files/documents/fema_national-risk-index_technical-documentation.pdf;</E>
                             FEMA, 
                            <E T="03">Data Glossary, https://hazards.fema.gov/nri/data-glossary</E>
                             (last visited Mar. 23, 2023).
                        </P>
                    </FTNT>
                    <P>Currently, the National Risk Index does not account for future conditions or anticipated impacts due to climate change.</P>
                    <P>With current National Risk Index information, users can discover a holistic view of their community's baseline and current risk from natural hazards via online maps and data downloads. With improved understanding of natural hazard risk, users can take action to reduce it and build more resilient communities. Potential users might be planners and emergency managers at the State, local, Tribal, Territorial, and Federal levels; as well as other decision makers, private sector entities and interested members of the public. The interactive mapping application can help decision makers better prepare for and mitigate natural hazard events by providing standardized risk data for planning and an overview of multiple risk factors. In turn, these data can help State, local, Tribal, or Territorial governments develop FEMA-approved hazard mitigation plans, required to apply for and/or receive certain FEMA assistance and mitigation grants. More importantly, use of these data can help all users plan for disasters and increase resilience.</P>
                    <P>
                        The National Risk Index is different from other traditional hazard data and models because of the scope and scale of its analyses. For communities that do not have access to natural hazard risk assessment services, the National Risk Index is a valuable product since it uses authoritative data from a variety of Federal, State, local, academic, non-profit, and private sector partners and contributors,
                        <SU>4</SU>
                        <FTREF/>
                         and provides users analysis of their risk to a natural hazard. The National Risk Index leverages best-available source data and methods to provide a holistic view of the current and baseline community-level risk nationwide by combining multiple hazards with socioeconomic and built environment factors.
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             FEMA, 
                            <E T="03">Risk Index Contributors, https://hazards.fema.gov/nri/contributors</E>
                             (last visited Mar. 23, 2023).
                        </P>
                    </FTNT>
                    <P>
                        In addition to Federal collaborators, the National Risk Index incorporates data from a wide range of relevant sources across the country to ensure the tool's robustness.
                        <SU>5</SU>
                        <FTREF/>
                         This includes more than 90 partners across the public and private sectors, including State, regional and local government agencies; academia; private organizations; and nonprofits. Data were collected from best available resources between 2018 and 2023.
                    </P>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             More information on the review and selection process for data used in the National Risk Index is available in the Technical Documentation. See FEMA, 
                            <E T="03">National Risk Index, Technical Documentation,</E>
                             2-4 to 2-6 (March 2023), 
                            <E T="03">https://www.fema.gov/sites/default/files/documents/fema_national-risk-index_technical-documentation.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        FEMA publishes and maintains a publicly available National Risk Index-specific Technical Document to highlight the National Risk Index research and methodologies for developing all components of the tool.
                        <SU>6</SU>
                        <FTREF/>
                         Previously released National Risk Index data versions, documentation, and data updates documentation are available through the National Risk Index Data Archive.
                        <SU>7</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             FEMA, 
                            <E T="03">National Risk Index, Technical Documentation</E>
                             (March 2023), 
                            <E T="03">https://www.fema.gov/sites/default/files/documents/fema_national-risk-index_technical-documentation.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             FEMA, 
                            <E T="03">National Risk Index Data Archive, https://hazards.fema.gov/nri/data-archive</E>
                             (last visited Mar. 23, 2023).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">III. Using the National Risk Index as the Natural Hazard Risk Product</HD>
                    <HD SOURCE="HD2">A. Alignment With Community Disaster Resilience Zones Act Requirements</HD>
                    <P>Section 206(c) (42 U.S.C. 5136(c)) specifies the natural hazard risk product must (1) show the risk of natural hazards; and (2) include ratings and data for loss exposure, social vulnerability, community resilience, and any other element determined necessary by the President. Section 206(e) (42 U.S.C. 5136(e)) requires FEMA to receive public input on the methodology and data used for the product.</P>
                    <P>As currently maintained, the National Risk Index meets the Community Disaster Resilience Zones Act requirements for a natural hazard risk product that can serve as the basis for community disaster resilience zone designations under section 206(d) (42 U.S.C. 5136(d)). The National Risk Index includes three components to define natural hazard risk: (1) a community's expected annual loss, based on hazard frequency, exposure, and historic loss ratio for buildings, population equivalence, and agriculture; (2) social vulnerability; and (3) community resilience.</P>
                    <P>Overall risk index scores and individual natural hazard risk index scores are calculated for each county and census tract included in the National Risk Index. An overall risk index score measures the risk of a location considering all 18 natural hazards included in the index. An individual natural hazard risk index score measures the risk of a location for a single natural hazard.</P>
                    <P>The National Risk Index uses the following equation to derive a risk index score, which is described in more detail below:</P>
                    <GPH SPAN="3" DEEP="24">
                        <GID>EN26MY23.028</GID>
                    </GPH>
                    <P>
                        <E T="03">Expected Annual Loss</E>
                         measures the potential average annual expected loss of building value, population/population equivalence (monetized fatalities and injuries), and agricultural (crop and livestock) value due to natural hazards. Data sources include, but are not limited to FEMA, the National Aeronautics and Space Administration (NASA), National Oceanic and Atmospheric Administration (NOAA), U.S. Census, U.S. Department of Agriculture (USDA), and U.S. Geological Survey (USGS), and are detailed in the National Risk Index Technical Documentation.
                        <SU>8</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             FEMA, 
                            <E T="03">National Risk Index, Technical Documentation</E>
                             (March 2023), 
                            <E T="03">https://www.fema.gov/sites/default/files/documents/fema_national-risk-index_technical-documentation.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Social Vulnerability</E>
                         measures the susceptibility of populations to the adverse impacts of natural hazards. A relatively higher social vulnerability score indicates that the community is 
                        <PRTPAGE P="34173"/>
                        either more likely to experience adverse impacts or that the impacts will be more severe. The National Risk Index currently uses the U.S. Department of Health and Human Services' Centers for Disease Control and Prevention, Social Vulnerability Index to measure social vulnerability.
                        <SU>9</SU>
                        <FTREF/>
                         The Centers for Disease Control and Prevention, Social Vulnerability Index does not have data for American Samoa, Guam, Northern Mariana Islands, or United States Virgin Islands.
                        <SU>10</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             Other tools measure social vulnerability using different analyses. See, 
                            <E T="03">e.g.,</E>
                             Council on Environmental Quality, 
                            <E T="03">Climate and Economic Justice Screening Tool, Methodology, https://screeningtool.geoplatform.gov/en/methodology#3/33.47/-97.5</E>
                             (last visited May 2, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             Sociodemographic census variables for Guam, American Samoa, the U.S. Virgin Islands, the Northern Mariana Islands are unavailable or are not collected at the geographic resolutions required for CDC/ATSDR SVI. See 
                            <E T="03">CDC/ATSDR SVI Frequently Asked Questions (FAQ), https://www.atsdr.cdc.gov/placeandhealth/svi/faq_svi.html</E>
                             (Oct. 26, 2022).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Community Resilience</E>
                         measures the ability of a community to prepare for anticipated natural hazards, adapt to changing conditions, and withstand and recover rapidly from disruptions.
                        <SU>11</SU>
                        <FTREF/>
                         The National Risk Index uses the Baseline Resilience Indicators for Communities index 
                        <SU>12</SU>
                        <FTREF/>
                         to measure community resilience. The Baseline Resilience Indicators for Communities is a place-based measurement of community resilience accounting for social, economic, community capital, institutional, infrastructural, and environmental resilience factors. A community with a relatively higher community resilience score indicates that community is more likely to absorb adverse natural hazard impacts. The Baseline Resilience Indicators for Communities does not have data for U.S. territories, and the data are only available at the county level.
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             This is based on a National Institute of Standards and Technology definition. See 
                            <E T="03">National Risk Index, Technical Documentation</E>
                             at 4-3; National Institute of Standards and Technology, 
                            <E T="03">Community Resilience, https://www.nist.gov/community-resilience</E>
                             (last visited Mar. 23, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             University of South Carolina, Hazard and Vulnerability Research Institute, 
                            <E T="03">Baseline Resilience Indicators for Communities Index, 2020 Update, https://sc.edu/study/colleges_schools/artsandsciences/centers_and_institutes/hvri/data_and_resources/bric/index.php</E>
                             (last visited Mar. 23, 2023).
                        </P>
                    </FTNT>
                    <P>The National Risk Index is only a snapshot of natural hazard risk primarily based on historically derived and generated hazard information (data collection timeframes are detailed in the National Risk Index Technical Documentation). This produces a baseline for natural hazard risk across the U.S. As the landscape of natural hazards, the built environment, and land use change over time, the National Risk Index must be updated to reflect these changes and to anticipate future conditions. To understand effects of changing climate on natural hazard risk, future conditions data are needed to support the creation of future natural hazard risk data. This includes, but is not limited to, natural hazard frequency, exposure, intensity and duration, building stock, population and demographics, and crop and livestock data.</P>
                    <HD SOURCE="HD2">B. Updates to the National Risk Index</HD>
                    <P>To further improve its suitability for Community Disaster Resilience Zone Act implementation, FEMA made several data and methodology changes to the National Risk Index as detailed below. These changes improve accuracy, address user feedback and needs, enable measurement of risk over time, and support future integration of climate change data.</P>
                    <P>As part of the National Risk Index data version 1.19.0 release on March 23, 2023, the following changes were made:</P>
                    <P>• Update to census tract geographies to reflect 2020 U.S. Census modifications.</P>
                    <P>• Migration from the University of South Carolina Social Vulnerability Index (SoVI®) to the Centers for Disease Control and Prevention, Social Vulnerability Index for use as the social vulnerability component of the National Risk Index.</P>
                    <P>• Generation of Expected Annual Loss data for some natural hazards for American Samoa, Guam, Northern Mariana Islands, Puerto Rico, and United States Virgin Islands.</P>
                    <P>• Inclusion of precalculated Expected Annual Loss Rates within schema and data downloads.</P>
                    <P>
                        • Enhancements to land cover/land use data, including updated building and population equivalence (monetized fatalities and injuries) 
                        <SU>13</SU>
                        <FTREF/>
                         values.
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             FEMA quantifies loss of life and injury using a Value of Statistical Life figure, which was increased in 2021. 
                            <E T="03">See</E>
                             Benefit-Cost Analysis Sustainment and Enhancements: Draft Standard Economic Values Methodology Report, Version 11.0, at 17 (September 2022), 
                            <E T="03">https://www.fema.gov/sites/default/files/documents/fema_standard-economic-values-methodology-report_092022.pdf.</E>
                             This Value of Statistical Life figure was updated again after the National Risk Index data version 1.19.0 was released. See Department of Transportation, 
                            <E T="03">Departmental Guidance on Valuation of a Statistical Life in Economic Analysis</E>
                             (May 1, 2023), 
                            <E T="03">https://www.transportation.gov/office-policy/transportation-policy/revised-departmental-guidance-on-valuation-of-a-statistical-life-in-economic-analysis.</E>
                             The newly updated figure may be integrated into future National Risk Index data updates.
                        </P>
                    </FTNT>
                    <P>• Hazard specific methodology updates for coastal flooding, drought, earthquake, hurricane, landslide, tornado, and tsunami.</P>
                    <P>• Development of Hazard Risk Value metric.</P>
                    <P>• Modification to how Social Vulnerability and Community Resilience values are applied to Expected Annual Loss.</P>
                    <P>• Conversion of Composite and Individual Hazard Risk Scores to Percentiles.</P>
                    <P>• Historic hazard data period of record updates.</P>
                    <P>• Enhanced methodology to estimate Historic Loss Ratio values separately for urban and rural communities.</P>
                    <P>• Application enhancements to static pages, map viewer, map sidebar, and reports.</P>
                    <P>
                        Current National Risk Index data and methodologies are detailed in the National Risk Index Technical Documentation, and more information about these and previous changes to data and methodologies are available in the Data Version and Update Documentation found on the National Risk Index Data Archive Page.
                        <SU>14</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             FEMA, 
                            <E T="03">National Risk Index, Technical Documentation</E>
                             (March 2023), 
                            <E T="03">https://www.fema.gov/sites/default/files/documents/fema_national-risk-index_technical-documentation.pdf;</E>
                             FEMA, 
                            <E T="03">National Risk Index Data Archive</E>
                             (March 2023), 
                            <E T="03">https://hazards.fema.gov/nri/data-archive.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">IV. Designating Community Disaster Resilience Zones and Targeting Assistance</HD>
                    <P>Section 206(d) (42 U.S.C. 5136(d)) requires that FEMA designate zones at the census tract level based on the natural hazard risk ratings derived from a natural hazard risk product maintained by the natural hazard assessment program. At a minimum, the community disaster resilience zones must include the 50 census tracts with the highest individual hazard risk ratings nationwide and at least one percent of high-risk census tracts in each State, maintaining a geographic balance across coastal, inland, urban, suburban, and rural areas and including census tracts on Tribal lands. The risk ratings used to designate the zones may also use any other elements determined by the President. Section 206(d)(4) specifies that community disaster resilience zone designations shall be effective for a period of no less than five years.</P>
                    <P>
                        As amended by the Community Disaster Resilience Zones Act, section 206(h) (42 U.S.C. 5136(h)) provides FEMA the discretion to provide financial and technical assistance to State, local, Tribal, and Territorial governments that plan to perform a resilience or mitigation project within, 
                        <PRTPAGE P="34174"/>
                        or that primarily benefits, a community disaster resilience zone. Section 206(h)(2) specifies that the purpose of this assistance is to support activities or preparation for a resilience or mitigation project or seek an evaluation and certification for a resilience or mitigation project before permanent work of the project begins. Section 206(h)(4) provides that FEMA may use funding it sets aside pursuant to section 203(i) of the Stafford Act (42 U.S.C. 5133(i)) to fund the financial and technical assistance for resilience or mitigation project planning.
                    </P>
                    <HD SOURCE="HD1">V. Questions for Commenters</HD>
                    <P>Consistent with the requirements of the Community Disaster Resilience Zones Act, FEMA seeks input from the public on the methodology and data used for its hazard assessment products, and other potential improvements to FEMA's provision of hazard data to inform future updates. Additionally, FEMA requests initial comment on the process used to designate these zones and the types of financial and technical assistance for resilience or mitigation projects that would benefit identified communities and serve as a catalyst for additional resilience investments in these communities. The following list of questions is non-exhaustive and is meant to assist members of the public in the formulation of comments. It is not intended to restrict the issues that commenters may address:</P>
                    <HD SOURCE="HD2">A. Risk Assessment—General Questions</HD>
                    <P>1. How does your organization use risk assessment products and associated risk ratings? What products do you use and why are they useful? How does your organization vet risk assessment tools and products? Are there additional data, information, analysis capabilities, or metrics that would be useful? Are there data that you do not currently have access to, but would like?</P>
                    <P>
                        2. Does your organization use the National Risk Index? How does your organization use the National Risk Index? What are the time horizons for decisions your organization is making using the National Risk Index (
                        <E T="03">e.g.,</E>
                         projects that will take place in 5, 20, 50+ years)? Are there specific features or aspects of the National Risk Index that you find particularly useful? Are there specific features or aspects that you would like to change? Does the addition of Expected Annual Loss Rate help in how your organization understands relative natural hazard risk? Would providing additional built in data filters (
                        <E T="03">e.g.,</E>
                         Hazard Mitigation Plan Status, National Flood Insurance Program participation, FEMA Disaster Declarations, Justice40 initiative investments, etc.) benefit the usability of National Risk Index data?
                    </P>
                    <P>
                        3. Risk Assessment capability within FEMA traditionally uses nationally available data. Some tools (including but not limited to Hazus 
                        <SU>15</SU>
                        <FTREF/>
                         and he Resilience Analysis and Planning Tool 
                        <SU>16</SU>
                        <FTREF/>
                        ) allow users to upload local information for decision support. How can FEMA work with State, local, Tribal, and Territorial partners to understand what more detailed information exists and how it can be incorporated into national level decision support tools? Should FEMA maintain products with baseline natural hazard risk data from consistently available national data sources and an enhanced product with additional local information? Are there specific features or aspects of the National Risk Index that you find particularly useful including features that could be added or altered?
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             FEMA, Hazus Software, 
                            <E T="03">https://www.fema.gov/flood-maps/products-tools/hazus</E>
                             (last visited Mar. 23, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             FEMA, Resilience Analysis &amp; Planning Tool (RAPT), 
                            <E T="03">https://www.fema.gov/emergency-managers/practitioners/resilience-analysis-and-planning-tool</E>
                             (last visited Mar. 23, 2023).
                        </P>
                    </FTNT>
                    <P>4. Is there potential to combine or integrate FEMA's hazard assessment products with other tools? If so, which tools and how?</P>
                    <P>5. Are there ways that FEMA could provide better outreach to communities and individuals with fewer resources to encourage use of its hazard assessment products? Are there partnerships that FEMA could explore to improve its outreach (and if so, with whom)? What other ways can FEMA and its partners present data and information to users to make data actionable? What other support could FEMA provide to help communities act on this information?</P>
                    <HD SOURCE="HD2">B. Risk Assessment—Methodology</HD>
                    <P>1. In general, how could FEMA improve its National Risk Index methodology used to understand, measure, and communicate community-level natural hazard risk across the country? Are there any potential biases within the National Risk Index data or methods? What methods exist for addressing these biases?</P>
                    <P>2. Do you have any feedback on the formula used to derive the National Risk Index risk ratings or the specific data used to measure expected annual loss, social vulnerability, or community resilience? </P>
                    <GPH SPAN="3" DEEP="23">
                        <GID>EN26MY23.029</GID>
                    </GPH>
                    <P>3. The National Risk Index incorporates Expected Annual Loss information for 18 different natural hazards. Are there ways that the National Risk Index could better represent these data? If so, how? What research exists to help guide FEMA in the development of Expected Annual Loss beyond the current methodology? What additional information should FEMA consider for the Expected Annual Loss factor?</P>
                    <P>4. While the National Risk Index incorporates the Centers for Disease Control and Preventions' Social Vulnerability Index, are there ways that the National Risk Index could better represent the broader societal impacts of natural hazards and/or measure how different populations are vulnerable to natural hazards? If so, how and based on what research? What research exists to explain the validity or predictability of social vulnerability factors and models?</P>
                    <P>5. The National Risk Index incorporates the Baseline Resilience Indicators for Communities as the Community Resilience component. Are there ways the National Risk Index could better represent resilient communities? If so, how? Recognizing that the Baseline Resilience Indicators for Communities does not currently include Territories, how can the Community Resilience component better measure Territories? What research exists to explain the validity or predictability of community resilience models?</P>
                    <HD SOURCE="HD2">C. Risk Assessment—Data</HD>
                    <P>
                        1. What mechanism exists or could be created to ensure that the National Risk Index is using the best available data? What additional information should be considered when developing the National Risk Index? How would these resources be incorporated? How often 
                        <PRTPAGE P="34175"/>
                        should this information be reviewed and incorporated? How often should the National Risk Index data be updated?
                    </P>
                    <P>2. What additional data sources should FEMA consider for the National Risk Index? Are these data sources national, including full U.S. Territory coverage or local/State equivalent specific, and are they publicly available? What is the period of record? How often are these data sources updated?</P>
                    <P>3. Can FEMA leverage new technologies to refine its risk assessment products? If so, what are they, and how can FEMA use new technologies?</P>
                    <P>4. What data could FEMA use to include place-based approaches for the U.S. Territories, including but not limited to frequency, exposure, and historic loss ratio data for hazards or social vulnerability and community resilience data?</P>
                    <HD SOURCE="HD2">D. Climate Change and Future Conditions Data</HD>
                    <P>
                        1. How should FEMA incorporate climate change and future conditions data into the National Risk Index? What tools/data sources should FEMA consider (
                        <E T="03">e.g.,</E>
                         Climate Risk &amp; Resilience Portal,
                        <SU>17</SU>
                        <FTREF/>
                         Climate Mapping for Resilience and Adaptation Tool,
                        <SU>18</SU>
                        <FTREF/>
                         or U.S. Climate Resilience Toolkit 
                        <SU>19</SU>
                        <FTREF/>
                        ) when expanding the National Risk Index to include anticipated impacts due to climate change? Who should FEMA consult with and include when developing this possible expansion?
                    </P>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             Argonne National Laboratory, Climate Risk &amp; Resilience Portal (ClimRR), 
                            <E T="03">https://disgeoportal.egs.anl.gov/ClimRR/</E>
                             (last visited Mar. 23, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             U.S. Global Change Research Program, Climate Mapping for Resilience and Adaption, 
                            <E T="03">https://resilience.climate.gov/</E>
                             (last visited Mar. 23, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             U.S. Global Change Research Program, U.S. Climate Resilience Toolkit, 
                            <E T="03">https://toolkit.climate.gov/</E>
                             (last visited Mar. 23, 2023).
                        </P>
                    </FTNT>
                    <P>2. How could the National Risk Index incorporate “derivative climate change,” and/or the cascading effects of natural hazard incidents? Which data or models could be utilized to show this relationship?</P>
                    <P>
                        3. What solutions exist that account for potential future resilience efforts (including but not limited to future building codes, land use planning and zoning, or nature-based solutions)? What existing data or methods are publicly available to support climate change data integration into the National Risk Index? What future conditions data and information exist to support the non-hazard components (
                        <E T="03">i.e.,</E>
                         economic, infrastructural, coping capacity) of the National Risk Index? What future population growth and movement, demographics, landscape change, building development, agriculture, cultivated crops, etc. information exists and how can these be applied to the existing National Risk Index framework? Are these linked with specific emissions scenarios? If not, how could they be linked to expected emissions?
                    </P>
                    <HD SOURCE="HD2">E. Questions To Identify Community Disaster Resilience Zones</HD>
                    <P>1. In accordance with the legislation, FEMA will designate community disaster resilience zones at the census tract level. How can FEMA best communicate this designation once it has been made to the relevant jurisdictions and communities? What additional data and information would be useful to communities who are designated community disaster resilience zones? Would it be beneficial for FEMA to use a phased in approach or announce in stages, making adjustments to the selection methodology based on lessons learned, feedback and results? If so, what data and information should FEMA consider for a phased approach and how frequently should these designations be reviewed and how? How can FEMA best include climate change, land use change, and demographic changes in these designations?</P>
                    <P>2. In addition to the census tracts based National Risk Index risk ratings and inclusion of Tribal lands, the legislation directs consideration of coastal, inland, urban, suburban, and rural areas for geographic balance. What additional criteria should FEMA consider in determining how to achieve geographic balance?</P>
                    <P>3. In the absence of social vulnerability and community resilience data for the U.S. Territories, how should FEMA help Territories prioritize census tracts and resources based on the level of risk and vulnerability in each community, as well as the unique characteristics of each community, so that resources can be allocated more efficiently and effectively to support disaster resilience efforts?</P>
                    <P>4. How should FEMA work with State, local, Tribal and Territorial Governments in designating zones? How can FEMA Partner with States, Tribes and Territorial government in working with local governments with community disaster resilience zones? What can FEMA do to help ensure community disaster resilience zones are supported by State, local, Tribal, and Territorial resilience efforts? Are there specific considerations that should be taken into account when designating zones in Tribes and Territories?</P>
                    <P>5. In what ways could FEMA encourage collaboration across jurisdictional boundaries to support a community's ability to reduce hazard risk?</P>
                    <P>6. What are the significant barriers that potential community disaster resilience zones face in accessing and leveraging Federal resources, and how can FEMA and other Federal agencies assist them in overcoming these barriers and make this process more equitable?</P>
                    <HD SOURCE="HD2">F. Resilience or Mitigation Project Planning Assistance</HD>
                    <P>1. What would be the most useful and equitable way for FEMA to provide financial and technical assistance to benefit communities with Community Disaster Resilience Zones to plan, apply for, and evaluate resilience or mitigation projects?</P>
                    <P>2. How can FEMA support comprehensive community resilience planning to benefit community disaster resilience zones and the larger communities those census tracts lie within?</P>
                    <P>3. How should FEMA engage with State, local, Tribal, Territorial, and nongovernmental levels to provide technical assistance to benefit communities within Community Disaster Resilience Zones?</P>
                    <P>4. What activities could FEMA undertake to help community disaster resilience zones understand and implement the types of projects, activities, or services that would minimize/reduce natural hazard risk?</P>
                    <P>5. What are potential unintended consequences of designating these zones and/or implementing other parts of this legislation that should be considered?</P>
                    <HD SOURCE="HD2">G. Community Disaster Resilience Zone Project Application and Certification Process and Other Investment Opportunities</HD>
                    <P>
                        1. As amended by the Community Disaster Resilience Zones Act, section 206(i) of the Stafford Act (42 U.S.C. 5136(i)) provides FEMA the discretion to execute an evaluation and certification program for projects within, or primarily benefiting, a community disaster resilience zone. FEMA may evaluate prospective projects to determine if the project is designed to reduce injuries, loss of life, or damage and destruction of property, such as damage to critical services and facilities; and substantially reduces the risk of, or increases resilience to, future damage, hardship, loss, or suffering. What is the most equitable way for FEMA to implement a certification process to minimize applicant burden while ensuring the most beneficial 
                        <PRTPAGE P="34176"/>
                        projects move forward, given this criteria? How should FEMA determine the extent to which proposed projects benefit the individual census tract(s) and promote comprehensive community-wide resilience?
                    </P>
                    <P>2. How can the identified community disaster resilience zones and FEMA's assistance amplify other Federal and non-Federal programs to direct resources to communities with high risk to natural hazards, high social vulnerability and low community resilience? What other programs would be complementary?</P>
                    <P>3. How can FEMA monitor progress of improving resilience in community disaster resilience zones over time? What are key data and other metrics that can be used to monitor and evaluate progress?</P>
                    <P>
                        4. In what ways could FEMA use the community disaster resilience zone designation as a catalyst for Federal and non-Federal funding, 
                        <E T="03">e.g.,</E>
                         encouraging communities with the designation to partner with non-governmental entities, such as private non-profit organizations, philanthropy, and private equity, to drive investments to benefit designated communities?
                    </P>
                    <P>5. For mitigation projects that benefit large areas covering many census tracts, how can FEMA help applicants determine if the project is “within” or “primarily benefits” a community disaster resilience zone? What tools or resources would help potential applicants design projects that prioritize these identified communities? How should these projects be evaluated for their efficacy in reducing natural hazard risk?</P>
                    <HD SOURCE="HD2">H. Community Disaster Resilience Zone Projects Causing Displacement</HD>
                    <P>1. How can FEMA best ensure any residents displaced by resilience or mitigation projects receive equitable treatment?</P>
                    <P>2. How can FEMA ensure comprehensive community engagement is a central component of any community resilience planning and project implementation for Community Disaster Resilience Zones?</P>
                    <P>3. How can FEMA work with local jurisdictions designated as Community Disaster Resilience Zones to support community driven relocation, where appropriate?</P>
                    <SIG>
                        <NAME>Deanne Criswell,</NAME>
                        <TITLE>Administrator, Federal Emergency Management Agency.</TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11268 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Fish and Wildlife Service</SUBAGY>
                <DEPDOC>[Docket No. FWS-R8-ES-2023-0043; FXES11140800000-234-FF08ECAR00]</DEPDOC>
                <SUBJECT>Endangered and Threatened Wildlife and Plants; Proposed Low-Effect Habitat Conservation Plan for the Sweetwater Authority Habitat Management Program and Habitat Recovery Project, County of San Diego, CA</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Fish and Wildlife 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>We, the U.S. Fish and Wildlife Service, announce receipt of an application for an incidental take permit under the Endangered Species Act and a draft habitat conservation plan from the Sweetwater Authority. We request public comment on the application, which includes the applicant's proposed habitat conservation plan (HCP), and on the Service's preliminary determination that the proposed permitting action may be eligible for a categorical exclusion pursuant to the Council on Environmental Quality's National Environmental Policy Act (NEPA) regulations, the Department of the Interior's (DOI) NEPA regulations, and the DOI Departmental Manual. To make this preliminary determination, we prepared a draft environmental action statement and low-effect screening form, which is also available for public review. We invite comment from the public and local, State, Tribal, and Federal agencies.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>To ensure consideration, please send your written comments by June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        <E T="03">Obtaining Documents:</E>
                         You may obtain copies of the documents this notice announces, along with public comments received, online in Docket No. FWS-R8-ES-2023-0043 at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        <E T="03">Submitting Comments:</E>
                         You may submit comments by one of the following methods:
                    </P>
                    <P>
                        • 
                        <E T="03">Online: https://www.regulations.gov.</E>
                         Search for and submit comments on Docket No. FWS-R8-ES-2023-0043.
                    </P>
                    <P>
                        • 
                        <E T="03">Email: fw8cfwocomments@fws.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Mr. Jonathan Snyder, Assistant Field Supervisor, Carlsbad Fish and Wildlife Office, 760-431-9440 (telephone). 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>
                    We, the U.S. Fish and Wildlife Service (Service), have received an application from the Sweetwater Authority (applicant) for a 5-year incidental take permit for five covered species pursuant to section 10(a)(1)(B) of the Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ). The applicant is seeking a permit to incidentally take four animal species and seeking assurance for one plant species (all are federally listed species) during the term of the proposed 5-year permit. The permit is needed to authorize take of listed animal species (including harm, death, and injury) in the course of activities associated with the implementation of the Sweetwater Reservoir Habitat Management Program (HMP), removal of the requirement to hold reservoir water elevation at or below 230 feet (ft), and implementation of the Sweetwater Reservoir Wetlands Habitat Recovery Project (HRP) within the HMP area in San Diego County, California. A conservation program to avoid, minimize, and mitigate anticipated impacts from project activities would be implemented as described in the habitat conservation plan (HCP) prepared by the applicant.
                </P>
                <P>We are requesting comments on the permit application, which includes the applicant's habitat conservation plan (HCP), and on the Service's preliminary determination that this proposed incidental take permit qualifies as “low effect” and may qualify for a categorical exclusion pursuant to the Council on Environmental Quality's National Environmental Policy Act (NEPA) regulations (40 CFR 1501.4), the Department of the Interior's (DOI) NEPA regulations (43 CFR 46), and the DOI's Departmental Manual (516 DM 8.5(C)(2)). To make this preliminary determination, we prepared a draft environmental action statement and low-effect screening form, which is also available for public review.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Section 9 of the Act and its implementing Federal regulations prohibit the take of animal species listed as endangered or threatened. “Take” is defined under the Act as to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect listed animal species, or to attempt to engage in such conduct (16 U.S.C. 1538). However, 
                    <PRTPAGE P="34177"/>
                    under section 10(a) of the Act, the Service may issue permits to authorize incidental take of listed animal species. “Incidental take” is defined by the Act's implementing regulations as take that is incidental to, and not the purpose of, carrying out an otherwise lawful activity. Regulations governing incidental take permits for endangered and threatened species, respectively, are found in the Code of Federal Regulations at 50 CFR 17.22 and 50 CFR 17.32. The definition of take under the Act does not apply to plant species; however, plant species identified in an HCP are included on the permit as covered species in recognition of the conservation measures provided for them under the HCP, and these plants receive “no surprises” regulatory assurances under the permit.
                </P>
                <P>
                    The HMP area is in southern San Diego County, south of the community of Spring Valley, along the Sweetwater River. The Sweetwater Reservoir is a managed surface water storage facility in the Sweetwater River Watershed that receives direct local runoff from the watershed's middle basin, water transfers from Loveland Reservoir (which captures water runoff from the watershed's upper basin), and imported water, when available, through the San Diego County Water Authority aqueduct. The HMP area supports coastal sage scrub, mulefat scrub, southern willow forest, and nonnative grassland vegetation communities, which include potential habitat for the covered species: the federally listed endangered least Bell's vireo (
                    <E T="03">Vireo bellii pusillus</E>
                    ) and southwestern willow flycatcher (
                    <E T="03">Empidonax traillii extimus</E>
                    ), and the federally listed threatened coastal California gnatcatcher (
                    <E T="03">Polioptila californica californica</E>
                    ), yellow-billed cuckoo (
                    <E T="03">Coccyzus americanus</E>
                    ), and Otay tarplant (
                    <E T="03">Deinadra conjugens</E>
                    ). More details on the specific parcels and their locations are available in the permit application (see 
                    <E T="02">ADDRESSES</E>
                    ).
                </P>
                <P>The applicant is seeking an incidental take permit for implementation of the HMP, removal of the 230-ft-elevation imported water restrictions, and implementation of the 66.9-acre (ac) HRP within the 250-ac HMP area. The HMP area was originally set aside for conservation in 1994 to preserve and manage least Bell's vireo and southwestern willow flycatcher and their habitat, while providing the applicant the ability to manage the Sweetwater Reservoir for drinking water purposes. In 2005, an irrevocable dedication of land for wildlife preservation was created on 52.5 ac of riparian habitat within the HMP area potentially suitable for least Bell's vireo, and associated mitigation credits were established for applicant project impacts to least Bell's vireo and riparian habitat. The HRP is a grant-funded project and will establish 66.9 ac of additional riparian and wetland habitat within the managed portion of Sweetwater Reservoir, using a combination of passive and active techniques. The applicant also proposes to remove the 230-ft restriction and allow the water elevation to reach the high point of the dam (239 ft) on an infrequent basis, to increase water storage during high-rainfall years. Raising the water elevation threshold may result in infrequent flooding and temporary impacts to riparian habitat, with reproductive impacts to least Bell's vireo, and also potentially to southwestern willow flycatcher and yellow-billed cuckoo should they be observed on site in the future. The HCP requires an update to the HMP to address changes in reservoir operations and adaptive management of reservoir levels; the HMP update must be completed and approved by the Service prior to allowing imported water above the 230-ft elevation. The updated HMP will allow for the establishment of additional mitigation credits based on newly established and restored riparian habitat placed under in-perpetuity conservation.</P>
                <P>The HMP area provides regionally important habitat for least Bell's vireo as well as potential habitat for southwestern willow flycatcher and yellow-billed cuckoo. We anticipate minor periodic impacts to least Bell's vireo, and potentially to southwestern willow flycatcher and yellow-billed cuckoos, during implementation of the HRP and HMP, and infrequent, temporary flooding impacts associated with the increase in the reservoir elevation in periods of high rainfall. Proposed maintenance activities within the HMP also have the potential to result in minor periodic impacts to the coastal California gnatcatcher in upland coastal sage scrub habitat. Critical habitat for least Bell's vireo, southwestern willow flycatcher, coastal California gnatcatcher, and Otay tarplant occur within the 250-ac HMP area proposed to be conserved in perpetuity.</P>
                <HD SOURCE="HD1">Proposed Action and Alternatives</HD>
                <P>The proposed action consists of the issuance of an incidental take permit and implementation of the proposed HCP, which includes measures to avoid, minimize, and mitigate impacts to covered species. The applicant proposes to preserve the entire 250-ac HMP in perpetuity through an irrevocable dedication or similar instrument. As project-specific mitigation, the applicant will debit 37.5 ac from established riparian habitat mitigation credits within the HMP. Funding for habitat management within the HMP will come from the applicant's general funds, an endowment for in-perpetuity funding, or other mechanism(s) agreed upon by the Service and the California Department of Fish and Wildlife.</P>
                <P>Three alternatives to the taking of the listed species under the proposed action are considered in the proposed HCP. Under the no-action alternative, no authorized incidental take of covered species would occur, and no additional habitat restoration or management would be conducted in the HMP to expand habitat for least Bell's vireo, southwestern willow flycatcher, or yellow-billed cuckoo. Under the HRP with channel modifications alternative, extensive grading and channel modifications within the floodplain would improve natural hydrology with substantial impacts to existing riparian habitat but ultimately more sustainable hydrological function. This alternative would result in an increase in the temporal loss of riparian habitat and breeding territories relative to the proposed action and require additional regulatory permitting. Under the alternative for retaining the 230-ft imported water restriction, the water storage capacity of the reservoir would not be increased to meet regional drinking water demands. While this alternative would reduce potential infrequent temporary impacts to least Bell's vireo, southwestern willow flycatcher, and yellow-billed cuckoo and their habitat, habitat flooding with the potential to impact covered riparian birds and their habitat may still occur within the HMP in high-rainfall years, and the applicant would not be eligible for the grant that is proposed to fund the HRP. The proposed project achieves the applicant's objectives and maximizes riparian vegetation and least Bell's vireo habitat, while minimizing potential impacts to covered species.</P>
                <HD SOURCE="HD1">Our Preliminary Determination</HD>
                <P>
                    The Service has made a preliminary determination that the applicant's proposed project would individually and cumulatively have a minor, nonsignificant effect on the covered species and the human environment. Therefore, we have preliminarily determined that the proposed Endangered Species Act section 10(a)(1)(B) permit would be a “low-effect” incidental take permit that individually or cumulatively would have a minor effect on the species and 
                    <PRTPAGE P="34178"/>
                    may qualify for application of a categorical exclusion pursuant to the Council on Environmental Quality's NEPA regulations, DOI's NEPA regulations, and the DOI Departmental Manual. A “low-effect” incidental take permit is one that would result in (1) minor or negligible effects on species covered in the HCP; (2) nonsignificant effects on the human environment; and (3) impacts that, when added together with the impacts of other past, present, and reasonably foreseeable actions, would not result in significant cumulative effects to the human environment.
                </P>
                <HD SOURCE="HD1">Public Comments</HD>
                <P>
                    If you wish to comment on the permit application, proposed HCP, and associated documents, you may submit comments by any of the methods noted in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">Public Availability of Comments</HD>
                <P>Written comments we receive become part of the public record associated with this action. Before including your address, phone number, email address, or other personal identifying information in your comments, 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>
                <HD SOURCE="HD1">Authority</HD>
                <P>
                    We provide this notice under section 10(c) of the Endangered Species Act (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ) and its implementing regulations (50 CFR 17.22 and 17.32) and the National Environmental Policy Act (42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ) and its implementing regulations (40 CFR 1500-1508 and 43 CFR 46).
                </P>
                <SIG>
                    <NAME>Jonathan Snyder,</NAME>
                    <TITLE>Acting Field Supervisor, Carlsbad Fish and Wildlife Office, Carlsbad, California.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11226 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4333-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[BLM_NV_FRN_MO #4500170412]</DEPDOC>
                <SUBJECT>Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Greenlink North Project in White Pine, Eureka, Lander, Churchill, and Lyon Counties, Nevada</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of intent.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) Nevada State Office, Reno, Nevada, intends to prepare an environmental impact statement (EIS) to consider the effects of a right-of-way (ROW) application for proposed transmission facilities from NV Energy for the Greenlink North Project. Publication of this notice initiates the scoping period to solicit public comments and identify issues to be analyzed in the Draft EIS.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This notice initiates the public scoping process for the EIS. The BLM requests the public submit comments concerning the scope of the analysis, potential alternatives, and identification of relevant information and studies by July 10, 2023. To afford the BLM the opportunity to consider issues raised by commenters in the Draft EIS, please ensure your comments are received prior to the close of the 45-day scoping period or 15 days after the last public scoping workshop, whichever is later.</P>
                    <P>The BLM will conduct a combination of virtual and in-person scoping workshops during the 45-day scoping period. The BLM will provide the public at least 15 days' notice prior to the workshops.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments on issues related to the Greenlink North Project by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Website: https://eplanning.blm.gov/eplanning-ui/project/2017033/510.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Email: blm_nv_greenlinknorth@blm.gov.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         BLM, Nevada State Office, Attn: Greenlink North Project, 1340 Financial Boulevard, Reno, NV 89502.
                    </P>
                    <P>Documents pertinent to this Project may also be examined at the Reno Nevada State Office.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Brian Buttazoni, Planning &amp; Environmental Specialist, telephone (775) 861-6491; address 1340 Financial Boulevard, Reno, NV 89502; email 
                        <E T="03">blm_nv_greenlinknorth@blm.gov.</E>
                         Contact us at this email address to have your name added to our mailing list. 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>This document provides notice that the BLM Nevada State Office intends to prepare an EIS to consider the effects of a ROW application for the Greenlink North Project, announces the beginning of the scoping process, and seeks public input on issues to be analyzed in the Draft EIS. The proposed Project is in White Pine, Eureka, Lander, Churchill, and Lyon counties, Nevada. The proposed Project encompasses approximately 1,394 acres of public lands administered by the BLM.</P>
                <HD SOURCE="HD1">Purpose and Need</HD>
                <P>In compliance with NEPA and FLPMA, the BLM Nevada State Office intends to prepare an EIS to analyze the environmental impacts associated with NV Energy's application seeking to obtain a ROW grant for the Greenlink North Project.</P>
                <P>
                    Under the Federal Energy Regulatory Commission's (FERC's) Open Access Transmission Tariff adopted in 18 CFR parts 35 and 385, Order No. 888 (75 FERC 61,080 (April 24, 1996)), NV Energy is required to plan and construct adequate transmission facilities to deliver the projected electric demand in Nevada. The State of Nevada is facing unprecedented changes in both system growth and resource requirements. By 2031, 1,000 megawatts (MW) of base load generation are planned for retirement, 
                    <E T="03">i.e.,</E>
                     will no longer be generating electricity. In addition, NV Energy has received more than 1,450 MW of new electric service requests in northern Nevada that will require additional transmission facilities. Currently, the maximum amount of power that can be provided in northern Nevada on the existing transmission network is 1,275 MW, and all 1,275 MW are being used by current network customers. The power demand in northern Nevada is forecast to increase by more than 700 MW within 10 years. New transmission infrastructure is required to deliver the anticipated electric power demand.
                </P>
                <P>
                    The Greenlink North Project would alleviate some of the capacity issues on existing transmission lines and enhance 
                    <PRTPAGE P="34179"/>
                    electric grid reliability by allowing interconnections to occur throughout the State. The purpose of this Federal action is to respond to the ROW application for construction, operation, and decommissioning of proposed electrical transmission facilities on Federal land. Based on the goals and objectives of the proponent and the BLM's authority, the BLM will evaluate the ROW application submitted by NV Energy in compliance with FLPMA, BLM regulations, and other applicable Federal laws and policies. The need for this Federal action is to fulfill the BLM's responsibilities under FLPMA and its ROW regulations to manage the public lands for multiple uses, including for “systems for generation, transmission, and distribution of electric energy” (43 U.S.C. 1761(a)(4)).
                </P>
                <HD SOURCE="HD1">Preliminary Proposed Action and Alternatives</HD>
                <P>The Proposed Action is to construct, operate and decommission a proposed system of new 525-kV, 345-kV, 230-kV, and 120-kV electric transmission facilities on approximately 1,394 acres of BLM administered lands. Additional action alternatives have not been identified to date but will be developed by taking into consideration comments and input received during the application evaluation determination process and scoping.</P>
                <P>Under the No Action Alternative, the BLM would not issue a ROW grant for the construction, operation and decommissioning of a proposed system of new 525-kV, 345-kV, 230-kV, and 120-kV electric transmission facilities. The proposed Project would not be constructed, and existing land uses in the project area would continue. The BLM welcomes comments on the preliminary Proposed Action as well as suggestions for additional alternatives.</P>
                <HD SOURCE="HD1">Summary of Expected Impacts</HD>
                <P>The analysis in the EIS will be focused on the proposed transmission project and associated facilities. The BLM evaluated the proposed Project application per the 43 CFR part 2800 application evaluation determination process. Through this process, the BLM gathered input from an interdisciplinary team of resource specialists and completed public outreach and agency and Indian Tribal Nations coordination specific to the proposed Project. From the input received during four pre-EIS virtual public workshops, the preliminary impacts from construction, operation, and eventual decommissioning of the Project and associated facilities could include:</P>
                <P>• Vegetation and soils.</P>
                <P>• Threatened, endangered, and BLM sensitive species.</P>
                <P>• Air quality and climate.</P>
                <P>• Cultural and historical resources.</P>
                <P>• Greater-sage grouse.</P>
                <P>• Access to public lands.</P>
                <P>• Socioeconomics.</P>
                <P>• Public health and safety.</P>
                <HD SOURCE="HD1">Anticipated Permits and Authorizations</HD>
                <P>
                    Along with a BLM ROW grant as required under 43 CFR 2801.9, NV Energy anticipates needing additional permits for the proposed project: a Nevada Public Utilities Commission Permit to Construct; Nevada Division of Water Resources water rights modification permits; and other permits, as necessary. A portion of the Project could occur on lands administered by the U.S. Forest Service, which would require a special use permit for the Project. The U.S. Forest Service would rely on the analysis contained in the EIS to support any special use permit. Further details on these permitting requirements may be found in the Preliminary Plan of Development which is available on the project website at: 
                    <E T="03">https://eplanning.blm.gov/eplanning-ui/admin/project/2017033/510.</E>
                </P>
                <HD SOURCE="HD1">Schedule for the Decision-Making Process</HD>
                <P>The BLM will provide additional opportunities for public participation consistent with the NEPA process, including a 60-day comment period on the Draft EIS. The Draft EIS is anticipated to be available for public review in winter 2024, and the Final EIS and subsequent Record of Decision are anticipated to be released in summer 2024.</P>
                <HD SOURCE="HD1">Public Scoping Process</HD>
                <P>This Notice of Intent initiates the public scoping process, which guides the development of the Draft EIS.</P>
                <P>
                    The BLM will be holding a combination of virtual and in-person scoping workshops. The specific date(s) and location(s) of scoping workshops will be announced at least 15 days in advance through the local media and the e-Planning web page: 
                    <E T="03">https://eplanning.blm.gov/eplanning-ui/project/2017033/510.</E>
                </P>
                <P>The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including alternatives and mitigation measures, and to guide the process for developing the Draft EIS. Federal, State, and local agencies, along with Indian Tribal Nations and stakeholders that may be interested or affected by the BLM's decision on this project, are invited to participate in the scoping process and, if eligible, may request or be requested by the BLM to participate as a cooperating agency. The BLM encourages comments concerning the proposed Greenlink North Project, possible measures to minimize and/or avoid adverse environmental impacts, and any other information relevant to the Proposed Action.</P>
                <P>The BLM also requests assistance with identifying potential reasonable alternatives to the Proposed Action. As alternatives should resolve an issue with the Proposed Action, please indicate the purpose of the suggested alternative. In addition, the BLM requests the identification of potential issues that should be analyzed. Issues should be a result of the Proposed Action or other reasonable alternatives; therefore, please identify the activity along with the potential issues.</P>
                <HD SOURCE="HD1">Lead and Cooperating Agencies</HD>
                <P>The BLM Nevada State Office is the lead Federal agency for this EIS. The BLM has initially identified the following agencies and organizations as potential Cooperating Agencies to participate in the environmental analysis of the Project: Department of the Air Force, Department of Defense, U.S. Forest Service, U.S. Environmental Protection Agency Region 9, U.S. Fish and Wildlife Service, Nevada Department of Transportation, Duckwater Shoshone Tribe, Ely Shoshone Tribe, Fallon Paiute-Shoshone Tribe, Pyramid Lake Paiute Tribe, Walker River Paiute Tribe, Yomba Shoshone Tribe, Nevada Department of Wildlife, Nevada Division of Environmental Protection, Nevada Division of Minerals, Churchill County, White Pine County, Lyon County, Eureka County, and Lander County.</P>
                <P>
                    The following Tribes were invited to participate as a Cooperating Agency in BLM's initial notification letter: Confederated Tribes of the Goshute Reservation, Duckwater Shoshone Tribe, Ely Shoshone Tribe, Fallon Paiute-Shoshone Tribe, Fort McDermitt Paiute and Shoshone Tribe, Lovelock Paiute Tribe, Moapa Band of Paiutes, Pahrump Paiute Tribe, Pyramid Lake Paiute Tribe, Reno-Sparks Indian Colony, Shoshone-Bannock Tribes, Shoshone-Paiute Tribes of Duck Valley, Summit Lake Paiute Tribe, Susanville Indian Rancheria, Te-Moak Tribe of Western Shoshone, Te-Moak Tribe-Battle Mountain Band, Te-Moak Tribe-Elko Band, Te-Moak Tribe-South Fork Band, Te-Moak Tribe-Wells Band, Timbisha Shoshone Tribe, Walker River Paiute Tribe, Washoe Tribe of Nevada and California, Winnemucca Indian Colony, Winnemucca Indian 
                    <PRTPAGE P="34180"/>
                    Colony, Yerington Paiute Tribe, and Yomba Shoshone Tribe. These and other federally recognized T`ribes may request Cooperating Agency status during preparation and review of the Draft EIS.
                </P>
                <HD SOURCE="HD1">Responsible Official</HD>
                <P>The Nevada State Office Director is the deciding official for the proposed Greenlink North Project.</P>
                <HD SOURCE="HD1">Nature of Decision To Be Made</HD>
                <P>The BLM will decide whether to grant, grant with conditions, or deny the right-of-way application. Pursuant to 43 CFR 2805.10, if the BLM issues a right-of-way grant(s), the BLM decision maker may include terms, conditions, and stipulations determined to be in the public interest.</P>
                <HD SOURCE="HD1">Interdisciplinary Team</HD>
                <P>The BLM will use an interdisciplinary approach to develop the EIS to consider the variety of resource issues and concerns identified. Specialists with expertise in the following disciplines will be involved in this process: air quality, archaeology, botany, climate change (greenhouse gases), environmental justice, fire and fuels, geology/mineral resources, hydrology, invasive/non-native species, lands and realty, National Conservation Lands, National Trails System, public health and safety, recreation/transportation, socioeconomics, soils, visual resources, and wildlife.</P>
                <HD SOURCE="HD1">Additional Information</HD>
                <P>The BLM will identify, analyze, and consider mitigation to address the reasonably foreseeable impacts to resources from all analyzed reasonable alternatives and, in accordance with 40 CFR 1502.14(e), include appropriate mitigation measures not already included in the proposed alternatives. Mitigation may include avoidance, minimization, rectification, reduction or elimination over time, and compensation; and may be considered at multiple scales, including the landscape scale.</P>
                <P>The BLM will utilize the NEPA process to help support compliance with applicable procedural requirements under Section 106 of the National Historic Preservation Act (54 U.S.C. 306108) as provided in 36 CFR 800.2(d)(3), including public involvement requirements of section 106. The information about historic and cultural resources and threatened and endangered species within the area potentially affected by the proposed Project will assist the BLM in identifying and evaluating impacts to such resources.</P>
                <P>The BLM will consult with Indian Tribal Nations on a government-to-government basis in accordance with Executive Order 13175, BLM Manual Section 1780, and other policies. Tribal concerns, including impacts on Indian trust assets and potential impacts to cultural resources, will be given due consideration. The BLM intends to hold government-to-government consultation meetings. The BLM will send invitations to potentially impacted Indian Tribal Nations prior to the meetings. The BLM will provide additional opportunities for government-to-government consultation during the NEPA process.</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>
                <EXTRACT>
                    <FP>(Authority: 40 CFR 1501.7 and 2800.)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Jon K. Raby,</NAME>
                    <TITLE>Nevada State Director.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11070 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4331-21-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[BLM_NV_FRN; MO #4500170409]</DEPDOC>
                <SUBJECT>Notice of Availability of the Draft Environmental Impact Statement and Resource Management Plan Amendments for the Greenlink West Project in Clark, Esmeralda, Lyon, Mineral, Nye, Storey, and Washoe Counties, NV</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) has prepared a draft environmental impact statement (Draft EIS)/resource management plan amendments (RMPA) for the Greenlink West Project and by this notice is providing information announcing the opening of the comment period on the Draft EIS/RMPA. The BLM Nevada State Office is the lead agency for purposes of the NEPA analysis with the U.S. National Park Service (NPS), Bureau of Indian Affairs (BIA), and other agencies serving as cooperating agencies.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        This notice announces the opening of a 90-day comment period for the Draft EIS/RMPA beginning with the date following the Environmental Protection Agency's (EPA) publication of its Notice of Availability (NOA) in the 
                        <E T="04">Federal Register</E>
                        . The EPA usually publishes its NOAs on Fridays.
                    </P>
                    <P>To afford the BLM the opportunity to consider comments in the Draft EIS/RMPA, please ensure your comments are received prior to the close of the 90-day comment period or 15 days after the last public meeting, whichever is later.</P>
                    <P>
                        The BLM will be hosting both virtual and in-person public meetings during the 90-public comment period. The dates and locations of any public meetings will be announced at least 15 days in advance through local media, newspapers, and the BLM website at: 
                        <E T="03">https://eplanning.blm.gov/eplanning-ui/project/2017391/510.</E>
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments related to the Greenlink West Project Draft EIS/RMPA by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">ePlanning Website: https://eplanning.blm.gov/eplanning-ui/project/2017391/510.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Email: BLM_NV_greenlinkwest@blm.gov.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         BLM Nevada State Office, Attn: Brian Buttazoni, Planning &amp; Environmental Specialist, Branch of Renewable Energy, BLM Nevada State Office, 1340 Financial Boulevard, Reno, Nevada 89502.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Brian Buttazoni, Planning &amp; Environmental Specialist, telephone (775) 861-6491; address: 1340 Financial Boulevard, Reno, NV 89502; email: 
                        <E T="03">blm_nv_greenlinkwest@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. 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>
                    On July 22, 2020, Nevada Power Company and Sierra Pacific Power Company dba NV Energy (NV Energy or Proponent) filed an Application for Transportation, Utility Systems, Telecommunications, and Facilities on Federal Lands and Property (Standard Form 299) and a preliminary Plan of Development with the BLM Nevada State Office for a 
                    <PRTPAGE P="34181"/>
                    FLPMA Right-of-Way and Short-Term Right-of-Way authorization for the Greenlink West Project (NVN-99863 and NVN-99863-01).
                </P>
                <P>The Draft EIS/RMPA analyzes the environmental impacts of the authorization of a 200-foot-wide right-of-way (ROW) by the BLM for the construction, operations, and decommissioning of the 525-kV line, a 160-foot-wide ROW for the 345-kV lines, and a 600-foot short-term ROW for construction and staging to NV Energy for a 474-mile system of new 525-kilovolt (kV), 345-kV, and 120-kV overhead electric transmission lines. The proposal also includes transmission and distribution lines, substations, microwave radio facilities, amplifier sites, access roads, and construction/material yards. The Draft EIS/RMPA analyzes the impacts of potential RMP amendments together with the impacts of the various alternative routes.</P>
                <P>
                    A Notice of Intent to Prepare an EIS for the Greenlink West Project published in the 
                    <E T="04">Federal Register</E>
                     on May 2, 2022 (87 FR 25658), providing notice to the public of potential amendments to RMPs, as required by 43 CFR 1610.2(c). The public scoping period closed on June 1, 2022. The BLM held four public scoping meetings and received approximately 81 public scoping comment letters during the 30-day scoping period. The scoping comments focused on biological resources, alternatives development, visual resources, cultural resources, impacts to general and special-status wildlife species, including threatened and endangered species and their habitat, social and economic conditions, vegetation/riparian/noxious and invasive weeds/special status plant species, including threatened and endangered species and their habitat, water resources, wilderness, wilderness study areas, lands with wilderness characteristics, special designations, recreation, socioeconomic concerns, and Native American cultural/sacred sites. The BLM prepared a scoping report, which is available on the project's ePlanning website—
                    <E T="03">https://eplanning.blm.gov/eplanning-ui/project/2017391/510.</E>
                </P>
                <HD SOURCE="HD1">Purpose and Need</HD>
                <P>The BLM's purpose is to respond to the ROW application submitted by the Proponent to construct, operate, maintain, and decommission a system of transmission facilities and associated infrastructure that would transmit electricity between the Harry Allen Substation in Clark County and the Mira Loma and Comstock Meadows substations in Washoe County and Storey County, respectively.</P>
                <P>The need for this action is to fulfill the BLM's responsibility under FLPMA and its ROW regulations to manage the public lands for multiple uses, including the transmission of electric energy. FLPMA, as amended, established a multiple-use mandate for the BLM's management of federal lands, including “systems for generation, transmission, and distribution of electric energy, except that the Proponent shall also comply with all applicable requirements of the FERC under the Federal Power Act, including Part I thereof (41 Stat. 1063, 16 U.S.C. 791a-825r).” (43 U.S.C. 1761(a)(4))</P>
                <P>The BIA's purpose, as a Department of the Interior (DOI) bureau with a NEPA compliance need, is to respond to the ROW application submitted by the Proponent to construct, operate, maintain, and decommission a transmission line over or across lands held in trust for the Las Vegas and Walker River Paiute Tribes, and the Timbisha Shoshone Tribe.</P>
                <P>The BIA's need for this action is to fulfill its responsibility under 25 CFR part 169 (Rights-of-Way over Indian Land) regulations to review and approve actions on Tribal trust lands. The BIA's purpose and need, pursuant to 25 U.S.C. 415, is to deny, grant, or grant with modifications the ROW agreements between the Walker River and Las Vegas Paiute Tribes, Timbisha Shoshone Tribe, and the Proponent. The final ROW grant would include any restrictions or conditions imposed in a consent document between the applicant and both the Las Vegas and Walker River Paiute Tribes, and the Timbisha Shoshone Tribe.</P>
                <P>The NPS's purpose, as a DOI bureau with a NEPA compliance need, is to respond to the ROW application submitted by the Proponent to operate and maintain a transmission line over or across NPS-administered lands designated to conserve and protect unique and nationally important paleontological resources.</P>
                <P>The need for this action is to fulfill the NPS responsibility under NPS ROW regulations to manage Tule Springs Fossil Beds National Monument in compliance with the 2015 National Defense Authorization Act (Pub. L. 113-291) enabling legislation and the NPS 2006 Management Policies. The NPS ROW permits are discretionary and revocable and do not convey an interest in land. All NPS ROW permit applications will be processed in accordance with the NPS ROW permitting guidance document, Reference Manual 53-B, and all other applicable regulations and policy. All new NPS ROW permits must be approved by the NPS Director or NPS Regional Director. Proposed uses of NPS-administered lands and waters may not be incompatible with the public interest or the NPS responsibilities under 54 U.S.C. 100101 (the 1916 Organic Act, expanded upon in 36 CFR 14). Under 54 U.S.C. 100902, the NPS has the authority to issue a ROW permit for utilities.</P>
                <HD SOURCE="HD1">Proposed Action and Alternatives, Including the Preferred Alternative</HD>
                <P>The BLM has analyzed the No Action Alternative, the Proposed Action as submitted by NV Energy, and the Preferred Alternative. In addition, the BLM has also analyzed several transmission route groups that it developed to address concerns by the public about impacts to cultural, biological, and socioeconomic resources. The BLM has identified a Preferred Alternative, which is a modification of the Proposed Action with the inclusion of transmission line, substation, and microwave alternatives. The BLM also considered 21 additional alternatives but dismissed these from detailed analysis as explained in Section 2.3 of the Draft EIS/RMPA.</P>
                <P>Under the No Action Alternative, the BLM would not authorize the ROW for the construction, operation, maintenance, and decommissioning of a system of transmission facilities and associated infrastructure. The agency purpose and need would not be met by the No Action Alternative.</P>
                <P>Under the Proposed Action and Preferred Alternative, the BLM, NPS and BIA would authorize ROWs for the construction, operation, maintenance, and decommissioning of a system of transmission facilities and associated infrastructure. Both alternatives would meet the agency purpose and need, however the Preferred Alternative would utilize certain different transmission line, substation, and microwave alternatives.</P>
                <P>
                    The BLM determined that two plan amendments to the 1998 Las Vegas RMP warranted evaluation in the Proposed Action. The Greenlink West Project area includes Visual Resource Management (VRM) Classes II, III, and IV. The BLM has evaluated the re-classification of a part of the alignment from VRM Class II to Class IV. The Greenlink West Project area also crosses a West-Wide Energy Corridor (WWEC). Portions of that WWEC that are unoccupied by utility infrastructure would be re-aligned to match that of the Greenlink West Project transmission line.
                    <PRTPAGE P="34182"/>
                </P>
                <HD SOURCE="HD1">Mitigation</HD>
                <P>
                    The BLM added an anti-perching/nesting mitigation measure to the Proposed Action to reduce the potential for raven predation on Bi-State sage-grouse and the Mohave desert tortoise through installation of tubular (no-lattice) transmission structures (
                    <E T="03">e.g.,</E>
                     tubular H-frame, three-pole dead end, or monopole structures). Perch and nest deterrent devices would also be installed on all transmission and distribution structures within Mojave desert tortoise recovery units and within two miles of Bi-State sage-grouse Priority Areas for Conservation.
                </P>
                <HD SOURCE="HD1">Anticipated Permits and Authorizations</HD>
                <P>If approved, the BLM, NPS, and BIA would issue a ROWs for their jurisdiction. The term of the ROWs would be for 30-years.</P>
                <HD SOURCE="HD1">Consultation Efforts</HD>
                <P>The BLM is utilizing the NEPA substitution process to comply with the requirements of Section 106 of the National Historic Preservation Act (NHPA), 54 U.S.C. 306108, consistent with 36 CFR 800.8(c). The BLM, as lead federal agency, has incorporated information and the steps of the Section 106 process into the Draft EIS, and publication of the Draft EIS will allow the consulting parties and the public an opportunity to review and comment on the process as provided in 36 CFR 800.8(c)(2).</P>
                <P>The BLM will continue to consult with Indian Tribal Nations on a government-to-government basis in accordance with Executive Order 13175, BLM MS 1780, and other Departmental policies. Tribal concerns, including impacts on Indian trust assets and potential impacts to cultural resources, will be given due consideration. Additional government-to-government meetings are planned, and coordination will continue through project implementation.</P>
                <HD SOURCE="HD1">Schedule for the Decision-Making Process</HD>
                <P>Consistent with the NEPA and BLM's land use planning regulations, the BLM will include a 30-day public protest period and a concurrent 60-day Governor's consistency review when the BLM publishes the Final EIS/Proposed RMPA. The Final EIS/Proposed RMPA is anticipated to be available in winter 2024 with an approved RMPA and Record of Decision in spring 2024.</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>
                <EXTRACT>
                    <FP>(Authority: 40 CFR 1506.6, 40 CFR 1506.10, 43 CFR 1610.2)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Jon K. Raby,</NAME>
                    <TITLE>Nevada State Director.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11102 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4331-21-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Ocean Energy Management</SUBAGY>
                <DEPDOC>[OMB Control Number 1010-0191; Docket ID: BOEM-2023-0004]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Negotiated Noncompetitive Agreement for the Use of Sand, Gravel, and Shell Resources on the Outer Continental Shelf</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Ocean Energy 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, the Bureau of Ocean Energy Management (BOEM) proposes this information collection request (ICR) to renew Office of Management and Budget (OMB) control number 1010-0191.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received by BOEM no later than July 25, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send your comments on this ICR by mail to the BOEM Information Collection Clearance Officer, Anna Atkinson, Bureau of Ocean Energy Management, 45600 Woodland Road, Sterling, Virginia 20166; or by email to 
                        <E T="03">anna.atkinson@boem.gov.</E>
                         Please reference OMB control number 1010-0191 in the subject line of your comments. You may also view the ICR and its related documents by searching the docket number “BOEM-2023-0004” at 
                        <E T="03">http://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Anna Atkinson by email at 
                        <E T="03">anna.atkinson@boem.gov,</E>
                         or by telephone at 703-787-1025. 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 of 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>In accordance with the Paperwork Reduction Act of 1995, BOEM provides the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps BOEM assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand BOEM's information collection requirements and provide the requested data in the desired format.</P>
                <P>BOEM is soliciting comments on the proposed ICR described below. BOEM is especially interested in public comments addressing the following issues: (1) is the collection necessary to the proper functions of BOEM; (2) what can BOEM do to ensure that this information is processed and used in a timely manner; (3) is the burden estimate accurate; (4) how might BOEM enhance the quality, utility, and clarity of the information to be collected; and (5) how might BOEM minimize the burden of this collection on the respondents, including minimizing the burden through the use of information technology?</P>
                <P>Comments submitted in response to this notice are a matter of public record. BOEM will include or summarize each comment in its ICR to OMB for approval of this information collection. You should be aware that your entire comment—including your address, phone number, email address, or other personally identifiable information included in your comment—may be made publicly available at any time.</P>
                <P>For BOEM to consider withholding from disclosure your personally identifiable information, you must identify, in a cover letter, any information contained in your comment that, if released, would constitute a clearly unwarranted invasion of your privacy. You must also briefly describe any possible harmful consequences of the disclosure of information, such as embarrassment, injury, or other harm.</P>
                <P>
                    Even if BOEM withholds your personally identifiable information in the context of this ICR, your comment is subject to the Freedom of Information Act (FOIA) (5 U.S.C. 552). If your comment is requested under FOIA, your information will only be withheld if a determination is made that one of the FOIA exemptions to disclosure applies. Such a determination will be made in accordance with the Department of the Interior's (DOI) FOIA implementing regulations (43 CFR part 2) and applicable law.
                    <PRTPAGE P="34183"/>
                </P>
                <P>BOEM will make available for public inspection all comments in their entirety (except proprietary information) submitted by organizations and businesses, or by individuals identifying themselves as representatives of organizations or businesses. BOEM protects proprietary information in accordance with FOIA and the DOI's implementing regulations.</P>
                <P>
                    <E T="03">Title of Collection:</E>
                     “30 CFR part 583, Negotiated Noncompetitive Agreements for the Use of Outer Continental Shelf Sand, Gravel, and/or Shell Resources.”
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     In 2017, BOEM published a final rule that created part 583 in title 30 of the Code of Federal Regulations to address the use of Outer Continental Shelf (OCS) sand, gravel, and shell resources for shore protection, beach restoration, or coastal wetlands restoration projects by Federal, State, or local government agencies, or for use in construction projects authorized by or funded in whole or in part by the Federal Government.
                </P>
                <P>
                    The OCS Lands Act, 43 U.S.C. 1331 
                    <E T="03">et seq.,</E>
                     authorizes the Secretary of the Interior to prescribe rules and regulations to administer leasing of mineral resources on the OCS. Section 1337(k)(2) of title 43 authorizes the Secretary to “. . . negotiate with any person an agreement for the use of Outer Continental Shelf sand, gravel and shell resources—(i) for use in a program of, or project for, shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, State, or local government agency; or (ii) for use in a construction project . . . that is funded in whole or in part by or authorized by the Federal Government.” The Secretary delegated this authority to BOEM.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1010-0191.
                </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>
                     Potential respondents include Federal, State, or local governments.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     45 responses.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     299 hours (Hours are same as currently approved).
                </P>
                <P>
                    <E T="03">Respondent's Obligation:</E>
                     Required to retain or obtain 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>
                     BOEM has identified no non-hour paperwork cost burdens for this collection.
                </P>
                <P>
                    <E T="03">Estimated Reporting and Recordkeeping Hour Burden:</E>
                     BOEM estimates that the annual reporting burden for this collection is 299 hours. BOEM has reviewed the hour burdens for requested information under this subpart. The following table details the regulatory sections containing information collections and their respective hour burden estimates.
                </P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,r150,12,12,12">
                    <TTITLE>Burden Table</TTITLE>
                    <BOXHD>
                        <CHED H="1">Citation 30 CFR 583 subpart A</CHED>
                        <CHED H="1">Reporting and recordkeeping requirement</CHED>
                        <CHED H="1">Hour burden</CHED>
                        <CHED H="1">
                            Average
                            <LI>number of</LI>
                            <LI>annual</LI>
                            <LI>responses</LI>
                        </CHED>
                        <CHED H="1">Annual burden hours</CHED>
                    </BOXHD>
                    <ROW EXPSTB="04" RUL="s">
                        <ENT I="21">
                            <E T="02">Subpart A—General—Federal, State, &amp; local governments</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00" RUL="n,n,s">
                        <ENT I="01">125</ENT>
                        <ENT>Apply for reconsideration to the BOEM Director within 15 days of notification; include statement of reasons; 1 copy to program office.</ENT>
                        <ENT>4</ENT>
                        <ENT>1</ENT>
                        <ENT>4</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total Subpart A</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>1 </ENT>
                        <ENT>4 </ENT>
                    </ROW>
                </GPOTABLE>
                <GPOTABLE COLS="5" OPTS="L2(0,,),ns,tp0,i1" CDEF="s50,r150,12,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Citation 30 CFR 583 subpart C</CHED>
                        <CHED H="1">Reporting and recordkeeping requirement</CHED>
                        <CHED H="1">Hour burden</CHED>
                        <CHED H="1">
                            Average
                            <LI>number of</LI>
                            <LI>annual</LI>
                            <LI>responses</LI>
                        </CHED>
                        <CHED H="1">Annual burden hours</CHED>
                    </BOXHD>
                    <ROW EXPSTB="04" RUL="s">
                        <ENT I="21">
                            <E T="02">Subpart C—OCS Sand, Gravel, &amp; Shell Resources Negotiated Agreements—State &amp; local governments</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">300</ENT>
                        <ENT>Submit to BOEM a written request to obtain agreement; including, but not limited to: detailed description of project; borrow area(s) and placement area(s); maps (geographic coordinates); G&amp;G data; description/documentation of environmental evaluations; target dates; description of parties involved; status of required permits, licenses, or authorizations; description of potential conflicts with CZMA plans and other applicable requirements; points of contact info. of all parties involved; statement of funding</ENT>
                        <ENT>20</ENT>
                        <ENT>8</ENT>
                        <ENT>160</ENT>
                    </ROW>
                    <ROW RUL="n,n,s,s,n">
                        <ENT I="01">305; 310(d)</ENT>
                        <ENT>Submit additional information as requested by BOEM</ENT>
                        <ENT>5</ENT>
                        <ENT>5</ENT>
                        <ENT>25</ENT>
                    </ROW>
                    <ROW RUL="n,n,s,s,n">
                        <ENT I="01">315(b);</ENT>
                        <ENT>Request BOEM Director reconsideration of a disapproved agreement</ENT>
                        <ENT A="01">Burden covered under 30 CFR 583 Subpart A</ENT>
                        <ENT>0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">315(c)-(e)</ENT>
                        <ENT>Review, comment, and negotiate draft agreement; sign and return copies for execution by BOEM</ENT>
                        <ENT>8</ENT>
                        <ENT>8</ENT>
                        <ENT>64</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">335(a)</ENT>
                        <ENT>Submit written notification to BOEM once resources authorized are obtained</ENT>
                        <ENT>2</ENT>
                        <ENT>8</ENT>
                        <ENT>16</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">340</ENT>
                        <ENT>Verify that all contractors comply with 2 CFR 180 &amp; 2 CFR 1400 in contract/transaction</ENT>
                        <ENT>2</ENT>
                        <ENT>8</ENT>
                        <ENT>16</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">345</ENT>
                        <ENT>Submit written request to extend, modify, or change agreement to BOEM at least 180 days before expiration; any necessary information and evaluations documentation requested by BOEM; sign and return amendment; request BOEM Director reconsideration</ENT>
                        <ENT>2</ENT>
                        <ENT>2</ENT>
                        <ENT>4</ENT>
                    </ROW>
                    <ROW RUL="n,n,s">
                        <ENT I="01">345(b)</ENT>
                        <ENT>Submit written request for letter amendment</ENT>
                        <ENT>2</ENT>
                        <ENT>5</ENT>
                        <ENT>10</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total Subpart C</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>44 </ENT>
                        <ENT>295 </ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="34184"/>
                        <ENT I="05">Overall Total</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>45 </ENT>
                        <ENT>299 </ENT>
                    </ROW>
                </GPOTABLE>
                <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. 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>Karen Thundiyil,</NAME>
                    <TITLE>Chief, Office of Regulations, Bureau of Ocean Energy Management.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11308 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4340-98-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Ocean Energy Management</SUBAGY>
                <DEPDOC>[Docket No. BOEM-2023-0029]</DEPDOC>
                <SUBJECT>Notice of Availability of a Final Environmental Impact Statement for Ocean Wind LLC's Proposed Wind Energy Facility Offshore New Jersey</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Ocean Energy Management (BOEM), Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability; final environmental impact statement.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>BOEM announces the availability of the final environmental impact statement (FEIS) for the construction and operations plan (COP) submitted by Ocean Wind LLC (Ocean Wind) for its proposed Ocean Wind 1 Offshore Wind Farm Project (Project) offshore New Jersey. The FEIS analyzes the potential environmental impacts of the Project as described in the COP (the proposed action) and the alternatives to the proposed action. The FEIS will inform BOEM's decision whether to approve, approve with modifications, or disapprove the COP.</P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The FEIS and detailed information about the Project, including the COP, can be found on BOEM's website at: 
                        <E T="03">https://www.boem.gov/renewable-energy/state-activities/ocean-wind-1.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jessica Stromberg, BOEM Office of Renewable Energy Programs, 45600 Woodland Road, Sterling, Virginia 20166, (703) 787-1730 or 
                        <E T="03">jessica.stromberg@boem.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Proposed Action:</E>
                     Ocean Wind seeks approval to construct, operate, and maintain the Project: a wind energy facility and its associated export cables on the Outer Continental Shelf (OCS) offshore New Jersey. The Project would be developed within the range of design parameters outlined in the Ocean Wind 1 COP, subject to applicable mitigation measures. The Project as proposed in the COP would include up to 98 wind turbine generators (WTGs), up to 3 offshore high voltage alternating current substations, inter-array cables linking the individual turbines to the offshore substations, substation interconnector cables linking the substations to each other, offshore export cables, an onshore export cable system, 2 onshore substations, and connections to the existing electrical grid in New Jersey. The WTGs, offshore substations, inter-array cables, and substation interconnector cables would be located on the OCS approximately 13 nautical miles (15 statute miles) southeast of Atlantic City, New Jersey, within the area defined by Renewable Energy Lease OCS-A 0498 (Lease Area). The offshore export cables would be buried below the seabed surface in the OCS and State of New Jersey-owned submerged lands. The onshore export cables, substations, and grid connections would be located in Ocean County and Cape May County, New Jersey.
                </P>
                <P>
                    <E T="03">Alternatives:</E>
                     BOEM considered 26 alternatives when preparing the draft environmental impact statement (DEIS) and carried forward 6 alternatives for further analysis in the DEIS and FEIS. These six alternatives include five action alternatives and the no action alternative. Twenty alternatives were rejected because they did not meet the purpose and need for the proposed action or did not meet screening criteria, which are presented appendix C of the FEIS. The screening criteria included consistency with law and regulations, technical and economic feasibility, environmental impact, and geographic considerations.
                </P>
                <P>
                    <E T="03">Availability of the FEIS:</E>
                     The FEIS, Ocean Wind 1 COP, and associated information are available on BOEM's website at: 
                    <E T="03">https://www.boem.gov/renewable-energy/state-activities/ocean-wind-1.</E>
                     BOEM has distributed digital copies of the FEIS to all parties listed in appendix K of the FEIS. If you require a digital copy of the FEIS on a flash drive or paper copy, BOEM will provide one upon request, as long as copies are available. You may request a flash drive or paper copy of the FEIS by contacting Lisa Landers at (703) 787-1520 or 
                    <E T="03">Lisa.Landers@boem.gov.</E>
                </P>
                <P>
                    <E T="03">Cooperating Agencies:</E>
                     The following 11 Federal agencies and State governmental entities participated as cooperating agencies in the preparation of the FEIS: Bureau of Safety and Environmental Enforcement; U.S. Environmental Protection Agency; National Marine Fisheries Service; National Park Service; U.S. Army Corps of Engineers; U.S. Coast Guard; U.S. Fish and Wildlife Service; Department of Defense; New Jersey Board of Public Utilities; New Jersey Department of Environmental Protection; and New York State Department of State.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     42 U.S.C. 4231 
                    <E T="03">et seq.</E>
                     (NEPA, as amended) and 40 CFR 1506.6.
                </P>
                <SIG>
                    <NAME>Karen Baker,</NAME>
                    <TITLE>Chief, Office of Renewable Energy Programs, Bureau of Ocean Energy Management.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-10890 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4340-98-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">INTERNATIONAL TRADE COMMISSION</AGENCY>
                <DEPDOC>[USITC SE-23-025]</DEPDOC>
                <SUBJECT>Sunshine Act Meetings</SUBJECT>
                <PREAMHD>
                    <HD SOURCE="HED">Agency Holding the Meeting:</HD>
                    <P> United States International Trade Commission.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">TIME AND DATE: </HD>
                    <P>June 1, 2023 at 9:30 a.m.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">PLACE: </HD>
                    <P>Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">STATUS: </HD>
                    <P>Open to the public.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">MATTERS TO BE CONSIDERED:</HD>
                    <P/>
                    <P>
                        1. 
                        <E T="03">Agendas for future meetings:</E>
                         none.
                    </P>
                    <P>2. Minutes.</P>
                    <P>3. Ratification List.</P>
                    <P>4. Commission vote on Inv. Nos. 731-TA-1064 and 1066-1068 (Third Review) (Frozen Warmwater Shrimp from China, India, Thailand, and Vietnam). The Commission currently is scheduled to complete and file its determinations and views of the Commission on June 20, 2023.</P>
                    <P>
                        5. 
                        <E T="03">Outstanding action jackets:</E>
                         none.
                    </P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">CONTACT PERSON FOR MORE INFORMATION: </HD>
                    <P>Sharon Bellamy, Acting Supervisory Hearings and Information Officer, 202-205-2000.</P>
                    <P>
                        The Commission is holding the meeting under the Government in the 
                        <PRTPAGE P="34185"/>
                        Sunshine Act, 5 U.S.C. 552(b). In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
                    </P>
                </PREAMHD>
                <SIG>
                    <P>By order of the Commission.</P>
                    <DATED>Issued: May 23, 2023.</DATED>
                    <NAME>Lisa Barton,</NAME>
                    <TITLE>Secretary to the Commission.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11360 Filed 5-24-23; 11:15 am]</FRDOC>
            <BILCOD>BILLING CODE 7020-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF JUSTICE</AGENCY>
                <DEPDOC>[OMB Number 1140-0020]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Proposed eCollection eComments Requested; Firearms Transaction Record/Registro de Transacción de Armas de Fuego</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>30-Day notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), Department of Justice (DOJ), will be submitting 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. The proposed information collection was previously published in the 
                        <E T="04">Federal Register</E>
                         on March 7, 2023, allowing a 60-day comment period.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments are encouraged and will be accepted for 30 days until June 26, 2023.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        John R. Carlson, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, 202-890-7240, or Two Constitution Square, 145 N Street NE, 4W-218 Washington, DC 20530. If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or send to 
                        <E T="03">OIRA_submissions@omb.eop.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">—Enhance the quality, utility, and clarity of the information to be collected; and/or</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>
                <P>
                    Written comments and recommendations for this 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 and entering either the title of the information collection or the OMB Control Number 1140-0020. This information collection request may be viewed at 
                    <E T="03">www.reginfo.gov.</E>
                     Follow the instructions to view Department of Justice, information collections currently under review by OMB.
                </P>
                <P>DOJ seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOJ notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.</P>
                <P>Overview of this information collection:</P>
                <P>
                    1. 
                    <E T="03">Type of Information Collection:</E>
                     Revision of a previously approved collection.
                </P>
                <P>
                    2. 
                    <E T="03">Title of the Form/Collection:</E>
                     Firearms Transaction Record/Registro de Transacción de Armas de Fuego.
                </P>
                <P>
                    3. 
                    <E T="03">Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection:</E>
                     Form number: ATF Form 4473 (5300.9).
                </P>
                <P>
                    <E T="03">Component:</E>
                     Bureau of Alcohol, Tobacco, Firearms and Explosives, 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">Affected Public:</E>
                     Individuals or households.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The Firearms Transaction Record/Registro de Transacción de Armas de Fuego allows Federal firearms licensees to determine the eligibility of persons purchasing firearms. It also alerts buyers to certain restrictions on the receipt and possession of firearms.
                </P>
                <P>
                    5. 
                    <E T="03">Obligation to Respond:</E>
                     Mandatory per 27 CFR 478.124.
                </P>
                <P>
                    6. 
                    <E T="03">Total Estimated Number of Respondents:</E>
                     16,102,962.
                </P>
                <P>
                    7. 
                    <E T="03">Total Estimated Number of Responses:</E>
                     16,102,962.
                </P>
                <P>
                    8. 
                    <E T="03">Time per Response:</E>
                     30 minutes.
                </P>
                <P>
                    9. 
                    <E T="03">Total Estimated Annual Time Burden:</E>
                     8,051,481 hours.
                </P>
                <P>
                    10. 
                    <E T="03">Total Estimated Annual Other Costs Burden:</E>
                     $0.
                </P>
                <P>If additional information is required, contact: John R. Carlson, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC 20530.</P>
                <SIG>
                    <DATED>Dated: May 11, 2023.</DATED>
                    <NAME>John R. Carlson,</NAME>
                    <TITLE>Department Clearance Officer for PRA, U.S. Department of Justice.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-10421 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-XX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <DEPDOC>[OMB Number 1117-0014]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Proposed eCollection, eComments Requested; Revision of a Currently Approved Collection; Application for Registration and Application for Registration Renewal; DEA Forms 224, 224A</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Drug Enforcement Administration, Department of Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>30-Day notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting 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. The proposed information collection was previously published in the 
                        <E T="04">Federal Register</E>
                        , volume 88 volume pages 13469-13470 on March 3, 2023, allowing for a 60 day comment period. No comments were received.
                    </P>
                </SUM>
                <DATES>
                    <PRTPAGE P="34186"/>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments are encouraged and will be accepted for 30 days until June 26, 2023.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact: Scott A. Brinks, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 776-3882.</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 proposed 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>
                <P>
                    Written comments and recommendations for this 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 and entering either the title of the information collection or the OMB Control Number 1117-0014. This information collection request may be viewed at 
                    <E T="03">www.reginfo.gov.</E>
                     Follow the instructions to view Department of Justice, information collections currently under review by OMB.
                </P>
                <P>DOJ seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOJ notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.</P>
                <HD SOURCE="HD1">Overview of This Information Collection</HD>
                <P>
                    1. 
                    <E T="03">Type of Information Collection:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    2. 
                    <E T="03">Title of the Form/Collection:</E>
                     Application for Registration and Application for Registration Renewal.
                </P>
                <P>
                    3. 
                    <E T="03">The agency form number, if any, and the applicable component of the Department sponsoring the collection:</E>
                     DEA Forms: 224, 224A. The applicable component within the Department of Justice is the Drug Enforcement Administration, Diversion Control Division.
                </P>
                <P>
                    4. 
                    <E T="03">Affected public who will be asked or required to respond, as well as a brief abstract:</E>
                     Affected public: Private Sector—business or other for-profit. Abstract: The Controlled Substances Act (CSA) (21 U.S.C. 801-971) requires all persons that manufacture, distribute, dispense, conduct research with, import, or export any controlled substance to obtain a registration issued by the Attorney General. The proposed revisions are implementations of the Restoring Hope for Mental Health and Well-Being Act of 2022, which was a part of the Consolidated Appropriations Act, Public Law 117-328. DEA would be revising the proposed information collections by adding a checkbox to the new application and renewal application for applicants to affirm that they have completed the new eight-hour training requirement. DEA would also be adding three questions to the applications in regards to the training requirements, in which they would be required to answer yes to at least one of the questions in order to proceed.
                </P>
                <P>
                    5. 
                    <E T="03">Obligation to respond:</E>
                     Required to retain or obtain a benefit.
                </P>
                <P>
                    6. 
                    <E T="03">Total Estimated Number of Respondents:</E>
                     # of respondents.
                </P>
                <P>
                    7. 
                    <E T="03">Estimated Time per Respondent:</E>
                     10 minutes for the DEA-224a form and 10 minutes for the DEA-224 form (average time per response is 15 minutes).
                </P>
                <P>
                    8. 
                    <E T="03">Frequency:</E>
                     Once a year.
                </P>
                <P>
                    9. 
                    <E T="03">Total Estimated Annual Time Burden:</E>
                     136,128.
                </P>
                <P>
                    10. 
                    <E T="03">Total Estimated Annual Other Costs Burden:</E>
                     $17,679,160.
                </P>
                <P>If additional information is required, contact: John R. Carlson, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE, 4W-218 Washington, DC 20530.</P>
                <SIG>
                    <DATED>Dated: May 22, 2023.</DATED>
                    <NAME>John R. Carlson,</NAME>
                    <TITLE>Department Clearance Officer for PRA, U.S. Department of Justice.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11329 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-09-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Parole Commission</SUBAGY>
                <SUBJECT>Sunshine Act Meetings</SUBJECT>
                <PREAMHD>
                    <HD SOURCE="HED">DATE AND TIME: </HD>
                    <P>Thursday June 1, 2023, at 1:30 p.m.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">PLACE: </HD>
                    <P>U.S. Parole Commission, 90 K Street NE, 3rd Floor, Washington, DC.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">STATUS: </HD>
                    <P>Open.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">MATTERS TO BE CONSIDERED:</HD>
                    <P/>
                    <P>1. Approval of October 4, 2022, Quarterly Meeting Minutes.</P>
                    <P>2. Updates since October Quarterly Meeting from the Acting Chairman, Commissioner, Acting Chief of Staff/Case Operations Administrator, Case Services Administrator, Executive Officer, and General Counsel.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">CONTACT PERSON FOR MORE INFORMATION: </HD>
                    <P>Jacquelyn Graham, Staff Assistant to the Chairman, U.S. Parole Commission, 90 K Street NE, 3rd Floor, Washington, DC 20530, (202) 346-7010. </P>
                </PREAMHD>
                <SIG>
                    <DATED>Dated: May 2, 2023. </DATED>
                    <NAME>Patricia K. Cushwa,</NAME>
                    <TITLE>Chairman (Acting), U.S. Parole Commission.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11381 Filed 5-24-23; 11:15 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-31-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Occupational Safety and Health Administration</SUBAGY>
                <DEPDOC>[Docket No. OSHA-2010-0008]</DEPDOC>
                <SUBJECT>The Construction Fall Protection Systems Criteria, Practices, and Training Requirements Standard; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Occupational Safety and Health Administration (OSHA), Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for public comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements specified in the Construction Fall Protection Systems Criteria, Practices, and Training Requirements Standard.</P>
                </SUM>
                <DATES>
                    <PRTPAGE P="34187"/>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be submitted (postmarked, sent, or received) by July 25, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P/>
                    <P>
                        <E T="03">Electronically:</E>
                         You may submit comments and attachments electronically at 
                        <E T="03">http://www.regulations.gov,</E>
                         which is the Federal eRulemaking Portal. Follow the instructions online for submitting comments.
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         To read or download comments or other material in the docket, go to 
                        <E T="03">http://www.regulations.gov.</E>
                         Documents in the docket are listed in the 
                        <E T="03">http://www.regulations.gov</E>
                         index; however, some information (
                        <E T="03">e.g.,</E>
                         copyrighted material) is not publicly available to read or download through the website. All submissions, including copyrighted material, are available for inspection through the OSHA Docket Office. Contact the OSHA Docket Office at (202) 693-2350 (TTY (877) 889-5627) for assistance in locating docket submissions.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions must include the agency name and OSHA docket number (OSHA-2010-0008) for the Information Collection Request (ICR). OSHA will place all comments, including any personal information, in the public docket, which may be made available online. Therefore, OSHA cautions interested parties about submitting personal information such as social security numbers and birthdates.
                    </P>
                    <P>
                        For further information on submitting comments, see the “Public Participation” heading in the section of this notice titled 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Seleda Perryman or Theda Kenney, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor; telephone (202) 693-2222.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    The Department of Labor, as part of the continuing effort to reduce paperwork and respondent (
                    <E T="03">i.e.,</E>
                     employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information collection requirements in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, the collection instruments are clearly understood, and OSHA's estimate of the information collection burden is accurate. The Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 
                    <E T="03">et seq.</E>
                    ) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of effort in obtaining information (29 U.S.C. 657).
                </P>
                <P>The following sections describe who uses the information collected under each requirement, as well as how they use it. The Construction Fall Protection Systems Criteria, Practices (29 CFR 1926.502), and Training Requirements (29 CFR 1926.503) Standard require employers to certify safety nets and develop fall protection plans, respectively, and prepare worker training certification records. These standards ensure that employers provide the required fall protection for their workers and provide the required training.</P>
                <HD SOURCE="HD1">II. Special Issues for Comment</HD>
                <P>OSHA has a particular interest in comments on the following issues:</P>
                <P>• Whether the proposed information collection requirements are necessary for the proper performance of the agency's functions to protect workers, including whether the information is useful;</P>
                <P>• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;</P>
                <P>• The quality, utility, and clarity of the information collected; and</P>
                <P>• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection, and transmission techniques.</P>
                <HD SOURCE="HD1">III. Proposed Actions</HD>
                <P>OSHA is requesting that OMB extend the approval of the information collection requirements contained in the Construction Fall Protection Systems Criteria, Practices (29 CFR 1926.502), and Training Requirements (29 CFR 1926.503) Standard. The agency is requesting an adjustment increase in the burden hours from 471,232 hours to 506,903 hours, a difference of 35,671 hours. The adjustment increase is primarily a result of an increase in the number of affected construction establishments going from 378,100 to 406,714 establishments. Also, the number of responses increased from 5,645,796 to 6,072,808.</P>
                <P>OSHA will summarize the comments submitted in response to this notice and will include this summary in the request to OMB to extend the approval of the information collection requirements.</P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Construction Fall Protection Systems Criteria, Practices and Training Requirements.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1218-0197.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profits.
                </P>
                <P>
                    <E T="03"> Number of Respondents:</E>
                     406,714.
                </P>
                <P>
                    <E T="03">Number of Responses:</E>
                     6,072,808.
                </P>
                <P>
                    <E T="03">Frequency of Responses:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Average Time per Response:</E>
                     Varies.
                </P>
                <P>
                    <E T="03">Estimated Total Burden Hours:</E>
                     506,903.
                </P>
                <P>
                    <E T="03">Estimated Cost (Operation and Maintenance):</E>
                     $0.
                </P>
                <HD SOURCE="HD1">IV. Public Participation—Submission of Comments on This Notice and Internet Access to Comments and Submissions</HD>
                <P>
                    You may submit comments in response to this document as follows: (1) electronically at 
                    <E T="03">http://www.regulations.gov,</E>
                     which is the Federal eRulemaking Portal; (2) by facsimile (fax); if your comments, including attachments, are not longer than 10 pages you may fax them to the OSHA Docket Office at 202-693-1648 or (3) by hard copy. All comments, attachments, and other material must identify the agency name and the OSHA docket number for the ICR (Docket No. OSHA-2010-0008). You may supplement electronic submissions by uploading document files electronically.
                </P>
                <P>
                    Comments and submissions are posted without change at 
                    <E T="03">http://www.regulations.gov.</E>
                     Therefore, OSHA cautions commenters about submitting personal information such as social security numbers and dates of birth. Although all submissions are listed in the 
                    <E T="03">http://www.regulations.gov</E>
                     index, some information (
                    <E T="03">e.g.,</E>
                     copyrighted material) is not publicly available to read or download from this website. All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. Information on using the 
                    <E T="03">http://www.regulations.gov</E>
                     website to submit comments and access the docket is available at the website's “User Tips” link. Contact the OSHA Docket Office at (202) 693-2350, (TTY (877) 889-5627) for information about materials not available from the website, and for assistance in using the internet to locate docket submissions.
                    <PRTPAGE P="34188"/>
                </P>
                <HD SOURCE="HD1">V. Authority and Signature</HD>
                <P>
                    James S. Frederick, Deputy Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506 
                    <E T="03">et seq.</E>
                    ) and Secretary of Labor's Order No. 8-2020 (85 FR 58393).
                </P>
                <SIG>
                    <DATED>Signed at Washington, DC, on May 22, 2023.</DATED>
                    <NAME>James S. Frederick,</NAME>
                    <TITLE>Deputy Assistant Secretary of Labor for Occupational Safety and Health.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11253 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-26-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Occupational Safety and Health Administration</SUBAGY>
                <DEPDOC>[Docket No.: OSHA-2022-0001]</DEPDOC>
                <SUBJECT>Advisory Committee on Construction Safety and Health (ACCSH)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Occupational Safety and Health Administration (OSHA), Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of ACCSH Membership.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On May 5, 2023, the Acting Secretary appointed 15 members to serve on the Advisory Committee on Construction Safety and Health (ACCSH).</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        <E T="03">For press inquiries:</E>
                         Mr. Frank Meilinger, Director, OSHA Office of Communications; telephone: (202) 693-1999; email: 
                        <E T="03">meilinger.francis2@dol.gov.</E>
                    </P>
                    <P>
                        <E T="03">For general information about ACCSH and ACCSH membership:</E>
                         Mr. Damon Bonneau, OSHA, Directorate of Construction; telephone: (202) 693-2020; email: 
                        <E T="03">bonneau.damon@dol.gov.</E>
                    </P>
                    <P>
                        <E T="03">Copies of this</E>
                          
                        <E T="7462">Federal Register</E>
                          
                        <E T="03">document:</E>
                         Electronic copies of this 
                        <E T="04">Federal Register</E>
                         document are available at 
                        <E T="03">https://www.regulations.gov.</E>
                         This document, as well as news releases and other relevant information, are also available on the OSHA web page at 
                        <E T="03">https://www.osha.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    ACCSH advises the Secretary of Labor and the Assistant Secretary of Labor for Occupational Safety and Health (Assistant Secretary) in the formulation of standards affecting the construction industry, and on policy matters arising in the administration of the safety and health provisions under the Contract Work Hours and Safety Standards Act (Construction Safety Act (CSA)) (40 U.S.C. 3701 
                    <E T="03">et seq.</E>
                    ) and the Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 
                    <E T="03">et seq.</E>
                    ) (see also 29 CFR 1911.10 and 1912.3). In addition, the CSA and OSHA regulations require the Assistant Secretary to consult with ACCSH before the agency proposes occupational safety and health standards affecting construction activities (40 U.S.C. 3704; 29 CFR 1911.10).
                </P>
                <P>
                    ACCSH operates in accordance with the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. App. 2), and the implementing regulations (41 CFR 102-3 
                    <E T="03">et seq.</E>
                    ); and Department of Labor Manual Series Chapter 1-900 (8/31/2020). ACCSH generally meets two to four times a year.
                </P>
                <HD SOURCE="HD1">II. Appointment of Committee Members:</HD>
                <P>ACCSH consists of 15 members whom the Secretary appoints. ACCSH members generally serve two-year terms, unless they resign, cease to be qualified, become unable to serve, or the Secretary removes them (29 CFR 1912.3(e)). The Secretary may appoint ACCSH members to successive terms. The allocation of members for each category of ACCSH membership is:</P>
                <P>• Five members who are qualified by experience and affiliation to present the viewpoint of employees in the construction industry;</P>
                <P>• Five members who are similarly qualified to present the viewpoint of employers in the construction industry;</P>
                <P>• Two public members, qualified by knowledge and experience to make a useful contribution to the work of ACCSH, such as those who have professional or technical experience and competence with occupational safety and health in the construction industry;</P>
                <P>• Two representatives of State safety and health agencies; and</P>
                <P>• One representative designated by the Secretary of the Department of Health and Human Services.</P>
                <P>OSHA received nominations of highly qualified individuals in response to the agency's request for nominations (87 FR 73333, November 29, 2022). The Acting Secretary appointed individuals to serve on the Committee who have broad experience relevant to the issues to be examined by the Committee. The ACCSH membership is as follows:</P>
                <HD SOURCE="HD2">Employee Representatives</HD>
                <P>• Christina Trahan Cain, North America's Building Trades Unions (ACCSH Chair);</P>
                <P>• Liliana A. Calderon, International Union of Bricklayers and Allied Craftworkers;</P>
                <P>• Ryan Papariello, Laborers Health and Safety Fund of North America;</P>
                <P>• Kenneth G. Seal, International Union of Painters and Allied Trades; and</P>
                <P>• Robert Seman, International Union of Operating Engineers.</P>
                <HD SOURCE="HD2">Employer Representatives</HD>
                <P>• Kevin Cannon, The Associated General Contractors of America;</P>
                <P>• Matthew Compher, Quanta Services, Inc.;</P>
                <P>• Michael P. Lawler, Walsh Construction Company;</P>
                <P>• Greg Sizemore, Associated Builders and Contractors; and</P>
                <P>• Mindy Uber, Skanska USA Building, Inc.</P>
                <HD SOURCE="HD2">Public Representatives</HD>
                <P>• Dr. Marissa G. Baker, University of Washington; and</P>
                <P>• Eric D. Fidler, The Manitowoc Company, Inc.</P>
                <HD SOURCE="HD2">State Representatives</HD>
                <P>• Christopher Scott Mabry, North Carolina Department of Labor; and</P>
                <P>• Charles Stribling, Kentucky Labor Cabinet Department of Workplace Standards.</P>
                <HD SOURCE="HD2">Federal Representative</HD>
                <P>• Dr. G. Scott Earnest, National Institute for Occupational Safety and Health.</P>
                <HD SOURCE="HD1">Authority and Signature</HD>
                <P>James S. Frederick, Deputy Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice pursuant to 29 U.S.C. 655, 40 U.S.C. 3704, Secretary of Labor's Order No. 8-2020 (85 FR 58393), 5 U.S.C. App. 2, and 29 CFR part 1912.</P>
                <SIG>
                    <DATED>Signed at Washington, DC, on May 18, 2023.</DATED>
                    <NAME>James S. Frederick,</NAME>
                    <TITLE>Deputy Assistant Secretary of Labor for Occupational Safety and Health.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11248 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-26-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Occupational Safety and Health Administration</SUBAGY>
                <DEPDOC>[Docket No. OSHA-2010-0009]</DEPDOC>
                <SUBJECT>The Standard on Presence Sensing Device Initiation (PSDI); Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Occupational Safety and Health Administration (OSHA), Labor.</P>
                </AGY>
                <ACT>
                    <PRTPAGE P="34189"/>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for public comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements specified in the Standard on Presence Sensing Device Initiation (PSDI).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be submitted (postmarked, sent, or received) by July 25, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P/>
                    <P>
                        <E T="03">Electronically:</E>
                         You may submit comments and attachments electronically at 
                        <E T="03">http://www.regulations.gov,</E>
                         which is the Federal eRulemaking Portal. Follow the instructions online for submitting comments.
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         To read or download comments or other material in the docket, go to 
                        <E T="03">http://www.regulations.gov.</E>
                         Documents in the docket are listed in the 
                        <E T="03">http://www.regulations.gov</E>
                         index; however, some information (
                        <E T="03">e.g.,</E>
                         copyrighted material) is not publicly available to read or download through the website. All submissions, including copyrighted material, are available for inspection through the OSHA Docket Office. Contact the OSHA Docket Office at (202) 693-2350 (TTY (877) 889-5627) for assistance in locating docket submissions.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions must include the agency name and OSHA docket number (Docket No. OSHA-2010-0009) for the Information Collection Request (ICR). OSHA will place all comments, including any personal information, in the public docket, which may be made available online. Therefore, OSHA cautions interested parties about submitting personal information such as social security numbers and birthdates.
                    </P>
                    <P>
                        For further information on submitting comments, see the “Public Participation” heading in the section of this notice titled 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        . 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Seleda Perryman or Theda Kenney, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor;telephone (202) 693-2222.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    The Department of Labor, as part of the continuing effort to reduce paperwork and respondent (
                    <E T="03">i.e.,</E>
                     employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information collection requirements in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, the collection instruments are clearly understood, and OSHA's estimate of the information collection burden is accurate. The Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 
                    <E T="03">et seq.</E>
                    ) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of effort in obtaining information (29 U.S.C. 657).
                </P>
                <P>
                    The following sections describe who uses the information collected under each requirement, as well as how they use it. Paragraph 1910.217(h) regulates the use of presence sensing devices (“PSDs”) used to initiate the operation of mechanical power presses; a PSD (
                    <E T="03">e.g.,</E>
                     a photoelectric field or curtain) automatically stops the stroke of a mechanical power press when the device detects an operator entering a danger zone near the press. A mechanical power press using presence sensing device initiation (PSDI) automatically starts (initiates) the stroke when the device detects no operator within the danger zone near the press. The certification/validation of safety systems for PSDI shall consider the press, controls, safeguards, operator, and environment as an integrated system which shall comply with 29 CFR 1910.217(a) through (h). Accordingly, the Standard protects employees from serious crush injuries, amputations, and death.
                </P>
                <HD SOURCE="HD1">II. Special Issues for Comment</HD>
                <P>OSHA has a particular interest in comments on the following issues:</P>
                <P>• Whether the proposed information collection requirements are necessary for the proper performance of the agency's functions to protect workers, including whether the information is useful;</P>
                <P>• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;</P>
                <P>• The quality, utility, and clarity of the information collected; and</P>
                <P>• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection, and transmission techniques.</P>
                <HD SOURCE="HD1">III. Proposed Actions</HD>
                <P>OSHA is requesting that OMB extend the approval of the information collection requirements contained in the Standard on Presence Sensing Device Initiation (PSDI) (29 CFR 1910.217(h)). The agency is requesting to retain its previous burden hour estimate of one (1) hour. There are no program changes or adjustments associated with the information collection requirement in the Standard. Additional requirements for DOL has estimated 10 responses in order to have the ICR comport to regulation 5 CFR 1320.3(c)(4)(i), which deems any rule of general applicability to involve at least 10 respondents. OSHA will summarize the comments submitted in response to this notice and will include this summary in the request to OMB to extend the approval of the information collection requirements.</P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Title:</E>
                     The Standard on Presence Sensing Device Initiation.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1218-0143.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profits.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     10.
                </P>
                <P>
                    <E T="03">Number of Responses:</E>
                     10.
                </P>
                <P>
                    <E T="03">Frequency of Responses:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Average Time per Response:</E>
                     6 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Burden Hours:</E>
                     1.
                </P>
                <P>
                    <E T="03">Estimated Cost (Operation and Maintenance):</E>
                     $0.
                </P>
                <HD SOURCE="HD1">IV. Public Participation—Submission of Comments on This Notice and Internet Access to Comments and Submissions</HD>
                <P>
                    You may submit comments in response to this document as follows: (1) electronically at 
                    <E T="03">http://www.regulations.gov,</E>
                     which is the Federal eRulemaking Portal; (2) by facsimile (fax); if your comments, including attachments, are not longer than 10 pages you may fax them to the OSHA Docket Office at 202-693-1648 or (3) by hard copy. All comments, attachments, and other material must identify the agency name and the OSHA docket number for the ICR (Docket No. OSHA-2010-0009). You may supplement electronic submissions by uploading document files electronically.Comments and submissions are posted without change at 
                    <E T="03">http://www.regulations.gov.</E>
                     Therefore, OSHA cautions commenters about submitting personal information 
                    <PRTPAGE P="34190"/>
                    such as social security numbers and dates of birth. Although all submissions are listed in the 
                    <E T="03">http://www.regulations.gov</E>
                     index, some information (
                    <E T="03">e.g.,</E>
                     copyrighted material) is not publicly available to read or download from this website. All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. Information on using the 
                    <E T="03">http://www.regulations.gov</E>
                     website to submit comments and access the docket is available at the website's “User Tips” link.
                </P>
                <P>Contact the OSHA Docket Office at (202) 693-2350, (TTY (877) 889-5627) for information about materials not available from the website, and for assistance in using the internet to locate docket submissions.</P>
                <HD SOURCE="HD1">V. Authority and Signature</HD>
                <P>
                    James S. Frederick, Deputy Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506 
                    <E T="03">et seq.</E>
                    ) and Secretary of Labor's Order No. 8-2020 (85 FR 58393).
                </P>
                <SIG>
                    <DATED>Signed at Washington, DC, on May 19, 2023.</DATED>
                    <NAME>James S. Frederick,</NAME>
                    <TITLE>Deputy Assistant Secretary of Labor for Occupational Safety and Health.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11254 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-26-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                <DEPDOC>[NOTICE: 23-059]</DEPDOC>
                <SUBJECT>Name of Information Collection: Improving Customer Experience (OMB Circular A-11, Section 280 Implementation)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Aeronautics and Space Administration (NASA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The National Aeronautics and Space Administration (NASA) as part of its continuing effort to reduce paperwork and respondent burden, is announcing an opportunity for public comment on a new proposed collection of information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the 
                        <E T="04">Federal Register</E>
                         concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on new collection proposed by the Agency.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments are due by July 25, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Submit comments identified by Information Collection 2700-0181, Improving Customer Experience (OMB Circular A-11, Section 280 Implementation), 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. Comments submitted electronically, including attachments to 
                        <E T="03">https://www.regulations.gov,</E>
                         will be posted to the docket unchanged.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Bill Edwards-Bodmer, NASA Clearance Officer, NASA Headquarters, 300 E Street SW, JF0000, Washington, DC 20546, 757-864-7998, or 
                        <E T="03">b.edwards-bodmer@nasa.gov.</E>
                         A-11 Section 280 Improving Customer Experience.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         Please submit comments only and cite Information Collection 2700-0181, Improving Customer Experience (OMB Circular A-11, Section 280 Implementation), in all correspondence related to this collection. To confirm receipt of your comment(s), please check 
                        <E T="03">regulations.gov,</E>
                         approximately two-to-three business days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Bill Edwards-Bodmer, NASA Clearance Officer, NASA Headquarters, 300 E Street SW, JF0000, Washington, DC 20546, 757-864-7998, or 
                        <E T="03">b.edwards-bodmer@nasa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Abstract</HD>
                <P>
                    Under the PRA, (44 U.S.C. 3501-3520) Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires Federal Agencies to provide a 60-day notice in the 
                    <E T="04">Federal Register</E>
                     concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, NASA is publishing notice of the proposed collection of information set forth in this document.
                </P>
                <P>Whether seeking a loan, Social Security benefits, veterans benefits, or other services provided by the Federal Government, individuals and businesses expect Government customer services to be efficient and intuitive, just like services from leading private-sector organizations. Yet the 2016 American Consumer Satisfaction Index and the 2017 Forrester Federal Customer Experience Index show that, on average, Government services lag nine percentage points behind the private sector.</P>
                <P>A modern, streamlined and responsive customer experience means: Raising government-wide customer experience to the average of the private sector service industry; developing indicators for high-impact Federal programs to monitor progress towards excellent customer experience and mature digital services; and providing the structure (including increasing transparency) and resources to ensure customer experience is a focal point for agency leadership. To support this, OMB Circular A-11 Section 280 established government-wide standards for mature customer experience organizations in government and measurement. To enable Federal programs to deliver the experience taxpayers deserve, they must undertake three general categories of activities: Conduct ongoing customer research, gather and share customer feedback, and test services and digital products.</P>
                <P>
                    These data collection efforts may be either qualitative or quantitative in nature or may consist of mixed methods. Additionally, data may be collected via a variety of means, including but not limited to electronic or social media, direct or indirect observation (
                    <E T="03">i.e.,</E>
                     in person, video and audio collections), interviews, questionnaires, surveys, and focus groups. NASA will limit its inquiries to data collections that solicit strictly voluntary opinions or responses. Steps will be taken to ensure anonymity of respondents in each activity covered by this request.
                </P>
                <P>
                    The results of the data collected will be used to improve the delivery of Federal services and programs. It will include the creation of personas, customer journey maps, and reports and summaries of customer feedback data and user insights. It will also provide government-wide data on customer experience that can be displayed on 
                    <E T="03">performance.gov</E>
                     to help build transparency and accountability of Federal programs to the customers they serve.
                    <PRTPAGE P="34191"/>
                </P>
                <HD SOURCE="HD1">II. Methods of Collection</HD>
                <P>NASA will collect this information by electronic means when possible, as well as by mail, fax, telephone, technical discussions, and in-person interviews.</P>
                <HD SOURCE="HD1">III. Data</HD>
                <P>
                    <E T="03">Title:</E>
                     Improving Customer Experience (OMB Circular A-11, Section 280 Implementation).
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     2700-0181.
                </P>
                <P>
                    <E T="03">Type of review:</E>
                     Extension.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Collections will be targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future. For the purposes of this request, “customers” are individuals, businesses, and organizations that interact with a Federal Government agency or program, either directly or via a Federal contractor. This could include individuals or households; businesses or other for-profit organizations; not-for-profit institutions; State, local or Tribal governments; Federal Government; and universities.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     2,001,550.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     Varied, dependent upon the data collection method used. The possible response time to complete a questionnaire or survey may be 3 minutes or up to 2 hours to participate in an interview.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     101,125.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Cost to Public:</E>
                     $0.
                </P>
                <HD SOURCE="HD1">IV. Request for Comments</HD>
                <P>Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) 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 automated collection techniques or the use of other forms of information technology.</P>
                <P>Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.</P>
                <SIG>
                    <NAME>William Edwards-Bodmer,</NAME>
                    <TITLE>NASA PRA Clearance Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11324 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7510-13-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                <DEPDOC>[NOTICE: 23-058]</DEPDOC>
                <SUBJECT>Name of Information Collection: NASA Grant Application Demographic Data</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Aeronautics and Space Administration (NASA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments are due by June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for these information collections 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>
                        Requests for additional information or copies of these information collection instruments and instructions should be directed to Bill Edwards-Bodmer, NASA Clearance Officer, NASA Headquarters, 300 E Street SW, JF0000, Washington, DC 20546, call 757-864-7998, or email 
                        <E T="03">b.edwards-bodmer@nasa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">2700-0161</HD>
                <HD SOURCE="HD1">I. Abstract</HD>
                <P>A Federal grant is an award of financial assistance from a Federal agency to a recipient to carry out a public purpose of support or stimulation authorized by a law of the United States. The NASA Procurement Office supports NASA research, science, and education communities through the award of research/education/and training grants in the science, technology, engineering, and math (STEM) fields. NASA has a continuing commitment to identify and address inequities associated with its grant review and awards processes. To support that commitment, NASA implemented a process to collect demographic data from grant applicants for the purpose of analyzing demographic differences associated with its award processes. Information collected includes the name, gender, race, ethnicity, disability status, citizenship status, education, and career data of the respondents. Submission of the information is voluntary and is not a precondition of award. However, if the information is not submitted, it will undermine the usefulness of information received from other respondents.</P>
                <HD SOURCE="HD1">II. Methods of Collection</HD>
                <P>Electronic.</P>
                <HD SOURCE="HD1">III. Data</HD>
                <P>
                    <E T="03">Title:</E>
                     NASA Grant Application Demographic Data.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     2700-0161.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Reinstatement of expired information collection in use.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Not-for-profit institutions.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     5,000.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     5 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Public Burden Hours:</E>
                     416.7.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Government Cost:</E>
                     $37,500.
                </P>
                <HD SOURCE="HD1">IV. Request for Comments</HD>
                <P>Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) 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 automated collection techniques or the use of other forms of information technology.</P>
                <P>Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.</P>
                <SIG>
                    <NAME>William Edwards-Bodmer,</NAME>
                    <TITLE>NASA PRA Clearance Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11323 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7510-13-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                <DEPDOC>[NOTICE: (23-057)]</DEPDOC>
                <SUBJECT>Name of Information Collection: Safety and Health Measures and Mishap Reporting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Aeronautics and Space Administration (NASA).</P>
                </AGY>
                <ACT>
                    <PRTPAGE P="34192"/>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments are due by June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for this information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                    </P>
                    <P>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>
                        Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Bill Edwards-Bodmer, NASA Clearance Officer, NASA Headquarters, 300 E Street SW, JF0000, Washington, DC 20546, 757-864-7998, or 
                        <E T="03">b.edwards-bodmer@nasa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Abstract</HD>
                <P>This is a request for authorization to collect information under the NASA Federal Acquisition Regulation Supplement (NFS) Clause, 1852.223-70, Safety and Health Measures and Mishap Reporting, formerly entitled “Safety and Health.” While the clause is proposed to be revised to eliminate some information collected requirements, two distinct information collection requirements will remain (1) notification of a Type A, B, C, or D Mishap, or a close call as defined in NASA Procedural Requirements (NPR) 8621.1 Mishap and Close Call Reporting, Investigating and Recordkeeping, and (2) quarterly reports specifying lost-time frequency rate, number of lost-time injuries, exposure, and accident/incident dollar losses.</P>
                <HD SOURCE="HD1">II. Methods of Collection</HD>
                <P>Electronic.</P>
                <HD SOURCE="HD1">III. Data</HD>
                <P>
                    <E T="03">Title:</E>
                     Safety and Health Measures and Mishap Reporting.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     2700-0160.
                </P>
                <P>
                    <E T="03">Type of review:</E>
                     Reinstatement.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     NASA contract personnel.
                </P>
                <P>
                    <E T="03">Estimated Annual Number of Activities:</E>
                     6.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents per Activity:</E>
                     154.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     924.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     5 hours.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     4,312.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Cost:</E>
                     $70,054.
                </P>
                <HD SOURCE="HD1">IV. Request for Comments</HD>
                <P>Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) 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 automated collection techniques or the use of other forms of information technology. Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.</P>
                <SIG>
                    <NAME>William Edwards-Bodmer,</NAME>
                    <TITLE>NASA PRA Clearance Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11328 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7510-13-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NUCLEAR REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[NRC-2023-0001]</DEPDOC>
                <SUBJECT>Sunshine Act Meetings</SUBJECT>
                <PREAMHD>
                    <HD SOURCE="HED">TIME AND DATE: </HD>
                    <P>
                        Weeks of May 29, June 5, 12, 19, 26, July 3, 2023. The schedule for Commission meetings is subject to change on short notice. The NRC Commission Meeting Schedule can be found on the internet at: 
                        <E T="03">https://www.nrc.gov/public-involve/public-meetings/schedule.html.</E>
                    </P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">PLACE: </HD>
                    <P>
                        The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings or need this meeting notice or the transcript or other information from the public meetings in another format (
                        <E T="03">e.g.,</E>
                         braille, large print), please notify Anne Silk, NRC Disability Program Specialist, at 301-287-0745, by videophone at 240-428-3217, or by email at 
                        <E T="03">Anne.Silk@nrc.gov.</E>
                         Determinations on requests for reasonable accommodation will be made on a case-by-case basis.
                    </P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">STATUS: </HD>
                    <P>Public.</P>
                    <P>
                        Members of the public may request to receive the information in these notices electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555, at 301-415-1969, or by email at 
                        <E T="03">Wendy.Moore@nrc.gov</E>
                         or 
                        <E T="03">Tyesha.Bush@nrc.gov.</E>
                    </P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">MATTERS TO BE CONSIDERED:</HD>
                    <P/>
                </PREAMHD>
                <HD SOURCE="HD1">Week of May 29, 2023</HD>
                <P>There are no meetings scheduled for the week of May 29, 2023.</P>
                <HD SOURCE="HD1">Week of June 5, 2023—Tentative</HD>
                <HD SOURCE="HD2">Friday, June 9, 2023</HD>
                <FP SOURCE="FP-1">10:00 a.m. Meeting with Advisory Committee on Reactor Safeguards (Public Meeting) (Contact: Larry Burkhart: 301-287-3775)</FP>
                <P>
                    <E T="03">Additional Information:</E>
                     The meeting will be held in the Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland. The public is invited to attend the Commission's meeting in person or watch live via webcast at the Web address—
                    <E T="03">https://video.nrc.gov/.</E>
                </P>
                <HD SOURCE="HD1">Week of June 12, 2023—Tentative</HD>
                <HD SOURCE="HD2">Tuesday, June 13, 2023</HD>
                <FP SOURCE="FP-1">10:00 a.m. Briefing on Human Capital and Equal Employment Opportunity (Public Meeting) (Contact: Angie Randall: 301-415-6806)</FP>
                <P>
                    <E T="03">Additional Information:</E>
                     The meeting will be held in the Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland. The public is invited to attend the Commission's meeting in person or watch live via webcast at the Web address—
                    <E T="03">https://video.nrc.gov/.</E>
                </P>
                <HD SOURCE="HD1">Week of June 19, 2023—Tentative</HD>
                <HD SOURCE="HD2">Tuesday, June 20, 2023</HD>
                <FP SOURCE="FP-1">9:00 a.m. Briefing on Results of the Agency Action Review Meeting (Public Meeting) (Contact: Nicole Fields: 630-829-9570)</FP>
                <P>
                    <E T="03">Additional Information:</E>
                     The meeting will be held in the Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland. The public is invited to attend the Commission's meeting in person or watch live via webcast at the Web address—
                    <E T="03">https://video.nrc.gov/.</E>
                </P>
                <HD SOURCE="HD1">Week of June 26, 2023—Tentative</HD>
                <P>There are no meetings scheduled for the week of June 26, 2023.</P>
                <HD SOURCE="HD1">Week of July 3, 2023—Tentative</HD>
                <P>There are no meetings scheduled for the week of July 3, 2023.</P>
                <PREAMHD>
                    <HD SOURCE="HED">CONTACT PERSON FOR MORE INFORMATION: </HD>
                    <P>
                        For more information or to verify the 
                        <PRTPAGE P="34193"/>
                        status of meetings, contact Wesley Held at 301-287-3591 or via email at 
                        <E T="03">Wesley.Held@nrc.gov.</E>
                    </P>
                    <P>The NRC is holding the meetings under the authority of the Government in the Sunshine Act, 5 U.S.C. 552b.</P>
                </PREAMHD>
                <SIG>
                    <DATED> Dated: May 24, 2023.</DATED>
                    <P>For the Nuclear Regulatory Commission.</P>
                    <NAME>Richard J. Laufer,</NAME>
                    <TITLE>Technical Coordinator, Office of the Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11374 Filed 5-24-23; 11:15 am]</FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">POSTAL REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[Docket Nos. CP2022-76; CP2022-92; MC2023-162 and CP2023-166; MC2023-163 and CP2023-167]</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>
                         May 30, 2023.
                    </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. Docketed Proceeding(s)</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the Market Dominant or the Competitive product list, or the modification of an existing product currently appearing on the Market Dominant or the Competitive product list.</P>
                <P>Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each 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 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.</P>
                <P>
                    The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
                    <E T="03">http://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>The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern Market Dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern Competitive product(s), 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 3040, subpart B. Comment deadline(s) for each request appear in section II.</P>
                <HD SOURCE="HD1">II. Docketed Proceeding(s)</HD>
                <P>
                    1. 
                    <E T="03">Docket No(s).:</E>
                     CP2022-76; 
                    <E T="03">Filing Title:</E>
                     USPS Notice of Amendment to Priority Mail Express, Priority Mail, First-Class Package Service &amp; Parcel Select Contract 13, Filed Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     May 19, 2023; 
                    <E T="03">Filing Authority:</E>
                     39 CFR 3035.105; 
                    <E T="03">Public Representative:</E>
                     Kenneth R. Moeller; 
                    <E T="03">Comments Due:</E>
                     May 30, 2023.
                </P>
                <P>
                    2. 
                    <E T="03">Docket No(s).:</E>
                     CP2022-92; 
                    <E T="03">Filing Title:</E>
                     USPS Notice of Amendment to Priority Mail Express, Priority Mail, First-Class Package Service &amp; Parcel Select Contract 18, Filed Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     May 19, 2023; 
                    <E T="03">Filing Authority:</E>
                     39 CFR 3035.105; 
                    <E T="03">Public Representative:</E>
                     Kenneth R. Moeller; 
                    <E T="03">Comments Due:</E>
                     May 30, 2023.
                </P>
                <P>
                    3. 
                    <E T="03">Docket No(s).:</E>
                     MC2023-162 and CP2023-166; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail, First-Class Package Service &amp; Parcel Select Contract 23 to Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     May 19, 2023; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3040.130 through 3040.135, and 39 CFR 3035.105; 
                    <E T="03">Public Representative:</E>
                     Gregory S. Stanton; 
                    <E T="03">Comments Due:</E>
                     May 30, 2023.
                </P>
                <P>
                    4. 
                    <E T="03">Docket No(s).:</E>
                     MC2023-163 and CP2023-167; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail, First-Class Package Service &amp; Parcel Select Contract 120 to Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     May 19, 2023; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3040.130 through 3040.135, and 39 CFR 3035.105; 
                    <E T="03">Public Representative:</E>
                     Gregory S. Stanton; 
                    <E T="03">Comments Due:</E>
                     May 30, 2023.
                </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. 2023-11247 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-FW-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[Docket Nos. MC2023-164 and CP2023-168]</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>
                         May 31, 2023.
                    </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. Docketed Proceeding(s)</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>
                    The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or 
                    <PRTPAGE P="34194"/>
                    removal of a negotiated service agreement from the Market Dominant or the Competitive product list, or the modification of an existing product currently appearing on the Market Dominant or the Competitive product list.
                </P>
                <P>Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each 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 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.</P>
                <P>
                    The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
                    <E T="03">http://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>The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern Market Dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern Competitive product(s), 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 3040, subpart B. Comment deadline(s) for each request appear in section II.</P>
                <HD SOURCE="HD1">II. Docketed Proceeding(s)</HD>
                <P>
                    1. 
                    <E T="03">Docket No(s).:</E>
                     MC2023-164 and CP2023-168; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail, First-Class Package Service &amp; Parcel Select Contract 24 to Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     May 22, 2023; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3040.130 through 3040.135, and 39 CFR 3035.105; 
                    <E T="03">Public Representative:</E>
                     Jennaca D. Upperman; 
                    <E T="03">Comments Due:</E>
                     May 31, 2023.
                </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. 2023-11304 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-FW-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SCIENCE AND TECHNOLOGY POLICY OFFICE</AGENCY>
                <SUBJECT>Request for Information; National Priorities for Artificial Intelligence</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Science and Technology Policy (OSTP).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of request for information.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Biden-Harris Administration is developing a National Artificial Intelligence (AI) Strategy that will chart a path for the United States to harness the benefits and mitigate the risks of AI. This strategy will build on the actions that the Federal Government has already taken to responsibly advance the development and use of AI. To inform this strategy, OSTP requests public comments to help update U.S. national priorities and future actions on AI.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested individuals and organizations are invited to submit comments by 5:00 p.m. ET on July 7, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments must be submitted via the Federal eRulemaking Portal at 
                        <E T="03">regulations.gov.</E>
                         However, if you require an accommodation or cannot otherwise submit your comments via 
                        <E T="03">regulations.gov,</E>
                         please contact the program contact person listed under 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                        . OSTP will not accept comments by fax or by email, or comments submitted after the comment period closes. To ensure that OSTP does not receive duplicate copies, please submit your comments only once. Additionally, please include the Docket ID at the top of your comments.
                    </P>
                    <P>
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">www.regulations.gov</E>
                         to submit your comments electronically. Information on how to use 
                        <E T="03">www.regulations.gov,</E>
                         including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under “FAQ” (
                        <E T="03">https://www.regulations.gov/faq</E>
                        ).
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Privacy Note:</HD>
                    <P>
                        OSTP's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at 
                        <E T="03">www.regulations.gov.</E>
                         Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available. OSTP requests that no proprietary information, copyrighted information, or personally identifiable information be submitted in response to this Request for Information (RFI).
                    </P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     Response to this RFI is voluntary. Each responding entity (individual or organization) is requested to submit only one response.
                </P>
                <P>
                    Responses may address one or more topics, as desired, from the enumerated list provided in this RFI. Responders should note the corresponding topic number(s) in their response. Submissions must not exceed 10 pages (exclusive of cover page and references) in 11-point or larger font. Responses should include the name of the person(s) or organization(s) filing the comment, as well as the respondent type (
                    <E T="03">e.g.,</E>
                     academic institution, advocacy group, professional society, community-based organization, industry, member of the public, government, other). Comments referencing materials that are not widely published should include copies or electronic links of the referenced materials. No business proprietary information, copyrighted information, or personally identifiable information (aside from that requested above) should be submitted in response to this RFI. Comments submitted in response to this RFI may be posted online or otherwise released publicly.
                </P>
                <P>In accordance with Federal Acquisitions Regulations Systems 15.202(3), responses to this notice are not offers and cannot be accepted by the Federal Government to form a binding contract. Additionally, those submitting responses are solely responsible for all expenses associated with response preparation.</P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For additional information, please direct questions to Nik Marda at 
                        <E T="03">AI-Strategy@ostp.eop.gov</E>
                         or 202-456-6121.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Background:</E>
                     AI has been part of American life for years, and it is one of the most powerful technologies of our generation. The pace of AI innovation is accelerating rapidly, which is creating new applications for AI across society. This presents extraordinary opportunities to improve the lives of the American people and solve some of the toughest global challenges. However, it also poses serious risks to democracy, the economy, national security, civil rights, and society at large. To fully harness the benefits of AI, the United States must mitigate AI's risks.
                </P>
                <P>
                    The Biden-Harris Administration has already taken significant steps to advance responsible innovation, protect 
                    <PRTPAGE P="34195"/>
                    the American people's rights and safety, and ensure all Americans benefit from AI. The Federal Government funds significant amounts of responsible research in AI, has issued an updated National AI R&amp;D Strategic Plan, and developed a plan to build a National AI Research Resource to ensure that more researchers have access to tools to leverage AI. The Biden-Harris Administration has protected national security and maintained global competitiveness, including by banning exports to the People's Republic of China of high-end computer chips used to build AI and by developing a strategy for responsible AI in defense. It has laid out a Blueprint for an AI Bill of Rights, an AI Risk Management Framework, provisions across multiple executive orders, and many actions across the Federal Government to promote responsible AI innovation, manage the risks associated with AI, and ensure AI systems are trustworthy and equitable. The Administration has also worked with like-minded partners around the world to assess AI's implications for the workforce, to advance collaborative AI research and development, and to ensure technology works for democracy.
                </P>
                <P>The Biden-Harris Administration is undertaking a process to ensure a cohesive and comprehensive approach to AI-related risks and opportunities. By developing a National AI Strategy, the Federal Government will provide a whole-of-society approach to AI. The strategy will pay particular attention to recent and projected advances in AI, to make sure that the United States is responsive to the latest opportunities and challenges posed by AI, as well as the global changes that will arrive in the coming years. Through this RFI, OSTP and its National AI Initiative Office seeks information about AI and associated actions related to AI that could inform the development of a National AI Strategy.</P>
                <P>OSTP will also draw on public input from ongoing and recent RFIs, including:</P>
                <P>• OSTP's RFI to the Update of the National Artificial Intelligence Research and Development Strategic Plan;</P>
                <P>• The National Telecommunication and Information Administration's Request for Comment on AI Accountability Policy;</P>
                <P>• OSTP's and the National Science Foundation's RFI on Implementing Initial Findings and Recommendations of the National Artificial Intelligence Research Resource Task Force;</P>
                <P>• OSTP's RFI on Automated Worker Surveillance and Management; and</P>
                <P>• OSTP's RFI on Public and Private Sector Uses of Biometric Technologies.</P>
                <P>If you have already responded to one or more of these RFIs, your prior input will be considered in the context of developing the National AI Strategy.</P>
                <P>
                    <E T="03">Scope:</E>
                     OSTP invites input from any interested stakeholders. OSTP will consider each comment, whether it contains a personal narrative, experiences with AI systems, or technical legal, research, policy, or scientific materials, or other content that meets the instructions for submissions to this RFI.
                </P>
                <P>
                    <E T="03">Information Requested:</E>
                     Respondents may provide information for one or more of the questions listed below, as desired. Note that the list below does not cover some AI topics as completely, such as AI research and development, given ongoing or recent RFIs on those topics.
                </P>
                <P>
                    <E T="03">Protecting rights, safety, and national security:</E>
                </P>
                <P>1. What specific measures—such as standards, regulations, investments, and improved trust and safety practices—are needed to ensure that AI systems are designed, developed, and deployed in a manner that protects people's rights and safety? Which specific entities should develop and implement these measures?</P>
                <P>2. How can the principles and practices for identifying and mitigating risks from AI, as outlined in the Blueprint for an AI Bill of Rights and the AI Risk Management Framework, be leveraged most effectively to tackle harms posed by the development and use of specific types of AI systems, such as large language models?</P>
                <P>3. Are there forms of voluntary or mandatory oversight of AI systems that would help mitigate risk? Can inspiration be drawn from analogous or instructive models of risk management in other sectors, such as laws and policies that promote oversight through registration, incentives, certification, or licensing?</P>
                <P>4. What are the national security benefits associated with AI? What can be done to maximize those benefits?</P>
                <P>5. How can AI, including large language models, be used to generate and maintain more secure software and hardware, including software code incorporating best practices in design, coding and post deployment vulnerabilities?</P>
                <P>6. How can AI rapidly identify cyber vulnerabilities in existing critical infrastructure systems and accelerate addressing them?</P>
                <P>7. What are the national security risks associated with AI? What can be done to mitigate these risks?</P>
                <P>8. How does AI affect the United States' commitment to cut greenhouse gases by 50-52% by 2030, and the Administration's objective of net-zero greenhouse gas emissions no later than 2050? How does it affect other aspects of environmental quality?</P>
                <P>
                    <E T="03">Advancing equity and strengthening civil rights:</E>
                </P>
                <P>9. What are the opportunities for AI to enhance equity and how can these be fostered? For example, what are the potential benefits for AI in enabling broadened prosperity, expanding economic and educational opportunity, increasing access to services, and advancing civil rights?</P>
                <P>10. What are the unique considerations for understanding the impacts of AI systems on underserved communities and particular groups, such as minors and people with disabilities? Are there additional considerations and safeguards that are important for preventing barriers to using these systems and protecting the rights and safety of these groups?</P>
                <P>11. How can the United States work with international partners, including low- and middle-income countries, to ensure that AI advances democratic values and to ensure that potential harms from AI do not disproportionately fall on global populations that have been historically underserved?</P>
                <P>
                    12. What additional considerations or measures are needed to assure that AI mitigates algorithmic discrimination, advances equal opportunity, and promotes positive outcomes for all, especially when developed and used in specific domains (
                    <E T="03">e.g.,</E>
                     in health and human services, in hiring and employment practices, in transportation)?
                </P>
                <P>13. How might existing laws and policies be updated to account for inequitable impacts from AI systems? For example, how might existing laws and policies be updated to account for the use of generative AI to create and disseminate non-consensual, sexualized content?</P>
                <P>
                    <E T="03">Bolstering democracy and civic participation:</E>
                </P>
                <P>14. How can AI be used to strengthen civic engagement and improve interactions between people and their government?</P>
                <P>15. What are the key challenges posed to democracy by AI systems? How should the United States address the challenges that AI-generated content poses to the information ecosystem, education, electoral process, participatory policymaking, and other key aspects of democracy?</P>
                <P>
                    16. What steps can the United States take to ensure that all individuals are equipped to interact with AI systems in 
                    <PRTPAGE P="34196"/>
                    their professional, personal, and civic lives?
                </P>
                <P>
                    <E T="03">Promoting economic growth and good jobs:</E>
                </P>
                <P>17. What will the principal benefits of AI be for the people of the United States? How can the United States best capture the benefits of AI across the economy, in domains such as education, health, and transportation? How can AI be harnessed to improve consumer access to and reduce costs associated with products and services? How can AI be used to increase competition and lower barriers to entry across the economy?</P>
                <P>18. How can the United States harness AI to improve the productivity and capabilities of American workers, while mitigating harmful impacts on workers?</P>
                <P>19. What specific measures—such as sector-specific policies, standards, and regulations—are needed to promote innovation, economic growth, competition, job creation, and a beneficial integration of advanced AI systems into everyday life for all Americans? Which specific entities should develop and implement these measures?</P>
                <P>20. What are potential harms and tradeoffs that might come from leveraging AI across the economy? How can the United States promote quality of jobs, protect workers, and prepare for labor market disruptions that might arise from the broader deployment of AI in the economy?</P>
                <P>21. What are the global labor force implications of AI across economies, and what role can the United States play in ensuring workforce stability in other nations, including low- and middle-income countries?</P>
                <P>22. What new job opportunities will AI create? What measures should be taken to strengthen the AI workforce, to ensure that Americans from all backgrounds and regions have opportunities to pursue careers in AI, and otherwise to prepare American workers for jobs augmented or affected by AI?</P>
                <P>23. How can the United States ensure adequate competition in the marketplace for advanced AI systems?</P>
                <P>
                    <E T="03">Innovating in public services:</E>
                </P>
                <P>24. How can the Federal Government effectively and responsibly leverage AI to improve Federal services and missions? What are the highest priority and most cost-effective ways to do so?</P>
                <P>25. How can Federal agencies use shared pools of resources, expertise, and lessons learned to better leverage AI in government?</P>
                <P>26. How can the Federal Government work with the private sector to ensure that procured AI systems include protections to safeguard people's rights and safety?</P>
                <P>27. What unique opportunities and risks would be presented by integrating recent advances in generative AI into Federal Government services and operations?</P>
                <P>28. What can state, Tribal, local, and territorial governments do to effectively and responsibly leverage AI to improve their public services, and what can the Federal Government do to support this work?</P>
                <P>
                    <E T="03">Additional input:</E>
                </P>
                <P>29. Do you have any other comments that you would like to provide to inform the National AI Strategy that are not covered by the questions above?</P>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Stacy Murphy,</NAME>
                    <TITLE>Deputy Chief Operations Officer and Security Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11346 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3270-F1-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[SEC File No. 270-619, OMB Control No. 3235-0681]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request; Extension: Rules 15Ba1-1 Through 15Ba1-8</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 (“PRA”) (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ), the Securities and Exchange Commission (“Commission”) is soliciting comments on the collection of information provided for in Rules 15Ba1-1 to 15Ba1-8 (17 CFR 240.15Ba1-1 to 17 CFR 240.15Ba1-8)—Registration of Municipal Advisors, under the Securities Exchange Act of 1934 (15 U.S.C. 78a 
                    <E T="03">et seq.</E>
                    ) (the “Exchange Act”). The Commission plans to submit this existing collection of information to the Office of Management and Budget (“OMB”) for extension and approval.
                </P>
                <P>
                    On September 20, 2013 (
                    <E T="03">see</E>
                     78 FR 67468, November 12, 2013), the Commission adopted Rules 15Ba1-1 through 15Ba1-8 and Rule 15Bc4-1 under the Exchange Act to establish the rules by which a municipal advisor must obtain, maintain, and terminate its registration with the Commission. In addition, the rules interpret the definition of the term “municipal advisor,” interpret the statutory exclusions from that definition, and provide certain additional regulatory exemptions. The rules became effective on January 13, 2014; however, on January 13, 2014, the Commission temporarily stayed such rules until July 1, 2014 (
                    <E T="03">see</E>
                     79 FR 2777, January 16, 2014). Amendments to Form MA and Form MA-I designed to eliminate aspects of the forms that request filers to provide certain forms of personally identifiable information of natural persons, including Social Security numbers, dates of birth, and foreign identity numbers became effective on May 14, 2018 (
                    <E T="03">see</E>
                     83 FR 22190, May 14, 2018). Section 15B(a)(1) of the Exchange Act makes it unlawful for a municipal advisor to provide advice to or on behalf of a municipal entity or obligated person with respect to municipal financial products or the issuance of municipal securities, or to undertake certain solicitations of a municipal entity or obligated person, unless the municipal advisor is registered with the Commission. The rules, among other things: (i) require municipal advisors to file certain forms (
                    <E T="03">i.e.,</E>
                     Form MA, Form MA-A, Form MA/A, Form MA-I, Form MA-I/A, Form MA-NR, and Form MA-W) with the Commission to obtain, maintain, or terminate their registration with the Commission and maintain certain books and records in accordance with the Exchange Act, and (ii) set forth how certain entities may meet the requirements of the statutory exclusions or regulatory exemptions from the definition of “municipal advisor.”
                </P>
                <HD SOURCE="HD1">Form MA</HD>
                <P>
                    The initial application for municipal advisor registration under Form MA is a one-time reporting burden. The Commission estimates that approximately 15 respondents will submit new Form MA applications annually in each of the next three years.
                    <SU>1</SU>
                    <FTREF/>
                     The Commission further estimates that the average amount of time for a municipal advisor to complete a new Form MA submission will be approximately 3.5 hours. Thus, the total annual burden borne by respondents for submitting an initial Form MA application will be approximately 53 hours.
                    <SU>2</SU>
                    <FTREF/>
                     The Commission estimates that respondents submitting new Form MA applications would, on average, consult with outside counsel for one hour, at a rate of $518/hour. Thus, the Commission estimates that the average total annual cost that 
                    <PRTPAGE P="34197"/>
                    may be incurred by all respondents filing new Form MA applications will be $7,770.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The estimate is derived by averaging the number of Form MA filings over the last three years. There were 21 Form MA submissions in 2020, 16 Form MA submissions in 2021, and 8 Form MA submissions in 2022.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         15 respondents × 3.5 hours = 52.5 hours.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         15 respondents × ($518/hour × 1 hour) = $7,770.
                    </P>
                </FTNT>
                <P>
                    In addition to filing initial Form MA applications, the rules require municipal advisors to amend Form MA once annually (Form MA-A) and after the occurrence of any enumerated material event (Form MA/A). The requirement to amend Form MA applies to all registered municipal advisors. As of December 31, 2022, there were approximately 446 municipal advisors registered with the Commission and, as noted above, the Commission anticipates receiving 15 new Form MA submissions annually in each of the next three years; however, the Commission also estimates that it will receive an average of 35 withdrawals on Form MA-W annually in each of the next three years,
                    <SU>4</SU>
                    <FTREF/>
                     and the Commission further estimates that it will enter orders cancelling or revoking the registration of 9 municipal advisors on average in each of the next three years,
                    <SU>5</SU>
                    <FTREF/>
                     for a net decrease of 29 municipal advisors annually in each of the next three years.
                    <SU>6</SU>
                    <FTREF/>
                     Therefore, the Commission expects that the rules' requirement to amend Form MA will apply to approximately 417 municipal advisors in year one, approximately 388 municipal advisors in year two, and approximately 359 municipal advisors in year three. The Commission estimates that the average amount of time for a municipal advisor to prepare an annual amendment to Form MA would be 1.5 hours, and the average amount of time necessary to prepare any interim updating amendment to Form MA other than the required annual amendment would be 0.5 hours. The Commission further estimates that each municipal advisor will likely submit two amendments annually in each of the next three years (one Form MA-A and one Form MA/A). Thus, the Commission estimates that the average annual burden borne by respondents for amending Form MA during the three-year period will be approximately 776 hours.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See infra</E>
                         Form MA-W section.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         The estimate is derived by averaging the number of CANCELLATION-MA and REVOCATION-MA filings over the last three years. There were 0 CANCELLATION-MA filings in 2020, 18 CANCELLATION-MA filings in 2021, and 9 CANCELLATION-MA filings in 2022. There were 0 REVOCATION-MA filings in 2020, 0 REVOCATION-MA filings in 2021, and 0 REVOCATION-MA filings in 2022. ((0 + 0) + (18 + 0) + (9 + 0))/3 = 9.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         15−(35 + 9) =−29.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         ((417 respondents × 2 hours) + (388 respondents × 2 hours) + (359 respondents × 2 hours))/3 = 776 hours.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Form MA-I</HD>
                <P>
                    The initial completion of Form MA-I for each natural person who is a person associated with a municipal advisor is a one-time reporting burden. The Commission estimates that it will receive approximately 330 new Form MA-I submissions annually in each of the next three years.
                    <SU>8</SU>
                    <FTREF/>
                     The Commission further estimates that the average amount of time for a municipal advisor to complete a new Form MA-I submission will be approximately three hours. Thus, the total annual burden borne by respondents submitting an initial Form MA-I will be approximately 990 hours.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         The estimate is derived by averaging the number of Form MA-I submissions over the last three years and rounding up. There were 293 Form MA-I submissions in 2020, 363 Form MA-I submissions in 2021, and 332 Form MA-I submissions in 2022.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         330 submissions × 3 hours = 990 hours.
                    </P>
                </FTNT>
                <P>
                    In addition, municipal advisors will need to complete updating amendments to Form MA-I whenever the information previously provided therein becomes inaccurate, or to indicate that the individual is no longer an associated person of the municipal advisor or no longer engages in municipal advisory activities on its behalf. The Commission estimates that a Form MA-I respondent will submit an average of 2.39 updating amendments annually in each of the next three years (Form MA-I/A), and that each such amendment will take approximately 0.5 hours to complete.
                    <SU>10</SU>
                    <FTREF/>
                     As of December 31, 2022, there were approximately 3,254 Form MA-Is on file with the Commission for natural persons actively associated with a municipal advisor 
                    <SU>11</SU>
                    <FTREF/>
                     and, as noted above, the Commission anticipates receiving 330 new Form MA-I submissions annually in each of the next three years. Therefore, the Commission expects the rules' requirement to amend Form MA-I to apply to approximately 3,584 Form MA-Is in year one, approximately 3,914 Form MA-Is in year two, and approximately 4,244 Form MA-Is in year three. Thus, the Commission estimates that the average annual burden borne by respondents submitting Form MA-I amendments during the three-year period will be approximately 4,677 hours.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         The estimate is derived by averaging the number of updating amendments submitted by respondents over the last three years. In 2020, the average number was 1,080 Form MA-I/As/525 municipal advisors = 2.06. In 2021, the average number was 1,163 Form MA-I/As/477 municipal advisors = 2.44. In 2022, the average number was 1,188 Form MA-I/As/446 municipal advisors = 2.66. Averaging the average number of updating amendments for the last three years: (2.06 (2020) + 2.44 (2021) + 2.66 (2022))/3 = 2.39 updating amendments per year.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         The estimated number of active Form MA-I filings is derived by taking the total number of Form MA-I submissions filed with the Commission from the inception of the rules to December 31, 2022, and subtracting the total number of Form MA-I/A withdrawals filed with the Commission from the inception of the rules to December 31, 2022. 8,488 (Form MA-I submissions)−5,234 (Form MA-I/A withdrawals) = 3,254 active Form MA-Is on file.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         (((3,584 Form MA-I/As × (2.39 amendments × 0.5 hours)) + ((3,914 Form MA-I/As × (2.39 amendments × 0.5 hours)) + ((4,244 Form MA-I/As × (2.39 amendments × 0.5 hours)))/3 = 4,677.23 hours.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Form MA-W</HD>
                <P>
                    Withdrawal from municipal advisor registration is a one-time reporting burden. The Commission estimates that it will receive an average of 35 Form MA-W submissions annually in each of the next three years.
                    <SU>13</SU>
                    <FTREF/>
                     The Commission further estimates that the average amount of time for a municipal advisor to complete each Form MA-W submission will be approximately 0.5 hours. Thus, the total annual burden borne by respondents submitting Form MA-W will be approximately 17.5 hours.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         The estimate of 35 Form MA-W submissions is derived by averaging the number of Form MA-W submissions over the last three years and rounding up. There were 28 Form MA-W submissions in 2020, 46 Form MA-W submissions in 2021, and 30 Form MA-W submissions in 2022.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         35 respondents × 0.5 hours = 17.5 hours.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Form MA-NR</HD>
                <P>
                    The designation of a U.S. agent for service of process is a one-time reporting burden. The Commission estimates that approximately three municipal advisors will have a non-resident general partner, non-resident managing agent, or non-resident associated person 
                    <SU>15</SU>
                    <FTREF/>
                     and such advisors will submit a total of approximately five Form MA-NRs annually in each of the next three years.
                    <SU>16</SU>
                    <FTREF/>
                     The Commission further estimates that each Form MA-NR submission will take, on average, approximately one hour to complete. Thus, the total annual burden borne by respondents submitting Form MA-NR will be approximately 5 hours.
                    <SU>17</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         The estimate is derived by averaging the number of Form MA-NR respondents over the last three years and rounding up. There were two Form MA-NR respondents in 2020, one Form MA-NR respondent in 2021, and four Form MA-NR respondents in 2022.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         The estimate is derived by averaging the number of Form MA-NR submissions over the last three years. There were seven Form MA-NR submissions in 2020, two Form MA-NR submissions in 2021, and six Form MA-NR submissions in 2022.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         3 respondents × (5 Form MA-NR submissions/3 respondents) × 1 hour = 5 hours.
                    </P>
                </FTNT>
                <P>
                    In addition, each respondent that submits a Form MA-NR must also provide an opinion of counsel on Form 
                    <PRTPAGE P="34198"/>
                    MA stating that the municipal advisor can, as a matter of law, provide the Commission with access to its books and records as required by law and submit to inspection and examination by the Commission. The Commission estimates that such an opinion of counsel would take three hours to complete, at a rate of $518/hour. Thus, the Commission estimates that the total annual burden borne by respondents providing an opinion of counsel will be approximately nine hours.
                    <SU>18</SU>
                    <FTREF/>
                     The estimated average total cost that may be incurred by all respondents providing an opinion of counsel will be $4,662.
                    <SU>19</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         3 respondents × 3 hours = 9 hours.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         3 respondents × (3 hours × $518/hour) = $4,662.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Consent To Service of Process From Certain Associated Persons</HD>
                <P>
                    The consent to service of process from certain associated persons is a one-time recordkeeping burden. The Commission estimates that all 15 new municipal advisors expected to register with the Commission annually in each of the next three years will have to develop a template document to use in obtaining written consents to service of process from their associated persons. The Commission further estimates that each template document will take approximately one hour to draft. Thus, the Commission estimates that the total annual burden borne by respondents developing a template document will be approximately 15 hours.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         15 respondents × 1 hour = 15 hours.
                    </P>
                </FTNT>
                <P>
                    In addition to the one-time burden borne by new municipal advisors that register with the Commission each year, the Commission estimates that municipal advisors will need to obtain 330 new consents to service of process from associated persons annually in each of the next three years. The Commission further estimates that, after the written consents are drafted, it will take municipal advisors approximately 0.10 hours to obtain each consent. Thus, the Commission estimates that the total annual burden borne by respondents obtaining consents to service of process will be 48 hours.
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         15 hours + (330 respondents × 0.1 hours) = 48 hours.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Books and Records To Be Made and Maintained by Municipal Advisors</HD>
                <P>
                    The maintenance of books and records is an ongoing annual recordkeeping burden. The Commission estimates that approximately 417, 388, and 359 municipal advisors will be subject to the books and records rules annually in each of the next three years, respectively. The Commission further estimates that the average annual burden for a municipal advisor to comply with the books and records requirement is approximately 182 hours. Thus, the Commission estimates that the average annual burden borne by respondents to comply with the books and records requirements during the three-year period will be approximately 70,616 hours.
                    <SU>22</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         ((417 respondents × 182 hours) + (388 respondents × 182 hours) + (359 respondents × 182 hours))/3 = 70,616 hours.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Independent Registered Municipal Advisor Exemption</HD>
                <P>
                    The written representations required pursuant to the exemption when a municipal entity or obligated person is represented by an independent registered municipal advisor is a one-time third-party disclosure burden. The Commission estimates that approximately 188 persons will seek to rely on the independent registered municipal advisor exemption annually in each of the next three years.
                    <SU>23</SU>
                    <FTREF/>
                     The Commission further estimates that the one-time burden of developing a template disclosure document to use in obtaining the written representations will be approximately one hour. Thus, the Commission estimates that the total one-time burden borne by respondents developing a template disclosure document will be approximately 188 hours.
                    <SU>24</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         Estimate based on information obtained from Mergent Municipal Bond Securities Database. The estimate is derived by averaging the number of underwriters that participated in negotiated transactions from 2020 to 2022 and rounding up. There were 193 underwriters that participated in negotiated transactions in 2020, 191 underwriters that participated in negotiated transactions in 2021, and 178 underwriters that participated in negotiated transactions in 2022.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         188 respondents × 1 hour = 188 hours.
                    </P>
                </FTNT>
                <P>
                    The Commission also recognizes that respondents will be subject to a recurring burden each time they seek to rely on the exemption. The Commission estimates that respondents may seek the exemption on approximately 12,170 transactions annually in each of the next three years.
                    <SU>25</SU>
                    <FTREF/>
                     The Commission further estimates that the burden of obtaining the written representations needed from the municipal entity or obligated person will be approximately 0.25 hours. Thus, the Commission estimates that the total annual burden borne by respondents seeking to rely on the independent registered municipal advisor exemption will be approximately 3,043 hours.
                    <SU>26</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Estimate based on information obtained from Mergent Municipal Bond Securities Database. The estimate is derived by averaging the number of negotiated deals using an underwriter each year from 2020 to 2022 and rounding up. There were 14,278 negotiated deals using an underwriter in 2020, 11,855 negotiated deals using an underwriter in 2021, and 10,376 negotiated deals using an underwriter in 2022.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         12,170 transactions × 0.25 hours = 3,042.5 hours.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Exception to Definition of Municipal Escrow Investments</HD>
                <P>
                    The written representations required to qualify for the exception for reasonable reliance on representations related to municipal escrow investments is a one-time third-party disclosure burden. The Commission believes that state-registered investment advisers with municipal entity clients are the persons most likely to rely on this exception. The Commission estimates that approximately 432 respondents will seek to rely on the exception.
                    <SU>27</SU>
                    <FTREF/>
                     The Commission further estimates that the one-time burden of creating a template document to use in obtaining the written representations necessary to rely on the exception will be approximately one hour. Thus, the Commission estimates that the total one-time burden borne by respondents developing a template document will be approximately 432 hours.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         The Commission estimates in this section are based on information reported directly by state-registered-only investment advisers (
                        <E T="03">i.e.,</E>
                         not dual registrants) in Item 5.D.(i)(1) within Form ADV, as of December 31, 2022. The number of state-registered investment advisers that reported state or municipal government entity clients in Item 5.D.(i)(1) within Form ADV = 432.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         432 respondents × 1 hour = 432 hours.
                    </P>
                </FTNT>
                <P>
                    The Commission also recognizes that respondents will be subject to a recurring burden each time they seek to rely on the exception. The Commission estimates that the respondents will seek to rely on the exception with approximately 1,356 municipal entity clients.
                    <SU>29</SU>
                    <FTREF/>
                     The Commission further estimates that the burden of obtaining the required written representations from the respondent's client will be approximately 0.25 hours. Thus, the Commission estimates that the total annual burden borne by respondents seeking to rely on the municipal escrow investments exemption will be approximately 339 hours.
                    <SU>30</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         The number of state or municipal government entity clients reported by state-registered investment advisers in Item 5.D.(i)(1) within Form ADV = 1,356.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         1,356 clients × 0.25 hours = 339 hours.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Exception to Definition of Proceeds of Municipal Securities</HD>
                <P>
                    The written representations required to qualify for the exception for reasonable reliance on representations related to proceeds of municipal securities is a one-time third-party disclosure burden. The Commission believes the persons most likely to rely on this exception are state-registered 
                    <PRTPAGE P="34199"/>
                    investment advisers with clients that are: (i) state or municipal government entities, or (ii) certain pooled investment vehicles in which municipal entities invest. The Commission estimates that approximately 479 respondents will seek to rely on the exception.
                    <SU>31</SU>
                    <FTREF/>
                     The Commission further estimates that the one-time burden of creating a template document to use in obtaining the written representations necessary to rely on the exception will be approximately one hour. Thus, the Commission estimates that the total one-time burden borne by respondents developing a template document will be approximately 479 hours.
                    <SU>32</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         The Commission estimates in this section are based on information reported directly by state-registered-only investment advisers (
                        <E T="03">i.e.,</E>
                         not dual registrants) in Items 5.D.(i)(1) and 5.D.(f)(1) within Form ADV, as of December 31, 2022. The number of state-registered investment advisers that reported pooled investment vehicle clients (other than investment company and business development company clients) in Item 5.D.(f)(1) within Form ADV = 592. The percentage of state-registered investment advisers that reported state or municipal government entity clients in Item 5.D.(f)(1) within Form ADV, out of the total number of state-registered investment advisers = 8%. (592 x .08) = approximately 47 state-registered investment advisers with clients that are pooled investment vehicles (other than registered investment companies and business development companies) in which municipal entities invest. The number of state-registered investment advisers that reported state or municipal government entity clients in Item 5.D.(i)(1) within Form ADV = 432. (47 + 432) = 479 respondents.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         479 respondents x 1 hour = 479 hours.
                    </P>
                </FTNT>
                <P>
                    The Commission also recognizes that respondents will be subject to a recurring burden each time they seek to rely on the exception. The Commission estimates that respondents will seek to rely on the exception in connection with services provided to approximately 2,989 clients.
                    <SU>33</SU>
                    <FTREF/>
                     The Commission further estimates that the burden of obtaining the required written representations from the respondent's client will be approximately 0.25 hours. Thus, the Commission estimates that the total annual burden borne by respondents seeking to rely on the proceeds of municipal securities exception will be approximately 747 hours.
                    <SU>34</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         The number of state or municipal government entity clients reported by state-registered investment advisers in Item 5.D.(i)(1) within Form ADV = 1,356 clients. The number of pooled investment vehicle clients (other than investment company and business development company clients) reported by state-registered investment advisers in Item 5.D.(f)(1) within Form ADV = 1,633 clients. (1,356 + 1,633) = 2,989 clients.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         2,989 clients x 0.25 hours = 747.25 hours.
                    </P>
                </FTNT>
                <P>Written comments are invited on: (a) whether this proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (b) the accuracy of the Commission's estimates of the burden imposed by 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 in writing within 60 days of this publication by July 25, 2023.</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 David Bottom, Director/Chief Information Officer, Securities and Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to 
                    <E T="03">PRA_Mailbox@sec.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: May 23, 2023.</DATED>
                    <NAME>Sherry R. Haywood,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11313 Filed 5-25-23; 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. 34-97542; File No. SR-Phlx-2023-18]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Offer Field-Programmable Gate Array Technology as an Optional Delivery Mechanism for PSX TotalView</SUBJECT>
                <DATE>May 22, 2023.</DATE>
                <P>
                    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/>
                     notice is hereby given that on May 12, 2023, Nasdaq PHLX LLC (“Phlx” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. 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>
                         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 offer field-programmable gate array (“FPGA”) technology as an optional delivery mechanism for PSX TotalView.</P>
                <P>
                    The text of the proposed rule change is available on the Exchange's website at 
                    <E T="03">https://listingcenter.nasdaq.com/rulebook/phlx/rules,</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 Exchange 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 these 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 aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    Phlx proposes to offer field-programmable gate array (“FPGA”) technology as an optional delivery mechanism for PSX TotalView.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         A proposal to make FPGA technology also available at the BX Exchange is being submitted together with this proposal. The Exchange initially filed this Proposal on May 4, 2023 (SR-Phlx-2023-17). On May 12, 2023, the Exchange withdrew SR-Phlx-2023-17 and replaced it with the instant filing. This filing corrects an error in the initial submission, but includes no substantive changes.
                    </P>
                </FTNT>
                <P>FPGA technology has been used for over a decade by the Nasdaq Stock Market to facilitate customer ingestion of large quantities of information at periods of peak activity. FPGA hardware is designed to facilitate the processing of large data packets without introducing variable queuing, thereby improving the predictability of data transfer on telecommunications ports, a process known as “determinism.” Outside of peak activity, FPGA helps customers establish more predictable consistency in message throughput over the course of the trading day.</P>
                <P>
                    The Exchange proposes to use FPGA technology to process PSX TotalView data. PSX TotalView is a real-time market data product that provides full order depth using a series of order 
                    <PRTPAGE P="34200"/>
                    messages to track the life of customer orders in the PSX market, as well as trade data for PSX executions and administrative messages such as Trading Action messages, Symbol Directory, and Event Control messages.
                    <SU>4</SU>
                    <FTREF/>
                     PSX TotalView allows users to view all displayed quotes and orders, access total displayed anonymous interest, and see total size of all displayed quotes and orders.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Nasdaq PHLX LLC Rules, Equity 7, Section 3 (Nasdaq PSX Fees), PSX TotalView; 
                        <E T="03">see also</E>
                         Securities Exchange Act Release No. 62876 (September 9, 2010), 75 FR 56624 (September 16, 2010) (SR-Phlx-2010-120) (introducing PSX TotalView as a product).
                    </P>
                </FTNT>
                <P>
                    FPGA technology has been offered by the Nasdaq Stock Exchange for over a decade, and the Nasdaq Options Market for nearly as long,
                    <SU>5</SU>
                    <FTREF/>
                     and has been cited by the SEC as an example of a technology useful in the distribution of market data products.
                    <SU>6</SU>
                    <FTREF/>
                     It is a well-established technology that is familiar to market participants.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 67297 (June 28, 2012), 77 FR 39752 (July 5, 2012) (SR-Nasdaq-2012-063) (introducing FPGA technology); 
                        <E T="03">see also</E>
                         Nasdaq Data News 2012-13, available at 
                        <E T="03">http://www.nasdaqtrader.com/TraderNews.aspx?id=dn2012-13</E>
                         (introducing TotalView FPGA service as of August 1, 2012); Securities Exchange Act Release No. 74745 (April 16, 2015), 80 FR 22588 (April 22, 2015) (SR-Nasdaq-2015-035) (establishing FPGA for the Nasdaq Options Market); 
                        <E T="03">see also</E>
                         The Nasdaq Stock Market LLC Rules, Equity 7, Section 126(c) (Hardware-Based Delivery of Nasdaq Depth data).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 90610, 86 FR 18596, 18647 (April 9, 2021) (File No. S7-03-20) (listing field programmable gate array services as an example of a technological innovation that could be employed by competing consolidators as part of the Market Data Infrastructure rule).
                    </P>
                </FTNT>
                <P>The purchase of FPGA technology is entirely optional because FPGA functionality can be replicated through a variety of software solutions. Our experience with Nasdaq TotalView is that some customers use FPGA technology to address determinism, others avail themselves of software solutions, some use both, and others alternate between both. Some market participants that have purchased FPGA technology in the past have discontinued its use. There are no systematic differences among market participants that choose to use or not to use FPGA technology beyond the compatibility of FPGA technology with the customer's specific technical systems, which can change over time as systems are modified, replaced or updated.</P>
                <P>The proposal to offer FPGA technology to customers of PSX TotalView is in response to customer demand. To date, lower levels of peak activity at the PSX Exchange relative to the Nasdaq Exchange have been associated with low levels of customer interest in this product. Recently, however, PSX has heard from customers interested in using FPGA technology for PSX TotalView. To address this customer demand, and to drive liquidity to the PSX Exchange by making it a more attractive trading venue, PSX has decided to offer this product to meet evolving customer needs.</P>
                <P>The Exchange will submit a proposed fee schedule for this product in a separate filing. The Exchange intends to make this product available on June 1, 2023.</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
                    <SU>7</SU>
                    <FTREF/>
                     in general, and furthers the objectives of Section 6(b)(5) of the Act,
                    <SU>8</SU>
                    <FTREF/>
                     in particular, in that it is designed to promote just and equitable principles of trade, 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>7</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <P>As noted above, the current proposal to offer FPGA technology with PSX TotalView is in response to changes in customer demand. This proposal reflects the need for the Exchange to stay competitive in the market for exchange services. It also promotes competition and innovation by providing market participants additional choices in the transmission of depth of book data.</P>
                <P>Offering this well-recognized technology to customers will facilitate their usage of the data. If the technology is not ultimately beneficial, the customer can discontinue it at any time, and for any reason, as they have done in the past. Customers that choose not to purchase FPGA technology will not be affected because these customers have alternative methods to facilitate determinism available to them.</P>
                <P>Approval of this proposal is in the public interest and otherwise furthers the objectives of Section 6(b)(5) of the Act because it promotes competition, facilitates the ingestion of market data by certain market participants, and has no impact on customers that do not elect to avail themselves of the service.</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 not necessary or appropriate in furtherance of the purposes of the Act.</P>
                <P>Nothing in the Proposal burdens inter-market competition (the competition among self-regulatory organizations) because approval of the Proposal does not impose any burden on the ability of other exchanges to compete. All exchanges are free introduce products that facilitate the ingestion of data at peak periods.</P>
                <P>Nothing in the Proposal burdens intra-market competition (the competition among consumers of exchange data) because FPGA technology will be available to any market participant on a non-discriminatory basis.</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 either solicited or received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    FINRA has filed the proposed rule change pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>9</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6) thereunder.
                    <SU>10</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 proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(6) thereunder.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <P>
                    A proposed rule change filed under Rule 19b-4(f)(6) 
                    <SU>11</SU>
                    <FTREF/>
                     normally does not become operative prior to 30 days after the date of the filing. However, Rule 19b-4(f)(6)(iii) 
                    <SU>12</SU>
                    <FTREF/>
                     permits the Commission to 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 proposal may become operative on June 1 so that any potential customer that wishes to obtain the FPGA service would be able to do so on June 1, 2023. The Exchange argues that an operative date of June 1, 2023 is consistent with the protection of investors and the public interest because market data services are typically initiated at the beginning of a 
                    <PRTPAGE P="34201"/>
                    calendar month, and the June 1 operative date would allow any interested customer to utilize the service for the entire month, while still allowing any interested party almost a month to review the proposal.
                    <SU>13</SU>
                    <FTREF/>
                     The Exchange also argues that the benefits of the full month of operation outweigh any costs associated with a slightly shorter operative delay, given that FPGA is a well-established technology that is familiar to market participants. The Commission believes that waiver of the 30-day operative delay is consistent with the protection of investors and the public interest. Accordingly, the Commission hereby waives the operative delay and designates the proposed rule change as operative upon filing.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         The Exchange initially filed the substance of this proposed rule change on May 4, 2023 as SR-Phlx-2023-17. This initial proposal was withdrawn and replaced on May 12, 2023.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).
                    </P>
                </FTNT>
                <P>At any time within 60 days of the filing of the 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 to determine whether the proposed rule change should be approved or disapproved.</P>
                <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">http://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-Phlx-2023-18 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-Phlx-2023-18. 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">http://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 10:00 a.m. and 3:00 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-Phlx-2023-18, and should be submitted on or before June 16, 2023.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>15</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>Sherry R. Haywood,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11240 Filed 5-25-23; 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. 34-97541; File No. SR-BX-2023-012]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Offer Field-Programmable Gate Array Technology as an Optional Delivery Mechanism for BX TotalView</SUBJECT>
                <DATE>May 22, 2023.</DATE>
                <P>
                    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/>
                     notice is hereby given that on May 12, 2023, Nasdaq BX, Inc. (“BX” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. 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>
                         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 offer field-programmable gate array (“FPGA”) technology as an optional delivery mechanism for BX TotalView.</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 Exchange 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 these 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 aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    BX proposes to offer field-programmable gate array (“FPGA”) technology as an optional delivery mechanism for BX TotalView.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         A proposal to make FPGA technology also available at the PSX Exchange is being submitted together with this proposal. The Exchange initially filed this Proposal on May 4, 2023 (SR-BX-2023-011). On May 12, 2023, the Exchange withdrew SR-BX-2023-011 and replaced it with the instant filing. This filing corrects an error in the initial submission, but includes no substantive changes.
                    </P>
                </FTNT>
                <P>
                    FPGA technology has been used for over a decade by the Nasdaq Stock Market to facilitate customer ingestion of large quantities of information at periods of peak activity. FPGA hardware is designed to facilitate the processing of large data packets without introducing variable queuing, thereby improving the predictability of data transfer on telecommunications ports, a process known as “determinism.” Outside of peak activity, FPGA helps customers establish more predictable consistency in message throughput over the course of the trading day.
                    <PRTPAGE P="34202"/>
                </P>
                <P>
                    The Exchange proposes to use FPGA technology to process BX TotalView data. BX TotalView is a real-time market data product that provides full order depth using a series of order messages to track the life of customer orders in the BX market, as well as trade data for BX executions and administrative messages such as Trading Action messages, Symbol Directory, and Event Control messages.
                    <SU>4</SU>
                    <FTREF/>
                     BX TotalView allows users to view all displayed quotes and orders, access total displayed anonymous interest, and see total size of all displayed quotes and orders.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Nasdaq BX, Inc. Rules, Equity 7, Section 123 (BX TotalView); 
                        <E T="03">see also</E>
                         Securities Exchange Act Release No. 59307 (January 28, 2009), 74 FR 6069 (February 4, 2009) (establishing fees for BX TotalView).
                    </P>
                </FTNT>
                <P>
                    FPGA technology has been offered by the Nasdaq Stock Exchange for over a decade, and the Nasdaq Options Market for nearly as long,
                    <SU>5</SU>
                    <FTREF/>
                     and has been cited by the SEC as an example of a technology useful in the distribution of market data products.
                    <SU>6</SU>
                    <FTREF/>
                     It is a well-established technology that is familiar to market participants.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 67297 (June 28, 2012), 77 FR 39752 (July 5, 2012) (SR-Nasdaq-2012-063) (introducing FPGA technology); 
                        <E T="03">see also</E>
                         Nasdaq Data News 2012-13, available at 
                        <E T="03">http://www.nasdaqtrader.com/TraderNews.aspx?id=dn2012-13</E>
                         (introducing TotalView FPGA service as of August 1, 2012); Securities Exchange Act Release No. 74745 (April 16, 2015), 80 FR 22588 (April 22, 2015) (SR-Nasdaq-2015-035) (establishing FPGA for the Nasdaq Options Market); 
                        <E T="03">see also</E>
                         The Nasdaq Stock Market LLC Rules, Equity 7, Section 126(c) (Hardware-Based Delivery of Nasdaq Depth data).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 90610, 86 FR 18596, 18647 (April 9, 2021) (File No. S7-03-20) (listing field programmable gate array services as an example of a technological innovation that could be employed by competing consolidators as part of the Market Data Infrastructure rule).
                    </P>
                </FTNT>
                <P>The purchase of FPGA technology is entirely optional because FPGA functionality can be replicated through a variety of software solutions. Our experience with Nasdaq TotalView is that some customers use FPGA technology to address determinism, others avail themselves of software solutions, some use both, and others alternate between both. Some market participants that have purchased FPGA technology in the past have discontinued its use. There are no systematic differences among market participants that choose to use or not to use FPGA technology beyond the compatibility of FPGA technology with the customer's specific technical systems, which can change over time as systems are modified, replaced or updated.</P>
                <P>The proposal to offer FPGA technology to customers of BX TotalView is in response to customer demand. To date, lower levels of peak activity at the BX Exchange relative to the Nasdaq Exchange have been associated with low levels of customer interest in this product. Recently, however, BX has heard from customers interested in using FPGA technology for BX TotalView. To address this customer demand, and to drive liquidity to the BX Exchange by making it a more attractive trading venue, BX has decided to offer this product to meet evolving customer needs.</P>
                <P>The Exchange will submit a proposed fee schedule for this product in a separate filing. The Exchange intends to make this product available on June 1, 2023.</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
                    <SU>7</SU>
                    <FTREF/>
                     in general, and furthers the objectives of Section 6(b)(5) of the Act,
                    <SU>8</SU>
                    <FTREF/>
                     in particular, in that it is designed to promote just and equitable principles of trade, 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>7</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <P>As noted above, the current proposal to offer FPGA technology with BX TotalView is in response to changes in customer demand. This proposal reflects the need for the Exchange to stay competitive in the market for exchange services. It also promotes competition and innovation by providing market participants additional choices in the transmission of depth of book data.</P>
                <P>Offering this well-recognized technology to customers will facilitate their usage of the data. If the technology is not ultimately beneficial, the customer can discontinue it at any time, and for any reason, as they have done in the past. Customers that choose not to purchase FPGA technology will not be affected because these customers have alternative methods to facilitate determinism available to them.</P>
                <P>Approval of this proposal is in the public interest and otherwise furthers the objectives of Section 6(b)(5) of the Act because it promotes competition, facilitates the ingestion of market data by certain market participants, and has no impact on customers that do not elect to avail themselves of the service.</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 not necessary or appropriate in furtherance of the purposes of the Act.</P>
                <P>Nothing in the Proposal burdens inter-market competition (the competition among self-regulatory organizations) because approval of the Proposal does not impose any burden on the ability of other exchanges to compete. All exchanges are free introduce products that facilitate the ingestion of data at peak periods.</P>
                <P>Nothing in the Proposal burdens intra-market competition (the competition among consumers of exchange data) because FPGA technology will be available to any market participant on a non-discriminatory basis.</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 either solicited or received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    FINRA has filed the proposed rule change pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>9</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6) thereunder.
                    <SU>10</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 proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(6) thereunder.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <P>
                    A proposed rule change filed under Rule 19b-4(f)(6) 
                    <SU>11</SU>
                    <FTREF/>
                     normally does not become operative prior to 30 days after the date of the filing. However, Rule 19b-4(f)(6)(iii) 
                    <SU>12</SU>
                    <FTREF/>
                     permits the Commission to 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 proposal may become operative on June 1 so that any potential customer that wishes to obtain 
                    <PRTPAGE P="34203"/>
                    the FPGA service would be able to do so on June 1, 2023. The Exchange argues that an operative date of June 1, 2023 is consistent with the protection of investors and the public interest because market data services are typically initiated at the beginning of a calendar month, and the June 1 operative date would allow any interested customer to utilize the service for the entire month, while still allowing any interested party almost a month to review the proposal.
                    <SU>13</SU>
                    <FTREF/>
                     The Exchange also argues that the benefits of the full month of operation outweigh any costs associated with a slightly shorter operative delay, given that FPGA is a well-established technology that is familiar to market participants. The Commission believes that waiver of the 30-day operative delay is consistent with the protection of investors and the public interest. Accordingly, the Commission hereby waives the operative delay and designates the proposed rule change as operative upon filing.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         The Exchange initially filed the substance of this proposed rule change on May 4, 2023 as SR-BX-2023-011. This initial proposal was withdrawn and replaced on May 12, 2023.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         For purposes only of waiving the 30-day operative delay, the Commission has also considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f).
                    </P>
                </FTNT>
                <P>At any time within 60 days of the filing of the 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 to determine whether the proposed rule change should be approved or disapproved.</P>
                <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">http://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-BX-2023-012 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-BX-2023-012. 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">http://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 10:00 a.m. and 3:00 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-BX-2023-012, and should be submitted on or before June 16, 2023.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>15</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>Sherry R. Haywood,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11239 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SELECTIVE SERVICE SYSTEM</AGENCY>
                <SUBJECT>Forms Submitted to the Office of Management and Budget for Extension of Clearance</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Selective Service System.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <P>The following form has been submitted to the Office of Management and Budget (OMB) for reinstatement with changes of an expired previously approved form in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35).</P>
                <HD SOURCE="HD1">SSS Form—404</HD>
                <P>
                    <E T="03">Title:</E>
                     Potential Board Member Information.
                </P>
                <P>
                    <E T="03">Purpose:</E>
                     Is used to identify individuals willing to serve as members of local, appeal or review boards in the Selective Service System.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Potential Board Members.
                </P>
                <P>
                    <E T="03">Burden:</E>
                     A burden of 15 minutes or less on the individual respondent.
                </P>
                <P>Copies of the above identified form can be obtained upon written request to the Selective Service System, Reports Clearance Officer, 1515 Wilson Boulevard, Arlington, Virginia 22209-2425.</P>
                <P>Written comments and recommendations for the proposed reinstatement of clearance of the form should be sent within 60 days of the publication of this notice to the Selective Service System, Reports Clearance Officer, 1515 Wilson Boulevard, Arlington, Virginia 22209-2425.</P>
                <P>A copy of the comments should be sent to the Office of Information and Regulatory Affairs, Attention: Desk Officer, Selective Service System, Office of Management and Budget, New Executive Office Building, Room 3235, Washington, DC 20503.</P>
                <SIG>
                    <NAME>Thomas T. Devine,</NAME>
                    <TITLE>Deputy Associate Director for Operations.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11320 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8015-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <DEPDOC>[Disaster Declaration #17937 and #17938; California Disaster Number CA-00383]</DEPDOC>
                <SUBJECT>Presidential Declaration of a Major Disaster for Public Assistance Only for the Soboba Band of Luiseño Indians</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Small Business Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the Soboba Band of Luiseño Indians (FEMA-4713-DR), dated 05/18/2023.</P>
                    <P>
                        <E T="03">Incident:</E>
                         Severe Winter Storm and Flooding.
                    </P>
                    <P>
                        <E T="03">Incident Period:</E>
                         02/23/2023 through 02/26/2023.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Issued on 05/18/2023.</P>
                    <P>
                        <E T="03">Physical Loan Application Deadline Date:</E>
                         07/17/2023.
                        <PRTPAGE P="34204"/>
                    </P>
                    <P>
                        <E T="03">Economic Injury (EIDL) Loan Application Deadline Date:</E>
                         02/20/2024.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        <E T="03">Submit completed loan applications to:</E>
                         U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>A. 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>Notice is hereby given that as a result of the President's major disaster declaration on 05/18/2023, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.</P>
                <P>The following areas have been determined to be adversely affected by the disaster:</P>
                <FP SOURCE="FP-2">
                    <E T="03">Primary Area:</E>
                     Soboba Band of Luiseño Indians.
                </FP>
                <P>The Interest Rates are:</P>
                <GPOTABLE COLS="2" OPTS="L2,nj,tp0,i1" CDEF="s25,8">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1">Percent</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="22">
                            <E T="03">For Physical Damage:</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="02">Non-Profit Organizations with Credit Available Elsewhere</ENT>
                        <ENT>2.375</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="02">Non-Profit Organizations without Credit Available Elsewhere</ENT>
                        <ENT>2.375</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">
                            <E T="03">For Economic Injury:</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="02">Non-Profit Organizations without Credit Available Elsewhere </ENT>
                        <ENT>2.375</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The number assigned to this disaster for physical damage is 17937 B and for economic injury is 17938 0.</P>
                <EXTRACT>
                    <FP>(Catalog of Federal Domestic Assistance Number 59008)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Francisco Sánchez, Jr.,</NAME>
                    <TITLE>Associate Administrator, Office of Disaster Recovery &amp; Resilience.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11244 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8026-09-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF STATE</AGENCY>
                <DEPDOC>[Public Notice: 12088]</DEPDOC>
                <SUBJECT>Notice of Shipping Coordinating Committee Meeting in Preparation for International Maritime Organization MEPC 80 Meeting</SUBJECT>
                <P>The Department of State will conduct a public meeting of the Shipping Coordinating Committee at 10:00 a.m. on Thursday, June 29, 2023, both in-person at Coast Guard Headquarters and via teleconference. The primary purpose of the meeting is to prepare for the eightieth session of the International Maritime Organization's (IMO) Marine Environment Protection Committee (MEPC 80) to be held at IMO Headquarters in London, United Kingdom from Monday, July 3, 2023 to Friday July 7, 2023.</P>
                <P>
                    Members of the public may participate up to the capacity of the teleconference phone line, which can handle 500 participants or up to the seating capacity of the room if attending in person. The meeting location will be the United States Coast Guard Headquarters, Ray Evans Conference Center, and the teleconference line will be provided to those who RSVP. To RSVP, participants should contact the meeting coordinator, LT Emily Rowan, by email at 
                    <E T="03">Emily.K.Rowan@uscg.mil.</E>
                     LT Rowan will provide access information for in-person and virtual attendance.
                </P>
                <P>The agenda items to be considered by the advisory committee at this meeting mirror those to be considered at MEPC 80, and include:</P>
                <FP SOURCE="FP-1">• Opening of the session</FP>
                <FP SOURCE="FP-1">• Adoption of the agenda</FP>
                <FP SOURCE="FP-1">• Decisions of other bodies</FP>
                <FP SOURCE="FP-1">• Consideration and adoption of amendments to mandatory instruments</FP>
                <FP SOURCE="FP-1">• Harmful aquatic organisms in ballast water</FP>
                <FP SOURCE="FP-1">• Air pollution prevention</FP>
                <FP SOURCE="FP-1">• Energy efficiency of ships</FP>
                <FP SOURCE="FP-1">• Reduction of GHG emissions from ships</FP>
                <FP SOURCE="FP-1">• Follow-up work emanating from the Action Plan to address marine plastic litter from ships</FP>
                <FP SOURCE="FP-1">• Pollution prevention and response</FP>
                <FP SOURCE="FP-1">• Reports of other sub-committees</FP>
                <FP SOURCE="FP-1">• Identification and protection of Special Areas, ECAs and PSSAs</FP>
                <FP SOURCE="FP-1">• Technical cooperation activities for the protection of the marine environment</FP>
                <FP SOURCE="FP-1">• Application of the Committee's method of work</FP>
                <FP SOURCE="FP-1">• Work programme of the Committee and subsidiary bodies</FP>
                <FP SOURCE="FP-1">• Election of the Chair and Vice-Chair</FP>
                <FP SOURCE="FP-1">• Any other business</FP>
                <FP SOURCE="FP-1">• Consideration of the report of the Committee</FP>
                <P>
                    <E T="03">Please note:</E>
                     the IMO may, on short notice, adjust the MEPC 80 agenda to accommodate the constraints associated with the meeting format. Any changes to the agenda will be reported to those who RSVP.
                </P>
                <P>
                    Those who plan to participate should contact the meeting coordinator, LT Emily Rowan, by email at 
                    <E T="03">Emily.K.Rowan@uscg.mil,</E>
                     or in writing at 2703 Martin Luther King Jr. Ave. SE, Stop 7509, Washington, DC 20593-7509, by June 14, 2023. Please note that, due to security considerations, two valid, government issued photo identifications must be presented to gain entrance to the Douglas A. Munro Coast Guard Headquarters Building at St. Elizabeth's. This building is accessible by taxi, public transportation, and privately owned conveyance (upon request). Additionally, members of the public needing reasonable accommodation should advise the meeting coordinator not later than June 14, 2023. Requests made after that date will be considered but might not be possible to fulfill.
                </P>
                <P>
                    Additional information regarding this and other IMO public meetings may be found at: 
                    <E T="03">https://www.dco.uscg.mil/IMO.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 22 U.S.C. 2656 and 5 U.S.C. 1009.)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Emily A. Rose,</NAME>
                    <TITLE>Executive Secretary, Shipping Coordinating Committee, Office of Ocean and Polar Affairs, Department of State.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11325 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4710-09-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SURFACE TRANSPORTATION BOARD</AGENCY>
                <DEPDOC>[Docket No. FD 36687]</DEPDOC>
                <SUBJECT>Rio Grande Pacific Corporation—Continuance in Control Exemption—Bogalusa and Northern Railway, LLC</SUBJECT>
                <P>Rio Grande Pacific Corporation (RGPC), a noncarrier, has filed a verified notice of exemption under 49 CFR 1180.2(d)(2) to continue in control of Bogalusa and Northern Railway, LLC (BNR), upon BNR's becoming a Class III rail carrier. RGPC owns, indirectly, 100 percent of the issued and outstanding stock of BNR, a limited liability company.</P>
                <P>
                    This transaction is related to a concurrently filed verified notice of exemption in 
                    <E T="03">Bogalusa &amp; Northern Railway—Change in Operator Exemption—Bogalusa Bayou Railroad,</E>
                     Docket No. FD 36686, in which BNR seeks Board approval to acquire overhead trackage rights over a one-mile line owned by Illinois Central Railroad Company (IC) extending between milepost 68.85, at Leescreek, La., and milepost 69.85, at Bogalusa, La.
                </P>
                <P>
                    <E T="03">RGPC currently controls four Class III railroads:</E>
                     Nebraska Central Railroad Company; New Orleans &amp; Gulf Coast Railway Company; Wichita, Tillman &amp; Jackson Railway Company; and Idaho Northern &amp; Pacific Railroad Company.
                    <PRTPAGE P="34205"/>
                </P>
                <P>
                    <E T="03">RGPC represents that:</E>
                     (1) the rail lines operated by the RGPC carriers do not connect with the rail line to be operated by BNR; (2) the transaction is not part of a series of anticipated transactions that would connect the rail line to be operated by BNR with any railroad in the RGPC corporate family; and (3) the transaction does not involve a Class I carrier. Therefore, the transaction is exempt from the prior approval requirements of 49 U.S.C. 11323. 
                    <E T="03">See</E>
                     49 CFR 1180.2(d)(2).
                </P>
                <P>Under 49 U.S.C. 10502(g), the Board may not use its exemption authority to relieve a rail carrier of its statutory obligation to protect the interests of its employees. However, 49 U.S.C. 11326(c) does not provide for labor protection for transactions under 49 U.S.C. 11324 and 11325 that involve only Class III rail carriers. Accordingly, because this transaction involves Class III rail carriers only, the Board may not impose labor protective conditions here.</P>
                <P>The earliest this transaction may be consummated is June 9, 2023, the effective date of the exemption (30 days after the verified notice was filed). If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(g) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed by June 2, 2023 (at least seven days before the exemption becomes effective).</P>
                <P>All pleadings, referring to Docket No. FD 36687, must be filed with the Surface Transportation Board either via e-filing on the Board's website or in writing addressed to 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on BNR's representative, Karl Morell, Karl Morell &amp; Associates, 440 1st Street NW, Suite 440, Washington, DC 20001.</P>
                <P>
                    Board decisions and notices are available at 
                    <E T="03">www.stb.gov.</E>
                </P>
                <SIG>
                    <DATED>Decided: May 22, 2023.</DATED>
                    <P>By the Board, Mai T. Dinh, Director, Office of Proceedings.</P>
                    <NAME>Eden Besera,</NAME>
                    <TITLE>Clearance Clerk.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11224 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4915-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SURFACE TRANSPORTATION BOARD</AGENCY>
                <DEPDOC>[Docket No. FD 36686]</DEPDOC>
                <SUBJECT>Bogalusa and Northern Railway, LLC—Change in Operator Exemption—Bogalusa Bayou Railroad, LLC</SUBJECT>
                <P>
                    Bogalusa and Northern Railway, LLC (BNR), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to permit BNR to acquire from Illinois Central Railroad Company (IC) trackage rights over a one-mile rail line extending between milepost 68.85, at Leescreek, La, and milepost 69.85, at Bogalusa, La. (the Line). The Line is currently operated by Bogalusa Bayou Railroad, LLC (BBRR), pursuant to a trackage rights agreement between IC and BBRR.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Bogalusa Bayou R.R.—Acquis. of Trackage Rights Exemption Containing Interchange Commitment—Ill. Cent. R.R.,</E>
                         FD 35880 (STB served Dec. 17, 2014).
                    </P>
                </FTNT>
                <P>
                    According to the verified notice, BNR and IC have entered into an agreement granting BNR restricted overhead rights over the Line limited to movements of crude tall oil, crude sulphate turpentine, pulpboard, and recycled paper.
                    <SU>2</SU>
                    <FTREF/>
                     IC will also continue to be an operator over the Line. The verified notice further states that the transaction will effectuate a change of common carrier operator from BBRR to BNR, under which, coterminous with BNR's commencement of common carrier operations, the current trackage rights agreement between BBRR and IC governing BBRR's operations will terminate and BBRR's common carrier operations will cease.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         BNR has provided public and confidential version of its trackage rights agreement. The confidential version was submitted under seal concurrently with a motion for protective order, which will be addressed in a separate Board decision.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         BNR states that BBRR is aware of the proposed change of operators and concurs in the same.
                    </P>
                </FTNT>
                <P>
                    This transaction is related to a concurrently filed verified notice of exemption in 
                    <E T="03">Rio Grande Pacific Corp.—Continuance in Control Exemption—Bogalusa &amp; Northern Railway,</E>
                     Docket No. FD 36687, in which Rio Grande Pacific Corporation seeks to continue in control of BNR upon BNR's becoming a Class III rail carrier.
                </P>
                <P>BNR certifies that the agreement between BNR and IC does not contain any provision that would limit interchange with a third-party carrier. BNR also certifies that its projected annual revenues as a result of this transaction will not result in it becoming a Class II or Class I rail carrier and that its projected annual revenue will not exceed $5 million.</P>
                <P>Under 49 CFR 1150.32(b), a change in operator requires that notice be given to shippers. BNR states that it has sent a copy of its verified notice to International Paper, the sole customer on the Line.</P>
                <P>The transaction may be consummated on or after June 9, 2023, the effective date of the exemption (30 days after the verified notice was filed).</P>
                <P>If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than June 2, 2023 (at least seven days before the exemption becomes effective).</P>
                <P>All pleadings, referring to Docket No. FD 36686, must be filed with the Surface Transportation Board via e-filing on the Board's website or in writing addressed to 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on BNR's representative, Karl Morell, Karl Morell &amp; Associates, 440 1st Street NW, Suite 440, Washington, DC 20001.</P>
                <P>According to BNR, this action is categorically excluded from environmental review under 49 CFR 1105.6(c) and from historic preservation reporting requirements under 49 CFR 1105.8(b)(1).</P>
                <P>
                    Board decisions and notices are available at 
                    <E T="03">www.stb.gov.</E>
                </P>
                <SIG>
                    <DATED> Decided: May 22, 2023.</DATED>
                    <P>By the Board, Mai T. Dinh, Director, Office of Proceedings.</P>
                    <NAME>Eden Besera,</NAME>
                    <TITLE>Clearance Clerk.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11223 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4915-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SURFACE TRANSPORTATION BOARD</AGENCY>
                <DEPDOC>[Docket No. FD 36702]</DEPDOC>
                <SUBJECT>Chesapeake and Indiana Railroad Company, LLC—Lease and Operation Exemption—Northern Indiana Railroad Company, LLC</SUBJECT>
                <P>
                    Chesapeake &amp; Indiana Railroad Company, LLC (CKIN), a Class III rail carrier, has filed a verified notice of exemption pursuant to 49 CFR 1150.41 to continue to lease and operate 27.52 miles of rail line that extend between milepost CF 0.63, at or near Lacrosse, Ind., and milepost CF 15.23, at or near Wellsboro, Ind., and between milepost CI 218.0, at or near English Lake, Ind., and milepost CI 230.92, at or near 
                    <PRTPAGE P="34206"/>
                    Malden, Ind., in LaPorte, Porter, and Starke Counties, Ind. (the Line).
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         By letter filed May 23, 2023, CKIN corrected the milepost description for the portion of the Line between Lacrosse and Wellsboro, indicating that all references in its verified notice to “milepost CF 0.23” should be replaced with “milepost CF 0.63” and all references to the Line constituting “27.92 miles” should be replaced with “27.52 miles.”
                    </P>
                </FTNT>
                <P>
                    According to the verified notice, the Line is currently owned by Northern Indiana Railroad, LLC (NIRC), and operated under lease by CKIN. CKIN's predecessor, Chesapeake &amp; Indiana Railroad, Inc.,
                    <SU>2</SU>
                    <FTREF/>
                     first obtained authorization to operate approximately 32.97 miles of track (including the Line and an additional 5.45-mile segment) in 2004 pursuant to a lease with the Line's former owner, the Town of North Judson, Ind. (the Town). 
                    <E T="03">Chesapeake &amp; Ind. R.R.—Operation Exemption—N. Judson, Ind.,</E>
                     FD 34529 (STB served Aug. 20, 2004). An amended lease between CKIN and the Town was subsequently filed with the Board and went into effect in 2017. 
                    <E T="03">Chesapeake &amp; Ind. R.R.—Amended Operation Exemption—N. Judson, Ind.,</E>
                     FD 36147 (STB served Oct. 20, 2017). CKIN subsequently discontinued service on the additional 5.45-mile segment. 
                    <E T="03">Chesapeake &amp; Ind. R.R.—Discontinuance of Serv. Exemption—in Starke Cnty., Ind.,</E>
                     AB 1259X (STB served Nov. 28, 2017).
                    <SU>3</SU>
                    <FTREF/>
                     In 2021, NIRC acquired from the Town the entire 32.97 miles of rail line (including the Line and the 5.45-mile segment over which service had been discontinued), 
                    <E T="03">see N. Ind. R.R.—Acquis. Exemption—N. Judson, Ind.,</E>
                     FD 36499 (STB served Apr. 2, 2021), and NIRC assumed the lease with CKIN. In connection with the sale transaction, CKIN and NIRC entered into a new lease agreement, amending the terms under which CKIN will continue its existing operations on the Line. CKIN states that the new lease agreement will become effective as of the effective date of this notice of exemption.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         CKIN was recently acquired by Gulf &amp; Atlantic Railways, LLC (an affiliate of Macquarie Infrastructure Partners V GP, LLC). As part of that transaction, CKIN was converted to a limited liability company through an asset transfer. (Verified Notice 2 n.1 (citing Macquarie Infrastructure Partners V GP, LLC, Verified Notice 3 n.5, 
                        <E T="03">Macquarie Infrastructure Partners V GP, LLC—Control Exemption—Camp Chase Rail, LLC,</E>
                         FD 36685).) Both the current CKIN and its predecessor are referred to herein as CKIN.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The discontinued segment extended between milepost CI 212.55, at or near North Judson, and milepost CI 218.0, at or near English Lake, in Starke County. (
                        <E T="03">See</E>
                         Verified Notice 3 n.4.)
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         CKIN states that, because CKIN is a Class III rail carrier and is seeking to lease and operate the rail property of a third party over which CKIN already operates, the new lease transaction is within the scope of the exemption set out in 49 CFR 1150.41. (Verified Notice 4 &amp; n.7 (citing 
                        <E T="03">C&amp;S R.R.—Lease &amp; Operation Exemption—Reading Blue Mountain &amp; N. R.R.,</E>
                         FD 36517 (STB served May 28, 2021); 
                        <E T="03">Portland &amp; W. R.R.—Amended Lease &amp; Operation Exemption Containing Interchange Commitment—BNSF Ry.,</E>
                         FD 36391 (STB served Apr. 16, 2020)).)
                    </P>
                </FTNT>
                <P>CKIN certifies that its projected annual revenues as a result of the transaction will not result in the creation of a Class II or Class I rail carrier and will not exceed $5 million. CKIN states that neither the new lease agreement nor the prior lease agreement contains any provision or agreement that may limit future interchange with a third party connecting carrier and that the Line is not subject to any agreement that imposes such an interchange commitment.</P>
                <P>The transaction may be consummated on or after June 11, 2023, the effective date of the exemption (30 days after the verified notice was filed).</P>
                <P>If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than June 2, 2023 (at least seven days before the exemption becomes effective).</P>
                <P>All pleadings, referring to Docket No. FD 36702, must be filed with the Surface Transportation Board either via e-filing on the Board's website or in writing addressed to 395 E Street, SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on CKIN's representative, Terence M. Hynes, Sidley Austin LLP, 1501 K St., NW, Washington, DC 20005.</P>
                <P>According to CKIN, this action is categorically excluded from environmental review under 49 CFR 1105.6(c) and from historic preservation reporting requirements under 49 CFR 1105.8(b).</P>
                <P>
                    Board decisions and notices are available at 
                    <E T="03">www.stb.gov.</E>
                </P>
                <SIG>
                    <DATED>Decided: May 23, 2023.</DATED>
                    <P>By the Board, Mai T. Dinh, Director, Office of Proceedings.</P>
                    <NAME>Stefan Rice,</NAME>
                    <TITLE>Clearance Clerk.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2023-11342 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4915-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <DEPDOC>[FAA Docket number: FAA-2023-1292]</DEPDOC>
                <SUBJECT>NextGen Advisory Committee; Notice of Public Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), Department of Transportation.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice announces a meeting of the NextGen Advisory Committee (NAC).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The meeting will be held on June 12, 2023, from 1:00 p.m.-4:30 p.m. ET. Requests to attend the meeting in person or virtually must be received by June 5, 2023. Requests for accommodations for a disability must be received by June 5, 2023. If you wish to make a public statement during the meeting, you must submit a written copy of your remarks by June 5, 2023. Written materials requested to be reviewed by NAC Members before the meeting must be received no later than June 5, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The meeting will be held at the Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591, with a virtual option. Virtual meeting information will be provided on the NAC internet website at least one week in advance of the meeting. Information on the NAC, including previous meeting minutes, is available on the NAC internet website at 
                        <E T="03">https://www.faa.gov/about/office_org/headquarters_offices/ang/nac/.</E>
                         Members of the public who wish to observe the meeting virtually or in person must send the required information listed in the 
                        <E T="02">SUPPLEMENTAL INFORMATION</E>
                         section to 
                        <E T="03">9-AWA-ANG-NACRegistration@faa.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kimberly Noonan, NAC Coordinator, U.S. Department of Transportation, at 
                        <E T="03">Kimberly.Noonan@faa.gov</E>
                         or 202-267-3760. Any requests or questions not regarding attendance registration should be sent to the person listed in this section.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    The Secretary of Transportation established the NAC under agency authority in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, Public Law 92-463, 5 U.S.C. app. 2, to provide independent advice and recommendations to the FAA and to respond to specific taskings received directly from the FAA. The NAC 
                    <PRTPAGE P="34207"/>
                    recommends consensus-driven advice for FAA consideration relating to Air Traffic Management System modernization.
                </P>
                <HD SOURCE="HD1">II. Agenda</HD>
                <P>At the meeting, the agenda will cover the following topics:</P>
                <FP SOURCE="FP-2">• NAC Chair's Report</FP>
                <FP SOURCE="FP-2">• FAA Report</FP>
                <FP SOURCE="FP-2">• NAC Subcommittee Chair's Report</FP>
                <FP SOURCE="FP1-2">○ Risk and Mitigations update for the following focus areas: Data Communications, Performance Based Navigation, Surface and Data Sharing, and Northeast Corridor</FP>
                <FP SOURCE="FP-2">• NAC Chair Closing Comments</FP>
                <P>The detailed agenda will be posted on the NAC internet website at least one week in advance of the meeting.</P>
                <HD SOURCE="HD1">III. Public Participation</HD>
                <P>
                    The meeting is open to the public. Members of the public who wish to attend are asked to register via email by submitting their full legal name, country of citizenship, contact information (telephone number and email address), and name of your industry association, or applicable affiliation, and if they would like to attend the meeting in-person or virtually. Please email this information to the email address listed in the 
                    <E T="02">ADDRESSES</E>
                     section. For foreign national in-person attendees, please also provide surname, given name, Country of Birth, Country of Citizenship, date of birth, title or position, Passport or Diplomatic ID#, and expiration date. When registration is confirmed, registrants who requested to attend virtually will be provided the virtual meeting information/teleconference call-in number and passcode. Callers are responsible for paying associated long-distance charges (if any).
                </P>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P> Only NAC Members, NAC working group members, FAA staff who are providing briefings, and members of the public who registered and were selected to make a public statement will have the ability to speak. All other attendees will be able to listen only.</P>
                </NOTE>
                <P>
                    The U.S. Department of Transportation is committed to providing equal access to this meeting for all participants. If you need alternative formats or services because of a disability, please contact the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section.
                </P>
                <P>
                    Six minutes will be allotted for oral comments from members of the public joining the meeting. To accommodate as many speakers as possible, the time for each commenter may be limited. Individuals wishing to reserve speaking time during the meeting must submit a request at the time of registration, along with the proposed speaker's name, address, organizational affiliation, and a written copy of the oral statement. If the number of registrants requesting to make oral statements is greater than can be reasonably accommodated during the meeting, the FAA will select speakers in the order the requests are received. Speakers are required to submit a copy of their prepared remarks for inclusion in the meeting records and for circulation to NAC members to the person listed under the heading 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    . All prepared remarks submitted on time will be accepted and considered as part of the meeting's record. Members of the public may submit written statements for inclusion in the meeting records and circulation to the NAC members. Written statements need to be submitted to the person listed under the heading 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    . Comments received after the due date listed in the 
                    <E T="02">DATES</E>
                     section will be distributed to the members but may not be reviewed prior to the meeting. Any member of the public may present a written statement to the committee at any time.
                </P>
                <SIG>
                    <P>Signed in Washington, DC.</P>
                    <NAME>Kimberly Noonan,</NAME>
                    <TITLE>Manager, Stakeholder and Collaboration Division (A), Management Services Office, ANG-A, Office of the Assistant Administrator for NextGen, Federal Aviation Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11340 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Highway Administration</SUBAGY>
                <DEPDOC>[Docket No. FHWA-2023-0018]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Request for Comments for a Revision of a Currently Approved Collection; State Right-of-Way Manuals, OMB Control Number 2125-0586</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Highway Administration (FHWA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice and request for comments.</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 a revision of a currently approved collection, which 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 July 25, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket ID 2023-0018 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">http://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>Melissa Corder, 202-366-5853, Office of Real Estate Services, Federal Highway Administration, Department of Transportation, 1200 New Jersey Ave. SE, Washington, DC, between 9 a.m. and 5 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>
                     State Right-of-Way Operations Manuals.
                </P>
                <P>
                    <E T="03">Background:</E>
                     It is the responsibility of each State Department of Transportation (State) to acquire, manage and dispose of real property in compliance with the legal requirements of State and Federal laws and regulations. Part of providing assurance of compliance is to describe in a right-of-way procedural (operations) manual the organization, policies and procedures of the State to such an extent that these guide State employees, local acquiring agencies, and contractors who acquire and manage real property that is used for a federally funded transportation project. Procedural manuals assure the FHWA that the requirements of the Uniform Relocation Assistance and Real Property Acquisition Policies Act (Uniform Act) will be met. The State responsibility to prepare and maintain an up-to-date, right-of-way procedural manual is set out in 23 CFR 710.201(c). The regulation allows States flexibility in determining how to meet the manual requirement. This flexibility allows States to prepare manuals in the format of their choosing, to the level of detail necessitated by State complexities. Each State decides how it will provide service to individuals and businesses affected by Federal or federally-assisted projects, while at the same time reducing the 
                    <PRTPAGE P="34208"/>
                    burden of government regulation. States are required to update manuals to reflect changes in Federal requirements for programs administered under Title 23 U.S.C. In addition to the annual updates, further lengthy updates of each manual will be required due to the amending of 23 CFR 710 and 49 CFR 24 regulations, as prompted by the enactment of the Moving Ahead for Progress in the 21st Century Act (MAP-21). The updated State manuals may be submitted to FHWA electronically or made available by posting on the State website.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                </P>
                <P>
                    <E T="03">Regular update of manual</E>
                    —52 State Departments of Transportation, including the District of Columbia and Puerto Rico (52 respondents).
                </P>
                <P>
                    <E T="03">23 CFR 710 regulatory revisions</E>
                    —52 State Departments of Transportation, including District of Columbia and Puerto Rico (52 respondents).
                </P>
                <P>
                    <E T="03">49 CFR 24 regulatory revisions</E>
                    —two additional DOT Modes with 50 large grantees each (100 respondents) &amp; 12 additional agencies with 12 grantees (12 respondents) 112 respondents.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                </P>
                <P>
                    <E T="03">Regular update of manual</E>
                    —Annual basis and certify every 5 years.
                </P>
                <P>
                    <E T="03">23 CFR 710 regulatory revisions</E>
                    —a one-time collection.
                </P>
                <P>
                    <E T="03">49 CFR 24 regulatory revisions</E>
                    —a one-time collection.
                </P>
                <P>
                    <E T="03">Estimated Average Burden per Response:</E>
                </P>
                <P>
                    <E T="03">Regular update of manual</E>
                    —15 hours.
                </P>
                <P>
                    <E T="03">23 CFR 710 regulatory revisions</E>
                    —225 hours.
                </P>
                <P>
                    <E T="03">49 CFR 24 regulatory revisions</E>
                    —225 hours.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                </P>
                <P>
                    <E T="03">Regular update of manual:</E>
                     52 respondents × 15 hours = 780 burden hours.
                </P>
                <P>
                    <E T="03">23 CFR 710 regulatory revisions:</E>
                     52 respondents × 225 hours = 11,700 burden hours.
                </P>
                <P>
                    <E T="03">49 CFR 24 regulatory revisions:</E>
                     112 respondents × 225 hours = 25,200 burden hours.
                </P>
                <P>
                    <E T="03">Total:</E>
                     780 hrs. + 11,700 hrs. + 25,200 hrs. = 
                    <E T="03">37,680</E>
                     total burden hours.
                </P>
                <P>
                    <E T="03">Public Comments Invited:</E>
                     You are asked to comment on any aspect of this 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: May 23, 2023.</DATED>
                    <NAME>Michael Howell,</NAME>
                    <TITLE>Information Collection Coordinator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11319 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0115]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: DEEP PLANE (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0115 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Search MARAD-2023-0115 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0115, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P>If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel DEEP PLANE is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “Charters carrying 6-12 passengers”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “New York, New Jersey, Delaware, Virginia, North Carolina, South Carolina, Georgia, Florida” (Base of Operations: Sag Harbor NY)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     75′5″ Motor Yacht
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0115 at 
                    <E T="03">https://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised 
                    <PRTPAGE P="34209"/>
                    that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">https://www.regulations.gov,</E>
                     keyword search MARAD-2023-0115 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11275 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0106]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: BABY BEAR (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0106 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Search MARAD-2023-0106 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0106, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P> If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel BABY BEAR is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel</E>
                    : “Transport passengers from ship to shore and vice versa”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “Alaska, Washington” (Base of Operations: Sitka AK)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     21′ Motor
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0106 at 
                    <E T="03">https://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled ADDRESSES. Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                    <PRTPAGE P="34210"/>
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">https://www.regulations.gov,</E>
                     keyword search MARAD-2023-0106 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11272 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0109]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: JAH REEL (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0109 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">http://www.regulations.gov.</E>
                         Search MARAD-2023-0109 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-20230109, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P> If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel JAH REEL is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “Fishing Charters”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “New York, Rhode Island” (Base of Operations: Blue Hill ME)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     29′ Motor
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0109 at 
                    <E T="03">http://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">http://www.regulations.gov,</E>
                     keyword search MARAD-2023-0109 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for 
                    <PRTPAGE P="34211"/>
                    hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11279 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0108]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: GRANDIEGO (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0108 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Search MARAD-2023-0108 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0108, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P> If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel GRANDIEGO is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “Bay charters on Mission Bay”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “California” (Base of Operations: Mission Bay, San Diego, CA)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     44.′8″ Motor
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0108 at 
                    <E T="03">https://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">https://www.regulations.gov,</E>
                     keyword search MARAD-2023-0108 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>
                    Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
                    <PRTPAGE P="34212"/>
                </P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11277 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0105]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: ALLORA (SAIL); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0105 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Search MARAD-2023-0105 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0105, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P> If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel ALLORA is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel</E>
                    : “Scouting trips in the Florida Keys”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “Florida” (Base of Operations: Key West, FL)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     40′ Sail
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0105 at 
                    <E T="03">https://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">https://www.regulations.gov,</E>
                     keyword search MARAD-2023-0105 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, 
                    <PRTPAGE P="34213"/>
                    please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11271 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0117]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: RUNNAMUCK V (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0117 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Search MARAD-2023-0117 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0117, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P>If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461, Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel RUNNAMUCK V is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “as no more than 6 passengers for hire within the state of Alaska. Sport fishing where fish are caught and not sold commercially”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “Alaska” Base of Operations: Homer AK)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     30′ Motor
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0117 at 
                    <E T="03">https://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">https://www.regulations.gov,</E>
                     keyword search MARAD-2023-0117 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>
                    In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be 
                    <PRTPAGE P="34214"/>
                    followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
                </P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11286 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0104]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: HUMMINGBIRD (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0104 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Search MARAD-2023-0104 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0104, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P>If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov</E>
                         .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel HUMMINGBIRD is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “Fishing charters, 6 pax charters”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “New Jersey, New York, Connecticut, Rhode Island, Massachusetts” (Base of Operations: Sag Harbor, NY)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     19′ Motor
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0104 at 
                    <E T="03">https://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">https://www.regulations.gov,</E>
                     keyword search MARAD-2023-0104 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on 
                    <PRTPAGE P="34215"/>
                    behalf of an association, business, labor union, etc.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11278 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0114]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: LUNA BLU (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0114 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">http://www.regulations.gov.</E>
                         Search MARAD-2023-0114 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0114, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P>If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel LUNA BLU is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “Charter”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “Maine, New Hampshire, Massachusetts, Rhode Island, Connecticut, New York, New Jersey, Delaware, Maryland, Virginia, North Carolina, South Carolina, Georgia, Florida, Alabama, Mississippi, Louisiana, and Texas” (Base of Operations: Lewes DE)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     100′4″ Motor Yacht
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0114 at 
                    <E T="03">http://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">http://www.regulations.gov,</E>
                     keyword search MARAD-2023-0114 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's 
                    <PRTPAGE P="34216"/>
                    compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11283 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0103]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: BATMAN (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0103 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Search MARAD-2023-0103 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0103, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P>If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel BATMAN is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “Charter Fishing”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “Alaska” (Base of Operations: Homer AK)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     30′ Motor
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0103 at 
                    <E T="03">https://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">https://www.regulations.gov,</E>
                     keyword search MARAD-2023-0103 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11273 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="34217"/>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0112]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: CAMELOT (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0112 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">http://www.regulations.gov.</E>
                         Search MARAD-2023-0112 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0112, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P> If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                         Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov</E>
                         .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P> As described in the application, the intended service of the vessel CAMELOT is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “Charter”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “Washington” (Base of Operations: Seattle WA)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     62′ Motor
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0112 at 
                    <E T="03">http://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">http://www.regulations.gov,</E>
                     keyword search MARAD-2023-0112 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11274 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0110]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: THE LILY PADS (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <PRTPAGE P="34218"/>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0110 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">http://www.regulations.gov.</E>
                         Search MARAD-2023-0110 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0110, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P>If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel THE LILY PADS is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “Will Be Used For Daytime/Early Evening Light Cruising With Under 10 Passengers”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “New Jersey” (Base of Operations: Harvey Cedars NJ)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     32′ Motor Pontoon
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0110 at 
                    <E T="03">http://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">http://www.regulations.gov,</E>
                     keyword search MARAD-2023-0110 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11282 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0116]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: THE ROWAN (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry 
                        <PRTPAGE P="34219"/>
                        no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0116 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Search MARAD-2023-0116 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0116, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P> If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel THE ROWAN is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “Half day/Full day ICW 6 passenger day trips”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “South Carolina” (Base of Operations: Charleston, SC)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     45′ Motor
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0116 at 
                    <E T="03">https://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">https://www.regulations.gov,</E>
                     keyword search MARAD-2023-0116 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11285 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0113]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: DREAM ON (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief 
                        <PRTPAGE P="34220"/>
                        description of the proposed service, is listed below.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P> Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P> You may submit comments identified by DOT Docket Number MARAD-2023-0113 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">http://www.regulations.gov.</E>
                         Search MARAD-2023-0113 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0113, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P> If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461, Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel DREAM ON is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “Carrying passengers for hire”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “Florida” (Base of Operations: Fort Lauderdale FL)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     86′7″ Motor Yacht
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0113 at 
                    <E T="03">http://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">http://www.regulations.gov,</E>
                     keyword search MARAD-2023-0113 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11276 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0107]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: LANDY LEENIE II (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0107 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">http://www.regulations.gov.</E>
                         Search 
                        <PRTPAGE P="34221"/>
                        MARAD-2023-0107 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0107, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P>If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel LANDY LEENIE II is:</P>
                <FP SOURCE="FP-1">
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “Charter”
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “Florida” (Base of Operations: Ba; Harbour FL)
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">Vessel Length and Type:</E>
                     76′ Motor Yacht
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0107 at 
                    <E T="03">http://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">http://www.regulations.gov,</E>
                     keyword search MARAD-2023-0107 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121.)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11281 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <SUBJECT>Solicitation of Applications for the Award of Two Maritime Security Program Operating Agreements</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, Department of Transportation.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Maritime Administration (MARAD) requests applications from qualified candidates to enter into Maritime Security Program (MSP) Operating Agreements for the operation of two U.S.-registered merchant vessels in international trade, subject to the availability of appropriations. The MSP maintains a fleet of active, commercially viable, militarily useful, privately-owned U.S.-flagged vessels that are engaged in international trade and are capable of supporting both U.S. economic competitiveness in peacetime and national defense and security requirements in times of conflict or emergency. This request for applications provides, among other things, application criteria and a deadline for submitting applications for vessel enrollment into MSP.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applications must be received no later than June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Applications may be submitted in hard copy or electronically. Applications may be submitted electronically to 
                        <E T="03">sealiftsupport@dot.gov</E>
                         and in hard copy to the U.S. Department of Transportation, Maritime Administration, Maritime Security Program, Room W25-310, 1200 New Jersey Avenue SE, Washington, DC 20590. Application forms and instructions are available on the MARAD website at 
                        <E T="03">
                            https://
                            <PRTPAGE P="34222"/>
                            maritime.dot.gov/national-security/strategic-sealift/maritime-security-program-msp.
                        </E>
                         Applicants with large electronic files should contact Richard Wanerman, Office of Sealift Support by telephone at (202) 366-2306 or email at 
                        <E T="03">Richard.Wanerman@dot.gov</E>
                         for large file transfer options.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>David Hatcher, Director, Office of Sealift Support, Telephone (202) 366-0688. For legal questions, contact Joseph Click, Office of Chief Counsel, Division of Maritime Programs, (202) 366-5882. For military utility questions, contact Tim Boemecke, U.S. Department of Defense, United States Transportation Command, (618) 220-1452.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>46 U.S.C. 53102(a) directs the Secretary of Transportation (Secretary), in consultation with the Secretary of Defense (SecDef), to establish a fleet of active, commercially-viable, militarily-useful, privately-owned, U.S.-registered vessels to meet national defense and other security requirements and to maintain a United States presence in international commercial shipping. In accordance with 46 U.S.C. 53103(d), MARAD may not enter into Operating Agreements for MSP covering more than 60 vessels in any given fiscal year. Payments to participating operators are subject to the availability of appropriations and are limited to the following amounts: $5.3 million per ship for fiscal years (FY) 2023 through 2025; $5.8 million per ship for FYs 2026 through 2028; $6.3 million per ship for FYs 2029 through 2031; and $6.8 million per ship for FYs 2032 through 2035.</P>
                <P>
                    On January 1, 2021, Congress established the Tanker Security Program (TSP) in section 3511(a) of the National Defense Authorization Act for FY 2021 (NDAA FY 21) (Pub. L. 116-283) (codified at 46 U.S.C. 53401-12), directing the Secretary and SecDef to establish a substantially-similar program to MSP for product tankers. NDAA FY 21 Sec. 3511(c)(3) further directed the Secretary to approve any applications for TSP from any MSP Operating Agreement holders that operated product tank vessels under MSP Operating Agreements at the time of NDAA FY 21's enactment. MARAD subsequently published the Tanker Security Program Application Solicitation in the 
                    <E T="04">Federal Register</E>
                     on December 9, 2022 (87 FR 75688-89), and received an application on January 31, 2023, from the sole operator of the two product tankers in MSP to operate them under TSP.
                </P>
                <P>Under 46 CFR 296.24(a), MARAD seeks to ensure that MSP Operating Agreement holders operate the maximum number of statutorily authorized vessels under MSP Operating Agreements at any given time. The maximum number is currently fixed at 60 vessels by 46 U.S.C. 53103(d). As the TSP application of January 31, 2023, will create two vacancies in the MSP fleet during FY 2023, MARAD is publishing this solicitation pursuant to 46 U.S.C. 53103(c) and 46 CFR 296.24 to select up to two eligible vessels from qualified applicants to operate in MSP and to award two MSP Operating Agreements to cover their operation (one agreement per vessel). MARAD expects to enter into MSP Operating Agreements with successful applicants as soon as practicable following the commencement of TSP. Consistent with the National Security Requirements section below, successful applicants will be required to make their commercial transportation resources available upon request by SecDef during times of war or national emergency.</P>
                <HD SOURCE="HD1">Application Criteria</HD>
                <P>46 U.S.C. 53103(c) and 46 CFR 296.24(a)(1)-(a)(3) establish a priority system whereby applications for subsequent award of MSP Operating Agreements are first evaluated on the basis of vessel type, as determined by Department of Defense (DoD) requirements, with secondary consideration based upon the citizenship status of the applicant, as defined in 46 U.S.C. 50501.</P>
                <HD SOURCE="HD1">Vessel Requirements</HD>
                <P>Acceptable vessels for these MSP Operating Agreements must meet the requirements of 46 U.S.C. 53102(b) and 46 CFR 296.11. In addition, the Commander, USTRANSCOM, has established DoD general evaluation criteria on the military requirements for eligible MSP vessels. Priority consideration, consistent with the requirements of 46 U.S.C. 53103(c), will be given to applications providing for enrollment of the following vessel types in order of priority:</P>
                <P>1. Roll-On/Roll-Off (RO/RO) Vessels.</P>
                <P>2. Geared Containerships and Multi-Purpose/Heavy Lift Vessels capable of carrying ammunition.</P>
                <P>3. All other vessel types, which will be considered after all applications for the above listed vessel types have been reviewed.</P>
                <P>For each individual application, the offered vessel's recognized classification society vessel-type designation will serve as the primary factor in determining the priority category in which the vessel is placed.</P>
                <HD SOURCE="HD1">National Security Requirements</HD>
                <P>
                    Successful applicants will be required to enter into an Emergency Preparedness Agreement (EPA) pursuant to 46 U.S.C. 53107 prior to or on the first effective date of the awarded MSP Operating Agreement. The Voluntary Intermodal Sealift Agreement (VISA), as published in 
                    <E T="04">Federal Register</E>
                     at 79 FR 64462 (Oct. 29, 2014) and renewed at 84 FR 51710 (Sept. 30, 2019), is the designated EPA for all non-tank vessels operating in MSP.
                </P>
                <HD SOURCE="HD1">Documentation</HD>
                <P>Vessels must be documented in the United States under 46 U.S.C. chapter 121 prior to operation under any MSP Operating Agreement and receipt of any payments under those Operating Agreements. Further, MARAD must receive proof of U.S. Coast Guard vessel documentation and inspection and must approve all relevant charter and management agreements governing the prospective operation of the vessel before the vessel will be eligible to receive MSP payments. If a vessel being offered for consideration by an applicant is not currently registered in the United States, MARAD requires the applicant to provide MARAD with a proposed plan for bringing the vessel under U.S. vessel registration.</P>
                <HD SOURCE="HD1">Vessel Operation</HD>
                <P>Vessels operating under MSP Operating Agreements shall be operated exclusively in foreign commerce as defined in 46 U.S.C. 53101(4) or in permissible mixed foreign commerce and domestic trade as provided by 46 U.S.C. 53105(a)(1)(A). Additionally, in accordance with 46 U.S.C. 53105(a)(2), any vessel selected under this solicitation may not engage in trades between points in the United States and its territories, either directly or via a foreign port, notwithstanding 46 U.S.C. 12111(b) &amp; 55101(b).</P>
                <HD SOURCE="HD1">USMMA Cadet Safe Training Environment Requirements</HD>
                <P>
                    In accordance with 46 U.S.C. 51307, the operator of any vessel selected under this solicitation must implement and enforce a MARAD-approved plan under 46 U.S.C. 51322 and the Every Mariner Builds A Respectful Culture (EMBARC) program to prevent and respond to sexual assault and harassment against any merchant marine cadet sailing aboard that vessel in fulfillment of their educational 
                    <PRTPAGE P="34223"/>
                    requirements. If an applicant currently has a MARAD approved EMBARC plan in place for other vessels it operates at the time it applies under this solicitation, it must state so in its application and describe the steps it has taken to implement the plan on its other vessels. If an applicant does not currently have an EMBARC plan, it must describe the steps it will take to implement and enforce such a plan in the application. If awarded an MSP Operating Agreement, the applicant must fully implement, or be prepared to fully implement, a MARAD approved EMBARC plan onboard the selected vessel prior to the execution of the Operating Agreement and the receipt of payments under it.
                </P>
                <HD SOURCE="HD1">Award</HD>
                <P>MARAD does not guarantee the award of any MSP Operating Agreements in response to applications submitted under this notice. In the event that MARAD does not award any operating agreements or does not select an application for award, MARAD will provide the applicant with a written explanation why the application was denied, consistent with the requirements of 46 U.S.C. 53103(c).</P>
                <HD SOURCE="HD1">Protection of Confidential Commercial or Financial Information</HD>
                <P>If the application includes information that the applicant considers to be a trade secret or confidential commercial or financial information (CCFI), the applicant should do the following: (1) Note on the front cover that the submission “Contains Confidential Commercial or Financial Information (CCFI)”; (2) mark each affected page “CCFI” in the header or footer; and (3) highlight or otherwise denote those portions of each page that the applicant considers to contain CCFI. MARAD will protect such information from disclosure to the extent allowed under applicable law. In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under that procedure will be exempt from disclosure under FOIA.</P>
                <EXTRACT>
                    <FP>(Authority: 46 U.S.C. 53102 and 53103; 46 CFR 296.24; 49 CFR 1.92 and 1.93.)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11287 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0102</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: KANINA (SAIL); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0102 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Search MARAD-2023-0102 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0102, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                    <P>
                        <E T="03">Note:</E>
                         If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                        <E T="03">www.regulations.gov,</E>
                         including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461 Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel KANINA is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “Luxury Sailing Charters”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “Texas, Louisiana, Mississippi, Alabama, Florida” (Base of Operations: Kemah TX)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     45′ Sail Catamaran
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0102 at 
                    <E T="03">https://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">https://www.regulations.gov,</E>
                     keyword search 
                    <PRTPAGE P="34224"/>
                    MARAD-2023-0102 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11280 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Maritime Administration</SUBAGY>
                <DEPDOC>[Docket No. MARAD-2023-0111]</DEPDOC>
                <SUBJECT>Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: PACIFIC BEAR (Motor); Invitation for Public Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Maritime Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by DOT Docket Number MARAD-2023-0111 by any one of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Search MARAD-2023-0111 and follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail or Hand Delivery:</E>
                         Docket Management Facility is in the West Building, Ground Floor of the U.S. Department of Transportation. The Docket Management Facility location address is: U.S. Department of Transportation, MARAD-2023-0111, 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
                    </P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Note:</HD>
                    <P>If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.</P>
                </NOTE>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the agency name and specific docket number. All comments received will be posted without change to the docket at 
                    <E T="03">www.regulations.gov,</E>
                     including any personal information provided. For detailed instructions on submitting comments, or to submit comments that are confidential in nature, see the section entitled Public Participation.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patricia Hagerty, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-461, Washington, DC 20590. Telephone 202-366-0903, Email 
                        <E T="03">patricia.hagerty@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>As described in the application, the intended service of the vessel PACIFIC BEAR is:</P>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Intended Commercial Use of Vessel:</E>
                     “6-Pack Charters”
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Geographic Region Including Base of Operations:</E>
                     “Alaska, Washington, Oregon, California” Base of Operations: Elfin Cove AK)
                </FP>
                <FP SOURCE="FP-1">
                    —
                    <E T="03">Vessel Length and Type:</E>
                     43′6″ Motor
                </FP>
                <P>
                    The complete application is available for review identified in the DOT docket as MARAD 2023-0111 at 
                    <E T="03">https://www.regulations.gov.</E>
                     Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with 46 U.S.C. 12121 and MARAD's regulations at 46 CFR part 388, that the employment of the vessel in the coastwise trade to carry no more than 12 passengers will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, MARAD will not issue an approval of the vessel's coastwise endorsement eligibility. Comments should refer to the vessel name, state the commenter's interest in the application, and address the eligibility criteria given in section 388.4 of MARAD's regulations at 46 CFR part 388.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">How do I submit comments?</HD>
                <P>
                    Please submit your comments, including the attachments, following the instructions provided under the above heading entitled 
                    <E T="02">ADDRESSES</E>
                    . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.
                </P>
                <HD SOURCE="HD2">Where do I go to read public comments, and find supporting information?</HD>
                <P>
                    Go to the docket online at 
                    <E T="03">http://www.regulations.gov,</E>
                     keyword search MARAD-2023-0111 or visit the Docket Management Facility (see 
                    <E T="02">ADDRESSES</E>
                     for 
                    <PRTPAGE P="34225"/>
                    hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.
                </P>
                <HD SOURCE="HD2">Will my comments be made available to the public?</HD>
                <P>Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.</P>
                <HD SOURCE="HD2">May I submit comments confidentially?</HD>
                <P>
                    If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to 
                    <E T="03">SmallVessels@dot.gov.</E>
                     Include in the email subject heading “Contains Confidential Commercial Information” or “Contains CCI” and state in your submission, with specificity, the basis for any such confidential claim highlighting or denoting the CCI portions. If possible, please provide a summary of your submission that can be made available to the public.
                </P>
                <P>In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    Anyone can search the electronic form of all comments received into 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.). For information on DOT's compliance with the Privacy Act, please visit 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                </P>
                <EXTRACT>
                    <FP>(Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121)</FP>
                </EXTRACT>
                <SIG>
                    <P>By Order of the Maritime Administrator.</P>
                    <NAME>T. Mitchell Hudson, Jr.,</NAME>
                    <TITLE>Secretary, Maritime Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11284 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-81-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Pipeline and Hazardous Materials Safety Administration</SUBAGY>
                <SUBJECT>Hazardous Materials: Notice of Actions on Special Permits</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of actions on special permit applications.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Record Center, Pipeline and Hazardous Materials Safety Administration U.S. Department of Transportation Washington, DC 20590.</P>
                    <P>Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Copies of the applications are available for inspection in the Records Center, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington DC.</P>
                <P>This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).</P>
                <SIG>
                    <DATED>Issued in Washington, DC, on May 16, 2023.</DATED>
                    <NAME>Donald P. Burger,</NAME>
                    <TITLE>Chief, General Approvals and Permits Branch.</TITLE>
                </SIG>
                <GPOTABLE COLS="4" OPTS="L2,nj,tp0,i1" CDEF="xs54,r50,r50,r100">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">
                            Application
                            <LI>No.</LI>
                        </CHED>
                        <CHED H="1">Applicant</CHED>
                        <CHED H="1">Regulation(s) affected</CHED>
                        <CHED H="1">Nature of the special permits thereof</CHED>
                    </BOXHD>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Special Permits Data—Granted</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">11771-M</ENT>
                        <ENT>Phillips 66 Pipeline LLC</ENT>
                        <ENT>172.302(c), 173.31(d)(1)(ii), 173.31(d)(1)(iv), 173.31(d)(1)(vi), 174.67(b), 174.67(c)</ENT>
                        <ENT>To modify the special permit to authorize DOT 117R rail cars.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21442-N</ENT>
                        <ENT>Cellblock FCS, LLC</ENT>
                        <ENT>172.200, 172.300, 172.400, 172.700(a), 173.185(b), 173.185(f)</ENT>
                        <ENT>To authorize the manufacture, mark, sale, and use of alternative packaging for the transportation of lithium batteries, including damaged, defective, and recalled lithium batteries, using alternative hazard communication.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21447-N</ENT>
                        <ENT>Subctech Gmbh</ENT>
                        <ENT>172.101(j), 173.185(a)(1)</ENT>
                        <ENT>To authorize the transportation in commerce of certain low production ion batteries weighing greater than 35 kg aboard cargo-only aircraft.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21479-N</ENT>
                        <ENT>Astra Space Operations, Inc</ENT>
                        <ENT>173.301(f)(1), 178.35(e)</ENT>
                        <ENT>To authorize the transportation in commerce of cylinders that are not equipped with pressure relief devices. spacecraft.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21483-N</ENT>
                        <ENT>Trinity Industries, Inc</ENT>
                        <ENT>179.100-12(c)</ENT>
                        <ENT>To authorize the manufacture, mark, sale, and use of certain DOT specification 105J600W and DOT specification 105J600I tank cars equipped with a welded protective housing for the transportation in commerce of Division 4.2 and Division 4.3 hazardous materials.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21487-N</ENT>
                        <ENT>Ford Motor Company</ENT>
                        <ENT>172.101(j)</ENT>
                        <ENT>To authorize the transportation in commerce of lithium batteries greater than 35 kg net weight aboard cargo-only aircraft.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <PRTPAGE P="34226"/>
                        <ENT I="01">21504-N</ENT>
                        <ENT>Construction Helicopters, Inc</ENT>
                        <ENT>172.101(j), 173.27(b)(2)</ENT>
                        <ENT>To authorize the transportation in commerce of Division 1.1, 1.2, 1.3 and 1.4 explosives, which are forbidden or exceed quantities authorized for transportation aboard cargo-only aircraft.</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Special Permits Data—Denied</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">21090-M</ENT>
                        <ENT>Shijiazhuang Enric Gas Equipment Co., Ltd</ENT>
                        <ENT>180.205</ENT>
                        <ENT>To modify the special permit to authorize an additional location.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21418-N</ENT>
                        <ENT>Kronebusch Industries LLC</ENT>
                        <ENT>178.33a-1</ENT>
                        <ENT>To authorize the transportation in commerce of fire extinguishers where the pressure receptacle does not conform to 49 CFR 173.309.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">21436-N</ENT>
                        <ENT>Contrivance Incorporated</ENT>
                        <ENT>180.211(c)(2)(ii)</ENT>
                        <ENT>To authorize the transportation in commerce of certain DOT 4L cylinders to be repaired without leak testing before and after assembly of the outer insulated jacket.</ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="21">
                            <E T="02">Special Permits Data—Withdrawn</E>
                        </ENT>
                    </ROW>
                </GPOTABLE>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11302 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Pipeline and Hazardous Materials Safety Administration</SUBAGY>
                <SUBJECT>Hazardous Materials: Notice of Applications for Modification to Special Permits</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>List of applications for modification of special permits.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 12, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation Washington, DC 20590.</P>
                    <P>Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.</P>
                <P>
                    Copies of the applications are available for inspection in the Records Center, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington DC or at 
                    <E T="03">http://regulations.gov.</E>
                </P>
                <P>This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).</P>
                <SIG>
                    <DATED>Issued in Washington, DC, on May 5, 2023.</DATED>
                    <NAME>Donald P. Burger,</NAME>
                    <TITLE>Chief, General Approvals and Permits Branch.</TITLE>
                </SIG>
                <GPOTABLE COLS="4" OPTS="L2,nj,i1" CDEF="s25,r50,r50,r100">
                    <TTITLE>Special Permits Data</TTITLE>
                    <BOXHD>
                        <CHED H="1">Application No.</CHED>
                        <CHED H="1">Applicant</CHED>
                        <CHED H="1">Regulation(s) affected</CHED>
                        <CHED H="1">Nature of the special permits thereof</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">7835-M</ENT>
                        <ENT>Versum Materials US, LLC</ENT>
                        <ENT>172.301(c), 177.848(d)</ENT>
                        <ENT>To modify the special permit to authorize DOT-SP 15267 packagings. (mode 1).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">9232-M</ENT>
                        <ENT>Department of Defense U.S. Army Military Surface Deployment &amp; Distribution Command</ENT>
                        <ENT>172.1, 175.1</ENT>
                        <ENT>To modify the special permit to remove paragraph 7.c.(10). (modes 4, 5).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">11379-M</ENT>
                        <ENT>ZF Passive Safety Systems US Inc</ENT>
                        <ENT>173.302(a)(1), 173.301(a)</ENT>
                        <ENT>To modify the special permit to authorize reduced frequency of cylinder burst testing. (modes 1, 2, 3, 4, 5).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">15343-M</ENT>
                        <ENT>Desert Air Transport, Inc</ENT>
                        <ENT>172.101(j), 173.242</ENT>
                        <ENT>To modify the special permit to authorize an additional packaging (mode 4).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">15642-M</ENT>
                        <ENT>Linde Gas &amp; Equipment Inc</ENT>
                        <ENT>172.203(a), 180.205(c), 180.209(a), 180.209(b), 180.209(b)(1)(iv)</ENT>
                        <ENT>To modify the special permit to extend the initial periodic requalification period of DOT 3AL and DOT-SP 12440 cylinders from 5 years to 10 years and to authorize certain newly manufactured DOT 3AL cylinders to be used in dedicated dry-gas service. (modes 1, 2, 3, 4, 5).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">16279-M</ENT>
                        <ENT>Stericycle, Inc</ENT>
                        <ENT>173.196(a)</ENT>
                        <ENT>To modify the special permit to authorize the transportation in commerce of the Marburg virus. (modes 1, 3).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">20251-M</ENT>
                        <ENT>Salco Products Inc</ENT>
                        <ENT>172.203(a), 178.345-1, 180.413</ENT>
                        <ENT>To modify the special permit to authorize additional manway configurations. (mode 1).</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="34227"/>
                        <ENT I="01">21360-M</ENT>
                        <ENT>ABG Bag, Inc</ENT>
                        <ENT>173.12(b)(2)(ii)(C), 178.707(d)</ENT>
                        <ENT>To modify the special permit to authorize Division 5.2 hazardous materials. (mode 1).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21460-M</ENT>
                        <ENT>Amerex Corporation</ENT>
                        <ENT>173.309(c), 172.203(a), 172.301(c)</ENT>
                        <ENT>To modify the special permit to remove the requirement that the special permit be provided to the air carrier and to authorize a copy of the special permit to be accessible electronically through a QR code directly applied to each extinguisher in lieu of having a paper copy of the special permit be maintained at each facility where the extinguishers are offered or reoffered. (modes 1, 2, 3, 4, 5).</ENT>
                    </ROW>
                </GPOTABLE>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11301 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Pipeline and Hazardous Materials Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. PHMSA-2022-0033 (Notice No. 2023-05)]</DEPDOC>
                <SUBJECT>Hazardous Materials: Adjusting Registration and Fee Assessment Program; Notice of Public Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>PHMSA's Office of Hazardous Materials Safety will hold a public meeting to solicit input on potential adjustments to the statutorily mandated hazardous materials registration and fee assessment program. The potential adjustment of fees may be necessary to fund PHMSA's national emergency preparedness grant programs at the newly authorized level in accordance with the Infrastructure Investment and Jobs Act of 2021.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The meeting will be held virtually on June 28, 2023, from 1:00 p.m. until 4:00 p.m.  Eastern Standard Time. Requests to attend the meeting must be received by June 21, 2023. Requests for accommodations for a disability must be received by June 21, 2023. Persons requesting to speak during the meeting must submit a written copy of their remarks to DOT by June 21, 2023. Requests to submit written materials to be reviewed during the meeting must be received no later than June 21, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The meeting will be held virtually at the following: 
                        <E T="03">https://usdot.zoomgov.com/meeting/register/vJItde2gqzgtGcv6ewzeLw34nzwwtO_IY68.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Yul B. Baker Jr., Standards and Rulemaking Division, Office of Hazardous Materials Safety, 202-366-8553, PHMSA, East Building, PHH10, 1200 New Jersey Avenue SE, Washington, DC 20590.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    The Pipeline and Hazardous Materials Safety Administration (PHMSA) is considering an adjustment to our statutorily mandated registration and fee assessment program for persons who offer for transportation or transport certain categories and quantities of hazardous materials. PHMSA conducts a national hazardous materials registration program under the mandate in 49 U.S.C. 5108 for a person who offers 
                    <SU>1</SU>
                    <FTREF/>
                     for transportation (
                    <E T="03">i.e.,</E>
                     shippers) or transports certain hazardous materials in intrastate, interstate, or foreign commerce. The registration program implements the mandate for persons to file a registration statement with the Secretary of Transportation—as delegated to PHMSA—and collects registration and processing fees from persons required to file a registration statement (hereafter referred to as “registrants”) to fund the Emergency Preparedness (EP) grants. EP grants support hazardous materials emergency response planning and training activities by states, local governments, and Native American tribes. EP grants also fund nonprofit organizations to provide “train-the-trainer” programs for hazardous materials emergency response training and hazardous materials employee training. Additionally, EP grants support the development of the Emergency Response Guidebook (ERG) that assists emergency responders in determining appropriate response measures and provides funds for grantee monitoring and technical assistance. Congress recognized in the Infrastructure Investment and Jobs Act of 2021 
                    <SU>2</SU>
                    <FTREF/>
                     (IIJA) (as evidenced by increased authorization levels for the EP Grant Program), and as congressional testimony was reinforced in the aftermath of the 2023 Norfolk Southern train derailment in East Palestine, Ohio, there is an increasing need for Federal support for first responders, particularly responders to hazardous materials related incidents, such as are supported through the EP grants.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Defined in 49 CFR 171.8.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Public Law 117-58.
                    </P>
                </FTNT>
                <P>
                    To raise additional revenue to meet the increasing needs for the EP Grant Program, PHMSA has discretion to require additional persons to register—beyond those who offer, and transport certain categories and quantities of hazardous materials listed in 49 U.S.C. 5108(a)(1)—and to set the annual registration fee between the statutorily mandated minimum and maximum amounts. 
                    <E T="03">See</E>
                     49 U.S.C. 5108(b), 5116, and 5128(b). PHMSA may currently set an annual registration fee between a minimum of $250 and maximum of $3,000. In the HM-208J Advanced Noticed of Proposed Rulemaking (ANPRM),
                    <SU>3</SU>
                    <FTREF/>
                     PHMSA presented a fee scenario table and options to solicit feedback from stakeholders on potential methods and any alternative methods to achieve the increased funding. PHMSA presented nine options for consideration, grouped between a scenario where the maximum fee remains $3,000 per year, and an alternative scenario where Congress increases the maximum fee. The options included:
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         87 FR 57859 (Sept. 22, 2022).
                    </P>
                </FTNT>
                <P>
                    <E T="03">If registration fees remain at a maximum $3,000 per year, PHMSA is considering the following options for comment:</E>
                </P>
                <P>1. Keep the existing registration requirements (see 49 CFR 107.601) and raise the registration fee for large businesses from $2,575 to $3,000.</P>
                <P>
                    2. Keep the existing registration requirements and apply a nominal fee (
                    <E T="03">e.g.,</E>
                     $25) for each facility or geographic location from which a registered person (
                    <E T="03">i.e.,</E>
                     a company) offers for transportation, or transports, certain hazardous materials.
                    <PRTPAGE P="34228"/>
                </P>
                <P>
                    3. Modify assignment of the registration fee and/or amount based on the commensurate hazard posed (
                    <E T="03">e.g.,</E>
                     shipping Packing Group I materials vs. Packing Group III materials) 
                    <SU>4</SU>
                    <FTREF/>
                     or risk profile (
                    <E T="03">e.g.,</E>
                     frequent vs. infrequent shipments).
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Packing group means a grouping according to the degree of danger presented by hazardous materials. Packing Group I indicates great danger; Packing Group II, medium danger; Packing Group III, minor danger.
                    </P>
                </FTNT>
                <P>4. Expand the registration requirements. For example, certain hazardous materials are not subject to placarding when shipped domestically. Therefore, a person who offers for transportation, or transports, these materials is generally exempt from registration, but these requirements could be expanded with appropriate risk-based justifications.</P>
                <P>5. Expand the registration fee requirements to include certain persons who acquire approvals or special permits from PHMSA that otherwise are not subject to registration, but which should be based on a public risk-based justification.</P>
                <P>
                    <E T="03">If Congress allows an increase in the maximum fee, PHMSA is considering the following options for comment:</E>
                </P>
                <P>1. Maintain the current maximum registration fees and create an upper tier of a higher fee for a certain category of very large businesses. If this approach is preferred, how should PHMSA define a “very large business?” Specifically, what risk factors should go into determining a very large business classification to better account for market-based risks to the public as well as equity factors between applicants.</P>
                <P>2. Change the registration requirements to reduce the overall number of registrants.</P>
                <P>
                    3. Keep the existing registration requirements and raise the registration fee for large businesses from $2,575 to a dollar value below the Congressionally authorized maximum fee (
                    <E T="03">e.g.,</E>
                     if the maximum allowed were increased from $3,000 to $5,000).
                </P>
                <P>
                    4. Raise fees for specific business types, classes of material, or commodities (
                    <E T="03">e.g.,</E>
                     poisonous by inhalation material), which are considered extremely high risk.
                </P>
                <P>Once the comment period concluded for the ANPRM, PHMSA received seven sets of comments from the regulated community—which provided some insight on how to adjust the mandated registration and fee assessment program. Some ideas expressed within the comments PHMSA received were:</P>
                <P>1. Maintaining a two-tiered fee structure and raising HAZMAT registration fees in a manner that will not disproportionately impact small businesses.</P>
                <P>2. Endorsing the current two-tiered fee system based on the level of commercial activity assigned to business entities by the Small Business Administration (SBA) and opposing broadening the universe of registrants beyond shippers and carriers of placarded loads.</P>
                <P>3. Raising the $3,000 per registrant fee cap.</P>
                <P>4. Supporting the current two-tiered fee structure as well established and capable of generating the additional funds authorized in the IIJA, minimizing complexity, and providing clear identification of those who are required to pay the appropriate fees.</P>
                <P>5. Opposing additional criteria, revising the defining criteria for small or non-small businesses, or adding additional types of businesses that would need to register.</P>
                <P>Due to the limited number of comments received, PHMSA is holding this public meeting in hopes of garnering more substantive feedback and information on the most appropriate and equitable manner to adjust the registration and fee assessment program to meet the authorized increase set forth in the IIJA.</P>
                <HD SOURCE="HD1">II. Meeting Agenda</HD>
                <P>At this meeting, PHMSA will address the following topics:</P>
                <P>1. Data points PHMSA has garnered from an independent working group.</P>
                <P>
                    2. Establishing a new registration group (
                    <E T="03">e.g.,</E>
                     packaging manufacturers) and potentially raising registration fees on businesses 
                    <E T="03">other than small businesses</E>
                     based on risk-based transport of hazardous materials.
                </P>
                <P>3. Open floor—any items not covered in the ANPRM, or new suggestions mentioned by commenters to the ANPRM.</P>
                <HD SOURCE="HD1">III. Public Participation</HD>
                <P>
                    The meeting will be open to the public; however, any member of the public who wishes to attend must RSVP in advance using the following: 
                    <E T="03">https://usdot.zoomgov.com/meeting/register/vJItde2gqzgtGcv6ewzeLw34nzwwtO_IY68.</E>
                </P>
                <P>
                    PHMSA is committed to providing equal access for all citizens and ensuring that information is available in appropriate alternative formats to meet the requirements of persons who have a disability. If you require an alternative version of files provided or alternative accommodations, please contact 
                    <E T="03">PHMSA-Accessibility@dot.gov</E>
                     no later than June 21, 2023.
                </P>
                <SIG>
                    <DATED> Issued in Washington, DC, on May 23, 2023, under the authority delegated in 49 CFR 1.97.</DATED>
                    <NAME>William S. Schoonover,</NAME>
                    <TITLE>Associate Administrator for Hazard Materials Safety, Pipeline and Hazardous Materials Safety Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11298 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-60-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Pipeline and Hazardous Materials Safety Administration</SUBAGY>
                <SUBJECT>Hazardous Materials: Notice of Applications for New Special Permits</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>List of applications for special permits.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 26, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Record Center, Pipeline and Hazardous Materials Safety Administration U.S. Department of Transportation Washington, DC 20590.</P>
                    <P>Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.</P>
                <P>
                    Copies of the applications are available for inspection in the Records Center, East Building, PHH-13, 1200 
                    <PRTPAGE P="34229"/>
                    New Jersey Avenue Southeast, Washington DC.
                </P>
                <P>This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).</P>
                <SIG>
                    <DATED>Issued in Washington, DC, on May 10, 2023.</DATED>
                    <NAME>Donald P. Burger,</NAME>
                    <TITLE>Chief, General Approvals and Permits Branch.</TITLE>
                </SIG>
                <GPOTABLE COLS="4" OPTS="L2,nj,i1" CDEF="s25,r50,r50,r100">
                    <TTITLE>Special Permits Data</TTITLE>
                    <BOXHD>
                        <CHED H="1">Application No.</CHED>
                        <CHED H="1">Applicant</CHED>
                        <CHED H="1">Regulation(s) affected</CHED>
                        <CHED H="1">Nature of the special permits thereof</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">21547-N</ENT>
                        <ENT>Mazda Motor of America, Inc</ENT>
                        <ENT>172.101(j)</ENT>
                        <ENT>To authorize the transportation in commerce of lithium ion batteries exceeding 35 kg net weight aboard cargo-only aircraft. (mode 4).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21549-N</ENT>
                        <ENT>Repligen Corporation</ENT>
                        <ENT>173.222(c)(2)(ii)</ENT>
                        <ENT>To authorize the transportation in commerce of dangerous goods in apparatus containing a total net quantity of liquid hazardous material exceeding 0.5 L aboard aircraft. (modes 4, 5).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21551-N</ENT>
                        <ENT>Bollore Logistics Germany Gmbh</ENT>
                        <ENT>172.101(j), 172.300, 172,400, 173.185(a)(1), 173.185(b), 173.301(f), 173.302a(a)(1)</ENT>
                        <ENT>To authorize the transportation in commerce of certain non-DOT specification containers containing certain Division 2.2 and 2.3 liquefied and compressed gases for use in specialty cooling applications such as satellites and military aircraft. (modes 1, 3, 4).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21553-N</ENT>
                        <ENT>Pacific Scientific Energetic Materials Company (California) LLC</ENT>
                        <ENT>173.21(b), 173.51(a), 173.54, 173.54(a), 173.56(b)</ENT>
                        <ENT>To authorize the transportation in commerce of unapproved explosives originating at Pacific Scientific Energetic Materials Company LLC, and transported to Clean Harbors Waste Facility in Colfax, LA for final disposal by dedicated motor transport vehicle only. (mode 1).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21555-N</ENT>
                        <ENT>Hach Company</ENT>
                        <ENT>172.301(c), 172.315</ENT>
                        <ENT>To authorize the transportation in commerce of certain Division 5.1, Class 8, and Class 9 materials between Hach Company facilities without having to apply the limited quantity marking each individual package when consolidated into an overpack displaying the limited quantity mark. (mode 1).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21560-N</ENT>
                        <ENT>Osram Sylvania Inc</ENT>
                        <ENT>173.436</ENT>
                        <ENT>To authorize the transportation in commerce of lamps containing Class 7 materials with activity limits exceeding those specified in 49 CFR 173.436, as excepted packages. (modes 1, 4, 5).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21561-N</ENT>
                        <ENT>Xtracan Gmbh</ENT>
                        <ENT>173.306(a)(3)</ENT>
                        <ENT>To authorize the manufacture, mark, sale and use of a non-DOT specification can that conforms to all regulations applicable to the DOT-2Q container, except for wall thickness; and which is used for the transportation in commerce of certain Division 2.1 and 2.2 aerosols. (modes 1, 2, 3, 4, 5).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21567-N</ENT>
                        <ENT>Spaceflight, Inc</ENT>
                        <ENT>173.185(a)(1), 173.185(b)(5)</ENT>
                        <ENT>To authorize the transportation in commerce of prototype lithium batteries integrated into a shipping container intended to transport spacecraft. (modes 1, 3, 4).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21568-N</ENT>
                        <ENT>Sodastream USA, Inc</ENT>
                        <ENT>180.209</ENT>
                        <ENT>To authorize the transportation in commerce of DOT 3AL, TC/3ALM and UN ISO 7866 specification cylinders that are not subject to the volumetric expansion test requalification requirements. (modes 1, 2, 3).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21569-N</ENT>
                        <ENT>National Air Cargo Group, Inc</ENT>
                        <ENT>172.204(c)(3), 172.101(j), 173.27(b)(2), 173.27(b)(3), 175.30(a)(1)</ENT>
                        <ENT>To authorize the transportation in commerce of certain Class 1 and Division 2.3 materials that are forbidden for transport via cargo-only aircraft by cargo-only aircraft. (mode 4).</ENT>
                    </ROW>
                </GPOTABLE>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11300 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBJECT>Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Internal Revenue Service (IRS) Information Collection Requests</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Departmental Offices, Department of the Treasury.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments should be received on or before June 26, 2023 to be assured of consideration.</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>
                        Copies of the submissions may be obtained from Melody Braswell by emailing 
                        <E T="03">PRA@treasury.gov,</E>
                         calling (202) 622-1035, or viewing the entire information collection request at 
                        <E T="03">www.reginfo.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <PRTPAGE P="34230"/>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Internal Revenue Service (IRS)</HD>
                <P>
                    <E T="03">1. Title:</E>
                     Application to Adopt, Change, or Retain a Tax Year.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-0134.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     1128.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Section 442 of the Internal Revenue Code requires that a change in a taxpayer's annual accounting period be approved by the Secretary. Under regulation section 1.442-1(b), a taxpayer must file Form 1128 to secure prior approval unless the taxpayer can automatically make the change. The IRS uses the information on the form to determine whether the application should be approved.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There are no changes being made to the form at this time.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit organizations, Individuals, Not-for-profit institutions, and Farms.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     9,788.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     23 hours, 43 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     232,066.
                </P>
                <P>
                    <E T="03">2. Title:</E>
                     Application for Extension of Time to File a Return and/or Pay U.S. Estate (and Generation-Skipping Transfer) Taxes.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-0181.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     Form 4768.
                </P>
                <P>Abstract Form 4768 is used to request an extension of time to file an estate (and generation-skipping) tax return and/or to pay the estate (and generation-skipping) taxes and to explain why the extension should be granted. IRS uses the information to decide whether the extension should be granted.</P>
                <P>
                    <E T="03">Current Actions:</E>
                     There is no change in the burden previously approved by OMB.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals and business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses:</E>
                     18,500.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     1 Hours 30 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     27,565.
                </P>
                <P>
                    <E T="03">3. Title:</E>
                     Information Returns with Respect to Energy Grants and Financing.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-0232.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     6497.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Section 6050D of the Internal Code requires an information return to be made by any person who administers a Federal, state, or local program providing nontaxable grants or subsidized energy financing. Form 6497 is used for making the information return. The IRS uses the information from the form to ensure that recipients have not claimed tax credits or other benefits with respect to the grants or subsidized financing.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There are no changes to the burden.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses and other for-profit organizations, and not-for-profit institutions.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     250.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     3 hours, 14 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     810 hours.
                </P>
                <P>
                    <E T="03">4. Title:</E>
                     Gas Guzzler Tax.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-0242.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     Form 6197.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The gas guzzler tax is imposed on the sale, use, or lease by the manufacturer or importer of an automobile of a model type that does not meet certain standards for fuel economy. Automobiles imported for business or personal use are subject to tax. Taxpayers use Form 6197 to compute the gas guzzler tax and report the tax on their quarterly Form 720 tax return. Taxpayers who are not required to file Form 720 quarterly and do not import gas guzzling automobiles in the normal course of their trade or business may be eligible to make a on-time filing of Form 6197 and Form 720. The IRS uses the information to verify computation of the tax and compliance with the law.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There is no change to the existing collection.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households, and business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses:</E>
                     385.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     7 hours, 42 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     2,968.
                </P>
                <P>
                    <E T="03">5. Title:</E>
                     Exemption From Withholding on Compensation for Independent (and Certain Dependent) Personal Services of a Nonresident Alien Individual.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-0795.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     Form 8233.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Compensation paid to a nonresident alien individual in the United States for independent personal services (self-employment) or certain dependent personal services (employee) is generally subject to 30% withholding or graduated rates. However, compensation may be exempt from withholding because of a tax treaty. Form 8233 is used to request exemption from withholding.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There is no change to the existing collection.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households, and Private Sector.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses:</E>
                     28,650.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     8 hours, 57 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     256,418.
                </P>
                <P>
                    <E T="03">6. Title:</E>
                     Return for Nuclear Decommissioning Funds and Certain Related Persons.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-0954.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     1120-ND.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Form 1120-ND is filed by utilities that have nuclear power plants. These utilities set up funds to provide cash to decommission the nuclear power plant. Form 1120-ND is used to determine the tax liability and income tax that the fund must pay.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There are no changes to the paperwork burden previously approved by OMB.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Businesses and other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     100.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     32 hours, 35 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     3,259.
                </P>
                <P>
                    <E T="03">7. Title:</E>
                     Request Relating to Return of Excise Tax on Undistributed Income of Real Estate Investment Trusts.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-1013.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     8612.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Form 8612 is used by real estate investment trusts to compute and pay the excise tax on undistributed income imposed under section 4981 of the Internal Revenue Code. The IRS uses the information to verify that the correct amount of tax has been reported.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There are no changes to burden.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     20.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     9 hours, 48 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     196 hours.
                </P>
                <P>
                    <E T="03">8. Title:</E>
                     Annual Certification of a Residential Rental Project.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-1038.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     8703.
                    <PRTPAGE P="34231"/>
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Form 8703 is used by the operator of a residential rental project to provide annual information that the IRS will use to determine whether a project continues to be a qualified residential rental project under Internal Revenue Code section 142(d). If so, and certain other requirements are met, bonds issued in connection with the project are considered “exempt facility bonds” and the interest paid on them is not taxable to the recipient.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There are no changes in the paperwork burden previously approved by OMB.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     6,000.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     12 hours, 47 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     76,620.
                </P>
                <P>
                    <E T="03">9. Title:</E>
                     U.S. Estate Tax Return for Qualified Domestic Trusts.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-1212.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     706 QDT.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Form 706-QDT is used by the trustee or the designated filer to compute and report the Federal estate tax imposed on qualified domestic trusts by Internal Revenue Code section 2056A. The IRS uses the information to enforce this tax and to verify that the tax has been properly computed.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There are no changes being made to the form at this time.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households, and business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     474.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     4 hours, 28 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     2,114 hours.
                </P>
                <P>
                    <E T="03">10. Title:</E>
                     Proceeds of Bonds Used for Reimbursement.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-1226.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     T.D. 8394.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This regulation clarifies when the allocation of bond proceeds to reimburse expenditures previously made by an issuer of the bond is treated as an expenditure of the bond proceeds. The issuer must express a reasonable official intent, on or prior to the date of payment, to reimburse the expenditure in order to assure that the reimbursement is not a device to evade requirements imposed by the Internal Revenue Code with respect to tax exempt bonds.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There is no change to this existing regulation.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     State, local or tribal governments, and not-for-profit institutions.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     2,500.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     2 hours, 24 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     6,000.
                </P>
                <P>
                    <E T="03">11. Title:</E>
                     Gasohol; Compressed Natural Gas; and Gasoline Excise Tax.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-1270.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     PS-66-93 (TD 8609) and PS-120-90 (TD 8241).
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     TD 8609: This regulation relates to gasohol blending and the tax on compressed natural gas (CNG). The sections relating to gasohol blending affect certain blenders, enterers, refiners, and through putters. The sections relating to CMG affect persons that sell or buy CNG for use as a fuel in a motor vehicle or motorboat. TD 8421: This regulation relates to the federal excise tax on gasoline. It affects refiners, importers, and distributors of gasoline and provides guidance relating to taxable transactions, persons liable for tax, gasoline blendstocks, and gasohol.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     The IRS is removing the burden associated with section 48.4081-6(c)(1)(ii). See Public Law 108-357, Title III, §  301(c)(7), Oct. 22, 2004, 118 Stat. 1461. There are no other changes in the paperwork burden previously approved by OMB; IRS is making this submission to renew the OMB approval.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit organizations, Not-for-profit institutions, Farms and State, Local or Tribal Governments.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     2,210.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     9 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     246.
                </P>
                <P>
                    <E T="03">12. Title:</E>
                     Tuition Statement.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-1574.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     Form 1098-T.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Section 6050S of the Internal Revenue Code quires eligible education institutions to report certain information to the IRS and to students. Form 1098-T has been developed to meet this requirement.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There are no changes being made to the form at this time that would affect burden.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit organizations, and not-for-profit institutions.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     24,239,614.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     13 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     5,575,112 hours.
                </P>
                <P>
                    <E T="03">13. Title:</E>
                     Information reporting requirements in section 6045(e).
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-1592.
                </P>
                <P>
                    <E T="03">Regulation Project Number:</E>
                     Rev. Proc. 2007-12.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This revenue procedure sets forth the acceptable form of the written assurances (certification) that a real estate reporting person must obtain from the seller of a principal residence to except such sale or exchange from the information reporting requirements for real estate transactions under section 6045(e)(5) of the Internal Revenue Code.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There is no change to the burden previously approved by OMB.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households, and business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     2,300,000.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     11 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     420,500.
                </P>
                <P>
                    <E T="03">14. Title:</E>
                     Handbook for Authorized IRS e-file Providers.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-1708.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     Publication 1345.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Publication 1345 informs those who participate in the IRS e-file Program for Individual Income Tax Returns of their obligations to the Internal Revenue Service, taxpayers, and other participants.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There are no changes to burden.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     200,000.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses:</E>
                     129,655,713.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     3 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     6,023,762.
                </P>
                <P>
                    <E T="03">15. Title:</E>
                     Extraterritorial Income Exclusion.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-1722.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     8873.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The FSC and Extraterritorial Income Exclusion Act of 2000 added section 114 to the Internal Revenue 
                    <PRTPAGE P="34232"/>
                    Code. Section 114 provides for an exclusion from gross income for certain transactions occurring after September 30, 2000, with respect to foreign trading gross receipts. Form 8873 is used to compute the amount of extraterritorial income excluded from gross income for the tax year.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There are no changes to the form or burden.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     100.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     25 hours, 27 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     2,545 hours.
                </P>
                <P>
                    <E T="03">16. Title:</E>
                     Electronic Payee Statements.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-1729.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     TD 9114.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This collect contains final regulations, TD 9114 (published February 18, 2004 [69 FR 7567]), relating to the voluntary electronic furnishing of statements on Forms W-2, “Wage and Tax Statement,” under sections 6041 and 6051, and statements on Forms 1098-T, “Tuition Statement,” and Forms 1098-E, “Student Loan Interest Statement,” under section 6050S. These final regulations affect businesses, other for-profit institutions, and eligible educational institutions that wish to furnish these required statements electronically. The regulations will also affect individuals (recipients), principally employees, students, and borrowers, who consent to receive these statements electronically.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There is no change to the burden previously approved by OMB. This form is being submitted for renewal purposes only.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     15,200.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     6 mins.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     2,844,950.
                </P>
                <P>
                    <E T="03">17. Title:</E>
                     Carrier Summary Report, Terminal Operator Report, and Request for Extension of Time to File an ExSTARS Information Return.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-1733.
                </P>
                <P>
                    <E T="03">Form Numbers:</E>
                     Forms 720-CS, 720-TO, and 8809-EX.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Representatives of the motor fuel industry, state governments, and the Federal government are working to ensure compliance with excise taxes on motor fuels. This joint effort has resulted in a system to track the movement of all products to and from terminals. Form 720-CS is an information return used by bulk transport carriers to report monthly receipts and disbursements of all liquid products at a storage location designated by a facility control number (FCN). Form 720-TO is completed by terminal operators to report monthly receipts and disbursements of all liquid products to and from all approved terminals. Form 8809-EX is used to request a 30-day extension of time to file an Excise Summary Terminal Activity Reporting System (ExSTARS) information report (Form 720-CS or Form 720-TO).
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There is no change to the existing collection.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses:</E>
                     544,380.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     4 hours, 39 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     2,530,383.
                </P>
                <P>
                    <E T="03">18. Title:</E>
                     Average Area Purchase Price Safe Harbors and Nationwide Purchase Prices under section 143.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-1877.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     Revenue Procedure 2022-17.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The revenue procedure under this collection provides issuers of qualified mortgage bonds, as defined in section 143(a) of the Internal Revenue Code (Code), and issuers of mortgage credit certificates, as defined in section 25(c), with (1) the nationwide average purchase price for residences located in the United States, and (2) average area purchase price safe harbors for residences located in statistical areas in each state, the District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, the Virgin Islands, and Guam.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There are no changes to burden.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     State, Local, and Tribal Governments.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     60.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     15 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     15 hours.
                </P>
                <P>
                    <E T="03">19. Title:</E>
                     Revenue Procedure 2011-34 Rules for Certain Rental Real Estate Activities.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-2194.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This revenue procedure grants relief under Section 1.469-9(g) for certain taxpayers to make late elections to treat all interests in rental real estate as a single rental real estate activity.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There is no change in the paperwork burden previously approved by OMB. This form is being submitted for renewal purposes only.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or Households.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     2,000.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     30 mins.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     1,000.
                </P>
                <P>
                    <E T="03">20. Title:</E>
                     IRS Taxpayer Burden Surveys.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-2212.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     N/A.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Each year, individual taxpayers in the United States submit more than 140 million tax returns to the Internal Revenue Service (IRS). The IRS uses the information in these returns, recorded on roughly one hundred distinct forms and supporting schedules, to administer a tax system whose rules span thousands of pages. Managing such a complex and broad-based tax system is costly but represents only a fraction of the total burden of the tax system. Equally, if not more burdensome, is the time and out-of-pocket expenses that taxpayers spend in order to comply with tax laws and regulations.
                </P>
                <P>Changes in tax regulations, tax administration, tax preparation methods, and taxpayer behavior continue to alter the amount and distribution of taxpayer burden. Data from updated surveys will better reflect the current tax rules and regulations, the increased usage of tax preparation software, increased efficiency of such software, changes in tax preparation regulations, the increased use of electronic filing, the behavioral response of taxpayers to the tax system, the changing use of services, both IRS and external, and related information collection needs.</P>
                <P>
                    <E T="03">Current Actions:</E>
                     The Taxpayer Burden Surveys allow RAAS to update and validate the IRS Taxpayer Burden Model which is used to provide estimates for consolidated taxpayer segments, such as OMB numbers 1545-0074, 1545-0123, and 1545-0047. This form is being submitted for revision purposes.
                </P>
                <P>
                    <E T="03">Data Collections and Burden Hours Covered Under This Clearance Request:</E>
                    <PRTPAGE P="34233"/>
                </P>
                <GPOTABLE COLS="6" OPTS="L2,tp0,i1" CDEF="xs36,r50,16,16,16,16">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Table</CHED>
                        <CHED H="1">Taxpayer segment</CHED>
                        <CHED H="1">Responses</CHED>
                        <CHED H="1">
                            Burden hours
                            <LI>period 1</LI>
                            <LI>6/1/2023-5/31/2024</LI>
                        </CHED>
                        <CHED H="1">
                            Burden hours
                            <LI>period 2</LI>
                            <LI>6/1/2024-5/31/2025</LI>
                        </CHED>
                        <CHED H="1">
                            Burden hours
                            <LI>period 3</LI>
                            <LI>6/1/2025-5/31/2026</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">1</ENT>
                        <ENT>Individual Taxpayers</ENT>
                        <ENT>64,575</ENT>
                        <ENT>4,232</ENT>
                        <ENT>4,234</ENT>
                        <ENT>4,234</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">2</ENT>
                        <ENT>Business Entities</ENT>
                        <ENT>42,375</ENT>
                        <ENT>2,610</ENT>
                        <ENT>5,220</ENT>
                        <ENT>870</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3</ENT>
                        <ENT>Tax-Exempt Organizations</ENT>
                        <ENT>14,475</ENT>
                        <ENT>645</ENT>
                        <ENT>1,504</ENT>
                        <ENT>324</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4</ENT>
                        <ENT>Trusts and Estate Form 1041 Filers</ENT>
                        <ENT>13,050</ENT>
                        <ENT>1,087</ENT>
                        <ENT>1,088</ENT>
                        <ENT>0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">5</ENT>
                        <ENT>Form 709 Gift Tax Return Filers</ENT>
                        <ENT>7,500</ENT>
                        <ENT>1,088</ENT>
                        <ENT>362</ENT>
                        <ENT>0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">6</ENT>
                        <ENT>Form 706 Estate Tax Return Filers</ENT>
                        <ENT>2,850</ENT>
                        <ENT>0</ENT>
                        <ENT>0</ENT>
                        <ENT>1,450</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">7</ENT>
                        <ENT>Excise Tax Return Filers</ENT>
                        <ENT>1,500</ENT>
                        <ENT>0</ENT>
                        <ENT>1,088</ENT>
                        <ENT>362</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">8</ENT>
                        <ENT>Employers</ENT>
                        <ENT>7,500</ENT>
                        <ENT>1,450</ENT>
                        <ENT>725</ENT>
                        <ENT>0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">9</ENT>
                        <ENT>Information Return Filers</ENT>
                        <ENT>10,000</ENT>
                        <ENT>0</ENT>
                        <ENT>0</ENT>
                        <ENT>5,800</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">10</ENT>
                        <ENT>Pension Plan Return Filers</ENT>
                        <ENT>3,000</ENT>
                        <ENT>1,450</ENT>
                        <ENT>0</ENT>
                        <ENT>0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT/>
                        <ENT>166,825</ENT>
                        <ENT>12,562</ENT>
                        <ENT>14,221</ENT>
                        <ENT>13,040</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">Type of Review:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individual, Business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Total Number of Respondents:</E>
                     140,658.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     17 min.
                </P>
                <P>
                    <E T="03">Estimated Total Burden Hours:</E>
                     39,853.
                </P>
                <P>
                    <E T="03">21. Title:</E>
                     Reporting Abusive Tax Promotions or Preparers.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1545-2219.
                </P>
                <P>
                    <E T="03">Form Numbers:</E>
                     14242 and 14242(SP).
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Form 14242 and Form 14242(SP) are used to document the information necessary to report an abusive tax avoidance scheme. Form 14242(SP) is the Spanish version of Form 14242. Respondents can be individuals, businesses and tax return preparers.
                </P>
                <P>
                    <E T="03">Current Actions:</E>
                     There are no changes being made to the forms at this time.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or Households, Farms, Businesses and other for-profit or not-for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     460.
                </P>
                <P>
                    <E T="03">Estimated Time per Respondent:</E>
                     10 minutes.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     77 hours.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <NAME>Melody Braswell,</NAME>
                    <TITLE>Treasury PRA Clearance Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11330 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4830-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">UNITED STATES SENTENCING COMMISSION</AGENCY>
                <SUBJECT>Request for Applications; Tribal Issues Advisory Group</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>United States Sentencing Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In view of an upcoming vacancy in the at-large membership of the Tribal Issues Advisory Group, the United States Sentencing Commission hereby invites any individual who is eligible to be appointed to the at-large membership of the Tribal Issues Advisory Group to apply. An applicant for membership in the Tribal Issues Advisory Group should apply by sending a letter of interest and resume to the Commission as indicated in the 
                        <E T="02">ADDRESSES</E>
                         section below. Application materials should be received by the Commission not later than July 31, 2023.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Application materials for the at-large membership of the Tribal Issues Advisory Group should be received not later than July 31, 2023.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        An applicant for the at-large membership of the Tribal Issues Advisory Group should apply by sending a letter of interest and resume to the Commission by electronic mail or regular mail. The email address is 
                        <E T="03">pubaffairs@ussc.gov.</E>
                         The regular mail address is United States Sentencing Commission, One Columbus Circle NE, Suite 2-500, South Lobby, Washington, DC 20002-8002, Attention: Public Affairs—TIAG Membership.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jennifer Dukes, Senior Public Affairs Specialist, (202) 502-4597. More information about the Tribal Issues Advisory Group is available on the Commission's website at 
                        <E T="03">http://www.ussc.gov/about/who-we-are/advisory-groups.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The United States Sentencing Commission is an independent agency in the judicial branch of the United States Government. The Commission promulgates sentencing guidelines and policy statements for federal courts pursuant to 28 U.S.C. 994(a). The Commission also periodically reviews and revises previously promulgated guidelines pursuant to 28 U.S.C. 994(o) and submits guideline amendments to the Congress not later than the first day of May each year pursuant to 28 U.S.C. 994(p).</P>
                <P>The Tribal Issues Advisory Group is a standing advisory group of the United States Sentencing Commission pursuant to 28 U.S.C. 995 and Rule 5.4 of the Commission's Rules of Practice and Procedure. Under the charter for the Tribal Issues Advisory Group, the purpose of the advisory group is (1) to assist the Commission in carrying out its statutory responsibilities under 28 U.S.C. 994(o); (2) to provide to the Commission its views on federal sentencing issues relating to American Indian and Alaska Native defendants and victims, and to offenses committed in Indian country; (3) to engage in meaningful consultation and outreach with tribes, tribal governments, and tribal organizations regarding federal sentencing issues that have tribal implications; (4) to disseminate information regarding federal sentencing issues to tribes, tribal governments, and tribal organizations; and (5) to perform any other related functions as the Commission requests. The advisory group consists of no more than 9 members, each of whom may serve not more than two consecutive three-year terms. Of those 9 members, not more than 1 shall be a federal judge; 2 shall be from the Executive Branch (one from the United States Department of Justice and one from the United States Department of the Interior); 1 shall be from a federal public defender organization or community defender organization; 1 shall be a tribal court judge; and not more than 4 shall be at-large members.</P>
                <P>
                    Members of the Tribal Issues Advisory Group are appointed by the Commission. To be eligible to serve as a member, an individual must have expertise, knowledge and/or experience in the issues considered by the Tribal 
                    <PRTPAGE P="34234"/>
                    Issues Advisory Group. The Commission intends that the at-large membership shall include individuals with membership in or experience with tribes, tribal governments, and tribal organizations, appointed in a manner that ensures representation among tribal communities diverse in size, geographic location, and other unique characteristics.
                </P>
                <P>
                    The Commission invites any individual who is eligible to be appointed to the at-large membership of the Tribal Issues Advisory Group to apply by sending a letter of interest and a resume to the Commission as indicated in the 
                    <E T="02">ADDRESSES</E>
                     section above.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     28 U.S.C. 994(a), (o), (p), 995; USSC Rules of Practice and Procedure 2.2(c), 5.4.
                </P>
                <SIG>
                    <NAME>Carlton W. Reeves,</NAME>
                    <TITLE>Chair.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11307 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 2210-40-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF VETERANS AFFAIRS</AGENCY>
                <SUBJECT>Annual Pay Ranges for Physicians, Dentists, and Podiatrists of the Veterans Health Administration</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of Veterans Affairs.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>VA hereby gives notice of the annual pay ranges, which are the sum of the base pay rate and market pay for VHA physicians, dentists and podiatrists as prescribed by the VA Secretary for Department-wide applicability. These annual pay ranges are intended to enhance the flexibility of the Department to recruit, develop and retain the most highly qualified providers to serve the Nation's Veterans and maintain a standard of excellence in the VA health care system.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The annual pay ranges are applicable July 30, 2023.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Ophelia A. Vicks, Executive Director of Human Capital Policies, Office of the Chief Human Capital Officer (05), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, 202-461-7765. This is not a toll-free number.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Under 38 U.S.C. 7431(e)(1)(A), not less often than once every 2 years, the Secretary must prescribe for Department-wide applicability the minimum and maximum amounts of annual pay that may be paid to VHA physicians, dentists and podiatrists. Per 38 U.S.C. 7431(e)(1)(B), the Secretary is allowed to prescribe separate minimum and maximum amounts of annual pay for a specialty or assignment. Pursuant to 38 U.S.C. 7431(e)(1)(C), amounts prescribed under subsection 7431(e) shall be published in the 
                    <E T="04">Federal Register</E>
                     and shall not take effect until at least 60 days after the date of publication.
                </P>
                <P>
                    In addition, under 38 U.S.C. 7431(e)(4), the total amount of compensation paid to a physician, dentist or podiatrist under title 38 of the United States Code cannot exceed, in any year, the amount of annual compensation (excluding expenses) of the President. For section 7431(e)(4), the total amount of compensation includes base pay, market pay, performance pay, and fee basis earnings, but excludes recruitment, relocation and retention incentives 
                    <SU>1</SU>
                    <FTREF/>
                     and awards for performance and superior accomplishments from total compensation calculations.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         In accordance with Title IX, 906 of the “Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act of 2022” (Pub. L. 117-168 dated August 10, 2022), recruitment, relocation, and retention incentives, along with awards for performance and superior accomplishments, shall not be considered in calculating the limitation under 38 U.S.C. 7431(e)(4).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Background</HD>
                <P>The Department of Veterans Affairs Health Care Personnel Enhancement Act of 2004, Public Law 108-445, was signed by the President on December 3, 2004. The major provisions of the law established a new pay system for VHA physicians and dentists consisting of base pay, market pay and performance pay. These three components create a system of pay that is driven by market indicators and employee performance, while recognizing employee tenure in VHA. While the base pay component is set by statute, market pay is intended to reflect the recruitment and retention needs for the specialty or assignment of a particular physician or dentist at a facility. Further, performance pay is intended to recognize the achievement of specific goals and performance objectives prescribed annually.</P>
                <P>On April 8, 2019, the President signed Public Law 116-12, which amended 38 U.S.C. 7431 to include podiatrists within the physician and dentist pay system, authorizing podiatrists to receive base pay, market pay, and performance pay. With this amendment, podiatrists are also subject to the same limitations and requirements as physicians and dentists under section 7431.</P>
                <P>
                    VA will be reducing the number of pay tables from 6 to 5 by consolidating pay tables 3 and 4. Pay tables 1, 2 and 3 will cover the clinical specialties, and pay tables 4 and 5 will cover executive assignments. The maximum amount for the newly combined pay table 3 will remain unchanged as described in the 2016 
                    <E T="04">Federal Register</E>
                     publication. However, there have been changes to the minimum and maximum amounts for pay tables 1, 2 and 5.
                </P>
                <HD SOURCE="HD1">Discussion</HD>
                <P>VA identified and utilized salary survey data sources that most closely represent VA comparability in practice setting, employment, environment and hospital/health care system. The Association of American Medical Colleges, Sullivan Cotter and Associates, Medical Group Management Association, Korn Ferry Healthcare National and Executive Report, Mercer Integrated Health Networks and the Survey of Dental Practice published by the American Dental Association were collectively utilized as benchmarks to prescribe annual pay ranges across the scope of assignments/specialties within the Department. While aggregating the data, a preponderance of weight was given to those surveys which most directly resembled the environment of the Department.</P>
                <P>VA continued the practice of grouping specialties into consolidated pay ranges when constructing annual pay ranges to accommodate the more than 40 specialties that currently exist in the VA system. This allows VA to use multiple sources that yield high numbers of salary data which help minimize disparities and aberrations that may surface from data involving smaller numbers for comparison and from sample changes year-to-year. By aggregating multiple survey sources into like groupings, greater confidence exists that the average compensation reported is truly representative. Additionally, the aggregation of data provides for a substantial sample size to provide vast pay ranges with maximum flexibility for VHA physicians, dentists and podiatrists.</P>
                <P>
                    In developing the annual pay ranges, distinctive principles were factored into the compensation analysis of the data. The first principle is to ensure that the minimum and maximum salary are at a level that accommodate special employment situations, from fellowships and medical research career development awards to Nobel Laureates, high-cost areas and internationally renowned clinicians. The second principle is to provide ranges large enough to accommodate career progression, geographic differences, 
                    <PRTPAGE P="34235"/>
                    sub-specialization and other special factors.
                </P>
                <P>Clinical specialties were reviewed against available relevant private sector data. The specialties are grouped into three (formerly four) clinical pay ranges that reflect comparable complexity in salary, recruitment and retention considerations. The Steering Committee recommendations included consolidating former pay tables 3 and 4; designating three clinical pay ranges (pay tables 1, 2 and 3) for the varying clinical specialties; and designating pay tables 4 and 5 for executive assignments. The Steering Committee also recommends adding new and realigning existing specialties to different clinical pay ranges, as well as changes to the minimum and maximum pay ranges.</P>
                <P>
                    VHA organizational improvement is focused on making operational improvements by redesigning VHA Central Office (VHACO); revising its governance functions; and creating integrated clinical communities. Additionally, as part of the VHACO organizational improvement and for consistency with the position titles outlined in 38 U.S.C. 7306, VHA is modifying titles for a senior-level physician, dentist and podiatrist leaders assigned to pay table 5 (formerly 6) of the VHA physician, dentist, and podiatrist pay system. The new structure clarifies office roles and streamlines responsibilities to eliminate fragmentation, overlap and duplication. It also allows VHA to be more agile and respond to changes and make decisions more quickly, positioning VHA to better support the Veteran Integrated Services Networks and facilities directly serving Veterans.
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Tier 1 and Tier 2 Minimums for Pay Tables 1 and 2 reflect the statutory minimum rate of pay for this pay system in accordance with Schedule 3 of the President's Executive Order 14090, Adjustments of Certain Rates of Pay, dated December 23, 2022.
                    </P>
                    <P>
                        <SU>3</SU>
                         Tier 1 Minimum for Pay Table 3 reflects the statutory minimum rate of pay for this pay system in accordance with Schedule 3 of the President's Executive Order 14090, Adjustments of Certain Rates of Pay, dated December 23, 2022.
                    </P>
                </FTNT>
                <P>Denis McDonough, Secretary of Veterans Affairs, approved this document on May 19, 2023, 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.</P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s50,10,10">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Tier level</CHED>
                        <CHED H="1">Minimum</CHED>
                        <CHED H="1">Maximum</CHED>
                    </BOXHD>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">Pay Table 1—Clinical Specialty</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Tier 1</ENT>
                        <ENT>
                            <SU>2</SU>
                             $115,587
                        </ENT>
                        <ENT>$243,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tier 2</ENT>
                        <ENT>115,587</ENT>
                        <ENT>260,000</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Tier 3</ENT>
                        <ENT>120,000</ENT>
                        <ENT>280,340</ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">Pay Table 1—Covered Clinical Specialties</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="01">Endocrinology; Family Medicine; General Practice—Dentistry; Internal Medicine; Palliative Care; Podiatry (General); Preventive Medicine; Primary Care; Prosthodontics; Rheumatology; All other specialties or assignments.</ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">Pay Table 2—Clinical Specialty</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Tier 1</ENT>
                        <ENT>$115,587</ENT>
                        <ENT>$300,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tier 2</ENT>
                        <ENT>115,587</ENT>
                        <ENT>320,000</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Tier 3</ENT>
                        <ENT>130,000</ENT>
                        <ENT>336,000</ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">Pay Table 2—Covered Clinical Specialties</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="01">Allergy and Immunology; Endodontics; Geriatrics; Health Informatics; Hospitalist; Infectious Diseases; Neurology; Nocturnist; Periodontics; Physical Medicine and Rehabilitation/Spinal Cord Injury; Podiatry (surgery—forefoot, rearfoot/ankle, advanced rearfoot/ankle); Psychiatry; Sleep Medicine.</ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">Pay Table 3—Clinical Specialty</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Tier 1</ENT>
                        <ENT>
                            <SU>3</SU>
                             $115,587
                        </ENT>
                        <ENT>$400,000</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Tier 2</ENT>
                        <ENT>120,000</ENT>
                        <ENT>400,000</ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">Pay Table 3—Covered Clinical Specialties</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="01">Anatomic Pathology; Anesthesiology; Cardiology (invasive/non-interventional); Cardiology (non-invasive); Cardio-Thoracic Surgery; Critical Care; Dermatology; Dermatology Mohs (a micrographic surgery)- -; Emergency Medicine; Gastroenterology; General Surgery; Gynecology; Hematology—Oncology; Interventional Cardiology; Interventional Radiology; Nephrology; Neurosurgery; Nuclear Medicine; Ophthalmology; Oral Surgery; Orthopedic Surgery; Otolaryngology; Pain Management (interventional and non-operating room anesthesiology); Pain Management (physical medicine and rehabilitation); Pathology; Plastic Surgery; Pulmonary; Radiology (diagnostic); Radiation Oncology; Urology; Vascular Surgery.</ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">Pay Table 4—Chief of Staff and Network Chief Medical Officers</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Tier 1</ENT>
                        <ENT>$150,000</ENT>
                        <ENT>$400,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tier 2</ENT>
                        <ENT>147,000</ENT>
                        <ENT>375,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tier 3</ENT>
                        <ENT>145,000</ENT>
                        <ENT>350,000</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Tier 4</ENT>
                        <ENT>140,000</ENT>
                        <ENT>325,000</ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">Pay Table 4—Covered Assignments</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="01">VHA Chiefs of Staff and Network Chief Medical Officers Tier assignments for Chiefs of Staff are based on published facility complexity level. Tier 1—Network Chief Medical Officer and Chief of Staff—Complexity Levels 1a and 1b. Tier 2—Chief of Staff—Complexity Levels 1c and 2. Tier 3—Chief of Staff—Complexity Level 3 and facilities with no designation level. Tier 4—Deputy Network Chief Medical Officer and Deputy Chief of Staff.</ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">Pay Table 5—Executive Assignments</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Tier 1</ENT>
                        <ENT>$145,000</ENT>
                        <ENT>$310,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tier 2</ENT>
                        <ENT>145,000</ENT>
                        <ENT>295,000</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Tier 3</ENT>
                        <ENT>145,000</ENT>
                        <ENT>285,000</ENT>
                    </ROW>
                    <ROW EXPSTB="02" RUL="s">
                        <ENT I="21">
                            <E T="02">Pay Table 5—Covered Assignments</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="02">
                        <ENT I="01">The Deputy Under Secretary for Health; Assistant Under Secretaries for Health; Associate Deputy Under Secretary for Health; Assistant Deputy Under Secretary for Health; Chief Officers (VHACO); Network Directors; Medical Center Directors; Executive Directors (VHACO); Deputy to the Assistant Under Secretaries for Health; Chief Consultants (VHACO); Deputy Chief Officers (VHACO); Deputy Chief Consultants (VHA CO); Deputy to the Executive Directors (VHACO); and VHACO physicians, dentists or podiatrists (non-senior executive service equivalents) with an administrative/executive role for more than 50% of their full-time equivalent employees.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Signing Authority</HD>
                <SIG>
                    <NAME>Luvenia Potts,</NAME>
                    <TITLE>Regulation Development Coordinator, Office of Regulation Policy &amp; Management, Office of General Counsel, Department of Veterans Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2023-11306 Filed 5-25-23; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8320-01-P</BILCOD>
        </NOTICE>
    </NOTICES>
    <VOL>88</VOL>
    <NO>102</NO>
    <DATE>Friday, May 26, 2023</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="34237"/>
            <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 433, 438, and 447</CFR>
            <TITLE> Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program; Proposed Rules</TITLE>
        </PTITLE>
        <PRORULES>
            <PRORULE>
                <PREAMB>
                    <PRTPAGE P="34238"/>
                    <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                    <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
                    <CFR>42 CFR Parts 433, 438, and 447</CFR>
                    <DEPDOC>[CMS-2434-P]</DEPDOC>
                    <RIN>RIN 0938-AU28</RIN>
                    <SUBJECT>Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program</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 seek to implement policies in the Medicaid Drug Rebate Program (MDRP) related to the new legislative requirements in the Medicaid Services Investment and Accountability Act of 2019 (MSIAA), which are needed to address drug misclassification, as well as drug pricing and product data misreporting by manufacturers. Additionally, we are proposing several other program integrity and program administration provisions or modifications in this proposed rule including revising and proposing key definitions used in the MDRP. This proposed rule also designates a time limitation on manufacturers initiating audits with States; clarifies and establishes requirements for State fee-for-service (FFS) pharmacy reimbursement; codifies conditions relating to States claiming FFP for physician-administered drugs (PADs); clarifies the requirement of accumulating price concessions when determining best price; designates drug price verification and transparency through data collection; and proposes two new contracting requirements between States and their Medicaid managed care plans. In addition, this rule includes a proposal unrelated to MDRP that would make revisions to the third-party liability regulation due to Bipartisan Budget Act (BBA) of 2018. Finally, we are proposing to rescind revisions made by the December 31, 2020 final rule “Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements” to the Determination of Best Price and Determination of Average Manufacturer Price (AMP) sections.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>To be assured consideration, comments must be received at one of the addresses provided below, by July 25, 2023.</P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>In commenting, please refer to file code CMS-2434-P.</P>
                        <P>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">https://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-2434-P, P.O. Box: 8016, Baltimore, MD 21244-8016.
                        </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-2434-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>Ruth Blatt, (410) 786-1767, for issues related to the definitions of vaccine, noninnovator multiple-source drug, market date, and covered outpatient drug (COD).</P>
                        <P>Ginger Boscas, (410) 786-3098, for issues related to third party liability.</P>
                        <P>Michael Forman, (410) 786-2666, for issues related to physician-administered drugs.</P>
                        <P>Whitney Swears (410) 786-6543, for issues related to time limitation on audits, definition of vaccine, diagnosis on prescriptions, professional dispensing fees, definition of a manufacturer.</P>
                        <P>Christine Hinds, (410) 786-4578, for issues related to internal investigation, removal of manufacturer rebate cap, drug cost transparency in Medicaid managed care contracts, “stacking” when determining best price, and drug price verification through data collection.</P>
                        <P>Lisa Shochet, (410) 786-5445, for issues related to Beneficiary Identification Number and Processor Control Number (BIN/PCN) and drug misclassifications.</P>
                        <P>Terry Simananda, (410) 786-8144, for issues related to the Collection of Information and Regulatory Impact Analysis sections.</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">https://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 individual will take actions to harm the 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>
                    <HD SOURCE="HD1">I. Background</HD>
                    <HD SOURCE="HD2">A. Introduction</HD>
                    <P>Under the Medicaid program, States may provide coverage of prescribed drugs as an optional benefit under section 1905(a)(12) of the Social Security Act (the Act). Section 1903(a) of the Act provides for Federal Financial Participation (FFP) in State expenditures for these drugs. In the case of a State that provides for medical assistance for covered outpatient drugs (CODs), as provided under section 1902(a)(54) of the Act, the State must comply with the requirements of section 1927 of the Act. Section 1927 of the Act governs the Medicaid Drug Rebate Program (MDRP) and payment for CODs, which are defined in section 1927(k)(2) of the Act. In general, for payment to be made available for CODs under section 1903(a) of the Act, manufacturers must enter into a National Drug Rebate Agreement (NDRA) as set forth in section 1927(a) of the Act. See also section 1903(i)(10) of the Act. The rebates paid by manufacturers to States help to partially offset the Federal and State costs of most outpatient prescription drugs dispensed to Medicaid beneficiaries. The MDRP provides specific requirements for manufacturer rebate agreements, drug pricing submission and confidentiality requirements, the formulas for calculating rebate payments, drug utilization reviews (DUR), and requirements for States for CODs.</P>
                    <P>
                        With limited exceptions, if a manufacturer wants payment to be 
                        <PRTPAGE P="34239"/>
                        available under Medicaid for their CODs, the manufacturer must participate (have entered into and have in effect a rebate agreement) in the MDRP, and agree to pay rebates for CODs dispensed and paid for under the State Plan. The amount of the rebate is determined by a formula set forth in section 1927(c) of the Act. Generally, the formula to calculate the rebate that applies to a particular drug depends on whether the drug is classified as (1) a single source drug (S drug) or innovator multiple source drug (I drug) (commonly referred to as a brand-name drug), or (2) other drugs, which include noninnovator multiple source drugs (N drug), commonly referred to as generic drugs, among others.
                    </P>
                    <P>Consistent with section 1927(b)(3)(A) of the Act, a manufacturer must report and certify certain drug product and drug pricing information for CODs to CMS not later than 30 days after the last day of each month and certain drug pricing information and drug product data 30 days after the last day of each quarter of a rebate period. For example, drug pricing information that manufacturers must submit and certify includes average manufacturer price (AMP) and best price data in addition to other information consistent with section 1927(b)(3)(A) of the Act each quarter. We use the reported data to calculate an accurate unit rebate amount (URA) for each covered outpatient drug to assist States with billing manufacturers for rebates. Drug product information that is reported includes the name of the drug, its National Drug Code (NDC), drug category, and drug type, among other items. However, manufacturers ultimately remain responsible for accurately calculating the URA for their drug products. Manufacturers pay rebates to States for each unit of the drug dispensed and paid for under the State Plan on the basis of the URA.</P>
                    <P>Thus, the failure of a manufacturer to submit and certify timely monthly and quarterly pricing and drug product data for a drug may impede the States' ability to invoice and collect appropriate rebate amounts. If a manufacturer fails to submit timely information, or misreports information, we may be unable to establish accurate URAs due to the misreporting or late reporting. While we provide URAs to the States each quarter to help facilitate billing manufacturers for rebates, it is ultimately the manufacturer's responsibility to assure that accurate rebates are paid to States for their CODs.</P>
                    <P>One specific element of drug product information that is required to be submitted by manufacturers includes drug category or drug classification information. Generally, drugs classified as single source or innovator multiple source pay higher rebates than those that are classified as an “other drug,” such as noninnovator multiple source drugs. In accordance with section 1927(c) of the Act and 42 CFR 447.509, the rebate calculation for a particular COD may also include an additional inflationary component to account for increases in the drug's Average Manufacturer's Price from the base date AMP quarter to the current calendar quarter's AMP. That is, this additional rebate is generally calculated based on the difference between the drug's current quarter AMP and its base date AMP adjusted to the current period by the Consumer Price Index for All Urban Consumers (CPI-U).</P>
                    <P>Prior to the enactment of the Medicaid Services Investment and Accountability Act of April 2019 (MSIAA) (Pub. L. 116-16; enacted April 18, 2019), section 1927(k)(7)(A)(iv) of the Act defined a single source drug as a covered outpatient drug which is produced or distributed under an original new drug application. Section 1927(k)(7)(A)(ii) of the Act similarly defined an innovator multiple source drug as a multiple source drug that was originally marketed under an original new drug application. A noninnovator multiple source drug was defined at section 1927(k)(7)(A)(iii) of the Act as a multiple source drug that is not an innovator multiple source drug.</P>
                    <P>Prior to the 2016 Medicaid Covered Outpatient Drug final rule with comment period (COD final rule) (81 FR 5170), the regulatory definitions of a single source and an innovator multiple source drug largely mirrored the statute and defined a drug as a single source or innovator multiple source drug based on whether it was produced, distributed, or marketed under an “original new drug application.” The statute did not expressly define “original NDA”. However, CMS' longstanding interpretation of the term was that an original new drug application (NDA) is an NDA approved under section 505(b)(1) or (2) of the Federal Food, Drug, and Cosmetic Act (FFDCA), as distinguished from one approved under an abbreviated NDA (ANDA) under section 505(j) of the FFDCA (Manufacturer's Release 113).</P>
                    <P>We codified new regulatory definitions of single source and innovator multiple source drugs in the COD final rule and added a narrow exception for “certain drugs [that] might be more appropriately treated as if they were approved under an ANDA and classified as a noninnovator multiple source drug” (81 FR 5191). The COD final rule also added a drug approved under a Biologics License Application (BLA) to the definition of single source drug (81 FR 5203).</P>
                    <P>
                        In the COD final rule, we also introduced a process by which drug manufacturers could submit a request for a narrow exception to have us recognize individual drugs approved under an NDA as noninnovator multiple source drugs prospectively from the effective date of the COD final rule. Instructions to manufacturers regarding this process were included in Manufacturer Release #98, May 2, 2016 (
                        <E T="03">https://www.medicaid.gov/medicaid-chip-program-information/by-topics/prescription-drugs/downloads/rx-releases/mfr-releases/mfr-rel-098.pdf</E>
                        ). The COD final rule did not, however, excuse manufacturers from their obligation to correctly report drugs approved under an NDA as either single source or innovator multiple source drugs prior to the effective date of the COD final rule, which was April 1, 2016.
                    </P>
                    <P>
                        Yet, notwithstanding our interpretation of the statute, many manufacturers have disregarded our reasonable interpretation of the statute and have continued to misreport drugs marketed under an NDA as noninnovator multiple source drugs for periods prior to April 1, 2016 (Manufacturer Release #113-
                        <E T="03">https://www.medicaid.gov/prescription-drugs/downloads/mfr-rel-113.pdf</E>
                        ).
                    </P>
                    <HD SOURCE="HD2">B. Amendments Made by the Medicaid Services Investment and Accountability Act of 2019 (MSIAA) to Section 1927 of the Act Regarding MDRP Drug Classification Enforcement and Penalties</HD>
                    <P>
                        Section 6 of the MSIAA, titled “Preventing the Misclassification of Drugs Under the Medicaid Drug Rebate Program,” amended sections 1903 and 1927 of the Act to specify the definitions for multiple source drug, single source drug and innovator multiple source drug, and to provide the Secretary with additional compliance, oversight and enforcement authorities to ensure compliance with program requirements with respect to manufacturers' reporting of drug product and pricing information, which includes the appropriate classification of a drug. Drug classification refers to how a drug should be classified—as a single source, innovator multiple source, or noninnovator multiple source drug for the purposes of determining the correct rebates that a manufacturer owes 
                        <PRTPAGE P="34240"/>
                        the States.
                        <SU>1</SU>
                        <FTREF/>
                         In general, a misclassification in the MDRP occurs when a manufacturer reports and certifies its covered outpatient drug under a drug category that is not supported by the statutory and regulatory definitions of S, I, or N. A drug that is misclassified is likely paying different rebates to States than those supported by statute and regulation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Section 1927(c)(3) of the Act describes rebates for “other drugs” and section 1927(c)(3)(A) of the Act, more specifically describes rebates for covered outpatient drugs “other than single source drugs and innovator multiple source drugs.” The MDRP reporting system provides for all “other drugs” that are covered outpatient drugs to be classified in the system as N drugs, regardless of whether they expressly meet the definition of noninnovator multiple source drug. This reporting methodology has been in effect for the history of the program and interested parties have understood that a covered outpatient drug that was not an S or an I drug is reported in the system as an N drug. In a later section of this proposed rule, we are proposing changes to the regulatory definition of a N drug to more clearly align with the statutory definition of N drug. This is a technical change and is not intended to modify any reporting requirements.
                        </P>
                    </FTNT>
                    <P>
                        We published guidance to manufacturers regarding compliance with drug pricing and drug product information reporting under this new law in Manufacturer Release #113 on June 5, 2020. See 
                        <E T="03">https://www.medicaid.gov/prescription-drugs/downloads/mfr-rel-113.pdf</E>
                        . Here, although much of this law is self-implementing, we are proposing a series of regulatory amendments at §§ 447.509 and 447.510 to implement and codify the statutory changes in regulation. We propose that a misclassification of a drug under the MDRP has occurred or is occurring when a manufacturer reports and certifies to the agency a drug category or drug product information relating to that COD that is not supported by the statutory and regulatory definitions of S, I, or N. We also define a misclassification as a situation in which a manufacturer is correctly reporting its drug category or drug product information for a COD, but is paying a different rebate amount to the States than is supported by the classification.
                    </P>
                    <P>The MSIAA also amended the Act to expressly require a manufacturer to report not later than 30 days after the last day of each month of a rebate period under the agreement, such drug product information as the Secretary shall require for each of the manufacturer's covered outpatient drugs. We are proposing a definition of “drug product information” for the purposes of the MDRP.</P>
                    <P>Similarly, the MSIAA amended the Act to specify that the reporting of false drug product information and data related to false drug product information would also be subject to possible civil monetary penalties (CMPs) by the HHS Office of the Inspector General (OIG), and to provide specific new authority to the Secretary to issue civil monetary penalties related to knowing misclassifications of drug product or misreported information. These new OIG authorities will not be the subject of this rulemaking.</P>
                    <P>Under the MSIAA, if a manufacturer fails to correct the misclassification of a drug in a timely manner after receiving notification from the agency that the drug is misclassified, in addition to the manufacturer having to pay past unpaid rebates to the States for the misclassified drug if applicable, the Secretary can take any or all of the following actions: (1) correct the misclassification, using drug product information provided by the manufacturer on behalf of the manufacturer; (2) suspend the misclassified drug, and the drug's status as a covered outpatient drug under the manufacturer's national rebate agreement, and exclude the misclassified drug from FFP (correlating amendments to section 1903 of the Act); and, (3) impose CMPs for each rebate period during which the drug is misclassified subject to certain limitations. The Act expressly provides that the imposition of such penalties may be in addition to other remedies, such as termination from the MDRP, or CMPs under Title XI.</P>
                    <P>
                        The manufacturer has an affirmative legal obligation to correctly report all necessary drug product and pricing information to the agency on a timely basis as described in the statute and regulations. When issues or questions regarding a drug's classification arise, we generally rely upon various sources of information to be able to determine if a drug is misclassified in MDRP. In its oversight role, the agency will use information reported by manufacturers to us, in combination with publicly available information, to be able to make determinations of whether a drug is misclassified in the MDRP. The agency also uses manufacturer reported information, such as the COD status code, in combination with information available on the Food and Drug Administration's (FDA's) Comprehensive NDC Structured Product Labeling (SPL) Data Elements file (NSDE) 
                        <E T="03">https://download.open.fda.gov/Comprehensive_NDC_SPL_Data_Elements_File.zip</E>
                        , and information from FDA's drugs@fda web page 
                        <E T="03">https://www.accessdata.fda.gov/scripts/cder/daf/</E>
                         to be able to verify that the national drug codes (NDCs) reported to the MDRP by manufacturers are appropriately classified and reported.
                    </P>
                    <P>Codifying these statutory amendments in our regulations provides an opportunity for the agency to give additional clarity to and guidance on the new legal authorities for ensuring oversight of, compliance with, and enforcement of the provisions of the MDRP, and ultimately, to ensure that Federal and State programs are receiving appropriate rebates and that CMS continues to be a stringent steward of the Medicaid program.</P>
                    <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s50,r100,r100">
                        <TTITLE>Table 1—History of the Changes in the Definition of Single Source Drug and Innovator Multiple Source Drug</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Statute</CHED>
                            <CHED H="1">Regulation</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Prior to April 18, 2019 MSIIA enactment</ENT>
                            <ENT O="xl">
                                Single Source drug
                                <LI O="xl">Section 1927(k)(7)(A)(iv) of the Act</LI>
                                <LI>A covered outpatient drug which is produced or distributed under an original new drug application approved by the Food and Drug Administration (FDA), including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34241"/>
                            <ENT I="22"> </ENT>
                            <ENT O="xl">
                                Innovator Multiple Source Drug
                                <LI O="xl">Section 1927(k)(7)(A)(ii) of the Act</LI>
                                <LI>A multiple source drug that was originally marketed under an original new drug application approved by the Food and Drug Administration</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2007 Final Rule</ENT>
                            <ENT/>
                            <ENT>
                                § 447.502
                                <LI>Single source drug</LI>
                                <LI>A covered outpatient drug that is produced or distributed under an original new drug application (NDA) approved by the FDA, including a drug product marketed by any cross-licensed producers or distributors operating under the NDA. It also includes a covered outpatient drug approved under a biological license application (BLA), product license approval (PLA), establishment license approval (ELA) or antibiotic drug approval (ADA) PLA, ELA, or ADA.</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT O="xl"/>
                            <ENT>
                                Innovator Multiple Source Drug
                                <LI>A multiple source drug that was originally marketed under an original NDA approved by the FDA, including an authorized generic drug. It includes a drug product marketed by any cross-licensed producers, labelers, or distributors operating under the NDA and a covered outpatient drug approved under a PLA, ELA, or ADA.</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2016 Final Rule</ENT>
                            <ENT/>
                            <ENT>The term “single source drug” means a covered outpatient drug that is produced or distributed under an original NDA approved by FDA and has an approved NDA number issued by FDA, including a drug product marketed by any cross licensed producers or distributors operating under the NDA. It also includes a covered outpatient drug approved under a BLA, PLA, ELA, or ADA. For purposes of this definition and the MDR program, an original NDA means an NDA, other than an ANDA, approved by the FDA for marketing, unless CMS determines that a narrow exception applies.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT O="xl"/>
                            <ENT>The term “innovator multiple source drug” means a multiple source drug that was originally marketed under an original NDA approved by FDA, including an authorized generic drug. It also includes a drug product marketed by any cross-licensed producers, labelers, or distributors operating under the NDA and a covered outpatient drug approved under a BLA, ELA, or ADA. For purposes of this definition and the Medicaid drug rebates (MDR) program, an original NDA means an NDA, other than an Abbreviated New Drug Application (ANDA), approved by the FDA for marketing, unless CMS determines that a narrow exception applies.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">MSIAA enactment on April 18, 2019</ENT>
                            <ENT O="xl">
                                Single Source drug
                                <LI O="xl">Section 1927(k)(7)(A)(iv) of the Act</LI>
                                <LI>The term “single source drug” means a covered outpatient drug, including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under paragraph (4), which is produced or distributed under a new drug application approved by the Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application unless the Secretary determines that a narrow exception applies (as described in 42 CFR 447.502 (or any successor regulation)). Such term also includes a covered outpatient drug that is a biological product licensed, produced, or distributed under a biologics license application approved by the Food and Drug Administration</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34242"/>
                            <ENT I="22"> </ENT>
                            <ENT O="xl">
                                Innovator Multiple Source Drug
                                <LI O="xl">Section 1927(k)(7)(A)(ii) of the Act</LI>
                                <LI>The term “innovator multiple source drug” means a multiple source drug that is marketed under a new drug application approved by the FDA, unless the Secretary determines that a narrow exception applies (as described in 42 CFR 447.502 (or any successor regulation))</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2020 Final Rule</ENT>
                            <ENT/>
                            <ENT>
                                The term “single source drug” means a covered outpatient drug, including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under section 1927(k)(4) of the Act, which is produced or distributed under a new drug application [
                                <E T="03">removing `original'</E>
                                ] approved by the FDA, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application unless the Secretary determines that a narrow exception applies (as described in this section), and includes a covered outpatient drug that is a biological product licensed, produced, or distributed under a biologics license application approved by the FDA.
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT O="xl"/>
                            <ENT>
                                The term “innovator multiple source drug” means a multiple source drug that is marketed [removing `was originally marketed'] under a new drug application [
                                <E T="03">removing `original'</E>
                                ] approved by the Food and Drug Administration, unless the Secretary determines that a narrow exception applies (as described in 42 CFR 447.502 (or any successor regulation)).
                            </ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD2">C. MDRP Program Administration Proposed Changes</HD>
                    <P>We are focused on increasing efficiency and economy of directing overall operations, resources, and activities of MDRP to better facilitate the needs of Medicaid beneficiaries. In that regard, we are proposing a number of new regulatory policies and clarification of existing policies.</P>
                    <P>Specifically, consistent with our statutory authorities, we are proposing to define, specify or amend the definitions for COD, internal investigation (for restatement purposes outside the 3-year time window), manufacturer (for NDRA purposes), market date, noninnovator multiple source drug, drug product information, and vaccine for the purpose of MDRP. We are also proposing to specify that the rebate provisions for a drug other than a single source drug or an innovator multiple source drug apply to an array of drugs, including those that may not satisfy the definition of multiple source drug. As noted above, based on longstanding operational processes, such drugs are properly classified as N drugs in the MDP reporting system.</P>
                    <P>Next, we are also proposing new policies, including to add a time limitation on manufacturer ability to initiate audits with States, to further clarify and establish the requirements for FFS pharmacy reimbursement, and to clarify the required collection of all National Drug Codes (NDC) for single and multiple source physician-administered drugs to receive FFP and secure manufacturer rebates.</P>
                    <P>We also propose to revise Medicaid managed care standard contract requirements to adopt a requirement for inclusion of Beneficiary Identification Number and Processor Control Number (BIN/PCN) numbers on Medicaid prescription identification cards, as well as enhance drug cost transparency by adopting specific requirements relating to the third-party administration of the pharmacy benefit.</P>
                    <P>These proposed revisions are designed to improve CMS oversight, and State administration of Medicaid pharmacy benefits by promoting greater consistency and accuracy of reporting, strengthened data, and robust stewardship of State and Federal funds. These proposals would help to strengthen and preserve the foundation of the MDRP by ensuring proper payments so Federal expenditures are spent appropriately on delivering quality, necessary care, while also ensuring sufficient access to care for Medicaid beneficiaries.</P>
                    <HD SOURCE="HD3">1. Proposal To Modify the Definition of Covered Outpatient Drug</HD>
                    <P>Sections 1927(k)(2) and (3) of the Act provide a definition of the term “covered outpatient drug” (COD) and a limiting definition, which excludes certain drugs, biological products, and insulin provided as part of, or as incident to and in the same setting as, enumerated services and settings. This exclusion is subject to a parenthetical, however, which limits the exclusion to when payment may be made as part of payment for the enumerated service or setting, and not as direct reimbursement for the drug. In the COD final rule, we finalized a regulatory definition of covered outpatient drug in § 447.502 that substantially mirrors the statutory definition, and consistent with section 1927(k)(3) of the Act, the regulatory language includes a limiting clause at § 447.502 (covered outpatient drug) that excludes from the definition of COD any drug, biological product, or insulin provided as part of or incident to and in the same setting in a list of services, and for which payment may be made as part of that service instead of as a direct reimbursement for the drug.</P>
                    <P>
                        Over the years we have received questions about when a payment is considered to be a direct reimbursement for a drug and whether identifying a 
                        <PRTPAGE P="34243"/>
                        drug separately on a claim for payment may qualify as direct reimbursement for a drug, rendering the drug eligible for rebates under section 1927 of the Act, or in other words, making the limiting definition inapplicable. To provide greater clarity, we propose to amend the regulatory definition of the term covered outpatient drug at § 447.502 to clarify when a payment is considered direct reimbursement for the drug.
                    </P>
                    <P>Additionally, we propose to more closely align the regulatory language to the statute by changing “. . . instead of as a direct reimbursement . . .” to “. . . and not as direct reimbursement . . .”</P>
                    <HD SOURCE="HD3">2. Proposed Definition of an Internal Investigation for Purposes of Pricing Metric Revisions</HD>
                    <P>In accordance with section 1927(b)(3) of the Act, § 447.510 of the applicable regulations, and the terms of the NDRA, manufacturers are required to report certain pricing and drug product information to CMS on a timely basis or could incur penalties or other compliance and enforcement measures. As explained in the “Medicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program” final rule (final time limitation rule) (68 FR 51912, August 29, 2003), in an effort to improve the administration and efficiency of the MDRP and assist States and manufacturers that would otherwise be required to retain drug utilization pricing data records indefinitely, we established the 12-quarter time frame for reporting revisions to AMP or best price information.</P>
                    <P>Despite the 12-quarter time frame, we continued to receive requests from manufacturers to make revisions to their pricing data that fall outside of the 12-quarter period. Consequently, in the COD final rule (81 FR 5278) we established § 447.510(b)(1), which provides that a manufacturer must report to CMS any revision to AMP, best price, customary prompt pay discounts or nominal prices (pricing data) for a period not to exceed 12 quarters from the quarter in which the data were due unless one of a number of enumerated exceptions applies. See § 447.510(b)(1)(i) through (vi).</P>
                    <P>Section 447.510(b)(1)(v) provides an exception to the 12-quarter price reporting rule if the change is to address specific rebate adjustments to States by manufacturers, as required by CMS or court order, or under an internal investigation, or an OIG or Department of Justice (DOJ) investigation. However, as part of that rule, we did not define the term internal investigation which has led to different interpretations of the nature of an internal investigation. Therefore, we propose to add a definition of internal investigation at § 447.502 and additional clarity around the 12-quarter rule at § 447.510.</P>
                    <HD SOURCE="HD3">3. Proposal To Modify the Definition of Manufacturer for National Drug Rebate Agreement (NDRA) Compliance Purposes</HD>
                    <P>At times, we receive requests from manufacturers to allow them to exclude a particular labeler that they may own or have a business affiliation with from participation in the MDRP, even though the labeler markets products that meet the definition of covered outpatient drug. It is our view that the statute requires that all labelers of a manufacturer that market CODs be required to participate in the MDRP to meet the statutory requirement that FFP is only available for a manufacturer's drugs if they participate in the program. That is, all the labelers of the manufacturer have to be in the program, or none of the labelers can be in the program.</P>
                    <P>We are proposing to further refine the definition manufacturer at § 447.502 to codify the requirements under section 1927(a)(1) of the Act which specifies that a manufacturer has to have entered into and have in effect a rebate agreement with the Secretary in order for payment to be available for their CODs under Medicaid. We are also proposing to codify in regulation that all labelers (with their applicable codes) that are associated or affiliated with a manufacturer must have a rebate agreement in effect in order for the manufacturer to satisfy the statutory requirement that the manufacturer have a rebate agreement in effect with the Secretary.</P>
                    <P>Additionally, we are also proposing a new paragraph (h) in § 447.510 to further specify the responsibilities of a manufacturer with respect to rebate agreements when that manufacturer acquires or purchases another labeler, acquires or purchases covered outpatient drugs from another labeler, or forms a new subsidiary or associated entity to ensure that any of a manufacturer's labeler codes that market CODs are included in the MDRP. We also specify that termination of one of the manufacturer's labelers from the program results in all labelers of that manufacturer being terminated from the program whether initiated by the manufacturer or the government. If the manufacturer is terminated for noncompliance, they can come back into the program under certain conditions, including resolving all compliance issues. However, the one-quarter delay in program re-entry provided for in section 1927(b)(4)(C) of the Act still applies unless good cause is found.</P>
                    <HD SOURCE="HD3">4. Proposal To Establish a Definition of Market Date for a COD for the Purposes of Determining a Base Date AMP for a COD</HD>
                    <P>Section 1927 of the Act governs the MDRP and payment for CODs which are defined in section 1927(k)(2) of the Act. Manufacturers that participate in the MDRP are required to pay rebates for CODs that are dispensed and paid for under the State Medicaid plan. See section 1927(b)(1)(A) of the Act.</P>
                    <P>The rebates due by manufacturers are calculated based on statutory formulas described in section 1927(c) of the Act and consist of a basic rebate and, in some cases, an additional rebate that is applicable when an increase in the AMP, with respect to each dosage form and strength of a drug, exceeds the rate of inflation. One of the factors in the calculation of the additional rebate is the base date AMP of the drug, a value that is determined based on the market date of the drug. Manufacturers are required to report the market date of each dosage form and strength of a COD for all of its CODs.</P>
                    <P>We have received numerous inquiries regarding the determination of market date for reporting to MDRP, and some manufacturers have reported incorrect market dates for their CODs. Because the term market date has not been previously defined in regulation and it is a critical factor in the determination of base date AMP, and ultimately, the calculation of applicable rebates, we are proposing to define the term market date at § 447.502 for the purpose of the MDRP.</P>
                    <HD SOURCE="HD3">5. Proposal To Modify the Definition of Noninnovator Multiple Source Drug</HD>
                    <P>
                        As discussed previously in this proposed rule, section 6(c) of the MSIAA included a number of amendments to statutory definitions in section 1927 of the Act. Generally, those statutory amendments were discussed in the “Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements” final rule published in the December 31, 2020 
                        <E T="04">Federal Register</E>
                         (the December 31, 2020 final rule) (see 85 FR 87000, 87032), where the regulatory definitions of multiple source drug, innovator multiple source (I) drug, and single source drug were amended 
                        <PRTPAGE P="34244"/>
                        consistent with the MSIAA. One of the amendments to the regulatory definitions was to remove the phrase “was originally marketed” from the definition of an I drug and replace it with “is marketed.”
                    </P>
                    <P>The change in the statutory and regulatory definitions of an I drug should have prompted us to also change the regulatory definition of noninnovator multiple source (N) drug, however we neglected to do so in the December 31, 2020 final rule. We are now proposing to amend the definition of an N drug at § 447.502 to maintain the clear distinction between an I drug and an N drug.</P>
                    <HD SOURCE="HD3">6. Proposal To Define Vaccine for the Purposes of the MDRP Only</HD>
                    <P>
                        Section 1927(k)(2)(B) of the Act specifically excludes vaccines from the definition of COD for purposes of the MDRP. This exclusion is codified in paragraph (1)(iv) of the regulatory definition of COD at § 447.502. Section 1927 of the Act, specifically, does not define vaccine. Nor is there a definition of vaccine in Title XI, XVIII, XIX, or XXI of the Act (applicable to Medicare, Medicaid, and Children's Health Insurance Program (CHIP)), that speaks to the specific kinds of biological products that qualify as vaccines, in terms of their actions in the human body and how and when they are used.
                        <SU>2</SU>
                        <FTREF/>
                         Moreover, we are not aware that any authorizing statutes for any other Department of Health and Human Services agencies include such a statutory definition of the term “vaccine.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             While section 1928(h) of the Act defines “pediatric vaccine” and “qualified pediatric vaccine,” those definitions do not speak to the actions of a vaccine in the human body and how and when it is used, and therefore do not help CMS determine when a product should count as a vaccine (as opposed to a drug) for purposes of the Medicaid Drug Rebate Program.
                        </P>
                    </FTNT>
                    <P>To date, we have not established a regulatory definition of the term vaccine as used in section 1927(k)(2)(B) of the Act for the specific purposes of the MDRP. However, given therapeutic advances that have occurred since 1990, when the original rebate statute was enacted, we believe that a regulatory definition is necessary to identify which products are considered vaccines for the purposes of the MDRP and thus, appropriately excluded from the definition of COD. We are therefore proposing a definition of vaccine at § 447.502 for the purpose of identifying products that do not satisfy the definition of COD and are therefore not subject to possible required coverage under the prescribed drugs benefit consistent with section 1927 of the Act, and applicable rebate liability under the MDRP. The regulatory definition of vaccine that is proposed to be added to § 447.502 would be established solely for the purposes of the MDRP, and be applicable only to that program. It would not apply under any title XIX statutory provisions other than section 1927(k)(2), or to separate CHIPs operating pursuant to 42 CFR 457.70(a)(1) and (d), or for purposes of the Vaccines for Children Program. Nor would it apply to any other programs within CMS or any other agencies within the Department of Health and Human Services, (for example, FDA, Centers for Disease Control and Prevention (CDC), or Health Resources and Services Administration (HRSA)). We note that these proposed changes would only specify which products are vaccines and are therefore excluded from the definition of a covered outpatient drug and are not subject to Medicaid drug rebates. This proposed policy would not apply with regard to any applicable Federal or State requirements to cover vaccines for Medicaid beneficiaries, as applicable.</P>
                    <HD SOURCE="HD3">7. Proposal To Accumulate Price Concessions and Discounts (“Stacking”) When Determining Best Price</HD>
                    <P>Section 1927(c)(1)(C) of the Act defines the term “best price” to mean with respect to a single source drug or innovator multiple source drug of a manufacturer (including the lowest price available to any entity for any such drug of a manufacturer that is sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act), the lowest price available from the manufacturer during the rebate period to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or governmental entity within the United States, subject to certain exceptions and special rules.</P>
                    <P>The implementing regulations for the determination of best price are found at § 447.505, and we propose to revise § 447.505(d)(3) to add language to make clearer that the manufacturer must adjust the best price for a drug for a rebate period if cumulative discounts, rebates, or other arrangements to best price eligible entities subsequently adjust the prices available from the manufacturer, and that those discounts, rebates, or other arrangements must be stacked for a single transaction to determine a final price realized by the manufacturer for a drug. In other words, we are proposing to make clearer that manufacturers have to stack all applicable discounts that they offer on a single sale of a covered outpatient drug, including discounts or rebates provided to more than one best price eligible entity.</P>
                    <HD SOURCE="HD3">8. Proposal To Establish a Time Limitation for Audits Over Utilization Data With States: 12-Quarter Rebate Dispute Time Limitation</HD>
                    <P>Currently, there is no time limit for a manufacturer to initiate an audit or resolve previously disputed State utilization data with respect to rebates owed, and section 1927 of the Act does not impose a specific timeframe on a manufacturer's audit authority. As a result, any dispute of State invoices arising from audits, reviews, or hearings of State information on State utilization data is not limited to current quarter rebate invoices, but may also be initiated for prior quarterly rebate invoices that have been previously paid in full. We are proposing to limit the time period for manufacturers to initiate disputes, hearing requests and audits of State-invoiced utilization data to 12 quarters from the last day of the quarter from the date of State invoice to the manufacturer. We propose to include a new paragraph (j), titled “Manufacturer audits of State-provided information,” at § 447.510, to limit the time a manufacturer has to initiate a dispute, hearing request or audit of State-invoiced utilization data with a State, to ensure more efficient administration of the Medicaid Drug Rebate Programs.</P>
                    <HD SOURCE="HD3">9. Proposal Regarding Drug Price Verification and Transparency Through Data Collection</HD>
                    <P>
                        Since the beginning of the MDRP in 1991, the Secretary has had the authority, under section 1927(b)(3)(B) of the Act, to survey wholesalers and manufacturers that directly distribute their covered outpatient drugs, when necessary, to verify manufacturer prices that are reported under section 1927(b)(3)(A) of the Act, if required to make a payment. The prices that are subject to this survey include a manufacturer's AMP, best price, Average Sales Price (ASP), and in certain cases, Wholesale Acquisition Cost (WAC) for a drug. (Note that in 2003, Congress amended section 1927(b)(3)(B) of the Act in the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 (Pub. L. 108-173, enacted December 8, 2003), to expand the original survey authority to include manufacturer's average sales prices (including wholesale acquisition cost or WAC).) These prices that are reported to the agency under section 1927(b)(3)(A) of the Act are used by various CMS programs, such as 
                        <PRTPAGE P="34245"/>
                        Medicare Part B and State Medicaid agencies, to pay for drugs for beneficiaries, as well as calculate rebates paid by manufacturers to States under MDRP. Thus, there is a direct connection between the prices reported to us and the payments made by Medicaid.
                    </P>
                    <P>The types of drugs paid for by Medicaid, manufacturers' pricing structures for these drugs, as well as the methods used by manufacturers to distribute these drugs, have evolved since the enactment of the MDRP, as well as the enactment of the MMA. New highly individualized gene and cell therapy drug treatments have resulted in manufacturer launch prices that have increased dramatically, impacting the manufacturers' prices reported to CMS. In addition, manufacturers and health plans now own pharmacy benefit managers (PBMs), and manufacturers are more frequently limiting the distribution of drugs through specialty pharmacies, some of which are owned by the PBMs themselves.</P>
                    <P>All of these factors impact how manufacturers set drug pricing, and, given that these prices are used to set payment rates, it affects the payments that State Medicaid programs make for these drugs. For example, State Medicaid programs use the ASP values reported by manufacturers to make payment for many physician-administered drugs. A product's WAC has generally tracked its acquisition cost to providers for brand name drugs, and this WAC value is used by payers to reimburse them for the drug cost component of providing the drug. AMP is used to calculate Federal Upper Limits (FULs) for multiple source drugs.</P>
                    <P>While the model of distribution from manufacturer to wholesaler to provider still exists, and the predominant provider of pharmacy services remains the community-based pharmacy, there are other arrangements emerging for the production and distribution of specialty and high-cost gene therapy drugs, and pricing structures for these drugs that were not necessarily existing in the market when the MDRP was enacted.</P>
                    <P>Section 1902(a)(30)(A) of the Act requires that Medicaid payments be consistent with economy, efficiency, and quality of care to enlist enough providers so that care and services are available under the plan to Medicaid beneficiaries at least to the extent that such care and services are available to the general population in the geographic area. It is important that the Medicaid program understand the production and distribution method for these drugs, as well as the impact on prices and charges, to assure beneficiary access to these medications. Therefore, using the authority at section 1927(b)(3)(B) of the Act, which grants the Secretary the ability to survey wholesalers and manufacturers to obtain information about manufacturer's prices for a drug reported to us under section 1927(b)(3)(A) of the Act, we are proposing rules to describe those situations when it is necessary for surveys to be sent to manufacturers and wholesalers to verify prices and charges, and the information that would be requested, to verify prices or charges such that payments can be made.</P>
                    <HD SOURCE="HD3">10. Proposal To Clarify and Establish Requirements for FFS Pharmacy Reimbursement</HD>
                    <P>In the COD final rule, we finalized regulations to move FFS pharmacy reimbursement to an actual acquisition cost-based reimbursement, under which pharmacists would be paid for the ingredient costs of the drug that was dispensed, and a professional dispensing fee (PDF) that reflected their costs of dispensing. Since that time, almost every State has made the appropriate transition, and the updated pharmacy reimbursement methodology is accurately reflected in approved amendments to their State Plans. Nonetheless, we are proposing to revise § 447.518, “State plan requirements, findings, and assurances,” in paragraph (d)(1) to ensure that pharmacy providers are reimbursed adequately for both their pharmacy ingredient costs and professional dispensing services costs consistent with the applicable statutory and regulatory requirements.</P>
                    <P>This regulation currently indicates that States are required to provide adequate data to support any proposed changes to either component of the reimbursement methodology (ingredient cost or PDF), such as a State or national survey of retail pharmacy providers or other reliable data other than a survey. We are proposing to provide clarity regarding adequate data so that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available at least to the extent that such care and services are available to the general population in the geographic area, by expressly providing in regulation that the research and data must be based on costs and be sufficient to establish the adequacy of the pharmacy reimbursement methodology under the State Plan. In addition, we are proposing to state in regulatory text that other data, such as reimbursements that pharmacies accept from third parties, are not cost-based data, and therefore, cannot be used by States to justify PDFs.</P>
                    <HD SOURCE="HD3">11. Proposals Implementing Section 1927(a)(7) of the Act and Federal Financial Participation (FFP): Conditions Relating to Physician-Administered Drugs</HD>
                    <P>Generally, physician-administered drugs may satisfy the definition of a covered outpatient drugs (COD) under section 1927(k)(2) of the Act, subject to the limiting definition at section 1927(k)(3) of the Act. Prior to the Deficit Reduction Act (DRA) of 2005 (Pub. L. 109-171, enacted February 8, 2006), States did not collect rebates on all physician-administered drugs when they were not identified by NDC number, because the NDC number is necessary for States to invoice manufacturers for rebates.</P>
                    <P>
                        Section 6002 of the DRA added sections 1903(i)(10)(C) and 1927(a)(7) to the Act to require the States to collect and submit certain utilization data on certain physician-administered drugs in order for FFP to be available for these drugs, and for States to secure rebates. More specifically, in accordance with section 1927(a)(7) of the Act, titled “Requirement For Submission Of Utilization Data For Certain Physician-Administered Drugs”, States are required to provide for the collection and submission of utilization data and coding (such as J-codes 
                        <SU>3</SU>
                        <FTREF/>
                         and NDC numbers) for a covered outpatient drug that is a single source or a multiple source drug that is a top 20 high dollar volume physician-administered drug on a published list (based on highest dollar volume dispensed under Medicaid identified by the Secretary) that the Secretary may specify in order for payment to be available under section 1903 of the Act and for States to secure applicable Medicaid rebates.
                        <SU>4</SU>
                        <FTREF/>
                         This list may be modified year to year to reflect changes in such volume.
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             J codes are a subset of the Healthcare Common Procedure Coding System (HCPCS) Level II code set used to primarily identify injectable drugs.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             
                            <E T="03">https://www.govinfo.gov/content/pkg/CFR-2007-title42-vol4/pdf/CFR-2007-title42-vol4-sec447-520.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        Regulations at § 447.520 were established to implement these statutory provisions in the final rule entitled “Medicaid Program; Prescription Drugs” (72 FR 39142, 39162) (hereinafter referred to as the July 17, 2007 final rule), specifying the conditions for FFP for physician-administered drugs.
                        <SU>5</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        We are proposing to amend § 447.520 to require States to collect NDC information on all covered outpatient single and multiple source physician-
                        <PRTPAGE P="34246"/>
                        administered drugs and to specify that States should be invoicing for rebates for all covered outpatient physician-administered drugs to receive FFP and secure manufacturer rebates.
                    </P>
                    <HD SOURCE="HD3">12. Proposal Related to Suspension of a Manufacturer's Drug Rebate Agreement</HD>
                    <P>We are proposing regulatory changes to further implement section 1927(b)(3)(C)(i) of the Act, which provides authority to suspend a rebate agreement for a manufacturer's failure to timely report drug pricing or drug product information to the agency, required under section 1927(b)(3)(A) of the Act, and when there is a continued failure to report after a 90-calendar day deadline for reporting of information is imposed by the agency. Specifically, the new § 447.510(i) proposes that a manufacturer who has failed to report timely information to the agency under § 447.510(a) and (d), would be imposed a 90-calendar day deadline determined by the agency, and communicated to electronically and in writing by the agency to report such information, or the manufacturer would have its rebate agreement suspended.</P>
                    <P>This section further proposes that failure to report such information to the agency after the end of the imposed 90-calendar day period would result in suspension of the rebate agreement, and that such agreement shall not be reinstated until such information is reported in full and certified, but not for a period of suspension of less than 30 calendar days. This suspension would apply to all of the manufacturer's labelers that have a rebate agreement with the Secretary, consistent with the proposed regulatory definition of “manufacturer.”</P>
                    <P>This rule also proposes that continued suspension of the rebate agreement could result in termination for cause. During the period of time of the suspension, FFP would not be available to the States for a manufacturer's CODs. The States would be given 30 calendar days' notice before such a suspension is implemented. This would allow States to notify prescribers and beneficiaries that a specific COD or specific CODs may be unavailable for a period of time, and to allow the beneficiary to switch to a different medication, if necessary. We are proposing that the suspension would only be applicable to the manufacturer's Medicaid program participation, and would not affect manufacturer participation in Medicare Part B or the 340B Drug Pricing Program during the time the rebate agreement is suspended. However, if continued suspension results in termination, such termination could affect Medicare Part B and 340B Drug Pricing Program participation.</P>
                    <HD SOURCE="HD3">13. Proposals Related to Managed Care Plan Standard Contract Requirements</HD>
                    <HD SOURCE="HD3">a. Requirement of BIN/PCN Inclusion on Medicaid Managed Care Pharmacy Identification Cards</HD>
                    <P>Patients enrolled in health care plans, including in Medicaid managed care plans such as Medicaid managed care organizations (MCOs), prepaid inpatient health plans (PIHPs), or prepaid ambulatory health plans (PAHPs), generally use identification cards at the pharmacy so they can obtain prescription drug benefits, as well as allow pharmacies to process and bill claims in real time. Health plans use two codes on the card to identify a patient's prescription health insurance and benefits—the National Council for Prescription Drug Programs (NCPDP) Processing Bank Identification Number (BIN) and Processor Control Number (PCN). This information, along with a group number, can specify that a beneficiary is part of a specific patient insurance group, such as being a Medicaid managed care beneficiary.</P>
                    <P>However, it is often difficult to determine from a Medicaid managed care beneficiary's health insurance card if he or she is covered under a Medicaid managed care plan or under non-Medicaid coverage, such as an employer-sponsored group health plan or individual market insurance, offered by the same organization or entity that offers the Medicaid managed care plan. This is due to the fact that Medicaid-specific BIN, PCN, and group numbers are not always placed on Medicaid managed care plan identification cards. However, if Medicaid-specific BIN/PCN and group information were included on the card, the pharmacy could enter this information into its claims processing system which would identify that the beneficiary is enrolled in a Medicaid managed care plan. We believe it is important that unique BIN/PCN/group numbers are established for Medicaid managed care plans for several program needs, including facilitating the appropriate identification of cost sharing and ensuring claims are billed and paid for appropriately.</P>
                    <P>Use of Medicaid-specific BIN/PCN/group numbers can help States and their managed care plans identify claims for drugs paid for under the 340B Drug Pricing Program (340B Program) and avoid invoicing for rebates on 340B drugs. Section 340B(a)(5)(A) of the Public Health Service Act (the PHS Act) prohibits duplicate discounts for drugs purchased under the Medicaid drug rebate program. Section 1927(a)(5)(C) of the Act requires the establishment of a mechanism to ensure against duplicate discounts or rebates and section 1927(j)(1) of the Act provides that covered outpatient drugs are not subject the requirements of section 1927 of the Act if they are dispensed by health maintenance organizations (HMOs), including MCOs that contract under section 1903(m) of the Act, and are subject to discounts under section 340B(a)(5)(A) of the PHS Act. Certain eligible entities and hospitals are permitted to purchase drugs under the 340B Drug Pricing Program and dispense these drugs to Medicaid beneficiaries. Identifying claims where the dispensed drug has been discounted under the 340B program is necessary to avoid duplicating that discount in the MDRP.</P>
                    <P>Duplicate discounts occur when a State erroneously bills a manufacturer for a Medicaid drug program rebate involving a drug that was purchased under the 340B Drug Pricing Program. That occurs because the claim was not identified as a 340B claim before it was sent to the State. If the identification card included a unique Medicaid BIN/PCN/group number, and the State permits the use of 340B drugs at contract pharmacies for individuals enrolled in Medicaid managed care, then it would allow for the inclusion of a modifier at the point of dispensing that would identify the claim as ineligible for a Medicaid rebate. This would assist States with identifying 340B drug claims that should not be invoiced for Medicaid drug rebates.</P>
                    <P>Section 1902(a)(4) of the Act allows the Secretary to specify “methods of administration” that are “found by the Secretary to be necessary for . . . proper and efficient operation.” We believe that having States require their MCOs, PIHPs, or PAHPs that provide CODs to Medicaid beneficiaries to add unique identifiers onto the identification cards would make the Medicaid drug program run more efficiently, help avoid duplicate discounts, and improve the level of pharmacy services provided to Medicaid beneficiaries.</P>
                    <P>
                        Therefore, under the authority of section 1902(a)(4) of the Act, as well as to ensure effective implementation of and compliance with sections 1927(a)(5)(C) and 1927(j)(1) of the Act, we are proposing to amend 42 CFR 438.3(s) to require MCOs, PIHPs, and PAHPs that provide coverage of CODs to assign and exclusively use unique Medicaid BIN, PCN, and group number identifiers for all Medicaid managed 
                        <PRTPAGE P="34247"/>
                        care beneficiary identification cards for pharmacy benefits.
                    </P>
                    <HD SOURCE="HD3">b. Drug Cost Transparency in Medicaid Managed Care Contracts</HD>
                    <P>Medicaid managed care plans often contract with a subcontractor PBM to operate the pharmacy benefit provided to Medicaid beneficiaries. In order for a Medicaid managed care plan to appropriately calculate and report its Medical Loss Ratio (MLR) under § 438.8, the plan must know from the subcontractor certain information relating to how much of the payments made to the Medicaid managed care plan by the State was used to pay for health care services and other specific categories outlined in § 438.8. To correctly report the MLR, a Medicaid managed care plan must distinguish between expenses that are for covered benefits (such as healthcare services and drug costs) and administrative expenses, such as fees paid to its PBM for PBM services (for example, claims adjudication, processing prior authorization requests, etc.).</P>
                    <P>Therefore, we are proposing that MCOs, PIHPs, and PAHPs that provide coverage of CODs structure any contract with any subcontractor to require the subcontractor report the amounts related to the incurred claims described in § 438.8(e)(2), such as reimbursement for the covered outpatient drug, payments for other patient services, and the fees paid to providers or pharmacies for dispensing or administer a covered outpatient drug, separately from any administrative costs, fees, and expenses of the subcontractor.</P>
                    <HD SOURCE="HD3">14. Proposal To Rescind Revisions Made by the December 31, 2020 Final Rule to Determination of Best Price (§ 447.505) and Determination of Average Manufacturer Price (AMP) (§ 447.504) Consistent With Court Order</HD>
                    <P>
                        On May 17, 2022, the United States District Court for the District of Columbia vacated and set aside the “accumulator adjustment rule of 2020” in response to a complaint filed against the Secretary regarding the best-price accumulator provisions within the December 31, 2020 final rule “Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements.” See 
                        <E T="03">Pharm. Rsch. &amp; Mfrs. of Am.</E>
                         v. 
                        <E T="03">Becerra,</E>
                         1:21-cv-01395-CJN (D.D.C. May 17, 2022). This final rule had revised the conditions for excluding patient assistance from AMP at § 447.504(c)(25) through (29) and (e)(13) through (17), and best price at § 447.505(c)(8) through (12), to add language (effective January 1, 2023) that would require manufacturers to “ensure” the full value of the assistance provided by patient assistance programs is passed on to the consumer and that the pharmacy, agent, or other AMP or best price eligible entity does not receive any price concession. While the district court's order focused on the changes to the patient-assistance program exclusions from best-price determinations, to which it referred as the “accumulator adjustment rule of 2020,” for consistency, we propose to withdraw the changes to both the AMP and best-price sections made by the December 31, 2020 final rule.
                    </P>
                    <P>As a result, the regulations would maintain the language that has been in place since 2016.</P>
                    <HD SOURCE="HD3">15. Proposals Related to Amendments Made by the American Rescue Act of 2021—Removal of Manufacturer Rebate Cap (100 Percent AMP)</HD>
                    <P>Section 9816 of the American Rescue Plan Act of 2021 (Pub. L. 117-2, enacted March 11, 2021) sunsets the limit on maximum rebate amounts for single source and innovator multiple source drugs by amending section 1927(c)(2)(D) of Act by adding “and before January 1, 2024,” after “December 31, 2009”. In accordance with section 1927(c)(3)(C)(i) of the Act and the special rules for application of provision in section 1927(c)(3)(C)(ii)(IV) and (V) of the Act, this sunset provision also applies to the limit on maximum rebate amounts for CODs other than single source or innovator multiple source drugs. Therefore, to conform § 447.509 with section 1927(c)(2)(D) of Act, as amended by the American Rescue Plan Act of 2021, and sections 1927(c)(3)(C)(i), (ii)(IV), and (ii)(V) of the Act, we are proposing to make conforming changes to § 447.509 to reflect the removal of the maximum rebate amounts for rebate periods beginning on or after January 1, 2024.</P>
                    <HD SOURCE="HD3">16. Request for Information—Comments on Issues Relating to Requiring a Diagnosis on Medicaid Prescriptions as a Condition for Claims Payment</HD>
                    <P>Under the MDRP, a COD is generally defined as a prescribed drug that is FDA approved and used for a medically accepted indication. While the statute limits the definition of a COD to those products used for “medically accepted indications,” without a diagnosis on a prescription drug claims, it is difficult to determine whether a drug is being used for a medically accepted indication, and if it therefore satisfies the definition of a COD, and is rebate eligible. We are soliciting comments on the possibility and potential impact of proposing a requirement that a patient's diagnosis be included on a prescription as a condition of receiving Medicaid FFP for that prescription. We are soliciting comment on the patient care, clinical, and operational impact of requiring that a patient's diagnosis be included on a prescription as a condition of a State receiving FFP for that prescription. We are particularly interested in understanding any operational implications, privacy related concerns, the burden associated, and how to negate any foreseeable impact on beneficiaries and providers, including what steps would be needed by States to successfully implement a Medicaid requirement for diagnosis on prescriptions. This is a request for information only.</P>
                    <HD SOURCE="HD3">17. Background on Coordination of Benefits/Third Party Liability Regulation Due to Bipartisan Budget Act of 2018 (BBA 2018)</HD>
                    <P>Medicaid is generally the payer of last resort, which means that other available resources—known as third party liability, or TPL—must be used before Medicaid pays for services received by a Medicaid-eligible individual. Title XIX of the Act requires State Medicaid programs to identify and seek payment from liable third parties, before billing Medicaid. Section 53102 of the Bipartisan Budget Act of 2018 (BBA 2018) (Pub. L. 115-123, enacted February 9, 2018) amended the TPL provision at section 1902(a)(25) of the Act.</P>
                    <P>
                        Specifically, section 1902(a)(25)(A) of the Act requires that States take all reasonable measures to ascertain the legal liability of third parties to pay for care and services available under the plan. That provision further specifies that a third party is any individual, entity, or program that is or may be liable to pay all or part of the expenditures for medical assistance furnished under a State Plan. Section 1902(a)(25)(A)(i) of the Act specifies that the State Plan must provide for the collection of sufficient information to enable the State to pursue claims against third parties. Examples of liable third parties include: Private insurance companies through employment-related or privately purchased health insurance; casualty coverage resulting from an accidental injury; payment received directly from an individual who has voluntarily accepted or been assigned legal responsibility for the health care of one or more Medicaid recipients; 
                        <PRTPAGE P="34248"/>
                        fraternal groups, unions, or State workers' compensation commissions; and medical support provided by a parent under a court or administrative order.
                    </P>
                    <P>To update the regulation for the recent statutory changes, a final rule was published on December 31, 2020, which went into effect on March 1, 2021, to include changes as authorized under the BBA 2018. We are submitting a correction due to an omission in the regulation text to require a State to make payments without regard to TPL for pediatric preventive services unless the State has made a determination related to cost-effectiveness and access to care that warrants cost avoidance for up to 90 days.</P>
                    <HD SOURCE="HD1">II. Provisions of the Proposed Regulations</HD>
                    <HD SOURCE="HD2">A. Payment of Claims (42 CFR 433.139)</HD>
                    <P>In 1980, under the authority in section 1902(a)(25)(A) of the Act, we issued regulations at part 433, subpart D, establishing requirements for State Medicaid agencies to support the coordination of benefits (COB) effort by identifying third party liability.</P>
                    <P>Section 433.139(b)(3)(i) and (b)(3)(ii)(B) detail the exception to standard COB cost avoidance by allowing pay and chase for certain types of care, as well as the timeframe allowed prior to Medicaid paying claims for certain types of care. Specifically, we proposed to revise § 433.139(b)(3)(i) by adding—“that requires a State to make payments without regard to third party liability for pediatric preventive services unless the State has made a determination related to cost-effectiveness and access to care that warrants cost avoidance for up to 90 days.” We propose to revise § 433.139(b)(3)(i) and (b)(3)(ii)(B) by adding “within” prior to the waiting periods Medicaid has to pay claims for preventive pediatric and medical child support claims. We also propose to revise § 433.139(b)(3)(ii)(B) by removing “from” and replacing it with “after;” and by removing “has not received payment from the liable third party” and adding the following language at the end of the sentence “provider of such services has initially submitted a claim to such third party for payment for such services, except that the State may make such payment within 30 days after such date if the State determines doing so is cost-effective and necessary to ensure access to care.” These revisions in language would permit States to pay claims sooner than the specified waiting periods, when appropriate.</P>
                    <HD SOURCE="HD2">B. Standard Medicaid Managed Care Contract Requirements (§ 438.3(s))</HD>
                    <HD SOURCE="HD3">1. BIN/PCN on Medicaid Managed Care Cards</HD>
                    <P>We propose to amend § 438.3(s) to add a new paragraph (s)(7) to require States that contract with MCOs, PIHPs, or PAHPs that provide coverage of CODs, to require those managed care plans to assign and exclusively use unique Medicaid-specific BIN, PCN, and group number identifiers for all Medicaid managed care beneficiary identification cards for pharmacy benefits. We propose that the managed care contracts, and thus MCOs, PIHPs and PAHPs, must comply with this new requirement no later than the next rating period for Medicaid managed care contracts, following the effective date of the final rule adopting this new regulatory provision. We believe that the delay between the effective date of the final rule and the start of the next rating period would provide both States and the affected Medicaid managed care plans with adequate time to prepare both the necessary contract terms, and finish the necessary administrative processes for creating and issuing beneficiary identification cards with these newly required Medicaid-specific BIN, PCN, and group number identifiers.</P>
                    <P>This proposal is under our authority in section 1902(a)(4) of the Act to specify “methods of administration” that are “found by the Secretary to be necessary for . . . proper and efficient operation.” Having States require their MCOs, PIHPs, or PAHPs that provide CODs to Medicaid beneficiaries to add these types of unique identifiers to the identification cards would make the Medicaid drug program run more efficiently, and improve the level of pharmacy services provided to Medicaid beneficiaries. With the inclusion of Medicaid-specific BIN/PCN and group numbers on the pharmacy identification cards issued to the enrollees of MCOs, PHIPs and PAHPs, pharmacies would be able to identify patients as Medicaid beneficiaries, and better provide pharmacy services. This would be helpful to all parties to ensure that Medicaid benefits are provided correctly, including the confirmation of accurate cost sharing amounts, along with assisting that claims are billed and paid for appropriately.</P>
                    <P>This proposed change would also help to reduce the incidence of 340B duplicate discounts. Section 340B(a)(5)(A) of the PHS Act prohibits duplicate discounts; that is, manufacturers are not required to both provide a 340B discounted price and pay the State a rebate under the Medicaid drug rebate program for the same drug. Section 1927(a)(5)(C) of the Act requires the establishment of a mechanism to ensure against duplicate discounts or rebates, and section 1927(j)(1) of the Act also provides that CODs are not subject to, among other requirements of section 1927 of the Act, MDRP rebates if: (1) they are dispensed by health maintenance organizations, including MCOs that contract under section 1903(m) of the Act, and are subject to 340B discounts and (2) the drugs are subject to 340B discounts. Therefore, CODs covered by MCOs, PIHPs, and PAHPs are within the scope of this provision designed to prevent duplicate discounts. The existing regulation at § 438.3(s)(3) already reflects the position that CODs covered by MCOs, PIHPs, and PAHPs must be identified to prevent duplicate discounts under both section 1927 of the Act and section 340B of the PHS Act. The identification of a Medicaid beneficiary at the point of dispensing can result in the pharmacy placing a code on the prescription, such as the NCPDP “20” submission clarification code, so that the claim will be excluded from the Medicaid rebate pool.</P>
                    <P>Medicare Part D has supported the inclusion of BIN/PCN numbers for pharmacy cards. That is, 42 CFR 423.120(c)(4) requires that Part D sponsors assign and exclusively use a unique Part D BIN or RxBIN and Part D processor control number (RxPCN) combination in its Medicare line of business. The use of the BIN/PCN ensures that a pharmacy claim can be accurately billed by the pharmacy. Medicare made the BIN/PCN unique to Part D so that a Part D sponsor clearly identifies the Medicare enrollee as part of a particular Part D plan and the pharmacy knows that Medicare statute and rules may apply, such as not allowing certain manufacturer coupons, which plan benefits apply, appeals rights, etc.</P>
                    <P>
                        In the absence of Medicaid-specific BIN, PCN, and group numbers to identify beneficiaries as being Medicaid participants, it is difficult for pharmacies and other providers, such as physicians and hospitals that administer drugs to Medicaid beneficiaries, to determine whether the beneficiary is enrolled in a Medicaid managed care plan, since a group number alone is not sufficient for Medicaid identification. Adding unique identifiers would make the beneficiary's Medicaid managed care status distinguishable from the other lines of business offered by the same organization or entity that contracts with the State to offer an 
                        <PRTPAGE P="34249"/>
                        MCO, PIHP or PAHP for Medicaid beneficiaries.
                    </P>
                    <P>Accordingly, we propose to amend the regulatory language in § 438.3(s) to add paragraph (s)(7) to mandate that Medicaid managed care contracts require that Medicaid MCO, PIHPs, or PAHPs that provide coverage of CODs must assign and exclusively use unique Medicaid BIN, PCN, and group number identifiers for all Medicaid managed care beneficiary identification cards for pharmacy benefits. We propose that Medicaid managed care contract must include this new requirement (which would require compliance by MCOs, PIHPs, and PAHPs) no later than the next rating period for Medicaid managed care contracts, following the effective date of the final rule adopting this new provision. We are soliciting comments on the implementation time frame and other possible operational issues of requiring unique Medicaid BIN, PCN, and group numbers to be on Medicaid managed care beneficiary identification cards.</P>
                    <HD SOURCE="HD3">2. Drug Cost Transparency in Medicaid Managed Care Contracts</HD>
                    <P>We propose that the contracts between States and MCOs, PIHPs, or PAHPs that provide coverage of CODs require those plans to structure contracts with any subcontractor for the delivery or administration of CODs, in a manner that ensures drug cost spending transparency by requiring the subcontractor to report separately certain expenses and costs. These subcontractors may include PBMs.</P>
                    <P>Most Medicaid beneficiaries receive either all or part of their health care benefits, including CODs, through Medicaid managed care plans. Because of the specialized nature of the COD benefit, many Medicaid managed care plans (that is, the MCOs, PIHPs, or PAHPs) may contract with, or have their own PBMs to administer the COD benefit.</P>
                    <P>PBMs are the middlemen of the relationship between the managed care plans and the health care (medical and pharmacy) providers that provide CODs. That is, they have contracts with both the managed care plans to administer the pharmacy benefit, as well as with the health care providers that administer or provide the drugs to patients that are enrolled in the managed care plan. Among other tasks in the marketplace, a PBM may be responsible for developing a drug formulary, collecting manufacturer rebates on behalf of the managed care plan, performing drug utilization review (DUR), adjudicating claims, and contracting with retail community pharmacies and other health care providers to develop a network of pharmacy providers that can dispense drugs to managed care enrolled patients.</P>
                    <P>The PBM also negotiates reimbursement rates on behalf of the various health plans, including managed care plans with which it contracts, and pays the pharmacy and other health care providers for the drugs that are dispensed or administered. In most cases, the pharmacy reimbursement rates are specified in the contract between the PBM and the pharmacy providers, and these include reimbursement rates for brand name and generic prescription drugs, as well as the dispensing fees paid to dispense or administer the prescription drug to the beneficiary. There are also administrative fees paid to the PBM by the managed care plans for its administration and operation of the pharmacy benefit.</P>
                    <P>PBMs' methods of reimbursing health care providers for prescription drugs may differ from those used to determine the charges to managed care plans for the dispensed prescription. That is, a PBM's set of reimbursement benchmarks can be used in one relationship, and another set of reimbursement benchmarks in another, making it difficult for health plans or Medicaid managed care plans to know how much they are paying for the actual cost of the drug compared to the fees for administering the benefit. For this reason, under Part D, CMS requires that the price the PBM pays to the pharmacy for the cost of the drug is passed through to the plan, and any “spread” that the PBM keeps is an administrative cost that must be reported to the plan.</P>
                    <P>Medicaid-contracted PBMs (that is, PBMs contracted with or on behalf of Medicaid managed care plans) often reimburse health care providers using methods similar to those used in the commercial and Medicare Part D markets, which are heavily dependent on drug pricing benchmarks provided by manufacturers, and published by commercial publishers of drug pricing data (that is Average Wholesale Price (AWP) or Wholesale Acquisition Cost (WAC)). The PBMs may also use a Maximum Allowable Cost (MAC) benchmark for generic drugs, which is a PBM proprietary benchmark that reimburses pharmacy providers for generics.</P>
                    <P>For PBMs' payment to contracted health care providers, reimbursement might be based on a discount off AWP, a markup on WAC, or the Maximum Allowable Cost (MAC) for generics, plus any contractually defined professional dispensing fee (PDF), which determines the total reimbursement for each COD. In contrast, the PBM might charge the managed care plans for dispensing that same COD based upon a different fixed percentage discount from AWP, or a higher percentage of WAC, either on a per-claim or aggregate spend basis. That is, a PBM's benchmarks, markups, or discount percentages may differ for the same COD. The result is that there is little to no transparency to the managed care plan as to how much the plan actually pays for the COD administered or dispensed to the patient, and how much is paid to the PBM for fees related to the administration of the COD benefit. The cost charged to the managed care plan for the COD by the PBM often includes both the amount that the PBM reimbursed the medical or pharmacy provider for the COD as well as the PBM's administrative fees for operating the benefit program.</P>
                    <P>The margin between the amount charged to a managed care plan for a COD, and the amount paid by a PBM to a pharmacy provider is referred to as the “spread” or “spread pricing.” This margin or “spread” may only be known by the PBM, unless a State Medicaid program or managed care plan (or other prime contractor in other contexts) specifically requires disclosure of the charge and payment data that are used to make these calculations. This information deficit results in a lack of accountability and transparency to the Medicaid program, which we believe is contrary to proper and efficient operation of the State Medicaid program and potentially creates conflicts of interest in connection with payment for CODs.</P>
                    <P>Section 1902(a)(4)(A) of the Act requires that the State Plan for medical assistance comply with methods of administration that are found by the Secretary to be necessary for the proper and efficient operation of the State Plan. Greater transparency and accountability by Medicaid managed care plans (and their subcontractors) to the States for how Medicaid benefits are paid compared to how administrative fees or services are paid are necessary for efficient and proper operation of Medicaid programs. Moreover, this lack of transparency makes it more difficult for Medicaid managed care plans to assure that the plan's MLR calculation is limited to the true medical costs associated with the provision of CODs.</P>
                    <P>
                        Medicaid managed care regulations at § 438.8 require States, through their contracts with managed care plans, to require each managed care plan to calculate and report an annual MLR starting on or after July 2017, consistent with the requirements of the regulation 
                        <PRTPAGE P="34250"/>
                        detailing the calculation, including which expenses are in the numerator and the denominator. We issued a Center for Medicaid &amp; CHIP Services (CMCS) Informational Bulletin on May 15, 2019, for Medicaid Managed Care plans, titled “Medicaid Loss Ratio (MLR) Requirements Related to Third Party Vendors” (“2019 CIB”) (see 
                        <E T="03">https://www.medicaid.gov/sites/default/files/Federal-Policy-Guidance/Downloads/cib051519.pdf</E>
                        ), regarding calculation of the MLR when a managed care plan uses subcontractors for plan activities.
                    </P>
                    <P>MLR calculations are used to develop capitation rates paid to Medicaid managed care plans, thus their accuracy is critical in assuring that Medicaid payments are reasonable, appropriate and necessary for health care services when using a Medicaid managed care plan. Managed care capitation rates must (1) be developed such that the plan would reasonably achieve an 85 percent MLR (§ 438.4(b)(9)) and (2) are developed using past MLR information for the plan (§ 438.5(b)(5)). In addition to other standards outlined in §§ 438.4 through 438.7, these requirements for capitation rates related to the MLR are key to ensuring that Medicaid managed care capitation rates are actuarially sound. In addition, Medicaid managed care plans may need to pay remittances (that is, refund part of the capitation payments) to States should they not achieve the specific MLR target. Thus, the accuracy of MLR calculation is important to conserving Medicaid funds.</P>
                    <P>This 2019 CIB provided additional guidance regarding the calculation of the MLR when third party vendors, such as PBMs, are involved. The purpose was to assist States in ensuring that revenues, expenditures and amounts are appropriately identified and classified for the MLRs submitted by managed care plans, especially when a subcontractor is used. The 2019 CIB uses PBM spread pricing as a specific example. Several States have already implemented prohibitions or other restrictions on the PBM practice of spread pricing. Although there is not currently a Federal prohibition on using spread pricing in Medicaid, as noted, we issued the 2019 CIB regarding the impact of the lack of transparency between costs for administrative functions versus actual Medicaid services on the managed care plan's MLR calculation. The 2019 CIB is clear that when the subcontractor, in this case the PBM, is performing administrative functions, such as eligibility and coverage verification, claims processing, utilization review, or network development, the expenditures and profits on these functions are a non-claims administrative expense as described in § 438.8(e)(2)(v)(A), and should not be counted as an incurred claim for the purposes of MLR calculations.</P>
                    <P>In addition, the Medicaid managed care regulation at § 438.230(c)(1) requires, through contractual requirements in the managed care contract between the managed care plan and the State, certain agreements to be in subcontracts, including that subcontractors agree to perform the delegated activities and reporting responsibilities in compliance with the managed care plan's contract obligations. Moreover, the reporting standards at § 438.8(k)(3) specify that managed care plans must require any third-party vendor providing claims adjudication activities to provide all underlying data associated with MLR calculation and reporting. The 2019 CIB explains how these regulatory obligations mean that all subcontractors that administer claims for the managed care plan must report the incurred claims, expenditures for activities that improve health care quality, and information about mandatory deductions or exclusions from incurred claims (overpayment recoveries, rebates, other non-claims costs, etc.) to the managed care plan.</P>
                    <P>The requirements and definitions in § 438.8 for these categories of costs and expenditures must be applied to the required reporting. The reporting from the subcontractor must have sufficient detail to allow a managed care plan to accurately incorporate the expenditures associated with the subcontractor's activities into the managed care plan's overall MLR calculation. The level of detail must meet the requirements in § 438.8(k)(3) and the level of detail that is required may vary based on what is necessary to accurately calculate an overall MLR or to comply with any additional reporting requirements imposed by the State in its contract with the managed care plan.</P>
                    <P>Medicaid managed care plans are generally paid by States using single monthly capitation payments that for the plan's coverage of the health care services covered under the Medicaid managed care contract, including CODs. If the managed care plan contracts with a PBM, there are different options for the managed care plan to pay the PBM for the administrative services provided by the PBM. Payment for administrative services is made in addition to the amount the managed care plan would reimburse the PBM for the actual COD and dispensing fee costs. In general, managed care plans have paid PBMs for administrative services in one of two ways, or a mix of these approaches—either through a flat administrative fee per prescription, or, as described above, by including it in the overall COD payment (that is through “spread pricing”).</P>
                    <P>When payments to the PBM for the administration services are included in the managed care plans' total COD payment without a clear delineation of which amount is for administrative services, it obscures how much of that total payment is actually paid to the provider for the prescription and what is paid for administrative services furnished by the PBM. In other words, it is difficult for the managed care plan to determine the proportion of the payment to the PBM that is attributable to the administrative service costs provided by the PBM.</P>
                    <P>Furthermore, incorrectly attributing administrative service costs as medical expenditures, may increase the MLR numerator, and thus increase the per-member-per-month (PMPM) revenue a managed care entity can receive while appearing to meet MLR requirements. Given this lack of transparency, the “spread”, which has been the basis for generating significant PBM profit, obscures from Medicaid and the managed care plans the actual cost of the CODs dispensed to plan enrollees. This makes it difficult for managed care plans and State Medicaid agencies to determine whether the amount that the PBM is charging to administer the benefit is a reasonable expense to be borne by a Medicaid program. Moreover, it makes it difficult for plans to ensure that their MLR calculations appropriately classify and account for expenditures.</P>
                    <P>
                        We provide a representative example of how spread pricing occurs in the context of Medicaid prescription drug coverage provided by a managed care plan. Specifically, in Table 2, we illustrate how a PBM might leverage a 5 percent difference in the AWP value between the amount charged to the plan and the amount paid to the pharmacy for a commonly-dispensed generic drug product, to ultimately capture 30.76 percent of the dollars spent by the managed care plan for the prescription.
                        <PRTPAGE P="34251"/>
                    </P>
                    <GPOTABLE COLS="2" OPTS="L2,p1,8/9,i1" CDEF="s100,r100">
                        <TTITLE>Table 2—Example of Spread Pricing</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Drug Product</ENT>
                            <ENT>NDC 1234567890, Drug 300 MG CAPSULE, 60 capsules in prescription.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Published AWP</ENT>
                            <ENT>$1.33 per capsule.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PBM Reimbursement to pharmacy (MAC)</ENT>
                            <ENT>((AWP−90%) * 60) + $1 dispensing fee = $8.98.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Amount PBM billed to Managed care plan</ENT>
                            <ENT>((AWP−85%) * 60) + $1 dispensing fee = $12.97.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PBM spread =</ENT>
                            <ENT>($12.97−$8.98) = $3.99.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PBM spread percentage =</ENT>
                            <ENT>($3.99/$12.97) = 30.76% of total cost to managed care plan.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>Table 2 shows that, while the pharmacy only received $8.98 in reimbursement from the PBM for the prescription, PBM charged the managed care plan $12.97, or about 31 percent more for the same prescription. Depending on the specifics of the contract that the PBM has with the managed care plan, some of this margin or spread might be used to pay the PBM for managing or administering the pharmacy benefit but in some cases, this spread may be in addition to administrative fees paid by the plan to the PBM. For example, there may already be included in the contract a specific fee that the Medicaid MCO is paying for the administration of the COD benefit. These fees would be in addition to the amounts being paid as part of the “spread pricing.”</P>
                    <P>However, unless the managed care plan knows the amounts that the pharmacy providers are being paid by the PBM, the managed care plan is unable to assess the full scope of payments to the PBM for administrative services furnished by the PBM. As a result, the plan may not know whether the PBM is being appropriately compensated for administering the COD benefit.</P>
                    <P>
                        While the per-prescription dollar amounts above may not appear substantial, the overall impact to a Medicaid managed care pharmacy program may be significant given generic claims represent greater than 90 percent of total pharmacy claims. For example, an analysis of Ohio's Medicaid managed care program by the Ohio Auditor of State revealed $208.4 million of spread within their managed care plan's PBM transactions for generic drug claims between April 1, 2017, and March 31, 2018.
                        <SU>6</SU>
                        <FTREF/>
                         For the time period analyzed, this amount of PBM spread represented 31.4 percent of total generic drug expenditures within the State's Medicaid managed care program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             David Yost, Ohio's Medicaid Managed Care Pharmacy Services Auditor of the State Report (2018), available at 
                            <E T="03">https://tinyurl.com/mbn75c</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        CMS has determined that 11 States 
                        <SU>7</SU>
                        <FTREF/>
                         have enacted relevant legislation related to the practice of spread pricing. Four of these States (Arkansas, Delaware, Michigan, and Oklahoma) have complete State-wide prohibitions on the practice of spread pricing for any PBM operating within the State, regardless of the payer. Five States (Kentucky, Louisiana, New York, Pennsylvania, and Virginia) prohibit the practice of spread pricing by PBMs or MCOs in Medicaid, explicitly. One State (Pennsylvania) further requires that all Medicaid MCOs include a spread pricing prohibition clause in all contracts with PBMs. Only 2 of the 11 States with spread pricing laws (Alabama and Montana) merely require disclosure of certain spread pricing information (that is, annual report of aggregate rebate information and whether the PBM engages in spread pricing). Spread pricing can increase Medicaid pharmacy program costs, reduce efficient operation of the Medicaid program, and reduce the transparency of State Medicaid expenditures within managed care programs. This makes it more difficult for managed care plans and States to discern which participants of the pharmacy supply chain retain the bulk of the COD reimbursement.
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             
                            <E T="03">https://nashp.org/comparison-of-state-pharmacy-benefit-managers-laws/</E>
                            .
                        </P>
                    </FTNT>
                    <P>For these reasons, we are proposing to amend § 438.3(s) to require Medicaid MCOs, PIHPs, and PAHPs that provide coverage of CODs to structure any contract with any subcontractor for the delivery or administration of the COD benefit require the subcontractor to report separately the amounts related to the incurred claims described in § 438.8(e)(2), such as reimbursement for the CODs, payments for other patient services, and the dispensing or administering providers fees, and subcontractor administrative fees. The proposal would ensure that MLRs reported by MCOs, PIHPs, and PAHPs that use subcontractors in the delivery of COD coverage would be more accurate and transparent. The separate payment requirements would help States and managed care plans better understand whether they are appropriately and efficiently paying for the delivery of CODs, a significant part of which is funded by the Federal Government. We note that this proposal does not change the applicability of the 2019 CIB to PBM subcontractors or to other subcontracting arrangements used by a Medicaid managed care plan; the 2019 CIB remains CMS' position on how §§ 438.8 and 438.230 apply. This proposal would create additional requirements for MCOs, PIHPs and PAHPs that help ensure that the objectives and responsibilities outlined in the 2019 CIB are met.</P>
                    <P>The proposal requires MCOs, PIHPs, and PAHPs that cover CODs to require their subcontractors to report their costs in a way that aligns more fully with the specific categories specified in § 438.8(e)(2) regarding the MLR numerator. Fully aligning the subcontractor's reports and billing (invoices) with how the MLR regulation categorizes and treats specific costs and expenditures would make clearer for the MCOs, PIHPs, and PAHPs how its payments to a subcontractor are used that would be subject to proposed § 438.3(s)(8), and allow those managed care plans to incorporate the subcontractor's costs into the MLR reporting and calculation. However, having the subcontractor's (in particular a PBM's) expenditures and costs reported in the categories that we are proposing might not be representative of how the industry works, might require systems changes and impose burden that we have not taken into account, or might result in unintended consequences. Therefore, we are specifically soliciting comment on this point and on other alternatives for how MCOs, PIHPs, and PAHPs should require information from their subcontractors and how they should structure payment or billing arrangements to achieve the policy goals we have outlined.</P>
                    <P>
                        We believe this new transparency requirement would assist States and Medicaid managed care plans in complying with § 438.8 and related guidance because subcontractor PBMs would be required to appropriately identify certain costs, so that the managed care plan can appropriately calculate its MLR. In particular with COD spending, the managed care plan would have to separately identify prescription drug and dispensing or administration fee claim costs when calculating the MLR, in contrast to 
                        <PRTPAGE P="34252"/>
                        administrative costs. As a result, any payments for costs over and above the cost of the prescription and dispensing fee would be separately identifiable by the managed care plan and cannot be used to inappropriately inflate the MLR which may result in managed care plan capitation rates that are not actuarially sound.
                    </P>
                    <HD SOURCE="HD2">C. MDRP Administrative and Program Integrity Changes</HD>
                    <HD SOURCE="HD3">1. Proposed Definitions (§ 447.502)</HD>
                    <HD SOURCE="HD3">a. Proposal To Modify the Definition of Covered Outpatient Drug (§ 447.502)</HD>
                    <P>Sections 1927(k)(2) and (3) of the Act provide a definition of the term “covered outpatient drug” (COD) and a limiting definition, which excludes certain drugs, biological products, and insulin provided as part of, or as incident to and in the same setting as, enumerated services and settings from the definition of COD. This exclusion is subject to a parenthetical, however, which limits the exclusion to when payment may be made as part of payment for the enumerated service or setting, and not as direct reimbursement for the drug.</P>
                    <P>In the COD final rule, we finalized a regulatory definition of COD in § 447.502 that substantially mirrors the statutory definition. Consistent with section 1927(k)(3) of the Act, the regulatory definition includes a limiting definition in paragraph (2) of the definition of covered outpatient drug at § 447.502 that excludes from the definition of COD any drug, biological product, or insulin provided as part of or incident to and in the same setting as any one in a list of services, and for which payment may be made as part of that service instead of as a direct reimbursement for the drug.</P>
                    <P>Over the years we have received questions about when a payment is considered to be a direct reimbursement for a drug and whether identifying a drug separately on a claim for payment may qualify as direct reimbursement for a drug, rendering the drug eligible for rebates under section 1927 of the Act as a COD, or in other words, garnering the limiting definition exclusion inapplicable. If a drug and its cost can be separately identified on a claim for payment it can be considered subject to direct reimbursement. That is, if the payment to the provider includes any reimbursement for the drug and the drug is separately identified, then the reimbursement for the drug is a direct reimbursement. Additionally, if the payment to the provider is solely for the drug (and no other services), and the drug is separately identified, it is also a direct reimbursement. Therefore, direct reimbursement may be reimbursement for a drug alone, or reimbursement for a drug plus the service, in one inclusive payment, if the drug plus the itemized cost of the drug are separately identified on the claim. In other words, the payment for the drug is not required to be a separate payment in order for such payment to be considered direct reimbursement.</P>
                    <P>To provide greater clarity on this point and the application of the limiting definition, we propose to amend the regulatory definition of the term covered outpatient drug at § 447.502 to add that direct reimbursement for the drug includes when a claim for payment identifies the drug plus the itemized cost of the drug. Specifically, we propose to add to the regulatory definition of covered outpatient drug at § 447.502 that the direct reimbursement for a drug may include both reimbursement for a drug alone, or reimbursement for a drug plus the service, in one inclusive payment, if the drug and the itemized cost of the drug are separately identified on the claim.</P>
                    <P>Additionally, the limiting definition in section 1927(k)(3) of the Act includes the following parenthetical: “. . . (and for which payment may be made under this subchapter as part of payment for [certain services] and not as direct reimbursement for the drug).” The term covered outpatient drug is defined in § 447.502 and includes this limiting definition parenthetical at paragraph (2): “. . . (and for which payment may be made as part of that service instead of as a direct reimbursement for the drug).”</P>
                    <P>There is no meaningful distinction between the statutory and regulatory language for purposes of the MDRP, and thus, we are proposing to make a technical change by modifying the regulatory language so that it more closely mirrors the statutory language. We propose to add “payment for” after “and for which payment may be made as part of” and to delete “instead of as a” in the limiting definition of covered outpatient drug and replace it with “and not as”.</P>
                    <P>The proposed definition would then read, in significant part, as “. . . (and for which payment may be made as part of payment for that service and not as direct reimbursement for the drug).”</P>
                    <HD SOURCE="HD3">b. Proposal To Define Drug Product Information (§ 447.502)</HD>
                    <P>Section 6(a)(1)(A)(iv) of MSIIA amended section 1927(b)(3) of the Act by adding the words “and drug product” to the title of section (b)(3), and adding section (b)(3)(A)(v), to require a manufacturer to report drug product information that the Secretary shall require for each of the manufacturer's CODs no later than 30 days after the last day of each month of a rebate period. Section 1927(b)(3)(A) of the Act describes the manufacturer drug product and pricing information that is required to be reported to the agency by statute, and with respect to the pricing information, specifically provides for the reporting of such information, such as AMP and best price. To support the implementation of this new statutory requirement to report drug product information, we propose to define drug product information at § 447.502.</P>
                    <P>We currently require manufacturers to submit drug product information when the covered outpatient drug is entered into the MDP system, although there is no regulatory definition of drug product information. When initially reporting drug product data upon the execution of an NDRA, manufacturers have 30 days after the date on which they enter into an NDRA to report drug product data for their existing CODs under section 1927(b)(3)(A) of the Act. After the execution of an NDRA, manufacturers have 30 days from the end of each rebate period to report drug product data for new CODs under section 1927(b)(3)(A)(v) of the Act.</P>
                    <P>We propose to define “drug product information” in § 447.502 as information that includes, but is not limited to, NDC number, drug name, units per package size (UPPS), drug category (“S”, “I”, “N”), unit type (for example, TAB, CAP, ML, EA), drug type (prescription, over-the counter), base date AMP, therapeutic equivalent code (TEC), line extension drug indicator, 5i indicator and route of administration, if applicable, FDA approval date and application number or OTC monograph citation if applicable, market date, COD status, and any other information deemed necessary by the agency to perform accurate URA calculations.</P>
                    <P>
                        As previously discussed in this proposed rule, the drug category for an NDC should be single source or innovator for the entire history of the NDC if it was always produced, distributed, or marketed under an NDA, unless a narrow exception applies, or single source if marketed under a BLA. If a narrow exception has been granted by CMS, the drug category for that NDC should historically be reported as single source or innovator, and can be changed to noninnovator, effective April 1, 2016. We use the FDA “applications.txt” file to verify the type of application associated with an application number. The file may be accessed using the link to the Drugs@FDA download file found 
                        <PRTPAGE P="34253"/>
                        on the FDA web page at 
                        <E T="03">https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files</E>
                        .
                    </P>
                    <P>The only situation in which a drug that is produced or marketed under an NDA may be reported as a noninnovator drug is if a narrow exception was granted by CMS in accordance with the process established in the COD final rule. See 81 FR 5191. Definitions for these drug categories can be found at section 1927(k)(7) of the Act and at § 447.502.</P>
                    <P>
                        Manufacturers should evaluate all of their NDCs for compliance with drug product information reporting, and if they determine corrections are required, they should contact the agency for assistance. In Manufacturer Release No. 113, we address a manufacturer's responsibility to ensure that all of their CODs are correctly classified and reported in the Drug Data Reporting system (DDR) for the history of the NDC, including such NDCs that may no longer be active: 
                        <E T="03">https://www.medicaid.gov/prescription-drugs/downloads/mfr-rel-113.pdf</E>
                        .
                    </P>
                    <P>As part of a manufacturer's evaluation of their NDCs for compliance with accurate drug product information reporting, they should ensure that each NDC is reported with an accurate market date. In this proposed rule, we are proposing to add a definition for “market date” for the purposes of the MDRP. Please see proposed § 447.502 for that proposed definition and elsewhere in this preamble for an explanation of how market date is used to determine the quarter that establishes each drug's base date AMP.</P>
                    <P>
                        Generally, a manufacturer cannot make the drug product information corrections in the CMS system without our intervention. To request corrections, a manufacturer should contact CMS using instructions that are available on 
                        <E T="03">Medicaid.gov</E>
                         (
                        <E T="03">https://www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program/medicaid-drug-rebate-program-change-request/index.html</E>
                        ) to correct drug product and pricing information. If we identify a misclassified or misreported NDC as part of the review of the information submitted by the manufacturer to support these drug pricing or product information changes, and notify the manufacturer, the link to the instructions for correcting the data would generally be included as part of that notification.
                    </P>
                    <P>For most drug product information changes, as outlined above, we would make the requested changes on behalf of the manufacturer in the CMS system, and those changes would subsequently be available for manufacturer certification. However, in some situations where monthly and/or quarterly pricing data must be updated as a result of the drug product information change, if necessary, we would notify the manufacturer that certain pricing data fields have been “unlocked” in the CMS system to allow the manufacturer to enter or correct required pricing information if applicable.</P>
                    <P>Regardless of whether we make a data change on behalf of a manufacturer or whether the manufacturer enters required data directly in the CMS system, manufacturers would be required to certify the information in accordance with § 447.510. If we make a data change at the request of a manufacturer, the manufacturer is not relieved of its responsibility to ensure the accuracy of such data, nor should it be inferred that we have approved a variance from the requirements of the statute.</P>
                    <P>Until certification is complete, the changes in the CMS system are not considered final and would not be used in any quarterly rebate calculations or transmitted to the States as part of the quarterly rebate files; however, the manufacturer is still responsible for correct URA calculations and rebate payments. If drug product information changes are left uncertified, the previously certified values would remain in effect; therefore, corrections made in the CMS system that remain uncertified would result in the drug continuing to be considered misclassified or misreported. We would consider this to be late reporting of product data for which a manufacturer's rebate agreement may be suspended from the MDRP under section 1927(b)(3)(C)(i) of the Act, and eventually terminated as authorized under section 1927(b)(4)(B) of the Act.</P>
                    <HD SOURCE="HD3">c. Proposal To Define Internal Investigation for Purposes of Pricing Metric Revisions (§§ 447.502 and 447.510)</HD>
                    <P>In accordance with section 1927(b)(3) of the Act, § 447.510 of the implementing regulations, and the terms of the NDRA, manufacturers are required to report certain pricing and drug product information to CMS on a timely basis or else they could incur penalties or be subject to other compliance and enforcement measures. As explained in the final time limitation rule, in an effort to improve the administration and efficiency of the MDRP and assist States and manufacturers that would otherwise be required to retain drug utilization pricing data records indefinitely, we established the 12-quarter time frame for reporting revisions to AMP or best price information. Notwithstanding the 12-quarter time frame for reporting revisions, we continued to receive requests outside of the 12-quarter period from manufacturers to revise pricing data. These types of manufacturer requests, which could span multiple years prior to the 12-quarter timeframe, and could sometimes result in substantial recoupment of Medicaid rebates already paid to States, impede the economic and efficient operation of the Medicaid program.</P>
                    <P>Consequently, in the COD final rule (81 FR 5278) we finalized § 447.510(b)(1), which provides that a manufacturer must report to CMS any revision to AMP, best price, customary prompt pay discounts or nominal prices (pricing data) for a period not to exceed 12 quarters from the quarter in which the data were due unless one of a number of enumerated exceptions applies. See § 447.510(b)(1)(i) through (vi). Of note, § 447.510(b)(1)(v) provides an exception to the 12-quarter price reporting rule if the change is to address specific rebate adjustments to States by manufacturers, as required by CMS or court order, or under an internal investigation, or an OIG or Department of Justice (DOJ) investigation.</P>
                    <P>In a response to comment in the preamble of the COD final rule, which added § 447.510(b)(1)(v), we indicated that internal investigation is intended to mean a manufacturer's internal investigation, and we further explained that in the event that a manufacturer discovers any discrepancy with its reported product and pricing data to the MDRP that are outside of the applicable timeframes, the manufacturer should determine if the change satisfies one of the enumerated exceptions. (81 FR 5280)</P>
                    <P>However, we did not further define or give any greater explanation for the applicability of the exception to the 12-quarter rule, particularly in instances when manufacturers perform an internal investigation of the prices (AMP and best price) reported and certified in the Medicaid Drug Product systems by another manufacturer. Given the absence of a definition of internal investigation or specificity as to when this exception applies, some manufacturers have broadly interpreted the internal investigation exception to the 12-quarter rule.</P>
                    <P>
                        Some manufacturers have requested revisions to AMP and best price outside of the 12-quarter rule based upon an internal investigation related to newly acquired products or lines of business 
                        <PRTPAGE P="34254"/>
                        previously certified by the prior manufacturers without making findings that the prior manufacturer violated any law. For example, some requests from manufacturers to revise AMP or best price for drug product and drug pricing information previously reported and certified from another manufacturer were based on internal reviews that did not result in proof that the prior manufacturer misapplied the laws or regulations, or acted in a fraudulent or illegal manner.
                    </P>
                    <P>In cases when a manufacturer requests an exception to the 12-quarter rule due to an internal investigation, we propose to specify that the manufacturer must make a finding that indicates a violation of statute or regulation made by the prior manufacturer before we consider such a request. For example, a request to restate or revise pricing outside of the 12-quarter time frame by a manufacturer to previously reported and certified data of a prior manufacturer based upon a mere disagreement with the prior manufacturer's government pricing calculations and assumptions would not be considered a valid reason to revise a prior manufacturer's pricing outside of the 12-quarter time frame. The manufacturer must make findings that include actual data as evidence that the prior manufacturer violated statute or regulation.</P>
                    <P>Manufacturers should not use the internal investigation exception to permit restatements to allow manufacturers to apply a different methodology or reasonable assumption to determine AMP and best price to its favor when the methodology originally applied was consistent with statute and regulation, and drug product and pricing information was properly reported and certified by the manufacturer at the time. To ensure clarity on when the internal investigation exception may be appropriately applied, we are proposing to define internal investigation at § 447.502 to mean a manufacturer's investigation of its AMP, best price, customary prompt pay discounts or nominal prices that have been previously certified in MDRP that results in a finding made by the manufacturer of fraud, abuse or violation of law or regulation. A manufacturer must make data available to CMS to support its finding. We are also proposing to amend § 447.510(b)(1)(v) to reference the proposed definition of internal investigation at § 447.502.</P>
                    <HD SOURCE="HD3">d. Proposal To Revise Definition of Manufacturer for NDRA Compliance (§ 447.502)</HD>
                    <P>When Congress passed the drug rebate provisions in 1990, they established a framework for coverage and payment of covered outpatient drugs under Medicaid, and prescribed drugs, generally. Often referenced as the “grand bargain” between the States, the Federal Government, and manufacturers, the MDRP made clear that if manufacturers paid rebates for the covered outpatient drugs dispensed and paid for under the State Plan, States would be required to cover their covered outpatient drugs, subject to limited permissible restrictions and exclusions. These policies would help increase Medicaid beneficiaries' access to medications, while assisting States in striving to deliver an economic and efficient Medicaid program. A key piece of the coverage and payment framework the MDRP established is captured in section 1927(a)(1) of the Act, which provides that in order for payment to be available under section 1903(a) or under part B of title XVIII for covered outpatient drugs of a manufacturer, the manufacturer must have entered into and have in effect a rebate agreement with the Secretary as described in section 1927(b) of the Act.</P>
                    <P>With an effectuated rebate agreement in place, manufacturers participating in the MDRP are required to provide periodic rebates for CODs dispensed and paid for under the State Plan, and also provide certain drug price and drug product information on a monthly and/or quarterly basis to the agency. While entering into a rebate agreement is voluntary, a manufacturer that does not enter into such an agreement forgoes payment and coverage, for their covered outpatient drugs under Medicaid. It also affects coverage under the 340B Drug Pricing Program and may affect Medicare Part B reimbursement.</P>
                    <P>To implement the important requirement set forth at section 1927(a)(1) of the Act, and in an effort to prevent selective reporting of NDCs, the agency has required manufacturers to ensure that all their associated labeler codes with CODs enter into a rebate agreement to comply with the terms of the NDRA. This requirement has been included in the NDRA since the inception of the program. (See section II., Manufacturer's Responsibilities, subsection (a) of the previous NDRA, and section II., Manufacturer's Responsibilities, subsection (b) of the updated NDRA.) We also reiterated this point most recently in the preamble to the updated NDRA, 83 FR 12770 (Mar. 23, 2018). In that final notice, we explained that manufacturers are required to report all CODs under their labeler code(s) to the MDRP, and may not be selective in reporting their national drug codes (NDCs) to the program.</P>
                    <P>We continue to maintain that this requirement applies to all the manufacturer's labeler codes, including newly acquired labeler codes, newly formed subsidiaries, and labeler codes previously omitted from the original rebate agreement. 83 FR 12771; see also Manufacturer Releases #13 and #48. Thus, once we review a request for a rebate agreement and the manufacturer confirms, among other things, that all of a manufacturer's CODs are listed, a rebate agreement will be issued. Manufacturers are then responsible for paying a rebate on those CODs that were dispensed and/or paid for, as applicable, under the State Plan. These rebates are paid by manufacturers on a quarterly basis to States, and are shared between the States and the Federal Government to partially offset the overall cost of prescription drugs under the Medicaid program.</P>
                    <P>The term “manufacturer” was first defined in statute in 1990, when section 1927 of the Act was established, and was interpreted in regulation in 2007 at § 447.502. Section 1927(k)(5) of the Act defines the term “manufacturer” as any entity which is engaged in: (1) the production, preparation, propagation, compounding, conversion, or processing of prescription drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis; or (2) in the packaging, repackaging, labeling, relabeling, or distribution of prescription drug products.</P>
                    <P>The regulations at § 447.502 define “manufacturer” to mean any entity that holds the NDC for a covered outpatient drug or biological product and meets the following criteria:</P>
                    <P>• Is engaged in the production, preparation, propagation, compounding, conversion, or processing of covered outpatient drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis; or</P>
                    <P>
                        • Is engaged in the packaging, repackaging, labeling, relabeling, or distribution of covered outpatient drug products and is not a wholesale distributor of drugs or a retail pharmacy licensed under State law.
                        <PRTPAGE P="34255"/>
                    </P>
                    <P>• For authorized generic products, the term “manufacturer” will also include the original holder of the NDA.</P>
                    <P>• For drugs subject to private labeling arrangements, the term “manufacturer” will also include the entity under whose own label or trade name the product will be distributed.</P>
                    <P>
                        The labeler code is a unique 5-digit number within the NDC,
                        <SU>8</SU>
                        <FTREF/>
                         assigned by the FDA, and one manufacturer may be assigned multiple labeler codes by FDA. A manufacturer can obtain a different labeler code for each manufacturing establishment or company under the same ownership since the labeler code identifies a company marketing a drug product.
                        <SU>9</SU>
                        <FTREF/>
                         Some drug companies that have several divisions have more than one labeler code, and a single manufacturer may be marketing its drugs across or under multiple labeler codes. Furthermore, a manufacturer may own, operate, or be associated or affiliated with several labeler code subsidiaries, each of which makes CODs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             See 21 CFR 207.33.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             Electronic Drug Registration and Listing Instructions | FDA.
                        </P>
                    </FTNT>
                    <P>
                        Consistent with the statute and regulation, our current policy is that each of these associated labeler codes would have to have an effectuated rebate agreement in order for the single manufacturer to be considered to be in compliance with the requirement under section 1927(a)(1) of the Act that a manufacturer have a rebate agreement in effect, and this has been noted in related guidance.
                        <SU>10</SU>
                        <FTREF/>
                         We treat each associated labeler code as part of the single manufacturer, and if any of the labeler codes of a manufacturer do not have an NDRA in effect, no FFP would be available for any of the CODs of the labeler codes of the manufacturer, and all of the labelers would be subject to potential termination from the MDRP.
                    </P>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             Manufacturer Release 013 (October 6, 1994), Manufacturer Release 048 (November 15, 2000) and 83 FR 12770, 12771 (Mar. 23, 2018).
                        </P>
                    </FTNT>
                    <P>We also explained in the final notice for the updated NDRA that manufacturers that wish to terminate an NDRA that have active CODs must request termination for all associated labeler codes, and provide a reason for the request (for example, all CODs under the labeler code are terminated), or if the request for termination is only for certain labeler codes, provide justification for such request (83 FR 12770, 12771). In that same final notice, we indicated that for purposes of ensuring beneficiary access to single source drugs and/or drugs that are not otherwise available in the MDRP, we may choose to grant an exception to issuing or reinstating an NDRA for certain labeler codes of a manufacturer prior to issuing an NDRA for all of the labeler codes of the manufacturer, or terminating certain labeler codes as mentioned above (83 FR 12771).</P>
                    <P>The requirement that manufacturers that enter into a rebate agreement cannot exclude any covered outpatient drug from their listings applies to all CODs associated with any of the manufacturer's labeler codes that market CODs, including newly-purchased labeler codes, and newly-formed subsidiaries. This means a manufacturer has to be “all in” for all its drugs, or “all out”. Otherwise, there is a possibility that a manufacturer would create separate labeler codes for some of its drugs, and enter into a rebate agreement for some of its labeler codes, and not others. Permitting a manufacturer to do so would allow them the benefit of receiving FFP for some of their CODs, while potentially avoiding the financial obligation to pay rebates for other drugs that would otherwise qualify as CODs and be subject to rebates. If a product meets the definition of a covered outpatient drug, but the manufacturer of such drug does not have a rebate agreement in effect, that drug is not eligible for FFP and may not be claimed on the CMS-64 form, even though the drug may meet the definition of a prescribed drug. In these situations, while States would not be required to provide mandatory coverage of such drugs, a State may still elect to cover these products with State only funds.</P>
                    <P>While we believe that the overwhelming majority of manufacturers are compliant with section 1927(a)(1) of the Act, and have had all their associated labelers enter into and maintain drug rebate agreements, this issue has been challenged by a few manufacturers. In more recent times, manufacturers have suggested certain associated labelers are exempt or not required to be included in the program under the manufacturer's rebate agreement, stating that such associated companies, parent entities and brother-sister entities are distinct separate manufacturers. They have stated that the agency has not required such a policy through final regulations, but rather has articulated this policy only in program releases and preamble statements, which are subregulatory guidance that do not carry the force of law.</P>
                    <P>To codify the requirement at section 1927(a)(1) of the Act, that a manufacturer have entered into and have in effect an agreement with the Secretary to receive FFP for its CODs, we are now proposing to modify the regulatory definition of manufacturer to specify how the term “manufacturer” is defined for purposes of complying with this statutory requirement. To satisfy the requirement that a manufacturer have entered into and have in effect an agreement with the Secretary, we are specifying at proposed § 447.510(h) that manufacturers must provide CMS with all labeler codes for all the manufacturer's applicable drugs. More specifically, we are proposing at § 447.510(h)(2) that if any manufacturer with a signed rebate agreement in effect, acquires or purchases another labeler, acquires or purchases covered outpatient drugs from another labeler code, or forms a new subsidiary, they must ensure that a signed rebate agreement is in effect for these entities or covered outpatient drugs, consistent with the definition of manufacturer at § 447.502, within the first 30 days of the next full calendar quarter beginning at least 60 days after the acquisition, purchase, asset transfer, or formation of the subsidiary.</P>
                    <P>
                        As first described in the “Medicaid Program; Payment for Covered Outpatient Drugs Under Drug Rebate Agreements With Manufacturers” proposed rule (95 FR 48442; hereinafter referenced as the “1995 proposed rule”), we have noted our intent that each associated manufacturer's labeler codes would have to have an effectuated rebate agreement in order for the single manufacturer to be considered to be in compliance with the requirement under section 1927(a)(1) of the Act that a manufacturer have a rebate agreement in effect. This 1995 proposed rule is informative and helpful to understanding and describing the agency's initial proposed policy and intentions with the Medicaid Drug Rebate Program.
                        <SU>11</SU>
                        <FTREF/>
                         In this proposal, CMS proposed to interpret the term “manufacturer” to specify that if a corporation meets the statutory definition of manufacturer (that is, section 1927(k)(5) of the Act) and possesses legal title to the NDC, the agency would consider the term to include associated companies, including parent corporations, brother-sister corporations, and subsidiary corporations. In addition, we further proposed to interpret the term to specify that if a corporation meets the statutory definition of manufacturer, and possesses legal title to the NDC number, we would consider the term to include: (1) Any corporation that owns at least 80 percent of the total combined voting power of all classes of stock or 80 percent of the total value of shares in all 
                        <PRTPAGE P="34256"/>
                        classes of stock in such entity (that is a parent corporation); (2) Any other corporation in which a parent corporation of the entity owns at least 80 percent of the total combined voting power of all classes of stock or 80 percent of the total value of shares. (60 FR 48447-48448)
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             60 FR 48447 through 48448.
                        </P>
                    </FTNT>
                    <P>
                        This policy comports with Congress' desire to maximize recipient access to medically necessary drugs, while at the same time providing a more favorable drug purchasing arrangement for State Medicaid programs.
                        <SU>12</SU>
                        <FTREF/>
                         When Congress passed the drug rebate provisions in 1990, they made it clear that States that elect to cover prescription drugs must, except for certain restrictions or exclusions allowed under the statute, cover the CODs of a manufacturer that enters into and complies with a drug rebate agreement. In return for such coverage, a manufacturer would be responsible for providing a rebate to the State that would give the Medicaid program the benefit of those discounts that other large public and private purchasers receive.
                        <SU>13</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             H.R. Conf. Rept. No. 964, 101st Cong., 2d Sess. 822, 832 (1990); H.R. Rept. No. 881, 101st Cong., 2d Sess. 996 (1990).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             Id.
                        </P>
                    </FTNT>
                    <P>
                        We believe it would be directly contrary to Congressional intent to apply the definition of a manufacturer in a manner that would permit a manufacturer (that is by forming a subsidiary corporation) to exclude some of its drugs from the drug rebate program.
                        <SU>14</SU>
                        <FTREF/>
                         Our proposal would prevent manufacturers from manipulating the system as to select drugs by assigning separate labeler codes, without consequence to all of their CODs, and codify a longstanding policy that has faced scrutiny more recently. As such, we continue to believe that when defining a manufacturer, the term “entity” should be interpreted to include parent, brother-sister, or subsidiary corporations, as well as, labelers that are owned, acquired, subsidiaries, affiliates, parent companies, franchises, business segments, part of holding companies, or under common corporate ownership or control.
                    </P>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             Id.
                        </P>
                    </FTNT>
                    <P>Therefore, to provide a clearer definition of the meaning of manufacturer with respect to section 1927(a)(1) of the Act, we are proposing to amend the regulatory definition of manufacturer at § 447.502. Consistent with the statute and our understanding of Congressional intent of the MDRP, which was increasing access to medications while at the same time helping States manage pharmacy program costs and maximizing Medicaid savings, we are proposing to include a new paragraph (5) as part of the definition of a manufacturer. This change explains that, for purposes of meeting the requirements in section 1927(a)(1) of the Act of maintaining an effectuated rebate agreement, that the term “manufacturer” means that all associated labeler entities of the manufacturer that sell prescription drugs, including, but not limited to, owned, acquired, affiliates, brother or sister corporations, operating subsidiaries, franchises, business segments, part of holding companies, divisions, or entities under common corporate ownership or control, must each maintain an effectuated rebate agreement in order for a manufacturer to satisfy the requirement at section 1927(a)(1) of the Act to have entered into and have in effect a rebate agreement with the Secretary.</P>
                    <P>Additionally, we are proposing a new paragraph (h), “Participation in the Medicaid Drug Rebate Program (MDRP),” in § 447.510 to further specify the responsibilities of a manufacturer, specifying in § 447.510(h)(1) that manufacturers participating in the MDRP must have a signed rebate agreement that complies with paragraph (5) in the definition of the manufacturer in § 447.502.</P>
                    <P>Furthermore, with respect to rebate agreements when a manufacturer acquires or purchases another manufacturer, acquires or purchases covered outpatient drugs from another manufacturer, or forms a new subsidiary, we are proposing to add § 447.510(h)(2), “Newly purchased labeler codes and covered outpatient drugs.” We are proposing that any manufacturer with a rebate agreement in effect that acquires or purchases another labeler code, acquires or purchases covered outpatient drugs from another labeler, or forms a new subsidiary, must have in effect a rebate agreement for these entities or covered outpatient drugs consistent with definition of manufacturer at § 447.502. The newly associated entity of the manufacturer must also have a rebate agreement in effect within the first 30 days of the next full calendar quarter beginning at least 60 days after the acquisition, purchase, asset transfer, or creation of a subsidiary has occurred. By including these provisions in regulation, we would better specify that a manufacturer must, in part, assure that a NDRA is in effect with the Secretary for all associated labeler codes and that MDRP requirements apply to all CODs of a manufacturer, including newly associated entities.</P>
                    <P>Finally, we are proposing to add a provision on termination in at § 447.510(h)(3) specifying that each associated labeler code of a manufacturer is considered to be part of the single manufacturer, and if any of the associated labeler codes as defined in paragraph (5) of the definition of manufacturer at § 447.502 do not have an NDRA in effect, or are terminated, then all of the labeler codes will be subject to termination.</P>
                    <HD SOURCE="HD3">e. Proposal To Define Market Date (§ 447.502)</HD>
                    <P>
                        Section 1927 of the Act governs the MDRP and payment for CODs which are defined in section 1927(k)(2) of the Act. Manufacturers that participate in the MDRP are required to pay rebates for CODs that are dispensed and paid for under the State Medicaid plan. (See section 1927(b)(1)(A) of the Act.) Section 1927 of the Act provides specific requirements for program implementation, including requirements for rebate agreements, submission of drug pricing and product information, confidentiality, the formulas for calculating rebate payments, and many others related to State and manufacturer obligations under the program. The rebates due by manufacturers are calculated based on statutory formulas described in section 1927(c) of the Act and consist of a basic rebate and, in some cases, an additional rebate that is applicable when an increase in the AMP, with respect to each dosage form and strength of a drug, exceeds the rate of inflation. This additional rebate formula is set forth in sections 1927(c)(2) and 1927(c)(3)(C) of the Act, and codified in regulation at § 447.509(a)(2) and (7).
                        <SU>15</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             Section 602 of the Bipartisan Budget Act (BBA) of 2015 amended section 1927(c)(3) of the Act, to require that manufacturers pay additional rebates when their covered outpatient drugs other than single source or innovator multiple source drugs' average manufacturer prices increase at a rate that exceeds the rate of inflation. In accordance with section 1927(c)(3) of the Act, as revised by section 602 of the BBA of 2015, manufacturers must calculate these additional rebates for these drugs beginning with the January 1, 2017 quarter (that is, first quarter of 2017).
                        </P>
                    </FTNT>
                    <P>
                        The additional rebate calculation requires a determination of the AMP for the dosage form and strength of the drug for the current rebate quarter, and a comparison of that AMP to the AMP for the dosage form and strength of that drug for a certain calendar quarter, generally referenced as the base date AMP quarter.
                        <SU>16</SU>
                        <FTREF/>
                         For S or I drugs, that 
                        <PRTPAGE P="34257"/>
                        base date AMP quarter is the third quarter of 1990, for drugs that were first marketed prior to fourth quarter of 1990, or the first full calendar quarter after the day on which the drug was first marketed for drugs that were first marketed on or after October 1, 1990.
                        <SU>17</SU>
                        <FTREF/>
                         See sections 1927(c)(2)(A) and 1927(c)(2)(B) of the Act. For other drugs (including N drugs and other drugs reported as N), that base date AMP quarter is the third quarter of 2014 for drugs that were first marketed prior to April 1, 2013, or the fifth full calendar quarter after the day on which the drug was first marketed for drugs that were first marketed on or after April 1, 2013. See section 1927(c)(3)(C) of the Act. To determine the applicable base date AMP, and ultimately, to calculate the additional rebate for a quarter, a critical data point is the day on which the drug was first marketed. We reference this date as a COD's “market date.” Manufacturers are required to report to CMS the market date of each dosage form and strength of a COD for all of its CODs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             Base Date AMP is defined in the National Drug Rebate Agreement (NDRA) at I.(c) as follows: “Base 
                            <PRTPAGE/>
                            Date AMP” will have the meaning set forth in sections 1927(c)(2)(A)(ii)(II) and 1927(c)(2)(B) of the Act. See also I.(l) definition of “marketed”. Section VIII.a, provides that the agreement is subject to any changes in the Medicaid statute or regulations that affect the rebate agreement. Thus, any changes to regulations will be incorporated into rebate agreements without further action. See also Manufacturer Release 113—Misclassification of Drugs (
                            <E T="03">medicaid.gov</E>
                            ); 
                            <E T="03">https://www.medicaid.gov/medicaid-chip-program-information/by-topics/prescription-drugs/downloads/rx-releases/mfr-releases/mfr-rel-009.pdf Manufacturer release No. 9; form 367c data definitions.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             For a drug with a market date prior to October 1, 1990, the MDRP reporting system defaults to a market date of September 30, 1990. The system assigns a base date AMP quarter of fourth quarter of 1990 to such drugs as the statute defines (section 1927(c)(2)(A)(ii) of the Act).
                        </P>
                    </FTNT>
                    <P>Section 1927(c)(2)(A)(ii)(II) of the Act expressly provides that the base date AMP quarter, with respect to a dosage form and strength of a drug, is established “without regard to whether or not the drug has been sold or transferred to an entity, including a division or subsidiary of the manufacturer. . .” This means the market date of a drug is the date that the drug was first marketed, regardless of the entity that marketed the drug. Consistent with the statute, the market date of a drug is not and cannot be based on the first date upon which a subsequent manufacturer first markets the drug, but rather the earliest date on which the drug was first marketed, by any manufacturer, or under any NDC.</P>
                    <P>
                        A new market date cannot be established for a drug that is marketed under the same FDA-approved NDA number, ANDA number or BLA license unless the drug is a new dosage form or strength because the rebate statute requires an additional rebate amount based on the market date for each dosage form and strength of a COD.
                        <SU>18</SU>
                        <FTREF/>
                         Thus, if a drug is purchased or otherwise acquired from another manufacturer, the market date should not change, and should equal the market date of the drug first marketed under the approved application.
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             The FDA approved application (for example the NDA itself) includes all FDA approved supplements to the application.
                        </P>
                    </FTNT>
                    <P>Some manufacturers have attempted to set a new market date to establish a new base date AMP for a drug by making changes to a drug already approved under an FDA application that are something other than changes to the dosage form or strength. If changes to the drug are approved under the same FDA application and do not constitute changes to the dosage form or strength, a new base date AMP is not appropriate.</P>
                    <P>Over the years, manufacturers have sporadically engaged in debate regarding the determination of a COD's market date, base date AMP quarter, and base date AMP under varied fact-driven scenarios. This proposed definition seeks to clarify the term “market date” as used in the MDRP and to end any further such debates.</P>
                    <P>AMP is defined in section 1927(k)(1) of the Act and the definition includes that it is “. . . the average price paid to the manufacturer for the drug. . . .” If there have not been any sales of the drug, there is no data upon which to determine an average price paid to the manufacturer to most accurately calculate the AMP value. Historically, in such cases where no sales may have occurred in a base date AMP quarter (because sometimes a new NDC may be available for sale during a quarter, but no sales occurred during that quarter), we have advised manufacturers to use reasonable assumptions, as appropriate, and consistent with applicable law to establish an AMP.</P>
                    <P>To assist manufacturers in reporting a more accurately calculated AMP, we are proposing to define market date based on the first sale of the drug, rather than the date the drug was first available for sale. Linking the market date determination to the date of the first sale, rather than the date the drug was first available for sale, would permit a manufacturer to establish and report a base date AMP without reliance on reasonable assumptions, and based on actual data. As a result, the URA would also be calculated more accurately because actual sales would be available for reporting.</P>
                    <P>For purposes of determining the base date AMP quarter and base date AMP, we propose that market date be based upon the earliest date on which the drug was first sold, by any manufacturer, or under any NDC, and define the term to mean the date on which the COD was first sold by any manufacturer.</P>
                    <P>We propose that first sold means any sale of the COD. We understand defining market date, for purposes of determining a COD's base date AMP, based on when the COD was first sold, may not completely eliminate a manufacturer's need to make reasonable assumptions because the first sales may include only AMP ineligible sales. For example, if all the sales during the first quarter of a drug's availability are made to entities other than retail community pharmacies or wholesalers, and are not eligible for a 5i AMP calculation, then there may not be any AMP eligible sales to use for the calculation of AMP for that quarter. In such cases, a manufacturer may still need to use reasonable assumptions to report an AMP for that quarter.</P>
                    <P>We propose that “sold” means that the drug has been transferred (including in transit) to a purchasing entity. We are requesting comments on this topic to determine what qualifies as “sold” for the purposes of determining the market date of a drug, as we have also experienced manufacturers interpreting the term “sold” differently across the industry.</P>
                    <P>Because the term market date has not been previously defined in regulation and it is data used in the determination of base date AMP, we are proposing a definition of market date for the purposes of the MDRP. We are proposing at § 447.502 that market date, for the purpose of establishing the base date AMP quarter, means the date on which the COD was first sold by any manufacturer.</P>
                    <HD SOURCE="HD3">f. Proposal To Modify the Definition of Noninnovator Multiple Source Drug (§ 447.502)</HD>
                    <P>As discussed previously in this proposed rule, section 6(c) of the MSIAA included a number of amendments to statutory definitions in section 1927 of the Act. Generally, those statutory amendments were discussed in the December 31, 2020 final rule (85 FR 87000, 87032) where the regulatory definitions of multiple source drug, innovator multiple source drug, and single source drug were amended consistent with the MSIAA.</P>
                    <P>
                        Although we made conforming changes to the regulatory definition of an I drug in the December 31, 2020 final rule, because the MSIAA did not 
                        <PRTPAGE P="34258"/>
                        expressly amend or clarify the statutory definition of an N drug we did not consider whether any changes to the regulatory definition of an N drug were necessary at that time. After further evaluation, we propose to amend the regulatory definition of an N drug to conform the regulatory definition of an N drug to the regulatory definition of an I drug. When we established a regulatory definition of an N drug in the July 17, 2007 final rule, we did so to distinguish between multiple source drugs approved under an ANDA (generally referenced as N drugs) and multiple source drugs approved under an NDA (that is, S or I drugs). Both I drugs and N drugs are generally multiple source drugs. The main difference between the definitions is the authority under which the drug is marketed. Generally speaking, I drugs are marketed under an NDA and N drugs are marketed under ANDA, or are unapproved.
                    </P>
                    <P>Section 1927(k)(7)(A)(iii) of the Act, which was not expressly amended or clarified by the MSIAA, defines a noninnovator multiple source (N) drug as a multiple source drug that is not an I drug. As noted, the MSIAA amended the statutory definition of an I drug by removing “was originally marketed” and adding “is marketed,” and we made conforming changes to the regulatory definition of an I drug in the December 31, 2020 final rule. When we modified the regulatory definition of an I drug to replace “was originally marketed” with “is marketed”, we neglected to make a corresponding change to the definition of an N drug to maintain the clear distinction between an I drug, which is marketed under an NDA, and an N drug, which is not marketed under an NDA. Paragraph (3) of the regulatory definition of an N drug, codified at § 447.502, continues to refer to a COD that entered the market before 1962 that was not originally marketed under an NDA.</P>
                    <P>To maintain the clear distinction between an I drug and an N drug, we propose to amend paragraph (3) of the definition of an N drug at § 447.502 by removing “was not originally marketed” and inserting in place “is not marketed.” As amended, the regulatory definition of an N drug would, in relevant part, have the same structure as the statutory and regulatory definitions of an I drug and distinguish between a multiple source drug approved under an ANDA (that is, an N drug) and a multiple source drug approved under an NDA (that is, an S or I drug) based on the authority under which the drug is marketed, not how the drug was originally marketed.</P>
                    <P>Accordingly, we propose to amend § 447.502 by revising paragraph (3) of the definition of an N drug to read, a COD that entered the market before 1962 that is not marketed under an NDA. We believe this to be a technical correction to the regulatory text.</P>
                    <HD SOURCE="HD3">g. Proposal To Define Vaccine for Purposes of the MDRP Only (§ 447.502)</HD>
                    <P>States that opt to cover prescribed drugs under section 1905(a)(12) of the Act in their State Plan are required to do so consistent with section 1927 of the Act, as set forth at section 1902(a)(54) of the Act. With limited exceptions, if a manufacturer wants payment to be available under Medicaid for their CODs, the manufacturer must participate (have entered into and have in effect a rebate agreement) in the MDRP, and agree to pay rebates for CODs dispensed and paid for under the State Plan. States are then required to cover the drugs of a manufacturer participating in the MDRP, if the drug satisfies the definition of COD, and then are required to invoice manufacturers for rebates on those CODs that are dispensed and paid for under the State Plan. If a particular drug or biological product of a participating manufacturer is excluded from or does not satisfy the definition of COD, then with limited exceptions, a State is not required to cover the product under the prescribed drugs benefit nor would it be subject to section 1927 of the Act. Moreover, those drugs or biological products are not eligible for rebate invoicing, even though a State may cover them and seek FFP.</P>
                    <P>
                        Section 1927(k)(2)(B) of the Act specifically excludes vaccines from the definition of COD for purposes of the MDRP. This exclusion is codified in paragraph (1)(iv) of the regulatory definition of COD at § 447.502. Section 1927 of the Act, specifically, does not define vaccine. Nor is there a definition of vaccine in Title XI, XVIII, XIX, or XXI of the Act (applicable to Medicare, Medicaid, and CHIP), that speaks to the specific kinds of biological products that qualify as vaccines, in terms of their actions in the human body and how and when they are used. Moreover, we are not aware that any authorizing statutes for any other Department of Health and Human Services agencies include such a statutory definition of the term “vaccine.” We have not established a regulatory definition of vaccine for purposes of the MDRP, and we are not aware of any other statutory or regulatory definition of vaccine (that speaks to the actions of a product in the human body and how and when it is used) that would be applicable for purposes of the MDRP. However, for the reasons discussed in this section, we believe that a regulatory definition of vaccine is necessary for the purposes of the MDRP to specify which products are considered vaccines and thus excluded from the definition of COD.
                        <SU>19</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             Currently, for vaccines other than COVID-19 vaccines, Medicaid coverage of vaccines and vaccine administration for adults is generally optional for States. Coverage of certain vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP) is required for children and youth under age 21 who are eligible for the Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit and for beneficiaries receiving Medicaid coverage through an Alternative Benefit Plan. Additionally, to receive a one percentage point increase in the Federal medical assistance percentage for certain expenditures, States must cover certain services, including approved adult vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP), without cost-sharing. See 
                            <E T="03">https://www.medicaid.gov/state-resource-center/downloads/covid-19-vaccine-toolkit.pdf</E>
                             for more information. Beginning October 1, 2023, under section 11405 of the Inflation Reduction Act of 2022, States are required to cover approved adult vaccines recommended by the ACIP, and their administration, for many adults enrolled in Medicaid and the CHIP program, without cost sharing.
                        </P>
                    </FTNT>
                    <P>Generally, drugs and biological products that are used to treat a disease fall into one of the categories of CODs set forth at section 1927(k)(2) of the Act. Since Congress excluded vaccines from the definition of COD in the original 1990 law, and vaccines that were licensed at that time have a different intended use than therapeutics, we believe that vaccines were excluded because of their unique characteristics among medical products marketed at the time of preventing disease by inducing an immune response.</P>
                    <P>
                        When the MDRP statute was enacted as part of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted November 5, 1990), the term “vaccine” referred to a product administered to provide active immunity to a person to prevent an infectious disease.
                        <SU>20</SU>
                        <FTREF/>
                         At the time, it was generally understood that vaccines are administered prophylactically, to prevent the development of an infectious disease, not to treat an existing non-infectious disease (such as a cancer). Although we have not found any legislative history specifically indicating why Congress chose to exclude vaccines from the definition of COD, it is likely Congress understood the term “vaccine” to refer to preventive vaccines only (that is, we do not believe that Congress understood the term to 
                        <PRTPAGE P="34259"/>
                        include therapeutic vaccines) because all licensed vaccines at the time the law was enacted shared those characteristics.
                    </P>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             See 
                            <E T="03">https://purplebooksearch.fda.gov/</E>
                            . The database at this link provides information about all FDA-licensed biological products, including the date on which they were licensed. All the vaccines listed in the “Purple Book” are licensed to prevent an infectious disease.
                        </P>
                    </FTNT>
                    <P>As the science of immunology has become more advanced, drugs and biological products have been, and continue to be, developed that treat diseases using immunotherapy, such as immunotherapy used to treat certain cancers. Some manufacturers refer to such products as “therapeutic” vaccines. While both preventive vaccines and “therapeutic vaccines” work by creating an immune response, each type of product has a unique role in health care.</P>
                    <P>
                        In general, a preventive vaccine provides active immunity to a disease, that is, it causes the body's immune system to produce an antigen-specific immune response (for example, antibodies and/or a cellular immune response) to antigens of the disease-causing organism.
                        <SU>21</SU>
                        <FTREF/>
                         A preventive vaccine is generally administered to induce immunity and a “memory” response to a particular infectious disease-causing organism so that in the event an individual is later exposed to that disease, the body will recognize the disease and respond before the disease has a chance to manifest or to reduce the severity of illness. There are also situations in which a preventive vaccine may be administered to an individual who has already been exposed to a disease-causing organism but the disease has not yet developed and may be prevented by a timely and robust vaccine-induced immune response (for example, rabies and anthrax vaccines).
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             CDC describes active immunity as a long-lasting immunity that develops by triggering antibody production. Conversely, they describe passive immunity as a short-term immunity provided by the administration of antibody-containing products. See 
                            <E T="03">https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm</E>
                            .
                        </P>
                    </FTNT>
                    <P>In contrast, “therapeutic vaccines” are generally biological products that are intended to induce an antigen specific immune response to treat an already established disease (for example, treatment of cancer by inducing a specific immune response to the tumor). This type of product is generally intended to be a treatment modality similar to other forms of immunotherapy such as the checkpoint inhibitors or strategies that are based on the transfer of a preformed immune response (for example, transfer of antibodies or immune effector cells.)</P>
                    <P>If “therapeutic vaccines” were considered vaccines that are excluded from the definition of COD at section 1927(k)(2)(B) of the Act, a Medicaid beneficiary's access to these products under the prescribed drugs benefit could be limited because States would not be required to cover them under that benefit. Moreover, coverage of such a product under other benefits might only be available if the CDC's Advisory Committee on Immunization Practices (ACIP) issued a recommendation for such a product. This potential lack of access to important therapies for Medicaid beneficiaries is a critical concern. Clinical research into “therapeutic vaccines” has been increasing and several have been licensed by FDA that offer treatments for diseases that previously had limited or no effective treatment available. Similarly, if products that provide passive immunity, such as immune globulins, were excluded from the definition of a COD, because they were identified as vaccines, such treatments may not be made available to Medicaid beneficiaries.</P>
                    <P>
                        Thus, with the increasing development and availability of products that use immunology to treat diseases, and because sometimes these products are referred to as “therapeutic vaccines”, we believe that adopting an MDRP regulatory definition of “vaccine” that reflects Congress' likely intent at the time of the enactment of section 1927 of the Act is imperative to ensure that only the appropriate products are excluded from the definition of a COD. This would ensure manufacturers are able to report their drug product and drug pricing data for all CODs accurately, pay appropriate rebates to States, and most critically, that Medicaid beneficiaries have access to these important therapies under the prescribed drugs benefit.
                        <SU>22</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             Even if a “therapeutic vaccine” product is required coverage under other Medicaid benefits, this proposal would help to ensure that manufacturers report product and pricing data accurately and pay rebates to States, as applicable.
                        </P>
                    </FTNT>
                    <P>Therefore, we are proposing to define “vaccine” at § 447.502 for the specific purposes of the MDRP, so that manufacturers understand which products are considered vaccines under the MDRP and are excluded from the definition of COD, and not subject to rebates. The definition would be applicable only to the MDRP and would not be applicable to any other agencies or agency program implementation, including FDA, CDC, and HRSA. The proposed definition of vaccine would not apply under any Title XIX statutory provisions other than section 1927(k)(2), or to separate CHIPs operating pursuant to § 457.70(a)(1) and (d), or for purposes of the Vaccines for Children Program. The definition would apply to the MDRP for purposes of Medicaid expansion CHIPs, pursuant to § 457.70(c)(2). This proposed policy would not alter any applicable Federal or State requirements to cover immunizations for Medicaid beneficiaries, as applicable. Specifically, we are proposing to define “vaccine” to mean a product that is administered prophylactically to induce active, antigen-specific immunity for the prevention of one or more specific infectious diseases and is included in a current or previous FDA published list of vaccines licensed for use in the United States.</P>
                    <P>We are including in the proposed definition that a vaccine must be administered prophylactically—that is, to prevent a disease and not to treat a disease—because we believe that States should generally not exclude from coverage, under the prescribed drugs benefit, drugs or biologicals that treat disease. We are also proposing that a vaccine must be administered to induce active, antigen-specific immunity because that is a characteristic of preventive vaccines.</P>
                    <P>
                        Finally, we are proposing to limit the definition of vaccine to those products that satisfy the conditions of being administered prophylactically, to prevent a disease, and induce active antigen-specific immunity, that also appear on a current or previous list compiled by FDA. FDA publishes a list of vaccines licensed for use in the United States.
                        <SU>23</SU>
                        <FTREF/>
                         As FDA is the agency responsible for licensing vaccines, we believe that if a product satisfying the previously described conditions appears on this list, it should be treated as a vaccine for the purposes of the MDRP. We seek comment on whether the proposed definition of vaccine, for purposes of the MDRP only, appropriately distinguishes between preventive vaccines (which would satisfy the definition of vaccine and, therefore, not satisfy the definition of a covered outpatient drug and would not be eligible for statutory rebates), and therapeutic vaccines (which would not satisfy the definition of vaccine and therefore could satisfy the definition of a covered outpatient drug and could therefore be eligible for statutory rebates).
                    </P>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             Vaccines Licensed for Use in the United States.
                        </P>
                    </FTNT>
                    <P>
                        Additionally, while we propose to cabin this definition to the MDRP, we seek comment on whether this definition might result in indirect consequences for Medicaid benefits other than the prescribed drugs benefit. We are also requesting comment about the consequences for Medicaid of ACIP recommending immunization with a 
                        <PRTPAGE P="34260"/>
                        product that would not qualify as a vaccine under this definition.
                    </P>
                    <HD SOURCE="HD2">D. Proposal To Account for Stacking When Determining Best Price—(§ 447.505)</HD>
                    <P>Section 1927(c)(1)(C) of the Act defines the term “best price” to mean with respect to a single source drug or innovator multiple source drug of a manufacturer (including the lowest price available to any entity for any such drug of a manufacturer that is sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act), the lowest price available from the manufacturer during the rebate period to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or governmental entity within the United States, subject to certain exceptions and special rules. The implementing regulations for the determination of best price are at § 447.505.</P>
                    <P>In the COD final rule, we addressed a comment to our proposal to make revisions to the determination of best price, and specify which prices are included in best price. The comment requested that CMS further adopt a policy with regard to the practice of a manufacturer stacking two different price concessions provided to two different entities, such that under these circumstances, the best price for a drug should reflect all rebates and payments associated with a transaction of a covered outpatient drug to a particular customer. (See 81 FR 5252.) In response to the commenter's request, we indicated that a manufacturer is responsible for including all price concessions that adjust the price realized by the manufacturer for the drug in its determination of best price. We also explained that if a manufacturer offers multiple price concessions to two entities for the same drug transaction, such as rebates to a PBM where the rebates are designed to adjust prices at the retail or provider level, in addition to discounts to a retail community pharmacy's final drug price, all discounts related to that transaction which adjust the price available from the manufacturer should be considered in the final price of that drug when determining best price (81 FR 5252 through 5253).</P>
                    <P>In the COD final rule with comment, we made minor revisions to the regulatory text at § 447.505(b) by deleting the reference to “associated” rebate and discounts and inserting a reference to “applicable discounts, rebates” so that it presently reads that the best price for CODs includes all prices, including applicable discounts, rebates or other transactions that adjust prices either directly or indirectly to the best price-eligible entities listed in § 447.505(a).</P>
                    <P>We addressed the question regarding stacking in the response to comments in the COD final rule, specifying that if multiple price concessions are provided to two entities for the same drug transaction, all discounts related to that transaction which adjust the price available from the manufacturer should be considered when determining best price. However, we did not revise or propose to revise the regulation text at § 447.505(d)(3) to address stacking in such detail. Section 447.505(d)(3) currently indicates that the manufacturer must adjust the best price for a rebate period if cumulative discounts, rebates or other arrangements subsequently adjust prices available, to the extent that such cumulative discounts, rebates or other arrangements are not excluded from the determination of best price by statute or regulation.</P>
                    <P>
                        However, in the case 
                        <E T="03">United States ex rel. Sheldon</E>
                         v. 
                        <E T="03">Allergan Sales, LLC.,</E>
                         a relator alleged that a drug manufacturer failed to aggregate discounts provided to separate customers for purposes of determining best price, and the manufacturer argued that the stacking requirement was not sufficiently clear. The district court granted Allergan's motion to dismiss, ruling that relator failed to plausibly allege either falsity or knowledge because Allergan's interpretation “is objectively reasonable” and CMS' rule had not specifically warned against it. On appeal, a panel of the United States Court of Appeals for the Fourth Circuit stated that, in that case, the drug manufacturer had not been “warned . . . by the authoritative guidance from CMS” and that CMS had “failed to clarify” the stacking issue.
                        <SU>24</SU>
                        <FTREF/>
                         The Government filed an amicus brief supporting the relator's petition for rehearing en banc, which the Fourth Circuit granted. Following argument, the Fourth Circuit issued its decision with no substantive opinion that vacated the prior panel decision and affirmed the district court by an equally divided court.
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             
                            <E T="03">United States ex rel. Sheldon</E>
                             v. 
                            <E T="03">Allergan Sales, LLC,</E>
                             24 F.4th 340, 351, 354 (4th Cir. 2022), 
                            <E T="03">reh'g en banc granted,</E>
                             No. 20-2330, 2022 WL 1467710 (4th Cir. May 10, 2022).
                        </P>
                    </FTNT>
                    <P>As noted, section 1927(c)(1)(C) of the Act defines the term “best price” to mean with respect to a single source drug or innovator multiple source drug of a manufacturer (including the lowest price available to any entity for any such drug of a manufacturer that is sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act), the lowest price available from the manufacturer during the rebate period to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or governmental entity within the United States. We interpreted this section expansively as the statute refers to a manufacturer's lowest price “available” “to any” entity on this statutory list. That is, if a manufacturer provides a discount to a wholesaler, then a rebate to the provider who dispensed the drug unit, and then another rebate to the insurer who covered that drug unit, CMS has concluded that “best price” must include (or “stack”) all the discounts and rebates associated with the final price, even if the entity did not buy the drug directly from the manufacturer. By stacking, best price reflects the lowest realized price at which the manufacturer made that drug unit available. We also note that manufacturers are required to take rebates into account for multiple entities when calculating AMP, and for logical reasons, best price should do so as well, since including them in AMP and not accounting for them in best price could result in AMP being lower than best price.</P>
                    <P>Therefore, to remove any potential doubt prospectively, we are proposing to revise § 447.505(d)(3) to add to the existing regulatory statement that the manufacturer must adjust the best price for a covered outpatient drug for a rebate period if cumulative discounts, rebates or other arrangements to best price eligible entities subsequently adjust the price available from the manufacturer for the drug. We are adding the clarifying statement that cumulative discounts, rebates or other arrangements must be stacked to generate a final price realized by the manufacturer for a covered outpatient drug, including discounts, rebates or other arrangements provided to different best price eligible entities.</P>
                    <HD SOURCE="HD2">E. Proposal To Rescind Revisions Made by the December 31, 2020 Final Rule to Determination of Best Price (§ 447.505) and Determination of Average Manufacturer Price (AMP) (§ 447.504) Consistent With Court Order</HD>
                    <P>
                        Pharmaceutical manufacturers have provided purported financial assistance payments (for example, in the form of copay coupons) to patients for purposes of paying the patient cost obligation of certain drugs.
                        <PRTPAGE P="34261"/>
                    </P>
                    <P>On June 19, 2020, CMS proposed regulations to address the effect of PBM accumulator adjustment programs on best price calculations (85 FR 37286) in relation to these purported manufacturer financial assistance payments by instructing manufacturers on how to consider the implementation of such programs when determining best price and AMP for purposes of the Medicaid Drug Rebate Program (MDRP). In particular, CMS proposed revising its regulations to provide that the exclusions for manufacturer's financial assistance payments “apply only to the extent the manufacturer ensures the full value of the assistance or benefit is passed on to the consumer or patient” (85 FR 37299). On December 31, 2020, CMS finalized its proposed revisions (85 FR 87000, 87048 through 87055, and 87102 through 87103). The final rule codified the proposed language to require that “the manufacturer ensures that the full value” of the assistance or benefit is passed on to the consumer or patient to exclude that assistance or benefit to an insured patient from the manufacturer's best price calculation and AMP. The final rule also delayed the effective date of the change until January 1, 2023, to “give manufacturers time to implement a system that will ensure the full value of assistance under their manufacturer-sponsored assistance program is passed on to the patient.”</P>
                    <P>In May 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint against the Secretary asking the court to vacate these amendments to § 447.505(c)(8) through (11) (85 FR 87102 and 87103), as set forth in the 2020 final rule (referred to by the Court as “the accumulator adjustment rule of 2020”). On May 17, 2022, the United States District Court for the District of Columbia ruled in favor of the plaintiff and ordered that the accumulator adjustment rule of 2020 be vacated and set aside.</P>
                    <P>
                        In response to this court order, we propose to withdraw the changes made to best price and to also withdraw the changes to AMP to apply consistent rules for determining best price and AMP. Therefore, we propose to remove the language added to these sections as part of the 2020 final rule: §§ 447.504(c)(25) through (29) and (e)(13) through (17) and 447.505(c)(8) through (12). 
                        <E T="03">See</E>
                         85 FR 87102 and 87103. Specifically, we would remove “the manufacturer ensures” from these provisions. As a result, these regulations would maintain the language that has been in place since 2016. To be clear, the changes to these regulations made by the 2020 final rule on January 1, 2023, were not effective as a result of the court's order.
                    </P>
                    <HD SOURCE="HD2">F. Drug Classification; Oversight and Enforcement of Manufacturer's Drug Product Data Reporting Requirements—Proposals Related to the Calculation of Medicaid Drug Rebates and Requirements for Manufacturers (§§ 447.509 and 447.510)</HD>
                    <HD SOURCE="HD3">1. Medicaid Drug Rebates (MDR) and Penalties (§ 447.509)</HD>
                    <P>
                        Section 6 of the MSIAA, titled “Preventing the Misclassification of Drugs Under the Medicaid Drug Rebate Program,” amended sections 1903 and 1927 of the Act to clarify the definitions for multiple source drug, single source drug and innovator multiple source drug, and to provide the Secretary with additional compliance, oversight and enforcement authorities to ensure compliance with program requirements with respect to manufacturers' reporting of drug product and pricing information, which includes the appropriate classification of a drug. Drug classification refers to how a drug should be classified—as a single source, innovator multiple source, or noninnovator multiple source drug—for the purposes of determining the correct rebates that a manufacturer owes the States.
                        <SU>25</SU>
                        <FTREF/>
                         When manufacturers misclassify their drugs in the rebate program, it can result in manufacturers paying rebates to States that are different than those that are supported by statute and regulation, and in some cases, can result in the manufacturer paying a lower per-unit rebate amount to the States.
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             Note that section 1927(c)(3) of the Act describes rebates for covered outpatient drugs other than single source and innovator multiple source drugs in section 1927(c)(3) of the Act as “rebates for other drugs.” The MDRP reporting system provides for all “other drugs” that are covered outpatient drugs to be classified in the system as N drugs, regardless of whether they expressly meet the statutory definition of noninnovator multiple source drug. This reporting methodology has been in effect for the history of the program and interested parties have understood that a covered outpatient drug that was not an S or an I drug is reported in the system as an N drug.
                        </P>
                    </FTNT>
                    <P>Specifically, section 1927(c)(4)(A) of the Act, “Recovery of Unpaid Rebate Amounts due to Misclassification of Drugs,” was added to the statute to provide new authorities to the agency to identify and correct a manufacturer's misclassification of a drug, as well as impose other penalties on manufacturers that fail to correct their misclassifications. In general, a misclassification in the MDRP occurs when a manufacturer reports and certifies its covered outpatient drug under a drug category, or uses drug product information, that is not supported by the statutory and regulatory definitions of S, I, or N.</P>
                    <P>
                        We published guidance to manufacturers regarding compliance with drug pricing and drug product information reporting under this new law in Manufacturer Release #113 on June 5, 2020. See 
                        <E T="03">https://www.medicaid.gov/prescription-drugs/downloads/mfr-rel-113.pdf</E>
                        .
                    </P>
                    <P>Although much of this law is self-implementing, we are proposing a series of regulatory amendments at §§ 447.509 and 447.510 to implement and codify the statutory changes in regulation. We propose that a misclassification of a drug under the MDRP has occurred or is occurring when a manufacturer reports its drug under a category that is not supported by the statutory and regulatory definitions of S, I, or N. A misclassification can also occur when a manufacturer's drug is appropriately classified, but the manufacturer is paying rebates at a different amount than required by the statute, or where the drug manufacturer's certified drug product information for the COD is also inconsistent with statute and regulation.</P>
                    <P>The MSIAA also amended the Act to expressly require a manufacturer to report not later than 30 days after the last day of each month of a rebate period under the agreement, such drug product information as the Secretary shall require for each of the manufacturer's covered outpatient drugs. In a separate section, we are proposing a definition of “drug product information” for the purposes of the MDRP.</P>
                    <P>Similarly, the MSIAA amended the Act to clarify that the reporting of false drug product information and data related to false drug product information would also be subject to possible CMPs by the HHS Office of the Inspector General (OIG), and to provide specific new authority to the Secretary to issue civil monetary penalties related to knowing misclassifications of drug product or misreported information. These new OIG authorities will not be the subject of this rulemaking.</P>
                    <P>
                        Under the MSIAA, if a manufacturer fails to correct the misclassification of a drug in a timely manner after receiving notification from the agency that the drug is misclassified, in addition to the manufacturer having to pay past unpaid rebates to the States for the misclassified drug if applicable, the Secretary can take any or all of the following actions: (1) correct the misclassification, using drug product information provided by the manufacturer on behalf of the manufacturer; (2) suspend the misclassified drug, and the drug's status as a covered outpatient drug under the 
                        <PRTPAGE P="34262"/>
                        manufacturer's national rebate agreement, and exclude the misclassified drug from FFP (correlating amendments to section 1903 of the Act); and, (3) impose civil monetary penalties (CMP) for each rebate period during which the drug is misclassified subject to certain limitations. The Act expressly provides that the imposition of such penalties may be in addition to other remedies, such as termination from the MDRP, or CMPs under Title XI.
                    </P>
                    <P>In § 447.509, we propose to include a new paragraph (d), “Manufacturer misclassification of a covered outpatient drug and recovery of unpaid rebate amounts due to misclassification and other penalties,” to implement additional penalty and compliance authorities outlined in section 6 of the MSIAA, which amended sections 1903 and 1927 of the Act. As some manufacturers may continue to misclassify drug products, we believe these proposed penalties are necessary so that manufacturers do not neglect to correct and certify their information, to assure that States receive the rebates that they deserve, to assure that public MDRP data are accurate, to protect the integrity of the MDRP, and to ensure the efficient and economic administration of the Federal Medicaid program.</P>
                    <P>Under the MDRP, a drug should be classified as a single source, innovator multiple source, or noninnovator multiple source drug for the purposes of determining the correct rebates that a manufacturer owes the States. We propose that a misclassification in the MDRP occurs when a manufacturer reports and certifies its covered outpatient drug under a drug category or other drug product data related to a COD that is not supported by the statutory and regulatory definitions of S, I, or N. We also propose to define as a misclassification a situation in which the manufacturer accurately reports and certifies its COD under a drug category or other related drug product data for a COD, but is paying a different rebate amount than that required by the statute and regulations. The statute expressly indicates at section 1927(d)(4) of the Act that a misclassification can occur without regard to whether the manufacturer knowingly made the misclassification or should have known that the misclassification was being made.</P>
                    <P>
                        It is the legal responsibility of the manufacturer to report and certify the correct classification of its covered outpatient drugs to the agency, and the drug product information related to a COD. The agency does not as a routine matter review or verify the drug category classifications and related drug product information reported and certified by the manufacturer. However, in its oversight role, the agency will review the classification and other drug product and pricing information reported by the manufacturer for a drug to determine its accuracy, as needed. For example, when questions arise, the agency will generally review the drug product and pricing information reported and certified by a manufacturer. To this end, we generally rely upon various sources of information to determine if a drug is misclassified in the MDRP. This includes information reported by manufacturers to CMS in combination with publicly available information in making determinations of whether a drug is misclassified in the MDRP. The agency also uses manufacturer reported information, such as the COD status code, in combination with information available on the FDA's Comprehensive NDC SPL Data Elements file (NSDE) 
                        <E T="03">https://download.open.fda.gov/Comprehensive_NDC_SPL_Data_Elements_File.zip,</E>
                         and information from FDA's Drugs@FDA web page 
                        <E T="03">https://www.accessdata.fda.gov/scripts/cder/daf/</E>
                         to verify that the national drug codes (NDCs) reported to the MDRP by manufacturers are appropriately classified and reported to MDRP.
                    </P>
                    <P>Therefore, we propose in the new § 447.509(d), the following process to identify, notify and correct a manufacturer's drug category misclassifications, and impose other penalties, while at the same time notifying the HHS OIG and/or other governmental agencies about possible violations of MDRP requirements.</P>
                    <HD SOURCE="HD3">a. Identification and Notification to Manufacturer To Correct Misclassification (§ 447.509(d)(1) Through (4))</HD>
                    <P>We are proposing in new paragraphs (d)(1) through (4) of § 447.509, requirements relating to the process by which the agency would identify when a misclassification of a drug has occurred in MDRP, subsequently notify a manufacturer that we have determined that a drug is misclassified in MDRP, indicate the penalties that may be imposed on the manufacturer, as well that the manufacturer may owe past due rebates.</P>
                    <P>We propose to define what constitutes a misclassification in paragraph (d)(1). As proposed at § 447.509(d)(1)(i), misclassification in the MDRP occurs when a manufacturer reports and certifies to the agency its drug category or drug product information related to a covered outpatient drug that is not supported by applicable statute or regulation. For example, a drug is misclassified by the manufacturer if it is reported as a noninnovator multiple source drug when the correct classification for the COD, as determined by the agency, is a single source drug or an innovator multiple source drug, based on application of relevant statutes and regulations. In such an example, it is likely that the manufacturer has paid or is paying a lower per unit rebate amount to a State as a result of the misclassification, and the agency would notify the manufacturer as part of the communication regarding the misclassification that rebates are owed to the States.</P>
                    <P>However, there may be circumstances where a manufacturer is reporting its drug as a S or I drug, when the appropriate category is a N drug. For example, a manufacturer may be categorizing a non-prescription drug as a brand drug, when it should be classified as a noninnovator drug for the purposes of MDRP. These situations would be considered misclassifications as well. These situations may result in States needing to pay rebates back to the manufacturer, which creates recordkeeping and fiscal issues for the States, as well as the need for the States to request FFP from the Federal Government to pay its share of the rebates that are due back to the manufacturer. There are two-year timely claims filing deadlines under section 1132(A) of the Act, which may prohibit States from claiming FFP in these situations.</P>
                    <P>A manufacturer may also have reported and certified an incorrect base date AMP to calculate its inflation penalty rebates, thus paying overall lower rebates to the States. This example would also be considered a misclassification under paragraph (d)(1)(i), as the incorrect drug product information related to a COD is being used by the manufacturer.</P>
                    <P>
                        We also propose in § 447.509(d)(1)(ii) that a misclassification includes a situation where a manufacturer has correctly reported and certified its drug classification as well its drug product information for a COD, but is paying rebates to States at a level other than that supported by statute and regulation applicable to the reported and certified data. For example, if a manufacturer is correctly reporting and certifying a COD as an S or I drug, but paying rebates that would be expected for that of an N drug, we would consider that to be a misclassification as well. Note that while the statute and regulations specify that rebates are paid to States based on classifications of CODs as S, I, or “other 
                        <PRTPAGE P="34263"/>
                        drugs”, the MDP system only allows for the classification of CODs as S, I, or N. The N category would include any drug that is not an S or I, which may include non-prescription drugs. Manufacturers should assure that those drugs that are classified as N in the MDP system are drugs other than S or I drugs.
                        <SU>26</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             Since the beginning of the MDRP, the term noninnovator multiple source drug, and its abbreviation (N), has been used very generally to identify a covered outpatient drug other than a single source drug or an innovator multiple source drug. The rebate is calculated using the same formula for all drugs other than a single source drug or an innovator multiple source drug, including both those that satisfy the definition of noninnovator multiple source drug and those that do not. Therefore, manufacturers are to report all of their drugs other than a single source drug or an innovator multiple source drug and identify them with the drug category of N, regardless if they satisfy the statutory definition of noninnovator multiple source drug.
                        </P>
                    </FTNT>
                    <P>We propose at § 447.509(d)(2) that if the agency makes a determination of a misclassification, the agency would send a written and electronic notification to the manufacturer that misclassified a drug of such misclassification, and any past rebates due, and the manufacturer would have 30 calendar days from date of the notification to submit to the agency the drug product and pricing information necessary to correct the misclassification or the incorrect product information, and calculate rebate obligations. If the manufacturer misclassified the drug as an N when it should have been an S or I, then the data submitted to the agency must include the drug's “best price” data for the period or periods during which it was misclassified. Once the information is changed in the MDP, the manufacturer must certify the data.</P>
                    <P>Upon receipt from the manufacturer of the requested corrected information as proposed in § 447.509(d)(2), we propose in § 447.509(d)(4) to review the information submitted by the manufacturer in response to the notice sent under proposed § 447.509(d)(2) to ensure consistency with published drug product information, and if the manufacturer fails to correct the misclassification, fails to certify applicable pricing and product data, and/or fails to pay rebates due as a result of misclassification in the timeframes proposed, we propose the enforcement actions the agency may further take. Upon notification by CMS that the manufacturer's information was updated in the system, we propose that the manufacturer certify the applicable price and drug product data. The proposed time period the manufacturer has to correct the misclassification, and respond to the agency's request to certify the information in the system, is 30 calendar days from the date of the original notification to the manufacturer of the misclassification.</P>
                    <P>The determination made by CMS and notification provided by CMS to the manufacturer as a result of the process proposed in § 447.509(d) regarding misclassification is limited by the information available to CMS and is specific to the facts and circumstances for each scenario. It does not release the manufacturer from any additional liabilities, or preclude actions against manufacturers by HHS, OIG, DOJ, or otherwise.</P>
                    <HD SOURCE="HD3">b. Manufacturer Payment of Unpaid Rebates Due to Misclassification (§ 447.509(d)(3))</HD>
                    <P>As required in section 1927(c)(4)(A) of the Act, the manufacturer is required to pay unpaid rebates to the State for a misclassified drug in an amount equal to the product of the difference of the URA paid to the State for the period, and the URA that the manufacturer would have paid to the State for the period, as determined by the agency, if the drug had been correctly classified or correctly reported by the manufacturer, or the drug product information had been reported correctly, and the total units of the drug paid for under the State Plan in the rebate period(s).</P>
                    <P>Therefore, once we determine that a misclassification has occurred in § 447.509(d)(1) and notify the manufacturer of the misclassification in accordance with the proposed process steps at § 447.509(d)(2), we are proposing in § 447.509(d)(3) the process by which manufacturers would pay unpaid rebates to the States resulting from a misclassification of a drug in the MDRP.</P>
                    <P>Specifically, we propose at § 447.509(d)(3) that when the agency determines that a misclassification of COD occurs as proposed under § 447.509(d)(1), and notification has been provided to the manufacturer as proposed under § 447.509(d)(2), a manufacturer shall pay to each State an amount equal to the sum of the products of the difference between: the per URA paid by the manufacturer for the COD to the State for each period during which the drug was misclassified, and the per URA that the manufacturer would have paid to the State for the COD for each period, as determined by the agency based on the data provided by the manufacturer under proposed paragraph (d)(2), if the drug had been correctly classified by the manufacturer, multiplied by the total units of the drug paid for under the State Plan in each period.</P>
                    <P>Consistent with section 1927(d)(4)(A) of the Act, we are proposing regulatory text in § 447.509(d)(3)(i) that requires manufacturers to pay these unpaid rebates amounts. We are also proposing to codify at § 447.509(d)(3) the time frame by which the manufacturer shall pay such unpaid rebates to the States for the period or periods of time that such COD was misclassified, based upon the proposed URA provided to the States by the agency for the unpaid rebate amounts. We are proposing to include a regulatory provision that requires such rebates be paid to the States by the manufacturer within 60 calendar days of the date of the notice that is sent by the agency to the manufacturer indicating that the drug is misclassified, and specifies that it is the manufacturer's burden to contact the States and pay the rebates that are due. We are also proposing that a manufacturer would be required to provide documentation to the agency that all past due rebates have been paid to the States within the 60 calendar day timeframe.</P>
                    <HD SOURCE="HD3">c. Agency Authority To Correct Misclassifications and Additional Penalties for Drug Misclassification (§ 447.509(d)(4))</HD>
                    <P>Consistent with section 1927(c)(4)(B) of the Act, which provides the authority to the Secretary to correct drug misclassifications in the system and impose other penalties, we propose to add § 447.509(d)(4), allowing CMS to correct the drug's misclassification on behalf of the manufacturer, as well as provide a plan of action for enforcement against the manufacturer. Specifically, we propose at § 447.509(d)(4) that the agency would review the information submitted by the manufacturer based on the notice sent under proposed paragraph (d)(2), and if a manufacturer fails to correct the misclassification within 30 calendar days from the date of the notification of the misclassification by the agency to the manufacturer, fails to certify applicable pricing and drug product data, and/or fails to pay the rebates that are due to the States as a result of the misclassification within 60 calendar days of receiving such notification, the agency may do any or all of the following:</P>
                    <P>• Correct the misclassification of the drug in the system, using any pricing and drug product information that may have been provided by the manufacturer, on behalf of the manufacturer;</P>
                    <P>
                        • Suspend the misclassified drug, and the drug's status as a COD under the manufacturer's rebate agreement from the MDRP, and exclude the 
                        <PRTPAGE P="34264"/>
                        misclassified drug from FFP in accordance with section 1903(i)(10)(E) of the Act;
                    </P>
                    <P>• Impose a Civil Monetary Penalty (CMP) for each rebate period during which the drug is misclassified, not to exceed an amount equal to the product of:</P>
                    <P>++ The total number of units of each dosage form and strength of such misclassified drug paid for under any State Plan during such a rebate period; and</P>
                    <P>++ 23.1 percent of the AMP for the dosage form and strength of such misclassified drug for that period.</P>
                    <P>Also, we propose at § 447.509(d)(4)(iv) to indicate that, in addition to the actions described previously in this proposed rule, we may take other actions or seek additional penalties that are available under section 1927 of the Act (or any other provision of law), against manufacturers that misclassify their drugs including referral to the HHS OIG and termination from the MDRP. Section 1927(b)(4)(B)(i) of the Act provides that the Secretary may terminate a manufacturer from the program for violation of the rebate agreement or other good cause. Furthermore, section 1927(c)(4)(D) of the Act indicates that other actions and penalties against a manufacturer for misclassification of a drug include termination from the program.</P>
                    <P>Therefore, we propose that a manufacturer is subject to termination from the program if it fails to meet agency's specifications for participation in the MDRP program as proposed when it is in violation of section 1927(b)(4)(B)(i) or 1927(c)(4)(D) of the Act, which includes failing to correct misclassified drugs as identified to the manufacturer by the agency, and continuing to have one or more drugs suspended from MDRP because of the lack of certification of the correct drug classification data in the system.</P>
                    <P>We note that as provided in section 1927(b)(4)(C) of the Act, a manufacturer with a terminated NDRA is prohibited from entering into a new NDRA for a period of not less than one calendar quarter from the effective date of the termination until all of the above or any subsequently discovered violations have been resolved, unless the Secretary finds good cause for an earlier reinstatement. In accordance with section 1927(b)(4)(B)(ii) of the Act, and section VII.(e) of the NDRA, termination shall not affect the manufacturer's liability for the payment of rebates due under the agreement before the termination effective date. Consequently, invoicing by States may continue beyond the manufacturer's termination from the program for any utilization that occurred prior to the effective date of the termination.</P>
                    <P>In addition to affecting Medicaid coverage of a manufacturer's drugs, the termination of the manufacturer's NDRA may impact the coverage of the drugs under the Medicare Part B program as well as the 340B Drug Pricing Program. Alternatively, we propose that suspension of a drug under this section as a COD would not affect its status as a reimbursable drug under the 340B Drug Pricing Program or Medicare Part B.</P>
                    <HD SOURCE="HD3">d. Transparency of Manufacturer Misclassification (§ 447.509(d)(5))</HD>
                    <P>Section 1927(c)(4)(C)(i) and (ii) of the Act requires information on CODs that have been identified as misclassified be reported to Congress on an annual basis, and that the annual report be made available to the public on a public website. Therefore, we propose to add new paragraph (d)(5) to § 447.509 to indicate that the agency would make available on a public website an annual report as required under section 1927(d)(4)(C)(ii) of the Act on the COD(s) that were identified as misclassified during the previous year. This report would include a description of any steps taken by the agency with respect to the manufacturer to reclassify the drugs, ensure the payment by the manufacturer of unpaid rebate amounts resulting from the misclassifications, and disclose the use of the expenditures from the fund created in section 1927(b)(3)(C)(iv) of the Act.</P>
                    <HD SOURCE="HD3">2. Proposed Requirements for Manufacturers Relating to Drug Category—Requirements for Manufacturers (§ 447.510)</HD>
                    <P>To implement section 1927(c)(4) of the Act, we propose to rename § 447.510 as “Requirements and penalties for manufacturers”.</P>
                    <HD SOURCE="HD3">a. Suspension of Manufacturer NDRA for Late Reporting of Pricing and Drug Product Information (§ 447.510(i))</HD>
                    <P>In accordance with section 1927(b)(3)(C)(i) of the Act, we propose to add paragraph (i) to § 447.510 to describe the process by which the suspension of a manufacturer's NDRA would occur when a manufacturer fails to report timely information, which includes drug pricing and drug product information, as described in section 1927(b)(3)(A) of the Act, which also includes the reporting timeframes for such information. This drug product and pricing information includes, but is not limited to AMP, best price, and drug product information as described in the proposed definition of drug product information included in this rule.</P>
                    <P>Specifically, the new paragraph § 447.510(i)(1) proposes that if a manufacturer fails to provide timely information required to be reported to the agency under § 447.510(a) and (d) of this section, the agency would provide written notice to the manufacturer of the failure to provide timely information. If such information is not reported within 90 calendar days of a deadline determined by the agency, and communicated to the manufacturer electronically and in writing by the agency, it shall result in suspension of the manufacturer's rebate agreement for all CODs furnished after the end of the 90-calendar day period for purposes of Medicaid and the MDRP only, and the rebate agreement shall remain suspended for Medicaid until such information is reported in full and certified, but not for a period of suspension of less than 30 calendar days. This section also proposes that continued suspension of the rebate agreement could result in termination for cause.</P>
                    <P>During the period of the suspension, the CODs of the manufacturer are not eligible for Medicaid coverage or reimbursement and Medicaid FFP. However, the manufacturer must continue to offer its CODs for purchase by 340B eligible entities, and reimbursement availability for such drugs under Medicare Part B would not change because, while suspended for purposes of the MDRP, the Medicaid drug rebate agreement with the manufacturer would remain in effect for purposes of Medicare Part B reimbursement and the 340B Drug Pricing Program.</P>
                    <P>Under proposed § 447.510(i)(2), the agency would notify the States 30 calendar days before the effective date of the manufacturer's suspension, which is 60 calendar days after the notice is sent to the manufacturer that the data are late. If a manufacturer fails to report and certify the complete information within this 30-calendar day period before the suspension begins, they would continue to be suspended from the program until such information is reported and certified, and would be subject to termination of the manufacturer rebate agreement.</P>
                    <P>
                        We understand that suspension of a manufacturer's agreement, and loss of the availability of FFP for a period of time, would likely mean that these manufacturers' drugs would not be available to Medicaid beneficiaries during the period of the suspension. We would give States sufficient time before 
                        <PRTPAGE P="34265"/>
                        the suspension begins—30 calendar days—to work with beneficiaries and their prescribers to transition to other covered outpatient drugs that would meet the clinical needs of the beneficiaries during the suspension period. We believe that the intermediate step of suspension rather than termination should be sufficient incentive to manufacturers to report pricing and product information within the statutory and regulatory requirements, without initially resorting to termination, which means that a manufacturer's drug could be unavailable to beneficiaries for a possible longer period of time.
                    </P>
                    <P>We believe this proposed process provides clearer implementation of the statutory authority to suspend a manufacturer's rebate agreement in the event of a failure to provide timely information, and would hopefully incentivize manufacturers to ensure the timely reporting of pricing and drug product information, which would further the efficient and economic operation of the MDRP.</P>
                    <P>For example, every month it is common that several manufacturers either do not report or only partially report their AMP data to the agency, which are used to calculate the Federal Upper Limits (FULs) for multiple source drugs, among other purposes. Such conduct reduces the agency's ability to set FULs on Medicaid payment for certain drugs, which means States may spend more money on multiple source drugs than they otherwise should. As a standard practice, we already notify these manufacturers that they are late in reporting or only have partially reported their information, and we also provide information about late reporting by manufacturers to OIG for possible imposition of CMPs. We consider partial reporting of information to also be late reporting, as the information that was not reported is late.</P>
                    <P>Consistent with the proposed clarification to the definition of manufacturer, the proposed suspension of the manufacturer's NDRA would be applied to all the associated labeler rebate agreements of the manufacturer.</P>
                    <HD SOURCE="HD2">G. Proposals Related to Amendments Made by the American Rescue Act of 2021—Removal of Manufacturer Rebate Cap (100 Percent AMP)</HD>
                    <P>Section 9816 of the American Rescue Plan Act of 2021 sunsets the limit on maximum rebate amounts for single source and innovator multiple source drugs by amending section 1927(c)(2)(D) of Act by adding “and before January 1, 2024,” after “December 31, 2009”. In accordance with section 1927(c)(3)(C)(i) of the Act and the special rules for application of provision in sections 1927(c)(3)(C)(ii)(IV) and (V) of the Act, this sunset provision also applies to the limit on maximum rebate amounts for CODs other than single source or innovator multiple source drugs.</P>
                    <P>Section 2501(e) of the Affordable Care Act amended section 1927(c)(2) of the Act by adding a new subparagraph (D) and established a maximum on the total rebate amount for each single source or innovator multiple source drug at 100 percent of AMP, effective January 1, 2010. This limit on maximum rebate amounts was codified at § 447.509(a)(5) for single source and innovator multiple source drugs, effective January 1, 2010. This limit was later extended to apply to drugs other than single source or innovator multiple source drugs by section 602 of the Bipartisan Budget Act of 2015 (Pub. L. 114-74, enacted November 2, 2015) (BBA 2015), which amended section 1927(c)(3) of the Act to require that manufacturers pay additional rebates on such drugs if the AMPs of the drug increase at a rate that exceeds the rate of inflation. This provision of BBA 2015 was effective beginning with the January 1, 2017 quarter, and the limit on maximum rebates for drugs other than single source or innovator multiple source drugs was added at § 447.509(a)(9).</P>
                    <P>Therefore, to conform § 447.509 with section 1927(c)(2)(D) of the Act, as amended by the American Rescue Plan Act of 2021, and sections 1927(c)(3)(C)(i), (ii)(IV), and (ii)(V) of the Act, we are proposing to make conforming changes to § 447.509 to reflect the removal of the maximum rebate amounts for rebate periods beginning on or after January 1, 2024. Specifically, we propose to amend § 447.509(a)(5) and (9) to state that the limit on maximum rebate amounts applies to certain time frames, which for all drugs, ends on December 31, 2023. That is, no maximum rebate amount would apply to rebate periods beginning on or after January 1, 2024.</P>
                    <HD SOURCE="HD2">H. Proposal To Clarify § 447.509(a)(6), (7), (8), and (9) and (c)(4) With Respect to “Other Drugs”</HD>
                    <P>Section 1927(c) of the Act describes how the unit rebate amount (URA) is determined for a covered outpatient drug. There is a defined calculation of the applicable basic rebate and additional rebate for a covered outpatient drug that is either a single source drug or innovator multiple source drug at sections 1927(c)(1) and (2) of the Act, and a different defined calculation for “other drugs,” that is, a covered outpatient drug that is a drug other than a single source drug or an innovator multiple source drug at section 1927(c)(3) of the Act.</P>
                    <P>Section 1927(c)(3) of the Act, titled “Rebate for other drugs,” describes in subsections (c)(3)(A) and (B) the basic rebate calculation for covered outpatient drugs other than single source drugs and innovator multiple source drugs. Section 1927(c)(3)(C) of the Act describes the additional rebate calculation for a covered outpatient drug other than a single source drug or an innovator multiple source drug. Thus, the statute makes it clear that rebates are applicable to all covered outpatient drugs, whether they are single source drugs, innovator multiple source drugs, or drugs other than such drugs.</P>
                    <P>Manufacturers are required to report all of their covered outpatient drugs in our MDRP reporting system and must select the appropriate drug category for each (that is, S, I, or N). Since the beginning of the MDRP, the term noninnovator multiple source drug, and its abbreviation (N), have been used very generally to identify a covered outpatient drug other than a single source drug or an innovator multiple source drug in our system for operational purposes. Choosing N in our reporting system thus can result in capturing drugs that satisfy the statutory definition of an N drug, but also other drugs that are not single source or innovator multiple source drugs. Because manufacturers are to report all of their covered outpatient drugs and identify the applicable drug category, all covered outpatient drugs other than a single source drug or an innovator multiple source drug should be identified with the drug category of N, regardless if they satisfy the definition of noninnovator multiple source drug.</P>
                    <P>In the July 17, 2007 final rule, we finalized a definition for “noninnovator multiple source drug” to clarify the distinction between multiple source drugs approved under an abbreviated new drug application (ANDA) and multiple source drugs approved under a new drug application (NDA). We also finalized that the term includes a drug that entered the market prior to 1962 that was not originally marketed under an NDA (72 FR 39162).</P>
                    <P>
                        Over the years, interested parties too have used the term “noninnovator multiple source drug” synonymously with “a covered outpatient drug that is a drug other than a single source drug or an innovator multiple source drug.” However, the statute specifically defines “noninnovator multiple source drug” at section 1927(k)(7)(iii) of the Act as a multiple source drug that is not an 
                        <PRTPAGE P="34266"/>
                        innovator multiple source drug. The regulatory definition of noninnovator multiple source drug goes beyond this statutory definition but does not capture every covered outpatient drug that is something other than a single source drug or an innovator multiple source drug because not every “other drug” is a multiple source drug. As a result, “other drugs” and “noninnovator multiple source drugs” are not synonymous. While the terms are not synonymous, they are treated so for purposes of reporting the COD in the MDRP system, as “other drugs” should be classified as N, if not an S or I drug.
                    </P>
                    <P>
                        As noted previously, the statute makes it clear that rebates apply to all covered outpatient drugs, regardless if they are single source drugs, innovator multiple source drugs or something other than a single source drug or innovator multiple source drug. To align our longstanding policy and practices of identifying “other drugs referenced in section 1927(c)(3) of the Act as N drugs, for purposes of the MDRP, we are proposing to modify language in § 447.509 by replacing each appearance of “noninnovator multiple source drug(s)” with “drug(s) other than a single source drug or an innovator multiple source drug.” 
                        <SU>27</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             Drugs other than single source drugs and innovator multiple source drugs should continue to be reported in the MDRP system with the drug category of “N”.
                        </P>
                    </FTNT>
                    <P>We propose to delete each appearance of “noninnovator multiple source drug(s)” in § 447.509 and replace it with “drug other than a single source drug or innovator multiple source drug(s).” The clarification is proposed to be made in § 447.509(a)(6), (7), (8), and (9) and (c)(4), and the language would change as set out in the proposed regulatory text at the end of the document.</P>
                    <P>• In paragraph (a)(8), we would specify the “total rebate”. Specifically, the total rebate amount for a drug other than a single source drug or innovator multiple source drug is equal to the basic rebate amount plus the additional rebate amount, if any.</P>
                    <P>• In paragraph (a)(9), we would specify the “limit on rebate”. Specifically, in no case would the total rebate amount exceed 100 percent of the AMP for a drug other than a single source drug or innovator multiple source drug.</P>
                    <P>• In paragraph (c)(4), we would specify that for a drug other than a single source drug or innovator multiple source drug, the offset amount is equal to 2.0 percent of the AMP (the difference between 13.0 percent of AMP and 11.0 percent of AMP).</P>
                    <HD SOURCE="HD2">I. Proposal To Establish a 12-Quarter Rebate Audit Time Limitation (§ 447.510)</HD>
                    <P>In accordance with sections 1927(b)(1) and 1927(c) of the Act, and section II. (b) of the NDRA, manufacturers are required to pay quarterly rebates to States for the CODs dispensed and paid for under the State Plan for the rebate period. Section 1927(b)(2)(B) of the Act provides that a manufacturer may audit the rebate billing information provided by the State as set forth under section 1927(b)(2)(A) of the Act on the total number of units of each dosage form, strength and package size of each COD dispensed and paid for under the State Plan during a rebate period, and authorizes that adjustments to rebates shall be made to the extent that the information provided by States indicates that utilization was greater or less than the amount previously specified. The statute does not impose a specific timeframe on a manufacturer's audit authority or limit when adjustments to rebates may occur.</P>
                    <P>For the purposes of this proposed regulation, audit authority is intended to refer to any process a manufacturer is using to seek an adjustment to utilization data under section 1927(b)(2)(B) of the Act. That audit authority encompasses many processes for seeking adjustments in utilization data, including disputes, assessments, reviews and hearings, and may involve paper procedures, informal phone calls, and emails or other mechanisms. This proposed provision is intended to provide a 12-quarter timeline for any of those processes related to initiation of audits.</P>
                    <P>
                        Section V. of the NDRA describes how the agency operationalizes the manufacturer audit authority; that is, it describes the procedures for dispute resolution once an audit identifies a dispute with the utilization data (that is, number of units for any given quarter) for which States are requesting rebates using a rebate invoice. A manufacturer can dispute State utilization on an original invoice or initiate a dispute on utilization that was previously paid. See section V, Dispute Resolution, “Medicaid Program: Announcement of Medicaid Drug Rebate Program National Rebate Agreement,” Final Notice, 83 FR 12770 (Mar. 23, 2018). The audit/dispute resolution processes are further discussed in a number of manufacturer releases (State Release 177,
                        <SU>28</SU>
                        <FTREF/>
                         State Release 181,
                        <SU>29</SU>
                        <FTREF/>
                         Manufacturer Release 95,
                        <SU>30</SU>
                        <FTREF/>
                         Manufacturer Release 105,
                        <SU>31</SU>
                        <FTREF/>
                         and Manufacturer Release 115 
                        <SU>32</SU>
                        <FTREF/>
                        ).
                    </P>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             
                            <E T="03">https://www.law.cornell.edu/definitions/index.php</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             
                            <E T="03">https://www.cbo.gov/system/files/2020-03/PDPRA-SFC.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             
                            <E T="03">https://www.medicaid.gov/medicaid-chip-program-information/by-topics/prescription-drugs/downloads/rx-releases/mfr-releases/mfr-rel-095.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             
                            <E T="03">https://www.medicaid.gov/prescription-drugs/downloads/mfr-rel-113.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             
                            <E T="03">https://www.accessdata.fda.gov/scripts/cder/daf/</E>
                            .
                        </P>
                    </FTNT>
                    <P>As provided at section 1927(b)(2)(A) of the Act, no later than 60 days of the end of each quarter, States invoice manufacturers for rebates based on utilization of the manufacturer's drugs in that quarter (§ 447.511(a)). Consistent with section 1927(b)(2)(B) of the Act, manufacturers may audit State utilization data for their covered outpatient drugs reported under section 1927(b)(2)(A) of the Act to determine if the data are accurate and appropriate. If a manufacturer's review of a quarterly State invoice determines that no adjustments are necessary, and that the total quarterly rebate amount can be paid as reflected on the invoice, the manufacturer pays the total invoiced amount in full. The manufacturer will use identifying documentation about payment from the State's records which may include, for example, the labeler code, the labeler name, the quarter and applicable Federal program(s) covered by the payment, or any other such pertinent information that would help identify from whom the rebate payment is being sent and for which quarter and Federal program the payment applies.</P>
                    <P>
                        In the event a potential discrepancy with State drug utilization data on the rebate invoice is discovered for a current period, the manufacturer will submit a Reconciliation of State Invoice (ROSI) form to the State, or if such a discrepancy is discovered for a prior rebate period's invoice after that rebate period has already been invoiced and paid, the manufacturer will submit a Prior Quarter Adjustment Statement (PQAS) to the State. When completing the ROSI or the PQAS, manufacturers must enter the appropriate code(s) to explain the bases or reasons for any adjustments. Both forms assist in standardizing data exchange elements and improving communication between manufacturers and States. Consistent with section 1927(b)(2)(B) of the Act, adjustments to rebates are made to the extent that the audit results in information indicating that utilization was greater or less than the amount previously specified by the State in its rebate invoice, and can result in manufacturers owing additional rebate 
                        <PRTPAGE P="34267"/>
                        amounts to the States, or the States owing credits to manufacturers.
                    </P>
                    <P>In State Release 56 and Manufacturer Release 20, we explained an adjustment is a correction in the number of units for any given NDC, or a correction to the unit rebate amount (URA) by the labeler for any given NDC. We clarified a dispute to mean “a disagreement between the labeler and the State regarding the number of units the State invoiced for any given quarter.” Consistent with section 1927(b)(2)(B) of the Act, all disputes must be resolved on a unit basis only, and not on any other factor (for example, monetary amounts, percentages, etc.) (State Release 181).</P>
                    <P>State Release Number 45 sets forth the Dispute Resolution Process for manufacturers and States to follow when engaged in a dispute. In that release, we specified that the manufacturer should notify a State of the disputed data no later than 38 days after the State utilization data is sent. However, we have been made aware that manufacturers initiate disputes far past this suggested timeline. For example, States have reported receiving new disputes on claims from more than 30 years ago.</P>
                    <P>
                        Previous OIG reports indicated that manufacturers have initiated disputes dating back many years. Although the rebate agreement notes that States and manufacturers should strive to resolve disputes within a reasonable timeframe, there is no mention of how far back a dispute can be initiated once a manufacturer receives an invoice.
                        <SU>33</SU>
                        <FTREF/>
                         While section V. of the NDRA, along with several CMS-issued program releases address dispute resolution procedures for when a manufacturer identifies State drug utilization data (SDUD) discrepancies based on the audit authority at section 1927(b)(2)(B) of the Act, no law or regulation, provides a specific time limitation for initiating a dispute over drug utilization data.
                        <SU>34</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             United States, Congress, Office of Inspector General. Medicaid Drug Rebate Dispute Resolution Could Be Improved, OEI-05-11-00580. Available at 
                            <E T="03">https://oig.hhs.gov/oei/reports/oei-05-11-00580.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             
                            <E T="03">https://www.ncpdp.org/NCPDP/media/pdf/WhitePaper/Medicaid-Drug-Rebate-Program-Challenges-Across-the-Industry.pdf?ext=.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>Section V of the NDRA describes the dispute resolution processes available to manufacturers and States when a manufacturer discovers a potential discrepancy with State drug utilization data on the rebate invoice, when the manufacturer and State in good faith are unable to resolve prior to the payment due date. As noted above, manufacturers use the ROSI or PQAS process, and shall use their best efforts to resolve a dispute within a reasonable timeframe, and if they are not able to resolve the dispute within a reasonable time frame, CMS will employ best efforts to ensure the State makes available to manufacturers (in accordance with § 447.253(e)) and as explained in State Release 181, the same State hearing mechanism available to providers for Medicaid payment disputes. The State hearing option is available to both States and manufacturers when they have reached an impasse through the normal dispute resolution process, or when one of the parties is not being responsive to another's efforts to engage in dispute resolution. Once a hearing has taken place and a finding is issued, States and manufacturers are expected to act in accordance with the finding. We believe having an unlimited timeframe to initiate such disputes on rebates can result in manufacturer, State and Federal resources being spent to adjudicate excessively old disputes and is not an efficient use of resources.</P>
                    <P>
                        Given the lack of timeframe for dispute resolution, both States and manufacturers have requested greater CMS involvement in resolving disputes.
                        <SU>35</SU>
                        <FTREF/>
                         More specifically, States have requested we establish a time limit for when a manufacturer may initiate a dispute. Establishing a time limit for manufacturers to initiate a dispute concerning State utilization data on the rebate invoice would promote the timely identification of outstanding disputes. Having an unlimited period to initiate disputes is not consistent with the proper and efficient operation of the rebate program. Due to recalculations involving hundreds of millions of State and Federal Medicaid dollars involving years of paperwork, we believe it is essential that a standard timeframe be established within which disputes are permitted.
                    </P>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             United States, Congress, Office of Inspector General. Medicaid Drug Rebate Dispute Resolution Could Be Improved, OEI-05-11-00580. Available at 
                            <E T="03">https://oig.hhs.gov/oei/reports/oei-05-11-00580.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>We propose to use our authority under sections 1102 and 1902(a)(4) of the Act to require efficient handling of disputes by limiting the period for manufacturers to initiate disputes, hearing requests and audits concerning State-specified COD utilization data to 12 quarters from the last day of the quarter from the date of the State invoice. Section 1102 of the Act requires the Secretary to “make and publish such rules and regulations, not inconsistent with this Act, as may be necessary to the efficient administration of the functions with which [he or she] is charged” under the Act.</P>
                    <P>Consistent with this authority, and with the authority found in section 1902(a)(4) of the Act, which allows the Secretary to specify such methods necessary for the proper and efficient operation of the plan, we are proposing to establish a 12-quarter time limit for manufacturers to initiate disputes, hearing requests, and audits for State-invoiced units on current rebates as well as to initiate disputes, hearing requests, and audits on rebates that have been paid in full. We are proposing a time limitation to help ensure that discrepancies are timely identified and resolved, thereby providing increased financial certainty to manufacturers and States and promoting the efficient operation of the MDRP. This limitation would only apply to disputes regarding State drug utilization data on State rebate invoices. We would continue to work with manufacturers to process appropriate change requests (for example: COD Status change requests, Market Date change requests, Base Date AMP change requests, and 5i Drug Indicator change requests).</P>
                    <P>We understand this proposal implicates the authority at section 1927(b)(2)(B) of the Act, and would result in adding a time limitation to a manufacturer's authority to audit information provided by States under section 1927(b)(2)(A) of the Act. However, we believe that this proposal and implications to the authority to audit comport with our policy goals and the authority bestowed by Congress to ensure the proper and efficient operation of the program.</P>
                    <P>
                        In considering an approach that is fair for both States and manufacturers, we believe that a regulation adopted in 2003 provides a way forward. The “Medicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program” final rule with comment period, 68 FR 51912 (August 29, 2003), set forth a 12-quarter time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to CMS.
                        <SU>36</SU>
                        <FTREF/>
                         Establishing a 12-quarter time limitation for manufacturers to initiate disputes concerning State-invoiced utilization data would align with the timelines for manufacturers to report changes to data elements relevant to the calculation of 
                        <PRTPAGE P="34268"/>
                        MDRP rebate amounts and for manufacturers to initiate disputes concerning State-supplied utilization data also necessary to the rebate calculation (§ 447.510(b)(1)), and would allow for more efficient administration of State operated drug rebate programs. This 12-quarter timeframe would also assist States that would otherwise be required to retain their drug utilization data indefinitely to verify changes in rebate amounts resulting from retroactive manufacturer recalculations. We would also like to specify, whenever we refer to a 3-year timeframe for disputes, we are interpreting it as 12 quarters from the last day of the quarter from the date of the State invoice.
                    </P>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             As stated in current regulation in § 447.510(b), manufacturers must report to CMS any revision to AMP, best price, customary prompt pay discounts, or nominal prices for a period not to exceed 12 quarters from the quarter in which the data were due, with limited exceptions.
                        </P>
                    </FTNT>
                    <P>We recognize the potential burden for States and manufacturers to comply with a 38-day dispute initiation timeframe as mentioned in State Release Number 45; however, we believe that a 12-quarter timeframe is reasonable because it comports with requirements for maintenance of records on State Medicaid expenditures at § 433.32. It also mirrors the manufacturer's timeline for reporting revisions to monthly AMP at § 447.510(d)(3). We also understand that there are two-year timely claims filing deadlines under section 1132(A) of the Act, and regulations at 45 CFR 95.7, which may prohibit States from claiming FFP in these situations, unless under a good cause waiver. Therefore, consistent with our authority at sections 1102 and 1902(a)(4) of the Act, we propose to ensure the efficient handling of rebate disputes, by limiting the period for manufacturers to initiate disputes, hearing requests or audits concerning State utilization data submitted pursuant to section 1927(b)(2)(A) of the Act to 12 quarters from the last day of the quarter from the date of the State invoice.</P>
                    <P>Accordingly, we are proposing a new paragraph (j), titled “Manufacturer audits of State-provided information,” at § 447.510, specifying that a manufacturer may, within 12 quarters from the last day of the quarter from the State invoice date, initiate a dispute, request a hearing or seek an audit with a State for any discrepancy with State drug utilization data reported under section 1927(b)(2)(A) of the Act on the State rebate invoices.</P>
                    <HD SOURCE="HD2">J. Proposal To Establish a Drug Price Verification Survey Process of Certain Reported CODs (§ 447.510)</HD>
                    <P>In this section of the proposed regulation, we describe the legal basis, rationale, and process we propose to survey manufacturers and wholesalers that directly distribute their CODs using our authority at section 1927(b)(3)(B) of the Act to obtain information about the prices they are reporting to us under section 1927(b)(3)(A) of the Act and in accordance with § 447.510. The purpose of this survey is to verify prices reported under section 1927(b)(3)(A) of the Act to assure that Medicaid payments and applicable rebates for CODs can be made, and that Medicaid payments are economical and efficient, as well as sufficient, to provide access to care.</P>
                    <P>Currently, there is no centralized collection of specific data from manufacturers (or wholesalers) used by CMS to verify prices manufacturers reported to us under section 1927(b)(3)(A) of the Act. Our proposal to survey manufacturers for certain information on specific CODs and our proposal to make certain manufacturer information publicly available (unless it is proprietary), would allow States to access this information and understand the derivation of a COD's price so that States may establish and negotiate payment for Medicaid CODs consistent with section 1902(a)(30)(A) of the Act. For example, transparency into a manufacturer's costs and process for establishing a drug price via the survey, along with other factors, would give States the ability to better negotiate supplemental rebates, and better understand the impact of the drug on its budget as supplemental rebates are negotiated.</P>
                    <P>The proposed drug price verification survey is not intended to limit or deny access to any of the CODs included on the survey list, assess cost effectiveness of such drugs, or supplant findings from the applicable FDA approval process. That is, we would not be using the survey data to further assess either the clinical or cost effectiveness of the COD. Furthermore, neither the selection of CODs subject to the survey, nor the information collected in response to a survey under this proposal, would impact coverage of a COD consistent with section 1927 of the Act, or supplant any of the Federal requirements established under section 1927 of the Act and the implementing regulations at 42 CFR part 447, subpart I. Section 1902(a)(30)(A) of the Act (42 U.S.C. 1396a(a)(30)(A)) requires that States have a State Plan that provides methods and procedures to ensure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available at least to the extent that such care and services are available to the general population in the geographic area. In turn, the agency has an overarching obligation under section 1902(a)(30)(A) of the Act to ensure that Medicaid payments are made in an economical and efficient, as well as sufficient, manner to provide access to care.</P>
                    <P>Section 1927(b)(3)(B) of the Act authorizes the Secretary to survey wholesalers and manufacturers that directly distribute their CODs, when necessary, to verify manufacturer prices reported to us under section 1927(b)(3)(A) of the Act. We are proposing to interpret this language broadly to provide authority to verify prices and charges from wholesalers and manufacturers that distribute their own drugs, including when the manufacturer distributes drugs directly to pharmacies and other providers. In other words, we believe it is meant to allow the Secretary to verify prices reported in both situations in which a manufacturer sells to wholesalers and/or distributes them directly on their own. The statute expressly provides at section 1927(b)(3)(B) of the Act the authority to verify “manufacturer prices and manufacturer's average sales prices (including wholesale acquisition cost)” and that requests for information may span “charges or prices.” We discuss later in this section which charges and prices we may request to verify the reported manufacturer prices.</P>
                    <P>The meaning of the term “verify,” as set forth in the Oxford English Dictionary means “make sure or demonstrate that (something) is true, accurate, or justified”. Viewing the authority provided under section 1927(b)(3)(B) of the Act through the lens of section 1902(a)(30)(A) of the Act obligations, we are proposing the following: (1) to describe the criteria by which we would develop a list of CODs (identified by NDC) that may be subject to a survey, and the manufacturers to whom the agency intends to send such a survey, to obtain additional information from said manufacturers or wholesalers to verify prices or charges of certain CODs that are reported to us under section 1927(b)(3)(A) of the Act; and, (2) the information that manufacturers and wholesalers would be required to report to satisfy the verification survey request.</P>
                    <P>
                        Under our proposal, a process would be established such that once the agency determines that a manufacturer and its COD would be subject to verification, the prices or charges that would be subject to verification may include those that are described in section 1927(b)(3)(A) of the Act and reported by manufacturers, including a manufacturer's AMP, best price, ASP, and WAC for a drug. We note that WAC is generally available through public sources, while the manufacturer reported AMP, best price, and ASP for 
                        <PRTPAGE P="34269"/>
                        CODs are generally not available through public sources.
                    </P>
                    <P>The CODs to which this verification survey would apply would be limited to those for which manufacturers that have a National Drug Rebate Agreement in place with the Secretary of HHS, as required under section 1927(a)(1) of the Act. Only these manufacturers would report applicable product and pricing data under section 1927(b)(3)(A) of the Act and proposed § 447.510. We note this rulemaking does not address the separate authority to conduct surveys under section 1847A(f)(2) of the Act to verify prices reported under section 1847A(f)(2).</P>
                    <P>We note that participating manufacturers are required to report and certify certain product and pricing data for each of their CODs on a monthly and quarterly basis to CMS. The COD pricing and product information is primarily used for the determination of the quarterly Medicaid drug rebates paid by participating manufacturers, but also serves as the basis for Medicaid payment for CODs. For example, the AMPs that are reported to the agency are used in the calculation of the Medicaid Federal Upper Limits (FULs) for payment of certain multiple source CODs under section 1927(e)(5) of the Act. The 340B Drug Pricing Program uses the AMP and the Unit Rebate Amount (which is the amount calculated to determine the Medicaid rebate for each dosage form and strength of a COD, and is based in part on AMP) to calculate the 340B ceiling price. Many States require that 340B entities are paid no more than the 340B ceiling price for CODs dispensed by 340B entities. Additionally, many State Medicaid programs use the ASP (as defined in section 1847A(b)(4)(A) of the Act) and the Wholesale Acquisition Cost (as defined in section 1847A(b)(4)(B) of the Act) for Medicaid payment for physician administered drugs, such as those administered in hospital outpatient departments and physician offices.</P>
                    <P>Since the aforementioned pricing data that manufacturers report to us under section 1927(b)(3)(A) of the Act (AMP, ASP, WAC) are often used by States for reimbursement under Medicaid, serve as a basis for payment to providers for CODs, including physician administered drugs, and thus have a significant impact on how much the Federal Government pays for CODs under Medicaid, CMS must ensure, in accordance with section 1902(a)(30)(A) of the Act, that Medicaid payments for CODs based on these reported prices, are made in an economical and efficient, as well as sufficient manner, to provide access to care.</P>
                    <P>To provide additional background on the need for the agency to use this survey authority, we note that Medicaid pays for CODs under both FFS programs and through Medicaid managed care plans. State Medicaid programs and their contracted managed care plans have been successful in managing the costs of the pharmacy benefit programs through the implementation of various drug cost containment strategies. The primary mechanisms used by States and managed care plans to manage their pharmacy program spending consist of manufacturer rebates that are collected under the MDRP, the use of lower-cost generic or multiple source drugs, prior authorization, and preferred drug lists, which allow States to leverage crowded therapeutic classes to negotiate supplemental rebates with manufacturers. Manufacturer rebates collected by the States totaled $42.9 billion on a total drug spending of $77.6 billion for the four-quarter period Q1 2022 through Q4 2022 or 55.3 percent of total drug spending.</P>
                    <P>We also finalized regulations in the COD final rule that require that reimbursement for drugs dispensed through retail pharmacies be based on a two-part formula which consists of: (1) the ingredient cost of the drug based on actual acquisition costs (AAC); and, (2) a professional dispensing fee (PDF) for the drug based on the pharmacy's cost of professional dispensing. See §§ 447.502, 447.512, and 447.518. States establish reimbursement methodologies for these two components based on actual acquisition cost data and costs associated with dispensing. To further assist States to pay for CODs, the agency publishes the National Average Drug Acquisition Cost (NADAC) file on a monthly basis, which is based on community pharmacy invoice prices for CODs. The NADAC is one source States can use to support their ingredient cost AAC-based portion of pharmacy reimbursement. This methodology provides greater transparency into Medicaid payment for prescription drugs dispensed through community pharmacies, and most States use this file to help assure that pharmacies are paid for the cost of the drug that is dispensed and the professional dispensing costs. No such survey process, however, exists for CODs paid for by Medicaid that are not traditionally dispensed through retail pharmacies, such as many physician-administered drugs and gene therapy drugs, which are not required to follow the regulations noted above with regard to pharmacy reimbursement and AAC and PDF requirements.</P>
                    <P>Thus, while Medicaid has implemented policies that generally provide effective management of traditional retail community pharmacy drug spending, while creating greater transparency around payment for drugs dispensed by retail community pharmacies, there are fewer effective policies in place for management of COD purchasing and reimbursement to non-retail health care providers.</P>
                    <P>
                        Substantial growth in non-retail community pharmacy drug spending is expected to continue. In March 2022, we estimated that for CY 2022, drugs that may require special handling or inpatient or outpatient hospitals stays will account for about 50 percent of the drug supply chain spending.
                        <SU>37</SU>
                        <FTREF/>
                         Additionally, Medicaid expenditures for CODs dispensed in non-retail community pharmacy settings continue to experience similar growth. Based on an analysis of CMS State utilization data from 2012 to 2019, total Medicaid non-retail community pharmacy drug expenditures as a percentage of total Medicaid drug expenditures grew from 28 percent to 47 percent, and total Medicaid non-retail community pharmacy dispensed drug expenditures grew from $10.58 billion to $30.70 billion.
                        <SU>38</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             Iqvia, National Sales Perspective, February 2022. Presentation given by Doug Long at Asembia, May 2022.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             Myers and Stauffer LC, Specialty Drugs Spend Trend 2012-2019 (2020) (unpublished analysis) (on file with Agency) (this analysis reviewed FFS and MCO combined spend for specialty drugs included on the Myers and Stauffer LC specialty list, based upon eight years of CMS National Utilization Data).
                        </P>
                    </FTNT>
                    <P>Thus, it is evident that the evolution in the types of drugs paid for by Medicaid, manufacturers' pricing structures for these drugs, as well as the methods used by manufacturers to distribute these drugs, have changed since the enactment of the MDRP, as well as the enactment of the MMA. While the model of distribution from manufacturer to wholesaler to provider still exists, and the predominant provider of pharmacy services remains the community-based pharmacy, there are other distribution and pricing arrangements for certain drugs, including high-cost gene therapy drugs that were not necessarily in existence in the market when the MDRP was enacted.</P>
                    <P>
                        In some of these situations, there is a need for more information or verification regarding how certain prices or charges reported to us for these high-cost CODs are calculated in order to make payment under Medicaid. For example, there is little or no public information available about the factors 
                        <PRTPAGE P="34270"/>
                        that influence the pricing of drugs dispensed in non-retail community pharmacy settings in Medicaid, the prices that pharmacies or wholesalers pay for these CODs, whether the prices or charges bear any relationship to the cost components of the COD, or whether the costs of distribution or preparation methods are included in the prices reported to us.
                    </P>
                    <P>States do not have access to invoice data of manufacturers or purchasers, or information as to how manufacturers have arrived at the prices they charge wholesalers or direct distributers. Therefore, States may assume that manufacturer prices reflect the manufacturer's cost inputs such as research, development, and production costs. However, States do not know how those costs relate to the prices available from the manufacturer. Manufacturers may also consider the relative value of that drug to the patient/payer versus other treatments for similar conditions when developing their prices. As such, States may assume that the manufacturer prices its drug(s) at a certain value because it either has the potential to cure the patient or substantially reduce other medical costs (for example, reduces a patient's need for higher cost inpatient hospital care). However, these assumptions may not be accurate since how the manufacturer arrives at its price is generally opaque.</P>
                    <P>We believe our proposed drug price verification survey process, along with the NADAC that we publish for retail community pharmacy costs, should provide CMS and the States a clearer understanding into a manufacturer's pricing for its covered outpatient drug to verify those prices and charges, and ensure that Medicaid payments are made in an economical and efficient, as well as sufficient manner, to provide access to care. A lack of current understanding of manufacturer pricing bears directly on whether payments can be made consistent with section 1902(a)(30)(A) of the Act. Moreover, Medicaid managed care plans may be able to use such public information about the prices or charges that are collected under this process to determine the appropriateness of their payments to PBMs, or for States and managed care plans to determine the appropriateness of the drug spending component of the overall Medicaid managed care capitation rate attributable to pharmacy services.</P>
                    <P>For the foregoing reasons, and as described below, we propose to use the statutory authority in section 1927(b)(3)(B) of the Act, coupled with that in section 1902(a)(30)(A) of the Act, and this proposed regulatory process, to collect additional charges and pricing information from manufacturers to verify the prices reported to us for CODs. We believe this verification is extremely important given the significant number of high cost drugs and biologics, including cell and gene therapy drugs entering the market; the prices associated with new and different distribution channels; and the continued use of WAC as a pricing metric in instances when actual acquisition cost data are not available. Gene and cell therapy drugs especially, while transformative in terms of therapeutic benefits, are being priced in the millions of dollars. States, with their limited budgets, are concerned about how they would be able to afford these medications as they are generally required to pay for these drugs that are CODs as part of the prescribed drugs benefit in accordance with the requirements of section 1927 of the Act and the Medicaid drug rebate program. As stated earlier in this rule, our proposal to survey manufacturers to verify price(s) and charge(s) involves collecting certain information on specific CODs, and our proposal to make certain manufacturer information publicly available (unless it is proprietary), would give States an additional tool to negotiate payment for Medicaid CODs consistent with section 1902(a)(30)(A) of the Act. For instance, while the survey would be used by CMS to verify prices, the access to certain non-proprietary data via the survey, for example, patient outcomes of the covered outpatient drug, could give States the ability to negotiate supplemental rebates with a full understanding of the impact of the drug on its budget and Medicaid patient population. This is important, particularly in light of the limited ability of States to negotiate additional supplemental rebates because of the few novel products in a particular drug class.</P>
                    <P>
                        We have also seen pricing-related issues relating to the production methods for these drugs, and query whether and how such methods should factor into the prices that are reported to us under section 1927(b)(3)(A) of the Act. For example, there are new preparation methods that modify or treat a patient's own cells, which are then placed back into the body to treat the patient's condition. This type of preparation method, while novel, raises issues of how such costs are included in the prices that are reported to us. We have also observed that certain manufacturers are using limited-distribution specialty pharmacies to distribute their drugs to providers and patients. Certain closed-door specialty pharmacies may have access to limited-distribution specialty drugs due to specific arrangements with pharmaceutical manufacturers or special monitoring provisions required by FDA.
                        <SU>39</SU>
                        <FTREF/>
                         Of the drugs approved by FDA in 2020 that were distributed through specialty pharmacies, 96 percent were for limited-distribution drugs.
                        <SU>40</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             Erin M. Turingan, et al., 
                            <E T="03">Financial Effect of a Drug Distribution Model Change on a Health System.</E>
                             52 Hosp. Pharm. 422 (2017).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             Anton Health, 
                            <E T="03">2020 Specialty Approvals—96% Via Limited Distribution,</E>
                             Anton RX Report (Jan. 15, 2021), 
                            <E T="03">https://antonhealth.com/2020-specialty-pharmacy-approvals/</E>
                            .
                        </P>
                    </FTNT>
                    <P>In addition to retail community and closed-door specialty pharmacies, other provider types may dispense and/or administer drugs dispensed in non-retail community pharmacy settings to Medicaid beneficiaries. These providers include, but are not limited to, physicians, home infusion pharmacies, hemophilia treatment centers, and clinics. In these situations, there may be questions regarding how a manufacturer calculates its AMP and best price that are reported to us under section 1927(b)(3)(A) of the Act, and how those data points compare to the actual invoice cost of the drug to the pharmacy. This directly affects Medicaid payments and rebates.</P>
                    <P>Manufacturers are also using innovative versions of third-party logistic arrangements to distribute their drugs, which include specialty pharmacies, under which the title of the drug does not transfer to the pharmacy. Questions have been raised by States as to how such arrangements work with respect to the Medicaid program's payment to the pharmacy, as well as the calculation of the covered outpatient drug's AMP and best price that are reported to us under section 1927(b)(3)(A) of the Act and used for purposes of calculating Medicaid rebates.</P>
                    <P>
                        And we note that many States and Medicaid programs continue to use WAC as the basis for reimbursement of many drugs dispensed in a non-retail community pharmacy setting—because of the lack of availability of acquisition cost data. However, we have observed that there may be a trend in Medicaid by some manufacturers with recently-marketed high cost CODs to increase their WACs at a rate faster than their AMPs, especially for specialty drugs. We have not identified this trend with respect to long-marketed drugs covered by Medicaid and dispensed at retail community pharmacies based upon a 
                        <PRTPAGE P="34271"/>
                        May 2023 CMS comparison research of changes to invoice prices vs. changes in WAC. This comparison showed consistent changes in invoice pricing and WAC. We believe consistent changes in invoice pricing and WAC also occur for drugs covered by Medicare Part D and dispensed at retail community pharmacies. Generally, when manufacturers increase their WACs at a rate faster than their AMPs, the higher the WAC for the COD, the greater the spread between the Medicaid reimbursement and the actual acquisition cost. This trend could affect whether Medicaid payments are consistent with sections 1927 and 1902(a)(30)(A) of the Act, as discussed previously in this proposed rule. That is, the use of WAC by the State for reimbursement purposes for certain drugs, such as high cost specialty drugs, may result in States overspending for a drug and manufacturers underpaying in rebates because of the much lower reported AMP for the drug.
                    </P>
                    <P>For example, based on an agency analysis of the relationship between WAC and AMP for a specific high-cost specialty drug, we found in 2018 that there was an 8.5 percent difference between the WAC and the AMP. Based on the latest data available, that difference is now 23 percent. Thus, States that use WAC that is reported to us under section 1927(b)(3)(A) of the Act to pay providers may significantly overspend for specialty drugs, given that AMP has traditionally been considered a closer proxy for the approximate revenues received by the manufacturer from sales of the drugs in the non-retail community pharmacy setting.</P>
                    <P>Given these situations, we propose that significant enough changes have occurred in the marketplace to warrant the use of the Secretary's authority to survey manufacturers and wholesalers in certain situations with respect to the prices and charges reported to us under section 1927(b)(3)(A) of the Act to make payment. Specifically, section 1927(b)(3)(B) of the Act gives the Secretary the authority to survey wholesalers and manufacturers that directly distribute their CODs, when necessary, to verify manufacturer prices and manufacturer's average sales prices (including wholesale acquisition cost) if required to make payment reported under section 1927(b)(3)(A) of the Act.</P>
                    <P>Therefore, we propose at § 447.510(k)(1) to use the authority granted to the Secretary under section 1927(b)(3)(B) of the Act to survey manufacturers with rebate agreements in effect with the Secretary to verify prices or charges for certain CODs for which drug product and pricing information is submitted under section 1927(b)(3)(A) of the Act and § 447.510, to make payment for the COD.</P>
                    <P>
                        We do not believe it is required or necessary that we survey every manufacturer's price or charge submitted under section 1927(b)(3)(A) of the Act, as the authority to verify via a survey of the prices under section 1927(b)(3)(B) of the Act indicates that the Secretary “may” verify. Notably, we propose to exclude those CODs that are subject to certain CMS drug pricing program(s) or initiatives under which participating manufacturers negotiate the COD's price directly with CMS. For example, under the Medicare Drug Price Negotiation program established under sections 11001 and 11002 of the Inflation Reduction Act of 2022, or potentially certain CMMI models that are developed in response to the President's Executive Order 14087 (see HHS response at 
                        <E T="03">https://innovation.cms.gov/data-and-reports/2023/eo-rx-drug-cost-response-report</E>
                        ), participating manufacturers will negotiate and collaborate with CMS on prices for certain CODs. This being the case, we propose to exclude CODs subject to these programs and initiatives from the survey verification, as CMS may have already successfully negotiated lower prices for the Medicare and/or Medicaid programs with these manufacturers. We intend to include a list of CMS drug pricing programs and initiatives under which manufacturers directly negotiate with CMS on a public website and would expect to update that list to reflect any future CMS drug pricing programs and initiatives that result in manufacturers' directly negotiating COD pricing with CMS.
                    </P>
                    <P>We further note that under section 1927(c)(1)(C)(ii)(V) of the Act, maximum fair prices (MFPs) that are negotiated for selected drugs under the Medicare Drug Price Negotiation Program would be included in the Medicaid best price; thus, State Medicaid programs will benefit from the MFPs negotiated under Medicare Part B and Part D to the extent that such drugs are CODs. In other words, the MFP negotiated for these drugs could potentially lower the best price and potentially increase the Federal Medicaid drug rebate. Furthermore, it is unlikely that CODs with an MFP would be selected for the proposed drug price verification survey under section 1927(b)(3)(B) of the Act because we expect that our proposal would verify drug prices that are more recently marketed high cost drugs not typically dispensed at non-retail community pharmacies, while drugs for which an MFP has been negotiated must have been approved for at least 7 years, in the case of drugs approved and marketed under section 505(c) of the FFDCA, or licensed for at least 11 in the case of biological products that are licensed and marketed under section 351 of the PHS Act. Moreover, as noted previously in this proposed rule, we do not believe the trend of WACs increasing at a rate faster than their AMPs is relevant for the types of drugs for which MFP likely will be negotiated. Therefore, in this rule, we are proposing to survey manufacturers to verify price (or prices) and/or charges regarding specific CODs based on a three-step process.</P>
                    <P>The first step would use objective measures related to Medicaid spending to identify CODs with the highest drug spending per claim, highest total Medicaid drug spending, highest 1 year price increase, or highest launch price, as determined and explained below. Specifically, we propose at § 447.510(k)(2) that CMS, on an annual basis, would compile a list of single source CODs that may be subject to a survey based on one or more of the criteria proposed at § 447.510(k)(2)(i) through (iv).</P>
                    <P>
                        The proposed measures in § 447.510(k)(2)(i) (highest drug spending per claim) and (ii) (highest total Medicaid drug spending) would use Medicaid drug spending data as reported from States to CMS in accordance with the State drug utilization data (SDUD) reporting (
                        <E T="03">https://www.medicaid.gov/medicaid/prescription-drugs/state-drug-utilization-data/index.html</E>
                        ). We note that the per claim Medicaid spending data used in § 447.510(k)(2)(i) is not reduced by Federal rebates since such rebates are not reported at the claim level. Further, the supplemental rebate data are reported in the aggregate to CMS from States on a quarterly basis, thus it is difficult to identify individual State supplemental rebate data to net State supplemental rebates from per claim Medicaid spending. However, we would review the reported annual total Medicaid spending at § 447.510(k)(2)(ii) as reported by the States net of Federal rebates when determining if a COD spend is greater than 0.5 percent of total annual Medicaid drug spend, net of Federal rebates.
                    </P>
                    <P>For proposed measure § 447.510(k)(2)(iii), we would look at published WACs to determine when a COD's price increase falls in the top 1 percent of CODs with the highest median WAC increase over a 12-month period.</P>
                    <P>
                        In proposed measure § 447.510(k)(2)(iv), we propose to look at the highest launch price, which we 
                        <PRTPAGE P="34272"/>
                        propose to do by estimating whether or not the covered outpatient drug's cost would be in the top 5th percentile of Medicaid spending by comparing a manufacturer's published launch price (available as a published WAC or published by the manufacturer) to Medicaid per claim spending or if treatment costs are greater than $500,000 (indexed for inflation using the CPI-U).
                    </P>
                    <P>We expect application of the measures proposed at § 447.510(k)(2)(i) through (iv) would capture an initial set of high-cost CODs that could significantly impact Medicaid covered outpatient drug spending. From a process standpoint, in subregulatory guidance, we would provide the applicable time periods that CMS would review the data in order to determine the initial list of CODs, which we propose to be finalized in April following publication of this final rule, and each April thereafter. We expect that we would use data from the prior calendar year or Federal fiscal year. The list of CODs as a result of this analysis would not be made public.</P>
                    <P>We propose at § 447.510(k)(3) to further refine this initial survey list of CODs in the second step by considering additional criteria such as a manufacturer's willingness to negotiate further rebates either through a CMS-authorized supplemental rebate, or a manufacturer's participation in a CMS drug pricing program or initiative under which participating manufacturers negotiate directly with CMS (see discussion above about proposal to exclude drugs under a CMS drug pricing program or initiative). At § 447.510(k)(3)(i), CMS proposes to exclude the CODs of manufacturers that participate in any CMS pricing program or initiative under which participating manufacturers negotiate a COD's price directly with CMS.</P>
                    <P>
                        CMS believes that a manufacturer's willingness to negotiate also may be demonstrated by the manufacturer's level of effort to work with States to make the identified COD more affordable, especially considering States' limited budgets. Therefore, by way of a State survey to determine a manufacturer's level of effort, we propose at § 447.510(k)(3)(ii) to further exclude covered outpatient drugs of manufacturers that have negotiated CMS-authorized supplemental rebates with at least 50 percent of the States, that when in combination with the Federal rebate results in a total (State and Federal) rebate for the drug of interest to total Medicaid spend (State and Federal) for the drug of interest, that is greater than the total Medicaid rebates (State and Federal) to total Medicaid drug spend for States that cover CODs only through fee-for-service, as reflected in the most recent Medicaid Financial Management Report (FMR).
                        <SU>41</SU>
                        <FTREF/>
                         The FMR reflects annual State expenditures collected on the CMS-64 report.
                        <SU>42</SU>
                        <FTREF/>
                         We propose to use the Federal fiscal year Medicaid FMR and analyze the rebates for those States that currently provide coverage of covered outpatient drugs only through fee-for-service (fee-for-service States). Specifically, we would determine total computable prescribed drugs expenditures for the States that cover CODs only through fee-for-service (currently 10 States) and determine the percentage of prescribed drug expenditures that are offset by State and Federal drug rebates. We propose to consider only States that cover CODs entirely through fee-for-service because the prescribed drugs expenditures in the FMR do not include COD expenditures made by managed care entities, while the rebate lines do include the managed care rebate offset. In other words, the denominator in the comparison of rebates to total expenditures would be understated, resulting in a higher percentage, if we included managed care COD expenditures and rebates in the calculation. Based upon the Federal fiscal year 2021 Medicaid FMR, the total Federal and State rebates range from 38 percent to 72 percent of total prescribed drug expenditures based upon analysis of eight States that pay for CODs entirely through fee-for-service (2 of the 10 such States had insufficient data reported for Federal fiscal year (FFY) 2021). We request comment on this proposal to refine the list of covered outpatient drugs to be surveyed, based upon a manufacturer's level of effort at reducing the price for the identified high cost drugs (that is, those drugs identified by applying measures proposed at § 447.510(k)(2)).
                    </P>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             
                            <E T="03">https://www.medicaid.gov/medicaid/financial-management/state-expenditure-reporting-for-medicaid-chip/expenditure-reports-mbescbes/index.html</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             
                            <E T="03">https://www.medicaid.gov/medicaid/financial-management/state-expenditure-reporting-medicaid-chip/index.html</E>
                            .
                        </P>
                    </FTNT>
                    <P>We also propose § 447.510(k)(3)(iii)(A) that if after application of § 447.510(k)(3)(i) and (ii), more than 10 CODs still remain, CMS would proceed to the third step and consider soliciting State-specific Medicaid program information as to the manufacturer's level of effort to lower drug price for the Medicaid program, such as a manufacturer offering other programs to lower the cost of the drug to the State such as subscription models, VBP arrangements under the multiple best price approach, or other special arrangements. We do not intend these examples of manufacturer effort to lower drug prices in § 447.510(k)(3)(iii)(A) to be exclusive or to encourage or discourage specific pricing approached; CMS recognizes that the pharmaceutical pricing market is fluid and States and manufacturers may pursue or negotiate arrangements not specifically listed in regulation. Additionally, we propose at § 447.510(k)(3)(iii)(B) that we would consider narrowing the list based on the highest cost CODs based on the factors outlined under § 447.510(k)(2) of this section, and before application of § 447.510(k)(3). We propose to collect the information in § 447.510(k)(3)(ii) and (k)(3)(iii)(A) using a State survey tool that we would develop if the rule is finalized as proposed. Once CMS determines a final list of CODs to be verified after the application of 447.510(k)(3), we would send a letter to the manufacturers of the identified drugs sometime in August, as discussed further below.</P>
                    <P>
                        While currently not proposed in regulation at § 447.510(k)(2) and (3), we also invite comments on whether CMS should consider surveying manufacturers of certain CODs that are identified under the proposed criteria at § 447.510(k)(2)(i) through (iv) that are also granted accelerated approval by FDA. The approval of a COD using the accelerated approval pathway relies on demonstrating an effect on surrogate or intermediate endpoint(s) that is reasonably likely to predict clinical benefit. Drug sponsors have been required by the FDA to conduct confirmatory trials after approval to verify and describe the predicted clinical benefit. However, the HHS OIG 
                        <SU>43</SU>
                        <FTREF/>
                         found that drug sponsors do not always complete trials promptly, which can result in drugs staying on the market—often at high prices with limited competition—and being administered for years with unverified clinical benefit. Subjecting accelerated approval drugs to the drug price verification survey process would not supplant any determination made by the FDA. However, CMS surveying manufacturers for verification of prices may be warranted by recent trends of high costs of some of these therapies, particularly in view of some manufacturers' noncompliance with FDA's requirement for further confirmatory trials. Accordingly, we seek comments regarding whether CODs included on the list under the proposed 
                        <PRTPAGE P="34273"/>
                        § 447.510(k)(2) that are approved under the FDA accelerated approval pathway should be surveyed when a manufacturer has failed to demonstrate the clinical benefits of the drug through further confirmatory trials required by the FDA.
                    </P>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             
                            <E T="03">https://oig.hhs.gov/oei/reports/OEI-01-21-00401.asp</E>
                            .
                        </P>
                    </FTNT>
                    <P>We propose at § 447.510(k)(4) that after a survey list of CODs is compiled after the application of the criteria in § 447.510(k)(2) and (3), the agency would post on a publicly accessible, government website the letter sent to the manufacturer indicating the name of the COD to be surveyed and the request for completion of the drug price verification survey.</P>
                    <P>In proposed § 447.510(k)(5), we propose that such survey to a manufacturer or wholesaler would request in a standard reporting format specific information that would include the information proposed at § 447.510(k)(5)(i) through (iv). The survey tool would be developed after the publication of the final rule, if this proposal is finalized.</P>
                    <P>In § 447.510(k)(5)(i), we propose to collect information on the pricing, charges, distribution and utilization for the COD. We propose to collect these utilization and pricing metrics from manufacturers to verify that the prices reported at section 1927(b)(3)(A) of the Act do not have the potential to negatively impact State budgets to the extent States are not able to cover the drugs, thus impeding Medicaid beneficiary access to treatment.</P>
                    <P>In § 447.510(k)(5)(ii), we propose to collect product and clinical information for the COD described in the proposed regulation text at § 447.511(k)(5)(ii)(A) through (E) to understand the clinical benefits and risks of the covered outpatient drug to verify that the price reported fairly represents the benefits and/or risks of the COD.</P>
                    <P>In § 447.510(k)(5)(iii), we propose to collect information on the costs of production, research, and marketing of the COD. We believe it is important to understand the costs to the manufacturer of researching, producing, and marketing of the drug and how those costs are accounted for in the prices and charges they report. We also note in this proposed subparagraph that research and development costs of a line extension drug shall not include the research and development costs of the initial single source or innovator multiple source covered outpatient drug.</P>
                    <P>In § 447.510(k)(5)(iv), we propose to collect other information as determined by the Secretary specific to the particular COD in question that would help inform CMS and States with their verification of drug prices. This additional information would likely be specific to each individual covered outpatient drug and may include additional requests associated with changes to the pharmaceutical marketplace. We may consider issuing additional guidance on the nature and scope of the other information we may request.</P>
                    <P>The agency understands that some of the data proposed to be collected would be confidential and likely protected under section 1927(b)(3)(D) of the Act, in addition to other privacy and confidentiality provisions, including the Trade Secrets Act.</P>
                    <P>Although the statute does not prescribe a method to verify prices or charges, we propose in § 447.510(k)(6) that CMS may post non-proprietary information provided by the manufacturer and wholesaler in response to the verification survey. By posting the non-proprietary information on our website, the public, beneficiaries, State Medicaid agencies, other Federal Government agencies and other affected interested parties would be afforded the opportunity to comment on public information as part of the verification process to ensure that those Medicaid payments are economical and efficient, as well as sufficient, to provide access to care and are sufficient to enlist enough providers so that care and services are available at least to the extent that such care and services are available to the general population in the geographic area.</P>
                    <P>Finally, section 1927(b)(3)(B) of the Act allows the Secretary to impose a civil monetary penalty in an amount not to exceed $100,000 on a wholesaler, manufacturer, or direct seller, if the wholesaler, manufacturer, or direct seller of a covered outpatient drug refuses a request for information about charges or prices by the Secretary in connection with a survey as proposed under § 447.510(k) or knowingly provides false information. The provisions of section 1128A of the Act (other than subsections (a) (with respect to amounts of penalties or additional assessments) and (b)) shall apply to a civil money penalty (CMP) under this subparagraph in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a) of the Act. The civil monetary penalty authority set forth in section 1927(b)(3)(B) of the Act has been delegated to OIG. We would provide information obtained through, and in connection with, this survey to OIG for the purposes of potential imposition of CMPs for failure to report information in connection with a survey or for knowingly providing false information. Therefore, we propose at § 447.510(k)(7) that if a manufacturer or wholesaler refuses a request for information pursuant to a drug price verification survey within 90 calendar days of CMS' request, or knowingly provides false information, the manufacturer or wholesaler would be referred to OIG for possible imposition of civil monetary penalties (CMPs) as set forth in section 1927(b)(3)(B) of the Act and section IV of the National Drug Rebate Agreement.</P>
                    <HD SOURCE="HD2">K. Proposals Related to State Plan Requirements, Findings, and Assurances (§ 447.518)</HD>
                    <P>Section 1902(a)(30)(A) of the Act requires that States include in their State Plan, methods and procedures to ensure that payments to providers are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available to the general population in the geographic area. Under that authority, the Secretary issued Federal regulations at §§ 447.502, 447.512, and 447.518 that further elaborate that generally, payments to pharmacies for drugs that they dispense, and are paid for under the State Plan, are to be based on a two-part formula which consists of: (1) the ingredient cost of the drug that is dispensed based on the actual acquisition cost (AAC); and, (2) a professional dispensing fee (PDF) for the drug based on the pharmacy's cost of dispensing, that is, the cost of the pharmacist's professional services for ensuring that the appropriate COD is dispensed or transferred to a Medicaid beneficiary.</P>
                    <P>AAC is defined at § 447.502 to mean the agency's determination of the pharmacy providers' actual prices paid to acquire drug products marketed or sold by specific manufacturers. As discussed in the COD final rule implementing this definition of AAC, a State can implement an AAC model of reimbursement based on various pricing methodologies for the ingredient cost of the drug so long as the ingredient cost represents the actual, current ingredient cost of the drug and is calculated based on the amounts that pharmacies pay for the drug (§ 447.518).</P>
                    <P>
                        We also discussed our view that the definition of AAC requires that States establish payment rates based on pharmacies' actual prices paid to acquire drug products, and explained that the expectation is that those prices would reflect current prices (see 81 FR 5176). In accordance with § 447.502, the professional dispensing fee is incurred at the point of sale or service and pays for pharmacy costs in excess of the 
                        <PRTPAGE P="34274"/>
                        ingredient cost of a COD each time a COD is dispensed. The fee includes, but is not limited to, reasonable costs associated with delivery, special packaging and overhead associated with maintaining the facility and equipment necessary to operate the pharmacy. Costs also include a pharmacist's time spent checking the computer for information about an individual's coverage, performing drug utilization review (DUR) and preferred drug list review activities, measuring or mixing, filling the prescription, counseling a beneficiary; and physically providing the completed prescription to the Medicaid beneficiary.
                    </P>
                    <P>Under § 447.518, States are required to ensure that pharmacy providers are reimbursed adequately for both their pharmacy ingredient costs and professional dispensing services in accordance with the requirements of section 1902(a)(30)(A) of the Act. The State Plan must comprehensively describe the agency's payment methodology for prescription drugs, including the agency's payment methodology for drugs and the professional dispensing fee. As provided under § 447.518(d)(1), when proposing changes to either AAC (ingredient cost reimbursement) or PDF reimbursement, States are required to evaluate their proposed changes consistent with section 1927 of the Act, and must consider both parts of the reimbursement formula to ensure that total reimbursement under the proposed changes are consistent with section 1902(a)(30)(A) of the Act.</P>
                    <P>These reimbursement formulas and any proposals to change either or both components of the reimbursement formula are subject to review and approval by CMS through the State Plan Amendment (SPA) process. In their SPA submission, States must provide adequate data such as a State or national survey of retail pharmacy providers or other reliable data (other than a survey) to support any proposed changes to either or both of the components of the reimbursement methodology.</P>
                    <P>While States are afforded the flexibility to adjust their professional dispensing fees through the SPA process in accordance with the requirements of sections 1902(a)(30)(A) and 1927 of the Act, they must substantiate how their reimbursement to pharmacy providers reasonably reflects the actual cost of the ingredients used to dispense the drug, and the actual costs of dispensing the drug, consistent with the regulatory definitions of AAC and professional dispensing fee. We review each State's proposed reimbursement methodology to assure it meets Federal requirements under sections 1902(a)(30)(A) and 1927 of the Act, and the implementing regulations, specifically at §§ 447.502, 447.512, and 447.518.</P>
                    <P>More recently, we have seen States submit proposed changes to either or both of the components of the reimbursement methodology without adequate supporting data that reflects current drug acquisition cost prices or actual costs to dispense. This is inconsistent with applicable law because the data submitted should reflect the actual cost of dispensing, consistent with Federal requirements under sections 1902(a)(30)(A) and 1927 of the Act and the implementing regulations, specifically at §§ 447.502, 447.512 and 447.518.</P>
                    <P>The professional dispensing fee should be based on pharmacy cost data, and not be based on a market-based review, such as an assessment or comparison of what other third-party payers may reimburse pharmacies for dispensing prescriptions. A State's periodic review and examination of market-based research for a comparison of what other payers reimburse for dispensing costs is an insufficient basis for determining or proposing changes to professional dispensing fees because it does not reflect actual costs to pharmacies to dispense prescriptions. The State must submit adequate cost data to CMS as part of its SPA process to justify its professional dispensing fee amounts. We are proposing that the data submitted cannot solely rely on the amounts that pharmacies are accepting from other private third-party payers.</P>
                    <P>Similarly, with respect to reimbursement of drug ingredient costs, which must be consistent with AAC, States must support determinations or proposed changes for ingredient cost reimbursement with adequate cost based data. With respect to the AAC, we discussed in the preamble of the COD final rule our view that the definition of AAC requires that States establish payment rates based on pharmacies' actual prices paid to acquire drug products, and explained that the expectation is that those prices would reflect current prices. (See 81 FR 5176.)</P>
                    <P>Pharmacy purchase prices for drugs are subject to many external factors and market conditions which can cause purchase prices to go up or down. Many of these factors are out of the control of the purchasing pharmacy. We explained various ways States could establish pharmacy reimbursement methodologies, noting that the pricing benchmarks CMS provide to States, for example, the weekly NADAC files, and the weekly and monthly AMP are updated regularly to reflect current prices.</P>
                    <P>After the COD final rule was issued, we issued further guidance to States in the State Medicaid Directors Letter, SHO #16-001, dated February 11, 2016, and Frequently Asked Questions (FAQs), dated July 6, 2016. In that SHO, CMS provided further detail on ways States can implement an AAC model of reimbursement, including utilizing a nationwide survey, like the NADAC files (which are published on a monthly basis and updated weekly, and are designed to represent a current national pricing methodology based upon a simple average of voluntarily-submitted retail pharmacy acquisition costs for most covered outpatient drugs), a State survey of retail community pharmacy providers' pricing, published compendia prices, or average manufacturer price-based pricing. In each of these instances, the ingredient cost represents the actual, current ingredient cost of the drug and is calculated based on the amounts that pharmacies pay for the drug.</P>
                    <P>Freezing AAC rates and establishing a static provider reimbursement would not be consistent with applicable laws and regulations. Reduced beneficiary access to medically necessary drugs can result if pharmacy providers are unable to purchase drugs at a rate reflective of current market conditions. Pharmacies are not likely to purchase and dispense a covered outpatient drug to a Medicaid beneficiary if the reimbursement for the drug is not sufficient. Certain pharmacies, such as small rural pharmacies, rely primarily on revenue from prescriptions. When reimbursement rates for drugs do not adapt to changing market conditions, pharmacies may stop filling prescriptions for Medicaid beneficiaries, or, depending on the number of Medicaid prescriptions they fill, could have to permanently go out of business. This can result in reduced access to medications and negatively impact health equity, as Medicaid beneficiaries may have to go to multiple pharmacies to obtain the medication, or may not be able to obtain it at all. This can also result in the need for other costlier medical interventions, such as hospitalization.</P>
                    <P>
                        In this proposed rule, we are proposing to clarify the data requirements that States must submit to establish the adequacy of both the current ingredient cost and the professional dispensing fee reimbursement. Furthermore, we are specifying professional dispensing fees cannot simply be determined by a market-based review of what other 
                        <PRTPAGE P="34275"/>
                        third-party payers may reimburse for dispensing prescriptions. That is, we are proposing to clarify in regulatory text that in a State's periodic review of the rates being paid to pharmacies, the examination of market-based research data used to justify dispensing costs is an inappropriate basis for determining professional dispensing fees. A State cannot rely on the amounts that pharmacies are accepting from other third-party payers as a means of determining professional dispensing costs. The data that are acceptable could be a State's own survey, a neighboring States' survey, or other credible survey data, but it must be adequate and must reflect the current cost of dispensing a prescription in the State (81 FR 5311).
                    </P>
                    <P>To pay based on costs, States need to periodically assess whether current rates being paid to pharmacies to reflect current costs. There is no specific requirement as to how often and when States have to review their current fees. However, any State currently reimbursing pharmacy providers a professional dispensing fee that does not reflect the pharmacy's actual acquisition cost and cost of dispensing must come into compliance.</P>
                    <P>Therefore, in consideration of ensuring that payments to providers are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers, we believe an update to the regulatory text is necessary so that care and services continue to be available to the general population. Accordingly, we are proposing to update § 447.518(d) heading as “Data requirements” and to include paragraph (d)(1) as set out at in the regulatory text at the end of this document.</P>
                    <P>Updating this language would assure that States provide adequate data to establish pharmacy reimbursement for ingredient costs and professional dispensing fees, and that such reimbursement is based on current actual costs.</P>
                    <HD SOURCE="HD2">L. Federal Financial Participation (FFP): Conditions Relating to Physician-Administered Drugs (§ 447.520)</HD>
                    <P>Generally, physician-administered drugs (PADs) may satisfy the definition of a covered outpatient drugs (COD) under section 1927(k)(2) of the Act, subject to the limiting definition at section 1927(k)(3) of the Act, and manufacturer rebates can be collected on these PADs.</P>
                    <P>Prior to section 6002 of the DRA of 2005, which added sections 1927(a)(7) and 1903(i)(10)(C) to the Act to require the States to collect and submit certain utilization data on certain PADs in order for FFP to be available for these drugs, and for States to secure rebates, many States did not collect rebates on PADs when they were not identified by a National Drug Code (NDC) number because the NDC number is necessary for States to bill manufacturers for rebates. The NDC identifies the specific manufacturer, product, and package size.</P>
                    <P>
                        In the past, many PADs were classified by Healthcare Common Procedure Coding System (HCPCS) 
                        <SU>44</SU>
                        <FTREF/>
                         codes (commonly referred to as J-codes), which group together different manufacturers of the same drug in the same code. These broad codes cannot be used to bill for rebates, as they do not identify the specific manufacturer. Many providers were submitting only these HCPCS codes to the States, rather than the NDC code of the specific drug, making it difficult for the State to bill for rebates.
                    </P>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             HCPCS is a collection of standardized codes that represent medical procedures, supplies, products and services. The codes are used to facilitate the processing of health insurance claims by Medicare and other insurers. HCPCS is divided into two subsystems, Level I and Level II. Level I is comprised of Current Procedural Terminology codes (HCPT). Level II HCPCS codes identify products, supplies, and services not included in CPT.
                        </P>
                    </FTNT>
                    <P>
                        In its report titled “Medicaid Rebates for Physician Administered Drugs” (April 2004, OEI-03-02-00660),
                        <SU>45</SU>
                        <FTREF/>
                         the OIG reported that, by 2003, 24 States either required providers to bill using NDC numbers or identified NDC numbers using a HCPCS-to-NDC crosswalk for PADs to collect rebates. Four of the 24 States were able to collect rebates for all PADs, both single source and multiple source drugs (one State only collected these rebates from targeted providers).
                    </P>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             
                            <E T="03">https://oig.hhs.gov/oei/reports/oei-03-02-00660.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>To address this situation, and to increase the rebates being invoiced by States for PADs, section 6002 of the DRA added sections 1927(a)(7) and 1903(i)(10)(C) to the Act to require the States to collect and submit certain utilization data on certain PADs in order for FFP to be available for these drugs, and for States to collect manufacturer rebates. More specifically, these provisions required that for payment to be available under section 1903(a) of the Act for a COD that is a PAD, States had to provide for the collection and submission of utilization data and coding (such as J-codes and NDC numbers) for a PAD that is a single source (after January 1, 2006) or a multiple source drug (after January 1, 2008) that is a top 20 high dollar volume PAD on a published list (based on highest dollar volume dispensed under Medicaid identified by the Secretary, after January 1, 2007) that the Secretary may specify in order for payment to be available under section 1903 of the Act and for States to secure applicable Medicaid rebates.</P>
                    <P>This list of the top 20 multiple source drugs may be modified year to year to reflect changes in such volume. (See section 1927(a)(7)(B)(i) of the Act.) The statute also required that only NDCs be used after January 1, 2007 for billing for all PADs that are CODs, unless the Secretary authorized that another alternative coding system be used. If States are not collecting NDCs and submitting the appropriate utilization data for these drugs, States should not receive Federal matching payments. In addition, States would be foregoing available rebates for these drugs.</P>
                    <P>Regulations at § 447.520 were established to implement these statutory provisions in the 2007 Medicaid Program; Prescription Drugs; Final Rule, specifying the conditions for FFP for PADs (72 FR 39142). Section 447.520(a) specifies that no FFP is available for PADs if the State has not required the submission of codes from its providers that allow it to appropriately bill manufacturers for rebates for PADs. For single source PADs, the requirement to submit appropriate coding went into effect as of January 1, 2006, and specifies under § 447.520(a)(1) that States must require providers to submit claims for single source PADs using HCPCS or NDC codes to secure rebates. Section 447.502(a)(2) further specifies that as of January 1, 2007, a State must require providers to submit claims for single source and the top 20 multiple source PADs identified by the Secretary, using NDC codes.</P>
                    <P>Under § 447.520(b), as of January 1, 2008, a State must require providers to submit claims for the top 20 multiple source drugs identified by the Secretary as having the highest dollar volume using NDC numbers to secure rebates, and § 447.520(c) provided the opportunity for States that require additional time to comply with the requirements of the applicable laws and regulations to apply for an extension to comply with the requirements. We proposed to retain this current regulatory language without modification in the 2012 COD proposed rule (77 FR 5367) and since no comments were received on that proposal, the current regulations were finalized without any modifications in the 2016 COD final rule. See 81 FR 5322.</P>
                    <P>
                        We propose to update the regulatory language at § 447.520 to more 
                        <PRTPAGE P="34276"/>
                        specifically and accurately conform with the statutory requirements captured at section 1927(a)(7) of the Act. In proposed § 447.520(a)(1) through (3) we specify the conditions under which FFP is available for States, as they relate to the codes they must require providers to use in order for the State to secure rebates for PADs that are CODs. The proposed language clarifies that rebates are only due for PADs that are CODs, and provides the conditions that data must be submitted by providers in the State in order for States to receive FFP and secure applicable rebates. We are proposing at § 447.520(b) a State require providers to submit claims for all covered outpatient drug single source and multisource physician-administered drugs using NDC numbers to collect FFP and secure rebates.
                    </P>
                    <P>
                        States also need to ensure that their managed care plans report required drug utilization data in order for States to invoice manufacturers for rebates for CODs, consistent with § 438.3(s)(2) and (3), which were adopted in the 2016 Medicaid Managed Care final rule.
                        <SU>46</SU>
                        <FTREF/>
                         Per § 438.3(s)(2) and (3), an MCO, PIHP or PAHP that covers CODs under its Medicaid managed care contract must (1) report drug utilization data to the State that is necessary for the State to bill manufacturers for rebates under section 1927 of the Act using NDC numbers for all CODs, including all single and multiple source PADs; and, (2) establish procedures to exclude utilization data for covered outpatient drugs that are subject to discounts under the 340B Drug Pricing Program from those reports if the State does not require submission of managed care drug claims data from covered entities directly to the State.
                    </P>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             86 FR 27498, May 6, 2016 (
                            <E T="03">https://www.govinfo.gov/content/pkg/FR-2016-05-06/pdf/2016-09581.pdf</E>
                            ).
                        </P>
                    </FTNT>
                    <P>Additionally, we are proposing at § 447.520(c) to continue to publish the top 20 list of multiple source PADs on an annual basis, as statutorily required, but it is our expectation that States would invoice rebates for all multiple source physician-administered drugs that are CODs. This section would make it clear that States are required to invoice for rebates for multiple source PADs on this list to receive Federal matching funds and to secure rebates. The proposed regulation would specify to States that they should invoice for rebates for all multiple source PADs that are CODs, and not limit such rebate invoicing to the top 20 high dollar volume list. As technology and systems are currently in place, this proposed regulation would reduce the administrative burden of monitoring any revisions to the top 20 multiple source PADs and allow States to secure rebates for these PADs that are CODs.</P>
                    <HD SOURCE="HD2">M. Request for Information on Requiring a Diagnosis on Medicaid Prescriptions</HD>
                    <P>Generally, a COD is a prescribed drug approved under section 505(c) or 505(j) of the FFDCA or section 351 of the Public Health Service (PHS) Act when used for a medically accepted indication. The term “medically accepted indication” is defined in statute at section 1927(k)(6) of the Act and means any use for a COD which is approved under the FFDCA or the use of which is supported by one or more citations included or approved for inclusion in compendia described in section 1927(g)(1)(B)(i) of the Act, which is the American Hospital Formulary Service-Drug Information (AHFS-DI), Drugdex, or United States Pharmacopoeia-Drug Information (USP-DI). Medicaid COD claims do not currently require a diagnosis code as a condition for payment. When reviewing claims, without a diagnosis, it is difficult to determine whether a drug is indeed being used for a medically accepted indication, and appropriately satisfies the definition of a COD, and therefore, is rebate eligible. Despite statutory language limiting Medicaid payment for covered outpatient drugs to when used for a “medically accepted indication,” there are not systems in place for States to determine whether a patient's outpatient prescription drug use is in fact for a medically accepted indication, or in other words, there is no mechanism to cross-reference a prescription drug use with a Medicaid patient's medical diagnoses to ensure a drug is being used for a medically accepted indication.</P>
                    <P>
                        In 2011, the OIG discovered in a Medicare audit that without a diagnosis, it is difficult for Part D sponsors to determine whether a drug claim is medically appropriate.
                        <SU>47</SU>
                        <FTREF/>
                         OIG stated that without access to diagnosis information, Part D sponsors cannot determine the indications for which drugs were used. Although this audit referenced Medicare, the same issue is applicable to Medicaid prescriptions. If States are not aware of the diagnosis for which the medication is being used, they are unable to determine if the drug is being used for a medically accepted indication and cannot determine if they should bill for rebates or if coverage is mandatory. Additionally, an article written by then Principal Deputy Inspector General (and now current Inspector General) and Chief Medical Officer from OIG. recently advocated for a new mandate that physicians include a diagnosis code with prescriptions.
                        <SU>48</SU>
                        <FTREF/>
                         In 2011, CMS did not concur with OIG's finding, stating that diagnosis information is not a required data element of pharmacy billing transactions, nor is it generally included on prescriptions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             
                            <E T="03">https://oig.hhs.gov/oei/reports/oei-07-08-00150.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             STAT Op-Ed by Christi A. Grimm &amp; Julie K. Taitsman | Office of Inspector General | Government Oversight | U.S. Department of Health and Human Services (
                            <E T="03">hhs.gov</E>
                            ).
                        </P>
                    </FTNT>
                    <P>
                        Since 2011, automation of prescribing has grown significantly, and in 2020 an estimated 84 percent of all prescriptions were e-prescriptions.
                        <SU>49</SU>
                        <FTREF/>
                         Electronic prescribing has increased so much so that in early 2021, most prescriptions for controlled substances under Medicare Part D must be transmitted electronically.
                        <SU>50</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             E-prescription rate U.S. 2020 | Statista available at 
                            <E T="03">https://www.statista.com/statistics/864380/share-of-us-e-prescriptions/?msclkid=a1c545e9b44d11ec81f5391e8e8d23cb</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             E-Prescribing | CMS available at 
                            <E T="03">https://www.cms.gov/Medicare/E-Health/Eprescribing?msclkid=27a13cf3b44e11ecb30d5dd85675d203</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        There are several instances in which a diagnosis on a prescription could help States implement certain Medicaid programs in which they are eligible for enhanced Federal matching funds, or for which they must implement a mandatory benefit. Federal funds support States in responding to the increased need for services, such as testing and treatment during the COVID-19 public health emergency, family planning, or allows States to provide innovative treatment services. For certain conditions, an increase in States' Federal medical assistance percentage (FMAP) leverages Medicaid's existing financing structure and allows enhanced Federal funds to treat that condition. For example, to be eligible for enhanced Federal funds in certain instances, such as when birth control drugs are used for family planning as opposed to other indications such as acne, moderate to severe abnormal vasomotor function, or postmenopausal osteoporosis the State needs to document when expenditures are being used to treat that condition. Without access to diagnosis information, States cannot accurately determine the indications for which drugs were used, especially when drugs have multiple indications, making identification of these costs very difficult, if not impossible, and very resource intensive. For example, if a family planning drug has multiple indications, and the family planning indication is eligible for enhanced Federal matching, then the State will only know when the drug is 
                        <PRTPAGE P="34277"/>
                        being used for birth control if there is a related diagnosis on the prescription. A requirement of diagnosis on prescriptions would allow States to easily and accurately identify drug expenditures qualifying for these enhanced Federal matching funds. State programs will be able to better determine if prescriptions meet payment requirements and can more accurately capture expenditures required for Federal matching.
                    </P>
                    <P>There are additional benefits for adding diagnosis on prescriptions for both providers and beneficiaries. For example, practitioners and beneficiaries benefit from systematic authorizations that are diagnosis based. Vulnerable groups, such as pregnant women, or specific diagnoses (COVID-19) can be easily exempt from out-of-pocket costs and copayments for certain services or conditions. Diagnosis information on prescriptions can help pharmacists identify safety issues and helps supplement prior DUR standards under section 1927(g) of the Act in ensuring prescriptions are appropriate, medically necessary, and not likely to result in adverse medical results. Adding diagnosis to prescriptions can contribute to safer prescribing, improved patient outcomes and medication use in multiple, synergistic ways. Including diagnosis on prescriptions may be a way to ensure drugs are being only used for FDA approved indications. State Medicaid programs may also be able to better manage drug utilization by mandating diagnosis codes on drug claims to ensure payments are limited to drugs with medically accepted indications as required by statute.</P>
                    <P>Finally, we believe, if such a provision were implemented, that the design and implementation of any adjudication specifications would be left to the States' discretion to meet State-specific needs. Given this flexibility, States can continue to monitor and fine-tune program specifics as they determine what works best for their population's health and well-being. For continuity of care among programs, if this provision was implemented in the future, we envision all Medicaid managed care programs would be included in this requirement, including MCOs, PIHPs, or PAHPs.</P>
                    <P>There are many interested parties that would have views on this requirement to include diagnosis on a prescription: patients, prescribers, pharmacists, States, and drug manufacturers. We are specifically soliciting comments on this topic, its impact on beneficiaries, providers, States, Medicaid, and any operational implications. We are particularly interested in understanding the burden with such a proposal and seeking comments on how to negate any foreseeable impact on beneficiaries and providers and steps which would be needed by States to successfully implement a Medicaid requirement for diagnosis on prescriptions as a condition of FFP. We are requesting comments regarding the potential impact of supporting such a policy to require Medicaid diagnoses on prescriptions on payment, health care quality, stigma and access to care, and program integrity. We are also requesting comments on what steps we should take to protect beneficiary access to commonly used, medically accepted, compendia supported, off-label prescriptions if we propose to implement such a policy. We are seeking comments from all interested parties on potential approaches and invite all comments on this topic.</P>
                    <HD SOURCE="HD1">III. 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” requirement is submitted to the Office of Management and Budget (OMB) for review and approval. For the purposes of the PRA and this section of the preamble, collection of information is defined under 5 CFR 1320.3(c) of the PRA's implementing regulations.
                    </P>
                    <P>To fairly evaluate whether an information collection 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 (see section III.D. of this proposed rule) on each of these issues for the following sections of this document that contain collection of information requirements. Comments, if received, will be responded to within the subsequent final rule.</P>
                    <HD SOURCE="HD2">A. Wage Estimates</HD>
                    <P>
                        To derive average costs, we used data from the U.S. Bureau of Labor Statistics' (BLS') May 2021 National Occupational Employment and Wage Estimates for all salary estimates (
                        <E T="03">http://www.bls.gov/oes/current/oes_nat.htm</E>
                        ). In this regard, Table 3 presents BLS' 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>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12C,12C,12C,12C">
                        <TTITLE>Table 3—National Occupational Employment and Wages Estimates</TTITLE>
                        <BOXHD>
                            <CHED H="1">Occupation title</CHED>
                            <CHED H="1">
                                Occupation
                                <LI>code</LI>
                            </CHED>
                            <CHED H="1">
                                Mean hourly
                                <LI>wage</LI>
                                <LI>($/hr)</LI>
                            </CHED>
                            <CHED H="1">
                                Fringe
                                <LI>benefits and</LI>
                                <LI>other indirect costs</LI>
                                <LI>($/hr)</LI>
                            </CHED>
                            <CHED H="1">
                                Adjusted
                                <LI>hourly wage</LI>
                                <LI>($/hr)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Operations Research Analyst</ENT>
                            <ENT>15-2031</ENT>
                            <ENT>46.07</ENT>
                            <ENT>46.07</ENT>
                            <ENT>92.14</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>As indicated, we are adjusting our hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because 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. Nonetheless, we believe that doubling the hourly wage to estimate the total cost is a reasonably accurate estimation method.</P>
                    <HD SOURCE="HD2">B. Proposed Information Collection Requirements (ICRs)</HD>
                    <HD SOURCE="HD3">1. ICRs Regarding Identification and Notification to Manufacturer To Correct Misclassification (§ 447.509(d)(1) Through (4))</HD>
                    <P>
                        As discussed in section II.F.1.a. of this proposed rule, we are proposing to add 
                        <PRTPAGE P="34278"/>
                        new paragraphs (d)(1) through (4) to § 447.509 that would add new requirements relating to the process by which CMS would identify when a misclassification of a drug has occurred in MDRP and subsequently notify the manufacturer of the misclassified drug. As such, a manufacturer's efforts to address the misclassification is currently approved by OMB under control number 0938-0578 (CMS-367). This package currently takes into account the time and cost incurred by manufacturers when compiling and reporting, or changing, Medicaid drug product and price information on a monthly, quarterly, and on an as-needed basis. The burden, however, is subject to a regulatory impact analysis which can be found in section V. of this proposed rule.
                    </P>
                    <HD SOURCE="HD3">2. ICRs Regarding Definitions (§ 447.502)</HD>
                    <P>As discussed in section II.C.1.d. of this proposed rule, we are proposing to modify the definition of manufacturer for NDRA purposes. The modification would establish a regulatory definition of manufacturer for purposes of satisfying the requirement that a manufacturer maintain an effectuated rebate agreement with the Secretary consistent with section 1927(a)(1) of the Act. Specifically, we are proposing that the term “manufacturer” means that all associated labeler entities of the manufacturer that sell CODs, including, but not limited to, owned, acquired, affiliates, brother or sister corporations, operating subsidiaries, franchises, business segments, part of holding companies, divisions, or entities under common corporate ownership or control, must each maintain an effectuated rebate agreement. The preparation and maintenance of an effectuated rebate agreement has been a long-standing requirement that we propose to codify in this rule. The effectuated rebate agreement requirement and burden are currently approved by OMB under control number 0938-0578 (CMS-367). This rule's proposed actions have no impact on our currently approved requirements and burden estimates and assumptions, including the universe of manufacturers. Consequently, we are not making any changes under that control number.</P>
                    <P>Additionally, we do not believe any of the following new terms and definition modifications and clarifications would require any effort or impose burden on any public or private entities: (1) proposal to modify the definition of “covered outpatient drug (§ 447.502), (2) proposal to define “drug product information” (§ 447.502), (3) proposal to define “market date” (§ 447.502), (4) proposal to modify the definition of “noninnovator multiple source drug” (§ 447.502), (5) proposal to clarify § 447.509(a)(6) through (9) and (c)(4) with respect to “other drugs”, and (6) proposal to define “vaccine for purposes of the MDRP only” (§ 447.502). Consequently, none of the definition changes are subject to the requirements of the PRA.</P>
                    <HD SOURCE="HD3">3. ICRs Regarding Proposals Related to State Plan Requirements, Findings, and Assurances (§ 447.518)</HD>
                    <P>As discussed in section II.K. of this proposed rule, we are proposing to specify in § 447.518(d)(1) that the professional dispensing fee (PDF) must be based on pharmacy cost data, and that it cannot be solely determined or supported by a market-based review or by an assessment or comparison of what other payers may reimburse pharmacies for dispensing prescriptions. The clarification also specifies the type of supporting data that we would accept as adequate to support a change to the PDF. The proposed clarification would not add any new or revised requirements or burden. If a State chooses to revise their State Plan for any updates to include a modification to their PDF, a SPA can be submitted to CMS for review and approval. The burden for such SPA submissions is currently approved by OMB under control number 0938-0193 (CMS-10398 #179 under attachment 4.19-B pertaining to the: methods and standards used for the payment of certain services, and methods and standards used for establishing payment rates for prescribed drugs). Since the proposed clarification would not add any new or revised requirements or burden, we are not making any changes under that control number.</P>
                    <HD SOURCE="HD3">4. ICRs Regarding Federal Financial Participation (FFP): Conditions Relating to Physician-Administered Drugs (§ 447.520)</HD>
                    <P>We propose to update § 447.520 to make it consistent with section 1927(a)(7) of the Act, and to codify the requirement that States must collect NDC information on all single and multiple source physician-administered drugs that are CODs for the purposes of invoicing manufacturers for rebates, and ensuring that FFP is available, as appropriate. We are proposing to require that States must be invoicing for rebates for all physician-administered drugs that are CODs. We propose to continue to publish the top 20 high dollar volume list of multiple source physician-administered drugs, as statutorily required, to provide a means of prohibiting Federal matching funds, as necessary, if States are not requiring the use of NDC codes, and invoicing for rebates on these drugs. This proposal would be applicable to all 50 States and the District of Columbia; however, we believe that this proposal would have no additional burden because States, based on their State Drug Utilization Data (SDUD) reported to CMS, are currently collecting NDC numbers for all CODs, including all single and multiple source physician-administered drugs and invoicing manufacturers for rebates as applicable under OMB control number 0938-1026 (CMS-10215). Since the proposed provisions would not add any new or revised requirements or burden, we are not making any changes under that control number.</P>
                    <HD SOURCE="HD3">5. ICRs Regarding Verification Survey of Reported CODs Through Data Collection (§ 447.510)</HD>
                    <P>
                        We are proposing at § 447.510(k) a process to survey wholesalers and manufacturers to verify prices and charges for certain CODs by requesting and collecting certain information about such prices and charges for a drug reported to us under section 1927(b)(3)(A) of the Act. The proposed survey instruments will be submitted to OMB for review after this proposed rule is finalized and our survey instruments (one for requesting information from States as proposed under § 447.510(k)(3)) and another for surveying manufacturers) have been developed. The tools are not ready yet, but will be made available to the public for its review under the standard non-rule PRA process which includes the publication of 60- and 30-day 
                        <E T="04">Federal Register</E>
                         notices. The CMS ID number for that package is CMS-10822 (OMB control number 0938-TBD 1). Since this would be a new collection of information request, the OMB control number has yet to be determined. OMB would issue that number upon its approval of the non-rule collection of information request. We are however setting out our preliminary burden figures (see below) as a means of scoring the impact of the proposed provisions.
                    </P>
                    <P>
                        Since the beginning of the MDRP in 1991, the Secretary has had the authority, under section 1927(b)(3)(B) of the Act, to survey wholesalers and manufacturers that directly distribute their covered outpatient drugs, when necessary, to verify manufacturer prices, such as AMP and ASP, including wholesale acquisition cost (WAC), reported under section 1927(b)(3)(A) of 
                        <PRTPAGE P="34279"/>
                        the Act, if required to make payment. Furthermore, section 1902(a)(30)(A) of the Act (42 U.S.C. 1396a(a)(30)(A)) requires that States have a State Plan that provides methods and procedures to ensure that such payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available at least to the extent that such care and services are available to the general population in the geographic area. Therefore, the agency has an overarching obligation under section 1902(a)(30)(A) of the Act to ensure that Medicaid payments are made in an efficient, economical, as well as sufficient manner to provide access to care.
                    </P>
                    <P>We have never used the section 1927(b)(3)(B) of the Act authority to survey manufacturers or wholesalers, nor have we interpreted this statutory section in regulation. Therefore, we are proposing at § 447.510(k) to identify a process to survey wholesalers and manufacturers to verify prices and charges for certain CODs by requesting and collecting certain information about such prices and charges for a drug reported to us under section 1927(b)(3)(A) of the Act. As part of the drug price verification survey process, CMS proposes to post the survey's non-proprietary information on its website.</P>
                    <P>In addition to the manufacturer survey, CMS also proposes to collect information from States to determine which drugs would be surveyed under § 447.510(k)(3). The simplified State survey would ask States whether or not manufacturers meet any of the criteria for excluding drugs from the list from application of § 447.510(k)(2) from such drug verification surveys, such as the level of manufacturer's effort in accordance with proposed § 447.510(k)(3)(ii). That is, the survey will ask a State if they were able to negotiate with the manufacturer a CMS-authorized supplemental rebate that when in combination with the Federal rebate results in a total (State and Federal) rebate that is greater than the average percentage of total national average Medicaid rebates (State and Federal) to total Medicaid drug spend as reflected in the most recent Medicaid Financial Management Report.</P>
                    <P>With regard to the State survey, we estimate that once a year, 52 respondents consisting of: the 50 States, the District of Columbia, and one territory participating in the Medicaid drug rebate program (Puerto Rico), would be surveyed to determine if manufacturers of high cost drugs are participating in negotiating supplemental rebates and any additional State Medicaid input under § 447.510(k)(3)(iii)(A). At this time, we estimate that the simplified State survey would take 15 minutes at $92.14/hr for an operations research analyst to complete. In aggregate, we estimate an annual burden of 13 hours ((52 surveys × 0.25 hr/survey) at a cost of $1,198 (13 hr × $92.14/hr). While CMS may seek additional information via non-standardized follow-up questions, the burden associated with such a request is not subject to the requirements of the PRA as described under 5 CFR 1320.3(h)(9).</P>
                    <P>With regard to the manufacturer survey, there are currently 792 labelers participating in the MDRP. While there is no way to know the exact number of labeler codes used by these manufacturers, most manufacturers have at least 2 labeler codes, so we are estimating approximately selecting from a universe of 396 (792 labelers/2 labeler codes) manufacturers could potentially be subject to completing a verification survey. However, the proposed requirement to survey would be limited to only when the Secretary determines it is necessary, such as when the drug prices reported under section 1927(b)(3)(A) of the Act exceed a proposed criteria. While we anticipate that there is the potential that 396 manufacturers may be eligible to receive a survey, we estimate that based upon the criteria proposed at § 447.510(k) for when a COD would be identified and selected and a manufacturer would be surveyed with respect to that drug, we would likely to undertake a minimum of three manufacturer surveys per year, with a maximum of ten surveys per year, taking 5 hours at $92.14/hr for an operations research analyst to complete the survey. So as to not under estimate the impact of this rule's proposed provisions, we are using the maximum of ten manufacturers surveyed per year. In aggregate, we estimate an annual burden of 50 hours (10 surveys × 5 hr/survey) at a cost of $4,607 (50 hr × $92.14/hr). While CMS may seek additional information via non-standardized follow-up questions, the burden associated with such a request is not subject to the requirements of the PRA as described under 5 CFR 1320.3(h)(9).</P>
                    <P>Through this proposed rule we are soliciting comments to help us develop the manufacturer survey and the State survey.</P>
                    <HD SOURCE="HD3">6. ICRs Regarding Standard Medicaid Managed Care Contract Requirements (§ 438.3(s))</HD>
                    <P>The following proposed changes regarding drug cost transparency in Medicaid managed care contracts will be submitted to OMB for review under control number 0938-TBD 2 (CMS-10855).</P>
                    <P>We are proposing to amend § 438.3(s) to require MCOs, PIHPs, and PAHPs that provide coverage of covered outpatient drugs to assign and exclusively use unique Medicaid-specific BIN, PCN, and group number identifiers on all issued Medicaid managed care beneficiary identification cards for pharmacy benefits. It is a usual and customary business practice for the MCOs, PIHPs, and PAHPs to routinely issue identification cards for pharmacy benefits, as they do routinely for all of their lines of business across the industry, to include commercial/private and public sector programs, such as Medicare and Medicaid. Since we believe that this is a usual and customary business practice that is exempt from the PRA (see 5 CFR 1320.3(b)(2)), we are not setting out such burden for managed care entities to program the new codes onto the cards and to issue such cards under this section of the preamble. The burden, however, is subject to a regulatory impact analysis which can be found in section V. of this proposed rule.</P>
                    <P>Additional proposed amendments to § 438.3(s) would require that MCOs, PIHPs, and PAHPs that provide coverage of covered outpatient drugs structure any contract with any subcontractor for the delivery or administration of the covered outpatient drug benefit to require the subcontractor to report separately the amounts related to:</P>
                    <P>(1) The incurred claims described in § 438.8(e)(2) such as reimbursement for the covered outpatient drug, payments for other patient services, and the fees paid to providers or pharmacies for dispensing or administering a covered outpatient drug; and</P>
                    <P>(2) Administrative costs, fees and expenses of the subcontractor.</P>
                    <P>
                        We estimate that the proposed reporting requirements would affect 282 managed care plans in the country and 40 States. We further estimate that it would take an operations research analyst at the State level, 25 hours at $92.14/hr to restructure 282 managed care contracts to require those plans to structure their subcontracts to require the subcontractor to separately report incurred claims expenses described in § 438.8(e)(2) from fees paid for administrative activities. In aggregate, we estimate a one-time burden of 1,000 hours (40 State responses × 25 hr/response) at a cost of $92,140 (1,000 hr × $92.14/hr).
                        <PRTPAGE P="34280"/>
                    </P>
                    <P>For the same contract changes between the MCOs and the subcontractors (mainly PBMs), we also estimate a one-time private sector burden of 7,050 hours (282 managed care plans × 25 hr/response) at a cost of $649,587 (7,050 hr × $92.14/hr).</P>
                    <P>With respect to the reporting burden, we estimate that 282 PBMs of those 282 managed care plans to separately report incurred claims expenses described in § 438.8(e)(2) from fees paid for administrative activities would take approximately 2 hours to identify these costs separately and report separately to the managed care plans. In aggregate we estimate an annual burden of 564 hours (282 PBMs × 2 hr/response) at a cost of $51,967 (564 hr × $92.14/hr).</P>
                    <HD SOURCE="HD2">C. Summary of Proposed Burden Estimates</HD>
                    <P>In Table 4, we present a summary of this rule's proposed collection of information requirements and associated burden estimates.</P>
                    <GPOTABLE COLS="8" OPTS="L2,nj,p7,7/8,i1" CDEF="s25,r50,r75,10,10,10,10,10">
                        <TTITLE>Table 4—Summary of Proposed Burden Estimates</TTITLE>
                        <BOXHD>
                            <CHED H="1">Regulatory section(s) under title 42 of the CFR</CHED>
                            <CHED H="1">
                                OMB control No.
                                <LI>(CMS ID No.)</LI>
                            </CHED>
                            <CHED H="1">
                                Number of
                                <LI>respondents</LI>
                            </CHED>
                            <CHED H="1">
                                Total
                                <LI>number of</LI>
                                <LI>responses</LI>
                            </CHED>
                            <CHED H="1">
                                Time per
                                <LI>response</LI>
                                <LI>(hr)</LI>
                            </CHED>
                            <CHED H="1">
                                Total time
                                <LI>(hr)</LI>
                            </CHED>
                            <CHED H="1">
                                Labor cost
                                <LI>($/hr)</LI>
                            </CHED>
                            <CHED H="1">
                                Total cost
                                <LI>($)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">§ 447.510</ENT>
                            <ENT>0938-TBD 1 (CMS-10822)</ENT>
                            <ENT>52 States</ENT>
                            <ENT>52</ENT>
                            <ENT>0.25</ENT>
                            <ENT>13</ENT>
                            <ENT>92.14</ENT>
                            <ENT>1,198</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">§ 447.510</ENT>
                            <ENT>0938-TBD 1 (CMS-10822)</ENT>
                            <ENT>10 manufacturers</ENT>
                            <ENT>10</ENT>
                            <ENT>5</ENT>
                            <ENT>50</ENT>
                            <ENT>92.14</ENT>
                            <ENT>4,607</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">§ 438.8(e)(2)</ENT>
                            <ENT>0938-TBD 2 (CMS-10855)</ENT>
                            <ENT>40 States</ENT>
                            <ENT>40</ENT>
                            <ENT>25</ENT>
                            <ENT>1,000</ENT>
                            <ENT>92.14</ENT>
                            <ENT>92,140</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">§ 438.8(e)(2)</ENT>
                            <ENT>0938-TBD 2 (CMS-10855)</ENT>
                            <ENT>282 managed care plans</ENT>
                            <ENT>282</ENT>
                            <ENT>25</ENT>
                            <ENT>7,050</ENT>
                            <ENT>92.14</ENT>
                            <ENT>649,587</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">§ 438.8(e)(2)</ENT>
                            <ENT>0938-TBD 2 (CMS-10855)</ENT>
                            <ENT>Subcontractor PBMs of the 282 managed care plans</ENT>
                            <ENT>282</ENT>
                            <ENT>2</ENT>
                            <ENT>564</ENT>
                            <ENT>92.14</ENT>
                            <ENT>51,967</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total</ENT>
                            <ENT>344</ENT>
                            <ENT>(52 States + 10 manufacturers + 282 managed care plans)</ENT>
                            <ENT>666</ENT>
                            <ENT>Varies</ENT>
                            <ENT>8,677</ENT>
                            <ENT>92.14</ENT>
                            <ENT>799,499</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD2">D. Submission of PRA-Related Comments</HD>
                    <P>We have submitted a copy of this proposed rule's information collection requirements to OMB for their review. 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 above, 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-2434-P), the ICR's CFR citation, and OMB control number.
                    </P>
                    <HD SOURCE="HD1">IV. 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 
                        <E T="02">DATES</E>
                         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>
                    <HD SOURCE="HD1">V. Regulatory Impact Analysis</HD>
                    <HD SOURCE="HD2">A. Statement of Need</HD>
                    <P>The intent of this proposed rule is to implement several new legislative requirements relating to the operation of the MDRP and other program integrity, and program administration proposals.</P>
                    <P>For example, section 6 of the MSIAA was signed into law on April 18, 2019. Section 6 of the MSIAA amended sections 1903 and 1927 of the Act to grant the Secretary additional authorities needed to address drug misclassification, drug pricing, and product data misreporting by manufacturers for purposes of the MDRP. This proposed rule includes policies to implement these new statutory authorities, as required.</P>
                    <P>This proposed regulation also aims to implement a provision in section 9816 of the American Rescue Plan Act of 2021, which amended section 1927(c)(2)(D) of the Act, by inserting a sunset date on the limitation on the maximum rebate amount for single source and innovator multiple source drugs, and other drugs.</P>
                    <P>We are also proposing several important MDRP program administration and integrity policies, which include the following: clarifying the definition of manufacturer for NDRA purposes; adopting a regulatory definition of vaccine for MDRP purposes; and, implementing a time limitation on manufacturer disputes and audits with States regarding rebates. This proposed rule also proposes to specify a number of existing policies, including: requirements for manufacturers for determining their best price for a covered outpatient drug; the requirements for State reimbursement for prescribed drugs, and the conditions relating to payment of FFP for PADs that are CODs dispensed and paid for under the State Plan.</P>
                    <P>We are proposing to include two new requirements for the contracts between States and their Medicaid managed care plans, specifically MCOs, PIHPs, and PHAPs. That is, States would be required to include in their contracts with MCOs, PIHPs, and PHAPs a requirement that each Medicaid enrollee's identification card used for pharmacy benefits would include a unique Medicaid-specific BIN/PCN. This inclusion of this unique Medicaid-specific BIN/PCN on these cards would have to be effective no later than the next rating period for Medicaid managed care contracts, following the effective date of the final rule adopting this new regulatory requirement. This requirement would assist providers in identifying patients as Medicaid beneficiaries.</P>
                    <P>In addition, we are proposing that Medicaid managed care plans that subcontract with a pharmacy benefit administrator or pharmacy benefit manager require the subcontractor to provide specific details to the Medicaid managed care plans about the various pharmacy and non-pharmacy (administrative) costs associated with providing the pharmacy benefit, so the managed care plan can appropriately calculate its Medicaid managed care MLR.</P>
                    <P>
                        Moreover, we are also proposing additional program integrity and administration policies including: amending the regulatory definition of noninnovator multiple source drug; adding regulatory definitions of a manufacturer's internal investigation; drug product information; market date; and, modifying the definition of COD. There is also included a proposal 
                        <PRTPAGE P="34281"/>
                        unrelated to MDRP; that, is a proposed revision to third party liability regulation resulting from statutory changes in the BBA 2018.
                    </P>
                    <P>We are solicitating comments relating to the issues, benefits and challenges of requiring a patient's diagnosis be included on Medicaid prescriptions, and the patient care and operational aspects of such a requirement. We are particularly interested in understanding the burden with such a proposal and seeking comments on how to mitigate any foreseeable impact on beneficiaries and providers, and steps which would be needed by States to successfully implement a Medicaid requirement for diagnosis on prescriptions.</P>
                    <P>On May 17, 2022, the United States District Court for the District of Columbia vacated and set aside the “accumulator adjustment rule of 2020” in response to a complaint filed against the Secretary regarding the accumulator provisions within the December 31, 2020 final rule.</P>
                    <P>The December 31, 2020 final rule had revised the various the regulatory patient assistance program exclusions from AMP and best price at §§ 447.504(c)(25) through (29) and (e)(13) through (17) and 447.505(c)(8) through (12), to add language (effective January 1, 2023), such that they would require manufacturers to “ensure” the full value of the assistance provided by these patient assistance programs is passed on to the consumer and that the pharmacy, agent, or other AMP or best price eligible entity does not receive any price concession, before excluding such amounts from the determination of best price or AMP. In response to the district court's order, we propose to withdraw the changes made to these sections by the December 31, 2020 final rule.</P>
                    <HD SOURCE="HD2">B. Overall Impact</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), 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). 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 and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, 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 or which centralized review would meaningfully further the President's priorities or the principles set forth in the Executive order.</P>
                    <P>Based on our estimates, OMB's Office of Information and Regulatory Affairs has determined this rulemaking is significant per section 3(f)(1) as measured by $200 million or more in any 1 year. Therefore, OMB has reviewed this proposed rule, and the Departments have provided the following assessment of their impact.</P>
                    <HD SOURCE="HD2">C. Detailed Economic Analysis</HD>
                    <P>There is a need for greater clarity regarding some of the administrative policies of the MDRP, and this proposed rule aims to establish regulations to provide guidance to States, manufacturers and other related parties. This proposed rule addresses these policy issues after considering the evolution of the pharmaceutical marketplace since the development of the MDRP, and the economic, social and other factors affecting Medicaid providers and beneficiaries. At the same time, this proposed rule is mindful of the impact of changes in regulations on affected interested parties, and the degree of compliance promulgated by the agency. Therefore, for these reasons, we prepared the economic impact estimates utilizing a baseline of “no action,” comparing the effect of the proposals against not proposing the rule at all.</P>
                    <P>If the proposals in this rule are not implemented, there would be no specific policies in place in the MDRP related to the new legislative requirements in the MSIAA, and no clear policies to address drug misclassification, drug pricing and product data misreporting by manufacturers. Accordingly, this proposed rule would address other situations in which manufacturers are paying fewer rebates to States than are supported by the pricing and product data that they are currently reporting to MDP. While we believe that most of the drugs in MDP are appropriately classified, we do not know an exact number of those which may be misclassified. For this reason, a robust analytical framework, with baseline scenarios and benchmarks, cannot be conducted at this time.</P>
                    <P>Additionally, if these proposals are not implemented, there would be no regulatory policies for addressing the authority for the American Rescue Plan Act to sunset the date on the limitation on the maximum rebate amount paid by manufacturers for single source and innovator multiple source drugs, in addition to noninnovator multiple source drugs.</P>
                    <P>At this time, program integrity and program administration provisions need to be proposed or specified to address the definitions for: covered outpatient drug (COD); drug product information; internal investigation; manufacturer; market date; noninnovator multiple source drug; and vaccine. Moreover, at this time there is a need to: establish a time limitation on manufacturer rebate disputes and audits with States; refine State requirements for State reimbursement for prescribed drugs; specify conditions relating to payment for PAD; specify the process for manufacturer to accumulate price concessions and discounts (“stacking”) when determining best price; establish a drug price verification survey process through data collection. The reasons and rationales for these provisions were detailed in the preamble section of this proposed rule. The economic impacts of these provisions are detailed below.</P>
                    <P>We are solicitating comments relating to the issues, benefits and challenges of requiring a diagnosis be included on Medicaid prescriptions, as well as any current data and estimates that could be used to develop an analytical framework for the proposals in this rule.</P>
                    <HD SOURCE="HD3">1. Benefits</HD>
                    <P>
                        The provision requiring that PBAs and PBMs report specific categories of drug expenditures to their contracted managed care entity would benefit States and Medicaid managed care plans, since it can help assure a more accurate calculation of their MLRs and managed care plan capitation rates, resulting in more accurate Medicaid spending. Some States have already eliminated “spread pricing” in their managed care contracts, meaning that the State requires the PBM pays the 
                        <PRTPAGE P="34282"/>
                        pharmacy the same price that the managed care plan is charged for the prescription, such that there would be no “spread” or difference between the two prices. That is, the PBM would not be allowed to charge the managed care plan a higher price than the amount paid to the pharmacy. This removes the “spread” or the difference of which is traditionally kept by the PBM to pay for administrative and other fees. Instead, such administrative fees would have to be separately identified by the PBM for the managed care plan. While this shift in policy has begun in many States, this benefit cannot be quantified at the national level as we do not have data on which States do this now versus States that would need to implement this because of the proposed rule.
                    </P>
                    <P>
                        However, a March 2020 Congressional Budget Office (CBO) estimate of the Federal proposal 
                        <SU>51</SU>
                        <FTREF/>
                         to require pass through pharmacy pricing finds the spread pricing provision would produce Federal savings of $929 million over 10 years, which translates to a less than 1 percent drop in Federal Medicaid prescription drug spending. It is unclear what analysis or assumptions went into these estimates, but they are highly dependent on assumptions or understanding of the extent to which spread pricing currently exists in Medicaid. We are soliciting comments relating to this provision.
                    </P>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             
                            <E T="03">https://www.kff.org/medicaid/issue-brief/costs-and-savings-under-federal-policy-approaches-to-address-medicaid-prescription-drug-spending/#:~:text=This%20estimate%20is%20based%20in,between%20states%20and%20the%20federal</E>
                            .
                        </P>
                    </FTNT>
                    <P>In regards to Medicaid Drug Rebates (MDR) and penalties with respect to manufacturer misclassification of drugs, benefits also include monetary and non-monetary penalties, which are not quantifiable at this time. For example, these provisions would implement the existing statute and would benefit States as they would be receiving any past rebates that are due to them as a result of a manufacturer's misclassification of drugs. That is, the manufacturers would be finally paying the appropriate amount in past due rebates.</P>
                    <P>The overwhelming majority of drugs are appropriately classified in the manufacturer discount program (MDP) at this time, but there may be some manufacturers that continue to list their drug as a noninnovator multiple-source drug in MDP, when the drug should be listed as a single-source drug or an innovator multiple source drug. The provision allows us to also pursue penalties against manufacturers that will not change their classification as a result of the denial of their narrow exception request, and would also allow us to impose penalties on manufacturers that pay a different amount in rebates to States than is supported by the product and pricing data that they are reporting to MDP.</P>
                    <P>For example, manufacturers have the opportunity to request that certain drugs be classified in the MDP as a noninnovator multiple source drug instead of a single source or innovator multiple source drug. If this request is denied, and the manufacturer will not change the classification, CMS can use the authority under the misclassification provisions of the statute to change the classification. Moreover, we have had instances of manufacturers who have decided to take it upon themselves to pay fewer rebates to States, even though the product and pricing information they report to MDP would support a different rebate amount, in most cases, a higher rebate than they are paying to States. This provision would allow us to consider both these situations to be misclassifications, subject to the penalties that are identified in the statute, and that we further describe in the proposed regulation.</P>
                    <P>Modifying the definition of covered outpatient drug would benefit the manufacturers, States, and CMS. The provision would support the States' ability to collect rebates on drugs administered in certain settings when a drug and its reimbursement amount are separately identified on a claim billed. It would benefit manufacturers by providing clarity on drugs that would satisfy the definition of covered outpatient drug and for which compliance with section 1927 of the Act is required. This is currently not quantifiable because we do not know how many drugs this would affect.</P>
                    <P>Defining internal investigation for purposes of pricing metric revisions would benefit States and manufacturers. It would benefit manufacturers because it would provide a clear definition of what CMS views as an internal investigation for purposes of requesting CMS consideration of recalculation of AMP, best price, and customary prompt pay outside of the 12-quarter rule as permitted under § 447.510. Additionally, defining this term would benefit States because it would deter manufacturers from submitting to CMS a request for restatement of AMP, best price, and customary prompt pay discounts outside of the 12-quarter timeframe, which could trigger manufacturers seeking to collect overpaid rebates unexpectedly. This benefit is not quantifiable as it is not known how many manufacturers would be deterred from submitting the request to restate outside of the 12-quarter timeframe. However, we do not get these requests frequently.</P>
                    <P>Revising the definition of manufacturer for greater NDRA compliance would benefit CMS and States, as well as manufacturers, by providing greater clarity, codifying existing policy, and specifying direction on an area of statutory and regulatory compliance that some manufacturers previously interpreted as ambiguous. Manufacturers would now know, with certainty, that all of their associated labeler codes with CODs must enter into a rebate agreement to comply with section 1927(a)(1) of the Act and the terms of the NDRA. The benefit is not quantifiable as we do not know how many manufacturers are not reporting all of their CODs because they do not have rebate agreements in effect for all of their associated labeler codes. However, we believe the majority of manufacturers have entered into a rebate agreement for all of their associated labeler codes.</P>
                    <P>The States also benefit as noncompliant manufacturers must now enter into the rebate program and pay rebates on all their CODs. While the clear majority of manufacturers are compliant with this provision, any manufacturer that is noncompliant must ensure that every labeler code that satisfies the definition of manufacturer has a rebate agreement in effect and that the manufacturer pays rebates on all of their CODs for all labeler codes. Rebates are paid by drug manufacturers on a quarterly basis to States and are shared between the States and the Federal Government. These outstanding manufacturers' rebates would be paid to the States and shared with the Federal Government to offset the overall cost of prescription drugs under the Medicaid program. This requirement helps ensure program integrity and prevents future underpayments of rebates by noncompliant manufacturers. As previously stated, the benefit is not quantifiable as we do not know how many manufacturers are not reporting all of their CODs because they do not have rebate agreements for all of their associated labeler codes. However, we believe the majority of manufacturers have entered into a rebate agreement for all of their associated labeler codes.</P>
                    <P>
                        The proposal to define market date using the date of first sale, rather than the date first available for sale, would benefit some manufacturers, CMS, and States. Manufacturers would not be required to report AMP information until they have actual data to report. They will appreciate not having to rely on reasonable assumptions to report AMP without actual data on which to 
                        <PRTPAGE P="34283"/>
                        base the AMP. CMS and States would also benefit because we would now have regulatory support for the longstanding policy of determining the baseline information for a drug based on the date the drug was first sold by any manufacturer. Some manufacturers have been incorrectly interpreting that the market date of their drug is the date on which their NDC was first sold or marketed, regardless of any prior manufacturer's marketing or sale of the same drug. That is, some manufacturers believe that they can reset the baseline information for a drug once they purchase the drug.
                    </P>
                    <P>States are likely to benefit from the proposal to establish a 12-quarter rebate manufacturer dispute, hearing, and audit time limitation in § 447.510(j). While the NDRA addresses rebate disputes, the lack of policy on audit and dispute-initiation timeframes has been interpreted as there being no timeline on initiation of disputes on drug utilization data, unreasonably burdening State rebate programs. We have heard from States that manufacturers are initiating rebate audits and disputes on claims greater than 30 years old. Some States have even stated that there have been repeated disputes on the same paper claim over the years. With this provision, States would no longer have to look back at and research paper claims dating back to as early as 1991 and the origin of the Medicaid Drug Rebate Program. We estimate this proposal would reduce the amount of time it would take States to research disputes on rebate claims since manufacturer disputes, hearing requests, and audits initiated after 12-quarters from the last day of the quarter from the date of State invoice would no longer be considered.</P>
                    <P>In regards to the proposed regulatory revisions regarding Federal Financial Participation for conditions relating to physician-administered drugs, these provisions would benefit States and the Federal Government. By revising the regulations to be consistent with the statute, States would gain a better understanding of the requirement that they must invoice for all covered outpatient single and multiple source physician-administered drugs. This proposed rule would assure Federal financial participation and provide additional rebate collection to increase State and Federal revenue. This benefit is not quantifiable because PAD utilization and costs vary among all State programs, but we believe that most if not all States are already billing for rebates for all PADs.</P>
                    <P>The proposal for inclusion of a BIN/PCN on Medicaid Managed Care Cards would benefit States, the Federal Government, providers and manufacturers. With the inclusion of Medicaid-specific BIN/PCN and group numbers on the pharmacy identification cards issued to the enrollees of MCOs, PHIPs and PAHPs, pharmacies would be able to identify patients as Medicaid beneficiaries. This would be helpful to all parties to ensure that Medicaid benefits are applied appropriately. This would also help avoid duplicate discounts between Medicaid and the 340B Drug Pricing Program, which occurs when a State bills for a Medicaid rebate on a discounted 340B drug, by providing notice to the provider that the claim should be identified as being for a 340B drug. This benefit is not quantifiable because it is currently unknown how often patients are not identified as Medicaid beneficiaries. However, we do believe that a significant number of duplicate discounts can be avoided through better identification of a 340B eligible individual at the time the prescription is being filled.</P>
                    <P>The provision for drug cost transparency in Medicaid Managed Care Contracts would benefit States and the Federal Government. It would assist Medicaid managed care plans in complying with Federal regulations regarding MLRs and guidance by effectively requiring subcontractors to appropriately identify and classify certain costs, so that the managed care plan can appropriately calculate their MLR.</P>
                    <P>In particular, we propose that managed care plans that provide coverage of covered outpatient drugs must structure any contract with any subcontractor for the delivery or administration of the covered outpatient drug benefit to require the subcontractor to report separately the amounts related to the incurred claims described in § 438.8(e)(2) (such as reimbursement for the covered outpatient drug, payments for other patient services, and the fees paid to providers or pharmacies for dispensing or administering a covered outpatient drug) from administrative costs, fees and expenses of the subcontractor. By receiving reports that separately identify fees that are outside of the prescription and dispensing fee costs of a drug, the MCO, PIHP, or PAHP would be able to accurately calculate and report its MLR.</P>
                    <P>MLR calculations are used to develop capitation rates paid to Medicaid managed care plans, thus their accuracy is critical in assuring that Medicaid payments are reasonable, appropriate and necessary for health care services when using a Medicaid managed care plan. Managed care capitation rates must (1) be developed such that the plan would reasonably achieve an 85 percent MLR (§ 438.4(b)(9)) and (2) are developed using past MLR information for the plan (§ 438.5(b)(5)). In addition to other standards outlined in §§ 438.4 through 438.7, these requirements for capitation rates related to the MLR are key to ensuring that Medicaid managed care capitation rates are actuarially sound. In addition, Medicaid managed care plans may need to pay remittances (that is, refund part of the capitation payments) to States should they not achieve the specific MLR target. Thus, the accuracy of MLR calculation is important to conserving Medicaid funds.</P>
                    <P>The payment of claims provision would benefit States, the Federal Government, providers, and beneficiaries. This provision would benefit both the Federal Government and States as it corrects omissions in regulatory language to align with statutory language, permitting Medicaid to remain the payer of last resort. These revisions would also benefit beneficiaries and providers as it permits States to pay claims sooner than the specified waiting period, when doing so is cost-effective and necessary to ensure access to care.</P>
                    <P>The proposal to account for manufacturer stacking of discounts when determining best price would benefit the States and Federal Government. It would remove any potential doubt prospectively that when determining the best price for a COD, the manufacturer should aggregate discounts such that cumulative discounts, rebates or other arrangements must be stacked to generate a final price realized by the manufacturer for a covered outpatient drug, including discounts, rebates or other arrangements provided to different best price eligible entities.</P>
                    <P>
                        The proposal regarding verification of manufacturer drug prices for certain CODs through data collection would benefit the States, Federal Government, consumers, and insurers. The impact is that it would allow the Federal Government to verify prices by obtaining from the manufacturer various related information used by the manufacturer to determine a drug's list price and, when permissible, share the non-proprietary information submitted by the manufacturer with the general public. This would benefit States in that it could help them negotiate further rebates with manufacturers for certain 
                        <PRTPAGE P="34284"/>
                        high cost or high spending Medicaid CODs.
                    </P>
                    <HD SOURCE="HD3">2. Costs</HD>
                    <HD SOURCE="HD3">a. Medicaid Drug Rebates (MDR) and Penalties</HD>
                    <P>In regards to the costs associated with this provision, if CMS identifies a drug misclassification, or other situations that would fall under the misclassification provisions, the manufacturer would be responsible for paying back past rebates to the States as a result of the misclassification. This would mean that the manufacturers would have to determine which prices to use to calculate the past due rebates, and for which units rebates are owed, and pay the States for these rebates. They would also have to proactively determine that all States that are due rebates are subsequently paid. In some cases, the States may have to pay rebates back to the manufacturer if the manufacturer's misclassification resulted in overpayment of rebates to the States.</P>
                    <P>This provision will not impose new costs on States, rather it will help assure that manufacturers are accurately paying rebates to States, thus benefitting the States. However, the amount of rebates that would be recovered because of these new misclassification provisions cannot be estimated. While there are several validation checks, we cannot predict how many, if any, drugs are or would be misclassified especially since the amount would also include penalties for misclassification of future drugs that have yet to be released to market.</P>
                    <P>b. Suspension of Manufacturer NDRA for Late Reporting of Pricing and Drug Product Information</P>
                    <P>This provision would implement existing statute and is being implemented to encourage manufacturer adherence with program requirements and enhance administrative efficiency. Manufacturers that are not reporting their pricing or product information in a timely manner per statutory and regulatory requirements would have their rebate agreement (and those of their associated labelers) suspended for purposes of Medicaid and the MDRP. This means that States would not have to cover or pay for the drugs of the manufacturer during the period of the suspension. Lack of timely reporting by manufacturers can also reduce rebates that are owed to States by a manufacturer, and can affect the number of multiple source drugs for which Federal Upper Limits (FULs) can be established. Thus, this suspension authority would serve as an incentive for manufacturers to report their product and pricing information timely so that drugs of the manufacturer would continue to be covered under Medicaid and the drug rebate program.</P>
                    <P>This provision would have minimal cost to the States as their only responsibility would be to notify prescribers and patients that a drug is not available under the MDRP for the period of the suspension. Similar to §§ 431.211 and 435.917, we are requiring that States notify beneficiaries at least 30 days before a drug is no longer available because of a suspension of a manufacturer's drug rebate agreement. Since States may choose their preferred method of notification of beneficiaries including through email, form letters, list serves, or Medicaid portals, we are requesting comments on how to develop a cost estimate.</P>
                    <HD SOURCE="HD3">c. Modify the Definition of Covered Outpatient Drug</HD>
                    <P>This proposed provision may increase manufacturers' rebate liability to the States because it would clarify those CODs that could be billed for rebates. At this time, we cannot determine an estimate of burden for manufacturers regarding this item because we do not have an estimate of the number of drugs that could potentially be billed for rebates as result of this clarification. States only have to report utilization of drugs for which rebates are invoiced. If States were not invoicing for rebates for certain types of claims previously, we do not have quantifiable information about the additional rebates that may be now collected. Additionally, States may need to educate their providers on billing procedures. We believe this would be involve minimal burden, as States could inform their providers as part of their regular communications.</P>
                    <HD SOURCE="HD3">d. Define Internal Investigation for Purposes of Pricing Metric Revisions</HD>
                    <P>
                        The cost of this new proposed definition would be the amount of time that needs to be taken by manufacturers' personnel to determine how to apply the definition of internal investigation when considering submitting a request to CMS for a recalculation. Furthermore, this legal analysis would not apply to every manufacturer or to every drug of the manufacturer. It would only apply if the manufacturer wants to submit a request for CMS to consider recalculation outside of 12-quarters for one or more of its CODs. At this time, we have received only a minimal number of such requests from manufacturers. We assume the time to perform legal analysis is 5 hours. Using the May, 2021 mean (average) wage information from the BLS for lawyers (Code 23-1011), we estimate that the cost of reviewing this provision is $142.34 per hour, including fringe benefits and other indirect costs (
                        <E T="03">https://www.bls.gov/oes/current/oes231011.htm</E>
                        ) with a total cost of ($142.34 × 5) is $711.70 for each manufacturer. We estimate that only one percent of manufacturers would submit a request for a recalculation annually outside of the 12-quarters. One percent of 792 manufacturers is approximately 8 manufacturers, with a total one-time cost of $5,693.60 (8 × $711.70). We estimated one percent because currently only one manufacturer has submitted such a request. This proposed provision will not impose substantial costs on the State.
                    </P>
                    <HD SOURCE="HD3">e. Revise Definition of Manufacturer for NDRA Compliance</HD>
                    <P>To better assess current manufacturer compliance with the requirement that all associated labeler codes of a manufacturer have a rebate agreement in effect, several analyses and reviews were performed. Our initial analysis identified 24 instances of related-party manufacturers and labelers that appear to have included some, but not all, of their product line within the MDRP representing 144 products, approximately 0.3 percent of all products in MDRP.</P>
                    <P>Additionally, if a manufacturer is noncompliant, the manufacturer would be responsible for having associated entities sign a rebate agreement and agree to participate in MDRP. That is, the manufacturers would have to determine which labelers are not currently participating in the program, submit rebate agreements, and pay the States for rebates for CODs of those labelers. For this reason, we are estimating a collection burden to allow manufacturers time to review and ensure compliance with this requirement. Manufacturers would need to review their respective labeler codes in the CMS-hosted online information technology system and ensure the list is complete.</P>
                    <P>
                        We estimate that the burden associated with the proposed modification to the definition of manufacturer is a one-time cost of $43,884.72, estimating it would take 792 manufacturers 0.5 hours at $110.82 per hour, including fringe benefits and other indirect costs, for an operations manager to log onto the CMS system and review associated labeler codes. This provision will not impose substantial costs on States. States would receive additional monetary rebates if a noncompliant manufacturer comes into compliance.
                        <PRTPAGE P="34285"/>
                    </P>
                    <P>While this policy has already been specified in guidance and preambles, codifying the requirement is necessary to ensure compliance and eliminate ambiguity.</P>
                    <HD SOURCE="HD3">f. Define Market Date</HD>
                    <P>In regards to costs associated with defining market date, if manufacturers have not provided CMS with accurate market dates, they may need to develop a methodology to determine the accurate dates. In addition, going forward, manufacturers will have to identify when their first sales of the COD occur to accurately identify the market date of the COD. At this time, we cannot determine cost estimates associated for this provision. This provision will not impose substantial costs on States.</P>
                    <HD SOURCE="HD3">g. Modify the Definition of Noninnovator Multiple Source Drug</HD>
                    <P>This provision proposes a technical correction to the regulatory text to conform the language in the definition of an N drug to the language in the definition of an I drug. We do not anticipate any impact on interested parties.</P>
                    <HD SOURCE="HD3">h. Define Vaccine for Purposes of the MDRP Only</HD>
                    <P>In regards to costs associated with the provision, if a manufacturer has not been reporting and paying rebates on a product because it believed the product was a vaccine, and the proposed definition would result in the product being a COD, not a vaccine, then the manufacturer would have both reporting and rebate liability on that product if the proposed definition is finalized. At this time, we cannot determine an estimate for this item. This provision would not impose substantial costs on the State.</P>
                    <HD SOURCE="HD3">i. Proposal To Establish a 12-Quarter Rebate Audit Time Limitation</HD>
                    <P>
                        We are estimating a decrease in burden associated with this proposal. After contacting several States, we estimate that per State, between 10 and 80 disputes are initiated routinely in a quarter on rebate claims greater than 3 years old, and those disputes on average take an Operations Research Analyst between 30 minutes to 4 months to resolve, depending on the complexity of the dispute and how long ago the claim was paid. For our best estimate of the quantifiable impact, with all 50 States, the District of Columbia, and Puerto Rico being affected, we estimate it would take 52 Operations Research Analysts (1 for each State) 7 hours to resolve a dispute at $92.14/hr (
                        <E T="03">https://www.bls.gov/oes/current/oes152031.htm</E>
                        ) $644.98 ($92.14 × 7) (for 45 outstanding disputes [(10 disputes + 80 disputes)/2] per State for claims greater than 3 years old. We, therefore, estimate a one-time decreased burden reduction of $6,037,012.80 (45 disputes × $644.98 hr/dispute × 52 States × 4 quarters (1 year)). Once this rule is finalized, manufacturers will only have the ability to dispute claims for up to 12-quarters, from the last day of the quarter from the date of State invoice.
                    </P>
                    <HD SOURCE="HD3">j. Proposals Related to State Plan Requirements, Findings, and Assurances</HD>
                    <P>This proposed clarification is necessary so payments to pharmacy providers are consistent with efficiency, economy, and quality of care, and are sufficient to provide access to care equivalent to the general population. Pharmacists must be accurately reimbursed by the State for drug ingredient costs and professional dispensing services under § 447.518.</P>
                    <P>All but one State, are currently in compliance with the PDF requirements. We have not included time and cost burdens for individual State dispensing fee surveys in this proposed rule because we cannot accurately determine whether a State would choose to conduct a State-specific cost of dispensing survey or use another State's survey. As such, this is an unquantifiable cost to States and therefore, we have not included an estimate. States have several options when reviewing and adjusting their professional dispensing fee (including using a neighboring State's survey results, conducting their own survey, or using survey data from a prior survey).</P>
                    <P>In this proposed rule, we specify that the type of data that States must submit to justify their professional dispensing fees must be based on actual costs of dispensing.</P>
                    <HD SOURCE="HD3">k. Federal Financial Participation: Conditions Relating to Physician-Administered Drugs</HD>
                    <P>All States currently have an existing process in place to collect and invoice for covered outpatient single source and the top 20 high volume multiple source physician-administered drugs in accordance with regulatory language in § 447.520, which may limit the additional burden associated with collecting and invoicing NDC information for all covered outpatient single and multiple source physician-administered drugs.</P>
                    <P>It is difficult to quantify a specific dollar value for the expected revenue increase at this time. PAD utilization and costs vary among all State programs; however, once implemented, and all States are collecting rebates for all single and multiple source COD PADs, a baseline can be established. All States currently have this process well established pursuant to regulatory language in § 447.520.</P>
                    <P>These provisions clarity the existing statute to ensure Federal financial participation and rebate collection for all covered outpatient single and multiple source physician-administered drugs.</P>
                    <HD SOURCE="HD3">l. BIN/PCN on Medicaid Managed Care Cards</HD>
                    <P>The cost is limited to the time the Medicaid managed care entities need to program the new codes onto the cards.</P>
                    <HD SOURCE="HD3">m. Drug Cost Transparency in Medicaid Managed Care Contracts</HD>
                    <P>The costs associated with this change is the cost to managed care plans and their subcontractors to negotiate and revise contracts to ensure administrative fees are separately identifiable from reimbursement for CODs, dispensing fee costs and other patient costs that need to be captured as incurred claims under § 483.8(e)(2). As discussed in the section III. of this proposed rule, we estimate that these requirements would affect 282 managed care plans and their subcontractors (mainly PBMs) in the country and 40 States. We estimate it would take an Operations Research Analyst (Code 15-2031) 25 hours at $92.14 per hour, including fringe benefits and other indirect costs, to renegotiate and restructure 282 Medicaid managed care contracts to require the MCO, PIHP or PAHP to require its subcontractors to separately report information on incurred costs (as described in § 438.8(e)(2)) and fees paid to the subcontractor for administrative services. We, therefore, estimate that the burden associated with the proposed dispute timeline limitation would be a one-time cost for each managed care plan of $2,303.50 or $649,587 for all managed care plans. There are 40 States with Medicaid managed care plans, therefore, we estimate the State's Operations Research Analyst (Code 15-2031) 25 hours at $92.14 per hour including fringe benefits and other indirect costs to restructure State contracts for a one-time cost per State of $2,303.50 or $92,140 for all 40 States.</P>
                    <P>
                        Federal savings may be captured by an estimate associated with a statutory change to eliminate PBM spread pricing 
                        <PRTPAGE P="34286"/>
                        at $929 Million over 10 years.
                        <SU>52</SU>
                        <FTREF/>
                         A March 2020 CBO 
                        <E T="03">estimate</E>
                         for the Federal proposal to require pass through pricing finds the spread pricing provision would produce Federal savings of $929 million over 10 years, which translates to a less than 1 percent drop in Federal Medicaid prescription drug spending. It is unclear what analysis or assumptions went into these estimates, but they are highly dependent on assumptions or understanding of the extent to which spread pricing currently exists in Medicaid.
                    </P>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             
                            <E T="03">https://www.kff.org/medicaid/issue-brief/costs-and-savings-under-federal-policy-approaches-to-address-medicaid-prescription-drug-spending/#:~:text=This%20estimate%20is%20based%20in,between%20states%20and%20the%20federal</E>
                            .
                        </P>
                    </FTNT>
                    <P>There is not currently a Federal prohibition on using spread pricing in Medicaid. As noted, we issued guidance in 2019 regarding the impact of the lack of transparency between costs for administrative functions versus actual costs for Medicaid-covered benefits on the managed care plan's MLR calculation. The 2019 CIB is clear that when the subcontractor, in this case the PBM, is performing administrative functions such as eligibility and coverage verification, claims processing, utilization review, or network development, the expenditures and profits on these functions are a non-claims administrative expense as described in § 438.8(e)(2)(v)(A), and should not be counted as an incurred claim for the purposes of MLR calculations.</P>
                    <P>If a subcontractor incorrectly categorizes these administrative fees as incurred claims under § 438.8(e)(2), it increases the MLR numerator, and thus increases the per-member-per-month (PMPM) revenue a managed care entity can receive from the State while still appearing to meet MLR requirements. By proposing to require that managed care plans require subcontractors to separately report their administrative fees (that is, separately identified from incurred claims such as reimbursement for covered outpatient drugs, dispensing fees, and other patient services), the managed care plan is better able to ensure the accuracy of MLR, which sets the PMPM revenue for Medicaid managed care plans, and accurately reflects only medical expenditures, thus generating savings to the Medicaid program. For those States that may not already have this requirement as part of its contract with the managed care plan, this provision would be a cost to the State to revise managed care plan contracts. It provides transparency to the State and the managed care plan as to which subcontractor costs are incurred claims under § 438.8(e)(2) (costs of CODs and dispensing fees) versus administrative fees.</P>
                    <HD SOURCE="HD3">n. Proposals Related to Amendments Made by the American Rescue Act of 2021—Removal of Manufacturer Rebate Cap (100 Percent AMP)</HD>
                    <P>
                        This provision is a direct result of a statutory change to remove the cap on Medicaid drug rebates (the maximum rebate amount). Medicaid savings would be generated by the increased rebates due to the removal of the cap on rebates with an estimate of an average of $14.21 billion over 10 years.
                        <E T="51">53 54</E>
                        <FTREF/>
                         By removing the cap on the amount manufacturers would be required to pay for Medicaid drug rebates, Medicaid rebate revenue would increase thus producing savings to the Federal Government (Table 6 includes the savings which are CBO estimates from when statute was amended). The costs associated with this requirement are to manufacturers. Manufacturers would also need to make minor changes to their systems to address the removal of the cap. As stated previously in this proposed rule, States would realize some savings because of the increase in rebates; however, it is not known if manufacturer drug prices to Medicaid would decrease because of the removal of the cap as manufacturers adjust pricing to reflect the increase in Medicaid drug rebates.
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             
                            <E T="03">https://www.kff.org/medicaid/issue-brief/costs-and-savings-under-federal-policy-approaches-to-address-medicaid-prescription-drug-spending/#:~:text=This%20estimate%20is%20based%20in,between%20states%20and%20the%20federal</E>
                            .
                        </P>
                        <P>
                            <SU>54</SU>
                             
                            <E T="03">https://www.macpac.gov/wp-content/uploads/2019/06/Next-Steps-in-Improving-Medicaid-Prescription-Drug-Policy.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">o. Payment of Claims</HD>
                    <P>At this time, there is no need to determine cost estimates for this item. The December 31, 2020 final rule revised the regulations and captured cost estimations and collection of information. This revision would add omitted statutory language to the existing regulation. This change would not produce new burden not already captured in final rule CMS-2482-F.</P>
                    <HD SOURCE="HD3">p. Requests for Information on Requiring a Diagnosis on Medicaid Prescriptions</HD>
                    <P>This provision is a request for information only. We are seeking comments on how to negate any foreseeable impact on beneficiaries and providers and steps which would be needed by States to successfully implement a Medicaid requirement for diagnosis on prescriptions.</P>
                    <HD SOURCE="HD3">q. Proposal To Account for Stacking When Determining Best Price</HD>
                    <P>When calculating the lowest price realized by a manufacturer by aggregating discounts and rebates across all best price eligible entities, the Medicaid drug rebate to the State and Federal Government increases. At this time, we cannot determine cost estimates for this item.</P>
                    <HD SOURCE="HD3">r. Proposal Regarding Drug Price Verification Survey Through Data Collection</HD>
                    <P>The costs for States to determine which manufacturers would be included in the State survey would be 0.25 hours per State for an Operations Research Analyst (Code 15-2031) at $92.14 an hour, including fringe benefits and other indirect costs, or $23.04 per State. We estimate that the Federal Government would survey 52 States (including the District of Columbia and Puerto Rico) annually for a cost of $1,198.08 (52 States × $23.04 per State).</P>
                    <P>The costs for the manufacturer/wholesaler who are selected for completing the survey would be 50 hours per manufacturer for an Operations Research Analysts (Code 15-2031) at $92.14 an hour, including fringe benefits and other indirect costs, or $4,607.00 per manufacturer (50 hrs × $92.14/hr). Federal Government would survey a minimum of three manufacturers per year, with a maximum of ten surveys per year, for an annual cost of $46,070.00 ($4,607.00 × 10 surveys), using the maximum of ten surveys per year. Savings is not quantifiable because we do not know if manufacturers would revise pricing in the event they are requested to verify their drug prices.</P>
                    <HD SOURCE="HD3">s. Proposal To Rescind Revisions Made by the December 31, 2020 Final Rule to Determination of Best Price (§ 447.505) and Determination of Average Manufacturer Price (AMP) (§ 447.504) Consistent With Court Order</HD>
                    <P>
                        In the December 31, 2020 final rule, CMS revised the various patient assistance program exclusions from AMP and best price at §§ 447.504(c)(25) through (29) and (e)(13) through (17) and 447.505(c)(8) through (12) to add language that would require manufacturers “to ensure” the assistance provided by these patient assistance programs is passed on to the consumer, to the pharmacy, to the agent, or to other AMP or best price eligible 
                        <PRTPAGE P="34287"/>
                        entity who does not receive any price concession.
                    </P>
                    <P>As part of the December 31, 2020 final rule, the impact analysis for the exclusions to ensure such patient assistance is passed on to the patient is discussed at length (see 85 FR 87098 through 87100). We concluded at that time that based upon the studies noted in the analysis, the value of patient assistance programs are being eroded by PBM copay accumulator programs because the patient assistance is accumulating to the economic benefits of health plans, not to patients, given that the health plans' spending on drugs for patient decreases. We also believed even with the changes in the rule, that manufacturers would continue to offer patient assistance because the infrastructure was there to ensure, in accordance with the regulation, the patient assistance accrued to the patient, rather than the plan. Therefore, we believed that patients would not be significantly impacted by the modifications that the manufacturers may have needed to do to ensure the pass through of the patient assistance to the patient consistent with section 1927 of the Act.</P>
                    <P>In May 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint against the Secretary asking the court to vacate these amendments to § 447.505(c)(8) through (11) (85 FR 87102 and 87103), as set forth in the 2020 final rule (referred to by the Court as “the accumulator adjustment rule of 2020”). On May 17, 2022, the United States District Court for the District of Columbia ruled in favor of the plaintiff and ordered that the accumulator adjustment rule of 2020 be vacated and set aside.</P>
                    <P>In response to the order made by the United States District Court for the District of Columbia to vacate the “accumulator adjustment rule of 2020,” we are proposing to withdraw the changes made to these sections and, for consistency, withdraw revisions to regulations addressing AMP made by the accumulator adjustment rule. At the time of the December 31, 2020 final rule, we could not quantify to what degree the changes would impact manufacturers or patients. Therefore, we cannot quantify the impact on manufacturers and patients because of the rescinding of this rule.</P>
                    <GPOTABLE COLS="4" OPTS="L2,nj,i1" CDEF="s75,15,r50,r50">
                        <TTITLE>Table 5—Summary of the One-Time Quantitative Costs and Benefits</TTITLE>
                        <BOXHD>
                            <CHED H="1">Line item</CHED>
                            <CHED H="1">Cost</CHED>
                            <CHED H="1">Entity</CHED>
                            <CHED H="1">Timeframe</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Regulatory review</ENT>
                            <ENT>$851,977.32</ENT>
                            <ENT>Manufacturers, States, Trade Association</ENT>
                            <ENT>One-time cost.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Define manufacturer internal investigation</ENT>
                            <ENT>5,693.60</ENT>
                            <ENT>Manufacturers</ENT>
                            <ENT>One-time cost.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Modify definition of manufacturer/labeler</ENT>
                            <ENT>43,884.72</ENT>
                            <ENT>Manufacturers</ENT>
                            <ENT>One-time cost.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Establish a 12-Quarter Rebate Audit Time Limitation</ENT>
                            <ENT>(6,037,012.80)</ENT>
                            <ENT>States and Federal Government</ENT>
                            <ENT>One-time cost savings.</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Restructure State Contracts</ENT>
                            <ENT>92,140.00</ENT>
                            <ENT>States</ENT>
                            <ENT>One-time cost.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total</ENT>
                            <ENT>(5,043,317.16)</ENT>
                        </ROW>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,nj,i1" CDEF="s75,20,r50,r50">
                        <TTITLE>Table 6—Summary of the Annual Quantitative Costs and Benefit</TTITLE>
                        <BOXHD>
                            <CHED H="1">Line item</CHED>
                            <CHED H="1">Cost</CHED>
                            <CHED H="1">Entity</CHED>
                            <CHED H="1">Timeframe</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Federal Government Survey for States</ENT>
                            <ENT>$1,198.08</ENT>
                            <ENT>Federal Government</ENT>
                            <ENT>Annually over 10 years.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Federal Government Survey for Manufacturers</ENT>
                            <ENT>46,607.00</ENT>
                            <ENT>Federal Government</ENT>
                            <ENT>Annually over 10 years.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Drug cost transparency in Medicaid managed care contracts</ENT>
                            <ENT>(929,000,000.00)</ENT>
                            <ENT>Federal Government</ENT>
                            <ENT>Annually over 10 years.</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Removal of manufacturer rebate cap (100% of AMP)</ENT>
                            <ENT>(14,211,000,000.00)</ENT>
                            <ENT>Federal and State Governments</ENT>
                            <ENT>Annually over 10 years.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total</ENT>
                            <ENT>(15,139,952,731.92)</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD3">3. Regulatory Review Cost Estimation</HD>
                    <P>If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will be directly impacted and will review this proposed rule, we assume that the total number of unique commenters are based on the current 792 manufacturers participating in the MDRP. While there is no way for CMS to specify the exact number of how many labeler codes are associated with each other, most manufacturers have at least 2 labeler codes. Nevertheless, we are estimating that the current 792 manufacturers would need to review the proposed rule.</P>
                    <P>Furthermore, we anticipate one medical and health service manager (Code 11-9111) from each of the 50 States, the District of Columbia, and Puerto Rico that cover prescription drugs under the MDRP, will review this proposed rule. Additionally, we estimate that 19 trade organizations may review the proposed rule. This estimate of trade organizations is based on a previous rule pertaining to the MDRP, in which 19 formal comments were received from trade organizations. It is possible that not all commenters or drug manufacturers will review this proposed rule in detail, and it is also possible that some reviewers will choose not to comment on the proposed rule. In addition, we assume that some entities will read summaries from trade newsletters, trade associations, and trade law firms within the normal course of keeping up with current news, incurring no additional cost. Therefore, we assume that approximately 863 (792 manufacturers + 52 States + 19 trade associations) entities may review the proposed rule. For these reasons, we thought that the number of commenters would be a fair estimate of the number of reviewers who are directly impacted by this proposed rule. We are soliciting comments on this assumption.</P>
                    <P>
                        We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule. However, for the purposes of our estimate, we assume 
                        <PRTPAGE P="34288"/>
                        that each reviewer reads 100 percent of this proposed rule.
                    </P>
                    <P>
                        Using the May 2021 mean (average) wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this proposed rule is $115.22 per hour, including fringe benefits and other indirect costs (
                        <E T="03">https://www.bls.gov/oes/current/oes119111</E>
                        ). Assuming an average reading speed of 250 words per minute, we estimate that it would take approximately 230 minutes (3.833 hours) for the staff to read this proposed rule, which is approximately 57,500 words. For each medical and health service manager (Code 11-9111) that reviews the proposed rule, the estimated cost is (3.833 × $115.22) or $441.64. In part, we estimate that the cost of reviewing this proposed rule by medical and health service managers is $381,133.82 ($441.64 × 863 reviewers). Additionally, there is also a lawyer who will review this proposed rule. Using the May, 2021 mean (average) wage information from the BLS for lawyers (Code 23-1011), we estimate that the cost of reviewing this proposed rule is $142.34 per hour, including fringe benefits and other indirect costs (
                        <E T="03">https://www.bls.gov/oes/current/oes231011.htm</E>
                        ). Assuming an average reading speed of 250 words per minute, we estimate that it would take approximately 230 minutes (3.833 hours) for the staff to review this proposed rule, which is approximately 57,000 words. For each lawyer (Code 23-1011) that reviews the proposed rule, the estimated cost is (3.833 × $142.34) or $545.59. In part, we estimate that the cost of reviewing this proposed rule by lawyers is $470,843.50 ($545.59 × 863 reviewers). In total, we estimate the one-time cost of reviewing this proposed rule is $851,977.32 ($381,133.82 + $470,843.50).
                    </P>
                    <P>We acknowledge that these assumptions may understate or overstate the costs of reviewing this proposed rule.</P>
                    <HD SOURCE="HD2">D. Alternatives Considered</HD>
                    <P>Some provisions are directly linked to statute and therefore alternatives cannot be considered. Nevertheless, alternatives which we have considered are detailed below.</P>
                    <P>We are proposing to modify the definition of manufacturer for purposes of satisfying the requirement at section 1927(a)(1) of the Act which requires a manufacturer to have entered into and have in effect a NDRA. While this policy has already been specified in guidance and preambles, codifying the requirement is necessary to ensure compliance and eliminate ambiguity. We have reiterated this point several times in subregulatory guidance; however, some manufacturers still challenge our policy. We do not permit manufacturers to selectively report CODs which would allow a manufacturer to benefit from the coverage of some of their CODs, while avoiding their financial obligation to pay rebates.</P>
                    <P>Therefore, we considered an alternative to retain the current definition of manufacturer for the NDRA, however, we believe the term “manufacturer” needs to be updated in regulation to ensure legal compliance with this requirement.</P>
                    <P>In regards to proposing to define vaccine, we could have refrained from defining the term and relied on manufacturers to make their own determination. At this time, we are only aware of one manufacturer who is making a claim that a product that would not be a vaccine under the proposed definition should be treated as a vaccine for the purposes of the Medicaid Drug Rebate Program. However, we are endeavoring to prevent future disputes of this type given that there may be more products coming to market for which this definition might help provide clarity.</P>
                    <P>We are proposing to specify the time limitation on manufacturers initiating disputes, hearings, or audits with States. While the NDRA addresses dispute resolution, it provides no guidance on whether a timeline applies to the initiation of such disputes, hearings or audits. There have been reports of new disputes being initiated on claims dating back several decades to paper claims, which is placing unnecessary burden on many State rebate programs. Implementation of this provision is necessary to ensure administrative efficiency. An alternative considered was to not clarify this provision; however, then disputes initiated on claims would continue to be disputed ongoing for any defined time-period, causing undue strain, work hours and costs on rebate programs, which directly counters the purpose of the program to offset the Federal and State costs of most outpatient prescription drugs dispensed to Medicaid patients.</P>
                    <HD SOURCE="HD2">E. Accounting Statement and Table</HD>
                    <P>
                        As required by OMB Circular A-4 (available at 
                        <E T="03">https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/circulars/A4/a-4.pdf</E>
                        ), we have prepared an accounting statement in Table 7 showing the classification of the impact associated with the provisions of this proposed rule.
                    </P>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s100,10,10,10,10">
                        <TTITLE>Table 7—Accounting Statement: Classification of Estimated Costs/Savings</TTITLE>
                        <BOXHD>
                            <CHED H="1">Category</CHED>
                            <CHED H="1">Estimates</CHED>
                            <CHED H="1">Units</CHED>
                            <CHED H="2">
                                Year
                                <LI>dollar</LI>
                            </CHED>
                            <CHED H="2">
                                Discount
                                <LI>rate</LI>
                                <LI>(%)</LI>
                            </CHED>
                            <CHED H="2">
                                Period
                                <LI>covered</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22">Costs/Savings:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Annualized Monetized ($million/year)</ENT>
                            <ENT>($0.67)</ENT>
                            <ENT>2021</ENT>
                            <ENT>7</ENT>
                            <ENT>2024-2034</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>(0.57)</ENT>
                            <ENT>2021</ENT>
                            <ENT>3</ENT>
                            <ENT>2024-2034</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Costs/Savings</ENT>
                            <ENT>−1,328.91</ENT>
                            <ENT>2021</ENT>
                            <ENT>7</ENT>
                            <ENT>2024-2034</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Annualized Monetized ($million/year)</ENT>
                            <ENT>−1,433.49</ENT>
                            <ENT>2021</ENT>
                            <ENT>3</ENT>
                            <ENT>2024-2034</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD2">F. Regulatory Flexibility Act (RFA)</HD>
                    <P>
                        The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that almost all Pharmaceutical and Medicine manufacturers are small entities, as that term is used in the RFA (including small businesses, nonprofit organizations, and small governmental jurisdictions). The great majority of hospitals and most other health care providers and suppliers are small entities, either by being nonprofit organizations or by meeting the Small Business Administration (SBA) definition of a small business (having employees of less than 1,250 in any 1 year) for businesses classified in the Pharmaceutical and Medicine 
                        <PRTPAGE P="34289"/>
                        Manufacturing industries. Note, the SBA does not provide any revenue data at this time as a measure of size for these industries.
                    </P>
                    <P>
                        According to the SBA's website at 
                        <E T="03">https://www.sba.gov/content/small-business-size-standards,</E>
                         the drug manufactures referred to in this proposed rule fall into both NAICS 325412, Pharmaceutical Preparation Manufacturing and NAICS 325414, Biologic Product (except Diagnostic) Manufacturing. The SBA defines small businesses engaged in Pharmaceutical and Medicine Manufacturing as businesses having less than 1,250 employees annually each for Pharmaceutical Preparation Manufacturing and Biologic Product (except Diagnostic) manufacturing industries. Table 8 presents the total number of small businesses in each of the two industries mentioned.
                    </P>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="xs60,r100,xs80,10">
                        <TTITLE>Table 8—NAICS 32541 Pharmaceutical and Medicine Manufacturing Size Standards</TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                NAICS
                                <LI>(6-digit)</LI>
                            </CHED>
                            <CHED H="1">Industry subsector description</CHED>
                            <CHED H="1">SBA size standard/small entity threshold</CHED>
                            <CHED H="1">
                                Total small
                                <LI>businesses</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">325412</ENT>
                            <ENT>Pharmaceutical Preparation Manufacturing</ENT>
                            <ENT>1,250 Employees</ENT>
                            <ENT>2,722</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">325414</ENT>
                            <ENT>Biologic Product (except Diagnostic)</ENT>
                            <ENT>1,250 Employees</ENT>
                            <ENT>587</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="03">Source:</E>
                             2019 Economic Census.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s100,10,12,10,12">
                        <TTITLE>Table 9—Concentration Ratios (NAICS 325412) Pharmaceutical Preparation</TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                Firm size
                                <LI>(by number of employees)</LI>
                            </CHED>
                            <CHED H="1">Firm count</CHED>
                            <CHED H="1">
                                Percentage of
                                <LI>small firms</LI>
                                <LI>(%)</LI>
                            </CHED>
                            <CHED H="1">
                                Total
                                <LI>employees</LI>
                            </CHED>
                            <CHED H="1">
                                Employee
                                <LI>per firm to</LI>
                                <LI>total</LI>
                                <LI>employee</LI>
                                <LI>(%)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22">Small Firms:</ENT>
                            <ENT>2,722</ENT>
                            <ENT>100</ENT>
                            <ENT>93,181</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">02: &lt;5 employees</ENT>
                            <ENT>390</ENT>
                            <ENT>14</ENT>
                            <ENT>633</ENT>
                            <ENT>0.679</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">03: 5-9 employees</ENT>
                            <ENT>159</ENT>
                            <ENT>6</ENT>
                            <ENT>1,058</ENT>
                            <ENT>1.135</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">04: 10-14 employees</ENT>
                            <ENT>65</ENT>
                            <ENT>2</ENT>
                            <ENT>752</ENT>
                            <ENT>0.807</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">05: 15-19 employees</ENT>
                            <ENT>48</ENT>
                            <ENT>2</ENT>
                            <ENT>766</ENT>
                            <ENT>0.822</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">06: &lt;20 employees</ENT>
                            <ENT>662</ENT>
                            <ENT>24</ENT>
                            <ENT>3,209</ENT>
                            <ENT>3.444</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">07: 20-24 employees</ENT>
                            <ENT>25</ENT>
                            <ENT>1</ENT>
                            <ENT>535</ENT>
                            <ENT>0.574</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">08: 25-29 employees</ENT>
                            <ENT>25</ENT>
                            <ENT>1</ENT>
                            <ENT>648</ENT>
                            <ENT>0.695</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">09: 30-34 employees</ENT>
                            <ENT>19</ENT>
                            <ENT>1</ENT>
                            <ENT>587</ENT>
                            <ENT>0.630</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">10: 35-39 employees</ENT>
                            <ENT>21</ENT>
                            <ENT>1</ENT>
                            <ENT>700</ENT>
                            <ENT>0.751</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">11: 40-49 employees</ENT>
                            <ENT>30</ENT>
                            <ENT>1</ENT>
                            <ENT>1,329</ENT>
                            <ENT>1.426</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">12: 50-74 employees</ENT>
                            <ENT>45</ENT>
                            <ENT>2</ENT>
                            <ENT>2,600</ENT>
                            <ENT>2.790</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">13: 75-99 employees</ENT>
                            <ENT>31</ENT>
                            <ENT>1</ENT>
                            <ENT>2,439</ENT>
                            <ENT>2.617</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">14: 100-149 employees</ENT>
                            <ENT>49</ENT>
                            <ENT>2</ENT>
                            <ENT>5,292</ENT>
                            <ENT>5.679</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">15: 150-199 employees</ENT>
                            <ENT>27</ENT>
                            <ENT>1</ENT>
                            <ENT>3,793</ENT>
                            <ENT>4.071</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">16: 200-299 employees</ENT>
                            <ENT>42</ENT>
                            <ENT>2</ENT>
                            <ENT>6,853</ENT>
                            <ENT>7.355</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">17: 300-399 employees</ENT>
                            <ENT>22</ENT>
                            <ENT>1</ENT>
                            <ENT>6,204</ENT>
                            <ENT>6.658</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">18: 400-499 employees</ENT>
                            <ENT>13</ENT>
                            <ENT>0</ENT>
                            <ENT>3,907</ENT>
                            <ENT>4.193</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">19: &lt;500 employees</ENT>
                            <ENT>1,011</ENT>
                            <ENT>37</ENT>
                            <ENT>38,096</ENT>
                            <ENT>40.884</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">20: 500-749 employees</ENT>
                            <ENT>19</ENT>
                            <ENT>1</ENT>
                            <ENT>6,514</ENT>
                            <ENT>6.991</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">21: 750-999 employees</ENT>
                            <ENT>10</ENT>
                            <ENT>0</ENT>
                            <ENT>3,635</ENT>
                            <ENT>3.901</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">22: 1,000-1,499 employees</ENT>
                            <ENT>9</ENT>
                            <ENT>0</ENT>
                            <ENT>3,631</ENT>
                            <ENT>3.897</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Large Firms:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Employees &gt;1,499</ENT>
                            <ENT>68</ENT>
                            <ENT>NA</ENT>
                            <ENT>94,707</ENT>
                            <ENT>NA</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="03">Source:</E>
                             2019 Economic Census.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s100,10,12,10,12">
                        <TTITLE>Table 10—Concentration Ratios (NAICS 325414) Biologic Product (Except Diagnostic) Manufacturing</TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                Firm size
                                <LI>(by number of employees)</LI>
                            </CHED>
                            <CHED H="1">Firm count</CHED>
                            <CHED H="1">
                                Percentage of
                                <LI>small firms</LI>
                                <LI>(%)</LI>
                            </CHED>
                            <CHED H="1">
                                Total
                                <LI>employees</LI>
                            </CHED>
                            <CHED H="1">
                                Employee
                                <LI>per firm to</LI>
                                <LI>total</LI>
                                <LI>employee</LI>
                                <LI>(%)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22">Small Firms:</ENT>
                            <ENT>587</ENT>
                            <ENT>100</ENT>
                            <ENT>21,789</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">02: &lt;5 employees</ENT>
                            <ENT>71</ENT>
                            <ENT>12</ENT>
                            <ENT>141</ENT>
                            <ENT>0.65</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">03: 5-9 employees</ENT>
                            <ENT>42</ENT>
                            <ENT>7</ENT>
                            <ENT>282</ENT>
                            <ENT>1.29</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">04: 10-14 employees</ENT>
                            <ENT>13</ENT>
                            <ENT>2</ENT>
                            <ENT>145</ENT>
                            <ENT>0.67</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">05: 15-19 employees</ENT>
                            <ENT>13</ENT>
                            <ENT>2</ENT>
                            <ENT>224</ENT>
                            <ENT>1.03</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">06: &lt;20 employees</ENT>
                            <ENT>139</ENT>
                            <ENT>24</ENT>
                            <ENT>792</ENT>
                            <ENT>3.63</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">07: 20-24 employees</ENT>
                            <ENT>12</ENT>
                            <ENT>2</ENT>
                            <ENT>261</ENT>
                            <ENT>1.20</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">08: 25-29 employees</ENT>
                            <ENT>7</ENT>
                            <ENT>1</ENT>
                            <ENT>167</ENT>
                            <ENT>0.77</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">09: 30-34 employees</ENT>
                            <ENT>6</ENT>
                            <ENT>1</ENT>
                            <ENT>184</ENT>
                            <ENT>0.84</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">11: 40-49 employees</ENT>
                            <ENT>6</ENT>
                            <ENT>1</ENT>
                            <ENT>247</ENT>
                            <ENT>1.13</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">12: 50-74 employees</ENT>
                            <ENT>13</ENT>
                            <ENT>2</ENT>
                            <ENT>624</ENT>
                            <ENT>2.86</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">13: 75-99 employees</ENT>
                            <ENT>5</ENT>
                            <ENT>1</ENT>
                            <ENT>384</ENT>
                            <ENT>1.76</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">14: 100-149 employees</ENT>
                            <ENT>8</ENT>
                            <ENT>1</ENT>
                            <ENT>799</ENT>
                            <ENT>3.67</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">15: 150-199 employees</ENT>
                            <ENT>6</ENT>
                            <ENT>1</ENT>
                            <ENT>720</ENT>
                            <ENT>3.30</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">16: 200-299 employees</ENT>
                            <ENT>8</ENT>
                            <ENT>1</ENT>
                            <ENT>1,561</ENT>
                            <ENT>7.16</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34290"/>
                            <ENT I="03">18: 400-499 employees</ENT>
                            <ENT>5</ENT>
                            <ENT>1</ENT>
                            <ENT>1,758</ENT>
                            <ENT>8.07</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">19: &lt;500 employees</ENT>
                            <ENT>219</ENT>
                            <ENT>37</ENT>
                            <ENT>8,012</ENT>
                            <ENT>36.77</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">20: 500-749 employees</ENT>
                            <ENT>4</ENT>
                            <ENT>1</ENT>
                            <ENT>1,293</ENT>
                            <ENT>5.93</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">21: 750-999 employees</ENT>
                            <ENT>5</ENT>
                            <ENT>1</ENT>
                            <ENT>1,868</ENT>
                            <ENT>8.57</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">22: 1,000-1,499 employees</ENT>
                            <ENT>5</ENT>
                            <ENT>1</ENT>
                            <ENT>2,327</ENT>
                            <ENT>10.68</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Large Firms:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Employees &gt;1,499</ENT>
                            <ENT>41</ENT>
                            <ENT>NA</ENT>
                            <ENT>42,822</ENT>
                            <ENT>NA</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="03">Source:</E>
                             2019 Economic Census.
                        </TNOTE>
                        <TNOTE>
                            <E T="02">Note:</E>
                             data are not available for businesses with 1,500 to 2,500 employees.
                        </TNOTE>
                    </GPOTABLE>
                    <P>As can be seen in Tables 9 and 10, the economic impacts are disproportionate for small firms. Tables 9 and 10 show the employees for each of the size categories and the employee impact per small entity. For example, in Table 9, 390 of the smallest firms employ only 0.68 percent of the employees in its industry; while, in Table 10, 71 of the smallest firms employ only 0.65 percent of the employees in its industry.</P>
                    <P>Therefore, as can be seen in Tables 9 and 10, almost all Pharmaceutical and Medicine Manufactures are small entities as that term is used in the RFA. Additionally, Tables 9 and 10 show the disproportionate impacts among firms, and between small and large firms. In Tables 9 and 10, each industry, Pharmaceutical Preparation Manufacturing and Biologic Product (except Diagnostic) manufacturing (by employment), firm count, percentage of small firms, total employee and percentage of total employee per firm size to total employees of the small firms were estimated separately to determine the Pharmaceutical and Medicine manufacturer concentration ratios.</P>
                    <P>For purposes of the RFA, approximately 98 percent of Pharmaceutical Preparation Manufacturing (2,722/2,790 firms) and approximately 93 percent of Biologic Product (except Diagnostic) (587/628) firms are considered small businesses according to the SBA's size standards with total employee of 1,250 in any one year.</P>
                    <P>At this time, revenue data are not currently available. However, 2012 revenue data from the U.S. Economic Census was used to obtain a proxy for revenue earned in the Pharmaceutical Preparation Manufacturing industry. Therefore, as of 2012, the total annual receipts for small establishments in the Pharmaceutical Preparation Manufacturing industry, earning less than $45 million accounted for approximately 3.1 percent of the revenue. Similarly, according to the 2012 data, total annual receipts for small establishments in the Biologic Product (except Diagnostic) accounted for approximately 3.5 percent of the revenue in its industry.</P>
                    <P>Individuals and States are not included in the definition of a small entity. This proposed rule will not have a significant impact measured change in revenue of 3 to 5 percent on a substantial number of small businesses or other small entities. As its measure of significant economic impact on a substantial number of small entities, HHS uses a change in revenue of more than 3 to 5 percent. At this time, we do not believe that this threshold will be reached by the requirements in this proposed rule. Therefore, the Secretary has certified that this proposed rule will not have a significant economic impact on a substantial number of small entities.</P>
                    <P>In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This proposed rule will not have a significant impact on small rural hospitals. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary has certified, that this proposed rule will not have a significant impact on the operations of a substantial number of small rural hospitals.</P>
                    <HD SOURCE="HD2">G. Unfunded Mandates Reform Act (UMRA)</HD>
                    <P>Section 202 of the Unfunded Mandates Reform Act of 1995 (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 2023, that threshold is approximately $177 million.</P>
                    <P>This proposed rule imposes mandates that would result in anticipated costs to State, local, and Tribal governments or private sector, but the transfer costs will be less than the threshold. Some of the costs that the States may incur for the requirements of reimbursement for prescribed drugs is the cost of conducting an individual State survey as an optional tool. This proposed rule would result in multiple benefits to the States including assuring that rebates would be paid accurately and timely to the States. States would receive additional monetary rebates from manufacturers brought into compliance with drug misclassification, would limit the timeframe manufacturers have to dispute rebates, identify patients to the pharmacist as Medicaid beneficiaries, provide transparency to the State as to which PBM costs are true services costs (costs of prescriptions and dispensing fees) versus administrative costs, and permit States to pay claims sooner than the specified waiting period, when doing so is cost-effective and necessary to ensure access to care.</P>
                    <P>As a result, this proposed rule would not impose a mandate that would result in the expenditure by State, local, and Tribal Governments, in the aggregate, or by the private sector, of more than $165 million in any 1 year.</P>
                    <HD SOURCE="HD2">H. Federalism</HD>
                    <P>
                        Executive Order 13132 establishes certain requirements that an agency 
                        <PRTPAGE P="34291"/>
                        must meet when it promulgates a proposed rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. This proposed rule will not have a substantial direct effect on State or local governments, preempt States, or otherwise have a federalism implication, therefore the requirements of Executive Order 13132 are not applicable.
                    </P>
                    <P>Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &amp; Medicaid Services, approved this document on May 2, 2023.</P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects</HD>
                        <CFR>42 CFR Part 433</CFR>
                        <P>Administrative practice and procedure, Child support, Claims, Grant programs—health, Medicaid, Reporting and recordkeeping requirements.</P>
                        <CFR>42 CFR Part 438</CFR>
                        <P>Citizenship and naturalization, Civil rights, Grant programs—health, Individuals with disabilities, Medicaid, Reporting and recordkeeping requirements, Sex discrimination.</P>
                        <CFR>42 CFR Part 447</CFR>
                        <P>Accounting, Administrative practice and procedure, Drugs, Grant programs—health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping requirements, Rural areas.</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 433—STATE FISCAL ADMINISTRATION</HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 433 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 42 U.S.C. 1302.</P>
                    </AUTH>
                    <AMDPAR>2. Amend § 433.139 by revising paragraphs (b)(3)(i) and (b)(3)(ii)(B) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 433.139</SECTNO>
                        <SUBJECT>Payment of claims.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(3) * * *</P>
                        <P>(i) The claim is for preventive pediatric services, including early and periodic screening, diagnosis and treatment services provided for under part 441, subpart B, of this chapter, that are covered under the State Plan that requires a State to make payments without regard to third party liability for pediatric preventive services except that the State may, if the State determines doing so is cost-effective and will not adversely affect access to care, only make such payment if a third party so liable has not made payment within 90 days after the date the provider of such services has initially submitted a claim to such third party for payment for such services; or</P>
                        <P>(ii) * * *</P>
                        <P>(B) For child support enforcement services beginning February 9, 2018, the provider certifies that before billing Medicaid, if the provider has billed a third party, the provider has waited up to 100 days after the date of the service and provider of such services has initially submitted a claim to such third party for payment for such services, except that the State may make such payment within 30 days after such date if the State determines doing so is cost-effective and necessary to ensure access to care.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 438—MANAGED CARE</HD>
                    </PART>
                    <AMDPAR> 3. The authority citation for part 438 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED"> Authority:</HD>
                        <P> 42 U.S.C. 1302.</P>
                    </AUTH>
                    <AMDPAR> 4. Amend § 438.3 by adding paragraphs (s)(7) and (8) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 438.3</SECTNO>
                        <SUBJECT>Standard contract requirements.</SUBJECT>
                        <STARS/>
                        <P>(s) * * *</P>
                        <P>(7) Assign and exclusively use unique Medicaid-specific Beneficiary Identification Number (BIN), Processor Control Number (PCN), and group number identifiers for all Medicaid managed care beneficiary identification cards for pharmacy benefits, beginning no later than the State's next rating period for the applicable Medicaid managed care contract, following [effective date of final rule].</P>
                        <P>(8) Structure any contract with any subcontractor for the delivery or administration of the covered outpatient drug benefit to require the subcontractor to report separately the amounts related to:</P>
                        <P>(i) The incurred claims described in § 438.8(e)(2) such as reimbursement for the covered outpatient drug, payments for other patient services, and the fees paid to providers or pharmacies for dispensing or administering a covered outpatient drug; and,</P>
                        <P>(ii) Administrative costs, fees and expenses of the subcontractor.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 447—PAYMENTS FOR SERVICES</HD>
                    </PART>
                    <AMDPAR>5. The authority citation for part 447 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 42 U.S.C. 1302 and 1396r-8.</P>
                    </AUTH>
                    <AMDPAR>6. Amend § 447.502 by—</AMDPAR>
                    <AMDPAR>a. In the definition of “Covered outpatient drug”:</AMDPAR>
                    <AMDPAR>
                        i. In the introductory text, adding “
                        <E T="03">(COD)</E>
                        ” immediately following “Covered outpatient drug”; and
                    </AMDPAR>
                    <AMDPAR>ii. Revising paragraph (2) introductory text;</AMDPAR>
                    <AMDPAR>b. Adding the definitions of “Drug product information” and “Internal investigation” in alphabetical order;</AMDPAR>
                    <AMDPAR>c. In the definition of “Manufacturer,” adding paragraph (5);</AMDPAR>
                    <AMDPAR>d. Adding the definition of “Market date” in alphabetical order;</AMDPAR>
                    <AMDPAR>e. In the definition of “Noninnovator multiple source drug,” revising paragraph (3); and</AMDPAR>
                    <AMDPAR>f. Adding the definition of a “Vaccine” in alphabetical order.</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 447.502</SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Covered outpatient drug (COD)</E>
                             * * *
                        </P>
                        <P>(2) A covered outpatient drug does not include any drug, biological product, or insulin provided as part of or incident to and in the same setting as any of the services in paragraphs (2)(i) through (viii) of this definition (and for which payment may be made as part of payment for that service and not as direct reimbursement for the drug). Direct reimbursement for a drug may include both reimbursement for a drug alone, or reimbursement for a drug plus the service, in one inclusive payment if the drug and the itemized cost of the drug are separately identified on the claim.</P>
                        <STARS/>
                        <P>
                            <E T="03">Drug product information</E>
                             includes but is not limited to National Drug Code (NDC), drug name, units per package size (UPPS), drug category (“S”, “I”, “N”), unit type (for example, TAB, CAP, ML, EA), drug product type (prescription, over-the-counter), base date AMP, therapeutic equivalent code (TEC), line extension indicator, 5i indicator and route of administration, if applicable, FDA approval date, FDA application number or OTC monograph citation as applicable, market date, COD status, and any other information deemed necessary by the agency to perform accurate unit rebate amount (URA) calculations.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Internal investigation</E>
                             means a manufacturer's investigation of its AMP, 
                            <PRTPAGE P="34292"/>
                            best price, customary prompt pay discounts or nominal prices that have been previously certified in the Medicaid Drug Rebate Program (MDRP) that results in a finding made by the manufacturer of fraud, abuse, or violation of law or regulation. A manufacturer must make data available to CMS to support its finding.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Manufacturer</E>
                             * * *
                        </P>
                        <P>(5) For the purposes of maintaining an effectuated rebate agreement consistent with section 1927(a)(1) of the Social Security Act, the term “manufacturer” means that all associated entities of the manufacturer that sell prescription drugs, including, but not limited to, owned, acquired, affiliates, brother or sister corporations, operating subsidiaries, franchises, business segments, part of holding companies, divisions, or entities under common corporate ownership or control, must each maintain an effectuated rebate agreement.</P>
                        <P>
                            <E T="03">Market date,</E>
                             for the purpose of establishing the base date AMP quarter, means the date on which the covered outpatient drug was first sold by any manufacturer.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Noninnovator multiple source drug</E>
                             * * *
                        </P>
                        <P>(3) A covered outpatient drug that entered the market before 1962 that is not marketed under an NDA;</P>
                        <STARS/>
                        <P>
                            <E T="03">Vaccine</E>
                             means a product that is administered prophylactically to induce active, antigen-specific immunity for the prevention of one or more specific infectious diseases and is included in a current or previous FDA published list of vaccines licensed for use in the United States.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>7. Amend § 447.504 by revising paragraphs (c)(25) through (29) and (e)(13) through (17) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 447.504</SECTNO>
                        <SUBJECT>Determination of average manufacturer price.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(25) Manufacturer coupons to a consumer redeemed by the manufacturer, agent, pharmacy or another entity acting on behalf of the manufacturer, but only to the extent that the full value of the coupon is passed on to the consumer and the pharmacy, agent, or other AMP-eligible entity does not receive any price concession.</P>
                        <P>(26) Manufacturer-sponsored programs that provide free goods, including but not limited to vouchers and patient assistance programs, but only to the extent that: The voucher or benefit of such a program is not contingent on any other purchase requirement; the full value of the voucher or benefit of such a program is passed on to the consumer; and the pharmacy, agent, or other AMP eligible entity does not receive any price concession.</P>
                        <P>(27) Manufacturer-sponsored drug discount card programs, but only to the extent that the full value of the discount is passed on to the consumer and the pharmacy, agent, or other AMP eligible entity does not receive any price concession.</P>
                        <P>(28) Manufacturer-sponsored patient refund/rebate programs, to the extent that the manufacturer provides a full or partial refund or rebate to the patient for out-of-pocket costs and the pharmacy, agent, or other AMP eligible entity does not receive any price concessions.</P>
                        <P>(29) Manufacturer copayment assistance programs, to the extent that the program benefits are provided entirely to the patient and the pharmacy, agent, or other AMP eligible entity does not receive any price concession.</P>
                        <STARS/>
                        <P>(e) * * *</P>
                        <P>(13) Manufacturer coupons to a consumer redeemed by the manufacturer, agent, pharmacy or another entity acting on behalf of the manufacturer, but only to the extent that the full value of the coupon is passed on to the consumer and the pharmacy, agent, or other AMP eligible entity does not receive any price concession.</P>
                        <P>(14) Manufacturer-sponsored programs that provide free goods, including, but not limited to vouchers and patient assistance programs, but only to the extent that the voucher or benefit of such a program is not contingent on any other purchase requirement; the full value of the voucher or benefit of such a program is passed on to the consumer; and the pharmacy, agent, or other AMP eligible entity does not receive any price concession.</P>
                        <P>(15) Manufacturer-sponsored drug discount card programs, but only to the extent that the full value of the discount is passed on to the consumer and the pharmacy, agent, or other AMP eligible entity does not receive any price concession.</P>
                        <P>(16) Manufacturer-sponsored patient refund/rebate programs, to the extent that the manufacturer provides a full or partial refund or rebate to the patient for out-of-pocket costs and the pharmacy, agent, or other AMP eligible entity does not receive any price concessions.</P>
                        <P>(17) Manufacturer copayment assistance programs, to the extent that the program benefits are provided entirely to the patient and the pharmacy, agent, or other AMP eligible entity does not receive any price concession.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>8. Amend § 447.505 by revising paragraphs (c)(8) through (12) and (d)(3) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 447.505</SECTNO>
                        <SUBJECT>Determination of best price.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(8) Manufacturer-sponsored drug discount card programs, but only to the extent that the full value of the discount is passed on to the consumer and the pharmacy, agent, or other entity does not receive any price concession.</P>
                        <P>(9) Manufacturer coupons to a consumer redeemed by a consumer, agent, pharmacy, or another entity acting on behalf of the manufacturer; but only to the extent that the full value of the coupon is passed on to the consumer, and the pharmacy, agent, or other entity does not receive any price concession.</P>
                        <P>(10) Manufacturer copayment assistance programs, to the extent that the program benefits are provided entirely to the patient and the pharmacy, agent, or other entity does not receive any price concession.</P>
                        <P>(11) Manufacturer-sponsored patient refund or rebate programs, to the extent that the manufacturer provides a full or partial refund or rebate to the patient for out-of-pocket costs and the pharmacy, agent, or other entity does not receive any price concession.</P>
                        <P>(12) Manufacturer-sponsored programs that provide free goods, including but not limited to vouchers and patient assistance programs, but only to the extent that the voucher or benefit of such a program is not contingent on any other purchase requirement; the full value of the voucher or benefit of such a program is passed on to the consumer; and the pharmacy, agent, or other entity does not receive any price concession.</P>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>
                            (3) The manufacturer must adjust the best price for a drug for a rebate period if cumulative discounts, rebates, or other arrangements to best price eligible entities subsequently adjust the price available from the manufacturer. Cumulative discounts, rebates, or other arrangements must be stacked to determine a final price realized by the manufacturer for a covered outpatient drug, including discounts, rebates, or 
                            <PRTPAGE P="34293"/>
                            other arrangements provided to different best price eligible entities.
                        </P>
                    </SECTION>
                    <AMDPAR>9. Amend § 447.509 by—</AMDPAR>
                    <AMDPAR>a. Revising paragraphs (a)(5), (a)(6) introductory text, (a)(7) introductory text, (a)(8) and (9), and (c)(4); and</AMDPAR>
                    <AMDPAR>b. Adding paragraph (d).</AMDPAR>
                    <P>The revisions and addition read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 447.509</SECTNO>
                        <SUBJECT>Medicaid drug rebates (MDR).</SUBJECT>
                        <P>(a) * * *</P>
                        <P>
                            (5) 
                            <E T="03">Limit on rebate.</E>
                             For a rebate period beginning after December 31, 2009, and before January 1, 2024, in no case will the total rebate amount exceed 100 percent of the AMP of the single source or innovator multiple source drug.
                        </P>
                        <P>
                            (6) 
                            <E T="03">Rebate for drugs other than a single source drug or innovator multiple source drug.</E>
                             The amount of the basic rebate for each dosage form and strength of a drug other than a single source drug or innovator multiple source drug will be equal to the product of:
                        </P>
                        <STARS/>
                        <P>
                            (7) 
                            <E T="03">Additional rebate for drugs other than a single source drug or innovator multiple source drug.</E>
                             In addition to the basic rebate described in paragraph (a)(6) of this section, for each dosage form and strength of a drug other than a single source drug or innovator multiple source drug, the rebate amount will be increased by an amount equal to the product of the following:
                        </P>
                        <STARS/>
                        <P>
                            (8) 
                            <E T="03">Total rebate.</E>
                             The total rebate amount for a drug other than a single source drug or innovator multiple source drug is equal to the basic rebate amount plus the additional rebate amount, if any.
                        </P>
                        <P>
                            (9) 
                            <E T="03">Limit on rebate.</E>
                             For a rebate period beginning after December 31, 2014, and before January 1, 2024, in no case will the total rebate amount exceed 100 percent of the AMP for a drug other than a single source drug or innovator multiple source drug.
                        </P>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(4) For a drug other than a single source drug or innovator multiple source drug, the offset amount is equal to 2.0 percent of the AMP (the difference between 13.0 percent of AMP and 11.0 percent of AMP).</P>
                        <P>
                            (d) 
                            <E T="03">Manufacturer misclassification of a covered outpatient drug and recovery of unpaid rebate amounts due to the misclassification and other penalties</E>
                            —(1) 
                            <E T="03">Definition of misclassification.</E>
                             A misclassification in the MDRP has occurred when a manufacturer has:
                        </P>
                        <P>(i) Reported and certified to the agency its drug category or drug product information related to a covered outpatient drug that is not supported by the statute and applicable regulations; or,</P>
                        <P>(ii) Reported and certified to the agency its drug category or drug product information that is supported by the statute and applicable regulations, but pays rebates to States at a level other than that associated with that classification.</P>
                        <P>
                            (2) 
                            <E T="03">Manufacturer notification by the agency of drug misclassification.</E>
                             If the agency determines that a misclassification has occurred as described in paragraph (d)(1) of this section, the agency will send written and electronic notification of this misclassification to the manufacturer of the covered outpatient drug, which may include a notification that past rebates are due. The manufacturer has 30 calendar days from the date of notification to:
                        </P>
                        <P>(i) Provide the agency such drug product and drug pricing information needed to correct the misclassification of the covered outpatient drug and calculate rebate obligations due, if any pursuant to paragraph (d)(3) of this section. The required pricing data submitted by the manufacturer to the agency shall include the best price information for the covered outpatient drug, if applicable, for the rebate periods for which the manufacturer misclassified the covered outpatient drug; and,</P>
                        <P>(ii) Certify applicable price and drug product data after entered into the system by the agency.</P>
                        <P>
                            (3) 
                            <E T="03">Manufacturer payment of unpaid rebates due to misclassification determined by agency.</E>
                             (i) When the agency has determined that a manufacturer has misclassified a covered outpatient drug as described in paragraph (d)(1) of this section, such that rebates are owed to the States, and notification has been provided to the manufacturer as provided under paragraph (d)(2) of this section, a manufacturer must pay to each State an amount equal to the sum of the products of:
                        </P>
                        <P>(A) The difference between:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) The per URA paid by the manufacturer for the covered outpatient drug to the State for a period during which the drug was misclassified; and
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) The per URA that the manufacturer would have paid to the State for the covered outpatient drug for each period, as determined by the agency based on the data provided and certified by the manufacturer under paragraph (d)(2) of this section, if the drug had been correctly classified by the manufacturer; and,
                        </P>
                        <P>(B) The total units of the drug paid for under the State Plan in each period.</P>
                        <P>(ii) Manufacturers must pay such rebates to the States for the period or periods of time that such covered outpatient drug was misclassified, based on the formula described in this section, within 60 calendar days of notification by the agency to the manufacturer of the misclassification, and provide documentation to the agency that the States were contacted by the manufacturer, and that such payments were made to the States within the 60 calendar days.</P>
                        <P>
                            (4) 
                            <E T="03">Agency authority to correct misclassifications and additional penalties for drug misclassification.</E>
                             The agency will review the information submitted by the manufacturer based on the notice sent under paragraph (d)(2) of this section. If a manufacturer fails to comply with paragraph (d)(2) of this section within 30 calendar days from the date of the notification by the agency of the misclassification to the manufacturer under paragraph (d)(1) of this section, fails to pay the rebates that are due to the States as a result of the misclassification within 60 calendar days from the date of the notification, if applicable, and/or fails to provide to the agency such documentation that such rebates have been paid, as described in paragraph (d)(3) of this section, the agency may do any or all of the following:
                        </P>
                        <P>(i) Correct the misclassification of the drug in the system on behalf of the manufacturer, using any pricing and drug product information that may have been provided by the manufacturer.</P>
                        <P>(ii) Suspend the misclassified drug and the drug's status as a covered outpatient drug under the manufacturer's rebate agreement from the MDRP, and exclude the misclassified drug from FFP in accordance with section 1903(i)(10)(E) of the Act.</P>
                        <P>(iii) Impose a civil monetary penalty (CMP) for each rebate period during which the drug is misclassified, not to exceed an amount equal to the product of:</P>
                        <P>(A) The total number of units of each dosage form and strength of such misclassified drug paid for under any State Plan during such a rebate period; and</P>
                        <P>(B) 23.1 percent of the AMP for the dosage form and strength of such misclassified drug for that period.</P>
                        <P>
                            (iv) Other actions and penalties available under section 1927 of the Act (or any other provision of law), including referral to the HHS Office of the Inspector General and termination from the MDRP.
                            <PRTPAGE P="34294"/>
                        </P>
                        <P>
                            (5) 
                            <E T="03">Transparency of manufacturers' drug misclassifications.</E>
                             The agency will make available on a public website an annual report as required under section 1927(c)(4)(C)(ii) of the Act on the covered outpatient drug(s) that were identified as misclassified during the previous year, any steps taken by the agency with respect to the manufacturer to reclassify the drugs and ensure the payment by the manufacturer of unpaid rebate amounts resulting from the misclassifications, and a disclosure of the expenditures from the fund created in section 1927(b)(3)(C)(iv) of the Act.
                        </P>
                    </SECTION>
                    <AMDPAR>10. Amend § 447.510 by—</AMDPAR>
                    <AMDPAR>a. Revising the section heading and paragraph (b)(1)(v);</AMDPAR>
                    <AMDPAR>b. Adding paragraphs (h) through (k).</AMDPAR>
                    <P>The additions and revision read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 447.510</SECTNO>
                        <SUBJECT>Requirement and penalties for manufacturers.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(1) * * *</P>
                        <P>(v) The change is to address specific rebate adjustments to States by manufacturers, as required by CMS or court order, or under an internal investigation as defined at § 447.502 or an Office of Inspector General (OIG) or Department of Justice investigation.</P>
                        <STARS/>
                        <P>
                            (h) 
                            <E T="03">Participation in the Medicaid Drug Rebate Program (MDRP).</E>
                             Manufacturers that participate in MDRP must meet the following requirements:
                        </P>
                        <P>
                            (1) 
                            <E T="03">Signed rebate agreement with the Secretary.</E>
                             Manufacturers participating in the MDRP must have a signed rebate agreement in effect that complies with paragraph (5) in the definition of 
                            <E T="03">manufacturer</E>
                             in § 447.502.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Newly purchased labeler codes and covered outpatient drugs.</E>
                             Any manufacturer with a signed rebate agreement in effect that acquires or purchases another labeler, acquires or purchases covered outpatient drugs from another labeler code, or forms a new subsidiary, must ensure that a signed rebate agreement is in effect for these entities or covered outpatient drugs, consistent with the definition of 
                            <E T="03">manufacturer</E>
                             at § 447.502, within the first 30 days of the next full calendar quarter beginning at least 60 days after the acquisition, purchase, asset transfer, or formation of the subsidiary.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Termination.</E>
                             Each associated labeler code of a manufacturer is considered to be part of the single manufacturer. If any of the associated labeler codes as defined in paragraph (5) in the definition of 
                            <E T="03">manufacturer</E>
                             at § 447.502 do not have a National Drug Rebate Agreement (NDRA) in effect, or are terminated, all of the labeler codes will be subject to termination.
                        </P>
                        <P>
                            (i) 
                            <E T="03">Suspension of manufacturer's NDRA for late reporting of drug pricing and drug product information.</E>
                             (1) If a manufacturer fails to timely provide information required to be reported to the agency under section 1927(b)(3)(A) of the Act, and paragraphs (a) and (d) of this section, the agency will provide written notice to the manufacturer of failure to provide timely information. If such information is not reported within 90 calendar days of the date of the notice communicated to the manufacturer electronically and in writing by the agency, such failure by the manufacturer to report such information in a timely manner shall result in suspension of the manufacturer's rebate agreement for all covered outpatient drugs furnished after the end of the 90-day calendar period. The rebate agreement will remain suspended until the date the information is reported to the agency in full and certified, and the agency reviews for completeness, but not for a period of fewer than 30 calendar days. Continued suspension of the rebate agreement could result in termination for cause. Suspension of a manufacturer's rebate agreement under this section applies for Medicaid purposes only, and does not affect manufacturer obligations and responsibilities under the 340B Drug Pricing Program or reimbursement under Medicare Part B during the period of the suspension.
                        </P>
                        <P>(2) During the period of the suspension, the covered outpatient drugs of the manufacturer are not eligible for FFP. The agency will notify the States 30 calendar days before the beginning of the suspension period for the manufacturer's rebate agreement and any applicable associated labeler rebate agreements.</P>
                        <P>
                            (j) 
                            <E T="03">Manufacturer audits of State-provided information.</E>
                             A manufacturer may only initiate a dispute, request a hearing, or seek an audit of a State regarding State drug utilization data, during a period not to exceed 12 quarters from the last day of the quarter from the date of the State invoice.
                        </P>
                        <P>
                            (k) 
                            <E T="03">Verification survey of reported covered outpatient drug pricing</E>
                            —(1) 
                            <E T="03">Survey of manufacturers.</E>
                             CMS may survey a manufacturer with a rebate agreement with the Secretary under this section, or a wholesaler as defined in § 447.502, to verify prices or charges for a covered outpatient drug identified through paragraphs (k)(2) and (3) of this section, reported to the agency under section 1927(b)(3)(A) of the Act and this section, to make payment for the covered outpatient drug.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Identification of covered outpatient drugs potentially subject to price verification.</E>
                             On an annual basis, CMS will compile a list of single source covered outpatient drugs that may be subject to a survey based on one or more of the following criteria (further refined based upon criteria in paragraph (k)(3) of this section). This list will identify drugs that have:
                        </P>
                        <P>(i) The highest Medicaid drug spend per claim, which is when the claim is in the top 5th percentile of Medicaid spending per claim;</P>
                        <P>(ii) The highest total Medicaid drug spend, which is when the annual Medicaid drug spend, net of Federal Medicaid drug rebates, is greater than 0.5 percent of total annual Medicaid drug spend, net of Federal Medicaid drug rebates;</P>
                        <P>(iii) The highest 1-year price increase among single source covered outpatient drugs, which is when the covered outpatient drug falls in the top 1 percent of covered outpatient drugs with the highest median Wholesale Acquisition Cost (WAC) increase over 12 months; or</P>
                        <P>(iv) The highest launch price, which is a launch price estimated to be in the top 5th percentile of Medicaid spending per claim, or a launch price that is estimated to result in a total annual treatment price that is greater than $500,000 (indexed annually for inflation using the Consumer Price Index for all Urban Consumers (CPI-U)).</P>
                        <P>
                            (3) 
                            <E T="03">Selection of covered outpatient drugs for price verification.</E>
                             The survey list compiled under paragraph (k)(2) of this section will be further refined by excluding covered outpatient drugs of manufacturers that have:
                        </P>
                        <P>(i) Participated in any CMS drug pricing program or initiative under which participating manufacturers negotiate a covered outpatient drug's price directly with CMS; or,</P>
                        <P>(ii) Negotiated CMS-authorized supplemental rebate with at least 50 percent of States, that when in combination with the Federal rebate results in a total (State and Federal) rebate for the drug of interest to total Medicaid spend (State and Federal) for the drug of interest, that is greater than the total Medicaid rebates (State and Federal) to total Medicaid drug spend for States that cover CODs only through the FFS delivery system, as reflected in the most recent Medicaid Financial Management Report.</P>
                        <P>
                            (iii) If after application of the criteria in paragraphs (k)(3)(i) and (ii) of this section more than 10 covered outpatient drugs remain on the survey list, CMS 
                            <PRTPAGE P="34295"/>
                            will consider narrowing the list based on:
                        </P>
                        <P>(A) State-specific Medicaid program input regarding manufacturer effort to lower drug price (including through mechanisms such as subscription models, value-based purchasing arrangements under the multiple best price approach, or other purchasing arrangements favorable to the Medicaid program); or,</P>
                        <P>(B) Highest cost covered outpatient drugs based on the factors outlined under paragraph (k)(2) of this section, and before application of paragraph (k)(3) of this section.</P>
                        <P>
                            (4) 
                            <E T="03">Posting of survey request.</E>
                             After a survey list is compiled based on the application of the criteria in paragraphs (k)(2) and (3) of this section, the agency will post on a publicly accessible, government website, the letter sent to the manufacturer indicating the name of the covered outpatient drug to be surveyed and the request for completion of the drug price verification survey.
                        </P>
                        <P>
                            (5) 
                            <E T="03">Covered outpatient drug price verification survey.</E>
                             Such survey to a manufacturer or wholesaler will request in a standard reporting format specific information that will include:
                        </P>
                        <P>
                            (i) 
                            <E T="03">Pricing, charges, distribution, and utilization.</E>
                             (A) WAC of the covered outpatient drug, including the types of discounts available to purchasers on the commercial market, or for a wholesaler or pharmacy affiliated with a manufacturer or wholesaler, the invoice price for the drug;
                        </P>
                        <P>(B) Calculated average price of the drug from the manufacturer to wholesalers and other direct purchasers for sales outside of the U.S.;</P>
                        <P>(C) Actual or expected utilization of the covered outpatient drug in the United States, including among the Medicare and Medicaid populations;</P>
                        <P>(D) Public prices for the drug to other Federal agencies, such as the Department of Veterans Affairs; and,</P>
                        <P>(E) Information relating to the costs of distribution of the covered outpatient drug.</P>
                        <P>
                            (ii) 
                            <E T="03">Product and clinical information.</E>
                             (A) Characteristics of the covered outpatient drug, including route and setting of administration, dosing frequency, duration of therapy, side effects, interactions and contraindications, and potential for misuse or abuse.
                        </P>
                        <P>(B) Manufacturer information regarding the clinical efficacy, effectiveness and outcomes of the drug.</P>
                        <P>(C) Therapeutic benefits to the patient including information such as the:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Seriousness and prevalence of the disease or condition that is treated by the covered outpatient drug.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) The extent to which the covered outpatient drug addresses an unmet medical need.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) The extent to which the use of the covered outpatient drug will reduce or eliminate the need for other health care services.
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) Whether there are therapeutic equivalents and the number of such equivalents available for the covered outpatient drug.
                        </P>
                        <P>(D) Whether there are other existing therapies (pharmacological and non-pharmacological) available to a patient to address the indicated medical condition and the estimated costs of such other therapies to the patient compared to the price of the covered outpatient drug.</P>
                        <P>(E) If the drug is approved using FDA's accelerated approval pathway in section 506(c) of the FFDCA, any additional post-market studies required by FDA.</P>
                        <P>
                            (iii) 
                            <E T="03">Costs of production, research, and marketing.</E>
                             (A) Manufacturer expenditures on materials and manufacturing for such covered outpatient drug, any costs of purchasing or acquiring the covered outpatient drug, and other processes needed to obtain, manufacture or license the covered outpatient drug.
                        </P>
                        <P>(B) Research and development costs, including total public funds used for such research and development. If the covered outpatient drug is a line extension of a single source or innovator multiple source drug, manufacturers shall not include the research and development costs of the initial single source or innovator multiple source covered outpatient drug.</P>
                        <P>(C) Total expenditures of the manufacturer associated with marketing and advertising for the applicable covered outpatient drug.</P>
                        <P>(D) Total revenue and net profit generated from the covered outpatient drug for each calendar year since drug approval, if applicable.</P>
                        <P>
                            (iv) 
                            <E T="03">Secretary information.</E>
                             Any other information as determined by the Secretary to verify the price or charge of the covered outpatient drug reported under section 1927(b)(3)(A) of the Act and this section.
                        </P>
                        <P>
                            (6) 
                            <E T="03">Posting of manufacturer/wholesaler information from survey for further verification.</E>
                             To further verify the prices and charges submitted by the manufacturer for a covered outpatient drug, CMS may post publicly non-proprietary information provided by the manufacturer and wholesaler in response to the verification survey. CMS may request that a manufacturer address the non-proprietary information specified in paragraph (k)(6) of this section in a public forum. CMS will seek comments from the public, beneficiaries, State Medicaid agencies, other governmental agencies, and other affected interested parties on the information posted.
                        </P>
                        <P>
                            (7) 
                            <E T="03">Civil monetary penalties (CMPs).</E>
                             A manufacturer or wholesaler that refuses a request for information pursuant to the drug price verification survey within 90 calendar days of CMS' request for such information, or knowingly provides false information, will be referred to the OIG for possible imposition of CMPs as set forth in section 1927(b)(3)(B) of the Act and section IV of the National Drug Rebate Agreement.
                        </P>
                    </SECTION>
                    <AMDPAR>11. Amend § 447.518 by adding a heading to paragraph (d) and revising paragraph (d)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 447.518</SECTNO>
                        <SUBJECT>State plan requirements, findings, and assurances.</SUBJECT>
                        <STARS/>
                        <P>
                            (d) 
                            <E T="03">Data requirements.</E>
                             (1) When proposing changes to either the ingredient cost reimbursement or professional dispensing fee reimbursement, States are required to evaluate their proposed changes in accordance with the requirements of this subpart, and States must consider both the ingredient cost reimbursement and the professional dispensing fee reimbursement when proposing such changes to ensure that total reimbursement to the pharmacy provider is in accordance with requirements of section 1902(a)(30)(A) of the Act. States must provide adequate cost-based data, such as a State or national survey of retail pharmacy providers or other reliable cost-based data other than a survey to support any proposed changes to either or both of the components of the reimbursement methodology. States must submit to CMS the proposed change in reimbursement and the supporting data through a State Plan Amendment formal review process. Research and data must be based on pharmacy costs and be sufficient to establish the adequacy of both current ingredient cost reimbursement and professional dispensing fee reimbursement. Submission by the State of data that are not based on pharmacy costs, such as market-based research (for example, third party payments accepted by pharmacies) to support the professional dispensing fee would not qualify as supporting data.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>12. Revise § 447.520 to read as follows:</AMDPAR>
                    <SECTION>
                        <PRTPAGE P="34296"/>
                        <SECTNO>§ 447.520</SECTNO>
                        <SUBJECT>Federal Financial Participation (FFP): Conditions relating to physician-administered drugs.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Availability of FFP.</E>
                             No FFP is available for physician-administered drugs that are covered outpatient drugs for which a State has not required the submission of claims using codes that identify the drugs sufficiently for the State to invoice a manufacturer for rebates.
                        </P>
                        <P>
                            (1) 
                            <E T="03">Single source drugs.</E>
                             For a covered outpatient drug that is a single source, physician-administered drug, administered on or after January 1, 2006, a State must require providers to submit claims for using National Drug Code (NDC) numbers to secure rebates and receive FFP.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Multiple source drugs.</E>
                             For a covered outpatient drug that is a multiple source, physician-administered drug on the list published by CMS described in paragraph (c) of this section, administered on or after January 1, 2008, a State must require providers to submit claims using NDC numbers to secure rebates and receive FFP. States are required to invoice for rebates for all multiple source physician-administered drugs that are CODs, and not limit such rebate invoicing to the top 20 multiple source physician-administered drug list.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Required coding.</E>
                             As of January 1, 2007, a State must require providers to submit claims for a covered outpatient drug that is described in paragraph (a)(1) or (2) of this section (any covered outpatient drug that is a physician-administered drug) using NDC numbers.
                        </P>
                        <P>
                            (c) 
                            <E T="03">Top 20 multiple source physician-administered drug list.</E>
                             The top 20 multiple source physician-administered drug list, identified by the Secretary as having the highest dollar volume of physician administered drugs dispensed under the Medicaid program, will be published and may be modified from year to year to reflect changes in such volume.
                        </P>
                        <P>
                            (d) 
                            <E T="03">Hardship waiver.</E>
                             A State that requires additional time to comply with the requirements of this section may apply to the Secretary for an extension.
                        </P>
                    </SECTION>
                    <SIG>
                        <DATED>Dated: May 18, 2023.</DATED>
                        <NAME>Xavier Becerra,</NAME>
                        <TITLE>Secretary, Department of Health and Human Services.</TITLE>
                    </SIG>
                </SUPLINF>
                <FRDOC>[FR Doc. 2023-10934 Filed 5-23-23; 4:15 pm]</FRDOC>
                <BILCOD> BILLING CODE 4120-01-P</BILCOD>
            </PRORULE>
        </PRORULES>
    </NEWPART>
    <VOL>88</VOL>
    <NO>102</NO>
    <DATE>Friday, May 26, 2023</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="34297"/>
            <PARTNO>Part III</PARTNO>
            <AGENCY TYPE="P">Department of Energy</AGENCY>
            <CFR>10 CFR Parts 429 and 430</CFR>
            <TITLE>Energy Conservation Program: Energy Conservation Standards for Room Air Conditioners; Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="34298"/>
                    <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                    <CFR>10 CFR Parts 429 and 430</CFR>
                    <DEPDOC>[EERE-2014-BT-STD-0059]</DEPDOC>
                    <RIN>RIN 1904-AD97</RIN>
                    <SUBJECT>Energy Conservation Program: Energy Conservation Standards for Room Air Conditioners</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Office of Energy Efficiency and Renewable Energy, Department of Energy.</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>The Energy Policy and Conservation Act, as amended (“EPCA”), prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including room air conditioners. EPCA also requires the U.S. Department of Energy (“DOE”) to periodically determine whether more-stringent, standards would be technologically feasible and economically justified, and would result in significant energy savings. In this final rule, DOE is adopting amended energy conservation standards for room air conditioners. It has determined that the amended energy conservation standards for these products would result in significant conservation of energy, and are technologically feasible and economically justified.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>The effective date of this rule is July 25, 2023. Compliance with the amended standards established for room air conditioners in this final rule is required on and after May 26, 2026.</P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>
                            The docket for this rulemaking, which includes 
                            <E T="04">Federal Register</E>
                             notices, public meeting attendee lists and transcripts, comments, and other supporting documents/materials, is available for review at 
                            <E T="03">www.regulations.gov.</E>
                             All documents in the docket are listed in the 
                            <E T="03">www.regulations.gov</E>
                             index. However, not all documents listed in the index may be publicly available, such as information that is exempt from public disclosure.
                        </P>
                        <P>
                            The docket web page can be found at 
                            <E T="03">www.regulations.gov/docket??D=EERE-2014-BT-STD-0059.</E>
                             The docket web page contains instructions on how to access all documents, including public comments, in the docket.
                        </P>
                        <P>
                            For further information on how to review the docket, contact the Appliance and Equipment Standards Program staff at (202) 287-1445 or by email: 
                            <E T="03">ApplianceStandardsQuestions@ee.doe.gov.</E>
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            Mr. Lucas Adin, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 287-5904. Email: 
                            <E T="03">ApplianceStandardsQuestions@ee.doe.gov.</E>
                        </P>
                        <P>
                            Ms. Sarah Butler, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 586-1777. Email: 
                            <E T="03">Sarah.Butler@hq.doe.gov.</E>
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <P/>
                    <HD SOURCE="HD1">Table of Contents</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">I. Synopsis of the Final Rule</FP>
                        <FP SOURCE="FP1-2">A. Benefits and Costs to Consumers</FP>
                        <FP SOURCE="FP1-2">B. Impact on Manufacturers</FP>
                        <FP SOURCE="FP1-2">C. National Benefits and Costs</FP>
                        <FP SOURCE="FP1-2">D. Conclusion</FP>
                        <FP SOURCE="FP-2">II. Introduction</FP>
                        <FP SOURCE="FP1-2">A. Authority</FP>
                        <FP SOURCE="FP1-2">B. Background</FP>
                        <FP SOURCE="FP1-2">1. Current Standards</FP>
                        <FP SOURCE="FP1-2">2. History of Standards Rulemaking for Room Air Conditioners</FP>
                        <FP SOURCE="FP-2">III. General Discussion</FP>
                        <FP SOURCE="FP1-2">A. Product Classes and Scope of Coverage</FP>
                        <FP SOURCE="FP1-2">B. Test Procedure</FP>
                        <FP SOURCE="FP1-2">C. Technological Feasibility</FP>
                        <FP SOURCE="FP1-2">1. General</FP>
                        <FP SOURCE="FP1-2">2. Maximum Technologically Feasible Levels</FP>
                        <FP SOURCE="FP1-2">D. Energy Savings</FP>
                        <FP SOURCE="FP1-2">1. Determination of Savings</FP>
                        <FP SOURCE="FP1-2">2. Significance of Savings</FP>
                        <FP SOURCE="FP1-2">E. Economic Justification</FP>
                        <FP SOURCE="FP1-2">1. Specific Criteria</FP>
                        <FP SOURCE="FP1-2">a. Economic Impact on Manufacturers and Consumers</FP>
                        <FP SOURCE="FP1-2">b. Savings in Operating Costs Compared to Increase in Price (LCC and PBP)</FP>
                        <FP SOURCE="FP1-2">c. Energy Savings</FP>
                        <FP SOURCE="FP1-2">d. Lessening of Utility or Performance of Products</FP>
                        <FP SOURCE="FP1-2">e. Impact of Any Lessening of Competition</FP>
                        <FP SOURCE="FP1-2">f. Need for National Energy Conservation</FP>
                        <FP SOURCE="FP1-2">g. Other Factors</FP>
                        <FP SOURCE="FP1-2">2. Rebuttable Presumption</FP>
                        <FP SOURCE="FP-2">IV. Methodology and Discussion of Related Comments</FP>
                        <FP SOURCE="FP1-2">A. Market and Technology Assessment</FP>
                        <FP SOURCE="FP1-2">1. Scope of Coverage and Product Classes</FP>
                        <FP SOURCE="FP1-2">2. Technology Options</FP>
                        <FP SOURCE="FP1-2">a. Alternative Refrigerants</FP>
                        <FP SOURCE="FP1-2">b. Product Weight</FP>
                        <FP SOURCE="FP1-2">B. Screening Analysis</FP>
                        <FP SOURCE="FP1-2">1. Screened-Out Technologies</FP>
                        <FP SOURCE="FP1-2">2. Remaining Technologies</FP>
                        <FP SOURCE="FP1-2">C. Engineering Analysis</FP>
                        <FP SOURCE="FP1-2">1. Efficiency Analysis</FP>
                        <FP SOURCE="FP1-2">a. Baseline Efficiency/Energy Use</FP>
                        <FP SOURCE="FP1-2">b. Higher Efficiency Levels</FP>
                        <FP SOURCE="FP1-2">2. Cost Analysis</FP>
                        <FP SOURCE="FP1-2">3. Cost-Efficiency Relationship</FP>
                        <FP SOURCE="FP1-2">4. Consumer Utility</FP>
                        <FP SOURCE="FP1-2">D. Markups Analysis</FP>
                        <FP SOURCE="FP1-2">E. Energy Use Analysis</FP>
                        <FP SOURCE="FP1-2">F. Life-Cycle Cost and Payback Period Analysis</FP>
                        <FP SOURCE="FP1-2">1. Product Cost</FP>
                        <FP SOURCE="FP1-2">2. Installation Cost</FP>
                        <FP SOURCE="FP1-2">3. Annual Energy Consumption</FP>
                        <FP SOURCE="FP1-2">a. Rebound Effect</FP>
                        <FP SOURCE="FP1-2">4. Energy Prices</FP>
                        <FP SOURCE="FP1-2">5. Maintenance and Repair Costs</FP>
                        <FP SOURCE="FP1-2">6. Product Lifetime</FP>
                        <FP SOURCE="FP1-2">7. Discount Rates</FP>
                        <FP SOURCE="FP1-2">8. Energy Efficiency Distribution in the No-New-Standards Case</FP>
                        <FP SOURCE="FP1-2">9. Payback Period Analysis</FP>
                        <FP SOURCE="FP1-2">G. Shipments Analysis</FP>
                        <FP SOURCE="FP1-2">H. National Impact Analysis</FP>
                        <FP SOURCE="FP1-2">1. Product Efficiency Trends</FP>
                        <FP SOURCE="FP1-2">2. National Energy Savings</FP>
                        <FP SOURCE="FP1-2">3. Net Present Value Analysis</FP>
                        <FP SOURCE="FP1-2">I. Consumer Subgroup Analysis</FP>
                        <FP SOURCE="FP1-2">J. Manufacturer Impact Analysis</FP>
                        <FP SOURCE="FP1-2">1. Overview</FP>
                        <FP SOURCE="FP1-2">2. Government Regulatory Impact Model and Key Inputs</FP>
                        <FP SOURCE="FP1-2">a. Manufacturer Production Costs</FP>
                        <FP SOURCE="FP1-2">b. Shipments Projections</FP>
                        <FP SOURCE="FP1-2">c. Product and Capital Conversion Costs</FP>
                        <FP SOURCE="FP1-2">d. Manufacturer Markup Scenarios</FP>
                        <FP SOURCE="FP1-2">3. Discussion of MIA Comments</FP>
                        <FP SOURCE="FP1-2">K. Emissions Analysis</FP>
                        <FP SOURCE="FP1-2">1. Air Quality Regulations Incorporated in DOE's Analysis</FP>
                        <FP SOURCE="FP1-2">L. Monetizing Emissions Impacts</FP>
                        <FP SOURCE="FP1-2">1. Monetization of Greenhouse Gas Emissions</FP>
                        <FP SOURCE="FP1-2">a. Social Cost of Carbon</FP>
                        <FP SOURCE="FP1-2">b. Social Cost of Methane and Nitrous Oxide</FP>
                        <FP SOURCE="FP1-2">2. Monetization of Other Emissions Impacts</FP>
                        <FP SOURCE="FP1-2">M. Utility Impact Analysis</FP>
                        <FP SOURCE="FP1-2">N. Employment Impact Analysis</FP>
                        <FP SOURCE="FP-2">V. Analytical Results and Conclusions</FP>
                        <FP SOURCE="FP1-2">A. Trial Standard Levels</FP>
                        <FP SOURCE="FP1-2">B. Economic Justification and Energy Savings</FP>
                        <FP SOURCE="FP1-2">1. Economic Impacts on Individual Consumers</FP>
                        <FP SOURCE="FP1-2">a. Life-Cycle Cost and Payback Period</FP>
                        <FP SOURCE="FP1-2">b. Consumer Subgroup Analysis</FP>
                        <FP SOURCE="FP1-2">c. Rebuttable Presumption Payback</FP>
                        <FP SOURCE="FP1-2">2. Economic Impacts on Manufacturers</FP>
                        <FP SOURCE="FP1-2">a. Industry Cash Flow Analysis Results</FP>
                        <FP SOURCE="FP1-2">b. Direct Impacts on Employment</FP>
                        <FP SOURCE="FP1-2">c. Impacts on Manufacturing Capacity</FP>
                        <FP SOURCE="FP1-2">d. Impacts on Subgroups of Manufacturers</FP>
                        <FP SOURCE="FP1-2">e. Cumulative Regulatory Burden</FP>
                        <FP SOURCE="FP1-2">3. National Impact Analysis</FP>
                        <FP SOURCE="FP1-2">a. Significance of Energy Savings</FP>
                        <FP SOURCE="FP1-2">b. Net Present Value of Consumer Costs and Benefits</FP>
                        <FP SOURCE="FP1-2">c. Indirect Impacts on Employment</FP>
                        <FP SOURCE="FP1-2">4. Impact on Utility or Performance of Products</FP>
                        <FP SOURCE="FP1-2">5. Impact of Any Lessening of Competition</FP>
                        <FP SOURCE="FP1-2">6. Need of the Nation To Conserve Energy</FP>
                        <FP SOURCE="FP1-2">7. Other Factors</FP>
                        <FP SOURCE="FP1-2">8. Summary of Economic Impacts</FP>
                        <FP SOURCE="FP1-2">C. Conclusion</FP>
                        <FP SOURCE="FP1-2">1. Benefits and Burdens of TSLs Considered for Room Air Conditioner Standards</FP>
                        <FP SOURCE="FP1-2">2. Annualized Benefits and Costs of the Adopted Standards</FP>
                        <FP SOURCE="FP-2">VI. Cooling Capacity Verification</FP>
                        <FP SOURCE="FP-2">VII. Procedural Issues and Regulatory Review</FP>
                        <FP SOURCE="FP1-2">A. Review Under Executive Orders 12866 and 13563</FP>
                        <FP SOURCE="FP1-2">
                            B. Review Under the Regulatory Flexibility Act
                            <PRTPAGE P="34299"/>
                        </FP>
                        <FP SOURCE="FP1-2">C. Review Under the Paperwork Reduction Act</FP>
                        <FP SOURCE="FP1-2">D. Review Under the National Environmental Policy Act of 1969</FP>
                        <FP SOURCE="FP1-2">E. Review Under Executive Order 13132</FP>
                        <FP SOURCE="FP1-2">F. Review Under Executive Order 12988</FP>
                        <FP SOURCE="FP1-2">G. Review Under the Unfunded Mandates Reform Act of 1995</FP>
                        <FP SOURCE="FP1-2">H. Review Under the Treasury and General Government Appropriations Act, 1999</FP>
                        <FP SOURCE="FP1-2">I. Review Under Executive Order 12630</FP>
                        <FP SOURCE="FP1-2">J. Review Under the Treasury and General Government Appropriations Act, 2001</FP>
                        <FP SOURCE="FP1-2">K. Review Under Executive Order 13211</FP>
                        <FP SOURCE="FP1-2">L. Information Quality</FP>
                        <FP SOURCE="FP1-2">M. Congressional Notification</FP>
                        <FP SOURCE="FP-2">VIII. Approval of the Office of the Secretary</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. Synopsis of the Final Rule</HD>
                    <P>
                        The Energy Policy and Conservation Act, Public Law 94-163, as amended (“EPCA”),
                        <SU>1</SU>
                        <FTREF/>
                         authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. (42 U.S.C. 6291-6317) Title III, Part B of EPCA 
                        <SU>2</SU>
                        <FTREF/>
                         established the Energy Conservation Program for Consumer Products Other Than Automobiles. (42 U.S.C. 6291-6309) These products include room air conditioners, the subject of this final rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             All references to EPCA in this document refer to the statute as amended through the Energy Act of 2020, Public Law. 116-260 (Dec. 27, 2020), which reflect the last statutory amendments that impact Parts A and A-1 of EPCA.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             For editorial reasons, upon codification in the U.S. Code, Part B was redesignated Part A.
                        </P>
                    </FTNT>
                    <P>Pursuant to EPCA, any new or amended energy conservation standard must be designed to achieve the maximum improvement in energy efficiency that DOE determines is technologically feasible and economically justified. (42 U.S.C. 6295(o)(2)(A)) Furthermore, the new or amended standard must result in significant conservation of energy. (42 U.S.C. 6295(o)(3)(B)) EPCA also provides that not later than 6 years after issuance of any final rule establishing or amending a standard, DOE must publish either a notice of determination that standards for the product do not need to be amended, or a notice of proposed rulemaking including new proposed energy conservation standards (proceeding to a final rule, as appropriate). (42 U.S.C. 6295(m))</P>
                    <P>In accordance with these and other statutory provisions discussed in this document, DOE is adopting amended energy conservation standards for room air conditioners. The adopted standards, which are expressed in the amount of cooling provided per amount of energy consumed, measured in British thermal units per watt-hour (“Btu/Wh”) are shown in Table I.1. These standards apply to all room air conditioners listed in Table I.1 and manufactured in, or imported into, the United States starting on May 26, 2026.</P>
                    <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s200,15">
                        <TTITLE>Table I.1—Energy Conservation Standards for Room Air Conditioners</TTITLE>
                        <TDESC>[Compliance starting May 26, 2026]</TDESC>
                        <BOXHD>
                            <CHED H="1">Equipment class</CHED>
                            <CHED H="1">
                                Combined energy
                                <LI>efficiency ratio</LI>
                                <LI>(CEER)</LI>
                                <LI>(Btu/Wh)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">1. Without reverse cycle, with louvered sides, and less than 6,000 British thermal units per hour (“Btu/h”)</ENT>
                            <ENT>13.1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2. Without reverse cycle, with louvered sides and 6,000 to 7,900 Btu/h</ENT>
                            <ENT>13.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3. Without reverse cycle, with louvered sides and 8,000 to 13,900 Btu/h</ENT>
                            <ENT>16.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4. Without reverse cycle, with louvered sides and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>16.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5a. Without reverse cycle, with louvered sides and 20,000 to 27,900 Btu/h</ENT>
                            <ENT>13.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5b. Without reverse cycle, with louvered sides and 28,000 Btu/h or more</ENT>
                            <ENT>13.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6. Without reverse cycle, without louvered sides, and less than 6,000 Btu/h</ENT>
                            <ENT>12.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">7. Without reverse cycle, without louvered sides and 6,000 to 7,900 Btu/h</ENT>
                            <ENT>12.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">8a. Without reverse cycle, without louvered sides and 8,000 to 10,900 Btu/h</ENT>
                            <ENT>14.1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">8b. Without reverse cycle, without louvered sides and 11,000 to 13,900 Btu/h</ENT>
                            <ENT>13.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">9. Without reverse cycle, without louvered sides and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>13.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">10. Without reverse cycle, without louvered sides and 20,000 Btu/h or more</ENT>
                            <ENT>13.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">11. With reverse cycle, with louvered sides, and less than 20,000 Btu/h</ENT>
                            <ENT>14.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">12. With reverse cycle, without louvered sides, and less than 14,000 Btu/h</ENT>
                            <ENT>13.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">13. With reverse cycle, with louvered sides, and 20,000 Btu/h or more</ENT>
                            <ENT>13.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">14. With reverse cycle, without louvered sides, and 14,000 Btu/h or more</ENT>
                            <ENT>12.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">15. Casement-Only</ENT>
                            <ENT>13.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">16. Casement-Slider</ENT>
                            <ENT>15.3</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD2">A. Benefits and Costs to Consumers</HD>
                    <P>
                        Table I.2 summarizes DOE's evaluation of the economic impacts of the adopted standards on consumers of room air conditioners, as measured by the average life-cycle cost (“LCC”) savings and the simple payback period (“PBP”).
                        <SU>3</SU>
                        <FTREF/>
                         The average LCC savings are positive for all product classes, and the PBP is less than the average lifetime of room air conditioners, which is estimated to be 9.3 years (see section IV.F of this document).
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             The average LCC savings refer to consumers that are affected by a standard and are measured relative to the efficiency distribution in the no-new-standards case, which depicts the market in the compliance year in the absence of new or amended standards (see section IV.F.9 of this document). The simple PBP, which is designed to compare specific efficiency levels, is measured relative to the baseline product (see section IV.C of this document).
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s200,15,15">
                        <TTITLE>Table I.2—Impacts of Adopted Energy Conservation Standards on Consumers of Room Air Conditioners</TTITLE>
                        <BOXHD>
                            <CHED H="1">Room air conditioner product class</CHED>
                            <CHED H="1">
                                Average LCC
                                <LI>savings</LI>
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="1">
                                Simple payback
                                <LI>period</LI>
                                <LI>(years)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">1. Without reverse cycle, with louvered sides, and less than 6,000 Btu/h</ENT>
                            <ENT>65</ENT>
                            <ENT>0.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2. Without reverse cycle, with louvered sides and 6,000 to 7,900 Btu/h</ENT>
                            <ENT>72</ENT>
                            <ENT>1.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3. Without reverse cycle, with louvered sides and 8,000 to 13,900 Btu/h</ENT>
                            <ENT>100</ENT>
                            <ENT>2.9</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34300"/>
                            <ENT I="01">4. Without reverse cycle, with louvered sides and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>92</ENT>
                            <ENT>3.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5a. Without reverse cycle, with louvered sides and 20,000 Btu/h to 27,900 Btu/h</ENT>
                            <ENT>148</ENT>
                            <ENT>2.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5b. Without reverse cycle, with louvered sides and 28,000 Btu/h or more</ENT>
                            <ENT>284</ENT>
                            <ENT>2.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">8a. Without reverse cycle, without louvered sides and 8,000 to 10,900 Btu/h</ENT>
                            <ENT>84</ENT>
                            <ENT>3.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">8b. Without reverse cycle, without louvered sides and 11,000 to 13,900 Btu/h</ENT>
                            <ENT>119</ENT>
                            <ENT>2.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">9. Without reverse cycle, without louvered sides and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>165</ENT>
                            <ENT>2.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">11. With reverse cycle, with louvered sides, and less than 20,000 Btu/h</ENT>
                            <ENT>134</ENT>
                            <ENT>3.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">12. With reverse cycle, without louvered sides, and less than 14,000 Btu/h</ENT>
                            <ENT>124</ENT>
                            <ENT>2.6</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">16. Casement-Slider</ENT>
                            <ENT>84</ENT>
                            <ENT>4.0</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>DOE's analysis of the impacts of the adopted standards on consumers is described in section IV.F of this document.</P>
                    <HD SOURCE="HD2">B. Impact on Manufacturers</HD>
                    <P>
                        The industry net present value (“INPV”) is the sum of the discounted cash flows to the industry from the announcement of the standard through the end of the analysis period (2023-2055). Using a real discount rate of 7.2 percent, DOE estimates that the INPV for manufacturers of room air conditioners in the case without amended standards is $1.20 billion.
                        <SU>4</SU>
                        <FTREF/>
                         Under the adopted standards, DOE estimates the change in INPV to range from −4.8 percent to 7.1 percent, which is approximately −$57.7 million to $85.6 million. In order to bring products into compliance with amended standards, it is estimated that industry will incur total conversion costs of $24.8 million.
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             All monetary values in this document are expressed in 2021 dollars.
                        </P>
                    </FTNT>
                    <P>DOE's analysis of the impacts of the adopted standards on manufacturers is described in sections IV.J and V.B.2 of this document.</P>
                    <HD SOURCE="HD2">C. National Benefits and Costs</HD>
                    <P>
                        DOE's analyses indicate that the adopted energy conservation standards for room air conditioners would save a significant amount of energy. Relative to the case without amended standards, the lifetime energy savings for room air conditioners purchased in the 30-year period that begins in the anticipated year of compliance with the amended standards (2026-2055), amount to 1.41 quadrillion British thermal units (“Btu”), or quads.
                        <SU>5</SU>
                        <FTREF/>
                         This represents a savings of 12 percent relative to the energy use of these products in the case without amended standards (referred to as the “no-new-standards case”).
                    </P>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             The quantity refers to full-fuel-cycle (FFC) energy savings. FFC energy savings includes the energy consumed in extracting, processing, and transporting primary fuels (
                            <E T="03">i.e.,</E>
                             coal, natural gas, petroleum fuels), and, thus, presents a more complete picture of the impacts of energy efficiency standards. For more information on the FFC metric, see section IV.H.1 of this document.
                        </P>
                    </FTNT>
                    <P>The cumulative net present value (“NPV”) of total consumer benefits of the standards for room air conditioners ranges from $5.39 billion (at a 7-percent discount rate) to $11.46 billion (at a 3-percent discount rate). This NPV expresses the estimated total value of future operating-cost savings minus the estimated increased product costs for room air conditioners purchased in 2026-2055.</P>
                    <P>
                        In addition, the adopted standards for room air conditioners are projected to yield significant environmental benefits. DOE estimates that the standards will result in cumulative emission reductions (over the same period as for energy savings) of 48.5 million metric tons (“Mt”) 
                        <SU>6</SU>
                        <FTREF/>
                         of carbon dioxide (“CO
                        <E T="52">2</E>
                        ”), 20.1 thousand tons of sulfur dioxide (“SO
                        <E T="52">2</E>
                        ”), 74.2 thousand tons of nitrogen oxides (“NO
                        <E T="52">X</E>
                        ”), 325.6 thousand tons of methane (“CH
                        <E T="52">4</E>
                        ”), 0.5 thousand tons of nitrous oxide (“N
                        <E T="52">2</E>
                        O”), and 0.1 tons of mercury (“Hg”).
                        <SU>7</SU>
                        <FTREF/>
                         The estimated cumulative reduction in CO
                        <E T="52">2</E>
                         emissions through 2030 amounts to 4.4 Mt, which is equivalent to the emissions resulting from the annual electricity use of more than 856,000 homes.
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             A metric ton is equivalent to 1.1 short tons. Results for emissions other than CO
                            <E T="52">2</E>
                             are presented in short tons.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             DOE calculated emissions reductions relative to the no-new-standards-case, which reflects key assumptions in the 
                            <E T="03">Annual Energy Outlook 2022</E>
                             (“
                            <E T="03">AEO2022</E>
                            ”). 
                            <E T="03">AEO2022</E>
                             represents current Federal and state legislation and final implementation of regulations as of the time of its preparation. See section IV.K of this document for further discussion of 
                            <E T="03">AEO2022</E>
                             assumptions that effect air pollutant emissions.
                        </P>
                    </FTNT>
                    <P>
                        DOE estimates the value of climate benefits from a reduction in greenhouse gases (GHG) using four different estimates of the social cost of CO
                        <E T="52">2</E>
                         (“SC-CO
                        <E T="52">2</E>
                        ”), the social cost of methane (“SC-CH
                        <E T="52">4</E>
                        ”), and the social cost of nitrous oxide (“SC-N
                        <E T="52">2</E>
                        O”). Together these represent the social cost of GHG (SC-GHG).
                        <SU>8</SU>
                        <FTREF/>
                         DOE used interim SC-GHG values developed by an Interagency Working Group on the Social Cost of Greenhouse Gases (IWG).
                        <SU>9</SU>
                        <FTREF/>
                         The derivation of these values is discussed in section IV.L.1 of this document. For presentational purposes, the climate benefits associated with the average SC-GHG at a 3-percent discount rate are estimated to be $2.51 billion. DOE does not have a single central SC-GHG point estimate and it emphasizes the importance and value of considering the benefits calculated using all four sets of SC-GHG estimates.
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             On March 16, 2022, the Fifth Circuit Court of Appeals (No. 22-30087) granted the Federal Government's emergency motion for stay pending appeal of the February 11, 2022, preliminary injunction issued in 
                            <E T="03">Louisiana</E>
                             v. 
                            <E T="03">Biden,</E>
                             No. 21-cv-1074-JDC-KK (W.D. La.). As a result of the Fifth Circuit's order, the preliminary injunction is no longer in effect, pending resolution of the Federal Government's appeal of that injunction or a further court order. Among other things, the preliminary injunction enjoined the defendants in that case from “adopting, employing, treating as binding, or relying upon” the interim estimates of the social cost of greenhouse gases—which were issued by the Interagency Working Group on the Social Cost of Greenhouse Gases on February 26, 2021—to monetize the benefits of reducing greenhouse gas emissions. As reflected in this rule, DOE has reverted to its approach prior to the injunction and presents monetized greenhouse gas abatement benefits where appropriate and permissible under law.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             See Interagency Working Group on Social Cost of Greenhouse Gases, Technical Support Document: Social Cost of Carbon, Methane, and Nitrous Oxide. Interim Estimates Under Executive Order 13990, Washington, DC, February 2021 (“February 2021 SC-GHG TSD”). 
                            <E T="03">www.whitehouse.gov/wp-content/uploads/2021/02/TechnicalSupportDocument_SocialCostofCarbonMethaneNitrousOxide.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        DOE estimated the monetary health benefits of SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                         emissions reductions, using benefit per ton estimates from the scientific literature, as discussed in section IV.L of this document. DOE estimated the present value of the health benefits would be $2.02 billion using a 7-percent discount rate, and $4.39 billion using a 3-percent 
                        <PRTPAGE P="34301"/>
                        discount rate.
                        <SU>10</SU>
                        <FTREF/>
                         DOE is currently only monetizing (for SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                        ) fine particulate matter (“PM
                        <E T="52">2.5</E>
                        ”) precursor health benefits and (for NO
                        <E T="52">X</E>
                        ) ozone precursor health benefits, but will continue to assess the ability to monetize other effects such as health benefits from reductions in direct PM
                        <E T="52">2.5</E>
                         emissions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             DOE estimates the economic value of these emissions reductions resulting from the considered TSLs for the purpose of complying with the requirements of Executive Order 12866.
                        </P>
                    </FTNT>
                    <P>Table I.3 summarizes the economic benefits and costs expected to result from the adopted standards for room air conditioners. There are other important unquantified effects, including certain unquantified climate benefits, unquantified public health benefits from the reduction of toxic air pollutants and other emissions, unquantified energy security benefits, and distributional effects, among others.</P>
                    <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s200,16">
                        <TTITLE>Table I.3—Summary of Economic Benefits and Costs of Adopted Energy Conservation Standards for Room Air Conditioners</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Billion $2021</CHED>
                        </BOXHD>
                        <ROW EXPSTB="01" RUL="s">
                            <ENT I="21">
                                <E T="02">3% discount rate</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Consumer Operating Cost Savings</ENT>
                            <ENT>14.63</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Climate Benefits *</ENT>
                            <ENT>2.51</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Health Benefits **</ENT>
                            <ENT>4.39</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total Benefits †</ENT>
                            <ENT>21.54</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Consumer Incremental Product Costs ‡</ENT>
                            <ENT>3.17</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="03">Net Benefits</ENT>
                            <ENT>18.37</ENT>
                        </ROW>
                        <ROW EXPSTB="01" RUL="s">
                            <ENT I="21">
                                <E T="02">7% discount rate</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Consumer Operating Cost Savings</ENT>
                            <ENT>7.46</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Climate Benefits * (3% discount rate)</ENT>
                            <ENT>2.51</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Health Benefits **</ENT>
                            <ENT>2.02</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total Benefits †</ENT>
                            <ENT>12.00</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Consumer Incremental Product Costs ‡</ENT>
                            <ENT>2.08</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Net Benefits</ENT>
                            <ENT>9.92</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             This table presents the costs and benefits associated with room air conditioners shipped in 2026-2055. These results include benefits to consumers which accrue after 2055 from the products shipped in 2026-2055.
                        </TNOTE>
                        <TNOTE>
                            * Climate benefits are calculated using four different estimates of the social cost of carbon (SC-CO
                            <E T="0732">2</E>
                            ), methane (SC-CH
                            <E T="0732">4</E>
                            ), and nitrous oxide (SC-N
                            <E T="0732">2</E>
                            O) (model average at 2.5 percent, 3 percent, and 5 percent discount rates; 95th percentile at 3 percent discount rate) (see section IV.L of this document). Together these represent the global SC-GHG. For presentational purposes of this table, the climate benefits associated with the average SC-GHG at a 3 percent discount rate are shown, but DOE does not have a single central SC-GHG point estimate. On March 16, 2022, the Fifth Circuit Court of Appeals (No. 22-30087) granted the Federal Government's emergency motion for stay pending appeal of the February 11, 2022, preliminary injunction issued in 
                            <E T="03">Louisiana</E>
                             v. 
                            <E T="03">Biden,</E>
                             No. 21-cv-1074-JDC-KK (W.D. La.). As a result of the Fifth Circuit's order, the preliminary injunction is no longer in effect, pending resolution of the Federal Government's appeal of that injunction or a further court order. Among other things, the preliminary injunction enjoined the defendants in that case from “adopting, employing, treating as binding, or relying upon” the interim estimates of the social cost of greenhouse gases—which were issued by the Interagency Working Group on the Social Cost of Greenhouse Gases on February 26, 2021—to monetize the benefits of reducing greenhouse gas emissions. As reflected in this rule, DOE has reverted to its approach prior to the injunction and presents monetized greenhouse gas abatement benefits where appropriate and permissible under law.
                        </TNOTE>
                        <TNOTE>
                            ** Health benefits are calculated using benefit-per-ton values for NO
                            <E T="0732">X</E>
                             and SO
                            <E T="0732">2</E>
                            . DOE is currently only monetizing (for SO
                            <E T="0732">2</E>
                             and NO
                            <E T="0732">X</E>
                            ) PM
                            <E T="0732">2.5</E>
                             precursor health benefits and (for NO
                            <E T="0732">X</E>
                            ) ozone precursor health benefits, but will continue to assess the ability to monetize other effects such as health benefits from reductions in direct PM
                            <E T="0732">2.5</E>
                             emissions. See section IV.L of this document for more details.
                        </TNOTE>
                        <TNOTE>† Total and net benefits include those consumer, climate, and health benefits that can be quantified and monetized. For presentation purposes, total and net benefits for both the 3-percent and 7-percent cases are presented using the average SC-GHG with 3-percent discount rate, but DOE does not have a single central SC-GHG point estimate. DOE emphasizes the importance and value of considering the benefits calculated using all four sets of SC-GHG estimates.</TNOTE>
                        <TNOTE>‡ Costs include incremental equipment costs as well as installation costs.</TNOTE>
                    </GPOTABLE>
                    <P>
                        The benefits and costs of the standards can also be expressed in terms of annualized values. The monetary values for the total annualized net benefits are (1) the reduced consumer operating costs, minus (2) the increase in product purchase prices and installation costs, plus (3) the value of climate and health benefits of emission reductions, all annualized.
                        <SU>11</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             To convert the time-series of costs and benefits into annualized values, DOE calculated a present value in 2022, the year used for discounting the NPV of total consumer costs and savings. For the benefits, DOE calculated a present value associated with each year's shipments in the year in which the shipments occur (
                            <E T="03">e.g.,</E>
                             2020 or 2030), and then discounted the present value from each year to 2022. Using the present value, DOE then calculated the fixed annual payment over a 30-year period, starting in the compliance year, that yields the same present value.
                        </P>
                    </FTNT>
                    <P>The national operating cost savings are domestic private U.S. consumer monetary savings that occur as a result of purchasing the covered products and are measured for the lifetime of room air conditioners shipped in 2026-2055. The benefits associated with reduced emissions achieved as a result of the adopted standards are also calculated based on the lifetime of room air conditioners shipped in 2026-2055. Total benefits for both the 3-percent and 7-percent cases are presented using the average GHG social costs with 3-percent discount rate. Estimates of SC-GHG values are presented for all four discount rates in section V.B.6 of this document.</P>
                    <P>
                        Table I.4 presents the total estimated monetized benefits and costs associated with the standard, expressed in terms of 
                        <PRTPAGE P="34302"/>
                        annualized values. The results under the primary estimate are as follows.
                    </P>
                    <P>
                        Using a 7-percent discount rate for consumer benefits and costs and health benefits from reduced NO
                        <E T="52">X</E>
                         and SO
                        <E T="0732">2</E>
                         emissions, and the 3-percent discount rate case for climate benefits from reduced GHG emissions, the estimated cost of the standards adopted in this rule is $205.2 million per year in increased equipment costs, while the estimated annual benefits are $736.9 million in reduced equipment operating costs, $140.1 million in climate benefits, and $199.9 million in health benefits. In this case, the net benefit would amount to $871.7 million per year.
                    </P>
                    <P>Using a 3-percent discount rate for all benefits and costs, the estimated cost of the standards is $176.8 million per year in increased equipment costs, while the estimated annual benefits are $815.8 million in reduced operating costs, $140.1 million in climate benefits, and $244.8 million in health benefits. In this case, the net benefit would amount to $1,023.9 million per year.</P>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s200,12,12,12">
                        <TTITLE>Table I.4—Annualized Benefits and Costs of Adopted Standards for Room Air Conditioners</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Million 2021$/year</CHED>
                            <CHED H="2">
                                Primary
                                <LI>estimate</LI>
                            </CHED>
                            <CHED H="2">
                                Low-net-
                                <LI>benefits</LI>
                                <LI>estimate</LI>
                            </CHED>
                            <CHED H="2">
                                High-net-
                                <LI>benefits</LI>
                                <LI>estimate</LI>
                            </CHED>
                        </BOXHD>
                        <ROW EXPSTB="03" RUL="s">
                            <ENT I="21">
                                <E T="02">3% discount rate</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Consumer Operating Cost Savings</ENT>
                            <ENT>815.8</ENT>
                            <ENT>784.9</ENT>
                            <ENT>851.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Climate Benefits *</ENT>
                            <ENT>140.1</ENT>
                            <ENT>137.6</ENT>
                            <ENT>142.5</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Health Benefits **</ENT>
                            <ENT>244.8</ENT>
                            <ENT>240.6</ENT>
                            <ENT>248.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total Benefits †</ENT>
                            <ENT>1,200.6</ENT>
                            <ENT>1,163.2</ENT>
                            <ENT>1,243.3</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Consumer Incremental Product Costs ‡</ENT>
                            <ENT>176.8</ENT>
                            <ENT>199.0</ENT>
                            <ENT>152.2</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="03">Net Benefits</ENT>
                            <ENT>1,023.9</ENT>
                            <ENT>964.1</ENT>
                            <ENT>1,091.1</ENT>
                        </ROW>
                        <ROW EXPSTB="03" RUL="s">
                            <ENT I="21">
                                <E T="02">7% discount rate</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Consumer Operating Cost Savings</ENT>
                            <ENT>736.9</ENT>
                            <ENT>712.3</ENT>
                            <ENT>765.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Climate Benefits * (3% discount rate)</ENT>
                            <ENT>140.1</ENT>
                            <ENT>137.6</ENT>
                            <ENT>142.5</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Health Benefits **</ENT>
                            <ENT>199.9</ENT>
                            <ENT>196.8</ENT>
                            <ENT>203.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total Benefits †</ENT>
                            <ENT>1,076.9</ENT>
                            <ENT>1,046.7</ENT>
                            <ENT>1,111.0</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Consumer Incremental Product Costs ‡</ENT>
                            <ENT>205.2</ENT>
                            <ENT>227.0</ENT>
                            <ENT>181.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Net Benefits</ENT>
                            <ENT>871.7</ENT>
                            <ENT>819.7</ENT>
                            <ENT>930.0</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             This table presents the costs and benefits associated with room air conditioners shipped in 2026-2055. These results include benefits to consumers which accrue after 2057 from the products shipped in 2028-2057. The Primary, Low Net Benefits, and High Net Benefits Estimates utilize projections of energy prices from the 
                            <E T="03">AEO2022</E>
                             Reference case, Low Economic Growth case, and High Economic Growth case, respectively. In addition, incremental equipment costs reflect a medium decline rate in the Primary Estimate, a low decline rate in the Low Net Benefits Estimate, and a high decline rate in the High Net Benefits Estimate. The methods used to derive projected price trends are explained in sections IV.F.1 and IV.H.3 of this document. Note that the Benefits and Costs may not sum to the Net Benefits due to rounding.
                        </TNOTE>
                        <TNOTE>
                            * Climate benefits are calculated using four different estimates of the global SC-GHG (see section IV.L of this document). For presentational purposes of this table, the climate benefits associated with the average SC-GHG at a 3 percent discount rate are shown, but the Department does not have a single central SC-GHG point estimate, and it emphasizes the importance and value of considering the benefits calculated using all four sets of SC-GHG estimates. On March 16, 2022, the Fifth Circuit Court of Appeals (No. 22-30087) granted the Federal Government's emergency motion for stay pending appeal of the February 11, 2022, preliminary injunction issued in 
                            <E T="03">Louisiana</E>
                             v. 
                            <E T="03">Biden,</E>
                             No. 21-cv-1074-JDC-KK (W.D. La.). As a result of the Fifth Circuit's order, the preliminary injunction is no longer in effect, pending resolution of the Federal Government's appeal of that injunction or a further court order. Among other things, the preliminary injunction enjoined the defendants in that case from “adopting, employing, treating as binding, or relying upon” the interim estimates of the social cost of greenhouse gases—which were issued by the Interagency Working Group on the Social Cost of Greenhouse Gases on February 26, 2021—to monetize the benefits of reducing greenhouse gas emissions. As reflected in this rule, DOE has reverted to its approach prior to the injunction and presents monetized greenhouse gas abatement benefits where appropriate and permissible under law.
                        </TNOTE>
                        <TNOTE>
                            ** Health benefits are calculated using benefit-per-ton values for NO
                            <E T="0732">X</E>
                             and SO
                            <E T="0732">2</E>
                            . DOE is currently only monetizing (for SO
                            <E T="0732">2</E>
                             and NO
                            <E T="0732">X</E>
                            ) PM
                            <E T="0732">2.5</E>
                             precursor health benefits and (for NO
                            <E T="0732">X</E>
                            ) ozone precursor health benefits, but will continue to assess the ability to monetize other effects such as health benefits from reductions in direct PM
                            <E T="0732">2.5</E>
                             emissions. The health benefits are presented at real discount rates of 3 and 7 percent. See section IV.L of this document for more details.
                        </TNOTE>
                        <TNOTE>† Total and net benefits include consumer, climate, and health benefits. For presentation purposes, total and net benefits for both the 3-percent and 7-percent cases are presented using the average SC-GHG with 3-percent discount rate, but the Department does not have a single central SC-GHG point estimate.</TNOTE>
                        <TNOTE>‡ Costs include incremental equipment costs as well as installation costs.</TNOTE>
                    </GPOTABLE>
                    <P>DOE's analysis of the national impacts of the adopted standards is described in sections IV.H, IV.K, and IV.L of this document.</P>
                    <HD SOURCE="HD2">D. Conclusion</HD>
                    <P>DOE concludes that the standards adopted in this final rule represent the maximum improvement in energy efficiency that is technologically feasible and economically justified, and would result in the significant conservation of energy. Specifically, with regards to technological feasibility products achieving these standard levels are already commercially available for all product classes covered by this rule. As for economic justification, DOE's analysis shows that the benefits of the standards exceed, to a great extent, the burdens of the standards.</P>
                    <P>
                        Using a 7-percent discount rate for consumer benefits and costs and NO
                        <E T="52">X</E>
                         and SO
                        <E T="52">2</E>
                         reduction benefits, and a 3-percent discount rate case for GHG social costs, the estimated cost of the standards for room air conditioners is 
                        <PRTPAGE P="34303"/>
                        $205.2 million per year in increased product costs, while the estimated annual benefits are $736.9 million in reduced product operating costs, $140.1 million in climate benefits, and $199.9 million in health benefits. The net benefit amounts to $871.7 million per year.
                    </P>
                    <P>
                        The significance of energy savings offered by a new or amended energy conservation standard cannot be determined without knowledge of the specific circumstances surrounding a given rulemaking.
                        <SU>12</SU>
                        <FTREF/>
                         For example, some covered products and equipment have most of their energy consumption occur during periods of peak energy demand. The impacts of these products on the energy infrastructure can be more pronounced than products with relatively constant demand. Accordingly, DOE evaluates the significance of energy savings on a case-by-case basis.
                    </P>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             Procedures, Interpretations, and Policies for Consideration in New or Revised Energy Conservation Standards and Test Procedures for Consumer Products and Commercial/Industrial Equipment, 86 FR 70892, 70901 (Dec. 13, 2021).
                        </P>
                    </FTNT>
                    <P>
                        As previously mentioned, the standards are projected to result in estimated national energy savings of 1.41 quad FFC, the equivalent of the primary annual energy use of 15 million homes. In addition, they are projected to reduce CO
                        <E T="52">2</E>
                         emissions by 48.5 Mt. Based on these findings, DOE has determined the energy savings from the standard levels adopted in this final rule are “significant” within the meaning of 42 U.S.C. 6295(o)(3)(B). A more detailed discussion of the basis for these conclusions is contained in the remainder of this document and the accompanying TSD.
                    </P>
                    <HD SOURCE="HD1">II. Introduction</HD>
                    <P>The following section briefly discusses the statutory authority underlying this final rule, as well as some of the relevant historical background related to the establishment of standards for room air conditioners.</P>
                    <HD SOURCE="HD2">A. Authority</HD>
                    <P>EPCA authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. Title III, Part B of EPCA established the Energy Conservation Program for Consumer Products Other Than Automobiles. These products include room air conditioners, the subject of this document. (42 U.S.C. 6292(a)(2)) EPCA prescribed energy conservation standards for these products (42 U.S.C. 6295(c)(1)), and directs DOE to conduct future rulemakings to determine whether to amend these standards. (42 U.S.C. 6295(c)(2)) EPCA further provides that, not later than 6 years after the issuance of any final rule establishing or amending a standard, DOE must publish either a notice of determination that standards for the product do not need to be amended, or a NOPR including new proposed energy conservation standards (proceeding to a final rule, as appropriate). (42 U.S.C. 6295(m)(1))</P>
                    <P>The energy conservation program under EPCA, consists essentially of four parts: (1) testing, (2) labeling, (3) the establishment of Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of EPCA specifically include definitions (42 U.S.C. 6291), test procedures (42 U.S.C. 6293), labeling provisions (42 U.S.C. 6294), energy conservation standards (42 U.S.C. 6295), and the authority to require information and reports from manufacturers (42 U.S.C. 6296).</P>
                    <P>Federal energy efficiency requirements for covered products established under EPCA generally supersede State laws and regulations concerning energy conservation testing, labeling, and standards. (42 U.S.C. 6297(a)-(c)) DOE may, however, grant waivers of Federal preemption in limited instances for particular State laws or regulations, in accordance with the procedures and other provisions set forth under EPCA. (See 42 U.S.C. 6297(d))</P>
                    <P>Subject to certain criteria and conditions, DOE is required to develop test procedures to measure the energy efficiency, energy use, or estimated annual operating cost of each covered product. (42 U.S.C. 6295(o)(3)(A) and 42 U.S.C. 6295(r)) Manufacturers of covered products must use the prescribed DOE test procedure as the basis for certifying to DOE that their products comply with the applicable energy conservation standards adopted under EPCA and when making representations to the public regarding the energy use or efficiency of those products. (42 U.S.C. 6293(c) and 6295(s)) Similarly, DOE must use these test procedures to determine whether the products comply with standards adopted pursuant to EPCA. (42 U.S.C. 6295(s)) The DOE test procedures for room air conditioners appear at title 10 of the Code of Federal Regulations (“CFR”), part 430, subpart B, appendix F.</P>
                    <P>DOE must follow specific statutory criteria for prescribing new or amended standards for covered products, including room air conditioners. Any new or amended standard for a covered product must be designed to achieve the maximum improvement in energy efficiency that the Secretary of Energy determines is technologically feasible and economically justified. (42 U.S.C. 6295(o)(2)(A) and (o)(3)(B)) Furthermore, DOE may not adopt any standard that would not result in the significant conservation of energy. (42 U.S.C. 6295(o)(3)) Moreover, DOE may not prescribe a standard (1) for certain products, including room air conditioners, if no test procedure has been established for the product, or (2) if DOE determines by rule that the standard is not technologically feasible or economically justified. (42 U.S.C. 6295(o)(3)(A)-(B)) In deciding whether a proposed standard is economically justified, DOE must determine whether the benefits of the standard exceed its burdens. (42 U.S.C. 6295(o)(2)(B)(i)) DOE must make this determination after receiving comments on the proposed standard, and by considering, to the greatest extent practicable, the following seven statutory factors:</P>
                    <EXTRACT>
                        <P>(1) The economic impact of the standard on manufacturers and consumers of the products subject to the standard;</P>
                        <P>(2) The savings in operating costs throughout the estimated average life of the covered products in the type (or class) compared to any increase in the price, initial charges, or maintenance expenses for the covered products that are likely to result from the standard;</P>
                        <P>(3) The total projected amount of energy (or as applicable, water) savings likely to result directly from the standard;</P>
                        <P>(4) Any lessening of the utility or the performance of the covered products likely to result from the standard;</P>
                        <P>(5) The impact of any lessening of competition, as determined in writing by the Attorney General, that is likely to result from the standard;</P>
                        <P>(6) The need for national energy and water conservation; and</P>
                        <P>(7) Other factors the Secretary of Energy (“Secretary”) considers relevant.</P>
                    </EXTRACT>
                    <FP>(42 U.S.C. 6295(o)(2)(B)(i)(I)-(VII))</FP>
                    <P>Further, EPCA, as codified, establishes a rebuttable presumption that a standard is economically justified if the Secretary finds that the additional cost to the consumer of purchasing a product complying with an energy conservation standard level will be less than three times the value of the energy savings during the first year that the consumer will receive as a result of the standard, as calculated under the applicable test procedure. (42 U.S.C. 6295(o)(2)(B)(iii))</P>
                    <P>
                        EPCA, as codified, also contains what is known as an “anti-backsliding” provision, which prevents the Secretary from prescribing any amended standard 
                        <PRTPAGE P="34304"/>
                        that either increases the maximum allowable energy use or decreases the minimum required energy efficiency of a covered product. (42 U.S.C. 6295(o)(1)) Also, the Secretary may not prescribe an amended or new standard if interested persons have established by a preponderance of the evidence that the standard is likely to result in the unavailability in the United States in any covered product type (or class) of performance characteristics (including reliability), features, sizes, capacities, and volumes that are substantially the same as those generally available in the United States. (42 U.S.C. 6295(o)(4))
                    </P>
                    <P>
                        Additionally, EPCA specifies requirements when promulgating an energy conservation standard for a covered product that has two or more subcategories. DOE must specify a different standard level for a type or class of products that has the same function or intended use if DOE determines that products within such group (A) consume a different kind of energy from that consumed by other covered products within such type (or class); or (B) have a capacity or other performance-related feature which other products within such type (or class) do not have and such feature justifies a higher or lower standard. (42 U.S.C. 6295(q)(1)) In determining whether a performance-related feature justifies a different standard for a group of products, DOE must consider such factors as the utility to the consumer of such a feature and other factors DOE deems appropriate. 
                        <E T="03">Id.</E>
                         Any rule prescribing such a standard must include an explanation of the basis on which such higher or lower level was established. (42 U.S.C. 6295(q)(2))
                    </P>
                    <P>Finally, pursuant to the amendments contained in the Energy Independence and Security Act of 2007 (EISA 2007), Public Law 110-140, any final rule for new or amended energy conservation standards promulgated after July 1, 2010, is required to address standby mode and off mode energy use. (42 U.S.C. 6295(gg)(3)) Specifically, when DOE adopts a standard for a covered product after that date, it must, if justified by the criteria for adoption of standards under EPCA (42 U.S.C. 6295(o)), incorporate standby mode and off mode energy use into a single standard, or, if that is not feasible, adopt a separate standard for such energy use for that product. (42 U.S.C. 6295(gg)(3)(A)-(B)) DOE's current test procedures and standards for room air conditioners address standby mode and off mode energy use, as do the amended standards adopted in this final rule.</P>
                    <HD SOURCE="HD2">B. Background</HD>
                    <HD SOURCE="HD3">1. Current Standards</HD>
                    <P>DOE prescribed the current energy conservation standards in a direct final rule published on April 21, 2011 (“April 2011 Direct Final Rule”), which apply to room air conditioners manufactured on and after April 21, 2014. 76 FR 22454. These standards are set forth in DOE's regulations at 10 CFR 430.32(b) and are repeated in Table II.1.</P>
                    <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s200,12">
                        <TTITLE>Table II.1—Federal Energy Efficiency Standards for Room Air Conditioners</TTITLE>
                        <BOXHD>
                            <CHED H="1">Room air conditioner product class</CHED>
                            <CHED H="1">
                                Minimum CEER
                                <LI>(Btu/Wh)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">1. Without reverse cycle, with louvered sides, and less than 6,000 Btu/h</ENT>
                            <ENT>11.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2. Without reverse cycle, with louvered sides and 6,000 to 7,999 Btu/h</ENT>
                            <ENT>11.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3. Without reverse cycle, with louvered sides and 8,000 to 13,999 Btu/h</ENT>
                            <ENT>10.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4. Without reverse cycle, with louvered sides and 14,000 to 19,999 Btu/h</ENT>
                            <ENT>10.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5a. Without reverse cycle, with louvered sides and 20,000 Btu/h to 27,999 Btu/h</ENT>
                            <ENT>9.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5b. Without reverse cycle, with louvered sides and 28,000 Btu/h or more</ENT>
                            <ENT>9.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6. Without reverse cycle, without louvered sides, and less than 6,000 Btu/h</ENT>
                            <ENT>10.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">7. Without reverse cycle, without louvered sides and 6,000 to 7,999 Btu/h</ENT>
                            <ENT>10.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">8a. Without reverse cycle, without louvered sides and 8,000 to 10,999 Btu/h</ENT>
                            <ENT>9.6</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">8b. Without reverse cycle, without louvered sides and 11,000 to 13,999 Btu/h</ENT>
                            <ENT>9.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">9. Without reverse cycle, without louvered sides and 14,000 to 19,999 Btu/h</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">10. Without reverse cycle, without louvered sides and 20,000 Btu/h or more</ENT>
                            <ENT>9.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">11. With reverse cycle, with louvered sides, and less than 20,000 Btu/h</ENT>
                            <ENT>9.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">12. With reverse cycle, without louvered sides, and less than 14,000 Btu/h</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">13. With reverse cycle, with louvered sides, and 20,000 Btu/h or more</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">14. With reverse cycle, without louvered sides, and 14,000 Btu/h or more</ENT>
                            <ENT>8.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">15. Casement-Only</ENT>
                            <ENT>9.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">16. Casement-Slider</ENT>
                            <ENT>10.4</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD3">2. History of Standards Rulemaking for Room Air Conditioners</HD>
                    <P>EPCA prescribed initial energy conservation standards for room air conditioners and further directed DOE to conduct two cycles of rulemakings to determine whether to amend these standards. (42 U.S.C. 6295(c)(1)-(2)) DOE completed the first of these rulemaking cycles on September 24, 1997, by adopting amended performance standards for room air conditioners manufactured on or after October 1, 2000. 62 FR 50122. Additionally, DOE completed a second rulemaking cycle to amend the standards for room air conditioners by issuing the April 2011 Direct Final Rule, in which DOE prescribed the current energy conservation standards for room air conditioners manufactured on or after April 21, 2014. 76 FR 22454 (April 21, 2011). DOE subsequently published a final rule amending the compliance date for the current room air conditioner standards to June 1, 2014. 76 FR 52852 (Aug. 24, 2011). In a separate document, also published on August 24, 2011, DOE confirmed the adoption of these energy conservation standards in a notice of effective date and compliance dates for the April 2011 Direct Final Rule. 76 FR 52854.</P>
                    <P>
                        As part of the current analysis, on June 18, 2015, DOE prepared a Request for Information (“June 2015 RFI”), which solicited information from the public to help DOE determine whether amended standards for room air conditioners would result in a significant amount of additional energy savings and whether those standards would be technologically feasible and economically justified.
                        <SU>13</SU>
                        <FTREF/>
                         80 FR 34843.
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             Pursuant to amendments to appendix A to 10 CFR part 430, subpart C (“appendix A”), DOE generally will issue an early assessment request for information announcing that DOE is considering initiating a rulemaking proceeding. Section 6(a)(1) of appendix A; 
                            <E T="03">see also</E>
                             85 FR 8626, 8637 (Feb. 14, 
                            <PRTPAGE/>
                            2020) and 86 FR 70892 (Dec. 13, 2021). Section 6(a)(2) of appendix A provides that if the DOE determines it is appropriate to proceed with a rulemaking, the preliminary stages of a rulemaking to issue or amend an energy conservation standard that DOE will undertake will be a Framework Document and Preliminary Analysis, or an advance notice of proposed rulemaking. Because this rulemaking was already in progress at the time the relevant amendments to appendix A were published, DOE did not reinitiate the entire rulemaking process. Additionally, the June 2015 RFI presented the issues, analyses, and processes relevant to consideration of amended standards for room air conditioners.
                        </P>
                    </FTNT>
                    <PRTPAGE P="34305"/>
                    <P>DOE published a notice of public meeting and availability of the preliminary technical support document (“TSD”) on June 17, 2020 (“June 2020 Preliminary Analysis”). 85 FR 36512.</P>
                    <P>
                        Comments received following the publication of the June 2020 Preliminary Analysis helped DOE identify and resolve issues related to the subsequent NOPR analysis.
                        <SU>14</SU>
                        <FTREF/>
                         DOE published a notice of proposed rulemaking on April 7, 2022 (“April 2022 NOPR”). 87 FR 20608. DOE subsequently held a public meeting on May 3, 2022, to discuss and receive comments on the NOPR. The NOPR TSD that presented the methodology and results of the NOPR analysis is available at: 
                        <E T="03">www.regulations.gov/document/EERE-2014-BT-STD-0059-0030.</E>
                    </P>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             Comments are available at 
                            <E T="03">www.regulations.gov/document/EERE-2014-BT-STD-0059-0031/comment.</E>
                        </P>
                    </FTNT>
                    <P>DOE received 17 written comments in response to the April 2022 NOPR from the interested parties listed in Table II.2.</P>
                    <GPOTABLE COLS="4" OPTS="L2,p7,7/8,i1" CDEF="s100,r75,12,xs90">
                        <TTITLE>Table II.2—April 2022 NOPR Written Comments</TTITLE>
                        <BOXHD>
                            <CHED H="1">Commenter(s)</CHED>
                            <CHED H="1">Abbreviation</CHED>
                            <CHED H="1">Comment No. in the docket</CHED>
                            <CHED H="1">Commenter type</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">
                                A. Krishna 
                                <SU>1</SU>
                            </ENT>
                            <ENT>Krishna</ENT>
                            <ENT>32</ENT>
                            <ENT>Individual.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anonymous Individual</ENT>
                            <ENT>University of Massachusetts Amherst Student</ENT>
                            <ENT>34</ENT>
                            <ENT>Individual.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">L. Adelman</ENT>
                            <ENT>University of Massachusetts Amherst Student</ENT>
                            <ENT>35</ENT>
                            <ENT>Individual.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">G. Larsen</ENT>
                            <ENT>University of Massachusetts Amherst Student</ENT>
                            <ENT>37</ENT>
                            <ENT>Individual.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">People's Republic of China</ENT>
                            <ENT>P.R. China</ENT>
                            <ENT>39</ENT>
                            <ENT>Government.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Treua Inc. (DBA Gradient)</ENT>
                            <ENT>Gradient</ENT>
                            <ENT>40</ENT>
                            <ENT>Manufacturer.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">New York State Energy Research and Development Authority</ENT>
                            <ENT>NYSERDA</ENT>
                            <ENT>41</ENT>
                            <ENT>Efficiency Organization.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Center for Law and Social Policy</ENT>
                            <ENT>CLASP</ENT>
                            <ENT>42</ENT>
                            <ENT>Efficiency Organization.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Association of Home Appliance Manufacturers</ENT>
                            <ENT>AHAM</ENT>
                            <ENT>43</ENT>
                            <ENT>Trade Association.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Friedrich Air Conditioning</ENT>
                            <ENT>Friedrich</ENT>
                            <ENT>44</ENT>
                            <ENT>Manufacturer.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Appliance Standards Awareness Project (ASAP), American Council for an Energy-Efficient Economy (ACEEE), CLASP, Consumer Federation of America (CFA), National Consumer Law Center (NCLC)</ENT>
                            <ENT>Joint Commenters</ENT>
                            <ENT>45</ENT>
                            <ENT>Efficiency Organizations.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Consumer Federation of America (CFA), National Consumer Law Center (NCLC)</ENT>
                            <ENT>CFA and NCLC</ENT>
                            <ENT>46</ENT>
                            <ENT>Efficiency Organizations.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Pacific Gas and Electric Company (PG&amp;E), San Diego Gas and Electric (SDG&amp;E), Southern California Edison (SCE)</ENT>
                            <ENT>California IOUs</ENT>
                            <ENT>47</ENT>
                            <ENT>Utilities.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Keith Rice</ENT>
                            <ENT>Rice</ENT>
                            <ENT>48</ENT>
                            <ENT>Individual.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">GE Appliances</ENT>
                            <ENT>GEA</ENT>
                            <ENT>49</ENT>
                            <ENT>Manufacturer.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Northwest Energy Efficiency Alliance (NEEA), Northwest Power and Conservation Council (NWPCC)</ENT>
                            <ENT>NEEA and NWPCC</ENT>
                            <ENT>50</ENT>
                            <ENT>Efficiency Advocates.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Center for Climate and Energy Solutions (C2ES), Institute for Policy Integrity (IPI), Natural Resources Defense Council (NRDC), Sierra Club, Union of Concerned Scientists</ENT>
                            <ENT>Climate Commenters.</ENT>
                            <ENT>51</ENT>
                            <ENT>Efficiency Advocate Group.</ENT>
                        </ROW>
                        <TNOTE>
                            <SU>1</SU>
                             The comment submitted by this individual did not pertain to room air conditioners.
                        </TNOTE>
                    </GPOTABLE>
                    <P>
                        A parenthetical reference at the end of a comment quotation or paraphrase provides the location of the item in the public record.
                        <SU>15</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             The parenthetical reference provides a reference for information located in the docket of DOE's rulemaking to develop energy conservation standards for room air conditioners. (Docket No. EERE-2014-BT-STD-0059, which is maintained at 
                            <E T="03">www.regulations.gov</E>
                            ) The references are arranged as follows: (commenter name, comment docket ID number, page of that document).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">III. General Discussion</HD>
                    <P>DOE developed this final rule after considering oral and written comments, data, and information from interested parties that represent a variety of interests. The following discussion addresses issues raised by these commenters.</P>
                    <HD SOURCE="HD2">A. Product Classes and Scope of Coverage</HD>
                    <P>When evaluating and establishing energy conservation standards, DOE divides covered products into product classes by the type of energy used or by capacity or other performance-related features that justify differing standards. In making a determination whether a performance-related feature justifies a different standard, DOE must consider such factors as the utility of the feature to the consumer and other factors DOE determines are appropriate. (42 U.S.C. 6295(q)) DOE's NOPR analysis indicated that the current room air conditioner products classes are still appropriate. For further discussion and responses to comments received regarding product classes see section IV.A.1 of this document.</P>
                    <HD SOURCE="HD2">B. Test Procedure</HD>
                    <P>
                        EPCA sets forth generally applicable criteria and procedures for DOE's adoption and amendment of test procedures. (42 U.S.C. 6293) Manufacturers of covered products must use these test procedures to certify to DOE that their product complies with energy conservation standards and to quantify the efficiency of their product. DOE's current energy conservation standards for room air conditioners are expressed in terms of combined energy efficiency ratio (CEER), in Btu/Wh. (
                        <E T="03">See</E>
                         10 CFR 430.32(b) and 10 CFR part 430, subpart B, appendix F.)
                    </P>
                    <HD SOURCE="HD2">C. Technological Feasibility</HD>
                    <HD SOURCE="HD3">1. General</HD>
                    <P>
                        In each energy conservation standards rulemaking, DOE conducts a screening analysis based on information gathered on all current technology options and prototype designs that could improve the efficiency of the products or equipment that are the subject of the rulemaking. As the first step in such an analysis, DOE develops a list of technology options for consideration in consultation with manufacturers, design engineers, and other interested parties. DOE then determines which of those means for improving efficiency are technologically feasible. DOE considers technologies incorporated in commercially available products or in 
                        <PRTPAGE P="34306"/>
                        working prototypes to be technologically feasible. Sections 6(b)(3)(i) and 7(b)(1) of appendix A to 10 CFR part 430, subpart C (“appendix A”).
                    </P>
                    <P>After DOE has determined that particular technology options are technologically feasible, it further evaluates each technology option in light of the following additional screening criteria: (1) practicability to manufacture, install, and service; (2) adverse impacts on product utility or availability; (3) adverse impacts on health or safety and (4) unique-pathway proprietary technologies. Section 7(b)(2)-(5) of appendix A. Section IV.B of this document discusses the results of the screening analysis for room air conditioners, particularly the designs DOE considered, those it screened out, and those that are the basis for the standards considered in this final rule. For further details on the screening analysis for this rulemaking, see chapter 4 of the final rule technical support document (“TSD”).</P>
                    <HD SOURCE="HD3">2. Maximum Technologically Feasible Levels</HD>
                    <P>When DOE proposes to adopt an amended standard for a type or class of covered product, it must determine the maximum improvement in energy efficiency or maximum reduction in energy use that is technologically feasible for such product. (42 U.S.C. 6295(p)(1)) Accordingly, in the engineering analysis, DOE determined the maximum technologically feasible (“max-tech”) improvements in energy efficiency for room air conditioners, using the design parameters for the most efficient products available on the market or in working prototypes. The max-tech levels that DOE determined for this rulemaking are described in section IV.C of this final rule and in chapter 5 of the final rule TSD.</P>
                    <HD SOURCE="HD2">D. Energy Savings</HD>
                    <HD SOURCE="HD3">1. Determination of Savings</HD>
                    <P>
                        For each trial standard level (“TSL”), DOE projected energy savings from application of the TSL to room air conditioners purchased in the 30-year period that begins in the year of compliance with the amended standards (2026-2055).
                        <SU>16</SU>
                        <FTREF/>
                         The savings are measured over the entire lifetime of products purchased in the 30-year analysis period. DOE quantified the energy savings attributable to each TSL as the difference in energy consumption between each standards case and the no-new-standards case. The no-new-standards case represents a projection of energy consumption that reflects how the market for a product would likely evolve in the absence of amended energy conservation standards.
                    </P>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             DOE also presents a sensitivity analysis that considers impacts for products shipped in a 9-year period.
                        </P>
                    </FTNT>
                    <P>
                        DOE used its national impact analysis (“NIA”) spreadsheet models to estimate national energy savings (“NES”) from potential amended standards for room air conditioners. The NIA spreadsheet model (described in section IV.H of this document) calculates energy savings in terms of site energy, which is the energy directly consumed by products at the locations where they are used. For electricity, DOE reports national energy savings in terms of primary energy savings, which is the savings in the energy that is used to generate and transmit the site electricity. For natural gas, the primary energy savings are considered to be equal to the site energy savings. DOE also calculates NES in terms of FFC energy savings. The FFC metric includes the energy consumed in extracting, processing, and transporting primary fuels (
                        <E T="03">i.e.,</E>
                         coal, natural gas, petroleum fuels), and thus presents a more complete picture of the impacts of energy conservation standards.
                        <SU>17</SU>
                        <FTREF/>
                         DOE's approach is based on the calculation of an FFC multiplier for each of the energy types used by covered products or equipment. For more information on FFC energy savings, see section IV.H.2 of this document.
                    </P>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             The FFC metric is discussed in DOE's statement of policy and notice of policy amendment. 76 FR 51282 (Aug. 18, 2011), as amended at 77 FR 49701 (Aug. 17, 2012).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Significance of Savings</HD>
                    <P>To adopt any new or amended standards for a covered product, DOE must determine that such action would result in significant energy savings. (42 U.S.C. 6295(o)(3)(B))</P>
                    <P>
                        The significance of energy savings offered by a new or amended energy conservation standard cannot be determined without knowledge of the specific circumstances surrounding a given rulemaking. For example, the United States has now rejoined the Paris Agreement on February 19, 2021. As part of that agreement, the United States has committed to reducing GHG emissions in order to limit the rise in mean global temperature.
                        <SU>18</SU>
                        <FTREF/>
                         As such, energy savings that reduce GHG emission have taken on greater importance. Additionally, some covered products and equipment have most of their energy consumption occur during periods of peak energy demand. The impacts of these products on the energy infrastructure can be more pronounced than products with relatively constant demand. In evaluating the significance of energy savings, DOE considers differences in primary energy and FFC effects for different covered products and equipment when determining whether energy savings are significant. FFC effects include the energy consumed in electricity production (depending on load shape), in distribution and transmission, and in extracting, processing, and transporting primary fuels (
                        <E T="03">i.e.,</E>
                         coal, natural gas, petroleum fuels), and thus present a more complete picture of the impacts of energy conservation standards. Accordingly, DOE evaluates the significance of energy savings on a case-by-case basis, taking into account the significance of cumulative FFC national energy savings, the cumulative FFC emissions reductions, and the need to confront the global climate crisis, among other factors.
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             
                            <E T="03">See</E>
                             E.O. 14008, 86 FR 7619 (Feb. 1, 2021) (“Tackling the Climate Crisis at Home and Abroad”).
                        </P>
                    </FTNT>
                    <P>
                        As stated, the standard levels adopted in this final rule are projected to result in national energy savings of 1.41 quad, the equivalent of the electricity use of 15 million homes in one year. They are projected to reduce CO
                        <E T="52">2</E>
                         emissions by 48.5 Mt. Based on these findings, DOE has determined the energy savings from the standard levels adopted in this final rule are “significant” within the meaning of 42 U.S.C. 6295(o)(3)(B).
                    </P>
                    <HD SOURCE="HD2">E. Economic Justification</HD>
                    <HD SOURCE="HD3">1. Specific Criteria</HD>
                    <P>As noted previously, EPCA provides seven factors to be evaluated in determining whether a potential energy conservation standard is economically justified. (42 U.S.C. 6295(o)(2)(B)(i)(I)(VII)) The following sections discuss how DOE has addressed each of those seven factors in this final rule.</P>
                    <HD SOURCE="HD3">a. Economic Impact on Manufacturers and Consumers</HD>
                    <P>
                        In determining the impacts of potential amended standards on manufacturers, DOE conducts a manufacturer impact analysis (“MIA”), as discussed in section IV.J of this document. DOE first uses an annual cash-flow approach to determine the quantitative impacts. This step includes both a short-term assessment—based on the cost and capital requirements during the period between when a regulation is issued and when entities must comply with the regulation—and a long-term assessment over a 30-year period. The industry-wide impacts analyzed include (1) INPV, which values the industry on the basis of expected future cash flows; 
                        <PRTPAGE P="34307"/>
                        (2) cash flows by year; (3) changes in revenue and income; and (4) other measures of impact, as appropriate. Second, DOE analyzes and reports the impacts on different types of manufacturers, including impacts on small manufacturers. Third, DOE considers the impact of standards on domestic manufacturer employment and manufacturing capacity, as well as the potential for standards to result in plant closures and loss of capital investment. Finally, DOE takes into account cumulative impacts of various DOE regulations and other regulatory requirements on manufacturers.
                    </P>
                    <P>For individual consumers, measures of economic impact include the changes in LCC and payback period (“PBP”) associated with new or amended standards. These measures are discussed further in the following section. For consumers in the aggregate, DOE also calculates the national net present value of the consumer costs and benefits expected to result from particular standards. DOE also evaluates the impacts of potential standards on identifiable subgroups of consumers that may be affected disproportionately by a standard.</P>
                    <HD SOURCE="HD3">b. Savings in Operating Costs Compared To Increase in Price (LCC and PBP)</HD>
                    <P>EPCA requires DOE to consider the savings in operating costs throughout the estimated average life of the covered product in the type (or class) compared to any increase in the price of, or in the initial charges for, or maintenance expenses of, the covered product that are likely to result from a standard. (42 U.S.C. 6295(o)(2)(B)(i)(II)) DOE conducts this comparison in its LCC and PBP analysis.</P>
                    <P>The LCC is the sum of the purchase price of a product (including its installation) and the operating cost (including energy, maintenance, and repair expenditures) discounted over the lifetime of the product. The LCC analysis requires a variety of inputs, such as product prices, product energy consumption, energy prices, maintenance and repair costs, product lifetime, and discount rates appropriate for consumers. To account for uncertainty and variability in specific inputs, such as product lifetime and discount rate, DOE uses a distribution of values, with probabilities attached to each value.</P>
                    <P>The PBP is the estimated amount of time (in years) it takes consumers to recover the increased purchase cost (including installation) of a more-efficient product through lower operating costs. DOE calculates the PBP by dividing the change in purchase cost due to a more-stringent standard by the change in annual operating cost for the year that standards are assumed to take effect.</P>
                    <P>For its LCC and PBP analysis, DOE assumes that consumers will purchase the covered products in the first year of compliance with new or amended standards. The LCC savings for the considered efficiency levels (“EL”) are calculated relative to the case that reflects projected market trends in the absence of new or amended standards. DOE's LCC and PBP analysis is discussed in further detail in section IV.F of this document.</P>
                    <HD SOURCE="HD3">c. Energy Savings</HD>
                    <P>Although significant conservation of energy is a separate statutory requirement for adopting an energy conservation standard, EPCA requires DOE, in determining the economic justification of a standard, to consider the total projected energy savings that are expected to result directly from the standard. (42 U.S.C. 6295(o)(2)(B)(i)(III)) As discussed in section IV.H of this document, DOE uses the NIA spreadsheet models to project national energy savings.</P>
                    <HD SOURCE="HD3">d. Lessening of Utility or Performance of Products</HD>
                    <P>In establishing product classes, and in evaluating design options and the impact of potential standard levels, DOE evaluates potential standards that would not lessen the utility or performance of the considered products. (42 U.S.C. 6295(o)(2)(B)(i)(IV)) Based on data available to DOE, the standards adopted in this document would not reduce the utility or performance of the products under consideration in this rulemaking.</P>
                    <HD SOURCE="HD3">e. Impact of Any Lessening of Competition</HD>
                    <P>EPCA directs DOE to consider the impact of any lessening of competition, as determined in writing by the Attorney General, that is likely to result from a standard. (42 U.S.C. 6295(o)(2)(B)(i)(V)) It also directs the Attorney General to determine the impact, if any, of any lessening of competition likely to result from a standard and to transmit such determination to the Secretary within 60 days of the publication of a proposed rule, together with an analysis of the nature and extent of the impact. (42 U.S.C. 6295(o)(2)(B)(ii)) To assist the Department of Justice (“DOJ”) in making such a determination, DOE transmitted copies of its proposed rule and the NOPR TSD to the Attorney General for review, with a request that the DOJ provide its determination on this issue. In its assessment letter responding to DOE, DOJ concluded that the proposed energy conservation standards for room air conditioners are unlikely to have a significant adverse impact on competition. DOE is publishing the Attorney General's assessment at the end of this final rule.</P>
                    <HD SOURCE="HD3">f. Need for National Energy Conservation</HD>
                    <P>DOE also considers the need for national energy and water conservation in determining whether a new or amended standard is economically justified. (42 U.S.C. 6295(o)(2)(B)(i)(VI)) The energy savings from the adopted standards are likely to provide improvements to the security and reliability of the Nation's energy system. Reductions in the demand for electricity also may result in reduced costs for maintaining the reliability of the Nation's electricity system. DOE conducts a utility impact analysis to estimate how standards may affect the Nation's needed power generation capacity, as discussed in section IV.M of this document.</P>
                    <P>DOE maintains that environmental and public health benefits associated with the more efficient use of energy are important to take into account when considering the need for national energy conservation. The adopted standards are likely to result in environmental benefits in the form of reduced emissions of air pollutants and greenhouse gases (“GHGs”) associated with energy production and use. DOE conducts an emissions analysis to estimate how potential standards may affect these emissions, as discussed in section IV.J.3 of this document; the estimated emissions impacts are reported in section V.B.6 of this document. DOE also estimates the economic value of emissions reductions resulting from the considered TSLs, as discussed in section IV.L of this document.</P>
                    <HD SOURCE="HD3">g. Other Factors</HD>
                    <P>In determining whether an energy conservation standard is economically justified, DOE may consider any other factors that the Secretary deems to be relevant. (42 U.S.C. 6295(o)(2)(B)(i)(VII)) To the extent DOE identifies any relevant information regarding economic justification that does not fit into the other categories described previously, DOE could consider such information under “other factors.”</P>
                    <PRTPAGE P="34308"/>
                    <HD SOURCE="HD3">2. Rebuttable Presumption</HD>
                    <P>As set forth in 42 U.S.C. 6295(o)(2)(B)(iii), EPCA creates a rebuttable presumption that an energy conservation standard is economically justified if the additional cost to the consumer of a product that meets the standard is less than three times the value of the first year's energy savings resulting from the standard, as calculated under the applicable DOE test procedure. DOE's LCC and PBP analyses generate values used to calculate the effect potential amended energy conservation standards would have on the payback period for consumers. These analyses include, but are not limited to, the 3-year payback period contemplated under the rebuttable-presumption test. In addition, DOE routinely conducts an economic analysis that considers the full range of impacts to consumers, manufacturers, the Nation, and the environment, as required under 42 U.S.C. 6295(o)(2)(B)(i). The results of this analysis serve as the basis for DOE's evaluation of the economic justification for a potential standard level (thereby supporting or rebutting the results of any preliminary determination of economic justification). The rebuttable presumption payback calculation is discussed in section IV.F of this final rule.</P>
                    <HD SOURCE="HD1">IV. Methodology and Discussion of Related Comments</HD>
                    <P>This section addresses the analyses DOE has performed for this rulemaking with regard to room air conditioners. Separate subsections address each component of DOE's analyses.</P>
                    <P>
                        DOE used several analytical tools to estimate the impact of the standards considered in this document. The first tool is a spreadsheet that calculates the LCC savings and PBP of potential amended or new energy conservation standards. The national impacts analysis uses a second spreadsheet set that provides shipments projections and calculates national energy savings and net present value of total consumer costs and savings expected to result from potential energy conservation standards. DOE uses the third spreadsheet tool, the Government Regulatory Impact Model (GRIM), to assess manufacturer impacts of potential standards. These three spreadsheet tools are available on the DOE website for this rulemaking: 
                        <E T="03">www.regulations.gov/docket??D=EERE-2014-BT-STD-0059.</E>
                         Additionally, DOE used output from the latest version of the Energy Information Administration's (“EIA's”) 
                        <E T="03">Annual Energy Outlook</E>
                         (
                        <E T="03">“AEO”</E>
                        ) for the emissions and utility impact analyses.
                    </P>
                    <HD SOURCE="HD2">A. Market and Technology Assessment</HD>
                    <P>DOE develops information in the market and technology assessment that provides an overall picture of the market for the products concerned, including the purpose of the products, the industry structure, manufacturers, market characteristics, and technologies used in the products. This activity includes both quantitative and qualitative assessments, based primarily on publicly available information. The subjects addressed in the market and technology assessment for this rulemaking include: (1) a determination of the scope of the rulemaking and product classes, (2) manufacturers and industry structure, (3) existing efficiency programs, (4) shipments information, (5) market and industry trends, and (6) technologies or design options that could improve the energy efficiency of room air conditioners. The key findings of DOE's market assessment are summarized in the following sections. See chapter 3 of the final rule TSD for further discussion of the market and technology assessment.</P>
                    <HD SOURCE="HD3">1. Scope of Coverage and Product Classes</HD>
                    <P>In the April 2022 NOPR, DOE did not propose any substantive changes to the room air conditioner scope of coverage or product classes, but did propose making clarifying amendments to the product class descriptions. Specifically, DOE proposed to revise the threshold values of cooling capacity in the product class descriptions to the nearest hundred Btu/h that would not exceed the existing thresholds, which is consistent with the cooling capacity delineation used in practice due to the rounding instruction at 10 CFR 429.15(a)(3) so would not impact compliance with current energy conservation standards. The proposed change to the product class delineation would add clarity and consistency amongst two existing regulatory provisions. 87 FR 20608. DOE requested comment on the room air conditioner scope of coverage and product classes.</P>
                    <P>Currently, reversible and one-way products are in separate product classes and are therefore not compared in any analysis conducted by DOE. However, according to the Center for Law and Social Policy (“CLASP”), taking the efficiency of alternate heating methods into account would allow DOE to treat the reverse cycle in both room and central air conditioners not as a feature meriting its own product class, but as a technology/design option to reduce energy consumption and high energy bills. In this manner, a one-way air conditioner would have the energy consumption of typical furnaces and boilers factored into its annual performance metric, while a reversible air conditioner could eliminate this energy consumption depending on its heating capacity and cold-climate performance potentially leading to energy conservation standards that require the use of reversing capabilities in all air conditioners. (CLASP, No. 42 at p. 2)</P>
                    <P>Room air conditioner energy conservation standards are currently based on the CEER metric, determined in accordance with the DOE test procedure for room air conditioners at appendix F to 10 CFR 430 (“appendix F”). Appendix F does not currently account for the energy consumption during heating operation, and therefore the CEER metric reflects the energy efficiency of a room air conditioner during cooling mode, and other low power modes. In order to account for the energy cost of alternate heating methods for non-reverse cycle room air conditioners, a test procedure amendment would be necessary to address heating mode performance, which is outside of the scope of this energy conservation standards rulemaking.</P>
                    <P>The Public Utilities recommended that DOE establish new product classes for room air conditioners with reverse cycle and &lt;8,000 British thermal units per hour (“Btu/h”) and to consider less stringent standards for such product classes so as to not preclude the introduction of such equipment and deprive consumers of any potential consumer utility. The Public Utilities also provided options for potential standards in these suggested product classes, noting that generally efficiencies for room air conditioners with reverse cycle are lower than those without reverse cycle. (Public Utilities, No. 47 at pp. 2-4)</P>
                    <P>
                        DOE is not aware of any room air conditioners currently sold on the market, or any prototypes in development, that meet the criteria outlined by the Public Utilities. DOE is unaware of any data suggesting that the current energy conservation standards preclude the introduction of room air conditioners with reverse cycle capabilities and capacity less than 8,000 Btu/h to the market. Furthermore, the lack of extant products that meet these criteria leaves DOE without the information needed to analyze whether a new product class is necessary. Therefore, DOE is not amending the product class structure at this time to 
                        <PRTPAGE P="34309"/>
                        specifically address room air conditioners with reverse cycle capabilities and capacity less than 8,000 Btu/h. DOE is, however, adopting the clarifying amendments to the product class descriptions, originally proposed in the April 2022 NOPR, to align with the rounding instruction at 10 CFR 429.15(a)(3).
                    </P>
                    <HD SOURCE="HD3">2. Technology Options</HD>
                    <P>In the NOPR market analysis and technology assessment, DOE identified 22 technology options initially determined to improve the efficiency of room air conditioners, as measured by the DOE test procedure:</P>
                    <GPOTABLE COLS="1" OPTS="L2,p1,8/9,i1" CDEF="s200">
                        <TTITLE>Table IV.1—Technology Options for Room Air Conditioners</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22">Increased Heat Transfer Surface Area:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">1. Increased heat exchanger surface area (frontal area, fin density and depth of coil).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">2. Condenser coil subcooler.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">3. Suction line heat exchanger.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Increased Heat Transfer Coefficient:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">4. Improved fin and tube design.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">5. Hydrophilic coating on fins.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">6. Microchannel heat exchangers.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">7. Spray condensate on condenser coil.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Component Improvements:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">8. Improved indoor blower and outdoor fan blade design.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">9. Improved blower/fan motor design.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">10. Improved compressor efficiency.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Improved Installation, Insulation, and Airflow:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">11. Improved installation materials.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">12. Reduced evaporator air recirculation.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">13. Reduced thermal bridging and internal air leakage.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Part-load Performance:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">14. Variable-speed compressors.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">15. Variable-speed drive fans and blowers.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">16. Thermostatic or electronic expansion valves.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">17. Thermostatic cyclic controls.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">18. Air and water economizers.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Standby Power Improvements:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">19. Low standby-power electronics.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">20. High frequency switching power supply.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Alternative Refrigerants:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">21. Significant New Alternatives Policy (“SNAP”)-approved refrigerants (R-32, R-441A, and R-290).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Other Improvements:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">22. Washable air filters.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD3">a. Alternative Refrigerants</HD>
                    <P>
                        In the April 2022 NOPR, DOE analyzed R-32 (difluoromethane or HFC-32), R-441A (hydrocarbon blend), and R-290 (propane or HC-290) as potential design options to replace R-410A to improve unit efficiency. DOE also analyzed the potential impact of implementing these alternative refrigerants on overall system cost and component efficiency. As discussed in chapter 3 of the NOPR TSD, while DOE did find efficiency benefits associated with R-441A and R-290 refrigerants relative to R410A, DOE did not rely upon those alternative refrigerants in the engineering analysis due to practical concerns regarding flammability and availability. DOE did not find reliable evidence of significant efficiency benefits from a change to R-32 refrigerant. However, based on DOE's expectation that manufacturers are likely to change the primary refrigerant used in room air conditioners to R-32 in response to recent California refrigerant regulations,
                        <SU>19</SU>
                        <FTREF/>
                         DOE analyzed the efficiency of compressors that use R-32 as part of the technology analysis and implemented these compressors in the engineering analysis in the April 2022 NOPR.
                    </P>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             The California Air Resources Board (CARB) finalized its rulemaking on Prohibitions on Use of Certain Hydrofluorocarbons in Stationary Refrigeration, Chillers, Aerosols-Propellants, and Foam End-Uses Regulation. See 
                            <E T="03">https://ww2.arb.ca.gov/rulemaking/2020/hfc2020.</E>
                             This regulation prohibits the sale of new room air conditioners with refrigerants with a GWP of 750 or greater in California beginning on January 1, 2023. See chapter 3 of this final rule TSD for additional discussion.
                        </P>
                    </FTNT>
                    <P>NEEA and NWPCC supported the inclusion of R-32 in the engineering analysis because of the potential energy savings, the number of products already using R-32, and the new California refrigerant requirements. In particular, NEEA agreed with the approached used by DOE to incorporate R-32 compressors into the design options used to achieve EL 3. (NEEA and NWPCC, No. 50 at pp. 4-5) NYSERDA also supported DOE's incorporation of R-32 refrigerants and variable speed compressors across the analysis, and urged DOE to move swiftly toward finalizing this standard to lock in the beneficial impacts as soon as possible. (NYSERDA, No. 41 at p. 3)</P>
                    <P>In this final rule analysis, DOE has maintained its approach to incorporating R-32 from the NOPR analysis.</P>
                    <P>
                        Larsen requested that DOE include calculations on the impacts of alternate refrigerants in room air conditioners in updating the standards of room air conditioners as well as changing DOE's priorities to include environmental impact and quality of life. Larsen referenced challenges to DOE's decision not to include refrigerants (R-32, R441A, R-290) approved by the Environmental Protection Agency (EPA) Significant New Alternatives Policy (“SNAP”) in its engineering analysis, and stated that technological feasibility, predicted costs in the wake of increased value in climate and health benefits, reduced global warming potential compared to the proposed refrigerant R-410A, and findings by the Oak Ridge National Laboratory that showed 
                        <PRTPAGE P="34310"/>
                        increased efficiency by around 3 percent warrant the inclusion of these calculations of benefits associated with alternative refrigerants, specifically R-32. (G. Larsen, No. 37 at pp. 1-4)
                    </P>
                    <P>EPCA requires that DOE focus on the efficiency impacts of various design options, rather than the overall environmental impact. (42 U.S.C. 6295(o)(2)(A)) DOE does consider adverse effects on consumer utility when evaluating technology options. As discussed in chapter 3 of the final rule TSD, DOE found varying reports of the efficiency benefits attributable from the change-over from R-410A to R-32, and as discussed in chapter 5 of the NOPR TSD, opted not to include R-32 specifically as an efficiency option but did include inherent efficiency differences between R-32 compressors and R-410A compressors in the analysis. Due to the varying reports of efficiency impacts and the limitation of scope for this energy conservations standards rulemaking, DOE maintains the same approach as the NOPR, to analyze a change over to R-32 refrigerant so as to utilize the compressor efficiency benefits of R-32 compressors relative to R-410A compressors, without considering specific efficiency benefits attributable to the refrigerant itself.</P>
                    <P>The Association of Home Appliance Manufacturers (AHAM) requested that DOE consider the recent safety testing challenges and safety concerns associated with the charge size of hydrocarbon refrigerants such as R-290 as, according to AHAM, DOE and the Electric Power Research Institute (“EPRI”) study projecting that use of R-290 would yield significant efficiency gains fail to take into account the practical considerations that prevent the use of R-290 in room air conditioners. AHAM stated that the safety standard UL 60335-2-40 will likely limit the charge size of hydrocarbon refrigerants such as R-290 to 114 grams due to lab safety concerns, significantly less than the 200-300 grams required for the smallest capacities of room air conditioners according to AHAM. Additionally, AHAM requested that DOE take the concerns of groups representing firefighters and fire services into account and should not rely on R-290 refrigerant to achieve efficiency gains in its analysis. (AHAM, No. 43 at p. 26)</P>
                    <P>In chapter 3 of the NOPR TSD, DOE noted that researchers have observed efficiency benefits associated with using R-290 as a refrigerant. However, DOE understands that this design option is still new to the room air conditioner industry and poses substantial design challenges to meet UL safety standards. DOE did not propose to rely on R-290 refrigerant as a design option in the NOPR analysis and maintained that approach in this final rule.</P>
                    <P>
                        Systemair requested clarification regarding whether R-454B was included in the analysis. (Systemair, Public Meeting Transcript, No. 38 at pp. 15-16) 
                        <SU>20</SU>
                        <FTREF/>
                         AHAM disagreed with the potential use of R-454B as a refrigerant as mentioned by Systemair because of considerable cost increases as it is a more expensive refrigerant than R-32, lower efficiency than R-32 compressors, and lack of availability. AHAM recommended that DOE reject the use of R-454B as a technology option. (AHAM, No. 43 at p. 27) Additionally, UL stated that for any refrigerant considered in DOE's analysis, SNAP approval would be required. (UL, Public Meeting Transcript, No. 38 at pp. 16-17)
                    </P>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             A notation in the form “Systemair, Public Meeting Transcript, No. 38 at pp. 15-16” identifies an oral comment that DOE received on May 3, 2022 during the public meeting, and was recorded in the public meeting transcript in the docket for this test procedure rulemaking (Docket No. EERE-2014-BT-STD-0059-0030). This particular notation refers to a comment (1) made by Systemair during the public meeting; (2) recorded in document number 38, which is the public meeting transcript that is filed in the docket of this energy conservations standards rulemaking; and (3) which appears on pages 15 through 16 of document number 38.
                        </P>
                    </FTNT>
                    <P>SNAP approved R-454B for use in residential air conditioning applications, subject to certain use conditions, in a final rule published on May 6, 2021. 86 FR 24444. Therefore, DOE investigated R-454B as a design option for this final rule analysis. DOE did find some efficiency benefit associated with implementation of R-454B but noted the additional costs associated with the technology and the design and supply challenges that AHAM discussed. The full design option analysis of R-454B can be found in the technology assessment in chapter 3 of the final rule TSD.</P>
                    <HD SOURCE="HD3">b. Product Weight</HD>
                    <P>AHAM stated that DOE did not sufficiently evaluate the impact of its proposals with respect to product weight, and requested that DOE consider design parameters of 50 or 150 pound weight thresholds for one or two person lifts set by manufacturers for worker safety standards, consumer utility, and other distribution requirements. According to information collected by AHAM from members on their models' weight and dimension characteristics, AHAM stated that there is a strong relationship between product weight and cooling capacity and claimed that DOE is underestimating the change in weight associated with technology options and design required to meet DOE's proposed standards for a significant number of models in the market. According to AHAM member data, there will likely be significant increase to product weight that exceeds DOE's identified acceptable limits, and that by generalizing the increase in product weight by product class, DOE is overlooking a significant portion of the market. According to AHAM, this increase in product weight is an ongoing consideration as products are often removed from windows seasonally, and senior citizens who rely on these products will have more difficulty with heavier products. According to member data, AHAM estimated that product weight increases of up to 14.6 pounds for Product Classes 1-3 would be required to meet the proposed standards, with each estimated resulting product weight above the 51-pound threshold determined by DOE as a reasonable upper limit for single-person portability. For Product Class 1, AHAM predicted product weight increases between 21 and 56 percent, compared to DOE's estimate of 17 to 46 percent. AHAM further estimated weight increases between 7 and 22 percent for Product Classes 3, 4, 5a, 8a, and 16. (AHAM, No. 43 at pp. 19-21)</P>
                    <P>
                        DOE understands that product weight is a concern to consumers, which is why DOE considered the effect on product weight when conducting the engineering analysis. DOE considered weight restrictions only for Product Class 1 because units in Product Class 2 already commonly exceed the 50-pound Occupational Safety and Health Administration (OSHA) recommendation for a single-person lift, implying that single-person lifts are not an important consumer attribute for Product Class 2 or for larger units. DOE modeled the potential increases in product weight due to more efficient compressors using compressor weight data from product teardowns. Based on this analysis, DOE expects that manufacturers will be able to preserve single-person lift capability for those products for which it is important to consumers (
                        <E T="03">i.e.,</E>
                         units within Product Class 1), as DOE predicts a unit weight increase between 17 and 46 percent for the models in DOE's teardown sample to achieve the max-tech efficiency level, but in no instance would unit weight exceed 51 pounds. DOE's analysis indicates that unit weights resulting from higher efficiency level design options that exceed a 150-pound two-person carry threshold were limited to two product classes, PC 5b and PC 11, 
                        <PRTPAGE P="34311"/>
                        where existing units either nearly or already exceed 150 pounds. DOE expects that these large units are already installed primarily with the assistance of professional installers, limiting the impact of increased weight on the consumer utility of these units.
                    </P>
                    <HD SOURCE="HD2">B. Screening Analysis</HD>
                    <P>DOE uses the following four screening criteria to determine which technology options are suitable for further consideration in an energy conservation standards rulemaking:</P>
                    <EXTRACT>
                        <P>
                            (1) 
                            <E T="03">Technological feasibility.</E>
                             Technologies that are not incorporated in commercial products or in commercially viable, existing prototypes will not be considered further.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Practicability to manufacture, install, and service.</E>
                             If it is determined that mass production of a technology in commerical products and reliable installation and servicing of the technology could not be achieved on the scale necessary to serve the relevant market at the time of the projected compliance date of the standard, then that technology will not be considered further.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Impacts on product utility.</E>
                             If a technology is determined to have a significant adverse impact on the utility of the product to significant subgroups of consumers or result in the unavailability of any covered product type with performance characteristics (including reliability), features, sizes, capacities, and volumes that are substantially the same as products generally available in the United States at the time, it will not be considered further.
                        </P>
                        <P>
                            (4) 
                            <E T="03">Safety of technologies.</E>
                             If it is determined that a technology would have significant adverse impacts on health or safety, it will not be considered further.
                        </P>
                        <P>
                            (5) 
                            <E T="03">Unique-pathway proprietary technologies.</E>
                             If a technology has proprietary protection and represents a unique pathway to achieving a given efficiency level, that technology will not be considered further due to the potential for monopolistic concerns.
                        </P>
                    </EXTRACT>
                    <P>Sections 6(b)(3) and 7(b) of appendix A.</P>
                    <P>In sum, if DOE determines that a technology, or a combination of technologies, fails to meet one or more of the listed five criteria, it will be excluded from further consideration in the engineering analysis. The reasons for eliminating any technology are discussed in the following sections.</P>
                    <P>The subsequent sections include comments from interested parties pertinent to the screening criteria, DOE's evaluation of each technology option against the screening analysis criteria, and whether DOE determined that a technology option should be excluded (“screened out”) based on the screening criteria.</P>
                    <HD SOURCE="HD3">1. Screened-Out Technologies</HD>
                    <P>In the April 2022 NOPR, DOE proposed screening out air and water economizers and suction-line heat exchangers in the screening analysis, based on their negative impacts on product utility to consumers and on manufacturing impracticality.</P>
                    <P>AHAM requested that DOE screen out installation materials like accordion side-curtains as there is no way to account for the energy savings according to the existing test procedure given that these features are not installed in the calorimeter during efficiency testing. AHAM also requested that DOE screen out the use of an extended polystyrene (EPS) panel as a technology option as the test procedure will not capture any efficiency gains given that calorimeters are balanced to avoid high differential pressure, which is the source of efficiency gains for this technology option. Additionally, AHAM stated that an EPS panel may conflict with the effectiveness of other technology options such as the condenser coil subcooler and increased heat transfer area. Further, AHAM stated that as most units on the market already use washable air filters, this technology option will not result in significant energy savings or efficiency gains. (AHAM, No. 43 at pp. 27-28)</P>
                    <P>
                        While the DOE test procedure does not account for the efficiency effects of installation materials (
                        <E T="03">e.g.,</E>
                         side-curtains, EPS panels, washable air filters), the technologies still meet the screening criteria, in that they are technically feasible, widely used and not a barrier to availability, manufacturing, installation, or service, do not pose a risk to health, and are not a proprietary technology. Therefore, DOE did not screen out installation materials at this stage. DOE notes that, as discussed in chapter 5 of the NOPR TSD, installation materials were not a design option used to construct efficiency levels for this analysis.
                    </P>
                    <HD SOURCE="HD3">2. Remaining Technologies</HD>
                    <P>Through a review of each technology, DOE concluded that all of the other identified technologies listed in section IV.B.2 of this document met all five screening criteria to be examined further as design options in DOE's final rule analysis. In summary, DOE did not screen out the following technology options:</P>
                    <P>Table IV.2 displays the design options retained for the engineering analysis.</P>
                    <GPOTABLE COLS="1" OPTS="L2,p1,8/9,i1" CDEF="s200">
                        <TTITLE>Table IV.2—Retained Design Options</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22">Increased Heat Transfer Surface Area:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">1. Increased heat exchanger surface area (frontal area, fin density and depth of coil).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">2. Condenser coil subcooler.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Increased Heat Transfer Coefficient:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">3. Improved fin and tube design.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">4. Hydrophilic coating on fins.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">5. Microchannel heat exchangers.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">6. Spray condensate on condenser coil.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Component Improvements:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">7. Improved indoor blower and outdoor fan blade design.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">8. Improved blower/fan motor design.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">9. Improved compressor efficiency.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Improved Installation, Insulation, and Airflow:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">10. Improved installation materials.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">11. Reduced evaporator air recirculation.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">12. Reduced thermal bridging and internal air leakage.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Part-load Performance:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">13. Variable-speed compressors.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">14. Variable-speed drive fans and blowers.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">15. Thermostatic or electronic expansion valves.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">16. Thermostatic cyclic controls.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Standby Power Improvements:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">17. Low standby-power electronics.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">18. High-frequency switching power supply.</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34312"/>
                            <ENT I="22">Alternative Refrigerants:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">19. SNAP-approved refrigerants (R-32, R-441A and R-290).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Other Improvements:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">20. Washable air filters.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        DOE determined that these technology options are technologically feasible because they are being used or have previously been used in commercially-available products or working prototypes. DOE also finds that all of the remaining technology options meet the other screening criteria (
                        <E T="03">i.e.,</E>
                         practicable to manufacture, install, and service and do not result in adverse impacts on consumer utility, product availability, health, or safety). For additional details, see chapter 4 of the final rule TSD.
                    </P>
                    <HD SOURCE="HD2">C. Engineering Analysis</HD>
                    <P>
                        The purpose of the engineering analysis is to establish the relationship between the efficiency and cost of room air conditioners. There are two elements to consider in the engineering analysis; the selection of efficiency levels to analyze (
                        <E T="03">i.e.,</E>
                         the “efficiency analysis”) and the determination of product cost at each efficiency level (
                        <E T="03">i.e.,</E>
                         the “cost analysis”). In determining the performance of higher-efficiency products, DOE considers technologies and design option combinations not eliminated by the screening analysis. For each product class, DOE estimates the baseline cost, as well as the incremental cost for the product/equipment at efficiency levels above the baseline. The output of the engineering analysis is a set of cost-efficiency “curves” that are used in downstream analyses (
                        <E T="03">i.e.,</E>
                         the LCC and PBP analyses and the NIA).
                    </P>
                    <HD SOURCE="HD3">1. Efficiency Analysis</HD>
                    <P>
                        DOE typically uses one of two approaches to develop energy efficiency levels for the engineering analysis: (1) relying on observed efficiency levels in the market (
                        <E T="03">i.e.,</E>
                         the efficiency-level approach), or (2) determining the incremental efficiency improvements associated with incorporating specific design options to a baseline model (
                        <E T="03">i.e.,</E>
                         the design-option approach). Using the efficiency-level approach, the efficiency levels established for the analysis are determined based on the market distribution of existing products (in other words, based on the range of efficiencies and efficiency level “clusters” that already exist on the market). Using the design option approach, the efficiency levels established for the analysis are determined through detailed engineering calculations and/or computer simulations of the efficiency improvements from implementing specific design options that have been identified in the technology assessment. DOE may also rely on a combination of these two approaches. For example, the efficiency-level approach (based on actual products on the market) may be extended using the design option approach to interpolate to define “gap fill” levels (to bridge large gaps between other identified efficiency levels) and/or to extrapolate to the “max-tech” level (particularly in cases where the “max-tech” level exceeds the maximum efficiency level currently available on the market).
                    </P>
                    <P>In this rulemaking, DOE relied on a combination of these two approaches. For each product class, DOE analyzed a few units from different manufacturers to ensure the analysis was representative of various designs on the market. The analysis involved physically disassembling commercially available products, reviewing publicly available cost information, and modeling equipment cost. From this information, DOE estimated the manufacturer production costs (“MPCs”) for a range of products currently available on the market. DOE then considered the design options manufacturers would likely rely on to improve product efficiencies. From this information, DOE estimated the cost and efficiency impacts of incorporating specific design options at each efficiency level.</P>
                    <P>DOE analyzed six efficiency levels as part of the engineering analysis: (1) The current DOE standard (baseline); (2) an intermediate level above the baseline but below the ENERGY STAR level, either halfway between the two or at a level where a number of models were certified (EL 1); (3) the ENERGY STAR efficiency criterion (EL 2); (4) the efficiency attainable by a unit with the most efficient R-32 single-speed compressor on the market (EL 3); (5) an intermediate level representing the efficiency of variable-speed units on the market, as tested by DOE using the recently amended test procedure (EL 4); and (6) the maximum technologically feasible (max-tech) efficiency (EL 5).</P>
                    <P>In evaluating the technologies manufacturers could use to achieve the analyzed efficiency levels, DOE considered design options which made the largest impact on unit efficiency and for which the cost-efficiency relationship was well defined. Accordingly, DOE implemented increased heat exchanger area, condenser coil subcoolers, improved blower motor efficiency, improved compressor efficiency, variable-speed compressors, and low standby-power electronic controls as design options, some or all of which were used to estimate the cost required to reach each efficiently level. DOE did not consider in its analysis certain technologies that met the screening criteria but that DOE was unable to evaluate for one or more of the following reasons: (1) Data were not available to evaluate the energy efficiency characteristics of the technology, (2) available data suggested that the efficiency benefits of the technology are negligible, and (3) certain technologies cannot be measured according to the conditions and methods specified in the existing test procedure. Further information on how the design options were chosen and implemented in the engineering analysis is available in chapter 5 of the final rule TSD.</P>
                    <HD SOURCE="HD3">a. Baseline Efficiency/Energy Use</HD>
                    <P>
                        For each product/equipment class, DOE generally selects a baseline model as a reference point for each class, and measures changes resulting from potential energy conservation standards against the baseline. The baseline model in each product/equipment class represents the characteristics of a product/equipment typical of that class (
                        <E T="03">e.g.,</E>
                         capacity, physical size). Generally, a baseline model is one that just meets current energy conservation standards, or, if no standards are in place, the baseline is typically the most common or least efficient unit on the market.
                    </P>
                    <P>
                        Of the 48 total units DOE selected for analysis in this rulemaking, 19 of them were baseline units that fell within 12 of the 16 room air conditioner product classes and served as reference points for each analyzed product class. DOE used these reference points to assess the effects of amended energy conservation standards, which in turn support the engineering, LCC, and PBP analyses. The baseline units in each of the analyzed product classes represent the 
                        <PRTPAGE P="34313"/>
                        basic characteristics of equipment in that class.
                    </P>
                    <HD SOURCE="HD3">b. Higher Efficiency Levels</HD>
                    <P>DOE considered five efficiency levels (“ELs”) above the baseline for this analysis. As discussed in chapter 5 of the final rule TSD, DOE modeled EL 1, EL 2, and EL 3 by analyzing the cost and efficiency impacts of implementing improved single-speed compressors. DOE also analyzed the impact of implementing tube-only or tube-and-fin subcoolers at EL 3 if the analyzed unit did not already have one. At EL 4, DOE considered the efficiency impacts of variable-speed compressors already available on the market and replacing permanent split capacitor (“PSC”) fan motors with more efficient electronically commutated motors (“ECMs”).</P>
                    <P>As part of DOE's analysis, the maximum available efficiency level is the highest efficiency unit currently available on the market. DOE also defines a “max-tech” efficiency level to represent the maximum possible efficiency for a given product. As discussed in chapter 5 of the final rule TSD, for the max-tech level, DOE modeled replacing single-speed compressors with the maximum efficiency variable-speed compressors available, reducing standby power to the minimum observed in DOE's teardown sample, and increasing the cabinet and heat exchanger to the largest feasible sizes to improve efficiency. For all product classes, the max-tech level identified for EL 5 exceeds any other regulatory or voluntary efficiency criteria currently in effect in the United States.</P>
                    <P>The max-tech level is based entirely on modeled combinations of design options that have not yet been combined in a commercially available room air conditioner. Notably, while the key design option implemented at max-tech, variable-speed compressors, is also considered at EL 4, the significant difference between the two is the level of variable-speed compressor efficiency being considered. At EL 4, DOE considers the variable-speed compressors currently implemented in room air conditioners on the market today, for which performance has been characterized through testing. At EL 5, DOE is considering the highest efficiency variable-speed compressor identified in compressor catalogs, which are not currently implemented in room air conditioner models on the market today or in prototypes. Therefore, the efficiency level at max-tech, EL 5, for each product class is a numerical estimation for the theoretical implementation of the highest efficiency variable-speed compressors. Furthermore, the DOE room air conditioner test procedure measures variable-speed unit performance differently than test procedures for other air conditioning products, so limited performance and efficiency data are available for the most efficient examples of this emergent technology for room air conditioners.</P>
                    <P>Additionally, the most efficient variable-speed compressors that DOE identified in compressor catalogs that were implemented in the analysis at the max-tech efficiency level are manufactured by one manufacturer and have rated Energy Efficiency Ratios (“EERs”) between 11.2 and 11.7 Btu/Wh, with a range of rated capacities between 4,705 Btu/h and 16,170 Btu/h. Given the lack of information regarding availability of these highest efficiency variable-speed compressors, and the limited number of variable-speed compressors rated at or near the compressors considered for the max-tech efficiency level, there may not be widespread availability of these high-efficiency variable-speed compressors.</P>
                    <P>Gradient stated that EL 4 accurately represents an intermediate efficiency level that represents the efficiency of variable-speed units on the market. According to Gradient, variable-speed compressors for room air conditioners with a capacity greater than 8,000 Btu/h are at this time a mature technology that is available from most manufacturers, and the technology needed for implementing variable-speed drives is no longer specialized. Therefore, Gradient strongly supported the proposal of EL 4 as the minimum efficiency level for room air conditioners with a capacity greater than 8,000 Btu/h. (Gradient, No. 40 at p. 2) NEEA and NWPCC also supported the new EL 4 level representing the efficiency of variable-speed units on the market below max tech. (NEEA and NWPCC, No. 50 at p. 5)</P>
                    <P>DOE agrees with Gradient that multiple units with cooling capacities greater than 8,000 Btu/h from several manufacturers employing variable-speed compressors are now available on the market. Further, DOE concludes that variable-speed compressors with efficiencies higher than those currently observed on the market are technically feasible, but there is uncertainty as to whether they would be available in the quantities that would be required to implement them on the necessary scale at the time that compliance with the standards being adopted in this final rule will be required.</P>
                    <P>In their comments, NEEA and NWPCC expressed disappointment in the reduction of EL 3 CEER from the preliminary analysis to the NOPR analysis because of the significant cost-effective national energy savings achievable by using high efficiency single-speed compressors. However, they agreed with the methodology used to reach the change, as they recognize that the reduction in maximum single-speed compressor efficiency to 12.7 Btu/Wh was based on a comprehensive survey of available compressors and accounted for the changeover to R-32 refrigerant. (NEEA and NWPCC, No. 50 at p. 5)</P>
                    <P>DOE is not making any changes to EL 3 in this final rule analysis, retaining the reduction in maximum single-speed compressor efficiency to 12.7 Btu/Wh as discussed in the NOPR.</P>
                    <P>AHAM requested clarification regarding DOE's conclusion that some of the technology options would not result in changes to chassis size and weight. (AHAM, Public Meeting Transcript, No. 38 at pp. 26-27) P.R. China stated that the proposed increases to efficiency ranging from 20 to 50 percent depending on the product class are unreasonable due to size, weight, and cost concerns and instead recommended controlling the increase in standards of each product class to about 15 percent. According to P.R. China, the upgrading technology paths introduced in the April 2022 NOPR would lead to increased costs and size of chassis associated with the proposed energy efficiency levels, and can lead to increased burden on consumers, and increased carbon emissions in the production process. Therefore, P.R. China suggests optimizing the proposed standards to reduce potential impacts on the supply chain. (P.R. China, No. 39 at pp. 3-4) Friedrich also indicated that based on its industry experience, EL 3 would require room air conditioner chassis to be enlarged and become heavier, due, in substantial part, to increased heat exchanger cross-sectional area and compressor size. (Friedrich, No. 44 at p. 5)</P>
                    <P>
                        According to AHAM, DOE underestimated the impacts that the considered technology options will have on chassis size, specifically with adoption of variable-speed compressors, feasible chassis width, and installation impacts/costs. AHAM stated that DOE should evaluate the space needed for compressor controls and transformers when considering the space needed for variable-speed compressors, as these additional components may not fit into existing sleeve sizes. Additionally, AHAM stated that at the proposed 
                        <PRTPAGE P="34314"/>
                        amended standard levels, chassis sizes will increase significantly to greater than DOE's estimated maximum feasible chassis width and therefore DOE is underestimating a significant portion of the market. AHAM presented percent changes to product dimensions based on member data that ranged from 6 to 15 percent in height, 2 to 19 percent in width, and 2 to 21 percent in depth across Product Classes 1, 2, 3, 4, and 16. AHAM indicated that these increased dimensions would lead to more efficient room air conditioners that are potentially incompatible with older buildings, and would require either reinstallation, changes to the building's infrastructure, or purchase of second-hand less efficient products that do fit windows in these older buildings leading to negative health impacts for low income consumers and those in underserved communities. AHAM also stated that with increased chassis sizes and weight, there will be the potential for an increase in packaging and structural robustness costs to ensure the product is not damaged during transport and to ensure the product passes the drop tests requirement outlined in UL 60335-2-40, Annex GG. AHAM requested that DOE update its analysis according to the information provided. (AHAM, No. 43 at pp. 21-23)
                    </P>
                    <P>Friedrich disputed the technological feasibility of increasing compressor efficiency to the levels DOE used to model EL 3 and EL 4. Friedrich stated that it was unable to source a single-speed compressor that would achieve EL 3 with an EER of 12.7 Btu/h and that the most efficient single-speed compressor it was able to source has an EER of 10.8 Btu/h. Friedrich added that it was also unable to source a variable-speed compressor with an EER of 13.2 Btu/h, though Friedrich did not provide any information about the variable-speed compressors that are available to them. (Friedrich, No. 52 at p. 2)</P>
                    <P>DOE identified the highly efficient compressors used in the design analysis in rotary compressor catalogues from companies that typically provide compressors for room air conditioners. The highest efficiency compressors available on the market used R-32 refrigerant. DOE incorporated only those compressors rated at American Society of Heating, Refrigerating, and Air-Conditioning Engineers (“ASHRAE”) test conditions in this analysis. On this basis, DOE concluded that these higher efficiency compressors would be an available option for increasing the efficiency of room air conditioners subject to the amended standards, including those discussed in Friedrich's comments.</P>
                    <P>DOE's analysis indicates that manufacturers should not need to increase chassis sizes in order to implement variable-speed compressors at EL 4. DOE has observed that compressor controls and transformers do not require additional chassis size; room air conditioners with variable-speed compressors currently on the market have similar or smaller chassis sizes compared to their equivalent single-speed counterparts, as discussed further in chapter 5 of the final rule TSD. With respect to more robust packaging, DOE agrees that as chassis sizes increase, additional packaging is needed. Therefore, DOE has altered the NOPR analysis to incorporate an incremental cost for packaging into its engineering analysis at max-tech, where DOE modeled chassis size increases.</P>
                    <P>As a part of the engineering analysis, DOE considered the weight increases associated with each design option for which a substantive weight impact was expected. Those design options included changes to the compressor efficiency, implementation of variable-speed compressors, and adjustments to the heat exchangers (including subcoolers) and resulting chassis size changes, which are discussed in detail both in this document and in chapters 3 and 5 of the final rule TSD. DOE determined that there is sufficient room in the chassis to swap a more efficient compressor of similar overall size and configuration, and therefore would not impact the overall size of the room air conditioner, unlike increases to the heat exchanger which would necessarily increase the model's overall size. In that way, DOE considered the changes to a model's overall size and weight resulting from implementing design options at each efficiency level. GEA indicated that, in order to meet the EL 3 requirements, either a variable-speed compressor or a large chassis size increase would be required, while DOE modeled the cost of meeting this efficiency level using only component replacements and a single-speed compressor. (GEA, No. 49 at pp.1-2)</P>
                    <P>While manufacturers may elect to either implement variable-speed compressors or increase chassis size as a means to reach EL 3, DOE's analysis shows that the most efficient single-speed compressor alone can allow room air conditioners to reach EL 3. As DOE's analysis estimates that manufacturers are likely to use the most cost-effective design options, DOE modeled EL 3 using the most efficient single-speed compressors instead of other possible design options.</P>
                    <P>Friedrich suggested that compressor data found in catalogues would be better if averaged rather than selecting the most efficient data for DOE's analysis, given that manufacturers may not always be able to implement the best compressors in their products. (Friedrich, Public Meeting Transcript, No. 38 at pp. 18-19)</P>
                    <P>EPCA requires DOE to adopt the maximum standards that are both technically justified and economically feasible. (42 U.S.C. 6295(o)(2)(A)) When assessing efficiency levels, and in particular the maximum technologically feasible room air conditioner efficiency level, DOE considered the compressor with the maximum available efficiency, based on product literature, to determine the limits of technical feasibility in room air conditioner compressors. Using an average would not provide DOE with the maximum technologically feasible result, though DOE notes that when considering efficiency levels above baseline and below max-tech, compressors of various efficiency were assessed and implemented in the analysis.</P>
                    <P>Gradient requested clarification regarding the evaporating and condensing temperature test conditions used to characterize compressor efficiency in catalogue data surveyed by DOE. (Gradient, Public Meeting Transcript, No. 38 at pp. 17-18)</P>
                    <P>In developing the engineering analysis, DOE considered compressors for which performance data were available in accordance with ASHRAE or Air Conditioning, Heating, &amp; Refrigeration Institute test conditions, which use a condenser temperature of 54.4 °C and an evaporation temperature of 7.2 °C. These compressor test conditions are an industry standard, and are commonly used in characterizing and determining relative compressor efficiency improvements.</P>
                    <P>Friedrich stated that most of the technology options in DOE's analysis, such as a suction line heat exchanger, do not offer any benefit for the refrigerant used, or have already been used to maximize efficiency like with condenser coil subcoolers, and direct current (DC) fan and blower motors. Friedrich also stated that microchannel heat exchangers may not be appropriate for R-32 applications where minimizing leakage is paramount, as such heat exchangers have issues with galvanic corrosion. (Friedrich, No. 44 at p. 9)</P>
                    <P>
                        As discussed in chapters 3 and 5 of the final rule TSD, DOE evaluates each technology option for its potential efficiency benefit. However, when developing the engineering analysis, DOE typically focuses on design options with substantial impact on efficiency that DOE expects manufacturers would 
                        <PRTPAGE P="34315"/>
                        implement in their designs to improve efficiency. In the case of condenser coil subcoolers, while DOE did find that most units implemented some form of this technology, DOE identified different types of subcoolers with varying efficiency benefits, and therefore retained subcoolers as a design option for those units for which efficiency improvements using a subcooler or improved subcooler design were feasible. In the case of fan and blower motors, DOE identified ECM motor technology as a potential improvement over the commonly implemented PSC motors, and considered the improvement at the two highest efficiency levels. DOE did not consider the implementation of microchannel heat exchangers as a design option for the engineering analysis due to the high cost and lack of room air conditioner application-specific efficiency data.
                    </P>
                    <P>NEEA and NWPCC stated that they could provide data on the cost-effectiveness of high efficiency models. (NEEA and NWPCC, No. 50 at p. 4)</P>
                    <P>DOE did not receive any additional information from NEEA and NWPCC on high efficiency models ahead of this final rule.</P>
                    <HD SOURCE="HD3">2. Cost Analysis</HD>
                    <P>The cost analysis portion of the engineering analysis is conducted using one or a combination of cost approaches. The selection of cost approach depends on a suite of factors, including the availability and reliability of public information, characteristics of the regulated product, the availability and timeliness of purchasing the product on the market. The cost approaches are summarized as follows:</P>
                    <P>
                        • 
                        <E T="03">Physical teardowns:</E>
                         Under this approach, DOE physically dismantles a commercially available product, component-by-component, to develop a detailed bill of materials for the product.
                    </P>
                    <P>
                        • 
                        <E T="03">Catalog teardowns:</E>
                         In lieu of physically deconstructing a product, DOE identifies each component using parts diagrams (available from manufacturer websites or appliance repair websites, for example) to develop the bill of materials for the product.
                    </P>
                    <P>
                        • 
                        <E T="03">Price surveys:</E>
                         If neither a physical nor catalog teardown is feasible (for example, for tightly integrated products such as fluorescent lamps, which are infeasible to disassemble and for which parts diagrams are unavailable) or cost-prohibitive and otherwise impractical (
                        <E T="03">e.g.</E>
                         large commercial boilers), DOE conducts price surveys using publicly available pricing data published on major online retailer websites and/or by soliciting prices from distributors and other commercial channels.
                    </P>
                    <P>In the present case, DOE conducted the analysis using physical teardowns. The resulting bill of materials (“BOM”) provides the basis for the MPC estimates. DOE estimated the cost of the highest efficiency single-speed and variable-speed compressors implemented in EL3 and EL 5, respectively, by extrapolating the costs from price surveys of other compressors. DOE used this approach because, as discussed previously, DOE is not aware of these most efficient single-speed and variable-speed compressors being implemented in any available room air conditioners to date.</P>
                    <P>
                        To account for manufacturers' non-production costs and profit margin, DOE applies a multiplier (the manufacturer markup) to the MPC. The resulting manufacturer selling price (“MSP”) is the price at which the manufacturer distributes a unit into commerce. DOE developed an average manufacturer markup by examining the annual Securities and Exchange Commission (“SEC”) 10-K reports 
                        <SU>21</SU>
                        <FTREF/>
                         filed by publicly-traded manufacturers primarily engaged in appliance manufacturing and whose combined product range includes room air conditioners. Chapter 12 of the final rule TSD provides additional information on the manufacturer markup.
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             U.S. Securities and Exchange Commission, Electronic Data Gathering, Analysis, and Retrieval (EDGAR) system. Available at 
                            <E T="03">www.sec.gov/edgar/search/</E>
                             (last accessed September 7, 2022).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Cost-Efficiency Relationship</HD>
                    <P>
                        The results of the engineering analysis are presented as cost-efficiency data for each of the efficiency levels for each of the product classes that were analyzed, as well as those extrapolated from a product class with similar cooling capacity and features. DOE developed estimates of MPCs for each unit in the teardown sample, and also performed additional modeling for each of the teardown samples, to develop a comprehensive set of MPCs at each efficiency level. DOE then consolidated the resulting MPCs for each of DOE's teardown units and modeled units using a weighted average for product classes in which DOE analyzed units from multiple manufacturers. DOE's weighting factors were based on a market penetration analysis for each of the manufacturers within each product class. The resulting weighted-average incremental MPCs (
                        <E T="03">i.e.,</E>
                         the additional costs manufacturers would likely incur by producing room air conditioners at each efficiency level compared to the baseline) are provided in Tables 5.5.5 and 5.5.6 in chapter 5 of the final rule TSD. See chapter 5 of the final rule TSD for additional detail on the engineering analysis.
                    </P>
                    <P>Gradient agreed with the incremental cost for Product Classes 1 through 5b including the expected trend of increased cost for higher capacity units, but stated that the incremental cost for variable-speed compressor technology should depend only on the capacity of the system, and as such, Gradient recommended applying the incremental costs for Product Classes 1 through 5b to systems of similar capacity in other product classes. (Gradient, No. 40 at p. 2)</P>
                    <P>DOE based its incremental costs for each product class on data derived from teardowns of units in that product class and a design option analysis. The differences in incremental costs observed between non-louvered and louvered units are not due to differences in cost estimates for the variable-speed compressor design option, but inherent differences in incremental cost estimates for a particular configuration. These inherent differences in incremental costs are driven by differences in design and component types, as shown by DOE's teardown analysis, as discussed in further detail in chapter 5 of the final rule TSD.</P>
                    <P>AHAM stated that reducing energy consumption in room air conditioners requires balancing multiple tradeoffs between cost, functional performance, and energy efficiency among numerous components, with different mixes of technology for each product platform. Accordingly, AHAM stated that manufacturers have therefore selected virtually all of the viable technologies across their product lines and requested that DOE recognize that there is limited new technology that would allow for significant per-unit reduction in energy consumption in room air conditioners and that the more radical or comprehensive the design change, the more likely that retooling is necessary and, thus, the greater the product cost increase and capital investment requirement. AHAM concluded that while there may be declining costs over time associated with energy efficient components, these are due to changes in productivity and/or value engineering that is independent of energy efficiency. (AHAM, No. 43 at pp. 18-19)</P>
                    <P>
                        While DOE recognizes that manufacturers face tradeoffs regarding cost, performance, and efficiency, DOE identified several feasible technologies for improving product efficiency across product lines that have only been implemented in a few room air 
                        <PRTPAGE P="34316"/>
                        conditioner models to date, such as variable-speed compressors and ECM fan motors. DOE's analysis in this final rule takes into account costs associated with retooling and capital investments when determining economic justification. See section IV.J.2.c of this document for a description of the conversion cost methodology.
                    </P>
                    <HD SOURCE="HD3">4. Consumer Utility</HD>
                    <P>According to AHAM, consumers may elect to use window units in wall sleeves because higher capacity through-the-wall room air conditioners are already more costly, larger, and heavier than their window counterparts, which may limit efficiency gains and even lead to safety concerns due to inadequate cooling of high-pressure components. AHAM requested that DOE avoid this result not only because it undercuts energy conservation savings goals, but also because it increases safety risks for consumers, with a disproportionate burden on lower income and underserved communities. (AHAM, No. 43 at pp. 22-23)</P>
                    <P>In its analyses, DOE assumes that consumers will install products according to manufacturer instructions and that they will not install units in an unsafe manner. DOE has no information from which to estimate the potential efficiency effects of the incorrect installation described.</P>
                    <HD SOURCE="HD2">D. Markups Analysis</HD>
                    <P>
                        The markups analysis develops appropriate markups (
                        <E T="03">e.g.,</E>
                         retailer markups, distributor markups, contractor markups) in the distribution chain and sales taxes to convert the MSP estimates derived in the engineering analysis to consumer prices, which are then used in the LCC and PBP analysis. At each step in the distribution channel, companies mark up the price of the product to cover business costs and profit margin.
                    </P>
                    <P>In the April 2022 NOPR, DOE assumed the main party in the distribution chain after manufacturers was retailers.</P>
                    <P>Friedrich requested additional details regarding the assumption that 100 percent of room air conditioners sales occur through the retail distribution channel. (Friedrich, Public Meeting Transcript, No. 38 at p. 29)</P>
                    <P>Unlike other larger space cooling equipment that require additional ductwork or installation materials, DOE was unable to find data suggesting that room air conditioners require a general or mechanical contractor for installation. In the absence of data or additional comment provided by stakeholders, DOE maintains the assumption in this final rule that 100 percent of sales occur through the retail distribution channel.</P>
                    <P>
                        DOE developed baseline and incremental markups for each actor in the distribution chain. Baseline markups are applied to the price of products with baseline efficiency, while incremental markups are applied to the difference in price between baseline and higher-efficiency models (the incremental cost increase). The incremental markup is typically less than the baseline markup and is designed to maintain similar per-unit operating profit before and after new or amended standards.
                        <SU>22</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             Because the projected price of standards-compliant products is typically higher than the price of baseline products, using the same markup for the incremental cost and the baseline cost would result in higher per-unit operating profit. While such an outcome is possible, DOE maintains that in markets that are reasonably competitive it is unlikely that standards would lead to a sustainable increase in profitability in the long run.
                        </P>
                    </FTNT>
                    <P>
                        DOE relied on economic data from the U.S. Census Bureau to estimate average baseline and incremental markups. Specifically, DOE used the 2017 Annual Retail Trade Survey for the “electronics and appliance stores” sector to develop retailer markups.
                        <SU>23</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             U.S. Census Bureau, Annual Retail Trade Survey. 2017. 
                            <E T="03">www.census.gov/programs-surveys/arts.html.</E>
                        </P>
                    </FTNT>
                    <P>Chapter 6 of the final rule TSD provides details on DOE's development of markups for room air conditioners.</P>
                    <HD SOURCE="HD2">E. Energy Use Analysis</HD>
                    <P>
                        The purpose of the energy use analysis is to determine the annual energy consumption of room air conditioners at different efficiencies in representative U.S. single-family homes, multi-family residences, and commercial buildings, and to assess the energy savings potential of increased room air conditioner efficiency. The energy use analysis estimates the range of energy use of room air conditioners in the field (
                        <E T="03">i.e.,</E>
                         as they are actually used by consumers). The energy use analysis provides the basis for other analyses DOE performed, particularly assessments of the energy savings and the savings in consumer operating costs that could result from adoption of amended or new standards.
                    </P>
                    <P>
                        To estimate annual room air conditioner usage and energy consumption in the April 2022 NOPR, DOE first calculated the number of operating hours in cooling mode for each room air conditioner in the residential and commercial samples using the reported energy use for room air conditioning in the EIA's Residential Energy Consumption Survey (“RECS”) 2015 
                        <SU>24</SU>
                        <FTREF/>
                         and Commercial Building Energy Consumption Survey (“CBECS”) 2012,
                        <SU>25</SU>
                        <FTREF/>
                         along with historical estimates of the EER of the room air conditioner(s) in each sample home or building. DOE based the latter on the reported age (or simulated age) of the unit and historical data on shipment-weighted average EER.
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             U.S. Department of Energy-Energy Information Administration. Residential Energy Consumption Survey. 2015. 
                            <E T="03">www.eia.gov/consumption/residential/data/2015/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             U.S. Department of Energy-Energy Information Administration. Commercial Buildings Energy Consumption Survey. 2012. 
                            <E T="03">www.eia.gov/consumption/commercial/data/2012/.</E>
                        </P>
                    </FTNT>
                    <P>AHAM questioned the accuracy of the RECS data more generally, pointing to several sources of potential error or uncertainty within the dataset. (AHAM, No. 43 at pp. 8-10)</P>
                    <P>
                        RECS represents the largest available data-set of installed residential appliance stock that is designed to be nationally representative.
                        <SU>26</SU>
                        <FTREF/>
                         Although there may be error or uncertainty in household responses, as in any survey, there is no evidence that responses to any of the questions regarding room air conditioners suffers from a systematic bias that would impact the energy use or LCC analysis. Additionally, the RECS end use energy consumption data, used is the energy use analysis, is derived from household energy bills provided by respondents and is an exact measurement that is not subject to response error from the household. The RECS end-use estimates are based on an engineering approach and calibrated based on the relative uncertainties of and correlations between the end uses.
                        <SU>27</SU>
                        <FTREF/>
                         A study comparing field-energy estimates from the Pecan Street Project 
                        <SU>28</SU>
                        <FTREF/>
                         to end-use estimates from RECS found good agreement between the air conditioning, water heating, and refrigerator consumption estimates as a fraction of the whole-home energy.
                        <SU>29</SU>
                        <FTREF/>
                         Although the authors found that the total energy consumption by end use was higher in RECS households, the authors attribute the difference to selection bias associated with the volunteer households within the Pecan Street dataset. For this final rule, DOE maintains that the RECS dataset 
                        <PRTPAGE P="34317"/>
                        provides the most reasonable, nationally representative estimate for room air conditioner energy consumption in the U.S.
                    </P>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             
                            <E T="03">www.eia.gov/consumption/residential/reports/2015/comparison/index.php.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             Energy Information Administration. RECS 2015 Consumption and Expenditures Technical Documentation Summary. 
                            <E T="03">www.eia.gov/consumption/residential/reports/2015/methodology/pdf/2015C&amp;EMethodology.pdf</E>
                             (last accessed September 12, 2022).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             
                            <E T="03">www.pecanstreet.org/dataport/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             Brock Glasgo, Chris Hendrickson, Inês M.L. Azevedo. 
                            <E T="03">Using advanced metering infrastructure to characterize residential energy use.</E>
                             The Electricity Journal, Volume 30, Issue 3, 2017, Pages 64-70.
                        </P>
                    </FTNT>
                    <P>
                        AHAM and Friedrich stated that it appears highly likely that DOE has overestimated the cooling hours substantially based on end-use energy consumption estimates from RECS 2015, and thus the energy usage and related potential savings from more efficient room air conditioners. (AHAM, No. 43, at p. 8; Friedrich, No. 44 at pp. 7-8) According to AHAM, in many, if not most cases, room air conditioners are not thermostat-driven, load-following but, rather, are turned on and off by users as required, and assuming a load-following pattern substantially overstates the number of hours a room air conditioner is actually on.
                        <SU>30</SU>
                        <FTREF/>
                         AHAM believes it to be more common that room air conditioners are turned on and off by user choice such as when it is especially hot or when a room is occupied, and that the usage hours in that control mode are likely to be much lower than estimates based on load modeling. In support of this point, AHAM stated that in the RECS data, nearly half the respondents report turning on their room air conditioners only when needed and an additional 17 percent adjust the temperature manually, while only 30 percent report setting one temperature and leaving the unit as is.
                    </P>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             RECS reports space cooling end-use energy consumption estimates based on calculated cooling load based on household characteristics and weather data.
                        </P>
                    </FTNT>
                    <P>DOE acknowledges that the statistical nature of the RECS end-use load analysis includes some uncertainty, but maintains that the RECS end-use energy consumption estimates remain the best available dataset for determining the hours of operation associated with room air conditioners. DOE notes that the responses within the household survey portion of RECS for room air conditioner usage do not necessarily imply higher or lower usage relative to DOE's estimates from RECS energy consumption data. For example, respondents that turn their unit on and off manually could potentially use their unit more than expected based only on cooling load-based operation.</P>
                    <P>DOE performed a sensitivity analysis to estimate the potential impact of overestimating operating hours for households that turn their unit on and off as needed. For this sensitivity analysis, DOE reduced the operating hours by half for households reported in RECS as turning their unit on and off as needed. Although energy savings are reduced due to the overall lower operating hours in this sensitivity analysis, the average LCC savings remains positive for all product classes at the adopted TSL with a majority of consumers receiving a net benefit. The average shipment-weighted LCC savings are $62 (relative to $85 in the reference case) and 25% of consumers are impacted negatively (relative to 17 percent in the reference case). As noted above, the assumption of reduced usage associated with household that manually turn their unit on or off is a conservative assumption given that these households could potentially use their unit more than estimated based cooling-load based operation. See appendix 8F of the final rule TSD for the full results of the analysis.</P>
                    <P>AHAM and Friedrich stated that portable air conditioners are a more appropriate analog for room air conditioner usage rather than assuming a cooling load-driven model, since both products are used as a last resort to meet a specific need and suggested DOE base operating hours on a field-metering study of portable air conditioners. (AHAM, No. 43 at p. 13; Friedrich, No. 44 at p. 8)</P>
                    <P>
                        The portable air conditioner field-metering study referenced by AHAM and Friedrich analyzed only 19 units for less than a full cooling season.
                        <SU>31</SU>
                        <FTREF/>
                         As stated in the report itself, given the limited number of test sites in two locations in the Northeast, the study was not intended to be statistically representative of portable air conditioner (“AC”) users in the United States. Even if portable air conditioners were a good analog to room air conditioners, the limitations of this dataset in terms of sample size and representation of usage would preclude its application for the energy use analysis.
                    </P>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             Burke 
                            <E T="03">et al.,</E>
                             2014. “Using Field-Metered Data to Quantify Annual Energy Use of Residential Portable Air Conditioners.” LBNL, Berkeley, CA. LBNL Report LBNL-6469E. September 2014.
                        </P>
                    </FTNT>
                    <P>In the April 2022 NOPR, DOE accounted for the reduction in energy use of models with a variable-speed compressor during part load operation based on the methodology developed for the DOE test procedure. DOE accounted for geographic-dependent climate variability by calculating U.S. State-dependent performance adjustment factors (“PAFs”) using historical climate data spanning the period from 2008-2016 from the National Oceanic and Atmospheric Administration. For each state in the United States, DOE performed a temperature bin analysis to calculate within the cooling season (June through August) the fraction of time the outdoor dry bulb temperature was in one of four temperature bins: 80-84 degrees Fahrenheit (“°F”), 85-89 °F, 90-94 °F, and 95-99 °F. DOE then calculated the corresponding PAF for each state using the methodology developed for variable-speed drive units in the test procedure and applied the PAF to the EER at full load.</P>
                    <P>AHAM stated that before DOE assigns significant value to expensive variable speed/capacity compressors and related control and other systems in its engineering analysis, it needs to validate its assumptions about room air conditioner operating conditions, operating hours, and the likelihood of part load operation. (AHAM, No. 43 at p. 17)</P>
                    <P>The methodology used in the April 2022 NOPR to estimate the energy savings associated with part-load operation is based on the DOE test procedure, as well as available data regarding room air conditioner usage. The development of the test procedure involved testing the performance of variable-speed units relative to single-speed units in a laboratory setting and measuring the relative efficiency gained by part-load operation. DOE is unaware of additional data that can be utilized to estimate the performance of variable-speed units. DOE's application of PAFs for variable-speed units used in the energy use analysis is consistent with the methodology used in DOE test procedure and represents DOE's best estimates to capture the efficiency gains of part load operation based on available data.</P>
                    <P>Rice stated that the energy use analysis in the April 2022 NOPR does not use the correct weighting factors to calculate room air conditioner (“RAC”) CEERs and performance adjustment factors (“PAFs”). Rice states that the weighting factors used by DOE were the fractional time spent in each bin, while the correct approach would be to use fractional cooling delivered, as done in the RAC test procedure final rule. Rice suggested DOE modify its approach in the final rule to use weighting factors derived by the fractional cooling delivered. (Rice, No. 48 at p. 2)</P>
                    <P>DOE clarifies that the calculated State-dependent CEERs and PAFs in the April 2022 NOPR were estimated on the fractional cooling delivered, as suggested by Rice, which are derived from the fractional time spent in each temperature bin. The description of the analysis has been updated in the final rule TSD to reflect this clarification.</P>
                    <P>
                        In the April 2022 NOPR analysis, DOE included the impact of fan-only mode energy consumption in the total energy 
                        <PRTPAGE P="34318"/>
                        use, based on available data for portable ACs. Based on field metering data of portable air conditioners, fan-only mode is estimated at 30 percent of cooling mode hours. DOE assumed that models below ENERGY STAR efficiency level would operate in fan-only mode 30 percent of cooling mode hours.
                        <SU>32</SU>
                        <FTREF/>
                         For ELs that meet or exceed the ENERGY STAR level, DOE estimated the amount of time the unit spent in fan-only mode based on the ENERGY STAR Version 4.2 criterion for room air conditioners criterion requiring that the unit run in off-cycle fan mode less than 17 percent of the time spent in off-cycle mode. Thus, for ELs that meet or exceed the ENERGY STAR efficiency level, DOE assumed units would operate in fan-only mode 5 percent of cooling mode hours.
                    </P>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>NEEA and NWPCC stated that DOE's assumption of fan-only mode being 30 percent of cooling mode hours for models below ENERGY STAR efficiency level is a reasonable assumption. Additionally, NEEA and NWPCC agree that more efficient units (those meet or exceed the ENERGY STAR level) would be less likely to operate in fan-only mode given their variable-speed fans and motors and support the assumed operation of fan-only model to be 5 percent of cooling mode hours for these units. (NEEA and NWPCC, No. 50 at p. 5)</P>
                    <P>In the April 2022 NOPR, DOE assumed that approximately half of room air conditioners are unplugged for half of the year. The “unplugged” time associated with these units is averaged over all units.</P>
                    <P>The California IOUs provided data supporting DOE's assumption. In an online survey conducted on behalf of the California IOUs by Evergreen Economics, results show that 48 percent of households with a room air conditioner reported removing their unit and reinstalling their equipment each year. (California IOUs, No. 47 at pp. 4-5)</P>
                    <P>DOE appreciates the data provided by the California IOUs supporting its assumption. DOE maintains its assumption for this final rule.</P>
                    <P>P.R. China suggested DOE account for the degradation in energy efficiency over the lifetime of the product and in different operating environments in the energy use and LCC analyses. (P.R. China, No. 39 at p. 4)</P>
                    <P>DOE is unaware of data suggesting a decrease in product efficiency over the lifetime of room air conditioners. Moreover, there is no indication that the degradation would preferentially impact more efficient products over less efficient ones. As this effect would impact the energy use of units at various efficiency levels, it would likely have a small impact on the overall LCC savings results.</P>
                    <P>Chapter 7 of the final rule TSD provides details on DOE's energy use analysis for room air conditioners.</P>
                    <HD SOURCE="HD2">F. Life-Cycle Cost and Payback Period Analysis</HD>
                    <P>DOE conducted LCC and PBP analyses to evaluate the economic impacts on individual consumers of potential energy conservation standards for room air conditioners. The effect of new or amended energy conservation standards on individual consumers usually involves a reduction in operating cost and an increase in purchase cost. DOE used the following two metrics to measure consumer impacts:</P>
                    <P>• The LCC is the total consumer expense of an appliance or product over the life of that product, consisting of total installed cost (manufacturer selling price, distribution chain markups, sales tax, and installation costs) plus operating costs (expenses for energy use, maintenance, and repair). To compute the operating costs, DOE discounts future operating costs to the time of purchase and sums them over the lifetime of the product.</P>
                    <P>• The PBP is the estimated amount of time (in years) it takes consumers to recover the increased purchase cost (including installation) of a more-efficient product through lower operating costs. DOE calculates the PBP by dividing the change in purchase cost at higher efficiency levels by the change in annual operating cost for the year that amended or new standards are assumed to take effect.</P>
                    <P>For any given efficiency level, DOE measures the change in LCC relative to the LCC in the no-new-standards case, which reflects the estimated efficiency distribution of room air conditioners in the absence of new or amended energy conservation standards. In contrast, the PBP for a given efficiency level is measured relative to the baseline product.</P>
                    <P>For each considered efficiency level in each product class, DOE calculated the LCC and PBP for a nationally representative set of housing units and commercial buildings. As stated previously, DOE developed household samples from the 2015 RECS and 2012 CBECS. For each sample household, DOE determined the energy consumption for room air conditioners and the appropriate energy price. By developing a representative sample of households, the analysis captured the variability in energy consumption and energy prices associated with the use of room air conditioners.</P>
                    <P>Inputs to the calculation of total installed cost include the cost of the product—which includes MPCs, manufacturer markups, retailer and distributor markups, and sales taxes—and installation costs. Inputs to the calculation of operating expenses include annual energy consumption, energy prices and price projections, repair and maintenance costs, product lifetimes, and discount rates. DOE created distributions of values for product lifetime, discount rates, and sales taxes, with probabilities attached to each value, to account for their uncertainty and variability.</P>
                    <P>
                        The computer model DOE uses to calculate the LCC and PBP relies on a Monte Carlo simulation to incorporate uncertainty and variability into the analysis. The Monte Carlo simulations randomly sample input values from the probability distributions and room air conditioner user samples. For this rulemaking, the Monte Carlo approach is implemented in MS Excel together with the Crystal Ball
                        <SU>TM</SU>
                         add-on.
                        <SU>33</SU>
                        <FTREF/>
                         The model calculated the LCC and PBP for products at each efficiency level for 10,000 housing units or commercial buildings per simulation run. The analytical results include a distribution of 10,000 data points showing the range of LCC savings for a given efficiency level relative to the no-new-standards case efficiency distribution. In performing an iteration of the Monte Carlo simulation for a given consumer, product efficiency is chosen based on its probability. If the chosen product efficiency is greater than or equal to the efficiency of the standard level under consideration, the LCC and PBP calculation reveals that a consumer is not impacted by the standard level. By accounting for consumers who already purchase more-efficient products, DOE avoids overstating the potential benefits from increasing product efficiency. DOE calculated the LCC and PBP for all consumers of room air conditioners as if each were to purchase a new product in the first year of required compliance with new or amended standards. Amended standards apply to room air conditioners manufactured 3 years after the date on which any new or amended standard is published. (42 U.S.C. 
                        <PRTPAGE P="34319"/>
                        6925(m)(4)(A)(i)) Therefore, DOE used 2026 as the first year of compliance with any amended standards for room air conditioners.
                    </P>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             Crystal Ball
                            <SU>TM</SU>
                             is commercially-available software tool to facilitate the creation of these types of models by generating probability distributions and summarizing results within Excel, available at 
                            <E T="03">www.oracle.com/technetwork/middleware/crystalball/overview/index.html</E>
                             (last accessed September 6, 2022).
                        </P>
                    </FTNT>
                    <P>Table IV.3 summarizes the approach and data DOE used to derive inputs to the LCC and PBP calculations. The subsections that follow provide further discussion. Details of the spreadsheet model, and of all the inputs to the LCC and PBP analyses, are contained in chapter 8 of the final rule TSD and its appendices.</P>
                    <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s90,r200">
                        <TTITLE>Table IV.3—Summary of Inputs and Methods for the LCC and PBP Analysis *</TTITLE>
                        <BOXHD>
                            <CHED H="1">Inputs</CHED>
                            <CHED H="1">Source/method</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Product Cost</ENT>
                            <ENT>Derived by multiplying MPCs by manufacturer and retailer markups and sales tax, as appropriate. Used historical data to derive a price scaling index to project product costs.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Installation Costs</ENT>
                            <ENT>Baseline installation cost determined with data from RSMeans 2022.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Annual Energy Use</ENT>
                            <ENT>
                                The total annual energy use by operating mode multiplied by the hours per year in each mode. 
                                <E T="03">Variability:</E>
                                 Based on the 2015 RECS and 2012 CBECS.
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Energy Prices</ENT>
                            <ENT>
                                <E T="03">Electricity:</E>
                                 Based on Edison Electric Institute data for 2021. 
                                <E T="03">Variability:</E>
                                 Regional energy prices determined for each Census Division.
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Energy Price Trends</ENT>
                            <ENT>
                                Based on 
                                <E T="03">AEO2022</E>
                                 price projections by Census Division.
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Repair and Maintenance Costs</ENT>
                            <ENT>Assumed no change with efficiency level for maintenance costs. Repair costs estimated for each product class and efficiency level.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Product Lifetime</ENT>
                            <ENT>
                                Weibull probability distribution developed from historical shipments, 
                                <E T="03">American Housing Survey,</E>
                                 and 
                                <E T="03">RECS,</E>
                                 with an average lifetime of 9 years.
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Discount Rates</ENT>
                            <ENT>Approach involves identifying all possible debt or asset classes that might be used to purchase the considered appliances, or might be affected indirectly. Primary data source was the Federal Reserve Board's Survey of Consumer Finances.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Compliance Date</ENT>
                            <ENT>2026.</ENT>
                        </ROW>
                        <TNOTE>* References for the data sources mentioned in this table are provided in the sections following the table or in chapter 8 of the final rule TSD.</TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD3">1. Product Cost</HD>
                    <P>To calculate consumer product costs, DOE multiplied the MPCs developed in the engineering analysis by the markups described previously (along with sales taxes). DOE used different markups for baseline products and higher-efficiency products, because DOE applies an incremental markup to the increase in MSP associated with higher-efficiency products.</P>
                    <P>
                        Economic literature and historical data suggest that the real costs of many products may trend downward over time according to “learning” or “experience” curves. Experience curve analysis implicitly includes factors such as efficiencies in labor, capital investment, automation, materials prices, distribution, and economies of scale at an industry-wide level. To derive the learning rate parameter for room air conditioners that utilize single-speed compressors, DOE obtained historical Producer Price Index (“PPI”) data for room air conditioners from the Bureau of Labor Statistics (“BLS”). A PPI specific to “room air-conditioners and dehumidifiers, except portable dehumidifiers” was available for the time period between 1990 and 2009.
                        <SU>34</SU>
                        <FTREF/>
                         After 2009, DOE used the primary products series of “air-conditioning, refrigeration and forced air heating equipment”, which includes room air conditioners, spanning the years 2010-2021.
                        <SU>35</SU>
                        <FTREF/>
                         Inflation-adjusted price indices were calculated by dividing the PPI series by the gross domestic product index from Bureau of Economic Analysis for the same years. Using the combined data from 1990-2021, the estimated learning rate (defined as the fractional reduction in price expected from each doubling of cumulative production) is 24 percent. For efficiency levels that include variable-speed compressors, DOE applied a different price trend to the controls portion of the variable-speed compressors that contributes to the price increments moving from EL 3 (an efficiency level achieved with the highest efficiency single-speed compressor) to EL 4 and EL 5. DOE used PPI data on “semiconductors and related device manufacturing” between 1967 and 2021 to estimate the historic price trend of electronic components in the control. The regression performed as an exponential trend line fit results in an R-square of 0.99, with an annual price decline rate of 6.3 percent. See chapter 8 of the final rule TSD for further details on this topic.
                    </P>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             Room air-conditioners and dehumidifiers, except portable dehumidifiers PPI series ID: PCU3334153334156; 
                            <E T="03">www.bls.gov/ppi/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             Air-conditioning, refrigeration, and forced air heating equipment manufacturing, Primary Products PPI series ID: PCU333415333415P; 
                            <E T="03">www.bls.gov/ppi/.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Installation Cost</HD>
                    <P>Installation cost includes labor, overhead, and any miscellaneous materials and parts needed to install the product. In the April 2022 NOPR, DOE assumed that the installation cost would be constant for all efficiency levels and, thus, did not include installation costs in the LCC calculation.</P>
                    <P>AHAM stated that even with minimal size increases in smaller room air conditioners, different chassis sizes will necessitate different installation brackets that do not cover louvers. AHAM requested that DOE analyze costs of necessary retrofits if chassis size changes and the increased installation costs due to heavier products. (AHAM, No. 43 at p. 23)</P>
                    <P>DOE agrees that a standard that changes the chassis size or weight of units may increase installation costs. For the final rule, DOE used data from RSMeans 2022 to estimate the labor and material cost necessary for installing units at various capacities. DOE matched the RSMeans installation costs derived by capacity to the corresponding baseline level within each product class. To account for additional labor hours in higher efficiency equipment with significantly larger dimensions and/or weight, DOE based the labor hour estimates on labor hours for higher capacity room air conditioners with similar dimensions/weight. DOE notes that chassis size only increases at the max-tech level and does not project an increased cost due to retrofits at the adopted TSL.</P>
                    <HD SOURCE="HD3">3. Annual Energy Consumption</HD>
                    <P>
                        For each sampled household or business, DOE determined the energy consumption for room air conditioners at different efficiency levels using the approach described previously in section IV.E of this document.
                        <PRTPAGE P="34320"/>
                    </P>
                    <HD SOURCE="HD3">a. Rebound Effect</HD>
                    <P>A direct rebound effect occurs when a product that is made more efficient is used more intensively, such that the expected energy savings from the efficiency improvement may not fully materialize. At the same time, consumers benefit from increased utilization of products due to rebound. Higher-efficiency room air conditioners reduce the operating costs for a consumer, which can lead to greater use of room air conditioners. Overall consumer welfare (taking into account additional costs and benefits of increased usage) is generally understood to increase from rebound. DOE did not find any data on the rebound effect that is specific to room air conditioners. In the April 2011 Direct Final Rule, DOE estimated a rebound of 15 percent for room air conditioners for the NIA but did not include rebound in the LCC analysis. 76 FR 22454, 22511. Given the uncertainty and lack of data specific to room air conditioners, DOE did not include the rebound effect in the LCC analysis for this final rule. DOE does include rebound in the NIA for a conservative estimate of national energy savings and the corresponding impact to consumer NPV. See sections IV.H.2 and IV.H.3 of this document for further details on how the rebound effect is applied in the NIA.</P>
                    <HD SOURCE="HD3">4. Energy Prices</HD>
                    <P>Because marginal electricity price more accurately captures the incremental savings associated with a change in energy use from higher efficiency, it provides a better representation of incremental change in consumer costs than average electricity prices. Therefore, DOE applied average electricity prices for the energy use of the product purchased in the no-new-standards case, and marginal electricity prices for the incremental change in energy use associated with the other efficiency levels considered.</P>
                    <P>
                        DOE derived electricity prices in 2021 using data from Edison Electric Institute (“EEI”) Typical Bills and Average Rates reports. Based upon comprehensive, industry-wide surveys, this semi-annual report presents typical monthly electric bills and average kilowatt-hour costs to the customer as charged by investor-owned utilities. For the residential sector, DOE calculated electricity prices using the methodology described in Coughlin and Beraki (2018).
                        <SU>36</SU>
                        <FTREF/>
                         For the commercial sector, DOE calculated electricity prices using the methodology described in Coughlin and Beraki (2019).
                        <SU>37</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             Coughlin, K. and B. Beraki.2018. Residential Electricity Prices: A Review of Data Sources and Estimation Methods. Lawrence Berkeley National Lab. Berkeley, CA. Report No. LBNL-2001169. 
                            <E T="03">https://ees.lbl.gov/publications/residential-electricity-prices-review.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             Coughlin, K. and B. Beraki. 2019. Non-residential Electricity Prices: A Review of Data Sources and Estimation Methods. Lawrence Berkeley National Lab. Berkeley, CA. Report No. LBNL-2001203. 
                            <E T="03">https://ees.lbl.gov/publications/non-residential-electricity-prices.</E>
                        </P>
                    </FTNT>
                    <P>DOE calculated weighted-average values for average and marginal price for the nine census divisions for both the residential and commercial sectors. As the EEI data are published separately for summer and winter, DOE calculated seasonal prices for each division and sector. See chapter 8 of the final rule TSD for details.</P>
                    <P>
                        To estimate energy prices in future years, DOE multiplied the 2021 energy prices by the projection of annual average price changes for each of the nine census divisions from the Reference case in 
                        <E T="03">AEO2022,</E>
                         which has an end year of 2050.
                        <SU>38</SU>
                        <FTREF/>
                         To estimate price trends after 2050, DOE used a constant value based on the simple average between 2046 through 2050.
                    </P>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             U.S. Department of Energy-Energy Information Administration. 
                            <E T="03">Annual Energy Outlook 2022 with Projections to 2050.</E>
                             Washington, DC. Available at 
                            <E T="03">www.eia.gov/forecasts/aeo/</E>
                             (last accessed September 6, 2022).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">5. Maintenance and Repair Costs</HD>
                    <P>Repair costs are associated with repairing or replacing product components that have failed in an appliance; maintenance costs are associated with maintaining the operation of the product. Typically, small incremental increases in product efficiency produce no, or only minor, changes in repair and maintenance costs compared to baseline efficiency products. In this final rule analysis, DOE did not include maintenance costs in the LCC.</P>
                    <P>In the April 2022 NOPR, DOE assumed that repair frequencies are low and increase for the higher-capacity units due to more expensive equipment costs. DOE assumed that 1 percent of small-sized units (below 8,000 Btu/h), 2 percent of medium-sized units (8,000 to 20,000 Btu/h), and 3 percent of large-sized units (above 20,000 Btu/h) are maintained or repaired each year. DOE assumed that an average service call and repair/maintenance takes about 1 hour for small and medium-sized units and 2 hours for large units, and that the average material cost is equal to one-half of the incremental equipment cost.</P>
                    <P>Friedrich states that DOE failed to incorporate increased repairs costs to service room air conditioners with variable-speed compressors and increased heat exchanger sizes. According to Friedrich, the likelihood and repair cost will increase due to complexity of components with variable-speed compressors or additional braze joints for larger heat exchangers. (Friedrich, No. 44 at pp. 8-9)</P>
                    <P>
                        DOE's analysis incorporates an increased repair cost due to the higher incremental costs associated with units with variable-speed compressors for more expensive components as suggested by Friedrich. DOE is unaware of any data indicating an increased likelihood of repair due to variable-speed compressors or increased heat exchanger sizes. A retrospective analysis of the April 2011 Direct Final Rule found that DOE's approach to estimating repair costs at each efficiency level based on the incremental equipment cost agreed with an analysis of consumer survey data.
                        <SU>39</SU>
                        <FTREF/>
                         DOE maintains its approach to estimating repair rates and costs for this final rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             Ganeshalingam, M., Ni, C., and Yang, H-C. 2021. A Retrospective Analysis of the 2011 Direct Final Rule for Room Air Conditioners. Lawrence Berkeley National Laboratory. LBNL-2001413.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">6. Product Lifetime</HD>
                    <P>
                        For room air conditioners, DOE developed a distribution of lifetimes from which specific values are assigned to the appliances in the samples. DOE conducted an analysis of actual lifetime in the field using a combination of historical shipments data, the stock of the considered appliances in the 
                        <E T="03">American Housing Survey,</E>
                         and responses in RECS on the age of the appliances in the homes. The data allowed DOE to estimate a survival function, which provides an average appliance lifetime. This analysis yielded a lifetime probability distribution with an average lifetime for room air conditioners of approximately 9 years.
                    </P>
                    <P>Friedrich states that the increase in braze joints needed for larger heat exchangers may increase the potential for refrigerant leaks. Friedrich adds that in the event of a refrigerant leak, consumers are more likely to retire their unit early rather than repair the unit due to the high repair cost resulting in a short lifetime for efficiency levels with this technology. (Friedrich, No. 44 at p. 9)</P>
                    <P>
                        As described in section IV.F.5, the April 2022 NOPR assumed a low repair rate (1-3 percent). Data was not provided by stakeholders during the rulemaking demonstrating the impact that larger heat exchangers would have on the repair rate or repair cost which 
                        <PRTPAGE P="34321"/>
                        could potentially lead to shorter product lifetimes. For this final rule, DOE maintained the same lifetime distribution for all efficiency levels.
                    </P>
                    <HD SOURCE="HD3">7. Discount Rates</HD>
                    <P>In the calculation of LCC, DOE applies discount rates appropriate to households to estimate the present value of future operating cost savings. DOE estimated a distribution of discount rates for room air conditioners based on the opportunity cost of consumer funds.</P>
                    <P>
                        DOE applies weighted average discount rates calculated from consumer debt and asset data, rather than marginal or implicit discount rates.
                        <SU>40</SU>
                        <FTREF/>
                         The LCC analysis estimates net present value over the lifetime of the product, so the appropriate discount rate will reflect the general opportunity cost of household funds, taking this time scale into account. Given the long time horizon modeled in the LCC, the application of a marginal interest rate associated with an initial source of funds is inaccurate. Regardless of the method of purchase, consumers are expected to continue to rebalance their debt and asset holdings over the LCC analysis period, based on the restrictions consumers face in their debt payment requirements and the relative size of the interest rates available on debts and assets. DOE estimates the aggregate impact of this rebalancing using the historical distribution of debts and assets.
                    </P>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             The implicit discount rate is inferred from a consumer purchase decision between two otherwise identical goods with different first cost and operating cost. It is the interest rate that equates the increment of first cost to the difference in net present value of lifetime operating cost, incorporating the influence of several factors: transaction costs; risk premiums and response to uncertainty; time preferences; interest rates at which a consumer is able to borrow or lend. The implicit discount rate is not appropriate for the LCC analysis because it reflects a range of factors that influence consumer purchase decisions, rather than the opportunity cost of the funds that are used in purchases.
                        </P>
                    </FTNT>
                    <P>
                        To establish residential discount rates for the LCC analysis, DOE identified all relevant household debt or asset classes in order to approximate a consumer's opportunity cost of funds related to appliance energy cost savings. It estimated the average percentage shares of the various types of debt and equity by household income group using data from the Federal Reserve Board's Survey of Consumer Finances 
                        <SU>41</SU>
                        <FTREF/>
                         (“SCF”) for 1995, 1998, 2001, 2004, 2007, 2010, 2013, 2016, and 2019. Using the SCF and other sources, DOE developed a distribution of rates for each type of debt and asset by income group to represent the rates that may apply in the year in which amended standards would take effect. DOE assigned each sample household a specific discount rate drawn from one of the distributions. The average rate across all types of household debt and equity and income groups, weighted by the shares of each type, is 4.3 percent.
                    </P>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             U.S. Board of Governors of the Federal Reserve System. Survey of Consumer Finances. 1995, 1998, 2001, 2004, 2007, 2010, 2013, 2016, and 2019. (Last accessed September 6, 2022.) 
                            <E T="03">www.federalreserve.gov/econresdata/scf/scfindex.htm.</E>
                        </P>
                    </FTNT>
                    <P>See chapter 8 of the final rule TSD for further details on the development of consumer discount rates.</P>
                    <HD SOURCE="HD3">8. Energy Efficiency Distribution in the No-New-Standards Case</HD>
                    <P>
                        To accurately estimate the share of consumers that would be affected by a potential energy conservation standard at a particular efficiency level, DOE's LCC analysis considered the projected distribution (market shares) of product efficiencies under the no-new-standards case (
                        <E T="03">i.e.,</E>
                         the case without amended or new energy conservation standards).
                    </P>
                    <P>
                        DOE utilized confidential 2019 shipments data disaggregated by product class and efficiency provided by AHAM in response to the June 2020 Preliminary Analysis to estimate the efficiency distribution in 2019. In the April 2022 NOPR, DOE assumed an annual 0.25 percent increase in shipment-weighted CEER for each product class to develop the efficiency distribution in 2026. The efficiency trend is supported by a retrospective analysis of the April 2011 Direct Final Rule which used a similar efficiency trend for single-speed compressor units.
                        <SU>42</SU>
                        <FTREF/>
                         For this final rule, DOE assumed this trend applied to efficiency levels with single-speed compressors (EL 0, EL 1, EL 2, and EL 3).
                    </P>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             Ganeshalingam, M., Ni, C., and Yang, H-C. 2021. A Retrospective Analysis of the 2011 Direct Final Rule for Room Air Conditioners. Lawrence Berkeley National Laboratory. LBNL-2001413.
                        </P>
                    </FTNT>
                    <P>In the 2022 NOPR, DOE assumed the adoption of variable-speed technologies would follow a Bass diffusion curve which describes how new technologies diffuse into the consumer market. DOE assumed that units with variable-speed technologies would account for 5 percent of shipments in each product class by 2026.</P>
                    <P>In response to the April 2022 NOPR, NEEA and NWPCC provided sales estimates for variable-speed units and all room air conditioners sold as part of the EPA ENERGY STAR® Retail Products Platform (ESRPP). NEEA and NWPCC encouraged DOE to use these data to calibrate the Bass diffusion curve for variable-speed models. (NEEA and NWPCC, No. 50 at pp. 2-4)</P>
                    <P>DOE thanks NEEA and NWPCC for the provided sales data needed to calibrate the Bass diffusion curve for the adoption of variable-speed technologies. The ESRPP data provided by NEEA and NWPCC indicated a faster adoption of variable-speed technologies than estimated in the April 2022 NOPR between 2018 and 2022, in particular for capacities greater than 8,000 Btu/h. For this final rule, DOE calibrated its Bass diffusion curve model for variable-speed models to reach 7 percent of shipments in 2026 with faster adoption for capacities greater than 8,000 Btu/h based on the provided data.</P>
                    <P>The estimated market shares for the no-new-standards case for room air conditioners in 2026 are shown in Tables IV.4 through IV.6. See chapter 8 of the final rule TSD for further information on the derivation of the efficiency distributions.</P>
                    <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s50,12,12,12,12,12,12">
                        <TTITLE>Table IV.4—Room Air Conditioners Without Reverse Cycle and With Louvered Sides: No-New-Standards Case Market Shares in 2026</TTITLE>
                        <BOXHD>
                            <CHED H="1">Efficiency level</CHED>
                            <CHED H="1">&lt;6,000 Btu/h (PC1)</CHED>
                            <CHED H="2">Efficiency</CHED>
                            <CHED H="3">CEER</CHED>
                            <CHED H="2">
                                Market share
                                <LI>(%)</LI>
                            </CHED>
                            <CHED H="1">6,000-7,900 Btu/h (PC2)</CHED>
                            <CHED H="2">Efficiency</CHED>
                            <CHED H="3">CEER</CHED>
                            <CHED H="2">
                                Market share
                                <LI>(%)</LI>
                            </CHED>
                            <CHED H="1">8,000-13,900 Btu/h (PC3)</CHED>
                            <CHED H="2">Efficiency</CHED>
                            <CHED H="3">CEER</CHED>
                            <CHED H="2">
                                Market share
                                <LI>(%)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Baseline</ENT>
                            <ENT>11.0</ENT>
                            <ENT>7.7</ENT>
                            <ENT>11.0</ENT>
                            <ENT>0.0</ENT>
                            <ENT>10.9</ENT>
                            <ENT>0.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>11.4</ENT>
                            <ENT>85.2</ENT>
                            <ENT>11.4</ENT>
                            <ENT>74.6</ENT>
                            <ENT>11.4</ENT>
                            <ENT>30.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>12.1</ENT>
                            <ENT>2.1</ENT>
                            <ENT>12.1</ENT>
                            <ENT>18.3</ENT>
                            <ENT>12.0</ENT>
                            <ENT>58.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>13.1</ENT>
                            <ENT>0.0</ENT>
                            <ENT>13.7</ENT>
                            <ENT>2.1</ENT>
                            <ENT>14.3</ENT>
                            <ENT>0.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>16.0</ENT>
                            <ENT>5.0</ENT>
                            <ENT>16.0</ENT>
                            <ENT>5.0</ENT>
                            <ENT>16.0</ENT>
                            <ENT>10.7</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <PRTPAGE P="34322"/>
                            <ENT I="01">5</ENT>
                            <ENT>20.2</ENT>
                            <ENT>0.0</ENT>
                            <ENT>21.2</ENT>
                            <ENT>0.0</ENT>
                            <ENT>21.9</ENT>
                            <ENT>0.0</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT A="01">14,000-19,900 Btu/h (PC4)</ENT>
                            <ENT A="01">20,000-27,900 Btu/h (PC5a)</ENT>
                            <ENT A="01">&gt;=28,000 Btu/h (PC5b)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Baseline</ENT>
                            <ENT>10.7</ENT>
                            <ENT>0.0</ENT>
                            <ENT>9.4</ENT>
                            <ENT>0.0</ENT>
                            <ENT>9.0</ENT>
                            <ENT>40.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>11.1</ENT>
                            <ENT>0.0</ENT>
                            <ENT>9.8</ENT>
                            <ENT>9.0</ENT>
                            <ENT>9.4</ENT>
                            <ENT>45.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>11.8</ENT>
                            <ENT>89.1</ENT>
                            <ENT>10.3</ENT>
                            <ENT>80.3</ENT>
                            <ENT>9.9</ENT>
                            <ENT>9.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>14.0</ENT>
                            <ENT>0.1</ENT>
                            <ENT>11.8</ENT>
                            <ENT>0.0</ENT>
                            <ENT>10.3</ENT>
                            <ENT>0.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>16.0</ENT>
                            <ENT>10.7</ENT>
                            <ENT>13.8</ENT>
                            <ENT>10.7</ENT>
                            <ENT>13.2</ENT>
                            <ENT>5.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>19.8</ENT>
                            <ENT>0.0</ENT>
                            <ENT>18.7</ENT>
                            <ENT>0.0</ENT>
                            <ENT>16.3</ENT>
                            <ENT>0.0</ENT>
                        </ROW>
                    </GPOTABLE>
                    <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s50,12,12,12,12,12,12">
                        <TTITLE>Table IV.5—Room Air Conditioners Without Reverse Cycle and Without Louvered Sides: No-New-Standards Case Market Shares in 2026</TTITLE>
                        <BOXHD>
                            <CHED H="1">Efficiency level</CHED>
                            <CHED H="1">8,000-10,900 Btu/h (PC 8a)</CHED>
                            <CHED H="2">Efficiency</CHED>
                            <CHED H="3">CEER</CHED>
                            <CHED H="2">
                                Market share
                                <LI>(%)</LI>
                            </CHED>
                            <CHED H="1">11,000-13,900 Btu/h (PC8b)</CHED>
                            <CHED H="2">Efficiency</CHED>
                            <CHED H="3">CEER</CHED>
                            <CHED H="2">
                                Market share
                                <LI>(%)</LI>
                            </CHED>
                            <CHED H="1">14,000-19,900 Btu/h (PC9)</CHED>
                            <CHED H="2">Efficiency</CHED>
                            <CHED H="3">CEER</CHED>
                            <CHED H="2">
                                Market share
                                <LI>(%)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Baseline</ENT>
                            <ENT>9.6</ENT>
                            <ENT>0.0</ENT>
                            <ENT>9.5</ENT>
                            <ENT>0.0</ENT>
                            <ENT>9.3</ENT>
                            <ENT>39.1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>10.1</ENT>
                            <ENT>11.4</ENT>
                            <ENT>10.0</ENT>
                            <ENT>0.0</ENT>
                            <ENT>9.7</ENT>
                            <ENT>46.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>10.6</ENT>
                            <ENT>83.6</ENT>
                            <ENT>10.5</ENT>
                            <ENT>94.3</ENT>
                            <ENT>10.2</ENT>
                            <ENT>9.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>12.3</ENT>
                            <ENT>0.0</ENT>
                            <ENT>12.3</ENT>
                            <ENT>0.7</ENT>
                            <ENT>10.9</ENT>
                            <ENT>0.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>14.1</ENT>
                            <ENT>5.0</ENT>
                            <ENT>13.9</ENT>
                            <ENT>5.0</ENT>
                            <ENT>13.7</ENT>
                            <ENT>5.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>18.7</ENT>
                            <ENT>0.0</ENT>
                            <ENT>19.0</ENT>
                            <ENT>0.0</ENT>
                            <ENT>16.8</ENT>
                            <ENT>0.0</ENT>
                        </ROW>
                    </GPOTABLE>
                    <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s50,12,12,12,12,12,12">
                        <TTITLE>Table IV.6—Room Air Conditioners With Reverse Cycle, Casement-Slider: No-New-Standards Case Market Shares in 2026</TTITLE>
                        <BOXHD>
                            <CHED H="1">Efficiency level</CHED>
                            <CHED H="1">w/louvers (PC11)</CHED>
                            <CHED H="2">&lt;20,000 Btu/h</CHED>
                            <CHED H="3">Efficiency</CHED>
                            <CHED H="4">CEER</CHED>
                            <CHED H="3">
                                Market share
                                <LI>(%)</LI>
                            </CHED>
                            <CHED H="1">wo/louvers (PC12)</CHED>
                            <CHED H="2">&lt;14,000 Btu/h</CHED>
                            <CHED H="3">Efficiency</CHED>
                            <CHED H="4">CEER</CHED>
                            <CHED H="3">
                                Market share
                                <LI>(%)</LI>
                            </CHED>
                            <CHED H="1">Casement-slider (PC16)</CHED>
                            <CHED H="2"> </CHED>
                            <CHED H="3">Efficiency</CHED>
                            <CHED H="4">CEER</CHED>
                            <CHED H="3">
                                Market share
                                <LI>(%)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Baseline</ENT>
                            <ENT>9.8</ENT>
                            <ENT>50.7</ENT>
                            <ENT>9.3</ENT>
                            <ENT>39.1</ENT>
                            <ENT>10.4</ENT>
                            <ENT>34.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>10.4</ENT>
                            <ENT>35.2</ENT>
                            <ENT>9.7</ENT>
                            <ENT>46.9</ENT>
                            <ENT>10.8</ENT>
                            <ENT>51.6</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>10.8</ENT>
                            <ENT>9.0</ENT>
                            <ENT>10.2</ENT>
                            <ENT>9.0</ENT>
                            <ENT>11.4</ENT>
                            <ENT>9.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>12.3</ENT>
                            <ENT>0.0</ENT>
                            <ENT>11.3</ENT>
                            <ENT>0.0</ENT>
                            <ENT>13.2</ENT>
                            <ENT>0.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>14.4</ENT>
                            <ENT>5.0</ENT>
                            <ENT>13.7</ENT>
                            <ENT>5.0</ENT>
                            <ENT>15.3</ENT>
                            <ENT>5.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>18.0</ENT>
                            <ENT>0.0</ENT>
                            <ENT>16.4</ENT>
                            <ENT>0.0</ENT>
                            <ENT>19.1</ENT>
                            <ENT>0.0</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD3">9. Payback Period Analysis</HD>
                    <P>The payback period is the amount of time it takes the consumer to recover the additional installed cost of more-efficient products, compared to baseline products, through energy cost savings. Payback periods are expressed in years. Payback periods that exceed the life of the product mean that the increased total installed cost is not recovered in reduced operating expenses.</P>
                    <P>The inputs to the PBP calculation for each efficiency level are the change in total installed cost of the product and the change in the first-year annual operating expenditures relative to the baseline. The PBP calculation uses the same inputs as the LCC analysis, except that discount rates are not needed.</P>
                    <P>As noted previously, EPCA establishes a rebuttable presumption that a standard is economically justified if the Secretary finds that the additional cost to the consumer of purchasing a product complying with an energy conservation standard level will be less than three times the value of the first year's energy savings resulting from the standard, as calculated under the applicable test procedure. (42 U.S.C. 6295(o)(2)(B)(iii)) For each considered efficiency level, DOE determined the value of the first year's energy savings by calculating the energy savings in accordance with the applicable DOE test procedure, and multiplying those savings by the average energy price projection for the year in which compliance with the amended standards would be required.</P>
                    <HD SOURCE="HD2">G. Shipments Analysis</HD>
                    <P>
                        DOE uses projections of annual product shipments to calculate the national impacts of potential amended or new energy conservation standards on energy use, NPV, and future manufacturer cash flows.
                        <SU>43</SU>
                        <FTREF/>
                         The 
                        <PRTPAGE P="34323"/>
                        shipments model takes an accounting approach, tracking market shares of each product class and the vintage of units in the stock. Stock accounting uses product shipments as inputs to estimate the age distribution of in-service product stocks for all years. The age distribution of in-service product stocks is a key input to calculations of both the NES and NPV, because operating costs for any year depend on the age distribution of the stock.
                    </P>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             DOE uses data on manufacturer shipments as a proxy for national sales, as aggregate data on sales 
                            <PRTPAGE/>
                            are lacking. In general, one would expect a close correspondence between shipments and sales.
                        </P>
                    </FTNT>
                    <P>
                        Total shipments for room air conditioners are developed by considering the demand from replacements for units in stock that fail and the demand from first-time owners in existing homes. DOE calculated shipments due to replacements using the retirement function developed for the LCC analysis. DOE calculated shipments due to first-time owners in existing households using estimates from room air conditioner saturation in RECS 2015 and projections of housing stock from 
                        <E T="03">AEO2022.</E>
                         See chapter 8 of the final rule TSD for details.
                    </P>
                    <P>
                        DOE considers the impacts on shipments from changes in product purchase price and operating cost associated with higher energy efficiency levels using a price elasticity and an efficiency elasticity. As in the April 2022 NOPR, DOE employs a 0.2-percent efficiency elasticity rate and a price elasticity of −0.45 in its shipments model. These values are based on analysis of aggregated data for five residential appliances including room air conditioners.
                        <SU>44</SU>
                        <FTREF/>
                         The market impact is defined as the difference between the product of price elasticity of demand and the change in price due to a standard level, and the product of the efficiency elasticity and the change in operating costs due to a standard level.
                    </P>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             Fujita, K. (2015) Estimating Price Elasticity using Market-Level Appliance Data. Lawrence Berkeley National Laboratory, LBNL-188289.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">H. National Impact Analysis</HD>
                    <P>
                        The NIA assesses the national energy savings (“NES”) and the NPV from a national perspective of total consumer costs and savings that would be expected to result from new or amended standards at specific efficiency levels.
                        <SU>45</SU>
                        <FTREF/>
                         (“Consumer” in this context refers to consumers of the product being regulated.) DOE calculates the NES and NPV for the potential standard levels considered based on projections of annual product shipments, along with the annual energy consumption and total installed cost data from the energy use and LCC analyses. For the present analysis, DOE projected the energy savings, operating cost savings, product costs, and NPV of consumer benefits over the lifetime of room air conditioners sold from 2026 through 2055.
                    </P>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             The NIA accounts for impacts in the 50 states and U.S. territories.
                        </P>
                    </FTNT>
                    <P>
                        DOE evaluates the impacts of new or amended standards by comparing a case without such standards with standards-case projections. The no-new-standards case characterizes energy use and consumer costs for each product class in the absence of new or amended energy conservation standards. For this projection, DOE considers historical trends in efficiency and various forces that are likely to affect the mix of efficiencies over time. DOE compares the no-new-standards case with projections characterizing the market for each product class if DOE adopted new or amended standards at specific energy efficiency levels (
                        <E T="03">i.e.,</E>
                         the TSLs or standards cases) for that class. For the standards cases, DOE considers how a given standard would likely affect the market shares of products with efficiencies greater than the standard.
                    </P>
                    <P>DOE uses a spreadsheet model to calculate the energy savings and the national consumer costs and savings from each TSL. Interested parties can review DOE's analyses by changing various input quantities within the spreadsheet. The NIA spreadsheet model uses typical values (as opposed to probability distributions) as inputs.</P>
                    <P>Table IV.7 summarizes the inputs and methods DOE used for the NIA analysis for the final rule. Discussion of these inputs and methods follows the table. See chapter 10 of the final rule TSD for further details.</P>
                    <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s90,r200">
                        <TTITLE>Table IV.7—Summary of Inputs and Methods for the National Impact Analysis</TTITLE>
                        <BOXHD>
                            <CHED H="1">Inputs</CHED>
                            <CHED H="1">Method</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Shipments</ENT>
                            <ENT>Annual shipments from shipments model.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Compliance Date of Standard</ENT>
                            <ENT>2026.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Efficiency Trends</ENT>
                            <ENT>Bass diffusion curve to allocate shipments to ELs with variable-speed technology and annual 0.25% increase in shipment-weighted CEER for ELs with single-speed technology.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Annual Energy Consumption per Unit</ENT>
                            <ENT>Calculated for each efficiency level based on inputs from energy use analysis.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Total Installed Cost per Unit</ENT>
                            <ENT>Calculated for each efficiency level based on inputs from the LCC analysis. Incorporates projection of future product prices based on historical data.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Annual Energy Cost per Unit</ENT>
                            <ENT>Annual weighted-average values as a function of the annual energy consumption per unit and energy prices.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Repair and Maintenance Cost per Unit</ENT>
                            <ENT>Calculated for each efficiency level on inputs from the LCC analysis.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Energy Price Trends</ENT>
                            <ENT>
                                <E T="03">AEO2022</E>
                                 projections (to 2050) and a constant value derived from simple average between 2046-2050 thereafter.
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Energy Site-to-Primary and FFC Conversion</ENT>
                            <ENT>
                                A time-series conversion factor based on 
                                <E T="03">AEO2022.</E>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Discount Rate</ENT>
                            <ENT>Three and seven percent.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Present Year</ENT>
                            <ENT>2022.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD3">1. Product Efficiency Trends</HD>
                    <P>
                        A key component of the NIA is the trend in energy efficiency projected for the no-new-standards case and each of the standards cases. Section IV.F.8 of this document describes how DOE developed an energy efficiency distribution for the no-new-standards case (which yields a shipment-weighted average efficiency) for each of the considered product classes for the year of anticipated compliance with an amended or new standard. To project the trend in efficiency absent amended standards for room air conditioners over the entire shipments projection period, DOE assumed that market share for ELs with variable-speed technologies would follow a Bass diffusion curve, while the shipment-weighted CEER for ELs with single-speed compressors would increase annually by 0.25 percent in CEER based on historical trends in 
                        <PRTPAGE P="34324"/>
                        shipment-weighted efficiency.
                        <SU>46</SU>
                        <FTREF/>
                         The approach is further described in chapter 10 of the final rule TSD.
                    </P>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             Ganeshalingam, M., Ni, C., and Yang, H-C. 2021. A Retrospective Analysis of the 2011 Direct Final Rule for Room Air Conditioners. Lawrence Berkeley National Laboratory. LBNL-2001413.
                        </P>
                    </FTNT>
                    <P>In its reference scenario, DOE assumed that variable-speed technologies would comprise 25 percent of the market by the end of the analysis period (2055). DOE also performed sensitivity scenarios assuming a low penetration of variable-speed technologies (10 percent of the market in 2055) and a high penetration of variable-speed technologies (50 percent of the market in 2055). The results of these scenarios can be found in appendix 10E of the final rule TSD.</P>
                    <P>For the standards cases, DOE used a “roll-up” scenario to establish the shipment-weighted efficiency for the year that standards are assumed to become effective in 2026. In the year of compliance, the market shares of products in the no-new-standards case that do not meet the standard under consideration would “roll up” to the minimum EL that meets the standard, and the market share of products above the standard would remain unchanged. As in the no-new-standards case, DOE assumed an annual increase of 0.25 percent in CEER over the analysis period for ELs with single-speed technology.</P>
                    <HD SOURCE="HD3">2. National Energy Savings</HD>
                    <P>
                        The national energy savings analysis involves a comparison of national energy consumption of the considered products between each potential standards case (“TSL”) and the case with no new or amended energy conservation standards. DOE calculated the national energy consumption by multiplying the number of units (stock) of each product (by vintage or age) by the unit energy consumption (also by vintage). DOE calculated annual NES based on the difference in national energy consumption for the no-new-standards case and for each higher efficiency standard case. DOE estimated energy consumption and savings based on site energy and converted the electricity consumption and savings to primary energy (
                        <E T="03">i.e.,</E>
                         the energy consumed by power plants to generate site electricity) using annual conversion factors derived from 
                        <E T="03">AEO2022.</E>
                         Cumulative energy savings are the sum of the NES for each year over the timeframe of the analysis.
                    </P>
                    <P>
                        Use of higher-efficiency products is sometimes associated with a direct rebound effect, which refers to an increase in utilization of the product due to the increase in efficiency. DOE did not find any data on the rebound effect specific to room air conditioners, but it applied a direct rebound effect of 15 percent as suggested by Sorrell 
                        <E T="03">et al.</E>
                         for space cooling appliances.
                        <SU>47</SU>
                        <FTREF/>
                         The calculated NES at each efficiency level is therefore reduced by 15 percent in residential applications. DOE also included the rebound effect in the NPV analysis by accounting for the additional net benefit from increased room air conditioner usage as described in section IV.H.3 of this document.
                    </P>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             Sorrell, S., J. Dimitropoulos, M. Sommerville. 2009. Empirical estimates of the direct rebound effect: A review. Energy Policy 37 (2009) 1356-1371.
                        </P>
                    </FTNT>
                    <P>
                        In 2011, in response to the recommendations of a committee on “Point-of-Use and Full-Fuel-Cycle Measurement Approaches to Energy Efficiency Standards” appointed by the National Academy of Sciences, DOE announced its intention to use FFC measures of energy use and greenhouse gas and other emissions in the national impact analyses and emissions analyses included in future energy conservation standards rulemakings. 76 FR 51281 (Aug. 18, 2011). After evaluating the approaches discussed in the August 18, 2011 document, DOE published a statement of amended policy in which DOE explained its determination that EIA's National Energy Modeling System (“NEMS”) is the most appropriate tool for its FFC analysis and its intention to use NEMS for that purpose. 77 FR 49701 (Aug. 17, 2012). NEMS is a public domain, multi-sector, partial equilibrium model of the U.S. energy sector 
                        <SU>48</SU>
                        <FTREF/>
                         that EIA uses to prepare its 
                        <E T="03">Annual Energy Outlook.</E>
                         The FFC factors incorporate losses in production and delivery in the case of natural gas (including fugitive emissions) and additional energy used to produce and deliver the various fuels used by power plants. The approach used for deriving FFC measures of energy use and emissions is described in appendix 10B of the final rule TSD.
                    </P>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             For more information on NEMS, refer to 
                            <E T="03">The National Energy Modeling System: An Overview 2018,</E>
                             DOE/EIA-0581(2019), April 2019. Available 
                            <E T="03">at www.eia.gov/outlooks/aeo/nems/documentation/</E>
                             (last accessed September 7, 2022).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Net Present Value Analysis</HD>
                    <P>The inputs for determining the NPV of the total costs and benefits experienced by consumers are (1) total annual installed cost, (2) total annual operating costs (energy costs and repair and maintenance costs), and (3) a discount factor to calculate the present value of costs and savings. DOE calculates net savings each year as the difference between the no-new-standards case and each standards case in terms of total savings in operating costs versus total increases in installed costs. DOE calculates operating cost savings over the lifetime of each product shipped during the projection period.</P>
                    <P>As discussed in section IV.F.1 of this document, DOE developed room air conditioner price trends based on combined historical PPI data of “room air-conditioners and dehumidifiers, except portable dehumidifiers” and primary air-conditioning, refrigeration and forced air heating equipment. DOE applied the same trends to project prices for each product class at each considered efficiency level. By 2055, the end date of the analysis period, the average single-speed compressor room air conditioner price is projected to drop 18 percent and the variable-speed compressor room air conditioner price is projected to drop about 31 percent relative to 2026. DOE's projection of product prices is described in appendix 10C of the final rule TSD.</P>
                    <P>To evaluate the effect of uncertainty regarding the price trend estimates, DOE investigated the impact of alternate product price projections on the consumer NPV for the considered TSLs for room air conditioners. In addition to the default price trend, DOE considered high and low product price sensitivity cases. In the high price scenario, DOE based the price decline of the non-variable speed controls portion on room air conditioner PPI data limited to the period 1990-2009, which shows a faster price decline relative to the full time series. For the variable-speed controls portion, DOE used a faster price decline derived from the exponential fit of “semiconductors and related device manufacturing” PPI series spanning between 1994 and 2021. In the low price decline scenario, DOE assumed a constant price for the non-variable-speed controls portion of the price and a slower price decline estimate for the variable-speed controls portion derived from the exponential fit of “semiconductors and related device manufacturing” PPI series spanning between 1967 and 1993. The derivation of these price trends and the results of these sensitivity cases are described in appendix 10C of the final rule TSD.</P>
                    <P>
                        The operating cost savings are energy cost savings, which are calculated using the estimated energy savings in each year and the projected price of the appropriate form of energy. To estimate energy prices in future years, DOE multiplied the average regional energy prices by the projection of annual national-average residential energy price 
                        <PRTPAGE P="34325"/>
                        changes in the Reference case from 
                        <E T="03">AEO2022,</E>
                         which has an end year of 2050. To estimate price trends after 2050, DOE used a constant value derived from a simple average of the price trend between 2046 through 2050. As part of the NIA, DOE also analyzed scenarios that used inputs from variants of the 
                        <E T="03">AEO2022</E>
                         Reference case that have lower and higher economic growth. Those cases have lower and higher energy price trends compared to the Reference case. NIA results based on these cases are presented in appendix 10C of the final rule TSD.
                    </P>
                    <P>
                        As previously described, DOE assumed a 15 percent rebound from an increase in utilization of the product arising from the increase in efficiency (
                        <E T="03">i.e.,</E>
                         the direct rebound effect). In considering the consumer welfare gained due to the direct rebound effect, DOE accounted for change in consumer surplus attributed to additional cooling from the purchase of a more efficient unit. Overall consumer welfare is generally understood to be enhanced from rebound. The net consumer impact of the rebound effect is included in the calculation of operating cost savings in the consumer NPV results. See appendix 10F of the final rule TSD for details on DOE's treatment of the monetary valuation of the rebound effect.
                    </P>
                    <P>
                        In calculating the NPV, DOE multiplies the net savings in future years by a discount factor to determine their present value. For this final rule, DOE estimated the NPV of consumer benefits using both a 3-percent and a 7-percent real discount rate. DOE uses these discount rates in accordance with guidance provided by the Office of Management and Budget (“OMB”) to Federal agencies on the development of regulatory analysis.
                        <SU>49</SU>
                        <FTREF/>
                         The discount rates for the determination of NPV are in contrast to the discount rates used in the LCC analysis, which are designed to reflect a consumer's perspective. The 7-percent real value is an estimate of the average before-tax rate of return to private capital in the U.S. economy. The 3-percent real value represents the “social rate of time preference,” which is the rate at which society discounts future consumption flows to their present value.
                    </P>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             United States Office of Management and Budget. 
                            <E T="03">Circular A-4: Regulatory Analysis.</E>
                             September 17, 2003. Section E. Available at 
                            <E T="03">www.whitehouse.gov/omb/memoranda/m03-21.html</E>
                             (last accessed September 7, 2022).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">I. Consumer Subgroup Analysis</HD>
                    <P>
                        In analyzing the potential impact of new or amended energy conservation standards on consumers, DOE evaluates the impact on identifiable subgroups of consumers that may be disproportionately affected by a new or amended national standard. The purpose of a subgroup analysis is to determine the extent of any such disproportional impacts. DOE evaluates impacts on particular subgroups of consumers by analyzing the LCC impacts and PBP for those particular consumers from alternative standard levels. For this final rule, DOE analyzed the impacts of the considered standard levels on two subgroups: (1) low-income households and (2) senior-only households. The analysis used subsets of the RECS 2015 sample composed of households that meet the criteria for the considered subgroups. DOE determined households in the low-income subgroup analysis using poverty thresholds from the U.S. Federal Poverty Guidelines which are based on household income and occupancy.
                        <SU>50</SU>
                        <FTREF/>
                         The subgroup, which represents a total of 12.1 million room ACs in 7.3 million low-income households across the U.S., is composed of 55 percent renters, 43 percent home-owners, 2 percent occupants living in homes without paying rent. Approximately 90 percent of the low-income sample have an annual household income of less than $20,000. Both the low-income and National consumer samples share a similar geographic distribution in ownership with a plurality (49 percent) of room AC units concentrated on the East Coast of the U.S. Based on an analysis of RECS 2015, low-income households were found to have 12 percent higher operating hours relative to the National sample. DOE used the LCC and PBP spreadsheet model to estimate the impacts of the considered efficiency levels on these subgroups. Chapter 11 in the final rule TSD describes the consumer subgroup analysis.
                    </P>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             Department of Health and Human Services, Poverty Thresholds. Available at 
                            <E T="03">https://aspe.hhs.gov/2015-poverty-guidelines</E>
                             (last accessed September 7, 2022).
                        </P>
                    </FTNT>
                    <P>AHAM stated that many lower and middle-income households have negative discretionary income and requested that DOE change its approach towards sub-group analysis to take into account real limitations on purchasing capability and the effects of increased costs on discretionary income, credit ratings, and the ability of consumers to meet other necessary bills. Additionally, AHAM stated that DOE does not take into account the 23 percent of households with incomes under $15,000 who are “unbanked” in its financial framework and therefore needs to rethink its approach to sub-groups and include a more comprehensive approach to impact analysis to ensure that traditionally marginalized subgroups are included in its analysis. (AHAM, No. 43 at pp. 5-8) AHAM and Friedrich commented that excessively stringent standards are likely to negatively impact the populations that use these and noted that it is particularly important not to price-out lower income and underserved communities from purchasing room air conditioners. (AHAM, No. 43 at pp. 3-4; Friedrich, No. 44 at pp. 2-4)</P>
                    <P>
                        DOE's approach to the low-income consumer subgroup analysis includes households that do not have assets or debts included in the SCF. It is likely that a majority of these “unbanked” households primarily rely on cash to complete transactions and as a form of savings, which is included in the distribution of discount rates associated with low-income consumers. Consumers that rely entirely on cash are assigned a discount rate of 0 percent as there is no lost opportunity cost from alternative non-cash assets or debts. For households that utilize non-traditional, non-bank financing, DOE's methodology includes a distribution of high discount rates (&gt;10%) which are representative of the opportunity cost associated with non-bank lines of credit. Additionally, DOE's subgroup analysis for low-income households found that, at the adopted TSL, the estimated installed cost increase is $28 while the average discounted lifetime operating cost savings is $110. (
                        <E T="03">See</E>
                         section V.B.1.b for results of the consumer subgroup analysis.) DOE also notes that its low-income subgroup analysis is a conservative estimate in that it assumes that renter households purchase the unit. In cases where the landlord purchases the unit but the renter pays the electricity bill, the renting household may not pay an increased purchase price due to a standard, but would benefit from reduced operating costs.
                    </P>
                    <P>CFA and NCLC supported DOE's proposed TSL and noted that low-income consumers in particular would benefit from reduced operating costs associated with more efficient room air conditioners as low-income households pay a disproportionately higher percentage of their incomes on energy bills compared to other households. (CFA and NCLC, No. 46 at pp. 1-2)</P>
                    <HD SOURCE="HD2">J. Manufacturer Impact Analysis</HD>
                    <HD SOURCE="HD3">1. Overview</HD>
                    <P>
                        DOE performed an MIA to estimate the financial impacts of amended energy conservation standards on 
                        <PRTPAGE P="34326"/>
                        manufacturers of room air conditioners and to estimate the potential impacts of such standards on employment and manufacturing capacity. The MIA has both quantitative and qualitative aspects and includes analyses of projected industry cash flows, the INPV, investments in research and development (“R&amp;D”) and manufacturing capital, and domestic manufacturing employment. Additionally, the MIA seeks to determine how amended energy conservation standards might affect manufacturing employment, capacity, and competition, as well as how standards contribute to overall regulatory burden. Finally, the MIA serves to identify any disproportionate impacts on manufacturer subgroups, including small business manufacturers.
                    </P>
                    <P>The quantitative part of the MIA primarily relies on the Government Regulatory Impact Model (“GRIM”), an industry cash flow model with inputs specific to this rulemaking. The key GRIM inputs include data on the industry cost structure, unit production costs, product shipments, manufacturer markups, and investments in R&amp;D and manufacturing capital required to produce compliant products. The key GRIM outputs are the INPV, which is the sum of industry annual cash flows over the analysis period, discounted using the industry-weighted average cost of capital, and the impact to domestic manufacturing employment. The model uses standard accounting principles to estimate the impacts of more-stringent energy conservation standards on a given industry by comparing changes in INPV and domestic manufacturing employment between a no-new-standards case and the various standards cases. To capture the uncertainty relating to manufacturer pricing strategies following amended standards, the GRIM estimates a range of possible impacts under different markup scenarios.</P>
                    <P>The qualitative part of the MIA addresses manufacturer characteristics and market trends. Specifically, the MIA considers such factors as a potential standard's impact on manufacturing capacity, competition within the industry, the cumulative impact of other DOE and non-DOE regulations, and impacts on manufacturer subgroups. The complete MIA is outlined in chapter 12 of the final rule TSD.</P>
                    <P>
                        DOE conducted the MIA for this rulemaking in three phases. In Phase 1 of the MIA, DOE prepared a profile of the room air conditioner manufacturing industry based on the market and technology assessment and publicly-available information. This included a top-down analysis of room air conditioner manufacturers that DOE used to derive preliminary financial inputs for the GRIM (
                        <E T="03">e.g.,</E>
                         revenues; materials, labor, overhead, and depreciation expenses; selling, general, and administrative expenses (“SG&amp;A”); and R&amp;D expenses). DOE also used public sources of information to further calibrate its initial characterization of the room air conditioner manufacturing industry, including company filings of form 10-K from the SEC,
                        <SU>51</SU>
                        <FTREF/>
                         corporate annual reports, April 2011 Direct Final Rule, the U.S. Census Bureau's 
                        <E T="03">Annual Survey of Manufactures</E>
                         (“
                        <E T="03">ASM</E>
                        ”),
                        <SU>52</SU>
                        <FTREF/>
                         and reports from Dun &amp; Bradstreet.
                        <SU>53</SU>
                        <FTREF/>
                         76 FR 22454.
                    </P>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             U.S. Securities and Exchange Commission, Electronic Data Gathering, Analysis, and Retrieval (EDGAR) system. Available at 
                            <E T="03">www.sec.gov/edgar/search/</E>
                             (last accessed September 7, 2022).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             U.S. Census Bureau, 
                            <E T="03">Annual Survey of Manufactures.</E>
                             “Summary Statistics for Industry Groups and Industries in the U.S (2020).” Available at: 
                            <E T="03">www.census.gov/data/tables/time-series/econ/asm/2018-2020-asm.html</E>
                             (last accessed September 7, 2022).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             The Dun &amp; Bradstreet Hoovers login is available at: 
                            <E T="03">app.dnbhoovers.com</E>
                             (last accessed September 7, 2022).
                        </P>
                    </FTNT>
                    <P>In Phase 2 of the MIA, DOE prepared a framework industry cash-flow analysis to quantify the potential impacts of amended energy conservation standards. The GRIM uses several factors to determine a series of annual cash flows starting with the announcement of the standard and extending over a 30-year period following the compliance date of the standard. These factors include annual expected revenues, costs of sales, SG&amp;A and R&amp;D expenses, taxes, and capital expenditures. In general, energy conservation standards can affect manufacturer cash flow in three distinct ways: (1) creating a need for increased investment, (2) raising production costs per unit, and (3) altering revenue due to higher per-unit prices and changes in sales volumes.</P>
                    <P>In addition, during Phase 2, DOE developed interview guides to distribute to manufacturers of room air conditioners in order to develop other key GRIM inputs, including product and capital conversion costs, and to gather additional information on the anticipated effects of energy conservation standards on revenues, direct employment, capital assets, industry competitiveness, and subgroup impacts.</P>
                    <P>In Phase 3 of the MIA, DOE conducted structured, detailed interviews with representative manufacturers. During these interviews, DOE discussed engineering, manufacturing, procurement, and financial topics to validate assumptions used in the GRIM and to identify key issues or concerns. As part of Phase 3, DOE also evaluated subgroups of manufacturers that may be disproportionately impacted by amended standards or that may not be accurately represented by the average cost assumptions used to develop the industry cash flow analysis. Such manufacturer subgroups may include small business manufacturers, low-volume manufacturers (“LVMs”), niche players, and/or manufacturers exhibiting a cost structure that largely differs from the industry average. DOE identified one subgroup for a separate impact analysis: small business manufacturers. The small business subgroup is discussed in section VII.B, “Review under the Regulatory Flexibility Act” and in chapter 12 of the final rule TSD.</P>
                    <HD SOURCE="HD3">2. Government Regulatory Impact Model and Key Inputs</HD>
                    <P>DOE uses the GRIM to quantify the changes in cash flow due to amended standards that result in a higher or lower industry value. The GRIM uses a standard, annual discounted cash-flow analysis that incorporates manufacturer costs, markups, shipments, and industry financial information as inputs. The GRIM models changes in costs, distribution of shipments, investments, and manufacturer margins that could result from an amended energy conservation standard. The GRIM spreadsheet uses the inputs to arrive at a series of annual cash flows, beginning in 2023 (the base year of the analysis) and continuing to 2055. DOE calculated INPVs by summing the stream of annual discounted cash flows during this period. For manufacturers of room air conditioners, DOE used a real discount rate of 7.2 percent, which was derived from industry financials and then modified according to feedback received during manufacturer interviews.</P>
                    <P>
                        The GRIM calculates cash flows using standard accounting principles and compares changes in INPV between the no-new-standards case and each standards case. The difference in INPV between the no-new-standards case and a standards case represents the financial impact of the amended energy conservation standard on manufacturers. As discussed previously, DOE developed critical GRIM inputs using a number of sources, including publicly available data, results of the engineering analysis and shipments analysis, and information gathered from industry stakeholders during the course of manufacturer interviews. The GRIM results are presented in section V.B.2 of 
                        <PRTPAGE P="34327"/>
                        this document. Additional details about the GRIM, the discount rate, and other financial parameters can be found in chapter 12 of the final rule TSD.
                    </P>
                    <HD SOURCE="HD3">a. Manufacturer Production Costs</HD>
                    <P>Manufacturing more efficient products is typically more expensive than manufacturing baseline products due to the use of more complex components, which are typically more costly than baseline components. The changes in the MPCs of covered products can affect the revenues, gross margins, and cash flow of the industry. DOE models the relationship between efficiency and MPCs as a part of its engineering analysis. For a complete description of the MPCs, see chapter 5 of the final rule TSD or section IV.C of this document.</P>
                    <HD SOURCE="HD3">b. Shipments Projections</HD>
                    <P>The GRIM estimates manufacturer revenues based on total unit shipment projections and the distribution of those shipments by efficiency level. Changes in sales volumes and efficiency mix over time can significantly affect manufacturer finances. For this analysis, the GRIM uses the NIA's annual shipment projections derived from the shipments analysis from 2023 (the base year) to 2055 (the end year of the analysis period). See chapter 9 of the final rule TSD for additional details or section IV.G of this document for additional details.</P>
                    <HD SOURCE="HD3">c. Product and Capital Conversion Costs</HD>
                    <P>Amended energy conservation standards could cause manufacturers to incur conversion costs to bring their production facilities and product designs into compliance. DOE evaluated the level of conversion-related expenditures that would be needed to comply with each considered efficiency level in each product class. For the MIA, DOE classified these conversion costs into two major groups: (1) product conversion costs; and (2) capital conversion costs. Product conversion costs are investments in research, development, testing, marketing, and other non-capitalized costs necessary to make product designs comply with amended energy conservation standards. Capital conversion costs are investments in property, plant, and equipment necessary to adapt or change existing production facilities such that new compliant product designs can be fabricated and assembled.</P>
                    <P>To calculate the MPCs for room air conditioners at and above the baseline, DOE performed teardowns for representative units. The data generated from these analyses were then used to estimate the capital investments in equipment, tooling, and conveyor required of original equipment manufacturers (“OEMs”) at each efficiency level, taking into account such factors as product design, raw materials, purchased components, and fabrication method. Changes in equipment, tooling, and conveyer were used to estimate capital conversion costs. Additionally, capital conversion costs accounted for investments in appearance tooling made by manufacturers that are not OEMs.</P>
                    <P>DOE relied on feedback from industry to evaluate the product conversion costs industry would likely incur at the considered standard levels. DOE integrated feedback from manufacturers, both OEM and non-OEM, on redesign effort and staffing to estimate product conversion costs. Manufacturer numbers were aggregated to protect confidential information. DOE adjusted the conversion cost estimates developed in support of the April 2022 NOPR to 2021$ for this analysis.</P>
                    <P>The conversion cost figures used in the GRIM can be found in section V.B.2 of this document. For additional information on the capital and product conversion costs, see chapter 12 of the final rule TSD.</P>
                    <P>In general, DOE assumes all conversion-related investments occur between the year of publication of the final rule and the year by which manufacturers must comply with the new standard. The conversion cost figures used in the GRIM can be found in section V.B.2 of this document. For additional information on the estimated capital and product conversion costs, see chapter 12 of the final rule TSD.</P>
                    <HD SOURCE="HD3">d. Manufacturer Markup Scenarios</HD>
                    <P>
                        MSPs include direct manufacturing production costs (
                        <E T="03">i.e.,</E>
                         labor, materials, and overhead estimated in DOE's MPCs) and all non-production costs (
                        <E T="03">i.e.,</E>
                         SG&amp;A, R&amp;D, and interest), along with profit. To calculate the MSPs in the GRIM, DOE applied a manufacturer markup to the MPCs estimated in the engineering analysis for each product class and efficiency level. Modifying these markups in the standards case yields different sets of impacts on manufacturers. For the MIA, DOE modeled two standards-case scenarios to represent uncertainty regarding the potential impacts on prices and profitability for manufacturers following the implementation of amended energy conservation standards: (1) a preservation of gross margin percentage scenario; and (2) a preservation of per-unit operating profit scenario. These scenarios lead to different markup values that, when applied to the MPCs, result in varying revenue and cash flow impacts.
                    </P>
                    <P>
                        Under the preservation of gross margin percentage scenario, DOE applied a single uniform “gross margin percentage” across all efficiency levels, which assumes that manufacturers would be able to maintain the same amount of profit as a percentage of revenues at all efficiency levels within a product class. As MPCs increase with efficiency, this scenario implies that the absolute dollar markup will increase as well. DOE assumed a gross margin percentage of 21 percent for all product classes.
                        <SU>54</SU>
                        <FTREF/>
                         Manufacturers tend to believe it is optimistic to assume that they would be able to maintain the same gross margin percentage markup as their production costs increase, particularly for minimally efficient products. Therefore, DOE assumes that this scenario represents a high bound to industry profitability under an amended energy conservation standard.
                    </P>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             The gross margin percentage of 21 percent is based on a manufacturer markup of 1.26.
                        </P>
                    </FTNT>
                    <P>In the preservation of per-unit operating profit scenario, as the cost of production goes up under a standards case, manufacturers are generally required to reduce their markups to a level that maintains base-case operating profit. DOE implemented this scenario in the GRIM by lowering the manufacturer markups at each TSL to yield approximately the same earnings before interest and taxes in the standards case as in the no-new-standards case in the year after the compliance date of the amended standards. The implicit assumption behind this scenario is that the industry can only maintain its operating profit in absolute dollars after the standard. A comparison of industry financial impacts under the two scenarios is presented in section V.B.2.a of this document.</P>
                    <HD SOURCE="HD3">3. Discussion of MIA Comments</HD>
                    <P>In response to the April 2022 NOPR, AHAM submitted written comments about the impact of supply chain constraints, tariffs, cumulative regulatory burden, and elevated shipping costs on manufacturers of room air conditioners. (AHAM, No. 43 at pp. 28-31)</P>
                    <P>
                        AHAM noted that manufacturers continue to face global supply chain challenges—including procuring semiconductors and experiencing transportation delays—and urged DOE to further review the current situation manufacturers are facing and to account for this in the MIA. (AHAM, No. 43 at 
                        <PRTPAGE P="34328"/>
                        p. 31) Although DOE is appreciative of these recent challenges, in the-long term manufacturers of room air conditioners face both evolving challenges and evolving opportunities. DOE does not attempt the forecast the global supply chain challenges in the timeframe of compliance. Increased costs associated with recent supply chain issues have been implemented in the cost analysis by way of 5-year moving averages for materials, purchase parts, and shipping costs.
                    </P>
                    <P>AHAM noted that room air conditioners as well as room air conditioner chassis are currently subject to United States Trade Representative (“USTR”) China section 301 tariffs at 25 percent and 10 percent, respectively. AHAM requested that DOE follow up with individual manufacturers to fully assess the impact of tariffs, as according to AHAM, these tariffs will likely remain in place. (AHAM, No. 43 at pp. 30-31) DOE contractors conducted manufacturer interviews during the NOPR phases of analysis to solicit information on manufacturer costs. Furthermore, DOE published its MPCs as part of the NOPR TSD. DOE's final rule analysis incorporates both confidential feedback and public comments from manufacturers on MPCs, which incorporates all costs and would include tariffs.</P>
                    <P>AHAM encouraged DOE to incorporate the financial results of the cumulative regulatory burden analysis into the MIA, stating that this could be done by adding the combined cost of complying with multiple regulations into the product conversion costs in the GRIM. (AHAM, No. 43 at pp. 28-29) AHAM noted other regulations impact room air conditioner manufacturers such as residential clothes washers, consumer clothes dryers, commercial clothes washers, consumer refrigerator/freezers, miscellaneous refrigeration products, cooking products, dishwashers, room air conditioners, dehumidifiers, portable air conditioners, and room air cleaner rulemakings. (AHAM, No. 43 at p. 29) Additionally, AHAM noted that DOE should not discount the time and resources needed for stakeholders to review test procedure and energy conservation standard rulemakings and assess their potential impacts. (AHAM, No. 43 at p. 28)</P>
                    <P>If DOE were to combine the conversion costs from multiple regulations, as requested, it would be appropriate to match the combined conversion costs against combined revenues of the regulated products. DOE expects that combined results would make it more difficult to discern the direct impact of this amended standard on room air conditioner manufacturers.</P>
                    <P>With regard to AHAM's request that DOE not discount the costs for stakeholders to review rulemakings, although appreciative that monitoring and responding to rulemakings does impose costs for stakeholders, DOE believes that this is outside the scope of analysis for individual product rulemakings. Because EPCA requires DOE to establish and maintain the energy conservation program for consumer products and to periodically propose new and amended standards and test procedures, DOE considers this rulemaking activity to be part of the analytical baseline. That is, these activities would exist regardless of the regulatory option that DOE adopts through a rulemaking and would be independent from the conversion costs required to adapt product designs and manufacturing facilitates to meet an amended standard. Nonetheless, DOE welcomes any available data on the costs of monitoring. As noted in the April 2022 NOPR, a summary of the job titles and annual hours per job title at a prototypical company would allow DOE to construct a detailed analysis of AHAM's monitoring costs and would help DOE assess whether these costs would materially affect future analyses.</P>
                    <P>AHAM noted that changes to room air conditioner chassis dimensions and product weight will increase shipping and transportation costs and requested that DOE account for this in its MIA through revision. (AHAM, No. 43 at p. 31)</P>
                    <P>As noted in sections IV.A.2.b and IV.C.1.b of this document, DOE evaluated the impact of design options on weight and chassis dimensions. DOE evaluated the impact of those changes in weight and dimensions on overseas container and domestic shipping rates. For efficiency levels below max-tech, DOE did not find increases in shipping costs at efficiency levels. At max-tech, there are increases in shipping costs that could affect downstream analyses. However, as discussed in the walk-down, DOE is not adopting max-tech for any product classes. Additional information about shipping costs is available in chapter 5 of the TSD.</P>
                    <HD SOURCE="HD2">K. Emissions Analysis</HD>
                    <P>
                        The emissions analysis consists of two components. The first component estimates the effect of potential energy conservation standards on power sector and site (where applicable) combustion emissions of CO
                        <E T="52">2</E>
                        , NO
                        <E T="52">X</E>
                        , SO
                        <E T="52">2</E>
                        , and Hg. The second component estimates the impacts of potential standards on emissions of two additional greenhouse gases, CH
                        <E T="52">4</E>
                         and N
                        <E T="52">2</E>
                        O, as well as the reductions in emissions of other gases due to “upstream” activities in the fuel production chain. These upstream activities comprise extraction, processing, and transporting fuels to the site of combustion.
                    </P>
                    <P>
                        The analysis of electric power sector emissions of CO
                        <E T="52">2</E>
                        , NO
                        <E T="52">X</E>
                        , SO
                        <E T="52">2</E>
                        , and Hg uses emissions intended to represent the marginal impacts of the change in electricity consumption associated with amended or new standards. The methodology is based on results published for the 
                        <E T="03">AEO,</E>
                         including a set of side cases that implement a variety of efficiency-related policies. The methodology is described in appendix 13A in the final rule TSD. The analysis presented in this rule uses projections from 
                        <E T="03">AEO2022.</E>
                         Power sector emissions of CH
                        <E T="52">4</E>
                         and N
                        <E T="52">2</E>
                        O from fuel combustion are estimated using Emission Factors for Greenhouse Gas Inventories published by the EPA.
                        <SU>55</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             Available at 
                            <E T="03">www.epa.gov/sites/production/files/2021-04/documents/emission-factors_apr2021.pdf</E>
                             (last accessed July 12, 2022).
                        </P>
                    </FTNT>
                    <P>
                        FFC upstream emissions, which include emissions from fuel combustion during extraction, processing, and transportation of fuels, and “fugitive” emissions (direct leakage to the atmosphere) of CH
                        <E T="52">4</E>
                         and CO
                        <E T="52">2</E>
                        , are estimated based on the methodology described in chapter 15 of the final rule TSD.
                    </P>
                    <P>The emissions intensity factors are expressed in terms of physical units per megawatt-hour (“MWh”) or million British thermal units (“MMBtu”) of site energy savings. For power sector emissions, specific emissions intensity factors are calculated by sector and end use. Total emissions reductions are estimated using the energy savings calculated in the national impact analysis.</P>
                    <HD SOURCE="HD3">1. Air Quality Regulations Incorporated in DOE's Analysis</HD>
                    <P>
                        DOE's no-new-standards case for the electric power sector reflects the 
                        <E T="03">AEO,</E>
                         which incorporates the projected impacts of existing air quality regulations on emissions. 
                        <E T="03">AEO2022</E>
                         generally represents current legislation and environmental regulations, including recent government actions, that were in place at the time of preparation of 
                        <E T="03">AEO2022,</E>
                         including the emissions control programs discussed in the following paragraphs.
                        <SU>56</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             For further information, see the Assumptions to 
                            <E T="03">AEO2022</E>
                             report that sets forth the major assumptions used to generate the projections in the Annual Energy Outlook. Available at 
                            <E T="03">www.eia.gov/outlooks/aeo/assumptions/</E>
                             (last accessed September 6, 2022).
                        </P>
                    </FTNT>
                    <PRTPAGE P="34329"/>
                    <P>
                        SO
                        <E T="52">2</E>
                         emissions from affected electric generating units (“EGUs”) are subject to nationwide and regional emissions cap-and-trade programs. Title IV of the Clean Air Act sets an annual emissions cap on SO
                        <E T="52">2</E>
                         for affected EGUs in the 48 contiguous States and the District of Columbia (“DC”). (42 U.S.C. 7651 
                        <E T="03">et seq.</E>
                        ) SO
                        <E T="52">2</E>
                         emissions from numerous States in the eastern half of the United States are also limited under the Cross-State Air Pollution Rule (“CSAPR”). 76 FR 48208 (Aug. 8, 2011). CSAPR requires these States to reduce certain emissions, including annual SO
                        <E T="52">2</E>
                         emissions, and went into effect as of January 1, 2015.
                        <FTREF/>
                        <SU>57</SU>
                          
                        <E T="03">AEO2022</E>
                         incorporates implementation of CSAPR, including the update to the CSAPR ozone season program emission budgets and target dates issued in 2016. 81 FR 74504 (Oct. 26, 2016). Compliance with CSAPR is flexible among EGUs and is enforced through the use of tradable emissions allowances. Under existing EPA regulations, for states subject to SO
                        <E T="52">2</E>
                         emissions limits under CSAPR, any excess SO
                        <E T="52">2</E>
                         emissions allowances resulting from the lower electricity demand caused by the adoption of an efficiency standard could be used to permit offsetting increases in SO
                        <E T="52">2</E>
                         emissions by another regulated EGU.
                    </P>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             CSAPR requires states to address annual emissions of SO
                            <E T="52">2</E>
                             and NO
                            <E T="52">X</E>
                            , precursors to the formation of fine particulate matter (“PM
                            <E T="52">2.5</E>
                            ”) pollution, in order to address the interstate transport of pollution with respect to the 1997 and 2006 PM
                            <E T="52">2.5</E>
                             National Ambient Air Quality Standards (“NAAQS”). CSAPR also requires certain states to address the ozone season (May-September) emissions of NO
                            <E T="52">X</E>
                            , a precursor to the formation of ozone pollution, in order to address the interstate transport of ozone pollution with respect to the 1997 ozone NAAQS. 76 FR 48208 (Aug. 8, 2011). EPA subsequently issued a supplemental rule that included an additional five states in the CSAPR ozone season program; 76 FR 80760 (Dec. 27, 2011) (Supplemental Rule), and EPA issued the CSAPR Update for the 2008 ozone NAAQS. 81 FR 74504 (Oct. 26, 2016).
                        </P>
                    </FTNT>
                    <P>
                        However, beginning in 2016, SO
                        <E T="52">2</E>
                         emissions began to fall as a result of the Mercury and Air Toxics Standards (“MATS”) for power plants. 77 FR 9304 (Feb. 16, 2012). The final rule establishes power plant emission standards for mercury, acid gases, and non-mercury metallic toxic pollutants. In order to continue operating, coal plants must have either flue gas desulfurization or dry sorbent injection systems installed. Both technologies, which are used to reduce acid gas emissions, also reduce SO
                        <E T="52">2</E>
                         emissions. Because of the emissions reductions under the MATS, it is unlikely that excess SO
                        <E T="52">2</E>
                         emissions allowances resulting from the lower electricity demand would be needed or used to permit offsetting increases in SO
                        <E T="52">2</E>
                         emissions by another regulated EGU. Therefore, energy conservation standards that decrease electricity generation will generally reduce SO
                        <E T="52">2</E>
                         emissions. DOE estimated SO
                        <E T="52">2</E>
                         emissions reduction using emissions factors based on 
                        <E T="03">AEO2022.</E>
                    </P>
                    <P>
                        CSAPR also established limits on NO
                        <E T="52">X</E>
                         emissions for numerous States in the eastern half of the United States. Energy conservation standards would have little effect on NO
                        <E T="52">X</E>
                         emissions in those States covered by CSAPR emissions limits if excess NO
                        <E T="52">X</E>
                         emissions allowances resulting from the lower electricity demand could be used to permit offsetting increases in NO
                        <E T="52">X</E>
                         emissions from other EGUs. In such case, NO
                        <E T="52">X</E>
                         emissions would remain near the limit even if electricity generation goes down. Depending on the configuration of the power sector in the different regions and the need for allowances, however, NO
                        <E T="52">X</E>
                         emissions might not remain at the limit in the case of lower electricity demand. That would mean that standards might reduce NO
                        <E T="52">X</E>
                         emissions in covered States. Despite this possibility, DOE has chosen to be conservative in its analysis and has maintained the assumption that standards will not reduce NO
                        <E T="52">X</E>
                         emissions in States covered by CSAPR. Standards would be expected to reduce NO
                        <E T="52">X</E>
                         emissions in the States not covered by CSAPR. DOE used 
                        <E T="03">AEO2022</E>
                         data to derive NO
                        <E T="52">X</E>
                         emissions factors for the group of States not covered by CSAPR.
                    </P>
                    <P>
                        The MATS limit mercury emissions from power plants, but they do not include emissions caps and, as such, DOE's energy conservation standards would be expected to slightly reduce Hg emissions. DOE estimated mercury emissions reduction using emissions factors based on 
                        <E T="03">AEO2022,</E>
                         which incorporates the MATS.
                    </P>
                    <HD SOURCE="HD2">L. Monetizing Emissions Impacts</HD>
                    <P>
                        As part of the development of this final rule, for the purpose of complying with the requirements of Executive Order 12866, DOE considered the estimated monetary benefits from the reduced emissions of CO
                        <E T="52">2</E>
                        , CH
                        <E T="52">4</E>
                        , N
                        <E T="52">2</E>
                        O, NO
                        <E T="52">X</E>
                        , and SO
                        <E T="52">2</E>
                         that are expected to result from each of the TSLs considered. In order to make this calculation analogous to the calculation of the NPV of consumer benefit, DOE considered the reduced emissions expected to result over the lifetime of products shipped in the projection period for each TSL. This section summarizes the basis for the values used for monetizing the emissions benefits and presents the values considered in this final rule.
                    </P>
                    <P>
                        On March 16, 2022, the Fifth Circuit Court of Appeals (No. 22-30087) granted the Federal Government's emergency motion for stay pending appeal of the February 11, 2022, preliminary injunction issued in 
                        <E T="03">Louisiana</E>
                         v. 
                        <E T="03">Biden,</E>
                         No. 21-cv-1074-JDC-KK (W.D. La.). As a result of the Fifth Circuit's order, the preliminary injunction is no longer in effect, pending resolution of the Federal Government's appeal of that injunction or a further court order. Among other things, the preliminary injunction enjoined the defendants in that case from “adopting, employing, treating as binding, or relying upon” the interim estimates of the social cost of greenhouse gases—which were issued by the Interagency Working Group on the Social Cost of Greenhouse Gases on February 26, 2021—to monetize the benefits of reducing greenhouse gas emissions. In the absence of further intervening court orders, DOE has reverted to its approach prior to the injunction and present monetized benefits where appropriate and permissible under law. DOE requests comment on how to address the climate benefits and other non-monetized effects of the proposal.
                    </P>
                    <HD SOURCE="HD3">1. Monetization of Greenhouse Gas Emissions</HD>
                    <P>
                        DOE estimates the monetized benefits of the reductions in emissions of CO
                        <E T="52">2</E>
                        , CH
                        <E T="52">4</E>
                        , and N
                        <E T="52">2</E>
                        O by using a measure of the SC of each pollutant (
                        <E T="03">e.g.,</E>
                         SC-CO
                        <E T="52">2</E>
                        ). These estimates represent the monetary value of the net harm to society associated with a marginal increase in emissions of these pollutants in a given year, or the benefit of avoiding that increase. These estimates are intended to include (but are not limited to) climate-change-related changes in net agricultural productivity, human health, property damages from increased flood risk, disruption of energy systems, risk of conflict, environmental migration, and the value of ecosystem services.
                    </P>
                    <P>DOE exercises its own judgment in presenting monetized climate benefits as recommended by applicable Executive orders, and DOE would reach the same conclusion presented in this final rule in the absence of the social cost of greenhouse gases including the February 2021 interim estimates presented by the Interagency Working Group on the Social Cost of Greenhouse Gases.</P>
                    <P>
                        DOE estimated the global social benefits of CO
                        <E T="52">2</E>
                        , CH
                        <E T="52">4</E>
                        , and N
                        <E T="52">2</E>
                        O reductions (
                        <E T="03">i.e.,</E>
                         SC-GHGs) using the estimates presented in the “Technical Support Document: Social Cost of Carbon, Methane, and Nitrous Oxide Interim Estimates under Executive Order 13990,” published in February 
                        <PRTPAGE P="34330"/>
                        2021 by the IWG. The SC-GHGs is the monetary value of the net harm to society associated with a marginal increase in emissions in a given year, or the benefit of avoiding that increase. In principle, SC-GHGs includes the value of all climate change impacts, including (but not limited to) changes in net agricultural productivity, human health effects, property damage from increased flood risk and natural disasters, disruption of energy systems, risk of conflict, environmental migration, and the value of ecosystem services. The SC-GHGs therefore, reflects the societal value of reducing emissions of the gas in question by one metric ton. The SC-GHGs is the theoretically appropriate value to use in conducting benefit-cost analyses of policies that affect CO
                        <E T="52">2</E>
                        , N
                        <E T="52">2</E>
                        O and CH
                        <E T="52">4</E>
                         emissions. As a member of the IWG involved in the development of the February 2021 SC-GHG TSD, DOE agrees that the interim SC-GHG estimates represent the most appropriate estimate of the SC-GHG until revised estimates have been developed reflecting the latest, peer-reviewed science.
                    </P>
                    <P>
                        The SC-GHGs estimates presented here were developed over many years, using transparent process, peer-reviewed methodologies, the best science available at the time of that process, and with input from the public. Specifically, in 2009, the IWG, that included the DOE and other executive branch agencies and offices was established to ensure that agencies were using the best available science and to promote consistency in the social cost of carbon (SC-CO
                        <E T="52">2</E>
                        ) values used across agencies. The IWG published SC-CO
                        <E T="52">2</E>
                         estimates in 2010 that were developed from an ensemble of three widely cited integrated assessment models (IAMs) that estimate global climate damages using highly aggregated representations of climate processes and the global economy combined into a single modeling framework. The three IAMs were run using a common set of input assumptions in each model for future population, economic, and CO
                        <E T="52">2</E>
                         emissions growth, as well as equilibrium climate sensitivity—a measure of the globally averaged temperature response to increased atmospheric CO
                        <E T="52">2</E>
                         concentrations. These estimates were updated in 2013 based on new versions of each IAM. In August 2016 the IWG published estimates of the social cost of methane (SC-CH
                        <E T="52">4</E>
                        ) and nitrous oxide (SC-N
                        <E T="52">2</E>
                        O) using methodologies that are consistent with the methodology underlying the SC-CO
                        <E T="52">2</E>
                         estimates. The modeling approach that extends the IWG SC-CO
                        <E T="52">2</E>
                         methodology to non-CO
                        <E T="52">2</E>
                         GHGs has undergone multiple stages of peer review. The SC-CH
                        <E T="52">4</E>
                         and SC-N
                        <E T="52">2</E>
                        O estimates were developed by Marten 
                        <E T="03">et al.</E>
                        <SU>58</SU>
                        <FTREF/>
                         and underwent a standard double-blind peer review process prior to journal publication. In 2015, as part of the response to public comments received to a 2013 solicitation for comments on the SC-CO
                        <E T="52">2</E>
                         estimates, the IWG announced a National Academies of Sciences, Engineering, and Medicine review of the SC-CO
                        <E T="52">2</E>
                         estimates to offer advice on how to approach future updates to ensure that the estimates continue to reflect the best available science and methodologies. In January 2017, the National Academies released their final report, “Valuing Climate Damages: Updating Estimation of the Social Cost of Carbon Dioxide,” and recommended specific criteria for future updates to the SC-CO
                        <E T="52">2</E>
                         estimates, a modeling framework to satisfy the specified criteria, and both near-term updates and longer-term research needs pertaining to various components of the estimation process (National Academies, 2017).
                        <SU>59</SU>
                        <FTREF/>
                         Shortly thereafter, in March 2017, President Trump issued Executive Order 13783, which disbanded the IWG, withdrew the previous TSDs, and directed agencies to ensure SC-CO
                        <E T="52">2</E>
                         estimates used in regulatory analyses are consistent with the guidance contained in OMB's Circular A-4, “including with respect to the consideration of domestic versus international impacts and the consideration of appropriate discount rates” (E.O. 13783, section 5(c)). Benefit-cost analyses following E.O. 13783 used SC-GHG estimates that attempted to focus on the U.S.-specific share of climate change damages as estimated by the models and were calculated using two discount rates recommended by Circular A-4, 3 percent and 7 percent. All other methodological decisions and model versions used in SC-GHG calculations remained the same as those used by the IWG in 2010 and 2013, respectively.
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             Marten, A.L., E.A. Kopits, C.W. Griffiths, S.C. Newbold, and A. Wolverton. Incremental CH
                            <E T="52">4</E>
                             and N
                            <E T="52">2</E>
                            O mitigation benefits consistent with the US Government's SC-CO
                            <E T="52">2</E>
                             estimates. 
                            <E T="03">Climate Policy.</E>
                             2015. 15(2): pp. 272-298.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             National Academies of Sciences, Engineering, and Medicine. 
                            <E T="03">Valuing Climate Damages: Updating Estimation of the Social Cost of Carbon Dioxide.</E>
                             2017. The National Academies Press: Washington, DC.
                        </P>
                    </FTNT>
                    <P>On January 20, 2021, President Biden issued Executive Order 13990, which re-established the IWG and directed it to ensure that the U.S. Government's estimates of the social cost of carbon and other greenhouse gases reflect the best available science and the recommendations of the National Academies (2017). The IWG was tasked with first reviewing the SC-GHG estimates currently used in Federal analyses and publishing interim estimates within 30 days of the E.O. that reflect the full impact of GHG emissions, including by taking global damages into account. The interim SC-GHG estimates published in February 2021 are used here to estimate the climate benefits for this rulemaking. The E.O. instructs the IWG to undertake a fuller update of the SC-GHG estimates by January 2022 that takes into consideration the advice of the National Academies (2017) and other recent scientific literature. The February 2021 SC-GHG TSD provides a complete discussion of the IWG's initial review conducted under E.O. 13990. In particular, the IWG found that the SC-GHG estimates used under E.O. 13783 fail to reflect the full impact of GHG emissions in multiple ways.</P>
                    <P>
                        First, the IWG found that the SC-GHG estimates used under E.O. 13783 fail to fully capture many climate impacts that affect the welfare of U.S. citizens and residents, and those impacts are better reflected by global measures of the SC-GHG. Examples of omitted effects from the E.O. 13783 estimates include direct effects on U.S. citizens, assets, and investments located abroad, supply chains, U.S. military assets and interests abroad, and tourism, and spillover pathways such as economic and political destabilization and global migration that can lead to adverse impacts on U.S. national security, public health, and humanitarian concerns. In addition, assessing the benefits of U.S. GHG mitigation activities requires consideration of how those actions may affect mitigation activities by other countries, as those international mitigation actions will provide a benefit to U.S. citizens and residents by mitigating climate impacts that affect U.S. citizens and residents. A wide range of scientific and economic experts have emphasized the issue of reciprocity as support for considering global damages of GHG emissions. If the United States does not consider impacts on other countries, it is difficult to convince other countries to consider the impacts of their emissions on the United States. The only way to achieve an efficient allocation of resources for emissions reduction on a global basis—and so benefit the United States and its citizens—is for all countries to base their policies on global estimates of damages. As a member of the IWG involved in the development of the 
                        <PRTPAGE P="34331"/>
                        February 2021 SC-GHG TSD, DOE agrees with this assessment and, therefore, in this rule DOE centers attention on a global measure of SC-GHG. This approach is the same as that taken in DOE regulatory analyses from 2012 through 2016. A robust estimate of climate damages that accrue only to U.S. citizens and residents does not currently exist in the literature. As explained in the February 2021 TSD, existing estimates are both incomplete and an underestimate of total damages that accrue to the citizens and residents of the United States because they do not fully capture the regional interactions and spillovers discussed above, nor do they include all of the important physical, ecological, and economic impacts of climate change recognized in the climate change literature. As noted in the February 2021 SC-GHG TSD, the IWG will continue to review developments in the literature, including more robust methodologies for estimating a U.S.-specific SC-GHG value, and explore ways to better inform the public of the full range of carbon impacts. As a member of the IWG, DOE will continue to follow developments in the literature pertaining to this issue.
                    </P>
                    <P>
                        Second, the IWG found that the use of the social rate of return on capital (7 percent under current OMB Circular A-4 guidance) to discount the future benefits of reducing GHG emissions inappropriately underestimates the impacts of climate change for the purposes of estimating the SC-GHG. Consistent with the findings of the National Academies (2017) and the economic literature, the IWG continued to conclude that the consumption rate of interest is the theoretically appropriate discount rate in an intergenerational context,
                        <SU>60</SU>
                        <FTREF/>
                         and recommended that discount rate uncertainty and relevant aspects of intergenerational ethical considerations be accounted for in selecting future discount rates.
                    </P>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             Interagency Working Group on Social Cost of Carbon. Social Cost of Carbon for Regulatory Impact Analysis under Executive Order 12866. 2010. United States Government. (Last accessed April 15, 2022.) 
                            <E T="03">www.epa.gov/sites/default/files/2016-12/documents/scc_tsd_2010.pdf;</E>
                             Interagency Working Group on Social Cost of Carbon. Technical Update of the Social Cost of Carbon for Regulatory Impact Analysis Under Executive Order No. 12866. 2013. (Last accessed April 15, 2022.) 78 FR 70586, November 26, 2013, 
                            <E T="03">www.federalregister.gov/documents/2013/11/26/2013-28242/technical-support-document-technical-update-of-the-social-cost-of-carbon-for-regulatory-impact;</E>
                             Interagency Working Group on Social Cost of Greenhouse Gases, United States Government. Technical Support Document: Technical Update on the Social Cost of Carbon for Regulatory Impact Analysis-Under Executive Order 12866. August 2016. (Last accessed January 18, 2022.) 
                            <E T="03">www.epa.gov/sites/default/files/2016-12/documents/sc_co2_tsd_august_2016.pdf;</E>
                             Interagency Working Group on Social Cost of Greenhouse Gases, United States Government. Addendum to Technical Support Document on Social Cost of Carbon for Regulatory Impact Analysis under Executive Order 12866: Application of the Methodology to Estimate the Social Cost of Methane and the Social Cost of Nitrous Oxide. August 2016. (Last accessed January 18, 2022.) 
                            <E T="03">www.epa.gov/sites/default/files/2016-12/documents/addendum_to_sc-ghg_tsd_august_2016.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Furthermore, the damage estimates developed for use in the SC-GHG are estimated in consumption-equivalent terms, and so an application of OMB Circular A-4's guidance for regulatory analysis would then use the consumption discount rate to calculate the SC-GHG. DOE agrees with this assessment and will continue to follow developments in the literature pertaining to this issue. DOE also notes that while OMB Circular A-4, as published in 2003, recommends using 3 percent and 7 percent discount rates as “default” values, Circular A-4 also reminds agencies that “different regulations may call for different emphases in the analysis, depending on the nature and complexity of the regulatory issues and the sensitivity of the benefit and cost estimates to the key assumptions.” On discounting, Circular A-4 recognizes that “special ethical considerations arise when comparing benefits and costs across generations,” and Circular A-4 acknowledges that analyses may appropriately “discount future costs and consumption benefits . . . at a lower rate than for intragenerational analysis.” In the 2015 Response to Comments on the Social Cost of Carbon for Regulatory Impact Analysis (“RIA”), OMB, DOE, and the other IWG members recognized that “Circular A-4 is a living document” and “the use of 7 percent is not considered appropriate for intergenerational discounting. There is wide support for this view in the academic literature, and it is recognized in Circular A-4 itself.” Thus, DOE concludes that a 7% discount rate is not appropriate to apply to value the social cost of greenhouse gases in the analysis presented in this analysis.</P>
                    <P>
                        To calculate the present and annualized values of climate benefits, DOE uses the same discount rate as the rate used to discount the value of damages from future GHG emissions, for internal consistency. That approach to discounting follows the same approach that the February 2021 TSD recommends “to ensure internal consistency—
                        <E T="03">i.e.,</E>
                         future damages from climate change using the SC-GHG at 2.5 percent should be discounted to the base year of the analysis using the same 2.5 percent rate.” DOE has also consulted the National Academies' 2017 recommendations on how SC-GHG estimates can “be combined in RIAs with other cost and benefits estimates that may use different discount rates.” The National Academies reviewed several options, including “presenting all discount rate combinations of other costs and benefits with [SC-GHG] estimates.”
                    </P>
                    <P>As a member of the IWG involved in the development of the February 2021 SC-GHG TSD, DOE agrees with the above assessment and will continue to follow developments in the literature pertaining to this issue. While the IWG works to assess how best to incorporate the latest, peer reviewed science to develop an updated set of SC-GHG estimates, it set the interim estimates to be the most recent estimates developed by the IWG prior to the group being disbanded in 2017. The estimates rely on the same models and harmonized inputs and are calculated using a range of discount rates. As explained in the February 2021 SC-GHG TSD, the IWG has recommended that agencies revert to the same set of four values drawn from the SC-GHG distributions based on three discount rates as were used in regulatory analyses between 2010 and 2016 and were subject to public comment. For each discount rate, the IWG combined the distributions across models and socioeconomic emissions scenarios (applying equal weight to each) and then selected a set of four values recommended for use in benefit-cost analyses: an average value resulting from the model runs for each of three discount rates (2.5 percent, 3 percent, and 5 percent), plus a fourth value, selected as the 95th percentile of estimates based on a 3 percent discount rate. The fourth value was included to provide information on potentially higher-than-expected economic impacts from climate change. As explained in the February 2021 SC-GHG TSD, and DOE agrees, this update reflects the immediate need to have an operational SC-GHG for use in regulatory benefit-cost analyses and other applications that was developed using a transparent process, peer-reviewed methodologies, and the science available at the time of that process. Those estimates were subject to public comment in the context of dozens of proposed rulemakings as well as in a dedicated public comment period in 2013.</P>
                    <P>
                        There are a number of limitations and uncertainties associated with the SC-GHG estimates. First, the current scientific and economic understanding of discounting approaches suggests discount rates appropriate for intergenerational analysis in the context of climate change are likely to be less 
                        <PRTPAGE P="34332"/>
                        than 3 percent, near 2 percent or lower.
                        <SU>61</SU>
                        <FTREF/>
                         Second, the IAMs used to produce these interim estimates do not include all of the important physical, ecological, and economic impacts of climate change recognized in the climate change literature and the science underlying their “damage functions”—
                        <E T="03">i.e.,</E>
                         the core parts of the IAMs that map global mean temperature changes and other physical impacts of climate change into economic (both market and nonmarket) damages—lags behind the most recent research. For example, limitations include the incomplete treatment of catastrophic and non-catastrophic impacts in the integrated assessment models, their incomplete treatment of adaptation and technological change, the incomplete way in which inter-regional and intersectoral linkages are modeled, uncertainty in the extrapolation of damages to high temperatures, and inadequate representation of the relationship between the discount rate and uncertainty in economic growth over long time horizons. Likewise, the socioeconomic and emissions scenarios used as inputs to the models do not reflect new information from the last decade of scenario generation or the full range of projections. The modeling limitations do not all work in the same direction in terms of their influence on the SC-CO
                        <E T="52">2</E>
                         estimates. However, as discussed in the February 2021 TSD, the IWG has recommended that, taken together, the limitations suggest that the interim SC-GHG estimates used in this final rule likely underestimate the damages from GHG emissions. DOE concurs with this assessment.
                    </P>
                    <FTNT>
                        <P>
                            <SU>61</SU>
                             Interagency Working Group on Social Cost of Greenhouse Gases (IWG). 2021. Technical Support Document: Social Cost of Carbon, Methane, and Nitrous Oxide Interim Estimates under Executive Order 13990. February. United States Government. Available at: 
                            <E T="03">www.whitehouse.gov/briefing-room/blog/2021/02/26/a-return-to-science-evidence-based-estimates-of-the-benefits-of-reducing-climate-pollution/.</E>
                        </P>
                    </FTNT>
                    <P>
                        AHAM objected to DOE using the social cost of carbon and other monetization of emissions reductions benefits in its analysis of the factors EPCA requires DOE to balance to determine the appropriate standard. AHAM stated that while it may be acceptable for DOE to continue its current practice of examining the social cost of carbon and monetization of other emissions reductions benefits as informational so long as the underlying interagency analysis is transparent and vigorous, the monetization analysis should not impact the TSLs DOE selects as a new or amended standard. AHAM noted that the scientific and economic knowledge surrounding the contribution of CO
                        <E T="52">2</E>
                         and other greenhouse gases to climate change is an upgoing field of study and monetization values are subject to change. AHAM further commented that it was unclear whether DOE relied upon the emissions monetization analysis when proposing a TSL. (AHAM, No. 43 at pp. 29-30)
                    </P>
                    <P>
                        As stated in section III.E.1.f of this document, DOE maintains that environmental and public health benefits associated with the more efficient use of energy, including those connected to global climate change, are important to take into account when considering the need for national energy conservation, which is one of the factors that EPCA requires DOE to evaluate in determining whether a potential energy conservation standard is economically justified. (42 U.S.C. 6295(o)(2)(B)(i)(VI)) In addition, Executive Order 13563, which was re-affirmed on January 20, 2021, states that each agency must, among other things: “select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity).” 
                        <SU>62</SU>
                        <FTREF/>
                         E.O. 13563, section 1(b). For these reasons, DOE includes monetized emissions reductions in its evaluation of potential standard levels. As previously stated, however, DOE would reach the same conclusion presented in this final rule in the absence of the social cost of greenhouse gases.
                    </P>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             
                            <E T="03">www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/modernizing-regulatory-review/.</E>
                        </P>
                    </FTNT>
                    <P>The Climate Commenters stated that DOE appropriately applies the social cost estimates developed by the Interagency Working Group on the Social Cost of Greenhouse Gases to its analysis of emissions reduction benefits generated by the proposed rule. They stated that DOE should expand upon its rationale for adopting a global damages valuation and for the range of discount rates it applies to climate effects, as there are additional legal, economic, and policy reasons for such methodological decisions that can further bolster DOE's support for these choices. They added that DOE should consider conducting sensitivity analysis using a sound domestic-only social cost estimate as a backstop, and should explicitly conclude that the rule is cost-benefit justified even using a domestic-only valuation that may still undercount climate benefits. They also urged DOE to consider providing additional sensitivity analysis using discount rates lower than 2.5 percent for climate impacts. (Climate Commenters, No. 51 at pp. 1-2)</P>
                    <P>In response, DOE maintains that the reasons for using global measures of the SC-GHG previously discussed are sufficient for the purposes of this rulemaking. DOE notes that further discussion of this topic is contained in the February 2021 SC-GHG TSD, and DOE agrees with the assessment therein. Regarding conducting sensitivity analysis using a domestic-only social cost estimate, DOE agrees with the assessment in the February 2021 SC-GHG TSD that the only currently-available quantitative characterization of domestic damages from GHG emissions is both incomplete and an underestimate of the share of total damages that accrue to the citizens and residents of the United States. Therefore, it would be of questionable value to conduct the suggested sensitivity analysis at this time. DOE considered performing sensitivity analysis using discount rates lower than 2.5 percent for climate impacts, as suggested by the IWG, but it concluded that such analysis would not add meaningful information or impact the rationale in the context of this rulemaking.</P>
                    <P>
                        The Climate Commenters also stated that DOE should provide additional justification for combining climate effects discounted at an appropriate consumption-based discount rate with other costs and benefits discounted at a capital-based rate (
                        <E T="03">i.e.,</E>
                         7%).
                        <SU>63</SU>
                        <FTREF/>
                         (Climate Commenters, No. 51 at p. 2) The reasons for using consumption-based discount rates for future climate effects were discussed previously, and are further elaborated in the February 2021 SC-GHG TSD. Combining climate benefits with health benefits and consumer economic benefits is in keeping with the guidance of OMB Circular A-4 to count all significant costs and benefits. DOE is aware that there are different approaches to combining climate benefits with other cost and benefits estimates that may use different discount rates, and the approach applied in this document (as well as in numerous other past DOE rulemaking actions) is among those discussed in the National Academies 2017 report (p. 182).
                        <SU>64</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             In several places in this final rule (
                            <E T="03">e.g.,</E>
                             Tables I-3 and I-4), the climate benefits of potential standards are combined with other benefits and costs that are discounted at rates of 3% and 7%, based on OMB Circular A-4 guidance.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                             National Academies of Sciences, Engineering, and Medicine. 
                            <E T="03">Valuing Climate Damages: Updating Estimation of the Social Cost of Carbon Dioxide.</E>
                             2017. The National Academies Press: Washington, 
                            <PRTPAGE/>
                            DC. Available at 
                            <E T="03">https://nap.nationalacademies.org/catalog/24651/valuing-climate-damages-updating-estimation-of-the-social-cost-of.</E>
                        </P>
                    </FTNT>
                    <PRTPAGE P="34333"/>
                    <P>
                        DOE's derivations of the SC-CO
                        <E T="52">2</E>
                        , SC-N
                        <E T="52">2</E>
                        O, and SC-CH
                        <E T="52">4</E>
                         values used for this final rule are discussed in the following sections, and the results of DOE's analyses estimating the benefits of the reductions in emissions of these pollutants are presented in section V.B.6 of this document.
                    </P>
                    <HD SOURCE="HD3">a. Social Cost of Carbon</HD>
                    <P>
                        The SC-CO
                        <E T="52">2</E>
                         values used for this final rule were based on the values developed for the IWG's February 2021 TSD. Table IV.8 shows the updated sets of SC-CO
                        <E T="52">2</E>
                         estimates from the IWG's TSD in 5-year increments from 2020 to 2050. The full set of annual values that DOE used is presented in appendix 14A of the final rule TSD. For purposes of capturing the uncertainties involved in regulatory impact analysis, DOE has determined it is appropriate to include all four sets of SC-CO
                        <E T="52">2</E>
                         values, as recommended by the IWG.
                        <SU>65</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             For example, the February 2021 TSD discusses how the understanding of discounting approaches suggests that discount rates appropriate for intergenerational analysis in the context of climate change may be lower than 3 percent.
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,15">
                        <TTITLE>
                            Table IV.8—Annual SC-CO
                            <E T="0732">2</E>
                             Values From 2021 Interagency Update, 2020-2050
                        </TTITLE>
                        <TDESC>
                            [2020$ per metric ton CO
                            <E T="0732">2</E>
                            ]
                        </TDESC>
                        <BOXHD>
                            <CHED H="1">Year</CHED>
                            <CHED H="1">Discount rate</CHED>
                            <CHED H="2">5%</CHED>
                            <CHED H="3">Average</CHED>
                            <CHED H="2">3%</CHED>
                            <CHED H="3">Average</CHED>
                            <CHED H="2">2.5%</CHED>
                            <CHED H="3">Average</CHED>
                            <CHED H="2">3%</CHED>
                            <CHED H="3">95th percentile</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">2020</ENT>
                            <ENT>14</ENT>
                            <ENT>51</ENT>
                            <ENT>76</ENT>
                            <ENT>152</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2025</ENT>
                            <ENT>17</ENT>
                            <ENT>56</ENT>
                            <ENT>83</ENT>
                            <ENT>169</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2030</ENT>
                            <ENT>19</ENT>
                            <ENT>62</ENT>
                            <ENT>89</ENT>
                            <ENT>187</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2035</ENT>
                            <ENT>22</ENT>
                            <ENT>67</ENT>
                            <ENT>96</ENT>
                            <ENT>206</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2040</ENT>
                            <ENT>25</ENT>
                            <ENT>73</ENT>
                            <ENT>103</ENT>
                            <ENT>225</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2045</ENT>
                            <ENT>28</ENT>
                            <ENT>79</ENT>
                            <ENT>110</ENT>
                            <ENT>242</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2050</ENT>
                            <ENT>32</ENT>
                            <ENT>85</ENT>
                            <ENT>116</ENT>
                            <ENT>260</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        For 2051 to 2070, DOE used SC-CO
                        <E T="52">2</E>
                         estimates published by EPA, adjusted to 2021$.
                        <SU>66</SU>
                        <FTREF/>
                         These estimates are based on methods, assumptions, and parameters identical to the 2020-2050 estimates published by the IWG. DOE expects additional climate benefits to accrue for any longer-life room air conditioners after 2070, but a lack of available SC-CO
                        <E T="52">2</E>
                         estimates for emissions years beyond 2070 prevents DOE from monetizing these potential benefits in this analysis.
                    </P>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             See EPA, Revised 2023 and Later Model Year Light-Duty Vehicle GHG Emissions Standards: Regulatory Impact Analysis, Washington, DC, December 2021. Available at: 
                            <E T="03">www.epa.gov/system/files/documents/2021-12/420r21028.pdf</E>
                             (last accessed September 12, 2022).
                        </P>
                    </FTNT>
                    <P>
                        DOE multiplied the CO
                        <E T="52">2</E>
                         emissions reduction estimated for each year by the SC-CO
                        <E T="52">2</E>
                         value for that year in each of the four cases. DOE adjusted the values to 2021$ using the implicit price deflator for gross domestic product (“GDP”) from the Bureau of Economic Analysis. To calculate a present value of the stream of monetary values, DOE discounted the values in each of the four cases using the specific discount rate that had been used to obtain the SC-CO
                        <E T="52">2</E>
                         values in each case.
                    </P>
                    <HD SOURCE="HD3">b. Social Cost of Methane and Nitrous Oxide</HD>
                    <P>
                        The SC-CH
                        <E T="52">4</E>
                         and SC-N
                        <E T="52">2</E>
                        O values used for this final rule were based on the values presented in the February 2021 TSD. Table IV.9 shows the updated sets of SC-CH
                        <E T="52">4</E>
                         and SC-N
                        <E T="52">2</E>
                        O estimates from the latest interagency update in 5-year increments from 2020 to 2050. The full set of annual values used is presented in appendix 14A of the final rule TSD. To capture the uncertainties involved in regulatory impact analysis, DOE has determined it is appropriate to include all four sets of SC-CH
                        <E T="52">4</E>
                         and SC-N
                        <E T="52">2</E>
                        O values, as recommended by the IWG. DOE derived values after 2050 using the approach described above for the SC-CO
                        <E T="52">2.</E>
                    </P>
                    <GPOTABLE COLS="9" OPTS="L2,i1" CDEF="s25,8,8,8,10,8,8,8,10">
                        <TTITLE>
                            Table IV.9—Annual SC-CH
                            <E T="0732">4</E>
                             and SC-N
                            <E T="0732">2</E>
                            O Values From 2021 Interagency Update, 2020-2050 
                        </TTITLE>
                        <TDESC>[2020$ per metric ton]</TDESC>
                        <BOXHD>
                            <CHED H="1">Year</CHED>
                            <CHED H="1">
                                SC-CH
                                <E T="0732">4</E>
                            </CHED>
                            <CHED H="2">Discount rate and statistic</CHED>
                            <CHED H="3">5%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">3%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">2.5%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">3%</CHED>
                            <CHED H="4">
                                95th 
                                <LI>percentile</LI>
                            </CHED>
                            <CHED H="1">
                                SC-N
                                <E T="0732">2</E>
                                O
                            </CHED>
                            <CHED H="2">Discount rate and statistic</CHED>
                            <CHED H="3">5%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">3%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">2.5%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">3%</CHED>
                            <CHED H="4">
                                95th 
                                <LI>percentile</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">2020</ENT>
                            <ENT>670</ENT>
                            <ENT>1500</ENT>
                            <ENT>2000</ENT>
                            <ENT>3900</ENT>
                            <ENT>5800</ENT>
                            <ENT>18000</ENT>
                            <ENT>27000</ENT>
                            <ENT>48000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2025</ENT>
                            <ENT>800</ENT>
                            <ENT>1700</ENT>
                            <ENT>2200</ENT>
                            <ENT>4500</ENT>
                            <ENT>6800</ENT>
                            <ENT>21000</ENT>
                            <ENT>30000</ENT>
                            <ENT>54000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2030</ENT>
                            <ENT>940</ENT>
                            <ENT>2000</ENT>
                            <ENT>2500</ENT>
                            <ENT>5200</ENT>
                            <ENT>7800</ENT>
                            <ENT>23000</ENT>
                            <ENT>33000</ENT>
                            <ENT>60000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2035</ENT>
                            <ENT>1100</ENT>
                            <ENT>2200</ENT>
                            <ENT>2800</ENT>
                            <ENT>6000</ENT>
                            <ENT>9000</ENT>
                            <ENT>25000</ENT>
                            <ENT>36000</ENT>
                            <ENT>67000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2040</ENT>
                            <ENT>1300</ENT>
                            <ENT>2500</ENT>
                            <ENT>3100</ENT>
                            <ENT>6700</ENT>
                            <ENT>10000</ENT>
                            <ENT>28000</ENT>
                            <ENT>39000</ENT>
                            <ENT>74000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2045</ENT>
                            <ENT>1500</ENT>
                            <ENT>2800</ENT>
                            <ENT>3500</ENT>
                            <ENT>7500</ENT>
                            <ENT>12000</ENT>
                            <ENT>30000</ENT>
                            <ENT>42000</ENT>
                            <ENT>81000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2050</ENT>
                            <ENT>1700</ENT>
                            <ENT>3100</ENT>
                            <ENT>3800</ENT>
                            <ENT>8200</ENT>
                            <ENT>13000</ENT>
                            <ENT>33000</ENT>
                            <ENT>45000</ENT>
                            <ENT>88000</ENT>
                        </ROW>
                    </GPOTABLE>
                    <PRTPAGE P="34334"/>
                    <P>
                        DOE multiplied the CH
                        <E T="52">4</E>
                         and N
                        <E T="52">2</E>
                        O emissions reduction estimated for each year by the SC-CH
                        <E T="52">4</E>
                         and SC-N
                        <E T="52">2</E>
                        O estimates for that year in each of the cases. DOE adjusted the values to 2021$ using the implicit price deflator for gross domestic product (“GDP”) from the Bureau of Economic Analysis. To calculate a present value of the stream of monetary values, DOE discounted the values in each of the cases using the specific discount rate that had been used to obtain the SC-CH
                        <E T="52">4</E>
                         and SC-N
                        <E T="52">2</E>
                        O estimates in each case.
                    </P>
                    <HD SOURCE="HD3">2. Monetization of Other Emissions Impacts</HD>
                    <P>
                        For the final rule, DOE estimated the monetized value of NO
                        <E T="52">X</E>
                         and SO
                        <E T="52">2</E>
                         emissions reductions from electricity generation using benefit per ton estimates for that sector from the EPA's Benefits Mapping and Analysis Program.
                        <SU>67</SU>
                        <FTREF/>
                         DOE used EPA's values for PM
                        <E T="52">2.5</E>
                        -related benefits associated with NO
                        <E T="52">X</E>
                         and SO
                        <E T="52">2</E>
                         and for ozone-related benefits associated with NO
                        <E T="52">X</E>
                         for 2025 and 2030, and 2040, calculated with discount rates of 3 percent and 7 percent. DOE used linear interpolation to define values for the years not given in the 2025 to 2040 range; for years beyond 2040 the values are held constant. DOE derived values specific to the sector for room air conditioners using a method described in appendix 14B of the final rule TSD.
                    </P>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             Estimating the Benefit per Ton of Reducing PM
                            <E T="52">2.5</E>
                             Precursors from 21 Sectors. 
                            <E T="03">www.epa.gov/benmap/estimating-benefit-ton-reducing-pm25-precursors-21-sectors.</E>
                        </P>
                    </FTNT>
                    <P>DOE multiplied the site emissions reduction (in tons) in each year by the associated $/ton values, and then discounted each series using discount rates of 3 percent and 7 percent as appropriate.</P>
                    <HD SOURCE="HD2">M. Utility Impact Analysis</HD>
                    <P>
                        The utility impact analysis estimates several effects on the electric power generation industry that would result from the adoption of new or amended energy conservation standards. The utility impact analysis estimates the changes in installed electrical capacity and generation that would result for each TSL. The analysis is based on published output from the NEMS associated with 
                        <E T="03">AEO2022.</E>
                         NEMS produces the 
                        <E T="03">AEO</E>
                         Reference case, as well as a number of side cases that estimate the economy-wide impacts of changes to energy supply and demand. For the current analysis, impacts are quantified by comparing the levels of electricity sector generation, installed capacity, fuel consumption and emissions in the 
                        <E T="03">AEO2022</E>
                         Reference case and various side cases. Details of the methodology are provided in the appendices to chapters 13 and 15 of the final rule TSD.
                    </P>
                    <P>The output of this analysis is a set of time-dependent coefficients that capture the change in electricity generation, primary fuel consumption, installed capacity and power sector emissions due to a unit reduction in demand for a given end use. These coefficients are multiplied by the stream of electricity savings calculated in the NIA to provide estimates of selected utility impacts of potential new or amended energy conservation standards.</P>
                    <HD SOURCE="HD2">N. Employment Impact Analysis</HD>
                    <P>DOE considers employment impacts in the domestic economy as one factor in selecting a standard. Employment impacts from new or amended energy conservation standards include both direct and indirect impacts. Direct employment impacts are any changes in the number of employees of manufacturers of the products subject to standards. The MIA addresses those impacts. Indirect employment impacts are changes in national employment that occur due to the shift in expenditures and capital investment caused by the purchase and operation of more-efficient appliances. Indirect employment impacts from standards consist of the net jobs created or eliminated in the national economy, other than in the manufacturing sector being regulated, caused by (1) reduced spending by consumers on energy, (2) reduced spending on new energy supply by the utility industry, (3) increased consumer spending on the products to which the new standards apply and other goods and services, and (4) the effects of those three factors throughout the economy.</P>
                    <P>
                        One method for assessing the possible effects on the demand for labor of such shifts in economic activity is to compare sector employment statistics developed by the Labor Department's BLS. BLS regularly publishes its estimates of the number of jobs per million dollars of economic activity in different sectors of the economy, as well as the jobs created elsewhere in the economy by this same economic activity. Data from BLS indicate that expenditures in the utility sector generally create fewer jobs (both directly and indirectly) than expenditures in other sectors of the economy.
                        <SU>68</SU>
                        <FTREF/>
                         There are many reasons for these differences, including wage differences and the fact that the utility sector is more capital-intensive and less labor-intensive than other sectors. Energy conservation standards have the effect of reducing consumer utility bills. Because reduced consumer expenditures for energy likely lead to increased expenditures in other sectors of the economy, the general effect of efficiency standards is to shift economic activity from a less labor-intensive sector (
                        <E T="03">i.e.,</E>
                         the utility sector) to more labor-intensive sectors (
                        <E T="03">e.g.,</E>
                         the retail and service sectors). Thus, the BLS data suggest that net national employment may increase due to shifts in economic activity resulting from energy conservation standards.
                    </P>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             
                            <E T="03">See</E>
                             U.S. Department of Commerce-Bureau of Economic Analysis. 
                            <E T="03">Regional Multipliers: A User Handbook for the Regional Input-Output Modeling System (“RIMS II”).</E>
                             1997. U.S. Government Printing Office: Washington, DC. Available at 
                            <E T="03">www.bea.gov/scb/pdf/regional/perinc/meth/rims2.pdf</E>
                             (last accessed July 1, 2021).
                        </P>
                    </FTNT>
                    <P>
                        DOE estimated indirect national employment impacts for the standard levels considered in this final rule using an input/output model of the U.S. economy called Impact of Sector Energy Technologies version 4 (“ImSET”).
                        <SU>69</SU>
                        <FTREF/>
                         ImSET is a special-purpose version of the “U.S. Benchmark National Input-Output” (“I-O”) model, which was designed to estimate the national employment and income effects of energy-saving technologies. The ImSET software includes a computer- based I-O model having structural coefficients that characterize economic flows among 187 sectors most relevant to industrial, commercial, and residential building energy use.
                    </P>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             Livingston, O.V., S.R. Bender, M.J. Scott, and R.W. Schultz. 
                            <E T="03">ImSET 4.0: Impact of Sector Energy Technologies Model Description and User's Guide.</E>
                             2015. Pacific Northwest National Laboratory: Richland, WA. PNNL-24563.
                        </P>
                    </FTNT>
                    <P>DOE notes that ImSET is not a general equilibrium forecasting model, and that the uncertainties involved in projecting employment impacts, especially changes in the later years of the analysis. Because ImSET does not incorporate price changes, the employment effects predicted by ImSET may over-estimate actual job impacts over the long run for this rule. Therefore, DOE used ImSET only to generate results for near-term timeframes (2026-2030), where these uncertainties are reduced. For more details on the employment impact analysis, see chapter 16 of the final rule TSD.</P>
                    <HD SOURCE="HD1">V. Analytical Results and Conclusions</HD>
                    <P>
                        The following section addresses the results from DOE's analyses with respect to the considered energy conservation standards for room air conditioners. It addresses the TSLs examined by DOE, the projected 
                        <PRTPAGE P="34335"/>
                        impacts of each of these levels if adopted as energy conservation standards for room air conditioners, and the standards levels that DOE is adopting in this final rule. Additional details regarding DOE's analyses are contained in the final rule TSD supporting this document.
                    </P>
                    <HD SOURCE="HD2">A. Trial Standard Levels</HD>
                    <P>In general, DOE typically evaluates potential amended standards for products and equipment by grouping individual efficiency levels for each class into TSLs. Use of TSLs allows DOE to identify and consider manufacturer cost interactions between the product classes, to the extent that there are such interactions, and market cross elasticity from consumer purchasing decisions that may change when different standard levels are set.</P>
                    <P>In the analysis conducted for this final rule, DOE analyzed the benefits and burdens of five TSLs for room air conditioners. DOE maintained the same TSL structure as proposed in the NOPR. TSL 5 represents the max-tech energy efficiency for all product classes and corresponds to EL 5. TSL 4 corresponds to EL 4 for all product classes, consistent with the implementation of commercially available variable-speed compressors based on the current availability of variable speed compressors at cooling capacities ≥8,000 Btu/h. However, as of 2022, there are no models commercially available that incorporate variable-speed compressors for cooling capacities less than 8,000 Btu/h, and the uncertainties of the possibilities of incorporating variable-speed compressors in smaller units may have the potential to eliminate room air conditioners with the smallest cooling capacities from the market. TSL 3, therefore, is constructed with EL 4 for product classes with cooling capacities ≥8,000 Btu/h, corresponding to the inclusion of commercially available variable-speed compressors, and EL 3 for cooling capacities &lt;8,000 Btu/h, corresponding to the incorporation of maximum energy efficient single-speed compressors. TSL 2 corresponds to EL 3 for all product classes and represents room air conditioners with the maximum energy efficient single-speed compressor. TSL 1 corresponds to EL 2 for all product classes and represents the current ENERGY STAR level. DOE presents the results for the TSLs in this document, while the results for all efficiency levels that DOE analyzed are in the final rule TSD. DOE presents the results for the TSLs in this document, while the results for all efficiency levels that DOE analyzed are in the final rule TSD.</P>
                    <P>Table V.1 presents the TSLs and the corresponding efficiency levels that DOE has identified for potential amended energy conservation standards for room air conditioners.</P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,8,8,8,8,8">
                        <TTITLE>Table V.1—Trial Standard Levels for Room Air Conditioners</TTITLE>
                        <BOXHD>
                            <CHED H="1">Product class</CHED>
                            <CHED H="1">TSL 1</CHED>
                            <CHED H="1">TSL 2</CHED>
                            <CHED H="1">TSL 3</CHED>
                            <CHED H="1">TSL 4</CHED>
                            <CHED H="1">TSL 5</CHED>
                        </BOXHD>
                        <ROW RUL="n,s">
                            <ENT I="25"> </ENT>
                            <ENT A="04">CEER (Btu/Wh)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Room Air Conditioner without reverse cycle, with louvered sides:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">&lt;6,000 Btu/h (PC 1)</ENT>
                            <ENT>12.1</ENT>
                            <ENT>13.1</ENT>
                            <ENT>13.1</ENT>
                            <ENT>16.0</ENT>
                            <ENT>20.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">6,000 to 7,900 Btu/h (PC 2)</ENT>
                            <ENT>12.1</ENT>
                            <ENT>13.7</ENT>
                            <ENT>13.7</ENT>
                            <ENT>16.0</ENT>
                            <ENT>21.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">8,000 to 13,900 Btu/h (PC 3)</ENT>
                            <ENT>12.0</ENT>
                            <ENT>14.3</ENT>
                            <ENT>16.0</ENT>
                            <ENT>16.0</ENT>
                            <ENT>21.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">14,000 to 19,900 Btu/h (PC 4)</ENT>
                            <ENT>11.8</ENT>
                            <ENT>14.0</ENT>
                            <ENT>16.0</ENT>
                            <ENT>16.0</ENT>
                            <ENT>19.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">20,000 to 27,900 Btu/h (PC 5a)</ENT>
                            <ENT>10.3</ENT>
                            <ENT>11.8</ENT>
                            <ENT>13.8</ENT>
                            <ENT>13.8</ENT>
                            <ENT>18.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≥28,000 Btu/h (PC 5b)</ENT>
                            <ENT>9.9</ENT>
                            <ENT>10.3</ENT>
                            <ENT>13.2</ENT>
                            <ENT>13.2</ENT>
                            <ENT>16.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Room Air Conditioner without reverse cycle, without louvered sides:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">&lt;6,000 Btu/h (PC 6)</ENT>
                            <ENT>11.0</ENT>
                            <ENT>12.8</ENT>
                            <ENT>12.8</ENT>
                            <ENT>14.7</ENT>
                            <ENT>19.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">6,000 to 7,900 Btu/h (PC 7)</ENT>
                            <ENT>11.0</ENT>
                            <ENT>12.8</ENT>
                            <ENT>12.8</ENT>
                            <ENT>14.7</ENT>
                            <ENT>19.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">8,000 to 10,900 Btu/h (PC 8a)</ENT>
                            <ENT>10.6</ENT>
                            <ENT>12.3</ENT>
                            <ENT>14.1</ENT>
                            <ENT>14.1</ENT>
                            <ENT>18.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">11,000 to 13,900 Btu/h (PC 8b)</ENT>
                            <ENT>10.5</ENT>
                            <ENT>12.3</ENT>
                            <ENT>13.9</ENT>
                            <ENT>13.9</ENT>
                            <ENT>19.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">14,000 to 19,900 Btu/h (PC 9)</ENT>
                            <ENT>10.2</ENT>
                            <ENT>10.9</ENT>
                            <ENT>13.7</ENT>
                            <ENT>13.7</ENT>
                            <ENT>16.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≥20,000 Btu/h (PC 10)</ENT>
                            <ENT>10.3</ENT>
                            <ENT>11.0</ENT>
                            <ENT>13.8</ENT>
                            <ENT>13.8</ENT>
                            <ENT>17.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Room Air Conditioner with reverse cycle, with louvered sides:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">&lt;20,000 Btu/h (PC 11)</ENT>
                            <ENT>10.8</ENT>
                            <ENT>12.3</ENT>
                            <ENT>14.4</ENT>
                            <ENT>14.4</ENT>
                            <ENT>18.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≥20,000 Btu/h (PC 13)</ENT>
                            <ENT>10.2</ENT>
                            <ENT>11.7</ENT>
                            <ENT>13.7</ENT>
                            <ENT>13.7</ENT>
                            <ENT>18.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Room Air Conditioner with reverse cycle, without louvered sides:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">&lt;14,000 Btu/h (PC 12)</ENT>
                            <ENT>10.2</ENT>
                            <ENT>11.3</ENT>
                            <ENT>13.7</ENT>
                            <ENT>13.7</ENT>
                            <ENT>16.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≥14,000 Btu/h (PC 14)</ENT>
                            <ENT>9.6</ENT>
                            <ENT>11.2</ENT>
                            <ENT>12.8</ENT>
                            <ENT>12.8</ENT>
                            <ENT>17.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Casement:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Casement-Only (PC 15)</ENT>
                            <ENT>10.5</ENT>
                            <ENT>12.2</ENT>
                            <ENT>13.9</ENT>
                            <ENT>13.9</ENT>
                            <ENT>17.6</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Casement-Slide (PC 16)</ENT>
                            <ENT>11.4</ENT>
                            <ENT>13.2</ENT>
                            <ENT>15.3</ENT>
                            <ENT>15.3</ENT>
                            <ENT>19.1</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        DOE constructed the TSLs for this final rule to include ELs representative of ELs with similar characteristics (
                        <E T="03">i.e.,</E>
                         using similar technologies and/or efficiencies, and having roughly comparable equipment availability). The use of representative ELs provided for greater distinction between the TSLs. While representative ELs were included in the TSLs, DOE considered all efficiency levels as part of its analysis.
                        <SU>70</SU>
                        <FTREF/>
                         DOE did not consider a TSL with EL 1 because DOE's projected efficiency distribution indicated a significant portion of the market would meet or exceed EL 1 in the no-new-standards case by the compliance year leading to smaller national energy savings and lower LCC savings for a standard set at EL 1 relative to EL 2. As such, the least efficient level considered for TSLs in this final rule is EL 2.
                    </P>
                    <FTNT>
                        <P>
                            <SU>70</SU>
                             Efficiency levels that were analyzed for this NOPR are discussed in section IV.C.1 of this document. Results by efficiency level are presented in chapters 8, 10, and 12 of the final rule TSD.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Economic Justification and Energy Savings</HD>
                    <HD SOURCE="HD3">1. Economic Impacts on Individual Consumers</HD>
                    <P>
                        DOE analyzed the economic impacts on room air conditioners consumers by looking at the effects that potential amended standards at each TSL would have on the LCC and PBP. DOE also examined the impacts of potential standards on selected consumer subgroups. These analyses are discussed in the following sections.
                        <PRTPAGE P="34336"/>
                    </P>
                    <HD SOURCE="HD3">a. Life-Cycle Cost and Payback Period</HD>
                    <P>
                        In general, higher-efficiency products affect consumers in two ways: (1) purchase price increases and (2) annual operating costs decrease. Inputs used for calculating the LCC and PBP include total installed costs (
                        <E T="03">i.e.,</E>
                         product price plus installation costs), and operating costs (
                        <E T="03">i.e.,</E>
                         annual energy use, energy prices, energy price trends, repair costs, and maintenance costs). The LCC calculation also uses product lifetime and a discount rate. Chapter 8 of the final rule TSD provides detailed information on the LCC and PBP analyses.
                    </P>
                    <P>Tables V.2 through V.25 show the LCC and PBP results for the TSLs considered for each product class. In the first of each pair of tables, the simple payback is measured relative to the baseline product. In the second table, the impacts are measured relative to the efficiency distribution in the in the no-new-standards case in the compliance year (see section IV.F.8 of this document). Because some consumers purchase products with higher efficiency in the no-new-standards case, the average savings are less than the difference between the average LCC of the baseline product and the average LCC at each TSL. The savings refer only to consumers who are affected by a standard at a given TSL. Those who already purchase a product with efficiency at or above a given TSL are not affected. Consumers for whom the LCC increases at a given TSL experience a net cost.</P>
                    <GPOTABLE COLS="9" OPTS="L2,p7,7/8,i1" CDEF="s25,8,8,10,12,10,8,8,8">
                        <TTITLE>
                            Table V.2—Average LCC and PBP Results for Room Air Conditioners PC 1, Without Reverse Cycle and With Louvers, Less Than 6,000 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">EL</CHED>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Average costs (2021$)</CHED>
                            <CHED H="2">
                                Installed
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                First year's
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                Lifetime
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">LCC</CHED>
                            <CHED H="1">
                                Simple
                                <LI>payback</LI>
                                <LI>
                                    <E T="03">(years)</E>
                                </LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>lifetime</LI>
                                <LI>
                                    <E T="03">(years)</E>
                                </LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT/>
                            <ENT>11.0</ENT>
                            <ENT>419</ENT>
                            <ENT>64</ENT>
                            <ENT>486</ENT>
                            <ENT>906</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT/>
                            <ENT>11.4</ENT>
                            <ENT>421</ENT>
                            <ENT>63</ENT>
                            <ENT>474</ENT>
                            <ENT>895</ENT>
                            <ENT>1.0</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1</ENT>
                            <ENT>12.1</ENT>
                            <ENT>424</ENT>
                            <ENT>57</ENT>
                            <ENT>428</ENT>
                            <ENT>852</ENT>
                            <ENT>0.6</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>2,3</ENT>
                            <ENT>13.1</ENT>
                            <ENT>429</ENT>
                            <ENT>52</ENT>
                            <ENT>397</ENT>
                            <ENT>826</ENT>
                            <ENT>0.8</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>4</ENT>
                            <ENT>16.0</ENT>
                            <ENT>518</ENT>
                            <ENT>43</ENT>
                            <ENT>328</ENT>
                            <ENT>846</ENT>
                            <ENT>4.6</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>5</ENT>
                            <ENT>20.2</ENT>
                            <ENT>532</ENT>
                            <ENT>35</ENT>
                            <ENT>267</ENT>
                            <ENT>799</ENT>
                            <ENT>3.8</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             The results for each TSL are calculated assuming that all consumers use products at that efficiency level. The PBP is measured relative to the baseline product.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,20,24">
                        <TTITLE>
                            Table V.3—Average LCC Savings Relative to the No-New-Standards Case for Room Air Conditioners PC 1, Without Reverse Cycle and With Louvers, Less Than 6,000 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Life-cycle cost savings</CHED>
                            <CHED H="2">
                                Average LCC savings *
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="2">
                                Percent of consumers that
                                <LI>experience net cost</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01"> </ENT>
                            <ENT>11.4</ENT>
                            <ENT>1</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>12.1</ENT>
                            <ENT>41</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2, 3</ENT>
                            <ENT>13.1</ENT>
                            <ENT>65</ENT>
                            <ENT>3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>16.0</ENT>
                            <ENT>47</ENT>
                            <ENT>41</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>20.2</ENT>
                            <ENT>93</ENT>
                            <ENT>34</ENT>
                        </ROW>
                        <TNOTE>* The savings represent the average LCC for affected consumers.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="9" OPTS="L2,p7,7/8,i1" CDEF="s25,8,8,10,12,10,8,8,8">
                        <TTITLE>
                            Table V.4—Average LCC and PBP Results for Room Air Conditioners PC 2, Without Reverse Cycle and With Louvers, 6,000-7,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">EL</CHED>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Average costs (2021$)</CHED>
                            <CHED H="2">
                                Installed
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                First year's
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                Lifetime
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">LCC</CHED>
                            <CHED H="1">
                                Simple
                                <LI>payback</LI>
                                <LI>(years)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>lifetime</LI>
                                <LI>(years)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT/>
                            <ENT>11.0</ENT>
                            <ENT>437</ENT>
                            <ENT>82</ENT>
                            <ENT>635</ENT>
                            <ENT>1,072</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT/>
                            <ENT>11.4</ENT>
                            <ENT>440</ENT>
                            <ENT>80</ENT>
                            <ENT>614</ENT>
                            <ENT>1,054</ENT>
                            <ENT>1.0</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1</ENT>
                            <ENT>12.1</ENT>
                            <ENT>444</ENT>
                            <ENT>73</ENT>
                            <ENT>563</ENT>
                            <ENT>1,007</ENT>
                            <ENT>0.7</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>2,3</ENT>
                            <ENT>13.7</ENT>
                            <ENT>463</ENT>
                            <ENT>65</ENT>
                            <ENT>504</ENT>
                            <ENT>967</ENT>
                            <ENT>1.5</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>4</ENT>
                            <ENT>16.0</ENT>
                            <ENT>539</ENT>
                            <ENT>56</ENT>
                            <ENT>431</ENT>
                            <ENT>970</ENT>
                            <ENT>3.8</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>5</ENT>
                            <ENT>21.2</ENT>
                            <ENT>599</ENT>
                            <ENT>44</ENT>
                            <ENT>337</ENT>
                            <ENT>936</ENT>
                            <ENT>4.2</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             The results for each TSL are calculated assuming that all consumers use products at that efficiency level. The PBP is measured relative to the baseline product.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,20,24">
                        <TTITLE>
                            Table V.5—Average LCC Savings Relative to the No-New-Standards Case for Room Air Conditioners PC 2, Without Reverse Cycle and With Louvers, 6,000-7,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Life-cycle cost savings</CHED>
                            <CHED H="2">
                                Average LCC savings *
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="2">
                                Percent of consumers that
                                <LI>experience net cost</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01"> </ENT>
                            <ENT>11.4</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>12.1</ENT>
                            <ENT>35</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34337"/>
                            <ENT I="01">2, 3</ENT>
                            <ENT>13.7</ENT>
                            <ENT>72</ENT>
                            <ENT>14</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>16.0</ENT>
                            <ENT>69</ENT>
                            <ENT>38</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>21.2</ENT>
                            <ENT>103</ENT>
                            <ENT>42</ENT>
                        </ROW>
                        <TNOTE>* The savings represent the average LCC for affected consumers.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="9" OPTS="L2,p7,7/8,i1" CDEF="s25,8,8,10,12,10,8,8,8">
                        <TTITLE>
                            Table V.6—Average LCC and PBP Results for Room Air Conditioners PC 3, Without Reverse Cycle, With Louvered Sides, and 8,000-13,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">EL</CHED>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Average costs (2021$)</CHED>
                            <CHED H="2">
                                Installed
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                First year's
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                Lifetime
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">LCC</CHED>
                            <CHED H="1">
                                Simple
                                <LI>payback</LI>
                                <LI>(years)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>lifetime</LI>
                                <LI>(years)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT/>
                            <ENT>10.9</ENT>
                            <ENT>561</ENT>
                            <ENT>106</ENT>
                            <ENT>809</ENT>
                            <ENT>1,370</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT/>
                            <ENT>11.4</ENT>
                            <ENT>564</ENT>
                            <ENT>102</ENT>
                            <ENT>781</ENT>
                            <ENT>1,345</ENT>
                            <ENT>0.7</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1</ENT>
                            <ENT>12.0</ENT>
                            <ENT>576</ENT>
                            <ENT>93</ENT>
                            <ENT>710</ENT>
                            <ENT>1,287</ENT>
                            <ENT>1.2</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>2</ENT>
                            <ENT>14.3</ENT>
                            <ENT>584</ENT>
                            <ENT>79</ENT>
                            <ENT>603</ENT>
                            <ENT>1,187</ENT>
                            <ENT>0.9</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>3,4</ENT>
                            <ENT>16.0</ENT>
                            <ENT>669</ENT>
                            <ENT>69</ENT>
                            <ENT>524</ENT>
                            <ENT>1,193</ENT>
                            <ENT>2.9</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>5</ENT>
                            <ENT>21.9</ENT>
                            <ENT>727</ENT>
                            <ENT>51</ENT>
                            <ENT>394</ENT>
                            <ENT>1,122</ENT>
                            <ENT>3.1</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             The results for each TSL are calculated assuming that all consumers use products at that efficiency level. The PBP is measured relative to the baseline product.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,20,24">
                        <TTITLE>
                            Table V.7—Average LCC Savings Relative to the No-New-Standards Case for Room Air Conditioners PC 3, Without Reverse Cycle, With Louvered Sides, and 8,000-13,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Life-cycle cost savings</CHED>
                            <CHED H="2">
                                Average LCC savings *
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="2">
                                Percent of consumers that
                                <LI>experience net cost</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01"> </ENT>
                            <ENT>11.4</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>12.0</ENT>
                            <ENT>17</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>14.3</ENT>
                            <ENT>105</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3, 4</ENT>
                            <ENT>16.0</ENT>
                            <ENT>100</ENT>
                            <ENT>26</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>21.9</ENT>
                            <ENT>171</ENT>
                            <ENT>30</ENT>
                        </ROW>
                        <TNOTE>* The savings represent the average LCC for affected consumers.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="9" OPTS="L2,p7,7/8,i1" CDEF="s25,8,8,10,12,10,8,8,8">
                        <TTITLE>
                            Table V.8—Average LCC and PBP Results for Room Air Conditioners PC 4, Without Reverse Cycle and With Louvers, 14,000-19,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">EL</CHED>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Average costs (2021$)</CHED>
                            <CHED H="2">
                                Installed
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                First year's
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                Lifetime
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">LCC</CHED>
                            <CHED H="1">
                                Simple
                                <LI>payback</LI>
                                <LI>(years)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>lifetime</LI>
                                <LI>(years)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT/>
                            <ENT>10.7</ENT>
                            <ENT>703</ENT>
                            <ENT>121</ENT>
                            <ENT>921</ENT>
                            <ENT>1,623</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT/>
                            <ENT>11.1</ENT>
                            <ENT>705</ENT>
                            <ENT>118</ENT>
                            <ENT>896</ENT>
                            <ENT>1,601</ENT>
                            <ENT>0.7</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1</ENT>
                            <ENT>11.8</ENT>
                            <ENT>713</ENT>
                            <ENT>107</ENT>
                            <ENT>813</ENT>
                            <ENT>1,526</ENT>
                            <ENT>0.7</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>2</ENT>
                            <ENT>14.0</ENT>
                            <ENT>739</ENT>
                            <ENT>91</ENT>
                            <ENT>692</ENT>
                            <ENT>1,431</ENT>
                            <ENT>1.2</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>3,4</ENT>
                            <ENT>16.0</ENT>
                            <ENT>835</ENT>
                            <ENT>77</ENT>
                            <ENT>588</ENT>
                            <ENT>1,423</ENT>
                            <ENT>3.0</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>5</ENT>
                            <ENT>19.8</ENT>
                            <ENT>868</ENT>
                            <ENT>63</ENT>
                            <ENT>479</ENT>
                            <ENT>1,347</ENT>
                            <ENT>2.8</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             The results for each TSL are calculated assuming that all consumers use products at that efficiency level. The PBP is measured relative to the baseline product.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,20,24">
                        <TTITLE>
                            Table V.9—Average LCC Savings Relative to the No-New-Standards Case for Room Air Conditioners PC 4, Without Reverse Cycle and With Louvers, 14,000-19,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Life-cycle cost savings</CHED>
                            <CHED H="2">
                                Average LCC savings *
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="2">
                                Percent of consumers that
                                <LI>experience net cost</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01"> </ENT>
                            <ENT>11.1</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>11.8</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>14.0</ENT>
                            <ENT>85</ENT>
                            <ENT>9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3,4</ENT>
                            <ENT>16.0</ENT>
                            <ENT>92</ENT>
                            <ENT>33</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34338"/>
                            <ENT I="01">5</ENT>
                            <ENT>19.8</ENT>
                            <ENT>168</ENT>
                            <ENT>30</ENT>
                        </ROW>
                        <TNOTE>* The savings represent the average LCC for affected consumers.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="9" OPTS="L2,p7,7/8,i1" CDEF="s25,8,8,10,12,10,8,8,8">
                        <TTITLE>
                            Table V.10—Average LCC and PBP Results for Room Air Conditioners PC 5a, Without Reverse Cycle and With Louvers, 20,000-27,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">EL</CHED>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Average costs (2021$)</CHED>
                            <CHED H="2">
                                Installed
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                First year's
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                Lifetime
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">LCC</CHED>
                            <CHED H="1">
                                Simple
                                <LI>payback</LI>
                                <LI>(years)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>lifetime</LI>
                                <LI>(years)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT/>
                            <ENT>9.4</ENT>
                            <ENT>876</ENT>
                            <ENT>148</ENT>
                            <ENT>1,086</ENT>
                            <ENT>1,962</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT/>
                            <ENT>9.8</ENT>
                            <ENT>879</ENT>
                            <ENT>142</ENT>
                            <ENT>1,047</ENT>
                            <ENT>1,926</ENT>
                            <ENT>0.6</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1</ENT>
                            <ENT>10.3</ENT>
                            <ENT>893</ENT>
                            <ENT>132</ENT>
                            <ENT>969</ENT>
                            <ENT>1,862</ENT>
                            <ENT>1.1</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>2</ENT>
                            <ENT>11.8</ENT>
                            <ENT>909</ENT>
                            <ENT>115</ENT>
                            <ENT>849</ENT>
                            <ENT>1,758</ENT>
                            <ENT>1.0</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>3,4</ENT>
                            <ENT>13.8</ENT>
                            <ENT>1,014</ENT>
                            <ENT>93</ENT>
                            <ENT>688</ENT>
                            <ENT>1,703</ENT>
                            <ENT>2.5</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>5</ENT>
                            <ENT>18.7</ENT>
                            <ENT>1,057</ENT>
                            <ENT>69</ENT>
                            <ENT>511</ENT>
                            <ENT>1,567</ENT>
                            <ENT>2.3</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             The results for each TSL are calculated assuming that all consumers use products at that efficiency level. The PBP is measured relative to the baseline product.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,20,24">
                        <TTITLE>
                            Table V.11—Average LCC Savings Relative to the No-New-Standards Case for Room Air Conditioners PC 5a, Without Reverse Cycle and With Louvers, 20,000-27,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Life-cycle cost savings</CHED>
                            <CHED H="2">
                                Average LCC savings *
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="2">
                                Percent of consumers that
                                <LI>experience net cost</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01"> </ENT>
                            <ENT>9.8</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>10.3</ENT>
                            <ENT>6</ENT>
                            <ENT>1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>11.8</ENT>
                            <ENT>99</ENT>
                            <ENT>5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3,4</ENT>
                            <ENT>13.8</ENT>
                            <ENT>148</ENT>
                            <ENT>30</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>18.7</ENT>
                            <ENT>284</ENT>
                            <ENT>27</ENT>
                        </ROW>
                        <TNOTE>* The savings represent the average LCC for affected consumers.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="9" OPTS="L2,p7,7/8,i1" CDEF="s25,8,8,10,12,10,8,8,8">
                        <TTITLE>
                            Table V.12—Average LCC and PBP Results for Room Air Conditioners PCs 5b, Without Reverse Cycle and With Louvers, Greater Than 28,000 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">EL</CHED>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Average costs (2021$)</CHED>
                            <CHED H="2">
                                Installed
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                First year's
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                Lifetime
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">LCC</CHED>
                            <CHED H="1">
                                Simple
                                <LI>payback</LI>
                                <LI>(years)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>lifetime</LI>
                                <LI>(years)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT/>
                            <ENT>9.0</ENT>
                            <ENT>926</ENT>
                            <ENT>180</ENT>
                            <ENT>1,322</ENT>
                            <ENT>2,248</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT/>
                            <ENT>9.4</ENT>
                            <ENT>929</ENT>
                            <ENT>172</ENT>
                            <ENT>1,268</ENT>
                            <ENT>2,197</ENT>
                            <ENT>0.4</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1</ENT>
                            <ENT>9.9</ENT>
                            <ENT>935</ENT>
                            <ENT>159</ENT>
                            <ENT>1,170</ENT>
                            <ENT>2,105</ENT>
                            <ENT>0.4</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>2</ENT>
                            <ENT>10.3</ENT>
                            <ENT>939</ENT>
                            <ENT>151</ENT>
                            <ENT>1,114</ENT>
                            <ENT>2,053</ENT>
                            <ENT>0.5</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>3,4</ENT>
                            <ENT>13.2</ENT>
                            <ENT>1,080</ENT>
                            <ENT>113</ENT>
                            <ENT>833</ENT>
                            <ENT>1,912</ENT>
                            <ENT>2.3</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>5</ENT>
                            <ENT>16.3</ENT>
                            <ENT>1,106</ENT>
                            <ENT>91</ENT>
                            <ENT>675</ENT>
                            <ENT>1,781</ENT>
                            <ENT>2.0</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             The results for each TSL are calculated assuming that all consumers use products at that efficiency level. The PBP is measured relative to the baseline product.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,20,24">
                        <TTITLE>
                            Table V.13—Average LCC Savings Relative to the No-New-Standards Case for Room Air Conditioners PCs 5b, Without Reverse Cycle and With Louvers, Greater Than 28,000 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Life-cycle cost savings</CHED>
                            <CHED H="2">
                                Average LCC savings *
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="2">
                                Percent of consumers that
                                <LI>experience net cost</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01"> </ENT>
                            <ENT>9.4</ENT>
                            <ENT>21</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>9.9</ENT>
                            <ENT>101</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>10.3</ENT>
                            <ENT>150</ENT>
                            <ENT>1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3, 4</ENT>
                            <ENT>13.2</ENT>
                            <ENT>284</ENT>
                            <ENT>24</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>16.3</ENT>
                            <ENT>415</ENT>
                            <ENT>21</ENT>
                        </ROW>
                        <TNOTE>* The savings represent the average LCC for affected consumers.</TNOTE>
                    </GPOTABLE>
                    <PRTPAGE P="34339"/>
                    <GPOTABLE COLS="9" OPTS="L2,p7,7/8,i1" CDEF="s25,8,8,10,12,10,8,8,8">
                        <TTITLE>
                            Table V.14—Average LCC and PBP Results for Room Air Conditioners PC 8a, Without Reverse Cycle and Without Louvered Sides, 8,000-10,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">EL</CHED>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Average costs (2021$)</CHED>
                            <CHED H="2">
                                Installed
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                First year's
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                Lifetime
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">LCC</CHED>
                            <CHED H="1">
                                Simple
                                <LI>payback</LI>
                                <LI>(years)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>lifetime</LI>
                                <LI>(years)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT/>
                            <ENT>9.6</ENT>
                            <ENT>577</ENT>
                            <ENT>108</ENT>
                            <ENT>823</ENT>
                            <ENT>1,400</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT/>
                            <ENT>10.1</ENT>
                            <ENT>580</ENT>
                            <ENT>103</ENT>
                            <ENT>787</ENT>
                            <ENT>1,368</ENT>
                            <ENT>0.8</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1</ENT>
                            <ENT>10.6</ENT>
                            <ENT>584</ENT>
                            <ENT>96</ENT>
                            <ENT>731</ENT>
                            <ENT>1,316</ENT>
                            <ENT>0.6</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>2</ENT>
                            <ENT>12.3</ENT>
                            <ENT>611</ENT>
                            <ENT>83</ENT>
                            <ENT>634</ENT>
                            <ENT>1,245</ENT>
                            <ENT>1.4</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>3,4</ENT>
                            <ENT>14.1</ENT>
                            <ENT>695</ENT>
                            <ENT>71</ENT>
                            <ENT>539</ENT>
                            <ENT>1,234</ENT>
                            <ENT>3.2</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>5</ENT>
                            <ENT>18.7</ENT>
                            <ENT>764</ENT>
                            <ENT>54</ENT>
                            <ENT>417</ENT>
                            <ENT>1,181</ENT>
                            <ENT>3.5</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             The results for each TSL are calculated assuming that all consumers use products at that efficiency level. The PBP is measured relative to the baseline product.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,20,24">
                        <TTITLE>
                            Table V.15—Average LCC Savings Relative to the No-New-Standards Case for Room Air Conditioners PC 8a, Without Reverse Cycle and Without Louvered Sides, 8,000-10,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Life-cycle cost savings</CHED>
                            <CHED H="2">
                                Average LCC savings *
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="2">
                                Percent of consumers that
                                <LI>experience net cost</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01"> </ENT>
                            <ENT>10.1</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>10.6</ENT>
                            <ENT>6</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>12.3</ENT>
                            <ENT>73</ENT>
                            <ENT>15</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3,4</ENT>
                            <ENT>14.1</ENT>
                            <ENT>84</ENT>
                            <ENT>34</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>18.7</ENT>
                            <ENT>137</ENT>
                            <ENT>38</ENT>
                        </ROW>
                        <TNOTE>* The savings represent the average LCC for affected consumers.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="9" OPTS="L2,p7,7/8,i1" CDEF="s25,8,8,10,12,10,8,8,8">
                        <TTITLE>
                            Table V.16—Average LCC and PBP Results for Room Air Conditioners PC 8b, Without Reverse Cycle and Without Louvered Sides, 11,000-13,999 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">EL</CHED>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Average costs (2021$)</CHED>
                            <CHED H="2">
                                Installed
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                First year's
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                Lifetime
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">LCC</CHED>
                            <CHED H="1">
                                Simple
                                <LI>payback</LI>
                                <LI>(years)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>lifetime</LI>
                                <LI>(years)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT/>
                            <ENT>9.5</ENT>
                            <ENT>626</ENT>
                            <ENT>132</ENT>
                            <ENT>1,010</ENT>
                            <ENT>1,636</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT/>
                            <ENT>10.0</ENT>
                            <ENT>629</ENT>
                            <ENT>127</ENT>
                            <ENT>968</ENT>
                            <ENT>1,597</ENT>
                            <ENT>0.6</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1</ENT>
                            <ENT>10.5</ENT>
                            <ENT>634</ENT>
                            <ENT>116</ENT>
                            <ENT>885</ENT>
                            <ENT>1,520</ENT>
                            <ENT>0.5</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>2</ENT>
                            <ENT>12.3</ENT>
                            <ENT>670</ENT>
                            <ENT>100</ENT>
                            <ENT>764</ENT>
                            <ENT>1,434</ENT>
                            <ENT>1.4</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>3,4</ENT>
                            <ENT>13.9</ENT>
                            <ENT>738</ENT>
                            <ENT>86</ENT>
                            <ENT>656</ENT>
                            <ENT>1,394</ENT>
                            <ENT>2.4</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>5</ENT>
                            <ENT>19.0</ENT>
                            <ENT>846</ENT>
                            <ENT>64</ENT>
                            <ENT>492</ENT>
                            <ENT>1,338</ENT>
                            <ENT>3.2</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             The results for each TSL are calculated assuming that all consumers use products at that efficiency level. The PBP is measured relative to the baseline product.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,20,24">
                        <TTITLE>
                            Table V.17—Average LCC Savings Relative to the No-New-Standards Case for Room Air Conditioners PC 8b, Without Reverse Cycle and Without Louvered Sides, 11,000-13,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Life-cycle cost savings</CHED>
                            <CHED H="2">
                                Average LCC savings *
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="2">
                                Percent of consumers that
                                <LI>experience net cost</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01"> </ENT>
                            <ENT>10.0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>10.5</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>12.3</ENT>
                            <ENT>81</ENT>
                            <ENT>17</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3,4</ENT>
                            <ENT>13.9</ENT>
                            <ENT>119</ENT>
                            <ENT>26</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>19.0</ENT>
                            <ENT>175</ENT>
                            <ENT>37</ENT>
                        </ROW>
                        <TNOTE>* The savings represent the average LCC for affected consumers.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="9" OPTS="L2,p7,7/8,i1" CDEF="s25,8,8,10,12,10,8,8,8">
                        <TTITLE>
                            Table V.18—Average LCC and PBP Results for Room Air Conditioners PC 9, Without Reverse Cycle and Without Louvered Sides, 14,000-19,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">EL</CHED>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Average costs (2021$)</CHED>
                            <CHED H="2">
                                Installed
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                First year's
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                Lifetime
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">LCC</CHED>
                            <CHED H="1">
                                Simple
                                <LI>payback</LI>
                                <LI>(years)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>lifetime</LI>
                                <LI>(years)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                            <ENT>756</ENT>
                            <ENT>119</ENT>
                            <ENT>901</ENT>
                            <ENT>1,658</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT/>
                            <ENT>9.7</ENT>
                            <ENT>760</ENT>
                            <ENT>115</ENT>
                            <ENT>867</ENT>
                            <ENT>1,627</ENT>
                            <ENT>0.8</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1</ENT>
                            <ENT>10.2</ENT>
                            <ENT>770</ENT>
                            <ENT>106</ENT>
                            <ENT>803</ENT>
                            <ENT>1,573</ENT>
                            <ENT>1.1</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34340"/>
                            <ENT I="01">3</ENT>
                            <ENT>2</ENT>
                            <ENT>10.9</ENT>
                            <ENT>795</ENT>
                            <ENT>99</ENT>
                            <ENT>754</ENT>
                            <ENT>1,549</ENT>
                            <ENT>2.0</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>3,4</ENT>
                            <ENT>13.7</ENT>
                            <ENT>877</ENT>
                            <ENT>77</ENT>
                            <ENT>584</ENT>
                            <ENT>1,461</ENT>
                            <ENT>2.9</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>5</ENT>
                            <ENT>16.8</ENT>
                            <ENT>964</ENT>
                            <ENT>63</ENT>
                            <ENT>482</ENT>
                            <ENT>1,446</ENT>
                            <ENT>3.7</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             The results for each TSL are calculated assuming that all consumers use products at that efficiency level. The PBP is measured relative to the baseline product.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,20,24">
                        <TTITLE>
                            Table V.19—Average LCC Savings Relative to the No-New-Standards Case for Room Air Conditioners PC 9, Without Reverse Cycle and Without Louvered Sides, 14,000-19,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Life-cycle cost savings</CHED>
                            <CHED H="2">
                                Average LCC savings *
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="2">
                                Percent of consumers that
                                <LI>experience net cost</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01"> </ENT>
                            <ENT>9.7</ENT>
                            <ENT>12</ENT>
                            <ENT>1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>10.2</ENT>
                            <ENT>58</ENT>
                            <ENT>4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>10.9</ENT>
                            <ENT>81</ENT>
                            <ENT>19</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3, 4</ENT>
                            <ENT>13.7</ENT>
                            <ENT>165</ENT>
                            <ENT>24</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>16.8</ENT>
                            <ENT>180</ENT>
                            <ENT>39</ENT>
                        </ROW>
                        <TNOTE>* The savings represent the average LCC for affected consumers.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="9" OPTS="L2,p7,7/8,i1" CDEF="s25,8,8,10,12,10,8,8,8">
                        <TTITLE>
                            Table V.20—Average LCC and PBP Results for Room Air Conditioners PC 11, With Reverse Cycle and With Louvered Sides, Less Than 20,000 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">EL</CHED>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Average costs (2021$)</CHED>
                            <CHED H="2">
                                Installed
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                First year's
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                Lifetime
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">LCC</CHED>
                            <CHED H="1">
                                Simple
                                <LI>payback</LI>
                                <LI>(years)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>lifetime</LI>
                                <LI>(years)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT/>
                            <ENT>9.8</ENT>
                            <ENT>659</ENT>
                            <ENT>108</ENT>
                            <ENT>829</ENT>
                            <ENT>1,488</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT/>
                            <ENT>10.4</ENT>
                            <ENT>663</ENT>
                            <ENT>102</ENT>
                            <ENT>788</ENT>
                            <ENT>1,451</ENT>
                            <ENT>0.8</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1</ENT>
                            <ENT>10.8</ENT>
                            <ENT>668</ENT>
                            <ENT>94</ENT>
                            <ENT>725</ENT>
                            <ENT>1,392</ENT>
                            <ENT>0.6</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>2</ENT>
                            <ENT>12.3</ENT>
                            <ENT>705</ENT>
                            <ENT>83</ENT>
                            <ENT>645</ENT>
                            <ENT>1,349</ENT>
                            <ENT>1.9</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>3,4</ENT>
                            <ENT>14.4</ENT>
                            <ENT>778</ENT>
                            <ENT>71</ENT>
                            <ENT>546</ENT>
                            <ENT>1,324</ENT>
                            <ENT>3.2</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>5</ENT>
                            <ENT>18.0</ENT>
                            <ENT>826</ENT>
                            <ENT>58</ENT>
                            <ENT>448</ENT>
                            <ENT>1,274</ENT>
                            <ENT>3.4</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             The results for each TSL are calculated assuming that all consumers use products at that efficiency level. The PBP is measured relative to the baseline product.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,20,24">
                        <TTITLE>
                            Table V.21—Average LCC Savings Relative to the No-New-Standards Case for Room Air Conditioners PC 11, With Reverse Cycle and With Louvered Sides, Less Than 20,000 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Life-cycle cost savings</CHED>
                            <CHED H="2">
                                Average LCC savings *
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="2">
                                Percent of consumers that
                                <LI>experience net cost</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01"> </ENT>
                            <ENT>10.4</ENT>
                            <ENT>18</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>10.8</ENT>
                            <ENT>69</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>12.3</ENT>
                            <ENT>110</ENT>
                            <ENT>19</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3,4</ENT>
                            <ENT>14.4</ENT>
                            <ENT>134</ENT>
                            <ENT>30</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>18.0</ENT>
                            <ENT>185</ENT>
                            <ENT>34</ENT>
                        </ROW>
                        <TNOTE>* The savings represent the average LCC for affected consumers.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="9" OPTS="L2,p7,7/8,i1" CDEF="s25,8,8,10,12,10,8,8,8">
                        <TTITLE>
                            Table V.22—Average LCC and PBP Results for Room Air Conditioners PC 12, With Reverse Cycle and Without Louvered Sides, Less Than 14,000 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">EL</CHED>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Average costs (2021$)</CHED>
                            <CHED H="2">
                                Installed
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                First year's
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                Lifetime
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">LCC</CHED>
                            <CHED H="1">
                                Simple payback
                                <LI>(years)</LI>
                            </CHED>
                            <CHED H="1">
                                Average lifetime
                                <LI>(years)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                            <ENT>776</ENT>
                            <ENT>88</ENT>
                            <ENT>674</ENT>
                            <ENT>1,449</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT/>
                            <ENT>9.7</ENT>
                            <ENT>779</ENT>
                            <ENT>85</ENT>
                            <ENT>649</ENT>
                            <ENT>1,428</ENT>
                            <ENT>1.0</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1</ENT>
                            <ENT>10.2</ENT>
                            <ENT>788</ENT>
                            <ENT>79</ENT>
                            <ENT>603</ENT>
                            <ENT>1,391</ENT>
                            <ENT>1.3</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>2</ENT>
                            <ENT>11.3</ENT>
                            <ENT>812</ENT>
                            <ENT>72</ENT>
                            <ENT>550</ENT>
                            <ENT>1,362</ENT>
                            <ENT>2.2</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>3,4</ENT>
                            <ENT>13.7</ENT>
                            <ENT>854</ENT>
                            <ENT>59</ENT>
                            <ENT>449</ENT>
                            <ENT>1,302</ENT>
                            <ENT>2.6</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34341"/>
                            <ENT I="01">5</ENT>
                            <ENT>5</ENT>
                            <ENT>16.4</ENT>
                            <ENT>915</ENT>
                            <ENT>50</ENT>
                            <ENT>383</ENT>
                            <ENT>1,298</ENT>
                            <ENT>3.6</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             The results for each TSL are calculated assuming that all consumers use products at that efficiency level. The PBP is measured relative to the baseline product.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,20,24">
                        <TTITLE>
                            Table V.23—Average LCC Savings Relative to the No-New-Standards Case for Room Air Conditioners PC 12, With Reverse Cycle and Without Louvered Sides, Less Than 14,000 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Life-cycle cost savings</CHED>
                            <CHED H="2">
                                Average LCC savings *
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="2">
                                Percent of consumers that
                                <LI>experience net cost</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01"> </ENT>
                            <ENT>9.7</ENT>
                            <ENT>8</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>10.2</ENT>
                            <ENT>40</ENT>
                            <ENT>8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>11.3</ENT>
                            <ENT>67</ENT>
                            <ENT>22</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3,4</ENT>
                            <ENT>13.7</ENT>
                            <ENT>124</ENT>
                            <ENT>21</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>16.4</ENT>
                            <ENT>128</ENT>
                            <ENT>36</ENT>
                        </ROW>
                        <TNOTE>* The savings represent the average LCC for affected consumers.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="9" OPTS="L2,p7,7/8,i1" CDEF="s25,8,8,10,12,10,8,8,8">
                        <TTITLE>Table V.24—Average LCC and PBP Results for Room Air Conditioners PC 16, Casement-Slider</TTITLE>
                        <BOXHD>
                            <CHED H="1">EL</CHED>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Average costs (2021$)</CHED>
                            <CHED H="2">
                                Installed
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                First year's
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">
                                Lifetime
                                <LI>operating</LI>
                                <LI>cost</LI>
                            </CHED>
                            <CHED H="2">LCC</CHED>
                            <CHED H="1">
                                Simple
                                <LI>payback</LI>
                                <LI>(years)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>lifetime</LI>
                                <LI>(years)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT/>
                            <ENT>10.4</ENT>
                            <ENT>554</ENT>
                            <ENT>88</ENT>
                            <ENT>677</ENT>
                            <ENT>1,230</ENT>
                            <ENT/>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT/>
                            <ENT>10.8</ENT>
                            <ENT>556</ENT>
                            <ENT>85</ENT>
                            <ENT>654</ENT>
                            <ENT>1,211</ENT>
                            <ENT>1.0</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1</ENT>
                            <ENT>11.4</ENT>
                            <ENT>560</ENT>
                            <ENT>78</ENT>
                            <ENT>599</ENT>
                            <ENT>1,159</ENT>
                            <ENT>0.7</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>2</ENT>
                            <ENT>13.2</ENT>
                            <ENT>571</ENT>
                            <ENT>69</ENT>
                            <ENT>529</ENT>
                            <ENT>1,100</ENT>
                            <ENT>0.9</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>3,4</ENT>
                            <ENT>15.3</ENT>
                            <ENT>672</ENT>
                            <ENT>59</ENT>
                            <ENT>452</ENT>
                            <ENT>1,124</ENT>
                            <ENT>4.0</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>5</ENT>
                            <ENT>19.1</ENT>
                            <ENT>689</ENT>
                            <ENT>48</ENT>
                            <ENT>372</ENT>
                            <ENT>1,061</ENT>
                            <ENT>3.4</ENT>
                            <ENT>9.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             The results for each TSL are calculated assuming that all consumers use products at that efficiency level. The PBP is measured relative to the baseline product.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,20,24">
                        <TTITLE>Table V.25—Average LCC Savings Relative to the No-New-Standards Case for Room Air Conditioners PC 16, Casement-Slider</TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">CEER</CHED>
                            <CHED H="1">Life-cycle cost savings</CHED>
                            <CHED H="2">
                                Average LCC savings *
                                <LI>(2021$)</LI>
                            </CHED>
                            <CHED H="2">
                                Percent of consumers that
                                <LI>experience net cost</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01"> </ENT>
                            <ENT>10.8</ENT>
                            <ENT>7</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>11.4</ENT>
                            <ENT>51</ENT>
                            <ENT>3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>13.2</ENT>
                            <ENT>107</ENT>
                            <ENT>5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3,4</ENT>
                            <ENT>15.3</ENT>
                            <ENT>84</ENT>
                            <ENT>38</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>19.1</ENT>
                            <ENT>147</ENT>
                            <ENT>32</ENT>
                        </ROW>
                        <TNOTE>* The savings represent the average LCC for affected consumers.</TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD3">b. Consumer Subgroup Analysis</HD>
                    <P>
                        In the consumer subgroup analysis, DOE estimated the impact of the considered TSLs on low-income households and senior-only households for product classes with a sufficient sample size in RECS 2015 to perform a Monte Carlo analysis. Tables V.26 through V.28 compares the average LCC savings and PBP at each efficiency level for the consumer subgroups with similar metrics for the entire consumer sample for product classes 1, 2, and 3. The percentage of consumers with either a net benefit or cost are calculated relative to consumers within that subgroup. Product Classes 4, 5a, 5b, 8a, 8b, 9, 11, 12, and 16 were not analyzed due to their low presence (&lt;5%) in low-income and senior-only households based on shipments and stock estimates from RECS 2015. In most cases, the average LCC savings and PBP for low-income households and senior-only households at the considered efficiency levels are not substantially different from the average for all households. Chapter 11 of the final rule TSD presents the complete LCC and PBP results for the subgroups.
                        <PRTPAGE P="34342"/>
                    </P>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,13,14,13">
                        <TTITLE>
                            Table V.26—Comparison of LCC Savings and PBP for Consumer Subgroups and All Households: Room Air Conditioners PC 1, Without Reverse Cycle and With Louvers, Less Than 6,000 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">
                                Low-income
                                <LI>households *</LI>
                            </CHED>
                            <CHED H="1">
                                Senior-only
                                <LI>households **</LI>
                            </CHED>
                            <CHED H="1">
                                All
                                <LI>households †</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22">Average LCC Savings (2021$):</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 1</ENT>
                            <ENT>$41</ENT>
                            <ENT/>
                            <ENT>$39</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 2, 3</ENT>
                            <ENT>$66</ENT>
                            <ENT/>
                            <ENT>$62</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 4</ENT>
                            <ENT>$53</ENT>
                            <ENT/>
                            <ENT>$40</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 5</ENT>
                            <ENT>$99</ENT>
                            <ENT/>
                            <ENT>$84</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Payback Period (years):</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 1</ENT>
                            <ENT>0.7</ENT>
                            <ENT/>
                            <ENT>0.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 2,3</ENT>
                            <ENT>0.8</ENT>
                            <ENT/>
                            <ENT>0.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 4</ENT>
                            <ENT>4.7</ENT>
                            <ENT/>
                            <ENT>5.1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 5</ENT>
                            <ENT>3.9</ENT>
                            <ENT/>
                            <ENT>4.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Consumers with Net Benefit (%):</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 1</ENT>
                            <ENT>93%</ENT>
                            <ENT/>
                            <ENT>92%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 2, 3</ENT>
                            <ENT>94%</ENT>
                            <ENT/>
                            <ENT>92%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 4</ENT>
                            <ENT>59%</ENT>
                            <ENT/>
                            <ENT>53%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 5</ENT>
                            <ENT>72%</ENT>
                            <ENT/>
                            <ENT>66%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Consumers with Net Cost (%):</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 1</ENT>
                            <ENT>0%</ENT>
                            <ENT/>
                            <ENT>1%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 2, 3</ENT>
                            <ENT>1%</ENT>
                            <ENT/>
                            <ENT>3%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 4</ENT>
                            <ENT>36%</ENT>
                            <ENT/>
                            <ENT>42%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 5</ENT>
                            <ENT>28%</ENT>
                            <ENT/>
                            <ENT>34%</ENT>
                        </ROW>
                        <TNOTE>* Low-income households represent 60.0 percent of all households for this product class.</TNOTE>
                        <TNOTE>** Insufficient sample size to conduct subgroup analysis.</TNOTE>
                        <TNOTE>† The savings represent results of residential consumers only and exclude results from commercial consumers.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,13,14,13">
                        <TTITLE>
                            Table V.27—Comparison of LCC Savings and PBP for Consumer Subgroups and All Households: Room Air Conditioners PC 2, Without Reverse Cycle and With Louvers, 6,000-7,900 
                            <E T="01">Btu/h</E>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">
                                Low-income
                                <LI>households *</LI>
                            </CHED>
                            <CHED H="1">
                                Senior-only
                                <LI>households **</LI>
                            </CHED>
                            <CHED H="1">
                                All
                                <LI>households †</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22">Average LCC Savings (2021$):</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 1</ENT>
                            <ENT>$37</ENT>
                            <ENT>$42</ENT>
                            <ENT>$36</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 2, 3</ENT>
                            <ENT>$78</ENT>
                            <ENT>$90</ENT>
                            <ENT>$75</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 4</ENT>
                            <ENT>$76</ENT>
                            <ENT>$97</ENT>
                            <ENT>$72</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 5</ENT>
                            <ENT>$117</ENT>
                            <ENT>$150</ENT>
                            <ENT>$109</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Payback Period (years):</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 1</ENT>
                            <ENT>0.7</ENT>
                            <ENT>0.6</ENT>
                            <ENT>0.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 2, 3</ENT>
                            <ENT>1.5</ENT>
                            <ENT>1.3</ENT>
                            <ENT>1.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 4</ENT>
                            <ENT>3.8</ENT>
                            <ENT>3.3</ENT>
                            <ENT>3.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 5</ENT>
                            <ENT>4.1</ENT>
                            <ENT>3.6</ENT>
                            <ENT>4.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Consumers with Net Benefit (%):</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 1</ENT>
                            <ENT>74%</ENT>
                            <ENT>72%</ENT>
                            <ENT>73%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 2, 3</ENT>
                            <ENT>83%</ENT>
                            <ENT>83%</ENT>
                            <ENT>80%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 4</ENT>
                            <ENT>60%</ENT>
                            <ENT>66%</ENT>
                            <ENT>59%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 5</ENT>
                            <ENT>61%</ENT>
                            <ENT>68%</ENT>
                            <ENT>60%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Consumers with Net Cost (%):</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 1</ENT>
                            <ENT>1%</ENT>
                            <ENT>3%</ENT>
                            <ENT>2%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 2, 3</ENT>
                            <ENT>10%</ENT>
                            <ENT>10%</ENT>
                            <ENT>13%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 4</ENT>
                            <ENT>35%</ENT>
                            <ENT>29%</ENT>
                            <ENT>36%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TSL 5</ENT>
                            <ENT>39%</ENT>
                            <ENT>32%</ENT>
                            <ENT>40%</ENT>
                        </ROW>
                        <TNOTE>* Low-income households represent 50.1 percent of all households for this product class.</TNOTE>
                        <TNOTE>** Senior-only households represent 24.7 percent of all households for this product class.</TNOTE>
                        <TNOTE>† The savings represent results of residential consumers only and exclude results from commercial consumers.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,13,14,13">
                        <TTITLE>Table V.28—Comparison of LCC Savings and PBP for Consumer Subgroups and All Households: Room Air Conditioners PC 3, Without Reverse Cycle, With Louvered Sides, and 8,000-13,900 Btu/h</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Low-income households *</CHED>
                            <CHED H="1">Senior-only households **</CHED>
                            <CHED H="1">All households †</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22">Average LCC savings (2021$):</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 1</ENT>
                            <ENT>$20</ENT>
                            <ENT>$16</ENT>
                            <ENT>$16</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 2</ENT>
                            <ENT>$122</ENT>
                            <ENT>$98</ENT>
                            <ENT>$101</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 3,4</ENT>
                            <ENT>$122</ENT>
                            <ENT>$83</ENT>
                            <ENT>$94</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 5</ENT>
                            <ENT>$214</ENT>
                            <ENT>$149</ENT>
                            <ENT>$161</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Payback Period (years):</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 1</ENT>
                            <ENT>1.1</ENT>
                            <ENT>1.3</ENT>
                            <ENT>1.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 2</ENT>
                            <ENT>0.8</ENT>
                            <ENT>0.9</ENT>
                            <ENT>0.9</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34343"/>
                            <ENT I="03">TSL 3,4</ENT>
                            <ENT>2.6</ENT>
                            <ENT>3.2</ENT>
                            <ENT>3.1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 5</ENT>
                            <ENT>2.8</ENT>
                            <ENT>3.4</ENT>
                            <ENT>3.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Consumers with Net Benefit (%):</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 1</ENT>
                            <ENT>27%</ENT>
                            <ENT>25%</ENT>
                            <ENT>27%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 2</ENT>
                            <ENT>86%</ENT>
                            <ENT>86%</ENT>
                            <ENT>87%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 3,4</ENT>
                            <ENT>64%</ENT>
                            <ENT>55%</ENT>
                            <ENT>64%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 5</ENT>
                            <ENT>71%</ENT>
                            <ENT>60%</ENT>
                            <ENT>70%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Consumers with Net Cost (%):</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 1</ENT>
                            <ENT>2%</ENT>
                            <ENT>4%</ENT>
                            <ENT>2%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 2</ENT>
                            <ENT>2%</ENT>
                            <ENT>2%</ENT>
                            <ENT>2%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 3,4</ENT>
                            <ENT>25%</ENT>
                            <ENT>34%</ENT>
                            <ENT>26%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">TSL 5</ENT>
                            <ENT>29%</ENT>
                            <ENT>40%</ENT>
                            <ENT>30%</ENT>
                        </ROW>
                        <TNOTE>* Low-income households represent 25.7 percent of all households for this product class.</TNOTE>
                        <TNOTE>** Senior-only households represent 26.6 percent of all households for this product class.</TNOTE>
                        <TNOTE>† The savings represent results of residential consumers only and exclude results from commercial consumers.</TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD3">c. Rebuttable Presumption Payback</HD>
                    <P>As discussed in section II.A of this document, EPCA establishes a rebuttable presumption that an energy conservation standard is economically justified if the increased purchase cost for a product that meets the standard is less than three times the value of the first-year energy savings resulting from the standard. In calculating a rebuttable presumption payback period for each of the considered TSLs, DOE used discrete values, and, as required by EPCA, based the energy use calculation on the DOE test procedures for room air conditioners. In contrast, the PBPs presented in section V.B.1.a of this document were calculated using distributions that reflect the range of energy use in the field.</P>
                    <P>Table V.29 presents the rebuttable-presumption payback periods for the considered TSLs for room air conditioners. While DOE examined the rebuttable-presumption criterion, it considered whether the standard levels considered for this rule are economically justified through a more detailed analysis of the economic impacts of those levels, pursuant to 42 U.S.C. 6295(o)(2)(B)(i), that considers the full range of impacts to the consumer, manufacturer, Nation, and environment. The results of that analysis serve as the basis for DOE to definitively evaluate the economic justification for a potential standard level, thereby supporting or rebutting the results of any preliminary determination of economic justification.</P>
                    <GPOTABLE COLS="6" OPTS="L2,nj,i1" CDEF="s200,6,6,6,6,6">
                        <TTITLE>Table V.29—Rebuttable-Presumption Payback Periods</TTITLE>
                        <BOXHD>
                            <CHED H="1">Product class</CHED>
                            <CHED H="1">Trial standard level</CHED>
                            <CHED H="2">1</CHED>
                            <CHED H="2">2</CHED>
                            <CHED H="2">3</CHED>
                            <CHED H="2">4</CHED>
                            <CHED H="2">5</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT A="04">(years)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC 1: Room Air Conditioners, without reverse cycle, with louvered sides, and less than 6,000 Btu/h</ENT>
                            <ENT>1.1</ENT>
                            <ENT>1.2</ENT>
                            <ENT>1.2</ENT>
                            <ENT>7.2</ENT>
                            <ENT>5.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC 2: Room Air Conditioners, without reverse cycle, with louvered sides, and 6,000 to 7,900 Btu/h</ENT>
                            <ENT>1.0</ENT>
                            <ENT>1.8</ENT>
                            <ENT>1.8</ENT>
                            <ENT>6.1</ENT>
                            <ENT>5.1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC 3: Room Air Conditioners, without reverse cycle, with louvered sides, and 8,000 to 13,900 Btu/h</ENT>
                            <ENT>1.4</ENT>
                            <ENT>0.9</ENT>
                            <ENT>4.0</ENT>
                            <ENT>4.0</ENT>
                            <ENT>3.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC 4: Room Air Conditioners, without reverse cycle, with louvered sides, and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>0.7</ENT>
                            <ENT>0.8</ENT>
                            <ENT>2.8</ENT>
                            <ENT>2.8</ENT>
                            <ENT>2.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC 5a: Room Air Conditioners, without reverse cycle, with louvered sides, and 20,000 to 27,900 Btu/h</ENT>
                            <ENT>0.7</ENT>
                            <ENT>0.6</ENT>
                            <ENT>1.8</ENT>
                            <ENT>1.8</ENT>
                            <ENT>1.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC 5b: Room Air Conditioners, without reverse cycle, with louvered sides, and 28,000 Btu/h or more</ENT>
                            <ENT>0.3</ENT>
                            <ENT>0.3</ENT>
                            <ENT>1.5</ENT>
                            <ENT>1.5</ENT>
                            <ENT>1.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC 8a: Room Air Conditioners, without reverse cycle, without louvered sides, and 8,000 to 10,900 Btu/h</ENT>
                            <ENT>0.7</ENT>
                            <ENT>1.2</ENT>
                            <ENT>4.3</ENT>
                            <ENT>4.3</ENT>
                            <ENT>3.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC 8b: Room Air Conditioners, without reverse cycle, without louvered sides, and 11,000 to 13,900 Btu/h</ENT>
                            <ENT>0.6</ENT>
                            <ENT>1.3</ENT>
                            <ENT>3.7</ENT>
                            <ENT>3.7</ENT>
                            <ENT>3.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC 9: Room Air Conditioners, without reverse cycle, without louvered sides, and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>0.8</ENT>
                            <ENT>1.2</ENT>
                            <ENT>2.7</ENT>
                            <ENT>2.7</ENT>
                            <ENT>2.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC 11: Room Air Conditioners, with reverse cycle, with louvered sides, and less than 20,000 Btu/h</ENT>
                            <ENT>0.8</ENT>
                            <ENT>1.9</ENT>
                            <ENT>4.4</ENT>
                            <ENT>4.4</ENT>
                            <ENT>3.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC 12: Room Air Conditioners, with reverse cycle, without louvered sides, and less than 14,000 Btu/h</ENT>
                            <ENT>1.5</ENT>
                            <ENT>2.1</ENT>
                            <ENT>3.6</ENT>
                            <ENT>3.6</ENT>
                            <ENT>3.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC 16: Room Air Conditioners, Casement-Slider</ENT>
                            <ENT>0.8</ENT>
                            <ENT>1.0</ENT>
                            <ENT>4.9</ENT>
                            <ENT>4.9</ENT>
                            <ENT>3.9</ENT>
                        </ROW>
                    </GPOTABLE>
                    <PRTPAGE P="34344"/>
                    <HD SOURCE="HD3">2. Economic Impacts on Manufacturers</HD>
                    <P>DOE performed an MIA to estimate the impact of amended energy conservation standards on manufacturers of room air conditioners. The next section describes the expected impacts on manufacturers at each considered TSL. Chapter 12 of the final rule TSD explains the analysis in further detail.</P>
                    <HD SOURCE="HD3">a. Industry Cash Flow Analysis Results</HD>
                    <P>In this section, DOE provides GRIM results from the analysis, which examines changes in the industry that would result from a standard. The following tables summarize the estimated financial impacts (represented by changes in INPV) of potential amended energy conservation standards on manufacturers of room air conditioners, as well as the conversion costs that DOE estimates manufacturers of room air conditioners would incur at each TSL.</P>
                    <P>The impact of potential amended energy conservation standards were analyzed under two scenarios: (1) the preservation of gross margin percentage; and (2) the preservation of per-unit operating profit, as discussed in section IV.J.2.d of this document. The preservation of gross margin percentage scenario provides the upper bound while the preservation of per-unit operating profit scenario results in the lower (or more severe) bound to impacts of potential amended standards on industry.</P>
                    <P>Each of the modeled scenarios results in a unique set of cash flows and corresponding INPV for each TSL. INPV is the sum of the discounted cash flows to the industry from the publication of the final rule through the end of the analysis period (2023-2055). The “change in INPV” results refer to the difference in industry value between the no-new-standards case and standards case at each TSL. To provide perspective on the short-run cash flow impact, DOE includes a comparison of free cash flow between the no-new-standards case and the standards case at each TSL in the year before amended standards would take effect. This figure provides an understanding of the magnitude of the required conversion costs relative to the cash flow generated by the industry in the no-new-standards case.</P>
                    <P>Conversion costs are one-time investments for manufacturers to bring their manufacturing facilities and product designs into compliance with potential amended standards. As described in section IV.J.2.c of this document, conversion cost investments occur between the year of publication of the final rule and the year by which manufacturers must comply with the new standard. The conversion costs can have a significant impact on the short-term cash flow on the industry and generally result in lower free cash flow in the period between the publication of the final rule and the compliance date of potential amended standards. Conversion costs are independent of the manufacturer markup scenarios and are not presented as a range in this analysis.</P>
                    <GPOTABLE COLS="8" OPTS="L2,p7,7/8,i1" CDEF="s25,xs40,10,xs60,xs60,xs60,xs60,xs60">
                        <TTITLE>Table V.30—Manufacturer Impact Analysis Results for the Room Air Conditioner Industry *</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Units</CHED>
                            <CHED H="1">No-New STDs case</CHED>
                            <CHED H="1">TSL 1</CHED>
                            <CHED H="1">TSL 2</CHED>
                            <CHED H="1">TSL 3</CHED>
                            <CHED H="1">TSL 4</CHED>
                            <CHED H="1">TSL 5</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">INPV</ENT>
                            <ENT>$2021 MM</ENT>
                            <ENT>1,198.5</ENT>
                            <ENT>1,188.7 to 1,192.9</ENT>
                            <ENT>1,167.8 to 1,197.2</ENT>
                            <ENT>1,140.8 to 1,284.1</ENT>
                            <ENT>1,097.7 to 1,369.0</ENT>
                            <ENT>857.5 to 1,211.5.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Change in INPV</ENT>
                            <ENT>%</ENT>
                            <ENT/>
                            <ENT>(0.8) to (0.5)</ENT>
                            <ENT>(2.6) to (0.1)</ENT>
                            <ENT>(4.8) to 7.1</ENT>
                            <ENT>(8.4) to 14.2</ENT>
                            <ENT>(28.4) to 1.1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Free Cash Flow (2025)</ENT>
                            <ENT>$2021 MM</ENT>
                            <ENT>86.1</ENT>
                            <ENT>79.9</ENT>
                            <ENT>72.6</ENT>
                            <ENT>76.9</ENT>
                            <ENT>75.5</ENT>
                            <ENT>(55.3).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Change in Free Cash Flow (2025)</ENT>
                            <ENT>%</ENT>
                            <ENT/>
                            <ENT>(7.2)</ENT>
                            <ENT>(15.7)</ENT>
                            <ENT>(10.7)</ENT>
                            <ENT>(12.4)</ENT>
                            <ENT>(164.2).</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Conversion Costs</ENT>
                            <ENT>$2021 MM</ENT>
                            <ENT/>
                            <ENT>14.6</ENT>
                            <ENT>31.3</ENT>
                            <ENT>24.8</ENT>
                            <ENT>29.0</ENT>
                            <ENT>319.7.</ENT>
                        </ROW>
                        <TNOTE>* Negative values denoted by parentheses.</TNOTE>
                    </GPOTABLE>
                    <P>At TSL 1, the standard is set to existing ENERGY STAR levels (EL 2) for all product classes. DOE estimates the change in INPV to be minimal under both manufacturer markup scenarios. INPV is expected to range from −0.8 percent to −0.5 percent. At this level, free cash flow is estimated to decrease by 7.2 percent compared to the no-new-standards case value of $86.1 million in the year 2025, the year before the standards year. DOE's shipments analysis estimates approximately 32 percent of current shipments meet this level. At TSL 1, DOE does not expect industry to adopt new or larger chassis sizes. Capital conversion costs may be necessary for incremental updates in tooling. Product conversion costs are driven by specification, sourcing, and testing of more efficient compressors. DOE estimates capital conversion costs of $11.4 million and product conversion costs of $3.2 million. Conversion costs total $14.6 million.</P>
                    <P>At TSL 2, the standard reflects an efficiency level attainable by units with the most efficient R-32 single-speed compressor on the market, in combination with other design options, for all product classes (EL 3). DOE estimates the change in INPV to range from −2.6 percent to −0.1 percent. At this level, free cash flow is estimated to decrease by 15.7 percent compared to the base-case value in the year before the standards year. DOE's shipments analysis estimates approximately 2 percent of current shipments meet this level. At TSL 2, DOE does not expect industry to adopt new or larger chassis designs. Capital conversion costs may be necessitated by the incorporation of additional design options, such as the inclusion of sub-cooling. Product conversion costs are driven by the need to redesign models to incorporate more efficient single-speed compressors as well as other design options. DOE estimates capital conversion costs of $26.2 million and product conversion costs of $5.1 million. Conversion costs total $31.3 million.</P>
                    <P>At TSL 3, the standard varies based by product class. For product classes with cooling capacities less than 8,000 Btu/h, the standard reflects an efficiency level attainable by units with the most efficient R-32 single-speed compressor on the market (EL 3) in combination with other design options. For product classes with cooling capacities greater than or equal to 8,000 Btu/h, the standard reflects an efficiency level consistent with the implementation commercially available variable-speed compressors (EL 4). DOE estimates the change in INPV to range from −4.8 percent to 7.1 percent. At this level, free cash flow is estimated to decrease by 10.7 percent compared to the base-case value in the year before the standards year. DOE's shipments analysis estimates approximately 2 percent of current shipments meet this level.</P>
                    <P>
                        At this level, DOE does not expect industry to adopt new or larger chassis designs. For product classes with cooling capacities greater than or equal to the 8,000 Btu/h threshold, additional capital conversion costs may be necessary to adjust appearance tooling. DOE anticipates greater redesign efforts and product conversion costs as 
                        <PRTPAGE P="34345"/>
                        manufacturers move these products to variable-speed compressor designs. DOE estimates capital conversion costs of $7.1 million and product conversion costs of $17.7 million. Conversion costs total $24.8 million.
                    </P>
                    <P>In interviews and through review of market data, DOE found that all but one OEM currently produce R-32 room air conditioner models. Additionally, based on interview feedback, all OEMs intend to entirely transition to R-32 room air conditioners by 2023 regardless of DOE actions related to the energy conservation standards for room air conditioners. Thus, DOE did not consider the redesign costs related to R-32 as conversion costs that are the result of any amended energy conservation standards. DOE accounted for the costs associated with the transition to low-GWP refrigerants in its modeling of the GRIM, consistent with the April 2022 NOPR.</P>
                    <P>
                        At TSL 4, the standard reflects the efficiency consistent with the implementation of commercially available variable-speed compressors for all product classes (EL 4). DOE estimates the change in INPV to range from −8.4 percent to 14.2 percent. At this level, free cash flow is estimated to decrease by 12.4 percent compared to the base-case value in the year before the standards year. DOE's shipments analysis estimates that less than 2 percent of current shipments meet this level. At this level, DOE does not expect industry to adopt new or larger chassis designs. Capital conversion costs may be necessary for adjustments in appearance tooling. Compared to lower efficiency levels, DOE anticipates significantly greater redesign efforts and product conversion costs as manufacturers move all products to variable-speed compressor designs. Based on DOE's Compliance Certification Database (“CCD”),
                        <SU>71</SU>
                        <FTREF/>
                         DOE estimates that OEMs would need to redesign all product platforms to meet the efficiency levels required by TSL 4. DOE estimates capital conversion costs of $6.9 million and product conversion costs of $22.0 million. Conversion costs total $29.0 million.
                    </P>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             U.S. Department of Energy's Compliance Certification Database. Available at: 
                            <E T="03">regulations.doe.gov/certification-data/#q=Product_Group_s%3A*</E>
                             (last accessed: March 17, 2021).
                        </P>
                    </FTNT>
                    <P>At TSL 5, the standard reflects max-tech efficiency (EL 5) for all product classes. DOE estimates the change in INPV to range from −28.4 percent to 1.1 percent. At this level, free cash flow is estimated to decrease by 164.2 percent compared to the base-case value in the year before the standards year. In DOE's review of the market, no models currently meet this level. DOE estimates capital conversion costs of $297.5 million and product conversion costs of $22.2 million. Conversion costs total $319.7 million.</P>
                    <P>At this level, DOE expects changes to chassis size for certain window and through-the-wall units. As a result, capital conversion costs increase significantly as manufacturers adjust equipment and tooling to accommodate new dimensions. As with EL 4, DOE anticipates significant redesign efforts and product conversion costs as manufacturers move all products to variable-speed compressor designs. OEMs would need to redesign all product platforms to meet the efficiency levels required by TSL 5.</P>
                    <P>At TSL 5, the large conversion costs result in a free cash flow dropping below zero in the years before the standard year. The negative free cash flow calculation indicates manufacturers may need to access cash reserves or outside capital to finance conversion efforts.</P>
                    <HD SOURCE="HD3">b. Direct Impacts on Employment</HD>
                    <P>DOE's research indicates no room air conditioners are currently made in domestic production facilities. DOE expects that amended standards would have no impact on domestic production employment, which would remain at zero. Manufacturers maintain offices in the United States to handle design, marketing, technical support, and other business needs. Large changes in total annual shipments may lead to companies reducing their non-production room air conditioner staff. However, DOE's shipments model does not forecast substantial changes in total annual shipments for TSL 3. If total shipments remain relatively steady DOE would not expect any change to non-production employment as a result of amended standards. See section IV.G of this document for additional details on DOE's shipments analysis.</P>
                    <HD SOURCE="HD3">c. Impacts on Manufacturing Capacity</HD>
                    <P>In interviews, manufacturers noted that the majority of room air conditioners are manufactured overseas by high-volume manufacturers producing product for a range of international markets. Manufacturers had few concerns about production line constraints below the max-tech level (TSL 5). However, at the max-tech level, some manufacturers noted concerns about having sufficient technical resources to oversee the redesign and testing of all room air conditioner products to incorporate variable-speed technology. Additionally, DOE notes that the most efficient variable-speed compressors that were implemented at the max-tech level (TSL 5) are offered by only a single manufacturer. Based on public information, DOE was unable to determine the availability and pricing of these compressors. Given the lack of information regarding availability of these highest efficiency variable-speed compressors and the limited number of variable-speed compressors rated at or near the efficiency of compressors considered for the max-tech efficiency level, there may not be sufficient availability of the highest efficiency variable-speed compressors to meet the entire industry's production capacity needs at all cooling capacities of room air conditioners at the max-tech level (TSL 5).</P>
                    <HD SOURCE="HD3">d. Impacts on Subgroups of Manufacturers</HD>
                    <P>Using average cost assumptions to develop industry cash-flow estimates may not capture the differential impacts among subgroups of manufacturers. Small manufacturers, niche players, or manufacturers exhibiting a cost structure that differs substantially from the industry average could be affected disproportionately. DOE investigated small businesses as a manufacturer subgroup that could be disproportionally impacted by energy conservation standards and could merit additional analysis. DOE did not identify any other adversely impacted manufacturer subgroups for this rulemaking based on the results of the industry characterization.</P>
                    <P>DOE analyzes the impacts on small businesses in a separate analysis in section VII.B of this document as part of the Regulatory Flexibility Analysis. For a discussion of the impacts on the small business manufacturer subgroup, see the Regulatory Flexibility Analysis in section VII.B of this document and chapter 12 of the final rule TSD.</P>
                    <HD SOURCE="HD3">e. Cumulative Regulatory Burden</HD>
                    <P>
                        One aspect of assessing manufacturer burden involves looking at the cumulative impact of multiple DOE standards and the regulatory actions of other Federal agencies and States that affect the manufacturers of a covered product or equipment. While any one regulation may not impose a significant burden on manufacturers, the combined effects of several existing or impending regulations may have serious consequences for some manufacturers, groups of manufacturers, or an entire industry. Multiple regulations affecting the same manufacturer can strain profits and lead companies to abandon product lines or markets with lower expected 
                        <PRTPAGE P="34346"/>
                        future returns than competing products. For these reasons, DOE conducts an analysis of cumulative regulatory burden as part of its rulemakings pertaining to appliance efficiency.
                    </P>
                    <P>Table V.31 presents the results of DOE's analysis which includes product-specific regulations that will take effect approximately three years before or after the 2026 compliance date of any amended energy conservation standards for room air conditioners.</P>
                    <GPOTABLE COLS="6" OPTS="L2,p7,7/8,i1" CDEF="s50,10,13,xs60,xs90,xs48">
                        <TTITLE>Table V.31—Compliance Dates and Expected Conversion Expenses of Federal Energy Conservation Standards Affecting Room Air Conditioner Manufacturers</TTITLE>
                        <BOXHD>
                            <CHED H="1">Federal energy conservation standard</CHED>
                            <CHED H="1">
                                Number of
                                <LI>OEMs *</LI>
                            </CHED>
                            <CHED H="1">
                                Number of
                                <LI>OEMs</LI>
                                <LI>affected from</LI>
                                <LI>the room air</LI>
                                <LI>conditioner</LI>
                                <LI>rule **</LI>
                            </CHED>
                            <CHED H="1">
                                Approx.
                                <LI>standards year</LI>
                            </CHED>
                            <CHED H="1">
                                Industry
                                <LI>conversion</LI>
                                <LI>costs</LI>
                                <LI>(millions $)</LI>
                            </CHED>
                            <CHED H="1">
                                Industry
                                <LI>conversion</LI>
                                <LI>costs/product</LI>
                                <LI>revenue ***</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Commercial Warm Air Furnaces 81 FR 2420 (January 15, 2016)</ENT>
                            <ENT>16</ENT>
                            <ENT>1</ENT>
                            <ENT>2023</ENT>
                            <ENT>$7.5 to $22.2 (2014$)</ENT>
                            <ENT>1.7% to 5.1%.†</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Small, Large, and Very Large Commercial Package Air Conditioning and Heating Equipment 81 FR 2420 (January 15, 2016)</ENT>
                            <ENT>29</ENT>
                            <ENT>4</ENT>
                            <ENT>2018 and 2023 ‡</ENT>
                            <ENT>$520.8 (2014$)</ENT>
                            <ENT>4.9%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Residential Central Air Conditioners and Heat Pumps 82 FR 1786 (January 6, 2017)</ENT>
                            <ENT>51</ENT>
                            <ENT>8</ENT>
                            <ENT>2023</ENT>
                            <ENT>$342.6 (2015$)</ENT>
                            <ENT>0.5%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Portable Air Conditioners 85 FR 1378 (January 10, 2020)</ENT>
                            <ENT>11</ENT>
                            <ENT>5</ENT>
                            <ENT>2025</ENT>
                            <ENT>$320.9 (2015$)</ENT>
                            <ENT>6.7%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Commercial Packaged Boilers 85 FR 1592 (January 10, 2020)</ENT>
                            <ENT>43</ENT>
                            <ENT>1</ENT>
                            <ENT>2023</ENT>
                            <ENT>$21.2 (2015$)</ENT>
                            <ENT>2.3%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Commercial Water Heating Equipment †† 87 FR 30610 (May 19, 2022)</ENT>
                            <ENT>14</ENT>
                            <ENT>1</ENT>
                            <ENT>2026</ENT>
                            <ENT>$34.6 (2020$)</ENT>
                            <ENT>4.7%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Consumer Furnaces †† 87 FR 40590 (July 7, 2022)</ENT>
                            <ENT>15</ENT>
                            <ENT>2</ENT>
                            <ENT>2029</ENT>
                            <ENT>$150.6 (2020$)</ENT>
                            <ENT>1.4%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Consumer Pool Heaters †† 87 FR 22640 (April 15, 2022)</ENT>
                            <ENT>21</ENT>
                            <ENT>1</ENT>
                            <ENT>2028</ENT>
                            <ENT>$38.8 (2020$)</ENT>
                            <ENT>1.9%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Consumer Clothes Dryers †† 87 FR 51734 (August 23, 2022)</ENT>
                            <ENT>15</ENT>
                            <ENT>4</ENT>
                            <ENT>2027</ENT>
                            <ENT>$149.7 (2020$)</ENT>
                            <ENT>1.8%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Microwave Ovens †† 87 FR 52282 (August 24, 2022)</ENT>
                            <ENT>18</ENT>
                            <ENT>4</ENT>
                            <ENT>2026</ENT>
                            <ENT>$46.1 (2021$)</ENT>
                            <ENT>0.7%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Consumer Conventional Cooking Products †† 88 FR 6818 (February 1, 2023)</ENT>
                            <ENT>34</ENT>
                            <ENT>3</ENT>
                            <ENT>2027</ENT>
                            <ENT>$183.4 (2021$)</ENT>
                            <ENT>1.2%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Residential Clothes Washers †† 88 FR 13520 (March 3, 2023)</ENT>
                            <ENT>19</ENT>
                            <ENT>4</ENT>
                            <ENT>2027</ENT>
                            <ENT>$690.8 (2021$)</ENT>
                            <ENT>5.2%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Refrigerators, Freezers, and Refrigerator-Freezers †† 88 FR 12452 (February 27, 2023)</ENT>
                            <ENT>49</ENT>
                            <ENT>4</ENT>
                            <ENT>2027</ENT>
                            <ENT>$1,323.6 (2021$)</ENT>
                            <ENT>3.8%.</ENT>
                        </ROW>
                        <TNOTE>* This column presents the total number of manufacturers identified in the energy conservation standard rule contributing to cumulative regulatory burden.</TNOTE>
                        <TNOTE>** This column presents the number of manufacturers producing room air conditioner products that are also listed as manufacturers in the listed energy conservation standard contributing to cumulative regulatory burden.</TNOTE>
                        <TNOTE>*** This column presents industry conversion costs as a percentage of product revenue during the conversion period. Industry conversion costs are the upfront investments manufacturers must make to sell compliant products/equipment. The revenue used for this calculation is the revenue from just the covered product/equipment associated with each row. The conversion period is the time frame over which conversion costs are made and lasts from the publication year of the final rule to the compliance year of the final rule. The conversion period typically ranges from 3 to 5 years, depending on the energy conservation standard.</TNOTE>
                        <TNOTE>† Low and high conversion cost scenarios were analyzed as part of this direct final rule. The range of estimated conversion expenses presented here reflects those two scenarios.</TNOTE>
                        <TNOTE>‡ The direct final rule for small, large, and very large commercial package air conditioning and heating equipment adopts an amended standard in 2018 and a higher amended standard in 2023. The conversion costs are spread over an 8-year conversion period ending in 2022, with over 80 percent of the conversion costs occurring between 2019 and 2022.</TNOTE>
                        <TNOTE>†† These rulemakings are in the proposed rule stage and all values are subject to change until finalized.</TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD3">3. National Impact Analysis</HD>
                    <P>This section presents DOE's estimates of the national energy savings and the NPV of consumer benefits that would result from each of the TSLs considered as potential amended standards.</P>
                    <HD SOURCE="HD3">a. Significance of Energy Savings</HD>
                    <P>To estimate the energy savings attributable to potential amended standards for room air conditioners, DOE compared their energy consumption under the no-new-standards case to their anticipated energy consumption under each TSL. The savings are measured over the entire lifetime of products purchased in the 30-year period that begins in the year of anticipated compliance with amended standards (2026-2055). Table V.32 presents DOE's projections of the national energy savings for each TSL considered for room air conditioners. The savings were calculated using the approach described in section IV.H.2 of this document.</P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,10,10,10,10,10">
                        <TTITLE>Table V.32—Cumulative National Energy Savings for Room Air Conditioners; 30 Years of Shipments</TTITLE>
                        <TDESC>[2026-2055]</TDESC>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Trial standard level</CHED>
                            <CHED H="2">1</CHED>
                            <CHED H="2">2</CHED>
                            <CHED H="2">3</CHED>
                            <CHED H="2">4</CHED>
                            <CHED H="2">5</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT A="04">(quads)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Primary energy</ENT>
                            <ENT>0.30</ENT>
                            <ENT>0.91</ENT>
                            <ENT>1.35</ENT>
                            <ENT>1.80</ENT>
                            <ENT>3.35</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">FFC energy</ENT>
                            <ENT>0.31</ENT>
                            <ENT>0.95</ENT>
                            <ENT>1.41</ENT>
                            <ENT>1.87</ENT>
                            <ENT>3.48</ENT>
                        </ROW>
                    </GPOTABLE>
                    <PRTPAGE P="34347"/>
                    <P>
                        OMB Circular A-4 
                        <SU>72</SU>
                        <FTREF/>
                         requires agencies to present analytical results, including separate schedules of the monetized benefits and costs that show the type and timing of benefits and costs. Circular A-4 also directs agencies to consider the variability of key elements underlying the estimates of benefits and costs. For this rulemaking, DOE undertook a sensitivity analysis using 9 years, rather than 30 years, of product shipments. The choice of a 9-year period is a proxy for the timeline in EPCA for the review of certain energy conservation standards and potential revision of and compliance with such revised standards.
                        <SU>73</SU>
                        <FTREF/>
                         The review timeframe established in EPCA is generally not synchronized with the product lifetime, product manufacturing cycles, or other factors specific to room air conditioners. Thus, such results are presented for informational purposes only and are not indicative of any change in DOE's analytical methodology. The NES sensitivity analysis results based on a 9-year analytical period are presented in Table V.33. The impacts are counted over the lifetime of room air conditioners purchased in 2026-2055.
                    </P>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             U.S. Office of Management and Budget. 
                            <E T="03">Circular A-4: Regulatory Analysis.</E>
                             September 17, 2003. 
                            <E T="03">https://obamawhitehouse.archives.gov/omb/circulars_a004_a-4/</E>
                             (last accessed May 22, 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             Section 325(m) of EPCA requires DOE to review its standards at least once every 6-years, and requires, for certain products, a 3-year period after any new standard is promulgated before compliance is required, except that in no case may any new standards be required within 6-years of the compliance date of the previous standards. While adding a 6-year review to the 3-year compliance period adds up to 9 years, DOE notes that it may undertake reviews at any time within the 6-year period and that the 3-year compliance date may yield to the 6-year backstop. A 9-year analysis period may not be appropriate given the variability that occurs in the timing of standards reviews and the fact that for some products, the compliance period is 5 years rather than 3 years.
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,10,10,10,10,10">
                        <TTITLE>Table V.33—Cumulative National Energy Savings for Room Air Conditioners; 9 Years of Shipments</TTITLE>
                        <TDESC>[2026-2034]</TDESC>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Trial standard level</CHED>
                            <CHED H="2">1</CHED>
                            <CHED H="2">2</CHED>
                            <CHED H="2">3</CHED>
                            <CHED H="2">4</CHED>
                            <CHED H="2">5</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT A="04">(quads)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Primary energy savings</ENT>
                            <ENT>0.12</ENT>
                            <ENT>0.36</ENT>
                            <ENT>0.50</ENT>
                            <ENT>0.64</ENT>
                            <ENT>1.09</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">FFC energy savings</ENT>
                            <ENT>0.12</ENT>
                            <ENT>0.38</ENT>
                            <ENT>0.52</ENT>
                            <ENT>0.67</ENT>
                            <ENT>1.13</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD3">b. Net Present Value of Consumer Costs and Benefits</HD>
                    <P>
                        DOE estimated the cumulative NPV of the total costs and savings for consumers that would result from the TSLs considered for room air conditioners. In accordance with OMB's guidelines on regulatory analysis,
                        <SU>74</SU>
                        <FTREF/>
                         DOE calculated NPV using both a 7-percent and a 3-percent real discount rate. Table V.34 shows the consumer NPV results with impacts counted over the lifetime of products purchased in 2026-2055.
                    </P>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             U.S. Office of Management and Budget. 
                            <E T="03">Circular A-4: Regulatory Analysis.</E>
                             September 17, 2003. 
                            <E T="03">https://obamawhitehouse.archives.gov/omb/circulars_a004_a-4/</E>
                             (last accessed May 22, 2023).
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,10,10,10,10,10">
                        <TTITLE>Table V.34—Cumulative Net Present Value of Consumer Benefits for Room Air Conditioners; 30 Years of Shipments</TTITLE>
                        <TDESC>[2026-2055]</TDESC>
                        <BOXHD>
                            <CHED H="1">Discount rate</CHED>
                            <CHED H="1">Trial standard level</CHED>
                            <CHED H="2">1</CHED>
                            <CHED H="2">2</CHED>
                            <CHED H="2">3</CHED>
                            <CHED H="2">4</CHED>
                            <CHED H="2">5</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT A="04">(billion 2021$)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3 percent</ENT>
                            <ENT>2.89</ENT>
                            <ENT>8.76</ENT>
                            <ENT>11.46</ENT>
                            <ENT>13.83</ENT>
                            <ENT>24.27</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">7 percent</ENT>
                            <ENT>1.47</ENT>
                            <ENT>4.45</ENT>
                            <ENT>5.39</ENT>
                            <ENT>6.11</ENT>
                            <ENT>10.63</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>The NPV results based on the aforementioned 9-year analytical period are presented in Table V.35. The impacts are counted over the lifetime of products purchased in 2026-2055. As mentioned previously, such results are presented for informational purposes only and are not indicative of any change in DOE's analytical methodology or decision criteria.</P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,10,10,10,10,10">
                        <TTITLE>Table V.35—Cumulative Net Present Value of Consumer Benefits for Room Air Conditioners; 9 Years of Shipments</TTITLE>
                        <TDESC>[2026-2034]</TDESC>
                        <BOXHD>
                            <CHED H="1">Discount rate</CHED>
                            <CHED H="1">Trial standard level</CHED>
                            <CHED H="2">1</CHED>
                            <CHED H="2">2</CHED>
                            <CHED H="2">3</CHED>
                            <CHED H="2">4</CHED>
                            <CHED H="2">5</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT A="04">(billion 2021$)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3 percent</ENT>
                            <ENT>1.45</ENT>
                            <ENT>4.39</ENT>
                            <ENT>4.94</ENT>
                            <ENT>5.34</ENT>
                            <ENT>9.33</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">7 percent</ENT>
                            <ENT>0.92</ENT>
                            <ENT>2.77</ENT>
                            <ENT>2.96</ENT>
                            <ENT>3.02</ENT>
                            <ENT>5.31</ENT>
                        </ROW>
                    </GPOTABLE>
                    <PRTPAGE P="34348"/>
                    <P>The previous results reflect the use of a default trend to estimate the change in price for room air conditioners over the analysis period (see section IV.H.3 of this document). DOE also conducted a sensitivity analysis that considered one scenario with a lower rate of price decline than the reference case and one scenario with a higher rate of price decline than the reference case. The results of these alternative cases are presented in appendix 10C of the final rule TSD. In the high-price-decline case, the NPV of consumer benefits is higher than in the default case. In the low-price-decline case, the NPV of consumer benefits is lower than in the default case. Under each sensitivity scenario, net benefits remain positive at the adopted TSL.</P>
                    <HD SOURCE="HD3">c. Indirect Impacts on Employment</HD>
                    <P>DOE estimates that amended energy conservation standards for room air conditioners will reduce energy expenditures for consumers of those products, with the resulting net savings being redirected to other forms of economic activity. These expected shifts in spending and economic activity could affect the demand for labor. As described in section IV.N of this document, DOE used an input/output model of the U.S. economy to estimate indirect employment impacts of the TSLs that DOE considered. There are uncertainties involved in projecting employment impacts, especially changes in the later years of the analysis. Therefore, DOE generated results for near-term timeframes (2026-2030), where these uncertainties are reduced.</P>
                    <P>The results suggest that the adopted standards are likely to have a negligible impact on the net demand for labor in the economy. The net change in jobs is so small that it would be imperceptible in national labor statistics and might be offset by other, unanticipated effects on employment. Chapter 16 of the final rule TSD presents detailed results regarding anticipated indirect employment impacts.</P>
                    <HD SOURCE="HD3">4. Impact on Utility or Performance of Products</HD>
                    <P>As discussed in section IV.C.1.b of this document, DOE has concluded that the standards adopted in this final rule will not lessen the utility or performance of the room air conditioners under consideration in this rulemaking. Manufacturers of these products currently offer units that meet or exceed the adopted standards.</P>
                    <HD SOURCE="HD3">5. Impact of Any Lessening of Competition</HD>
                    <P>DOE considered any lessening of competition that would be likely to result from new or amended standards. As discussed in section III.E.1.e of this document, EPCA directs the Attorney General of the United States (“Attorney General”) to determine the impact, if any, of any lessening of competition likely to result from a proposed standard and to transmit such determination in writing to the Secretary within 60 days of the publication of a proposed rule, together with an analysis of the nature and extent of the impact. To assist the Attorney General in making this determination, DOE provided DOJ with copies of the NOPR and the TSD for review. In its assessment letter responding to DOE, DOJ concluded that the proposed energy conservation standards for room air conditioners are unlikely to have a significant adverse impact on competition. DOE is publishing the Attorney General's assessment at the end of this final rule.</P>
                    <HD SOURCE="HD3">6. Need of the Nation To Conserve Energy</HD>
                    <P>Enhanced energy efficiency, where economically justified, improves the Nation's energy security, strengthens the economy, and reduces the environmental impacts (costs) of energy production. Reduced electricity demand due to energy conservation standards is also likely to reduce the cost of maintaining the reliability of the electricity system, particularly during peak-load periods. Chapter 15 in the final rule TSD presents the estimated impacts on electricity generating capacity, relative to the no-new-standards case, for the TSLs that DOE considered in this rulemaking.</P>
                    <P>Energy conservation resulting from potential energy conservation standards for room air conditioners is expected to yield environmental benefits in the form of reduced emissions of certain air pollutants and greenhouse gases. Table V.36 provides DOE's estimate of cumulative emissions reductions expected to result from the TSLs considered in this rulemaking. The emissions were calculated using the multipliers discussed in section IV.J.3 of this document. DOE reports annual emissions reductions for each TSL in chapter 13 of the final rule TSD.</P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,10,10,10,10,10">
                        <TTITLE>Table V.36—Cumulative Emissions Reduction for Room Air Conditioners Shipped in 2026-2055</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Trial standard level</CHED>
                            <CHED H="2">1</CHED>
                            <CHED H="2">2</CHED>
                            <CHED H="2">3</CHED>
                            <CHED H="2">4</CHED>
                            <CHED H="2">5</CHED>
                        </BOXHD>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">Power Sector and Site Emissions</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">
                                CO
                                <E T="0732">2</E>
                                 (
                                <E T="03">million metric tons</E>
                                )
                            </ENT>
                            <ENT>9.97</ENT>
                            <ENT>30.44</ENT>
                            <ENT>45.05</ENT>
                            <ENT>59.87</ENT>
                            <ENT>110.45</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                CH
                                <E T="0732">4</E>
                                 (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>0.72</ENT>
                            <ENT>2.21</ENT>
                            <ENT>3.26</ENT>
                            <ENT>4.32</ENT>
                            <ENT>7.94</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                N
                                <E T="0732">2</E>
                                O (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>0.10</ENT>
                            <ENT>0.31</ENT>
                            <ENT>0.45</ENT>
                            <ENT>0.60</ENT>
                            <ENT>1.10</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                NO
                                <E T="0732">X</E>
                                 (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>4.99</ENT>
                            <ENT>15.27</ENT>
                            <ENT>22.48</ENT>
                            <ENT>29.81</ENT>
                            <ENT>54.71</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                SO
                                <E T="0732">2</E>
                                 (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>4.40</ENT>
                            <ENT>13.45</ENT>
                            <ENT>19.80</ENT>
                            <ENT>26.26</ENT>
                            <ENT>48.20</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">
                                Hg (
                                <E T="03">tons</E>
                                )
                            </ENT>
                            <ENT>0.03</ENT>
                            <ENT>0.08</ENT>
                            <ENT>0.12</ENT>
                            <ENT>0.16</ENT>
                            <ENT>0.30</ENT>
                        </ROW>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">Upstream Emissions</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">
                                CO
                                <E T="0732">2</E>
                                 (
                                <E T="03">million metric tons</E>
                                )
                            </ENT>
                            <ENT>0.76</ENT>
                            <ENT>2.31</ENT>
                            <ENT>3.43</ENT>
                            <ENT>4.56</ENT>
                            <ENT>8.45</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                CH
                                <E T="0732">4</E>
                                 (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>71.16</ENT>
                            <ENT>216.71</ENT>
                            <ENT>322.37</ENT>
                            <ENT>429.43</ENT>
                            <ENT>796.29</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                N
                                <E T="0732">2</E>
                                O (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.01</ENT>
                            <ENT>0.02</ENT>
                            <ENT>0.02</ENT>
                            <ENT>0.04</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                NO
                                <E T="0732">X</E>
                                 (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>11.42</ENT>
                            <ENT>34.77</ENT>
                            <ENT>51.71</ENT>
                            <ENT>68.88</ENT>
                            <ENT>127.68</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                SO
                                <E T="0732">2</E>
                                 (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>0.06</ENT>
                            <ENT>0.17</ENT>
                            <ENT>0.25</ENT>
                            <ENT>0.33</ENT>
                            <ENT>0.61</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">
                                Hg (
                                <E T="03">tons</E>
                                )
                            </ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                        </ROW>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">Total FFC Emissions</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">
                                CO
                                <E T="0732">2</E>
                                 (
                                <E T="03">million metric tons</E>
                                )
                            </ENT>
                            <ENT>10.73</ENT>
                            <ENT>32.74</ENT>
                            <ENT>48.48</ENT>
                            <ENT>64.43</ENT>
                            <ENT>118.90</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34349"/>
                            <ENT I="01">
                                CH
                                <E T="0732">4</E>
                                 (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>71.88</ENT>
                            <ENT>218.92</ENT>
                            <ENT>325.63</ENT>
                            <ENT>433.76</ENT>
                            <ENT>804.23</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                N
                                <E T="0732">2</E>
                                O (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>0.10</ENT>
                            <ENT>0.32</ENT>
                            <ENT>0.47</ENT>
                            <ENT>0.62</ENT>
                            <ENT>1.15</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                NO
                                <E T="0732">X</E>
                                 (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>16.41</ENT>
                            <ENT>50.04</ENT>
                            <ENT>74.20</ENT>
                            <ENT>98.69</ENT>
                            <ENT>182.39</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                SO
                                <E T="0732">2</E>
                                 (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>4.46</ENT>
                            <ENT>13.62</ENT>
                            <ENT>20.05</ENT>
                            <ENT>26.60</ENT>
                            <ENT>48.82</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                Hg (
                                <E T="03">tons</E>
                                )
                            </ENT>
                            <ENT>0.03</ENT>
                            <ENT>0.08</ENT>
                            <ENT>0.12</ENT>
                            <ENT>0.16</ENT>
                            <ENT>0.30</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        As part of the analysis for this rule, DOE estimated monetary benefits likely to result from the reduced emissions of CO
                        <E T="52">2</E>
                         that DOE estimated for each of the considered TSLs for room air conditioners. Section IV.L.1 of this document discusses the estimated SC-CO
                        <E T="52">2</E>
                         values that DOE used. Table V.37 presents the value of CO
                        <E T="52">2</E>
                         emissions reduction at each TSL for each of the SC-CO
                        <E T="52">2</E>
                         cases. The time-series of annual values is presented for the selected TSL in chapter 14 of the final rule TSD.
                    </P>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,14">
                        <TTITLE>
                            Table V.37—Present Value of CO
                            <E T="0732">2</E>
                             Emissions Reduction for Room Air Conditioners Shipped in 2026-2055
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">
                                SC-CO
                                <E T="0732">2</E>
                                 case
                            </CHED>
                            <CHED H="2">Discount rate and statistics</CHED>
                            <CHED H="3">5%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">3%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">2.5%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">3%</CHED>
                            <CHED H="4">95th percentile</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT A="03">(million 2021$)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>111</ENT>
                            <ENT>461</ENT>
                            <ENT>714</ENT>
                            <ENT>1,402</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>342</ENT>
                            <ENT>1,415</ENT>
                            <ENT>2,189</ENT>
                            <ENT>4,307</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>499</ENT>
                            <ENT>2,075</ENT>
                            <ENT>3,215</ENT>
                            <ENT>6,313</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>658</ENT>
                            <ENT>2,745</ENT>
                            <ENT>4,257</ENT>
                            <ENT>8,350</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>1,194</ENT>
                            <ENT>5,013</ENT>
                            <ENT>7,789</ENT>
                            <ENT>15,250</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        As discussed in section IV.L.2 of this document, DOE estimated the climate benefits likely to result from the reduced emissions of methane and N
                        <E T="52">2</E>
                        O that DOE estimated for each of the considered TSLs for room air conditioners. Table V.38 presents the value of the CH
                        <E T="52">4</E>
                         emissions reduction at each TSL, and Table V.39 presents the value of the N
                        <E T="52">2</E>
                        O emissions reduction at each TSL. The time-series of annual values is presented for the selected TSL in chapter 14 of the final rule TSD.
                    </P>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,14">
                        <TTITLE>Table V.38—Present Value of Methane Emissions Reduction for Room Air Conditioners Shipped in 2026-2055</TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">
                                SC-CH
                                <E T="0732">4</E>
                                 case
                            </CHED>
                            <CHED H="2">Discount rate and statistics</CHED>
                            <CHED H="3">5%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">3%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">2.5%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">3%</CHED>
                            <CHED H="4">95th percentile</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT A="03">(million 2021$)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>34</ENT>
                            <ENT>95</ENT>
                            <ENT>132</ENT>
                            <ENT>253</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>103</ENT>
                            <ENT>292</ENT>
                            <ENT>403</ENT>
                            <ENT>775</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>151</ENT>
                            <ENT>431</ENT>
                            <ENT>596</ENT>
                            <ENT>1,144</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>200</ENT>
                            <ENT>573</ENT>
                            <ENT>793</ENT>
                            <ENT>1,519</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>365</ENT>
                            <ENT>1,055</ENT>
                            <ENT>1,463</ENT>
                            <ENT>2,797</ENT>
                        </ROW>
                    </GPOTABLE>
                    <PRTPAGE P="34350"/>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,14">
                        <TTITLE>Table V.39—Present Value of Nitrous Oxide Emissions Reduction for Room Air Conditioners Shipped in 2026-2055</TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">
                                SC-N
                                <E T="0732">2</E>
                                O case
                            </CHED>
                            <CHED H="2">Discount rate and statistics</CHED>
                            <CHED H="3">5%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">3%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">2.5%</CHED>
                            <CHED H="4">Average</CHED>
                            <CHED H="3">3%</CHED>
                            <CHED H="4">95th percentile</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT A="03">(million 2021$)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>0.4</ENT>
                            <ENT>1.6</ENT>
                            <ENT>2.4</ENT>
                            <ENT>4.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1.3</ENT>
                            <ENT>4.8</ENT>
                            <ENT>7.4</ENT>
                            <ENT>12.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>1.8</ENT>
                            <ENT>7.0</ENT>
                            <ENT>10.8</ENT>
                            <ENT>18.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>2.4</ENT>
                            <ENT>9.3</ENT>
                            <ENT>14.3</ENT>
                            <ENT>24.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>4.4</ENT>
                            <ENT>17.0</ENT>
                            <ENT>26.1</ENT>
                            <ENT>45.1</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        DOE is well aware that scientific and economic knowledge about the contribution of CO
                        <E T="52">2</E>
                         and other GHG emissions to changes in the future global climate and the potential resulting damages to the global and U.S. economy continues to evolve rapidly. DOE, together with other Federal agencies, will continue to review methodologies for estimating the monetary value of reductions in CO
                        <E T="52">2</E>
                         and other GHG emissions. This ongoing review will consider the comments on this subject that are part of the public record for this and other rulemakings, as well as other methodological assumptions and issues. DOE notes, however, that the adopted standards would be economically justified even without inclusion of monetized benefits of reduced GHG emissions.
                    </P>
                    <P>
                        DOE also estimated the monetary value of the economic benefits associated with NO
                        <E T="52">X</E>
                         and SO
                        <E T="52">2</E>
                         emissions reductions anticipated to result from the considered TSLs for room air conditioners. The dollar-per-ton values that DOE used are discussed in section IV.L of this document. Table V.40 presents the present value for NO
                        <E T="52">X</E>
                         emissions reduction for each TSL calculated using 7-percent and 3-percent discount rates, and Table V.41 presents similar results for SO
                        <E T="52">2</E>
                         emissions reductions. The results in these tables reflect application of EPA's low dollar-per-ton values, which DOE used to be conservative. The time-series of annual values is presented for the selected TSL in chapter 14 of the final rule TSD.
                    </P>
                    <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,16,16">
                        <TTITLE>
                            Table V.40—Present Value of NO
                            <E T="0732">X</E>
                             Emissions Reduction for Room Air Conditioners Shipped in 2026-2055
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">7% Discount rate</CHED>
                            <CHED H="1">3% Discount rate</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT A="01">(million 2021$)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>329</ENT>
                            <ENT>713</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>1,022</ENT>
                            <ENT>2,196</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>1,465</ENT>
                            <ENT>3,209</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>1,915</ENT>
                            <ENT>4,238</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>3,408</ENT>
                            <ENT>7,714</ENT>
                        </ROW>
                    </GPOTABLE>
                    <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,16,16">
                        <TTITLE>
                            Table V.41—Present Value of SO
                            <E T="0732">2</E>
                             Emissions Reduction for Room Air Conditioners Shipped in 2026-2055
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">TSL</CHED>
                            <CHED H="1">7% Discount rate</CHED>
                            <CHED H="1">3% Discount rate</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT A="01">(million 2021$)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>127</ENT>
                            <ENT>264</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>394</ENT>
                            <ENT>814</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>560</ENT>
                            <ENT>1,182</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>730</ENT>
                            <ENT>1,556</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>1,290</ENT>
                            <ENT>2,813</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD3">7. Other Factors</HD>
                    <P>The Secretary of Energy, in determining whether a standard is economically justified, may consider any other factors that the Secretary deems to be relevant. (42 U.S.C. 6295(o)(2)(B)(i)(VII)) No other factors were considered in this analysis.</P>
                    <HD SOURCE="HD3">8. Summary of Economic Impacts</HD>
                    <P>
                        Table V.42 presents the NPV values that result from adding the estimates of the economic benefits resulting from reduced GHG and NO
                        <E T="52">X</E>
                         and SO
                        <E T="52">2</E>
                         emissions to the NPV of consumer benefits calculated for each TSL considered in this rulemaking. The consumer benefits are domestic U.S. monetary savings that occur as a result of purchasing the covered room air conditioners, and are measured for the lifetime of products shipped in 2026-2055. The benefits associated with reduced GHG emissions resulting from the adopted standards are global benefits, and are also calculated based on the lifetime of room air conditioners shipped in 2026-2055.
                        <PRTPAGE P="34351"/>
                    </P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s100,10,10,10,10,10">
                        <TTITLE>Table V.42—Consumer NPV Combined With Present Value of Benefits From Climate and Health</TTITLE>
                        <BOXHD>
                            <CHED H="1">Category</CHED>
                            <CHED H="1">TSL 1</CHED>
                            <CHED H="1">TSL 2</CHED>
                            <CHED H="1">TSL 3</CHED>
                            <CHED H="1">TSL 4</CHED>
                            <CHED H="1">TSL 5</CHED>
                        </BOXHD>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">3% discount rate for NPV of Consumer and Health Benefits (billion 2021$)</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">5% d.r., Average SC-GHG case</ENT>
                            <ENT>4.0</ENT>
                            <ENT>12.2</ENT>
                            <ENT>16.5</ENT>
                            <ENT>20.5</ENT>
                            <ENT>36.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3% d.r., Average SC-GHG case</ENT>
                            <ENT>4.4</ENT>
                            <ENT>13.5</ENT>
                            <ENT>18.4</ENT>
                            <ENT>22.9</ENT>
                            <ENT>40.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2.5% d.r., Average SC-GHG case</ENT>
                            <ENT>4.7</ENT>
                            <ENT>14.4</ENT>
                            <ENT>19.7</ENT>
                            <ENT>24.7</ENT>
                            <ENT>44.1</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">3% d.r., 95th percentile SC-GHG case</ENT>
                            <ENT>5.5</ENT>
                            <ENT>16.9</ENT>
                            <ENT>23.3</ENT>
                            <ENT>29.5</ENT>
                            <ENT>52.9</ENT>
                        </ROW>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">7% discount rate for NPV of Consumer and Health Benefits (billion 2021$)</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">5% d.r., Average SC-GHG case</ENT>
                            <ENT>2.1</ENT>
                            <ENT>6.3</ENT>
                            <ENT>8.1</ENT>
                            <ENT>9.6</ENT>
                            <ENT>16.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3% d.r., Average SC-GHG case</ENT>
                            <ENT>2.5</ENT>
                            <ENT>7.6</ENT>
                            <ENT>9.9</ENT>
                            <ENT>12.1</ENT>
                            <ENT>21.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2.5% d.r., Average SC-GHG case</ENT>
                            <ENT>2.8</ENT>
                            <ENT>8.5</ENT>
                            <ENT>11.2</ENT>
                            <ENT>13.8</ENT>
                            <ENT>24.6</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3% d.r., 95th percentile SC-GHG case</ENT>
                            <ENT>3.6</ENT>
                            <ENT>11.0</ENT>
                            <ENT>14.9</ENT>
                            <ENT>18.7</ENT>
                            <ENT>33.4</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD2">C. Conclusion</HD>
                    <P>When considering new or amended energy conservation standards, the standards that DOE adopts for any type (or class) of covered product must be designed to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. (42 U.S.C. 6295(o)(2)(A)) In determining whether a standard is economically justified, the Secretary must determine whether the benefits of the standard exceed its burdens by, to the greatest extent practicable, considering the seven statutory factors discussed previously. (42 U.S.C. 6295(o)(2)(B)(i)) The new or amended standard must also result in significant conservation of energy. (42 U.S.C. 6295(o)(3)(B))</P>
                    <P>In the April 2022 NOPR, DOE proposed energy conservation standards for room air conditioners at TSL 3, as constructed for that analysis. The minimum CEERs corresponding to TSL 3 from the April 2022 NOPR are shown in Table V.43. 87 FR 20608, 20678 (Apr. 7, 2022).</P>
                    <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s200,12">
                        <TTITLE>Table V.43—April 2022 NOPR Proposed Energy Conservation Standards for Room Air Conditioners</TTITLE>
                        <BOXHD>
                            <CHED H="1">Equipment class</CHED>
                            <CHED H="1">
                                CEER
                                <LI>(Btu/Wh)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">1. Without reverse cycle, with louvered sides, and less than 6,000 Btu/h</ENT>
                            <ENT>13.1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2. Without reverse cycle, with louvered sides and 6,000 to 7,900 Btu/h</ENT>
                            <ENT>13.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3. Without reverse cycle, with louvered sides and 8,000 to 13,900 Btu/h</ENT>
                            <ENT>16.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4. Without reverse cycle, with louvered sides and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>16.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5a. Without reverse cycle, with louvered sides and 20,000 to 27,900 Btu/h</ENT>
                            <ENT>13.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5b. Without reverse cycle, with louvered sides and 28,000 Btu/h or more</ENT>
                            <ENT>13.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6. Without reverse cycle, without louvered sides, and less than 6,000 Btu/h</ENT>
                            <ENT>12.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">7. Without reverse cycle, without louvered sides and 6,000 to 7,900 Btu/h</ENT>
                            <ENT>12.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">8a. Without reverse cycle, without louvered sides and 8,000 to 10,900 Btu/h</ENT>
                            <ENT>14.1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">8b. Without reverse cycle, without louvered sides and 11,000 to 13,900 Btu/h</ENT>
                            <ENT>13.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">9. Without reverse cycle, without louvered sides and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>13.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">10. Without reverse cycle, without louvered sides and 20,000 Btu/h or more</ENT>
                            <ENT>13.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">11. With reverse cycle, with louvered sides, and less than 20,000 Btu/h</ENT>
                            <ENT>14.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">12. With reverse cycle, without louvered sides, and less than 14,000 Btu/h</ENT>
                            <ENT>13.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">13. With reverse cycle, with louvered sides, and 20,000 Btu/h or more</ENT>
                            <ENT>13.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">14. With reverse cycle, without louvered sides, and 14,000 Btu/h or more</ENT>
                            <ENT>12.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">15. Casement-Only</ENT>
                            <ENT>13.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">16. Casement-Slider</ENT>
                            <ENT>15.3</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>Gradient, NYSERDA, NEEA, and NWPCC supported DOE's proposed standards and stated that these proposed standards are technologically achievable and cost-effective, and should therefore be adopted in order to provide the predicted cost and energy savings. (Gradient, No. 40 at pp. 1-2; NYSERDA, No. 41 at p. 2; NEEA and NWPCC, No. 50 at pp. 1-2)</P>
                    <P>While NYSERDA supported DOE's proposed energy conservation standards for room air conditioners, NYSERDA strongly urged DOE to set more aggressive standards at or potentially even above the proposed ELs if the analysis supports more aggressive standards such as those that incorporate ECM fan motors in the smaller capacity product class sizes, given the multitude of technology options DOE showed could be used to achieve higher efficiencies. (NYSERDA, No. 41 at p. 2)</P>
                    <P>DOE reviewed the comments directly concerning proposed standards and TSLs analyzed in the April 2022 NOPR. In this final rule, DOE reassessed the benefits and burdens of the TSLs while considering all comments received, as detailed.</P>
                    <P>For this final rule, DOE considered the impacts of amended standards for room air conditioners at each TSL, beginning with the maximum technologically feasible level, to determine whether that level was economically justified. Where the max-tech level was not justified, DOE then considered the next most efficient level and undertook the same evaluation until it reached the highest efficiency level that is both technologically feasible and economically justified and saves a significant amount of energy.</P>
                    <P>
                        To aid the reader as DOE discusses the benefits and/or burdens of each TSL, tables in this section present a summary of the results of DOE's quantitative analysis for each TSL. In addition to the 
                        <PRTPAGE P="34352"/>
                        quantitative results presented in the tables, DOE also considers other burdens and benefits that affect economic justification. These include the impacts on identifiable subgroups of consumers who may be disproportionately affected by a national standard and impacts on employment.
                    </P>
                    <P>DOE also notes that the economics literature provides a wide-ranging discussion of how consumers trade off upfront costs and energy savings in the absence of Government intervention. Much of this literature attempts to explain why consumers appear to undervalue energy efficiency improvements. There is evidence that consumers undervalue future energy savings as a result of (1) a lack of information; (2) a lack of sufficient salience of the long-term or aggregate benefits; (3) a lack of sufficient savings to warrant delaying or altering purchases; (4) excessive focus on the short term, in the form of inconsistent weighting of future energy cost savings relative to available returns on other investments; (5) computational or other difficulties associated with the evaluation of relevant tradeoffs; and (6) a divergence in incentives (for example, between renters and owners, or builders and purchasers). Having less than perfect foresight and a high degree of uncertainty about the future, consumers may trade off these types of investments at a higher than expected rate between current consumption and uncertain future energy cost savings.</P>
                    <P>
                        In DOE's current regulatory analysis, potential changes in the benefits and costs of a regulation due to changes in consumer purchase decisions are included in two ways. First, if consumers forego the purchase of a product in the standards case, this decreases sales for product manufacturers, and the impact on manufacturers attributed to lost revenue is included in the MIA. Second, DOE accounts for energy savings attributable only to products actually used by consumers in the standards case; if a standard decreases the number of products purchased by consumers, this decreases the potential energy savings from an energy conservation standard. DOE provides estimates of shipments and changes in the volume of product purchases in chapter 9 of the final rule TSD. However, DOE's current analysis does not explicitly control for heterogeneity in consumer preferences, preferences across subcategories of products or specific features, or consumer price sensitivity variation according to household income.
                        <SU>75</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             P.C. Reiss and M.W. White. Household Electricity Demand, Revisited. 
                            <E T="03">Review of Economic Studies.</E>
                             2005. 72(3): pp. 853-883. doi: 
                            <E T="03">10.1111/0034-6527.00354.</E>
                        </P>
                    </FTNT>
                    <P>
                        While DOE is not prepared at present to provide a fuller quantifiable framework for estimating the benefits and costs of changes in consumer purchase decisions due to an energy conservation standard, DOE is committed to developing a framework that can support empirical quantitative tools for improved assessment of the consumer welfare impacts of appliance standards. DOE has posted a paper that discusses the issue of consumer welfare impacts of appliance energy conservation standards, and potential enhancements to the methodology by which these impacts are defined and estimated in the regulatory process.
                        <SU>76</SU>
                        <FTREF/>
                         DOE welcomes comments on how to more fully assess the potential impact of energy conservation standards on consumer choice and how to quantify this impact in its regulatory analysis in future rulemakings.
                    </P>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             Sanstad, A.H. 
                            <E T="03">Notes on the Economics of Household Energy Consumption and Technology Choice.</E>
                             2010. Lawrence Berkeley National Laboratory. 
                            <E T="03">www1.eere.energy.gov/buildings/appliance_standards/pdfs/consumer_ee_theory.pdf</E>
                             (last accessed July 1, 2021).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. Benefits and Burdens of TSLs Considered for Room Air Conditioner Standards</HD>
                    <P>Tables V.44 and V.45 summarize the quantitative impacts estimated for each TSL for room air conditioners. The national impacts are measured over the lifetime of room air conditioners purchased in the 30-year period that begins in the anticipated year of compliance with amended standards (2026-2055). The energy savings, emissions reductions, and value of emissions reductions refer to full-fuel-cycle results. DOE is presenting monetized benefits in accordance with the applicable Executive orders and DOE would reach the same conclusion presented in this rule in the absence of the social cost of greenhouse gases, including the Interim Estimates presented by the Interagency Working Group. The efficiency levels contained in each TSL are described in section V.A of this document.</P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,9,9,9,9,9">
                        <TTITLE>Table V.44—Summary of Analytical Results for Room Air Conditioners TSLs—National Impacts</TTITLE>
                        <BOXHD>
                            <CHED H="1">Category</CHED>
                            <CHED H="1">TSL 1</CHED>
                            <CHED H="1">TSL 2</CHED>
                            <CHED H="1">TSL 3</CHED>
                            <CHED H="1">TSL 4</CHED>
                            <CHED H="1">TSL 5</CHED>
                        </BOXHD>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">Cumulative FFC National Energy Savings</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00" RUL="s">
                            <ENT I="01">Quads</ENT>
                            <ENT>0.31</ENT>
                            <ENT>0.95</ENT>
                            <ENT>1.41</ENT>
                            <ENT>1.87</ENT>
                            <ENT>3.48</ENT>
                        </ROW>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">Cumulative FFC Emissions Reduction</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">
                                CO
                                <E T="0732">2</E>
                                 (
                                <E T="03">million metric tons</E>
                                )
                            </ENT>
                            <ENT>10.73</ENT>
                            <ENT>32.74</ENT>
                            <ENT>48.48</ENT>
                            <ENT>64.43</ENT>
                            <ENT>118.90</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                CH
                                <E T="0732">4</E>
                                 (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>71.88</ENT>
                            <ENT>218.92</ENT>
                            <ENT>325.63</ENT>
                            <ENT>433.76</ENT>
                            <ENT>804.23</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                N
                                <E T="0732">2</E>
                                O (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>0.10</ENT>
                            <ENT>0.32</ENT>
                            <ENT>0.47</ENT>
                            <ENT>0.62</ENT>
                            <ENT>1.15</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                NO
                                <E T="0732">X</E>
                                 (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>16.41</ENT>
                            <ENT>50.04</ENT>
                            <ENT>74.20</ENT>
                            <ENT>98.69</ENT>
                            <ENT>182.39</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                SO
                                <E T="0732">2</E>
                                 (
                                <E T="03">thousand tons</E>
                                )
                            </ENT>
                            <ENT>4.46</ENT>
                            <ENT>13.62</ENT>
                            <ENT>20.05</ENT>
                            <ENT>26.60</ENT>
                            <ENT>48.82</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">
                                Hg (
                                <E T="03">tons</E>
                                )
                            </ENT>
                            <ENT>0.03</ENT>
                            <ENT>0.08</ENT>
                            <ENT>0.12</ENT>
                            <ENT>0.16</ENT>
                            <ENT>0.30</ENT>
                        </ROW>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">Present Value of Benefits and Costs (3% discount rate, billion 2021$)</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Consumer Operating Cost Savings</ENT>
                            <ENT>3.23</ENT>
                            <ENT>9.99</ENT>
                            <ENT>14.63</ENT>
                            <ENT>19.37</ENT>
                            <ENT>35.77</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Climate Benefits *</ENT>
                            <ENT>0.56</ENT>
                            <ENT>1.71</ENT>
                            <ENT>2.51</ENT>
                            <ENT>3.33</ENT>
                            <ENT>6.09</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <PRTPAGE P="34353"/>
                            <ENT I="01">Health Benefits **</ENT>
                            <ENT>0.98</ENT>
                            <ENT>3.01</ENT>
                            <ENT>4.39</ENT>
                            <ENT>5.79</ENT>
                            <ENT>10.53</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total Benefits †</ENT>
                            <ENT>4.76</ENT>
                            <ENT>14.71</ENT>
                            <ENT>21.54</ENT>
                            <ENT>28.49</ENT>
                            <ENT>52.38</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Consumer Incremental Product Costs ‡</ENT>
                            <ENT>0.33</ENT>
                            <ENT>1.23</ENT>
                            <ENT>3.17</ENT>
                            <ENT>5.55</ENT>
                            <ENT>11.49</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Consumer Net Benefits</ENT>
                            <ENT>2.89</ENT>
                            <ENT>8.76</ENT>
                            <ENT>11.46</ENT>
                            <ENT>13.83</ENT>
                            <ENT>24.27</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="05">Total Net Benefits</ENT>
                            <ENT>4.43</ENT>
                            <ENT>13.48</ENT>
                            <ENT>18.37</ENT>
                            <ENT>22.95</ENT>
                            <ENT>40.89</ENT>
                        </ROW>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">Present Value of Benefits and Costs (7% discount rate, billion 2021$)</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Consumer Operating Cost Savings</ENT>
                            <ENT>1.66</ENT>
                            <ENT>5.20</ENT>
                            <ENT>7.46</ENT>
                            <ENT>9.79</ENT>
                            <ENT>17.65</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Climate Benefits *</ENT>
                            <ENT>0.56</ENT>
                            <ENT>1.71</ENT>
                            <ENT>2.51</ENT>
                            <ENT>3.33</ENT>
                            <ENT>6.09</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Health Benefits **</ENT>
                            <ENT>0.46</ENT>
                            <ENT>1.42</ENT>
                            <ENT>2.02</ENT>
                            <ENT>2.65</ENT>
                            <ENT>4.70</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total Benefits †</ENT>
                            <ENT>2.68</ENT>
                            <ENT>8.32</ENT>
                            <ENT>12.00</ENT>
                            <ENT>15.76</ENT>
                            <ENT>28.43</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Consumer Incremental Product Costs ‡</ENT>
                            <ENT>0.19</ENT>
                            <ENT>0.75</ENT>
                            <ENT>2.08</ENT>
                            <ENT>3.67</ENT>
                            <ENT>7.02</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Consumer Net Benefits</ENT>
                            <ENT>1.47</ENT>
                            <ENT>4.45</ENT>
                            <ENT>5.39</ENT>
                            <ENT>6.11</ENT>
                            <ENT>10.63</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="05">Total Net Benefits</ENT>
                            <ENT>2.49</ENT>
                            <ENT>7.58</ENT>
                            <ENT>9.92</ENT>
                            <ENT>12.08</ENT>
                            <ENT>21.41</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             This table presents the costs and benefits associated with room air conditioners shipped in 2026-2055. These results include benefits to consumers which accrue after 2055 from the products shipped in 2026-2055.
                        </TNOTE>
                        <TNOTE>
                            * Climate benefits are calculated using four different estimates of the SC-CO
                            <E T="0732">2</E>
                            , SC-CH
                            <E T="0732">4</E>
                            , and SC-N
                            <E T="0732">2</E>
                            O. Together these represent the global SC-GHG. For presentational purposes of this table, the climate benefits associated with the average SC-GHG at a 3 percent discount rate are shown, but the Department does not have a single central SC-GHG point estimate. On March 16, 2022, the Fifth Circuit Court of Appeals (No. 22-30087) granted the Federal Government's emergency motion for stay pending appeal of the February 11, 2022, preliminary injunction issued in 
                            <E T="03">Louisiana</E>
                             v. 
                            <E T="03">Biden,</E>
                             No. 21-cv-1074-JDC-KK (W.D. La.). As a result of the Fifth Circuit's order, the preliminary injunction is no longer in effect, pending resolution of the Federal Government's appeal of that injunction or a further court order. Among other things, the preliminary injunction enjoined the defendants in that case from “adopting, employing, treating as binding, or relying upon” the interim estimates of the social cost of greenhouse gases—which were issued by the Interagency Working Group on the Social Cost of Greenhouse Gases on February 26, 2021—to monetize the benefits of reducing greenhouse gas emissions. As reflected in this rule, DOE has reverted to its approach prior to the injunction and presents monetized greenhouse gas abatement benefits where appropriate and permissible under law.
                        </TNOTE>
                        <TNOTE>
                            ** Health benefits are calculated using benefit-per-ton values for NO
                            <E T="0732">X</E>
                             and SO
                            <E T="0732">2</E>
                            . DOE is currently only monetizing (for NO
                            <E T="0732">X</E>
                             and SO
                            <E T="0732">2</E>
                            ) PM
                            <E T="0732">2.5</E>
                             precursor health benefits and (for NO
                            <E T="0732">X</E>
                            ) ozone precursor health benefits, but will continue to assess the ability to monetize other effects such as health benefits from reductions in direct PM
                            <E T="0732">2.5</E>
                             emissions. The health benefits are presented at real discount rates of 3 and 7 percent. See section IV.L of this document for more details.
                        </TNOTE>
                        <TNOTE>† Total and net benefits include consumer, climate, and health benefits. For presentation purposes, total and net benefits for both the 3-percent and 7-percent cases are presented using the average SC-GHG with 3-percent discount rate, but the Department does not have a single central SC-GHG point estimate. DOE emphasizes the importance and value of considering the benefits calculated using all four sets of SC-GHG estimates.</TNOTE>
                        <TNOTE>‡ Costs include incremental equipment costs as well as installation costs.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="6" OPTS="L2,nj,p7,7/8,i1" CDEF="s50,xs72,xs72,xs72,xs72,xs72">
                        <TTITLE>Table V.45—Summary of Analytical Results for Room Air Conditioners TSLs: Manufacturer and Consumer Impacts</TTITLE>
                        <BOXHD>
                            <CHED H="1">Category</CHED>
                            <CHED H="1">TSL 1</CHED>
                            <CHED H="1">TSL 2</CHED>
                            <CHED H="1">TSL 3</CHED>
                            <CHED H="1">TSL 4</CHED>
                            <CHED H="1">TSL 5</CHED>
                        </BOXHD>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">Manufacturer Impacts</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">
                                Industry NPV (
                                <E T="03">million 2021$</E>
                                ) (No-new-standards case INPV = 1,189.5)
                            </ENT>
                            <ENT>1,188.7 to 1,192.9</ENT>
                            <ENT>1,167.8 to 1,197.2</ENT>
                            <ENT>1,140.8 to 1,284.1</ENT>
                            <ENT>1,097.7 to 1,369.0</ENT>
                            <ENT>857.5 to 1,211.5.</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">
                                Industry NPV 
                                <E T="03">(% change</E>
                                )
                            </ENT>
                            <ENT>(0.8) to (0.5)</ENT>
                            <ENT>(2.6) to (0.1)</ENT>
                            <ENT>(4.8) to 7.1</ENT>
                            <ENT>(8.4) to 14.2</ENT>
                            <ENT>(28.4) to 1.1.</ENT>
                        </ROW>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">Consumer Average LCC Savings (2021$)</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">PC1: Room Air Conditioners, without reverse cycle, with louvered sides, and less than 6,000 Btu/h</ENT>
                            <ENT>41</ENT>
                            <ENT>65</ENT>
                            <ENT>65</ENT>
                            <ENT>47</ENT>
                            <ENT>93.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC2: Room Air Conditioners, without reverse cycle, with louvered sides, and 6,000 to 7,900 Btu/h</ENT>
                            <ENT>35</ENT>
                            <ENT>72</ENT>
                            <ENT>72</ENT>
                            <ENT>69</ENT>
                            <ENT>103.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC3: Room Air Conditioners, without reverse cycle, with louvered sides, and 8,000 to 13,900 Btu/h</ENT>
                            <ENT>17</ENT>
                            <ENT>105</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>171.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC4: Room Air Conditioners, without reverse cycle, with louvered sides, and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>0</ENT>
                            <ENT>85</ENT>
                            <ENT>92</ENT>
                            <ENT>92</ENT>
                            <ENT>168.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC5a: Room Air Conditioners, without reverse cycle, with louvered sides, and 20,000 to 27,900 Btu/h</ENT>
                            <ENT>6</ENT>
                            <ENT>99</ENT>
                            <ENT>148</ENT>
                            <ENT>148</ENT>
                            <ENT>284.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC5b: Room Air Conditioners, without reverse cycle, with louvered sides, and 28,000 Btu/h or more</ENT>
                            <ENT>101</ENT>
                            <ENT>150</ENT>
                            <ENT>284</ENT>
                            <ENT>284</ENT>
                            <ENT>415.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC8a: Room Air Conditioners, without reverse cycle, without louvered sides, and 8,000 to 10,900 Btu/h</ENT>
                            <ENT>6</ENT>
                            <ENT>73</ENT>
                            <ENT>84</ENT>
                            <ENT>84</ENT>
                            <ENT>137.</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34354"/>
                            <ENT I="01">PC8b: Room Air Conditioners, without reverse cycle, without louvered sides, and 11,000 to 13,900 Btu/h</ENT>
                            <ENT>0</ENT>
                            <ENT>81</ENT>
                            <ENT>119</ENT>
                            <ENT>119</ENT>
                            <ENT>175.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC9: Room Air Conditioners, without reverse cycle, without louvered sides, and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>58</ENT>
                            <ENT>81</ENT>
                            <ENT>165</ENT>
                            <ENT>165</ENT>
                            <ENT>180.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC11: Room Air Conditioners, with reverse cycle, with louvered sides, and less than 20,000 Btu/h</ENT>
                            <ENT>69</ENT>
                            <ENT>110</ENT>
                            <ENT>134</ENT>
                            <ENT>134</ENT>
                            <ENT>185.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC12: Room Air Conditioners, with reverse cycle, without louvered sides, and less than 14,000 Btu/h</ENT>
                            <ENT>40</ENT>
                            <ENT>67</ENT>
                            <ENT>124</ENT>
                            <ENT>124</ENT>
                            <ENT>128.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC16: Room Air Conditioners, Casement-Slider</ENT>
                            <ENT>51</ENT>
                            <ENT>107</ENT>
                            <ENT>84</ENT>
                            <ENT>84</ENT>
                            <ENT>147.</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Shipment-Weighted Average *</ENT>
                            <ENT>27</ENT>
                            <ENT>83</ENT>
                            <ENT>85</ENT>
                            <ENT>78</ENT>
                            <ENT>134.</ENT>
                        </ROW>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">Consumer Simple PBP (years)</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">PC1: Room Air Conditioners, without reverse cycle, with louvered sides, and less than 6,000 Btu/h</ENT>
                            <ENT>0.6</ENT>
                            <ENT>0.8</ENT>
                            <ENT>0.8</ENT>
                            <ENT>4.6</ENT>
                            <ENT>3.8.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC2: Room Air Conditioners, without reverse cycle, with louvered sides, and 6,000 to 7,900 Btu/h</ENT>
                            <ENT>0.7</ENT>
                            <ENT>1.5</ENT>
                            <ENT>1.5</ENT>
                            <ENT>3.8</ENT>
                            <ENT>4.2.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC3: Room Air Conditioners, without reverse cycle, with louvered sides, and 8,000 to 13,900 Btu/h</ENT>
                            <ENT>1.2</ENT>
                            <ENT>0.9</ENT>
                            <ENT>2.9</ENT>
                            <ENT>2.9</ENT>
                            <ENT>3.1.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC4: Room Air Conditioners, without reverse cycle, with louvered sides, and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>0.7</ENT>
                            <ENT>1.2</ENT>
                            <ENT>3.0</ENT>
                            <ENT>3.0</ENT>
                            <ENT>2.8.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC5a: Room Air Conditioners, without reverse cycle, with louvered sides, and 20,000 to 27,900 Btu/h</ENT>
                            <ENT>1.1</ENT>
                            <ENT>1.0</ENT>
                            <ENT>2.5</ENT>
                            <ENT>2.5</ENT>
                            <ENT>2.3.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC5b: Room Air Conditioners, without reverse cycle, with louvered sides, and 28,000 Btu/h or more</ENT>
                            <ENT>0.4</ENT>
                            <ENT>0.5</ENT>
                            <ENT>2.3</ENT>
                            <ENT>2.3</ENT>
                            <ENT>2.0.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC8a: Room Air Conditioners, without reverse cycle, without louvered sides, and 8,000 to 10,900 Btu/h</ENT>
                            <ENT>0.6</ENT>
                            <ENT>1.4</ENT>
                            <ENT>3.2</ENT>
                            <ENT>3.2</ENT>
                            <ENT>3.5.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC8b: Room Air Conditioners, without reverse cycle, without louvered sides, and 11,000 to 13,900 Btu/h</ENT>
                            <ENT>0.5</ENT>
                            <ENT>1.4</ENT>
                            <ENT>2.4</ENT>
                            <ENT>2.4</ENT>
                            <ENT>3.2.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC9: Room Air Conditioners, without reverse cycle, without louvered sides, and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>1.1</ENT>
                            <ENT>2.0</ENT>
                            <ENT>2.9</ENT>
                            <ENT>2.9</ENT>
                            <ENT>3.7.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC11: Room Air Conditioners, with reverse cycle, with louvered sides, and less than 20,000 Btu/h</ENT>
                            <ENT>0.6</ENT>
                            <ENT>1.9</ENT>
                            <ENT>3.2</ENT>
                            <ENT>3.2</ENT>
                            <ENT>3.4.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC12: Room Air Conditioners, with reverse cycle, without louvered sides, and less than 14,000 Btu/h</ENT>
                            <ENT>1.3</ENT>
                            <ENT>2.2</ENT>
                            <ENT>2.6</ENT>
                            <ENT>2.6</ENT>
                            <ENT>3.6.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC16: Room Air Conditioners, Casement-Slider</ENT>
                            <ENT>0.7</ENT>
                            <ENT>0.9</ENT>
                            <ENT>4.0</ENT>
                            <ENT>4.0</ENT>
                            <ENT>3.4.</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Shipment-Weighted Average *</ENT>
                            <ENT>0.8</ENT>
                            <ENT>1.0</ENT>
                            <ENT>1.9</ENT>
                            <ENT>3.6</ENT>
                            <ENT>3.5.</ENT>
                        </ROW>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">Percent of Consumers That Experience a Net Cost</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">PC1: Room Air Conditioners, without reverse cycle, with louvered sides, and less than 6,000 Btu/h</ENT>
                            <ENT>2%</ENT>
                            <ENT>3%</ENT>
                            <ENT>3%</ENT>
                            <ENT>41%</ENT>
                            <ENT>34%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC2: Room Air Conditioners, without reverse cycle, with louvered sides, and 6,000 to 7,900 Btu/h</ENT>
                            <ENT>2%</ENT>
                            <ENT>14%</ENT>
                            <ENT>14%</ENT>
                            <ENT>38%</ENT>
                            <ENT>42%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC3: Room Air Conditioners, without reverse cycle, with louvered sides, and 8,000 to 13,900 Btu/h</ENT>
                            <ENT>2%</ENT>
                            <ENT>2%</ENT>
                            <ENT>26%</ENT>
                            <ENT>26%</ENT>
                            <ENT>30%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC4: Room Air Conditioners, without reverse cycle, with louvered sides, and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>0%</ENT>
                            <ENT>9%</ENT>
                            <ENT>33%</ENT>
                            <ENT>33%</ENT>
                            <ENT>30%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC5a: Room Air Conditioners, without reverse cycle, with louvered sides, and 20,000 to 27,900 Btu/h</ENT>
                            <ENT>1%</ENT>
                            <ENT>5%</ENT>
                            <ENT>30%</ENT>
                            <ENT>30%</ENT>
                            <ENT>27%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC5b: Room Air Conditioners, without reverse cycle, with louvered sides, and 28,000 Btu/h or more</ENT>
                            <ENT>0%</ENT>
                            <ENT>1%</ENT>
                            <ENT>24%</ENT>
                            <ENT>24%</ENT>
                            <ENT>21%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC8a: Room Air Conditioners, without reverse cycle, without louvered sides, and 8,000 to 10,900 Btu/h</ENT>
                            <ENT>0%</ENT>
                            <ENT>15%</ENT>
                            <ENT>34%</ENT>
                            <ENT>34%</ENT>
                            <ENT>38%.</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34355"/>
                            <ENT I="01">PC8b: Room Air Conditioners, without reverse cycle, without louvered sides, and 11,000 to 13,900 Btu/h</ENT>
                            <ENT>0%</ENT>
                            <ENT>17%</ENT>
                            <ENT>26%</ENT>
                            <ENT>26%</ENT>
                            <ENT>37%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC9: Room Air Conditioners, without reverse cycle, without louvered sides, and 14,000 to 19,900 Btu/h</ENT>
                            <ENT>4%</ENT>
                            <ENT>19%</ENT>
                            <ENT>24%</ENT>
                            <ENT>24%</ENT>
                            <ENT>39%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC11: Room Air Conditioners, with reverse cycle, with louvered sides, and less than 20,000 Btu/h</ENT>
                            <ENT>2%</ENT>
                            <ENT>19%</ENT>
                            <ENT>30%</ENT>
                            <ENT>30%</ENT>
                            <ENT>34%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC12: Room Air Conditioners, with reverse cycle, without louvered sides, and less than 14,000 Btu/h</ENT>
                            <ENT>8%</ENT>
                            <ENT>22%</ENT>
                            <ENT>21%</ENT>
                            <ENT>21%</ENT>
                            <ENT>36%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">PC16: Room Air Conditioners, Casement-Slider</ENT>
                            <ENT>3%</ENT>
                            <ENT>5%</ENT>
                            <ENT>38%</ENT>
                            <ENT>38%</ENT>
                            <ENT>32%.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Shipment-Weighted Average *</ENT>
                            <ENT>2%</ENT>
                            <ENT>6%</ENT>
                            <ENT>17%</ENT>
                            <ENT>34%</ENT>
                            <ENT>34%.</ENT>
                        </ROW>
                        <TNOTE>Parentheses indicate negative (−) values.</TNOTE>
                        <TNOTE>* Weighted by shares of each product class in total projected shipments in 2026.</TNOTE>
                    </GPOTABLE>
                    <P>DOE first considered TSL 5, which represents the max-tech efficiency levels. At this level, DOE expects room air conditioners would require the maximum available efficiency variable-speed compressor at all product classes. TSL 5 would save an estimated 3.48 quads of energy, an amount DOE considers significant. Under TSL 5, the NPV of consumer benefit would be $10.63 billion using a discount rate of 7 percent, and $24.27 billion using a discount rate of 3 percent.</P>
                    <P>
                        The cumulative emissions reductions at TSL 5 are 118.9 Mt of CO
                        <E T="52">2</E>
                        , 48.8 thousand tons of SO
                        <E T="0732">2</E>
                        , 182.4 thousand tons of NO
                        <E T="52">X</E>
                        , 0.3 tons of Hg, 804.2 thousand tons of CH
                        <E T="52">4</E>
                        , and 1.1 thousand tons of N
                        <E T="52">2</E>
                        O. The estimated monetary value of the climate benefits from reduced GHG emissions (associated with the average SC-GHG at a 3-percent discount rate) at TSL 5 is $6.09 billion. The estimated monetary value of the health benefits from reduced SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                         emissions at TSL 5 is $4.70 billion using a 7-percent discount rate and $10.53 billion using a 3-percent discount rate.
                    </P>
                    <P>
                        Using a 7-percent discount rate for consumer benefits and costs, health benefits from reduced SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                         emissions, and the 3-percent discount rate case for climate benefits from reduced GHG emissions, the estimated total NPV at TSL 5 is $21.41 billion. Using a 3-percent discount rate for all benefits and costs, the estimated total NPV at TSL 5 is $40.89 billion. The estimated total NPV is provided for additional information, however DOE primarily relies upon the NPV of consumer benefits when determining whether a proposed standard level is economically justified.
                    </P>
                    <P>At TSL 5, for the product classes with the largest market share, the average LCC impact is $93 for PC 1, $103 for PC 2, and $171 for PC 3. The simple payback period is 3.8 years for PC 1, 4.2 years for PC 2, and 3.1 years for PC 3. The fraction of consumers who experience a net LCC cost is 34 percent for PC 1, 42 percent for PC 2, and 30 percent for PC 3. Overall, 34 percent of consumers would experience a net cost.</P>
                    <P>At TSL 5, the projected change in INPV ranges from a decrease of $341.0 million to an increase of $13.0 million, which corresponds to a decrease of 28.4 percent and an increase of 1.1 percent, respectively. Conversion costs total $319.7 million.</P>
                    <P>As discussed in section IV.C.1 of this document, DOE believes there is uncertainty regarding the estimated compressor cost and availability of the highest efficiency variable-speed compressors across the full range of capacities at TSL 5, particularly in the smaller capacity room air conditioners. These uncertainties stem from the fact that the efficiency level for TSL 5 is obtained by using the highest efficiency variable-speed compressors that are currently available to be incorporated into room air conditioners at the time the analysis was competed. In addition, variable speed compressors representing these efficiencies are manufactured by just one manufacturer. It is unclear whether the highest efficiency variable-speed compressors will be available to all manufacturers of room air conditioners since there is only a single supplier at this time. In addition, these highest efficiency variable-speed compressors are not currently available in the full range of capacities of air room air conditioners, which could limit the current product offerings by manufacturers. Furthermore, due to the single supplier for these highest efficiency variable-speed compressors and their unknown manufacturing volume and potential bottlenecks for ramp-up manufacturing capabilities, there is a likelihood that there may not be sufficient supply to meet the demand of the market for the full range of cooling capacities for room air conditioners, should TSL 5 be selected. This may have the potential to result in the unavailability of room air conditioners of certain cooling capacities from the market, which would contradict the requirements in 42 U.S.C. 6295(o)(4) for any amended energy conservation standards, as well impact the overall number of room air conditioners available on the market should TSL 5 be selected.</P>
                    <P>The Secretary concludes that at TSL 5 for room air conditioners, the benefits of energy savings, positive NPV of consumer benefits, emission reductions, and the estimated monetary value of the climate and health benefits would be outweighed by the impacts on manufacturers, including the conversion costs and profit margin impacts that could result in a large reduction in INPV, and the potential for product unavailability due to limitations in key components such as the highest efficiency variable-speed compressors necessary to reach the max-tech efficiency levels. Consequently, the Secretary has concluded that TSL 5 is not economically justified.</P>
                    <P>DOE then considered TSL 4. At TSL 4, DOE expects that all room air conditioners product classes would require variable-speed compressors. TSL 4 would save an estimated 1.87 quads of energy, an amount DOE considers significant. Under TSL 4, the NPV of consumer benefit would be $6.11 billion using a discount rate of 7 percent, and $13.83 billion using a discount rate of 3 percent.</P>
                    <P>
                        The cumulative emissions reductions at TSL 4 are 64.4 Mt of CO
                        <E T="52">2</E>
                        , 26.6 thousand tons of SO
                        <E T="52">2</E>
                        , 98.7 thousand 
                        <PRTPAGE P="34356"/>
                        tons of NO
                        <E T="52">X</E>
                        , 0.16 tons of Hg, 433.8 thousand tons of CH
                        <E T="52">4</E>
                        , and 0.62 thousand tons of N
                        <E T="52">2</E>
                        O. The estimated monetary value of the climate benefits from reduced GHG emissions (associated with the average SC-GHG at a 3-percent discount rate) at TSL 4 is $3.33 billion. The estimated monetary value of the health benefits from reduced SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                         emissions at TSL 4 is $2.65 billion using a 7-percent discount rate and $5.79 billion using a 3-percent discount rate.
                    </P>
                    <P>
                        Using a 7-percent discount rate for consumer benefits and costs, health benefits from reduced SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                         emissions, and the 3-percent discount rate case for climate benefits from reduced GHG emissions, the estimated total NPV at TSL 4 is $12.08 billion. Using a 3-percent discount rate for all benefits and costs, the estimated total NPV at TSL 4 is $22.95 billion. The estimated total NPV is provided for additional information, however DOE primarily relies upon the NPV of consumer benefits when determining whether a proposed standard level is economically justified.
                    </P>
                    <P>At TSL 4, for the product classes with the largest market share, the average LCC impact is $47 for PC 1, $69 for PC 2, and $100 for PC 3. The simple payback period is 4.6 years for PC 1, 3.8 years for PC 2, and 2.9 years for PC 3. The fraction of consumers who experience a net LCC cost is 41 percent for PC 1, 38 percent for PC 2, and 26 percent for PC 3. Overall, 34 percent of consumers would experience a net cost across all product classes.</P>
                    <P>At TSL 4, the projected change in INPV ranges from a decrease of $100.8 million to an increase of $170.5 million, which corresponds to a decrease of 8.4 percent and an increase of 14.2 percent, respectively. Conversion costs total $29.0 million.</P>
                    <P>
                        TSL 4 represents commercially available room air conditioners that implement variable-speed compressors, based on models with cooling capacities greater than 8,000 Btu/h. However, for room air conditioners with the smallest cooling capacities (
                        <E T="03">i.e.,</E>
                         less than 8,000 Btu/h), uncertainties exist regarding both the availability of variable-speed compressors that can be integrated into these smaller-size units and the feasibility of incorporating these variable-speed compressors with related components into a more space-constrained chassis than for larger-capacity room air conditioners. There are no models commercially available that incorporate variable-speed compressors for cooling capacities less than 8,000 Btu/h, and the uncertainty in the availability of those compressors may have the potential to eliminate room air conditioners with the smallest cooling capacities from the market, should TSL 4 be selected. While there are similarly no room air conditioners currently on the market with variable-speed compressors at cooling capacities greater than 22,000 Btu/h, other air conditioning products with such cooling capacities (
                        <E T="03">e.g.,</E>
                         mini-split air conditioners) do exist in the U.S. market, thereby not giving rise to the same uncertainties as for the smallest cooling capacities. Based on an analysis of RECS 2015 and historical shipments data, approximately 78 percent of consumers in the low-income sample purchase units in PC 1 and PC 2. The unavailability of products at this capacity range would disproportionally impact the low-income consumers and their ability to access cooling from room air conditioners.
                    </P>
                    <P>The Secretary concludes that at TSL 4 for room air conditioners, the benefits of energy savings, positive NPV of consumer benefits, emission reductions, and the estimated monetary value of the climate and health benefits would be outweighed by the impacts on manufacturers, including the conversion costs and profit margin impacts that could result in a reduction in INPV and potential unavailability of key components for small-capacity product classes. Consequently, the Secretary has concluded that TSL 4 is not economically justified.</P>
                    <P>
                        DOE then considered TSL 3, which would save an estimated 1.41 quads of energy, an amount DOE considers significant. TSL 3 represents the same efficiency levels as TSL 4 for product classes with cooling capacities greater than or equal to 8,000 Btu/h. For product classes, less than 8,000 Btu/h, TSL 3 corresponds to the implementation of the maximum efficiency single-speed compressor (
                        <E T="03">i.e.,</E>
                         one efficiency level lower than at TSL 4). At TSL 3, the NPV of consumer benefit would be $5.39 billion using a discount rate of 7 percent, and $11.46 billion using a discount rate of 3 percent.
                    </P>
                    <P>
                        The cumulative emissions reductions at TSL 3 are 48.5 Mt of CO
                        <E T="52">2</E>
                        , 20.1 thousand tons of SO
                        <E T="52">2</E>
                        , 74.2 thousand tons of NO
                        <E T="52">X</E>
                        , 0.1 tons of Hg, 325.6 thousand tons of CH
                        <E T="52">4</E>
                        , and 0.5 thousand tons of N
                        <E T="52">2</E>
                        O. The estimated monetary value of the climate benefits from reduced GHG emissions (associated with the average SC-GHG at a 3-percent discount rate) at TSL 3 is $2.51 billion. The estimated monetary value of the health benefits from reduced SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                         emissions at TSL 3 is $2.02 billion using a 7-percent discount rate and $4.39 billion using a 3-percent discount rate.
                    </P>
                    <P>
                        Using a 7-percent discount rate for consumer benefits and costs, SO
                        <E T="52">2</E>
                         reduction benefits, and NO
                        <E T="52">X</E>
                         reduction benefits, and the 3-percent discount rate for GHG social costs, the estimated combined monetized NPV at TSL 3 is $9.92 billion. Using a 3-percent discount rate for all consumer and emissions benefits and costs, the estimated combined monetized NPV at TSL 3 is $18.37 billion. The estimated total monetized NPV is provided for additional information; however, DOE primarily relies upon the consumer NPV when determining whether a standard level is economically justified.
                    </P>
                    <P>At TSL 3, for the product classes with the largest market share, the average LCC impact is $65 for PC 1, $72 for PC 2, and $100 for PC 3. The simple payback period is 0.8 years for PC 1, 1.5 years for PC 2, and 2.9 years for PC 3. The fraction of consumers who experience a net LCC cost is 3 percent for PC 1, 14 percent for PC 2, and 26 percent for PC 3. Overall, 17 percent of consumers would experience a net cost across all product classes.</P>
                    <P>Based on an analysis of RECS 2015 and historical shipments data, approximately 78% of consumers in the low-income sample purchase units in PC 1 and PC 2. At TSL 3, the percentage of consumers who experience a net LCC cost is 1 percent for PC 1 and 10 percent for PC 2. Additionally, the low-income subgroup analysis conservatively estimates the impact to low-income consumers by assuming all renters (64% of low-income sample) are paying the first cost of a room air conditioner. In cases where the landlord purchases the unit and renter pays electricity bill, the renter would not pay an increased first cost, but would benefit from operating cost savings due to a higher efficiency standard.</P>
                    <P>At TSL 3, the projected change in manufacturer INPV ranges from a decrease of $57.7 million to an increase of $85.6 million, which corresponds to a decrease of 4.8 percent and an increase of 7.1 percent, respectively. Conversion costs total $24.8 million.</P>
                    <P>
                        After considering the analysis and weighing the benefits and burdens, the Secretary has concluded that a standard set at TSL 3 for room air conditioners would be economically justified. At this TSL, the average LCC savings for room air conditioner consumers is positive, meaning that the average consumer would experience net savings from the standard. An estimated 17 percent of room air conditioner consumers would experience a net cost. The FFC national energy savings of 1.41 quads are 
                        <PRTPAGE P="34357"/>
                        significant and the NPV of consumer benefits is positive using both a 3-percent and 7-percent discount rate. Notably, the benefits to consumers vastly outweigh the cost to manufacturers. At TSL 3, the NPV of consumer benefits, even measured at the more conservative discount rate of 7 percent, is 96 times higher than the maximum estimated manufacturers' loss in INPV. The positive LCC savings—a different way of quantifying consumer benefits—reinforces this conclusion. The standard levels at TSL 3 are economically justified even without weighing the estimated monetary value of emissions reductions. When those monetized climate benefits from GHG emissions reductions and health benefits from SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                         emissions reductions are included—representing $2.51 billion in climate benefits (associated with the average SC-GHG at a 3-percent discount rate), and $4.39 billion (using a 3-percent discount rate) or $2.02 billion (using a 7-percent discount rate) in health benefits—the rationale becomes stronger still.
                    </P>
                    <P>As stated, DOE conducts the walk-down analysis to determine the TSL that represents the maximum improvement in energy efficiency that is technologically feasible and economically justified as required under EPCA. The walk-down is not a comparative analysis, as a comparative analysis would result in the maximization of net benefits instead of energy savings that are technologically feasible and economically justified, which would be contrary to the statute. 86 FR 70892, 70908. Although DOE has not conducted a comparative analysis to select the amended energy conservation standards, DOE notes that as compared to TSL 4 and TSL 5, TSL 3 has a shorter payback period, smaller percentages of consumer experiencing a net cost, a lower maximum decrease in INPV, and lower manufacturer conversion costs.</P>
                    <P>Although DOE considered amended standard levels for room air conditioners by grouping the efficiency levels for each product class into TSLs, DOE evaluates all analyzed efficiency levels in its analysis. For room air conditioners with cooling capacities greater than or equal to 8,000 Btu/h, TSL 3 corresponds to EL 4, the highest efficiency level below max-tech, incorporating commercially available variable-speed compressors. The variable-speed compressor required to achieve the max-tech efficiency level is currently available from only a single manufacturer, leading to the likelihood there may not be sufficient supply at that efficiency level to meet the demand of the market for the full range of cooling capacities for room air conditioners. For room air conditioners with cooling capacities less than 8,000 Btu/h, TSL 3 corresponds to EL 3, incorporating the maximum energy efficient single-speed compressors commercially available. Both EL 4 and EL 5 for room air conditioners with cooling capacities less than 8,000 Btu/h incorporate variable-speed compressors based on modeling of available compressors for models with cooling capacities greater than or equal to 8,000 Btu/h. Uncertainties exist at those efficiency levels regarding both the availability of variable-speed compressors that can be integrated into these smaller-size units and the feasibility of incorporating these variable-speed compressors with related components into a more space-constrained chassis than for larger-capacity room air conditioners. There are no models commercially available that incorporate variable-speed compressors for cooling capacities less than 8,000 Btu/h. Additionally, average LCC savings are higher at EL 3 relative to EL 4 for product classes with cooling capacities less than 8,000 Btu/h. The adopted standard levels at TSL 3 results in positive LCC savings for all product classes, significantly reduce the number of consumers experiencing a net cost, and reduce the decrease in INPV and conversion costs to the point where DOE has concluded they are economically justified, as discussed for TSL 3 in the preceding paragraphs.</P>
                    <P>Therefore, based on the previous considerations, DOE adopts the energy conservation standards for room air conditioners at TSL 3. The amended energy conservation standards for room air conditioners, which are expressed as CEER, are shown in Table V.46.</P>
                    <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s200,21">
                        <TTITLE>Table V.46—Amended Energy Conservation Standards for Room Air Conditioners</TTITLE>
                        <BOXHD>
                            <CHED H="1">Product class</CHED>
                            <CHED H="1">
                                Adopted standard CEER
                                <LI>(Btu/h)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22">Room Air Conditioner without reverse cycle, with louvered sides:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">&lt;6,000 Btu/h (1)</ENT>
                            <ENT>13.1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">6,000 to 7,900 Btu/h (2)</ENT>
                            <ENT>13.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">8,000 to 13,900 Btu/h (3)</ENT>
                            <ENT>16.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">14,000 to 19,900 Btu/h (4)</ENT>
                            <ENT>16.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">20,000 to 27,900 Btu/h (5a)</ENT>
                            <ENT>13.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≥28,000 Btu/h (5b)</ENT>
                            <ENT>13.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Room Air Conditioner without reverse cycle, without louvered sides:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">&lt;6,000 Btu/h (6)</ENT>
                            <ENT>12.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">6,000 to 7,900 Btu/h (7)</ENT>
                            <ENT>12.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">8,000 to 10,900 Btu/h (8a)</ENT>
                            <ENT>14.1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">11,000 to 13,900 Btu/h (8b)</ENT>
                            <ENT>13.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">14,000 to 19,900 Btu/h (9)</ENT>
                            <ENT>13.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≥20,000 Btu/h (10)</ENT>
                            <ENT>13.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Room Air Conditioner with reverse cycle, with louvered sides:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">&lt;20,000 Btu/h (11)</ENT>
                            <ENT>14.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≥20,000 Btu/h (13)</ENT>
                            <ENT>13.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Room Air Conditioner with reverse cycle, without louvered sides:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">&lt;14,000 Btu/h (12)</ENT>
                            <ENT>13.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≥14,000 Btu/h (14)</ENT>
                            <ENT>12.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Casement:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Casement-Only (15)</ENT>
                            <ENT>13.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Casement-Slider (16)</ENT>
                            <ENT>15.3</ENT>
                        </ROW>
                    </GPOTABLE>
                    <PRTPAGE P="34358"/>
                    <HD SOURCE="HD3">2. Annualized Benefits and Costs of the Adopted Standards</HD>
                    <P>The benefits and costs of the adopted standards can also be expressed in terms of annualized values. The annualized net benefit is (1) the annualized national economic value (expressed in 2021$) of the benefits from operating products that meet the adopted standards (consisting primarily of operating cost savings from using less energy), minus increases in product purchase costs, and (2) the annualized monetary value of the climate and health benefits.</P>
                    <P>Table V.47 shows the annualized values for room air conditioners under TSL 3, expressed in 2021$. The results under the primary estimate are as follows.</P>
                    <P>
                        Using a 7-percent discount rate for consumer benefits and costs and NO
                        <E T="52">X</E>
                         and SO
                        <E T="52">2</E>
                         reductions, and the 3-percent discount rate case for GHG social costs, the estimated cost of the adopted standards for room air conditioners is $205.2 million per year in increased equipment installed costs, while the estimated annual benefits are $736.9 million from reduced equipment operating costs, $140.1 million in GHG reductions, and $199.9 million from reduced NO
                        <E T="52">X</E>
                         and SO
                        <E T="52">2</E>
                         emissions. In this case, the net benefit amounts to $871.7 million per year.
                    </P>
                    <P>
                        Using a 3-percent discount rate for all benefits and costs, the estimated cost of the adopted standards for room air conditioners is $176.8 million per year in increased equipment costs, while the estimated annual benefits are $815.8 million in reduced operating costs, $140.1 million from GHG reductions, and $244.8 million from reduced NO
                        <E T="52">X</E>
                         and SO
                        <E T="52">2</E>
                         emissions. In this case, the net benefit amounts to $1,023.9 million per year.
                    </P>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s100,17,17,17">
                        <TTITLE>Table V.47—Annualized Benefits and Costs of Adopted Standards (TSL 3) for Room Air Conditioners</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Million 2021$/year</CHED>
                            <CHED H="2">Primary estimate</CHED>
                            <CHED H="2">
                                Low-net-benefits
                                <LI>estimate</LI>
                            </CHED>
                            <CHED H="2">
                                High-net-benefits
                                <LI>estimate</LI>
                            </CHED>
                        </BOXHD>
                        <ROW EXPSTB="03" RUL="s">
                            <ENT I="21">
                                <E T="02">3% discount rate</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Consumer Operating Cost Savings</ENT>
                            <ENT>815.8</ENT>
                            <ENT>784.9</ENT>
                            <ENT>851.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Climate Benefits *</ENT>
                            <ENT>140.1</ENT>
                            <ENT>137.6</ENT>
                            <ENT>142.5</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Health Benefits **</ENT>
                            <ENT>244.8</ENT>
                            <ENT>240.6</ENT>
                            <ENT>248.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total Benefits †</ENT>
                            <ENT>1,200.6</ENT>
                            <ENT>1,163.2</ENT>
                            <ENT>1,243.3</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Consumer Incremental Product Costs ‡</ENT>
                            <ENT>176.8</ENT>
                            <ENT>199.0</ENT>
                            <ENT>152.2</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="03">Net Benefits</ENT>
                            <ENT>1,023.9</ENT>
                            <ENT>964.1</ENT>
                            <ENT>1,091.1</ENT>
                        </ROW>
                        <ROW EXPSTB="03" RUL="s">
                            <ENT I="21">
                                <E T="02">7% discount rate</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Consumer Operating Cost Savings</ENT>
                            <ENT>736.9</ENT>
                            <ENT>712.3</ENT>
                            <ENT>765.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Climate Benefits *</ENT>
                            <ENT>140.1</ENT>
                            <ENT>137.6</ENT>
                            <ENT>142.5</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Health Benefits **</ENT>
                            <ENT>199.9</ENT>
                            <ENT>196.8</ENT>
                            <ENT>203.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total Benefits †</ENT>
                            <ENT>1,076.9</ENT>
                            <ENT>1,046.7</ENT>
                            <ENT>1,111.0</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Consumer Incremental Product Costs ‡</ENT>
                            <ENT>205.2</ENT>
                            <ENT>227.0</ENT>
                            <ENT>181.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Net Benefits</ENT>
                            <ENT>871.7</ENT>
                            <ENT>819.7</ENT>
                            <ENT>930.0</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             This table presents the costs and benefits associated with room air conditioners shipped in 2026-2055. These results include benefits to consumers which accrue after 2057 from the products shipped in 2028-2057. The Primary, Low Net Benefits, and High Net Benefits Estimates utilize projections of energy prices from the 
                            <E T="03">AEO2022</E>
                             Reference case, Low Economic Growth case, and High Economic Growth case, respectively. In addition, incremental equipment costs reflect a medium decline rate in the Primary Estimate, a low decline rate in the Low Net Benefits Estimate, and a high decline rate in the High Net Benefits Estimate. The methods used to derive projected price trends are explained in sections IV.F.1 and IV.H.3 of this document. Note that the Benefits and Costs may not sum to the Net Benefits due to rounding.
                        </TNOTE>
                        <TNOTE>
                            * Climate benefits are calculated using four different estimates of the global SC-GHG (see section IV.L of this document). For presentational purposes of this table, the climate benefits associated with the average SC-GHG at a 3 percent discount rate are shown, but the Department does not have a single central SC-GHG point estimate, and it emphasizes the importance and value of considering the benefits calculated using all four sets of SC-GHG estimates. On March 16, 2022, the Fifth Circuit Court of Appeals (No. 22-30087) granted the Federal Government's emergency motion for stay pending appeal of the February 11, 2022, preliminary injunction issued in 
                            <E T="03">Louisiana</E>
                             v. 
                            <E T="03">Biden,</E>
                             No. 21-cv-1074-JDC-KK (W.D. La.). As a result of the Fifth Circuit's order, the preliminary injunction is no longer in effect, pending resolution of the Federal Government's appeal of that injunction or a further court order. Among other things, the preliminary injunction enjoined the defendants in that case from “adopting, employing, treating as binding, or relying upon” the interim estimates of the social cost of greenhouse gases—which were issued by the Interagency Working Group on the Social Cost of Greenhouse Gases on February 26, 2021—to monetize the benefits of reducing greenhouse gas emissions. As reflected in this rule, DOE has reverted to its approach prior to the injunction and presents monetized greenhouse gas abatement benefits where appropriate and permissible under law.
                        </TNOTE>
                        <TNOTE>
                            ** Health benefits are calculated using benefit-per-ton values for NO
                            <E T="0732">X</E>
                             and SO
                            <E T="0732">2</E>
                            . DOE is currently only monetizing (for SO
                            <E T="0732">2</E>
                             and NO
                            <E T="0732">X</E>
                            ) PM
                            <E T="0732">2.5</E>
                             precursor health benefits and (for NO
                            <E T="0732">X</E>
                            ) ozone precursor health benefits, but will continue to assess the ability to monetize other effects such as health benefits from reductions in direct PM
                            <E T="0732">2.5</E>
                             emissions. The health benefits are presented at real discount rates of 3 and 7 percent. See section IV.L of this document for more details.
                        </TNOTE>
                        <TNOTE>† Total and net benefits include consumer, climate, and health benefits. For presentation purposes, total and net benefits for both the 3-percent and 7-percent cases are presented using the average SC-GHG with 3-percent discount rate, but the Department does not have a single central SC-GHG point estimate.</TNOTE>
                        <TNOTE>‡ Costs include incremental equipment costs as well as installation costs.</TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD1">VI. Cooling Capacity Verification</HD>
                    <P>
                        In the April 2022 NOPR, DOE proposed to add the cooling capacity of room air conditioners to 10 CFR 429.134 to help regulated entities understand how DOE will determine the product class that applies to a given basic model in the context of an enforcement investigation. DOE proposed a similar approach to other products, where DOE would compare the mean of the tested cooling capacity from the units of a 
                        <PRTPAGE P="34359"/>
                        given basic model that DOE has tested for enforcement rounded to the nearest hundred to the certified cooling capacity by the manufacturer. DOE would use the certified cooling capacity of the manufacturer if the mean of the DOE tested units is within 5 percent of the certified cooling capacity. If the manufacturer does not have a valid certification, including if the certified cooling capacity was incorrectly certified, or the certified cooling capacity is found to be outside of the 5 percent tolerance, DOE would use the rounded mean of the DOE tested units within the enforcement sample to determine the applicable product class and energy conservation standard for this particular basic model.
                    </P>
                    <P>DOE received no comments on the proposed cooling capacity verification instructions and maintains that the provisions proposed in the April 2022 NOPR provide additional clarity and transparency to the enforcement process. Therefore, DOE is adopting the 10 CFR 429.134 amendments, as proposed in the April 2022 NOPR, in this final rule.</P>
                    <HD SOURCE="HD1">VII. Procedural Issues and Regulatory Review</HD>
                    <HD SOURCE="HD2">A. Review Under Executive Orders 12866 and 13563</HD>
                    <P>Executive Order (“E.O.”) 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 4, 1993), as supplemented and reaffirmed by E.O. 13563, “Improving Regulation and Regulatory Review”, 76 FR 3821 (Jan. 21, 2011), requires agencies, to the extent permitted by law, to: (1) propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public. DOE emphasizes as well that E.O. 13563 requires agencies to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible. In its guidance, the Office of Information and Regulatory Affairs (“OIRA”) in OMB has emphasized that such techniques may include identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes. For the reasons stated in the preamble, this final regulatory action is consistent with these principles.</P>
                    <P>Section 6(a) of E.O. 12866 also requires agencies to submit “significant regulatory actions” to OIRA for review. OIRA has determined that this final regulatory action constitutes a “significant regulatory action” within the scope of section 3(f)(1) of E.O. 12866. Accordingly, pursuant to section 6(a)(3)(C) of E.O. 12866, DOE has provided to OIRA an assessment, including the underlying analysis, of benefits and costs anticipated from the final regulatory action, together with, to the extent feasible, a quantification of those costs; and an assessment, including the underlying analysis, of costs and benefits of potentially effective and reasonably feasible alternatives to the planned regulation, and an explanation why the planned regulatory action is preferable to the identified potential alternatives. These assessments are summarized in this preamble and further detail can be found in the technical support document for this rulemaking.</P>
                    <HD SOURCE="HD2">B. Review Under the Regulatory Flexibility Act</HD>
                    <P>
                        The Regulatory Flexibility Act (5 U.S.C. 601 
                        <E T="03">et seq.</E>
                        ) requires preparation of an initial regulatory flexibility analysis (“IRFA”) and a final regulatory flexibility analysis (“FRFA”) for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by E.O. 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (Aug. 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the rulemaking process. 68 FR 7990. DOE has made its procedures and policies available on the Office of the General Counsel's website (
                        <E T="03">www.energy.gov/gc/office-general-counsel</E>
                        ).
                    </P>
                    <P>DOE reviewed this final rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. DOE certifies that the final rule would not have significant economic impact on a substantial number of small entities. The factual basis of this certification is set forth in the following paragraphs.</P>
                    <P>
                        For manufacturers of room air conditioners, the U.S. Small Business Administration (“SBA”) has set a size threshold, which defines those entities classified as “small businesses” for the purposes of the statute. DOE used the SBA's small business size standards to determine whether any small entities would be subject to the requirements of the rule. (See 13 CFR part 121.) The size standards are listed by North American Industry Classification System (“NAICS”) code and industry description and are available at 
                        <E T="03">www.sba.gov/document/support--table-size-standards.</E>
                         Manufacturing of room air conditioners is classified under NAICS 333415, “Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing.” The SBA sets a threshold of 1,250 employees or fewer for an entity to be considered as a small business for this category.
                    </P>
                    <P>
                        EPCA authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. (42 U.S.C. 6291-6317) Title III, Part B of EPCA 
                        <SU>77</SU>
                        <FTREF/>
                         established the Energy Conservation Program for Consumer Products Other Than Automobiles. (42 U.S.C. 6291-6309) These products include room air conditioners, the subject of this rulemaking.
                    </P>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             For editorial reasons, upon codification in the U.S. Code, Part B was redesignated Part A.
                        </P>
                    </FTNT>
                    <P>
                        Pursuant to EPCA, any new or amended energy conservation standard must be designed to achieve the maximum improvement in energy efficiency that DOE determines is technologically feasible and economically justified. (42 U.S.C. 6295(o)(2)(A)) Furthermore, the new or amended standard must result in significant conservation of energy. (42 U.S.C. 6295(o)(3)(B)) EPCA also provides that not later than 6 years after issuance of any final rule establishing or amending a standard, DOE must publish either a notice of determination that standards for the product do not need to be amended, or a notice of proposed rulemaking including new proposed energy conservation standards 
                        <PRTPAGE P="34360"/>
                        (proceeding to a final rule, as appropriate). (42 U.S.C. 6295(m))
                    </P>
                    <P>In accordance with these and other statutory provisions discussed in this document, DOE is adopting amended energy conservation standards for room air conditioners.</P>
                    <P>
                        To estimate the number of companies that could be small business manufacturers of products covered by this final rule, DOE conducted a market survey using public information and subscription-based company reports to identify potential small manufacturers. DOE's research involved DOE's Compliance Certification Database (“CCD”),
                        <SU>78</SU>
                        <FTREF/>
                         California Energy Commission's Modernized Appliance Efficiency Database System (“MAEDbS”),
                        <SU>79</SU>
                        <FTREF/>
                         ENERGY STAR Product Finder,
                        <SU>80</SU>
                        <FTREF/>
                         individual company websites, and market research tools (
                        <E T="03">e.g.,</E>
                         reports from Dun &amp; Bradstreet 
                        <SU>81</SU>
                        <FTREF/>
                        ) to create a list of companies that manufacture, produce, import, or assemble the products covered by this rulemaking. DOE also asked stakeholders and industry representatives if they were aware of any other small manufacturers during manufacturer interviews and at DOE public meetings.
                    </P>
                    <FTNT>
                        <P>
                            <SU>78</SU>
                             U.S. Department of Energy's Compliance Certification Database. Available at: 
                            <E T="03">regulations.doe.gov/certification-data/#q=Product_Group_s%3A*</E>
                             (last accessed: March 17, 2021).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>79</SU>
                             California Energy Commission's Modernized Appliance Efficiency Database System. Available at: 
                            <E T="03">cacertappliances.energy.ca.gov/Pages/ApplianceSearch.aspx</E>
                             (last accessed: March 17, 2021).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>80</SU>
                             U.S. Environmental Protection Agency's ENERGY STAR data set. Available at: 
                            <E T="03">energystar.gov/productfinder/</E>
                             (last accessed March 17, 2021).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>81</SU>
                             Dun &amp; Bradstreet subscription login is available at: 
                            <E T="03">app.dnbhoovers.com</E>
                             (last accessed September 14, 2022).
                        </P>
                    </FTNT>
                    <P>
                        DOE identified eight OEMs of room air conditioner products sold in the United States. Upon initial review, one OEM was identified as a small manufacturer based in the United States. However, in August 2021, a large manufacturer acquired the small manufacturer.
                        <SU>82</SU>
                        <FTREF/>
                         Following that acquisition, no domestic room air conditioner OEMs qualify as a small business. Given the lack of small entities with a direct compliance burden, DOE certifies that the proposed rule would not have “a significant economic impact on a substantial number of small entities.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>82</SU>
                             Rheem Manufacturing Company. 
                            <E T="03">Press Release.</E>
                             Available at: 
                            <E T="03">www.rheem.com/about/news-releases/rheem-acquires-friedrich-air-conditioning</E>
                             (published August 30, 2021).
                        </P>
                    </FTNT>
                    <P>DOE did not receive written comments in response to the April 2022 NOPR that specifically addressed the potential impacts on small businesses.</P>
                    <P>DOE has transmitted the certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the SBA for review under 5 U.S.C. 605(b).</P>
                    <HD SOURCE="HD2">C. Review Under the Paperwork Reduction Act</HD>
                    <P>
                        Manufacturers of room air conditioners must certify to DOE that their products comply with any applicable energy conservation standards. In certifying compliance, manufacturers must test their products according to the DOE test procedures for room air conditioners, including any amendments adopted for those test procedures. DOE has established regulations for the certification and recordkeeping requirements for all covered consumer products and commercial equipment, including room air conditioners. (
                        <E T="03">See generally</E>
                         10 CFR part 429.) The collection-of-information requirement for the certification and recordkeeping is subject to review and approval by OMB under the Paperwork Reduction Act (“PRA”). This requirement has been approved by OMB under OMB control number 1910-1400. Public reporting burden for the certification is estimated to average 35 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
                    </P>
                    <P>Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.</P>
                    <HD SOURCE="HD2">D. Review Under the National Environmental Policy Act of 1969</HD>
                    <P>
                        Pursuant to the National Environmental Policy Act of 1969 (“NEPA”), DOE has analyzed this rule in accordance with NEPA and DOE's NEPA implementing regulations (10 CFR part 1021). DOE has determined that this rule qualifies for categorical exclusion under 10 CFR part 1021, subpart D, appendix B, section B5.1, because it is a rulemaking that establishes energy conservation standards for consumer products or industrial equipment, none of the exceptions identified in section B5.1(b) apply, no extraordinary circumstances exist that require further environmental analysis, and it meets the requirements for application of a categorical exclusion. 
                        <E T="03">See</E>
                         10 CFR 1021.410. Therefore, DOE has determined that promulgation of this rule is not a major Federal action significantly affecting the quality of the human environment within the meaning of NEPA, and does not require an environmental assessment or an environmental impact statement.
                    </P>
                    <HD SOURCE="HD2">E. Review Under Executive Order 13132</HD>
                    <P>E.O. 13132, “Federalism,” 64 FR 43255 (Aug. 10, 1999), imposes certain requirements on Federal agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. The Executive order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this rule and has determined that it 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. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of this final rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297) Therefore, no further action is required by Executive Order 13132.</P>
                    <HD SOURCE="HD2">F. Review Under Executive Order 12988</HD>
                    <P>
                        With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of E.O. 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) eliminate drafting errors and ambiguity, (2) write regulations to minimize litigation, (3) provide a clear legal standard for affected conduct rather than a general standard, and (4) promote simplification and burden reduction. 61 FR 4729 (Feb. 7, 1996). Regarding the review required by section 3(a), section 3(b) of E.O. 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation (1) clearly specifies the 
                        <PRTPAGE P="34361"/>
                        preemptive effect, if any, (2) clearly specifies any effect on existing Federal law or regulation, (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction, (4) specifies the retroactive effect, if any, (5) adequately defines key terms, and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of E.O. 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this final rule meets the relevant standards of E.O. 12988.
                    </P>
                    <HD SOURCE="HD2">G. Review Under the Unfunded Mandates Reform Act of 1995</HD>
                    <P>
                        Title II of the Unfunded Mandates Reform Act of 1995 (“UMRA”) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, section. 201 (codified at 2 U.S.C. 1531). For a regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820. DOE's policy statement is also available at 
                        <E T="03">www.energy.gov/sites/prod/files/gcprod/documents/umra_97.pdf.</E>
                    </P>
                    <P>DOE has concluded that this final rule may require expenditures of $100 million or more in any one year by the private sector. Such expenditures may include (1) investment in research and development and in capital expenditures by room air conditioner manufacturers in the years between the final rule and the compliance date for the new standards and (2) incremental additional expenditures by consumers to purchase higher-efficiency room air conditioners, starting at the compliance date for the applicable standard.</P>
                    <P>
                        Section 202 of UMRA authorizes a Federal agency to respond to the content requirements of UMRA in any other statement or analysis that accompanies the final rule. (2 U.S.C. 1532(c)) The content requirements of section 202(b) of UMRA relevant to a private sector mandate substantially overlap the economic analysis requirements that apply under section 325(o) of EPCA and Executive Order 12866. This 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section and the TSD for this final rule respond to those requirements.
                    </P>
                    <P>Under section 205 of UMRA, the Department is obligated to identify and consider a reasonable number of regulatory alternatives before promulgating a rule for which a written statement under section 202 is required. (2 U.S.C. 1535(a)) DOE is required to select from those alternatives the most cost-effective and least burdensome alternative that achieves the objectives of the rule unless DOE publishes an explanation for doing otherwise, or the selection of such an alternative is inconsistent with law. As required by 42 U.S.C. 6295(m), this final rule establishes amended energy conservation standards for room air conditioners that are designed to achieve the maximum improvement in energy efficiency that DOE has determined to be both technologically feasible and economically justified, as required by 6295(o)(2)(A) and 6295(o)(3)(B). A full discussion of the alternatives considered by DOE is presented in chapter 17 of the TSD for this final rule.</P>
                    <HD SOURCE="HD2">H. Review Under the Treasury and General Government Appropriations Act, 1999</HD>
                    <P>Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.</P>
                    <HD SOURCE="HD2">I. Review Under Executive Order 12630</HD>
                    <P>Pursuant to E.O. 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,” 53 FR 8859 (Mar. 18, 1988), DOE has determined that this rule would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.</P>
                    <HD SOURCE="HD2">J. Review Under the Treasury and General Government Appropriations Act, 2001</HD>
                    <P>
                        Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for Federal agencies to review most disseminations of information to the public under information quality guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). Pursuant to OMB Memorandum M-19-15, Improving Implementation of the Information Quality Act (April 24, 2019), DOE published updated guidelines which are available at 
                        <E T="03">www.energy.gov/sites/prod/files/2019/12/f70/DOE%20Final%20Updated%20IQA%20Guidelines%20Dec%202019.pdf.</E>
                         DOE has reviewed this final rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
                    </P>
                    <HD SOURCE="HD2">K. Review Under Executive Order 13211</HD>
                    <P>E.O. 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OIRA at OMB, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that (1) is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.</P>
                    <P>
                        DOE has concluded that this regulatory action, which sets forth amended energy conservation standards for room air conditioners, is not a significant energy action because the standards are not likely to have a significant adverse effect on the supply, 
                        <PRTPAGE P="34362"/>
                        distribution, or use of energy, nor has it been designated as such by the Administrator at OIRA. Accordingly, DOE has not prepared a Statement of Energy Effects on this final rule.
                    </P>
                    <HD SOURCE="HD2">L. Information Quality</HD>
                    <P>On December 16, 2004, OMB, in consultation with the Office of Science and Technology Policy (“OSTP”), issued its Final Information Quality Bulletin for Peer Review (“the Bulletin”). 70 FR 2664 (Jan. 14, 2005). The Bulletin establishes that certain scientific information shall be peer reviewed by qualified specialists before it is disseminated by the Federal Government, including influential scientific information related to agency regulatory actions. The purpose of the Bulletin is to enhance the quality and credibility of the Government's scientific information. Under the Bulletin, the energy conservation standards rulemaking analyses are “influential scientific information,” which the Bulletin defines as “scientific information the agency reasonably can determine will have, or does have, a clear and substantial impact on important public policies or private sector decisions.” 70 FR 2664, 2667.</P>
                    <P>
                        In response to OMB's Bulletin, DOE conducted formal peer reviews of the energy conservation standards development process and the analyses that are typically used and prepared a report describing that peer review.
                        <SU>83</SU>
                        <FTREF/>
                         Generation of this report involved a rigorous, formal, and documented evaluation using objective criteria and qualified and independent reviewers to make a judgment as to the technical/scientific/business merit, the actual or anticipated results, and the productivity and management effectiveness of programs and/or projects. Because available data, models, and technological understanding have changed since 2007, DOE has engaged with the National Academy of Sciences to review DOE's analytical methodologies to ascertain whether modifications are needed to improve the Department's analyses. DOE is in the process of evaluating the resulting report.
                        <SU>84</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>83</SU>
                             The 2007 “Energy Conservation Standards Rulemaking Peer Review Report” is available at the following website: 
                            <E T="03">energy.gov/eere/buildings/downloads/energy-conservation-standards-rulemaking-peer-review-report-0</E>
                             (last accessed September 12, 2022).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>84</SU>
                             The report is available at 
                            <E T="03">www.nationalacademies.org/our-work/review-of-methods-for-setting-building-and-equipment-performance-standards.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">M. Congressional Notification</HD>
                    <P>As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule prior to its effective date. The report will state that it has been determined that the rule is a “major rule” as defined by 5 U.S.C. 804(2).</P>
                    <HD SOURCE="HD1">VIII. Approval of the Office of the Secretary</HD>
                    <P>The Secretary of Energy has approved publication of this final rule.</P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects</HD>
                        <CFR>10 CFR Part 429</CFR>
                        <P>Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Reporting and recordkeeping requirements.</P>
                        <CFR>10 CFR Part 430</CFR>
                        <P>Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Intergovernmental relations, Reporting and recordkeeping requirements, Small businesses.</P>
                    </LSTSUB>
                    <HD SOURCE="HD1">Signing Authority</HD>
                    <P>
                        This document of the Department of Energy was signed on March 22, 2023, by Francisco Alejandro Moreno, Acting Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. 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>
                        <P>Signed in Washington, DC, on May 10, 2023.</P>
                        <NAME>Treena V. Garrett,</NAME>
                        <TITLE>Federal Register Liaison Officer, U.S. Department of Energy.</TITLE>
                    </SIG>
                    <P>For the reasons stated in the preamble, DOE amends parts 429 and 430 of chapter II, subchapter D, of title 10 of the Code of Federal Regulations, as set forth below:</P>
                    <PART>
                        <HD SOURCE="HED">PART 429—CERTIFICATION, COMPLIANCE, AND ENFORCEMENT FOR CONSUMER PRODUCTS AND COMMERCIAL AND INDUSTRIAL EQUIPMENT</HD>
                    </PART>
                    <REGTEXT TITLE="10" PART="429">
                        <AMDPAR>1. The authority citation for part 429 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P> 42 U.S.C. 6291-6317; 28 U.S.C. 2461 note.</P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="10" PART="429">
                        <AMDPAR>2. Amend § 429.134 by adding paragraph (bb) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 429.134</SECTNO>
                            <SUBJECT>Product-specific enforcement provisions.</SUBJECT>
                            <STARS/>
                            <P>
                                (bb) 
                                <E T="03">Room air conditioners.</E>
                                 The cooling capacity will be measured pursuant to the test requirements of 10 CFR part 430 for each unit tested. The results of the measurement(s) will be averaged and compared to the value of cooling capacity certified by the manufacturer for the basic model. The certified cooling capacity will be considered valid only if the measurement is within five percent of the certified cooling capacity.
                            </P>
                            <P>(1) If the certified cooling capacity is found to be valid, the certified cooling capacity will be used as the basis for determining the minimum combined energy efficiency ratio allowed for the basic model.</P>
                            <P>(2) If the certified cooling capacity is found to be invalid, the average measured cooling capacity of the units in the sample will be used as the basis for determining the minimum combined energy efficiency ratio allowed for the basic model.</P>
                        </SECTION>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 430—ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS</HD>
                    </PART>
                    <REGTEXT TITLE="10" PART="430">
                        <AMDPAR>3. The authority citation for part 430 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority: </HD>
                            <P>42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.</P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="10" PART="430">
                        <AMDPAR>4. Amend § 430.32 by revising paragraph (b) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 430.32</SECTNO>
                            <SUBJECT>Energy and water conservation standards and their compliance dates.</SUBJECT>
                            <STARS/>
                            <P>
                                (b) 
                                <E T="03">Room air conditioners.</E>
                                 (1) The following standards remain in effect from June 1, 2014, until May 26, 2026:
                                <PRTPAGE P="34363"/>
                            </P>
                            <GPOTABLE COLS="2" OPTS="L2,nj,i1" CDEF="s200,15">
                                <TTITLE>
                                    Table 3 to Paragraph (
                                    <E T="01">b</E>
                                    )
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">Equipment class</CHED>
                                    <CHED H="1">
                                        Combined energy
                                        <LI>efficiency ratio</LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">
                                        1. Without reverse cycle, with louvered sides, and with a certified cooling capacity 
                                        <SU>1</SU>
                                         less than 6,000 Btu/h
                                    </ENT>
                                    <ENT>11.0</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">2. Without reverse cycle, with louvered sides and with a certified cooling capacity of 6,000 to 7,999 Btu/h</ENT>
                                    <ENT>11.0</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">3. Without reverse cycle, with louvered sides and with a certified cooling capacity of 8,000 to 13,999 Btu/h</ENT>
                                    <ENT>10.9</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">4. Without reverse cycle, with louvered sides and with a certified cooling capacity of 14,000 to 19,999 Btu/h</ENT>
                                    <ENT>10.7</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">5a. Without reverse cycle, with louvered sides and with a certified cooling capacity of 20,000 Btu/h to 27,999 Btu/h</ENT>
                                    <ENT>9.4</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">5b. Without reverse cycle, with louvered sides and with a certified cooling capacity of 28,000 Btu/h or more</ENT>
                                    <ENT>9.0</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">6. Without reverse cycle, without louvered sides, and with a certified cooling capacity less than 6,000 Btu/h</ENT>
                                    <ENT>10.0</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">7. Without reverse cycle, without louvered sides and with a certified cooling capacity of 6,000 to 7,999 Btu/h</ENT>
                                    <ENT>10.0</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">8a. Without reverse cycle, without louvered sides and with a certified cooling capacity of 8,000 to 10,999 Btu/h</ENT>
                                    <ENT>9.6</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">8b. Without reverse cycle, without louvered sides and with a certified cooling capacity of 11,000 to 13,999 Btu/h</ENT>
                                    <ENT>9.5</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">9. Without reverse cycle, without louvered sides and with a certified cooling capacity of 14,000 to 19,999 Btu/h</ENT>
                                    <ENT>9.3</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">10. Without reverse cycle, without louvered sides and with a certified cooling capacity of 20,000 Btu/h or more</ENT>
                                    <ENT>9.4</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">11. With reverse cycle, with louvered sides, and with a certified cooling capacity less than 20,000 Btu/h</ENT>
                                    <ENT>9.8</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">12. With reverse cycle, without louvered sides, and with a certified cooling capacity less than 14,000 Btu/h</ENT>
                                    <ENT>9.3</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">13. With reverse cycle, with louvered sides, and with a certified cooling capacity of 20,000 Btu/h or more</ENT>
                                    <ENT>9.3</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">14. With reverse cycle, without louvered sides, and with a certified cooling capacity of 14,000 Btu/h or more</ENT>
                                    <ENT>8.7</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">15. Casement-Only</ENT>
                                    <ENT>9.5</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">16. Casement-Slider</ENT>
                                    <ENT>10.4</ENT>
                                </ROW>
                                <TNOTE>
                                    <SU>1</SU>
                                     The certified cooling capacity is determined by the manufacturer in accordance with 10 CFR 429.15(a)(3).
                                </TNOTE>
                            </GPOTABLE>
                            <P>(2) The following standards apply to products manufactured starting May 26, 2026:</P>
                            <GPOTABLE COLS="2" OPTS="L2,nj,i1" CDEF="s200,15">
                                <TTITLE>
                                    Table 4 to Paragraph (
                                    <E T="01">b</E>
                                    )(2)
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">Equipment class</CHED>
                                    <CHED H="1">
                                        Combined energy
                                        <LI>efficiency ratio</LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">
                                        1. Without reverse cycle, with louvered sides, and with a certified cooling capacity 
                                        <SU>1</SU>
                                         less than 6,000 Btu/h
                                    </ENT>
                                    <ENT>13.1</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">2. Without reverse cycle, with louvered sides and with a certified cooling capacity of 6,000 to 7,900 Btu/h</ENT>
                                    <ENT>13.7</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">3. Without reverse cycle, with louvered sides and with a certified cooling capacity of 8,000 to 13,900 Btu/h</ENT>
                                    <ENT>16.0</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">4. Without reverse cycle, with louvered sides and with a certified cooling capacity of 14,000 to 19,900 Btu/h</ENT>
                                    <ENT>16.0</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">5a. Without reverse cycle, with louvered sides and with a certified cooling capacity of 20,000 Btu/h to 27,900 Btu/h</ENT>
                                    <ENT>13.8</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">5b. Without reverse cycle, with louvered sides and with a certified cooling capacity of 28,000 Btu/h or more</ENT>
                                    <ENT>13.2</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">6. Without reverse cycle, without louvered sides, and with a certified cooling capacity less than 6,000 Btu/h</ENT>
                                    <ENT>12.8</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">7. Without reverse cycle, without louvered sides and with a certified cooling capacity of 6,000 to 7,900 Btu/h</ENT>
                                    <ENT>12.8</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">8a. Without reverse cycle, without louvered sides and with a certified cooling capacity of 8,000 to 10,900 Btu/h</ENT>
                                    <ENT>14.1</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">8b. Without reverse cycle, without louvered sides and with a certified cooling capacity of 11,000 to 13,900 Btu/h</ENT>
                                    <ENT>13.9</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">9. Without reverse cycle, without louvered sides and with a certified cooling capacity of 14,000 to 19,900 Btu/h</ENT>
                                    <ENT>13.7</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">10. Without reverse cycle, without louvered sides and with a certified cooling capacity of 20,000 Btu/h or more</ENT>
                                    <ENT>13.8</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">11. With reverse cycle, with louvered sides, and with a certified cooling capacity less than 20,000 Btu/h</ENT>
                                    <ENT>14.4</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">12. With reverse cycle, without louvered sides, and with a certified cooling capacity less than 14,000 Btu/h</ENT>
                                    <ENT>13.7</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">13. With reverse cycle, with louvered sides, and with a certified cooling capacity of 20,000 Btu/h or more</ENT>
                                    <ENT>13.7</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">14. With reverse cycle, without louvered sides, and with a certified cooling capacity of 14,000 Btu/h or more</ENT>
                                    <ENT>12.8</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">15. Casement-Only</ENT>
                                    <ENT>13.9</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">16. Casement-Slider</ENT>
                                    <ENT>15.3</ENT>
                                </ROW>
                                <TNOTE>
                                    <SU>1</SU>
                                     The certified cooling capacity is determined by the manufacturer in accordance with 10 CFR 429.15(a)(3).
                                </TNOTE>
                            </GPOTABLE>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <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—Letter From the Department of Justice to the Department of Energy</HD>
                        <FP SOURCE="FP-1">U.S. Department of Justice, Antitrust Division, Jonathan S. Kanter, Assistant Attorney General, Main Justice Building, 950 Pennsylvania Avenue NW, Washington, DC 20530-0001, (202) 514-2401/(202) 616-2645 (Fax), May 31, 2022</FP>
                        <FP SOURCE="FP-1">
                            Ami Grace-Tardy, Assistant General Counsel for Legislation, Regulation and Energy Efficiency, U.S. Department of Energy, Washington, DC 20585, 
                            <E T="03">Ami.Grace-Tardy@hq.doe.gov</E>
                        </FP>
                        <P>Dear Assistant General Counsel Grace-Tardy:</P>
                        <P>I am responding to your April 7, 2022, letter seeking the views of the Attorney General about the potential impact on competition of proposed energy conservation standards for room air conditioners (room ACs). Your request was submitted under Section 325(o)(2)(B)(i)(V) of the Energy Policy and Conservation Act, as amended (EPCA), 42 U.S.C. 6295(o)(2)(B)(i)(V) and 42 U.S.C. 6316(a), which requires the Attorney General to make a determination of the impact of any lessening of competition that is likely to result from the imposition of proposed energy conservation standards. The Attorney General's responsibility for responding to requests from other departments about the effect of a program on competition has been delegated to the Assistant Attorney General for the Antitrust Division in 28 CFR 0.40(g).</P>
                        <P>
                            In conducting its analysis, the Antitrust Division examines whether a proposed standard may lessen competition, for example, by substantially limiting consumer choice or increasing industry concentration. A lessening of competition could result in higher prices to manufacturers and consumers. We have reviewed the proposed standards contained in the Notice of Proposed Rulemaking (87 FR 20608 April 7, 2022), and the related technical support documents. We also reviewed the transcript 
                            <PRTPAGE P="34364"/>
                            from the public meeting held on May 3, 2022 and reviewed public comments submitted by industry members in response to DOE's Request for Information in this matter.
                        </P>
                        <P>Based on the information currently available, we do not believe that the proposed energy conservation standards for room ACs are likely to have a significant adverse impact on competition.</P>
                        <P>Sincerely,</P>
                        <FP>Jonathan S. Kanter,</FP>
                    </APPENDIX>
                </SUPLINF>
                <FRDOC>[FR Doc. 2023-10287 Filed 5-25-23; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 6450-01-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
    <VOL>88</VOL>
    <NO>102</NO>
    <DATE>Friday, May 26, 2023</DATE>
    <UNITNAME>Notices</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="34365"/>
            <PARTNO>Part IV</PARTNO>
            <AGENCY TYPE="P"> Department of Transportation</AGENCY>
            <SUBAGY>National Highway Traffic Safety Administration</SUBAGY>
            <TITLE>New Car Assessment Program; Notice</TITLE>
        </PTITLE>
        <NOTICES>
            <NOTICE>
                <PREAMB>
                    <PRTPAGE P="34366"/>
                    <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                    <SUBAGY>National Highway Traffic Safety Administration</SUBAGY>
                    <DEPDOC>[Docket No. NHTSA-2023-0020]</DEPDOC>
                    <SUBJECT>New Car Assessment Program</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Request for comments (RFC).</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>This notice requests comment on a proposal to update the National Highway Traffic Safety Administration's New Car Assessment Program (NCAP) to provide consumers with information about crashworthiness pedestrian protection of new vehicles. The proposed updates to NCAP would provide valuable safety information to consumers about the ability of vehicles to protect pedestrians and could incentivize vehicle manufacturers to produce vehicles that provide better protection for vulnerable road users such as pedestrians. In addition, this proposal addresses several mandates set forth in section 24213 of the November 2021 Bipartisan Infrastructure Law, enacted as the Infrastructure Investment and Jobs Act.</P>
                    </SUM>
                    <DATES>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>Comments should be submitted no later than July 25, 2023.</P>
                    </DATES>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>Comments should refer to the docket number above and be submitted by one of the following methods:</P>
                        <P>
                            • 
                            <E T="03">Federal Rulemaking Portal: http://www.regulations.gov.</E>
                             Follow the online instructions for submitting comments.
                        </P>
                        <P>
                            • 
                            <E T="03">Mail:</E>
                             Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590-0001.
                        </P>
                        <P>
                            • 
                            <E T="03">Hand Delivery:</E>
                             1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC, between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal Holidays.
                        </P>
                        <P>
                            • 
                            <E T="03">Instructions:</E>
                             For detailed instructions on submitting comments, see the Public Participation heading of the 
                            <E T="02">SUPPLEMENTARY INFORMATION</E>
                             section of this document. Note that all comments received will be posted without change to 
                            <E T="03">http://www.regulations.gov,</E>
                             including any personal information provided.
                        </P>
                        <P>
                            • 
                            <E T="03">Privacy Act:</E>
                             Anyone can search the electronic form of all 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.). You may review DOT's complete Privacy Act Statement in the 
                            <E T="04">Federal Register</E>
                             published on April 11, 2000 (65 FR 19477-78) or at 
                            <E T="03">https://www.transportation.gov/privacy.</E>
                             For access to the docket to read background documents or comments received, go to 
                            <E T="03">http://www.regulations.gov</E>
                             or the street address listed above. Follow the online instructions for accessing the dockets.
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>For technical issues, you may contact Ms. Jennifer N. Dang, Division Chief, New Car Assessment Program, Office of Crashworthiness Standards (Telephone: 202-366-1810). For legal issues, you may contact Ms. Sara R. Bennett, Office of Chief Counsel (Telephone: 202-366-2992). You may send mail to either of these officials at the National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE, West Building, Washington, DC 20590-0001.</P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">Table of Contents</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">I. Executive Summary</FP>
                        <FP SOURCE="FP-2">II. Background</FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">A. December 16, 2015, Request for Comments</E>
                        </FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">B. October 1, 2018, Public Meeting</E>
                        </FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">C. Bipartisan Infrastructure Law and March 9, 2022, Request for Comments</E>
                        </FP>
                        <FP SOURCE="FP-2">III. Purpose and Rationale</FP>
                        <FP SOURCE="FP-2">IV. Crashworthiness Pedestrian Protection Testing Program</FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">A. Safety Need</E>
                        </FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">B. System Designs Exist</E>
                        </FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">C. Potential Safety Benefits</E>
                        </FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">D. Objective Test Procedure Exists</E>
                        </FP>
                        <FP SOURCE="FP1-2">1. Headforms and Head Impacts</FP>
                        <FP SOURCE="FP1-2">2. Legforms and Leg Impacts</FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">E. Response to Comments Received in Previous Actions</E>
                        </FP>
                        <FP SOURCE="FP1-2">1. General Pedestrian Protection Comments</FP>
                        <FP SOURCE="FP1-2">2. Part 581 Issues</FP>
                        <FP SOURCE="FP1-2">3. Test Device Issues</FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">F. Proposal in Detail</E>
                        </FP>
                        <FP SOURCE="FP1-2">1. Differences From Euro NCAP Tests and Assessment Protocols</FP>
                        <FP SOURCE="FP1-2">a. Self-Reporting Data</FP>
                        <FP SOURCE="FP1-2">b. No “Blue Points” for Predicted Head Impact Test Data</FP>
                        <FP SOURCE="FP1-2">c. Use of FlexPLI on Pickup Trucks and Large SUVs</FP>
                        <FP SOURCE="FP1-2">d. No Bumper Testing When LBRL is Greater Than 500 mm</FP>
                        <FP SOURCE="FP1-2">e. Addressing Artificial Interference in High-Bumper Vehicles</FP>
                        <FP SOURCE="FP1-2">f. Revised Bumper Corner Definition</FP>
                        <FP SOURCE="FP1-2">g. FlexPLI Qualification</FP>
                        <FP SOURCE="FP1-2">h. Active Hood Detection Area</FP>
                        <FP SOURCE="FP1-2">2. Injury Limits and Scoring Process</FP>
                        <FP SOURCE="FP1-2">3. NCAP Proposal for Awarding Credit</FP>
                        <FP SOURCE="FP1-2">4. NCAP Verification Testing</FP>
                        <FP SOURCE="FP-2">V. Conclusion</FP>
                        <FP SOURCE="FP-2">VI. Economic Analysis</FP>
                        <FP SOURCE="FP-2">VII. Public Participation</FP>
                        <FP SOURCE="FP-2">VIII. Appendices</FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">A. Additional Pedestrian Crash Data</E>
                        </FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">B. Vehicle Scoring and Verification Testing Example</E>
                        </FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">C. Questions Asked Throughout This Notice</E>
                        </FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. Executive Summary</HD>
                    <P>The National Highway Traffic Safety Administration's (NHTSA) New Car Assessment Program (NCAP) provides comparative information on the safety performance of new vehicles and availability of new vehicle safety features to assist consumers with vehicle purchasing decisions and to encourage safety improvements. NCAP is one of several programs that NHTSA uses to fulfill its mission of reducing the number of fatalities, injuries, and economic losses that occur on United States (U.S.) roadways. This Request for Comments focuses on the inclusion of the first ever pedestrian protection program in U.S. NCAP.</P>
                    <P>
                        While passenger vehicle occupant fatalities decreased from 32,225 in 2000 
                        <SU>1</SU>
                        <FTREF/>
                         to 23,824 in 2020,
                        <SU>2</SU>
                        <FTREF/>
                         during that same timeframe, pedestrian fatalities increased by 37 percent, from 4,739 in 2000 to 6,516 in 2020.
                        <SU>3</SU>
                         
                        <SU>4</SU>
                        <FTREF/>
                         These 6,516 pedestrian deaths in 2020 represent 17 percent of all traffic fatalities that year. In contrast, pedestrian injuries (54,769) were less than 3 percent of all motor vehicle occupant injuries (2,093,246) in 2020. Although vehicle-to-pedestrian crashes do not occur as frequently as vehicle-to-vehicle crashes, they are especially deadly. In fact, a NHTSA study that grouped various pre-crash scenarios into nine distinct pre-crash scenario groups,
                        <SU>5</SU>
                        <FTREF/>
                         including a group involving light vehicle 
                        <SU>6</SU>
                        <FTREF/>
                         crashes with a pedestrian, estimated that on an annual 
                        <PRTPAGE P="34367"/>
                        average, 53 of every 1,000 vehicle-to-pedestrian crashes is a fatal crash.
                        <SU>7</SU>
                        <FTREF/>
                         This fatality statistic in the light vehicle-pedestrian pre-crash scenario group is significantly greater than any of the other eight pre-crash scenario groups in the study.
                        <SU>8</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Traffic Safety Facts 2019 “A Complication of Motor Vehicle Crash Data.” U.S. Department of Transportation. National Highway Traffic Safety Administration.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             Stewart, T. (2022, March). Overview of motor vehicle crashes in 2020 (Report No. DOT HS 813 266). National Highway Traffic Safety Administration.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             Traffic Safety Facts 2000 “
                            <E T="03">A Compilation of Motor Vehicle Crash Data from the Fatality Analysis Reporting System and the General Estimates System.</E>
                            ” U.S. Department of Transportation. National Highway Traffic Safety Administration.
                        </P>
                        <P>
                            <SU>4</SU>
                             Stewart, T. (2022, March). Overview of motor vehicle crashes in 2020 (Report No. DOT HS 813 266). National Highway Traffic Safety Administration.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             The nine pre-crash scenario groups are: control loss (vehicle lost control), road departure (vehicle departed road), animal (vehicle struck animal), pedestrian (vehicle struck pedestrian), pedalcyclist (vehicle struck pedalcyclist), lane change (vehicle made lane change), opposite direction (vehicle maneuvered into opposite direction), rear-end (vehicle struck rear of other vehicle), and crossing paths (vehicle traveled straight crossing another vehicle's path or turned and crossed another vehicle's path).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             Light vehicles include all passenger cars, vans, minivans, sport utility vehicles, or light pickup trucks with gross vehicle weight ratings less than or equal to 4,536 kilograms.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             Swanson, E., Foderaro, F., Yanagisawa, M., Najm, W.G., &amp; Azeredo, P. (2019, August). Statistics of light-vehicle pre-crash scenarios based on 2011-2015 national crash data (Report No. DOT HS 812 745). Table ES1—Yearly Average Statistics—Scenario Groups Based on 2011-2015 FARS and GES. Washington, DC. National Highway Traffic Safety Administration.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             The pre-crash scenario group “Opposite Direction” resulted in 32.3 fatal crashes per thousand crashes, the second highest. One of the lowest scenario groups was “Rear-End,” which only resulted in 0.7 fatal crashes per thousand crashes. On average, the nine scenario groups resulted in 4.9 fatal crashes per thousand crashes.
                        </P>
                    </FTNT>
                    <P>
                        Historically, features rated or otherwise included in NCAP have focused largely on the protection of occupants in motor vehicles. However, NHTSA has also recognized the importance of protecting vulnerable road users, such as pedestrians, from injury and death due to motor vehicle crashes. In support of furthering the goal of protecting pedestrians from being seriously injured or killed in motor vehicle crashes, NHTSA has conducted a number of activities including research, international regulation development, and domestic regulation development.
                        <SU>9</SU>
                        <FTREF/>
                         On December 16, 2015, NHTSA published a broad request for comment (RFC) (the December 2015 Notice) 
                        <SU>10</SU>
                        <FTREF/>
                         and sought public comment on the Agency's proposal that included, among other things, a new crashworthiness pedestrian protection testing program in NCAP. The December 2015 Notice proposed adding to NCAP test procedures and evaluation criteria similar to those used by the European New Car Assessment Programme (Euro NCAP) at the time to assess new vehicles for crashworthiness pedestrian protection performance.
                    </P>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             
                            <E T="03">https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202204&amp;RIN=2127-AK98.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             80 FR 78522.
                        </P>
                    </FTNT>
                    <P>
                        In this RFC, NHTSA is proposing to add crashworthiness pedestrian protection to NCAP to spur vehicle technologies that help address the rising number of fatalities and injuries that involve pedestrians. NHTSA proposes to test vehicles using all four test devices currently utilized in Euro NCAP—adult and child headforms (representative of the weight of an adult and child head), the upper legform, and the FlexPLI lower legform.
                        <SU>11</SU>
                        <FTREF/>
                         The Agency is also proposing to adopt the majority of Euro NCAP's pedestrian crashworthiness assessment methods, including the injury limits for each test device and the method in which scores for each impact point are calculated. However, this RFC does not propose a comparative rating system for crashworthiness pedestrian protection. Instead, NHTSA is proposing to identify new model year vehicles that meet a certain minimum safety threshold on the Agency's website and in other published literature.
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             The terms “headform” and “legform” are used to describe the pedestrian head and leg test devices, which are general representations of human heads and legs. The head and leg test devices are described in greater detail later in this notice.
                        </P>
                    </FTNT>
                    <P>
                        While the subject of this RFC also covers pedestrian protection, it should be viewed as a new initiative, not an extension of the December 2015 Notice. To this point, NHTSA noted in its March 9, 2022, NCAP RFC 
                        <SU>12</SU>
                        <FTREF/>
                         that finalizing that 2022 RFC would close the December 16, 2015 proceeding and notice. The March 2022 NCAP RFC proposed adding four new advanced driver assistance systems (ADAS) technologies to those currently recommended in NCAP, increasing stringency of the evaluation of currently recommended ADAS technologies, and a ten-year roadmap of NHTSA's plans to upgrade NCAP in phases. NHTSA noted in the March 2022 notice that all information previously collected by NHTSA may be used in the development of future notices, such as this one. As such, this notice replaces the previous NCAP crashworthiness pedestrian protection proposal from the December 2015 RFC, in its entirety.
                    </P>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             87 FR 13452.
                        </P>
                    </FTNT>
                    <P>
                        This proposal is part of the Agency's multi-faceted effort to encourage pedestrian safety improvements in vehicles by providing comprehensive vehicle safety information to consumers on (1) whether a vehicle can offer better protection to pedestrians in the event of a collision with a pedestrian and (2) whether a vehicle can prevent a collision with a pedestrian or reduce the severity of injuries to a pedestrian when equipped with advanced driver assistance systems such as pedestrian automatic emergency braking. The latter was proposed to be added to NCAP in the March 2022 RFC. In addition, NHTSA is working to issue a proposal mandating such systems in all new light vehicles. As stated in the Department of Transportation's National Roadway Safety Strategy, proposals to update NCAP are expected to emphasize safety features that protect people both inside and outside of the vehicle, and may include consideration of pedestrian protection systems, better understanding of impacts to pedestrians (
                        <E T="03">e.g.,</E>
                         specific considerations for children), and automatic emergency braking and lane keeping assistance to benefit bicyclists and pedestrians.
                        <SU>13</SU>
                        <FTREF/>
                         The Agency is also pursuing a rulemaking to set minimum safety standards for pedestrian protection.
                        <SU>14</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             
                            <E T="03">See https://www.transportation.gov/sites/dot.gov/files/2022-02/USDOT-National-Roadway-Safety-Strategy.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             RIN 2127-AK98 available at 
                            <E T="03">https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202204&amp;RIN=2127-AK98.</E>
                        </P>
                    </FTNT>
                    <P>
                        From a testing perspective, NHTSA still plans to align with, to the extent feasible, the Euro NCAP test procedures and evaluation criteria for pedestrian protection 
                        <SU>15</SU>
                        <FTREF/>
                         for the Agency's new crashworthiness pedestrian protection testing program. However, in order to accelerate the adoption of pedestrian protection features into new vehicles, NHTSA is not proposing changes to the 5-star ratings system at this time.
                        <SU>16</SU>
                        <FTREF/>
                         As discussed in the notice that was published on March 9, 2022, NHTSA plans for multiple updates to NCAP in the next several years—as part of the Agency's short-term roadmap that will include various enhanced tools and techniques (advanced dummies, tests, rating systems, etc.) in both crashworthiness and crash avoidance programs. Until NHTSA completes a rulemaking to update the Monroney label, NHTSA plans to introduce the new crashworthiness pedestrian safety program in NCAP by highlighting on the NHTSA website new vehicles that meet NHTSA's performance test criteria for providing better pedestrian protection in the event of a collision with a pedestrian. NHTSA proposes using a pass/fail scoring system, described below, and will consider including pedestrian protection in the rating system when it updates the Monroney label.
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             Euro NCAP Pedestrian Testing Protocol—euro-ncap-pedestrian-testing-protocol-v85.201811091256001913.pdf (
                            <E T="03">euroncap.com</E>
                            ) and Part I Pedestrian Impact Assessment in 
                            <E T="03">https://cdn.euroncap.com/media/67553/euro-ncap-assessment-protocol-vru-v1005.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             Currently, the existing 5-star ratings system does not address pedestrian safety evaluation.
                        </P>
                    </FTNT>
                    <P>
                        The testing methodology proposed in this notice is very similar to that of Euro NCAP.
                        <SU>17</SU>
                        <FTREF/>
                         The pedestrian protection testing evaluates the potential risk of head, pelvis, leg, and knee injuries to pedestrians hit by the front of vehicles that result in impacts between the pedestrian and the bumper, leading edge, hood, and windshield of a vehicle. A vehicle that scores well in these tests will likely utilize designs that absorb 
                        <PRTPAGE P="34368"/>
                        energy, reduce hard points of contact, and include front end shapes that would cause less harm (
                        <E T="03">i.e.,</E>
                         injuries) to a pedestrian if a vehicle hits that pedestrian. The crashworthiness pedestrian protection test procedures in Euro NCAP consist of standardized instructions to (1) prepare a vehicle for testing, (2) conduct impact tests using various test devices, and (3) assess a vehicle's performance based on the result of the impact tests.
                    </P>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             
                            <E T="03">https://cdn.euroncap.com/media/41769/euro-ncap-pedestrian-testing-protocol-v85.201811091256001913.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        However, NHTSA plans to use a different scoring distribution than the one used in Euro NCAP. Specifically, for this proposal, the weightings are as follows: (1) the adult and child head impact test results would contribute 
                        <FR>3/8</FR>
                         (37.5 percent) of the available points for a maximum component score of 13.5 points; (2) the upper leg impact test results would account for 
                        <FR>2/8</FR>
                         (or 25 percent) of the available points for a maximum component score of 9 points; and (3) the lower leg impact test results would cover 
                        <FR>3/8</FR>
                         (or 37.5 percent) of the available points for a maximum component score of 13.5 points. Also, NHTSA is proposing to award credit for pedestrian protection safety to vehicles that score 60 percent (21.6 out of 36.0 points) or above. Furthermore, NHTSA is proposing to implement this new program as a self-reporting program in which (1) vehicle manufacturers provide data to the Agency, (2) NHTSA reviews the data and awards credit as appropriate, and (3) NHTSA performs verification tests on certain new model year vehicles each year to ensure they meet the performance levels indicated by the vehicle manufacturer. A similar self-reporting and verification testing approach is currently used for evaluating certain ADAS technologies in NCAP.
                    </P>
                    <P>
                        This RFC fulfills portions of the requirements in Section 24213(b) of the Bipartisan Infrastructure Law, enacted as the Infrastructure Investment and Jobs Act 
                        <SU>18</SU>
                        <FTREF/>
                         and signed on November 15, 2021, which require that the Agency “publish a notice, for purposes of public review and comment, to establish a means for providing to consumers information relating to pedestrian, bicyclist, or other vulnerable road user safety technologies.” 
                        <SU>19</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             (Pub. L. 117-58).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             Further discussion on the BIL requirements appears in section II. Background, later in this notice.
                        </P>
                    </FTNT>
                    <P>Furthermore, NHTSA is committed to ensuring safety is equitable for all pedestrians, regardless of gender. The proposed test requirements cover the entire front end of the vehicle—the bumper, the grille, the hood leading edge, the hood, and the windshield—encompassing a large area causing injury to child and adult pedestrians in the real world. NHTSA believes that by covering such a large area, crash protection will be afforded to both male and female pedestrians of varying stature. Additionally, testing is conducted using two different headforms representing average child to adult heads.</P>
                    <P>The remainder of this notice outlines NHTSA's proposal in detail, including the self-reporting requirements and the process of conducting verification testing. Also, this notice describes in detail deviations from the Euro NCAP test procedures and requests public comment on the overall proposal as well as specific details of the proposal.</P>
                    <HD SOURCE="HD1">II. Background</HD>
                    <P>
                        NHTSA established the New Car Assessment Program (NCAP) in 1978 in response to Title II of the Motor Vehicle Information and Cost Savings Act of 1972. When the program first began providing consumers with vehicle safety information derived from frontal crashworthiness testing, consumer interest in vehicle safety and manufacturers' attention to enhanced vehicle safety features was relatively new. Over the years, NCAP has periodically expanded the scope of the safety information the program provides to consumers. For example, the program added safety features to protect vehicle occupants involved in additional types of crashes, more specifically side impacts and rollovers. As more consumers focused on vehicle safety, making it a top factor in their vehicle purchasing decisions,
                        <SU>20</SU>
                        <FTREF/>
                         vehicle manufacturers responded to consumer demands by continually making safety improvements to their vehicles with enhanced safety features. These additional safety improvements have led to improved vehicle safety performance. This improvement in safety performance has translated into higher NCAP star ratings. In recent years, NHTSA has also incorporated various advanced driver assistance technologies in NCAP, including automatic emergency braking, and highlighted those technologies (via the Agency's website) if they meet NHTSA's system performance criteria. For the first time in the program's history, NHTSA is now, through this notice and the March 2022 RFC, taking steps to expand the program to also spur safety protection for those outside of the motor vehicle, with a particular focus on pedestrian safety.
                    </P>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             See 
                            <E T="03">www.regulations.gov,</E>
                             Docket No. NHTSA-2020-0016 for a report of “New Car Assessment Program 5-Star Quantitative Consumer Research.”
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. December 16, 2015, Request for Comments</HD>
                    <P>
                        The Agency requested comment on broad, sweeping changes to NCAP in a December 2015 notice.
                        <SU>21</SU>
                        <FTREF/>
                         As part of that proposal, NHTSA outlined, among other things, details of a pedestrian protection safety rating category comprised of (1) pedestrian automatic emergency braking and (2) pedestrian crashworthiness. For pedestrian crashworthiness, the Agency proposed to evaluate how well a vehicle could reduce injuries sustained to a pedestrian in a frontal collision where the vehicle hit the pedestrian. The pedestrian crashworthiness impact tests proposed in the notice involved the use of adult and child headforms, an upper legform, and a FlexPLI lower legform.
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             80 FR 78521 (Dec. 16, 2015).
                        </P>
                    </FTNT>
                    <P>
                        The Agency received more than 300 comments in response to the December 2015 notice. The Agency also received responses to the notice at two public hearings, one in Detroit, Michigan, on January 14, 2016, and the second at U.S. DOT Headquarters in Washington, DC, on January 29, 2016. By request, the Agency also held several meetings with stakeholders.
                        <SU>22</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             See 
                            <E T="03">http://www.regulations.gov,</E>
                             Docket No. NHTSA-2015-0119 for a full listing of the commenters and the comments they submitted, as well as records of the public hearings and ex parte meetings relating to the RFC that occurred.
                        </P>
                    </FTNT>
                    <P>
                        Regarding the Agency's pedestrian proposals, most commenters generally supported efforts to protect pedestrians using both pedestrian crash avoidance technologies and crashworthiness pedestrian safety. Commenters were divided on whether pedestrian crashworthiness should be applicable as a Federal Motor Vehicle Safety Standard (FMVSS) or if it was more appropriate for NCAP, even though the former application (
                        <E T="03">i.e.,</E>
                         development of a FMVSS) was outside the scope of the RFC. Many commenters outlined technical issues with the pedestrian crashworthiness test devices and test procedures, with the majority of concern focused on the leg impactors. Furthermore, commenters noted that there were difficulties in meeting both 49 CFR part 581, “Bumper Standard,” and the proposed pedestrian crashworthiness requirements in NCAP. Commenters noted that some vehicles, such as sport utility vehicles (SUVs) and pickups, would have difficulty meeting pedestrian crashworthiness requirements due to their front-end geometry. Comments from vehicle manufacturers and suppliers generally supported the Agency's proposal to 
                        <PRTPAGE P="34369"/>
                        harmonize with Euro NCAP pedestrian requirements. On the other hand, safety advocate organizations requested different test procedures and scoring from that in Euro NCAP to account for differences in vehicle fleets and promote new technology development.
                    </P>
                    <P>
                        Commenters were divided on how to implement pedestrian safety ratings in NCAP. Some commenters favored a separate pedestrian rating category that combines pedestrian crash avoidance and crashworthiness protection, while other commenters preferred a pedestrian safety assessment that splits into the crashworthiness protection category (
                        <E T="03">i.e.,</E>
                         this proposal—vehicle performance evaluation for pedestrian protection) and the crash avoidance category (
                        <E T="03">i.e.,</E>
                         pedestrian automatic emergency braking system performance evaluation for avoiding a collision with a pedestrian). As stated previously, some commenters supported crashworthiness pedestrian protection as part of an FMVSS instead of an NCAP rating.
                    </P>
                    <HD SOURCE="HD2">B. October 1, 2018, Public Meeting</HD>
                    <P>
                        In 2018, NHTSA held a public meeting at the Department of Transportation's headquarters in Washington, DC to reengage stakeholders regarding potential changes to NCAP.
                        <SU>23</SU>
                        <FTREF/>
                         Thirty-five parties participated in the public meeting, 32 of which submitted written comments to the docket. Additional written comments were submitted by other entities or public citizens who did not attend.
                    </P>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             
                            <E T="03">https://www.regulations.gov,</E>
                             Docket No. NHTSA-2018-0055.
                        </P>
                    </FTNT>
                    <P>In a notice announcing this meeting, NHTSA requested comments on a variety of topics, including both the crash avoidance and crashworthiness portions of the program. Although no pedestrian crashworthiness programs were proposed as part of the public meeting notice, nor were specific sessions of the public meeting targeted on pedestrian crashworthiness, several attendees and commenters suggested that the Agency continue to pursue pedestrian safety in NCAP. Specifically, a large number of individuals submitted comments supporting the League of American Bicyclists' comment that requested NHTSA to include pedestrians and bicyclists in the NCAP rating system.</P>
                    <P>Most commenters suggested an NCAP roadmap that lays out planned changes to the program and details when those changes are likely to occur. Some commenters pointed to the roadmaps of Euro NCAP and stated that an update to the U.S. NCAP program was overdue.</P>
                    <HD SOURCE="HD2">C. Bipartisan Infrastructure Law and March 9, 2022, Request for Comments</HD>
                    <P>Section 24213(b) of the Bipartisan Infrastructure Law includes requirements to add to NCAP information about advanced crash avoidance technologies and vulnerable road user safety. NHTSA is directed to publish an RFC to establish a means for providing consumers information relating to advanced crash avoidance technologies and pedestrian, bicyclist, or other vulnerable road user safety technologies.</P>
                    <P>For both advanced crash avoidance technologies and vulnerable road user safety, Section 24213(b) of the Bipartisan Infrastructure Law requires NHTSA to (i) determine which technologies shall be included, (ii) develop performance test criteria, (iii) determine distinct ratings for each technology, and (iv) update the overall vehicle rating to incorporate the new technology ratings in the public notices.</P>
                    <P>In March 2022, NHTSA published an RFC that proposed, among other things, adding four new ADAS technologies to NCAP, including Pedestrian Automatic Emergency Braking (PAEB). Because the March 2022 notice described in detail why NHTSA chose the four ADAS technologies for inclusion in NCAP, proposed performance test criteria for evaluating the technologies, and proposed PAEB for enhancing pedestrian safety as one of the four proposed ADAS technologies, NHTSA fulfilled requirements (i) and (ii) listed above of the Bipartisan Infrastructure Law Section 24213(b) for both advanced crash avoidance technologies and vulnerable road user safety. NHTSA anticipates finalizing the March 2022 proposal in a forthcoming notice. Adopting the changes proposed in the March 2022 notice would mark the first time in the history of NCAP that the program evaluates vehicle technologies that specifically target pedestrian safety, and thus could help address the rising number of fatalities and injuries that involve pedestrians.</P>
                    <P>Besides PAEB, there are other safety technologies to protect pedestrians. This notice describes crashworthiness pedestrian protection safety technologies and proposes their introduction into NCAP. Since this RFC seeks public comment on the inclusion of crashworthiness technologies for pedestrian protection into NCAP and the proposed performance tests and criteria to evaluate these technologies, it also fulfills parts (i) and (ii) listed above of Section 24213(b) of the Bipartisan Infrastructure Law with respect to vulnerable road user safety. The remaining requirements of section 24213(b) of the Bipartisan Infrastructure Law (iii and iv listed above) will be fulfilled once NHTSA proposes and then finalizes a new rating system for the crash avoidance technologies in NCAP, updates the current crashworthiness 5-star rating program, and proposes and finalizes an overall vehicle rating that incorporates crash avoidance and crashworthiness technology evaluations. Section 24213(b) of the Bipartisan Infrastructure Law also requires that NHTSA submit reports to Congress on its plans for fulfilling the abovementioned requirements. NHTSA plans to address these reporting requirements in a timely manner. In the March 2022 RFC, the Agency also sought public comment on a proposed ten-year roadmap outlining future updates to NCAP (mid-term and long-term timelines) in the next several years. A number of commenters noted that modern vehicles are larger, with higher front ends, and less visibility of non-occupants. These commenters expressed support for NHTSA's inclusion of crashworthiness pedestrian protection in the NCAP roadmap. Today's notice serves as the next step for the crashworthiness pedestrian protection update to NCAP.</P>
                    <HD SOURCE="HD1">III. Purpose and Rationale</HD>
                    <P>
                        This RFC carries out NHTSA's goals of improving pedestrian safety from a crashworthiness perspective and, in the process, partially fulfills section 24213(b) of the Bipartisan Infrastructure Law that requires the Agency to publish a request for comment notice to establish a means of providing consumers information relating to pedestrian, bicyclist, or other vulnerable road user safety technologies. Unlike the March 2022 RFC,
                        <SU>24</SU>
                        <FTREF/>
                         which focused on four advanced driver assistance systems, this notice focuses solely on the Agency's efforts to improve pedestrian safety from a crashworthiness perspective by evaluating how well a vehicle protects a pedestrian in the event of a frontal collision between the vehicle and the pedestrian. This RFC also works towards addressing recommendations from the National Transportation Safety Board (NTSB) and the Government Accountability Office (GAO).
                        <SU>25</SU>
                         
                        <SU>26</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             NHTSA's March 2022 RFC proposed four new ADAS technologies, including PAEB for improving pedestrian safety and therefore also partially addresses the Bipartisan Infrastructure Law Sec. 24213(b).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             NTSB Special Investigation Report—Pedestrian Safety (NTSB/SIR-18/03) Adopted September 25, 2018.
                            <PRTPAGE/>
                        </P>
                        <P>
                            <SU>26</SU>
                             GAO Report—Pedestrian Safety (GAO-20-419), April 2020.
                        </P>
                    </FTNT>
                    <PRTPAGE P="34370"/>
                    <P>In particular, this notice seeks comment on a revised proposal to add pedestrian crashworthiness evaluations to NCAP. The Agency believes that the pedestrian crashworthiness test devices, test procedures, and evaluation criteria proposed in this RFC are well-established, and that incorporating pedestrian crashworthiness evaluations into NCAP has the potential to further reduce fatalities and injuries on U.S. roadways. Furthermore, by continuing to make safety information readily available to consumers, NHTSA hopes to increase consumer awareness of pedestrian safety issues.</P>
                    <P>The Agency includes numbered questions in this notice to highlight specific topics on which the Agency seeks comment. To ensure that NHTSA addresses all comments, the Agency requests that commenters provide corresponding numbering in their responses. The questions are compiled for the reader's convenience in appendix C.</P>
                    <HD SOURCE="HD1">IV. Crashworthiness Pedestrian Protection Testing Program</HD>
                    <P>NHTSA currently conducts testing for NCAP in two different ways. The NCAP crashworthiness safety ratings program conducts physical crash tests with anthropomorphic test devices (ATDs, or crash test dummies), determines injury values based on ATD sensors, and assigns star ratings based on the resulting injury values. The NCAP crash avoidance safety testing program highlights vehicles equipped with certain advanced driver assistance system technologies (recommended by NHTSA through NCAP) if the vehicles meet NHTSA's system performance test criteria. Unlike the NCAP crashworthiness safety program, the crash avoidance safety program uses test data reported by vehicle manufacturers to determine whether a vehicle meets system performance criteria set forth under NCAP and awards credit as applicable. Each year, a certain number of advanced driver assistance systems are selected and tested to verify system performance as part of the NCAP crash avoidance safety testing program.</P>
                    <P>NHTSA's 2015 proposal for the crashworthiness pedestrian safety program was similar to that of the NCAP crashworthiness safety testing program. Vehicles would undergo physical testing with test devices (head and leg impactors), NCAP would determine injury values from the test devices' sensors, and the program would then assign star ratings based on the test results.</P>
                    <P>Today's proposal would operate more similarly to the NCAP crash avoidance safety testing program than the crashworthiness program. Under the proposal, NHTSA would collect voluntary self-reported data from vehicle manufacturers. If a vehicle manufacturer submits self-reported data for its vehicle, NCAP would first review data for accuracy and completeness and award credit where applicable. In addition, NHTSA would perform verification testing on a number of vehicles selected each year through NCAP. Instead of rating vehicles on a scale of 1 to 5 stars, the Agency plans to initially implement this program in NCAP by awarding pedestrian crashworthiness credit to vehicles that meet NHTSA's performance test criteria. This change from NHTSA's 2015 proposal will provide consumers the crashworthiness pedestrian safety information sooner rather than later as the Agency is working on other initiatives (discussed in the March 2022 proposals) to allow for a complete overhaul of the existing rating system in the future. More specifically, once NHTSA completes its planned updates to the NCAP crashworthiness and crash avoidance programs and concludes the Agency's ongoing consumer research for a new NCAP labeling concept on the Monroney label, NHTSA plans to update its safety ratings system to include pedestrian safety information. In the meantime, NHTSA believes that the proposal in this notice would provide consumers with valuable information and continue to incentivize vehicle safety improvements to help protect pedestrians.</P>
                    <P>
                        The test procedures and evaluation criteria proposed in this RFC would make use of four pedestrian test device impactors—an adult headform, a child headform, an upper legform, and a FlexPLI lower legform. NHTSA proposes to carry out testing in the manner described in the Euro NCAP pedestrian test protocols, with some differences that will be explained in detail later in this notice.
                        <SU>27</SU>
                        <FTREF/>
                         Vehicles are first prepared by measuring and marking the front end of the vehicle in a prescriptive way to locate the test boundaries and impact points on the vehicle. The impact points are marked on a 100 mm by 100 mm grid on the hood, windshield, and surrounding components for the head impact tests; in a line along the hood (or bonnet) leading edge every 100 mm for the upper leg impact tests; and in a line along the front bumper every 100 mm for the lower leg impact tests. The test procedures then provide instructions on how to prepare and launch the test devices at the predetermined impact points—specifically, the adult and child headforms for the hood and windshield area points, the Transport Research Laboratory (TRL) upper legform for the hood leading edge points, and the Flexible Pedestrian Legform Impactor (FlexPLI) for the lower leg impact points. Finally, the procedures describe how a vehicle is scored and rated based on the resulting measurements collected from each impact test.
                    </P>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             
                            <E T="03">https://www.euroncap.com/en/for-engineers/protocols/vulnerable-road-user-vru-protection/.</E>
                             See “Pedestrian Test Protocol” and Part I of the “Assessment Protocol—VRU.” Part II of the “Assessment Protocol” and the “AEB VRU Test Protocol” do not apply and are not part of this proposal.
                        </P>
                    </FTNT>
                    <P>
                        NHTSA believes that crashworthiness pedestrian protection is a suitable candidate for inclusion in NCAP because it satisfies four prerequisites the Agency previously established for inclusion of new safety programs in NCAP. The prerequisites are: (1) the update to the program addresses a safety need; (2) there are system designs (countermeasures) that can mitigate the safety problem; (3) existing or new vehicle designs have safety benefit potential; and (4) a performance-based objective test procedure exists that can assess vehicle performance.
                        <SU>28</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             78 FR 20599 (Apr. 5, 2013).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. Safety Need</HD>
                    <P>In NHTSA's December 2015 RFC, the Agency outlined the safety need to upgrade NCAP with crashworthiness pedestrian protection. In that notice, NHTSA noted that over 4,000 motor-vehicle related pedestrian fatalities and 70,000 pedestrian injuries have occurred annually since the Agency began tracking these data in 1975.</P>
                    <P>
                        Since that RFC was published in 2015, the number of pedestrians killed or injured in motor vehicle traffic crashes continued to grow. In fact, over the past 10 years (as shown in Table 1), motor vehicle related pedestrian fatalities in the U.S. have increased more than 46 percent—from 4,457 fatalities in 2011 to 6,516 fatalities in 2020. In the same time period, the proportion of pedestrians killed in motor vehicle crashes relative to all roadway crash fatalities increased from 14 percent to 17 percent, respectively.
                        <SU>29</SU>
                         
                        <SU>30</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             National Center for Statistics and Analysis. (2021, May). Pedestrians: 2019 data (Traffic Safety Facts. Report No. DOT HS 813 079).
                        </P>
                        <P>
                            <SU>30</SU>
                             Stewart, T. (2022, March). Overview of motor vehicle crashes in 2020 (Report No. DOT HS 813 
                            <PRTPAGE/>
                            266). National Highway Traffic Safety Administration.
                        </P>
                    </FTNT>
                    <PRTPAGE P="34371"/>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s25,12,12,12">
                        <TTITLE>Table 1—Pedestrian Fatalities by Year</TTITLE>
                        <BOXHD>
                            <CHED H="1">Year</CHED>
                            <CHED H="1">Total fatalities</CHED>
                            <CHED H="1">Pedestrian fatalities</CHED>
                            <CHED H="2">Number</CHED>
                            <CHED H="2">
                                Percentage of
                                <LI>total fatalities</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">2011</ENT>
                            <ENT>32,479</ENT>
                            <ENT>4,457</ENT>
                            <ENT>14</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2012</ENT>
                            <ENT>33,782</ENT>
                            <ENT>4,818</ENT>
                            <ENT>14</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2013</ENT>
                            <ENT>32,893</ENT>
                            <ENT>4,779</ENT>
                            <ENT>15</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2014</ENT>
                            <ENT>32,744</ENT>
                            <ENT>4,910</ENT>
                            <ENT>15</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2015</ENT>
                            <ENT>35,484</ENT>
                            <ENT>5,494</ENT>
                            <ENT>15</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2016</ENT>
                            <ENT>37,806</ENT>
                            <ENT>6,080</ENT>
                            <ENT>16</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2017</ENT>
                            <ENT>37,473</ENT>
                            <ENT>6,075</ENT>
                            <ENT>16</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2018</ENT>
                            <ENT>36,835</ENT>
                            <ENT>6,374</ENT>
                            <ENT>17</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2019</ENT>
                            <ENT>36,355</ENT>
                            <ENT>6,272</ENT>
                            <ENT>17</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2020</ENT>
                            <ENT>38,824</ENT>
                            <ENT>6,516</ENT>
                            <ENT>17</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             2011-2018 data are from DOT HS 813 079 and 2019-2020 data are from DOT HS 813 266.
                        </TNOTE>
                    </GPOTABLE>
                    <P>
                        Motor vehicle related crashes involving pedestrians are especially deadly. Although they do not occur as frequently as crashes involving only motor vehicles, they result in fatalities more frequently. A 2019 NHTSA report examined the critical event and specific vehicle movements just prior to crashes that occurred from 2011 to 2015.
                        <SU>31</SU>
                        <FTREF/>
                         The report defined 36 distinct pre-crash scenarios arranged into nine groups, which accounted for 94 percent of fatal crashes. The pre-crash scenarios were grouped in terms of environmental conditions, road geometry, crash location, vehicle/crash-related factors, driver characteristics, attempted avoidance maneuver, traffic violations, and crash contributing factors. One of the pre-crash scenario groups studied was “pedestrian,” in which each crash included in this group involved at least one light vehicle (
                        <E T="03">i.e.,</E>
                         less than 4,536 kilograms gross vehicle weight rating (GVWR)) striking a pedestrian. The report found an average of 3,731 fatal crashes and a total of 70,461 crashes a year included the critical event of a vehicle striking a pedestrian—as shown in Table 2. Although 70,461 crashes represent only one percent of all crashes, 3,731 fatal crashes represent 15 percent of all fatal crashes. This represents 53 fatal crashes per thousand crashes, the highest among any pre-crash scenario group identified in the report.
                    </P>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             Swanson, E., Foderaro, F., Yanagisawa, M., Najm, W.G., &amp; Azeredo, P. (2019, August). Statistics of light-vehicle pre-crash scenarios based on 2011-2015 national crash data (Report No. DOT HS 812 745). Washington, DC: National Highway Traffic Safety Administration.
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="8" OPTS="L2,p7,7/8,i1" CDEF="s100,10,4,10,3,10,6,10">
                        <TTITLE>Table 2—Nine Scenario Groups Yearly Average Based on 2011-2015 FARS and GES</TTITLE>
                        <BOXHD>
                            <CHED H="1">Scenario group</CHED>
                            <CHED H="1">Crashes where the light vehicle is making the critical action</CHED>
                            <CHED H="2">Fatal crashes</CHED>
                            <CHED H="3">Total</CHED>
                            <CHED H="3">%</CHED>
                            <CHED H="2">All crashes</CHED>
                            <CHED H="3">Total</CHED>
                            <CHED H="3">%</CHED>
                            <CHED H="2">Number of crashes per billion light vehicle miles traveled</CHED>
                            <CHED H="3">Fatal</CHED>
                            <CHED H="3">All</CHED>
                            <CHED H="1">
                                Number
                                <LI>of fatal</LI>
                                <LI>crashes</LI>
                                <LI>per 1,000</LI>
                                <LI>crashes</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">1. Control Loss</ENT>
                            <ENT>4,456</ENT>
                            <ENT>18%</ENT>
                            <ENT>470,733</ENT>
                            <ENT>9%</ENT>
                            <ENT>1.6</ENT>
                            <ENT>174</ENT>
                            <ENT>9.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2. Road Departure</ENT>
                            <ENT>6,500</ENT>
                            <ENT>26</ENT>
                            <ENT>547,098</ENT>
                            <ENT>11</ENT>
                            <ENT>2.4</ENT>
                            <ENT>202</ENT>
                            <ENT>11.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3. Animal</ENT>
                            <ENT>102</ENT>
                            <ENT>0</ENT>
                            <ENT>297,968</ENT>
                            <ENT>6</ENT>
                            <ENT>0.0</ENT>
                            <ENT>110</ENT>
                            <ENT>0.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4. Pedestrian</ENT>
                            <ENT>3,731</ENT>
                            <ENT>15</ENT>
                            <ENT>70,461</ENT>
                            <ENT>1</ENT>
                            <ENT>1.4</ENT>
                            <ENT>26</ENT>
                            <ENT>53.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5. Pedalcyclist</ENT>
                            <ENT>518</ENT>
                            <ENT>2</ENT>
                            <ENT>47,927</ENT>
                            <ENT>1</ENT>
                            <ENT>0.2</ENT>
                            <ENT>18</ENT>
                            <ENT>10.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6. Lane Change</ENT>
                            <ENT>752</ENT>
                            <ENT>3</ENT>
                            <ENT>644,099</ENT>
                            <ENT>13</ENT>
                            <ENT>0.3</ENT>
                            <ENT>238</ENT>
                            <ENT>1.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">7. Opposite Direction</ENT>
                            <ENT>3,258</ENT>
                            <ENT>13</ENT>
                            <ENT>100,786</ENT>
                            <ENT>2</ENT>
                            <ENT>1.2</ENT>
                            <ENT>37</ENT>
                            <ENT>32.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">8. Rear-End</ENT>
                            <ENT>1,245</ENT>
                            <ENT>5</ENT>
                            <ENT>1,709,717</ENT>
                            <ENT>34</ENT>
                            <ENT>0.5</ENT>
                            <ENT>632</ENT>
                            <ENT>0.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">9. Crossing Paths</ENT>
                            <ENT>3,972</ENT>
                            <ENT>16</ENT>
                            <ENT>1,131,273</ENT>
                            <ENT>23</ENT>
                            <ENT>1.5</ENT>
                            <ENT>418</ENT>
                            <ENT>3.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Nine Group Total</ENT>
                            <ENT>24,534</ENT>
                            <ENT>100</ENT>
                            <ENT>5,020,062</ENT>
                            <ENT>100</ENT>
                            <ENT>9.1</ENT>
                            <ENT>1,855</ENT>
                            <ENT>4.9</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        Most pedestrian traffic motor vehicle related fatalities are due to a collision with a single-vehicle (under 4,536 kilograms GVWR) where the impacting point is the front of the vehicle. Between 2011 and 2020, 55,775 pedestrians were killed in motor vehicle crashes.
                        <SU>32</SU>
                        <FTREF/>
                         Of these pedestrians, 71.8 percent (40,093) were killed by light vehicles (
                        <E T="03">i.e.,</E>
                         passenger cars, pickups, SUVs, and vans under 4,536 kilograms GVWR) in single-vehicle crashes.
                        <SU>33</SU>
                        <FTREF/>
                         Ninety percent (36,076) of the aforementioned single-vehicle crashes were frontal impacts.
                        <SU>34</SU>
                        <FTREF/>
                         Passenger cars were responsible for approximately half (18,194) of these 36,076 fatalities, and light trucks (
                        <E T="03">i.e.,</E>
                         SUVs, pickups, and vans) were responsible for the other half (17,882).
                        <SU>35</SU>
                        <FTREF/>
                         Large trucks and buses over 4,536 kilograms GVWR in single-vehicle crashes with pedestrians accounted for a much smaller portion of single vehicle pedestrian fatalities; about 7 percent (3,388).
                        <SU>36</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             See Table 16 in appendix A.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             See Table 17 in appendix A.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             See Table 18 in appendix A.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             See Table 18 in appendix A.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             See Table 17 in appendix A.
                        </P>
                    </FTNT>
                    <P>In addition to fatalities that occur in traffic motor vehicle-to-pedestrian crashes, there are notable numbers of nonoccupants killed and injured in non-traffic motor vehicle related crashes. Non-traffic crashes frequently occur in private roadways, parking facilities, and driveways, places in which NHTSA's </P>
                    <PRTPAGE P="34372"/>
                    <FP>
                        Fatality Analysis Reporting System (FARS) and Crash Report Sampling System (CRSS) data systems do not capture data. NHTSA's Non-Traffic Surveillance (NTS) system recorded an average additional 386 nonoccupants killed and 14,265 injured annually from forward-moving vehicles between 2016 and 2020.
                        <SU>37</SU>
                        <FTREF/>
                         These average annual numbers are similar to data collected through the NTS in 2012-2015.
                        <E T="51">38 39</E>
                        <FTREF/>
                         Although the data may include some non-pedestrian nonoccupants (such as bicyclists), it highlights the dangers of moving motor vehicles to nonoccupants around them, even in lower speed environments outside of roadways.
                    </FP>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             National Center for Statistics and Analysis. (2022, September). Non-Traffic Surveillance: Fatality and injury statistics in nontraffic crashes, 2016 to 2020. (Report No. DOT HS 813 363). National Highway Traffic Safety Administration.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             Singh, S. (2016, August). Non-Traffic Surveillance: Fatality and injury statistics in non-traffic crashes, 2012 to 2014. (Report No. DOT HS 812 311).
                        </P>
                        <P>
                            <SU>39</SU>
                             National Center for Statistics and Analysis. (2018, April). Non-traffic surveillance: fatality and injury statistics in nontraffic crashes in 2015 (Traffic Safety Facts. Report No. DOT HS 812 515).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. System Designs Exist</HD>
                    <P>As discussed in the 2015 NCAP RFC, the Agency selected the speed of 40 kph (25 mph) for testing in the NCAP crashworthiness pedestrian protection program because most pedestrian crashes occur at this speed or below. Thus, there is opportunity to improve pedestrian safety. In crashes that occur at these speeds—up to 40 kph (25 mph), for low profile vehicles such as passenger cars—the typical pedestrian-vehicle interactions are as follows: (1) the pedestrian's lower legs generally engage with the vehicle bumper, (2) the upper leg and pelvis make contact with the vehicle's leading edge, (3) the body is rotated around the vehicle and the torso swings downward, and (4) the pedestrian's head makes contact with the vehicle's hood or windshield. Higher-profile vehicles, such as large SUVs, vans, and trucks, may engage with the pedestrian's pelvis earlier in the dynamic event. At speeds greater than 40 kph (25 mph), impact dynamics often cause the pedestrian's head to overshoot the hood and windshield and therefore countermeasures become less relevant to reduce head injuries to pedestrians.</P>
                    <P>
                        The fatalities and serious injuries that occur from motor vehicle crashes involving pedestrians can be attributed to specific body regions. A NHTSA study using both U.S. and German crash data found that the head and lower extremities are the most common injury locations on a struck pedestrian.
                        <SU>40</SU>
                        <FTREF/>
                         For seriously-injured pedestrians (Abbreviated Injury Scale (AIS) 3 or higher), the thorax is the third most common body location to sustain an injury.
                        <SU>41</SU>
                        <FTREF/>
                         For disabling injuries, where the pedestrian is still disabled one year after the crash, the thorax injury is less prevalent, and the pelvis/hip area is the third most common body location injured.
                        <SU>42</SU>
                        <FTREF/>
                         Thus, the head, legs, and thorax are the most common locations of serious injury, and the head, legs, and pelvis/hip are the most common locations for disabling injuries.
                    </P>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             Mallory, A., Fredriksson, R., Rosen, E., Donnelly, B. (2012, October). Pedestrian Injuries By Source: Serious and Disabling Injuries in US and European Cases. 56th AAAM Annual Conference.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             The Abbreviated Injury Scale (AIS) is a classification system for assessing impact injury severity developed and published by the Association for the Advancement of Automotive Medicine and is used for coding single injuries, assessing multiple injuries, or for assessing cumulative effects on more than one injury. AIS ranks individual injuries by body region on a scale of 1 to 6 where 1=minor, 2=moderate, 3=serious, 4=severe, 5=critical, and 6=maximum (untreatable).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             Disabling injuries were estimated using the Functional Capacity Index (FCI). In the FCI system, each AIS code is assigned an FCI value to reflect the expected disability one year following the injury for initially healthy adults between the ages of 18 and 34.
                        </P>
                    </FTNT>
                    <P>
                        The same NHTSA study also showed that pedestrian injuries sustained to the body regions mentioned above can be primarily attributed to areas of the impacting vehicle. For instance, the bumper and valence 
                        <SU>43</SU>
                        <FTREF/>
                         of a vehicle are responsible for the majority of serious and disabling injuries caused primarily to the lower legs. Also, the hood (or bonnet) of a vehicle is the cause of injuries to numerous areas of the body including the head and face, thorax, upper extremities, abdomen, and pelvis and hip. Furthermore, the hood leading edge is a significant source of injuries to the thorax and pelvis and hip, especially in larger vehicles. Finally, the windshield of a vehicle is the second highest source of injury—just behind the bumper, and the leading cause of head injuries.
                    </P>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             The valence is a thin panel located under the bumper that is generally used as a styling element, to improve aerodynamics, or to protect the underside of the vehicle.
                        </P>
                    </FTNT>
                    <P>Vehicles can be designed to mitigate injury to a pedestrian for the body areas discussed above. For example, a vehicle's bumper and hood leading edge can be designed to have geometric and material properties to minimize bending moments and ligament extension in a pedestrian's leg and knee or excessive force in the pelvis and hip. Similarly, the hood may be designed to have space underneath to crush without bottoming out on any rigid components, such as an engine block. The hood and hood hinges may also be designed in a way to make them less rigid and to allow more deformation when impacting a pedestrian. The deformation of components on a vehicle would absorb some of the energy of the impact and transfer less energy to the pedestrian's head—thus lessening the chance of a head injury. Certain vehicles are even designed with an active hood that deploys upon contact with a pedestrian to allow more space between the hood and engine bay components for additional deformation and energy absorption.</P>
                    <P>
                        Since other consumer information vehicle safety programs such as The European New Car Assessment Programme (Euro NCAP), The Australasian New Car Assessment Program (ANCAP), Japan New Car Assessment Program (JNCAP), and Korean New Car Assessment Program (KNCAP) have been evaluating crashworthiness pedestrian protection over the years, vehicles with pedestrian safety countermeasures have been available in the market globally. In preparation for incorporating the crashworthiness pedestrian protection program in U.S. NCAP, NHTSA surveyed vehicles in the U.S. fleet by conducting a feasibility study on nine model year (MY) 2015-2017 vehicles to evaluate their pedestrian protection performance against the Euro NCAP test procedures.
                        <SU>44</SU>
                        <FTREF/>
                         The nine vehicles included pickups, SUVs, and passenger cars, domestic-only models and global platform 
                        <SU>45</SU>
                        <FTREF/>
                         vehicles that are not only sold in the U.S. but also are available in other markets with minor design changes. As shown in Table 3, four of the tested vehicles exceeded the 60 percent score necessary to receive a 5-star overall rating in Euro NCAP.
                        <SU>46</SU>
                        <FTREF/>
                         Four of the vehicles scored under the 60 percent threshold, and one vehicle received a 60 percent score. In general, the global platform vehicles were found to perform better overall in the pedestrian impact tests (using the Euro NCAP test procedures) than the domestic-only models. This study 
                        <PRTPAGE P="34373"/>
                        shows that not only can vehicles in the U.S. market be designed with pedestrian safety in mind, but also additional safety gains can be made for currently underperforming vehicles through better vehicle designs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             Suntay, B., Stammen, J., &amp; Martin, P. (2019, June). Pedestrian protection—Assessment of the U.S. vehicle fleet (Report No. DOT HS 812 723). Washington, DC: National Highway Traffic Safety Administration.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             Global platform vehicles are vehicles that have variants sold in both the U.S. and European markets.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             For MY2022, vehicles must receive a vulnerable road user sub-score of 60 percent or greater to be eligible to receive a 5-star overall rating in Euro NCAP. Euro NCAP's vulnerable road user sub-score also includes active crash avoidance systems, such as PAEB, that were not factored into NHTSA's crashworthiness only assessment of pedestrian protection.
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,12,12">
                        <TTITLE>Table 3—U.S. Fleet Vehicles Tested Using Euro NCAP Scoring Methodology</TTITLE>
                        <BOXHD>
                            <CHED H="1">Vehicle</CHED>
                            <CHED H="1">
                                Scores
                                <LI>(max 36 pts)</LI>
                            </CHED>
                            <CHED H="1">Percentage</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">2017 Audi A4 *</ENT>
                            <ENT>24.41</ENT>
                            <ENT>67.8%</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2016 Chevrolet Malibu</ENT>
                            <ENT>21.75</ENT>
                            <ENT>60.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2016 Chevrolet Tahoe</ENT>
                            <ENT>14.98</ENT>
                            <ENT>41.6</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2016 Ford Edge *</ENT>
                            <ENT>18.60</ENT>
                            <ENT>51.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2015 Ford F-150</ENT>
                            <ENT>11.02</ENT>
                            <ENT>30.6</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2016 Honda Fit *</ENT>
                            <ENT>24.67</ENT>
                            <ENT>68.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2016 Nissan Rogue *</ENT>
                            <ENT>30.00</ENT>
                            <ENT>83.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2016 Toyota Prius *</ENT>
                            <ENT>30.12</ENT>
                            <ENT>83.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2015 Toyota Sienna</ENT>
                            <ENT>19.10</ENT>
                            <ENT>53.1</ENT>
                        </ROW>
                        <TNOTE>* Global platform vehicles with European variants tested by Euro NCAP</TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD2">C. Potential Safety Benefits</HD>
                    <P>
                        While pedestrian
                        <FTREF/>
                         fatalities have been increasing in the U.S. in recent years, there has been a steady decline in pedestrian fatalities in other developed countries. Figure 1 shows that pedestrian fatalities related to motor vehicle crashes significantly decreased in Europe and gradually decreased in Japan—especially from 2000 to 2010. Pedestrian fatalities in the U.S., on the other hand, remained the same during that time period but then steadily increased over the past ten years and at a much faster pace for several years now. One difference between the other countries in Figure 1 and the U.S. is that other countries have adopted crashworthiness pedestrian protection vehicle safety consumer information programs and pedestrian protection regulations, while the U.S. has not yet adopted either.
                    </P>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             Sources: FARS (U.S.), European Road Safety Observatory (E. U.), Institute for Traffic Accidents Research and Data Analysis (Japan)
                        </P>
                    </FTNT>
                    <BILCOD>BILLING CODE 4910-59-P</BILCOD>
                    <GPH SPAN="3" DEEP="354">
                        <GID>EN26MY23.000</GID>
                    </GPH>
                    <PRTPAGE P="34374"/>
                    <P>
                        As discussed previously, other consumer information vehicle safety programs have implemented various crashworthiness pedestrian protection testing programs over the years. A paper published by the German Federal Highway Research Institute (BASt) studied the effectiveness of crashworthiness pedestrian protection requirements in Germany.
                        <SU>48</SU>
                        <FTREF/>
                         By examining crash data from Germany, this paper found a correlation between Euro NCAP pedestrian protection scores and pedestrian injuries and fatalities. The author concluded that “each point in [the Euro] NCAP [pedestrian] score relates to a relative reduction in probability of 2.5 percent for fatalities, and 1 percent for serious injuries.” Similarly, a paper published by the Swedish Transport Administration found vehicles that scored better in the Euro NCAP pedestrian crashworthiness tests produced less serious injuries in real-world crashes.
                        <SU>49</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             Pastor, C., “Correlation between pedestrian injury severity in real-life crashes and Euro NCAP pedestrian test results,” The 23rd International Technical Conference on the Enhanced Safety of Vehicles, Paper No. 13-0308, 2013.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             Standroth, J. et al. (2014), “Correlation between Euro NCAP pedestrian test results and injury severity in injury crashes with pedestrians and bicyclists in Sweden,” Stapp Car Crash Journal, Vol. 58 (November 2014), pp. 213-231.
                        </P>
                    </FTNT>
                    <P>
                        The DOT believes that the crashworthiness pedestrian protection tests outlined in this proposal have the potential to reduce the rising number of pedestrian fatalities and injuries in the U.S. As discussed previously, there were 36,076 pedestrian fatalities between 2011-2020 involving single-vehicle crashes between the front end of a light vehicle and a pedestrian.
                        <SU>50</SU>
                        <FTREF/>
                         When travel speed was known, 13.2 percent of fatal crashes occurred at travel speeds of 40 kph (25 mph) or below (Figure 2).
                        <SU>51</SU>
                        <FTREF/>
                         From 2011-2020, the front end of passenger cars and light trucks caused approximately 479,000 injuries to pedestrians in single-vehicle crashes,
                        <SU>52</SU>
                        <FTREF/>
                         and 68.7 percent of those crashes occurred at travel speeds of 40 kph (25 mph) and below when travel speed was known.
                        <SU>53</SU>
                        <FTREF/>
                         Looking at these data on an annual basis, approximately 476 fatalities and 32,907 injuries could be mitigated by crashworthiness pedestrian protection contemplated under the proposed testing program. Based on this data, the DOT believes that the proposed test speed of 40 kph (25 mph) is an appropriate threshold for the new crashworthiness pedestrian protection tests in NCAP.
                    </P>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             See Table 18 in appendix A.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             See Table 19 in appendix A.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             See Table 20 in appendix A.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             See Table 19 in appendix A.
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="388">
                        <GID>EN26MY23.001</GID>
                    </GPH>
                    <PRTPAGE P="34375"/>
                    <P>Although these numbers only account for crashes occurring at 40 kph (25 mph) or less, it is possible that some residual benefit could also be afforded in crashes that occur at slightly higher speeds. Furthermore, as PAEB continues to proliferate in the vehicle fleet, it is expected that vehicles traveling at speeds above 40 kph (25 mph) may impact pedestrians as it slows down to speeds at or below 40 kph (25 mph) if the PAEB system engages but is unable to fully stop the vehicle. Thus, crashworthiness pedestrian protection countermeasures along with PAEB technology may provide pedestrians some safety benefit even at higher speeds, either by avoiding pedestrian collision or by reducing the impact speeds to levels at which crashworthiness pedestrian protection countermeasures would work.</P>
                    <HD SOURCE="HD2">D. Objective Test Procedure Exists</HD>
                    <P>
                        The last guiding principle in NHTSA's four pre-requisites when considering a new safety program for inclusion in NCAP is whether there is an objective test procedure to assess for vehicle performance. NHTSA has been conducting research, developing test devices, and creating test procedures to simulate pedestrian crash impacts since the 1980s. As early as 1990, NHTSA published a test procedure for evaluating head impacts to the hood of a test vehicle.
                        <SU>54</SU>
                        <FTREF/>
                         Some of the elements of the early test procedures are still used in these currently proposed pedestrian crashworthiness test procedures, such as the use of an adult and child headform to measure head injury criteria (HIC), the layout of test locations on the hood of a test vehicle, test speeds at 40 kph (25 mph), and the concept of a “wrap around distance” (WAD)—as shown in Figure 3.
                        <SU>55</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             MacLaughlin, T. and Kessler, J., “Pedestrian Head Impact Against the Central Hood of Motor Vehicles—Test Procedure and Results,” SAE Technical Paper 902315, 1990.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             The term “Wrap Around Distance (WAD)” is a distance measurement made using a flexible tape measure. One end of the tape is held at ground level directly below the bumper. The other end is wrapped around the front end of a vehicle and held taut and in contact with a point on the hood or windshield.
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="282">
                        <GID>EN26MY23.002</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4910-59-C</BILCOD>
                    <P>
                        Over
                        <FTREF/>
                         the years, many advancements to pedestrian crashworthiness evaluations have occurred in part due to the introduction of similar pedestrian safety programs in other NCAP programs worldwide. For instance, in addition to using the headforms for head injury assessment, other impactors such as the legforms that measure forces, bending moments, and ligament elongation for the knees have been developed. Test devices have also undergone design changes to improve biofidelity and durability. Furthermore, the test zone is no longer limited to just the central portion of the hood as it has been extended to other areas on a vehicle such as the front bumper, hood leading edge, windshield, and A-pillars, to include assessment of other injury sources to pedestrians. Also, test procedures have been refined to ensure that the layout of test points and the aiming method of test impactors are more repeatable. Most of NHTSA's recent research activities on crashworthiness pedestrian safety may be found in 
                        <E T="03">http://www.Regulations.gov</E>
                         (Docket Number: NHTSA-2019-0112), and additional work is published on the National Transportation Library website with the search keywords “Pedestrian Safety.” 
                        <E T="51">57 58</E>
                        <FTREF/>
                         DOT notes that some documents contained in these repositories do not directly relate to this proposal to update NCAP.
                    </P>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             Copyright Euro NCAP 2018. Reproduced with permission from Euro NCAP Pedestrian Testing Protocol V8.5 Figure 9.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             
                            <E T="03">Regulations.gov</E>
                             docket available here: 
                            <E T="03">https://www.regulations.gov/docket/NHTSA-2019-0112.</E>
                        </P>
                        <P>
                            <SU>58</SU>
                             
                            <E T="03">https://rosap.ntl.bts.gov/gsearch?pid=dot%3A40796&amp;parentId=dot%3A40796&amp;sm_key_words=Pedestrian%20safety.</E>
                             Search keywords “pedestrian safety”.
                        </P>
                    </FTNT>
                    <P>
                        Table 4 through Table 8 summarize the various crashworthiness pedestrian protection testing programs being 
                        <PRTPAGE P="34376"/>
                        conducted around the world. The tables display both consumer information programs (NCAPs) as well as regulations. Global Technical Regulation No. 9 Pedestrian Safety 
                        <SU>59</SU>
                        <FTREF/>
                         is the basis for the regulation adopted in Europe—UNECE R127; 
                        <SU>60</SU>
                        <FTREF/>
                         the regulation adopted in Korea—Korean Motor Vehicle Safety Standard 102-2; and the regulation adopted in Japan—Article 18 Attachment 99. The purpose of the consumer information programs is to provide information to new vehicle buyers and often incentivize safety improvements that extend beyond the established standards, while the purpose of the regulations is to set minimum performance standards. Therefore, the consumer information programs award zero points for tests that do not meet certain established performance criteria.
                    </P>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             
                            <E T="03">https://unece.org/transport/standards/transport/vehicle-regulations-wp29/global-technical-regulations-gtrs.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             The United Nations Economic Commission for Europe, Regulation No. 127-00, “Motor Vehicles Pedestrian Safety Performance.”
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s75,15,15,15,15,15">
                        <TTITLE>Table 4—Adult Headform Test Comparison</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Consumer information programs</CHED>
                            <CHED H="2">Euro NCAP and ANCAP</CHED>
                            <CHED H="2">JNCAP</CHED>
                            <CHED H="2">KNCAP</CHED>
                            <CHED H="2">C-NCAP</CHED>
                            <CHED H="1">GTR 9 and UN R127 and KMVSS 102-2 and Japan article 18 att. 99</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Impact Velocity (kph)</ENT>
                            <ENT>40</ENT>
                            <ENT>40</ENT>
                            <ENT>40</ENT>
                            <ENT>40</ENT>
                            <ENT>35</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">WAD (mm)</ENT>
                            <ENT>* 1500/1700-2100</ENT>
                            <ENT>1700-2100</ENT>
                            <ENT>1700-2100</ENT>
                            <ENT>1500/1700-2300</ENT>
                            <ENT>1700-2100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact Angle (degrees)</ENT>
                            <ENT>65</ENT>
                            <ENT>65</ENT>
                            <ENT>65</ENT>
                            <ENT>65</ENT>
                            <ENT>65</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Test on windshield?</ENT>
                            <ENT>Yes</ENT>
                            <ENT>Yes</ENT>
                            <ENT>Yes</ENT>
                            <ENT>Yes</ENT>
                            <ENT>No</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">HIC Max. Score</ENT>
                            <ENT>650</ENT>
                            <ENT>650</ENT>
                            <ENT>650</ENT>
                            <ENT>650</ENT>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">HIC Zero Score</ENT>
                            <ENT>1700</ENT>
                            <ENT>1700</ENT>
                            <ENT>1700</ENT>
                            <ENT>1700</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">HIC Limit</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>1000/1700</ENT>
                        </ROW>
                        <TNOTE>* In Euro NCAP and ANCAP, points rearward of the bonnet rear reference line between 1500 mm and 1700 mm WAD and up to 2100 mm WAD are assessed using the adult impactor.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s75,15,15,15,15,15">
                        <TTITLE>Table 5—Child Headform Test Comparison</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Consumer information programs</CHED>
                            <CHED H="2">Euro NCAP and ANCAP</CHED>
                            <CHED H="2">JNCAP</CHED>
                            <CHED H="2">KNCAP</CHED>
                            <CHED H="2">C-NCAP</CHED>
                            <CHED H="1">GTR 9 and UN R127 and KMVSS 102-2 and Japan article 18 att. 99</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Impact Velocity (kph)</ENT>
                            <ENT>40</ENT>
                            <ENT>40</ENT>
                            <ENT>40</ENT>
                            <ENT>40</ENT>
                            <ENT>35</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">WAD (mm)</ENT>
                            <ENT>* 1000-1500/1700</ENT>
                            <ENT>1000-1700</ENT>
                            <ENT>1000-1700</ENT>
                            <ENT>1000-1500/1700</ENT>
                            <ENT>1000-1700</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact Angle (degrees)</ENT>
                            <ENT>50</ENT>
                            <ENT>50</ENT>
                            <ENT>50</ENT>
                            <ENT>50</ENT>
                            <ENT>50</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Test on windshield?</ENT>
                            <ENT>Yes</ENT>
                            <ENT>Yes</ENT>
                            <ENT>Yes</ENT>
                            <ENT>Yes</ENT>
                            <ENT>No</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">HIC Max. Score</ENT>
                            <ENT>650</ENT>
                            <ENT>650</ENT>
                            <ENT>650</ENT>
                            <ENT>650</ENT>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">HIC Zero Score</ENT>
                            <ENT>1700</ENT>
                            <ENT>1700</ENT>
                            <ENT>1700</ENT>
                            <ENT>1700</ENT>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">HIC Limit</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>1000/1700</ENT>
                        </ROW>
                        <TNOTE>* In Euro NCAP and ANCAP, where the bonnet rear reference line is between 1500 mm and 1700 mm WAD, points forward of and directly on the BRRL are assessed using the child headform. Where the BRRL is rearward of 1700 mm WAD, the child headform is used up to and including 1700 mm.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s75,r25,15,15,15,15">
                        <TTITLE>Table 6—Upper Legform to WAD775 Test Comparison</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Consumer information programs</CHED>
                            <CHED H="2">Euro NCAP and ANCAP</CHED>
                            <CHED H="2">JNCAP</CHED>
                            <CHED H="2">KNCAP</CHED>
                            <CHED H="2">C-NCAP</CHED>
                            <CHED H="1">GTR 9 and UN R127 and KMVSS 102-2 and Japan article 18 att. 99</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Impact Angle (°)</ENT>
                            <ENT>90° leading edge</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact Velocity (kph)</ENT>
                            <ENT>20-33</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sum of forces (N) Max. Score</ENT>
                            <ENT>5000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sum of forces (N) Zero Score</ENT>
                            <ENT>6000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Bending moment (Nm) Max. Score</ENT>
                            <ENT>285</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Bending moment (Nm) Zero Score</ENT>
                            <ENT>350</ENT>
                        </ROW>
                    </GPOTABLE>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s75,12,12,12,12,15">
                        <TTITLE>Table 7—Upper Legform to Bumper Test Comparison</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Consumer information programs</CHED>
                            <CHED H="2">
                                Euro NCAP and
                                <LI>ANCAP</LI>
                            </CHED>
                            <CHED H="2">JNCAP</CHED>
                            <CHED H="2">KNCAP</CHED>
                            <CHED H="2">C-NCAP</CHED>
                            <CHED H="1">GTR 9 and UN R127 and KMVSS 102-2 and Japan article 18 att. 99</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Impact Velocity (kph)</ENT>
                            <ENT>40</ENT>
                            <ENT/>
                            <ENT>40</ENT>
                            <ENT/>
                            <ENT>40</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sum of forces (N) Max. Score</ENT>
                            <ENT>5000</ENT>
                            <ENT/>
                            <ENT>5000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sum of forces (N) Zero Score</ENT>
                            <ENT>6000</ENT>
                            <ENT/>
                            <ENT>7500</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34377"/>
                            <ENT I="01">Sum of forces (N) Limit</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>7500</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Bending moment (Nm) Max. Score</ENT>
                            <ENT>285</ENT>
                            <ENT/>
                            <ENT>300</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Bending moment (Nm) Zero Score</ENT>
                            <ENT>350</ENT>
                            <ENT/>
                            <ENT>510</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Bending moment (Nm) Limit</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>510</ENT>
                        </ROW>
                    </GPOTABLE>
                    <GPOTABLE COLS="6" OPTS="L2,p7,7/8,i1" CDEF="s75,r25,r25,r25,r25,r25">
                        <TTITLE>Table 8—Lower Legform to Bumper Test Comparison</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Consumer information programs</CHED>
                            <CHED H="2">Euro NCAP and ANCAP</CHED>
                            <CHED H="2">JNCAP</CHED>
                            <CHED H="2">KNCAP</CHED>
                            <CHED H="2">C-NCAP</CHED>
                            <CHED H="1">GTR 9 and UN R127 and KMVSS 102-2 and Japan article 18 att. 99</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Legform Used</ENT>
                            <ENT>Flex PLI</ENT>
                            <ENT>Flex PLI</ENT>
                            <ENT>Flex PLI</ENT>
                            <ENT>aPLI</ENT>
                            <ENT>Flex PLI.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact Velocity (kph)</ENT>
                            <ENT>40</ENT>
                            <ENT>40</ENT>
                            <ENT>40</ENT>
                            <ENT>40</ENT>
                            <ENT>40.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Ground clearance (mm)</ENT>
                            <ENT>75</ENT>
                            <ENT>75</ENT>
                            <ENT>75</ENT>
                            <ENT>25</ENT>
                            <ENT>75.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Femur bending (Nm) Max. Score</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT O="xl">390.</ENT>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">Femur bending (Nm) Zero Score</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>440</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Tibia bending (Nm) Max. Score</ENT>
                            <ENT>282</ENT>
                            <ENT>202</ENT>
                            <ENT>282</ENT>
                            <ENT O="xl">275.</ENT>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">Tibia bending (Nm) Zero Score</ENT>
                            <ENT>340</ENT>
                            <ENT>306</ENT>
                            <ENT>340</ENT>
                            <ENT>320</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Tibia bending (Nm) Limit</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>340/380.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">MCL elongation (mm) Max. Score</ENT>
                            <ENT>19</ENT>
                            <ENT>14.8</ENT>
                            <ENT>19</ENT>
                            <ENT O="xl">27.</ENT>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">MCL elongation (mm) Zero Score</ENT>
                            <ENT>22</ENT>
                            <ENT>19.8</ENT>
                            <ENT>22</ENT>
                            <ENT O="xl">32.</ENT>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">MCL elongation (mm) Limit</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>22.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">ACL/PCL elongation (mm) Max. Score *</ENT>
                            <ENT>10</ENT>
                            <ENT>13</ENT>
                            <ENT O="xl">10.</ENT>
                            <ENT O="xl"/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">ACL/PCL elongation (mm) Zero Score *</ENT>
                            <ENT>10</ENT>
                            <ENT>13</ENT>
                            <ENT O="xl">10.</ENT>
                            <ENT O="xl"/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">ACL/PCL elongation (mm) Limit</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>13.</ENT>
                        </ROW>
                        <TNOTE>* In Euro NCAP, ANCAP, JNCAP, and KNCAP the ACL and PCL elongations act as modifiers. If the stated limit is exceeded that impact is awarded zero points regardless of the MCL or Tibia results.</TNOTE>
                    </GPOTABLE>
                    <P>The crashworthiness pedestrian protection test procedures in Euro NCAP consist of standardized instructions to (1) prepare a vehicle for testing, (2) conduct impact tests using various test devices, and (3) assess a vehicle's performance based on the result of the impact tests. Vehicles are first prepared by measuring and marking the front end of the vehicle in a prescriptive way to locate the test boundaries and impact points on the vehicle. The impact points are marked on a 100 mm by 100 mm grid on the hood, windshield, and surrounding components for the head impact tests; in a line along the hood (or bonnet) leading edge every 100 mm for the upper leg to WAD775 impact tests; and in a line along the front bumper every 100 mm for the lower leg to bumper impact tests. The Euro NCAP test procedures then provide instructions on how to prepare and launch the test devices at the predetermined impact points—specifically, the adult and child headforms for the hood and windshield area points, the TRL upper legform for the WAD775 points, and the FlexPLI for the bumper impact points. Finally, the procedures describe how a vehicle is scored and rated based on the resulting measurements collected from each impact test. The next several sections discuss in detail the individual tests and test procedures currently used in Euro NCAP and will be used in this proposed U.S. NCAP's crashworthiness pedestrian protection testing program.</P>
                    <HD SOURCE="HD3">1. Headforms and Head Impacts</HD>
                    <P>
                        As discussed earlier, since NHTSA began its research efforts on pedestrian safety in the 1980s and 1990s, head impact testing has been introduced in other NCAP programs (
                        <E T="03">e.g.,</E>
                         Euro NCAP, ANCAP, JNCAP, KNCAP) worldwide. Test devices, specifically the child and adult headforms, have been standardized in other countries (
                        <E T="03">e.g.,</E>
                         UNECE R127, Korean Motor Vehicle Safety Standard 102-2, Japan Article 18 Attachment 99, and Global Technical Regulation No. 9).
                    </P>
                    <P>
                        The headforms used in Euro NCAP are featureless, hemispherical impact devices that represent an adult and a 6-year-old child's head. Although each headform has the same diameter −165 mm (6.5 in), the adult headform weighs 4.5 kg (9.9 pounds), based on an average adult male, and the child headform weighs 3.5 kg (7.7 pounds). Early research and protocols used a smaller child headform with a mass of 2.5 kg (5.5 pounds) and a diameter of 130 mm and found the smaller and lighter headform produced higher accelerations when striking a hood but a heavier headform was more likely to bottom out against a hard underlying structure. Thus, mass was determined to be the most important parameter in assessing pedestrian head injury risk. The two head test devices cover a range of head masses from children to small adults to average sized adult males and encompasses a large percentage of adult females. The test procedures cover a range of components over an area of the vehicle that are injurious to pedestrians of all sizes. Both headforms use a triaxial arrangement of accelerometers to measure HIC values. The HIC skull fracture risk function is based on adult male cadaveric data but the Agency is not aware of biomechanical data suggesting that a female head may be more vulnerable than a male head for the same impact condition.
                        <SU>61</SU>
                        <FTREF/>
                         Therefore, NHTSA believes that any countermeasure that is beneficial for a male pedestrian would also be beneficial for a female pedestrian.
                    </P>
                    <FTNT>
                        <P>
                            <SU>61</SU>
                             The head injury assessment reference values used for the 50th percentile adult male dummy and the 5th percentile adult female dummy are the same in frontal and side impact crash tests in NCAP and in Federal motor vehicle safety standards.
                        </P>
                    </FTNT>
                    <P>
                        NHTSA proposes to use these headforms in the NCAP program proposed in this RFC. The adult headform that is used in Euro NCAP has been evaluated by NHTSA, and the Agency has published drawings and Procedures for Assembly, Disassembly, 
                        <PRTPAGE P="34378"/>
                        and Inspection (PADI).
                        <SU>62</SU>
                        <FTREF/>
                         Similarly, the Agency has evaluated the child headform and published drawings and the associated PADI.
                        <SU>63</SU>
                        <FTREF/>
                         Furthermore, both adult and child headforms from multiple manufacturers were evaluated for durability, repeatability, and reproducibility by conducting impact tests on a variety of U.S. fleet vehicles and found them to perform well.
                        <SU>64</SU>
                        <FTREF/>
                         Qualification procedures also exist for these test devices.
                        <SU>65</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             Both documents are available at: 
                            <E T="03">https://www.regulations.gov/document/NHTSA-2019-0112-0024.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             Both documents are available at: 
                            <E T="03">https://www.regulations.gov/document/NHTSA-2019-0112-0025.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                             Suntay, B., Stammen, J., Vehicle Hood Testing to Evaluate Pedestrian Headform Reproducibility, GTR No. 9 Test Procedural Issues, and U.S. Fleet Performance, August 2018.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             
                            <E T="03">https://www.regulations.gov/document/NHTSA-2019-0112-0028.</E>
                        </P>
                    </FTNT>
                    <P>
                        Euro NCAP conducts head impacts at a speed of 40 kph (25 mph).
                        <SU>66</SU>
                        <FTREF/>
                         The tests are carried out over a large area on the front of the vehicle including the hood, windshield, and A-pillars on a 100 mm by 100 mm grid pattern. The child headform generally covers the portion of the vehicle's front end closer to the bumper, and the assessment zone for the adult headform covers an area further back, toward the windshield. The head impactors are aimed at the impact locations through the headform centerline and line of flight as shown in Figure 4. There is no HIC limit for each impact point, and Euro NCAP averages scores across all test locations—awarding higher scores for test locations with low HIC values (&lt;650) and lower scores for test locations with high HIC values (≤1,700).
                    </P>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             See Euro NCAP Pedestrian Testing Protocol V8.5 Section 12 “Headform Testing” for instructions for carrying out the headform impact tests. euro-ncap-pedestrian-testing-protocol-v85.201811091256001913.pdf (euroncap.com).
                        </P>
                    </FTNT>
                    <BILCOD>BILLING CODE 4910-59-P</BILCOD>
                    <GPH SPAN="3" DEEP="298">
                        <GID>EN26MY23.003</GID>
                    </GPH>
                    <P>
                        NHTSA
                        <FTREF/>
                         has evaluated the Euro NCAP head impact test procedures over several years, including in support of NHTSA's 2015 RFC regarding potentially incorporating those test procedures into the U.S. NCAP. For that effort, NHTSA evaluated nine U.S. vehicles, including passenger cars, SUVs, pickups, and a minivan. The vehicles included both U.S. market-only and global platform vehicles. Since the latter vehicles are vehicles that are sold in the U.S. as well as in other countries, results from the Agency's tests could be compared to Euro NCAP scores. NHTSA's assessment of the global platform vehicles showed that not only the head impact location markups but also the resulting headform scores were similar.
                    </P>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             Copyright Euro NCAP 2018. Reproduced with permission from Euro NCAP Pedestrian Testing Protocol V8.5 Figure 24.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Legforms and Leg Impacts</HD>
                    <P>
                        In addition to the headforms mentioned above, Euro NCAP also currently uses a pair of legforms for crashworthiness pedestrian protection safety evaluations. One of these legforms is a test device used in Euro NCAP to evaluate injuries to the upper leg, pelvis, and hip. This upper legform impactor, created by the Transport Research Laboratory (TRL), measures bending moments for femur fracture and forces for pelvis fracture. The TRL upper legform impactor consists of a front and rear member with a torque limiting joint, which is used to protect the test equipment in cases of extreme forces. The device is wrapped in two layers of foam to simulate a human leg with flesh. The TRL upper legform also has adjustable ballast to change the impactor mass depending on the test application. A comprehensive NHTSA evaluation, which was published in 
                        <PRTPAGE P="34379"/>
                        2019, found that the TRL upper legform impactor was durable, repeatable, reproducible, sensitive to vehicle design, and could measure the relative stiffness of a vehicle's leading edge.
                        <SU>68</SU>
                        <FTREF/>
                         Similar to the other test devices discussed in this notice, NHTSA has published drawings and a PADI for the TRL upper legform impactor.
                        <SU>69</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             
                            <E T="03">https://www.regulations.gov/document/NHTSA-2019-0112-0007.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             
                            <E T="03">https://www.regulations.gov/document/NHTSA-2019-0112-0027.</E>
                        </P>
                    </FTNT>
                    <P>
                        The TRL upper legform impactor is utilized in two separate tests.
                        <SU>70</SU>
                        <FTREF/>
                         In Euro NCAP, the upper legform may be used in place of the FlexPLI legform for bumper impacts on certain vehicles. If the lower bumper reference line (LBRL), as measured in Figure 5,
                        <SU>71</SU>
                        <FTREF/>
                         is equal to or greater than 425 mm but less than or equal to 500 mm, the vehicle manufacturer may choose to use either the FlexPLI or the TRL upper legform for bumper impact tests. 
                        <E T="51">72 73</E>
                        <FTREF/>
                         If the LBRL of a vehicle is greater than 500 mm, the TRL upper legform impactor must be utilized on those vehicles. The FlexPLI is not utilized in vehicles with very high LBRL (greater than 500 mm) due to the impactor's poor kinematic response.
                    </P>
                    <FTNT>
                        <P>
                            <SU>70</SU>
                             Unlike the headform and FlexPLI impactor tests, which are projectile impacts, the TRL upper legform impactor test is a linearly guided impact.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             The LBRL is identified by the geometric trace between the bumper and a straight edge at a 25° forward incline. It represents the lower boundary of significant points of contact with a pedestrian leg and the bumper.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             Euro NCAP plans to remove this option beginning with MY 2023, see Vulnerable Road User Testing Protocol V9.0 at 
                            <E T="03">https://www.euroncap.com/en/for-engineers/protocols/vulnerable-road-user-vru-protection/.</E>
                        </P>
                        <P>
                            <SU>73</SU>
                             See Euro NCAP Pedestrian Testing Protocol V8.5 Section 9 “Legform Tests” for instructions for carrying out the FlexPLI to bumper impact test and Section 10 “Upper Legform to Bumper Tests” for instructions for carrying out the upper legform to bumper impact test. euro-ncap-pedestrian-testing-protocol-v85.201811091256001913.pdf (euroncap.com).
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="229">
                        <GID>EN26MY23.004</GID>
                    </GPH>
                    <P>
                        Additionally,
                        <FTREF/>
                         Euro NCAP employs an impact test along the bonnet (or hood) leading edge with the TRL upper legform impactor known as the Upper Legform to WAD775mm Test.
                        <SU>75</SU>
                        <FTREF/>
                         The WAD775 test, which is conducted at a WAD of 775 mm, simulates a pedestrian's upper leg and hip wrapping around the front end of the vehicle in the transition area between the bumper and the hood. Because the pedestrian's hip wraps around the front end of the vehicle, the upper legform impactor is set up to strike the vehicle at an angle perpendicular to the internal bumper reference line (IBRL) (shown in Figure 6) and a point along the WAD at 930 mm.
                        <SU>76</SU>
                        <FTREF/>
                         These tests are conducted at a speed between 20 and 33 kph (12 and 21 mph) and at an impact angle depending on vehicle geometry, and maximum points are awarded for forces below 5 kN and bending moments below 280 Nm. The test setup is shown in Figure 7. Vehicles with higher front ends tend to have lower impact angles (relative to horizontal) and higher impact speeds with more energy. Vehicles with lower front ends tend to have higher impact angles (relative to horizontal) and lower impact speeds with less energy. The Upper Legform to WAD775mm Test in Euro NCAP has remained the same since 2015.
                    </P>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             Copyright Euro NCAP 2018. Reproduced with permission from Euro NCAP Pedestrian Testing Protocol V8.5 Figure 13.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             See Euro NCAP Pedestrian Testing Protocol V8.5 Section 11 “Upper Legform to WAD775mm Tests” for instructions for carrying out the upper legform to WAD775 test. euro-ncap-pedestrian-testing-protocol-v85.201811091256001913.pdf (euroncap.com).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             The IBRL height is identified where a vertical plane contacts the bumper beam up to 10mm into the profile of the bumper beam.
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="359">
                        <PRTPAGE P="34380"/>
                        <GID>EN26MY23.005</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="258">
                        <GID>EN26MY23.006</GID>
                    </GPH>
                    <PRTPAGE P="34381"/>
                    <P>
                        In addition
                        <FTREF/>
                         to the TRL upper legform, the Flexible Pedestrian Legform Impactor (FlexPLI), represents an adult human's femur, knee, and tibia. Prior to the creation of the FlexPLI, the European Enhanced Vehicle-Safety Committee (EEVC) legform impactor was utilized in Euro NCAP. The EEVC legform had limitations because (1) it has a rigid femur and tibia, (2) the knee joint was unable to simulate combined loading, and (3) the steel ligaments needed to be replaced after every test. Unlike the EEVC legform impactor, the FlexPLI has not only an articulated femur and leg bone elements but also an articulated knee structure. The bone elements for the FlexPLI are instrumented with strain gauges, and the knee segment is instrumented with four potentiometer ligaments that retract and elongate. The entire FlexPLI assembly, which weighs 13.2 kg (29.1 pounds), is wrapped in rubber layers and a neoprene cover simulating flesh and skin of a human leg. The FlexPLI has been used by Euro NCAP since 2014. In 2014, a comprehensive NHTSA evaluation of the FlexPLI found the impactor to be durable, biofidelic, repeatable, reproducible, and sensitive to vehicle design.
                        <SU>79</SU>
                         NHTSA has published drawings and a PADI for the FlexPLI.
                        <SU>80</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             Copyright Euro NCAP 2018. Reproduced with permission from Euro NCAP Pedestrian Testing Protocol V8.5 Figure 15.
                        </P>
                        <P>
                            <SU>78</SU>
                             Copyright Euro NCAP 2018. Reproduced with permission from Euro NCAP Pedestrian Testing Protocol V8.5 Figure 29.
                        </P>
                        <P>
                            <SU>79</SU>
                             
                            <E T="03">https://www.regulations.gov/document/NHTSA-2019-0112-0003.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>80</SU>
                             
                            <E T="03">https://www.regulations.gov/document/NHTSA-2019-0112-0026.</E>
                        </P>
                    </FTNT>
                    <P>
                        To evaluate injuries to a pedestrian's knee and lower leg, the FlexPLI is launched in free flight, perpendicular to the ground, at a fixed height, into the front bumper of a vehicle at an impact velocity of 40 kph (25 mph).
                        <SU>81</SU>
                        <FTREF/>
                         The test setup is shown in Figure 8. The FlexPLI test has remained relatively the same in Euro NCAP since its addition to the program in 2014. Euro NCAP evaluates tibia bending moments and knee ligament elongations. Maximum points are awarded for tibia bending moments 282 Nm and lower, and zero points are awarded for tibia bending moments above 340 Nm. Knee ligament elongations are measured for the medial collateral ligament (MCL), and maximum points are awarded for an elongation less than 19 mm and zero points are awarded for an elongation greater than 22 mm. In addition, the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) cannot exceed 10 mm elongation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>81</SU>
                             See Euro NCAP Pedestrian Testing Protocol V8.5 Section 9 “Legform Tests” for instructions for carrying out the FlexPLI to bumper impact test.
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="235">
                        <GID>EN26MY23.007</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4910-59-C</BILCOD>
                    <P>
                        The upper
                        <FTREF/>
                         legform and the FlexPLI are based on a 50th percentile average adult male in both mass and stature. These legforms are the most current anthropomorphic legforms available that have been thoroughly researched and reviewed by NHTSA. Comments are requested on whether other legforms that represent smaller adult females are available, the injury criteria and test procedures associated with them, and the safety need for such legforms. As with the headforms, NHTSA believes that testing with heavier legforms is more stringent because the heavier legforms are more likely to bottom out on and hit more rigid structures. NHTSA seeks comment on the topic of female leg safety. Are there data showing that vehicle front end designs that perform well in the FlexPLI and upper legform impact tests would not afford protection to female pedestrians? Are there any legforms representing female or small stature pedestrians? Are there female specific data and associated 5th percentile female specific injury criteria for use with a 5th percentile female legform impactor? [1] 
                        <SU>83</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>82</SU>
                             Copyright Euro NCAP 2018. Reproduced with permission from Euro NCAP Pedestrian Testing Protocol V8.5 Figure 26.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>83</SU>
                             The number in square brackets signifies the question number on which NHTSA seeks comment.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">E. Response to Comments Received in Previous Actions</HD>
                    <P>
                        The following section addresses comments received from the public in response to NHTSA's December 2015 RFC section on pedestrian protection and the public meeting in 2018.
                        <PRTPAGE P="34382"/>
                    </P>
                    <HD SOURCE="HD3">1. General Pedestrian Protection Comments</HD>
                    <P>NHTSA received many comments in general support of adding a crashworthiness pedestrian protection testing component to NCAP. Furthermore, many of the comments in response to the December 2015 notice stated that both pedestrian crash avoidance and pedestrian crashworthiness elements were appropriate for inclusion in NCAP. The Agency's most recent RFC, which was issued in March 2022, proposed to include pedestrian automatic emergency breaking technology in NCAP. That proposal focused on the crash avoidance aspect of pedestrian safety in NCAP. The March 2022 notice also included a roadmap outlining crashworthiness pedestrian protection as a future update. NHTSA received a number of comments in support of adding crashworthiness pedestrian protection to NCAP, with commenters noting that vehicles are getting larger and pedestrian and cyclist fatalities are increasing in recent years. The commenters requested adopting a crashworthiness pedestrian protection testing program and rating system similar to that implemented in Euro NCAP. Commenters requested ensuring protection for a wide range of pedestrian sizes and weights. Some suggested designing the tests to protect children and smaller adults and others suggested including protection for cyclists and using female specific test devices. This proposal continues the Agency's efforts to improve pedestrian safety from a crashworthiness perspective, demonstrating a multi-prong approach to improving pedestrian safety and preventing pedestrian injury and death related to motor vehicle crashes in the United States.</P>
                    <P>A common theme in the comments received from the public on NCAP updates was that NHTSA should work to harmonize with other NCAPs; thus, many commenters were supportive of the proposal in the December 2015 Notice to adopt the Euro NCAP test procedures. However, a few commenters noted that harmonization may not always be appropriate because (1) there are differences in the U.S. and European vehicle fleet and (2) different tests may address a broader spectrum of real-world scenarios. Many commenters also suggested that NHTSA continue to monitor updates to Euro NCAP and consider applying those to the U.S. NCAP.</P>
                    <P>
                        The proposal in this RFC draws from the most recent Euro NCAP pedestrian crashworthiness test procedures.
                        <SU>84</SU>
                        <FTREF/>
                         Although NHTSA is mainly proposing to adopt the Euro NCAP test devices and test procedures, to ensure that the overall score better reflects the pedestrian protection provided by the vehicle's front end, the Agency is proposing some changes to FlexPLI and TRL upper legform bumper and WAD775 testing. As noted by many commenters in the March 2022 notice, U.S. vehicle front ends are getting taller and these changes to the test procedure will ensure these taller vehicles are tested appropriately. Furthermore, NHTSA is proposing changes to the apportionment that each test device contributes to a vehicle's overall score, to align with injury data in the U.S.
                    </P>
                    <FTNT>
                        <P>
                            <SU>84</SU>
                             Euro NCAP Pedestrian Testing Protocol—euro-ncap-pedestrian-testing-protocol-v85.201811091256001913.pdf (euroncap.com) and Part I Pedestrian Impact Assessment in 
                            <E T="03">https://cdn.euroncap.com/media/67553/euro-ncap-assessment-protocol-vru-v1005.pdf.</E>
                        </P>
                    </FTNT>
                    <P>A few commenters specifically requested that NHTSA use the Euro NCAP pedestrian crashworthiness test procedures rather than the GTR 9 procedures for the U.S. NCAP because the grid markup method and point scoring method have been shown to be suitable for use to evaluate and score vehicles in that consumer information program. NHTSA is considering Euro NCAP test procedures for inclusion in the U.S. NCAP in this proposal.</P>
                    <P>
                        Some commenters, including the Alliance for Automotive Innovation (formerly the Alliance of Automobile Manufacturers and Association of Global Automakers), suggested that pedestrian crashworthiness was not appropriate for NCAP, but would instead be more appropriate for a Federal motor vehicle safety standard (FMVSS). The Agency agreed to portions of GTR 9 and is currently developing a rulemaking proposal on requirements to protect pedestrian heads impacting vehicle hoods that is based on the requirements in GTR 9.
                        <SU>85</SU>
                        <FTREF/>
                         On first impression these programs might appear identical, but there are important differences that differentiate the NCAP proposal discussed in this RFC from the future GTR 9 rulemaking that the Agency is developing. The proposal in this RFC evaluates protection afforded by the front of vehicles for the head, pelvis, leg, and knee in pedestrian impacts with the front of the vehicle, while the GTR 9 rulemaking focuses on protection for the head. There are also key differences for the head impact testing procedures. Those differences between GTR 9 and Euro NCAP (which are similar to that proposed in this RFC) are detailed in Tables 4 and 5. Specifically, the headform impact speed in this RFC is 5 km/h greater than that in GTR 9. Additionally, the Agency proposes to conduct impact tests on the windshield with the adult headform if the windshield is within WAD of 2100 mm while GTR 9 does not conduct head impact tests beyond the hood test area. This proposal to include a crashworthiness pedestrian protection testing program in NCAP along with a future rulemaking proposal (GTR 9) align with previous agency efforts to address a safety need using both non-regulatory and regulatory approaches. One example would be the incorporation of a dynamic pole test in Federal motor vehicle safety standard (FMVSS), No. 214, “Side impact protection,” 
                        <SU>86</SU>
                        <FTREF/>
                         as well as NCAP.
                        <SU>87</SU>
                        <FTREF/>
                         In addition, BIL explicitly incorporates concern over the safety of pedestrians and other vulnerable road users into NCAP, thus making any question that may have existed on this issue at the time of the 2015 notice moot.
                    </P>
                    <FTNT>
                        <P>
                            <SU>85</SU>
                             RIN AK98 on the 2022 Spring Agenda available at 
                            <E T="03">https://www.reginfo.gov/public/do/eAgendaMain.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>86</SU>
                             72 FR 51908.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>87</SU>
                             73 FR 40015.
                        </P>
                    </FTNT>
                    <P>
                        In its comment, BMW questioned the effectiveness of a crashworthiness pedestrian protection testing program. BMW noted that pedestrian crashworthiness requirements are part of European and Japanese regulations, and it is unclear if the reductions in pedestrian injuries and fatalities in Europe and Japan are due to these regulations or due to improvements in roadway infrastructure. As noted earlier, a review of 7,576 crashes in the German National Accident Records from 2009-2011 involving Euro NCAP rated vehicles showed a significant correlation between Euro NCAP pedestrian score and injury outcome in real-life car-to-pedestrian crashes.
                        <SU>88</SU>
                        <FTREF/>
                         Comparing a vehicle that earned 5 points to a vehicle that earned 22 points, the conditional probability of fatal injury to a pedestrian from the latter vehicle was reduced by 35 percent. Additionally, the probability of serious injury from the latter vehicle was reduced by 16 percent.
                        <SU>89</SU>
                        <FTREF/>
                         Furthermore, a review of the FlexPLI bumper tests from the Federal Highway Research Institute (BASt) indicated that 11 fatalities and 506 serious injuries 
                        <PRTPAGE P="34383"/>
                        were reduced annually 
                        <SU>90</SU>
                        <FTREF/>
                         in Germany.
                        <SU>91</SU>
                        <FTREF/>
                         BASt conducted this study in relation to the GTR 9 testing requirements (not Euro NCAP requirements). However, the test procedures are similar (same impactor and similar test speed) to those in Euro NCAP, but the Euro NCAP testing protocol has more stringent injury criteria to achieve a non-zero score.
                    </P>
                    <FTNT>
                        <P>
                            <SU>88</SU>
                             Pastor C. Correlation between pedestrian injury severity in real-life crashes and Euro NCAP pedestrian test results, In: Proceedings of the 23rd Technical Conference on the Enhanced Safety of Vehicles (ESV). Seoul, 2013.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>89</SU>
                             See Table 21 in appendix A.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>90</SU>
                             This study utilized “AIS-1” shifting where some fatalities would have instead been serious injuries and where some serious injuries would have instead been slight injuries.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>91</SU>
                             Estimation of Cost Reduction due to Introduction of FlexPLI within GTR9. 5th Meeting of Informal Group GTR9 Phase 2. Federal Highway Research Institute (BASt). Bergisch Gladbach, December 6th—7th, 2012. Available at 
                            <E T="03">https://wiki.unece.org/display/trans/GTR9-2+5th+session.</E>
                        </P>
                    </FTNT>
                    <P>Some commenters to the March 2022 NCAP RFC requested a rating system for crashworthiness pedestrian protection similar to EuroNCAP. Several previously received comments suggested a “soft landing” approach to introducing new elements in NCAP. A soft landing is an approach in which requirements are either gradually introduced or the stringency is gradually increased. The Agency agrees that there is merit to such an approach and therefore is introducing the crashworthiness pedestrian protection testing program in NCAP first as a program similar to the current crash avoidance testing program in NCAP. In other words, NHTSA would give credit to vehicles that pass the Agency's performance test criteria on the Agency's website. Initially, it will not be part of a rating system. As discussed in the March 2022 notice, after NHTSA completes its comprehensive consumer research on updating the safety rating section of the Monroney label, the Agency plans to completely overhaul its ratings system to include, among other things, crash avoidance testing, crashworthiness pedestrian testing, and other planned updates. By introducing the crashworthiness pedestrian testing program in this manner, NHTSA intends to encourage early adopters by highlighting vehicles that perform well, while also providing sufficient time for manufacturers to plan and incorporate the necessary design changes for pedestrian safety improvements before the label includes information about new crash avoidance or pedestrian protection systems.</P>
                    <P>Many individuals who support initiatives from the League of American Bicyclists suggested that NHTSA should incorporate bicyclists into the Agency's assessment of pedestrian safety. NHTSA notes that, at this time, there are not widely accepted objective test procedures for crashworthiness bicyclist protection evaluation of vehicles, and thus it does not meet the four prerequisites for inclusion NCAP. However, it may be possible that countermeasures that reduce injury risk for pedestrians may also have a positive effect for bicyclists. The Agency recognizes that Euro NCAP has proposed incorporating bicyclist impact tests in the future. NHTSA will continue to monitor that effort, continue to evaluate whether objective test procedures can be developed, and may reassess the inclusion of bicyclist safety in NCAP in the future.</P>
                    <HD SOURCE="HD3">2. Part 581 Issues</HD>
                    <P>Many vehicle manufacturers noted that NHTSA's proposal to incorporate Euro NCAP lower leg bumper testing as part of the proposed pedestrian crashworthiness testing program would be difficult due to conflicts with the bumper damageability requirements outlined in 49 CFR part 581. Commenters argued that part 581 bumper damageability requirements require designs to a vehicle's front end that tend to increase the severity of injury to pedestrians. Commenters also noted that the United Nations Economic Commission for Europe Regulation No. 42 (ECE R42) bumper standard allows more flexibility in vehicle front end design and requested that NHTSA consider replacing the part 581 bumper standard with a standard similar to ECE R42.</P>
                    <P>
                        NHTSA has examined potential conflicts between the part 581 requirements and pedestrian crashworthiness leg impact testing. During the 2014 Society of Automotive Engineers Government/Industry Meeting, NHTSA presented the results of its research study.
                        <SU>92</SU>
                        <FTREF/>
                         One of the vehicles tested for this study was the 2013 Ford Fusion, which is subject to part 581 bumper requirements. The Ford Fusion passed all GTR 9 lower leg injury requirements without modification.
                        <SU>93</SU>
                        <FTREF/>
                         Similarly, a 2011 Chevrolet Cruze and a 2006 Volkswagen Passat were also included in this study. These two vehicles were U.S. vehicles subject to part 581 bumper requirements that were modified with parts from their corresponding overseas models. In both cases, the lower apron was replaced with the comparable overseas part, which was believed to be stiffer than the U.S. part. Once modified, the Chevrolet Cruze met the GTR 9 lower leg injury requirements and the Volkswagen Passat nearly met the lower leg injury requirements. At the conclusion of the GTR 9 testing, these three vehicles were evaluated to see if they met the part 581 impact requirements.
                        <SU>94</SU>
                        <FTREF/>
                         Although the part 581 testing was not exhaustive and only the frontal pendulum test was conducted, all vehicles passed without incident. Furthermore, although these vehicles were evaluated using the GTR 9 FlexPLI test procedures and injury criteria, the Euro NCAP FlexPLI test procedures and injury criteria are very similar, and it is therefore anticipated that vehicles will be able to meet both part 581 requirements and receive a non-zero score in the Euro NCAP FlexPLI tests.
                    </P>
                    <FTNT>
                        <P>
                            <SU>92</SU>
                             
                            <E T="03">https://www.regulations.gov/document/NHTSA-2019-0112-0023.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>93</SU>
                             See Table 22 in appendix A.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>94</SU>
                             See Table 23 in appendix A.
                        </P>
                    </FTNT>
                    <P>
                        More recently, NHTSA conducted fleet testing on several U.S. vehicles using the Euro NCAP test procedures.
                        <SU>95</SU>
                        <FTREF/>
                         Among these vehicles were global platform vehicles that were believed to be equipped with some pedestrian safety countermeasures. One of these models, a 2016 Toyota Prius, obtained a good result of 4.41 out of 6.00 points for the lower leg impact testing. The 2016 Prius was also subject to part 581. Although other global platform vehicles that were also subject to part 581 did not perform as well, the case of the Toyota Prius shows that it is possible to meet both lower leg impact tests and part 581 requirements.
                    </P>
                    <FTNT>
                        <P>
                            <SU>95</SU>
                             DOT HS 812 723.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Test Device Issues</HD>
                    <P>Some commenters requested that pedestrian crashworthiness test devices be federalized into 49 CFR part 572 before including them in NCAP. NHTSA does not plan to incorporate the test devices into part 572 at this time, but has instead released drawings, PADIs, and qualification procedures to inform stakeholders that NHTSA will be using those test device specifications and procedures as well as the criteria set forth in this RFC to award credit to vehicles that meet the Agency's performance testing criteria.</P>
                    <P>
                        A variety of commenters raised issues with the various test devices proposed for pedestrian crashworthiness testing. Many of these comments raised concerns with the FlexPLI related to the qualification procedures, biofidelity, and usage in bumper testing. When the FlexPLI was proposed in the 2015 RFC, the test device was relatively new (compared to the more mature headforms), and Euro NCAP had used it for about one year. Since the Agency's 2015 proposal, there have been no changes to the FlexPLI, and it has been 
                        <PRTPAGE P="34384"/>
                        adopted by other programs including phase 2 of GTR 9.
                    </P>
                    <P>
                        Commenters also questioned the biofidelity of the TRL upper legform impactor. While NHTSA agrees there is limited biomechanical basis for upper leg measurements, the Agency's research has shown that, as a test tool, the upper legform impactor demonstrates the ability to measure the relative stiffness of a vehicle's front end and is sensitive to different vehicle designs. Therefore, the Agency believes it is an acceptable tool to evaluate the pedestrian crashworthiness of a vehicle's front end. Also, several commenters questioned the repeatability and reproducibility of the TRL upper legform impactor. NHTSA investigated the repeatability and reproducibility of the upper legform in both qualification testing and vehicle testing.
                        <SU>96</SU>
                        <FTREF/>
                         For the repeatability tests, which used the same impactor to strike a vehicle multiple times in the same location, all tests were conducted with a coefficient of variation (CV) less than 10 percent. CV is a measure of variability expressed as a percentage of the mean, and a CV of less than 10 percent is considered acceptable.
                        <SU>97</SU>
                        <FTREF/>
                         Similarly, the reproducibility tests, which used multiple legforms to impact the same location, produced a CV less than 10 percent in 21 of the 24 impacts. During this testing, NHTSA found that the foams used in the upper legform are sensitive to changes in temperature and humidity. Therefore, NHTSA is considering qualification and vehicle test humidity ranges more tightly defined than that specified in the standards currently used in other countries. NHTSA seeks comment on what an acceptable humidity tolerance should be for the qualification tests of the upper legform impactor and the associated vehicle test with the upper legform. [2]
                    </P>
                    <FTNT>
                        <P>
                            <SU>96</SU>
                             
                            <E T="03">https://www.regulations.gov/document/NHTSA-2019-0112-0007.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>97</SU>
                             Rhule, D., Rhule, H., &amp; Donnelly, B. (2005). The process of evaluation and documentation of crash test dummies for part 572 of the Code of Federal Regulations. 19th International Technical Conference on the Enhanced Safety of Vehicles, Washington, DC, June 6-9, 2005.
                        </P>
                    </FTNT>
                    <P>With regard to the FlexPLI, Humanetics suggested that NHTSA incorporate the qualification tests from UNECE R127. UNECE R127 specifies two dynamic qualification tests—a Pendulum test and an Inverse Impact test, in addition to a series of quasi-static tests. In UNECE R127, the dynamic qualification tests are performed before and throughout a test series, while the quasi-static tests are performed on an annual basis. Euro NCAP only specifies the dynamic Inverse Impact test and the quasi-static tests. NHTSA conducted its evaluation of the FlexPLI using only the Pendulum qualification test and did not evaluate the Inverse Impact test. The Agency found the Pendulum test to be efficient, repeatable, and easy to conduct without disturbing the vehicle setup. NHTSA did not evaluate the quasi-static deflection qualification tests. However, NHTSA is in the process of evaluating the Inverse Impact qualification test. NHTSA is requesting comment on the FlexPLI qualification procedures—specifically which procedures (dynamic and quasi-static) should be used for qualification, and how often they should be conducted? [3]</P>
                    <P>Some commenters expressed concern with using the FlexPLI to test vehicles that have higher bumpers such as large trucks and SUVs. In Euro NCAP and GTR 9, the TRL upper legform can be used in lieu of the FlexPLI for vehicles with an LBRL equal to or greater than 425 mm but less than or equal to 500 mm. NHTSA does not believe this is appropriate for a consumer information program and instead proposes the use of the FlexPLI for any vehicle with an LBRL less than or equal to 500 mm. For vehicle models with an LBRL between 425 mm and 500 mm, where the TRL upper legform was used instead of the FlexPLI (as permitted in Euro NCAP), it could lead to a better score as discussed in a later section of this notice, giving consumers a false impression of the vehicles' crashworthiness pedestrian protection performance.</P>
                    <P>
                        Ford commented that the apportionment of the leg impacts to the overall pedestrian score should remain low until technical challenges are addressed with the legforms. While NHTSA believes that there are no remaining technical issues preventing the use of the FlexPLI and upper legform in pedestrian impact tests, the Agency is seeking comment on the combined scoring of the head impact, lower leg impact, and upper leg impact tests. In Euro NCAP, head impact tests account for 24.00 out of the maximum 36.00 points (67 percent). Each leg impact test accounts for 6.00 of the remaining 12.00 points.
                        <SU>98</SU>
                        <FTREF/>
                         In a NHTSA study that evaluated the relative frequency of injuries in the U.S., the Agency found that the proportion of pedestrian injury across body regions did not align with the Euro NCAP proportion of points awarded.
                        <SU>99</SU>
                        <FTREF/>
                         An Agency study of Abbreviated Injury Scale (AIS) 
                        <SU>100</SU>
                        <FTREF/>
                         3+ pedestrian injuries in the U.S. showed that the apportionment of points in NCAP for crashworthiness pedestrian protection should be 3/8th for head impact test results (37.5 percent), 3/8th for lower leg impact test results (37.5 percent), and 2/8th for upper leg impact test (25 percent).
                        <SU>101</SU>
                        <FTREF/>
                         NHTSA seeks comment on whether injury severity or frequency would be the most appropriate basis for point allocation apportionment. [4]
                    </P>
                    <FTNT>
                        <P>
                            <SU>98</SU>
                             For 2023 and beyond, Euro NCAP has noted that head testing will contribute 18/36 points and the leg tests will contribute the other 18/36 points.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>99</SU>
                             
                            <E T="03">https://www.regulations.gov/document/NHTSA-2019-0112-0006.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>100</SU>
                             The Abbreviated Injury Scale is a 6-point ranking system used for ranking the severity of injuries. AIS 3+ Injuries means injuries of severity level 3 (serious), 4 (severe), 5 (critical), and 6 (fatal) according to the Abbreviate Injury Scale. 
                            <E T="03">www.aaam.org.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>101</SU>
                             See Table 24 in appendix A.
                        </P>
                    </FTNT>
                    <P>The Partnership for Dummy Technology and Biomechanics (PDB) commented on biofidelity concerns related to the FlexPLI legform, specifically regarding the knee and ligaments. As concluded in the Agency's FlexPLI research report, NHTSA believes the FlexPLI legform is biofidelic and seeks comment from the public on whether biofidelity concerns with the FlexPLI still remain at this time. [5]</P>
                    <P>
                        Many commenters discussed the impact angle of the FlexPLI relative to the front bumper. In Euro NCAP, the FlexPLI is launched parallel to the travel direction of the vehicle. Commenters noted that tests on the outside edges of the test zone may have a large impact angle due to the curvature of the bumper and lead to excessive rotation in the FlexPLI, reduce biofidelity of the test device, and cause erroneous ligament measurements. Some commenters suggested that all lower leg impacts should be performed normal (
                        <E T="03">i.e.,</E>
                         perpendicular) to the point of contact on the bumper. NHTSA does not agree that all lower leg impacts should be performed normal to the point of contact because that would make the tests less comparable to real-world conditions. Additionally, performing tests normal to each impact point would increase test complexity because the vehicle or the launcher would need to be moved in an arc instead of along a single axis. However, the Agency notes that defining the corners and test width of a vehicle is an area where the regulations (GTR 9 and UNECE R127) differ from Euro NCAP. Since the corners of bumpers are often swept back, these areas can lead to more oblique impact points. Euro NCAP uses a vertical plane at a 60-degree angle to 
                        <PRTPAGE P="34385"/>
                        mark the
                        <FTREF/>
                         bumper corner (shown in Figure 9), compares this width to that of the hard bumper beam, and tests the larger of the two areas. The regulations instead use a corner gauge method at a 60-degree angle that can be moved vertically, which generally decreases the bumper test zone width but is intended to alleviate extreme impact angles—as illustrated in Figure 10 and Figure 11. Section IV.F.1.f of this notice discusses in detail the corner gauge method. In NHTSA's fleet testing with the FlexPLI using the Euro NCAP test procedures, the Agency did not encounter issues with impact points along the corners. Also, the Agency evaluated the FlexPLI for GTR 9, but that study was performed before the updates made in the regulations to use the corner gauge method. NHTSA is seeking comment on what procedure it should use for marking the test zone on bumpers. In other words, should the procedure harmonize with the Euro NCAP 60-degree angle method or should it follow the GTR 9 and UNECE R127 corner gauge method? [6]
                    </P>
                    <FTNT>
                        <P>
                            <SU>102</SU>
                             Copyright Euro NCAP 2018. Reproduced with permission from Euro NCAP Pedestrian Testing Protocol V8.5 Figure 14.
                        </P>
                    </FTNT>
                    <BILCOD>BILLING CODE 4910-59-P</BILCOD>
                    <GPH SPAN="3" DEEP="355">
                        <GID>EN26MY23.008</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="285">
                        <PRTPAGE P="34386"/>
                        <GID>EN26MY23.009</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="280">
                        <GID>EN26MY23.010</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4910-59-C</BILCOD>
                    <PRTPAGE P="34387"/>
                    <P>
                        Similar to the above concerns with FlexPLI impacts at high angles, GM commented that trucks and other large vehicles with exposed metal bumpers warrant additional consideration. GM suggested that if a vehicle has an exposed bumper, the bumper test zone should use the 60-degree angle method instead of testing the full bumper width to eliminate testing at the extreme edge of what may be a curved bumper. NHTSA requests comment on this concern as well, as it is similar to the previous question for bumper test zones. [7]
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>103</SU>
                             Reproduced from GTR 9 Amendment 2 Figure 5B.
                        </P>
                        <P>
                            <SU>104</SU>
                             Reproduced from GTR 9 Amendment 2 Figure 5C.
                        </P>
                    </FTNT>
                    <P>Some commenters to the March 2022 RFC requested that NHTSA utilize female specific test devices for crashworthiness pedestrian protection testing and ensure protection for a wide range of pedestrian sizes and weights, including children and small adults. NHTSA discussed the headform and legform test devices and test procedures in Section IV.D. of this notice and noted that we believe protection will be afforded to a range of pedestrian sizes from children to large adults because of the large test zone and variety of components that are evaluated in these tests. Furthermore, we noted that we are not aware of female specific leg test devices available for evaluation at this time, but request comment on the issue.</P>
                    <HD SOURCE="HD2">F. Proposal in Detail</HD>
                    <P>In the December 2015 RFC, NHTSA proposed adopting Euro NCAP test devices, test procedures, and scoring methods for its crashworthiness pedestrian protection testing program in NCAP. As stated in the 2015 notice, the Euro NCAP test procedures and test devices simulate a 6-year-old child and average-size adult male crossing the street and being struck in the side by a vehicle travelling at 40 kph (25 mph). NHTSA notes that the twenty-five miles per hour test speed reflects real-world pedestrian head to hood impacts. As impact speed increases so does the likelihood that a pedestrian's head overshoots the vehicle's hood and windshield, especially in vehicles with lower front ends. However, given the pedestrian death and injury crisis on U.S. roadways NHTSA is seeking comment on test speeds. Should test speeds for either of the head or leg tests be increased in an attempt to provide better protection to pedestrians in vehicle to pedestrian crashes? Should the area of assessment be increased beyond the WAD 2100 mm currently proposed to account for pedestrian heads overshooting the hood and impacting the windshield or the roof of the vehicle? [8]</P>
                    <P>In this proposal, the Agency is proposing to adopt the Euro NCAP crashworthiness pedestrian protection test devices, test procedures, and some (not all) of the scoring methods. Since the December 2015 notice, there were several updates to Euro NCAP procedures. NHTSA is proposing to adopt the following test procedures and versions:</P>
                    <P>
                        (1) Euro NCAP Pedestrian Testing Protocol, Version 8.5, October 2018. This protocol describes vehicle preparation, test devices, qualification procedures, and test procedures.
                        <SU>105</SU>
                        <FTREF/>
                         As discussed later in this notice, NHTSA would conduct the headform test described in Section 12 of the Euro NCAP testing protocol, the upper legform to WAD775 tests described in Section 11 of the Euro NCAP testing protocol, and the FlexPLI to bumper tests described in Section 9 of the Euro NCAP testing protocol. NHTSA would not conduct the upper legform to bumper tests described in Section 10 of the Euro NCAP testing protocol.
                    </P>
                    <FTNT>
                        <P>
                            <SU>105</SU>
                             
                            <E T="03">https://cdn.euroncap.com/media/41769/euro-ncap-pedestrian-testing-protocol-v85.201811091256001913.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        (2) Euro NCAP Assessment Protocol—Vulnerable Road User Protection, Part 1—Pedestrian Impact Assessment, Version 10.0.3, June 2020. Once vehicle test data is collected, this document can be used to determine a resulting score.
                        <SU>106</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>106</SU>
                             
                            <E T="03">https://cdn.euroncap.com/media/58230/euro-ncap-assessment-protocol-vru-v1003.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        (3) Euro NCAP Pedestrian Headform Point Selection, V2.1, October 2017. This Microsoft Excel file is used to generate verification points to be tested by NHTSA.
                        <SU>107</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>107</SU>
                             
                            <E T="03">https://cdn.euroncap.com/media/30651/euro-ncap-pedestrian-point-selection-v21.xlsm.</E>
                        </P>
                    </FTNT>
                    <P>
                        (4) Euro NCAP Film and Photo Protocol, Chapter 8—Pedestrian Subsystem Tests, V1.3, January 2020. This document describes the camera set-up procedure only.
                        <SU>108</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>108</SU>
                             
                            <E T="03">https://cdn.euroncap.com/media/57993/euro-ncap-film-and-photo-protocol-v13.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        (5) Euro NCAP Technical Bulletin, TB 008, Windscreen Replacement for Pedestrian Testing, Version 1.0, September 2009. This document describes exceptions on bonding agents when windshields are replaced during the course of a vehicle test series.
                        <SU>109</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>109</SU>
                             
                            <E T="03">https://cdn.euroncap.com/media/1352/tb-008-windscreen-replacement-v10-0-b4576306-91fe-4aa9-bf9c-5e5d0883e95e.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        (6) Euro NCAP Technical Bulletin TB 019, Headform to Bonnet Leading Edge Tests, Version 1.0, June 2014. This document describes a procedure for child headform testing under the special case when test grid points lie forward of the hood and within the grille or hood leading edge area.
                        <SU>110</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>110</SU>
                             
                            <E T="03">https://cdn.euroncap.com/media/1367/tb-019-headform-to-ble-v10-0-94085bc9-76d7-4dab-af81-e59e9ed747aa.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        (7) Euro NCAP Technical Bulletin TB 024, Pedestrian Human Model Certification, V2.0, November 2019. This document lists various computer-aided engineering models that have been deemed acceptable for use by a vehicle manufacturer in demonstrating the operation and performance of an active hood.
                        <SU>111</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>111</SU>
                             
                            <E T="03">https://cdn.euroncap.com/media/56949/tb-024-pedestrian-human-model-certification-v20.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Items 5 and 6 from the above list have not been updated since the December 2015 proposal, and therefore the same versions of these documents, which were proposed in 2015, are being proposed again in this notice. Items 1, 2, 3, and 4 have been updated since NHTSA's 2015 RFC, and therefore NHTSA is proposing the current versions of these documents at this time for incorporation into NCAP. NHTSA requests comment on the seven Euro NCAP documents proposed in section IV. F. (Euro NCAP Pedestrian Testing Protocol Version 8.5, Euro NCAP Assessment Protocol—Vulnerable Road User Protection Part 1—Pedestrian Impact Assessment Version 10.0.3, Euro NCAP Pedestrian Headform Point Selection V2.1, Euro NCAP Film and Photo Protocol Chapter 8—Pedestrian Subsystem Tests V1.3, Euro NCAP Technical Bulletin TB 008 Windscreen Replacement for Pedestrian Testing Version 1.0, Euro NCAP Technical Bulletin TB 019 Headform to Bonnet Leading Edge Tests Version 1.0, and Euro NCAP Technical Bulletin TB 024 Pedestrian Human Model Certification V2.0)—do any elements of these documents need modification for the U.S. NCAP? [9]</P>
                    <P>There are two notable differences from the list of documents proposed in 2015 compared to the list in this notice. The first is the removal of the Pedestrian Testing Protocol V5.3.1 that the Agency proposed in 2015 to address instances where a vehicle manufacturer did not provide NHTSA its test point data. This protocol was removed from the list because the proposed crashworthiness pedestrian protection protocol will be a self-reporting program in which a vehicle manufacturer will provide NHTSA with test data in order for a vehicle to be awarded credit. Thus, this document is no longer relevant.</P>
                    <P>
                        The second notable change from the 2015 document list is the replacement 
                        <PRTPAGE P="34388"/>
                        of Technical Bulletin (TB) 013 with Technical Bulletin (TB) 024 (item 7 above). Both of these documents discuss computer models used to validate active hoods used for head-to-hood impact tests. NHTSA requests comment on TB 024 and its relevance to the U.S. NCAP. Should the models and methods in TB 024 or some other method be used to calculate head impact times to evaluate vehicles with active hoods? [10]
                    </P>
                    <P>Although this proposal is to follow the Euro NCAP procedures with some proposed changes, NHTSA plans to generate its own test procedures and associated documents in the near future based on public input received from this notice and release these documents concurrent with the final decision notice. The documents will include additional requirements for contract test laboratories and will be formatted similarly to other NCAP test procedures and reference documents. Below are details of differences between the U.S. NCAP and Euro NCAP pedestrian protection testing protocols and evaluation methods.</P>
                    <HD SOURCE="HD3">1. Differences From Euro NCAP Tests and Assessment Protocols</HD>
                    <P>NHTSA proposes to use the Euro NCAP testing protocol to conduct its assessment on all selected vehicles, including pickup trucks and large SUVs. For the most part, the procedures of Euro NCAP Testing Protocol V8.5 are applicable to all vehicles eligible for testing under the U.S. NCAP (vehicles with a gross vehicle weight rating less than or equal to 4,536 kilograms). This includes headform testing on grid points forward of the hood (or bonnet) leading edge (BLE), where the procedure stipulates an impact angle of 20 degrees relative to the ground. However, some adjustments to the Euro NCAP testing protocol are needed to align with the self-reporting aspect of the proposed program in U.S. NCAP, to better reflect pedestrian protection provided by the vehicle's front end, and to improve test practices.</P>
                    <HD SOURCE="HD3">a. Self-Reporting Data</HD>
                    <P>In Euro NCAP, manufacturers typically self-report predicted head impact test data of their vehicles prior to Euro NCAP conducting its impact testing on those vehicles. However, upper leg and lower leg impact test data are not provided by the manufacturer. Instead, these data are gathered from the testing conducted by the Euro NCAP test facilities. For now, the U.S. NCAP proposes to operate its crashworthiness pedestrian protection program in a fully self-reported manner—similar to the Agency's crash avoidance testing program. Therefore, vehicle manufacturers would be expected to report all predicted head, upper leg, and lower leg impact test data to NCAP in order to receive crashworthiness pedestrian protection credit for their vehicles. NHTSA seeks comment on what level of detail should be required for self-reported data. Should manufacturers be allowed to submit predicted head and leg response data, or only actual physical test results? Should reporting consist of just the results for each test location, or should full data traces or a comprehensive test report including photographs and videos be required? [11]</P>
                    <HD SOURCE="HD3">b. No “Blue Points” for Predicted Head Impact Test Data</HD>
                    <P>
                        In Euro NCAP, manufacturers may elect to nominate some “blue points” as part of the predicted head impact test data. Blue grid points are those where pedestrian protection performance measure is unpredictable,
                        <SU>112</SU>
                        <FTREF/>
                         as indicated by the test results provided by the manufacturer. Due to the unpredictable nature of these grid points, the manufacturer does not include blue points in computing the overall score for the head impact testing assessment submitted to Euro NCAP. Euro NCAP always tests the identified blue points (instead of randomly selecting grid points) and includes the head impact assessment at these blue points in computing the overall head impact score. For the U.S. NCAP program, in order for a manufacturer to self-report that its vehicle meets the NCAP performance criteria and receives crashworthiness pedestrian protection credit, the manufacturer must have sufficient data to support a predicted point/color value for every head grid point and every upper and lower leg impact test point.
                    </P>
                    <FTNT>
                        <P>
                            <SU>112</SU>
                             Blue grid points are limited to the following structures: plastic scuttle, windscreen wiper arms and windscreen base, headlamp glazing, and break-away structures.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">c. Use of FlexPLI on Pickup Trucks and Large SUVs</HD>
                    <P>For this proposal, all vehicles would be tested with the FlexPLI, including pickup trucks, vans, and SUVs where a vehicle's LBRL is equal to or greater than 425 mm and less than or equal to 500 mm. As discussed previously, when the lower bumper reference line of a vehicle equals or exceeds 425 mm but is less than or equal to 500 mm, Euro NCAP allows manufacturers the option to test with the TRL upper legform instead of the FlexPLI. However, the Agency proposes to use the FlexPLI even if a vehicle's LBRL equals or exceeds 425 mm but is less than or equal to 500 mm. The option to test with either legform could lead to a situation where a high-bumper vehicle, such as a pickup truck, receives a similar score as a low-bumper vehicle even though the two vehicles could be subjected to two different test devices and test procedures. Furthermore, allowing the option to use different test devices could generate conflicting or misleading scores since the test parameters and test devices used to generate the scorings are not the same. Thus, in an effort to provide consumers with comparative vehicle safety information, NHTSA believes that vehicles should be subjected to the same test devices, testing protocols, and evaluation methods.</P>
                    <HD SOURCE="HD3">d. No Bumper Testing When LBRL Is Greater Than 500 mm</HD>
                    <P>
                        For vehicles that have an LBRL value of greater than 500 mm, the Agency does not propose to conduct a bumper assessment using the FlexPLI. Instead, the Agency proposes to simply assign a “default red, no points” score to the particular point under assessment (
                        <E T="03">e.g.,</E>
                         some bumper points may be above 500 mm and not tested while others may be equal to or below 500 mm and tested). In 2009, the Insurance Institute for Highway Safety (IIHS) measured bumper heights for 68 light trucks and vans (LTVs or pickups, SUVs, and vans).
                        <SU>113</SU>
                        <FTREF/>
                         Fourteen vehicles (20 percent) that were measured had a height from ground to the bottom of the bumper equal to or greater than 500 mm. NHTSA also collected bumper height data on select MY 1989-1998 vehicles for its Pedestrian Crash Data Study (PCDS).
                        <SU>114</SU>
                        <FTREF/>
                         That study, which included both passenger cars and LTVs, showed that over 95 percent of vehicles measured had lower bumper heights (under 500 mm). The PCDS data set also identified approximately 20 percent of LTVs with bumper heights above 500 mm, closely matching the IIHS data. NHTSA expects that all passenger cars would have bumper heights less than 500 mm and be eligible for FlexPLI bumper testing. Only certain large SUVs and pickups would have bumper heights above 500 mm and thus those vehicles would not be eligible for FlexPLI bumper testing.
                    </P>
                    <FTNT>
                        <P>
                            <SU>113</SU>
                             
                            <E T="03">https://www.regulations.gov/comment/NHTSA-2009-0047-0010.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>114</SU>
                             
                            <E T="03">https://www.regulations.gov/document/NHTSA-2019-0112-0016.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Agency notes that the Euro NCAP testing protocol specifies that the TRL upper legform must be used when a 
                        <PRTPAGE P="34389"/>
                        vehicle's LBRL exceeds 500 mm, and that there is no option to use the FlexPLI for testing. Similar to NHTSA's rationale on its procedures, when a vehicle's LBRL equals or exceeds 425 mm but is less than or equal to 500 mm, the Agency believes that using the upper legform in lieu of the FlexPLI could result in an inaccurate or misleading bumper score. Furthermore, NHTSA is proposing to use the TRL upper legform for the WAD775 test as it is used in Euro NCAP. Thus, using the TRL upper legform for bumper testing when the LBRL exceeds 500 mm would result in a test redundancy because the WAD775 upper legform test and the “in lieu of the FlexPLI” upper legform test would be carried out on target points that are very close together.
                    </P>
                    <P>
                        As briefly discussed before, NHTSA believes that assessing the bumper using the FlexPLI when a vehicle's LBRL is greater than 500 mm is not an appropriate use of the test device. Such a test condition is beyond the limits for which the FlexPLI serves as a useful tool, which is also why it is not used in GTR 9 when a vehicle's LBRL exceeds 500 mm.
                        <SU>115</SU>
                        <FTREF/>
                         If a FlexPLI test is conducted on such a bumper, the legform's lack of an upper body structure could result in a condition where, upon impact, it is redirected groundward with very little tibia bending and knee displacement, thus leading to an artificially high test score. Such kinematics do not represent a human-to-vehicle interaction. In a real-world situation, bumpers that strike above the knee level cause the upper body and lower leg to rotate in opposite directions, which increases the likelihood of severe knee trauma.
                        <SU>116</SU>
                        <FTREF/>
                         Therefore, NHTSA believes that vehicles with an LBRL of 500 mm or higher should be given “default red, no points” for the bumper assessment. NHTSA would still conduct the WAD775 assessment with the upper legform. NHTSA requests comment on whether vehicles with an LBRL greater than 500 mm should be eligible to receive crashworthiness pedestrian protection credit because they will automatically receive a zero score for the FlexPLI bumper tests. [12]
                    </P>
                    <FTNT>
                        <P>
                            <SU>115</SU>
                             See “Rationale for limiting the lower legform test” paragraph 99 of GTR 9.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>116</SU>
                             Simms C and Wood D (2009), “Pedestrian and cyclist impact: a biomechanical perspective,” Springer, IBSN 978-90-481-2742-9, Dordrecht, London, Heidelberg, New York, 2009.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">e. Addressing Artificial Interference in High-Bumper Vehicles</HD>
                    <P>When testing a high-bumper vehicle, the WAD775 mark may appear on the grille of the vehicle, well below the bonnet leading edge. In this instance, the TRL upper legform is propelled horizontally into the front face of the vehicle's front-end with contact points along the entire impactor, from top to bottom. If the front-end of a vehicle is not completely flush with protruding design elements, it could lead to a condition in which either the top or bottom edge of the impactor would just “catch” a protruding vehicle component, such as the top edge of the bumper—as shown in Figure 12. When this occurs, the impactor could glance off the component in such a way that it could absorb a significant amount of impactor energy without registering a significant moment or force in the instrument. This situation is an artifact of the component test and does not represent real-world vehicle-to-pedestrian interaction. The Agency encountered this situation when it tested the 2015 Ford F-150. In this proposal, if this situation occurs during a test, NHTSA will eliminate the effect by re-positioning the upper legform and moving it up or down the WAD line to a “worst-case” position that is no greater than +/- 50 mm from the WAD775 target. A worst-case position would be chosen such that the likelihood of a glancing blow would be minimized, and the impact energy would be maximized. NHTSA expects that most interference will come from the top edge of a bumper on a high bumper vehicle, thus the upper legform would be moved upward to avoid interference with the bumper. Multiple impacts could also be performed within +/- 50 mm from the WAD775 target and the worst-case result could be used for that impact point. NHTSA requests comment on the proposal to reposition the upper legform +/- 50 mm from the WAD775 target when artificial interference is present or to conduct multiple impacts within +/- 50 mm from the WAD775 target and use the worst-case result when artificial interference is present. [13]</P>
                    <GPH SPAN="3" DEEP="248">
                        <GID>EN26MY23.011</GID>
                    </GPH>
                    <PRTPAGE P="34390"/>
                    <HD SOURCE="HD3">f. Revised Bumper Corner Definition</HD>
                    <P>
                        In the Euro NCAP test protocol, the width of the FlexPLI test area is defined by the point of contact of a 60-degree plane and the forward-most point on the vehicle front-end (shown in Figure 9). Until 2016, the same definition was used in European pedestrian regulations that resulted in a vehicle design trend in which protruding “touch points” are molded into the lower portion of the fascia.
                        <SU>117</SU>
                        <FTREF/>
                         The touch points may be placed strategically to contact the 60-degree plane as a means for vehicle manufacturers to control the width of the test area. In some models, the touch points reduce the test area to as little as 40 percent of the vehicle width.
                    </P>
                    <FTNT>
                        <P>
                            <SU>117</SU>
                             Fascia refers to the materials that cover a vehicle's bumper beam. The fascia is often made of plastic and includes decorative contours.
                        </P>
                    </FTNT>
                    <P>
                        An analysis of pedestrian casualty data from the United Kingdom (U.K.) and Germany showed that vehicle-to-pedestrian contacts were distributed across the width of the vehicle, and pedestrians who were struck by a vehicle could receive leg injuries from all areas of the vehicle front-end.
                        <SU>118</SU>
                        <FTREF/>
                         In fact, it was not obvious that any one area was particularly safe or injurious. NHTSA believes that the same situation exists in the U.S.
                    </P>
                    <FTNT>
                        <P>
                            <SU>118</SU>
                             TRL CPR1825 from the GTR 9 Bumper Test Area Task Force, 6th session: 
                            <E T="03">https://wiki.unece.org/download/attachments/23101696/TF-BTA-6-09e.pdf.</E>
                        </P>
                    </FTNT>
                    <P>In 2016, UNECE R127 was amended to include a new procedure that utilizes a corner gauge and diminishes the width-reducing effects of fascia touch points—as previously shown in Figure 10 and Figure 11. The new procedure also includes a specification to ensure that the entire width of the bumper beam (the very stiff structure underlying the fascia) is included in the test area. This bumper beam width requirement has also been included in the Euro NCAP test protocol since 2013, though Euro NCAP does not utilize the corner gauge. NHTSA tentatively plans to use the corner gauge and bumper beam width procedure for corner definition for this NCAP proposal and requests comment on this change. [14]</P>
                    <HD SOURCE="HD3">g. FlexPLI Qualification</HD>
                    <P>In UNECE R127, the specifications for the FlexPLI qualification requirements involve a dynamic Pendulum test, a dynamic Inverse Impact test, and quasi-static force-deflection tests. However, in Euro NCAP, only the Inverse Impact and quasi-static tests are specified. For this proposal, NHTSA proposes to specify only the Pendulum test and quasi-static tests. As mentioned previously, NHTSA found the Pendulum test procedure easy to administer while vehicle testing is in progress. Also, the Agency is satisfied that the proposed qualification test assures the legform is performing correctly before resuming vehicle tests. NHTSA seeks comment on whether there is benefit in requiring both the Pendulum and Inverse Impact dynamic qualification tests in addition to the quasi-static tests. Also, what should the qualification test schedule for the FlexPLI be? For instance, the Pendulum test would be performed before every vehicle test series and the quasi-static qualification tests would be performed on an annual basis. [15]</P>
                    <HD SOURCE="HD3">h. Active Hood Detection Area</HD>
                    <P>
                        For vehicles with active hoods, the Agency would require manufacturers to demonstrate that their system does activate when there is a leg-to-bumper impact both at the vehicle centerline and as far outboard as the outboard end of the bumper test zone. This is the same requirement in the Euro NCAP test procedure. However, NHTSA would utilize the revised corner definition discussed above when determining the outboard end of the bumper test zone. Having said that, the Agency notes that the Informal Working Group for Deployable Pedestrian Protection Systems (IWG-DPPS) is actively meeting and discussing alternative definitions for the detection zone.
                        <SU>119</SU>
                        <FTREF/>
                         The IWG-DPPS is also investigating the use of the Flex-PLI in place of the Pedestrian Detection Impactor 2 (PDI2) legform to check deployment of active hoods. Therefore, NHTSA seeks comment on what the required detection area should be for vehicles with active hoods. Additionally, which device should be used for assuring the system activates properly, the Flex-PLI or the PDI2? [16]
                    </P>
                    <FTNT>
                        <P>
                            <SU>119</SU>
                             More information including meeting minutes and presentations available at 
                            <E T="03">https://wiki.unece.org/pages/viewpage.action?pageId=45383713.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Injury Limits and Scoring Process</HD>
                    <P>The Euro NCAP Assessment Protocol—Vulnerable Road User Protection, Part 1—Pedestrian Impact Assessment, Version 10.0.3, June 2020 document listed above describes the injury limits and scoring process for the crashworthiness pedestrian protection impact tests proposed in this notice. That process is also summarized in the paragraphs below.</P>
                    <P>
                        Each group of component tests (
                        <E T="03">i.e.,</E>
                         headform tests, upper legform tests, FlexPLI tests) are first scored individually; these component scores are then summed to determine a crashworthiness pedestrian protection score for each vehicle. The exact number of impact points varies depending on the geometry of a vehicle. For instance, there may be 200 head impact points on the hood, windshield, and A-pillars, 15 upper leg impact points on the forward edge of the vehicle's front-end, and 15 lower leg impact points on the vehicle's bumper area. Each impact point for each test device is scored between 0 and 1 point depending on the resulting injury values from the impact test. Thus, each impact point for the head test carries equal weighting to every other impact point for the head. Each impact point for the upper leg carries equal weighting to every other impact point for the upper leg. Each impact point for the FlexPLI leg carries equal weighting to every other impact point for the FlexPLI.
                    </P>
                    <P>
                        In Euro NCAP, the overall pedestrian crashworthiness score combines the results from the headform tests, TRL upper legform tests, and FlexPLI tests with a maximum score of 36.00 points. The scoring distribution is as follows: 24.00 points (66.67 percent) are apportioned to test results with the headforms, 6.00 points (16.67 percent) are allocated to the upper legform, and 6.00 points (16.67 percent) are allotted to the FlexPLI. As previously discussed, NHTSA's review of pedestrian injuries in the U.S. indicated that serious to fatal injuries (AIS 3 or higher) may more closely be represented by apportioning 37.5 percent (
                        <FR>3/8</FR>
                         or 13.50 of 36.00 points) to the headform, 25 percent (
                        <FR>2/8</FR>
                         or 9.00 of 36.00 points) to the upper legform, and 37.5 percent (
                        <FR>3/8</FR>
                         or 13.50 of 36.00 points) to the FlexPLI.
                        <SU>120</SU>
                        <FTREF/>
                         Therefore, the Agency is proposing a maximum of 13.50 points for the headform tests, 9.00 points for the upper legform tests as shown, and 13.50 points for the FlexPLI tests—as shown in Table 9. The Agency proposes utilizing a modified 
                        <FR>3/8</FR>
                        , 
                        <FR>3/8</FR>
                        , 
                        <FR>2/8</FR>
                         scoring apportionment for the head impacts, Flex PLI impacts, and upper leg impacts respectively for NCAP and requests comment on this proposal. [17]
                    </P>
                    <FTNT>
                        <P>
                            <SU>120</SU>
                             DOT HS 812 658.
                        </P>
                    </FTNT>
                    <PRTPAGE P="34391"/>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s100,12,12,12">
                        <TTITLE>Table 9—Apportionment of Pedestrian Impact Test Scores</TTITLE>
                        <BOXHD>
                            <CHED H="1">Component</CHED>
                            <CHED H="1">Apportionment</CHED>
                            <CHED H="1">
                                Apportionment
                                <LI>(percentage)</LI>
                            </CHED>
                            <CHED H="1">Maximum points</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Head</ENT>
                            <ENT>3/8</ENT>
                            <ENT>37.5</ENT>
                            <ENT>13.50</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Upper Legform</ENT>
                            <ENT>2/8</ENT>
                            <ENT>25.0</ENT>
                            <ENT>9.00</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">FlexPLI</ENT>
                            <ENT>3/8</ENT>
                            <ENT>37.5</ENT>
                            <ENT>13.50</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>Each of the head impact locations on a vehicle contribute equally to the component level sub-score for the head tests. The Euro NCAP assessment protocol designates a color and awards either 0.00, 0.25, 0.50, 0.75, or 1.00 point to each head impact location using the following criteria:</P>
                    <GPOTABLE COLS="4" OPTS="L2,p7,7/8,i1" CDEF="s50,8,8,8">
                        <TTITLE>Table 10—Headform Scoring</TTITLE>
                        <BOXHD>
                            <CHED H="1">Color</CHED>
                            <CHED H="1">HIC min.</CHED>
                            <CHED H="1">HIC max.</CHED>
                            <CHED H="1">Point value</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Green</ENT>
                            <ENT/>
                            <ENT>&lt;650</ENT>
                            <ENT>1.00</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Yellow</ENT>
                            <ENT>650</ENT>
                            <ENT>&lt;1,000</ENT>
                            <ENT>0.75</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Orange</ENT>
                            <ENT>1,000</ENT>
                            <ENT>&lt;1,350</ENT>
                            <ENT>0.50</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Brown</ENT>
                            <ENT>1,350</ENT>
                            <ENT>&lt;1,700</ENT>
                            <ENT>0.25</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Red</ENT>
                            <ENT>1,700</ENT>
                            <ENT/>
                            <ENT>0.00</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>Thus, any HIC score that falls in the “Green” range will receive a point value of 1.00, any HIC score that falls in the “Yellow” range will receive a point value of 0.75, any HIC score that falls in the “Orange” range will receive a point value of 0.50, etc.</P>
                    <P>The head impact sub-score is calculated according to the following formula:</P>
                    <GPH SPAN="3" DEEP="68">
                        <GID>EN26MY23.012</GID>
                    </GPH>
                    <P>Each of the upper legform impact locations contributes equally to the component level sub-score for the upper legform impacts. Each impact location may be awarded up to 1.00 point on a linear sliding scale between the upper and lower injury limits. This is different than the headform scoring where injury values are put in discrete scoring bands. The worst-performing injury metric (one of three moments—upper, middle, or lower; or sum of forces) is used to determine the score using the following criteria:</P>
                    <GPOTABLE COLS="4" OPTS="L2,p7,7/8,i1" CDEF="s50,8,8,8">
                        <TTITLE>Table 11—Upper Legform Scoring</TTITLE>
                        <BOXHD>
                            <CHED H="1">Component</CHED>
                            <CHED H="1">
                                Min.
                                <LI>injury</LI>
                            </CHED>
                            <CHED H="1">
                                Max.
                                <LI>injury</LI>
                            </CHED>
                            <CHED H="1">Max. point value</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Bending Moment (Nm)</ENT>
                            <ENT>285</ENT>
                            <ENT>350</ENT>
                            <ENT>1.00</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sum of forces (N)</ENT>
                            <ENT>5000</ENT>
                            <ENT>6000</ENT>
                            <ENT/>
                        </ROW>
                    </GPOTABLE>
                    <P>The upper legform scoring is shown graphically in Figure 13 and Figure 14. Injury values closer to the minimum injury values earn more points and injury values closer to the maximum injury values earn fewer points.</P>
                    <BILCOD>BILLING CODE 4910-59-P</BILCOD>
                    <GPH SPAN="3" DEEP="236">
                        <GID>EN26MY23.013</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="244">
                        <PRTPAGE P="34392"/>
                        <GID>EN26MY23.014</GID>
                    </GPH>
                    <P>The upper legform impact sub-score is calculated according to the following formula:</P>
                    <GPH SPAN="3" DEEP="78">
                        <GID>EN26MY23.015</GID>
                    </GPH>
                    <P>Similarly, each of the FlexPLI impact locations on a vehicle contributes equally to the component level sub-score for the FlexPLI tests. Each impact location may receive up to 0.50 points from the tibia moments and up to 0.50 points from the ligament elongations. The tibia score is determined from the worst of the four tibia measurements—T1, T2, T3, or T4. The ligament elongation is scored from the MCL as long as neither the ACL nor PCL exceeds the 10 mm elongation limit. If either the ACL or PCL exceed this limit, the overall ligament elongation score is 0.00. Similar to the upper legform scoring, the Euro NCAP assessment protocol awards points based on a linear sliding scale between the upper and lower injury limits using the criteria in Figure 8. Again, this is different than the headform scoring method where injury values are put in discrete scoring bands.</P>
                    <GPOTABLE COLS="4" OPTS="L2,p7,7/8,i1" CDEF="s50,8,8,8">
                        <TTITLE>Table 12—FlexPLI Scoring</TTITLE>
                        <BOXHD>
                            <CHED H="1">Component</CHED>
                            <CHED H="1">
                                Min.
                                <LI>injury</LI>
                            </CHED>
                            <CHED H="1">
                                Max.
                                <LI>injury</LI>
                            </CHED>
                            <CHED H="1">Max. point value</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Tibia bending (Nm)</ENT>
                            <ENT>282</ENT>
                            <ENT>340</ENT>
                            <ENT>0.50</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">MCL elongation (mm)</ENT>
                            <ENT>19</ENT>
                            <ENT>22</ENT>
                            <ENT>0.50</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">ACL/PCL elongation (mm)</ENT>
                            <ENT/>
                            <ENT>10</ENT>
                            <ENT>0.00</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>The FlexPLI scoring is shown graphically in Figure 15 and Figure 16. Injury values closer to the minimum injury value earn more points, and injury values closer to the maximum injury value earn fewer points.</P>
                    <GPH SPAN="3" DEEP="256">
                        <PRTPAGE P="34393"/>
                        <GID>EN26MY23.016</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="244">
                        <GID>EN26MY23.017</GID>
                    </GPH>
                    <P>The FlexPLI impact sub-score is calculated according to the following formula:</P>
                    <GPH SPAN="3" DEEP="78">
                        <GID>EN26MY23.018</GID>
                    </GPH>
                    <PRTPAGE P="34394"/>
                    <P>The resulting crashworthiness pedestrian protection score is the summation of the three component sub-scores and is calculated according to the following formula:</P>
                    <GPH SPAN="3" DEEP="90">
                        <GID>EN26MY23.019</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4910-59-C</BILCOD>
                    <HD SOURCE="HD3">3. NCAP Proposal for Awarding Credit</HD>
                    <P>As stated earlier in this notice, NHTSA proposes to implement the crashworthiness pedestrian protection testing program initially by assigning credit to vehicles that meet NCAP performance test requirements before including them as part of a future rating system. In other words, instead of rating a vehicle's crashworthiness pedestrian protection on a scale of 1 to 5 stars, initially, NHTSA proposes to assign credit to vehicles if they meet a certain minimum scoring threshold for crashworthiness pedestrian protection. The Agency believes that consumers would still be able to compare crashworthiness pedestrian protection by identifying vehicles that have been designated by NHTSA as meeting this minimum level of pedestrian safety. Furthermore, this approach would not only allow early adopters to participate in the program, but also provide sufficient time for manufacturers to redesign their vehicles to improve pedestrian crashworthiness safety.</P>
                    <P>
                        In Euro NCAP, a MY 2022 vehicle must receive a Vulnerable Road User (VRU) sub-score of 60 percent or greater to receive a 5-star overall vehicle safety rating, or 50 percent or greater to receive a 4-star overall vehicle safety rating. The VRU sub-score is a combination of crashworthiness pedestrian protection as well as pedestrian and pedalcyclist crash avoidance. Omitting the crash avoidance portion from the VRU score, a vehicle must score 21.60 points or greater in crashworthiness pedestrian protection to achieve the 60 percent threshold and receive a 5-star overall vehicle safety rating in Euro NCAP. Similarly, a vehicle must score 18.00 points or greater to attain the 50 percent threshold and receive a 4-star overall vehicle safety rating in Euro NCAP. For MY 2023 and beyond, Euro NCAP's assessment protocol will become more stringent. For instance, a 70 percent VRU score will be required to achieve an overall 5-star vehicle safety rating, and 60 percent VRU will be needed to earn an overall 4-star rating.
                        <SU>121</SU>
                        <FTREF/>
                         In terms of points, this would equate to 25.20 points for a 5-star overall rating, or 21.60 points for a 4-star overall rating.
                    </P>
                    <FTNT>
                        <P>
                            <SU>121</SU>
                             See Euro NCAP Assessment Protocol—Overall Rating v9.1. 
                            <E T="03">https://cdn.euroncap.com/media/64096/euro-ncap-assessment-protocol-overall-rating-v91.pdf.</E>
                        </P>
                        <P>
                            <SU>122</SU>
                             DOT HS 812 723.
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s100,12,12,12,12">
                        <TTITLE>Table 13—U.S. and European Fleet Pedestrian Protection Scores</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">
                                U.S. fleet scores
                                <LI>(MY 2015-2017)</LI>
                            </CHED>
                            <CHED H="2">Points</CHED>
                            <CHED H="2">Percentage</CHED>
                            <CHED H="1">
                                Euro NCAP vehicle scores
                                <LI>(MY 2018-2021)</LI>
                            </CHED>
                            <CHED H="2">Points</CHED>
                            <CHED H="2">Percentage</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Headform (24.00 max.)</ENT>
                            <ENT>16.43</ENT>
                            <ENT>68</ENT>
                            <ENT>16.50</ENT>
                            <ENT>69</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Upper Legform (6.00 max.)</ENT>
                            <ENT>3.52</ENT>
                            <ENT>59</ENT>
                            <ENT>4.06</ENT>
                            <ENT>68</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Lower Legform (6.00 max.)</ENT>
                            <ENT>1.67</ENT>
                            <ENT>28</ENT>
                            <ENT>5.93</ENT>
                            <ENT>99</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Overall (36.00 max.)</ENT>
                            <ENT>21.63</ENT>
                            <ENT>60</ENT>
                            <ENT>26.49</ENT>
                            <ENT>74</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>NHTSA reviewed approximately 100 European vehicles rated by Euro NCAP from model years 2018 to 2021 for crashworthiness pedestrian protection—as shown in Table 13 above. Of those vehicles, the average overall score for all three tests was 26.49 points out of a possible 36.00, or 74 percent, and only one vehicle had an overall score of less than 21.60 points (60 percent). At a component level, the average score was 16.50 out of a possible 24.00 points for the head tests, 4.06 out of a possible 6.00 for the upper legform impact test, and 5.93 out of a possible 6.00 for the lower leg impact test. The upper legform impact test had the most variable scores as many vehicles received a perfect 6.00 points, but many vehicles also received 0.00 points.</P>
                    <P>
                        NHTSA also evaluated nine U.S. vehicles from model years 2015 to 2017 using head impact tests, upper leg impact tests, and lower leg impact tests.
                        <SU>122</SU>
                         Also, as illustrated in Table 13, of the nine vehicles tested, the average overall score was 21.63 points out of 36.00 points, or 60 percent. Overall scores ranged from 11.02 to 30.12 points. Four of the nine vehicles scored less than 21.60 points, or 60 percent. For the head component testing, vehicles in the NHTSA evaluation scored an average of 16.43 points out of a possible 24.00 points. As shown in Table 13, the average head score of 16.43 points for NHTSA's fleet testing of U.S. vehicles is only slightly less than the Euro NCAP average head score of 16.50 points. For the upper legform testing, the U.S. fleet scored an average of 3.52 points and the European fleet scored an average of 4.06 points. Although these two averages are similar, the European data has a median score of 4.06 points, and many vehicles received high scores for the WAD775 tests while some vehicles received very low scores, which brought the average score down. For the lower legform testing, NHTSA fleet testing also had low scores from 
                        <PRTPAGE P="34395"/>
                        the U.S. fleet vehicles with an average of 1.67 points out of a maximum of 6.00 points while the 100 vehicles rated by Euro NCAP had an average of 5.93 points—nearly perfect.
                    </P>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s100,12,12,12,12">
                        <TTITLE>Table 14—U.S. and European Fleet Pedestrian Protection Scores Using a Modified Scoring System</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">
                                U.S. fleet scores
                                <LI>(MY 2015-2017)</LI>
                            </CHED>
                            <CHED H="2">Average points</CHED>
                            <CHED H="2">Percentage</CHED>
                            <CHED H="1">
                                Euro NCAP vehicle scores
                                <LI>(MY 2018-2021)</LI>
                            </CHED>
                            <CHED H="2">Average points</CHED>
                            <CHED H="2">Percentage</CHED>
                        </BOXHD>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">
                                    Modified 
                                    <FR>3/8</FR>
                                    , 
                                    <FR>3/8</FR>
                                    , 
                                    <FR>2/8</FR>
                                     Scoring
                                </E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Headform (13.50 max.)</ENT>
                            <ENT>9.24</ENT>
                            <ENT>68</ENT>
                            <ENT>9.28</ENT>
                            <ENT>69</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Upper Legform (9.00 max.)</ENT>
                            <ENT>5.29</ENT>
                            <ENT>59</ENT>
                            <ENT>6.09</ENT>
                            <ENT>68</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Lower Legform (13.50 max.)</ENT>
                            <ENT>3.76</ENT>
                            <ENT>28</ENT>
                            <ENT>13.35</ENT>
                            <ENT>99</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Overall (36.00 max.)</ENT>
                            <ENT>18.29</ENT>
                            <ENT>51</ENT>
                            <ENT>28.72</ENT>
                            <ENT>80</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        Table 14 presents the same nine U.S. fleet vehicles and approximately 100 Euro NCAP vehicles but with the proposed 
                        <FR>3/8</FR>
                        , 
                        <FR>3/8</FR>
                        , 
                        <FR>2/8</FR>
                         modified apportionment scoring for the U.S. NCAP program discussed earlier in this notice. As shown in the table, the spread in overall scoring between the existing U.S. vehicles and Euro NCAP vehicles is much wider. The overall score is reduced for the U.S. vehicles because more weight is distributed in the upper and lower leg impact tests, which perform poorly compared to the Euro NCAP vehicles. In this proposed apportionment method, less weight is assigned to the head impact tests, in which the U.S. vehicles' performance was comparable to the Euro NCAP vehicles. The data not only shows that this modified apportionment of the component scores more closely reflect real-world AIS 3+ injuries in the U.S., but also highlights the disparity between the European and U.S. fleets and the need for additional safety improvements for the latter.
                    </P>
                    <P>
                        In order for a vehicle to be recognized by NHTSA as meeting the performance requirements for crashworthiness pedestrian protection, it must score at least 21.60 out of 36.00 points (or 60 percent) combined for the head, upper leg, and lower leg impact tests when tested and scored in accordance with the documents outlined in the previous section of this notice and the modified 
                        <FR>3/8</FR>
                        , 
                        <FR>3/8</FR>
                        , 
                        <FR>2/8</FR>
                         apportionment scoring. Six of the nine vehicles NHTSA evaluated did not meet this minimum score, but all of the approximately 100 vehicles rated in Euro NCAP's published data met this minimum score with the modified apportionment.
                    </P>
                    <P>
                        As discussed previously, NHTSA proposes to implement this by initially awarding credit to vehicles that meet the Agency's performance requirements under NCAP. As the Agency is still considering the best approach to convey vehicle safety information on the Monroney label and developing a new rating system that will include several planned NCAP updates, NHTSA is not proposing changes to the Monroney label at this time. Therefore, NHTSA proposes to inform consumers of vehicles that receive crashworthiness pedestrian protection credit through its website, 
                        <E T="03">http://www.NHTSA.gov.</E>
                         This approach is very similar to the current crash avoidance testing program in NCAP. Currently, ADAS technologies are identified through the use of check marks on the Agency's website. NHTSA seeks comment on whether this is an appropriate way to identify vehicles that meet the Agency's minimum criteria for crashworthiness pedestrian protection, or if some other notation or identifying means is more appropriate.[18]
                    </P>
                    <P>Currently, NHTSA reports vehicle safety ratings on a per-model basis, with separate ratings for different drivetrains due to differences in rollover resistance. For the crashworthiness testing program in NCAP, vehicles are tested without optional safety equipment. For the crash avoidance testing program, vehicles that are equipped with an ADAS technology as standard equipment are noted as such, as are vehicles that have the same technology as optional equipment. NHTSA notes that for the proposed crashworthiness pedestrian protection program, there may be other factors to consider, such as trim lines or other vehicle options that may affect the performance of the vehicle's countermeasures. NHTSA anticipates that trim lines or options that change the ride height of the vehicle, the clearance under the hood, or the shape of the headlights may have significant effects on the outcome of the crashworthiness pedestrian protection tests. NHTSA seeks comment on what options or features might exist within the same vehicle model that would affect the vehicle's performance of crashworthiness pedestrian protection. NHTSA also seeks comment on whether the Agency should assign credit to vehicles based on the worst-performing configuration for a specific vehicle model, or if vehicle models with optional equipment that affect the crashworthiness pedestrian protection credit should be noted as such.[19]</P>
                    <HD SOURCE="HD3">4. NCAP Verification Testing</HD>
                    <P>NHTSA believes that in order to maintain the integrity of the NCAP program and public trust, the Agency must not rely solely upon manufacturer self-reported data but must also implement a verification testing process—similar to the crash avoidance testing program in NCAP. Therefore, NHTSA is proposing the following processes for the crashworthiness pedestrian protection program.</P>
                    <P>If a manufacturer believes that a vehicle model meets the minimum criteria outlined above and wishes to self-report that vehicle for crashworthiness pedestrian protection credit, the manufacturer must submit test data to NHTSA in a standardized format developed by NHTSA. This process is consistent with the process for the crash avoidance testing program that NCAP has evaluated for a number of years. As mentioned previously in this notice, the manufacturer would need to submit predicted scores for every head impact grid point and every upper and lower leg impact test location. NHTSA would review this information for accuracy and completeness and award credit if the submitted data meet the minimum criteria outlined previously.</P>
                    <P>
                        For each new model year, NHTSA selects and acquires vehicles for testing under NCAP. Consistent with the processes used in the crash avoidance testing program, NHTSA proposes to select and acquire new model year vehicles for verification testing of their crashworthiness pedestrian protection performance. As part of NCAP, NHTSA proposes to select only vehicles with 
                        <PRTPAGE P="34396"/>
                        test data submitted by the manufacturers and approved by NHTSA as meeting the minimum performance criteria for crashworthiness pedestrian protection.
                    </P>
                    <P>For the crashworthiness pedestrian protection testing program, NHTSA is proposing to test a number of head impact points, upper leg impact test locations, and lower leg impact test locations on each vehicle that is selected for verification testing under NCAP.</P>
                    <P>NHTSA proposes to use the manufacturer's supplied predicted head impact test data in conjunction with the data collected during the verification testing, similar to the process used by Euro NCAP. The resulting NCAP data would be compared to the manufacturer's predicted data to determine a correction factor to apply to the entire head impact test data set. If the sum of the NHTSA test scores is lower than the sum of the manufacturer predicted scores, then the manufacturer predicted scores are multiplied by a factor less than 1.0. If the sum of the NHTSA test scores is higher than the sum of the manufacturer predicted scores, then the manufacturer predicted scores are multiplied by a factor greater than 1.0. If the sums of the scores are the same, the correction factor is 1.0, and thus the manufacturer's predicted head scores would not be modified. An example of this scoring method is given later in this notice.</P>
                    <P>NHTSA also proposes to conduct FlexPLI and upper leg impact testing across the entire width of the vehicle utilizing symmetry and adjacency. Symmetry and adjacency are concepts also utilized in Euro NCAP bumper and WAD775 testing with the FlexPLI and upper legform. In order to reduce test burden, it is assumed that a vehicle's front end is symmetrical, and thus the test result on a specific point on one side of the vehicle will also be applied to that same point on the other side of the vehicle. Likewise, an untested point would receive the same score as the lowest scored adjacent point. Typically, complete FlexPLI and upper legform scores can be determined with just four impacts for each test using symmetry and adjacency methods.</P>
                    <P>After NHTSA completes verification testing, the resulting data from the legform impact tests would replace the manufacturer-supplied data for that model. The data from the upper leg, lower leg, and head impact tests (with correction factor applied) would be used to generate a new crashworthiness pedestrian protection score for that vehicle model. If that score still meets NHTSA's minimum requirement for NCAP crashworthiness pedestrian protection (60 percent), the model would maintain its credit. If the new score no longer meets the minimum, that vehicle would have its credit removed.</P>
                    <P>NHTSA is proposing to test ten head impact points as part of the verification testing process, consistent with the Euro NCAP test procedure. As stated before, NHTSA does not propose to allow “blue points” in this proposed program, so all 10 test points would be chosen from the entire pool of head impact test locations. NHTSA believes that, for most vehicles, three or four upper leg impact points and three or four FlexPLI impact points would be necessary to generate a complete score for the bumper and WAD775. Thus, the Agency proposes to conduct either three or four tests with each device, as appropriate, for a given vehicle model.</P>
                    <P>The Euro NCAP test procedures cited previously in this notice outline an acceptable HIC tolerance for the head impact tests. NHTSA proposes to utilize this established tolerance for the proposed head impact tests under NCAP (see Table 15 below). Self-reported data from a manufacturer would be submitted to NHTSA in a specific HIC “color band”; each color band would have a 10 percent tolerance for verification testing. If NHTSA conducts a verification test on a selected head impact grid point and the resulting HIC value falls outside of the acceptable HIC range for the predicted color band, that point would be changed to the corresponding color band. After all 10 verification tests for the head impact test are complete, the resulting score for those 10 locations would be compared to the manufacturer's predicted score for the 10 locations. A correction factor would be determined (Equation 5) and applied to the entire head test zone, excluding default red and default green locations—similar to the method used in Euro NCAP (Equation 6). A detailed example of the head impact verification test is provided in appendix B.</P>
                    <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s50,r100,r100">
                        <TTITLE>Table 15—Acceptable HIC Range for Verification Testing</TTITLE>
                        <BOXHD>
                            <CHED H="1">Predicted color band</CHED>
                            <CHED H="1">
                                HIC
                                <E T="0732">15</E>
                                 range
                            </CHED>
                            <CHED H="1">
                                Acceptable HIC
                                <E T="0732">15</E>
                                 range
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Green</ENT>
                            <ENT>
                                HIC
                                <E T="0732">15</E>
                                 &lt;650
                            </ENT>
                            <ENT>
                                HIC
                                <E T="0732">15</E>
                                 &lt;722.22
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Yellow</ENT>
                            <ENT>
                                650 ≤ HIC
                                <E T="0732">15</E>
                                 &lt;1,000
                            </ENT>
                            <ENT>
                                590.91 ≤ HIC
                                <E T="0732">15</E>
                                 &lt;1,111.11
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Orange</ENT>
                            <ENT>
                                1,000 ≤ HIC
                                <E T="0732">15</E>
                                 &lt;1,350
                            </ENT>
                            <ENT>
                                909.09 ≤ HIC
                                <E T="0732">15</E>
                                 &lt;1,500.00
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Brown</ENT>
                            <ENT>
                                1,350 ≤ HIC
                                <E T="0732">15</E>
                                 &lt;1,700
                            </ENT>
                            <ENT>
                                1,227.27 ≤ HIC
                                <E T="0732">15</E>
                                 &lt;1,888.89
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Red</ENT>
                            <ENT>
                                1,700 ≤ HIC
                                <E T="0732">15</E>
                            </ENT>
                            <ENT>
                                1,545.45 ≤ HIC
                                <E T="0732">15</E>
                            </ENT>
                        </ROW>
                    </GPOTABLE>
                    <GPH SPAN="3" DEEP="50">
                        <GID>EN26MY23.020</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="90">
                        <GID>EN26MY23.021</GID>
                    </GPH>
                    <PRTPAGE P="34397"/>
                    <P>Unlike the head impact tests, NHTSA would not use a correction factor for the upper leg impact and lower leg impact tests. Instead, NHTSA would conduct a complete set of tests with each test device and determine a resulting score for the bumper and WAD775 using the established rules of symmetry and adjacency. The NHTSA-derived scores for the WAD775 (upper leg) and bumper (lower leg) would be used in conjunction with the corrected hood (head) score (calculated according to Equation 6) to determine a new crashworthiness pedestrian protection score for the vehicle model. If the resulting score continues to be 60 percent or greater, the vehicle would maintain its crashworthiness pedestrian protection credit status. Otherwise, that credit would be removed. NHTSA seeks comment on the proposal to conduct verification testing as part of the crashworthiness pedestrian protection program by adjusting the head score using a conversion factor determined from laboratory tests and replacing manufacturer supplied FlexPLI and upper leg scores with NHTSA scores from laboratory tests. [20]</P>
                    <HD SOURCE="HD1">V. Conclusion</HD>
                    <P>This RFC proposes to add a crashworthiness pedestrian protection testing program to NCAP. In doing so, it responds to comments received on pedestrian safety to previous NCAP RFCs and seeks comment on a program that would accept self-reported data from vehicle manufacturers and conduct verification testing on select new model year vehicles each year. Finally, when adopted, the changes proposed in this notice would fulfill the mandate set forth in the BIL to amend NCAP to provide the public with important safety information regarding the protection of vulnerable road users.</P>
                    <HD SOURCE="HD1">VI. Economic Analysis</HD>
                    <P>The changes to NCAP proposed in this RFC would ultimately enable a rating system that improves consumer awareness of crashworthiness pedestrian protection systems and the improvements to safety that stem from those systems and encourage manufacturers to accelerate their adoption. The accelerated adoption of pedestrian protection systems would drive any economic and societal impacts that result from these changes and are thus the focus of this discussion of economic analysis. Hence, the Agency has considered the potential economic effects for pedestrian protection systems proposed for inclusion in NCAP and the potential benefit of eventually developing a new rating system that would include this information.</P>
                    <P>
                        Crashworthiness pedestrian protection systems are unique because the safety improvements are attributable to improved 
                        <E T="03">pedestrian</E>
                         protection, as opposed to improvements in 
                        <E T="03">occupant</E>
                         protection that the other crashworthiness components in NCAP provide. Unlike advanced driver assistance systems, their effectiveness is the reduction of pedestrian injury and prevention of pedestrian fatalities when a crash between a motor vehicle and pedestrian does occur. This effectiveness is typically measured by using a combination of real-world statistical data, laboratory testing, and Agency expertise.
                    </P>
                    <P>As discussed in detail in this notice, crashes between pedestrians and motor vehicles present significant safety issues and NHTSA is particularly concerned about the steady rise in pedestrian fatalities over the last several years. The data from countries that prioritize crashworthiness pedestrian protection systems, via both regulation and other consumer information programs, indicate that these systems are effective in reducing pedestrian injuries and fatalities. BASt in Germany found a correlation between Euro NCAP pedestrian protection scores and pedestrian injuries and fatalities. The Swedish Transport Administration also found that vehicles that score better in the Euro NCAP pedestrian crashworthiness tests tended to reduce injury in actual crashes. Although these studies have been limited to certain geographic areas, which may not represent the entire U.S. fleet, they do illustrate how these systems can provide safety benefits. Thus, although the Agency does not have sufficient data to determine the monetized safety impacts resulting from these systems in a way similar to that frequently done for mandated technologies—when compared to the future without the proposed update to NCAP, NHTSA expects that these changes would likely have substantial positive safety effects by promoting earlier and more widespread deployment of crashworthiness pedestrian protection systems.</P>
                    <P>
                        NCAP also helps address the issue of asymmetric information (
                        <E T="03">i.e.,</E>
                         when one party in a transaction is in possession of more information than the other), which can be considered a market failure. Regarding consumer information, the introduction of a potential new component to the NCAP rating system is anticipated to provide consumers additional vehicle safety information regarding the safety of vulnerable road users to help them make more informed purchasing decisions by presenting the relative safety benefits of systems designed to protect not only occupants inside the vehicle but also persons outside the vehicle. While NHTSA knows that consumers value information about the protection of vehicle occupants when making purchasing decisions, the Agency believes that as a society, most consumers are also interested in protecting people that share their roads. Hence, there is an unquantifiable value to consumers and to the society as a whole for the Agency to provide accurate and comparable vehicle safety information about protecting all lives. At this time, the Agency does not have sufficient data, such as unit cost and information on how soon the full adoption of pedestrian protections systems would be reached, to predict the net increase in cost to consumers with a high degree of certainty.
                    </P>
                    <HD SOURCE="HD1">VII. Public Participation</HD>
                    <P>Interested parties are strongly encouraged to submit thorough and detailed comments relating to each of the relevant areas discussed in this notice. Please see Appendix C for a summarized list of specific questions that have been posed in this notice. Comments submitted will help the Agency make informed decisions as it strives to advance NCAP by encouraging continuous safety improvements for new vehicles and enhancing consumer information.</P>
                    <HD SOURCE="HD2">How do I prepare and submit comments?</HD>
                    <P>To ensure that your comments are filed correctly in the docket, please include the docket number of this document in your comments.</P>
                    <P>Your comments must not be more than 15 pages long (49 CFR 553.21). NHTSA established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.</P>
                    <P>
                        Please submit one copy (two copies if submitting by mail or hand delivery) of your comments, including the attachments, to the docket following the instructions given above under 
                        <E T="02">ADDRESSES</E>
                        . Please note, if you are submitting comments electronically as a PDF (Adobe) file, NHTSA asks that the documents submitted be scanned using an Optical Character Recognition (OCR) process, thus allowing the Agency to search and copy certain portions of your submissions.
                        <PRTPAGE P="34398"/>
                    </P>
                    <HD SOURCE="HD2">How do I submit confidential business information?</HD>
                    <P>
                        If you wish to submit any information under a claim of confidentiality, submit these materials to NHTSA's Office of the Chief Counsel in accordance with 49 CFR part 512. All requests for confidential treatment must be submitted directly to the Office of the Chief Counsel. NHTSA is currently treating electronic submission as an acceptable method for submitting confidential business information to the agency under part 512. If you claim that any of the information or documents provided in your response constitutes confidential business information within the meaning of 5 U.S.C. 552(b)(4), or are protected from disclosure pursuant to 18 U.S.C. 1905, you may submit your request via email to Dan Rabinovitz in the Office of the Chief Counsel at 
                        <E T="03">Daniel.Rabinovitz@dot.gov,</E>
                         or the legal contact listed under 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                        . Do not send a hardcopy of a request for confidential treatment to NHTSA's headquarters.
                    </P>
                    <HD SOURCE="HD2">Will the Agency consider late comments?</HD>
                    <P>
                        NHTSA will consider all comments received before the close of business on the comment closing date indicated above under 
                        <E T="02">DATES</E>
                        . To the extent possible, the Agency will also consider comments received after that date. Please note that even after the comment closing date, we will continue to file relevant information in the docket as it becomes available. Accordingly, we recommend that interested people periodically check the docket for new material. You may read the comments received at the address given above under 
                        <E T="02">ADDRESSES</E>
                        . The hours of the docket are indicated above in the same location. You may also see the comments on the internet, identified by the docket number at the heading of this notice, at 
                        <E T="03">www.regulations.gov.</E>
                    </P>
                    <HD SOURCE="HD1">VIII. Appendices</HD>
                    <HD SOURCE="HD2">A. Additional Pedestrian Crash Data</HD>
                    <GPOTABLE COLS="10" OPTS="L2,i1" CDEF="s25,12,6,6,6,6,6,6,6,12">
                        <TTITLE>Table 16—Pedestrians Killed by Number of Striking Vehicles 2011-2020</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="2">Year</CHED>
                            <CHED H="1">Number of striking vehicles</CHED>
                            <CHED H="2">1</CHED>
                            <CHED H="2">2</CHED>
                            <CHED H="2">3</CHED>
                            <CHED H="2">4</CHED>
                            <CHED H="2">5</CHED>
                            <CHED H="2">7</CHED>
                            <CHED H="2">8</CHED>
                            <CHED H="2">20</CHED>
                            <CHED H="2">Total</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">2011</ENT>
                            <ENT>4,365</ENT>
                            <ENT>77</ENT>
                            <ENT>15</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>4,457</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2012</ENT>
                            <ENT>4,709</ENT>
                            <ENT>94</ENT>
                            <ENT>12</ENT>
                            <ENT>2</ENT>
                            <ENT>1</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>4,818</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2013</ENT>
                            <ENT>4,658</ENT>
                            <ENT>99</ENT>
                            <ENT>18</ENT>
                            <ENT>2</ENT>
                            <ENT>1</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>1</ENT>
                            <ENT>4,779</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2014</ENT>
                            <ENT>4,776</ENT>
                            <ENT>119</ENT>
                            <ENT>12</ENT>
                            <ENT>2</ENT>
                            <ENT>1</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>4,910</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2015</ENT>
                            <ENT>5,373</ENT>
                            <ENT>112</ENT>
                            <ENT>5</ENT>
                            <ENT>1</ENT>
                            <ENT>2</ENT>
                            <ENT>0</ENT>
                            <ENT>1</ENT>
                            <ENT>0</ENT>
                            <ENT>5,494</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2016</ENT>
                            <ENT>5,942</ENT>
                            <ENT>121</ENT>
                            <ENT>14</ENT>
                            <ENT>2</ENT>
                            <ENT>0</ENT>
                            <ENT>1</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>6,080</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2017</ENT>
                            <ENT>5,938</ENT>
                            <ENT>124</ENT>
                            <ENT>11</ENT>
                            <ENT>2</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>6,075</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2018</ENT>
                            <ENT>6,230</ENT>
                            <ENT>120</ENT>
                            <ENT>17</ENT>
                            <ENT>6</ENT>
                            <ENT>1</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>6,374</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2019</ENT>
                            <ENT>6,132</ENT>
                            <ENT>125</ENT>
                            <ENT>14</ENT>
                            <ENT>1</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>6,272</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">2020</ENT>
                            <ENT>6,329</ENT>
                            <ENT>158</ENT>
                            <ENT>19</ENT>
                            <ENT>9</ENT>
                            <ENT>1</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>6,516</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total</ENT>
                            <ENT>54,452</ENT>
                            <ENT>1,149</ENT>
                            <ENT>137</ENT>
                            <ENT>27</ENT>
                            <ENT>7</ENT>
                            <ENT>1</ENT>
                            <ENT>1</ENT>
                            <ENT>1</ENT>
                            <ENT>55,775</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Source:</E>
                             NHTSA Fatality Analysis Reporting System (FARS).
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s50,12,12,12,12,12,12">
                        <TTITLE>Table 17—Pedestrians Killed by Striking Vehicle Body Type 2011-2020</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="2">Year</CHED>
                            <CHED H="1">Vehicle body type</CHED>
                            <CHED H="2">Passenger car</CHED>
                            <CHED H="2">Light truck</CHED>
                            <CHED H="2">Large truck</CHED>
                            <CHED H="2">Bus</CHED>
                            <CHED H="2">
                                Other/
                                <LI>unknown</LI>
                                <LI>vehicle</LI>
                            </CHED>
                            <CHED H="2">Total</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">2011</ENT>
                            <ENT>1,591</ENT>
                            <ENT>1,599</ENT>
                            <ENT>247</ENT>
                            <ENT>62</ENT>
                            <ENT>350</ENT>
                            <ENT>3,849</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2012</ENT>
                            <ENT>1,817</ENT>
                            <ENT>1,698</ENT>
                            <ENT>231</ENT>
                            <ENT>68</ENT>
                            <ENT>368</ENT>
                            <ENT>4,182</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2013</ENT>
                            <ENT>1,686</ENT>
                            <ENT>1,721</ENT>
                            <ENT>260</ENT>
                            <ENT>64</ENT>
                            <ENT>420</ENT>
                            <ENT>4,151</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2014</ENT>
                            <ENT>1,778</ENT>
                            <ENT>1,817</ENT>
                            <ENT>226</ENT>
                            <ENT>73</ENT>
                            <ENT>379</ENT>
                            <ENT>4,273</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2015</ENT>
                            <ENT>2,061</ENT>
                            <ENT>1,941</ENT>
                            <ENT>246</ENT>
                            <ENT>60</ENT>
                            <ENT>470</ENT>
                            <ENT>4,778</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2016</ENT>
                            <ENT>2,228</ENT>
                            <ENT>2,217</ENT>
                            <ENT>297</ENT>
                            <ENT>46</ENT>
                            <ENT>533</ENT>
                            <ENT>5,321</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2017</ENT>
                            <ENT>2,215</ENT>
                            <ENT>2,240</ENT>
                            <ENT>282</ENT>
                            <ENT>34</ENT>
                            <ENT>504</ENT>
                            <ENT>5,275</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2018</ENT>
                            <ENT>2,314</ENT>
                            <ENT>2,286</ENT>
                            <ENT>325</ENT>
                            <ENT>45</ENT>
                            <ENT>538</ENT>
                            <ENT>5,508</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2019</ENT>
                            <ENT>2,182</ENT>
                            <ENT>2,343</ENT>
                            <ENT>353</ENT>
                            <ENT>52</ENT>
                            <ENT>528</ENT>
                            <ENT>5,458</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">2020</ENT>
                            <ENT>2,160</ENT>
                            <ENT>2,199</ENT>
                            <ENT>379</ENT>
                            <ENT>38</ENT>
                            <ENT>760</ENT>
                            <ENT>5,536</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="03">Total</ENT>
                            <ENT>20,032</ENT>
                            <ENT>20,061</ENT>
                            <ENT>2,846</ENT>
                            <ENT>542</ENT>
                            <ENT>4,850</ENT>
                            <ENT>48,331</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="05">Totals grouped</ENT>
                            <ENT A="01">40,093</ENT>
                            <ENT A="01">3,388</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             this table filters by first harmful event = pedestrian and number of motor vehicles in transport = 1. Source: NHTSA FARS.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s50,12,12,12,12,12,12">
                        <TTITLE>Table 18—Pedestrians Killed in Frontal Crashes 2011-2020</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="2">Year</CHED>
                            <CHED H="1">Body type</CHED>
                            <CHED H="2">Passenger car</CHED>
                            <CHED H="2">Light truck</CHED>
                            <CHED H="2">Large truck</CHED>
                            <CHED H="2">Bus</CHED>
                            <CHED H="2">
                                Other/
                                <LI>unknown</LI>
                                <LI>vehicle</LI>
                            </CHED>
                            <CHED H="2">Total</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">2011</ENT>
                            <ENT>1,463</ENT>
                            <ENT>1,421</ENT>
                            <ENT>168</ENT>
                            <ENT>42</ENT>
                            <ENT>190</ENT>
                            <ENT>3,284</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2012</ENT>
                            <ENT>1,664</ENT>
                            <ENT>1,517</ENT>
                            <ENT>161</ENT>
                            <ENT>46</ENT>
                            <ENT>205</ENT>
                            <ENT>3,593</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34399"/>
                            <ENT I="01">2013</ENT>
                            <ENT>1,559</ENT>
                            <ENT>1,533</ENT>
                            <ENT>182</ENT>
                            <ENT>45</ENT>
                            <ENT>229</ENT>
                            <ENT>3,548</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2014</ENT>
                            <ENT>1,610</ENT>
                            <ENT>1,625</ENT>
                            <ENT>168</ENT>
                            <ENT>47</ENT>
                            <ENT>227</ENT>
                            <ENT>3,677</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2015</ENT>
                            <ENT>1,860</ENT>
                            <ENT>1,728</ENT>
                            <ENT>169</ENT>
                            <ENT>42</ENT>
                            <ENT>228</ENT>
                            <ENT>4,027</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2016</ENT>
                            <ENT>1,980</ENT>
                            <ENT>1,943</ENT>
                            <ENT>222</ENT>
                            <ENT>27</ENT>
                            <ENT>270</ENT>
                            <ENT>4,442</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2017</ENT>
                            <ENT>1,997</ENT>
                            <ENT>1,997</ENT>
                            <ENT>207</ENT>
                            <ENT>25</ENT>
                            <ENT>267</ENT>
                            <ENT>4,493</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2018</ENT>
                            <ENT>2,113</ENT>
                            <ENT>2,056</ENT>
                            <ENT>252</ENT>
                            <ENT>32</ENT>
                            <ENT>265</ENT>
                            <ENT>4,718</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2019</ENT>
                            <ENT>1,976</ENT>
                            <ENT>2,093</ENT>
                            <ENT>255</ENT>
                            <ENT>34</ENT>
                            <ENT>280</ENT>
                            <ENT>4,638</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">2020</ENT>
                            <ENT>1,972</ENT>
                            <ENT>1,969</ENT>
                            <ENT>274</ENT>
                            <ENT>21</ENT>
                            <ENT>386</ENT>
                            <ENT>4,622</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="03">Total</ENT>
                            <ENT>18,194</ENT>
                            <ENT>17,882</ENT>
                            <ENT>2,058</ENT>
                            <ENT>361</ENT>
                            <ENT>2,547</ENT>
                            <ENT>41,042</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="05">Totals grouped</ENT>
                            <ENT A="01">36,076</ENT>
                            <ENT A="01">2,419</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             this table filters by first harmful event = pedestrian, number of motor vehicles in transport = 1, and impact point = front. Source: NHTSA FARS.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s50,12,12,12,12,12,12">
                        <TTITLE>Table 19—Pedestrian Fatalities and Injuries With Known Travel Speed 2011-2020</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="2">Speed</CHED>
                            <CHED H="1">Fatalities 2011-2020</CHED>
                            <CHED H="2">Count</CHED>
                            <CHED H="2">Cumulative count</CHED>
                            <CHED H="2">Cumulative percentage</CHED>
                            <CHED H="1">Injuries 2011-2020</CHED>
                            <CHED H="2">Count</CHED>
                            <CHED H="2">Cumulative count</CHED>
                            <CHED H="2">Cumulative percentage</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0</ENT>
                            <ENT>315</ENT>
                            <ENT>315</ENT>
                            <ENT>1.5</ENT>
                            <ENT>5,179</ENT>
                            <ENT>5,179</ENT>
                            <ENT>2.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">1-25 mph</ENT>
                            <ENT>2,467</ENT>
                            <ENT>2,782</ENT>
                            <ENT>13.2</ENT>
                            <ENT>128,365</ENT>
                            <ENT>133,544</ENT>
                            <ENT>68.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">26-30 mph</ENT>
                            <ENT>1,505</ENT>
                            <ENT>4,287</ENT>
                            <ENT>20.3</ENT>
                            <ENT>15,497</ENT>
                            <ENT>149,041</ENT>
                            <ENT>76.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">31-35 mph</ENT>
                            <ENT>2,748</ENT>
                            <ENT>7,035</ENT>
                            <ENT>33.4</ENT>
                            <ENT>17,641</ENT>
                            <ENT>166,682</ENT>
                            <ENT>85.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">36-40 mph</ENT>
                            <ENT>2,880</ENT>
                            <ENT>9,915</ENT>
                            <ENT>47.1</ENT>
                            <ENT>9,115</ENT>
                            <ENT>175,797</ENT>
                            <ENT>90.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">41-45 mph</ENT>
                            <ENT>3,684</ENT>
                            <ENT>13,599</ENT>
                            <ENT>64.5</ENT>
                            <ENT>8,583</ENT>
                            <ENT>184,380</ENT>
                            <ENT>94.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">46-50 mph</ENT>
                            <ENT>1,604</ENT>
                            <ENT>15,203</ENT>
                            <ENT>72.2</ENT>
                            <ENT>2,438</ENT>
                            <ENT>186,818</ENT>
                            <ENT>96.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">51-55 mph</ENT>
                            <ENT>2,134</ENT>
                            <ENT>17,337</ENT>
                            <ENT>82.3</ENT>
                            <ENT>3,338</ENT>
                            <ENT>190,156</ENT>
                            <ENT>97.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">56-60 mph</ENT>
                            <ENT>1,055</ENT>
                            <ENT>18,392</ENT>
                            <ENT>87.3</ENT>
                            <ENT>1,088</ENT>
                            <ENT>191,244</ENT>
                            <ENT>98.4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">61-65 mph</ENT>
                            <ENT>1,171</ENT>
                            <ENT>19,563</ENT>
                            <ENT>92.8</ENT>
                            <ENT>1,376</ENT>
                            <ENT>192,620</ENT>
                            <ENT>99.1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">66-70 mph</ENT>
                            <ENT>845</ENT>
                            <ENT>20,408</ENT>
                            <ENT>96.9</ENT>
                            <ENT>935</ENT>
                            <ENT>193,555</ENT>
                            <ENT>99.6</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">71-75 mph</ENT>
                            <ENT>254</ENT>
                            <ENT>20,662</ENT>
                            <ENT>98.1</ENT>
                            <ENT>435</ENT>
                            <ENT>193,990</ENT>
                            <ENT>99.8</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">76-80 mph</ENT>
                            <ENT>120</ENT>
                            <ENT>20,782</ENT>
                            <ENT>98.6</ENT>
                            <ENT>138</ENT>
                            <ENT>194,128</ENT>
                            <ENT>99.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">81-151 mph</ENT>
                            <ENT>285</ENT>
                            <ENT>21,067</ENT>
                            <ENT>100.0</ENT>
                            <ENT>134</ENT>
                            <ENT>194,262</ENT>
                            <ENT>100.0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">More than 151 mph</ENT>
                            <ENT>3</ENT>
                            <ENT>21,070</ENT>
                            <ENT>100.0</ENT>
                            <ENT>23</ENT>
                            <ENT>194,285</ENT>
                            <ENT>100.0</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Source:</E>
                             NHTSA FARS and General Estimates System (GES).
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,p7,7/8,i1" CDEF="s50,12,12,12">
                        <TTITLE>Table 20—Rounded Total Pedestrians Injured in Front End Crashes</TTITLE>
                        <TDESC>[GES &amp; FARS]</TDESC>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="2">Year</CHED>
                            <CHED H="1">Body type</CHED>
                            <CHED H="2">Passenger car</CHED>
                            <CHED H="2">Light truck</CHED>
                            <CHED H="2">Total</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">2011</ENT>
                            <ENT>29,000</ENT>
                            <ENT>16,000</ENT>
                            <ENT>45,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2012</ENT>
                            <ENT>32,000</ENT>
                            <ENT>18,000</ENT>
                            <ENT>50,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2013</ENT>
                            <ENT>24,000</ENT>
                            <ENT>18,000</ENT>
                            <ENT>42,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2014</ENT>
                            <ENT>26,000</ENT>
                            <ENT>17,000</ENT>
                            <ENT>43,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2015</ENT>
                            <ENT>31,000</ENT>
                            <ENT>17,000</ENT>
                            <ENT>48,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2016</ENT>
                            <ENT>37,000</ENT>
                            <ENT>23,000</ENT>
                            <ENT>60,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2017</ENT>
                            <ENT>30,000</ENT>
                            <ENT>19,000</ENT>
                            <ENT>49,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2018</ENT>
                            <ENT>30,000</ENT>
                            <ENT>21,000</ENT>
                            <ENT>51,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2019</ENT>
                            <ENT>31,000</ENT>
                            <ENT>20,000</ENT>
                            <ENT>51,000</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">2020</ENT>
                            <ENT>23,000</ENT>
                            <ENT>16,000</ENT>
                            <ENT>39,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total</ENT>
                            <ENT>293,000</ENT>
                            <ENT>187,000</ENT>
                            <ENT>479,000</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             Injury numbers are rounded because GES numbers are estimates. Source: NHTSA GES &amp; FARS.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="4" OPTS="L2,p7,7/8,i1" CDEF="s50,12C,12C,12C">
                        <TTITLE>Table 21—Probabilities for Fatal/Serious Injury and Euro NCAP Pedestrian Score</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Euro NCAP pedestrian score</CHED>
                            <CHED H="2">5 Points</CHED>
                            <CHED H="2">22 Points</CHED>
                            <CHED H="2">
                                Reduction
                                <LI>(percent)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Fatal Injury probability (percent)</ENT>
                            <ENT>0.58</ENT>
                            <ENT>0.37</ENT>
                            <ENT>36</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="34400"/>
                            <ENT I="01">Serious Injury Probability (percent)</ENT>
                            <ENT>27.4</ENT>
                            <ENT>22.9</ENT>
                            <ENT>16</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Source:</E>
                             Pastor, C. Correlation between pedestrian injury severity in real-life crashes and Euro NCAP pedestrian test results, In: Proceedings of the 23rd Technical Conference on the Enhanced Safety of Vehicles (ESV). Seoul, 2013.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="8" OPTS="L2,i1" CDEF="s100,10,10,10,10,10,10,10">
                        <TTITLE>Table 22—FlexPLI Impact Data for U.S. Market Vehicles</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">
                                Tibia bending moment
                                <LI>(IARV = 340 Nm)</LI>
                            </CHED>
                            <CHED H="2">
                                Value
                                <LI>(Nm)</LI>
                            </CHED>
                            <CHED H="2">
                                % of
                                <LI>IARV</LI>
                            </CHED>
                            <CHED H="1">
                                MCL elongation
                                <LI>(IARV = 22 mm)</LI>
                            </CHED>
                            <CHED H="2">
                                Value
                                <LI>(mm)</LI>
                            </CHED>
                            <CHED H="2">% of IARV</CHED>
                            <CHED H="1">
                                ACL elongation
                                <LI>(IARV = 13 mm</LI>
                                <LI>(GTR) 10 mm (EuroNCAP))</LI>
                            </CHED>
                            <CHED H="2">
                                Value
                                <LI>(mm)</LI>
                            </CHED>
                            <CHED H="2">
                                % of IARV
                                <LI>(GTR)</LI>
                            </CHED>
                            <CHED H="2">
                                % of IARV
                                <LI>(EuroNCAP) *</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">2013 Ford Fusion (Center)</ENT>
                            <ENT>250</ENT>
                            <ENT>74</ENT>
                            <ENT>18</ENT>
                            <ENT>82</ENT>
                            <ENT>7.2</ENT>
                            <ENT>55</ENT>
                            <ENT>72</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2013 Ford Fusion (Outboard 1)</ENT>
                            <ENT>177</ENT>
                            <ENT>52</ENT>
                            <ENT>14.6</ENT>
                            <ENT>66</ENT>
                            <ENT>6.7</ENT>
                            <ENT>52</ENT>
                            <ENT>67</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2013 Ford Fusion (Outboard 2)</ENT>
                            <ENT>184</ENT>
                            <ENT>54</ENT>
                            <ENT>15.1</ENT>
                            <ENT>69</ENT>
                            <ENT>7.4</ENT>
                            <ENT>57</ENT>
                            <ENT>74</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2011 Chevrolet Cruze (Modified)</ENT>
                            <ENT>335</ENT>
                            <ENT>99</ENT>
                            <ENT>14.9</ENT>
                            <ENT>68</ENT>
                            <ENT>8.1</ENT>
                            <ENT>62</ENT>
                            <ENT>81</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2006 Volkswagen Passat (Modified)</ENT>
                            <ENT>354</ENT>
                            <ENT>104</ENT>
                            <ENT>21.3</ENT>
                            <ENT>97</ENT>
                            <ENT>13.1</ENT>
                            <ENT>101</ENT>
                            <ENT>131</ENT>
                        </ROW>
                        <TNOTE>
                            * 
                            <E T="02">Note:</E>
                             A comparison to Euro NCAP injury values was not done as part of the original study. It's included here for reference. Source: NHTSA Research.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s100,12,12,12,12,r50">
                        <TTITLE>Table 23—Part 581 Test Results for U.S. Market Vehicles</TTITLE>
                        <BOXHD>
                            <CHED H="1">Vehicle</CHED>
                            <CHED H="1">
                                Longitudinal impact
                                <LI>(2.5 mph)</LI>
                            </CHED>
                            <CHED H="2">
                                Upper (B) + lower
                                <LI>(A) plane force (N)</LI>
                            </CHED>
                            <CHED H="2">Mid-plane force (N)</CHED>
                            <CHED H="1">
                                Corner impact
                                <LI>(1.5 mph)</LI>
                            </CHED>
                            <CHED H="2">
                                Upper (B) + lower
                                <LI>(A) plane force (N)</LI>
                            </CHED>
                            <CHED H="2">Mid-plane force (N)</CHED>
                            <CHED H="1">Non-bumper damage?</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">2013 Ford Fusion</ENT>
                            <ENT>704</ENT>
                            <ENT>17783</ENT>
                            <ENT>1043</ENT>
                            <ENT>24791</ENT>
                            <ENT O="xl">No.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2011 Chevrolet Cruze (Modified)</ENT>
                            <ENT>1861</ENT>
                            <ENT>24485</ENT>
                            <ENT>1527</ENT>
                            <ENT>24452</ENT>
                            <ENT O="xl">No.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2006 Volkswagen Passat (Modified)</ENT>
                            <ENT>1576</ENT>
                            <ENT>30048</ENT>
                            <ENT>770</ENT>
                            <ENT>15675</ENT>
                            <ENT O="xl">No.</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Source:</E>
                             NHTSA Research.
                        </TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,12">
                        <TTITLE>Table 24—Potential Effects of Test Procedures Associated With Each Pedestrian Impactor</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">
                                MAIS 2+
                                <LI>(%)</LI>
                            </CHED>
                            <CHED H="1">
                                MAIS 3+
                                <LI>(%)</LI>
                            </CHED>
                            <CHED H="1">
                                MAIS 4+
                                <LI>(%)</LI>
                            </CHED>
                            <CHED H="1">
                                Fatal cases
                                <LI>(%)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Pedestrians Potentially Affected by Each Type of Test Procedure</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Headform Test</ENT>
                            <ENT>26.3</ENT>
                            <ENT>22.2</ENT>
                            <ENT>34.0</ENT>
                            <ENT>35.6</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TRL Upper Legform Test</ENT>
                            <ENT>12.5</ENT>
                            <ENT>14.4</ENT>
                            <ENT>1.7</ENT>
                            <ENT>5.2</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">FlexPLI Test</ENT>
                            <ENT>31.0</ENT>
                            <ENT>22.0</ENT>
                            <ENT>0.4</ENT>
                            <ENT>1.8</ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Sum of Total Potential Effects for Component-Level Pedestrian Test Procedures</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00" RUL="s">
                            <ENT I="01">Sum of Total Potential Effects From 3 Tests</ENT>
                            <ENT>69.9</ENT>
                            <ENT>58.6</ENT>
                            <ENT>36.1</ENT>
                            <ENT>42.6</ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Proportion of Total Effects by Test Procedure</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Headform Test</ENT>
                            <ENT>37.7</ENT>
                            <ENT>37.8</ENT>
                            <ENT>94.1</ENT>
                            <ENT>83.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">TRL Upper Legform Test</ENT>
                            <ENT>17.9</ENT>
                            <ENT>24.6</ENT>
                            <ENT>4.8</ENT>
                            <ENT>12.2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">FlexPLI Test</ENT>
                            <ENT>44.4</ENT>
                            <ENT>37.6</ENT>
                            <ENT>1.0</ENT>
                            <ENT>4.3</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Source:</E>
                             Mallory, A., Yarnell, B., Kender, A., &amp; Stammen, J. (2019, May). Relative frequency of U.S. pedestrian injuries associated with risk measured in component-level pedestrian tests (Re-port No. DOT HS 812 658). Washington, DC: National Highway Traffic Safety Administration.
                        </TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD2">B. Vehicle Scoring and Verification Testing Example</HD>
                    <P>
                        In the hypothetical example of a verification test presented below, the vehicle is assumed to have met NHTSA's minimum requirements for pedestrian protection credit and verification testing. In other words, the manufacturer reported to NHTSA that its vehicle met the minimum requirements (
                        <E T="03">i.e.,</E>
                         at least 60 percent or 21.600 out of 36.000 points); the manufacturer provided predicted and/or actual test data in a standardized format; NHTSA reviewed this data for accuracy and completeness; and NHTSA selected this vehicle for verification testing.
                    </P>
                    <P>
                        Figure 17 and Table 25 are examples of the format of head impact data a manufacturer would provide to NHTSA in order to receive credit for meeting 
                        <PRTPAGE P="34401"/>
                        NHTSA's pedestrian protection criteria under NCAP. This figure shows the grid points along the various WAD lines eligible for testing based on vehicle geometry and the manufacturer's predicted color band for each location. Similar to the Euro NCAP test procedures, some points are considered “default red” and “default green” based on their location on the vehicle.
                        <SU>123</SU>
                        <FTREF/>
                         The rest of the eligible grid points are filled in with predicted HIC ranges from the manufacturer. Table 25 shows the tabulated data from Figure 17 and the manufacturer's predicted score (81.000 out of a possible 142.000) for the head. Figure 17 also denotes with an “X” which grid points were chosen for verification testing by NHTSA.
                    </P>
                    <FTNT>
                        <P>
                            <SU>123</SU>
                             Euro NCAP stipulates that test points located on the A-pillars are default red, and test points located in the central portion of the windshield glazing away from edges or underlying components are default green.
                        </P>
                    </FTNT>
                    <BILCOD>BILLING CODE 4910-59-P</BILCOD>
                    <GPH SPAN="3" DEEP="335">
                        <GID>EN26MY23.022</GID>
                    </GPH>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,12,12,12,12,12">
                        <TTITLE>Table 25—Example of Scoring of Manufacturer's Predicted Head Impact Data</TTITLE>
                        <BOXHD>
                            <CHED H="1">Manufacturer prediction</CHED>
                            <CHED H="1">HIC min.</CHED>
                            <CHED H="1">HIC max.</CHED>
                            <CHED H="1">Point value</CHED>
                            <CHED H="1">Number points</CHED>
                            <CHED H="1">Predicted score</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Default green</ENT>
                            <ENT>n/a</ENT>
                            <ENT>n/a</ENT>
                            <ENT>1.000</ENT>
                            <ENT>18</ENT>
                            <ENT>18.000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Green</ENT>
                            <ENT/>
                            <ENT>&lt;650</ENT>
                            <ENT>1.000</ENT>
                            <ENT>13</ENT>
                            <ENT>13.000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Yellow</ENT>
                            <ENT>650</ENT>
                            <ENT>&lt;1,000</ENT>
                            <ENT>0.750</ENT>
                            <ENT>51</ENT>
                            <ENT>38.250</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Orange</ENT>
                            <ENT>1,000</ENT>
                            <ENT>&lt;1,350</ENT>
                            <ENT>0.500</ENT>
                            <ENT>19</ENT>
                            <ENT>9.500</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Brown</ENT>
                            <ENT>1,350</ENT>
                            <ENT>&lt;1,700</ENT>
                            <ENT>0.250</ENT>
                            <ENT>9</ENT>
                            <ENT>2.250</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Red</ENT>
                            <ENT>1,700</ENT>
                            <ENT/>
                            <ENT>0.000</ENT>
                            <ENT>22</ENT>
                            <ENT>0.000</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Default Red</ENT>
                            <ENT>n/a</ENT>
                            <ENT>n/a</ENT>
                            <ENT>0.000</ENT>
                            <ENT>10</ENT>
                            <ENT>0.000</ENT>
                        </ROW>
                        <ROW EXPSTB="03" RUL="s">
                            <ENT I="01">Sum of all points excluding default points to be used for correction factor</ENT>
                            <ENT>114</ENT>
                            <ENT>63.000</ENT>
                        </ROW>
                        <ROW EXPSTB="03">
                            <ENT I="01">Predicted headform score</ENT>
                            <ENT>142</ENT>
                            <ENT>81.000</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        Table 26 includes both the manufacturer's predicted scores for each grid point undergoing testing as well as the actual verification test result in the form of the HIC and resulting scoring band. In this example, 7 of the 10 test points resulted in the same scoring band as the prediction, 2 test points resulted in a lower scoring band than the prediction, and 1 test point resulted in a higher scoring band than the prediction. One test location of particular interest in this example is test location (4,−3). The resulting HIC at this test location was 1,046.87, outside 
                        <PRTPAGE P="34402"/>
                        the boundaries for the predicted yellow color band, but still within the acceptable HIC range for verification testing as described in Table 15. The manufacturer predicted that the 10 test points under consideration would contribute a score of 5.250—as shown in Table 26. However, verification testing determined that these 10 test points scored 4.500 instead of 5.250. Thus, based on Equation 5, to determine a correction factor value (also shown below Table 26), the difference between the manufacturer's predicted values and those tested resulted in a correction factor of 0.857 (three significant digits).
                    </P>
                    <GPH SPAN="3" DEEP="291">
                        <GID>EN26MY23.023</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4910-59-C</BILCOD>
                    <P>
                        Table 27 calculates the resulting Final Pedestrian Headform Score for this hypothetical vehicle. The correction factor determined above is applied to all grid points that are not default green grid points. Thus, instead of those points contributing a predicted score of 63.000 points, they only contribute a score of 53.991 points. The 18 default green points still contribute a score of 18.000 (shown in Table 25 and Table 27), giving the vehicle a score of 71.991, or, when reduced for the 
                        <FR>3/8</FR>
                        , 
                        <FR>3/8</FR>
                        , 
                        <FR>2/8</FR>
                         scoring allocation, a score of 6.844 out of 13.500 points.
                    </P>
                    <GPOTABLE COLS="4" OPTS="L2,p1,8/9,i1" CDEF="s50,r75,r75,12">
                        <TTITLE>Table 27—Example of Headform Score With Correction Factor Applied</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW RUL="n,s">
                            <ENT I="01">114</ENT>
                            <ENT>Predicted (excluding Default Green)</ENT>
                            <ENT A="01">63.000 × 0.857 = 53.991</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">10</ENT>
                            <ENT A="L01">Default Red</ENT>
                            <ENT>0.000</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">18</ENT>
                            <ENT A="L01">Default Green</ENT>
                            <ENT>18.000</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">142</ENT>
                            <ENT>Total Grid Points</ENT>
                            <ENT>Vehicle Score</ENT>
                            <ENT>71.991</ENT>
                        </ROW>
                        <ROW EXPSTB="02" RUL="s">
                            <ENT I="01">
                                Maximum Pedestrian Headform Score (As shown in Table 9 or 
                                <FR>3/8</FR>
                                 allocation of 36 points)
                            </ENT>
                            <ENT>13.500</ENT>
                        </ROW>
                        <ROW EXPSTB="01">
                            <ENT I="01">Final Pedestrian Headform Score</ENT>
                            <ENT A="L01">71.991/142 * 13.500 = 6.844</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>For the upper legform score, Table 29 below shows the upper legform verification testing results of the hypothetical vehicle. Due to vehicle geometry, a total of 13 points were eligible for testing, and it was decided that testing would be at test location U 0. Additional tests were conducted at locations U +2, U −4, and U −6. Utilizing symmetry and adjacency, all 13 test locations received scores.</P>
                    <P>
                        Test locations were scored according to Table 11, and the scores are illustrated below as Table 28 for reference. Test location U 0 received a score of 0.000 because all the bending moments and the sum of forces exceeded the maximum injury limits. Test location U +2 also received a score of 0.000. Although some of the bending moments (upper and lower) were below the maximum injury limit, the upper legform test utilizes the worst performing injury metric for the test location's score. Both the center bending moment and the sum of forces exceeded the maximum injury limit, thus this test location received a score of 0.000. Had test location U +2 been scored based on 
                        <PRTPAGE P="34403"/>
                        the upper bending moment, it would have received a score of 0.475; and similarly, had it been scored based on the lower bending moment, it would have received as core of 0.356. Injury values above the minimum injury but below the maximum injury are scored on a sliding scale between 0.000 and 1.000 points for the upper legform. On the other hand, test locations U −4 and U −6 each received scores of 1.000 because all injury criteria were below the minimum injury limit.
                    </P>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,12,12">
                        <TTITLE>Table 28—Upper Legform Scoring</TTITLE>
                        <BOXHD>
                            <CHED H="1">Component</CHED>
                            <CHED H="1">Min. injury</CHED>
                            <CHED H="1">Max. injury</CHED>
                            <CHED H="1">Max. point value</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Bending Moment (Nm)</ENT>
                            <ENT>285</ENT>
                            <ENT>350</ENT>
                            <ENT>1.00</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Sum of forces (N)</ENT>
                            <ENT>5,000</ENT>
                            <ENT>6,000</ENT>
                            <ENT/>
                        </ROW>
                    </GPOTABLE>
                    <P>Using symmetry, test location U -2 receives a score of 0.000 because that is what test location U +2 received. Test locations U +4 and U +6 receive scores of 1.000 because of tests conducted at U −4 and U −6. Using adjacency, test locations U +1, U −1, U +3, and U −3 all receive scores of 0.000 because they are adjacent to a test location that received a score of 0.000. Likewise, test locations U +5 and U −5 each receive a score of 1.000, being adjacent to two locations each scoring 1.000. In some cases, a manufacturer may provide data explaining why their vehicle should not be subject to symmetry or adjacency.</P>
                    <P>
                        Table 30 shows the scoring for the hypothetical upper legform test. Overall, the vehicle received a score of 6.000 out of a possible 13.000 for the upper legform test. When scored against the 
                        <FR>2/8</FR>
                         points allocation (out of 36 points), the upper legform can receive a maximum score of 9.000 points. This testing results in a final upper legform score of 4.154 out of 9.000 points.
                    </P>
                    <BILCOD>BILLING CODE 4910-59-P</BILCOD>
                    <GPH SPAN="3" DEEP="522">
                        <PRTPAGE P="34404"/>
                        <GID>EN26MY23.024</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="34405"/>
                        <GID>EN26MY23.025</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4910-59-C</BILCOD>
                    <PRTPAGE P="34406"/>
                    <P>Finally, Table 32 below shows the lower legform FlexPLI verification testing results of the hypothetical vehicle. Like the upper legform WAD775 tests, this vehicle's geometry requires 13 locations to be tested for the bumper testing. In this test series, testing began at location L +1 and additional tests were carried out at locations L -3 and L -5.</P>
                    <P>Test locations were scored according to Table 12 as illustrated below in Table 31 for reference. Testing conducted at location L +1 yielded a score of 0.932 (0.500 + 0.432). The tibia bending moments were all below the minimum injury limit, awarding full points for that component. The MCL elongation fell in between the minimum injury limit and maximum injury limit, awarding partial points. For FlexPLI injury values above the minimum injury threshold and below the maximum injury threshold, points are awarded between 0.000 and 0.500 on a linear sliding scale. Neither the ACL nor PCL exceeded the limit. Thus, this test location received a score of 0.932. Tests conducted at locations L−3 and L -5 yielded full points as none of the values exceeded the minimum injury limits, nor were the ACL nor PCL limits exceeded.</P>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,12,12">
                        <TTITLE>Table 31—FlexPLI Scoring</TTITLE>
                        <BOXHD>
                            <CHED H="1">Component</CHED>
                            <CHED H="1">Min. injury</CHED>
                            <CHED H="1">Max. injury</CHED>
                            <CHED H="1">Max. point value</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Tibia bending (Nm)</ENT>
                            <ENT>282</ENT>
                            <ENT>340</ENT>
                            <ENT>0.50</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">MCL elongation (mm)</ENT>
                            <ENT>19</ENT>
                            <ENT>22</ENT>
                            <ENT>0.50</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">ACL/PCL elongation (mm)</ENT>
                            <ENT/>
                            <ENT>10</ENT>
                            <ENT>0.00</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>Using the same symmetry concepts discussed above, test locations L−1, L +3, and L +5 inherited the scores from the opposite side. Using adjacency, test locations U 0, U +2, and U−2 each inherited a score of 0.932 because that was the lowest score of the two adjacent test locations. Test locations L +4, L−4, L +6 and L−6 each inherited a perfect score of 1.000 because both adjacent test locations had scores of 1.000.</P>
                    <P>
                        The resulting lower legform score for this vehicle is shown below in Table 33 and was 12.660 out of a maximum 13.000, or 13.147 out of a maximum 13.500 when using the 
                        <FR>3/8</FR>
                        , 
                        <FR>3/8</FR>
                        , 
                        <FR>2/8</FR>
                         scoring allocation.
                    </P>
                    <BILCOD>BILLING CODE 4910-59-P</BILCOD>
                    <GPH SPAN="3" DEEP="528">
                        <PRTPAGE P="34407"/>
                        <GID>EN26MY23.026</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="34408"/>
                        <GID>EN26MY23.027</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4910-59-C</BILCOD>
                    <PRTPAGE P="34409"/>
                    <P>
                        In Table 34 below, the scores from the 3 component tests are summed together and compared to the maximum available score. In this scenario, the hypothetical vehicle had reduced component level scores in each of the three categories, but still maintained a total score above 21.6 (60 percent). Therefore, this vehicle would continue to receive pedestrian protection credit on 
                        <E T="03">http://www.NHTSA.gov.</E>
                    </P>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,12,12">
                        <TTITLE>Table 34—Example of Overall Pedestrian Protection Score</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Actual score</CHED>
                            <CHED H="1">Maximum score</CHED>
                            <CHED H="1">Percentage</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Headform Test</ENT>
                            <ENT>6.844</ENT>
                            <ENT>13.500</ENT>
                            <ENT>50.7</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Upper Legform Test</ENT>
                            <ENT>4.154</ENT>
                            <ENT>9.000</ENT>
                            <ENT>46.2</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Lower Legform Test</ENT>
                            <ENT>13.147</ENT>
                            <ENT>13.500</ENT>
                            <ENT>97.4</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="03">Total</ENT>
                            <ENT>24.145</ENT>
                            <ENT>36.000</ENT>
                            <ENT>67.1</ENT>
                        </ROW>
                        <ROW EXPSTB="02">
                            <ENT I="05">Received Pedestrian Protection Credit?</ENT>
                            <ENT>Yes.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD2">C. Questions Asked Throughout This Notice</HD>
                    <P>[1] NHTSA seeks comment on the topic of female leg safety. Are there data showing that vehicle front end designs that perform well in the FlexPLI and upper legform impact tests would not afford protection to female pedestrians? Are there any legforms representing female or small stature pedestrians? Are there female specific data and associated 5th percentile female specific injury criteria for use with a 5th percentile female legform impactor?</P>
                    <P>[2] NHTSA seeks comment on what an acceptable humidity tolerance should be for the qualification tests of the upper legform impactor and the associated vehicle test with the upper legform.</P>
                    <P>[3] NHTSA is requesting comment on the FlexPLI qualification procedures—specifically which procedures (dynamic and quasi-static) should be used for qualification, and how often they should be conducted?</P>
                    <P>
                        [4] An Agency study of Abbreviated Injury Scale (AIS) 3+ pedestrian injuries in the U.S. showed that the apportionment of points in NCAP for crashworthiness pedestrian protection should be 
                        <FR>3/8</FR>
                        th for head impact test results (37.5 percent), 
                        <FR>3/8</FR>
                        th for lower leg impact test results (37.5 percent), and 
                        <FR>2/8</FR>
                        th for upper leg impact test (25 percent). NHTSA seeks comment on whether injury severity or frequency would be this the most appropriate basis for point allocation apportionment.
                    </P>
                    <P>[5] As concluded in the Agency's FlexPLI research report, NHTSA believes the FlexPLI legform is biofidelic and seeks comment from the public on whether biofidelity concerns with the FlexPLI still remain at this time.</P>
                    <P>[6] NHTSA is seeking comment on what procedure it should use for marking the test zone on bumpers. In other words, should the procedure harmonize with the Euro NCAP 60-degree angle method or should it follow the GTR 9 and UNECE R127 corner gauge method?</P>
                    <P>[7] GM suggested that if a vehicle has an exposed bumper, the bumper test zone should use the 60-degree angle method instead of testing the full bumper width to eliminate testing at the extreme edge of what may be a curved bumper. NHTSA requests comment on this concern as well, as it is similar to the previous question for bumper test zones.</P>
                    <P>[8] Given the pedestrian death and injury crisis on U.S. roadways NHTSA is seeking comment on test speeds. Should test speeds for either of the head or leg tests be increased in an attempt to provide better protection to pedestrians in vehicle to pedestrian crashes? Should the area of assessment be increased beyond the WAD 2100 mm currently proposed to account for pedestrian heads overshooting the hood and impacting the windshield or the roof of the vehicle? </P>
                    <P>[9] NHTSA requests comment on the seven Euro NCAP documents proposed in section IV. F. (Euro NCAP Pedestrian Testing Protocol Version 8.5, Euro NCAP Assessment Protocol—Vulnerable Road User Protection Part 1—Pedestrian Impact Assessment Version 10.0.3, Euro NCAP Pedestrian Headform Point Selection V2.1, Euro NCAP Film and Photo Protocol Chapter 8—Pedestrian Subsystem Tests V1.3, Euro NCAP Technical Bulletin TB 008 Windscreen Replacement for Pedestrian Testing Version 1.0, Euro NCAP Technical Bulletin TB 019 Headform to Bonnet Leading Edge Tests Version 1.0, and Euro NCAP Technical Bulletin TB 024 Pedestrian Human Model Certification V2.0)—do any elements of these documents need modification for the U.S. NCAP?</P>
                    <P>[10] NHTSA requests comment on TB 024 and its relevance to the U.S. NCAP. Should the models and methods in TB 024 or some other method be used to calculate head impact times to evaluate vehicles with active hoods?</P>
                    <P>[11] NHTSA seeks comment on what level of detail should be required for self-reported data. Should manufacturers be allowed to submit predicted head and leg response data, or only actual physical test results? Should reporting consist of just the results for each test location, or should full data traces or a comprehensive test report including photographs and videos be required?</P>
                    <P>[12] NHTSA requests comment on whether vehicles with an LBRL greater than 500 mm should be eligible to receive crashworthiness pedestrian protection credit because they will automatically receive a zero score for the FlexPLI bumper tests.</P>
                    <P>[13] NHTSA requests comment on the proposal to reposition the upper legform ±50 mm from the WAD775 target when artificial interference is present or to conduct multiple impacts within ±50 mm from the WAD775 target and use the worst-case result when artificial interference is present.</P>
                    <P>[14] NHTSA tentatively plans to use the corner gauge and bumper beam width procedure for corner definition for this NCAP proposal and requests comment on this change.</P>
                    <P>[15] NHTSA seeks comments on whether there is benefit in requiring both the Pendulum and Inverse Impact dynamic qualification tests in addition to the quasi-static tests. Also, what should the qualification test schedule be for the FlexPLI be?</P>
                    <P>[16] NHTSA seeks comment on what the required detection area should be for vehicles with active hoods. Additionally, which device should be used for assuring the system activates properly, the Flex-PLI or the PDI2?</P>
                    <P>
                        [17] NHTSA proposes utilizing a modified 
                        <FR>3/8</FR>
                        , 
                        <FR>3/8</FR>
                        , 
                        <FR>2/8</FR>
                         scoring apportionment for the head impacts, Flex PLI impacts, and upper leg impacts 
                        <PRTPAGE P="34410"/>
                        respectively for NCAP and requests comment on this proposal.
                    </P>
                    <P>
                        [18] NHTSA seeks comment on whether [a checkmark on 
                        <E T="03">NHTSA.gov</E>
                        ] is an appropriate way to identify vehicles that meet the Agency's minimum criteria for crashworthiness pedestrian protection, or if some other notation or identifying means is more appropriate.
                    </P>
                    <P>[19] NHTSA seeks comment on what options or features might exist within the same vehicle model that would affect the vehicle's performance of crashworthiness pedestrian protection. NHTSA also seeks comment on whether the Agency should assign credit to vehicles based on the worst-performing configuration for a specific vehicle model, or if vehicle models with optional equipment that affect the crashworthiness pedestrian protection credit should be noted as such.</P>
                    <P>[20] NHTSA seeks comment on the proposal to conduct verification testing as part of the crashworthiness pedestrian protection program by adjusting the head score using a conversion factor determined from laboratory tests and replacing manufacturer supplied FlexPLI and upper leg scores with NHTSA scores from laboratory tests.</P>
                    <SIG>
                        <P>Issued in Washington, DC, under authority delegated in 49 CFR 1.95 and 501.5.</P>
                        <NAME>Sophie Shulman,</NAME>
                        <TITLE>Deputy Administrator.</TITLE>
                    </SIG>
                </SUPLINF>
                <FRDOC>[FR Doc. 2023-11201 Filed 5-25-23; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 4910-59-P</BILCOD>
            </NOTICE>
        </NOTICES>
    </NEWPART>
</FEDREG>
